[Senate Hearing 107-452]
[From the U.S. Government Publishing Office]
S. Hrg. 107-452
BIOTERRORISM, 2001
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HEARINGS
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARINGS
OCTOBER 3, 2001--WASHINGTON, DC
OCTOBER 28, 2001--WASHINGTON, DC
NOVEMBER 2, 2001--WASHINGTON, DC
NOVEMBER 29, 2001--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
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senate
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Deputy Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DeWINE, Ohio
Professional Staff
Ellen Murray
Jim Sourwine
Mark Laisch
Adrienne Hallett
Erik Fatemi
Adam Gluck
Bettilou Taylor (Minority)
Mary Dietrich (Minority)
Sudip Shrikant Parikh (Minority)
Administrative Support
Carole Geagley
Emma Ashburn (Minority)
C O N T E N T S
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Wednesday, October 3, 2001
Page
Opening statement of Senator Tom Harkin.......................... 1
Prepared statement of the American Pharmaceutical Association.... 3
Prepared statement of the American Society of Clinical
Pathologists................................................... 5
Prepared statement of the Commissioned Officers Association of
the U.S. Public Health Service................................. 6
Prepared statement of the Association of State and Territorial
Health Officials...............................................
Opening statement of Senator Arlen Specter....................... 13
Opening statement of Senator Robert C. Byrd...................... 14
Statement of Hon. Edward M. Kennedy, U.S. Senator from
Massachusetts.................................................. 16
Prepared statement........................................... 19
Statement of Hon. Bill Frist, U.S. Senator from Tennessee........ 20
Prepared statement........................................... 23
Statement of Hon. Chuck Hagel, U.S. Senator from Nebraska........ 28
Statement of Hon. John R. Edwards, U.S. Senator from North
Carolina....................................................... 29
Statement of Hon. Tommy G. Thompson, Secretary, Department of
Health and Human Services...................................... 32
Prepared statement........................................... 36
Opening statement of Senator Mike DeWine......................... 46
Opening statement of Senator Richard J. Durbin................... 46
Opening statement of Senator Judd Gregg.......................... 48
Opening statement of Senator Herb Kohl........................... 49
Statement of Jonathan Tucker, Ph.D., director, Chemical &
Biological Weapons Nonproliferation Program, Monterey Institute
of International
Studies........................................................ 52
Prepared statement........................................... 55
Statement of Stephen Cantrill, M.D., associate director,
Department of Emergency Medicine, Denver Health Medical Center. 62
Prepared statement........................................... 64
Statement of Jerome M. Hauer, managing director, Crisis and
Consequences Management, Kroll Associates...................... 66
Statement of Patricia Quinlisk, M.D., M.P.H., medical director
and State epidemiologist, Iowa Department of Health............ 68
Prepared statement........................................... 71
Statement of Rex Archer, M.D., M.P.H., director, Kansas City
Health Department.............................................. 79
Prepared statement........................................... 81
Tuesday, October 23, 2001
Opening statement of Senator Tom Harkin.......................... 93
Opening statement of Senator Arlen Specter....................... 95
Statement of Jeffrey P. Koplan, M.D., M.P.H., Director, Centers
for Disease Control and Prevention, Department of Health and
Human Services................................................. 98
Prepared statement........................................... 104
Statement of James T. Caruso, Deputy Assistant Director,
Counterterrorism Division, Federal Bureau of Investigation,
Department of Justice.......................................... 109
Statement of Bob Kramer, president and chief operating officer,
Bioport Corporation............................................ 123
Prepared statement........................................... 125
Statement of Mary Kuhn, vice president of operations, Bayer
Corporation.................................................... 129
Prepared statement........................................... 131
Statement of Barbara Hunt, R.N., M.P.A., district health officer,
Washoe County Health Department, Reno, Nevada.................. 133
Prepared statement........................................... 135
Statement of Hilary Koprowski, M.D., president, Biotechnology
Foundation, Inc., Philadelphia, PA, professor, Department of
Microbiology and Immunology, director, Center of Neurovirology
and Biotechnology Foundation Laboratories at Thomas Jefferson
University..................................................... 136
Prepared statement........................................... 137
Statement of Thomas P. Monath, M.D., vice president for Research
and Medical Affairs, Acambia, Inc.............................. 138
Prepared statement........................................... 140
Statement of Mary J.R. Gilchrist, Ph.D., director, University of
Iowa Hygienic Laboratory....................................... 141
Prepared statement........................................... 143
Friday, November 2, 2001
Opening statement of Senator Tom Harkin.......................... 155
Opening statement of Senator Arlen Specter....................... 156
Opening statement of Senator Robert C. Byrd...................... 157
Opening statement of Senator Ted Stevens......................... 160
Statement of Anthony S. Fauci, M.D., Director, National Institute
of Allergy and Infectious Diseases, National Institutes of
Health, Department of Health and Human Services................ 160
Prepared statement........................................... 162
Statement of James W. LeDuc, Ph.D., Acting Director, Division of
Viral and Rickettsial Diseases, National Center for Infectious
Diseases, Centers for Disease Control and Prevention,
Department of Health and Human Services........................ 164
Prepared statement........................................... 165
Statement of Michael Friedman, M.D., chief medical officer for
biomedical preparedness, Pharmaceutical Research and
Manufacturers of America....................................... 171
Prepared statement........................................... 172
Statement of M. Anita Barry, M.D., M.P.H., director, Communicable
Disease Control, Boston Public Health Commission, and member,
National Association of County and City Health Officials....... 177
Prepared statement........................................... 179
Thursday, November 29, 2001
Opening statement of Senator Tom Harkin.......................... 201
Opening statement of Senator Arlen Specter....................... 202
Opening statement of Senator Ted Stevens......................... 204
Statement of Jeffrey P. Koplan, M.D., M.P.H., Director, Centers
for Disease Control and Prevention, Department of Health and
Human Services................................................. 205
Prepared statement........................................... 207
Statement of Anthony S. Fauci, M.D., Director, National Institute
of Allergy and Infectious Diseases, National Institutes of
Health......................................................... 210
Prepared statement........................................... 211
Opening statement of Senator Herb Kohl........................... 218
Opening statement of Senator Mary L. Landrieu.................... 224
Prepared statement........................................... 226
Statement of Ken Alibek, M.D., president, Advanced Biosystems,
Inc............................................................ 229
Prepared statement........................................... 231
Statement of Joseph Barbera, M.D., associate professor and co-
director, Institute for Crisis, Disaster, and Risk Management,
the George Washington University............................... 233
Prepared statement........................................... 235
Statement of Joseph LeValley, senior vice president for planning
and systems development, Mercy Medical Center of Des Moines,
Des Moines, Iowa............................................... 237
Prepared statement........................................... 239
BIOTERRORISM
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WEDNESDAY, OCTOBER 3, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:35 a.m., in room 216, Hart
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Byrd, Kohl, Murray, Durbin,
Landrieu, Specter, Gregg, and DeWine.
Opening statement of Senator Tom Harkin
Senator Harkin. Good morning. The hearing of the
Appropriations Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies, will come to
order.
History will note that on September 11, 2001, our freedom
was attacked. These attacks have made us realize that a free
America must be a vigilant America. Vigilance requires that we
prepare to meet the likely threats posed by our enemies. While
I do not want to overstate its likelihood, or incite
unnecessary panic, we must take a hard look at the threat posed
by biological weapons and our Nation's preparedness to meet
that threat.
This is not science fiction fantasy. Iraq had a biological
weapons program, although we have no evidence that it was
successful. They had already shown a willingness to use
chemical weapons on combat against their own citizens. I
believe we are not far from the day when a nation or
organization will possess both biological weapons and chemical
weapons and the will to use them, so the time for us to prepare
is now.
Preparedness requires an investment in our public health
infrastructure on the local, State, and Federal level. They
must have the resources and expertise needed to respond to an
array of terrorist actions. It is no longer a matter of public
health, it is a matter of national defense.
Imagine how we would meet a biological attack, given our
Nation's current state of readiness. On May 20, a western
State's department of public health begins receiving reports
that increasing numbers of people are seeking medical attention
at a city's area hospital for coughing and fever during the
previous evening. By early afternoon on May 20, 500 persons
with these symptoms have received medical care, and 25 have
died.
The State declares a public health emergency. Hospitals and
clinics around the area who just days before were dealing with
what appeared to be just an unusual case of influenza are
recalling staffs, but hospital staffs are beginning to call in
sick. More and more people and resources are scarce. The
State's Governor then restricts travel, including bus, rail,
and air travel into and out of the affected area. All
antibiotics that can be used to prevent or treat the plague are
commandeered. Citizens are told to seek treatment at a medical
facility if they're feeling ill. By the end of that day, 783
cases of pneumonic plague have occurred, and 123 people have
died.
On day 2, May 21, a cable news network reports that a
national crash effort is underway to move large quantities of
antibiotics to the region. A push pack of needed medical
supplies from the National Pharmaceutical Stockpile arrives in
the city, but there are great difficulties moving antibiotics
from the stockpile delivery point to the persons who need it
for treatment. Out-of-State cases now begin to be reported. The
CDC notifies bordering States of the epidemic.
On day 3, May 22, hospitals cannot manage the influx of
sick patients. By noon, there are 3,060 United States and
international cases of the plague and 795 have died.
On the day 4, May 23, there are conflicting reports of the
number of sick and dead. Some reports show an estimated 3,700
cases of pneumonic plague, with 950 deaths. Others are
reporting over 4,000 cases, and more than 2,000 deaths.
The good news from this? This was an exercise, just an
exercise. In this scenario, an aerosol of plague, (Y. pestis)
bacilli was released at the Denver Performing Arts Center, and
we can see the results of this. Clearly, we are not
sufficiently prepared, but we have made some progress.
Several years ago, this subcommittee, under the leadership
of Senator Specter from Pennsylvania, began to put more and
more effort into protecting us from bioterrorism. Over the past
2 years, we have appropriated $545 million to the Center for
Disease Control for this purpose. That investment has improved
the detection, treatment, and containment of a potential
bioterrorist attack by strengthening the Federal, State, and
local partnerships that are the first and even second lines of
defense. In addition, two of our distinguished witnesses,
Senators Kennedy and Frist, led the effort to pass the Public
Health Threats and Emergencies Act. That legislation will
further strengthen our efforts.
In the near term, we will put forward a plan on how to
allocate the $20 billion in anti-terrorism funds we approved 2
weeks ago. It is my hope that this hearing will help us focus
on how a portion of those funds can be used to combat
bioterrorism. Should the unthinkable happen, our local public
health departments will be the first line of defense. Unlike a
conventional or chemical weapons attack, a biological weapon
can be launched and can strike without even a sound.
It will be our emergency room personnel and urgent care
providers who will recognize the attack and counter it. That
requires training and effective surveillance systems that can
put pieces of information together in a meaningful plan. That
is how public health threats are tracked and contained.
For example, in New York, a doctor who had recently
attended a public health seminar on the importance of this type
of tracking and reporting had the presence of mind to report
two unusual cases of encephalitis to the public health
department. That information led to the identification of the
West Nile virus outbreak.
In the case of biological weapons, we will require trained
personnel and equipment to first detect the attack, the ability
to treat a large number of exposed individuals, and immediate
access to the necessary pharmaceuticals, whether it be
vaccines, antibiotics, or something else.
We have made some progress in meeting the threat, but how
much further do we need to go to protect Americans from a
biological attack? That is the question we must address today.
We have a very distinguished and knowledgeable panel of
witnesses, who I know will add a great deal to this hearing,
and I want to thank them for joining us. Before we begin with
our first distinguished panel, I would ask unanimous consent
that a number of statements from various experts who asked to
testify today, but who were unable to be accommodated, be
inserted into the record.
[The statements follow:]
Prepared Statement of the American Pharmaceutical Association
The American Pharmaceutical Association (APhA), the national
professional society of pharmacists, is pleased that the Committee is
addressing the important issue of bioterrorism and ways to prepare for
and provide a response to a biological or chemical terrorist attack.
APhA is the first established and largest professional association of
pharmacists in the United States. APhA's 50,000 members include
practicing pharmacists, pharmaceutical scientists, pharmacy students,
pharmacy technicians, and others interested in advancing the
profession. Pharmacy is the third largest health profession in America.
The Association is extremely proud of the role our pharmacist members
played in meeting the needs of individuals who, in the aftermath of the
terrorist attacks, were stranded away from home or working on rescue
efforts and were in need of medications or other healthcare needs.
The roots of pharmacy's involvement with public health initiatives
go back well over a century. Pharmacists have served as local,
decentralized extenders of public health departments, playing a major
role in the distribution and administration of vital vaccines,
medications, supplies and health care services.\1\ The nation's
pharmacists have demonstrated a serious commitment to preventing
disease and stand ready to serve the needs of our nation in the event
of a biological or chemical attack. Indeed, the profession recognizes
the deadly threat that an attack of this nature would pose with the
population of our nation at risk of fatal infection with little notice.
When an attack occurs, time will be short to mount a preventive program
to preserve the public's health. Pharmacists' accessibility in every
community provides an excellent opportunity to reach individuals in
need of preventive care, healthcare services, medications and supplies,
vaccines, and information. Pharmacists want to actively participate in
whatever response or preventive plan is implemented, and are available
to assist in preparedness efforts and response to bioterrorism. APhA
pledges its services and communications vehicles to help mobilize this
vital resource.
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\1\ Pharmacy in History, American Institute of the History of
Pharmacy; Vol. 41, pgs. 137-149, 1999.
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Pharmacists' contributions to such efforts can include: Monitoring
for and surveillance of signs and symptoms of a possible biological or
chemical attack. Pharmacists are a trusted source of health care
information for the public. Patients often seek the advice of
pharmacists, even before going to a physician, when they require health
information. The initial symptoms presented by several potential
biological agents that could be utilized against our citizenry resemble
those of the flu. Many patients may attempt to self medicate and will
seek a remedy from their local pharmacy shelf before going to the
physician's office or hospital. As one of the most accessible health
care professionals, pharmacists are in an excellent position to assist
in monitoring any patterns of symptoms or diseases reported by
patients. Pharmacists' involvement in this area can help to serve as an
early warning that a bioterrorism attack has occurred.
The pharmacist is an expert in medication use, both prescription
and over-the-counter. This expertise is invaluable in determining which
pharmaceuticals should be stored and which can be used as second and
third line agents if the supply of first line agents is limited.\2\
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\2\ Supplement to the Journal of the American Pharmaceutical
Association, September/October 2000.
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The resources and talents of the nation's pharmacists may be
extended beyond dispensing necessary medications and working with
patients to make those medications work. For example, pharmacists in 31
states may administer vaccines and provide general support for
immunization programs. There is substantial evidence that pharmacists
are readily accessible, trusted professionals who can motivate the
public to be vaccinated and enhance vaccine delivery. These
capabilities will be helpful in a national infectious disease
emergency. Here are some of the practical ways pharmacists could help:
Community pharmacists at more than 52,000 neighborhood pharmacies
can educate the public and, in 31 states, actually immunize them. In
many rural areas, a pharmacist is the only health professional
conveniently located to patients. The nation's community pharmacies
could serve as 52,000 bases of operation and communication for
immunization programs coordinated by state health departments.
Pharmacists in hospitals and other health systems can educate,
motivate, support, and immunize inpatients and outpatients in these
settings. As medication experts, pharmacists link the clinical,
logistic, and administrative functions of hospitals and health systems.
Consultant pharmacists can enhance immunization delivery to
residents of nursing homes and other institutions. Consultant
pharmacists review residents' drug regimens monthly and are already
integral contributors to health quality in these settings.
Pharmacists are trained to take any of three roles in support of
the national preparedness plan. These three roles are:
Motivating: Pharmacists can distribute literature, display posters,
perform one-on-one counseling, speak to local civic groups, and similar
activities. Scientific studies demonstrate that 50 percent to 94
percent of the people to whom a pharmacist recommends immunization
accept this recommendation.\3\ In the confusion and uncertainty
possible in any national immunization campaign, pharmacists can be
voices of reason and sources of factual information and advice.
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\3\ Spruill et al., 1982; Grabenstein et al., 1986; Morton et al.,
1988; Grabenstein et al., 1990.
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Hosting: In 1997, more than 5 million doses of influenza vaccine
were administered at more than 15,000 pharmacies across the country,
more than one-quarter of all pharmacies. Even in the pharmacies where
pharmacists are not yet trained to immunize, nurses or other vaccine
providers could administer vaccines or establish vaccine supply depots.
These sites are equipped to store refrigerated medications, are widely
dispersed in urban, suburban, and rural settings, near population
centers of diverse sizes. Most are open long hours and have large
parking lots that could accommodate large patient flows. Further, given
that more than 95 percent of pharmacies already have electronic
communications capabilities, pharmacies could serve as communication
centers for sending and receiving instructions and data between state
health authorities and field workers during a pandemic. In addition,
pharmacists can serve as information resources to consumers, media, and
other health care professionals.
Immunizing: Estimates are that there are currently more than 3,000
immunizing pharmacists, delivering more than 300,000 doses of vaccine
to adults during recent flu seasons. Pharmacists are authorized to
administer drugs in 31 states, corresponding to a population of over
135 million people. Additional states are considering empowering
pharmacists with this authority to advance the public health.
Pharmacists could be enlisted to administer vaccine dose(s) during
bioterrorism events, reporting to state authorities, as well as
providing areas for vaccine and medication storage and distribution.
APhA has made available to its members educational programming
focusing on bioterrorism at Association annual meetings. Additionally,
a bioterrorism resource center located on APhA's homepage
(www.aphanet.org) was developed to assist pharmacists and consumers
with education about and preparing for a bioterrorism attack.
All of these actions will be greatly facilitated by having Congress
express interest in including the nation's pharmacists in plans to
defend the nation against these threats.
Thank you for the opportunity to provide comments on this important
issue. The American Pharmaceutical Association and its members stand
ready to assist the government in any way possible to prepare for and
respond to bioterrorism.
Contact information: American Pharmaceutical Association 2215
Constitution Avenue, NW Washington, DC 20037 (202) 429-7575.
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Prepared Statement of the American Society of Clinical Pathologists
In light of the tragic events of September 11, 2001, we appreciate
you holding this hearing to address the issue of bioterrorism. We hope
the following comments will provide you with some specific suggestions
on how to improve the public health infrastructure and prepare for
potential biological and chemical attacks.
As the world's largest organization representing laboratory
personnel, the American Society of Clinical Pathologists' 75,000 board
certified pathologists, clinical scientists, certified technologists
and technicians, are the individuals most likely to first receive
patient specimens for etiologic agents that are likely to be used in
bioterrorism and toxins that may be used as chemical weapons. These
professionals must provide prompt and accurate laboratory test results
so that a potential outbreak can be detected, provide support for
hospitals and clinics caring for affected patients, and assist in the
development of an integrated epidemiologic network, especially for law
enforcement purposes.
Bioterrorist events will likely present as outbreaks of acute
febrile illnesses or as unusual infectious diseases with no readily
apparent point source. Therefore, clinicians will rely heavily upon
laboratory tests for diagnostic clues as to the etiologic agent.
Laboratory professionals must be trained to identify microbial
pathogens likely to be used for bioterrorism, to safely collect,
transport, and process specimens containing biological agents
associated with bioterrorist acts, to follow chain of custody and other
legal requirements, and to have familiarity with needs of mass disaster
support services.
Unfortunately, there is growing concern over the serious shortage
of medical laboratory personnel in our nation's health care system. In
the United States, vacancy rates for seven of ten key laboratory
medicine positions are at an all time high. Since the early 1980s, the
number of accredited educational programs for laboratory positions has
decreased significantly, and laboratory professionals who entered the
workforce in the 1960s and 1970s will be retiring soon.
To assist in reversing this shortage, we respectfully request two
amendments to the legislation offering appropriations for the Public
Health Improvement Act, Public Law 106-505. Specifically, we ask that
the legislation allow schools and programs of allied health to qualify
for grants. The ``Public Health Threats and Emergencies; Education of
Medical and Public Health Personnel'' program already allows grants to
be given to state or local public health agencies to train laboratory
personnel in the recognition or identification of resistance in
pathogens. Similarly, we ask that schools and programs be eligible for
grants in order to train medical laboratory personnel in disciplines
that recognize or identify a potential biological agent. The ``Public
Health Threats and Emergencies; Public Health Countermeasures to a
Bioterrorist Attack'' program allows states, hospitals, clinics, or
primary care facilities to qualify for grants to enhance the ability of
personnel to recognize the symptoms and epidemiological characteristics
of exposure to a potential weapon. The Centers for Disease Control and
Prevention should implement these training initiatives, and provide
grants to schools and programs that train medical laboratory personnel
and to other public or private non-profit entities. We suggest
appropriating $25 million for education training grants. The
Association of Public Health Laboratories concurs with this approach.
Also, in order to protect the health of the citizens of the United
States from bioterrorism, emerging infectious diseases, foodborne
diseases, and environmentally associated diseases, it is imperative to
establish a national system of laboratories to help detect, coordinate,
and control these threats. A national laboratory system is where public
health, hospital and independent laboratories throughout the United
States would build a collaborative infrastructure, to assure that
timely and accurate laboratory information can be shared. The Centers
for Disease Control and Prevention has determined that ``maintaining
and developing a national laboratory system that is efficient at
detecting and timely in reporting is critical to minimize the negative
impact of disease or other adverse public health events in the
community.'' A national laboratory system is intended to assure the
availability of consistent public health laboratory capacity regardless
of the location.
Development of a national laboratory system is already underway
with the establishment of four demonstration projects in Nebraska,
Minnesota, Michigan and Washington state, but much more needs to be
accomplished to weave an effective national system, and quickly. A
national laboratory system would permit partnership building among
clinical laboratories, public health laboratories, and the government.
It would assess staffing and capacity needs, provide guidance for
training in bioterrorism specimens, and create voluntary standards for
the public health infrastructure.
To carry out this function, we respectfully request $50 million for
the national laboratory system. To maintain the system, an additional
$50 million should be authorized for future years.
The American Society of Clinical Pathologists also supports funding
the Centers for Disease Control and Prevention at $500 million for
building and upgrading state and local public health capacity.
Thank you for the opportunity to comment on this critical public
health concern. If you have questions or need additional information,
please contact the American Society of Clinical Pathologists at (202)
347-4450.
______
Prepared Statement of the Commissioned Officers Association of the U.S.
Public Health Service
introduction
The Commissioned Officers Association (COA) of the U.S. Public
Health Service appreciates the interest of this Subcommittee in the
very important issue of bioterrorism. We are pleased that this
Subcommittee recognizes the vulnerability of the nation to acts of
bioterrorism by fringe groups and rogue nations, and is willing to take
a leadership role in seeing to it that the various governmental
agencies (local, state and federal) are asking the necessary questions
and taking the necessary steps to ensure the nation is prepared if the
unthinkable should occur.
COA believes the threat of bioterrorism is a serious one, and the
Federal Government must have a clear, coherent and coordinated plan to
deal with potential incidents that could impact upon the safety and
health of large numbers of Americans. COA also strongly supports the
enhancement of the Nation's public health infrastructure at all levels
of government. In our view, such an effort is necessary irrespective of
the magnitude of the bioterrorism threat we may face. Too often the
bulk of Federal health funds has been expended for direct health care
costs or to support biomedical research, while Federal expenditures for
public health programs have lagged far behind. Consequently, we would
urge this Subcommittee to examine not only the ability of our public
health agencies to respond to bioterrorism, but also to review their
ability to meet the current demands being placed upon them.
the commissioned corps of the u.s. public health service
In our view any planning that takes place with regard to response
to an incident of bioterrorism ``must'' take into consideration the
capabilities of the Commissioned Corps of the U.S. Public Health
Service. This view has been supported on a number of occasions, most
recently by Secretary Thompson in testimony before the Senate
Appropriations Committee, Subcommittee on Commerce, Justice, State, and
the Judiciary this past May 9th. In that hearing he stated:
``In order to advance an orderly and comprehensive approach to the
many issues involved in such preparation (for a bioterrorism event), I
will appoint a special assistant within the Immediate Office of the
Secretary to lead the department's bioterrorism initiative. This person
will report to me directly. I plan to call a national meeting of HHS
agencies to evaluate the status of bioterrorism activities and report
back to Congress on our efforts. In addition, the new special assistant
will support the Surgeon General's efforts to revitalize the Public
Health Service Commissioned Corps and its Readiness Force. Let me
assure you that this is a top priority for me and for my entire
department.''
Congress has also noted that the Commissioned Corps has much to
offer in the area of bioterrorism. In 1998 the Senate Armed Services
Committee, in the Committee Report that accompanied the Department of
Defense Authorization Act for fiscal year 1999, observed: ``The
Committee notes the efforts underway within the Department of Defense
to develop the means to respond to acts of terrorism involving weapons
of mass destruction. In this regard, the committee directs the
Secretary of Defense to ensure the assessment of needs and capabilities
includes an analysis of the capabilities that exist within the
Commissioned Officer Corps of the U.S. Public Health Service, who, as
members of the uniformed services, might be easily integrated into
Department of Defense plans to respond to emergencies involving weapons
of mass destruction.''
The Commissioned Corps has a history of deploying with the military
that goes well beyond mobilization in times of war. In such instances
the uniform and rank structure of the Commissioned Corps, as noted by
the Senate Armed Services Committee, has indeed facilitated the
relationship among the services.
This Committee came to a similar conclusion. In the report
accompanying the Appropriations Bill for the Departments of Labor, HHS
and Education for fiscal year 1999, the Committee stated: ``In
developing plans for bioterrorism countermeasures, the Committee notes
the standing personnel and reserves of the Public Health Service are a
valuable resource that ought to be well-integrated.''
The Commissioned Corps, as a uniformed service, brings some unique
capabilities to the public health and emergency response arenas, making
these officers especially well-suited for the public health response
required in the aftermath of a bioterrorism incident. As noted in a
February 1998 Report prepared by a Special Advisory Committee of
esteemed public health professionals headed by Former Surgeon General
C. Everett Koop, ``. . . expertise which is resident in the Corps to
deal with biological and chemical agents is a critical resource that
can be called upon in the event of terrorist attack.'' Tab A briefly
describes some of the important characteristics of the Commissioned
Corps, among them:
--public health training and experience;
--on call 24 hours a day, like their military counterparts;
--available for assignment to accommodate changing public health
needs and priorities;
--an exceptional track record in the area of emergency response;
--presence in 49 of 50 states, with large concentrations of officers
in nearly every region of the country, thereby allowing for an
expedited response.
The Commissioned Corps is also a rich source of epidemiologists
whose expertise will be critical as part of a bioterrorist response.
In August 1997 Minnesota's former governor, Arne H. Carlson sent a
letter to then-DHHS Secretary Shalala praising the outstanding
assistance provided by Commissioned Corps task forces to the citizens
of Minnesota in the aftermath of the devastating spring floods.
Governor Carlson noted that one of the lesser publicized, but serious
impacts of the flooding was an estimated 2500 flooded private wells,
requiring the restoration of safe water supplies for many of
Minnesota's citizens. He observed that ``(t)he three task forces
entered the state fully equipped and thoroughly organized to operate
with a minimum of state involvement'', and they brought the long, dirty
and sometimes dangerous work to a successful conclusion in six weeks.
Tab B further details the emergency response capability of the
Commissioned Corps based upon actual experience since the late 1980's.
One special component of the Commissioned Corps (cited by Secretary
Thompson in his May 9th testimony before the Senate Appropriations
Committee, Subcommittee on Commerce, Justice, State, and the Judiciary)
is the Commissioned Corps Readiness Force (CCRF), which was created by
the Office of the Surgeon General in 1994 to improve the DHHS ability
to respond to public health emergencies. The CCRF is a cadre of nearly
1500 PHS active duty officers who are uniquely qualified by virtue of
their education, skills and experience to respond to public health
emergencies, and who can be mobilized quickly for this purpose.
The Commissioned Corps is also a vital part of the Nation's
emergency response capacity through its role with Disaster Medical
Assistance Teams (DMATs), which consist of both federal and private
sector personnel. One of these DMATs (PHS-1) is comprised primarily of
Commissioned Corps Officers (approximately 80 percent). This team has
been stationed at high profile national events to provide the initial
public health response in the event of a bioterrorism incident.
In 1999 the first National Symposium on Medical and Public Health
Response to Bioterrorism was held in Arlington, VA. During a panel
discussion of a smallpox scenario, Mr. Jerome H. Hauer, then Director,
Office of Emergency Management, New York City, stated that in the event
of a smallpox outbreak in New York, he would require hundreds of
investigators in the metropolitan area. In addition, he noted the
requirement for personnel to provide smallpox vaccinations, observing
that the vaccination process is complex, and the average health care
provider is not trained in this area.
Mr. Hauer's needs can most certainly be met by the Commissioned
Corps. With hundreds of public health professionals stationed within a
short drive of New York City, a rapid response can be achieved. The
variety of locations nationwide where Commissioned Corps officers are
stationed permits the mobilization of a large number of Commissioned
Corps officers anywhere in the country in a very short period of time.
Furthermore, with some improvements to the administration and training
of the inactive reserve component of the Commissioned Corps (discussed
below), an additional response capacity, or a backfill capacity, as
circumstances require can be made available. The medical expertise also
resides within the Commissioned Corps to staff alternate care
facilities as needed (e.g. hospitals to handle small pox cases).
While the Commissioned Corps is currently the best available source
of public health expertise, a few modest initiatives will make it even
better. Some of the initiatives may require legislation, while others
may simply require policy changes within the Department of Health and
Human Services. Clearly, however, oversight from this Committee is
crucial to ensure that the necessary steps are taken. The following are
some of the actions that would enhance the ability of the Commissioned
Corps to respond to a bioterrorism incident:
--Clarification of the ability to mobilize the Commissioned Corps
under a single operational control in the event of an incident
involving a weapon of mass destruction.--The Surgeon General,
the uniformed leader of the Commissioned Corps, administers the
Corps and as such is responsible for formulating Commissioned
Corps policy. However, Commissioned Officers are assigned to
agencies both within and outside the Department of Health and
Human Services. This diversity in assignments is a clear
advantage, and one of the great strengths of the Commissioned
Corps. However, those agencies to which officers are assigned
retain significant control over the work performed by their
officers. There should be no question that the Surgeon General
has authority to direct all PHS officers to respond to a
bioterrorism incident, regardless of the agency to which the
officers are assigned.
--Provide additional training.--The public health background these
officers bring to the bioterrorism scenario is a significant
advantage. However, it is important that, as in any specialized
area, the officers receive ongoing training to develop/maintain
their expertise.
--Formalize the Inactive Reserve program.--This issue was touched
upon above. Unlike the inactive reserve components of the other
services, the Commissioned Corps program has been run on an
informal basis, with a somewhat loose affiliation by the
members. Nearly all members of the PHS inactive reserve have
served at least two years on active duty and thus are familiar
with Federal programs and procedures. The potential of this
program has been recognized by many in Congress, including the
House Appropriations Committee that directed a study to
ascertain the viability of establishing an Office of Reserve
Coordination to administer the program. Without question the
inactive reserve program, and public health in general, could
be dramatically enhanced if even modest resources were
committed to the maintenance of the reserve program and to the
training and utilization of inactive reserve officers.
Once again, the Commissioned Officers Association very much
appreciates this opportunity to submit its views to this distinguished
Subcommittee. We look forward to addressing further details of these
and other issues with you and the Subcommittee staff.
______
Prepared Statement of the Association of State and Territorial Health
Officials
The Association of State and Territorial Health Officials (ASTHO)
appreciates this opportunity to provide comments to the U.S. Senate
Subcommittee on Labor, Health and Human Services, and Education
Appropriations on public health preparedness particularly for potential
terrorist attacks using biological or chemical agents.
ASTHO represents the state and territorial public health agencies
of the U.S. states, the U.S. territories, and the District of Columbia.
ASTHO's members are the chief executive officers of the health agencies
of these jurisdictions. In response to the tragic events of September
11, ASTHO has established an Anti- terrorism Preparedness Task Force to
provide expert information and advice on relevant preparedness policy
and programmatic, and legislative priorities.
For years, public health professionals have identified the need for
strengthening the United States' public health infrastructure as a
major national issue. Public health surveillance capabilities provide
an early warning system for our nation. However, challenges such as
emerging infectious diseases continue to tax this system. The terrorist
events of September 11 have further shown that disaster preparedness
and strengthening the public health system's ability to identify and
respond to such disasters must be a top national priority.
Within the past few days, members of Congress have proposed
appropriations in excess of $1.6 billion to improve the nation's
bioterrorism preparedness, with a major portion of those funds devoted
to critical public health response programs through state and local
health agencies. We fully endorse this proposed allocation as a
critical down payment for future vigilance against a tragic threat that
is here to stay.
Ten days after the September 11th tragedies, ASTHO produced a
special closed circuit satellite telecast to discuss public health
infrastructure in the context of emergency preparedness. The
conference, moderated by ASTHO's President Dr. Georges Benjamin of
Maryland, featured presentations from state health commissioners in
several of the affected states (E. Anne Peterson, MD, MPH, Virginia;
George T. DiFernando, Jr., MD, MPH, New Jersey; and Robert S.
Zimmerman, Jr., Pennsylvania); HHS Deputy Secretary Claude Allen;
Jeffrey Koplan, MD, MPH, Director of the Centers for Disease Control
and Prevention (CDC); and Elizabeth M. Duke, Ph.D., Acting
Administrator of the Health Resources and Services Administration
(HRSA). The discussion focused on the public health response to the
terrorist events: the successes, challenges, and unresolved issues. Dr.
Koplan listed seven critical areas of public health capacity that must
be strengthened to ensure national preparedness against a biological or
chemical threat:
(1) public health workforce;
(2) laboratory capacity;
(3) epidemiology and surveillance;
(4) secure and accessible information systems;
(5) communication;
(6) effective policy and evaluation; and
(7) preparedness and response capacity.
We believe these key areas are absolutely essential to preparedness
planning and require additional resources to assure their availability.
States are at different stages of preparedness in each of these seven
critical areas. Therefore the states will have different priority
needs.
In addition, resources and leadership are needed at the federal
level to support state planning and coordination and development of a
national strategy for preparedness. We encourage Congress to utilize
and build upon the expertise, experience, and leadership that CDC has
demonstrated in recent years in developing our nation's public health
response to bioterrorism.
critical response areas
Public health workforce
A well-trained, fully prepared public health workforce is the
foundation of our public health system. The public health workforce
includes a range of disciplines such as physicians, nurses, dentists,
social workers, nutritionists, environmental health specialists,
epidemiologists, veterinarians, laboratorians, health educators,
disease investigators, and outreach workers. These professionals work
to improve the public's health through prevention, education, research,
and policy development.
The current public health workforce is not sufficiently trained to
meet the growing needs of emerging infectious diseases, new vaccines,
and more far-reaching prevention efforts, in addition to planning for
potential threats of terrorism or emergencies such as a global pandemic
influenza. A Status Report recently prepared by CDC on the Public
Health's Infrastructure indicates that as of 1997, 78 percent of local
health officers did not have graduate degrees in public health.\1\
Moreover, many public health professionals lack opportunities for
continuing education in their fields due to insufficient budgets, staff
shortages, and proximity to education and training programs.\2\ If we
are to be fully prepared to respond, these trends must be reversed.
---------------------------------------------------------------------------
\1\ A Status Report, ``Public Health's Infrastructure'' prepared
for the Appropriations Committee of the United States Senate by the
Department of Health and Human Services and the Centers for Disease
Control and Prevention, 2000.
\2\ Ibid.
---------------------------------------------------------------------------
The Status Report also shows that the governmental portion of the
public health workforce includes nearly 500,000 professionals deployed
at the local, state, and national levels. With the increasingly complex
patterns of disease, interventions, technology and partnerships;
advanced education and training are becoming increasingly important.\3\
At the same time, hiring freezes and low salaries have hindered the
ability of health agencies to recruit and retain talented public health
officials. The average tenure of a state health official is less than
two years.
---------------------------------------------------------------------------
\3\ Ibid.
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Laboratory capacity
Active surveillance depends on the ability of the public health
laboratory to rapidly and accurately analyze and identify samples
submitted to them for analysis. For example, in 1997, the Colorado
State Public Health Laboratory was responsible for determining that an
outbreak of E. coli O157: H7 had occurred and that contaminated
hamburger patties were the source of infection. Their rapid response
prevented serious cases of hemolytic uremic syndrome that frequently
result from this infection from occurring across the nation as a result
of the largest recall of contaminated meat products in our nation's
history.
Public health laboratories are ideally suited for the critical role
of identifying biological agents. Unfortunately, some state public
health laboratories are not equipped to detect the most likely
biological agents such as anthrax and smallpox. State laboratory
facilities need to be upgraded with appropriate equipment and trained
personnel.
Laboratory personnel in all 50 states and territories should have
access to advanced training in both the identification of bioterrorist
agents, using the newest detection techniques, and in handling the
agents safely. Responding to these issues is not a short-term
proposition. Laboratory support for public health programs requires
ongoing investment in new techniques, new equipment, methods
development and documentation, staff training, and quality assurance
procedures.
Another related issue pertains to the need to train hospital and
private clinical laboratory personnel to recognize an unusual pathogen,
a critical public health role in emergency preparedness. The importance
of timely detection cannot be overemphasized. In the case of many
biologic agents, the time lag between exposure to the pathogen and the
onset of symptoms may vary from hours to weeks. An effective response
will depend jointly on the ability of the clinician to identify and
accurately diagnose an uncommon disease or toxic response and on a
surveillance system for collecting and organizing information from
clinicians and laboratories.
Three excellent programs currently exist within CDC to enhance
laboratory capacity and coordination but not all states receive funding
to support these efforts. ASTHO recommends enhancement of these
programs: the Laboratory Response Network, the National Laboratory
System, and the development of a Chemical Terrorism Preparedness
program to include all states.
Epidemiology and surveillance
Epidemiology and surveillance programs of state health agencies
detect outbreaks of common diseases or rare occurrences of unusual
diseases. Epidemiological investigation determines when and where the
exposure took place and whether cases are still occurring. To conduct
such surveillance, state health agencies need adequate numbers of
epidemiologists trained to recognize both natural and intentional
events and to institute appropriate measures to control them.
In additional to trained personnel, there is also a need for
electronic reporting capabilities. An electronic disease reporting
system enhances state and local surveillance partnerships which are
critical throughout the detection and response process. An electronic
system would connect reporting entities, such as hospitals, private
laboratories, physician offices and local health agencies with state
and national public health officials. Such systems require not only
technology but also support in the areas of technical support persons,
hardware, and software.
Secure and accessible information systems
The ability to rapidly communicate with state and local health
agencies is critical in responding to bioterrorist and infectious
disease outbreaks. Rapid communication was an essential component of
the coordinated response to the September 11 attacks in Virginia, New
York, and Pennsylvania.
All states need state of the art computer systems with high speed
Internet access. Satellites for distance learning are essential and
videoconference capability is also greatly needed to improve the
ability to disseminate information routinely and in the event of an
emergency. Information is only as reliable as the data management that
supports it. Upgrading information systems is an ongoing challenge.
Many states' analyses of their data systems show major gaps in
infrastructure. Weaknesses exist particularly in linking databases, in
assuring the security necessary to increasing web applications, and in
interactions with the provider community, the source of much public
health data. Three systems have been developed by CDC to begin to
address the aforementioned gaps; however, these systems are not fully
implemented.
The first of these three systems, the Epidemic Information Exchange
(Epi-X), was designed to instantly notify public health practitioners
of urgent public health events and request assistance from CDC on-
line. Epi-X assists bioterrorism preparedness efforts by providing a
secure communication channel for public health officials. Future
enhancements of the system include providing secure communications for
multi-state outbreak-response teams, links between disease surveillance
programs and the Health Alert Network, and improved software to
automate the recognition of similar disease outbreaks across
jurisdictions.
The National Electronic Disease Surveillance System (NEDSS) assists
in the management of surveillance systems and allows the public health
community to respond more quickly to public health threats. When
completed, NEDSS will electronically integrate and link together a wide
variety of surveillance activities and will facilitate more accurate
and timely reporting of disease information to CDC and state and local
health agencies. To accelerate NEDSS deployment, additional resources
are needed to strengthen state data security infrastructure, fast-track
the availability of the NEDSS Base System, and enhance NEDSS
functionality at the state level.
The Health Alert Network serves as the backbone for the public
health communication strategy developed by CDC. This network will
ensure communications capacity at all local and state health agencies.
The Health Alert Network was operational 24 hours per day, seven days
per week during September 11 to September 28 to provide critical
information to state and local health agencies about the response and
recovery activities associated with the terrorist attacks. Additional
resources are needed to accelerate the development, coordination, and
full implementation of these systems.
Communication
The importance of effective communication in times of emergencies
cannot be overstated. Just as states and local health agencies need
effective information systems, they also need up to date information
and appropriate messages to share. Health officials are on the front
lines and their message and communication approach will not only
coordinate response, but will also reassure a fearful public.
Communication channels must be established before an emergency
takes place, and must be inclusive of all partners involved in the
response. Rapid, reliable information and communication among federal,
state, and local public heath authorities, health care delivery
systems, police, firefighters, emergency management services (EMS),
emergency personnel, and others is essential.
Effective policy and evaluation
The events of September 11 have served to increase our
understanding of the need for sound public health policy. Issues of
conflicting legislative and regulatory provisions across state lines
could impede the ability of public health to respond to critical health
needs in the event of a bioterrorist event. The ASTHO Task Force on
Anti-terrorism Preparedness will help identify many of the specific
issues encountered during the days after the tragic events and will be
prepared to make recommendations as to policy and even legislative
needs in this regard in the near future.
CDC, in partnership with ASTHO, the National Association of County
and City Health Officials (NACCHO), the National Association of Local
Boards of Health, the Public Health Foundation and the American Public
Health Association, has developed the National Public Health
Performance Standards Program. Three assessment tools have been
designed specifically for state and local health agencies and local
boards of health. These assessment tools provide performance measures
by which the public health system, including public and private
partners who contribute to the public's health, can be evaluated.
Specific to bioterrorism preparedness evaluation, the Bioterrorism
Preparedness and Response Core Capacity Project, which is co-chaired by
CDC, ASTHO and NACCHO, is in the process of identifying core capacities
for bioterrorism and emergency response preparedness.
States also have taken steps to evaluate their public health
systems. For example, Washington State has begun to assess how well
prepared its public health system is to respond to a major public
health threat or emergency. The state has developed and tested
performance standards for the public health system, evaluating how well
its 34 local health jurisdictions and state department of health can
perform in five key areas of public health practice. The state has also
established a baseline assessment of county-level preparedness
capacities examining the processes, procedures, and relationships
necessary to effectively detect and respond to public health
emergencies. This is typical of the types of exercises underway in
other states.
Preparedness and response
Successful preparation for weapons of mass destruction emergencies
will depend on the development of a well-orchestrated plan to be used
in responding to an event. The implementation of that plan will vary,
depending on the nature of the attack. If the incident involves
biological agents, public health officials as well as emergency room
personnel and critical care unit personnel will be key players and
first responders. If the incident involves chemical or explosive
agents, public health officials would be complementary to the
management of the emergency. Regardless of the nature of the attack,
the responsibilities of public health officials will include
identification of existing assets and assessment of needs, resource
allocation for preparedness, stockpiling of supplies, medical training
for treatment, and communication with the public.
Planning and coordination
Planning and coordination go hand in hand with all areas previously
mentioned. If the response to a biological threat or chemical attack
has not been well planned, it carries the potential of being
ineffective. States are currently working to better define and test the
roles of various entities, including local health agencies, state
laboratories, emergency responders, hospitals, and others to establish
policy to address unexpected events. Pre-emergency response planning
forges better communications between public health and emergency
response sectors, which in many states operate independently.
Improvements in infrastructure made now to address the major elements
of emergency preparedness planning can have immediate and lasting
benefits.
Emergency planning for bioterrorism requires special emphasis on
certain functions not normally included in disaster plans. Examples
include special surveillance operations, delivery of vaccines and
antimicrobial agents, and other mitigation efforts. The widespread
nature of adverse health effects due to the disruption of critical
human infrastructure will require the expansion of the typical disaster
management team. Public health officials bring essential contributions
to such strategic planning teams.
National strategy
There is sufficient crossover and concurrence in each of these
seven areas to necessitate appropriate coordination at the national
level. In the event of a bioterrorist event, the magnitude of the
problem, essential treatment and prevention measures, and environmental
impact are continually assessed. If an infectious agent is involved,
public health officials may have to house ill individuals in isolation
units in hospitals, or in make-shift facilities, attended by medical
personnel who are protected by specialized clothing, or who have
received advance immunization. Public health officials may also be
forced to place a large number of individuals in quarantine and
temporarily close large public gathering places and transport centers.
Massive distribution of stockpiled vaccine and medical treatments such
as antibiotics will also be necessary. Assurance of safe food and water
supplies will be especially critical. These are just a few of the many
issues that require a strong national strategy.
Addressing the threat of smallpox and anthrax
The threat of a terrorist attack using smallpox remains unlikely,
but health officials recognize that it is prudent to be prepared. It is
important to move as rapidly as possible to accelerate production of
smallpox vaccine. In addition, a plan should be developed outlining the
appropriate course of action in the event of a smallpox attack,
including the use of vaccine. Planning and resource allocation must be
undertaken to ensure that vaccine delivery and administration and other
appropriate actions are immediate, efficient, and effective.
ASTHO makes this recommendation on the basis of the following
assessments: (a) while the probability of such an event appears low, a
smallpox attack by terrorists is nonetheless a credible possibility;
(b) the threat of smallpox is a threat that we do have the ability to
substantially mitigate or even abrogate through effective use of
vaccine; (c) smallpox is a threat for which there are really no good
alternatives to vaccination for effective response; and (d) smallpox is
a threat that carries the potential for great harm and global spread if
there is not an effective response.
ASTHO also encourages expeditious exploration of methods to provide
protection to civilian populations in the event of terrorist use of
anthrax. ASTHO encourages CDC to develop rational, reasonable, and
balanced communications tools concerning smallpox and anthrax which are
suitable for the general public and can be shared with all state health
agencies. ASTHO encourages Congress to provide additional resources as
needed to support these recommended activities.
Conclusions and closing recommendations
The Department of Health and Human Services, through CDC, has been
leading the effort to upgrade national public health capabilities to
address any potential bioterrorist event. CDC has initiated a
cooperative agreement program for state and major local health agencies
to help upgrade their capabilities. Eligible applicants can request
support under the following five focus areas: Preparedness Planning and
Readiness Assessment; Surveillance and Epidemiology Capacity;
Laboratory Capacity-Biologic Agents; Laboratory Capacity-Chemical
Agents; and the Health Alert Network. These funds have enabled state
and local health agencies to link and integrate their preparedness
activities and local and county preparations for crisis and consequence
management of a terrorist event. ASTHO commends the Congress for making
these resources available. However, all states are not funded in all
areas and additional resources are urgently needed to address the
concerns outlined in this document.
ASTHO urges the Subcommittee to assure that:
--The federal government assumes an appropriate leadership role in
strengthening the national public health infrastructure and
capacity;
--The federal government makes the necessary resources available for
public health workforce training, preparedness planning, and
readiness assessment at the state and local health agency level
to assist in the development and implementation of plans to
address public health issues following a biologic or chemical
terrorist attack;
--Public health agencies at the local, state and federal levels are
sufficiently enhanced to detect, monitor, and contain disease
outbreaks. Rapid detection of a biological attack can prevent a
local epidemic from becoming a national epidemic;
--Sufficient resources are provided to develop medical counter-
measures against a bioterrorist attack, including funding to
speed up vaccine production and to stockpile antibiotics; and
--Our nation's hospitals are properly equipped and health
professionals are properly trained to respond to bioterrorism.
The public health system is the vital link in our ability to
preserve and protect human life when disaster strikes. Services we all
count on must be present in the event of a major epidemic, a
bioterrorism incident, exposure to a chemical hazard, radiological
release or contamination of food and water supplies. We thank the
Subcommittee for its understanding of the vital importance of a
national policy and appropriate resources to strengthen public health's
capacity to identify and respond to bioterrorist events, and its
recognition that by doing so, public health's overall capacity to
protect our nation's health and well-being will be enhanced.
We look forward to working with the Subcommittee to assure the
availability of the critical funding needed to address each of these
urgent issues.
Senator Harkin. Before I turn to our first panel, I will
yield to our distinguished ranking member, Senator Specter, for
his opening remarks.
opening Statement of Senator Arlen Specter
Senator Specter. Thank you very much, Mr. Chairman, and
thank you for convening this important hearing, and for your
leadership in this important field.
Earlier this week, I held town meetings at Cheney and
Lincoln Universities in Pennsylvania, and one of the key topics
on the minds of the students and faculty there was what would
happen in the case of an attack by biological weapons or
chemical weapons. It is obvious that there is great concern in
America today with the potential for weapons of mass
destruction.
When we have seen what the terrorists did on September 11,
there is no doubt that they have the capacity and the evil to
render unlimited damage on America to the maximum extent of
their capabilities, and there is obvious concern that, as well-
financed as they are, and as sophisticated as they are, that
they may have biological and chemical weapons and other weapons
of mass destruction, so this is a matter of the utmost urgency.
The issue is joined today with contrasting viewpoints, with
Secretary of Health and Human Services Thompson being quoted
earlier this week that the administration was: ``very confident
that we could act and react to any kind of bioterrorist
breakout,'' and Secretary Thompson insisting that the
Government: ``can handle any contingency right now.''
One of our witnesses today is Dr. Steven Cantrill, of the
Department of Emergency Medicine of the Denver Health Medical
Center, who categorically disagrees, saying: ``an additional
concern is the illusion shared by many that our health care
system could adequately deal with a significant weapons of mass
destruction incident.''
In this area, I must respectfully disagree with Secretary
Thompson, and Dr. Cantrill goes on to say: ``this problem would
only be partially alleviated by dispatching Federal resources
to a specific locale, and could be of no help if terrorism
opted to involve dozens of metropolitan areas simultaneously.''
This subcommittee has responded with almost doubling the
funding for bioterrorism from 1999 through the projections for
the year 2002. We find that there is again a fragmentation of
our efforts among the Department of Health and Human Services,
the Department of Justice, the Department of Energy, the EPA,
and emergency response.
We now have a new leader coming into the field later this
week, Governor Tom Ridge, announced as being the Secretary of
Homeland Security, and now there are issues raised as to the
scope of his authority, and a number of us are drafting
legislation to try to put a number of the agencies and
resources under his control, like Border Patrol, Coast Guard,
Immigration, and Naturalization, and a significant hand in
intelligence.
Just having an agency in the Federal Government analogous
to the National Security Advisor raises very serious questions
as to whether that is enough authority on this very, very
important matter. In a testimonial to the importance of this
issue, we have four distinguished U.S. Senators here today.
That is the most Senators this subcommittee has drawn in the 21
years that I have been here, so we know, ipso facto, this is an
important subject.
Mr. Chairman, while we are having this hearing, down the
hall there is a Subcommittee on Constitutional Law hearing on
terrorism legislation which is probably of equal importance to
what we are hearing today, so I am going to be shuttling back
and forth, but I do welcome our colleagues here today, Senators
Kennedy, Frist, Hagel, and Edwards, and look forward to their
testimony.
Thank you.
Senator Harkin. Thank you. Now I would recognize the
distinguished chairman of the full Appropriations Committee,
Senator Byrd.
Opening Statement of Senator Robert C. Byrd
Senator Byrd. Thank you, Mr. Chairman. Thank you for
holding this hearing. This is a very important hearing. I have
been saying in the Armed Services Committee for a long time
that we had better be thinking about chemical and biological
weapons being used against us. While I think that debate was
with respect to a nuclear attack and how a missile shield is
important, this is as important, if not more so. So I
congratulate you on holding this hearing, and I congratulate
the ranking member, and these four eminent Senators who are on
authorizing committees that are very important in this battle.
I was just sitting here thinking about the nine plagues of
Egypt. You recall, Moses sought to get the pharaoh to let our
people go, and pharaoh was hard-nosed about it, so God threw
Moses and these plagues upon Egypt. There were nine of them.
Let me see if I can remember them in sequence. First was blood,
the rivers turned to blood--you can write it down and check me.
Blood, frogs, lice, flies, cattle, boils, hail, locusts,
and darkness, nine plagues, so to translate that into today's
language, and into today's modern life, that would be, I
suppose, biological warfare in that day.
I am concerned about biological warfare. Unlike an
explosion, a cloud of microbes released from a small plane
would not trigger alarm like dropping a bomb. Many of the
initial symptoms in humans could first be mistaken as an
ordinary cold or the flu.
Most public health departments don't even have computers to
track diseases, and yet several of the most dangerous
biological warfare agents, plague, anthrax, and others, respond
to antibiotics, so quick detection of an outbreak and rapid
availability of drugs could save numerous lives. It is critical
that adequate supplies of drugs be available, and that plans
exist for their efficient distribution.
Are we ready? We might ask the Secretary when he comes. I
may not be here at that time. I am trying to get these
appropriations bills moving, Senator Kennedy. It is like moving
a stone uphill, but Sisyphus kept trying, and so I will
continue to try.
Unfortunately, public health experts believe that the
Nation is currently tens of millions of vaccine doses short to
effectively defend against a biological attack, and stockpiles
of antibiotics and other medicine are inadequate. Just go over
to Fairfax Hospital and look at the emergency room. I took my
wife over there just a while back. She had pneumonia--we did
not know it was pneumonia--then atrial fibrillation. She was in
that emergency room all day, and I was right there with her.
They cannot handle it. We do not have the infrastructure to
handle the crowds that come to these hospitals.
Fairfax Hospital is a great hospital. But they do not have
the infrastructure. Hospitals have reduced in-patient care in
recent years. They are unprepared to handle large numbers of
critically ill patients. If you have not been there, go over to
Fairfax Hospital or any of the other hospitals in the area. Go
to the emergency rooms. That is where we are likely to go,
those of us who are past 80. You have got a long time to wait.
But the administration's belief is that Osama bin Laden and
his Al Qaeda network may already have the means to use chemical
and biological agents as terror weapons. A Department of
Defense report released in January of 2001 indicated that Iraq,
Iran, Syria, Sudan, and Libya all have active chemical or
biological weapons programs.
Now, Mr. Chairman, that completes my statement. Thank you
for conducting this exercise. We're both on appropriations, and
so is Mr. Specter, and the Senators here who are on the
authorizing committees will be talking with us about
appropriating. There is no more important problem facing us as
appropriators, or as authorizers, than this one. Enough said.
Thank you.
Senator Harkin. Mr. Chairman, you really put it succinctly,
and we appreciate you being here and thank you for your
leadership on the full committee in this effort. I know I can
speak from having served on this committee now for 17 years,
that I know we can look to you for the guidance and the
leadership necessary to put the funds out there to make sure we
meet this emerging national threat, and we thank you for your
leadership in this area.
As our chairman said, as appropriators we look to our
authorizers for guidance on how we spend this money. Regarding
the $20 billion, we look to our authorizers to give us guidance
and direction. We turn now to our distinguished first panel
with those authorizers, and first I would recognize Senator
Kennedy from Massachusetts.
Senator Kennedy, along with Senator Frist, introduced the
legislation last year which was the Public Health Threats and
Emergencies Act. It was passed and signed into law, and
basically was the first step to building up our first line of
defense and our basic infrastructure. Senator Kennedy and
Senator Frist, I want to applaud both of you for being way
ahead of the curve on this. You had the foresight to do it.
So Senator Byrd, I would just say we do have some basic
legislation right now, thanks to Senator Kennedy and Senator
Frist, to which we can look for the guidance on where we would
want to put this money to build up that basic infrastructure.
With that, I want to thank both of you, and we will go in
order of seniority, and I will recognize Senator Kennedy first.
STATEMENT OF HON. EDWARD M. KENNEDY, U.S. SENATOR FROM
MASSACHUSETTS
Senator Kennedy. Thank you very much, Mr. Chairman. If I
could I'd like to submit my full statement in the record. I
know the committee has a full schedule, so we will not take an
undue amount of time.
First of all, I want to thank this committee for their
superb statements that have been made this morning. This is a
committee that has responsibility for allocating resources, and
it is quite clear, not only from the statements this morning
but also the actions that have been taken in the past,
particularly in terms of the support for the research and the
development of various vaccines and antibiotics, that this
committee has been ahead of the curve. That is why we
particularly appreciate the chance to work with the committee
in terms of ensuring that we are going to have adequate
resources to try and meet our responsibilities to the American
people.
I want to first of all thank my colleague, Senator Frist,
and my other colleagues as well, Senators Edwards and Hagel.
Senator Frist and I embarked on a series of hearings in 1998 on
this subject matter, and into 1999, and developed the
legislation in 1999, and then passed it last year, and we have
worked very closely together. It represented our best judgment
and the judgment of the committee, and I enjoyed working with
him.
While we worked very closely on this legislation and will
continue to do so, I thank Senator Edwards and Senator Hagel.
They have given with their legislation an additional component
in dealing with the agricultural challenge. That was not dealt
with in our committee. We did not include it, but we noted it,
and it is an extremely important aspect which they will speak
to, as well as to their sense of the importance of the
legislation.
I want to also thank Secretary Thompson. He has been
designated as the principal lead person for the administration.
I have spent time with Secretary Thompson. He is very familiar
with the General Accounting Office review, as well as other
reviews about the inadequacies of our system, and the GAO has
pointed out that there needed to be a great deal more
coordination. There was fragmentation between the various
agencies. He is addressing that issue. You will have more of a
chance to get into that question. Also the GAO talks about the
various gaps in our system, and I know you will hear from him
on this issue. We address a number of those components that
have been outlined in the GAO report, and that is why we are
glad to be here.
As has been mentioned here, the September 11 terrorist
attack indicates that we may very well face a different kind of
attack in the future, and we are here to mention very briefly
at least how we believe the focus and attention of resources
ought to be focused.
First of all, we want to emphasize the area of prevention.
The best way to assure the health and well-being of our
citizens is to prevent a bioterrorist attack. That is going to
be done as part of the administration's overall efforts in
terms of the intelligence-gathering, information-gathering, the
penetration of these various cells, as well as penetrating the
free flow of resources that are going to various terrorist
activity. That kind of aspect is underway at the present time,
and it is something that is outside of what we are going to
talk about, but it is of enormous importance.
Second, we take note that as there has been the development
of weapons of mass destruction, both biological and chemical,
the principal source of the storage of this material is in the
former Soviet Union. As we have made important progress with
the former Soviet Union in terms of the storage of nuclear
material, we are very hopeful that the administration is
working on assuring that we are going to have adequate storage
in the former Soviet Union with regards to biological weapons.
Also the scientists and researchers that are very much involved
in the development of that program, and a similar kind of a
program that has been worked on in the Nunn-Lugar proposal,
could also have application here. Those are issues for another
time, but they are, we believe, of importance.
The three items that I want to mention is, first, the
issues of detection, second, the issues of treatment, and
third, the issues of containment. This chart, which is
difficult to read, Mr. Chairman, and then my colleague, Senator
Frist, will go into greater details regarding how these
particular features can be addressed in terms of the
appropriations.
The first item, in order to have detection of any attack,
is improving the State and local disease surveillance. This is
primarily the public health system. You will see that reflected
in the high priorities we give to the public health system.
That has been also a deficient area which has been identified
by the GAO.
We have not addressed again the issue of food safety.
Secretary Thompson will. Again, we have a small part of food
safety in our committee. Most of that is in the Agriculture
Committee. The chairman of the committee is very familiar with
this issue, but that is an important part of it.
Next is the upgrading of the capacity of laboratories to
identify biological weapons. There has to be an upgrading at
the local level in terms of detection. That can be done in some
parts of our country. Where it is being done, they have the
ultimate in terms of the cutting edge technologies. We ought to
make sure that those kinds of technologies are going to be
available to communities all over the country.
The first line of defense is going to be in our public
health system. Our proposal, then, is to improve the detection
of an attack.
Second, our proposal will improve the treatment for victims
of an attack. This comes by improving the ability of our
hospitals to increase their emergency capacity. As Senator Byrd
and others have pointed out, we have seen a contraction in the
number of hospitals. That has been true in urban areas, it has
been true in rural areas. We have gone in my own State of
Massachusetts from 132 hospitals to 84 hospitals over the
period of the last 5 years, and we know that in many of the
urban areas people wait out in the corridors, even to go into
the emergency rooms.
This is going to be called upon as the first order of
priority. There are a number of different ways that their
assets can be extended. There is good planning in a number of
our great medical centers about how to do that. We ought to
share that information, but we ought to now have the kind of
investment that permits them to do this in very short order.
That is a feature of our proposal.
Next is the development and enhancing of local and Federal
medical response. This also includes training. Senator Frist,
and many of us have heard him speak on this, will mention that
in all the times he has been a doctor, in 25 years, he has not
been able to detect smallpox, or has not had smallpox in front
of him. We have to make sure we are going to have the training
for the personnel to be able to detect this. This is training
health professionals to diagnose and treat the victims of a
bioterrorist attack.
Finally, our proposal will improve the containment of an
attack by providing better vaccines to limit the spread of
infection, by improving the national pharmaceutical stockpile,
and by increasing research in medications. You will have an
opportunity to hear from the top of our research community.
They can give you different guidance as to what needs help and
support, and there are a variety of different undertakings even
at the present time, but as we understand right at the outset,
most of those products do not have a private market. It is
going to take an investment by the Federal Government, and the
Federal Government is going to have to invest in terms of
stockpiling those products.
Finally, I would like to just say, Mr. Chairman, the
administration has approximately $350 to $400 million in their
budget. Our budget recommendation is for an additional $1.4
billion. That comes to about $1.8 billion. In terms of our
recommendations this amounts now to about a sixfold increase.
Money is not the answer to everything. We think that this is a
prudent and reasonable kind of investment that can at least
start us down the road to meet our first responsibilities.
The final point I would like to mention, Mr. Chairman, I
would hope as a Nation that we are not going to be frightened
by this prospect. I think that that would be very, very
dangerous. We know that there are individuals that are taking
action, as has been pointed out. This is a national
responsibility, and we would hope that you are going to deal
with it in a responsible way, a serious way, and a way that
underlines the importance of preparation.
prepared statement
Some steps have been taken, other steps are needed, more
steps are needed, a greater investment is needed, but the
American people ought to understand this is serious. It is
dangerous, but at least we have an understanding about what
needs to be done in the very early stages of it, and that
hopefully this committee and the Congress are prepared to make
the kind of investment that is going to be a meaningful down
payment to give the kind of protection the American people
deserve.
[The statement follows:]
Prepared Statement of Senator Edward M. Kennedy
Thank you, Senator Harkin, and thank you also Senator Specter for
holding today's hearing on this topic of special importance--improving
the nation's preparedness for bioterrorism. Your own leadership in
providing resources for public health and medical research has already
done a great deal to strengthen the nation's preparedness to meet this
challenge. It's a privilege to be here today with Senator Frist.
September 11th was a turning point in America's history. For two
centuries, the continental United States was spared from foreign
attack. The vicious air attacks of September 11th shattered that
security. In the aftermath, we must clearly strengthen our ability to
defend the American people against all forms of terrorist attacks.
One of the most destructive ways an enemy could attack the nation
would be to use a biological weapon. The difficulty of mounting a
biological attack has given the nation a reprieve--but none of us knows
how long that reprieve will last.
Over the past two years, Senator Frist and I have held hearings on
the dangers of bioterrorism. As we learned at those hearings, a
biological weapon could unleash destruction on a very broad scale, and
we need to be better prepared. A substantially increased investment
must be a major part of the nation's response, and I am confident this
committee will provide it. This investment is a sound price to pay for
the greater security it will bring to every American and every
community in the nation.
Our first priority must be to prevent an attack from ever
occurring, and we are moving quickly to strengthen our intelligence
capacity and take other needed steps to do so.
We also need to work with nations that have stocks of dangerous
biological agents to ensure that they do not fall into the hands of
terrorists. Russia currently holds the largest supply of potential
biological weapons. I've spoken with Secretary Thompson about the
situation in Russia, and I believe there's a real opportunity to make
progress in securing and destroying these dangerous biological
materials. We've worked with Russia on containing nuclear weapons. Now
we must work together on preventing the spread of biological weapons.
But we must also enhance our preparedness for a bioterrorist
attack. Americans need not live their lives in fear of a biological
attack, but building strong defenses is the right thing to do.
If a bioterrorist attack does occur, the keys to responding
effectively lie in three key concepts: immediate detection, immediate
treatment and immediate containment.
Unlike the assaults on New York and Washington, a biological attack
would not be accompanied by explosions and police sirens. Instead,
terrorists could release a lethal bioweapon in a crowded shopping mall
or subway station. They might expose millions to the deadly microbes by
spraying a biological weapon over a city.
In the days that followed, victims of emergency room, complaining
of mild fevers, aches in the joints or perhaps a sore throat. Doctors
need to be well aware of the symptoms of a bioterrorist attack, or
precious hours will be lost as doctors try to diagnose their patients.
In Boston, a recently installed electronic communication system
would allow physicians to report unusual symptoms rapidly to local
health officials so that an epidemic could be identified quickly. Too
often, however, as a CDC report has stated: ``Global travel and
commerce can move microbes around the world at jet speed, yet our
public health surveillance systems still rely on a `Pony Express'
system of paper-based reporting and telephone calls.''
In addition, public health laboratories need the training, the
equipment and the personnel to identify anthrax, plague, smallpox or
other potential biological weapons as quickly as possible.
Emergency care facilities will also be essential. Boston, New York
and a few other communities have plans to convert National Guard
armories and other public buildings into temporary medical facilities,
and other communities need to be well prepared too. Even cities with
extensive plans need more resources to ensure that those plans will be
effective when they are needed.
It has been an honor to work with Senator Frist on legislation to
enhance the country's preparedness for bioterrorism. Congress enacted
that initial legislation last November, and it has already served one
of its intended purposes. That legislation gave the Secretary of HHS
the authority to act decisively to protect the public health during a
bioterrorist attack or other health emergency. Secretary Thompson used
this new authority wisely to send medical supplies and personnel to New
York, where they were so urgently needed, and I commend him for his
prompt and effective action.
To improve detection, treatment and containment of a bioterrorist
attack at the state and local level, the legislation authorized
investments in disease surveillance, food safety, and new research
initiatives to diagnose such attacks. The Act also called for new
investments in hospital preparedness, so that medical facilities will
have the planning and resources needed to assist victims. To improve
containment, the legislation called for federal supplies of vaccines
and antibiotics to be available quickly to assist local public health
officials in containing an epidemic. Federal stockpiles of vaccines and
antibiotics will be essential to contain any outbreak and save lives.
Under the leadership of Secretary Thompson and Secretary Shalala,
much has been done to improve the nation's readiness. We are better
prepared now, but we need to be even more prepared. Senator Frist and I
look forward to working with our colleagues on this committee and in
Congress to achieve these extremely important goals.
Senator Harkin. Senator Kennedy, thank you for your very,
very strong statement, and thank you for your leadership on
this issue in getting the legislation passed last year.
Now we turn to the cosponsor of that legislation, who has
been a great source of information and guidance for all of us
here in the Senate because of his strong medical background,
and that is Senator Frist from Tennessee.
STATEMENT OF HON. BILL FRIST, U.S. SENATOR FROM
TENNESSEE
Senator Frist. Thank you, Senators Harkin, Specter, and
colleagues for holding this hearing on what is a pressing
challenge for us all, and one of the most disturbing issues of
our time, given the events of September 11, and that is the
threat of germ weapons being used by terrorists.
Let me open by saying we are all walking a fine line in
terms of both the potential for being alarmist, and at the same
time laying out the information that is important for us to
recognize in terms of our vulnerability as a Nation and as a
people. The threat is real. There is no question about that.
The overall probability is low. Nobody can give a number. There
is uncertainty around the number, but it is low, yet is
increasing. Given the events of September 11, I believe that it
is increasing quite dramatically.
Bioweapons, germ weapons have huge consequence, much, much
further than anything than we have ever seen in recent
humanity, where we are talking about the potential destruction
of millions, not thousands, not hundreds, not tens, and we are
highly vulnerable. Again that is where we have to be very
careful in terms of saying how vulnerable are we, but we are
vulnerable not because we are unprepared today, and we will
hear over the course of the day that in many ways we are very,
very prepared, and have made tremendous progress, but that we
are underprepared, and that there are certain gaps that we have
a responsibility at this juncture to address.
We will hear a lot from respected experts a little bit
later in the subsequent panels, but I think the message that I
would like to leave is the following, and that is that as
Nation, with respect to germ weapons in the hands of terrorists
whose stated goal, and we know that today, and we did not know
that quite as well a year ago, whose stated goal is to cripple
the United States of America, that we are vulnerable not
because we are unprepared, but because we are underprepared,
and it is our responsibility to identify those gaps and to fill
those gaps, to reduce that vulnerability.
Now, if our goal is to eliminate those gaps, it is
important for this particular committee to address which gaps
are significant, and in doing that, I would encourage you to
look at least at what we started with in 1999, as Senator
Kennedy laid out, and that is the Public Health Threats and
Emergencies Act of 2000, because our specific purpose at that
point in time was to develop a strategy and a framework that
reflects coherency and comprehensiveness in terms of a national
defense policy.
It does this in addressing three different areas. One is
prevention. Senator Kennedy spoke to the importance of that.
The second is preparedness, how ready are we, and what is the
responsibility there, and then the response, and these can be
looked at discretely, but clearly work in an interrelated
fashion.
Why do I say the threat is increasing? Why do we act now,
and why do we put such figures as $1.4 billion in addition now?
The threat is increasing. If we look, Osama bin Laden has had
public pronouncements that acquisition of biological and
biochemical weapons of mass destruction are a religious duty of
his. We know that now. We have not focused on it, but we know
that now.
Coupled with that is that just 3 weeks ago he used
something we had never thought about as a weapons of mass
destruction, and that is an airplane loaded with fuel. He has
the money, again something new. We know that he has money, and
we know that technology is out there, available.
Senator Kennedy mentioned that during the 1980's the Soviet
Union for that whole decade has more than 7,000 scientists
working full-time on developing bio weapons that could be used
for destructive purposes.
Second, the threat has increased because of technology, and
you will hear different people in the third panel talking about
the technology there. Let me just say, from a hospital
standpoint we use nebulizers all the time--we did not have them
15 years ago--to aerosolize sprays. Perfumes are being
aerosolized all the time. We know that from department stores.
The aerosolization is just an example of how increasing
technology has made it possible to distribute and deliver these
biochemical, biological weapons, these germs in a way that just
was not possible 10 years ago or 15 years ago.
The third issue is that issue which Senator Kennedy
mentioned, is that the expertise is out there, there is no
question about it. Even since the 1980's the science, in terms
of genetic recombinant issues, genetic engineering, it is there
today, and if it is not there today, it will be there within 6
months or a year. In certain areas the expertise is out there.
It is out there probably to the highest bidder.
What we have done is propose an additional $1.4 billion
specifically, not to cover everything, but when you look at
some of the list you will say, you are all over the place. But
look at the original framework of prevention, preparedness, and
response, and you will see that we are really putting that
increased funding where gaps have been identified.
We will hear again differing opinions about how prepared
are we at the Federal level. In certain areas, we are very
prepared, but without that local front line surge capacity at
the hospitals, physicians who can recognize that rash which
they have never seen, or never been trained to recognize
before, or that cough, or that flu illness coming in being
presented, out of the last thousand cases you have seen zero
pneumonic plague, or pneumonic anthrax, to raise that bar up,
if you cannot recognize it and detect it in an expeditious way,
no matter how good the Federal response is, no matter how much
money is spent at the Federal level, unless you have this
vertical integration of Federal, State, and local coordination,
it does not do any good. It does not do any good.
Now, very quickly--and again, we do not need to go through
what we have done overall, but regarding prevention, there are
three areas. First, regarding intelligence, we have got to know
who has access to things such as smallpox, anthrax, the more
naturally occurring things like tularemia, and the nerve toxins
that are out there.
The issue of food has been mentioned and must be mentioned
once again, and there are many people who think, we all know,
we have underinvested in food safety. We have fewer than 1,000
inspectors, 56,000 sites out there where we need to be doing
inspections. We only inspect about 1 percent of the food that
is imported into this country. We have underinvested in the
past, and you will hear more about that today. It absolutely
must be addressed.
The third area as we look at prevention is this whole area
of research. If we do not have a cure for smallpox, and
smallpox has a 40 percent mortality rate today, and if we do
not have a cure for that, we do have to invest in research so
that we will have antiviral therapy. Anthrax has a 100 percent
mortality rate if untreated, and as Senator Byrd pointed out,
it has to be treated in the first 24 hours, so you have to be
able to detect it--after 24 hours. We don't know that the
vaccines that we have today are going to be entirely as good as
we think, and we need a second generation that will have the
advantages that we know will protect.
The second issue of preparedness, again I do not need to go
into too much, because we hear a lot about it at the Federal
level. At the Federal level we are doing very well, I think,
compared to 3 years ago. We can clearly do more. Most of the
bulk of the funding of the more than $1 billion that we are
saying should be put into the system is at the State and local
level of preparedness, looking at medical surveillance, looking
at medical epidemiology, addressing the issues of fax machines,
Internet connections, so when one public health institution or
unit identifies a rash which they suspect to be something, they
can at least communicate broadly.
The last area--and we will hear more about stockpiling, I
want to mention is this issue of stockpiling again. We have
done very well. We hear about how well we have done, but
clearly we have a long way to go in terms of having an adequate
response at the stockpiling level. We have specific funding in
for that stockpiling, and to improve that stockpiling so we can
really give the security to the American people that they
deserve.
In closing, let me just say that I think our most
significant failure in this country as we look at this coherent
strategy of prevention, of preparedness and response, is the
lack of investment in our public health infrastructure. Our
public health infrastructure is the front line. Without the
front line, nothing else can click. Nothing else can work. That
is the huge gap that we have underinvested in.
The good news about it, it is dual use. If we do not ever,
and I pray that we do not ever see a chemical or bioterrorist
attack in the United States, if we never see that, it is dual
use investment, because at the same time you are investing in
that public health infrastructure you are addressing the
potential for a flu outbreak, a flu epidemic, better treatment
for HIV and AIDS, and the other viral illnesses are out there.
prepared statement
Mr. Chairman, we sort of laid a template in the bill that
we put forth last year that is now the law of the land. I would
encourage this committee to use that as part of a coherent
strategy as we go forward, in view of what I would argue is an
increased threat of a bioterrorist attack. I think that we now
need to identify those peculiar gaps that are out there, mainly
at the State and at the local level, fill those gaps, and by
doing that we will move from our underprepared state to a
prepared state.
Thank you.
[The statement follows:]
Prepared Statement of Senator Bill Frist
Thank you, Senators Harkin and Specter, for calling today's hearing
on one of the most pressing and disturbing issues of our time--the
threat of germ weapons used by terrorists. That threat is real.
Although the threat has low probability, I would argue strongly that
there is an increasing probability--with huge consequences. Today, we
remain highly vulnerable.
You will hear from respected experts on these particular issues
shortly. I will focus my comments on the following simple message: As a
nation, with respect to biological weapons, we remain highly
vulnerable, not because we are unprepared, but because we are under-
prepared.
You will hear shortly from Secretary Thompson about the tremendous
advances made by the Department of Health and Human Services over the
past three years. Although we have made significant progress, there are
still large gaps in our current approach. Our goal should be to
eliminate these gaps and reduce the risk to our nation and our people.
Part of the progress that has been made is tied to crucial
legislation--the Frist-Kennedy ``Public Health Threats and Emergencies
Act of 2000,'' a law which provides the strategy and framework for a
coherent national biodefense policy. This bill addresses bioterrorism
from three discrete but interdependent vantage points--prevention,
maximizing our preparedness, and response.
With this framework in place, we can identify shortcomings within
our ability to prevent, to prepare, and to respond. As a critical first
step, Senator Kennedy and I are strongly recommending today that
Congress work together with the Administration to provide sufficient
funding for the priorities specifically established in the Public
Health Threats and Emergencies Act. Just a few months ago, Senator
Kennedy and I wrote the members of this Committee earlier this year,
requesting full funding for our legislation. Today, we outline what
additional steps should be taken in light of the September 11 attacks.
The threat of a bioterrorist attack is still remote, but it is
higher today for a variety of reasons. First, Osama bin Laden has
publicly pronounced that it is his religious duty to acquire weapons of
mass destruction, including chemical and biological weapons. He has
shown his disregard of human life, using weapons of mass destruction
that we had never envisioned. Furthermore, he has the resources and
motivation to use germ warfare.
Additionally, the threat is increased because of the recent
scientific and technological advances. Rapid advances in agent delivery
technology such as aerosolization have made weaponization of germs,
such as anthrax, much easier. Finally, the expertise of scientists
expert in germ warfare is available. Through the 1980s, over 7,000
scientists in the Soviet Union were part of a committed program to
create and maximize the effectiveness of bioweapons. With the fall of
the Soviet Union, these experts are unemployed and soliciting their
expertise around the world.
Now that we are all aware of this potential threat, we must
concentrate on our response and invest approximately $1.4 billion
specifically to fill the gaps in our current biodefense and
surveillance system. We must take necessary actions to prevent the use
of bioweapons, prepare our communities, and improve our capacity to
respond. We have shared these documents with the subcommittee and I ask
that these documents be included in the record following my statement.
prevention
Our first national priority must be enhanced on-the-ground
intelligence to know who has access to and is capable of deploying
biochemical agents, which will require increased investment for general
intelligence capabilities. Much of that work is already being done
within the Department of Defense, in an effort to significantly
increase our human intelligence capabilities. Within the Department of
Health and Human Services, however, we must increase international
surveillance and cooperation activities. With this investment, we can
enhance our intelligence capabilities to monitor other country's
bioterrorism capabilities; improve coordination of international
surveillance activities; and reduce threats posed by the former Soviet
Union.
Bioterrorism has been successfully used only one time in our
country and that was in 1984 in Oregon--and the method of delivery was
food. We have underinvested in food safety. Less than 1 percent of all
food imports are properly inspected. We have fewer than a thousand food
inspectors expected to oversee 56,000 food sites. Given that two of the
major biochemical agents--anthrax and tularemia--as well as a large
number of disease-producing organisms may be transmitted through the
food supply, we absolutely must do more to ensure the safety of our
food.
Finally, for those likely bioterrorist agents for which we have no
treatment and for those infections for which we have inadequate
vaccines, we must invest in research. Specifically, we need anti-viral
therapies for smallpox and newer, improved and more powerful versions
of an anthrax vaccine.
preparedness
Even if we do all that we can to prevent a bioterrorism attack, our
preparedness will ultimately define the impact if such an attack were
to occur. Therefore, our proposal to bolster preparedness includes what
we must do, and if implemented properly, will ensure that we are
perched and ready to respond at every level--federal, state and local.
As GAO reported last week, we must strengthen and better coordinate
our federal bio- response program. As Secretary Thompson has stated,
the federal government has already done a lot. We have a rapid response
team of over 7000 health care providers for medical emergencies. We can
deploy truckloads of therapeutics and medical supplies in ``12 Hour
Push Packages''--the key component of the National Pharmaceutical
Stockpile. However, we must do more to strengthen our resources.
Currently, the stockpile has enough antibiotics to give complete
prophylaxis to 2 million people after an anthrax exposure, but that
number is not large enough. To expand the contents and number of the
push packages as well as increase our drug and vaccine inventories, we
are asking for a doubling of the amount currently being spent to supply
and support the national stockpile.
However, the federal preparedness is not sufficient unless our
state and local agencies are also prepared. Unfortunately, our local
preparedness is severely lacking today because it is inadequately
underfunded. We have allowed our public health system--the front line
of our defense--to deteriorate over the past 20 years. We must buttress
our local response by upgrading local and state medical surveillance
epidemiology; assuring adequate staffing and training of health
professionals to diagnose and care for victims of bioterrorism; and
improving our public health laboratories, many of which simply are not
equipped to efficiently diagnose infections and other diseases
associated with biochemical weapons. Finally, we must ensure that local
entities are prepared to cope with the early situation--from
recognition through diagnosis and initiation of treatment, until
federal assistance in the form of push packages and other assistance
can arrive.
For all of these reasons, most of the funding in our proposal
almost $1 billion--is directed to improve our state and local
responsiveness, and this investment will take a few years to fully
implement.
response
Once preparedness is maximized, the key to response and mitigation
of disaster rests principally with coordination and seamless crisis
management. Therefore, our proposal ensures that we have the plans and
resources developed for an appropriate response by ensuring adequate
health care personnel and hospital preparedness. We must improve our
disaster response medical systems, including strengthening the National
Disaster Medical System, the Metropolitan Medical Response System, and
the Epidemic Intelligence Service.
Hospitals will be the natural destination for those who are victims
of a bioterrorist attack and for those who seek relief from fear.
However, only one in five hospitals have developed a plan for such a
calamity. They are ill-prepared for the resulting surge capacity. We
must ensure that local hospitals are equipped to provide appropriate
crisis management structures--by ensuring that every hospital not only
has a plan for dealing with a bioterrorist attack but also has
appropriate surge capacity, decontamination units, and necessary
supplies for the immediate needs. With all of the proposed preparation,
we will be able to respond by implementing our detailed plans of
action, deploying appropriately trained health care professionals and
resources to care for thousands of individuals who will seek care, and
providing up-to-date information regarding risk reduction.
One of the marvelous things about this particular investment is its
dual use--not just preparing for a rapid response to in the event of
germ warfare but also strengthening a system that every single day
contributes to the improved health of all Americans. Now is the time to
strengthen our public health system and ensure that we can adequately
prepare for and respond to potential bioterrorist attacks, natural
infectious disease outbreaks, or other challenges to the public health.
I commend the Administration for taking steps to address
bioterrorism by not only increasing funding before the attacks of
September 11, but also assigning Governor Ridge as the primary federal
coordinator of such activities.
The Frist-Kennedy Public Health Threats and Emergencies Act
provides the appropriate framework for a comprehensive biodefense plan.
Now is the time to fund this authorizing legislation. In view of the
increased risks of a bioterrorist attack, we must act now to fill the
gaps we have identified--gaps that if allowed to persist debilitate our
response--and to move us from the under-prepared to the appropriately
prepared state.
Senator Harkin. Thank you very much, Senator Frist, and
Senator Kennedy.
Just as a postscript, Senator Frist, I was back home this
last weekend, and a friend of mine who is a doctor in Des
Moines came up to me and said, how am I supposed to recognize
it? He said, I have never been trained to recognize anthrax. He
said, we need help out here to start to recognize it. That is
one of the points you just made there. We need to get that
information out and training out at the local level, so I
appreciate your comments. This just happened to me this last
weekend.
I am now going to move to Senator Hagel and Senator
Edwards, who just introduced new legislation, and I recognize
the time constraints and how busy our Senators are, Senator
Kennedy, Senator Frist, and please stay if you would like, but
if you would like to leave, we would excuse you at this time.
Senator Byrd. Mr. Chairman, in the event that these two
Senators need to leave, they mentioned a figure of $1.4
billion. How did you arrive at the $1.4 billion? How do you
break that down, and how much of that needs to be appropriated
immediately? Can it be broken down into phases that would help
us to better understand it? I do not know how we can spend $1.4
billion better than in this very exercise here.
Senator Kennedy. Quickly, Senator, half of it is, as
Senator Frist pointed out, for our public health services.
Those resources will be invested in the States. That is the
front line. That is on the basis of figures estimated by the
public health service, and the particular organizations, the
Public Health Laboratories, for example. This is basically how
we got it, and it was rather a lean budget on that.
You will find about another quarter or so of it is for the
hospitals in terms of developing outreach programs, and the
remaining third are listed here, and cover a number of the
different kinds of programs that Senator Frist pointed out in
terms of surveillance, the development of various vaccines, and
the storage and purchase of those programs. This breakdown
which is a part of our testimony is an activity sheet where we
give the figures, the allocations of the $1.4 billion to each
of probably 10 different initiatives, and we will be glad to
submit to the committee the additional kinds of support for
each of those.
There are some provisions that are not on there. Food
protection is not on here. The agricultural aspects are not on
here. There is not a program on here, although the Secretary
will probably talk about it, like the Nunn-Lugar programs, in
order to try to do something over in the former Soviet Union in
terms of the employment of some of those scientists, so those
elements are not on here and probably may have to be added. but
this is really the public health aspect of the program, and we
have submitted it, and we will be glad to work with the staffs
of the committee to give the particular justification.
Senator Frist. Mr. Chairman, could I just add to that very
briefly? The documents from this chart should be made a part of
the record, and should be before you. There are certain
elements up here, and you see that $635 million of the $1.4
billion is for State and local preparedness capabilities. We
absolutely must address that particular issue. Some of the $635
million could be multiyear. It needs to be made available now,
but it could be multiyear in terms of the way it is carried
forth.
What we have done is looked at what is needed and backed it
forward, recognizing that we see this increased risk. If you go
down that list, the second area, improving hospital response
capabilities, the $295 million, it is important that it be
addressed. We would recommend that it be provided this year. To
carry out that program fully will take 2 to 3 years. Our staff
will be working with the committee staff, because as you go
down that list there are a few things on there that could be
multiyear. It does not have to all be right now. If it is right
now, we will obviously be able to go from an unprepared to a
prepared state.
Senator Byrd. Thank you.
Senator Harkin. Mr. Chairman, since I have got your
attention on this, we mentioned food safety, and I would like
to just give you these figures. You might think about them, and
you can write them down.
Senator Byrd. My problem is, I cannot write. I cannot read
my own writing after I get it down.
Senator Harkin. I have the same problem.
Senator Byrd. That is why I do not play the violin any
more.
Senator Harkin. That is a loss, because I have heard you
play the violin in the past. But I want to give you these
figures about food safety, and I have been harping on this for
sometime. Last year, USDA received $712 million to inspect
6,000 meat, poultry, egg product and import establishments. So
they got $712 million to inspect 6,000 establishments. FDA
received $260 million, one-third as much, to inspect 57,000
food establishments and over 9,000 animal, drug and feed
establishments, as well as a majority of food imported into the
United States.
Of the 7,000 food-borne illnesses that we detected, 85
percent were linked to foods regulated by FDA. We have a gaping
hole out there in our food safety, especially in terms of the
importation of foods into this country. We just have a big,
gaping hole there, and we have got to fill that. I would hope
that we would look at some of that $1.4 billion in terms of
that, and getting to the FDA and giving them the resources they
need to do these inspections.
Senator Durbin. Mr. Chairman, if I could just comment on
that very briefly, one issue that I have been focused on is
putting together one science-driven food safety inspection
agency. We now have 12 different Federal agencies involved in
food safety inspection, and 35 different laws. Senator Frist
and Senator Kennedy, thanks for raising this issue.
Next week, on October 10, we are going to have a hearing in
the Government Affairs Committee that is going to focus on food
safety and security. Believe me, this is a big undertaking, to
finally harmonize this, and I look forward to working with you
in trying to make sure we do the right thing.
Senator Harkin. You have a been a leader on that, and we
appreciate it, and we do need one central food agency. It is
all spread out now. We need one agency to look at food safety
in this country, and we need to combine those that are in USDA
and FDA some how.
Again, I thank the Senators, and please stay or leave as
you so desire.
Now I turn to Senator Edwards and Senator Hagel, who have
introduced the Biological and Chemical Weapons Preparedness Act
of 2001, and going down the line of seniority I would recognize
my good friend and my neighbor from across the Missouri,
Senator Hagel of Nebraska.
STATEMENT OF HON. CHUCK HAGEL, U.S. SENATOR FROM
NEBRASKA
Senator Hagel. Mr. Chairman, thank you, and to you and to
our Ranking Member, Senator Specter, we are very appreciative
that you would put the focus on this, as has already been
established this morning, because of its most critical nature,
and to Chairman Byrd, thank you, because you will play a rather
important role in all of this, and to our colleagues Senators
Kennedy and Frist, I, too, would add my appreciation for their
leadership and commitment to, in fact, as much as anyone could
have, stay ahead of this issue.
I am reminded, Mr. Chairman, when Wayne Gretzky, the great
hockey player, was asked why was he so great, he responded by
saying, well, I am not sure I was that great, but if there was
anything I tried to do, it is that I tried to skate not where
the puck was, but where I thought the puck would be. Certainly
Senators Kennedy and Frist have skated to where they thought
the puck would be, and they were right.
In the interests of time, Mr. Chairman, I will submit a
statement for the record. My colleague, Senator Edwards, has
taken a very significant lead role on this issue through his
committee assignments and his own interest in something very
important, as one of the great challenges of our time, and I
appreciate working with him. This issue has been referred to
this morning by those who have spoken. It is a critical,
integral part of our long-term war on terrorism.
It is about, as we have heard, preparation, prevention, and
defense, but, as Senators Kennedy and Frist have laid out, all
the components of this now must come together. I hope that what
Senator Edwards and I have done by introducing our legislation,
which he will speak to in a more framed way, I suspect, is to
move forward what is critically important to coordinate the
local, State, and Federal responses, meaning that this
coordination is going to be absolutely essential. It is going
to require resources that it now does not possess. It is going
to require infrastructure which we do not now have. It is going
to require thinking that we have not applied before.
So what Senators Kennedy and Frist have done is laid down a
very important baseline. Senator Kennedy mentioned, as you did,
Mr. Chairman of the Agriculture Committee, the need to deal
with the agriculture piece here, and this is an area that
Senator Edwards and I felt that we could contribute to by
adding onto what Senators Kennedy and Frist have already done.
We have done that, and we will be prepared to answer any
questions.
As to where we think some of this money should go, our
overall number is $1.6 billion. We have that broken down, and
we would be glad to share that with you whenever you would
like.
I would summarize my thoughts on this by saying, Mr.
Chairman, as both Senators Frist and Kennedy have noted, that
it is important that we not panic the American public. It is
important that we speak plainly, directly, clearly, and
honestly to the American public, as the President is doing, and
as Secretary Thompson is doing. But we need to keep this in
proportion, so that the American people can be assured, and as
we continue our efforts here they will be assured, that we are
dealing with this and they should have a high degree of
confidence in what we are doing.
As you all know, and many of you have been around here a
lot longer than I have and have provided leadership to this
great country, we are now confronted with the great challenge
of our time. Not since World War II has our Nation been
confronted with such enormity in the completeness of this
challenge. I believe our country is up to it. I believe our
leadership is up to it. I think we have seen some testament to
that over the last 3 weeks in how our House and Senate, and our
Democrats and Republicans have worked together on this. This
certainly seems to be, regarding this area that we are dealing
with this morning, a very clear example of how that is coming
together.
There is one last point I would make, which I think says it
all, Mr. Chairman. You probably have seen the cover of Time
Magazine this week. Time Magazine's cover, and a very, very
good story about this issue, does not say it all, but it says
an awful lot. It asks: How real is this threat? That is what we
are talking about this morning. We all agree the threat is very
real.
Mr. Chairman, thank you.
Senator Harkin. Thank you. I brought Newsweek, which asks:
How scared should we be?
It is almost the same cover.
Well, thank you for your leadership in this area, Senator
Hagel.
Now I turn to Senator Edwards. Senator Edwards, I know you
have spoken to me a number of times about this issue and your
concern about it, and your focus on working with Senator Hagel
to develop this legislation. So we do appreciate that, and we
thank you for your leadership, and thank you for being here
this morning.
STATEMENT OF HON. JOHN R. EDWARDS, U.S. SENATOR FROM
NORTH CAROLINA
Senator Edwards. Mr. Chairman, thank you very much, and
Senator Byrd, we thank you for your critical time on this
issue. I think what this hearing shows, Mr. Chairman, is that
the Senate is prepared to deal with not just the terrorist
attacks of the past, but also the potential terrorist attacks
of the future. I want to begin, as Senator Hagel did, by
commending my colleagues Senators Kennedy and Frist, who have
been leaders along with members of this subcommittee on this
issue for years.
We fully endorse their request for additional resources. I
do believe, though, Mr. Chairman, in addition to additional
resources, we are also going to need to see some changes in our
policies to deal with the national security threat to our
country.
Let me start, Mr. Chairman, if I could, by asking you and
others to picture in your mind's eye what a biological attack
would look like. First, there would be no explosion. There
would be no plane crash. There would be no catastrophic event
of any type. Instead, it would be a silent attack. It may not
be seen for days, or even weeks, and it would first show up, as
Senator Byrd described, as a case that looked very much like a
bad cold or the flu in a hospital on one side of town. Then you
would have another case with a child on the other side of town,
and then you would have a case out in the county somewhere at a
hospital, or seen by a primary care provider.
The critical question is, how much time passes before we
recognize that there is something more than a cold or the flu
going on, and the only people who can make that determination
are your local emergency room personnel, the local health care
providers, primary care physicians, and local nurses. Those are
the people. They are our first line of defense in any kind of
biological attack, and they are the key.
We could have all the teams in the world with extraordinary
expertise gathered together in Washington, DC, but if these
people who are on the front lines of providing health care
across the country are not ready, it is very difficult for us
as a Nation to be ready. Senator Frist talked about how few, if
any, of these people have ever seen a case of anthrax or
smallpox. They do not know what to look for, what the symptoms
are, and they also do not know how to react.
That is the reason, Mr. Chairman, we are not adequately
prepared, but all of us are here to say to the American people,
we will be, and we are committed to being completely prepared.
It is not flashy, it is not high tech, but it is the key to
getting us ready to respond to the potential for a serious
biological attack on our country.
I want to also commend Secretary Thompson for the work he
has done. He knows from being Governor how critical these
primary care providers are, and how critical they are to our
response.
Senator Hagel mentioned he and I have offered legislation
in addition to complementing the work that has been done by
Senators Kennedy and Frist. There are two components of our
legislation that we hope builds on the work that they have
done.
One component is that we have a significant amount of
money, $555 million, specifically in the form of block grants
that go to State and local agencies, so that we do not have the
money staying in Washington, DC, but we in fact get it to the
front lines, to those people that we have all talked about this
morning that are so critical in any sort of response on a
national level to a biological attack, to get them trained, get
them educated, get them prepared to put a disease surveillance
system in place so that they could communicate the information
among themselves to the people who need to know.
The second area that we have added is the issue of
agriterrorism, of which both Senators Kennedy and Frist have
made mention. Everyone recognizes this is a serious issue. We
have $100 million in the form of block grants for agricultural
terrorism, and $350 million for food safety, and also in the
area of Federal Government programs for agricultural terrorism.
So we are working with our colleagues. All of us are
committed to do what is necessary. The work that Senators
Kennedy and Frist have done and have shown extraordinary
leadership on, along with the work of this subcommittee, has
been critical. The work that Senator Hagel and I have done I
think builds on that, first, by getting money directly to the
people who we believe need it most, the people who are going to
have to recognize that a biological attack has occurred and
coordinate the response to that biological attack, and second,
by dealing with the specific issue of agriterrorism and food
safety, which all of us are concerned about and recognize is a
serious national threat.
So Mr. Chairman, what I would say, and I think all of us
would say to the American people, while we may not be fully
prepared at this moment to respond, we are committed to being
completely and totally prepared very quickly.
Thank you, Mr. Chairman.
Senator Harkin. Senator Edwards, thank you for a great
statement. Thank you for your leadership on this issue in light
of what has been happening lately, and for working with Senator
Hagel and all of us to move this forward.
Senator Byrd. Mr. Chairman, may I ask a quick question? You
asked for $1.6 billion. Senator Frist and Senator Kennedy are
talking about $1.4 billion. How does your $350 million, your
$100 million, and your $555 million square with similar items
in their requests?
Senator Edwards. Senator Byrd, I think we have worked with
Senators Kennedy and Frist in coming up with these numbers. I
think it is a matter of how we describe the figures. In fact,
the additional money that is in our bill, in addition to what
Senators Kennedy and Frist are proposing, is primarily aimed at
agricultural terrorism, which is not something that is
specifically addressed in their request. I believe, though,
that our numbers are very much in line, because we have been
working with them.
Senator Byrd. And your initial request, let us say it could
be appropriated this year, what would it be, the initial
portion of the $1.6 billion?
Senator Edwards. I think it is a 1-year appropriation
request, Senator.
Senator Byrd. The $1.6 billion?
Senator Edwards. Yes, sir.
Senator Byrd. Then is that the case, Dr. Frist, with yours?
Senator Frist. Conceptually, about .4 of the $1.4 billion
needs to be for filling these gaps, and is ultimately going to
need to be factored into a baseline as we go forward. There are
just huge gaps in public health infrastructure and the like.
Conceptually, about $1 billion of that is in response to the
emergency money that needs to come in now. I do not know if it
would come out of the $20 billion that was mentioned. That
depends on how you determine it.
Of that $1 billion, just big picture overall, about 50
percent of that could be over a 2- to 3-year period.
Senator Hagel. Senator Byrd, our percentages are not unlike
what Senator Frist has said, too. We all recognize that, as
Senator Frist said, the infrastructure is not in place now to
be able to absorb that much resources coming within a 12-month
period.
Senator Byrd. Thank you. Thank you very much.
Senator Harkin. Thank you all very much. I thank Senators
Kennedy, Frist, Hagel, and Edwards for being here.
Now we will turn to Secretary Thompson, Secretary of Health
and Human Services, who we welcome. I want to welcome you,
Secretary Thompson, and commend you and your Department for its
rapid and professional response to September 11.
I understand, Mr. Secretary, you personally supervised
HHS's response to the attack, sending health officials to New
York to provide expertise and assistance in deploying Push
Packages of emergency materials, including pharmaceuticals,
that arrived in New York in under 7 hours. You are to be
commended for HHS's level of preparedness, and your calm and
speedy response to the crisis.
And with that, Secretary Thompson, your full statement will
be made a part of the record. I know that you are under some
time constraints. Welcome again to the subcommittee, and please
proceed as you so desire.
STATEMENT OF HON. TOMMY G. THOMPSON, SECRETARY,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
ACCOMPANIED BY DR. SCOTT LILLIBRIDGE
Secretary Thompson. Thank you very much, Mr. Chairman,
Senator Specter, other distinguished members of the
subcommittee. I appreciate very much this opportunity to appear
in front of you. I also want to thank Senators Kennedy and
Frist and Hagel and Edwards for their tremendous support and
their tremendous introduction of legislation that can be very
helpful.
I would like to thank you, Mr. Chairman, for your attention
to a subject that has long been of very much interest to me,
and has become a concern of all Americans since the terrorist
attacks.
The Department of Health and Human Services is responsible
for the public health responses to any biological or chemical
attack, as well as for disease surveillance and medical
preparedness. In the wake of September 11, there are questions
about how prepared our Nation is to respond to a biological
attack, and rightfully so.
Let me characterize our status this way. We are prepared to
respond, but there is much more that can and should be done to
strengthen that response. We have needs in the short term and
in the long term. At HHS we are aggressively pursuing those
needs so that we can build the strongest, most coordinated
response possible to a biological attack.
Let me outline for you this morning what steps have been
taken, what we are doing currently, and what our most pressing
needs really are. We made great strides in our preparedness in
the past 8 months, because the President and his administration
have made it a priority, designating Vice President Cheney to
lead a task force on this and just recently nominating Governor
Tom Ridge, an outstanding Governor, to head up the national
security.
For me, bioterrorism has been a concern for years. In fact,
after being nominated for this position last December, the
first briefing I received while still back in Wisconsin was on
bioterrorism, when we moved rapidly to make sure the Department
was improving its ability to respond. We began by making sure
we were better coordinated, not only within our Department and
the administration, but within the State and local partners who
depend so much on a strong and efficient response.
I moved bioterrorism into my immediate office, appointing
Dr. Scott Lillibridge, who is with me today, who is a doctor,
and at CDC as my Special Assistant for Bioterrorism. Dr. Scott
Lillibridge is one of the country's most respected bioterrorism
experts, and I charged him with making sure that the Department
was working in a coordinated and aggressive manner to
strengthen its capabilities. We sent a strong message to our
Department that this issue is a priority, and that we will be
ready.
We have also reached out to work more closely with the
State and local governments, but a lot more needs to be done in
that area. We have taken steps to improve our pharmaceutical
stockpiles, and made investments in research in our public
health infrastructure. In fact, this week we sent another $10
million out to 25 cities through the metropolitan medical
response system to go from 97 cities to 122 cities that have
the expertise to handle bioterrorism, and just this past week,
we accelerated the production of a new smallpox vaccine.
We brought together CDC, NIH, FDA, manufacturers, and some
outside consultants, and we have developed an accelerated plan
that would produce the new smallpox vaccine by mid to late next
year, and 40 million doses were to be delivered in the year
2005. Now it will be delivered in the year 2002. This shows how
aggressively we are striving to strengthen our readiness and
our response, but my confidence in our ability to respond comes
from how our Department performed on September 11.
We had two major cities, as all of us know, that were
simultaneously hit with terrorist attacks. When we began to
respond that morning, we did not know if there was bioterrorism
involved, and we did not know how many injuries or casualties
there would be, and yet we immediately implemented our health
alert system at the Centers for Disease Control. We contacted
all the State health departments and put tham on alert, saying
that if you see something suspicious, please contact us. This
immediately put State and local health departments on alert for
anything unusual or mysterious in terms of illness.
We also put 81 health laboratories across America on alert
so that they could analyze any blood samples or any tissue
samples that came in.
We then activated our national disaster medical system,
which comprises 90 DMAT teams, or 7,000 medical professionals
across America. We ended up that day sending five of these DMAT
teams in to the City of New York, teams of doctors and nurses,
over 200 individuals, as well as EMT's, and four to the
Pentagon within hours on that first day. These medical teams
were on the ground, supplementing the local health care system.
In addition, we sent mortuary teams to New York, Virginia,
and Pennsylvania to assist with identification and with the
fatalities. Within the first 24 hours, we sent from CDC a group
of 35 epidemiologists. Now that has been increased to 55, to
also help supplement local medical needs. These highly trained
experts were in New York hospitals looking for any signs of
bioterrorism, or the potential for any outbreak of disease as a
result of the damage.
For the first time ever, we sent a Push Pack containing 50
tons of medical supplies to New York City. We have eight of
these packs strategically located throughout the country, and
they are supposed to arrive at any location within 12 hours. We
were able to deliver that Push Pack to the City of New York
within 7 hours.
This is the first time our emergency response system had
been tested at this extreme level, and they responded without a
hitch. Granted, we did not find any signs of bioterrorism, but
we were there quickly. We had experts looking for any problems,
and we were prepared to move rapidly to contain and treat any
problematic disease. That response encouraged me, I believe it
should encourage this committee and the Congress, and it should
encourage the American public that we do have the ability to
respond.
Now, I by no means contend that our system is perfect or
without weaknesses. We have gaps. We can, indeed, make our
responses stronger, and it is imperative, ladies and gentlemen,
that we do so. We must continue to accelerate our preparedness
efforts, and that is going to require a strong partnership with
this committee and with Congress.
Frankly, bioterrorism preparedness has not been the highest
fiscal priority in the past, as it competed with other public
needs. My hope is that this will change as a result of greater
awareness of our needs. Here are the areas in which we need to
move more aggressively. You heard a lot about it today, and the
first one, and by far it surpasses anything else, is our local
public health infrastructure. Without question, this is our
greatest need.
We must continue working with State and local public health
systems to make sure that they are strong and prepared. This is
going to include developing response and contingency plans,
making sure that they have the tools to respond in educating
their medical community. A strong and coordinated response
between Federal, State, and local Governments is absolutely
essential and fundamental to our ability to respond effectively
and in an emergency. We must continue to strengthen that
partnership.
We also need to make sure that doctors and medical
professionals are able to get the continuing education and
training that they will need to be astute in the area of
identifying diseases from a biological attack. To supplement
this effort, we plan to hold a bioterrorism conference every
year for emergency medical professionals, the Nation's best
experts and scientists will keep them up to speed with the
latest in preparing for, identifying, and treating diseases
from biological warfare.
We would also benefit from expanding the number of slots--I
know that is something Senator Specter has been very interested
in, and I applaud him for it--and that is in the CDC Epidemic
and Intelligence Service, so we have moved highly trained
experts in the field of identifying diseases. In fact, I would
recommend to this committee that the Federal Government
consider paying and placing more EIS graduates in State health
departments. Currently, there are 42 EIS experts in the States,
but we must make sure that every State has at least one of
these EIS epidemiology specialists in their health departments,
and we should add more to the States that could use the extra
resources.
This program, ladies and gentlemen, would put uniquely
trained individuals on the ground in each State who can be a
valuable resource for public health departments in educating
and training their medical community, as well as helping to
identify anything suspicious or unusual.
Also in regard to public infrastructure I have created an
advisory committee of public health experts, and I have asked
Dr. D. A. Henderson, who is the doctor that led the eradication
of smallpox, to lead that, including State and local officials.
They are going to help us and assist us in devising the most
effective and rapid ways to strengthen our local preparedness,
and I have asked the Nation's Governors, public health
agencies, public health industries--I met with the American
Medical Association, the American Health Association last week
and asked them to convene a summit with the Department in order
to discuss bioterrorism.
I have spent the past few weeks meeting with leaders in the
biotech, the medical device, the pharmaceutical insurance
industries, as well as the major medical societies. They agreed
that we need to work more closely together in the public and
private sectors to make sure there are no weaknesses in our
biodefense. We must continue investing in our local health care
systems so that we are ready to respond in a very effective and
coordinated manner in the event of a catastrophe.
The second area, pharmaceuticals, we must continue to
accelerate the production of vaccines and antibiotics, invest
in the research, bolster our stockpiles and more Push Packs. I
would like this committee and Congress to add two more Push
Packs to our arsenal, making more emergency medical supplies
available throughout the country. After our New York experience
in deploying a Push Pack for the first time, we are doing a
review of the packages and their contents. The packages
performed well, and yet we expect to further strengthen the
Push Packages by better organizing them in terms of contents.
For example, we are in the process of developing a Push
Package specifically for a chemical attack, and one
specifically for a biological attack. We want to continue
planning for tomorrow by making sure that the stockpile and the
Push Packs are as up-to-date as possible. The third area--and
Senator Harkin, this has been one of yours and Senator Durbin's
and my real passions, and that is food safety.
We need more inspectors. We have 750 inspectors in FDA to
ensure the safety of our food supply and to inspect 55,000
different sites. The FDA can use more help in monitoring our
food, for this is one area in which we are lacking, and which
we must be much more vigilant. We are aggressively working with
the food industry as well to make sure that their awareness is
appropriately heightened, and I thank you, Senator Harkin, for
your leadership, and they are taking the necessary steps to
secure the production and delivery of food.
Security, finally, we need continued help with improving
security of all of our facilities and the resources those
facilities hold. Public health is a national security issue. It
must be treated as such, especially in these times. Therefore,
we must not only make sure that we could respond to a crisis,
but that we are secure in defending our stockpiles, our
institutions, and our products, and throughout the past 3 weeks
I have spent a great deal of time meeting with Members of
Congress, the Senate and the House. We have discussed our
preparedness, our response, and our needs. I appreciate all of
your attention to this issue.
While I am personally confident in our ability to respond
because of the strides we have made in the past few months and
years, I appreciate this committee reaching out to determine
what we can do better, and what resources we need to become
stronger. This endeavor must be pursued in partnership not just
in this city, but within cities all across America. As a
Nation, we must deal with this sensitive issue in a rational
manner. People, Americans should not be scared, and believe
that they need to be gas-masked, and people should not be
frightened in using medicine and food. There is nothing that we
know of that would warrant such actions.
People should be vigilant, should be aware and alert. A
biological attack is certainly possible, but as President Bush
has said, we must not be intimidated. We must get back to
living our lives. Yes, we need to do more on bioterrorism, but
we are prepared to respond. The mission now is to accelerate
the efforts to strengthen that response and make sure that our
local public health systems are able to respond as well.
prepared statement
We are doing today what this country once thought it could
put off until tomorrow, and I applaud you. As always, I am
confident that you, this Congress and all Americans, will rise
to the challenge.
[The statement follows:]
Prepared Statement of Tommy G. Thompson
Mr. Chairman and Members of the Subcommittee, thank you for
inviting me here today to discuss the Department of Health and Human
Services (HHS) preparedness to respond to acts of terrorism involving
biological agents.
Among weapons of mass destruction, bioterrorism features several
characteristics that set it apart from other acts of terrorism
involving, for example, explosives or chemical agents. While explosions
or chemical attacks cause immediate and visible casualties, an
intentional release of a biological weapon would unfold over the course
of days or weeks, culminating potentially in a major epidemic. Until
sufficient numbers of people arrive in emergency rooms, doctors'
offices and health clinics with similar illnesses, there may be no sign
that a bioterrorist attack has taken place.
Three important points must be considered in bioterrorism
preparations. First, biological agents are easy to conceal. A small
amount may be sufficient to harm large populations and cause epidemics
over a broad geographic region. Second, the contagious nature of some
infectious diseases means that once persons are exposed and infected
they can continue to spread the disease to others. Third, in the most
worrisome scenario of a surreptitious attack, the first responders are
likely to be health professionals in emergency rooms, physician
offices, outpatient clinics, public health settings, and other health-
care activities rather than the traditional first responders. The
longer the terrorist-induced epidemic goes unrecognized and
undiagnosed, the longer the delay in initiating treatment and other
control efforts to prevent further infectious outbreaks.
The broad goals of a national response to bioterrorism, or any
epidemic involving a large population will be to detect the problem,
control the epidemic's spread and treat the victims. HHS's approach to
this challenge has been to strengthen public health infrastructure to
deal more effectively with epidemics and other emergencies, and to hone
our emergency health and medical response capacities at the federal,
state and local level. HHS has also worked to forge new partnerships
with organizations related to national security.
What has HHS been doing to prepare for this kind of event? Our
efforts are focused on improving the nation's public health
surveillance network to quickly detect and identify the biological
agent that has been released; strengthening the capacities for medical
response, especially at the local level; expanding the stockpile of
pharmaceuticals for use if needed; expanding research on disease agents
that might be released; developing new and more rapid methods for
identifying biological agents and improved treatments and vaccines;
improving information and communications systems; and preventing
bioterrorism by regulation of the shipment of hazardous biological
agents or toxins.
Several HHS agencies play a key role in our preparedness for
terrorist events, including the Office of Emergency Preparedness (OEP),
the Centers for Disease Control and Prevention (CDC), the Food and Drug
Administration (FDA), and the National Institutes for Health (NIH).
In order to advance an orderly and comprehensive approach to the
many issues involved in such preparation, in July of this year I
appointed a special assistant within the Immediate Office of the
Secretary to lead the Department's bioterrorism initiative. I have
directed this individual, Dr. Scott Lillibridge, to begin creating a
unified HHS preparedness and response system to deal with these
important issues. Under my direction, Dr. Lillibridge will provide
executive leadership and organizational direction for HHS budget,
policy, and program implementation on terrorism preparedness issues.
Let me assure you that this is a top priority for me and for my entire
Department.
We are striving at HHS to strengthen our readiness and response,
and our ability to respond has been greatly improved over the last
several years. The system is not perfect, however, and we must continue
to accelerate our preparedness efforts.
improved surveillance is key to detection
If a terrorist used a biological or chemical weapon against the
civilian population, how quickly the outbreak is detected, analyzed,
understood and addressed would be the responsibility of state and local
public health jurisdictions and the Centers for Disease Control and
Prevention.
The CDC has used funds provided by the past several congresses to
begin the process of improving the expertise, facilities and procedures
of state and local health departments and within CDC itself related to
bioterrorism. CDC has established a Bioterrorism Preparedness and
Response Program within its National Center for Infectious Diseases to
direct and coordinate their activities. CDC has a dedicated anti-
bioterrorism staff of more than 100 full-time professionals comprising
expertise in epidemiology, surveillance, and laboratory diagnostics.
Over the last three years, the agency has awarded more than $130
million in cooperative agreements to 50 states, one territory and four
major metropolitan health departments to support,
(1) Preparedness planning and readiness assessment;
(2) Epidemiology and surveillance;
(3) Laboratory capacity for biological or chemical agents; and
(4) The Health Alert Network (a nationwide, integrated, electronic
communications system).
The CDC has launched an effort to improve public health
laboratories that likely would be called upon to identify a biological
or chemical attack. The Laboratory Response Network (LRN), a
partnership among the Association of Public Health Laboratories (APHL),
CDC, FBI, State Public Health Laboratories, DOD and the Nation's
clinical laboratories, will help ensure that the highest level of
containment and expertise in the identification of rare and lethal
biological agents is available in an emergency event. The LRN also
includes the Rapid Response and Advanced Technology Laboratory at CDC,
which has the sole responsibility of providing rapid and accurate
triage and subsequent analysis of biological agents suspected of being
terrorist weapons.
The CDC is also working to provide coordinated communications in
the public health system, between federal agencies and between public
health officials and the public itself. To this end, CDC has the
``Epidemic Information Exchange (EPI-X).'' The EPI-X is a secure, Web-
based communications network that will strengthen bioterrorism
preparedness efforts by facilitating the sharing of preliminary
information about disease outbreaks and other health events among
officials across jurisdictions and provide experience in the use of a
secure communications system.
CDC has invested $90 million in the Health Alert Network (HAN), a
nationwide system that will distribute health advisories, prevention
guidelines, distance learning, national disease surveillance
information, laboratory findings and other information relevant to
state and local readiness for handling disease outbreaks. HAN provides
high-speed Internet connections for local health officials; rapid
communications with first responder agencies and others; transmission
of surveillance, laboratory and other sensitive data; and on-line,
Internet- and satellite-based distance learning. With the addition of
several recent awards, CDC has provided HAN funding and technical
assistance to 50 state health agencies, Guam, the District of Columbia,
three metropolitan health departments and three exemplar Centers for
Public Health Preparedness.
CDC also manages the National Pharmaceutical Stockpile (NPS), which
provides us with the ability to rapidly respond to a domestic
biological or chemical terrorist event with antibiotics, antidotes,
vaccines and medical materiel to help save lives and prevent further
spread of disease resulting from the terrorist threat agent. The NPS
Program provides an initial, broad-based response within 12 hours of
the federal authorization to deploy, followed by a prompt and more
targeted response as dictated by the specific nature of the biological
or chemical agent that is used. The first emergency deployment of the
NPS occurred in response to the tragedy in New York city.
Because food may be a likely medium for spreading infectious
diseases, FDA as well as CDC have enhanced their surveillance
activities with respect to diseases caused by foodborne pathogens.
PulseNet, a national network of public health laboratories created,
administered and coordinated by CDC in collaboration with FDA and USDA,
enables the comparison of bacteria isolated from patients from
widespread locations, from foods and from food production facilities.
This type of rapid comparison allows public health officials to connect
what may appear to be unrelated clusters of illnesses, thus
facilitating the identification of the source of an outbreak caused by
intentional or unintentional contamination of foods.
bioterrorism preparedness and response
HHS coordinates and provides health leadership to the National
Disaster Medical System (NDMS), which is a partnership that brings
together HHS, DOD, FEMA, and the Department of Veterans Affairs (VA).
The NDMS provides medical response, patient evacuation, and definitive
medical care for mass casualty events. This system addresses both
disaster situations and military contingencies. More than 7,000 private
citizens across the country volunteer their time and expertise as
members of response teams to support this effort. This system also
includes approximately 2,000 participating non-federal hospitals. VA
and DOD's expertise and resources are critical to many key aspects of
NDMS response, and I would note that these Departments have
distinguished themselves on many occasions.
In most localized disasters, including the scurrilous attacks on
the World Trade Centers in New York and the Pentagon here in
Washington, HHS organizes its medical field response through the Office
of Emergency Preparedness using a team structure. Teams can include
Disaster Medical Assistance Teams, specialty medical teams (such as
burn and pediatric), and Disaster Mortuary Teams. In addition, National
Medical Response Teams are able to deploy to sites anywhere in the
country with a supply of specialized pharmaceuticals to treat up to
5,000 patients. Currently, HHS can draw on 27 such teams that can be
federalized and deployed to assist victims. Such teams have been sent
to many areas in the aftermath of disasters in support of FEMA-
coordinated relief activities.
HHS, through OEP, has the capability to mobilize NDMS resources,
the Public Health Service's Commissioned Corps Readiness Force, as well
as enlist the support of other federal agencies, such as DOD and VA, to
help provide needed medical and public health services to treat
disaster victims. In the last few years, these assets were deployed to
New York, Florida, Texas, Louisiana, Alabama, Mississippi, the Virgin
Islands and Puerto Rico in the aftermath of hurricanes and tropical
storms, and to New York and Virginia in response to the events of
September 11, 2001.
However, regional or national response to a health emergency
involving bioterrorism will also require that additional capacities be
in place at the state and local level before the disaster strikes. HHS,
primarily through CDC, is supporting state and local governments to
strengthen their surveillance, epidemiological investigation and
laboratory detection capabilities, as well as continuing development of
a national stockpile of critical pharmaceuticals and vaccines to
supplement local and state resources.
The Office of Emergency Preparedness is working on a number of
fronts to assist local hospitals and medical practitioners to deal with
the effects of bioterrorism and other terrorist acts. Since fiscal year
1995, for example, OEP has been developing local Metropolitan Medical
Response Systems (MMRS). Through contractual relationships, the MMRS
uses existing emergency response systems--emergency management, medical
and mental health providers, public health departments, law
enforcement, fire departments, EMS and the National Guard--to provide
an integrated, unified response to a mass casualty event. As of
September 30, 2001, OEP will has contracted with 97 municipalities to
develop MMRSs. The fiscal year 2002 budget includes funding for an
additional 25 MMRSs (for a total of 122).
MMRS contracts require the development of local capability for mass
immunization/prophylaxis for the first 24 hours following an identified
disease outbreak; distribution of materiel deployed to the local site
from the National Pharmaceutical Stockpile; local capability for mass
patient care, including procedures to augment existing care facilities;
local medical staff trained to recognize disease symptoms so that they
can initiate treatment; and local capability to manage the remains of
the deceased.
training
HHS has used classroom training, distance learning, and hands-on
training activities to prepare the health and medical community for
contingencies such as bioterrorism and other terrorism events. For
example, in fiscal year 1999, Congress appropriated funds for OEP to
renovate and modernize the Noble Army Hospital at Ft. McClellan,
Alabama, so the hospital can be used to train doctors, nurses,
paramedics and emergency medical technicians to recognize and treat
patients with chemical exposures and other public health emergencies.
Expansion of the bioterrorism component of Noble Training Center
curriculum is a high priority for HHS.
HHS has been working closely with the Office of Justice Program's
(OJP) National Domestic Preparedness Consortium and we will continue
our excellent relationship with them. OJP and HHS have teamed together
to develop a healthcare assessment tool and have also delivered a
combined MMRS/first responder training program.
CDC has participated with DOD, most notably to provide distance-
based learning for bioterrorism and disease awareness to the clinical
community. CDC is now moving to expand such training with
organizations, such as the Infectious Disease Society of America
(IDSA), and Schools of Public Health, such as the Johns Hopkins Center
for Civilian Biodefense. The recent FEMA-CDC initiative to expand the
scope of FEMA's Integrated Emergency Management Course (IEMC) will
serve as a vehicle to integrate the emergency management and health
community response efforts in a way that has not been possible in the
past. It is clear that these communities can best respond together if
they are able to train together toward realistic scenarios that
leverage the best of both organizations.
conclusion
In conclusion, the Department of Health and Human Services is
committed to ensuring the health and medical care of our citizens. We
have made substantial progress to date in enhancing the nation's
capability to respond to a bioterrorist event. And, Mr. Chairman, the
Department is prepared to respond! But there is more we can do--- and
must do--- to strengthen the response. Priorities include strengthening
our local and state public health surveillance capacity, continuing to
enhance the National Pharmaceutical Stockpile, and helping our local
hospitals and medical professionals better prepare for responding to a
bioterrorist attack. Our mission is to accelerate these efforts.
Mr. Chairman, that concludes my prepared remarks. I would be
pleased to answer any questions you or members of the Subcommittee may
have.
Senator Harkin. Mr. Secretary, thank you for a very
poignant and well-stated statement. It was right to the point.
Two things I would observe before I ask just one question.
First, I just want to note for the record and recognize Mr.
Scott Lillibridge, who is with you as the Special Assistant for
Bioterrorism. You mentioned public health being part of
national security. I think that is a concept that we now really
have to think about. Public health is a part of our national
security, and so I applaud you for thinking about it in those
terms.
Second, there is a lot of talk, of course, about increasing
airport security and federalizing employees and making them
more professional. Again, I am glad that you noted in your
comments another part of our uniformed services that gets
overlooked a lot in our country, and that is the Public Health
Service Commissioned Corps. The Corps is one of our uniformed
services, and again, I think we need to do more to heighten
their public appearances out there so that people know who
these Commissioned Corps officers are, to elevate their status,
and to bring more people into the Public Health Service.
Secretary Thompson. Thank you for saying that, Senator. I
congratulate you.
Senator Harkin. I would like to work with you on that.
Secretary Thompson. Scott Lillibridge is a captain.
Senator Harkin. Well, that's good that he is in the
uniformed services, and we have got to do more to get
information on this out there to people, and we will work with
you on that. The only question I have, Mr. Secretary, and I
know your time is precious, in the next few weeks we are going
to be working, as Senator Byrd said, to allocate this $20
billion that we appropriated earlier. Again, we want to work
with you to get the resources you need for CDC, and the rest of
your Department. I understand that you have submitted certain
requests to OMB; you have submited a budget for this additional
funding, and they are reviewing it.
Can you provide this subcommittee with your professional
judgement of what those needs are, such as how much is needed
for stockpiling activities, the training you mentioned, the
local public health departments, the EIS people? We need to
have some of that information. If you cannot provide it now,
could you help get it to us? In other words, just as we are
asking Senators Kennedy and Frist where they think we need to
go, we need to ask you, also, where do you think we need to put
this?
Secretary Thompson. Thank you, Senator Harkin. I have to
defer until OMB makes a decision on my request, but my request
is very much in line with what Senators Kennedy and Frist have
indicated, and we have worked with Senators Kennedy and Frist's
staff, and we are relatively close on the numbers, not
completely, but I am very impressed by their proposal and where
they want to spend the money.
The public health system at the local level is where we
need to invest our dollars, and that is the area that I think
the Senators have indicated, what you talked about, Senator
Specter has talked about, and I applaud you for that, and that
is exactly what we need.
Senator Harkin. Thank you very much.
Secretary Thompson. I will get you more information by the
end of the week, as soon as OMB makes a decision.
Senator Harkin. Senator Specter.
Senator Specter. Thank you, Mr. Chairman. Secretary
Thompson, the day before yesterday I was at Lincoln University
in the Philadelphia suburbs, and was asked about protection for
the populace, and I was asked about gas masks, and I told them
I had no gas mask, and from what you have testified to I take
it you have no gas mask either.
Secretary Thompson. I do not, Senator.
Senator Specter. With respect to any special antibiotics to
counter any bioterrorism, I told them that Senators had no
special antibiotics. I take it you have none, either.
Secretary Thompson. I have none, but we have 400 tons of
that in our Push Packs for the American people at large.
Senator Specter. So that will be available to Secretary
Thompson and Arlen Specter, like any other citizens, with no
special preferential treatment for the Cabinet?
Secretary Thompson. No preferential for the Cabinet, I am
sorry to report, or the Congress.
Senator Specter. Well, that is what equal protection means,
Mr. Secretary.
Mr. Secretary, you have been quoted as saying that the
Government can, quote, handle any contingency right now. Your
statement in your oral testimony has been that the Government
is prepared to respond, but that there are gaps. Was that an
accurate quotation that the Government, quote, can handle any
contingency right now, and do you stand by that?
Secretary Thompson. We can handle, we think we can handle
any contingency dealing with bioterrorism at this point in
time, Senator, but we also understand that there needs to be
improvements, especially in the local public health system. I
mentioned that, and the quote that you mentioned, was on ``60
Minutes''. I went on to articulate that we need to invest money
in the local health system for education, for infrastructure,
and I also pointed out that I would like to see some EIS agents
that graduate from CDC's educational program after 2 years
placed in every State health department.
Senator Specter. Mr. Secretary, stay with C-SPAN. They do
not edit your comments.
I can understand your caution, and your measured words. How
would you respond to Dr. Steven Cantrill, who is going to
testify later, probably early this evening the way we are
proceeding so far--he is with the Emergency Medicine Department
at Denver Health Medical Center--when he said, quote, this
problem would only be partially alleviated by the dispatching
of Federal resources to a specific locale, and would be further
of no help if terrorists opt to involve dozens of metropolitan
areas simultaneously?
When you see the coordination of four hijackings, and
perhaps others which failed, and you see the level of
sophistication and their resources, what are the realities if,
as Dr. Cantrill says, dozens of metropolitan areas are attacked
simultaneously?
Secretary Thompson. How we have got it set up, Senator, is
we have the Health Alert Network, and we put that on notice.
Every one of the 50 State health departments immediately after
bioterrorism attacks, or even after the terrorist attacks on
September 11--they were notified, and we monitor State health
departments. They are supposed to feed into CDC any mysterious
outbreaks of any illnesses whatsoever.
We have also got 81 laboratories on notice that will be
able to analyze any blood or any samples, and we would send CDC
EIS specialists like Scott Lillibridge into communities if
there was any type of an outbreak, if we found anything
mysterious whatsoever, and they would get on the ground in that
community, in Denver, in Milwaukee, in Pittsburgh, and be able
to work with the State and local health departments.
Senator Specter. You did not mention Philadelphia.
Secretary Thompson. And Philadelphia, I am sorry, and we
would then be able to develop a plan, and if necessary move our
Push Package in, move extra personnel in. We have 7,000 DMAT
teams ready to be activated and placed into any particular
community.
I agree with the doctor that at the local level there needs
to be more education, more opportunities for research, and more
things--we think we could provide a good share of that through
CDC, Senator.
Senator Specter. Are the lights on? They should be set for
5 minutes so we can control the time, but I am going to
conclude here. Just very briefly let me ask you about the
comments of the GAO report, Mr. Secretary, which focused on the
lack of laboratory capacity for a large outbreak, and the lack
of hospital emergency capacity. How do you respond to those
accounts by the GAO?
Secretary Thompson. I think we do lack laboratory
capability and we do lack hospital space, and we discussed
that. I discussed that with the American Hospital Association,
I believe last Friday. I also discussed it with the Department
of Defense last week. I talked to Secretary Don Rumsfeld and I
asked if, in fact, we needed some mobile hospitals from the
Department of Defense, could we be able to use them, and he
said absolutely. We also asked them the same thing about
vaccines, dealing with anthrax, and the Department of Defense
said, absolutely.
Senator Specter. My final question relates to the issue
raised by the GAO regarding the adequacy of coordination with
the responsibilities being lodged in many departments, HHS, the
Department of Justice, the Department of Energy, the
Environmental Protection Agency, FEMA, and others.
Governor Ridge's duties have not been defined with any
precision, and in the speech that the President made, he talked
about a Cabinet-level position, a Secretary of Homeland
Defense, and now there is talk about an agency, and I think we
are really in the formative stage as to what is going to be
done here.
I am preparing some legislation in collaboration with
Senator Lieberman, and it is our view, or it is my view--we
have not worked it all out yet--that there ought to be Cabinet
rank and there ought to be a way to have some authority when
you start dealing with various Secretaries. Washington is
famous for turf battles, and absent----
Secretary Thompson. I am understanding that, Senator.
Senator Specter. I understand that you understand that. I
have seen that. I have seen some of the understanding back and
forth.
Now, I know you cannot speak for the President, but as a
judgment, if Governor Ridge is going to come in and do an
effective job, is he not going to need some line of authority
beyond having access to the President? To try to arbitrate
every single dispute, we know the reality is that simply cannot
happen. You have been very experienced in Government. Do you
think we need a Cabinet level position? Do you think we need
some specific statutory authorization which will enable
Governor Ridge to do an effective job?
Secretary Thompson. First off, I think Governor Ridge is
going to do an outstanding job. He is a wonderful individual,
and I think the President chose very wisely. I think the
President is looking at this. I have not been privy to those
discussions as such, and so I do not think I should be talking
for the White House on this subject, Senator.
Senator Specter. Thank you very much, Secretary Thompson.
Senator Byrd, Senator Harkin had to absent himself for a
few minutes. We are going to proceed in order of arrival:
Senator Byrd, Senator DeWine, Senator Landrieu, Senator Durbin,
Senator Murray, Senator Gregg, and Senator Kohl, and I think
Senator Gregg ought to be higher here. He came in earlier.
Senator Gregg. That is okay.
Senator Specter. Senator Byrd.
Senator Byrd. Thank you, Mr. Chairman.
Mr. Secretary, you indicated that 42 epidemiologists were
in the 50 States. I believe you said 42.
Secretary Thompson. That is correct.
Senator Byrd. You said we needed one in each State.
Secretary Thompson. I said at least one in each State.
Senator Byrd. How many States do not have at least one?
Secretary Thompson. I would think there are 13 at the
present time.
Senator Byrd. Including West Virginia?
Secretary Thompson. I am not sure about that, but I can
check and get back to you. I understand West Virginia does not
have one.
Senator Byrd. How much money do you need to have 13
additional epidemiologists?
Secretary Thompson. We have them, but we would have to give
money to the States, or put in a Federal position in the State
health departments. I do not exactly know. We think that we
should have at least one in each and every State, Senator. I
can get you the exact figures and send them to you without any
problem whatsoever.
Senator Byrd. Yes, if you would, please. Also, you
indicated that your proposal is pretty much like the proposals
that are being talked about by Senators Kennedy, Frist, Hagel,
and Edwards. How much difference is there in your amounts?
Secretary Thompson. There is some difference--I think,
Senators Hagel and Edwards, about $1.6 billion, I think
Senators Kennedy and Frist about $1.4 billion. I think ours is
a little bit under that, and we have made a proposal to OMB.
But together, there is very much uniformity in strengthening
the local public health systems and protecting food safety and
security.
Senator Byrd. How much do you need? If it could be
appropriated in the remainder of this calendar year, how much
do you need immediately?
Secretary Thompson. We think we need somewhere around $800
million.
Senator Byrd. May I ask, if you already have not done it,
that you break that down and send it to this committee
immediately?
Secretary Thompson. I have to wait till OMB makes a
decision, but I would be more than happy to give it to you.
Senator Byrd. If we could know what you are asking for.
Secretary Thompson. I certainly will, Senator. I will get
it to you by the end of the week.
Senator Byrd. Very well. Now, you mentioned local, State,
and Federal health officials, and you emphasized the problem
that exists in preparing the local and State officials to
adequately deal with a bioterrorism attack.
What is being done to establish clear channels of
communication between local, Federal, State, and other
officials to enable them to consult with one another in the
aftermath of a bioterrorist attack, and what do you think needs
to be done at the Federal level to best equip our State and
local health departments to effectively prepare for and respond
to a chemical or biological terrorist attack?
Secretary Thompson. The best thing we could do right now is
to connect every State health department and as many of the
local health departments as possible with our Health Alert
Network. We have a very sophisticated computerized system in
Atlanta through CDC. That is where the experts are in
infectious diseases, and what we need to do is expand that into
the regional and to local health departments. That would be the
best way to disseminate information as well as education from
CDC through the States down to the local levels.
The second thing is, putting, as you have indicated, these
EIS specialists in every State health department--at least one
and probably more. Third, we have got to put on more expanded
educational courses, especially for emergency doctors and
nurses that go into the emergency clinics. Fourth, we have got
to discuss how we would get the extra hospital beds if we
needed them in a surge capacity kind of situation.
Those are the four things, and it is communication, it is
education, it is personnel, and it is space.
Senator Byrd. Now, as to Federal resources to help bring
these things together, do you have a figure, and if so, has
that request been made to OMB?
Secretary Thompson. Those requests have been made to OMB,
and those requests have also been made by Senators Kennedy and
Frist in their proposal.
Senator Byrd. Would you mind adding that to the information
you are going to provide me?
Secretary Thompson. Absolutely, Senator.
Senator Byrd. One final question--and is the light red?
Senator Specter. I think it is yellow for you, Mr.
Chairman.
Senator Byrd. Mr. Secretary, reference has been made to
some of your public statements to the media. You have said, or
are supposed to have said, in a recent media interview that the
U.S. Government is: ``prepared to take care of any contingency,
any consequence that develops from any kind of bioterrorism
attack.'' That is a pretty broad statement.
Secretary Thompson. It is.
Senator Byrd. Do you stand by that today?
Secretary Thompson. I do.
Senator Byrd. Well, Mr. Secretary, I want to tell you in
the nicest way I know how----
Secretary Thompson. I said we could respond, and evidenced
by what we did on September 11, I am absolutely assured that we
could respond to any contingency and control it.
Senator Byrd. Well, will you still love me if I say to you,
I do not believe that?
Secretary Thompson. I still love you.
When you are the chairman of the Appropriations Committee,
I will love you even more, Senator.
Senator Byrd. That is a broad statement, and Washington is
so full of hyperbole and broad statements. We know, or we
should know, because we make them, too. They tell me that it is
a bad thing to do if we mislead, and I know you do not intend
to do that.
Secretary Thompson. I do not want to mislead. I want to
calm the American people so that people understand that we are
prepared.
Senator Byrd. Well, I just do not believe that, and I say
that to you very kindly. I think we ought to be very careful. I
try to be. Next year is my 50th year in Congress, and I have
heard a lot of broad statements made, and some of them were not
kept, but I hope that we will both be very careful what we say
in this matter. There is nothing more important. I want to help
you get the money you need. I want to do what I can.
Secretary Thompson. Thank you very much, Senator.
Senator Byrd. Thank you.
Senator Harkin. Secretary Thompson, I would support what
Senator Byrd just said. There is a lot of concern in the land,
but I think Americans are not going to be intimidated, or
reassured from what you testified to regarding the response on
September 11. Those categorical statements will not really
help, but the specification as to what is being done in
addition I think will be helpful. I think America will be
reassured that Senator Byrd spent a couple of hours at this
hearing, because he deals with the final markup in the
appropriations process.
Secretary Thompson. All I can say, Senator, is that we meet
on a daily basis with, I think, the best doctors and
researchers and scientists in the country--on a daily basis on
this subject, and Scott Lillibridge, if you would respond, are
we prepared?
Dr. Lillibridge. Let me say we are ready to respond, that
we have many, many things in progress for preparedness, and
that those things need to be accelerated. Many of those things
have been. There is a complex task before us, and I agree that
the public health infrastructure, the hospital community and
the other components need to move in lockstep.
Senator Specter. I would yield back to the new chairman and
call on Senator DeWine first.
Senator Harkin. If I just might interject, Senator DeWine,
if you would defer just a second, Mr. Secretary, I do not know
what your time is. I had information that you had to leave. I
hope that Senators would respect that, and please let us know
if you have something urgent that you have to go to. If you do,
we would respect that. Maybe Dr. Lillibridge could stay and
answer questions that are not answered by the time you have to
leave.
Secretary Thompson. Thank you.
Opening Statement of Senator Mike De Wine
Senator DeWine. Mr. Chairman, I will be very brief.
Mr. Secretary, thank you very much for joining us. I want
you to put your old hat back on as Governor and look at it from
the point of view of a Governor or local official. It seems to
me that we have an immense challenge, certainly not a challenge
we cannot meet, but it is an immense challenge.
My home State is probably not unusual. We have county
health departments, we have a State health department, we have
local fire departments, some entirely voluntary, some are
mixed, some totally paid, Nation-wide tens of thousands of
them, and within a State, so many different people that may be
the first line of defense, the first people who respond to the
problem, or maybe the first people who have to try to detect
that we do have a problem. From a Government point of view,
from a Governor's point of view, what do you think are the
biggest challenges, and how are we meeting those?
The second question related to that is, what has been your
consultation with Governors and with mayors and with local
officials?
Secretary Thompson. I think some States are better prepared
than others. As it is in any case, any issue you will find some
States excel in certain areas and are far superior to other
States. I think what Governors have got to do is, they have got
to work with the National Governor's Association, with the
Department of Health and Human Services, and with FEMA, and
they should be setting up an annual meeting, a summit on
bioterrorism preparedness, and I think it should be in
consultation with our Department.
In fact, I sent out a letter, Senator DeWine, asking the
National Governors Association to call such a summit as soon as
possible, in consultation with us. I think that is the best
way.
I think also that our local health support network is not
as strong as it should be, and I have said that many times, and
even though I think we are prepared to respond at the Federal
level, I do not believe that all State local health departments
are as ready as they need to be, and some of them will not be
able to recognize, some of them will probably not have the
education or the experience, and that needs to be strengthened.
That is why these EIS specialists that I am asking be put in
every State health department is so very important.
In regards to what I would suggest from Governors, I would
suggest that they come together and form an advisory committee
through the National Governor's Association to put together
more information, more education opportunities for local health
departments.
Senator DeWine. Thank you, Mr. Secretary. Thank you, Mr.
Chairman.
Senator Harkin. Thank you, Senator DeWine. Senator Durbin.
Opening Statement of Senator Richard J. Durbin
Senator Durbin. Thank you, Mr. Chairman. I want to thank
the subcommittee for their gracious hospitality. I will be very
brief, and speak to one particular issue, and it is one that
has been already alluded to in terms of my interest and Senator
Harkin's interest. We at this moment in history have a great
challenge and a great opportunity. For 40 years, we have been
debating bringing together under one agency food safety
inspection in America. Everyone is agreed in theory, and we
have been unable to do it.
We have, as I mentioned earlier, a dozen agencies, and 35
different laws. We have no standards that we can point to that
make any sense from the aspect of food safety or security.
Now we have a convergence of events here. We have the
election of a President who campaigned on creating such an
agency. We have a national challenge to deal with the safety
and security of our food supply, and I think we have a better
political environment than at any time in recent memory to
finally tackle this.
I would like to ask you, Mr. Secretary, two questions.
First, will you join with Senator Harkin and myself and people
from the administration to talk about the road map to move us
from where we are today to such an agency? How we might achieve
that in a timely fashion?
Secretary Thompson. Absolutely, without a doubt, I think we
need to discuss it. I am not sure that we need a separate
Department. I think put under the rubric of FDA we could handle
it. But I certainly would love to discuss it, because to me,
food safety has got to be uppermost in every one of our minds.
We have got to do a better job, and we have not invested the
resources.
I have got lots of ideas and I would like to share them
with you, Senator Durbin. I know you are passionate about it.
And Senator Harkin, I would love to be able to have the
opportunity to sit down with the two of you or your staffs or
whatever and discuss how we might be able to proceed to get
this job done.
Senator Durbin. I am going to have a hearing next week, and
I hope if you cannot attend that someone from your Department
can attend.
Secretary Thompson. I will try and attend.
Senator Durbin. Thank you very much.
The second point is fairly obvious. Once we have
established to our satisfaction the improvement and
modernization of our food safety inspection system, it is clear
that there will be countries around the world who export food
into the United States who will also want to be part of this
conversation so that they can export and we can import with
peace of mind.
I am hoping that we can then take whatever our initial
thinking is on this and expand it into a much larger dialogue
involving the European Union and other friendly, civilized
countries around the world that want to help us establish
standards of safety and security so that we can say to the
American people, our food supply is not only the safest in the
world today, it will continue to be, even if we bring in food
from overseas. So I hope that we can find a way to bridge our
conversation into a much larger context.
Secretary Thompson. I would like to make sure that we
invite Secretary Veneman, because I know she is also, as
Secretary of Agriculture, extremely interested in this subject,
and is very knowledgeable.
Senator Durbin. Thank you. Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Durbin. Senator Gregg.
Opening Statement of Senator Judd Gregg
Senator Gregg. Thank you, Mr. Chairman. Mr. Secretary, it
is a pleasure to discuss this issue with you.
The chairman, in opening this hearing, in fact went into
some length about the exercise Top Off, which was an exercise
which was energized as a result of the Commerce, State, Justice
Subcommittee of the Appropriations Committee and which we
discussed, in fact in this room about 4 months ago when all the
major Departments involved in terrorism testified, and one of
the conclusions which I think came out of that hearing was that
we did not have adequate coordination amongst our Departments
especially in a variety of areas, but especially in the area of
health care, and the doctors who were on the ground in Denver
who came and testified felt very strongly that that was the
case. I was wondering to what extent your agency has reviewed
the Top Off findings in Denver, and what conclusions you have
come to as a result of that.
Secretary Thompson. We have reviewed Top Off, we have
reviewed Dark Winter, and we have taken all of the suggestions
and conclusions in developing them, and we looked at the
problem. We have tried to come up with a solution--how we would
fix it--and that is what Dr. Lillibridge has been doing for the
last 5 months. He has been evaluating them, and I think we have
been making a lot of progress in that area. But coordination is
still a problem.
Senator Gregg. It is a huge problem. I congratulate the
President for bringing in Governor Ridge. I think that is going
to be a very significant effort in coordinating, but one of the
issues that was raised there was the availability of vaccine.
Today, as I understand it, there is no vaccine being
manufactured for anthrax, none for pneumonic plague, none for
botulism, and the smallpox vaccine is being manufactured both
for DOD and for HHS, but the HHS timetable is next year, which
I congratulate you on accelerating that, but basically, it
means we really do not have any current existing new product in
any of these areas, is that correct?
Secretary Thompson. That is correct. I would like to point
out, though, that NIH is doing a wonderful job of research in
coming up with some new vaccines. They are not there yet, but
there is a lot more money that has been put into Dr. Tony
Faucci's expertise in trying to come up with this.
Senator Gregg. What should we do at FDA, then, I guess is
my question, to assist us in accelerating this process?
Secretary Thompson. What we do about every morning, Dr.
Scott Lillibridge meets with Kathy Zuhn from FDA and several
other specialists, and we are looking at ways in which we could
expedite and move this along, and I would rather have Dr. Scott
Lillibridge answer that question.
Dr. Lillibridge. Let me just mention this in brief
discussion of the activities. It takes a lot of elbow grease
with the manufacturer, FDA, scientific experts, and our best
team from NIH, CDC, and FDA to get together and push this issue
forward. We have in the space of about 2 weeks begun to
accelerate smallpox vaccine production activity. We have a
timeline, we have a process, and again, as the Secretary
mentioned, we had a timeline of 2005, and we are moving it
down.
I think you also allude to the systemic problem of getting
at vaccines. A couple of things on the horizon--we are working
with the Secretary of Defense on finalizing plans and
collaborations on a Government-owned contractor-operated
facility for vaccines. We are reaching out to the manufacturers
in ways that we have not before. We have also invited foreign
manufacturers to come to the United States to present their
data about safety and efficacy, to get it expedited and
reviewed so we can use it to protect the population.
As for anthrax vaccine, the production facility is being
worked with almost on a weekly basis, daily basis with the Food
& Drug Administration to help that facility get into full
production shortly. And they anticipate in perhaps as soon as 6
weeks they will be able to resume production towards a licensed
product.
Senator Gregg. Is this Dynpor?
Dr. Lillibridge. I would hesitate to mention the
manufacturer, but suffice it to say, the manufacturer for
anthrax vaccine in this country.
Senator Gregg. Now, if we would put the Defense Department
in charge of manufacturing vaccines, which is essentially one
of the proposals, is that really the best approach? One of the
problems we had that I think it was that we stopped producing
pneumonic plague vaccine because we could not get the Defense
Department to be the big player.
Dr. Lillibridge. Sir, that is exactly right. As we looked
at this, it looks like it is going to require multiple
solutions, some with the Government, some with private
industry, some within regulatory issues that we have to work
through, and incentives across the industry, both public and
private partnership working together and looking at some of the
off-shore options as well to get complete coverage on all these
issues.
Senator Gregg. My time is about up, but should this be
decided by you folks or by the Defense Department or by the
Homeland Secretary, the decision as to where these
manufacturing capability occurs, and what the time line is, and
who is going to drive the process of getting it done?
Secretary Thompson. I think it should be done in
consultation with all three, plus this subcommittee and your
subcommittee.
Senator Gregg. Where does the buck have to stop?
Secretary Thompson. I think the buck has to stop on the
medical and health conditions. I think that has got to be the
determining factor.
Senator Gregg. Okay.
Secretary Thompson. Suffice it to say, it should be a
medical decision as much as possible.
Senator Harkin. Senator Kohl.
Opening statement of Senator Herb Kohl
Senator Kohl. Governor Thompson, good to see you.
Mr. Secretary, I appreciate the tremendous efforts you made
at your Department to respond to a biological attack, and I
know it is a comfort to many Americans to know that our
Government, through your efforts, is prepared, but the question
I most often get asked by my constituents back in Wisconsin is,
what should I do, not so much what are you doing, but what
should I do?
People want to know what they can do today to protect their
families from a biological attack. They ask questions like,
should they ask the doctors for vaccines, should they secure a
room in their house, should they make efforts to avoid public
places, or certain areas of the country, are there questions
they should ask their doctor to determine whether or not the
doctor is capable of recognizing the symptoms of a biological
attack?
Is the Department issuing recommendations or advice, Mr.
Secretary? In other words, what can you tell, or what would you
say to Americans all across our country today with respect to
what they can or should be doing to respond to this threat?
Secretary Thompson. I would strongly tell Mr. and Mrs.
Siddleson of Milwaukee, as I would Philadelphia, as I would San
Francisco, be very vigilant. Be very vigilant about your
activities, and anything suspicious, any kind of cold, or
anything mysterious dealing with your body. Illness or
infections or rashes or coughing, get to a doctor and ask that
doctor if he or she knows anything about smallpox, anthrax,
botulism and so on.
I would not suggest buy a gas mask. I would not suggest
that they go out and buy a lot of cyprofloxin, or doxycycline,
or penicillin. I would strongly just urge them to be more alert
than they have in the past. If there is anything that their
body is telling them, they should check with their doctor as
soon as possible, and they should ask their doctor if their
doctor knows things about bioterrorism.
Senator Kohl. All right, Governor. As you know, some of the
most advanced biological research in the world is occurring
every day at federally funded labs and our public universities,
including the University of Wisconsin, as you well know. We
also know that very important and vital research involves the
use of dangerous biological agents. Of course, we must secure
these labs and not allow these lethal pathogens to fall into
the wrong hands.
The CDC regulation that will go into effect next January
will require upgraded security measures at these labs. I read
in the paper that you said that you would like to expend funds
in order to increase security at Government labs. My question
to you is, what are we going to do at university labs?
Secretary Thompson. I think we should find ways to increase
the security in all of our laboratories. I think it is very
important, Senator Kohl. I am very happy you brought that up,
and if I might I would just like to ask Scott Lillibridge--I
forgot to do this--about getting vaccinated, because I think
this is a question that a lot of people--and I think that we
have looked at it, and we would strongly suggest that that is
not the best way to go. Scott.
Dr. Lillibridge. Thank you, sir. I have two things I wanted
to mention. Although the public health infrastructure is weak
and we are investing in the infrastructure to improve
surveillance, the laboratory science, and health alerting, our
medical community and our public health officers have never
been better in history. They have had more information, better
education, local people must still trust and seek advice
locally. I do not want to dissuade anybody from doing that.
The first issue, of course, in lockstep with, do we need
gas masks, is, do we need vaccinations at this time, and the
answer is no. We are not taking them in our senior management,
nor are we recommending them to the population, and the primary
reason is that most of the things we deal with have an
incubation period. And second, in the absence of disease, we
would be confronted with large numbers of side effects.
Senator Kohl. But don't you, or don't we vaccinate our
soldiers before they get involved in situations in which they
may be threatened?
Dr. Lillibridge. Well, I will not speak to the DOD
vaccination policy on soldiers in combat or staged in potential
combat areas, but we think the risks for civilians are
different.
Senator Kohl. Is it because we do not have enough to
vaccinate all Americans today?
Dr. Lillibridge. No, sir. The primary issue is health and
safety, and our confidence that we would use those at the time
of crisis to be able to control the epidemic.
Senator Kohl. That is fine, and I will not spend too much
time contending that with you, but it does seem not to answer
the question of why would we vaccinate our military personnel
as they are entering combat, but not suggest that the civilian
population needs the same kind of protection. I do not think
you have really responded to that in a way that I understand.
Dr. Lillibridge. Well, let me just add, then, that the
policies of the Department of Defense on vaccination have to do
with practical situations, expected exposures, and the way they
deploy their troops in high-risk areas. Looking at what we know
and the way we respond now, we do vaccinate for illnesses that
are present in the population. A case in point, childhood
immunizations. However, we do not vaccinate nor recommend in a
public health standard at this time to vaccinate the public for
illnesses that are not moving through the population if we have
the capacity to respond accordingly.
The other thing, in specific anthrax in the military, the
Department has taken the position that our response--primary
response modality--is not vaccine. It is antibiotics for 30 or
60 days, for a length of time to treat and prevent the illness,
and that makes it a little different for us on that issue.
As for smallpox, again there is an incubation period, and
we can target the vaccine most effectively. If you look back at
the smallpox eradication campaigns, it was not area vaccination
that controlled the outbreak, it was targeted surveillance and
containment that helped us control the outbreak, and we would
do likewise if that would recur in this country.
Senator Kohl. I just would like to get an answer from you,
Governor, on whether or not there will be some Federal funds
available to help university labs meet new security
requirements.
Secretary Thompson. I cannot answer that, Senator Kohl. I
wish I could, but I cannot. A lot depends upon the request we
put into OMB. A lot depends upon Senators Kennedy and Frist's
proposal. I do not think they put that kind of money in for
securing labs on our universities, but I think it is something
that States should certainly consider strongly.
Senator Kohl. Thank you. Thank you, Mr. Chairman.
Senator Harkin. Thank you very much, Mr. Secretary, for
being so generous with your time and your expertise, and thank
you for your leadership on this issue. Again, following up on
Senator Durbin's comments, we look forward to working with you.
Secretary Thompson. I appreciate that. Thank you very much.
Senator Harkin. We will now turn to panel 3. I would like
to call to the witness table Jonathan Tucker, Stephen Cantrill,
Jerome Hauer, Patricia Quinlisk, and Rex Archer. I thank this
panel for being so patient and for being here this morning.
Some of you are coming a great distance.
I will again state that all of your statements will be made
a part of the record in their entirety. We would be
appreciative if you could summarize them succinctly and hit the
high points for us. We would appreciate that so we might get
into a generalized discussion with you, the experts in this
area, and we will just go down the line in which I called the
names, or in which I have them listed here.
First I would recognize Dr. Jonathan Tucker, who directs
the Chemical and Biological Weapons Nonproliferation Program at
the Monterey Institute of International Studies, and is the
editor of Toxic Terror: Assessing Terrorist Use of Chemical and
Biological Weapons. He is also the author of Scourge: The Once
and Future Threat of Smallpox.
Dr. Tucker, welcome to the committee.
STATEMENT OF JONATHAN TUCKER, Ph.D., DIRECTOR, CHEMICAL
& BIOLOGICAL WEAPONS NONPROLIFERATION
PROGRAM, MONTEREY INSTITUTE OF
INTERNATIONAL STUDIES
Dr. Tucker. Thank you, Mr. Chairman. Mr. Chairman,
distinguished members of the subcommittee and guests, many
thanks for the opportunity to testify before you today on a
concern that has gripped the Nation in the wake of the
September 11 terrorist attacks on the World Trade Center and
the Pentagon, which is the possibility that terrorists might
escalate their horrific campaign of death and destruction by
resorting to the use of unconventional weapons, including
biological pathogens.
Although experts disagree on the ease with which terrorists
could acquire and use biological agents, many studies have
concluded that the threat of bioterrorism against the United
States is growing, and that the Nation is not adequately
prepared to handle even a medium-sized biological attack. With
a potential health emergency in the making, time is of the
essence in reducing our vulnerability to this threat, and I
believe there is much we can do in the near term.
It is important to note that bioterrorism and the growing
challenge of national emerging infectious diseases are two
sides of the same coin. Both phenomenon would manifest
themselves in an unusual outbreak of infectious disease, one
that would have to be rapidly detected, identified, and
contained to minimize the harmful consequences. Because some of
the most deadly biological warfare agents such as anthrax and
plague respond to antibiotics administered during the early
phase of the infection, prompt diagnosis and treatment could
save many lives.
In the case of a contagious agent, rapid containment by
isolation and vaccination could prevent further spread. Both
the emerging infection and bioterrorist threats can be
addressed most effectively by strengthening the Nation's public
health systems, which unfortunately have been allowed to
atrophy over the past several decades.
In the event of a major outbreak of disease, whether the
result of a natural emerging infection or a deliberate
terrorist attack, city, county, and State health departments
would be the Nation's first line of defense, backed up by the
medical detectives and virus centers at the CDC, the National
Institutes of Health, and other Federal agencies.
The first indication of an unusual disease outbreak, as
others have testified today, would be when the initial victims
became ill and sought treatment at emergency rooms and doctor's
offices. For example, a group of people in an urban
neighborhood or an office building who were infected by a
covert bioterrorist attack might come down days later with
nonspecific, flu-like symptoms.
Today, I believe it is essential to bridge three critical
gaps that would seriously impede the Nation's ability to detect
and respond rapidly to an unusual outbreak of disease. The
first gap in the U.S. infectious disease surveillance system is
between primary care providers and public health departments.
Today, disease surveillance systems in the United States are
patchy in their coverage and lack adequate resources.
In the case of the West Nile virus in New York City, the
surveillance system worked. Reporting by an alert physician was
key to the early detection of the outbreak. Nevertheless, a
bioterrorist attack or serious natural outbreak of disease
would permit little margin for error. If health care providers
are to be effective sentinels of an epidemic, they must have
the necessary training and professional awareness to include
the possibility of emerging infections and bioterrorism in the
differential diagnosis. In addition, they must have direct
communication channels to the public health department, and be
able to report cases at any time, day or night.
The second gap in the Nation's infectious disease
surveillance system is between the human health and animal
health communities. Many emerging infectious diseases and
putative bioterrorist agents are zoonotic, which means that
they originate in animals but can also affect humans.
Given the considerable overlap of animal and human
pathogens, animals can serve as useful sentinels for outbreaks
of zoonotic diseases. The West Nile investigation, however,
exposed a major gap between the veterinary and public health
communities. Although the key to identifying the causative
agent lay in merging information from the parallel
investigations of the bird and human outbreaks, communication
between animal health and public health agencies was poor, and
what limited cooperation occurred was the result of informal
personal relationships, rather than official coordinating
mechanisms.
Finally, the third gap in the Nation's infectious disease
surveillance system is between public health specialists and
intelligence analysts. The dual threats of emerging infections
and bioterrorism pose major conceptual and technical challenges
for the U.S. intelligence community, such as distinguishing
between an actual outbreak of an emerging disease and the
deliberate release of a pathogen by terrorists.
Although the CIA has recruited a few microbiologists and
other scientists for its analytical staff, this solution is not
optimal, because scientists need to interact freely with
colleagues from other countries if they are to remain current
and well-informed. A better approach would be to provide for
routine exchanges of people and training between the U.S.
public health and intelligence agencies. To date, however,
sharp differences in organizational culture such as the need
for secrecy versus scientific openness have impeded interagency
collaboration in analyzing bioterrorist threats.
I would like to make a number of recommendations now on how
these three gaps can be filled. To bridge the first gap between
primary health care providers and public health practitioners,
I would recommend the following steps. First, the Department of
Health and Human Services should expand the national program of
awareness training by professional medical societies for
primary health care providers, including health care
practitioners, emergency room physicians, and nurse
practitioners.
Second, the Department should provide grants to State and
local public health agencies to establish simple reporting
mechanisms and clear communication channels between medical
practitioners and city, State, or county public health
departments, including 24-hour telephone or e-mail hotlines to
respond effectively when doctors call, day or night. State and
local health departments will need additional funds to hire
more staff members with expertise in infectious disease
epidemiology and information technology.
To briefly summarize my other recommendations on the need
to bridge the second gap between human and animal health
communities, I recommend that the Department of Health and
Human Services and Department of Agriculture establish a
surveillance network that covers livestock, zoo animals, and
wildlife so that unusual patterns of zoonotic disease will be
reported promptly to State and local health departments.
And to bridge the third gap between public health
specialists and intelligence analysts, I recommend the
Department of Health and Human Services establish formal
exchanges of people and training between public health agencies
such as CDC and Federal intelligence services.
In conclusion, Mr. Chairman, the natural emergence of a
deadly and contagious infectious disease such as the Spanish
flu of 1918, or the deliberate release of anthrax or some other
pathogen as an act of bioterrorism could result in serious loss
of life and social disruption. Unless corrected, the three gaps
that currently exist among the U.S. medical, public health,
animal health, and intelligence communities could seriously
delay detection of the resulting disease outbreak and impede
the prompt response needed to minimize its medical impact and
social consequences. Bridging these three gaps will be
essential if the Nation is to be better prepared to deal with
the dual threats posed by emerging infections and bioterrorism.
prepared statement
The good news is that, despite the anxieties we all share
today over this issue, the U.S. Government can take practical
steps to reduce the threat. Improved disease surveillance,
combined with other preparedness measures, may make it possible
in the not-too-distant future to render biological weapons in
the hands of terrorists, to borrow a phrase from President
Ronald Reagan, impotent and obsolete.
Thank you.
[The statement follows:]
Prepared Statement of Jonathan B. Tucker
Mr. Chairman, distinguished Members of the Subcommittee, and
guests: Many thanks for the opportunity to testify before you today on
a concern that has gripped the nation in the wake of the September 11
terrorist attacks on the World Trade Center and the Pentagon: the
possibility that terrorists might escalate their horrific campaign of
death and destruction by resorting to the use of unconventional
weapons, including biological pathogens. Although experts disagree over
the ease with which terrorists could acquire and use biological
weapons, many studies have concluded that the threat of bioterrorism
against the United States is growing, and that the nation is not
adequately prepared to handle even a medium-sized biological attack.
With a potential health emergency in the making, time is of the essence
in reducing our vulnerability to this threat, and I believe there is
much we can do in the near-term.
It is important to note that bioterrorism and the growing challenge
of natural emerging infectious diseases are two sides of the same coin.
Both phenomena would manifest themselves in the form of an unusual
outbreak of infectious disease-one that would have to be rapidly
detected, identified, and contained to minimize the harmful
consequences. Because some of the most deadly biological warfare
agents, such as anthrax and plague, respond to antibiotics administered
during the early phase of infection, prompt detection and treatment of
an outbreak could save many lives. With a contagious agent, rapid
containment by isolation and vaccination could prevent further spread.
The threats of emerging infections and bioterrorism can both be
addressed most effectively by strengthening the nation's public health
systems, which have been allowed to atrophy over the past several
decades.\1\ Back in the 1950s and 1960s, publicly supported community
hospitals and public health laboratories supported an effective early-
warning network for detecting and containing epidemics. Since then,
however, the shift to privatized medicine and managed care has largely
eliminated this system. Shortages of manpower and infrastructure in the
nation's public health departments have also impeded effective
epidemiological surveillance, leaving the public more vulnerable to
serious outbreaks of infectious disease.\2\
---------------------------------------------------------------------------
\1\ This testimony draws extensively on the following publication:
Jonathan B. Tucker and Robert P. Kadlec, ``Infectious Disease and
National Security,'' Strategic Review, vol. XXIX, no.
\2\ (Spring 2001), pp. 12-20. 2 Rick Weiss and Ellen Nakashima,
``Biological Attack Concerns Spur Warnings,'' Washington Post,
September 22, 2001, p. A04.
---------------------------------------------------------------------------
My testimony will briefly address the dual threats of bioterrorism
and emerging infectious diseases, point out some key gaps and
weaknesses in our current public health defenses, and conclude with a
number of practical policy recommendations for improving U.S. response
capabilities.
the threat of bioterrorism
Although it is unlikely that a small terrorist group working on its
own would have the technical and financial resources to carry out a
major bioterrorist attack on the scale of the September 11 event, a
state-sponsor might provide the terrorists with the necessary know-how,
seed cultures, and specialized dissemination equipment. Alternatively,
a wealthy terrorist organization might be able to recruit scientists
and engineers formerly employed by a state-level biowarfare program,
such as that of Iraq, South Africa, or the former Soviet Union. As the
biotechnology industry continues to spread rapidly around the world,
fermentation tanks and other equipment used to produce biological
warfare agents-much of which has commercial as well as military
applications-will become increasingly accessible to terrorists.
Moreover, given the current high level of public anxiety over
bioterrorism, even a relatively small-scale attack with anthrax or some
other biological agent could have a disproportionate psychological
impact, eliciting widespread panic and undermining trust in government.
Defense analysts also worry about the possible use of biological
agents by hostile states as a means of ``asymmetric warfare"-David-and-
Goliath strategies in which small countries would seek to circumvent or
blunt the conventional military supremacy of the United States and its
ability to intervene in regional conflicts. Such strategies might
involve the use of disease agents to attack troops or civilians,
destroy U.S. crops or livestock, or contaminate the nation's food
supply. Biological attacks could be carried out on a scale large enough
to hamper or deter U.S. intervention abroad, yet without crossing the
mass-casualty threshold that could credibly trigger nuclear
retaliation. Even in the face of U.S. deterrent threats, a rogue state
or terrorist group that believed it could carry out an attack without
attribution might be tempted to do so, particularly in the heat of
crisis or war.
A bioterrorist attack would probably involve the covert release of
a microbial pathogen that would give rise to detectable illness only
after an asymptomatic delay, or incubation period, when the
microorganism is multiplying in the host to cause disease. For example,
Bacillus anthracis, the bacterium that causes anthrax, has an
incubation period of roughly six days. Individuals who had been exposed
to an invisible aerosol cloud of anthrax spores would probably be
unaware at the time that they had been infected. The first evidence of
the attack would emerge days later, when the infected individuals, by
now widely dispersed, began to develop nonspecific, flu-like symptoms
such as fever, fatigue, cough, and chest discomfort. A few days later,
severe symptoms would set in, including pneumonia, sweating, anoxia
(causing the victim to turn blue), and death, if the disease remained
untreated. Anthrax is not-I repeat, not-transmissible from person to
person, but because the disease is generally fatal within 24 to 36
hours after the onset of severe symptoms, antibiotic therapy (possibly
combined with post-exposure vaccination to enhance the patient's immune
response) must begin as soon as possible to have any chance of success.
It is therefore essential to identify an outbreak linked to a
bioterrorist attack early, while the disease is still treatable.
An even more challenging scenario would involve the deliberate
release of a contagious agent, such as plague bacteria or smallpox
virus. Plague has an incubation period of one to six days, whereas
smallpox has an incubation period of roughly 12 to 14 days. By the time
the first cases of smallpox were diagnosed, the initial group of cases
would probably have infected close contacts, such as family and
friends. In this case, it would be essential to launch an aggressive
vaccination campaign to contain the epidemic before the infection
spread through the general population in a series of expanding waves.
the threat of natural emerging infections
In parallel to the emerging threat of bioterrorism, the United
States faces a growing problem of infectious disease from natural
sources. During the 1960s and 1970s, powerful antibiotic drugs and
vaccines appeared to have banished the major infectious scourges from
the industrialized world, leading to a sense of complacency and neglect
of programs for disease surveillance and prevention. Over the past two
decades, however, several well-known diseases, such as tuberculosis,
malaria, and cholera, have re-emerged in more virulent or drug-
resistant forms or have spread geographically. At the same time,
scientists have identified a host of previously unknown infections,
including Legionnaire's disease, AIDS, Lyme disease, Sin Nombre virus,
hepatitis C, ``mad cow disease,'' Nipah virus, and new strains of
influenza. AIDS was not recognized until the 1980s, yet it now infects
some 36 million people worldwide and kills 3 million annually. Since
1980, the U.S. death rate from AIDS and other infectious diseases has
increased by about 4.8 percent per year, compared with an annual
decrease of 2.3 percent for the 15 years before 1980.\3\
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\3\ National Intelligence Council, The Global Infectious Disease
Threat and Its Implications for the United States, NIE 99-17D, January
2000 [www.cia.gov/cia/publications/nie/report/nie99-17d.html].
---------------------------------------------------------------------------
Several factors have contributed to the problem of emerging
infections:
--The inappropriate use of antibiotic drugs has fostered the
evolution of resistant strains of tuberculosis and other
bacterial diseases, even as the development of new generations
of antibiotics has lagged.
--Ecosystem disturbances, such as clearing rainforests for economic
gain or human settlements, have altered the geographical
distribution of disease vectors such as rodents, monkeys, and
mosquitoes, increasing their contact with humans.
--Rapid population growth and rural-urban migration have given rise
to ``megacities'' in the developing world with poor public
health infrastructure, enabling diseases that once remained
isolated in rural areas to spread to large urban populations.
--The collapse of public health systems in Russia and other parts of
the former Communist world have fostered the spread of diseases
such as AIDS and drug-resistant tuberculosis.
--The rising volume of tourism, trade, and imported agricultural
goods associated with economic globalization has created new
opportunities for the introduction into the United States of
disease vectors and microbial pathogens from other parts of the
world.
Because most U.S. cities are within a 36-hour commercial flight of
any part of the globe, or less than the incubation period of many
infectious diseases, infected individuals may not be visibly ill when
they cross a U.S. border. The risk of disease importations is greatest
in major hubs of global commerce such as New York City, Los Angeles,
and Miami. Indeed, the source of the 1999 outbreak in New York of West
Nile encephalitis, a viral disease never before seen in the Western
Hemisphere, may have been travelers from the Middle East who were
incubating the disease or a stray infected mosquito on an airplane.
Having spread widely over the past three years, West Nile virus is now
permanently entrenched in the United States.
A future emerging infection introduced into our country could be
far more deadly. In the worst-case scenario, a new pathogen would have
the attributes of the 1918 strain of influenza virus, or Spanish Flu,
which was highly transmissible through the air and uncharacteristically
lethal to young, healthy people. This disease caused a global pandemic
that claimed more than 20 million lives in less than two years. The
speed at which the U.S. public health system could identify and contain
such an outbreak would mean the difference between life and death for a
large number of Americans.
current deficiencies in infectious disease surveillance
In the event of a major outbreak of disease-whether the result of a
natural emerging infection or a deliberate terrorist attack-city,
county, and state health departments would be the nation's first line
of defense, backed up by the medical detectives and virus hunters at
the Centers for Disease Control and Prevention (CDC), the National
Institutes of Health (NIH), and other federal agencies. The first
indication of an unusual disease outbreak would be when the initial
victims became ill and sought treatment at emergency rooms and doctors'
offices. For example, a group of people living in an urban neighborhood
or working in an office building that had been subjected to a covert
bioterrorist attack might initially develop nonspecific, flu-like
symptoms. Detection and containment of a disease outbreak would entail
four basic steps:
1. Recognition and diagnosis by primary health care
practitioners.--Medical clinicians would identify cases of an unusual
infectious disease or an undiagnosed ``syndrome'' (cluster of
symptoms). Clinical laboratories would then attempt to identify the
causative agent from patient blood, urine, or other specimens.
2. Communication of surveillance information to public health
authorities.--Physicians and infectious-disease specialists who had
detected an unusual pattern of disease incidence, such as several
patients with the same symptoms, would report their observations to
local or state public health authorities.
3. Epidemiological analysis of the raw surveillance data.--
Epidemiologists working for the health department would interpret the
disease-surveillance data to determine the source of the outbreak, the
mode of transmission, and the extent of exposure. They would then make
recommendations for appropriate treatment and public health measures
(e.g., vaccination) to contain the outbreak.\4\
---------------------------------------------------------------------------
\4\ Chemical and Biological Arms Control Institute, Bioterrorism in
the United States: Threat, Preparedness, and Response, Executive
Summary, November 2000, p. 12.
---------------------------------------------------------------------------
4. Delivery of the appropriate medical treatment and public health
measures.--Patients seriously affected by the disease would be admitted
to hospitals for treatment. Those infected with a contagious agent
would be isolated and all potential contacts vaccinated (if vaccine is
available) to prevent the disease from spreading.
Today, a major epidemic arising either from a natural emerging
infection or an act of bioterrorism would pose serious challenges to
the U.S. public health system in all four areas identified above.
Useful lessons can be drawn from the 1999 epidemic of West Nile
encephalitis in New York City, which revealed some serious gaps in the
existing system of disease surveillance and response. These gaps must
be remedied if the nation is to be better prepared in the future.
The first manifestation of the West Nile epidemic appeared in early
July 1999, when common birds such as sparrows, robins, and crows began
to die in unusual numbers in northern Queens and the South Bronx. One
month later, humans in the same area began to be stricken with
encephalitis, or inflammation of the brain, although a possible
connection with the bird die-off was not suspected at the time. The
human outbreak was detected when a physician at a hospital in Queens
admitted several elderly patients with an atypical form of encephalitis
that was accompanied by severe muscle weakness. Unable to diagnose this
condition, she took the initiative of reporting the unusual cases to
the New York City Department of Health. Recognizing the possibility of
an infectious disease outbreak, health department officials then called
doctors at 70 hospitals around the city and identified 30 similar cases
of encephalitis.\5\
---------------------------------------------------------------------------
\5\ Jennifer Steinhauer and Judith Miller, ``In New York Outbreak,
Glimpses of Gaps in Biological Defenses,'' New York Times, October 11,
1999.
---------------------------------------------------------------------------
In early September 1999, the Centers for Disease Control's
laboratory for vector-borne infectious diseases in Fort Collins, Colo.,
analyzed patient specimens from the New York outbreak and identified
the causative agent as St. Louis encephalitis virus. Three weeks later,
however, the CDC was forced to admit that its initial diagnosis had
been incorrect and that the infectious agent was actually West Nile
virus, a disease endemic to East Africa and the Middle East that had
never before been reported in the Western Hemisphere. The three-week
delay in reaching the correct diagnosis revealed some significant
deficiencies in the U.S. public health system:
--CDC scientists investigating the outbreak suffered from ``tunnel
vision'' by screening only for encephalitis viruses commonly
found in the United States and neglecting those linked to
foreign outbreaks or possibly developed for bioterrorism.
--CDC scientists repeatedly rebuffed a veterinary pathologist at the
Bronx Zoo who suspected a possible link between the bird and
human outbreaks. Community newspapers in northern Queens had
reported bird die-offs as early as late June 1999, or five
weeks before the first human cases were detected. If the
veterinary investigation had begun earlier and been pursued
more aggressively, it is possible that the human epidemic could
have been mitigated or even averted.
--Throughout the outbreak investigation, communication among the 18
participating local, state, and federal agencies was complex
and difficult, and was achieved primarily through conference
calls lasting several hours.
--The various city, state, and federal laboratories involved in the
case used different diagnostic techniques, making it difficult
to compare results.\6\
---------------------------------------------------------------------------
\6\ Marcelle Layton, M.D., M.P.H., ``Outbreak Surveillance and
Management at the State and Local Level: Current Realities,''
presentation at the Second National Symposium on Medical and Public
Health Response to Bioterrorism, Washington, D.C., November 28, 2000,
transcript.
---------------------------------------------------------------------------
This experience indicates the need for better information-sharing
at all levels, as well as a common database for disease surveillance
and laboratory tracking.
bridging the gaps
Today, the U.S. response to a serious epidemic resulting from an
emerging infectious disease or an act of bioterrorism would be
seriously constrained by poor communication and coordination among the
diverse array of federal, state, county, and city agencies responsible
for medical care, public health, animal health, law enforcement, and
intelligence collection. Efforts to improve interagency coordination
face formidable obstacles, including fragmented jurisdiction and
differences in organizational mission and culture among the various
players.
In particular, it is essential to bridge three critical gaps that
would seriously impede the nation's ability to detect and respond
rapidly to unusual outbreaks of disease. These disconnects exist
between: (1) primary care providers and the public health system, (2)
the human and animal health communities, and (3) public health experts
and intelligence analysts.
The Gap Between Primary Care Providers and Public Health Departments
Disease surveillance systems in the United States are patchy in
their coverage, and most rely on reporting by primary health care
providers. In the most common type of surveillance, physicians and
nurse-practitioners are required to report certain infectious diseases
or ``syndromes'' (undiagnosed clusters of symptoms) to local health
departments. Even when disease or syndromic reporting is mandatory,
however, it is often incomplete. Doctors may be too busy to comply, or
they may simply not know to whom to report.
In the case of West Nile virus, the system worked: reporting by an
alert physician was key to the early detection of the outbreak.
Nevertheless, a bioterrorist attack or a serious natural outbreak would
permit little margin for error. If health-care providers are to be
effective sentinels of an epidemic, they must have the necessary
training and professional awareness to include the possibility of
emerging infections and bioterrorism in their differential diagnosis.
In addition, they must have direct communication channels to the public
health department and be able to report cases at any time, day or
night.
The Gap Between the Human and Animal Health Communities
Many emerging infectious diseases and putative bioterrorist agents
are ``zoonotic,'' meaning that they originate in animals but can also
infect humans. Examples of zoonotic diseases that have been developed
as biological warfare agents include anthrax, tularemia, brucellosis,
plague, and Venezuelan equine encephalitis. In addition, many natural
epidemics have begun in wild or domesticated animals and then spread to
humans, including the outbreaks of bubonic plague in India, Sin Nombre
virus in the U.S. Southwest, Nipah virus in Malaysia, avian influenza
in Hong Kong, and West Nile virus in New York City.
Given the considerable overlap of animal and human pathogens,
animals can serve as useful ``sentinels'' for outbreaks of zoonotic
diseases. Sheep, for example, are far more sensitive to anthrax
infection than humans. Nevertheless, the West Nile investigation
exposed a major gap between the veterinary and public health
communities. Although the key to identifying the causative agent lay in
merging information from the parallel investigations of the bird and
human outbreaks, communication between animal health and public health
agencies was poor. What limited cooperation occurred was the result of
informal personal relationships rather than official coordinating
mechanisms.
This disconnect arose from the fact that the expert communities
that address the health of people, domesticated animals, and wildlife
are separated organizationally, geographically, and jurisdictionally-
despite the fact that infectious diseases do not respect these
artificial boundaries. State and local veterinary agencies focus on the
health of domestic pets, horses, livestock, and other economically
important species, but they rarely communicate with agencies involved
in safeguarding human health. Low priority and funding are devoted to
the health of wildlife, particularly non-endangered species such as
crows and rats, which are the responsibility of parks departments and
animal control officers. Monitoring the health of zoo animals is
another ``gray area'' with no clear leadership, and only six zoos in
the United States employ full-time veterinary pathologists.\7\
---------------------------------------------------------------------------
\7\ Tracey McNamara, Bronx Zoo, presentation at Workshop on Agro-
Terrorism, Cornell University, November 13, 2000.
---------------------------------------------------------------------------
The 1999 outbreak of West Nile encephalitis in New York City
indicated that outbreaks of zoonotic disease in wildlife and zoo animal
populations could provide early warning of an impending human epidemic.
In 2001, the CDC agreed to fund a pilot project for monitoring the
spread of West Nile virus by testing blood and tissue specimens from
zoo animals, as well as dead birds and other wildlife found on zoo
property. A centralized database will be established to summarize the
results, which will be made available to the public health surveillance
system. For the project to be effective, the participating zoo
pathologists must build a relationship with local public health
officials, and the zoo data must be reliable (using a validated
diagnostic methodology), consistent, and reported in a timely fashion.
If this pilot program is successful, it could serve as the basis for
further interaction between the zoo and public health communities for
the surveillance of other zoonotic diseases.\8\
---------------------------------------------------------------------------
\8\ Tracey S. McNamara and Dominic Travis, Project Co-coordinators,
Surveillance for West Nile Virus in Zoological Institutions: Report of
a Workshop, June 21-22, 2001, Lincoln Park Zoo, Chicago.
---------------------------------------------------------------------------
The Gap Between the Public Health Specialists and Intelligence Analysts
The dual threats of emerging infections and bioterrorism pose major
conceptual and technical challenges for the U.S. intelligence
community, such as distinguishing between a natural outbreak of an
emerging disease and the deliberate release of a pathogen by
terrorists. In 1984, for example, members of the Oregon-based
Rajneeshee cult used salmonella bacteria to contaminate ten restaurant
salad bars in a trial run of a scheme to manipulate the outcome of a
local election by making large numbers of voters too sick to go to the
polls. After 751 people fell ill with food poisoning, public health
investigators concluded initially that the outbreak had resulted from
natural sources. The true cause did not emerge until a year later, when
a cult member confessed to the crime.\9\
---------------------------------------------------------------------------
\9\ W. Seth Carus, ``The Rajneeshees (1984),'' in Jonathan B.
Tucker, ed., Toxic Terror: Assessing Terrorist Use of Chemical and
Biological Weapons (Cambridge, Mass.: MIT Press, 2000), pp. 115-137.
---------------------------------------------------------------------------
During the West Nile investigation, the belated discovery that the
causative virus had originated in the Middle East reportedly raised red
flags with biological warfare analysts at the Central Intelligence
Agency (CIA). The reason was an eerie coincidence. In April 1999,
Mikhael Ramadan, a self-declared Iraqi defector who claimed to have
worked as a body-double for Saddam Hussein, published a memoir in
England titled In the Shadow of Saddam in which he asserted that in
1997, the Iraqi leader had ordered the development of a highly virulent
strain of West Nile virus as a bioterrorist weapon.\10\ Additional
concern was raised by the fact that during the 1980s, the CDC had
shipped an Israeli strain of West Nile virus to a microbiologist in
Basra, Iraq, ostensibly for public health research.\11\ Nevertheless,
further analysis turned up no evidence that the Iraqis had developed
West Nile virus as a biological weapon.\12\
---------------------------------------------------------------------------
\10\ Richard Preston, ``West Nile Mystery,'' The New Yorker,
October 18-25, 1999, pp. 90-108.
\11\ Jonathan B. Tucker, ``Lessons of Iraq's Biological Warfare
Programme,'' Arms Control/Contemporary Security Policy, vol. 14, no. 3
(December 1993), p. 238.
\12\ Vernon Loeb, ``CIA Finds No Sign N.Y. Virus Was an Attack,''
Washington Post, October 12, 1999, p. A2.
---------------------------------------------------------------------------
The ability of the CIA to assess whether the West Nile outbreak was
a deliberate attack was hampered by the agency's lack of technical
expertise: few intelligence analysts have a solid grounding in
infectious diseases or epidemiology. Trained epidemiologists would have
recognized immediately that West Nile virus was a poor candidate as a
bioterrorist weapon because it causes neurological injury and death in
only about 5 to 10 percent of those infected, mainly children, the
elderly, and those with a weakened immune system. Moreover, because the
virus is transmitted to humans by mosquitoes, the putative terrorists
would have had to import virus-infected insects, release them, and wait
for the disease to spread-an unlikely scenario.
Although the CIA has recruited a few microbiologists and other
scientists for its analytical staff, this solution is not optimal
because scientists need to interact freely with colleagues from other
countries if they are to remain current and well informed. A better
approach would be to provide for routine exchanges of people and
training between U.S. public health and intelligence agencies, but
differences in organizational culture have impeded collaboration in
analyzing bioterrorist threats. For intelligence specialists, working
closely with medical doctors and epidemiologists pose risks to the
security and effectiveness of their operations. CDC epidemiologists,
for their part, see themselves as members of the international
scientific community, publish their research results, and interact with
colleagues from politically sensitive countries; few are cleared for
classified information or have access to encrypted phone and fax lines.
Public health experts also worry that cooperation with defense, law
enforcement, or intelligence agencies could taint their public image.
Indeed, any link between the CDC and the U.S. intelligence community,
however innocent, could undermine the ability of epidemiologists to
investigate natural disease outbreaks in foreign countries.
policy recommendations
New policies are needed to bridge the three gaps identified above
in order to improve the nation's preparedness for rapidly identifying
and containing outbreaks of disease associated either with emerging
infections or bioterrorism.
Bridging the Gap Between Primary Care Providers and Public Health
Departments
--The Department of Health and Human Services (DHHS) should expand
the national program of awareness training for primary health
care providers. To ensure timely detection of an unusual
outbreak of disease, general practitioners, emergency-room
physicians, and nurse-practitioners must be familiar with the
signs and symptoms of exotic diseases that they would not
normally encounter in their medical practice. Professional
medical societies, physician-oriented web sites, and continuing
medical education programs should offer training and refresher
courses in the diagnosis and treatment of bioterrorist agents.
Such courses might eventually be made a prerequisite for
medical licensing or board certification.
--DHHS should provide grants to state and local public health
agencies to establish simple reporting mechanisms and clear
communication channels between medical practitioners and city,
state, or county public health departments, including 24-hour
telephone or e-mail ``hot lines.'' To respond effectively when
doctors call, day or night, state and local health departments
will need additional funds to hire more staff members with
expertise in infectious diseases, epidemiology, and information
technology.
--DHHS should increase the number of clinical laboratories associated
with public health departments around the country that are
capable of diagnosing exotic diseases, including suspected
bioterrorist agents. Standardized testing protocols should be
developed so that laboratories can easily exchange and compare
diagnostic findings.
--In conjunction with the Department of Defense, DHHS should improve
basic and applied research on bioterrorist threat agents by
increasing funding for this purpose. Knowledge of the
pathophysiology, virulence factors, immunology, and genomic
structure of disease agents is vital for the development of
improved diagnostic tests, therapeutics, and vaccines. Yet such
knowledge is limited for the roughly two dozen classical
biological warfare agents, and almost nonexistent for more than
100 microbial pathogens of potential bioterrorist concern.
--DHHS should facilitate prompt and accurate disease reporting by
expanding its current efforts to establish an electronic
infrastructure for this purpose at the city, county, and state
levels. At present, few cities have established electronic
systems for the exchange of surveillance data, and roughly half
the public health agencies in the United States are not
connected to the Internet. Also needed is a national electronic
information system for exchanging disease-reporting data
between state health departments and the CDC.
--DHHS should attempt to attract more talented individuals into the
public health field by offering mid-career fellowships and
internships for medical doctors, both at CDC and at public
health departments around the country.
--CDC should assist hospitals to incorporate bioterrorist scenarios
in their emergency response plans and to carry out frequent
dress rehearsals.
Bridging the Gap Between the Human and Animal Health Communities
--If the pilot zoo surveillance project for West Nile virus is
successful, DHHS and the U.S. Department of Agriculture (USDA)
should expand this program into a veterinary surveillance
network in which unusual patterns of zoonotic disease in
livestock, zoo animals, or wild animals are reported promptly
to state and local public health departments. In some cases,
susceptible species living in a city zoo could serve as
``sentinels'' of a covert bioterrorist attack against the urban
population.
--DHHS and USDA should support improved communications infrastructure
between veterinary agencies and public health departments,
including telephone and e-mail hot lines, so that unusual
outbreaks of zoonotic disease in animals can be reported to the
appropriate public health authorities.
--DHHS should fund more epidemiological research on the complex
relationships between human and animal health. Already, the
West Nile outbreak has served as a catalyst for greater
interdisciplinary cooperation among veterinarians, physicians,
ecologists, and wildlife biologists.
Bridging the Gap Between Public Health Specialists and Intelligence
Analysts
--The U.S. intelligence community should recruit more individuals
with advanced training in microbiology, infectious disease, and
epidemiology to work as intelligence analysts focusing on
biowarfare and bioterrorist threats. In particular, the Defense
Intelligence Agency's Armed Forces Medical Intelligence Center
(AFMIC), the one intelligence organization specializing in
infectious diseases, should be expanded by hiring more
technically trained staff. Individuals with experience in the
biotechnology industry are also needed to detect the subtle
indicators of clandestine biological weapons production,
particularly at dual-use facilities such as vaccine plants.
--DHHS should establish formal exchanges of people and training
between public health agencies such as the CDC and federal
intelligence services such as the CIA, the Defense Intelligence
Agency (DIA), the National Security Agency (NSA), and the
Federal Bureau of Investigation (FBI). To this end, DHHS should
create a cadre of specialists in public health and biomedicine
who have security clearances and access to secure
communications, such as encrypted phone, fax, and
videoconferencing facilities. These experts could then provide
technical advice to intelligence analysts as needed concerning
suspicious disease outbreaks that could be the result of covert
biological weapons use.
--CDC should establish a reporting mechanism so that unusual
outbreaks of disease in the United States detected by the
Epidemic Intelligence Service (EIS) are routinely reported to
the FBI and other law-enforcement agencies.
In conclusion, the natural emergence of a deadly and contagious
infectious disease such as the Spanish Flu of 1918, or the deliberate
release of anthrax or some other pathogen as an act of bioterrorism,
could result in a serious loss of life and social disruption. Unless
corrected, the communication gaps that currently exist among the U.S.
medical, public health, animal health, and intelligence communities
could seriously delay detection of the resulting disease outbreak and
impede the prompt response needed to minimize its medical impact and
social consequences.
Bridging these gaps will be essential if the nation is to be better
prepared to deal with the dual threats posed by emerging infections and
bioterrorism. The good news is that despite the anxieties we all share
today about this issue, the U.S. government can take practical steps to
reduce the threat. Improved infectious disease surveillance, combined
with other preparedness measures and continued research, may make it
possible in the not-too-distant future to render biological weapons in
the hands of terrorists--to borrow a phrase from President Ronald
Reagan--``impotent and obsolete.''
Senator Harkin. Thank you. Now we will go to Dr. Stephen
Cantrill, associate director, Department of Emergency Medicine,
Denver Health Medical Center. Dr. Cantrill served as the
Regional Medical Coordinator for Denver's participation in
Operation Top Off, which simulated a bioterrorist incident,
which I mentioned in my opening statement a while ago. He has
also been involved in weapons of mass destruction training for
the Denver area.
Dr. Cantrill, welcome.
STATEMENT OF STEPHEN CANTRILL, M.D., ASSOCIATE
DIRECTOR, DEPARTMENT OF EMERGENCY MEDICINE,
DENVER HEALTH MEDICAL CENTER
Dr. Cantrill. Mr. Chairman, and members of the
subcommittee, thank you. I consider it a privilege to have been
asked to testify before this subcommittee today on our
experience with Operation Top Off and on some local
perspectives and concerns about our country's efforts to
improve our domestic preparedness to deal with the possibility
of a bioterrorism event.
Even before our participation in Top Off, a major issue of
concern in our preparedness was achieving adequate involvement
in training on the part of the general medical and public
health communities. This oversight has been partially remedied
by recent CDC grants to State public health departments, but
lack of awareness training and preparedness in the general
medical community continues to be a major issue.
This also represents a major paradigm switch for the public
health sector, as they have not been trained in medical aspects
of disaster management and medical incident command, which are
two areas of major importance in adequately dealing with a
biological terrorism attack. We must somehow stimulate interest
and seek incentives for the individuals in these communities so
they will avail themselves of WMD training.
We must also stimulate and encourage training and
integration between hospitals and State and local departments
of public health, especially in the areas of information
systems, communication systems, and coordinated test readiness.
This task will be made especially difficult by the decades-old
contraction of the public health infrastructure in this
country, which must be reversed. It will also be complicated by
the recent adoption of the Federal HIPAA regulations governing
excessive confidentiality of patient information that could
potentially be used to detect the early stages of bioterrorist
attack, and most domestic WMD preparedness hospitals and other
health care institutions have been the forgotten components.
Most hospitals are financially strapped due to low levels
of reimbursement for care. At this time there are few public
policy incentives to encourage or enable health care
institutions to invest in WMD planning or training. With a
large number of dollars going to other sectors, we must not
forget our hospitals and public health institutions to assist
them in their preparedness.
An additional concern is the illusion shared by many that
our health care system could adequately deal with a significant
WMD incident. In this area, I must respectfully disagree with
Secretary Thompson, as you heard me quoted earlier. Due to
multiple pressures, including fiscal, regulatory, and
inadequate available staff, our hospitals today have no surge
capacity. They could not adjust to a sudden increase in patient
load without degenerating into chaos.
This has been clear to those of us in health care, and it
is well-demonstrated by Operation Top Off. This problem would
only be partially alleviated by the dispatching of our Federal
resources to a specific locale, and could be of no help if
terrorists opt to involve dozens of metropolitan areas
simultaneously. This problem is further complicated by
regulations such as the Centers for Medicare and Medicaid
Services, the old HCFA, EMTALA regulations.
Our national capability to limit the spread of a WMD
infectious agent is also inadequate in many areas. For example,
with an estimated 42 percent of our population susceptible to
smallpox, and with the potential case fatality rate of 20
percent or greater, our national lack of adequate smallpox
vaccine and smallpox immunoglobulin would severely limit our
ability to contain the spread of this dreaded disease where it
is used as part of a terrorist attack. Such an attack would
make our 1918 influenza pandemic truly look like a walk in the
park. The ongoing problems with the manufacture and
availability of anthrax vaccine are also troubling.
Another concern is the potential lack of coordination
between federally funded efforts such as the Metropolitan
Medical Response System, the MMRS, and systems that are already
in place. Every effort must be made to have these new
initiatives interdigitate with plans and systems that already
serve these metropolitan areas. When possible, it would be
better to augment current systems rather than constructing
competing systems.
The Federal Government should also increase its research
efforts in some other potential aspects of dealing with a WMD
incident. For example, what are the best techniques to use for
the emergency vaccination of thousands of people in a
metropolitan area? How do we expeditiously distribute
prophylactic antibiotics to a million people in 48 hours? These
and other operational issues must be researched and the results
disseminated and incorporated into the planning for all major
metropolitan areas.
All said, I do not want to appear negative or ungrateful. I
applaud the Federal Government's effort at initiating and
encouraging local training and planning for a potential
bioterrorism or other WMD event. I do feel we have made
significant strides in the area of WMD awareness and
preparedness. We now have an opportunity to fine-tune and
improve our efforts for domestic preparedness.
In closing, I would like to thank you, Mr. Chairman, and
the subcommittee for this opportunity to discuss some of the
issues that are of concern to the medical and public health
communities in our preparations to combat domestic terrorism at
the local level.
prepared statement
Mr. Chairman, this concludes my testimony. My written
testimony does include other comments concerning the national
disaster medical system, and the National Pharmaceutical
Stockpile. I am happy to address any questions you or the
subcommittee members may have.
Thank you.
[The statement follows:]
Prepared Statement of Dr. Stephen V. Cantrill
Mr. Chairman and members of the Subcommittee, I am Dr. Stephen
Cantrill, Associate Director of Emergency Medicine at Denver Health
Medical Center in Denver, Colorado. I have been involved in local
preparation and training for weapons of mass destruction for the last
four years and was a participant in the planning and execution of
Operation TopOff in May, 2000. I consider it a privilege to have been
asked to testify before the Subcommittee today on our experience with
Operation TopOff and some local perspectives and concerns about our
country's efforts to improve our domestic preparedness to deal with the
possibility of a bioterrorism event, even though I do so with a heavy
heart, due to the recent terrorist events that have shocked our
country.
As you may know, Operation TopOff was a Congressionally mandated,
no-notice, multi-site disaster exercise to evaluate our country's
ability to deal with multiple simultaneous disasters from weapons of
mass destruction. We in Denver had the good fortune to be selected to
participate in this exercise as the site for a simulated bioterrorism
attack with pneumonic plague. This exercise involved initial exposure
of more than 2500 patients with thousands of fatalities and tens of
thousands of ill patients. Even before our participation in this
exercise, a major issue of concern in our preparedness was achieving
adequate involvement and training on the part of the general medical
and public health communities. Many efforts to date have focused on
training and material support for police, fire and emergency medical
services. This includes the training efforts under the Nunn-Lugar-
Domenici Act that were directed towards ``first responders'' with no
attempt to engage the general medical community nor the state and local
public health sectors. This oversight has been partially remedied by
recent CDC grants to the state public health departments, but lack of
awareness, training and preparedness in the general medical community
continues to be a major issue. The message must be clearly conveyed
that our health care system is of central importance in our fight
against weapons of mass destruction. Medicine and public health must be
called to the table and included and supported in the planning and
training for dealing with weapons of mass destruction. This will be a
major paradigm switch, especially for the public health sector, as they
have not been trained in the medical aspects of disaster management and
medical incident command, two areas of major importance in adequately
dealing with a biological terrorism attack. Current efforts in these
areas have been largely done pro-bono by a small number of dedicated
individuals with little interest or enthusiasm on the part of the
general medical or public health communities. We must somehow stimulate
interest and seek incentives for the individuals in these communities
so they will avail themselves of WMD training. We must also stimulate
and encourage training and integration between hospitals and state and
local departments of public health, especially in the areas of
information systems, communication systems and coordinated tests of
readiness. This task will be made especially difficult by the decades
old contraction of the public health infrastructure in this country,
which must be reversed. It will also be complicated by the recent
adoption of the federal HIPPA regulations governing excessive
confidentiality of patient information that could potentially be used
to detect the early stages of a bioterrorist attack.
In most domestic WMD preparedness, hospitals and other health care
institutions have been the forgotten components. For example, hospitals
are not currently allowed to receive any Department of Justice or CDC
grant monies to deal with their WMD needs including drugs and equipment
that would be specifically used for a WMD event. Most hospitals are
financially strapped due to low levels of reimbursement for care. They
cannot pass on these WMD preparedness costs to normal patients. At this
time, there are few public policies or incentives to encourage or
enable health care institutions to invest in WMD planning or training.
The federal government must engage and support the medical and public
health leadership in building the critical elements of WMD
preparedness. With the large number of dollars going to other sectors,
we must not forget about our hospitals and public health institutions
to assist them in their preparedness.
An additional concern is the illusion shared by many that our
health care system could adequately deal with a significant WMD
incident. In this area I must respectfully disagree with Secretary
Thompson. Due to multiple pressures, including fiscal, regulatory, and
inadequate available staff, our hospitals today have no ``surge
capacity''. They could not adjust to a sudden increase in patient load
without degenerating into chaos. This has been clear to those of us in
health care and was well demonstrated by Operation TopOff.
Unfortunately, this problem is not well appreciated in many
governmental circles and by the lay public. This problem would only be
partially alleviated by the dispatching our federal resources to a
specific locale and could be of no help if terrorists opt to involve
dozens of metropolitan areas simultaneously. This problem is further
complicated by regulations such as the Centers for Medicare and
Medicaid Services (the old HCFA) EMTALA regulations that require a
medical screening examination for all who present to an emergency
department but do not allow for suspension or alteration of these
requirements under the duress of a patient load that could balloon to
ten to twenty times normal.
Dealing with a massive increase in hospital admissions in a
metropolitan area during a WMD attack could theoretically be alleviated
through the activation of the National Disaster Medical System, with
transfer of patients to distant participating hospitals. It is not
clear to us in the trenches, however, that this system, which was
designed more for dealing with natural disasters, could adequately
ameliorate the problems seen with a WMD incident. Would remote
hospitals, whose participation is voluntary, be willing to accept
contagious patients suffering from plague? The capacity and design of
this system should be reassessed in light of these issues.
Several areas in which WMD preparedness work has begun could
benefit from some additional attention. The National Pharmaceutical
Stockpile maintained by the CDC is a major step forward in our ability
to deal with a WMD attack. However, the packaging of the drug items in
the stockpile remains largely oriented towards fiscally advantageous
stock rotation, not efficient distribution once the stockpile arrives
at the locale of the terrorist attack. Also, significant thought should
be given to increasing stocks of several of the drugs at a local level:
a 12 to 24 wait would render most of the utility of the treatments for
a chemical attack unhelpful as most of the severely afflicted patients
would be dead. Also, more effort must be made to incorporate state-of-
the-art treatments that are widely used in Europe (such as
hydroxocobalamin for the treatment of cyanide poisoning) into our
medical armentarium in the United States.
Our national capability to limit the spread of a WMD infectious
agent is also inadequate in many areas. For example, with an estimated
42 percent of our population susceptible to smallpox and with a
potential case-fatality rate of 30 percent or greater, our national
lack of adequate smallpox vaccine and smallpox immune globulin would
severely limit our ability to contain the spread of this dreaded
disease were it used as part of a terrorist attack. Such an attack
would make our 1918 influenza pandemic, with a case-fatality rate of 2
percent and more than 670,000 deaths, truly look like a walk in the
park. The ongoing problems with the manufacture and availability of
anthrax vaccine are also troubling.
Another concern is the potential lack of coordination between
federally funded efforts, such at the Metropolitan Medical Response
Systems (MMRS) and systems that are already in place. Every effort must
be made to have these new initiatives interdigitate with plans and
systems that already serve these metropolitan areas. Unfortunately,
often the federal funding stream has been haphazard, uncoordinated and
operated in a counter-productive fashion, thwarting successful
integration. We must be careful not to create new systems that not only
conflict with current in-place systems, but also may not have
sufficient ongoing maintenance funding to successfully survive if they
are not integrated into current plans and organizational structures.
When possible, it would be better to augment current systems, rather
than constructing competing systems.
This process, by its very nature, will take time. It is not
something that we can throw a lot of money at and expect instant
success, but rather will require a long-term, ongoing commitment. It
would be most helpful, if it could be achieved, for all regional
funding to have a single point of contact. There should also be an
increased emphasis on involving regional emergency managers in this
integration process. Our goal should not be to develop a separate
system to deal with nuclear- chemical-biological events, but rather to
have this preparedness be part of the existing systems that we have in
place to deal with all other disasters. Hopefully, FEMA's announced
role as an integrative force in this area will address some of these
deficiencies.
The federal government should also increase its research efforts in
some of the practical aspects of dealing with a WMD incident. For
example, what are the best techniques to use for the emergent
vaccination of thousands of people in a metropolitan area? How do we
expeditiously distribute prophylactic antibiotics to a million people
in 48 hours? In Denver, during Operation TopOff, we exercised a
demonstration distribution center for the dispensing of prophylactic
antibiotics to the general population. With 60 workers, we could
dispense to only 3360 patients in a 24 hour period. Extrapolating this
to the need to deliver prophylaxis to a population of one million
patients within a 48 hour period, we would need 1400 distribution
centers utilizing 84,000 workers. Clearly not doable. These and other
operational issues must be researched and the results disseminated and
incorporated into the planning for all major metropolitan areas.
All said, I do not want to appear negative or ungrateful. I applaud
the federal government's efforts in initiating and encouraging local
training and planning for a potential bioterrorism or other WMD event.
I do feel we have made significant strides in the area of WMD awareness
and preparedness. Exercises such as Operation TopOff have proven
invaluable to stimulate interest and planning for the unthinkable. We
now have an opportunity to fine tune and improve our efforts for
domestic preparedness.
In closing, I would like to thank you, Mr. Chairman, and the
Subcommittee, for this opportunity to discuss some of the issues that
are of concern to the medical and public health communities in our
preparations to combat domestic terrorism at the local level. Mr.
Chairman, this concludes my testimony. I am happy to address any
questions that you or the Subcommittee members might have.
Senator Harkin. Thank you, Dr. Cantrill. Next, we will go
to Mr. Jerome Hauer. Mr. Hauer is director of the Crisis and
Consequences Management Group at Kroll Associates. Previously
he was director of New York City's Office of Emergency
Management, where he was responsible for drafting the city's
emergency response plans to national and manmade disasters,
including biological terrorism.
Mr. Hauer, welcome.
STATEMENT OF JEROME M. HAUER, MANAGING DIRECTOR, CRISIS
AND CONSEQUENCES MANAGEMENT, KROLL
ASSOCIATES
Mr. Hauer. Thank you, Mr. Chairman. I appreciate the
invitation to be here today, and I, too, would like to commend
you for your leadership in holding these hearings. As you
mentioned, I am former Director of the Mayor's Office of
Emergency Management, and I also served as an advisor to
Secretary Thompson on national security issues. I would like to
spend the next few minutes addressing the issues State and
local governments confront as they plan for managing the
consequences of biological terrorism.
Let me begin by stating the obvious. A biological incident
is significantly different from that of a chemical incident. A
chemical incident is a lights and sirens response by fire
departments, police departments, and emergency medical
services.
A biological incident, however, evolves over days, and may
not be evident until victims begin to die. It will be
recognized by primary care providers and changes in health care
utilization, and not your first responders. Preparing for a
biological incident at the local level, therefore, does not
entail protective suits and decontamination units, but,rather,
training, surveillance, and developing plans to support the
needs of the community following the incident.
A window of opportunity exists following the release of a
biological agent. If a State and local government is prepared,
they can reduce morbidity and mortality, and if they are
unprepared at the time of detection of an incident, people will
die unnecessarily. The key is ensuring that the window of
opportunity is as large as possible.
Let me take a few moments to talk about three areas,
training, surveillance, and logistical support. I will start
with training. Most primary care practitioners have never seen
a case of anthrax or smallpox. The symptoms would likely be
missed, or thought to be those of more common illnesses like
cold or flu. For a patient with anthrax, this delay could mean
the difference between receiving care that could save their
life, or being sent home with a misdiagnosis and then returning
in 48 hours and being untreatable.
Training is essential for these care providers in two
realms. The first is in recognizing these diseases and symptoms
of other threat agents, and the second is in knowing what to do
when there is a suspicion that something out of the ordinary
has occurred.
Few physicians or nurses know who to call in their local
health department when they have a concern about an unusual
cluster of disease. Most contact with the local county health
department is a three-part disease or reporting form for a
limited number of reportable diseases. It is important we
develop strong links between the medical community and the
public health community, which brings me to my next point.
The public health infrastructure in this country has been
allowed to deteriorate over the past 2 decades. The key to
recognizing that something out of the ordinary has occurred is
by having a sensitive surveillance system in place that
monitors the health of the community and sets off alarms when
something out of the ordinary is occurring.
In New York, we developed a system called the DHI, or daily
health indicators, that tracks a number of activities. Any
spike in any one of these indicators requires investigation by
the department of health. Things such as EMS runs for
respiratory or abdominal symptoms, admissions to the hospitals
through the emergency rooms, sale of antidiarrheal and cold and
flu medication over the counter, and influenza-like illness in
nursing homes, are monitored and an algorithm is in place that
causes an alarm when a spike in any one of the indicators
occurs.
The data is also linked to a geographic information system
so that patterns can be relayed on a map, and geographic
distributions of the patients can be discerned. This system is
simple in its design, and can be used in any city or county or
State in the United States. Once it is determined that an
incident has occurred, cities must be prepared to manage
massive numbers of patients and have plans in place to
distribute antibiotics or vaccinate people in a very short
period of time.
The logistical support necessary for this will have to come
from State and Federal resources. No city in this country can
handle the demands that will be placed on them during one of
these events. Let me give you a quick example as I conclude my
remarks.
In New York, we modeled two scenarios, one in which we went
door-to-door to give out antibiotics, and the other in which we
set up POD's, or points of distribution so that people could
come in to pick up antibiotics. To go door-to-door in Manhattan
alone I would need over 40,000 people to give out antibiotics
in a 36-hour period. To set up POD's, I would need about the
same amount of people, but I could give antibiotics out to the
entire city.
In either case, these resources are simply not available in
New York. I have not yet discussed the large number of medical
personnel that would be required to treat those who have
succumbed to the disease. We have developed plans to set up
alternate care facilities to take the load off hospitals and
casualty collection points to treat or isolate the overflow of
patients.
In summary, I believe that we must continue to build our
stockpiles of vaccines and antibiotics at the national level,
as it is impractical for cities and States to do this. HHS is
moving forward on this aggressively. Congress, however, must
make a commitment to reinvigorate the public health system of
this Nation, beginning with the development of sophisticated
surveillance systems in all State and local health departments
to detect a terrorist attack. Cities and counties should feed
their data into State health departments and State health
departments should feed their data into CDC's so cross-
jurisdictional patterns can be detected.
Mr. Chairman, it is important we as a Nation focus on these
threats. We have underestimated the level of sophistication
that our enemies have. We know that the capability to
manufacture these weapons exists in countries that are not our
friends.
Mr. Chairman, that concludes my remarks, and I would be
happy to answer any questions you have.
Senator Harkin. Thank you very much, Mr. Hauer, for your
leadership in this area.
Now we turn to Dr. Patricia Quinlisk, medical director and
State epidemiologist for the Iowa Department of Health. She is
the former President of the Council of State and Territorial
Epidemiologists, and is one of its primary consultants on
bioterrorism preparedness. She is also a member of the Gilmore
Commission which is assessing the capabilities for responding
to terrorist incidents involving weapons of mass destruction.
Dr. Quinlisk, welcome.
STATEMENT OF PATRICIA QUINLISK, M.D., M.P.H., MEDICAL
DIRECTOR AND STATE EPIDEMIOLOGIST, IOWA
DEPARTMENT OF HEALTH
Dr. Quinlisk. Thank you very much. I am honored to appear
today before the subcommittee dealing with this very important
issue, and I am particularly honored to testify before you, Mr.
Chairman, one of Iowa's Senators and an important long-time
advocate of public health, for which we deeply appreciate your
leadership.
Since the horrible attacks of September 11, we have seen
from news and media reports that some members of the public are
becoming so frightened by the possibility of a terrorist attack
involving biological/chemical agents that they are purchasing
antibiotics and gas masks in a mistaken belief that these
measures will protect them from harm. However, since many of
these agents are colorless, odorless, could be released
covertly and, most importantly, especially with biological
agents, would have an incubation period before symptoms occur,
an individual would have to be taking these antibiotics or
wearing their gas masks continuously for protection.
Therefore, the best defense against grievous harm that
would result from one of these chemical or biological attacks
is a robust public health system at the local, State, and
Federal level. This system would be able to detect rapidly that
an attack had occurred, investigate the nature of that attack,
diagnose the agent involved rapidly, immediately institute
responses that would get the right treatment to those who are
ill and the right prevention measures to those who are exposed,
and implement other protection strategies for everyone else.
But right now, the Nation's public health system is not
robust. It is fragmented, ill-equipped, and seriously
understaffed. There are not trained epidemiologists, those
people who detect, investigate, and stop epidemics. There are
not trained laboratorians or other critical personnel.
Over the past 3 years, CDC has had a bioterrorism
preparedness cooperative grant program for State and local
health departments. This is an important beginning, but it is
only that, a beginning. Last year, Congress enacted the Public
Health Threats and Emergencies Act to focus on building our
Nation's public health infrastructure.
This has resulted in a consensus process, now accelerated,
about needed core capacity and an appropriate assessment tool,
but to date there has been no funding for States to conduct
these assessments, which must be done in order to determine how
to be fully prepared and where we have weaknesses. While I lack
the resources of a documented assessment, I have been asked to
provide this subcommittee with a description of what Iowa would
need to be prepared for a terrorist attack. I am confident that
a formal review would confirm much of what I am going to tell
you, and I am also confident that Iowa's needs are typical of
all the States.
Iowa's public health system needs strengthening in five
major areas: Workforce, particularly in epidemiology,
laboratories, communications, information systems, and
planning. With regard to workforce, the Iowa Department of
Public Health estimates it would need at a minimum 25
additional people at the State level alone to address the
present needs.
Currently, we only have one person whose job it is to
enhance surveillance for possible terrorist agents, to
coordinate education with health care professionals in over 100
hospitals on identification and reporting, to organize an
emergency alert system, and everything else that is needed. A
similar number of people would be needed at the local level. We
estimate that this would cost approximately $8 million.
I would like to emphasize that finding and attracting
trained infectious disease epidemiologists to fill these types
of positions will be difficult, particularly in this
environment of intense competition with other States. Iowa
tried to hire a bioterrorism coordinator. It took us over a
year and three rounds of position announcements and interviews
to find someone. I urge that the subcommittee give immediate
attention to the problems of the public health workforce
training, particularly epidemiology.
Iowa's public health laboratory needs are ongoing for
support for equipment, materials, staff, and training, and
needs to add chemical terrorism capacity. This alone will cost
another $1 million.
An additional $500,000 to $1 million would be needed to
build a comprehensive, rapid, and secure communications system.
I will give you just two other examples of our basic
communication needs. Right now in Iowa, only about 10 of the 99
counties have anyone on call 24 hours day, 7 days a week.
The State public health laboratory system currently reports
diseases to me, the State epidemiologist, on paper through the
U.S. mail system. The National Electronic Disease Surveillance
system is a priority both for CDC and epidemiologists. It is
designed to technically integrate as many as 100 separate data
systems currently used in our Nation's public health system. It
will allow the rapid identification of disease trends which may
signify biological or chemical attacks much clearer and more
quickly across States and regions.
CDC estimates this program should be funded at a minimum of
$50 million. Iowa has received only planning and assessment
funding, and will need $1 million to implement and integrate a
disease information collection and analysis system. I cannot
stress enough the critical nature of planning, including
regular testing with exercises for preparedness for biological
and chemical attacks. Iowa, as well as 39 other States, receive
no funding to address this formal need. I would guess $200,000
per year would be needed for this activity.
In summary, looking only to Iowa's public health system's
needs to prepare and respond to a biological or chemical
attack, the total comes to approximately $11.5 million. This
estimated amount is much closer to Iowa's real minimum needs
than to the funding that we have already received under the
current preparedness programs. This level of funding also needs
to be made available over a period of several years, because it
will take time to build the system, particularly in light of a
workforce that is not prepared. After this, significant funding
must continue to keep the system maintained. This is consistent
with the $1.4 billion mentioned earlier.
prepared statement
One final point. By building a robust public health system,
we will be building a multiuse system for diseases and
situations that are occurring every day, such as emerging
diseases like West Nile virus, which was now discovered in Iowa
2 weeks ago, the predicted pandemic flu, as well as every-day
food poisoning outbreaks. Thus, when and if a terrorist event
occurs, the system will be well-tested and familiar to those
involved in ensuring an effective and efficient functioning
system in a crisis.
Thank you again for the opportunity to provide testimony on
this important matter.
[The statement follows:]
Prepared Statement of Dr. Patricia Quinlisk
Mr. Chairman, Members of the Subcommittee, I am Patricia Quinlisk,
MD, MPH, Medical Director and State Epidemiologist for the Iowa
Department of Public Health. I am here today not only representing the
Iowa Department of Public Health, but also the Council of State and
Territorial Epidemiologists (CSTE) as a former Council President and as
one of its primary consultants on bioterrorism preparedness. In
addition, my written statement includes comments provided by the
Association of Public Health Laboratories (APHL) on the need for
enhanced laboratory capacity at the state and local level.
I am very honored to appear before the Subcommittee today, and
particularly you, Mr. Chairman, as one of Iowa's Senators and an
important, long-time advocate for public health. The Iowa Department of
Public Health deeply appreciates your leadership.
I am also very honored to provide testimony on one of the most
critical issues facing our nation: terrorism preparedness. The comments
I will provide are from the perspective of a state health department
and our specific and immediate, as well as long-term needs, to be
prepared for a serious terrorist event involving biological or chemical
agents.
biological and chemical terrorism: strategic plan for preparedness and
response.
Over a year ago, the national Biological and Chemical Terrorism:
Strategic Plan for Preparedness and Response was developed with input
from experts from across the public health spectrum. This strategic
plan is based on the following five focus areas, each of which is a
primary function of public health:
--Preparedness and prevention;
--Detection and surveillance;
--Diagnosis and characterization of biological and chemical agents;
--Response; and
--Communication.
Working in coordination, federal, state and local public health
agencies will also rely on other groups in the health and medical
community to fully address each area to ensure preparedness. Examples
are:
--Medical research centers,
--Health-care providers and their networks,
--Professional societies,
--Medical examiners,
--Emergency response units and responder organizations,
--Safety and medical equipment manufacturers,
--U.S. Office of Emergency Preparedness and other Department of
Health and Human Services agencies.
In the state of Iowa, the Iowa Department of Public Health has been
given statewide responsibility in four areas: traditional public health
functions, medical services, mass casualty, and radiologic
preparedness. I believe that most state public health agencies have
similar preparedness responsibility in addition to their more
traditional functions. Thus, in the above list, Iowa's Department of
Public Health not only needs to coordinate with the listed groups that
are state based, but also has primary responsibility to ensure their
preparedness.
The national plan identifies nine critical steps in preparing for
Chemical and Biologic attacks. I am going to name each step, and
describe in each case where Iowa, a typical state, stands.
steps in preparing for biological and chemical attacks
--Enhance epidemiologic capacity to detect and respond to biological
and chemical attacks.--Right now, Iowa depends entirely upon
physicians and other health care providers to recognize and
respond to illness in a possible victim of a biological or
chemical attack. Yet after the events of two weeks ago, I
received many phone calls from medical professionals asking
what they should be looking for, and how to report suspicious
illnesses. I would guess that the majority of Iowa health care
providers do not know what to look for, how to send laboratory
specimens for diagnosis of these rare diseases and whom to
notify if they do suspect something. And yet this is the base
of our present surveillance system. We need help in providing
these professionals with education and training, diagnostic
tools, and communication systems for rapid reporting.
--Supply diagnostic reagents to state and local public health
agencies.--Right now in Iowa, if a large attack using anthrax
occurred, there is only one laboratory that has the reagents,
i.e. laboratory supplies, to rapidly and correctly diagnosis
this disease. And the supply of these critical laboratory
reagents would be depleted within hours.
--Establish communication programs to ensure delivery of accurate
information.--Right now in Iowa, I, as the state
epidemiologist, have no easy means to alert the health care
system, or our public health department, other than personally
calling someone. I am able to fax or send e-mail messages, but
if an incident occurs after working hours, I would have to
call. Only about 10 of the 99 local health departments in Iowa
have someone on call 24 hours-a-day, 7 days-a-week. Two years
ago, when a petting zoo bear was diagnosed with rabies on a
Saturday, there were several health departments with victims
living in their counties that I could not contact until the
next Monday morning when their offices opened. Also, the
systems I do have available are not secure, thus I would not be
able to send or receive confidential information without
jeopardizing the privacy of that information. Our state public
health laboratory, located in Iowa City, sends confidential
patient information via the U.S. postal service, on paper, to
insure safety.
--Enhance chemical and bioterrorism-related education and training
for health-care professionals, as well as traditional first
responders.--Right now in Iowa, public health only has one
person with the responsibility to address training for over 100
hospitals, all health care providers, and emergency medical
personnel regarding biological and chemical terrorism and
medical/public health coordination. This is obviously
inadequate. Everyday, we receive requests to give seminars,
lectures, and provide information on these diseases and the
appropriate response to terrorist events. We are lucky in Iowa
to have a statewide fiber optics network, which we used two
days ago to broadcast a ``lunch time briefing on terrorism'' to
almost 200 sites, and thousands of health care providers. But
since only the basic information can be addressed in an hour,
this can only be the beginning of our educational efforts.
--Prepare educational materials that will inform and reassure the
public during and after a biological or chemical attack.--Since
terror, rather than illness and death, is the primary goal of
terrorist, one of the best tools we have against this is
timely, accurate and believable information. Iowa has only just
begun to work with the media on this issue, yet this may be one
of the most important actions we take during an attack.
--Stockpile appropriate vaccines, drugs and antidotes.--It is
estimated that it will take approximately six to twelve hours
for some of the federal stockpiles of critical medical supplies
to reach Iowa, we believe it is necessary to survey Iowa's
hospitals and pharmacies to understand the resources that would
already be here prior to an attack. Yet this takes time and
personnel, which we do not currently have.
--Establish molecular surveillance for microbial strains, including
unusual or drug- resistant strains.--The use of DNA
fingerprinting of bacteria is critical since those destined to
become ill may disperse across the US after exposure. Thus
laboratories must be able to link infections they identify with
those occurring in other states to understand the scope of the
attack. However, right now this is only occurring with about
six bacteria, most of which would not be used in a biologic
attack.
--Support the development of diagnostic tests.--Since some chemicals,
such as toxins that a terrorist might use, do not persist in
the human body, we need to develop tests for surrogates to
enable us to quickly recognize what chemical was being used so
that we can protect others by providing antidotes.
--Encourage research on antiviral drugs, vaccines and bioassays for
chemical injuries.--Right now there is no effective treatment
for smallpox. Research is needed to develop treatment, as well
as preventive vaccines, for some of these diseases.
As the Iowa examples above illustrate, in order to implement many
of these critical preparedness steps, capacity at the state and local
level must be built. Consensus about what constitutes core public
health capacity to prepare and respond to bioterrorism, and how to
assess that state by state, is now occurring within the public health
community.
developing national consensus on core capacity to prepare and respond
to bioterrorism
Dr. Jeffrey Koplan, Director of the Centers for Disease Control and
Prevention (CDC), gave an address over the Public Health Training
Network Broadcast to state and local public health officials a week
after the September 11th attacks. His topic was the importance of
strengthening the nation's public health infrastructure to protect the
public's health. He stressed seven priority areas for capacity building
at the state and local level that have been developed through a
consensus process. These are, briefly:
(1) Public health workforce.--a well-trained, well-staffed, fully
prepared public health workforce is the most fundamental need in Iowa
and in all states;
(2) Laboratory capacity.--to produce timely and accurate results
for diagnosis and investigation
(3) Epidemiology and Surveillance.--to rapidly detect health
threats;
(4) Information systems.--that are accessible, rapid, permitting
effective analysis and interpretation of health data and provide public
access to health information;
(5) Communication.--that is rapid, secure, two-way flow of
information that includes the ability to provide timely, accurate
information to the public and advice to policy-makers in public health
emergencies;
(6) Policy and evaluation.--routine evaluation of how effective we
are at rapidly detecting health threats and making improvements; and
(7) Preparedness and response.--developing response plans and then
regularly testing them to maintain a high-level of preparedness.
The enactment of the Public Health Threats and Emergencies Act
(PHTEA) last year has provided an authorized process for accomplishing
these seven priorities. This process has now been accelerated, and is
concentrating first on bioterrorism preparedness. CDC is about to
publish a document identifying the core capacities needed by state and
local health departments for terrorism preparedness and response. It
reflects the input of epidemiologists, laboratories, state and local
health officers, and many others in the public health practitioner
community.
The next step is for CDC to provide grants to states to assess
themselves against these core capacities. Assessment tools have been
developed for this purpose and CSTE has provided its capacity
assessment tools for epidemiologic surveillance and response to CDC's
Public Health Practice Program Office (PHPPO) for use in the assessment
phase (see attached document). However, at this time, there are no
federal resources for conducting this assessment of bioterrorism
capacity even though it is clear that every state should undertake this
task.
The final step authorized under PHTEA is for CDC to provide grants
to state and local health departments to fill any gaps they have
identified in their assessment process. Again, while there has been
three years of bioterrorism preparedness funding flowing to state and
local health departments via CDC--and this has been a critical
beginning for most states--it has been far too little to begin to fill
the gaps that are going to be identified more systematically in the
capacity assessment phase--if and when that phase is funded.
some specifics on what constitutes core epidemiologic capacity in state
health departments
To make the core capacity assessment process concrete let me give
you a specific example. The first goal listed for CDC's document
Bioterrorism Preparedness and Response Core Capacity Project 2001, now
in final draft, is: Surveillance and Epidemiologic Investigation: The
public health system monitors community health status to detect the
presence of critical bioterrorism agents and characterize the public
health emergency. Under this goal, the first objective is: Ensure early
detection of an outbreak through prompt and systematic collection and
interpretation of timely patient-based and healthcare utilization data.
Under this objective are a number of indicators in three groups. I will
provide and discuss a few of these:
--Legal authority to collect personal information.--Iowa is in the
administrative process of making diseases and syndromes that
may be the result of a deliberate act using biologic or
chemical agents notifiable. This allows us the authority to
collect appropriate medical information, however, it does not
ensure the timely identification and reporting of these
diseases and syndromes.
--Disseminate notifiable disease information and reporting
requirements on a periodic basis.--As mentioned earlier, Iowa
has no means to immediately alert all its health departments in
99 counties, over 100 hospitals, its public health laboratory,
and other key entities such as community health centers and
large physician group practices on either a routine basis, or
in the event of a possible terrorist attack, especially during
non-office hours. At the very least, every local health
department in Iowa should have coverage 24/7. All of them need
pagers, and secure communications systems to send confidential
information to the state health department. Also, a system for
secure, rapid communications with Iowa's health care systems,
including laboratories is critical, yet even the state's public
health laboratory reports its findings on paper via the U.S.
Mail service.
--Establish systematic data collection protocols that monitor
community health indicators (e.g., aberrations in utilization
trends or syndrome-based presentations).--Iowa has no
systematic surveillance for syndromes, instead we are relying
on the traditional passive surveillance system and two sentinel
surveillance systems. We have no capacity to monitor
aberrations in, for instance, emergency room utilization trends
based on syndromic presentations. This is now being done in New
York City requiring 70 individuals with some epidemiologic
training who are conducting syndromic sweeps of all major
emergency rooms in the city. This is funded under CDC's
bioterrorism grants for special epidemiologic projects. It
requires intensive efforts to educate health care
professionals, set up systems to do surveillance and report the
findings, and personnel to assess the incoming data for
indications of a possible terrorist event. Iowa, like most
states, does not even come close to having this capacity.
--Ensure healthcare providers understand the medical effects and
public health consequences of diseases caused by bioterrorism
agents.--As mentioned earlier, two days ago, the Iowa
Department of Public Health presented health care professionals
with a briefing on terrorism. We asked the hospitals to pull
out their emergency plans, most of which address disasters such
as airline crashes, and review them for ability to respond to a
biological or chemical attack. Items that need to be assessed
include isolation beds for infectious disease and
decontamination facilities for chemical injuries. This is just
one hour for healthcare providers when they need on-going,
regular communication and assessment assistance from either
their state or local health department, regular, on-going
education of their physicians about biologic and chemical
terrorist agents and their lab personnel about what and how to
handle specimens. What is needed, immediately in Iowa, is ten
additional masters level, or equivalently experienced
bachelor's level, public health personnel to liaison,
continually, with Iowa's hospitals and other health care
providers: community health centers, health clinics, major
physician group practices, etc. This will insure timely
response to requests for training and information, a
knowledgeable cadre of providers, good reporting of syndromes
and diseases, and coordination of the communications systems.
In addition, each large local health department in Iowa needs
at least one person to coordinate the health and medical
aspects of terrorism response with the law enforcement
agencies, fire and HAZMAT departments, and emergency management
in their county.
--Train public health, infection control, and clinical staff to
collect and rapidly analyze and interpret surveillance data.--
As already noted, at the state health department level, Iowa
needs 10 additional, trained individuals to connect to the
medical care system to educate, monitor, assess, and collect
data in an on-going fashion. Iowa also needs three additional
epidemiologists at the state level to conduct training of staff
at local health departments, conduct on-going, active
surveillance, including analysis of disease clusters, and to
coordinate communications and investigations.
iowa's other pressing terrorism preparedness needs
In addition to the above examples of Iowa's current capacity gaps
when compared with core bioterrorism capacity goals, Iowa has great
needs in several other areas. Iowa is a major agricultural state, but
it currently has only one public health veterinarian assigned to the
state health department. Iowa needs at least one additional public
health veterinarian to set up and conduct active surveillance on
animals to monitor for West Nile Virus, and economically devastating
diseases such as Bovine Spongiform Encephalapathy (or mad cow disease)
and Foot and Mouth Disease. The latter would be a very effective
bioweapon in a state like Iowa or in any state with a large
agricultural base. Also, surveillance for animal diseases can serve as
the ``canary in the mine'' and give us advance notice for diseases that
can affect human health.
Iowa's medical examiner's office, which has been given the
responsibility for mass casualty response, urgently needs one nurse
administrator full-time to: 1) organize medical examiner teams for
response to a mass casualty event; 2) survey available resource such as
refrigerator trucks, x-ray equipment, autopsy supplies; 3) conduct and
coordinate surveillance for unusual deaths; and 4) prepare for
coordination of information and possible notification of victims
families.
Also, Iowa needs one doctoral level person who can educate medical
professionals, coordinate communications, and provide consultation to
the medical care system with regard to chemical weapons. This will free
up the one person currently assigned to chemical weapons to conduct
full time surveillance for chemical related injuries. Right now, Iowa
is relying on our poison control center for information about chemical
injuries and possible attacks. This is haphazard at best.
Iowa is currently trying to develop a critical response capacity
with Medical Assistance Disaster Teams. These teams, critical in rural
states that have no major metropolitan centers like Iowa, will be
recruited from the medical care system. They will be able to move in a
moment's notice anywhere within Iowa's borders, or surrounding states,
in the case of a terrorist attack involving mass trauma, or illness, to
assist the local medical care system since it will take at least 24-36
hours before federal teams can get to Iowa. The Iowa Department of
Public Health has absolutely no additional resources to coordinate and
train these teams, or to pay for their deployment if needed.
Another pressing need in Iowa, and many other states as I have
learned from my colleagues around the country, is more a problem of
perception than funding. Public health has to be seen by all as a major
player, and having expertise, thus needing to have control over some
issues, especially in bioterrorist events. We need to be at the table,
not an after thought. Last Saturday, a town hall meeting was put
together in Iowa, to address ``Terrorism: Risk and Response.'' Five
U.S. Congressmen, police, fire, a city manager, the CIA, former FBI,
etc were invited. Not one single public health or even a practicing
health care professional was invited. We continue to be forgotten.
Finally, last week, Iowa has created an Office of Medical and
Public Health Disaster Preparedness. The director will coordinate all
of the various public health and medical elements in the state health
department that might respond to a natural or deliberate disaster. This
is a function every state needs to address. We have hired a director,
but have taken her from the Emergency Medical System (EMS) unit, which
the health department also administers. EMS will have to fill this
vacated position in the current climate of terrorism preparedness. The
new director will eventually need to hire additional staff to manage
all of the required duties. Each county in Iowa with 500,000 or more
population also needs a full-time bioterrorism coordinator in the local
health department.
cdc grants to iowa for bioterrorism preparedness
Iowa has received a total of $953,181 over three years under CDC's
Public Health Preparedness and Response for Bioterrorism Cooperative
Agreement Awards program. Of this amount, $545,430 has been used to
help Iowa's public health lab meet the specifications of a Bio Level 3
laboratory. But more funding is needed to keep the lab sustained--
adequately equipped, with appropriate reagents for example, and trained
staff. In addition, the lab needs to add an entire chemical terrorism
capability. Finally, funding is needed to make it part of the National
Laboratory System with enhanced communication and collaboration with
Iowa's independent and hospital based clinical labs, and secure
electronic connection to the state health department's epidemiology
office, at a minimum.
Iowa received no epidemiologic and surveillance funding in the
first year of CDC's grant program and only $96,000 in Year 2. This
money has been used to hire an epidemiology nurse for my office, the
state epidemiology office, but we need three more epi-trained
individuals. It took three rounds of position announcements and
interviews to find and hire this person; hiring additional trained
individuals is clearly going to be very difficult and we are competing
intensely now with many other states. The Year 2 epi-surveillance
funding has also been used to pay for the one-hour broadcasted
terrorism seminar for the medical system described earlier, and to
provide support for the newly hired terrorism coordinator. Iowa has
just received $170,000 for epidemiology and surveillance for the
current fiscal year--Year 3. While we are still working on specific
plans, we will be attempting to hire more epi-trained individuals.
Iowa also just received its first Health Alert Network grant for
$143,000. This money will be used to facilitate training and education
of our state's public health workforce and to begin to address a system
for emergency alerts. It will clearly not be enough to establish the
communication network for local health departments and medical systems
that is needed across the state that I have described earlier.
And, as I mentioned before, Iowa has received no planning money--
the logical first step in bioterrorism preparedness.
These funding levels are not unusual. A colleague in Texas, who
helped CDC design its bioterrorism planning grant, also has not
received any planning funding. He was so concerned about preparing his
state that he dropped all his other public health duties to work with
his staff to plan for a biological or chemical attack. This is typical
of dedicated individuals in state health departments where there is a
chronic shortage of trained staff. This shortage has also been well
documented in federal reports on health workforce needs.
I also know that my Texas colleague has been seeking, at a minimum,
33 additional trained staff for the state health department alone to
conduct surveillance and provide response. Only about six of Texas'
major cities have an identified epidemiologist on staff in their health
department. This slows down the ability to detect disease and puts
additional burden on the state to cover. And these deficiencies do not
include concerns the department may have about the needs of its public
health laboratory, or the continuing need for overall planning, and
testing that plan in regular training exercises. Texas' needs,
therefore, mirror Iowa's only on a larger scale.
The past three years of federal funding has been critical to begin
to build the nation's public health terrorism preparedness and
response. But it is simply not enough when states like Iowa and Texas
cannot get planning money, and can only get a fraction of what they
need for epidemiologic surveillance and response, laboratory capacity,
and secure, electronic communications. This also does not address other
related issues such as information systems that are accessible, and
allow for rapid analysis and interpretation of health data as Dr.
Koplan noted. The National Electronic Disease Surveillance System, or
NEDSS, is an important CDC effort in collaboration with states, to
allow the technical integration of a myriad separate data bases that
currently obfuscate important disease trends, or service utilization,
and so slow down our ability to detect outbreaks of disease and quickly
respond. NEDSS is a CDC and a CSTE priority and it needs to be fully
funded at $50 million.
comments from the association of public health laboratories
Iowa needs to enhance its public health laboratory system. This is
also true for all of our states' public health laboratories. The public
health laboratory is a critical component of the national and state
surveillance for bioterrorism. In order to be prepared for bioterrorism
public health laboratories need safe facilities, trained personnel,
modern equipment, rapid assays, and communications tools. Courier
services are also needed to move specimens to the public health
laboratory. To prepare for chemical terrorism our states need
containment laboratories, trained personnel and equipment to perform
rapid screening for toxic chemicals.
To prepare Iowa, and our nation's public health laboratories, we
recommend enhancement of the following three programs: The Laboratory
Response Network, the National Laboratory System and the development of
a Chemical Terrorism Preparedness program.
The Laboratory Response Network (LRN) is critical to the success of
the United States response to terrorism. The national Laboratory
Response Network (LRN) is composed of county, city, state, and federal
public health laboratories, and was established to help public health
laboratories across the nation prepare for and respond to acts of
terrorism. This network of laboratories can accept specimens and
samples from hospitals, clinics, the Federal Bureau of Investigation
(FBI) and other law enforcement groups, emergency medical services, the
military, and other agencies. With adequate resources, this multi-level
network will be able to function effectively even if airplane travel is
simultaneously grounded. During the recent events in New York City and
Washington, D.C., if there had been simultaneous attacks with physical
and bioterrorism agents, patient samples could have easily been
transported over the ground to adjacent states.
Definitive identification of agents of biologic terrorism in both
an overt or covert attack will depend on laboratories having technical
capabilities, equipment and trained personnel. Laboratories must be
able to identify a broad range of potential agents including organisms
that could be used to compromise the food supply, water or air.
Conventional identification methods are now in place and more rapid
methods are being evaluated prior to implementation in public health
laboratories. There is no reliable alternative to the testing by the
network laboratories. The hand held devices that are widely touted by
industry often provide false positive results and false negative
results and cannot be relied upon to provide accurate testing at this
time. Therefore, the LRN should not only be sustained it must be
augmented. In order to prepare the LRN member labs at the local, state,
and federal level an additional $50 million is needed.
The National Laboratory System (NLS) is an essential component of a
laboratory preparedness plan for biological and chemical terrorism. The
National Laboratory System (NLS) is a demonstration program funded by
the Centers for Disease Control and Prevention (CDC) in response to the
growing threat to public health posed by bioterrorism, food-borne
diseases, and emerging infectious diseases. A major goal of the NLS is
to facilitate communication between public health laboratories and the
medical community and hospital/independent laboratories. Accurate and
timely laboratory detection is critically important to identify, track,
and limit public health threats like biologic and chemical terrorism.
Today, most diagnostic testing for infectious agents occurs in 170,000
private hospital or commercial laboratories nationwide. These
facilities will very likely be the primary sites for detecting an act
of bioterrorism or the introduction of an unusual infectious agent into
a community. Improvements are needed in the integration of public
health laboratories and private clinical laboratories. These two types
of laboratories have independent yet complementary roles to safeguard
public health. To reach this goal, the CDC, in conjunction with the
Association of Public Health Laboratories, has been piloting the
National Laboratory System within the states of Minnesota, Michigan,
Nebraska and Washington. The National Laboratory System focuses on
building enhanced collaboration, communication and coordination between
Public Health Laboratories and private clinical laboratories to develop
a network of alert and responsive laboratories. The National Laboratory
System must be expanded to all states to maximize our nation's
preparedness to detect and provide public health interventions for
infectious disease outbreaks. Through improvements in communication,
collaboration, and coordination, the NLS initiative is successfully
providing links to the public and private sectors necessary for an
effective response to terrorism, emerging infectious disease,
antimicrobial resistance, and food borne diseases. Mr. Chairman, Iowa
needs to be part of a National Laboratory System. An additional $50
million is needed to fully implement the NLS in all 50 states.
For Chemical Terrorism Preparedness, expanding the number of
laboratories able to handle chemical agents and agents present in
environmental samples is essential. The likelihood that chemical agents
will be used for terrorist purposes is high. Unlike biological agents,
chemical agents can produce immediate effects; are cheap, easy to use,
stable, and can be precisely delivered; and can be easily, efficiently,
and rapidly dispersed. Terrorists can use thousands of commercially
available chemicals. These chemicals can be purchased throughout the
world. These include herbicides, blood agents, choking agents,
blistering agents, and nerve agents. Currently only five state public
health laboratories (New York, Virginia, New Mexico, California and
Michigan) have received funding and training from the CDC, and are
beginning to serve as ``surge capacity'' laboratories for CDC chemical
terrorism analyses of clinical specimens. At present there are no
efforts to coordinate laboratories testing environmental samples for
evidence of terrorist attacks. Additional public health laboratories,
strategically located throughout the country, must be prepared for the
threat of chemical terrorism. At a minimum, a total of $25 million
additional dollars is needed to enhance and expand public health
laboratories testing clinical specimens for chemical terrorism.
Additional dollars would also be needed to fully implement a program of
testing for environmental samples.
summary and recommendations
(1) Capacity Assessment Needs.--In order to provide you with a
well-documented cost estimate of Iowa's needs with regard to capacity
for terrorism Iowa would need to conduct an adequately funded
assessment. A consensus process for this is well underway, but has
received no funding to date. I understand that CDC believes each state
will need $1 million to conduct an assessment of capacities under three
categories authorized by PHTEA: bioterrorism, antimicrobial resistance,
and major naturally occurring infectious diseases. I do not know if CDC
would estimate it will cost less to limit this to bioterrorism,
including chemical and radiological agents. I would guess that it will
cost Iowa a minimum of $750,000 to conduct a thorough biological and
chemical terrorism preparedness and response assessment.
(2) Workforce Needs.--Again, I am reluctant to make specific
funding recommendations until and when an adequately funded assessment
is concluded. However, the Department of Public Health estimates it
will need, at a minimum, 25 additional people--at the state level
alone--to address the needs of the epidemiologic surveillance system as
described in this statement. This is estimated to cost $2 million in
salaries, taxes, and benefits. But each additional person will also
need office space, a computer, educational materials, and various
support staff including data analysis and computer technicians. This
will cost an estimated additional $2 million. We also estimate that
this amount will be needed at the local health department level, for a
total of $8 million for an investment in the right kind of trained
workforce for Iowa. I would like to stress that finding and attracting
trained, infectious disease epidemiologists to fill these positions
will be difficult, if not impossible, particularly in an environment of
intense competition with other states. Great attention needs to be
given immediately to public health workforce training, particularly
epidemiology.
(3) Laboratory Needs.--I cannot speak specifically for Iowa's
public health laboratory, and it would obviously be included in a
capacity assessment process, but it is clear that it will need on-going
support for equipment and materials, staff and training, and will need
to add chemical terrorism capacity. As the APHL comments make clear,
Iowa's lab should also be part of a National Laboratory System that
will improve its connection to the numerous clinical labs and tie it
electronically to the state epidemiology office, at a minimum. I would
assume that this level of need is approximately $1 million.
(4) Communication Needs.--The $143,000 grant to begin to establish
a Heath Alert Network in Iowa is an important beginning. The
communication goal must be comprehensive, rapid, and timely. This means
it needs to be electronic, two-way, and secure and include all major
medical system sites, state and all local health departments, the
public health lab, the state's clinical labs, and the CDC. This needs
to be supplemented with a system that allows immediate ability to
contact at least one person in each county health department on a 24
hour, seven day-a-week, availability. Again, I am hesitant to estimate
the cost of a comprehensive communications system for Iowa. Some of
this cost is built into the estimated cost for workforce needs, and
laboratory needs. But I would guess an additional $500,000--$1 million
would be needed for the whole system.
I would like to mention here the importance of CDC's Epi-X program.
The mission of Epi-X is to provide rapid, secure communication about
outbreaks and other acute or emerging health events among public health
officials. It is a secure Web-based system with participants from CDC,
state health departments, and the military. Epi-X also provides
emergency notification by: telephone, including office, home, and cell;
fax; pager; e-mail. During the September 11th attacks, Epi-X provided
secure communications for state epidemiologists to post information on
surveillance and response activities for 500 public health officials
around the country, including the U.S. military. As Iowa's state
epidemiologist, I have found Epi-X to be extremely effective. CSTE
urges the Subcommittee to provide $10 million in annual funding for
Epi-X.
(5) Information Systems Needs.--Every state has now received at
least $85,000 in funding for assessment and planning under the National
Electronic Disease Surveillance (NEDSS) program. Several states are
progressing to the next stage, the inclusion of element development, at
an average cost of $300,000 and even finished, prototype testing at an
average cost of $1 million. The NEDSS program is designed to
technically integrate as many as 100 separate data systems currently
used by the nation's public health system so that data analysis can be
done rapidly, across data sets, across regions including multi-states,
and so that mandated reporters, such as physicians, will find reporting
diseases significantly simplified. This is a priority program for CDC
and CSTE; it will make trends that may signify a biological or chemical
attack much clearer more quickly. It will also, eventually, permit
analysis of many other disease trends including environmental exposures
and chronic disease. CDC estimates the NEDSS program should be funded
at a minimum of $50 million. Iowa has only received planning and
assessment funding and would need an estimated $1 million to fully
implement an integrated data collection and analysis system.
(6) Planning Needs.--I cannot stress enough the critical nature of
planning, including real and regular testing of the plan, to be
prepared for a biological or chemical attack. Iowa, as well as 39 other
states, has received no funding to address this foremost need in the
nation's effort to combat terrorism. Again, this is an unprepared, and
undocumented estimate of what Iowa needs in this area, but I would
guess $200,000 per year, should be committed to this activity.
(7) Bioterrorism Response Needs.--This would need careful review
under a well-funded assessment process, but I would anticipate that if
Iowa can put in place the workforce, laboratory, communications and
information systems identified here as needed for bioterorism--and
chemical terrorism--this is the system, with regard to public health,
that would also respond in the event of an attack. The workforce would
need to be immediately expanded in an emergency to conduct an outbreak
investigation in the case of infectious disease, or evaluation of
victims exposed to toxins in the case of a chemical attack. But we
could draw upon epidemiological staff in other areas to accomplish
this. CDC's Epidemic Intelligence Service teams would likely supplement
these efforts. Iowa would additionally draw upon the Medical Assistance
Disaster Teams we hope to create to fill the gap that would necessarily
occur before federal D-MAT and D-MORT teams could arrive. None of these
estimated expenditures address the deficiencies of our medical system,
which will need to develop surge capacity for infectious disease
patients and victims of chemical attack including decontamination
facilities. It also does not include the expense involved in conducting
a survey, which Iowa feels it must do now, of its hospitals and
pharmacies to determine the resources our state has on hand immediately
in case of attack. Again, obtaining and distributing national stockpile
pharmaceuticals will take at least 24 hours.
Total Estimated Needs for Iowa to Prepare and Respond to a
Biological or Chemical Attack.--Looking only at Iowa's public health
system needs, items 1-6 above, the total comes to $11,450,000. This
does not include the specific response needs noted in item 7. It does
include preparedness for a chemical, as well as a biological attack. It
also includes some items that may be one-time expenditures, or periodic
expenditures. But this estimated amount is much closer to Iowa's real
minimum needs than the funding we, or any state, has received under the
current CDC bioterrorism preparedness program. This level of funding
also needs to be made available over a period of several years, as it
will take time to build the system, particularly the right workforce.
After that, significant funding must continue to keep the system
maintained.
Estimated National Need.--CSTE is aware of a proposal by Senator
Kennedy, Chairman of the Senate Health, Education, Labor and Pensions
(HELP) Committee to provide $625 million to improve the ability of
state and local health agencies to monitor, contain, and respond
effectively to the effects of a bioterrorist attack. CSTE believes this
is much closer to the real needs of the nation in confronting an enemy
that could strike with terror using biological or chemical weapons.
I would like to make one final point about the extended value of
strengthening public health while preparing for a bioterrorist attack.
By continuing to build toward a robust comprehensive public health
system, we will be building a multi-use system that will be used for
diseases and situations that are occurring everyday. For example,
responding to emerging diseases like West Nile Virus, which was
discovered in Iowa two weeks ago, the predicted pandemic flu and the
more mundane food poisoning outbreaks. Thus, when and if a terrorist
event occurs, the system will be familiar to those involved which will
help ensure efficient and effective functioning in a crisis.
Thank you again for this opportunity to provide testimony on this
important matter before the Subcommittee. I am pleased to answer any
questions you may have.
Senator Harkin. Thank you very much, Dr. Quinlisk, for your
statement.
Now we turn to our final panelist, Dr. Archer, who is here
on behalf of the National Association of County and City Health
Officials. Dr. Archer is the director of Kansas City Health
Department, and is chairman of the Bioterrorism and Emergency
Response Task Force of the National Association of County
Health Officials. He has been involved in bioterrorism and
emergency preparedness planning in Kansas City, and has helped
to develop guidance and performance standards on bioterrorism
preparedness for local public health systems.
Welcome, Dr. Archer.
STATEMENT OF REX ARCHER, M.D., M.P.H., DIRECTOR, KANSAS
CITY HEALTH DEPARTMENT
Dr. Archer. Thank you. On behalf of those almost 3,000
local health departments, we really want to thank you for your
leadership on this issue. Are we prepared for bioterrorism? One
of the advantages of being last is, I do not have to repeat
everything in my written comments, so I am going to jump right
into this. As said earlier, we are not unprepared, but we are
certainly underprepared, and I think everybody testified that
it is at the local level that we are most vulnerable. We have
been working very strongly on partnerships with CDC, with a lot
of different partners on this, but it does not get you where
you need to go if you do not have all the resources.
One of the advantages here is that every dollar we spend at
the local level for preparedness really can improve our overall
public health threats response. As mentioned, I have been
working with a number of partners on a core set of capacities
that are needed at the State and local level. That work is what
our needs at the local level is based on.
It might surprise you that in almost every city, in fact
almost every community that I am aware of in the United States,
we have more deaths from infectious diseases, natural causes,
than we have from motor vehicle crashes, burns, drowning,
falls, and homicides combined. So again, everything that we
need we should be already doing, and we should be recognized as
public safety agencies, but in the last 2 decades this system
has really been crumbling.
We have a 50-percent increase in deaths from infectious
disease over the last couple of decades. We have been doing a
lot of innovative activity at the local level, attempting to
take all of these silos of grants and create generalists so
that we have surge capacity to be able to handle an outbreak,
but our field staffs still have to handle over 800 cases in a
year in regards to being able to do all of the contact tracing
and to make sure that that disease is not spreading to others.
We believe that that needs to be cut in half in regards to
those caseloads. We do 24-hour-7 days a week coverage, but we
don't pay the people anything for it. It is just an added
responsibility that they have to carry the pager.
I want to go down the kind of staffing we need. Obviously,
we need a full-time bioterrorism coordinator. We are almost a
one-half million population. In the metropolitan area we are
1.8 million. We have 9 or 10 hospitals--one may be closing--but
we believe we need a liaison staff person from our health
department at these hospitals that would be working with them
on infectious diseases, on reportability, and on training.
All the kinds of issues that have been talked about, such
as coordination, that have been trouble at times at the Federal
level, have been issues at the local level. Any dollars that
come into the local community, we need to be aware of them. We
need to coordinate that activity, and if we are doing training
of physicians, nurses, and other providers, public health needs
to coordinate and be at that training table, because then the
providers will report to you if they see a face and they know
who you are when they are being trained.
This is not one-time training, either. We all know that
this has to be ongoing. We need a full-time training
coordinator because of that.
In addition, as I mentioned, we need to double our
epidemiological field staff; that is another 12 individuals. We
believe we need at least four data entry people to be able to
maintain our Health Alert Network and other systems. Those
broadcast-back systems are not any good if the numbers are not
correct and are not updated.
In addition, we believe that we need a full-time high-level
computer professional, because actually the first responders
are actually probably going to be in the pharmacies. If you
think about it, people self-medicate first, and as was
mentioned earlier, with Milwaukee or other places, it is
actually in the pharmacies that you will run out of the anti-
diarrhea medication or the cough medicine.
So if you add that up, that is about 30 people. Take that
up at a per capita rate across our Nation, and that is probably
around 13,000 additional local public health workers that we
need in this country. So I could say very conservatively, at
least let us get 10,000 up and running right now.
prepared statement
I know you share our sense of urgency, and it is really a
shame that we have had to take this catastrophe to pull us
together to move forward on this. We must keep our military
defense strong, but it is now obviously even more apparent that
we have to keep our public health system strong, and unless
somebody comes up with a better way to name this, I think what
we need to call this is really Operation Bio Shield, and that
is improving our infrastructure for public health, for all of
these purposes.
Thank you.
[The statement follows:]
Prepared Statement of Dr. Rex Archer
Good morning, Mr. Chairman and members of the Subcommittee. I am
Rex Archer, MD, MPH. I am Director of the Kansas City Health Department
in Missouri. I chair the Bioterrorism and Emergency Preparedness
Committee of the National Association of County and City Health
Officials (NACCHO). NACCHO is the organization representing the almost
3,000 local public health departments in the country. I have been
deeply engaged in bioterrorism and emergency preparedness planning in
Kansas City. I have also participated in national work to develop
guidance and performance standards in bioterrorism preparedness for
local public health systems. I am here today to tell you about some of
the lessons we have learned in our work, and how much farther we need
to go.
Senator Harkin and Senator Specter, you have been leaders in
providing funding for public health preparedness and in recognizing how
local health departments serve on the front lines in battling public
health crises of all types. Local public health agencies are the first
responders on the ground in a bioterrorism incident. We are
particularly grateful for your support of the Health Alert Network. CDC
used this system, although it is not yet complete, at mid-day on
September 11 to advise public health officials to begin heightened
disease surveillance.
Are we prepared for bioterrorism? Not nearly enough. Local public
health departments have long experience in responding to infectious
disease outbreaks and other local emergencies with public health
implications. We have made progress and learned important lessons about
the challenges of bioterrorism preparedness in the last few years. But
we have a very long way to go to achieve the capacities we need to
detect and respond to an act of bioterrorism as quickly as possible, to
prevent the spread of disease and save as many lives as possible.
Our nation's bioterrorism preparedness activities have been
limited, but we are not starting from scratch. We have some experience
and some results from funding that Congress has appropriated thus far
that I will share with you. In addition, we have a legislative
framework in place for expanding our general public health
preparedness. The Public Health Threats and Emergencies Act of 2000,
which has not yet been funded, establishes a process for systematically
defining what our federal, state and local public health systems need
to do, for assessing what they already can do, and for filling in the
gaps. Every component of the public health system plays a vital role.
State and local public health agencies must collaborate closely,
sharing information and resources. Properly equipped laboratories and
data management and communication systems are essential, as is
leadership and support from the Centers for Disease Control and
Prevention (CDC).
We urge you to provide ample funding to allow bioterrorism
preparedness to move forward swiftly. The Chairman of the authorizing
committee, Senator Kennedy, is requesting sums that we are confident
will provide an excellent, reasonable start. We fully believe that,
when a systematic assessment permits us to quantify more precisely the
national needs for staffing and systems, we will find that developing
and maintaining the state and local public health preparedness
capacities the nation needs will require more than a one-time boost.
lessons learned from the health alert network program
The Health Alert Network (HAN) program was established to enable
rapid, secure communications among local and state public health
agencies and CDC. In addition to helping fund electronic communications
systems in 37 states and 3 large cities, HAN has funded three Local
Centers for Public Health Preparedness. These are model programs that
have explored how local bioterrorism preparedness can be built,
emphasizing cutting-edge uses of information technology. These programs
have shown us what can be done with additional resources and we're
ready to apply the lessons learned in many more jurisdictions.
The three model programs are in Denver, Colorado, DeKalb County,
Georgia (near Atlanta), and Monroe County, New York (Rochester). CDC
has spent $4 million total on these three centers, beginning in fiscal
year 2000. The Centers used the funds to develop their capacities in
three areas: advanced communication and information systems; advanced
operational readiness assessment; and comprehensive training. These
three public health agencies already had advanced levels of information
technology. To build on that, Monroe County developed software to link
various local networks together to enable secure communications across
multiple agencies involved in bioterrorism detection and response. They
are installing desktop computers in hospital emergency departments to
enable instant reporting of unusual disease syndromes. In Denver, new
handheld devices are being piloted and will be used in data collection
for disease surveillance and field investigation of outbreaks. Disease
investigators will be able to input data directly from the field into
the state reportable disease system. DeKalb County has built the
capacity to acquire electronic data from a variety of sources,
including 911 systems, county emergency medical services, the medical
examiners' office, and local hospitals. This is being used to develop a
web-based notifiable disease reporting system that will enable early
recognition of unusual events.
The three centers are also using unique approaches to training, so
that bioterrorism preparedness training is available and appropriate
for all the people who need it. Denver has developed Web-based
curricula to address personal protective equipment, epidemiology and
disease surveillance, victims' assistance, and hospital logistics and
operational readiness. As these modules are used, they will also be
evaluated to see how well they work and what more is needed. DeKalb and
Monroe counties have devoted some resources to assessing types of
preparedness training among private physicians, hospital staff, fire
departments, law enforcement, and the medical examiner, as well as
public health staff. All three Centers have gained extensive experience
developing and conducting tabletop exercises and other preparedness
drills in which hospitals and all other first responders have
participated.
The lessons are still coming in. What have we learned so far?
First, we have learned that the real challenges to improving technology
are not really technical. Rather, they are related to training,
institutionalizing the use of new technology, and finding the funding
to sustain it.
Another important lesson, which many other jurisdictions that have
undertaken bioterrorism preparedness planning also have learned, is
that partnerships between public health agencies, health care
providers, and the traditional first responder communities, such as
fire, police and emergency services, can be built and are essential to
progress. When many public and private agencies in a city or county
have to work together to respond to an emergency, they need to know
each other and to have planned together far in advance. Local
surveillance and response systems won't work unless we have people to
use them and the people who use them know exactly what to do and gets
lots of practice in doing it.
Finally, we have demonstrated what we really already knew--that
preparing for bioterrorism also prepares us for other public health
emergencies. The three Local Centers are stronger public health
agencies in many ways, not just in their ability to address
bioterrorism. The systems for disease surveillance, for communication,
for data management, for interagency planning, for mobilizing the
community to respond, are the same for bioterrorism as they are for any
other disease outbreaks. They have multiple uses, extending even to
improving our abilities to address other public health problems more
effectively. Every dollar we spend on bioterrorism preparedness will
pay off in countless other ways.
The three model centers are showing us what can be done. It is
important to note that they embarked upon building state-of-the-art
bioterrorism preparedness with better, more advanced technology and
programs than the average local public health department has. Many
local public health agencies will need significant resources just to
get to the level that the three model centers had before they started
their upgrades.
providing guidance to local and state public health agencies
NACCHO has also been working with CDC and other public health
partners on a national level to define just what public health agencies
need to prepare for and respond to a bioterrorist act and to provide
them solid guidance. We have developed a set of core capacities and
some ways to measure whether an agency has achieved them. Defining
measurable objectives is an essential part of achieving preparedness.
Setting standards will enable us not only to assess where we stand, but
also to assure that funds are spent prudently, and that the outcome
ultimately will be an effective system serving the country's needs.
These core capacities include (but are not limited to):
--Routine surveillance and epidemiologic investigation
--Enhanced surveillance during a suspected emergency
--Laboratory work to identify or rule out biological threat agents
--Rapid reporting of laboratory results to the right people and
agencies
--Communications networks among the agencies involved in emergency
detection and management
--Methods and systems to receive and transmit data needed to make
emergency management decisions
--Plans and protocols for communicating to the public
--Integrating the public health emergency response into a community's
overall emergency response planning
--Activating and enforcing emergency public health and infection
control measures, including mass distribution of medications or
vaccination, closure of public places, travel restrictions, and
evaluation and handling of the dead.
The next step is to enable states, counties, cities and towns to
transform this framework into their own practical action plan for
bioterrorism preparedness and response. One of our highest priorities
now must be to give states and localities the resources to take this
next step and to develop more tools to help them. Evaluating their
progress against measurable objectives is critical to assuring
accountability.
a case study--bioterrorism preparedness in kansas city
We have never had a bioterrorism incident in Kansas City and I hope
we never do. Nonetheless, we lose more lives from infectious diseases
in Kansas City than we do from all motor vehicle crashes, burns,
drownings, falls, and homicides, combined. The local public health
department is just as essential a public safety agency as the police or
the fire department. At the moment, though, we have just one duty
officer on call for nights and weekends, after regular business hours.
We can't afford 24/7 coverage for urgent situations or emergencies.
I am proud of some innovative steps we have taken to maximize the
resources we do have. Our funding for disease surveillance systems has
been based on programmatic funding, one disease at a time. We have
eliminated these ``silos'' and have developed a fully integrated
surveillance staff that handles everything from HIV to measles. Yet we
need additional staff to make their workload more manageable and to
provide for surge capacity in the event of an epidemic. Each member of
our epidemiology field staff handles 800 case reports of reportable
disease a year, doing whatever is necessary to locate and interview
patients, trace contacts, assure that infectious disease is being
contained as much as possible. We need to double our staff to reduce
the workload to 400 cases a year and have enough trained people to work
24/7 in a crisis.
Let me tell you what I think my agency needs in terms of human
resources to have an effective system for detecting and responding to a
bioterrorist event. First, we need a full-time bioterrorism coordinator
to work with other city agencies and the health care community. Kansas
City has nine hospitals. I would like to place one full-time infectious
disease officer in each institution, to work with hospital staff in
bioterrorism training and emergency planning, to assist with their
ongoing infection control work, particularly antimicrobial resistance,
and to be in place as the active liaison with the health department in
any public health emergency. We need a full-time trainer in the health
department to train both health department employees and the medical
care community on bioterrorism surveillance and response. We need a
full-time public information officer to develop working communication
relationships with the media and the public, so that mechanisms are in
place when we must help the public understand and deal with an
emergency. We need a full-time high-level computer professional to
manage the funds and contracts for building an electronic disease
reporting system and four lower-level data entry and processing staff.
We need twelve additional epidemiology field staff. Including
supervisory and support staff, we need 30 more people. As you can see,
we will gain in two ways. These staff will position us to detect and
respond more effectively to a bioterrorism incident. In addition, their
ongoing responsibilities will improve our overall effectiveness as a
public safety agency.
On a per capita basis, Kansas City's need for 30 additional public
health personnel to prepare for bioterrorism and for other public
health emergencies translates nationally to about 15,000 more people
working at the local level. The cost of adding such personnel, who are
the backbone of surveillance and emergency response systems, does not
include the costs of additional training, enhanced laboratories, secure
and reliable communication and data management systems--all the
components of public health emergency response that the public may take
for granted, but that we know are not in place.
Mr. Chairman, I know that you share my sense of urgency and
recognition that we have before us a momentous challenge. We wish that
it hadn't taken a catastrophe to call public attention to the fact
that, just as we must keep our military defenses strong, so must we
also keep our public health defenses strong. Thank you for our
longstanding encouragement and support.
Senator Harkin. Dr. Archer, thank you very much. I know
Senator Specter is late for another appointment. I am going to
turn to him now.
Senator Specter. Thank you very much, Mr. Chairman. We are
working simultaneously on the Judiciary Committee down the
hall. We are working on the antiterrorism bills, but I want to
join Senator Harkin in thanking all of you for coming.
You are devoted professionals. You have been standing in
the wings, and now you are on center stage, and this is a
matter of tremendous urgency, and we thank you for your
professionalism and for your testimony, and there is a great
deal which has to be done. It is very reassuring to this
subcommittee and really to the entire Congress that you
professionals are here to help us out and give us direction. I
do have to excuse myself at this point in time, so given the 5
minutes for my questioning, I would allocate it to Senator
Harkin. Thank you all very much.
Thank you, Tom.
Senator Harkin. Again, I would just join Senator Specter in
appreciating your past service in which you have all been
leaders, and I have read your testimonies and your backgrounds,
and it is true you are now going to be in the forefront of this
effort nationally, and as more than one of you have said in
your statements, while we are not totally prepared, we are not
starting from scratch. Someone said that, I forget who, and
that is true, we are not starting from scratch.
We do have a good infrastructure out there. We do have the
network. We have the Public Health Service, we have our
epidemiologists, but there are gaps. A couple of you talked
about the gaps. I think we are in pretty good shape for
addressing naturally occurring types of biological outbreaks.
Are we in reasonably good shape? Correct me if I am wrong. I
thought we were not in very good shape if it is not naturally
occurring, either biological or chemical.
Dr. Archer. Many natural outbreaks happen over weeks or a
month, whereas this kind of an event, it is hours and days, so
it really ramps up your surge capacity. But with West Nile,
which was natural, it crippled or it stressed one of the
strongest health departments we have in the country, and so our
public information side is not adequate to handle these issues.
Senator Harkin. Dr. Quinlisk.
Dr. Quinlisk. I would just like to add, if you are talking
about the small, food-borne outbreaks, something like that, I
think we are handling those. But any time you have an outbreak
where there is serious illness, with large numbers of people
ill, unexpectedly occurring, basically right now in Iowa, the
people who are supposed to be handling this cannot do it. We
start having to pull people from other areas of the health
department to assist in calling people, doing interviews,
whatever, which then takes them away from the other things,
such as vaccinating children.
So I would say small things, maybe yes, we have the
capacity, but once you get beyond a small number, no, we really
do not have that capacity, and systems that support that
capacity, such as laboratory reporting, the coordination with
the health care agencies, data analysis, that is woefully
inadequate at this point.
Senator Harkin. Now, Dr. Cantrill, I have talked about,
read the whole scenario of Operation Top Off, and obviously
that sort of indicates that we are not prepared to meet at
least the nonnaturally occurring. Do you want to address
yourself to that?
Dr. Cantrill. I think that is definitely true. Even now, as
I mentioned, we have no surge capacity. People will wait in
emergency departments for hours, sometimes days for a bed to
become available upstairs, which I think is bad medical care.
Because of bed availability in most metropolitan areas there
are major problems with getting patients beds in institutions
in those cities, and so then you add an additional stress on
top of that.
Quite honestly, pretty quickly the wheels come off. You are
doing the best you can. We certainly would do the best we could
do, but I think it would be very, very difficult. I think we
would really compromise care in many cases.
Dr. Tucker. I just wanted to comment on the threat of
naturally emerging infections. The scenario that scares a lot
of epidemiologists is the possible resurgence of an endemic
influenza that is highly virulent, such as what occurred in
this country in 1918, 1919. We are overdue for another major
epidemic of this type, and our public health system is not
prepared even for that contingency.
Senator Harkin. Now, again, just thinking this whole thing
through as I have for sometime now, it seems that you have got
a problem first of all in initial recognition among primary
care providers out there. You may have heard earlier, I said
that a doctor over the weekend in Iowa had said to me, we need
training. He wouldn't even know what to look for in these
things. He has never had any training in this area. It seems to
me that is the first area.
Dr. Cantrill. Senator, I think that may be a little less of
an issue in terms of knowing there is something bad going on,
at least from the emergency department point of view. When you
in one 8-hour period admit your second normally healthy adult
individual who has to be intubated to go to the intensive care
unit, the light should click on, and that is where we need to
increase awareness amongst medical personnel that something is
bad, and we need to train them to go ahead and call their State
health department to get them going. I think we will know,
especially when people are breaking down your doors to get into
the ED because they are so ill, you will know there is
something bad going on. You will not know what it is yet.
Senator Harkin. Well, Operation Top Off indicated there was
some lag time.
Dr. Cantrill. Nominally 12 hours.
Mr. Hauer. There is a lag time, Senator, and the problem we
have got is, with most of these types of agents our
surveillance systems are not sensitive enough at this point in
time to pick up the early indications of an incident. We have
to rely on our primary care providers to recognize that, and
the training at the local level for our primary care providers
has not been there.
It is evolving now, and HHS has been rolling it out, but as
Secretary Thompson said, we need to do more along these lines.
The training at the local level is a big issue, and not just
the primary care providers in emergency rooms, but nurse
practitioners that take care of rural areas, family
practitioners, they have to be trained as well.
Dr. Quinlisk. I was going to add that I think that a
medical system realizing something might be odd probably does
occur, it does occur quickly. One of the biggest problems I see
is, since there is no training for them regarding how to then
take that information they have and get it to the health
department, there is an incredible gap there.
We had whole busloads of ill children brought into the
emergency rooms, and not a single person ever even thought to
contact the health department. I do not think that ER doc did
not realize something was going on, but there was the
disconnect between the medical system and the public health
system that desperately needs to be addressed.
Dr. Archer. That is why I propose we need that liaison
function there in the hospital that is part of the health
department that keeps that on a day-to-day basis, because one-
shot training will not do it. You have to keep that
relationship going.
Senator Harkin. There has to be a system whereby those
primary care providers who may not be an M.D., such as a nurse
practitioner, could report this quickly through some
centralized board, where you would recognize it.
Now, something has to be done immediately, and I do not
know that that kind of system is in place.
Mr. Hauer. In point of fact, in most county and State
health departments it is a 9-to-5 operation. Some of them do
have on-call folks, some do not.
When I worked for then-Governor Bayh in Indiana, and I was
out there for 7 years overseeing the public safety agencies, we
had an occasion to call the department of health, and we put a
system in place. But when the Governor first came into office
there was no system, and getting people on the weekends was
impossible. We could not find a public health professional on
the weekends. There was no on-call system. If they wanted to
report, you called in Monday morning to report.
Senator Harkin. If you are a bioterrorist you would strike
Friday night.
Mr. Hauer. Absolutely right.
Senator Harkin. And you would have the whole weekend.
Mr. Hauer. By Monday morning, particularly with anthrax,
the event would be so far along, that window of opportunity
would be so narrow that we would at that point not be treating
people, because once you get through the first phase of
anthrax, they are not treatable.
Senator Harkin. Dr. Quinlisk.
Dr. Quinlisk. I wanted to make the point too it is not just
getting information from the hospitals to the public health
system, but the public health system has to get information
down to the hospital level to alert them to look for specific
things, or that things might be happening. We talk about the
Health Alert Network, and it is true that CDC alerted everybody
on September 11, but the problem is, they came to me at the
State health department in Iowa.
Right now I have no easy way of getting information out to
the hospitals, or down even to our local public health
departments. We sent out an e-mail, but then we had to call
everybody in our department to start making phone calls to tell
people to go look at their e-mail that they received.
Now, we were lucky that that happened on a week-day. If
that had happened on an evening or a weekend, I do not know
that we would have had any possibility other than just call
everybody we can by telephone to put them on alert that way.
That would have been 99 county health departments even if we
had been able to get a hold of somebody, and calling over 100
hospitals personally in that kind of system just is not going
to meet these needs.
Mr. Hauer. Senator, I think one important point is, part of
this is our fault in public health. We have never looked at
this as a responsive or proactive type of approach. There has
always been the luxury of time. In public health emergencies in
the past you did not have to respond in 4, 6, 12 hours.
Most reporting, as I mentioned in my testimony, has been by
three-part cards that you mail in to the department of health,
and they get it, and sometime over the next 4 or 5 months it
gets entered into the computer, because it has been mostly for
sexually transmitted diseases or other types of diseases that
are required to be reported. That urgency has not been there in
the public health arena, and that is something we have to
instill, and we are instilling into the public health arena. It
has not been there in the past.
Dr. Archer. We changed our reporting ordinance so that
within 4 hours of the suspicion of any of these conditions you
had to report those kinds of things. You would not have a
police or fire department close at 5:00 and not be available
until the next morning, or over the weekend, and yet we allow
that with our public health agencies.
For years we have underfunded our public health positions
at the local level. Those individuals, then, if they did not
want to do shiftwork in a hospital, might take a lower paid
position. Even if we want to go 24-7 and go 12-on, 12-off
during an emergency we have people who's lives may not be
easily adjusted to even do that, because we have not thought in
that way. We have got some major overhauling that needs to be
done.
Senator Harkin. Let me, if I might, turn to another aspect
of this which you heard me talk about and others talk about
today, and that is the whole issue of food safety. Now, again,
it seems to me there are at least a couple of objectives of
terrorists. One is to kill people. Now, that is what we are
talking about when you are talking about anthrax and botulism
and these virulent pathogens. That is meant to kill people and
strike terror. But there may be another objective of striking
terror into people and disrupting the economic system of our
country.
With the food distribution system we have in America today,
an animal could be slaughtered in Kansas, and it could be
processed and within 24 hours people in Portland, Oregon could
be eating some of that, people in Miami, Florida could be
having some of that, and people in New York City could be
having some of that. It just goes all over the country within a
day, and we have seen cases where we have had to track back to
find out exactly where the origin of some salmonella, for
example, originated.
I mean, consider the scenario that might happen if someone
were to place within our food supply chain at a certain point
certain pathogens that might not kill you, but could really
make you awfully sick, and what would happen to the public
confidence in our food supply system if that were detected and
we found that it was a manmade cause that was injected at a
certain point?
The scenario would be that people would become very
terrified of buying food, and where would they go to get the
best food, and how could they be reassured, and yet from my
vantage point of being both on the Agriculture Committee and on
this subcommittee, we really have not done much to address
that, and I need your thoughts and your suggestions on how we
might, both prevent and rapidly address this to reassure people
that we have caught it, that we have stopped it, and that they
are assured that the food they buy the next day is going to be
safe.
Do I make myself clear on that? How do we do that? Can we
set up that system?
Dr. Archer. One problem is that we might not even know that
if the cases are spread out enough, because now frequently
these people are treated symptomatically without laboratory
testing or confirmation. It is probably something we need to
change, that if the physician feels or sees more than one case,
that the companies would pay for even the laboratory testing,
because we miss most food-borne illness. We do not even pick it
up, so we have got that piece also. If we picked up more, we
could handle, I think, more of these types of things.
Most of these pathogens, if you cook it adequately, if you
do the food preparation things that people used to get in home
economics and may not get any more, then it would help reduce
that risk.
Mr. Hauer. Also, finding out this is an intentional type of
an event is very difficult in one of these outbreaks. If you
remember the 1984 incident in Oregon, with the Rajneesh, over
750 people were impacted.
Senator Harkin. That was salmonella.
Mr. Hauer. Right, and it was almost 2 years later that we
found out that it was not accidental. When the FBI was
interrogating one of the members, they found out that it was,
in fact, intentional. Accidental outbreaks versus intentional
outbreaks can be very difficult to discern in this kind of an
environment.
Dr. Quinlisk. That is the public health function. Hopefully
these things could be investigated very quickly, and we could
find out those kinds of things much more quickly and then do
whatever kind of prevention measures necessary to then go back
to the public and say, we have taken care of this, and you can
go buy your food tomorrow and feel okay.
Dr. Cantrill. Senator, one of my concerns is, if we start
having to report every case of diarrhea to the public health
department, that is a very onerous obligation. In medicine
today we are just overregulated, and this would be an
additional regulation if every time I have a case of diarrhea I
have to fill out a form in three parts, so we need to work on
smoothing those things out.
And quite honestly, the HIPAA regulations are an issue here
too, in terms of patient confidentiality. I think we have not
fully investigated those yet, but I think those may compromise
some of our abilities to look over from a global vision point
of view and see patterns of diseases. We can maybe look at the
individual patterns, but we cannot get to the patient because
that information is protected, so there are some very complex
issues here we have to address.
Mr. Hauer. Senator, I understand Steve's concern about
reporting, but I think with the right data-mining systems in
place, the right surveillance systems, it can all be automated
as we have done in New York City, and you really take the load
off the medical care providers and just do it in an automated
fashion.
There are some issues with hospitals. They are concerned
about sharing data with their local health departments or their
local emergency management agencies, and we ran into that. But
when they realize that we were going to shield patient ID's, or
maintain confidentiality, and that we were not looking at their
morbidity and mortality rates, which was a big concern and real
sensitive issue, and that we were really just trying to track
the health status of the city on a daily basis, we got a fair
amount of cooperation.
Dr. Tucker. Just in terms of threat assessment or
probability of bioterrorism, I think food contamination is
probably the most likely type of incident, because the
technical challenges are quite limited.
The Rajneesh, for example, used a low tech approach. They
just took vials of salmonella and poured them on restaurant
salad bars in 10 restaurants in the town of The Dalles, Oregon.
It did not require a sophisticated dissemination system that
many people have talked about.
So if, as you said, terrorists are just wanting to scare
people and kill a few and scare a lot more, this would be the
easiest approach.
Dr. Quinlisk. I would just add something. The Dalles
salmonella and the shigella from the medical center in Texas,
were both laboratory organisms. They actually went into a
laboratory that actually had the legal authority to have those
organisms. So going back to some of the security things that
need to be done, we do need to make sure that the people who
have the right to have those organisms have them under some
kind of a secure method so that somebody else cannot get a hold
of them.
Senator Harkin. There is one last thing I just wanted to
cover with you before we adjourn, and we have gone on long
enough, but I keep hearing about surge capacity. I think I have
a vague idea of what you are talking about. It is about the
influx of patients and we do not have the room, or the places,
or the emergency rooms to take care of that. How do we address
the surge capacity problem that hospitals have?
Mr. Hauer. Quite frankly, I do not think we ought to put
these patients in the hospitals. I think initially a lot of
them will go to hospitals, but as Steve has said, hospitals
will be overcrowded. We did some modeling in New York, and we
believe that you can set up alternate care facilities and
depending on the nature of the agent and the type of illness
you shunt these people away from the hospital, and then if they
are really sick, you put them in the hospital, or if the
hospitals are overwhelmed, you set up alternative facilities.
We identified a number of locations throughout New York
where we could put 5,000 or 10,000 people, like the Javits
Convention Center. The biggest problem you have is needing to
have a surge of medical personnel, because I have to assume
that a certain percentage of the medical providers are victims
themselves, and will want to stay home with their families. So
I might lose 10 to 15 percent of the medical care providers
that I already need, so I am going to have to rely on State and
Federal resources to come in and provide the care.
Finding the facilities should be relatively easy, and if it
is a prolonged type of an incident, as you would see with
smallpox or anthrax, DOD also has the ability to come in and
set up medical facilities as well, but I think this is a role
that local government should be providing, and they ought to be
identifying these facilities now.
Senator Harkin. Get them identified now, and locate them
now, so that they are ready.
Mr. Hauer. Then you integrate Federal and State resources
into the local response, and that ought to be the hallmark of
any response. You take Federal assets and integrate them into
the State and local response to supplement what is going on at
the State and local level.
Dr. Archer. We have to look back at our history such as the
1918 flu pandemic. We certainly have more hospital beds now
than we did then. Our city charter allows me to in effect
commandeer hotels, and set those up as a place to be able to
put patients. If this is communicable, we do not have enough
negative pressure rooms in our hospitals to have these patients
there anyway, and we cannot afford to take our hospitals
offline for other treatment purposes.
We have talked about issues of using drive-through banks
and fast-food places to hand out medication to be able to keep
people from getting in the same air space even, as a way to
reduce the spread.
The other issue on surge capacity, though, is being able to
do the outbreak investigation. What I mean by that is, we talk
about in some cities whether can we get the second SWAT team
there in 15 minutes. With this, we need to be able to
interview, like, 100 patients at 10 different sites in less
than an hour, get them entered into a computer data base, merge
that, do an analysis to see whether they all were at this
building, this sporting event, where were they exposed, so we
can prioritize where we do our prophylaxis so we know what we
are dealing with. We do not have that capacity, but we are
working on it.
Dr. Quinlisk. I would just like to say, too, one of the
things we have learned from some of these terrorist attacks,
specifically, the Sarin in the Tokyo subway, is that the number
of people who were actually killed by this and the number of
people who were actually injured were very, very low, as
compared to the numbers of people who showed up for emergency
care because they were concerned, the worried well. That is, I
think, a very big issue we need to be addressing, and not just
at the hospital systems or the public health systems, but with
the media.
They have got to get the correct information out to people
and not to panic them, because we have seen instances where the
media has, unfortunately, played into people's panic and
created more of a hysteria than maybe was necessary. So that is
another area that I think we need to have very good
relationships with and communications with to make sure that
the proper information gets out to the public, because that is
who people are going to be relying on to get their medical
information at a time of crisis.
Senator Harkin. That is an excellent point.
Dr. Cantrill. One issue about the surge capacity, as
Senator Kennedy mentioned, hospitals continue to close, and I
think that heightens any potential surge capacity problem we
might have.
We have had 5 hospitals close in Denver in the last 5
years. We have fewer beds now than we had 15 years ago, and
1\1/2\ times the population. This is a major problem. I do not
have the answer for it, but I think it really does need to be
looked at. We need to keep every bed that we have now.
I think staffing certainly has become an issue as well.
Even though we may have alternative sites, we may not have
enough staff to deal with some of the very ill patients.
Senator Harkin. Any final comments or suggestions, advice
you might have, before we adjourn?
Dr. Cantrill. I would like to personally thank you for
having these hearings. Having been in this area for several
years, I am very encouraged now that there is a resurgence of
interest in this area, and I think it is marvelous.
Senator Harkin. The one thing that I hope comes out of it,
and I am sure that will come out of it, is a renewed interest
in our Public Health Service, and public health in general. It
has been sort of relegated to the back porch for a long time,
and I think now we should recognize we are all in this thing
together. We need stronger support for all of our public health
systems out there in very many ways.
So hopefully this will at least boost that recognition, and
get the necessary funds out there to help on the local, State,
and Federal level to coordinate this. Public health, as someone
said earlier, is a national security issue, it really is, and
now I think we are seeing recognition of that.
So again, I thank you, as Senator Specter did, for your
public service and for your help in this area. As we move ahead
in developing different responses and funding programs, please
feel free to give us your input either by phone or by e-mail,
or whatever. If you see us doing things you think we should not
be doing, or we need to boost something else, please, you are
the experts, and we rely on you, so please give us your best
input as we move forward.
subcommittee recess
Thank you all very much for being here, that concludes our
hearing.
[Whereupon, at 1:40 p.m., Wednesday, October 3, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
BIOTERRORISM
----------
TUESDAY, OCTOBER 23, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 11 a.m., in room S-5, the Capitol,
Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Reid, Murray, Landrieu, Specter,
Hutchison, and Craig.
Opening statement of Senator Tom Harkin
Senator Harkin. The Subcommittee on Labor, Health and Human
Services, and Education Appropriations Committee will come to
order. Among the duties we have on this subcommittee is to
provide the necessary funding for the protection of the public
health here in America. It is an important responsibility, and
one that has taken on even greater significance over the last
month.
In combatting bioterrorism, we face one of the greatest
public health challenges of our lifetime. Meeting that
challenge will require considerable resolve, know-how, and
resources. Read that as money.
This subcommittee is prepared to do its part and I hope
that the Department of Health & Human Services understands that
it is this subcommittee of the Appropriations Committee on the
Senate side that will decide how much and how that money is
going to be spent. I have a feeling that some people at the
Department of Health and Human Services do not understand that,
and they had better understand it, and they had better start
working with us so that we can get the right information and
that we are able to decide on an appropriate basis not only how
much, but where that money is to go.
Several weeks ago we heard from Secretary Thompson and
other experts about the extent of the threat of bioterrorism. I
think we all came away understanding that we need to view our
public health system as a front line of our national defense.
Just as we need an army of well-trained and well-equipped
soldiers to defend us overseas, we need a well-trained and
well-equipped public health force to defend against
bioterrorism. While we have made some improvements, today I
state emphatically we are in no way as well-prepared to fight
bioterrorism here at home as we are to defeat enemies overseas.
To use military terms, our troop force is inadequate and ill-
trained, our radar and communications systems are outdated, we
are short on ammunition, and our weapons systems need updating.
Well, we want to change that. Over the last several weeks,
Senator Specter and I have consulted with experts, our
colleagues, and the administration to try to develop a
comprehensive antibioterrorism plan to include in the emergency
supplemental appropriations bill. We have put forward a $2.3
billion proposal that both Senator Specter and I have worked
on.
Now, the administration says that they think $1.5 billion
is enough. We think that is insufficient, and we need them to
get back to the pencils and sharpen them a little bit.
Now, in terms of medicine supplies and equipment, we
believe we need $643.6 million to acquire medicine, supplies,
and equipment for the National Pharmaceutical Stockpile. This
would enable us to treat an additional 10 million Americans
exposed to anthrax and other bacterial infections, and others
exposed to possible chemical weapons. We believe we need $509
million to acquire and stockpile enough doses of the smallpox
vaccine, and we will hear about that this morning, to inoculate
every American should that ever become necessary.
We feel we need at least $700 million to beef up our State
and local public health capabilities and hospital surge
capacity. This would include training of doctors, nurses, and
other health professionals, expanding the Health Alert Network,
improving their capacity for early detection and surveillance,
and increasing the capacity and security of public health
laboratories.
We believe we need $140 million to expand the capacity of
CDC, including their labs, and assigning every State trained
disease investigators to be on duty 24 hours a day, 7 days a
week.
We need $10 million to establish a comprehensive data base
and tracking system for all biohazardous pathogens. We have
this for nuclear material. We should have it for biological
agents. I know this is difficult, and there may be some
problems involved, but I think we have to tackle it.
We feel we need $250 million to double our commitment to
the inspection of imported foods. Only about 1 percent of those
foods are currently being inspected. The administration only
asks for $75 million. We believe we need $250 million.
So today's hearing will enable us to get input on this
plan. We will try to get answers on a number of questions, like
how quickly we can acquire this stockpile of vaccines we need,
what steps are most urgent to take, what resources are
required, what is the most effective course of treatment for
those exposed to anthrax and other biological pathogens, and
what about electronic pasteurization, and I will speak more
about this with Dr. Koplan and others.
Can electronic pasteurization, which is approved by the FDA
for food safety processes, be used to make our mail safe and,
if so, how rapidly can we get it involved in some of our mail
processing centers?
What can be done better, and I am glad the FBI is here
today, to coordinate public health and law enforcement
resources? From what I have seen, there has been some
disconnect there and I think we need to reassure ourselves that
there is a good working relationship between law enforcement
and our epidemiologists.
We have a very distinguished panel of witnesses. I look
forward to hearing from each of them. I want to just conclude
with this. This is not the time to panic. We do not need to
push any panic buttons. That is what the bioterrorists want.
But it is the time for us to meet the requirements necessary to
protect the American people and to make sure we do it in the
most expeditious, efficacious manner possible.
There is a lot of misinformation out there. Misinformation
can lead to panic and unbased fears, but I believe we need
better coordination, we need better information, and I will be
asking the FBI about that. Where do you cross the line? They
are doing investigations, and a lot of it they need to keep
secret, I understand that. But the public needs information.
Our public health agencies need information on which to make
decisions to protect the American public. That is what we are
talking about, not a panic, but we need to determine a course
of action and we need to start on it now.
Now, with that, I would recognize my distinguished
colleague, Senator Specter.
Opening statement of Senator Arlen Specter
Senator Specter. Thank you, Mr. Chairman, and thank you and
the staff for convening this very important hearing under very
difficult circumstances. Those who may be watching this on C-
SPAN do not know that we are in the tombs of the Capitol, not
in our customary hearing room in the Dirksen Senate Office
Building, because that building is closed. The Hart Senate
Office Building and the Russell Senate Office Building are also
closed. But we have pushed hard to convene this hearing today
because of the importance of this subject.
The terror of September 11 has resulted in a war on the
terrorists now being waged in Afghanistan, but the public
concerns and the focal point of attention of America today is
on bioterrorism, and that is the subject we are going to
address. We have very distinguished witnesses. We have the
Director of the Center for Disease Control, a key official from
the FBI on counterterrorism, representatives of the scientific
and commercial community to deal with this subject, and we do
so because of the need for the inquiry to determine just
precisely what appropriations need to be made.
The Congress responded immediately on the Friday after the
attack by appropriating $40 billion. A portion of that funding
is going to be directed to bioterrorism, and we are a rich and
powerful and ingenious country, and we can meet the challenge,
but we have to do so in a way which is totally realistic.
This subcommittee heard from Secretary of Health and Human
Services Thompson a couple of weeks ago and had assurances
which Senator Byrd, who is the chairman of the full committee,
categorized in very blunt terms, waving his arms for the
evening news and saying, I do not believe you. We need to be
realistic as to what our problems are and where we are going
and assure the American people that the Congress is functioning
and that we do have a plan and that we are prepared to do what
is necessary.
This subcommittee, and Senator Harkin and I have worked
hand in glove as partners for more than a decade. He is now the
chairman. We had a little reorganizational event in May, but it
has not made any difference. When I was the chairman for 6\1/2\
years and Senator Harkin was ranking and we were reversed we
formed a seamless operation. He and I learned a long time ago
if you want to get something done in Washington you have to
cross party lines, and we have been attentive to this issue,
and that was before September 11.
I made a visit to the Centers for Disease Control a year-
and-a-half ago to respond to what I heard were the deplorable
conditions there, but they were not as deplorable as I had
heard. They were worse, and more than a year ago this
subcommittee took the lead in putting up $175 million to
improve the infrastructure for the Centers for Disease Control.
Before September 11 we put up some $250 million in fiscal year
2002 to continue those improvements at the Centers for Disease
Control. The warnings were clear as to what was happening, but
the reality is that no one knew the intensity of the problem or
could focus on it until the wake-up call came on September 11,
and now we are mobilized. Senator Harkin outlined our
determination to put up the funds which are necessary.
I found that, being back in the State that there was a real
need for Senators and Members of the House of Representatives
to communicate with their constituents. There has been a
feeling for a long time that if Government was not irrelevant,
it was close to irrelevant. You get the Government out of the
way and private enterprise will take care of things. Suddenly,
Government has become relevant, and shortly before this hearing
was convened, the leaders were talking about finishing up our
business, which I think we have to do by Thanksgiving, and
making the decisions and putting politics aside and returning
to our States to take care of very important business and
talking to our constituents.
We really should finish our business by September 30, and
Thanksgiving it seems to me is the outside date, so Senator
Harkin, I thank you for pushing ahead today, and the staff.
Late yesterday afternoon we did not think we would have a
hearing. We were shut out of the Russell Building, but we are
here today and we are prepared to go to work to solve this
problem.
Thank you, Mr. Chairman.
Senator Harkin. Thank you very much, Senator Specter.
Our first panel will be Dr. Jeffrey Koplan, Director of the
Centers for Diseases Control. Dr. Koplan has had a very
distinguished career. He was a member of the CDC team that
helped eradicate smallpox. He has served as Assistant Surgeon
General and has been involved in public health for most of his
adult life. He has his B.A. from Yale, his M.D. from Mount
Sinai School of Medicine, and a master's in public health from
Harvard. Also on the first panel is Mr. James Caruso, Deputy
Assistant Director of the Counterterrorism Division at the FBI.
Before being appointed to his current post, Mr. Caruso served
as Special Agent in Charge of the National Security Division in
Washington, and also served on the investigation staff of the
U.S. House of Representatives Committee on Appropriations.
Before I turn to you, Dr. Koplan, you know I have the
greatest respect for you personally and professionally. I have
the highest respect for the FBI and for the Centers for Disease
Control and Prevention, with whom I have worked closely for the
past 15 years. I must tell you I have some deep concerns, and I
might as well get it off my chest right now, about the actions
of the CDC recently involving the events surrounding the deaths
of the two postal workers here in Washington. This is where I
hope to get some information from both of you about what is
happening in terms of coordination.
Now, I am not one that believes the headlines all the time,
but it says here in The Washington Post: `` Workers Question
Response; CDC Says Policy Evolving. Officials at the U.S.
Center for Disease Control acknowledged yesterday that
recommendations for postal workers are still evolving.'' It
says in the paper this morning: ``We are dealing with something
that up until 2 or 3 weeks ago we had not dealt with before,
said CDC spokesman Tom Skinner.''
Well, that is what CDC is for. Of course there are things
we have not been up against before, but we would hope that CDC
would have had some kind of a plan that they could have used to
trace back, to use the epidemiologists to ensure that we would
trace everything back and make sure that everything was
covered.
Here is another quote from the story: ``What we do is still
sort of a work in progress. We are making decisions based on
the best scientific information we have at the time.
``Based on that record, and on the absence of evidence of
contamination inside the Brentwood building, CDC officials
advised the U.S. Postal Service the workers there did not need
to take antibiotics. They reversed that advice on Sunday, when
the first Brentwood employee was diagnosed with the inhaled
form of anthrax.''
Well, first of all, we get the letter that comes into
Senator Daschle's office. Hundreds and hundreds of people here
in the Capitol were tested. We knew at that time, or shortly
thereafter, that a couple of officials in Trenton, New Jersey
had come down with the skin form of anthrax. Trenton, New
Jersey to here, someone here gets it, at least they tested
positive, and we know that the powder substance was anthrax. We
have officials in Trenton, New Jersey at the postal facility
that come down with the skin form of anthrax. In between, it
goes through Brentwood, and yet the people at Brentwood are
told do not worry about it. At least, that is my reading, and I
am very concerned, Dr. Koplan, about what CDC is doing, and how
they are operating to make sure that those who have any
possible connection with this in any of these facilities are
alerted, that they are tested, and that they are treated in a
timely fashion.
Now, I do not know, maybe I am wrong, but it just seems to
me something broke down here, or is broken down. I do not know
whether it is the FBI in terms of trying to find out who is
doing this, and trying to trace it back, and needing some
secrecy. I do not know if that is a part of the problem. If it
is, we have got to get over it, because obviously, people are
getting sick and people are dying, and we cannot afford to
continue to have this happen.
So whatever happened at Brentwood we just cannot afford to
let happen anywhere else. We count on CDC. You are our line of
defense at CDC to set out the procedures, the processes, the
steps we take to make sure that our people are protected, and
quite frankly, as you can tell by my tone of voice, I am a
little upset about this, because I felt all along that CDC
really was on top of this. Maybe they still are, and maybe you
can reassure us this morning that they are.
Dr. Koplan. I hope to.
Senator Harkin. I appreciate that. Thank you very much, Dr.
Koplan, and I would turn it over to you for an opening
statement.
STATEMENT OF JEFFREY P. KOPLAN, M.D., M.P.H., DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Koplan. Thank you, Mr. Chairman, and Senator Specter, I
will address in detail the issues you have raised and try to
reassure you and every one here and the public that the
expectations they have of us have been met and are being met
and will be met in this outbreak, and provide you with an
explanation and some understanding of the issues you have just
described.
Thank you for the invitation to update you on CDC's public
health response to the threat of bioterrorism. All of our
vigilance, preparedness, and understanding shifted after
September 11, but prior to that, this committee under both of
your leaderships has recognized the importance of bioterrorism,
and has provided us support for many key programs in this
regard, but the public health system of the United States is
severely challenged at the moment.
At CDC we have reorganized ourselves. We have reassigned
staff, deployed over 200 people to the field investigations at
several sites, we have laboratory epidemiologists and other
public health professionals working 24 hours a day. At State
and local levels similar efforts are being undertaken, but the
system is stressed through years of neglect and
underinvestment. Labs are inundated with specimens.
Epidemiologic investigative staff, where present, are being run
ragged. Communications capabilities are strained, and cash-
strapped States and localities face extraordinary unbudgeted
costs for overtime, reagents for tests, extra equipment, et
cetera.
Despite this stress, one can see how public health works in
a crisis, and the unseen system which has been taken for
granted and now expected to perform has performed admirably,
from the initial disaster in New York and the response to the
New York City Health Department to a wide variety of health
problems there, in trying to anticipate other health problems.
We have worked with them from September 11 afternoon on, and
still have many dozen staff there working on everything from
bioterrorism issues to environmental health issues, in Florida
and in New York and Washington, D.C. similarly.
If you like, I could now expand on the situation in
Washington that you have just targeted and explain a little
bit, but if you will permit me, let me back up a little bit to
some of the other investigations, because these are stepwise
pieces of information that we acquired.
Yes, we are amongst the most knowledgeable places in the
world in epidemiologic investigation and in the problems of
anthrax as well, but sometimes the information we have on day
14, which would have been very valuable on day 10, cannot be
used on day 10 when you do not get it until day 14, and while
we do try to anticipate things like this, there is a stepwise
process of building information that derives both an epidemic
investigation and permits us to take the appropriate steps to
control it. Let me back up a little bit and talk about some of
these pieces.
In the initial investigation in Florida--you have heard a
lot about what state the U.S. public health system is in. Here
is a case where an astute clinician could have easily passed
over an ill patient and said, I just do not know what this is,
and we will ascribe it to a pneumonia or a meningitis of
unknown cause, but instead this individual sent specimens, took
collected specimens, sent them to a lab specifically to test
for anthrax, which he had never seen before, had not been
present in the State of Florida for years, but because of this
increased sensitivity, because of educational courses provided
for infectious disease specialists on potential bioterrorist
agents his antennae were up. He got an initial positive.
It was then sent to the Florida State lab. Through support
that you all have provided to us, that Florida State lab had
had recent training on the diagnosis of anthrax at CDC and had
the reagents to do it, and they did that testing and got an
initial positive.
At that point, they needed confirmation from another backup
facility and called us. They called us on a Wednesday night,
late, described the situation to us, described the results,
wanted to send a specimen, got it on a plane that night, we
received it on Thursday morning in Atlanta, and had confirmed
the diagnosis by noon.
Prior to that, not even waiting for that diagnosis, we, in
consultation with the Florida State Health Department, had put
together an investigative team, had them on a plane and on
their way, prior to the confirmation being received, and that
investigation went into play.
Yes, we know something about anthrax, but I would have you
keep in mind that in the course of our 50-plus years of history
there have been 200 cases of anthrax in this country as a
whole, all of them associated with people who deal with hides,
animals, wool-sorting, et cetera, so we have a body of
experienced based on that, and like everyone else in the world,
most of the rest of our experience is on reading things,
studying things, doing things in the laboratory, but we are all
thankful we have not had to have the experience with a
bioterrorist event, per se, before.
In the case in Florida and then in our subsequent
information in New York, we began to piece together what placed
people at risk in these circumstances and in Florida, as you
know, there have been only two cases, and very unfortunately
one of the gentlemen died from inhalation anthrax, another
person is still hospitalized and stable with it, but it was
related to either opening mail or being in a closed space where
mail was opened, and again from past knowledge, from reading
about others' experiences with anthrax, one has to base one's
approach from the information available and towards what we
learn on a day-to-day basis from the lab and, as you say,
epidemiologic investigations.
So as we pursued things in Florida, we looked for all
different kinds of spread and other modes of transmission, and
we backed up through the system. We go upstream from where the
cases are, and continue to look, is there exposure, are there
cases--we reach a wider community. Are there cases that we are
missing of this that would give us more information?
In this instance, there continued to be the linkage between
an opened letter, and it's a physical property, a physical
substance that this anthrax is present in a powdered form and
needs to get out in order to expose people.
Following that, we had experience working closely with our
New York City Health Department colleagues on cases in New
York, again, where we and our colleagues at FBI are open as to
how is this being spread? You cannot assume the same cause each
time, but here was again a place where the letters were
received, where an incriminating letter this time was found,
and that is the difference between New York and Florida. Each
one of these is a little different.
In Florida, we did not have a letter in our hand. We knew
the people worked with mail, and suspected that is what had
happened, and they remembered having mail that was suspect that
had come through, but we did not have that letter in our hand
that we could look at and test to see what the powder was, to
see how it might have been transmitted, to see what its
properties were.
In New York, there was such a letter, which in turn
confirmed this association with mail from Florida, and in turn,
in New York, the association with the letter and opening it
involved a second form of anthrax, a less severe form called
cutaneous anthrax on the skin, and there was no evidence of
inhalation disease there.
We are puzzled. Why was there inhalation disease in Florida
attached to the letter there, but there was no explanation.
There was no one present when the individual involved had
opened it. He opened it in a way that caused the dust to come
out. Was there more dust in that letter--and we do not have the
letter, so we cannot tell whether it was ragged or whether it
was leaking, or whether it had other properties attached to it.
So that we end up at this point with two cases of
inhalation anthrax associated with opened mail, and all of our
cases in New York associated with either a given open letter,
or places where mail gets opened, desk tops, people whose job
it is to open the mail, not just to handle the mail but to open
the mail.
So one of our questions throughout this has been, how far
back up the mail chain do you go? It can go to every household
in the country eventually, at an extreme, or it can go to every
post office in the country, or what we try to do is go
backwards from the cases that we found and see, is there
evidence of anthrax present in these places, is there evidence
of illness in these other places, to go backstream to it.
Here in Washington, we have been involved with a number of
other partners. In both Florida and New York and in New Jersey
our primary linkage is with State and local health officials
and with the FBI who do the criminal investigations out of
this. In Washington, there have been a number of folks involved
in this, where it started at the Hart Office Building, and
again, let me reassure you and say, absolutely that we used the
same standards, we used the same approach, and we tried to be
as diligent, as quick, and as thorough no matter where or to
whom these cases appear, or where the threat is.
We work in public health. There is no favoritism. In fact,
it is quite the reverse. We are most interested in folks who
are less famous, less well-off, and less visible, throughout
the field of public health, so our approach has been to take a
systematic, rational approach to dealing with this, because it
is natural in epidemics, and we have experience in thousands of
epidemics, for people to want to rush to make a decision early,
and it may be the wrong one and can cause more harm and illness
than not.
Let me also add the antibiotics in this are not without
harm themselves. We have no desire to withhold antibiotics, nor
does anyone in the health field, from people who need it. Our
key goal is to identify who needs it, and let us make sure they
get it, and not have people take it unnecessarily, because
there is a risk.
We have already had some significant and serious adverse
reactions from people taking these, including some of our own
staff taking these antibiotics, so we want people on them who
need them, and we do not want people to take them
unnecessarily, so there is a balance in there. Where we have to
err, we want to err on the side of more people taking
antibiotics to better cover them for this serious disease.
In the case of the Hart Building, the investigation again,
just as you indicated, Senator Harkin, we tried to target it by
epidemiologic grounds. In other words, just not distribute
samples and distribute environmental swabs all over the place,
but target where there is a problem. Again there is a letter,
and it is a letter on someone's desk, and we are able to go
find a potential source of exposure in this instance. The
letter was opened, and again the people right around it were
the ones at greatest risk, and our experience in New York, when
we did both environmental specimens from people and from
surfaces, the spread was pretty much confined If we opened a
letter here, it would be in this space around here, with very
little going beyond it, so that was our approach in the Hart
Building as well.
Many people came who wanted both swabs and who wanted
antibiotics, and our policy wherever we have been is not to
discourage anyone who wants it from getting it, and so many
staff came who we did not feel were likely to be exposed, but
ours is not to say you cannot have it or you should not get it.
Instead we say, and we have said it in every instance,
including the Postal Service, take it, take it for x number of
days. It comes to in some cases 10 days, in some cases 14, in
some cases fewer, and we will come back to you then and
determine what your risk is. You may have to take it for 60. We
may be able to say to you, your risk is really negligible, you
do not have to keep taking it.
And I think that is what we have seen at the Hart Office
Building, where the environmental isolation was targeted, not
just in the suites immediately around Senator Daschle's office,
but on the fifth and sixth floor, and a mailroom in Dirksen, so
we used the environmental specimens to correlate our previous
observations, and that makes a rational approach in this, where
lots of people do not have to be on the antibiotics
unnecessarily, with potential risk to them, yet the people who
need it are taking it.
In the issue with the mail sorting facility, as we had had
no cases of inhalation anthrax in a mail-sorting facility, and
there was no reason to think, based on everything we had seen
so far, that this was a possibility, because open mail had been
the relationship between these cases and mail was not being
opened in these facilities, as soon as the first inhalation
case became known, we immediately, working with--and we are
part of the larger team in this.
There is the D.C. Health Department, there is the Postal
Service itself, and let me just say to you that my very first
conversation with the Postmaster General, as soon as this
started his word to us was, he will do whatever is necessary to
protect the health of his workers. That is number 1, and that
no modification has to take place for any other of their
responsibilities. Nothing supersedes the health of his workers,
and he has had that attitude at every discussion we have had
together.
On inspecting that place, we could not be sure what letters
had gone through there.
Senator Harkin. What place, Brentwood?
Dr. Koplan. I am sorry, the Brentwood facility. On getting
there, what was troublesome was that obviously mail is not
opened there, so that the hypothesis we were working on all
along, that you had to have an open letter to spread this,
which--and I hope you will agree with me is somewhat
reasonable. Most things that are in letters are in that letter,
and our past experience in other places was that only when it
was opened did the person get inhalation anthrax, and even in
some cases where it was opened, it was still cutaneous, and we
had not seen inhalation anthrax in places where the mail was
not opened, so this was the first case, with that very first
case, which was new information, and very different from what
we had been seeing.
We immediately--in consultation with the Postal Service,
the station was closed by them. Specimens were taken from all
over. All of the staff was offered antibiotics, and that was
supplied. We had the material here in town, and got it to them
to take. Everyone was told to take it. The people in the
immediate area around the facility where the first case
occurred were urged and told that they were going to need to
take it for 60 days, even then. Everyone else was told, here is
10 days, and we will determine further needs then.
Senator Harkin. Do you remember what day that was, Doctor?
Dr. Koplan. I am afraid all of these days are flowing
together. It was, I believe, Sunday or Monday morning.
Senator Harkin. Like, yesterday?
Dr. Koplan. Exactly.
Senator Harkin. After the two people had already expired?
Dr. Koplan. The two people that expired were not--yes, that
may have happened after the two people had expired, but those
two people who expired had not been identified earlier either
to us or had come through the system. You can only act on the
information you have got in hand.
We were not passively collecting information. One of the
things we do in Florida and New York and Washington, DC is we
had active surveillance going on in hospitals throughout Metro
DC, including Virginia and Maryland, looking for other ill
people who might even possibly have inhalation anthrax, and
these two did not turn up. I think in one of them--and these
are terrible circumstances for the individuals and their
families, and again let me assure you, we are health
professionals. Our job is for people not to get ill or to die,
so these are tragedies for us as well, and not something that
we take lightly in the least, but you have got to know about
the cases as well in order to take action on them, and one of
these individuals had been seen, had relatively mild symptoms,
and was not associated with the outbreak in any way, or the
Brentwood mail facility, and progressed very rapidly, extremely
rapidly, and died before the medical staff could do much at
that point.
So that yes, these two cases came in, but already action
had been taken. The action, the decision to both close the
facility and to get people on treatment did not await these two
cases. My understanding from discussion with colleagues up here
was that that decision was made immediately after that first
case. It did not await these two deaths.
Senator Harkin. Do you mean the decision was made to put
everyone on antibiotics?
Dr. Koplan. Put everyone on antibiotics and begin to take
specimens, close the facility to take environmental specimens
to see how far the anthrax had spread.
Let me reiterate. Knowing what we know today, would we have
done things differently 3 days ago, or 4 days ago, yes. Let me
add that that is true in every epidemic I have ever
investigated. We always learn things, because we are out
looking for things a day after or 2 days after that could have
helped us 2 or 3 days before, but the absence of this
investigative approach, the absence of doing this at all can
mean a much more serious and longstanding epidemic.
We do not want any cases, and we do not want any deaths,
but we do not always get the information necessary to permit us
to operate that way.
Senator Harkin. I hate to interrupt you, but you had the
Trenton facility, and you had the postal workers there that had
cutaneous anthrax. Now, was that because of open mail, that
they opened something in that facility, or what?
Dr. Koplan. There seemingly was a heavier level of
contamination related to the Trenton area.
Senator Harkin. But you do not know if it was open mail or
unopened mail?
Dr. Koplan. We do not know, nor do we know whether it was
packages or what it was. We only know that the postmark on a
couple of these letters did come through Trenton, and we had a
letter from NBC in New York that had a Trenton postmark on it,
and then I believe Senator Daschle's had a Trenton postmark.
Senator Harkin. So when did you first test the Brentwood
facility?
Dr. Koplan. I believe Friday night was the first time we
got into the Brentwood facility. I do not have a chronology in
front of me to go over this with you, but we could certainly
provide that.
Senator Harkin. Would you provide a chronological order of
that, because I want to know how soon it was after the workers
in Trenton were diagnosed, how soon after that did you start to
test or start to at least inform the employees at the Brentwood
facility. I would ask for that chronology.
Dr. Koplan. Sure.
Senator Harkin. But the point is, we do not know whether
the contamination at Trenton was from open mail or not. We just
simply do not know that.
Dr. Koplan. I think that is being investigated now. There
are several cases there. They perform different tasks, and we
are checking as to what they might have been exposed to and
what they did and what they saw. I think the supposition that
it has to be open mail is clearly not a sole supposition now.
Clearly, that puts people more at risk, but what is very
disturbing about this to all of us is that apparently closed
envelopes can potentially transmit as well. We do not know
whether that is out of open flaps in the envelopes, whether it
potentially can pass through the envelope, we do not know. Lots
of this would be easier if we had answers to all of these
things. Some of them we learn as we go along, and some we may
not know for sometime, but we have investigated thousands of
outbreaks over 50 years, and have a pretty good track record. I
have investigated dozens myself.
prepared statement
The difference is, this one is--as you are all well aware,
is not a naturally occurring event, and we have experience with
how things pattern themselves in a naturally occurring event,
but here we have an ongoing malevolent force working against us
and possibly a force with some level of sophistication, so I
can assure you we are working hard, we are working fast, and
absolutely working equitably in every single place. We do
this--whether we can get the answers as fast as we would all
like to have them, probably that will not be the case, because
we would like to have those answers yesterday, but I do not
think you would find a better place, or an institution, or a
people to be doing this than the ones you have doing this,
whether it is in New York, Florida, New Jersey, or Washington,
D.C.
[The statement follows:]
Prepared Statement of Dr. Jeffrey P. Koplan
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Dr. Jeffrey P. Koplan, Director, Centers for Disease Control and
Prevention (CDC). Thank you for the invitation to update you on CDC's
public health response to the threat of bioterrorism. I will update you
on CDC's response to recent anthrax exposures, and I will discuss the
status of implementing the overall goals of our bioterrorism
preparedness program.
As has been highlighted recently, increased vigilance and
preparedness for unexplained illnesses and injuries are an essential
part of the public health effort to protect the American people against
bioterrorism. Prior to the September 11 attack on the United States,
CDC was making substantial progress toward defining, developing, and
implementing a nationwide public health response network to increase
the capacity of public health officials at all levels--federal, state,
and local--to prepare for and respond to deliberate attacks on the
health of our citizens. The events of September 11 were a defining
moment for all of us, and since then we have dramatically increased our
levels of preparedness and are implementing plans to increase it even
further.
recent anthrax exposures
As you are aware, many facilities in communities around the country
have received anthrax threat letters. Most were received as empty
envelopes; some have contained powdery substances. Moreover, in a few
cases, actual anthrax exposures have occurred. On Wednesday, October 3,
the Florida Department of Health notified CDC of a positive anthrax
laboratory test result in a Florida resident who had recently visited
North Carolina. Samples were sent overnight to CDC for confirmatory
testing, and CDC dispatched two investigative teams--to Florida and
North Carolina--the next day. By Sunday, October 7, test results
confirmed that a second person--a coworker of the first individual--had
been exposed to anthrax and that traces of the bacteria had been found
in the workplace. A decision was made to close the building, and
additional CDC staff were sent to help manage notification, health
evaluations of other coworkers, and provision of prophylactic
antibiotics after the National Pharmaceutical Stockpile was deployed.
As CDC was continuing to receive clinical specimens and
environmental samples from Florida, we became aware of a possible case
of cutaneous anthrax in New York City. This person, an NBC employee in
Rockefeller Plaza, had received an envelope containing powder on
September 25. The diagnosis was confirmed by im-munohistochemistry on a
skin biopsy specimen in CDC's laboratory in the early morning of
October 12, and the New York City Health Department and CDC immediately
implemented appropriate public health actions, including restricting
activity on two floors of 30 Rockefeller Plaza and evaluating workers
for the need for prophylactic therapy. CDC sent additional
investigative personnel to New York, joining the more than 30
epidemiologists and other CDC stall assisting with worker injury and
enhanced syndrome surveillance following the September 11 terrorist
attack. Laboratory studies on the powder from the September 25 letter
were negative for the organism causing anthrax. Subsequent
investigation identified a second letter that arrived on September 18,
which was found to be contaminated with Bacillus anthracis, the
organism that causes anthrax.
Last week, on October 15, CDC was notified of a possible anthrax
exposure on Capitol Hill. A letter, which has now been confirmed to
have contained B. anthracis, was opened by a Senate staff member. This
person took appropriate action, notifying emergency personnel, and
Capitol, local, and federal emergency workers immediately implemented
public health measures. Certain areas of the office building were
closed, and employees were screened by history for exposure and started
on antibiotic prophylaxis after a nasal swab was obtained for
epidemiologic purposes. CDC sent two teams of epidemiologists to assist
local, state, and federal authorities in the investigation.
The best defense against such biologic threats continues to be
accurate information regarding how to recognize a potential threat and
knowledge of appropriate actions. In the Morbidity and Mortality Weekly
Report (MMWR) and in multiple health advisories distributed via the
Health Alert Network, CDC has issued several updates on the
investigations as well as interim guidelines for state health
departments with recommended procedures for handling such incidents.
These guidelines include advice to the public and state and local
health officials dealing with suspicious incidents, as well as guidance
to clinical laboratory personnel in recognizing Bacillus anthracis in a
clinical specimen. The guidelines also outline post-exposure
prophylaxis recommendations. In persons exposed to Bacillus anthracis,
disease can be prevented with antibiotic treatment. Early antibiotic
treatment of all forms of anthrax is essential. Bacillus anthracis
usually is susceptible to penicillin, doxycycline, and
fluoroquinolones; but for bioterrorism planning, ciprofloxacin or
doxycycline is recommended as the antibiotic for initial use for
prophylaxis. Copies of the October 19, 2001, MMWR, which addresses
these issues, have been provided to the Subcommittee.
In collaboration with state and local health and law enforcement
officials, CDC and the FBI are continuing to conduct investigations
related to anthrax exposures. During this heightened surveillance,
cases of illness that may reasonably resemble symptoms of anthrax will
be thoroughly reviewed until anthrax can be ruled out. The public
health and medical communities continue to be on a heightened level of
disease monitoring to ensure that any potential exposure is recognized
and that appropriate medical evaluations are given. This is an example
of the disease monitoring system in action, and that system is working.
As of noon October 22, 2 cases of inhalational anthrax have been
identified in Florida, 2 cases of inhalational anthrax have been
identified in Washington, DC, 5 cases of cutaneous anthrax have been
identified in New York City, and 3 cases of cutaneous anthrax have been
identified in New Jersey.
public health leadership
The Department of Health and Human Services' (DHHS) anti-
bioterrorism efforts are focused on improving the nation's public
health surveillance network to quickly detect and identify the
biological agent that has been released; strengthening the capacities
for medical response, especially at the local level; expanding the
stockpile of pharmaceuticals for use if needed; expanding research on
disease agents that might be released, rapid methods for identifying
biological agents, and improved treatments and vaccines; and preventing
bioterrorism by regulation of the shipment of hazardous biological
agents or toxins.
As the nation's disease prevention and control agency, it is CDC's
responsibility on behalf of DHHS to provide national leadership in the
public health and medical communities in a concerted effort to detect,
diagnose, respond to, and prevent illnesses, including those that occur
as a result of a deliberate release of biological agents. This task is
an integral part of CDC's overall mission to monitor and protect the
health of the U.S. population.
In 1998, CDC issued Preventing Emerging Infectious Diseases: A
Strategy for the 21st Century, which describes CDC's plan for combating
today's emerging diseases and preventing those of tomorrow. It focuses
on four goals, each of which has direct relevance to preparedness for
bioterrorism: Disease surveillance and outbreak response; applied
research to identify risk factors for disease and to develop diagnostic
tests, drugs, vaccines, and surveillance tools; infrastructure and
training; and disease prevention and control. This plan was developed
with input from state and local health departments, disease experts,
and partner organizations such as the American Society for
Microbiology, the Association of Public Health Laboratories, the
Council of State and Territorial Epidemiologists, and the Infectious
Disease Society of America. It emphasizes the need to be prepared for
the unexpected--whether it is a naturally occurring influenza pandemic
or the deliberate release of smallpox by a terrorist. It is within the
context of these overall goals that CDC has begun to address preparing
our nation's public health infrastructure to respond to acts of
biological terrorism. Copies of this CDC plan have been provided
previously to the Subcommittee. In addition, CDC presented in March a
report to the Senate entitled Public Health's Infrastructure: A Status
Report. Recommendations in this report complement the strategies
outlined for emerging infectious diseases and preparedness and response
to bioterrorism. These recommendations include training of the public
health workforce, strengthening of data and communications systems, and
improving the public health systems at the state and local level.
cdc's strategic plan for bioterrorism
CDC outlined necessary steps for strengthening public health and
healthcare capacity to protect the nation against bioterrorist threats
in its April 21, 2001, MMWR release of Biological and Chemical
Terrorism: Strategic Plan for Preparedness and Response--
Recommendations of the CDC Strategic Planning Workgroup. This report
reinforces the work CDC has been contributing to this effort since 1998
and lays a framework from which to enhance public health
infrastructure. In keeping with the message of this report, five key
focus areas have been identified which provide the foundation for
local, state, and federal planning efforts: Preparedness and
Prevention, Detection and Surveillance, Diagnosis and Characterization
of Biological and Chemical Agents, Response, and Communication. These
areas capture the goals of CDC's Bioterrorism Preparedness and Response
Program for general bioterrorism preparedness.
Preparedness and Prevention
CDC has been working to ensure that all levels of the public health
community--federal, state, and local--are prepared to work in
coordination with the medical and emergency response communities to
address the public health consequences of biological and chemical
terrorism.
CDC is creating diagnostic and epidemiological guidelines for state
and local health departments and will help states conduct drills and
exercises to assess local readiness for bioterrorism. In addition, CDC,
the Food and Drug Administration (FDA), the National Institutes of
Health (NIH), the Department of Defense (DOD), and other agencies are
supporting and encouraging research to address scientific issues
related to bioterrorism. In some cases, new vaccines, antitoxins, or
innovative drug treatments need to be developed, manufactured, and/or
stocked. Moreover, we need to learn more about the pathogenesis and
epidemiology of the infectious diseases which do not affect the U.S.
population currently. We have only limited knowledge about how
artificial methods of dispersion may affect the infection rate, range
of illness, and public health impact of these biological agents.
Detection and Surveillance
As was evidenced in Florida, New York, and Washington, DC, the
initial detection of a biological terrorist attack occurs at the local
level. Therefore, it is essential to educate and train members of the
medical community--both public and private--who may be the first to
examine and treat the victims. It is also necessary to upgrade the
surveillance systems of state and local health departments, as well as
within healthcare facilities such as hospitals, which will be relied
upon to spot unusual patterns of disease occurrence and to identify any
additional cases of illness. CDC is providing terrorism-related
training to epidemiologists and laboratorians, infection control
personnel, emergency responders, emergency department personnel and
other front-line health-care providers, and health and safety
personnel. CDC is providing educational materials regarding potential
bioterrorism agents to the medical and public health communities on its
website for Public Health Emergency Preparedness and Response at
www.bt.cdc.gov. CDC is working with partners such as the Johns Hopkins
Center for Civilian Biodefense Studies (www.hopkins-biodefense.org) and
the Infectious Diseases Society of America to develop training and
educational materials for incorporation into medical and public health
graduate and postgraduate curricula. With public health partners, CDC
is spearheading the development of the National Electronic Disease
Surveillance System, which will facilitate automated, timely electronic
capture of data from the healthcare system.
Diagnosis and Characterization of Biological and Chemical Agents
To ensure that prevention and treatment measures can be implemented
quickly in the event of a biological or chemical terrorist attack,
rapid diagnosis is critical. CDC has developed guidelines and quality
assurance standards for the safe and secure collection, storage,
transport, and processing of biologic and environmental samples. In
collaboration with other federal and nonfederal partners, CDC is co-
sponsoring a series of training exercises for state public health
laboratory personnel on requirements for the safe use, containment, and
transport of dangerous biological agents and toxins. CDC, also in
cooperation with the Association of Public Health Laboratories (APHL)
and the National Laboratory Training Network (NLTN) have sponsored a
``hands-on'' laboratory course for public health microbiologists. In
conjunction with the course, CDC produced two videos that were
distributed to the participants as well as to members of the NLTN. The
participants in this course are now using these videos and the other
materials developed by CDC to train other laboratorians in their
states. CDC is also enhancing its efforts to foster the safe design and
operation of Biosafety Level 3 laboratories, which are required for
handling many highly dangerous pathogens. Furthermore, CDC is
developing a Rapid Toxic Screen to detect people's exposure to 150
chemical agents using blood or urine samples.
Response
A decisive and timely response to a biological terrorist event
involves a fully documented and well rehearsed plan of detection,
epidemiologic investigation, and medical treatment for affected
persons, and the initiation of disease prevention measures to minimize
illness, injury and death. CDC is addressing this by (1) assisting
state and local health agencies in developing their plans for
investigating and responding to unusual events and unexplained
illnesses, and (2) bolstering CDC's capacities within the overall
federal bioterrorism response effort. CDC is formalizing current draft
plans for the notification and mobilization of personnel and laboratory
resources in response to a bioterrorism emergency, as well as overall
strategies for vaccination, and development and implementation of other
potential outbreak control strategies such as quarantine measures. In
addition, CDC is developing national standards to ensure that
respirators used by first responders and by other health care providers
responding to terrorist acts provide adequate protection against
weapons of terrorism.
Communication Systems
Rapid and secure communications are crucial to ensure a prompt and
coordinated response to an intentional release of a biological agent.
Thus, strengthening communication among clinicians, emergency rooms,
infection control practitioners, hospitals, pharmaceutical companies,
and public health personnel is of paramount importance. To this end,
CDC is making a significant investment in building the nation's public
health communications infrastructure through the Health Alert Network
(HAN). HAN is a nationwide program to establish the communications,
information, distance-learning, and organizational infrastructure for a
new level of defense against health threats, including bioterrorism.
Currently, 13 states are connected to all of their local health
jurisdictions; 37 states have begun connecting to local providers as
well; and CDC is also directly connecting to groups, such as the
American Medical Association, to cast a broad net of coverage. CDC has
also established the Epidemic Information Exchange (Epi-X), a secure,
Web-based communications system that provides information sharing
capabilities to state and local health officials. CDC also provides
timely satellite broadcast and web-broadcast training through the
Public Health Training Network. For example, just last week, CDC
experts shared information on anthrax with physicians, hospitals, and
other healthcare providers across the country.
Ongoing communication of accurate and up-to-date information helps
calm public fears and limit collateral effects of the attack. CDC
communicates with the public directly through its website on emergency
preparedness and through a public inquiry telephone and e-mail system,
which, since the recent attacks, has responded to hundreds of questions
daily. In addition, CDC communicates to the public by releasing daily
updates to the news media, answering inquiries from the press and
providing medical experts for interviews.
the national pharmaceutical stockpile
Another integral component of public health preparedness at CDC has
been the development of a National Pharmaceutical Stockpile (NPS),
which is mobilized in response to an episode caused by a biological or
chemical agent. The role of the CDC's NPS program is to maintain a
national repository of life-saving pharmaceuticals and medical material
that can be delivered to the site or sites of a biological or chemical
terrorism event in order to reduce morbidity and mortality in a
civilian population. The NPS is a backup and means of support to state
and local first responders, healthcare providers, and public health
officials. The NPS program consists of a two-tier response: (1) 12-hour
push packages, which are pre-assembled arrays of pharmaceuticals and
medical supplies that can be delivered to the scene of a terrorism
event within 12 hours of the federal decision to deploy the assets and
that will make possible the treatment or prophylaxis of disease caused
by a variety of threat agents; and (2) a Vendor-Managed Inventory (VMI)
that can be tailored to a specific threat agent. Components of the VMI
will arrive at the scene 24 to 36 hours after activation. The NPS was
mobilized for the first time on September 11, when a 12-hour push pack
was deployed to New York City, delivering 50 tons of medical supplies
to the site of the disaster in 7 hours. In addition, substantial
quantities of VMI were delivered to New York City within 24 hours.
Components of the VMI were deployed to Palm Beach, Florida, this month
to provide adequate supplies of ciprofloxacin to provide prophylaxis to
individuals who were potentially exposed to anthrax. CDC has developed
this program in collaboration with federal and private sector partners
and with input from the states.
core capacities for state and local health bioterrorism preparedness
and response
CDC has been working with partners at all levels to develop core
capacities needed to respond to pubic health threats and emergencies.
CDC is also developing specific guidelines to assist public health
agencies in their efforts to build comprehensive bioterrorism
preparedness and response programs. This collaborative effort engages
federal, state, and local partners in determining what is needed for
state and local public health agencies to improve their preparedness
and response to bioterrorism. This process enables health departments
to more effectively target specific improvements to protect the
public's health in the event of a biological or chemical terrorist
event and will provide the framework for future program efforts. The
core capacities effort is for dual purpose. While these capacities
focus on bioterrorism events, they are also relevant to naturally
occurring infectious disease outbreaks and natural disasters.
challenges
CDC has been addressing issues of detection, epidemiologic
investigation, diagnostics, and enhanced infrastructure and
communications as part of its overall bioterrorism preparedness
strategies. Based on federal, state, and local response in the weeks
following the events of September 11, and on recent training
experiences, such as the National TOPOFF event and the Dark Winter
exercise, CDC has learned valuable lessons and identified gaps that
exist in bioterrorism preparedness and response at federal, state, and
local levels. CDC will continue to work with partners to address
challenges such as improving coordination among other federal agencies
during a response and understanding the necessary relationship needed
between conducting a criminal investigation versus an epidemiologic
case investigation. These issues, as well as overall preparedness
planning at federal, state, and local levels, require additional action
to ensure that the nation is fully prepared to respond to acts of
biological and chemical terrorism.
Disease experts at CDC are developing strategies to prevent the
spread of disease during and after bioterrorist attacks. Specific
components include (1) creating protocols for immunizing at-risk
populations; (2) isolating large numbers of exposed individuals; (3)
reducing occupational exposures; (4) assessing methods of safeguarding
food and water from deliberate contamination; and (5) exploring ways to
improve linkages between animal and human disease surveillance networks
since threat agents that affect both humans and animals may first be
detected in animals.
conclusion
In conclusion, CDC is committed to working with other federal
agencies and partners as well as state and local public health
departments to ensure the health and medical care of our citizens. We
have made substantial progress to date in enhancing the nation's
capability to prepare for and respond to a bioterrorist event. The best
public health strategy to protect the health of civilians against
biological terrorism is the development, organization, and enhancement
of public health prevention systems and tools. Priorities include
strengthened public health laboratory capacity, increased surveillance
and outbreak investigation capacity, and health communications,
education, and training at the federal, state, and local levels. Not
only will this approach ensure that we are prepared for deliberate
bioterrorist threats, but it will also ensure that we will be able to
recognize and control naturally occurring new or re-emerging infectious
diseases. A strong and flexible public health infrastructure is the
best defense against any disease outbreak.
Thank you very much for your attention. I will be happy to answer
any questions you may have.
Senator Harkin. Is there anything else? I am going to turn
to Mr. Caruso, now, from the FBI, and to brief us on, along the
same line of questioning here, what you see as the situation
right now regarding the anthrax investigation, and I will have
questions for you about this investigation.
STATEMENT OF JAMES T. CARUSO, DEPUTY ASSISTANT
DIRECTOR, COUNTERTERRORISM DIVISION,
FEDERAL BUREAU OF INVESTIGATION, DEPARTMENT
OF JUSTICE
Mr. Caruso. Thank you, Mr. Chairman, Senator Specter,
members of the committee. I will briefly address the FBI's
coordination with State and local law enforcement agencies, the
first responders and the scientific and medical communities.
Each FBI field office, in addition to having squads responsible
for investigating suspected acts of domestic and international
terrorism, has weapons of mass destruction (WMD) coordinators.
These individuals are trained to address incidents involving
chemical, biological or radiological attacks or incidents that
the Federal Government, State, and local agencies need to be
prepared to deal with, as we have been dealing with over the
past weeks, and this committee is discussing.
DUTIES OF WEAPON'S OF MASS DESTRUCTION COORDINATOR'S
The WMD coordinator's duties include establishing and
maintaining liaison with State and local first responder
communities, such as the police, fire, hazmat materials units,
and establishing a local FBI WMD incident contingency plan,
which is our own FBI response to a suspected or actual WMD
incident.
The coordinator participates in planning and execution of
State and local WMD exercises and participates in established
counterterrorism working groups. Additionally, many FBI field
offices have established Joint Terrorism Task Forces, JTTF's.
Presently, there are 35 JTTF's Nation-wide, with 24 of those
task forces participating in 6 Regional Terrorism Task Forces
(RTTF's). As a result, all 50 States are represented, receive
and contribute to the flow of information at law enforcement
centers of intelligence.
JTTF's are staffed by FBI, State and local law enforcement,
as well as with other personel from Federal agencies. The FBI
utilizes the JTTF's, the RTTF's, and the National Law
Enforcement Telecommunications System, known as NLETS, to
provide hazardous materials assistance and guidance to first
responders.
Beginning in 1998, the FBI, the Centers for Disease Control
(CDC), and the Association of Public Health Laboratories
(APHL), partnered together to assure a united and coordinated
response to suspected and actual biological incidents. Known as
the Laboratory Response Network (LRN), this group was composed
of over 80 State public health, private, and military
laboratories. The CDC and the APHL set out the scientific
protocols for the testing of specimens. The FBI sets out the
chain of evidence, or evidentiary protocols to be used in
gathering and testing specimens.
A question posed to the FBI is, what have we done to
coordinate efforts with State and local representatives on
crime scenes? In the anthrax venues such as those in Miami, New
York, New Jersey, and Washington, DC, the local FBI field
offices work closely with State and local government officials,
public health agencies, and law enforcement and first responder
units, to expeditiously identify and isolate any potential
crime scene. The FBI is coordinating sampling, and testing
operations with the CDC and the Department of Health and Human
Services (HHS) to ensure public safety. We are also closely
aligned with the U.S. Postal Service and the Office of the
Chief Postal Inspector at the local and headquarters levels.
The FBI deployed members of its Hazardous Materials
Response Unit out of Quantico, Virginia to assist State, local,
and Federal personnel in the sampling of locations and
facilities believed to be contaminated with anthrax. Currently,
there is a CDC official and U.S. Postal Service officer
assigned to the domestic terrorism section at FBI Headquarters
to ensure direct connectivity and information-sharing.
Finally, Mr. Chairman, the FBI's mission is to investigate
and to prevent future acts of terrorism, whether committed by a
single individual or a terrorist cabal.
Thank you.
BIOTERRORIST INCIDENTS AND INFORMATION
Senator Harkin. Thank you, Mr. Caruso. I just have one more
question, and then I will turn to Senator Specter and the other
Senators who are here. This is the question I started out with.
In the bioterrorist incidents, it is necessary we tell
people what is going on. People have to have information. Our
public health officials, not only at CDC but those at the State
and local levels, have to have information. Do you think there
is a conflict with the FBI's need to control that information
due to the fact that it is an ongoing criminal investigation? I
am getting a sense there may be some conflict here, and I do
not know who is ruling the roost.
Is it Dr. Koplan and the people at CDC on whom we rely to
do the epidemiology of this, to track it down, to let us know
where it is coming from, how to control it and contain it? Or
are you ruling the roost in trying to go after the people who
are doing it, and trying to do a criminal investigation? How
well is that being coordinated? Who is running this show?
Mr. Caruso. Mr. Chairman, the mission of the FBI is to
investigate and prevent act of terrorism, thereby saving lives.
We turn to the CDC for guidance in doing that. If there is
information that is law enforcement-sensitive, or information
that may tip into the classified world, we find a way to make
sure that information gets to the proper authorities so that we
can save American lives. There is no question in our mind what
our mission is with reference to that, and we try to live up to
that every day.
Senator Harkin. I have no doubt about that.
Dr. Koplan. Can I expand on that a bit? We are not two
agencies that normally work together on a day-to-day basis. We
have had some contact on West Nile, and some laboratory work,
as has just been indicated. In this particular instance, from
the get-go both of us were involved in the Florida
investigation, and it became clear we were mutually dependent
on each other for a wide range of activities, and it worked
extraordinarily well. That does not mean that every day there
was not a question on who does what and how do we do it, but we
got it resolved well.
We had a team leader, they had an investigative team
leader. We assigned someone from our epidemiology staff to sit
in their emergency operations office, and they did the same
with us. We assigned a senior CDC person who knows this area
well to come to FBI Headquarters in Washington and sit there
and we have made great efforts to ensure an enmeshed
cooperative venture in this, and I think it has worked well.
So in terms of, they lead the criminal investigation, we
lead the epidemiologic investigation, and when we get in the
way of each other, we try to sort it out.
Senator Harkin. Well, that is sort of the concern that I
have, and others have, too, and it is a balancing act. I assure
you we want to get these people, there is no doubt about it.
But we also want to protect people, too, so we need as much
information about what is going on so we can protect people. I
can assure you there is a great deal of concern here, when we
think about that Brentwood facility. The fact that we were here
and had exposure, and so did Trenton, and it was not until
somebody got sick there that we finally decided to start
testing people there and giving antibiotics, that is something
that bothers us.
Mr. Caruso. Mr. Chairman, from early on in this
investigation, under the leadership of Attorney General
Ashcroft and Director Mueller, the FBI has provided information
to the State and local representatives. One of the ways we do
that most effectively is through the National Law Enforcement
Telecommunications Center, NLETS, and that is a communications
system that electronically connects us to about 18,000 law
enforcement agencies across the country.
Under General Ashcroft and Director Mueller's leadership,
we have been providing information even of a general threat
nature to the law enforcement community to make sure that they
are properly postured, and that we get information out.
Sometimes we have been criticized for giving information
out that was not terribly specific in particular areas. It is
more important to have the law enforcement and the American
people be informed. That is the springboard from which we in
the FBI are coming with reference to providing information as
soon as we can get it.
Senator Harkin. Thank you very much.
Senator Specter.
Senator Specter. Thank you, Mr. Chairman.
Mr. Chairman, since we are in this makeshift room we do not
have the lights on, and I am going to take 5 minutes, which is
our custom, and I would appreciate it if the clerk would hand
me a note when I have 1 minute left so I will know when my time
is up. We have a very long list of panelists beyond Dr. Koplan
and Mr. Caruso, and we have caucus luncheons where we have to
figure out the schedule as to how we are going to complete our
business, so we are going to be under very tight time
constraints, so I am prepared to observe time limits
meticulously.
RESONSIBILITY FOR ANTHRAX DISTRIBUTION
Mr. Caruso, it is very important that we be sure about what
we say as to who is spreading the anthrax. We speculate or
wonder if there is a connection between the September 11 attack
by Osama bin Laden and Al Qaeda and the anthrax, and until we
know, we should not jump to any conclusions.
There has also been speculation about what is happening
with Saddam Hussein and Iraq. As we know, we have not been able
to inspect Iraq for many years now, and we know that Saddam
Hussein has been actively engaged in bioterrorism. Is there
anything in the FBI investigation which suggests any connection
to either Osama bin Laden or Al Qaeda or Iraq's Saddam Hussein?
Mr. Caruso. Senator, we do not have information at this
point that would make evidentiary links to Osama bin Laden or
Al Qaeda.
POSSIBLE RANGE OF BIOTERRORIST THREATS
Senator Specter. When you say evidentiary links, I do not
think we need admissible evidence in court, but that is
something which is very much on our minds, so while not to jump
to any conclusions at all that is something that we ought to
focus on, and the subcommittee would like a follow-up from you,
if you could give it to us, as to what your line of inquiry is
and we will treat it on a confidential basis.
Now, Dr. Koplan, looking at the broader picture on
bioterrorism, you hear a lot of talk about smallpox. You hear
talk about anthrax. There are concerns about water, and there
are concerns about chemicals, as the Japanese subway incident
several years ago. As a matter of public information, what is
the range of possibility with respect to bioterrorist attacks?
Dr. Koplan. Unfortunately, it is very broad. There is a
wide range of agents, both biological and chemical, that can be
used.
Senator Specter. Would you furnish to this subcommittee a
list as to those substances?
Dr. Koplan. Sure.
Senator Specter. Would you also furnish to this
subcommittee a list as to what ought to be done about it? We
have certain responses to anthrax. We would like to have an
update as to what is happening with respect to smallpox. We
would like to have a specification as to what other threats are
out there, and what ought to be done by the Government to act
if we find that they strike, and we also need to know what the
cost factor is.
Senator Byrd and Senator Stevens, Senator Harkin and I
wrote to the President several weeks ago after Secretary
Thompson testified asking what figure we need, and we are
prepared to spend whatever it takes, but we need to have the
specifications and the range of problems, and what the answers
are and what the costs are.
You see a lot of information about crop-dusting. What kind
of a risk is posed to Americans across the land by materials
which could be spread with crop-dusters?
Dr. Koplan. Again, it is difficult to determine. There is a
variety of factors in that, many of which involve the criminal
FBI side of this.
Senator Specter. I only have 60 seconds left, Dr. Koplan.
Dr. Koplan. So I should not use up a lot of it. Quickly,
there are some elements that could be sprayed in that form, but
it s not quite as simple as people would think in terms of
clumping and particle size and all of that. It is an issue.
Senator Specter. A last question. I have 25 seconds left,
and I want to be within the time limits. If somebody in America
has a problem, or a question, what should they do? Whom should
they call? Do you have a number, or a hotline?
Dr. Koplan. I think the best source of information for
everybody in the country is their local county or city health
department, No. 1, their State health department, No. 2. They
have been given a wide range.
Senator Specter. Dr. Koplan, could I suggest we establish a
national hotline so that we have one number where people could
call?
Dr. Koplan. We have a hotline for State and local health
departments but it would be virtually impossible to answer all
of the calls on a national basis.
Senator Specter. I am glad it is only virtually impossible.
Thank you, Mr. Chairman.
Senator Harkin. In order of appearance, let us now turn to
Senator Murray.
TESTING OF POSTAL FACILITIES AND WORKERS
Senator Murray. Thank you very much, Mr. Chairman,
especially for holding this hearing today.
Dr. Koplan, I know many of us are very concerned that the
postal workers at the Brentwood facility were not tested in now
what appears, looking back, a timely manner, and given the
treatment that many people here on the Hill were given almost
immediately, and I think that is very disconcerting to many of
us here.
It seems to me, if I remember correctly, that we knew on
Wednesday that there was anthrax on a mail machine in the
Dirksen Building. At what point did we go backwards from there
and start checking where did this mail come from? Obviously, it
is on a postal machine in Dirksen, and where was it before, and
why was there a gap between that and the Brentwood facility and
beginning to take a look at whether there was exposure there?
Dr. Koplan. Thank you, Senator Murray. Before you came in I
offered to get a chronology of this for Senator Harkin. The
presence of environmental isolates in places does not
necessarily correlate with people getting ill from the disease,
and as I indicated, there had still been no evidence of
inhalation anthrax in a place where people had not opened mail,
and that is the change in what we learned in this instance.
On the Wednesday you are referring to, I do not think we
had received, or anyone had received results of any isolations
from the Brentwood facility. There was an association with a
sorting machine in--and I am not sure where the environmental
specimen was from in Dirksen--the mail room, but I believe the
investigation had continued at that point, looking again
downstream. There is a P Street station that was looked at, and
then Brentwood after that.
Senator Murray. So that was ongoing?
Dr. Koplan. I believe it was.
Senator Murray. Well, obviously we have learned a lot in a
week in terms of unopened mail, opened mail, where exposure can
be and all of that, and I am curious, are we now putting
together a protocol so that the next time a letter appears some
place we will know immediately how to backtrack it?
Dr. Koplan. Well, we have been trying to put together
protocols at each day in this, and have had to change them each
day based upon new information as it comes in, and absolutely
we have been working for several days with the Postal Service
and others to try to come up with what is a rational and the
best approach to take to make workers safe in the postal
facilities.
It has to change based upon new information, but we are
discussing on a daily basis with the postal authorities and
their unions and everyone else involved what are the best steps
we can take. Some of this I will tell you is somewhat
arbitrary, and we are not sure on all of these things, but we
are going to try to step as far over towards workers' safety as
we possibly can to get this thing done.
Some of the questions are, what type of protective
barriers--there has been a focus on protective barriers of
gloves and masks, et cetera, and which are the best of those to
use. It is more complicated than just saying gloves and masks.
For some of the equipment I understand postal workers use there
can be a danger in getting a hand caught, or something caught.
PROPER PROCEDURES TO HANDLE OPENING OF MAIL
Senator Murray. And I think that goes to my second concern.
Everybody hears something different. Are we doing research
quickly, I mean, really quickly to let postal workers or people
in offices who open mail know what is the proper procedure? We
hear from one group to wear gloves, we hear from another do not
wear gloves.
Dr. Koplan. We are not waiting for research for this. We
are trying to bring folks who have the most to offer, and it is
mixed skill sets, occupational experts and occupational health
and safety.
Senator Murray. How soon will we know what those rules are?
Dr. Koplan. We are meeting later today to talk about it,
but I would rather have rules that make sense and work, rather
than just get rules out in the next couple of hours. We will be
working as quickly as we possibly can to get valid and
appropriate rules out, in the meantime trying not to put anyone
at further risk.
Senator Murray. I think that is really important, that
people just have the facts so that they know how to deal with
this. Most people just want to know, how do I protect myself?
GETTING INFORMATION TO HEALTH CARE PROFESSIONALS
My time is almost up. I have a few other questions. It
seems to me there was so much information in the press and
everywhere we went about anthrax. How could it possibly be that
someone showed up at a health care professional's office and
was turned away and sent home who may have been exposed to
anthrax and subsequently died? How do you get information out
there? Where was the hole?
Dr. Koplan. Well, we have had a number of people who have
recognized it, or whose antenna went up and reported it both in
the cutaneous cases in New York and in the case in Florida and
some other instances. In this particular instance, when doctors
or health professionals see people it is not always obvious
what that is, and unfortunately in the early stages of
inhalation anthrax it can look like any one of a number of
things that people see hundreds of cases of every day, and
again, it is easy for me sitting here thinking that I might
have thought, well, maybe it is anthrax, I probably would not
if someone comes in with a cough and a cold and a headache.
The difference now is, I think the level of suspicion is up
all over. Nevertheless, it is hard for me to find fault with an
individual in that circumstance, and one of the issues in this
particular unfortunate patient was the rapid deterioration that
occurred after what was seemingly symptoms like you see for a
large number of other illnesses.
A key issue here, and an important issue for the public and
the health education message is, it is the combination of those
symptoms and where this person worked, and that is the key
linkage.
Senator Murray. That was my last question. Is that going to
be part of the protocol for doctors to understand?
Dr. Koplan. Yes, and now one of the things is we have
association with handling mail, and not just opening mail, that
that has got to be raised, and it is one of the things that all
health professionals now have to say to people is, you have got
a cold, you have got a cough, you have got a fever, now what
kind of job do you do and where do you do it, and do you handle
mail. It is again something we would not have asked 2 weeks ago
that we need to ask now.
Senator Murray. Thank you very much.
Senator Harkin. Thank you, Senator Murray.
Senator Landrieu.
Senator Landrieu. Let me just begin by following up
briefly, and thank you, Mr. Chairman, for holding this hearing,
and our Ranking Member, for the timeliness of this hearing.
But to follow up with what Senator Murray said, it does
seem difficult to fathom, though, how here in the District,
that anybody showing up at a hospital who was a postal worker
with flu-like symptoms could have been sent home. I just think
we need to explore that in a little bit more detail, because it
is important, as the chairman said, to learn our lessons
quickly, because of course these families have suffered
tremendous loss, and there are thousands and thousands of
postal workers and families and children of the postal workers
and mothers and fathers of postal workers throughout the Nation
that are obviously very, very concerned. So it is very
important, Mr. Chairman, that we learn that lesson quickly and
apply it.
Second, I think to keep this in perspective, because I
think it is important for all of us, the Members of Congress
and the public generally to do that, I found a quote that
Samuel Adams gave in a speech in 1771, and I thought, Mr.
Chairman, I would share that. He says: ``the necessity of the
times more than ever calls for our utmost circumspection,
deliberation, fortitude, and perseverance. Let us remember that
if we suffer tamely a lawless attack upon our liberty, we
encourage it, and involve others in our doom.''
Now, of course, this was prior to the Revolution, but
throughout the history of our Nation we have had very serious
attacks, and this is one that we are in.
Another point I want to make, and we continue to refer in
this hearing to this outbreak, this anthrax outbreak, I would
suggest that we use a little tougher language to understand
what we are in, because this is an attack. We do not know the
perpetrators. We do not know the exact linkages, but we do know
enough of the substance to realize that someone most certainly
intended this act to cause death and destruction and
disruption, and to a certain degree they obviously have been
successful, and so this is not just our usual public health
situation. This is a purposeful, merciless attack in this way,
and it may not be, unfortunately, the last time that we see it.
PROUD POSTAL WORKERS AND AWARENESS
The next point is that I have shared with my staff, and
many of the Senators and House members have expressed this to
their staffs, that although we do not show up in a uniform, we
wear regular clothes, we are, this staff here, like we wear a
uniform. The postal workers out there, I want them to be proud
of the uniform that they wear, because everything that we do,
whether it is opening mail, delivering mail, preparing for
hearings like this, giving speeches, conducting hearings in
very difficult circumstances like the chairman has had to put
this hearing together, and all of you, it is a way that we
stand up to the flag every day, and I hope that we can
communicate that.
There is no sense in blaming, but we do need to get about
quickly finding some answers, and so for my question, I wanted
to ask the FBI, because we went to the web site and looked at
the advisory that has been put out for letters that is on the
FBI web site, and it is obvious to me just looking at this that
we might need to revise the web site somewhat. It talks about
letters, for us to be aware of. Be aware of letters, it says,
with no return addresses. Be aware of letters with postage that
is more than necessary. Be aware of letters that are postmarked
or post-stamped from a foreign source.
Well, these letters, at least the letter to Senator Daschle
that we know of, had a return address from a fourth grade class
in New Jersey, it was clearly marked, the postage was mailed
from a domestic box with a local postmark in New Jersey, so I
think that is what Senator Murray and others are referring to.
We realize we are all learning, but the faster we learn, and
the more clear, specific, reliable information that we can put
out there, the better. I would only ask, first, and I know I
have got a minute left, can this be revised, and should it be?
My second question is, what is the FBI doing to rely on and
connect to the military, which does have a lot of experience
dealing with weapons of mass destruction, which this most
certainly is?
And my third question to the FBI is, of the 2,300 incidents
that you say that have been reported, could you provide to the
chairman, because we do not have time to go over this, our time
is short, how many of those incidents were shared with local
law enforcement, and how many were not? I think that would be
important for this committee to know so we can see if the local
law enforcement is, in fact, getting the information that they
need to be getting.
And finally, you can submit this for the record later,
because we do not have time, what is the penalty for hoaxes
that the FBI is either suggesting for Congress to consider, or
suggesting for local legislators to take up across this
country, because Mr. Chairman, the last thing we need is for
our resources to be stretched with people who are sort of
conducting hoaxes on their own. I think the swiftest penalties
need to be given out so that we can nip this in the bud and
give the American people the confidence and the comfort they
need.
You can answer one or two for the time, and then if you
would just submit the rest in writing. Thank you.
[The information follows:]
Information Sharing With Local Law Enforcement
The response to suspected Weapons of Mass Destruction (WMD) threats
or incidents typically involves both the Federal Bureau of
Investigation FBI and local law enforcement entities. In reference to
the 2,300 mentioned incidents, the majority (no specific number
available) were investigated by both FBI and local law enforcement.
The FBI maintains weekly statistics of all FBI responses to
suspected or actual WMD threats or incidents to include anthrax. For
the period between September 11, 2001, and November 19, 2001, the FBI
responded to approximately 14,000 incidents throughout the United
States in which the distribution/release of anthrax was suspected, as
well as responding to approximately 750 incidents in which other WMD
were suspected of being involved. The FBI response to these incidents
was based on information that it received from a variety of sources, to
include referrals from local law enforcement and first response
entities and telephonic tips from the general public. The FBI takes
each and every report seriously and expends the resources necessary to
address the threat and provide a measured response.
As noted in Mr. Caruso's statement, the FBI has established several
mechanisms that facilitate the sharing of WMD-related information with
local law enforcement entities. The working relationships emanating
from the existence of Joint Terrorism Task Forces/Regional Terrorism
Task Forces (JTTF/RTTF) and the outreach efforts of field office WMD
coordinators have resulted in the establishment of mechanisms for the
exchange of information with local law enforcement entities. These
mechanisms, which can include passing information to local police
officer's on a JTTF or telephonic contacts between a field office WMD
coordinator or management official and the appropriate counterparts at
local law enforcement entities, serve as the means for timely
dissemination of information regarding incidents in which a WMD is
suspected of being involved.
FIRST RESPONDERS
Mr. Caruso. I think your suggestions on the announcement
there are very wise, and we will see if we can incorporate
those to make them look a bit more like some of the letters you
referred to. I think that is a very good observation. Thank you
for that.
We are working closely with the Department of Defense in
those areas where we can. For example, we use their institute
to take a look at some of the anthrax or the material that they
determine to be anthrax, and we have a very good, close working
relationship with them, as well as with CDC. With reference to
the 2,300 incidents, I will get you that information.
Specifically, my expectation is the vast majority, if not
all of them, have local law enforcement involvement because
local law enforcement or fire departments are really the first
entities who are called by an individual who says, ``I have a
strange and suspicious package before me. What do I do?'' It is
the first responders, the local law enforcement agencies and
five departments that are the first responders. But I can get
you some more specific information. My expectation is the vast
majority will have local connectivity and response with the
FBI.
PENALTIES
The hoaxes penalty issue is something that I will talk with
the Department of Justice about. The Attorney General, as you
know, and Director Mueller have vigorously gone after and
arrested individuals who have played hoaxes to show individuals
that their comedic attempt is not appreciated, and we will
apply the full extent of the law against what they have done.
There have been a number of instances in that regard.
Increasing penalties is something to be discussed with the
Department of Justice.
Thank you.
[The information follows:]
Penalty for Hoaxes
Prior to October 23, 2001, no penalties existed for weapons of mass
destruction ``hoax devices'' in the Federal Criminal Code. However,
within sections 175 (biological weapons), 229 (chemical weapons), 831
(nuclear material), and 2332a (weapons of mass destruction), it is
illegal to threaten the use of such weapons. The threatened use of a
WMD does not constitute a ``hoax,'' but involves the articulated threat
that a chemical, biological, nuclear, radiological, or high explosive
device is present. A statute is needed which specifically addresses
instances in which an individual falsely reports the presence of a WMD
or the action does not rise to the level of a threat. The proposed
language, H.R. 3209, satisfies this law enforcement need.
Specific to the question regarding current penalties under these
statutes:
Section 175.--As of October 24, 2001, Section 175 was amended
pursuant to the ``Patriot Act'' to include a penalty provision, 175
(c), which includes fines and imprisonment of not more than 10 years or
both.
Section 229.--As defined under 229A, Criminal penalties include:
fines or imprisonment for any term of years, or both; death penalty or
life imprisonment where violation of 229 results in the death of
another person; and, Civil Penalties may include an amount not to
exceed $100,000.
Section 831.--As defined under 831 (b), Criminal penalties include:
a fine and imprisonment for any terms of years or life, depending on
relevant conduct.
Section 2332a.--As defined under 2332a (b), imprisonment for any
term of years or life; and if death results, punishment by death, or
any term of years or for life.
Under the proposed H.R. 3209, an individual who violates this
statute may be fined or imprisoned for not more than 5 years.
ANTHRAX AND SMALLPOX AS BIOTERRORIST TOOLS
Senator Harkin. Senator Craig.
Senator Craig. Mr. Chairman, thank you. Again, I would echo
my colleagues' appreciation for the timeliness as we work with
people like our folks at the FBI and the CDC to learn as we go,
and hopefully gain very rapidly from these experiences.
In what we have had made available to us as it relates to
the use of anthrax as a bioterrorist tool, it appears that
while it does and can take life, and we are now experiencing
that, it is rather limited in its application. The ability to
apply it to a wide range of the population would be more
difficult, and we do have the appropriate medical application,
and we are on alert, if you will to largely save lives and how
to substantially lessen impact on the populace.
I think it was the Soviets, when they were developing
bioterrorists, said they had more of a psychological impact on
a society than an actual, physical impact, and we are learning
that, although it is not in any way to suggest that what has
occurred is not important, and we are very concerned about it.
We hear a great deal, though, being talked about in the
media, and therefore the public is concerned about smallpox,
the discontinuation of the kinds of treatments we have had in
the past for our children to be inoculated some number of years
ago, wiping it off, or believing we have wiped it off the face
of the earth.
Doctor, could you tell the committee, or talk to the
committee briefly about--and I know you are going to list these
and provide us additional information--the ability to apply
smallpox to a broader base of the population? It has a tool of
bioterrorism versus that of anthrax. Now, we are talking about
19-plus million inoculations available, or something in that
range. We are proposing to spend a great deal more money and
possibly attempt to inoculate the whole population in this
country and get back into the business of inoculation. I think
that all has to shape itself with the use of it as a tool and
the ability to apply it as a tool to expose a broad population
base in this country.
What are the factors? What are the risks?
Dr. Koplan. Thank you, Senator Craig. My first job in
public health was working in the smallpox eradication.
Senator Craig. Then I have asked the right person.
Dr. Koplan. I do not know about that. I had two roles, one
when I started in 1972 at CDC it was to discourage the routine,
continued use of smallpox vaccination, because we had
determined that the risk of the vaccine outweighed the benefits
of being vaccinated, because the risks in the U.S. were so low
at that time.
The other half of my job was to work on the worldwide
smallpox eradication, including doing clinical care of patients
with smallpox in Bangladesh. I thought that this was a
wonderful experience. At the end of those 2 years I would never
have to use this information again, and it shows you how
humbling health and public health events are, that something
that I had hoped would remain history is something that is very
much now present upon us.
The issues you raise are considerable. The vaccine which we
are in the process of funding in, and we will hear from a
colleague who is actively involved in the production of this
vaccine, we have a contract in for the production of many more
millions of doses of this vaccine. Some of the issues are,
should it be deployed, should it be held and await its need,
how much vaccine is necessary?
The decision of the Department has been, and we are part of
that, is that it is valuable to have enough vaccine should we
need it for every American in the country. The widespread use
of the vaccine, though, would be attendant with a certain
number of predictable adverse reactions, including enough for
hospitalization, enough for people to have if there is an
encephalitis attached to it.
So that is the balance that has to be taken into play, is
both the investment in the vaccine, which I think is
worthwhile, but whether to deploy it prior to is an issue of,
you will certainly have people severely ill, and some deaths
from the use of the vaccine alone, and then that has to be
matched with the risk of introduction and the threat.
SMALLPOX PREVENTION AND USE AS A THREAT
One of the advantages of smallpox vaccine, there is no
treatment for smallpox. There is no antibiotic, no
antimicrobial, no antiviral that has been proven effective
against smallpox, so the vaccine is the only preventive device,
and yet it is a vaccine that can be used in the first few days
of exposure, which is quite unusual, and gives us some leeway
to get it into people in those first few days of exposure.
Senator Craig. You are suggesting, then, if there is a
known exposure of a population base and we have a vaccine
available, they can be treated and it would lessen the impact
of that exposure dramatically?
Dr. Koplan. It can prevent the disease, but a key element
of that is not just the production of the vaccine, and let me
emphasize to all of you, it is the ability of State and local
health departments to then distribute that vaccine and get it
into people, and the degree to which State and local health
departments are pressed now, they would be sorely tried, with
current resources, to get those vaccines into people. They do
it, but they would sure need some help in getting it done.
Senator Craig. Mr. Chairman, I understand I have a little
time left. I did ask another question that was maybe a bit
elusive, and that is the ability to use it as a tool of
bioterrorism, and therefore the ability to apply it.
Dr. Koplan. This is smallpox itself?
Senator Craig. Smallpox itself, comparatively to anthrax.
Dr. Koplan. I think one, and I hate to even use this
phrase, but one aspect of anthrax which is in all of our
advantages is, it cannot spread from person to person. It is
not contagious. It is horrible when one person gets it, a
tragedy when that person dies, but it cannot be spread from
that person to another person.
Smallpox is a contagious illness, and can be spread from
person to person, making it--we have a vaccine for it, but it
is contagious, so with each of these agents, there are
different approaches, different ways of dealing with it, and
different downsides to them that makes them more difficult, one
than another.
ANTHRAX ANTITOXIN
Senator Harkin. Senator Hutchison.
Senator Hutchison. Thank you, Mr. Chairman. Dr. Koplan, I
picked up the Austin American Statesman on October 10, and the
headline is: ``UT researchers close in on antidote to anthrax
toxin.'' It appears that there is a consortium of the
University of Texas, Texas Tech, and the University of South
Florida that has been testing an anthrax antibody on mice, and
that the antibody has been demonstrated to kill the anthrax
bacteria.
The next step for them is to inject the mice with live
anthrax, rather than just the anthrax toxin, and test it there,
but they say they are some weeks away from this antidote. I
wondered if you are aware of this. My original intention had
been to see if we could get the money from the emergency
appropriations bill we have already passed to let them proceed
with their experiments on an expedited basis, particularly
considering the ongoing threat of anthrax attacks. So I just
wanted to ask you if you were aware of this research, and
whether or not you think there is something that we might be
able to do to facilitate these experiments?
Dr. Koplan. Thank you. That certainly sounds promising. I
was aware of antitoxin work going on. I did not know the
particulars of this experimentation. There is a real time gap
between mouse experiments and work there, and then getting it
into humans, which even in trying to increase the amount of
research, it still takes time to sort out the experimentation.
I would be glad to have folks look into it and see whether we
can make direct linkages. Certainly FDA would have an interest
in this, and NIH as well, and we would be glad to get the
information.
Senator Hutchison. That is exactly what I want. I want to
do all the right things, but I am sure that if the NIH and the
FDA and you are working on something, perhaps we could speed it
up if this is going to continue to be the urgent problem that
we see it, at least isolated in this area. I would like to just
try to do everything we can to get it on the right track and
shorten the timetable if, in fact, it would help save some of
these lives that have already been hurt by this anthrax.
ANTIBIOTICS FOR USE AGAINST ANTHRAX
Thank you, Mr. Chairman, for giving us this opportunity.
Senator Harkin. Thank you, Senator Hutchison. Just one last
thing. In every instance of anthrax exposure during the past 2
weeks, Cipro has been prescribed, but my understanding is the
FDA is officially approving the use of two additional generic
antibiotics for the treatment of anthrax, doxycycline and
penicillin. My question is, why are we giving people Cipro when
other drugs are available? Secondly, can people who are now on
Cipro switch to a cheaper drug?
Dr. Koplan. Expense has not been our primary consideration
to get started. As you indicated, there are several antibiotics
that can be used in this, and in the antibiotic sensitivities
we have gotten from the organisms we have isolated from these
different outbreaks there are a number of antibiotics that seem
susceptible to it.
I believe today we are coming out--we have gotten a group
of experienced clinicians, people who care for people and take
care of people and engage in treatment for infectious diseases
to spell out alternative antibiotic guidelines, but Cipro
remains a primary drug of choice for people who are sick with
the disease. Other antibiotics may also be used in that regard
for people who are taking it in a preventive way, such as folks
exposed, or in the city Cipro might be a reasonable start and
then shift after a period of time to doxycycline. All of these
things have some side effects to them, and so probably the
thing is to explain to people what the options are for them and
both make a suggestion to them, but let them choose which they
think would be best for them as well.
An example is doxycycline, you cannot go out in the sun
with it. It causes a skin rash if you are in the sun. That
might not be an issue for most of us who spend all of our time
indoors, but certainly in Florida it was not something we
wanted the people exposed to, so it is a balancing act, but you
are absolutely right, doxycycline, there has been this rush for
Cipro, but doxycycline works terribly well, and we would
recommend it.
Senator Harkin. And penicillin?
Dr. Koplan. Penicillin, our folks are looking at in a
little more detail in the lab as to whether in the isolates we
are seeing whether that is going to be recommended. I think at
the moment I would stick with doxycycline or Cipro for these
cases we are seeing now.
Senator Harkin. Dr. Koplan, Mr. Caruso, thank you very
much. I think you have given us some good reassurances. I think
what you have just spelled out indicates that CDC is on track,
and I am hopeful that we will continue to get the kind of
information we need and support for our public health agencies.
Thank you so much.
Our next panel will include Mr. Robert Kramer, president
and chief operating officer of the BioPort Corporation, who is
accompanied by Robert Myers, who is a doctor of veterinary
medicine and is executive vice president of Bioport; Mary Kuhn,
vice president of Bayer Corporation, makers of Cipro; Thomas
Monath, vice president of research and medical affairs for
Acambis, the makers of smallpox vaccine; Hilary Koprowski from
Thomas Jefferson University; Mary Gilchrist, director of the
University of Iowa Hygienic Lab; and Barbara Hunt, district
health officer for the Washoe County health department in
Nevada.
Again, I would ask if you have any lengthy types of
documents, if you would submit those for the record. Barring
any objections, all of your statements will be made a part of
the record in their entirety. I would hope that you could, in
less than 5 minutes, sum up for us your views and your opinions
of what has happened during the recent events, and any advice
and suggestions you have for us as we pursue this. With that, I
would open first with Mr. Bob Kramer of the BioPort
Corporation.
STATEMENT OF BOB KRAMER, PRESIDENT AND CHIEF OPERATING
OFFICER, BIOPORT CORPORATION, ACCOMPANIED
BY DR. ROBERT MYERS, EXECUTIVE VICE
PRESIDENT
Mr. Kramer. Thank you, Mr. Chairman. I want to thank you
for your invitation to discuss the anthrax vaccine and the
current status of the vaccine production, and the process we
have been working through with the FDA. In addition, I will use
this opportunity to set the record straight on BioPort and our
FDA licensed anthrax vaccine.
Before I begin, I would like to introduce Dr. Robert Myers,
our executive vice president of BioPort, who will assist me in
answering your questions.
The history of the anthrax vaccine begins in Michigan, with
its Department of Public Health. During the 1920's, Michigan
was one of several States with its own vaccine research
facility. Michigan developed a number of critical vaccines to
protect public health, including one of the first combined
pediatric vaccines in the country. In response to Department of
Defense requests, the Michigan facility took over development
of the anthrax vaccine in 1965, when no one else was
interested, and in 1970 a U.S. license was granted for the
Michigan anthrax vaccine, the only FDA licensed anthrax vaccine
in the Nation.
From 1970 to 1989, the Michigan facility shipped 68,000
doses of the anthrax vaccine. Then in 1990 Iraq invaded Kuwait,
and the Persian Gulf conflict began. The Michigan plant stepped
up again to meet the needs of the U.S. military at the request
of the Department of Defense. During the past 10 years, the FDA
has continued to increase its compliance standards for
biologics manufacturers. These higher standards more fully
assure that vaccines and other biologic products will continue
to be safe, pure, and effective. We fully support these higher
standards.
By 1996, in the midst of having amassed a sizeable
stockpile of anthrax vaccine, the State of Michigan facility
faced a serious regulatory challenge. Consequently, in 1997 the
State moved forward with its decision to sell the assets of the
facility. Meanwhile, to address these concerns, Michigan State
government officials, in tandem with the Department of Defense,
decided to suspend production of the anthrax vaccine in January
of 1998 to begin a long-planned, much-needed renovation of the
facilities.
BioPort Corporation, the only U.S. company participating in
the final round of bids, acquired the facility from the State
of Michigan on September 4, 1998, and became responsible for
the renovation. We completed the renovation process, resumed
production in 1999, and submitted our biologics license
application supplement to the FDA. The FDA subsequently
conducted a preapproval inspection, and identified more work in
order to get the facility approved.
BioPort immediately prepared a detailed plan. The FDA has
concurred with that plan, and we have since met regularly with
them, briefing them on our execution. We submitted our amended
biologics license application supplement to the FDA on Friday,
October 12 of this year, and are confident that this
submission, the culmination of 20 months of work, satisfies all
FDA requirements and will allow the agency to complete its
comprehensive review and approval process. We stand ready to
respond to any additional questions raised by the FDA during
this review period.
The events of September 11 and the subsequent intentional
exposure to anthrax have undoubtedly changed the landscape of
public health and protection from terrorist attacks for years
to come. As well, recent national events have altered the
profile of the BioPort Corporation, a privately held vaccine
manufacturer that employs 220 people.
The media coverage of anthrax exposures, and the subsequent
public health response, was initially characterized as an
Olympics of misinformation. As it relates to BioPort
Corporation and its vaccine, this is certainly the case. I
would like to correct some of these myths that have been out
there.
Senator Harkin. I am going to ask you to collapse them. I
think they are very good, but you cannot read them all. We do
not have the time. Just give us the myth and a brief fact.
Senator Kramer. The first myth was the anthrax vaccine is
not safe and may not be effective. The truth is, there are over
18 studies by independent professionals who consistently
demonstrate and show the vaccine is safe, and as well the FDA
has consistently testified to the same.
The second myth is that we have failed to produce any
anthrax vaccine since acquiring the facility from the State of
Michigan. Contrary to this, BioPort has maintained and
significantly added to a significant stockpile of the anthrax
vaccine and can make it available, with the concurrence of the
Department of Defense who owns the anthrax vaccine stockpile,
to the CDC, who would make the medical determination when it is
necessary, and the FDA must release the product.
The third myth was that BioPort has been mismanaged since
acquiring the facilities from the State of Michigan. The fact
is that we have hired and been successful in bringing in a
number of experienced managers from the industry and technical
experts, and we have the right people doing the right things to
get this job done, and we will get the approval of the
renovated facility.
The funding from the Department of Defense in the last 3
years has been substantial, and BioPort is grateful for the
Department of Defense's continued support, but these
expenditures need to be placed in the overall perspective of
the industrial cost of vaccine development and manufacture. It
is comforting to hear from Senator Specter that you are
prepared to spend whatever is necessary to make sure these
important products are made available.
Senator Harkin. How much would it cost?
Mr. Kramer. I guess I would have to ask, cost to do what?
Senator Harkin. To vaccine Americans with this vaccine.
Mr. Kramer. For all public citizens?
Senator Harkin. Yes.
prepared statement
Mr. Kramer. If you are talking about 300 million people,
our contract right now with the Department of Defense has us
selling the vaccine to them for just under $11 a dose. That
will likely increase as we work with the Department of Defense
in the current contract, but that is probably a good ballpark.
Senator Harkin. Over $3 billion. Thank you very much, Mr.
Kramer.
[The statement follows:]
Prepared Statement of Bob Kramer
Good afternoon Chairman Harkin and esteemed members of the
committee. I'm Bob Kramer, President and Chief Operating Officer of
BioPort Corporation. I want to thank the members of the committee for
the invitation to discuss the history of the anthrax vaccine, the
current status of vaccine production, and the approval process we have
been working through with the FDA. In addition, I will use this
opportunity to set the record straight on BioPort and our FDA-licensed
anthrax vaccine. Before I begin, I would like to introduce Dr. Robert
Myers, Executive Vice President of BioPort, who is with me today to
assist in answering your questions.
vaccine history
The history of the anthrax vaccine begins in Michigan, with its
Department of Public Health. During the 1920s, Michigan was one of
several states with its own vaccine research facility. Michigan
developed a number of critical vaccines to protect public health,
including one of the first combined pediatric vaccines in the country.
Anthrax was a disease feared by a limited population, particularly
by textile workers who handled imported wool and hides, and farmers and
ranchers who worked with livestock.
The Department of Defense conducted the initial work on an anthrax
vaccine. The department's results were outlined in a patent that
highlighted the concept of the vaccine and its manufacture. Merck
produced some initial lots of a further developed vaccine in the 1950s
for the original field tests. The company declined continued work on
the vaccine.
In response to a Department of Defense solicitation, the Michigan
facility took over development of the anthrax vaccine in 1965, and, in
1970, a U.S. license was granted for the Michigan anthrax vaccine--the
only FDA-licensed anthrax vaccine in the nation.
From 1970 through 1989, the Michigan facility shipped 68,000 doses
of the anthrax vaccine. Then, in 1990, Iraq invaded Kuwait, and the
Gulf War began. Since Saddam Hussein had developed anthrax weapons, the
Michigan plant stepped up production to meet the needs of the U.S.
military at the request of the Department of Defense. Approximately
400,000 additional doses were shipped to protect our service members
during the Gulf War.
During the past ten years, the FDA has continued to increase its
compliance standards for biologics manufacturers. The agency now
requires manufacturers of biologics to meet the highest global
standards for process validation and Good Manufacturing Practices.
These higher standards more fully assure that vaccines and other
biologic products will continue to be safe, pure and effective. We
fully support these higher standards. Another dynamic has occurred in
the past 10 years--a declining interest in vaccine production, due
principally to the aforementioned rising compliance standards and the
diminishing profitability of vaccines. This is particularly true for
bio-defense vaccines, where the non-government market is uncertain.
Beginning in 1996, the State of Michigan's facility faced serious
regulatory challenges. In 1997, the State made the decision to sell the
assets of the vaccine facility, and allow private business to assume
the renovation and subsequent production of vaccine.
Meanwhile, in January of 1998, Michigan state government
officials--in tandem with the Department of Defense--made the decision
to suspend production of the anthrax vaccine in order to begin a long-
planned and much-needed renovation of the facility. BioPort
Corporation, the only U.S. company participating in the final round of
bids, acquired the facility from the state of Michigan on September 4,
1998. One of the early decisions we made was to suspend all production
of other biological products so we could concentrate on the anthrax
vaccine.
And so the renovation of the facility became BioPort's
responsibility. We completed the renovation process and resumed
production in May 1999. BioPort submitted its Biologics License
Amendment supplement to the FDA in August 1999. The FDA subsequently
conducted a pre-approval inspection in November 1999, and imposed
additional requirements before approval of the renovated facility would
be granted. The additional requirements were directly related to the
higher standards imposed by the FDA on vaccine manufacturers.
BioPort immediately prepared a detailed plan for meeting the
additional requirements and presented it to the FDA in January 2000.
The FDA concurred with the plan and implementation by BioPort began.
Since then, we have met regularly with FDA representatives, providing
updates on our progress. We submitted our amended BLA supplement to the
FDA on Friday, October 12, 2001 and are confident that this
submission--the culmination of 20 months of work--satisfies all FDA
requirements and will allow the agency to complete its comprehensive
review and approval process. We stand ready to respond to any
additional questions raised by the FDA during this review period.
myths vs. facts
The events of September 11, and the subsequent intentional
exposures to anthrax have undoubtedly changed the landscape of public
health and protection from terrorists attacks for years to come. As
well, recent national events have altered the profile of BioPort
Corporation--a privately held vaccine manufacturer that employs 220
people.
The media coverage of anthrax exposures and the subsequent public
health response was recently characterized as an Olympics of
misinformation. As it relates to BioPort Corporation and its vaccine,
this is most certainly the case. I will first point out the myths and
then lend clarification.
Myth.--The anthrax vaccine is not safe.
Fact.--The safety of this vaccine is well documented. It is one of
the most studied vaccines. To date, 18 human studies and the CDC's
independent expert Advisory Committee on Immunization Practices have
assessed the safety of the anthrax vaccine. Some of these studies
stretch back many decades. They also include very close scrutiny of
more than two million doses of anthrax vaccine given to over 500,000
recipients over the past three years. The side effects of this vaccine
are similar to those of other vaccines routinely administered to both
adults and children.
An independent, civilian vaccine expert safety panel, the Anthrax
Vaccine Expert Committee (AVEC), has reviewed all reported reaction
rate data and found no evidence of a causal link between the vaccine
and serious, long-term medical conditions. As of October 2, 2001 the
AVEC has reviewed 1,623 adverse event reports obtained through the
FDA's Vaccine Adverse Event Reporting System. From these reports, there
were 57 that involved hospitalization. The AVEC found that only 10 of
these were likely caused by the anthrax vaccine. All 10 involved
allergic, inflammation reactions at the injection site and the patients
have since recovered.
The FDA has concurred with this assessment. On October 3, 2000,
Mark Elengold, Deputy Director of the Center for Biologics Evaluation
and Research, in testimony to the House Government Reform Committee,
commented about the 1,561 adverse event reports that had at the time
been submitted. He said: ``None of these events, except for the
injection site reactions, can be attributed to the vaccine with a high
level of confidence, nor can contribution of the vaccine to the event
be entirely ruled out. With the exception of injection site reactions,
all of the adverse events noted above occur in the absence of
immunization.'' He further went on to say, ``FDA continues to view the
anthrax vaccine as safe and effective for individuals at high risk of
exposure to anthrax, when used in accordance with the approved
labeling.''
Earlier that year, on April 13, 2000, before the Senate Armed
Services Committee, Dr. Kathryn Zoon, the Director of the Center for
Biologics Evaluation and Research, said in her concluding remarks: ``We
believe the anthrax vaccine is a safe and effective vaccine for the
prevention of anthrax disease--an often-fatal disease--when used
according to FDA approved label.''
In conclusion, on the topic of safety, extensive studies of those
vaccinated as well as independent review of reported adverse events,
lead to the certain conclusion that anthrax vaccine is safe. The FDA,
in its testimonies before congressional committees, has also stated it
has found the vaccine to be safe.
Myth.--BioPort's anthrax vaccine is not effective.
Fact.--The effectiveness of the anthrax vaccine was documented in
three ways:
--Clinical trials showing protection of human subjects exposed to the
infectious agent;
--Demonstration of a measurable immune response following
immunization;
--Demonstration of protection of immunized animals when challenged
with the infectious agent.
I will now describe these in further detail.
Clinical Trials.--A single-blinded well-controlled trial was
conducted in the 1950s by Dr. Phillip S. Brachman and co-workers in the
employees of four U. S. textile mills. Those workers were processing
imported goat hair known to be occasionally contaminated with anthrax
spores. A similar but less potent predecessor to the current vaccine
was used in this trial. A total of 26 cases of cutaneous and
inhalational anthrax occurred during the course of the trial. The
efficacy of the vaccine in preventing anthrax was found to be 92.5
percent. In one of these mills, five cases of inhalational anthrax
(four of them fatal) occurred among the unvaccinated workers. No cases
of inhalational anthrax occurred in mill workers who had received the
anthrax vaccine. With the occurrence of these inhalational anthrax
cases, the study was stopped in the mill so that all employees could be
offered immunization since it would have been unethical to continue the
study. The number of cases of inhalation anthrax was, thus, too small
to demonstrate a statistically significant decrease in the vaccinated
group. Following universal immunization of employees in this mill, the
occurrence rate of anthrax fell precipitously. The FDA has subsequently
indicated at Congressional hearings that based on the data from this
clinical trial, when supplemented by additional case control studies in
humans, and studies in vaccinated animals protected from exposure to
inhalational anthrax, there is strong evidence that the vaccine
protects humans against inhalational anthrax.
In the 1980s, an Advisory Review Panel was established to review
information on biologic products licensed prior to July, 1972. In 1985
this panel recommended continuation of the anthrax vaccine based on
substantial evidence of safety and efficacy. This review included a
CDC-sponsored vaccine safety study, in which approximately 16,000 doses
of vaccine were administered according to the current six-dose schedule
to approximately 7,000 study participants from 1967 to 1971. The panel
also reviewed surveillance efficacy data collected by the CDC between
1962 and 1974. During this period, 27 cases of anthrax were identified
in employees working in or near goat hair mills. Twenty four of these
employees were unvaccinated and the remaining three had received only
one or two doses of the anthrax vaccine. These two studies, in addition
to the efficacy data from the Brachman study, served as the basis for
the panel's recommendation. No anthrax cases have been reported in
fully vaccinated persons. Since the availability of the current
vaccine, the occurrence of anthrax in ``at risk'' industrial settings,
including laboratory workers, has been nearly eliminated.
Demonstration of immune response.--Human immune response studies
were recently performed by Dr. Phillip Pittman and co-workers, using an
assay which measured the development of antibodies specific for B.
anthracis Protective Antigen (PA) known to be important to protection.
In 28 volunteers immunized according to the current schedule of
subcutaneous injections, (0, 2, and 4 weeks), significant immune
responses (i.e. seroconversion) were detected in almost all of the
recipients after two doses of vaccine, and in all persons after three
doses. Other volunteers received vaccine at 0 and 4 weeks only, one
group by the subcutaneous route (n=23) and one by the intra-muscular
route (n=22). Except for one individual in the intra-muscular group,
all volunteers tested were found to have seroconverted after the second
(4-week) dose. The size of this study was not considered large enough
to support a change in the dosing schedule or the route of
administration.
Demonstration of protection.--Because it would be unethical to
challenge immunized persons with B. anthracis, such studies must be
performed in animals. Nonhuman primates, which develop inhalational
anthrax much like that seen in humans, have been used extensively. A
total of 65 non-human primates, immunized with only one or two doses of
anthrax vaccine, have been given inhalation challenges containing
hundreds of times the number of anthrax spores known to be lethal in
unvaccinated animals. Of these, 62 animals (95 percent) survived the
challenges. When eight of the non-human primates received a high-dose
inhalation challenge two years after they received two doses of the
vaccine, seven survived, indicating long-term immunity.
Similar anthrax inhalation challenges were performed in rabbits,
which also develop inhalational anthrax similar to that seen in non-
human primates and in humans. Of 117 rabbits challenged following two
doses of vaccine, 114 (97 percent) survived.
Dr. Arthur Friedlander and co-workers performed a post-exposure
study in nonhuman primates, some of which had also received a 30-day
course of antibiotics. The group of animals that received both vaccine
and antibiotics following inhalation exposure remained free of disease
throughout, and long after, the 30-day period of antibiotic treatment.
Furthermore, this was the only group of animals that survived a second
inhalation exposure -indicating that they had developed immunity
against the anthrax.
The above series of studies of the anthrax vaccine illustrate
several ways to overcome the inherent difficulty in demonstrating the
efficacy of vaccines to be used for defense against bio-terrorism and
bio-warfare agents. Since natural exposure to many of these agents does
not exist, and because human challenge studies would be considered
unethical, straightforward efficacy studies cannot be performed.
Instead, a careful assessment of the immune responses following
vaccination in humans, as well as evaluations of protection against
infectious challenges in relevant animal models, must be made.
The currently licensed schedule of subcutaneous injections given
over 18 months, will soon be evaluated in a large CDC-sponsored study.
Along with evaluations of the safety of the vaccine, the impact of
reductions in the number of doses administered, as well as the route of
administration (subcutaneous v. intra-muscular), on the immune response
to B. anthracis will be determined. These immune responses will be
compared to those seen in a parallel study involving non-human
primates, which will later be subjected to inhalational challenges with
anthrax. Through these studies, a deeper understanding of the immune
correlates of protection will be achieved, and the most appropriate
dosing schedules determined.
The Advisory Committee on Immunization Practices (ACIP) has
recently recommended that in a confirmed post-exposure setting, where
anthrax vaccine is available, antibiotic prophylaxis should continue
for 4 weeks and until three doses of vaccine have been administered.
The consensus that three doses are expected to provide significant
protection is justified in the context of the most current medical
information available. This includes the known human immune response
data and, the above-mentioned, long-term protection seen in non-human
primates following only one or two doses.
Our present understanding of the immune system, coupled with the
findings of these animal and human studies lead to a reasonable
expectation that the anthrax vaccine should be protective after two or
three doses. The challenge is to conclusively demonstrate this when
direct efficacy studies in humans cannot be undertaken. This challenge
applies not only to the current anthrax vaccine, but also to any
anthrax vaccine now under development.
Myth.--BioPort has failed to produce anthrax vaccine since
acquiring the facility from the State of Michigan.
Fact.--Contrary to news reports, BioPort has maintained and
significantly added to a stockpile of anthrax vaccine since acquiring
the facilities in Lansing, Michigan, three years ago. Although we
cannot discuss the specific numbers contained in that stockpile, there
is now a considerable amount of anthrax vaccine that could be made
immediately available in an emergency, if fully supported by the FDA.
It requires coordination, decisionmaking and action across three
Federal agencies:
--The Department of Defense, which owns the vaccine;
--The Department of Health and Human Services, which based on the
advise of the medical experts in the CDC, would recommend its
use; and
--The FDA, which would authorize the release of the vaccine.
Further, we stand ready to manufacture the licensed anthrax vaccine
to full capacity in our renovated facilities. We have met regularly
with representatives from each of these agencies to discuss this
considerable stockpile and to offer our full assistance and support in
the event that vaccine is needed on an emergency basis.
Myth.--BioPort has been mismanaged since acquiring the facilities
from the State of Michigan.
Fact.--There is now and there has for some time been a capable
management team in place. We have been successful in hiring industry-
experienced managers and technical experts. The company culture has
been transformed from that of a state bureaucracy to a results-oriented
business. For the last two years, we have been meeting regularly with
the FDA to update our progress. The relationship with FDA is
constructive and the agency has expeditiously reviewed the various
segments of our submission. We are also working closely with our
partner, the Department of Defense. In short, we have the right people,
in the right places, doing the right things to get this job done.
On the financial side, when BioPort took over the vaccine
manufacturing facilities from the State of Michigan we were well aware
that we were taking over an unprofitable venture with an aging physical
plant that had never been operated in a commercial environment. The
State had no effective financial accounting system in place for
tracking costs. To meet the heightened FDA biological product
regulatory standards, a company in this business must have substantial
quality control systems, which takes considerable time and expense to
put in place. Unfortunately, the State's management practices did not
include calculation of these costs. There was no direct relationship
between Michigan's total costs of producing the anthrax vaccine and the
prices paid by the Department of Defense. It became clear to us that
the prices paid to Michigan by the government for the vaccine were
significantly below the costs for producing the vaccine under modern
regulatory standards. Audits which were conducted by the Department of
Defense, supported an adjustment to the contract price of the vaccine.
Furthermore, in the last two years, there have been five major
financial audits by the Defense Contract Audit Agency (DCAA). BioPort
has submitted over 50 financial reports during this time. Our
compliance with contract accounting standards has been consistently
confirmed by these audits.
In addition to these accounting audits there was a widely reported
criminal investigation conducted by the Defense Investigative Services
(DIS). What has not been reported is the fact that we were completely
cleared of any wrongdoing. A recent DIS letter confirms that fact.
The funding from the DOD in the last three years has been
substantial and BioPort is grateful for the department's continued
support. But these expenditures need to be placed in the overall
perspective of the industrial costs of vaccine development and
manufacture. DOD's investment in BioPort over the past three years is
the most cost-effective investment that any agency in the federal
government is committing to insure the availability of the needed
defense or civilian vaccines. DOD's own report on the costs for vaccine
research, development and manufacturing estimates that it will require
an average of $400 million over a 5- to 10-year period for each FDA-
licensed vaccine. Another vaccine company, Aviron has reported that
they will have expended between $400 to $500 million over many years in
developing and manufacturing their intranasal flu vaccine. They are
still awaiting their FDA license. The government has indicated that it
will take several billion dollars and many years for other defense
vaccines to be developed and manufactured. An October 2000 independent
report by the Institute for Defense Analysis (IDA) concluded that the
fastest route to a continued supply of licensed anthrax vaccine is
through BioPort. Now a year since that report, its findings are still
valid.
future considerations
Allow me to make a few final points. As you, our nation's
policymakers, look to the future for a viable long-term vaccine
program, several issues must be resolved. Important among these are:
The oversight and management of the development and manufacture of
defense vaccines must be streamlined, becoming less bureaucratic. The
creation of a cabinet level position and the appointment of Governor
Ridge to that position are encouraging early steps.
The dollars committed to protection against biological threats need
to better match the nation's goals. Facing the potential of a cost of
$400 million per vaccine developed, the financial commitments now being
pledged by Congress will better enable the goals to be met.
There must be adequate incentives to assure the engagement of the
private sector to meet these goals. We are aware that several bills are
being drafted to specifically address this point and firmly believe
that incentives will be adequately considered.
In addition to these incentives, some form of protection from tort
is needed for defense vaccines' use in the civilian sector as it is for
several products supplied to the DOD.
Just as important, misinformation must be corrected vigorously as
soon as it surfaces. As has been clearly demonstrated for anthrax
vaccine, left unanswered, misinformation erodes confidence and progress
in defense vaccine development and manufacture. It must be countered
whenever it occurs.
Once again, thank you for this opportunity. I am eager to respond
to your questions.
Senator Harkin. Next is Mary Kuhn, head of operations for
Bayer Corporation.
STATEMENT OF MARY KUHN, VICE PRESIDENT OF OPERATIONS,
BAYER CORPORATION
Ms. Kuhn. Thank you, Senator Harkin, Senator Specter, and
other distinguished members of this Senate appropriations
subcommittee. My name is Mary Kuhn, and I am head of operations
for the Bayer Corporation Pharmaceutical Division in Westhaven,
Connecticut. The core objective of Bayer Pharmaceutical is to
significantly improve health worldwide. Since the events of
September 11 and the days that have followed, we stand even
more committed to that purpose. We at Bayer Corporation would
like to assure Congress that we will meet the Nation's demands
for Cipro, our antibiotic, which has FDA approval for post-
inhalation anthrax.
The issue that looms large with this subcommittee and, of
course, with the American public is, can Bayer fulfill our
Nation's Cipro requirements? The answer to that question is
yes. Please allow me to elaborate.
Bayer is currently producing Cipro at an incredibly rapid
and unprecedented rate, over 2 million tablets each and every
day. We continue to work closely with the Centers for Disease
Control and the Department of Health and Human Services to make
available this key weapon in the fight against anthrax. Bayer's
U.S. facilities shipped more than 50 million tablets of Cipro
in the month beginning September 16 through October 16. In
response to the increased demand, Bayer has tripled its
production of Cipro.
Prior to the terrorist attacks, typical production of Cipro
was about 20 million tablets per month. We have now committed
to supplying 200 million tablets over the next 3 months. That
is more than 15 million tablets a week. In addition, because of
Bayer's global resources, we will be able to supply additional
Cipro tablets.
In order to manufacture this quantity, Bayer is now running
its Connecticut Cipro production facilities on an expanded
production schedule. We are also reopening an additional
manufacturing plant to augment active ingredient stock. We are
sending shipments of Cipro out every day of the week, including
Saturdays and Sundays. We believe that with current
inventories, plus the amount we are now supplying, in
conjunction with other FDA-approved drugs such as doxycycline,
there will be enough Cipro in Government pharmacies and other
facilities to treat over 12 million Americans for anthrax, the
objective recently set by the Department of Health and Human
Services.
In addition, Bayer does support the Food & Drug
Administration's approval of doxycycline for the treatment of
all forms of anthrax, including inhalation anthrax. These drugs
are widely available from a variety of generic manufacturers.
We are confident that there should be no concerns about an
adequate supply of safe and effective treatments for anthrax.
We feel it is important for this subcommittee to realize that
Bayer has fulfilled every order from the United States
Government within the requested delivery schedule.
We continue to work daily with the Government to define and
fulfill future orders. To our knowledge, everyone who has
needed Cipro in response to an anthrax event has been able to
get Cipro. Soldiers going overseas carry Cipro. The people in
New York, Florida, New Jersey and Washington who have been
exposed to anthrax have had Cipro prescribed and have been able
to procure it.
The CDC, which is in charge of stockpiling the drug, has
ordered millions of tablets. These orders have been filled
completely, and the agency has them in their inventory. We are
working closely with the Nation's drug distribution system to
get Cipro to those locales and to those people who are most
immediately in need of it.
Our confidence in the adequacy of antibiotic supplies to
treat anthrax is further enhanced by the efforts of Secretary
Thompson, Surgeon General Satcher, and countless other
Government and non-Government authorities. These leaders are
advising the public of the harm that could be caused by taking
antibiotics just in case, and to warn people against hoarding
drugs through advertising and other initiatives, such as this
one in today's paper. Bayer is adding its voice to ensure that
these critical messages are understood and followed.
To address any concerns that we will not be able to meet
this commitment, we would like to point out that this is not
the first time that we have had to respond quickly in a
national emergency. During the Persian Gulf War, we were called
upon by the Department of Defense to supply 45 million Cipro
tablets for air and ground troops. Bayer met these urgent
production and delivery targets.
The support of Secretary Thompson, Surgeon General Satcher
and others in their educational efforts regarding appropriate
use, personal stockpiling, and the wide availability of generic
treatment alternatives will help to manage the demand for Cipro
in pharmacies throughout the country.
Bayer fully recognizes that it has a compelling
responsibility to assist the Nation in addressing bioterrorist
threats. We are proud to have a role in this effort to confront
this national emergency and protect the health of the American
public. We have fulfilled that role in the past, and we
continue to do that today.
prepared statement
There is no doubt that comprehensive coordination between
relevant branches of Government and the pharmaceutical industry
is absolutely critical to addressing bioterrorist threats. We
urge this subcommittee to do all in its powers to assure this
coordination and cooperation continues. We will face this
latest challenge together, and we will succeed.
[The statement follows:]
Prepared Statement of Mary Kun
Chairman Harkin, Senator Specter and other distinguished members of
this Senate Appropriations subcommittee, my name is Mary Kuhn, and I am
the Head of Operations for the Bayer Corporation Pharmaceutical
Division in West Haven, Connecticut.
The core objective of Bayer Pharmaceutical is to significantly
improve health worldwide. Since the events of September 11 and the days
that have followed, we stand even more committed to that purpose. We at
Bayer Corporation would like to assure Congress that we will meet the
nation's demands for Cipro, our antibiotic which has FDA
approval for post-inhalation anthrax.
The issue that looms large with this subcommittee and of course
with the American public is: Can Bayer fulfill our nation's CIPRO
requirements?
The answer is yes.
Please allow me to elaborate:
Bayer is currently producing Cipro at an incredibly rapid and
unprecedented rate . . . over 2 million tablets each and every day. We
continue to work closely with the Centers for Disease Control and the
Department of Health and Human Services to make available this key
weapon in the fight against anthrax.
--Bayer US facilities shipped more than 50 million tablets of Cipro
in the month beginning September 16 to October 16.
--In response to the increased demand, Bayer has tripled its
production of Cipro.
--Prior to the bioterrorism attacks, typical production of Cipro was
20 million tablets per month. We have now committed to
supplying 200 million tablets over the next three months--
that's more than 15 million tablets a week.
--In addition, because of Bayer's global resources we will be able
supply additional CIPRO tablets
In order to manufacture this quantity Bayer is now running its
Connecticut Cipro production facilities on an expanded production
schedule. We are also reopening an additional manufacturing plant to
augment active ingredient stock. We are sending shipments of Cipro out
every day of the week, including Saturdays and Sundays.
We believe that with current inventories plus the amount we are now
supplying, in conjunction with other FDA approved drugs such as
doxycycline, there will be enough Cipro in government, pharmacy and
other facilities to treat over 12 million Americans for anthrax, the
objective recently set by the Department of Health and Human Services.
In addition, Bayer supports the Food and Drug Administration's
approval of doxycycline for the treatment of all forms of anthrax,
including inhalation anthrax. These drugs are widely available from a
variety of generic manufacturers. We are confident that there should be
no concerns about an adequate supply of safe and effective treatments
for anthrax.
We feel it is important for this subcommittee to realize that Bayer
has fulfilled every order from the United States government within the
requested delivery schedule. We continue to work daily with the
government to define and fulfill future orders. To our knowledge,
everyone who has needed Cipro in response to an anthrax event, has been
able to get Cipro. Soldiers going overseas carry Cipro. The people in
New York, Florida, New Jersey and Washington who have been exposed to
anthrax have had Cipro prescribed and have been able to procure it. The
CDC, which is in charge of stockpiling the drug, has ordered millions
of tablets. The orders have been filled completely and the agency has
them in their inventory. We are working closely with the nation's drug
distribution system to get Cipro to those locales, and to those people
who are most immediately in need of it.
Our confidence in the adequacy of antibiotic supplies to treat
anthrax is further enhanced by the efforts of Secretary Thompson,
Surgeon General Satcher and countless other government and non-
government health authorities. These leaders are advising the public of
the harm that could be caused by taking antibiotics ``just in case,''
and to warn people against hoarding drugs. Through advertising and
other initiatives, such as this one in today's newspaper, Bayer is
adding its voice to ensure that these critical messages are understood
and followed.
To address any concerns that we will not be able to meet this
commitment, we would like to point out that this is not the first time
we have responded quickly in a national emergency. During the Persian
Gulf War we were called upon by the Department of Defense to supply 45
million Cipro tablets for air and ground troops. Bayer met these urgent
production and delivery targets.
The support of Secretary Thompson, Surgeon General Satcher and
others in their educational efforts regarding appropriate use, personal
stockpiling, and the wide availability of generic treatment
alternatives will help to manage the demand for Cipro in pharmacies
throughout the country.
Bayer fully recognizes that it has a compelling responsibility to
assist the nation in addressing bioterrorist threats. We are proud to
have a role in the effort to confront this national emergency and
protect the health of the American public. We have fulfilled that role
in the past and we continue to do that today. There is no doubt that
comprehensive coordination between relevant branches of government and
the pharmaceutical industry is absolutely critical to addressing
bioterrorist threats. We urge this subcommittee to do all in its powers
to assure that this coordination and cooperation continues.
We will face this latest challenge together and we will succeed.
Senator Harkin. Thank you, Ms. Kuhn. Now I would just like
to recognize Senator Reid for the purpose of an introduction of
our next witness.
Senator Reid. Senator Harkin, Senator Specter, I apologize
for being late, but I have literally been on the floor since we
last spoke. Typically, let me just say that this hearing is
very important, like all those you have done on stem cells,
diabetes, and I could go on and on.
Senator Specter. Go ahead, Senator Reid.
Senator Reid. I appreciate this hearing, but I want to take
just a minute to introduce Barbara Lee Hunt, who is the Washoe
County Health District Health Officer. Washoe County is, we
know, the second most populous county in the State of Nevada.
She has certainly been in the trenches.
As you know, Reno was deemed to have an anthrax problem 2
weeks ago, or 3 weeks ago, and as a result of the work that was
done in Reno, by Barbara Hunt, and all the screening she
supervised, she is qualified and very important to speak to
what we are trying to determine here in this committee, and it
is a pleasure to introduce Barbara Hunt to this committee.
Senator Harkin. Thank you very much, Senator Reid. Ms.
Hunt, welcome to the committee. Please proceed.
STATEMENT OF BARBARA HUNT, R.N., M.P.A., DISTRICT
HEALTH OFFICER, WASHOE COUNTY HEALTH
DEPARTMENT, RENO, NEVADA
Ms. Hunt. Good morning, Mr. Chairman, Senator Specter, and
members of this subcommittee. I am Barbara Lee Hunt, District
Health Officer for Washoe County. I was asked to present a
little bit of our experience in Reno a couple of weeks ago, and
I will try to do that as briefly as possible.
I think a key point is that when it became public that a
suspicious letter that was delivered to Microsoft in Reno had
tested presumptively positive for the bacillus anthracis, both
health departments, Clark Health Department in Las Vegas and
our department in Reno, and our Reno 911 dispatch centers were
inundated with calls from concerned citizens, hospitals, law
enforcement, and physicians' offices, to the point that the
State Emergency Operations Center had to be activated to help
take calls.
The District Health Department in Reno appropriately took
the lead in the public health investigation and the overall
response. We identified, interviewed, and collected specimens
for testing from six people who had contact with the letter. We
did personal and environmental risk assessment, and made
appropriate recommendations. We coordinated with the hospitals,
law enforcement, and emergency medical responders, and we were
the local information source.
What went well was the State Emergency Operations Center.
It took calls for the entire State for 3 days. The Health Alert
Network worked well in sending us updates on anthrax and
related issues on a regular basis.
We managed to prevent further strain on public health and
safety systems by educating the public with frequent,
consistent, and coordinated communications through the media
and by other means. We provided intensive on-site education for
hundreds of employees in the Sierra Pacific Power Building
where Microsoft is located.
We were in constant communication with Microsoft and the
Sierra Pacific Power management, forging relationships that
resulted in support for our recommendations. Despite some
pressure from offices and the advice of medical consultants
that conflicted with our recommendations, they even
participated in all of our press conferences.
What did not go quite so well is that the initial publicity
placed us in a reactive position for a few hours, which
contributed to delays in communication and coordination with
health and public safety agencies and delayed the establishment
of telephone hotlines. This contributed to an initial
overloading of the ambulance and 911 dispatch systems. Hospital
emergency rooms were flooded with the worried well. It took
quite a while to get definitive laboratory results.
What we learned was that we can handle small, contained
events. A larger event, especially a covert attack with a
disease agent that is transmissible person-to-person would
overwhelm not only the public health system but our hospitals
and public safety systems, and emergency medical responders as
well.
What we have identified as needs to improve our response
capabilities include increased public health laboratory staff,
equipment, and training for more rapid assessment of biological
threat agents. A great deal of public concern could have been
avoided if we had been able to obtain definitive laboratory
results sooner. In Nevada, we also need another location for
our public health laboratory. There is one location in the
entire State. That is in Reno. Las Vegas needs a public health
laboratory.
As we know across the country, not only public health
practitioners but physicians, hospitals, and emergency
responders all need training in bioterrorism and how to respond
to it. We found a situation where a local official advised
Sierra Pacific Power not to bring their employees together for
an educational meeting about anthrax because they thought it
would be risky.
Additional epidemiology staff for the State and local
health departments is extremely important. We must increase our
capacity to conduct public health investigations and
surveillance, and particularly to heighten surveillance during
high profile events that are so common in Las Vegas and Nevada,
and that bring so many tourists from all over the world, not to
mention all over the country. We need a bioterrorism
coordinator to coordinate training and preparation not only in-
house, but coordinate training and preparation with the
community, the hospitals, public safety, and emergency
responders.
We found that something very important to have was a public
information officer to coordinate communication with the
public. The health department needs such a public information
officer. If Washoe County had not generously loaned us their
entire public education staff we would have had much greater
public concern and a greater strain on health and public safety
resources.
Our key objective was to avoid the kind of panic that had
people flooding the 911 system and the hospital emergency
rooms. We need good data systems at Washoe County District
Health Department. We need a full-time physician. We do not
have a physician on staff. We have a medical consultant who has
other full-time employment.
Hospital capacity is an issue, particularly in Las Vegas.
An ordinary flu season can overwhelm the hospitals.
prepared statement
I would like to thank you very much for your support of
public health, and to urge that full funding be allocated for
the public health threats and emergencies. Thank you.
[The statement follows:]
Prepared Statement of Barbara Lee Hunt
Good morning, Mr. Chairman and members of the Subcommittee, I am
Barbara Lee Hunt, District Health Officer for the Washoe County
District Health Department, serving Reno, Sparks and Washoe County,
Nevada.
background
The only other local health district in Nevada is Clark County
Health District, serving Las Vegas. Five hundred miles separate Reno
and Las Vegas. The State Health Division serves the remaining 15 rural
counties.
We host many high profile events that draw thousands of tourists
from all over the world, creating attractive terrorist targets.
Depending on the agent used, a bioterrorist attack in Reno or Las Vegas
could have national and international impacts.
what happened
When it became public that a suspicious letter delivered to
Microsoft in Reno had tested presumptively positive for Bacillus
anthracis, both health districts and Reno's 911 dispatch center were
inundated with calls from concerned citizens, physicians' offices, law
enforcement, and hospital emergency rooms. The State Emergency
Operations Center even had to be activated to assist with calls.
The District Health Department appropriately took the lead in the
public health investigation and overall response. We identified,
interviewed and collected specimens for testing from 6 people who'd had
contact with the letter. We did personal and environmental risk
assessment and made appropriate recommendations. We coordinated with
hospitals, law enforcement and emergency medical responders. We were
the local information source.
what went well
The State Emergency Operations Center worked well, taking calls for
3 days. The Health Alert Network worked well.
We prevented further strain on the public health and safety systems
by educating the public with frequent, consistent and coordinated
communication through the media. We provided intensive, onsite
education for hundreds of employees in the Sierra Pacific Power
building, where Microsoft is located.
We were in constant communication with Microsoft and Sierra Pacific
Power management, forging relationships that resulted in support for
our recommendations, despite pressure from their corporate offices and
advice from their medical and environmental consultants that conflicted
with our advice. They even participated in all our press conferences.
what did not go well
Initial publicity placed us in a reactive position for several
hours, contributing to delays in communication and coordination with
health and public safety agencies and delaying establishment of
hotlines. This contributed to initial overloading of the ambulance and
911 dispatch systems. Hospital emergency rooms were flooded with
``worried well''. Definitive laboratory results took a week.
what we learned
We learned that we can handle small, contained events. A larger
event, especially a covert attack with a disease transmissible from
person to person, would overwhelm our public health and safety systems,
hospitals and emergency medical responders.
What we need to improve our response capabilities are:
--Increased public health laboratory staff, equipment and training
for more rapid assessment of biological threat agents. A great
deal of public concern could have been avoided if we had been
able to obtain a definitive result sooner.
--Training--few of our staff have had any level of bioterrorism
training, and we're not alone. A physician advised Sierra
Pacific Power not to bring their employees together for a
meeting, advising that it would be risky to have them in the
same room.
--Additional epidemiology staff for the state and both local health
departments. We must increase our capacity to conduct public
health surveillance and epidemiological investigations and
heighten surveillance during high profile events.
--A bioterrorism coordinator for each local health district and the
state, to coordinate training and preparation in house and with
our hospitals, public safety and emergency medical responders.
--A health department public information officer to coordinate
communication with the public. Without the loan of public
information staff from Washoe County, we would have had
increased public concern and greater strain on health and
public safety resources.
--A physician--we do not have a physician on staff. We have a medical
consultant who has other fulltime employment.
--Hospital capacity to handle a sudden surge of patients.
In addition, our disaster planning must include biological
scenarios and realistic simulation exercises.
All of these resources would serve us in day to day public health
work and in emergencies, such as emerging infectious diseases,
communicable disease outbreaks, toxic spills, and natural disasters.
The Kennedy-Frist bill proposes appropriate initial funding for
state and local public health preparedness and response to
bioterrorism. I ask that you support it.
Thank you.
Senator Harkin. Thank you for being here. That is why I
think we have more money in our bill for this.
I would recognize Senator Specter for purposes of an
introduction.
Senator Specter. Thank you, Mr. Chairman. Just a word or
two about our next witness, Dr. Hilary Koprowski, one of the
world's greatest scientists since he received his M.D. degree
from the University of Warsaw in Poland in 1939, and that puts
you on the record for 62 years of active work, Dr. Koprowski.
Among his many accomplishments involve his contribution to
the development of the first live polio vaccine. I would not
want to use his full 5 minutes by describing all of his honors
or positions which he holds.
STATEMENT OF HILARY KOPROWSKI, M.D., PRESIDENT,
BIOTECHNOLOGY FOUNDATION, INC.,
PHILADELPHIA, PA, PROFESSOR, DEPARTMENT OF
MICROBIOLOGY AND IMMUNOLOGY, DIRECTOR,
CENTER OF NEUROVIROLOGY AND BIOTECHNOLOGY
FOUNDATION LABORATORIES AT THOMAS JEFFERSON
UNIVERSITY
Dr. Koprowski. Thank you, Senator Specter. Mr. Chairman, I
am Director of the Biotechnology Foundation of Thomas Jefferson
University, Pennsylvania, and head of the Microbiology
Institute. As Senator Specter said, I have developed the first
oral polio vaccine that led to the first mass trial with oral
polio vaccine, and this bridged the way to eradicate polio from
the world in 2004.
For the past 10 years, I have led a team of scientists to
study plants as vectors for the production of vaccines and
other biomedicals, and our studies of the virus B vaccine was
found to create protection of hepatitis, the vaccine which we
grew in spinach and fed to human volunteers.
We have successfully in the laboratory created the
experimental vaccine in tobacco plants against AIDS. We have
both the knowledge and techniques to produce any vaccine,
whether it be bacteria or whether it be viral, like smallpox or
any other thing, in plants using two techniques. We transform
plants whose foreign agents produce vaccines either in seeds,
leaves, or fruit. Such plants can be provided indefinitely as a
source of vaccine production.
Another approach is we use plant viruses to fuel these
foreign agents. Plants were infected with these compounds, and
they were isolated in plant virus and the foreign agent to
produce vaccine.
As far as the anthrax vaccine project, for several years we
have proposed this anthrax project which we thought might be of
interest to the military. The project is aimed at developing
safe, cost-effective vaccine which could be used for mass oral
vaccinations. Our immediate goal of this project is to
stabilize the protective antigen of anthrax, the fusion of the
plant protein, and then transformations of lettuce and
radishes.
Laboratory animals will be fed with raw plants which have
been transformed and then tested for resistance at Fort
Dietrick. In addition, the transformed plant material will be
processed to produce tablets containing the antigen and the
vaccines in trials. Clinical trials in man can follow
immediately the experimental procedure, which we are dealing
with plants, not with animal tissue. This we can process in a
safe way, and you have no cross-contaminants which can be
produced in animal tissue.
Now, within a year of founding the project, we could start
properly having clinical trials. Now, the advantages of this,
no cross-contamination, it does not require sophisticated and
expensive facilities. Four pounds of specific protein can be
recovered from an acre of plants. It can be grown in different
geographical and climactic conditions, and it can be used as a
vehicle for oral delivery of vaccine.
prepared statement
So this is what I would like to say in our proposal today,
that we have done something already with anthrax, and this is,
we took three or four domains of the protective antigen and
fuse it with a plant virus and then infect it with a plant
virus in tobacco plants, and if funds would be available we can
check whether it produces immunity. This is just to tell you
that there is feasibility in this project and it can be applied
to almost every biomedical in the world.
Thank you very much.
[The statement follows:]
Prepared Statement of Hilary Koprowski
My name is Hilary Koprowski. I am presently the Director of the
Biotechnology Foundation located at Thomas Jefferson University, Head
of the Center of Neurovirology and Professor of Microbiology and
Immunology also at Thomas Jefferson University in Philadelphia,
Pennsylvania.
To tell you a little bit about myself, I developed the first oral
polio vaccine and conducted the first mass trial immunization by oral
route with polio vaccine. This bridged the way for a plan to eradicate
polio from the world in 2004.
For the past 10 years I led a team of scientists to study plants as
vehicles for the production of vaccines and other biomedicals. In our
studies, Hepatitis B vaccine, grown in lettuce was administered to
human volunteers by feeding and was found to produce antibodies against
Hepatitis virus. Rabies vaccine, which we grew in spinach and fed to
human volunteers led to immune reactivity to rabies. We have
successfully created an experimental vaccine in tobacco plants against
AIDS.
We have both the knowledge and the techniques to produce any
vaccine in plants using two techniques to achieve our goals:
(1) We transformed plants with foreign agents to produce vaccines
either in seeds, leaves or fruit. Such plants can propagate
indefinitely as a source of vaccine production.
(2) In the other approach, we used plant viruses to fuse with
foreign agents. Plants were infected with these compounds and we
isolated the plant virus and the foreign agent to produce the vaccine.
anthrax vaccine project
For several years we have proposed this Anthrax project, which we
thought might be of interest to the military. The project is aimed to
develop a new, safe, cost-effective vaccine which could be used for
mass oral vaccination against anthrax. Our immediate goal of this
project is to stabilize the Anthrax Protective Antigen (Pa) through
fusion with the stable plant protein called ubiquitin and to use this
recombinant for transformation of lettuce and radishes. Laboratory
animals will be fed raw plants which have been transformed by Pa and
then tested for resistance to infection at Fort Dietrich. In addition,
the transformed plant material will be processed to produce tablets
containing the Pa antigen and these, in turn, will be tested for
immunogenic potential. Clinical trials in man will follow the
successful outcome of laboratory investigation within a year after
funding for the project is made available. The great advantages of
plant-derived vaccines are as follows:
--Safety.--No cross contamination
--Inexpensive.--Does not require sophisticated and expensive
facilities; Up to 4 pounds of specific protein can be recovered
from an acre of plants.
--Distribution.--Can be grown in different geographical and climactic
conditions; can be produced locally.
--Delivery.--Can be used as a vehicle for oral delivery of vaccines.
--Continuous production.--Once transgenic lettuce and radishes become
available they can be propagated ad infinitum as a source of
anthrax vaccine.
progress up to date
In preliminary experiments, we succeeded in the expression (in
tobacco plants) of three fragments of anthrax protective antigen
(Domains 1, 4 and part of 4) fused with a plant virus in tobacco
plants. Virus particles obtained from plant extracts were purified and
are ready to be checked for their immunogenicity in animals when funds
become available. We are ready to proceed! We are just waiting for
funding and the ``go ahead.''
Senator Harkin. That is fascinating. We will follow up on
that one. Thank you, Dr. Koprowski.
Now let us move to Thomas Monath, vice president for
research and medical affairs for Acambis, makers of smallpox
vaccine.
STATEMENT OF THOMAS P. MONATH, M.D., VICE PRESIDENT FOR
RESEARCH AND MEDICAL AFFAIRS, ACAMBIA, INC.
Dr. Monath. Mr. Chairman, members of the subcommittee,
thank you for the opportunity to speak today about smallpox
vaccine and the threat of bioterrorism.
As mentioned, I represent a company called Acambis, a
publicly traded company headquartered in the United Kingdom.
Our vaccine program is performed solely in the United States,
by our division in Massachusetts. I also spent 20 years of my
life with the CDC, and I have a perspective on the use of
vaccines from a public perspective as well.
As you know, smallpox vaccination has been performed for
over 200 years. The market, however, for this vaccine collapsed
after eradication of the disease in the late 1970's. The last
vaccine made in the United States by Wyeth was in 1982. This
was a crude vaccine, made in the way that it had been for 2
centuries, collecting serum from the skin of cows and
processing that into a vaccine. That is not a modern way to
make a vaccine, so it is really not feasible to go back to that
method of preparing a new product.
Now, the last administration became concerned about
bioterrorism and the threat of smallpox, and that led to a
contract awarded to our company about a year ago, September
2000, to produce about a 40 million-dose stockpile of new,
modern smallpox vaccine, using cell culture techniques. Our
goal was to prepare a vaccine that matched as closely as
possible the biological characteristics of the original
vaccine, since it was unlikely we could actually demonstrate
efficacy, since the disease had disappeared.
We were successful in the first few months of this program.
Our scientists created a new vaccine with those properties, and
the remaining time since the award has been devoted to making
the vaccine in a way that the Food and Drug Administration
would find acceptable for a new human product, and we are
almost there. We plan to begin clinical trials of the new
vaccine in January of next year.
Now, the original contract I mentioned was for 40 million
doses, and the world has obviously changed. We got a change
order to our contract recently to increase it to about 54
million doses, and to accelerate the program. As was mentioned
here already, the Government and HHS has determined that they
should afford the American people one dose per person, roughly
300 million doses of vaccine, and we are currently responding
to a request for information from HHS to greatly increase and
accelerate the amount of vaccine that our company could
provide.
We teamed up with Baxter Health Care, a big U.S.
pharmaceutical company, in order to achieve this. Baxter owns a
significant equity share in our company. We have a strong
collaboration with them on many fronts. It is our belief we
could manufacture the amount of vaccine that the Government has
requested in about the first 9 months of 2002. We are looking
at the cost of doing this. We are not sure that the estimate
that has been mentioned today of $509 million is going to cover
such an effort. We will know more in the next day or so.
I want to also make the committee aware that in addition to
the vaccine, we have to think about distributing the vaccine.
The art of how you perform vaccinations is a lost art, and
people need training in order to do this.
There are two other matters which I feel important to bring
to the subcommittee's attention. The first is that what we are
doing is unheard of in the history of vaccine development. The
normal cycle of development of a new vaccine is roughly 10
years, and it is a very difficult proposition to get through
all of the regulatory hurdles and clinical trials and so on, so
we are planning to do something in record time.
A highly proactive collaboration with the Food and Drug
Administration is absolutely critical to make things happen.
This is not going to be business as usual, but we have to make
sure that no short-cuts are taken, because the product must be
of highest quality, since one can certainly imagine the
situation in which a lot of vaccine might be given when faced
with a threat, only to find out later that that was just a
threat and nothing was actually happening. So we need a safe
vaccine that meets all of FDA regulations regarding product
quality.
Second, I would like to make the point that vaccine
manufacturers, including us, require indemnification against
tort claims resulting from vaccine-associated adverse events.
Dr. Koplan mentioned if the entire U.S. population were
immunized with a new vaccine, more than 40 percent or so having
never been vaccinated before, that we could expect 2,000-3,000
adverse events, potentially lethal events, so particularly
where the threat is uncertain the safety of a vaccine is
imperative.
prepared statement
It is quite extraordinary, but we got this contract from
CDC based on our providing private insurance against claims
against us and the Government associated with any adverse
events. In the setting of providing 300 million doses of
vaccine, there is no private insurers willing to pick up that
kind of risk. It must be done by the Government, and at the
present time, although it has been talked about and there are
efforts underway, we are unable to make a proposal to the
Government for a lot of new vaccine absent assurances regarding
the indemnification piece.
I thank you for allowing me to speak today.
[The statement follows:]
Prepared Statement of Thomas P. Monath
Senator Harkin, Senator Spector, members of the Committee, thank
you for the opportunity to speak about smallpox vaccine and the threat
of bioterrorism. I represent a bio-pharmaceutical company, Acambis,
which has a contract with the CDC to develop, manufacture, store and
distribute a new smallpox vaccine. Acambis is a publicly traded company
headquartered in the United Kingdom but, our vaccine program is
performed by the United States branch of the Company, located in,
Massachusetts. I wish to inform the Committee that I have a financial
interest in matters pertaining to smallpox vaccine, and my statements
should be viewed accordingly.
Smallpox is a truly horrific disease known from ancient times. Over
200 years ago, a British surgeon, Edward Jenner, developed use of
cowpox (a virus related to smallpox) for vaccination. Vaccine was made
by scarifying the skin of calves, and serum and pus containing vaccine
virus was harvested from the skin. This crude way of making vaccine
continued up to 1982. Vaccine manufacture ceased because smallpox
disappeared after an intensive eradication program in the 1970s. The
possibility that smallpox would be re-introduced as a bio-weapon was
not a sufficient priority for governments, including the US, to
maintain a manufacturing capability. Worldwide supplies of old, calf-
skin vaccine have dwindled to about 60 million doses, of which 15
million reside in the United States.
Rising concern about bioterrorism during the Clinton
administration, led--in 1999--to an effort to protect the American
people against the threat of epidemic disease. The first step, taken in
July 1999 was to identify an appropriate bio-pharmaceutical company
willing and able to perform the task. A formal RFP was issued in
February 2000, and the CDC contract was awarded in September 2000, at
which time our Company initiated work.
The vaccine is a live attenuated virus, which is introduced into
the most superficial layer of the skin using a needle using the so-
called ``multiple puncture'' technique, unlike other vaccines which are
inoculated under the skin using a syringe. It is worth noting that the
method of delivering vaccinia requires skill and experience lost by
virtually all medical personnel in the US. Wide-scale use of smallpox
vaccine will require concurrent training of medical personnel in the
art of vaccination.
After introduction of the virus into the skin, the vaccinia virus
produces a limited local infection, which typically results in
formation of a single pock within 3-7 days. There are two features of
this process that are worth noting. First, the formation of a visible
pock rapid evidence of immunity that is obvious and reassuring to both
patient and physician. This is unique, since all other vaccines
stimulate immunity silently and require a blood test to determine if a
``take'' has occurred. The second unique feature of the vaccine is that
it can be applied up to 3-4 days after exposure to smallpox virus and
still .provide protection. Since smallpox virus is transmitted only by
patients who have overt signs of rash, and since contacts can be
effectively protected by vaccination up to several days after exposure
to such patients, there is a very real opportunity to interrupt the
spread of the disease. The problem we face is supply and distribution
of sufficient vaccine to deal with a wide range of possible scenarios
should a bioterrorist attack occur.
Our original contract with CDC was to produce 40 million doses of
vaccine using modern methods in cell culture rather than in calf skin.
Our program at Acambis has been devoted to the creation of a new
vaccine that matches the safety and effectiveness of the original
vaccine. This was accomplished by our scientists in the first few
months of the program. The remaining time since the contract award has
been devoted to the manufacturing of vaccine that meets the stringent
requirements of the Food and Drug Administration. Vaccine manufacturing
is being scaled up in our facility, to reach very high levels of
production next year.
Acambis, together with our partner Baxter HealthCare, is also
responding to a request from the Government for a large number of
vaccine doses beyond the scope of the current contract. It is the
Government's intent to make sufficient vaccine over the next 12 months,
i.e., approximately 300 million doses, to provide for universal
coverage of the American people in case of an emergency or a decision
to reinstitute routine immunization.
I would like to take this opportunity to make two comments about
this accelerated program. First, the Committee should note that what is
being tasked is highly unusual, indeed unheard of in the history of
vaccine development. The cycle of development from the initial stages
through FDA licensure of a new vaccine typically takes 10 years,
despite the best efforts on the part of industry to minimize timelines.
A highly proactive collaboration between industry and the FDA will be
required to achieve the Government's objective. However it is critical
that shortcuts do not compromise product quality or demonstration of
safety and effectiveness in clinical trials, since is easy to imagine a
situation where large numbers of individuals are exposed unnecessarily
to the vaccine, which may have a significant risk of serious adverse
events.
Second, the Committee should take note of the fact that vaccine
manufacturers will require indemnity against tort claims resulting from
vaccine-related adverse events. Our current contract at Acambis was
awarded based in part on our company having provided private insurance
against such claims for the use of up to 40 million doses of FDA-
licensed vaccine. The new plan to develop a much larger stockpile of
vaccine, which could be used as investigational product in advance of
FDA licensure, is certainly beyond the scope of any possibility of
coverage by private insurers. If this plan is to succeed, the
Government must solve the problem of indemnification. Thank you once
again for the opportunity to address the committee.
Senator Harkin. Did you state $509 million?
Dr. Monath. I think that was the figure you mentioned.
Senator Harkin. What did you say?
Dr. Monath. We are looking at the cost of providing 300
million doses of vaccine. We are not quite there. I think in
the next day we have to provide those figures to the
Government. I am not sure the $509 million is going to be
enough.
Senator Specter. But you read it in the newspaper?
Dr. Monath. I read it in the newspaper.
Senator Harkin. That is what we have been asking for, and
if it is not enough, we had better know about it.
Senator Specter. It is interesting you would read it in the
newspaper.
Senator Harkin. Now we turn to Dr. Mary Gilchrist. Dr.
Gilchrist is director of the University of Iowa Hygienic Lab,
and president of the Association of Public Health Laboratories.
I visited the Hygienic Lab at the University just a couple of
weeks ago, and was very impressed with your ability to rapidly
respond, so welcome, and please proceed.
STATEMENT OF MARY J.R. GILCHRIST, Ph.D., DIRECTOR,
UNIVERSITY OF IOWA HYGIENIC LABORATORY
Dr. Gilchrist. Thank you, Mr. Chairman, distinguished
members of the subcommittee. I am honored to be here today to
discuss the critical role the public health laboratories play
in bioterrorism response, including the most recent anthrax
attacks. I am going to address three important components that
do require attention, the bioterrorism response network,
linkages between public health and clinical laboratories, and
the chemical terrorism response network.
The public health laboratory community spent the last 3
years preparing for a potential bioterrorism event. The
Laboratory Response Network, anchored by the CDC, was formed.
The public health laboratories in the cities and States were
designated to shoulder much of the testing. Methods for
identification of bacteria, toxins, and viruses were written,
and technologists are being trained and tested with unknown
specimens.
Much remains to be done, but the basic structure is
effective, as demonstrated by the case in Florida. Now is the
time to strengthen the system and fully equip the public health
laboratories. At present, many of the 81 labs in the network
are inundated with suspicious packages, powders, and other
challenging specimens. They require great effort to work up
safely, as each is unique. The testing cannot be sustained
indefinitely without burnout, given the long hours that the
technologists are enduring. The testing must be sustained,
however. When testing is readily available, it helps to control
fear so that it does not progress to panic.
Last year, a total of only $8.3 million was provided to
fund the network. This money helped to build a foundation that
should now be enhanced. The APHL is disappointed in the
President's recently announced emergency budget for the LRN. We
must move beyond the startup phase, and this will require a
substantial increase in funding that far exceeds the
administration's request.
To adequately fund the LRN, a total of $125 million should
be distributed to the States. Funding is necessary for new
instruments that will perform rapid tests, for staffing,
chemical supplies, communications, information management,
facilities, courier systems, biosafety and security.
Let me provide an example that we experienced regarding
security. In Iowa, following the unconfirmed report that the
Ames strain may have been used in Florida, our security issues
became acute. Misleading and inaccurate wording in the press
suggesting an Iowa laboratory connection brought the National
Guard to our door, and this was pictured on the front page of
the New York Times, which spawned interest by other media.
Although the controlled strain at our lab is a vaccine and
not a virulent strain, it was deemed necessary to increase
security against any anthrax agents that may be isolated in the
future. These security advancements were not inexpensive,
particularly in a building that was built in 1917 to serve as a
tuberculosis sanitarium. Public health laboratories throughout
the Nation are critical infrastructure, and these assets must
be secure.
The National Laboratory System is a concept that will more
closely tie the public health laboratories to the 170,000
hospital and other clinical laboratories, which do most of the
testing for infectious agents. Without good linkages between
hospital, reference, and public health laboratories, the rapid
emergence of threat agents may be missed. The complexities of
antibiotic resistance and bioterrorism demand that this system
be fully funded and instituted. To fully fund the LNS, $75
million is necessary.
The chemical terrorism laboratory system also requires
greater funding. Currently, only five laboratories in the
Nation have this capacity, and none of these five are located
in the Plains States. Through the events of the past few weeks,
we have learned that our laboratories will be called on to
detect both microorganisms and chemicals in order to evaluate
the threats to our society. However, most, like those in Iowa,
do not have the biomonitoring instruments that cost several
hundred thousand dollars each. To fully implement this program,
a minimum of $100 million is necessary.
The events of the last few weeks have fully demonstrated
that response capabilities must be distributed to the States,
and not solely available through the Federal system for three
major reasons. First, the Nation's public health laboratories
can provide important redundancy so that if one or more is
incapacitated the rest can take up the slack and provide surge
capacity.
Second, they provide geographic dispersal so that ground
transportation can be employed should air transport again be
compromised.
Third and most importantly, they provide local control so
that the most urgent specimens can be prioritized instead of
ending up in a queue of nameless specimens at a regional
laboratory.
prepared statement
We must sustain and augment this critical infrastructure.
This can only be accomplished with your help.
Thank you for the opportunity to testify today. I would be
pleased to answer any questions you might have.
[The statement follows:]
Prepared Statement of Mary J.R. Gilchrist
Mr. Chairman and distinguished members of the subcommittee, my name
is Dr. Mary Gilchrist. I am the Director of the University Hygienic
Laboratory (UHL), Iowa's public health and environmental laboratory. I
am also the president of the Association of Public Health Laboratories
(APHL), representing state and local public health laboratories across
this nation. We are pleased that the Council of State and Territorial
Epidemiologists (CSTE) support this testimony, and the written
statement reflects comments provided by our epidemiology partners. Both
epidemiology and the laboratory must have equivalent strength so that
they may function effectively.
I am honored to be here today to discuss the critical role that
public health laboratories play in bioterrorism response, and
specifically the most recent anthrax threats and attacks.
The public health laboratory is a critical component of national
and state surveillance for bioterrorism. In order to be prepared for
bioterrorism, public health laboratories need safe and secure
facilities, trained personnel, modern equipment, rapid assays, and
communications tools. Courier services are also needed to move
specimens to the public health laboratory. To prepare for chemical
terrorism our states need containment laboratories, trained personnel
and equipment to perform rapid screening for toxic chemicals.
In Iowa, following the unconfirmed and false announcement that an
Ames or Iowa strain may have been used in Florida, our security issues
became acute. News that the Iowa National Guard was guarding
laboratories in Iowa City was carried on the front page of the New York
Times and this revelation spawned inquiries from the networks. Much
misinformation was circulated regarding the Ames strain, an isolate of
Bacillus anthracis that was identified at the National Veterinary
Services Laboratories (NVSL) in Ames some twenty years ago and widely
circulated to other facilities for research purposes. Indeed, although
the Bacillus anthracis control strain at UHL is a vaccine strain and
not the Ames strain, it was deemed necessary to increase security
against any anthrax agents that may be isolated in the future. These
security advancements are not inexpensive particularly in a building
that originally served as a tuberculosis sanitarium.
To prepare our nation's public health laboratories for the
biological and chemical terrorism threats our nation faces we urge
enhancement of the following three programs: The Laboratory Response
Network, the National Laboratory System and the further development of
a Chemical Terrorism Preparedness and response program. The approximate
cost for the three components would be $300,000,000. Details for each
of the three components follow.
The Laboratory Response Network (LRN) is critical to the success of
the United States response to terrorism. In order to prepare the LRN
member labs at the local, state, and federal level, and to ensure
adequate and appropriate expansion, an additional $125 million is
needed, at a minimum.
The Laboratory Response Network is composed of county, city, state,
and federal public health laboratories, and was established to help
public health laboratories across the nation prepare for and respond to
acts of terrorism. It is a joint program of the CDC and the Association
of Public Health Laboratories and was begun about three years ago. This
network of laboratories can accept specimens and samples from
hospitals, clinics, the Federal Bureau of Investigation (FBI) and other
law enforcement groups, emergency medical services, the military, and
other agencies. With adequate resources this multi-level network will
be able to function effectively even if airplane travel is grounded.
During the September 11 attacks in New York City and Washington, if
there had been simultaneous attacks with physical and bioterrorism
agents patient samples could have easily been transported over the
ground to adjacent states.
The public health laboratory community spent the last three years
preparing for a potential bioterrorism event. The public health
laboratories in the cities and states were designated to shoulder the
bulk of the testing for dangerous biologic agents such as Anthrax,
Botulism, Plague, Tularemia and Brucellosis. In fact, the first (index)
case of anthrax in Florida was diagnosed because astute private
healthcare personnel (a clinician and a laboratorian) saw suspicious
``gram-positive'' rods and immediately forwarded the sample to the
state public health laboratory, which conducted more sophisticated and
more definitive tests, and then went on to alert the CDC.
Methods for identification of the designated threat strains of
bacteria, toxins and viruses were written and laboratory technologists
were trained and tested with unknown specimens. The basic structure is
effective but we must fully fund the infrastructure in our laboratories
to sustain the efforts that are currently underway.
At present, the laboratories in the network are inundated with many
suspicious packages, powders and other very challenging specimens. They
arrive in complex and challenging packaging and require great effort to
work up as each is unique. This testing is demanding and cannot be
sustained indefinitely without burnout, given the risks and long hours
that our technologists are enduring.
Definitive identification of agents of biologic terrorism in both
an overt or covert attack is dependent on laboratories having technical
capabilities, equipment and trained personnel. Laboratories must be
able to identify a broad range of potential agents including organisms
that could be used to compromise the food supply, water or air.
Conventional identification methods are now in place and more rapid
methods are being evaluated prior to implementation in public health
laboratories. There is no reliable alternative to the testing by the
network laboratories.
The hand held devices that are widely touted by industry often
provide false positive results and false negative results and cannot be
relied upon to provide accurate testing at this time. If there are
accurate devices, it is not easy to distinguish them from the
problematic ones because reliable evaluations have not been published
in an adequate fashion. In fact a recent CDC Health Alert states the
following: ``Hand-held assays (sometimes referred to as ``Smart
Tickets'') are sold commercially for the rapid detection of Bacillus
anthracis. These assays are intended only for the screening of
environmental samples. First responder and law enforcement communities
are using these as instant screening devices and should forward any
positive samples to authorities for more sensitive and specialized
confirmatory testing. The results of these assays should not be used to
make decisions about patient management or prophylaxis. The utility and
validity of these assays are unknown. At this time, CDC does not have
enough scientific data to recommend the use of these assays.''
Importantly, the testing taking place in the public health
laboratories controls panic and fear. The ready availability of the
testing of these packages, powders and environmental specimens is also
providing the CDC respite from a volume of testing that could never be
performed in their laboratories even if the problems with transport,
chain of custody and jurisdiction could easily be solved.
Last year, CDC distributed $8.3 million to the state public health
laboratories to prepare for bioterrorism. The dollars provided by the
CDC were helpful for a network in formation. It has helped to build a
foundation that can be enhanced. It is now essential that we fully fund
the network.
Therefore, we call for substantial increases for the programs at
the CDC that are needed for biological terrorism preparedness and
response. Furthermore, we must ensure that the money designated for the
CDC flows to our nation's public health laboratories. The state,
county, and city public health laboratories are on the frontlines in
our nation's response to this crisis. Without a needed influx of
dollars our state's public health laboratories will not have the
capacity and capability needed to respond to an emergency situation.
Funding is necessary for the following: new instruments that will
perform rapid tests; staffing; chemicals and supplies; communications;
information management; facilities; courier systems; and biosafety and
security. Once again, we call for $125 million for the LRN.
The National Laboratory System (NLS) is an essential component of a
laboratory preparedness plan for biological and chemical terrorism.
Currently, the National Laboratory System (NLS) is a demonstration
program funded by the CDC in response to the growing threat to public
health posed by bioterrorism, food-borne diseases, and emerging
infectious diseases. At a minimum, $75 million is needed to begin to
fully implement the NLS in all 50 states.
We are all aware that the health of citizens of the United States
is at risk due to potential and real bioterrorist events or exposure to
other infectious diseases including organisms that develop
antimicrobial resistance. A recent GAO report (Emerging Infectious
Diseases, February 1999), and a Lewin Group Report (Public Health
Laboratories and Health System Change, October 1997) both address the
need for development of a cohesive laboratory system. Consequently, it
is important to develop a system that will allow rapid and accurate
information to flow between public and private laboratories and to
define the roles of each in containing the diseases. Detection of a
causative agent and its unique properties is essential for effective
public health intervention.
All clinical laboratories are the front-line' of detection of
events, whether those events be biologic or chemical. Patients show up
at doctor's offices and emergency rooms, not at public health
laboratories or public health programs. So public health is dependent
on clinical laboratories to be aware of public health concerns and to
route appropriate specimens/isolates to public health laboratories.
A major goal of the NLS is to facilitate communication and
coordination between public health laboratories and the medical
community and hospital/independent laboratories. Accurate and timely
laboratory detection is critically important to identify, track, and
limit public health threats like biologic and chemical terrorism.
Today, most diagnostic testing for infectious agents occurs in 170,000
private hospital or commercial laboratories nationwide. These
facilities will very likely be the primary sites for detecting an act
of bioterrorism or the introduction of an unusual infectious agent into
a community.
Improvements are needed in the integration of public health
laboratories and private clinical and hospital laboratories. These two
types of laboratories have independent yet complementary roles to
safeguard public health. To reach this goal, the CDC, in conjunction
with the Association of Public Health Laboratories, has been piloting
the National Laboratory System within the states of Minnesota,
Michigan, Nebraska and Washington.
The National Laboratory System must be expanded to all states to
maximize our nation's preparedness to detect and provide public health
interventions for infectious disease outbreaks. Through improvements in
communication, collaboration, and coordination, the NLS initiative is
successfully providing links to the public and private sectors
necessary for an effective response to terrorism, emerging infectious
disease, antimicrobial resistance, and foodborne diseases. All states
must be part of a National Laboratory System. We urge you to provide
$75 million to build the NLS.
For Chemical Terrorism Preparedness and Response, expanding the
number of laboratories able to handle chemical agents and agents
present in environmental samples is essential. Minimally, $100 million
is needed to enhance and expand public health laboratories testing
human specimens for chemical terrorism agents as well as to implement a
program of testing for environmental samples. Currently there is no
program in place to test environmental samples and this is a major gap
in testing.
The likelihood that chemical agents will be used for terrorist
purposes is high. Unlike biological agents, chemical agents can produce
immediate effects; are cheap, easy to use, stable, and can be precisely
delivered; and can be easily, efficiently, and rapidly dispersed.
Terrorists can use thousands of commercially available chemicals. These
chemicals can be purchased throughout the world. These include
herbicides, blood agents, choking agents, blistering agents, and nerve
agents.
Last year CDC provided $3.1 million to five state public health
laboratories (New York, Virginia, New Mexico, California and Michigan).
In addition to funding, these laboratories have received training from
the CDC, and are beginning to serve as ``surge capacity'' laboratories
for CDC chemical terrorism analyses of clinical specimens. At present
there are no efforts to provide coordinated laboratory testing of
environmental samples for evidence of terrorist attacks. Once again, we
need a minimum of $100 million to begin to fully implement these
programs.
APHL supports the following testimony regarding building state
epidemiology capacity. These portions of my testimony have been
provided to us by the Council of State and Territorial Epidemiologists.
The Council of State and Territorial Epidemiologists (CSTE)
supports the white paper, Providing a Framework for Public Health
Action and Bioterrorism Preparedness: Recommendations for Federal
Funding of Public Health Activities, prepared by the Center for
Infectious Disease Research and Policy at the University of Minnesota,
and the Workgroup on Bioterrorism Preparedness. While this document is
still a work in progress with regard to supporting points, the overall
funding recommendations, and general funding categories, are endorsed
by CSTE.
With the Framework as a context, CSTE has specific recommendations
within two funding categories. Under item #1, Improving State and Local
Preparedness, item (b), Staffing, Training, Epidemiology and
Surveillance, a total of $400 million is recommended. Within this
total, CSTE recommends the following: $60 million (per year) to expand
the Emerging Infections Program (EIP). The current funding level is $18
million. State and local health departments must improve their ability
to recognize and respond to bioterrorism events by integrating
bioterrorism preparedness activities into existing communicable disease
prevention and control programs. CDC's Emerging Infections Programs
(EIPs), now operational in nine states, have been highly successful in
enhancing the kind of long-term epidemiologic capacity needed at the
state level and county level. The EIPs are built around specific
``cutting edge'' surveillance projects that are collaborative efforts
between state and county health departments and the CDC. The
infrastructure created by these projects provides a level of
surveillance infrastructure that is uniquely suited to challenges posed
by bioterorrism. The EIPs also have the flexibility to enhance their
capacity to detect a bioterrorism event. This amount of funding would
permit expansion to 16-20 states and several additional large cities.
$65 million (per year) to expand the Epidemiology and Laboratory
Capacity for Infectious Diseases program (ELC). The current funding
level is $50 million. The ELC for Infectious Diseases program is less
structured than the EIP Network and builds more basic epidemiologic and
surveillance capacity in states and eligible local health departments.
Some states have used the ELC to build capacity and have gone on to
become part of the EIP Network. dsELC for Infectious Diseases was
established in 1995 in response to CDC's national strategy to address
emerging infections. Resources are used to hire and train staff,
develop diagnostic and subtyping methods, implement electronic disease
reporting systems, and strengthen collaboration between laboratory
scientists and epidemiologists. As of April, 2001, all states and six
Metropolitan health departments, and Puerto Rico have received funds
through ELC. More than 200 epidemiologists, laboratory scientists, and
technicians have been hired with ELC funding and many states now have
modern molecular diagnostic and communications tools. The recommended
funding level would double existing core capacity funding, which
averages $250,000 per site, and add a bioterrorism component.
Again, within the Framework document, under Item (c) under
Improving State and Local Preparedness is Information and
Communications Systems and totals $200 million. Within this total for
this purpose, CSTE recommends the following: $50 million (per year) to
fully implement the National Electronic Disease Surveillance System
(NEDSS). The current funding level is $27 million. NEDSS is a system
designed by CDC to integrate a myriad separate databases for public
health surveillance so that reporting can be simplified and outbreaks
(including bioterrorism attacks) can be rapidly detected and
characterized across the different systems and, very importantly,
across an entire state and multi-state region. The system also provides
new, upgraded features such as automatic laboratory electronic
reporting and Geographic Information Systems, or mapping to show where
cases are occurring. While, this year, 57 states and jurisdictions
received some NEDSS funding, 21 states who applied for funds to move
their systems ahead were not funded due to insufficient resources. Only
two states have fully implemented systems. With additional funding, CDC
could provide intermediate NEDSS capacity to all 50 states; it could
add resources to state grants to permit re-examination of their
Information Technology security issues which are not adequate; and it
could broaden the software licenses beyond just intrastate laboratories
to include intrastate providers, reporters, and non-laboratory
facilities.
$10 million (per year) to fully implement Epi-X. There is no
current appropriation for Epi-X. The Epidemic Information Exchange is
software created to provide rapid, secure communication about outbreaks
and other acute or emerging health events among public health
officials. Epi-X is a secure web-based system with participants from
CDC, state and local health departments, and the military. Epi-X also
provides emergency notification by telephone and/or pager for defined
groups of public health officials. The funding level requested would
support state and local health department efforts in all 50 states and
large city health departments to integrate Epi-X capabilities into
their existing and future disease surveillance and outbreak
communications plans.
In closing, I want to thank the members of the Committee for the
opportunity to testify during this time of great need.
Senator Harkin. Thank you very much, Dr. Gilchrist. Thank
you all for being here.
I will try to ask just a couple of questions. To BioPort,
the anthrax vaccine right now is not available to civilians.
Should it be made available to civilians?
Mr. Kramer. As you correctly point out, the stockpile of
vaccine we have is owned by the Department of Defense.
Senator Harkin. How many doses do they have?
Mr. Kramer. I have been asked not to comment about the
number of doses that is in the stockpile, but I have been
assured that the HHS and the DOD are coordinating to make sure
that that vaccine will be made available on an emergency basis
with the approval of the FDA.
Senator Harkin. You are saying the number of vaccines we
have available for anthrax is a classified matter?
Mr. Kramer. I have been asked not to comment on the number
of doses that are in the stockpile.
Senator Harkin. I am just wondering, in open testimony, why
it is classified. Does anybody know? Well, I will try to find
out why it is classified. Why should it be? Do you know why it
is classified?
Senator Specter. No.
Senator Harkin. I do not know, either. Well, I do not know
what the level of classification is.
The other thing on the anthrax vaccine, do I understand
correctly that if someone is exposed, and they have tested
positive, this vaccine be helpful to them?
Mr. Kramer. I will let Dr. Myers answer that question.
Dr. Myers. Animal studies have shown that when both vaccine
and antibiotic are given concurrently after exposure, that
protection is 100 percent. In those same animal studies, if
only antibiotics were given for a 30-day period, some 17
percent of the animals, regardless of the antibiotic, 9 out of
29 animals would later develop anthrax after the antibiotic
were taken away.
It suggests also that perhaps the course of antibiotic
therapy can be reduced, therefore expanding the amount of
antibiotic that is available for exposures as well as
preventing disease on reexposure, so we think it has a place,
and we think it is certainly up to the Centers for Disease
Control and Health and Human Services to determine what that
place is.
Senator Specter. Does that mean that it works?
Dr. Myers. Yes, it does.
Senator Harkin. That is what it sounds like, although this
is based on animal studies.
Dr. Myers. That is correct.
Senator Harkin. If you gave this vaccine to someone who is
exposed, what is the risk to that person?
Dr. Myers. Let me be clear that vaccine alone after
exposure is not protective. It requires vaccine plus
antibiotic, but it may prevent some cases of anthrax that would
occur after antibiotic treatment is completed.
Senator Harkin. How about if someone has inhalation
anthrax, would there still be time for the vaccine to work
after that?
Dr. Myers. The Advisory Committee on Immunization Practices
recommends that anthrax vaccine be made available, and that
post exposure treatment be both vaccine and antibiotic for 30
days, until three doses of vaccine have been given.
Senator Harkin. Just from a layman's standpoint, it seems
to me if someone has the symptoms of inhalation anthrax, in
which I think the mortality rate is quite high--I do not know
what it is, but it is quite high--then what would be the harm
in giving that person the regimen that you suggest, which is
antibiotics plus anthrax vaccination?
Dr. Myers. Certainly what we have seen thus far, and what
we would expect from animal studies, is that once symptoms have
occurred, the prognosis is poor, and with very aggressive,
supportive therapy, as we have seen, a death might still occur,
even if vaccine and antibiotics were given after the symptoms
begin. So it is probably not going to be real useful at all,
after symptoms of inhalational anthrax occur.
Senator Harkin. If you tested positive at some point for
exposure for anthrax, that is when it is useful?
Dr. Myers. That is correct, before disease begins, and that
is the recommendation of the Advisory Community on Immunization
Practices.
Senator Harkin. Thank you very much.
Ms. Kuhn, what is the price of Cipro right now?
Ms. Kuhn. We have an average wholesale price, and there are
other Government prices, but in my job as operations, I am not
really involved in the pricing structure.
Senator Harkin. So you cannot tell me how much Cipro is?
Ms. Kuhn. There are varying prices, depending upon where
the purchase is, but if you would like to discuss the pricing
further I can take the questions and get back to you.
Senator Harkin. Senator Specter just said here Bayer
supplies Cipro to the U.S. Government at a price of $1.83 per
tablet. I guess my question is, could you provide for the
record what was the cost to the Government per tablet 12 months
ago?
Ms. Kuhn. I do not have that information with me. I can get
back to you with that.
Senator Harkin. I think it is incumbent on us to take a
look at what the pricing structure of this is, since it is
going to be something that is going to be, I think, widely used
in the United States. We should take a look at that.
Ms. Kuhn. Thank you for that question, and we would welcome
that opportunity.
Senator Harkin. My time is up. Senator Specter.
Senator Specter. Thank you very much, Mr. Chairman.
I am very encouraged by what I hear today. When I listen to
the comments from BioPort and Bayer and Acambis and Dr.
Koprowski, I think the terrorists are overmatched. I think that
we have the ingenuity and the capability of meeting this
crisis.
When we talk about how much things cost--we always do that
around here--but the real question is, what can be produced?
What is our capacity for solving the problems? It is very
reassuring to hear how good it is, so that it is a matter of
pursuing these various courses.
Ms. Kuhn, you talk about what Bayer does and what Cipro
does. I think that it is important to inform the public that
Bayer officials are meeting today with Governor Ridge and also
Secretary of Health and Human Services Thompson to make a
determination as to what the needs are of the Departments to
actively protect Americans. Are the costs being negotiated and
discussed in those meetings, to your knowledge?
Ms. Kuhn. I do not have the agenda for that meeting so I do
not know if it is being discussed, but we certainly would
welcome the opportunity to have those discussions, because we
would also like to finalize these contracts.
Senator Specter. Well, I am sure those people are not
sitting down without getting down to brass tacks, but we would
appreciate it if you could provide the subcommittee with the
specifics on that letter, and I know in the morning press
releases that the issue between Bayer and Canada has been
solved. There had been an issue as to your patents and the
takeover of the patents, and that has been worked out with
Canada, recognizing your patents.
Ms. Kuhn. That is correct, Senator Specter. We have reached
a deal with the health ministry in Canada for 1 million
tablets. Those 1 million tablets are in their inventory, and in
addition we will take over inventory management of the generic
product and use that as necessary.
Senator Specter. The issue of patents, or respecting
patents is a very important one, so that there is motivation in
our society for ingenuity and for development and an
appropriate compensation, but not an inappropriate
compensation, and it is important that pharmaceutical
companies, when dealing with a problem of this sort, deal with
the Government, as Bayer is, with the Homeland Security
Director, Governor Ridge, and the Secretary of Health and Human
Services, Secretary Thompson, to arrive at what is a fair
price, and we want to be kept informed about that.
We want to encourage people to develop products, and you
have a constitutional requirement in America that you cannot
expropriate property. You cannot take property without due
process of law, but the other side of it is that there be
fairness, and we want to pursue that, Ms. Kuhn, and we would
appreciate it if you would report back to us on that.
Ms. Kuhn. I will do that, Senator Specter.
Senator Specter. Dr. Koprowski, the comments you have made
are really fascinating, especially when the praise does not
come from your home State Senator, but it comes from Senator
Harkin, who does not lavish praise without real cause, and so I
think that is quite a tribute to you.
Dr. Koprowski, how fast could this vaccine for anthrax be
developed by your procedures, if you could give us an estimate?
Dr. Koprowski. Senator Specter, it depends upon funds. The
larger the funds, the quicker we can get space and organize it.
I have said in my report that it would be not less, but perhaps
not more than a year. However, if we had more funds we could
accelerate the process, because it really involves growing
plants and putting the vaccine in plants.
Senator Specter. So if you were funded appropriately,
adequately, you could do it in less than a year?
Dr. Koprowski. Yes, we could do it in less than a year if
properly funded.
Senator Specter. Well, we are going to ask the Federal
officials to take a look at your program to see its potential,
and with your record for solving problems that is something we
really want to take a close look at.
Dr. Monath, when you talk about doses for 54 million
people, are you talking about doses for all Americans?
Dr. Monath. It has been a changing set of requirements. Our
original contract was for 40 million. That came out of some
considerations of the minimum number of doses needed to
interrupt an event using some dynamic modeling. I think
everyone has kind of woken up in the anthrax crisis.
Senator Specter. Could you provide us with what it would
cost for 300 million Americans, tell us what that would cost
and how long it would take you to produce it?
Now, are the risks reduced with the vaccine that you are
working on? Dr. Koplan testified earlier that the risks
outweigh the benefits, and I heard actually my son tell me
yesterday that there was one chance out of 4,000 on a smallpox
vaccine that there would be very, very serious medical
problems. Do you know if that is accurate?
Dr. Monath. Well, you are referring to the original
vaccine, the only material that is in the stockpile that exists
today, the 15 million doses at CDC.
Senator Specter. The question is, is there a significant
risk?
Dr. Monath. It is about 5 to 10 per million of very severe
adverse events.
Senator Specter. How about the vaccine which you are
preparing?
Dr. Monath. Well, it has not been made, but our goal is to
match the characteristics of the old vaccine.
Senator Specter. In that event, the risk would be present?
Dr. Monath. The risks are going to be significant, so we
really need to determine, or have a clear policy regarding, the
use of smallpox vaccine.
Senator Specter. Well, I compliment you on all you are
doing and the public health experts. This is a massive problem,
and I like what I hear. There is productivity and there is
capacity and there is ingenuity, and there are plans, and it
might take us a little time to get on track, but the Congress
is just a facilitator. You people are the real answers to the
problems.
With all the money that we would put up, it would not be
anything unless we had the productivity and the ingenuity to
solve the problem, and I think the terrorists are overmatched,
and we are going to prove it.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter.
Dr. Monath, on smallpox vaccine, once you have it, and you
have it in a vial, does it degenerate over time? How long will
it last? How long will it still have efficacy?
Dr. Monath. You have to remember the material was made by
Wyeth in 1982 which still constitutes our stockpiles. It is a
very stable virus. We are estimating a shelf life of 5 years or
more, but it will be determined by actual testing, real time
stability testing.
Senator Harkin. What you develop will have a shorter shelf
life than what we did previously?
Dr. Monath. Well, the FDA will give us a shelf life, and
what is happening now with the old stockpile is that it is
tested every year.
Senator Harkin. We have 15 million doses right now in the
United States, 15 million, and we are relying upon that, I
think. If there ever was an outbreak of smallpox, as I
understand it, that they would begin to vaccinate ever larger
concentric circles and that type of thing. How certain are we
that these 15 million vials of viruses are good, or
efficacious, or that they will work? How certain are we of
that?
Dr. Monath. We are quite certain. There is a simple test
that can be performed on the materials.
Senator Harkin. That is 20 years old.
Dr. Monath. Well, people have gotten these pox viruses out
of materials that have been sitting around on a shelf for
decades, and they are still viable. They are very stable
viruses. They are the only class of viruses that have that
characteristic, so the vaccine is remarkably stable. It has to
be retested to establish its stability from time to time, and
we expect that the new vaccine will have a long shelf life. We
will have to replace it on a regular schedule. Our contract
calls for a 20-year program.
Senator Harkin. How would someone ever be able to get a
hold of a smallpox virus that could infect people?
Senator Specter. You do not have to answer that question,
Dr. Monath. We do not want to give people any information about
that.
Dr. Monath. Well, I have lived in a world of BW for much of
my career. It could happen.
Senator Harkin. I just wonder what our real fears are. Are
there real fears out there that people could manufacture or get
a hold of smallpox vaccine? I think we have a right to know. Is
this something serious, or is it not?
Dr. Monath. I consider it to be serious. We knew in 1989,
with the first Russian defector of a high level, that the
Russians had weaponized smallpox and what has happened to that
program is quite uncertain. Much has been said about the
possibility that other countries, rogue states, have acquired
materials from that program, or maybe acquired it from other
means, so I think there is a credible threat.
I think it is less easy to perpetrate than anthrax for a
variety of reasons, but it cannot be dismissed, and it has a
bigger problem associated with it because it can spread, as was
mentioned, so it is a potential epidemic disease.
So whether or not the bad guys have it, I do not know. I do
not think anybody knows, but I think there is a real possible
risk, and we have to be prepared for it.
Senator Harkin. I understand. Regarding the 300 million
doses, I figured it would cost up to a little over $3 billion
as an estimate.
Dr. Monath. I hesitate, Mr. Harkin, to give you a number.
Senator Harkin. You gave me $11 a dose.
Dr. Monath. That was the anthrax vaccine. I do not think it
is going to be quite that much.
Senator Harkin. Well, I would like to get a handle on that,
and how fast we could ramp up.
Dr. Monath. We are providing information to the Government
Thursday.
Senator Harkin. Could you provide us with that kind of
information?
Dr. Monath. The information actually is being provided to
the Department on Thursday in response to a request for
information issued last week.
Senator Harkin. One last question I have, and I wanted to
ask Dr. Koplan about it, but maybe I will ask some of you.
Maybe, Dr. Gilchrist, you are the proper person to respond to
this.
There is a front-page article in the paper this morning,
well, maybe not the front page. It was on page 11. It says,
irradiation is the answer to anthrax. The process used on food
can be adapted to rid the mail of pathogens. They talk about
electron beams. I am very familiar with that, having started
funding a long time ago in the House for the first food
irradiator at Iowa State University almost 20 years ago. They
first used cobalt, and then they moved into electronic beam
pasteurization, or irradiation.
There is a facility now right outside of Sioux City, which
I saw a year or so ago. It is now being operated by this
company mentioned here in the paper, the Titan Corporation, and
a subsidiary called Sure-Beam Incorporated. They have a big
electronic pasteurization facility there for meat in Sioux
City, Iowa, so all of the hamburger and meat that goes through
this electronic pasteurization kills all the pathogens.
They asked whether the beam could kill anthrax, and they
replied yes, anthrax bacteria and the spores. Evidently it
could do it right within envelopes, within packages and things
like that. Could you enlighten us, any of you, on this, and is
this a viable thing to look at as a way of protecting our
people?
Dr. Gilchrist. To me it seems very probable that it would
work here. You are usually trying to get at the nucleic acids,
the spore's resistance, because it protects other parts of the
cell. So the fact that you would have to irradiate the envelope
and get to the spores, there would be some physical needs you
would have to pay attention to. Obviously the need up front is
to make sure that the envelope from where it was mailed to
where it was irradiated was not a risk to anyone, so those are
the things that I see.
I think it should work, absent the concern for the pre-
attention to the irradiation. We are now concerned about where
were they mailing things, for example, and where do they get
sorted. It has to be handled somehow before it gets irradiated,
so those would be the only concerns that I would have right
now.
Senator Specter. Mr. Chairman, I have one more question, if
I may.
Mr. Kramer or Dr. Myers, there had been reports in the
media about people in the military who were given the anthrax
immunization objecting to it, getting sick from it. Are those
myths?
Mr. Kramer. I think if you look at the safety studies that
have been provided in the written testimony, you will see that
the anthrax vaccine has a side-effect profile that is very
similar to any other vaccine. At the site of injection you get
redness. There is some swelling.
Senator Specter. So there are some side effects?
Mr. Kramer. There are some local side effects, but not
unlike any other vaccine such as diphtheria or tetanus which we
give our children.
Senator Specter. Some of the military personnel, according
to the reports, refused to take it. Do you know if that is a
myth, or true?
Mr. Kramer. Well, you are correct in that some of the
military people have refused to take the vaccine, but there is
no evidence that I am aware of to support their allegations
that what they are claiming was caused by the vaccine.
Senator Specter. Thank you very much.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter. Thank you all
for being here. I think one thing is quite clear that came out
of this, and that is, we are going to do more to help our local
public health agencies in the bill that we are coming up with,
aside from looking at how much we need to put in for smallpox.
subcommittee recess
Thank you all very much for being here, that concludes our
hearing.
[Whereupon, at 1:30 p.m., Tuesday, October 23, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
BIOTERRORISM
----------
FRIDAY, NOVEMBER 2, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:05 a.m., in room SD-192, Dirksen
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Byrd, Specter, and Stevens.
SMALLPOX
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. The Subcommittee on Labor, Health, Human
Services, Education, and Related Agencies of the Senate
Appropriations Committee will come to order. The subcommittee
today will have its third hearing on the subject of our
Nation's preparedness for bioterrorism.
This morning's hearing will focus on the threat posed by
smallpox. In the past couple of weeks we have seen the havoc
that can be created by just a few grams of anthrax spores.
Several Congressional office buildings were shut down, mail has
been disrupted over much of the east coast, and four people
have died. So I find it less than comforting when I am told
that the greatest risk is not from anthrax, but from smallpox.
An exercise this past June called Dark Winter started with
24 simulated cases of smallpox in Oklahoma, Pennsylvania, and
Georgia. The exercise ended after 2 weeks with 1,000 people
dead, 15,000 people infected, and the Nation's stockpile of 15
million vaccine doses entirely gone. Had it continued, they
expected the number of cases would have grown by a factor of 10
every 2 weeks. Fortunately, this was just an exercise. Nearly
one-third of people who contracted the most common type of
smallpox died and there is no known cure. Unlike anthrax,
smallpox is contagious and a small attack could spin out of
control.
There seems little doubt that our efforts to date have not
adequately prepared us for this threat. We do not have enough
vaccines to respond to an attack. Our public health system has
been allowed to decay and needs more help to detect an outbreak
quickly, to treat a large number of infectious patients, and to
vaccinate large parts of the country.
Under the leadership of Senator Byrd, the proposal that we
have put together includes funding for the production of enough
smallpox vaccine for every American, should that ever be
necessary. It also includes funds to beef up our public health
capacity at the local level so that we will be better able to
identify and track and contain a smallpox outbreak should we
ever be confronted with it. We expect and hope to include our
package in the emergency supplemental appropriations bill to be
taken up shortly.
This morning I hope we will learn more about what we can do
to better protect against the threat of smallpox. I hope
several questions will be answered today: How likely is the
threat of a smallpox attack? What is the current state of the
stockpile? How many of the doses that we have are still
effective? How can we get these doses out rapidly? How quickly
can 100 million doses be made to protect all Americans? What
else do we need to do to protect ourselves, and how prepared
are we at the local level to vaccinate on a mass scale?
So again, as I said, this subcommittee, under the
leadership of Senator Byrd and with Senator Specter, has
developed a comprehensive $2.3 billion plan to better protect
Americans from the threat of smallpox and other bioterrorism
threats.
We have a distinguished panel this morning who will help to
enlighten us on these questions. I look forward to the
testimony and to their answers to the subcommittee's questions.
Before we start, I will recognize first my ranking member
Senator Specter and then our distinguished chairman of our full
committee, Senator Byrd.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Well, thank you very much, Mr. Chairman. I
commend you for convening this hearing on a Friday morning. I
think it is appropriate to note that this subcommittee has been
very attentive to health care issues. Senator Harkin was
chairman of the committee in 1991, 1992, 1993, and 1994. I took
over in 1995, 1996, 1997, 1998, and 2000, until the middle part
of this year.
But what Senator Harkin and I like to emphasize, and I
think it is worth noting because people are so concerned about
the need for bipartisanship and to end the bickering on Capitol
Hill, is that it does not make any difference which of us is
chairman. I slightly prefer it when I am chairman, but the
public interest is promoted either way.
We got a very unique compliment this morning, which I do
not think is confidential, I will share with you. Senator Byrd
called us ``the health care twins.'' I said to Senator Byrd,
who is the senior Member of Congress, having been elected in
1952 to the House and 1958 to the Senate, about to celebrate 50
years on Capitol Hill, that was quite a high compliment.
Senator Harkin and I have been very attentive to the
National Institutes of Health and to health funding at every
level. We have taken a look at this issue of bioterrorism and
before the recent concerns we had put in the budget $338
million, last year over $290 million, the year before $255
million. But the fact is that until there was such a focus of
attention there was not the ability to put the kind of funds in
which are really necessary to deal with the threat that we have
now.
We had the Secretary of Health and Human Services in a few
weeks ago and we were a little concerned about being candid
with the American people and that there ought not to be an
overrepresentation, as the statement had been made that we were
prepared for any contingency. I made a comment that I thought
it was counterproductive to do that. If we lay it on the line,
people will understand. They want to know what we are doing
now.
When Senator Byrd's turn came he said, in an interesting,
maybe flamboyant, gesture: I do not believe you. That is the
value of separation of powers. We can speak perhaps a little
more candidly and a little more bluntly because we are separate
and we are independent. But before that day was up a letter
drafted by Senator Byrd, the chairman of the full committee,
was sent out with Senator Stevens, ranking on the full
committee, and Senator Harkin and myself to the President,
asking him what he needed and we were prepared to give him what
he needed, Congress was prepared to do that.
As Senator Harkin has noted, we have a package in excess of
$2 billion and it may go beyond that, because the real issue is
what are the resources of our country, our capability for the
vaccines and the health preparedness measures. We have a very
wealthy, productive, ingenious country and we can meet this
threat.
I might tell you on the personal level it is disconcerting
to be 100 yards from the Hart Building and not to be able to
get into my office. Senator Daschle had the anthrax envelope. I
am right above him. We could not get in the office, and I was
tested, fortunately negative, and took Cipro. It is no fun--an
adverse reaction. I missed a day of squash.
But I did not think it was possible to get Congress more
fighting mad than the September 11 attack, but this anthrax
business has done that, and we are prepared to move. I am glad
to see the experts here to give us the information as to what
ought to be done and how it ought to be done, and we will
provide the funding from the Appropriations Committee.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter.
Now I turn to our distinguished chairman of our entire
Appropriations Committee, Senator Byrd.
OPENING STATEMENT OF SENATOR ROBERT C. BYRD
Senator Byrd. Thank you, Mr. Chairman. Thank you for
conducting these hearings. This is where the action is, and
these are indeed the health care twins. They are both very
courteous, very responsive to our health needs, and they are
men of action. I have found that in the case of each of them
when each has been chairman. So I compliment them and thank
them.
I thank you for convening this important hearing on
smallpox. I thank the chairman for giving me this moment to
address the subcommittee and the witnesses.
Smallpox, whose world eradication in 1980 was hailed as one
of public health's greatest triumphs, has turned from a success
story to a bioweapons specter. Banquo's ghost at the head of
the table is there. Now public health officials in the wake of
the September 11 terror attacks are scrambling on several
fronts to guard against a nightmare scenario involving the
intentional release of the smallpox virus on a vulnerable
population with waning immunity or none at all against the
disease.
Smallpox epidemics have changed the course of history,
killing as many as half their victims and crippling entire
civilizations. In the Twentieth Century, smallpox has killed
millions, scores of millions, even hundreds of millions of
people, far more than all of the century's wars combined.
Smallpox causes unspeakable misery. It cannot be cured with
current drugs and spreads easily from person to person.
Thus, in the event of a bioterrorist smallpox attack, our
country needs to be prepared to avert widespread fever and
immediate system disruptions on a national scale. The only hope
of containing an outbreak is when it is still in the foothill
stages, when the number of infections is low and targeted
vaccination can be used to choke off the virus. Catching an
outbreak early keeps it from erupting.
Unfortunately, the public health community seems ill-
prepared for an influx of patients and the ensuing chaos.
Remember Milton's ``Paradise Lost.'' He used the word
``chaos''--chaos.
Since the first case of anthrax was diagnosed in Florida a
month ago, almost every assumption about anthrax has been
challenged, if not disproved outright. Scientific and medical
wisdom has been revised daily, it seems. As our Nation prepares
for potential smallpox attacks, it is imperative that we learn
from the experience that we have gained in dealing with the
anthrax problem.
You know, there were ten plagues of Egypt, and I will see
if I can name them in order: blood, frogs, lice, flies; and
then there is murrain, I believe it is murrain of cattle,
horses, camels, m-u-r-r-a-i-n. That is the one I want to settle
upon, so I will not complete the seven. There are actually 10
plagues.
But that is the one, murrain. So I have looked up that word
``murrain.'' It was spoken of in the book of Exodus, having to
do with the efforts of Moses to get pharaoh to release the
people, release his people. So I have looked it up in the
dictionary. The dictionary tells me that it is a disease of
cattle, like anthrax; murrain, like anthrax.
So among the seven plagues, the nine plagues of Egypt--some
will say there are 10--there is murrain of cattle, a disease
like anthrax. That is going back a long way.
It is my hope that we can translate our discussions today
into a tangible plan of action to deal with the threat of
bioterrorism that for too long we have been reluctant to
recognize. Shoring up our public health infrastructure is
certainly one of the solutions and we have been tardy in coming
to a realization of the importance of our doing something about
these potential catastrophes.
As I have been saying for some time, we need to make more
investments in the wellbeing of our citizens on our own soil.
As part of a $20 billion economic stimulus package, as the
chairman has said, I have recently proposed $3.1 billion for
bioterrorism prevention and response efforts to strengthen our
public health infrastructure and restore confidence in our
homeland security.
Congress must act now to ensure the security of this Nation
and the American people. You are taking a great first step
here. Here is where the action is. You impressed me greatly the
other day, Mr. Chairman, when you spoke of the need to spend $2
billion or $2.5 billion on clean water, on safe water, when you
pointed out that there are $22 billion requests backlogged for
clean and safe water. Now you are dealing with the problem
another day in another way and having this hearing.
I certainly thank you, and I thank Senator Specter.
Senator Harkin. Mr. Chairman, thank you so much. It is
always a learning experience to listen to you and a learning
experience to be on your committee.
I personally, and I think on behalf of all the American
people, want to thank you for your strong leadership in this
area. You were the first one, when we started talking about
putting all of this money in to fight terrorism, to say, wait a
minute, we have to think about bioterrorism and think about
putting that money aside for that and focusing on it.
You have led the way on that and we are proud to follow in
your wake.
Senator Byrd. You are my chairman. Just command me; I am
your lieutenant.
Senator Harkin. I think it is the other way around. But
thank you so much, Mr. Chairman.
We have a good panel here. I will introduce each of them
and then we will start with Dr. Fauci and work on down. First
we have Dr. Fauci, who first joined the National Institute of
Health in 1968. Since then he has had a distinguished career at
the National Institute of Allergy and Infectious Diseases. He
became Director of that Institute in 1984. Dr. Fauci has made
many important contributions to research regarding immune-
mediated diseases, especially with regard to the AIDS virus.
Next will be Dr. James LeDuc. Dr. LeDuc is the Acting
Director of the Division of Virus and Rickettsial Diseases of
the Centers for Disease Control and Prevention. Prior to
joining the CDC, Dr. LeDuc served for more than 20 years as an
officer in the U.S. Army, where he directed studies on the
epidemiology of virus diseases.
Dr. Michael Friedman was appointed this week to coordinate
the pharmaceutical industry's initiative to combat
bioterrorism. He is currently a Senior Vice President at
Pharmacia Corporation. Prior to joining the pharmaceutical
industry, Dr. Friedman served in the Public Health Service for
20 years and held the rank of Rear Admiral and Assistant
Surgeon General.
Dr. Anita Barry is the Director of Communicable Disease
Control at the Boston Public Health Commission. She is a member
of the Council of State and Territorial Epidemiologists and the
American Society for Microbiology, and serves on the Advisory
Board for the Greater Boston Biodefense Collaborative.
We thank you very much for taking time from your busy
schedules to be here to enlighten us.
We are now graced also by our ranking member of the full
Appropriations Committee, the former chairman, Senator Stevens.
I am delighted to yield to Senator Stevens for any opening
remarks or comments that Senator Stevens might have.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator Stevens. I have extreme interest in this subject
and am pleased to join you. Thank you.
Senator Harkin. Thank you very much.
We are graced by both the chairman and the ranking member
of the entire Appropriations Committee, so you can see how
important this is to our Senate.
STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS
DISEASES, NATIONAL INSTITUTES OF HEALTH,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Senator Harkin. With that, Dr. Fauci, welcome. All your
statements will be made a part of the record in their entirety,
and we would like if you could sort of sum up in maybe 5, 7
minutes each, I would sure appreciate it. Dr. Fauci.
Dr. Fauci. Thank you, Mr. Chairman, Senator Byrd, Senator
Stevens. We appreciate your calling this hearing and giving us,
my colleagues and I, the opportunity to address the threat of
smallpox bioterrorism and how we may as a group defend against
the bioterrorist potential of this pathogen. I represent the
National Institutes of Health, which is a component of a
multifaceted effort including government and nongovernment, our
colleagues, others represented here at this table.
Smallpox is just one of many bioterrorist threats, as you
have just mentioned, Mr. Chairman, but perhaps it is the most
frightening. Even though the disease was eliminated from the
world with the last case documented in 1977, stocks of smallpox
vaccine are known to exist in secure facilities, one in the
United States and one in Russia. But there are other
possibilities that stores may exist outside of those locations,
so the threat of the use of smallpox as a bioterrorist weapon
are real.
Smallpox is caused by Variola major. It is a virus that is
easily transmitted from person to person through aerosolized
droplets from saliva and other body fluids. It is unlike
anthrax in that it can be transmitted from person to person and
not just a danger by a direct contact. The symptoms typically
appear about 12 days after exposure, with a characteristic
clinical syndrome. At least 30 percent of people infected die
and many survivors are disfigured.
In some respects, the situation that we are in today is
what we call a victim of our own success, because smallpox was
eradicated with a very good vaccine in what is probably the
most successful and unprecedented story of a public health
victory in the eradication of smallpox.
The Dryvax vaccine, or the classic vaccine that for decades
has been used in the ultimate elimination of smallpox, was last
produced about 20 years ago. It is very effective in prevention
and also likely in post-exposure prophylaxis. This vaccine has
not been given routinely in the United States since 1972,
except for, for example, workers, laboratory workers who work
with related viruses. The military discontinued it several
years ago.
In other words, the population, as you alluded to just a
little bit ago, who were vaccinated years ago certainly have
waning immunity, namely decreasing immuniaty. The exact extent
of that residual immunity is really unclear.
In that regard, we have about 15 million doses of the
classic original Dryvax vaccine available and owned by the
Federal Government. This is not enough for a large-scale
epidemic. In this regard, a three-pronged or three-phased
approach has been implemented to increase the availability of
vaccine.
The first is one that I am sure you have heard of, is the
dilutional study, namely to take the 15 million doses, take an
aliquot of that and determine, if you dilute it one to five or
one to ten, do you get comparable safety as well as what we
call a take rate, namely a characteristic skin lesion
accompanied by an immunological response. If we are successful,
and we have reason to believe that we very well might be since
a preliminary study showed that a one to a hundred dilution
really did not give a good response, one to ten gave
approximately 70 percent take. We want to do better than that.
In the end of October, literally now, October the 26th, we
initiated a second dilutional study involving over 650 people.
In that we are comparing a one to five with a one to ten
dilution. If for example a one to five dilution is successful,
then we will have amplified our 15 million doses to
approximately 75 million doses. We consider that a short-term,
not solution, but a short-term amelioration of the shortage
response.
This must come in parallel with what we call an
intermediate and a long-range solution. The intermediate
solution is to produce a second generation smallpox using not
the typical calf lymph approach, but using a cell culture-based
approach that will be revved up and accelerated using not only
the company that was originally contracted, namely Acambis, but
also other large corporations that are being discussed now,
which will be large pharmaceutical corporations that would
hopefully get us to the desired 300 million doses by the end of
the year 2002 and perhaps before that.
There is a third generation of smallpox vaccines that are
in the research phase, namely one that we look to several years
from now, anywhere from 2 or more years, one that is using a
type of virus that might give less potential toxicities such
that pregnant women and people with weakened immune systems
might be able to be vaccinated. That is more than a year or so
away. We consider that the long-range solution.
Finally, in therapeutics, currently only supportive therapy
is used for individuals who are infected for smallpox. However,
screening efforts have identified the possibility of using
anti-virals not only to combat as a second line defense against
the potential toxicities of vaccination, but also in an
experimental fashion to use in the treatment. One, for example,
is a drug called Cidofovir that is made by the company Gilead,
that was originally made as a drug to combat cytomegalovirus in
HIV-infected individuals.
We now have an investigational new drug application to look
at this drug in the vaccination program and we are working
towards getting an IND to perhaps use it in treatment if
necessary. In addition, we are working with the United States
Army and USAMRIID to screen a number of compounds that might
have potential use as a treatment of smallpox.
prepared statement
In conclusion, the NIH is committed to focusing its basic
and clinical research efforts to approach and hopefully
overcome this bioterrorism threat. We are committed to working
together with our sister agencies in the Federal Government as
well as with industry and the local and State public health
groups in a comprehensive effort to keep the citizens of our
Nation safe from the threat of a smallpox bioterrorism attack.
Thank you, Mr. Chairman. I would be happy to answer
questions later.
[The statement follows:]
Prepared Statement of Dr. Anthony S. Fauci
Mr. Chairman and Members of the Committee, thank you for inviting
me here today to discuss the threat of smallpox as a weapon of
bioterrorism and the current efforts by the National Institutes of
Health (NIH) to accelerate basic and clinical research related to the
prevention and treatment of smallpox.
Recent events, notably the attacks on the World Trade Center and
Pentagon and numerous incidents involving the intentional spread of
anthrax spores, have highlighted our Nation's vulnerability to attack
by bioterrorists. In addition to anthrax, other potential agents of
bioterrorism include smallpox virus, the bacteria that cause plague and
tularemia, botulinum toxin, filoviruses (e.g. Ebola virus) and
arenaviruses (e.g. Lassa virus), and other selected pathogens.
As concern grows about the use of biological agents in acts of
terrorism or war, federal health agencies are evaluating and
accelerating measures to protect the public from the health
consequences of such an attack. The National Institute of Allergy and
Infectious Diseases (NIAID), a component of the NIH, supports research
on the diagnosis, prevention and treatment of infections caused by a
wide variety of pathogens, including those with potential for use as
biological weapons.
Our ability to detect and counter bioterrorism depends to a large
degree on the state of biomedical science. Basic and applied research
supported by NIH complements the efforts of other agencies by
developing the essential tools--diagnostic tests, therapies and
vaccines--needed by physicians, nurses, epidemiologists and other
public health workers to prevent and control a disease outbreak.
smallpox: the disease
Smallpox, caused by a virus known as Variola major, is considered
one of the most dangerous potential biological weapons because it is
easily transmitted from person to person, and because few people carry
full immunity to the virus. Although a worldwide immunization program
eradicated smallpox disease in 1977, small quantities of smallpox virus
still exist in two secure facilities in the United States and Russia.
However, it is possible that unrecognized stores of smallpox virus
exist elsewhere in the world.
The symptoms of smallpox infection appear approximately 12 days
(range: 7 to 17 days) following exposure. Initial symptoms include high
fever, fatigue, and head and back aches. A characteristic rash, most
prominent on the face, arms, and legs, follows in 2-3 days. The rash
starts with flat red lesions (a ``maculopapular'' rash); the lesions
evolve at the same rate. Lesions become pus-filled and begin to crust
early in the second week. Scabs develop and then separate and fall off
after about 3-4 weeks. Individuals are generally infectious to others
from the time period immediately prior to the eruption of the
maculopapular rash until the time of the shedding of scabs. The
mortality of smallpox infection is approximately 30 percent; those
patients who recover frequently have disfiguring scars. Smallpox
spreads directly from person to person, primarily by aerosolized saliva
droplets expelled from an infected person. Contaminated clothing or bed
linens also can spread the virus.
Smallpox vaccine has proven to be highly effective in preventing
infection. In unvaccinated people exposed to smallpox, the vaccine can
lessen the severity of, or even prevent, illness if given within 4 days
after exposure. Vaccine against smallpox does not contain the smallpox
virus, but rather a laboratory strain of a related virus called
vaccinia.
Vaccinations to prevent smallpox have not been required in the
United States since 1972. People vaccinated prior to 1972 very likely
have diminished immunity to smallpox; people born in the United States
after 1972 are not routinely vaccinated. Currently, smallpox
vaccination is recommended and available only for individuals who are
at risk of imminent exposure, such as laboratory personnel who work
with orthopox viruses related to smallpox virus, including vaccinia. No
new smallpox vaccine has been manufactured in almost 20 years.
smallpox research: vaccines
The NIAID strategy for smallpox vaccine research is a three-part
program that addresses immediate, intermediate, and long-term needs. In
the near-term, a bioterrorist attack involving smallpox would require
the utilization of stores of the existing smallpox vaccine.
Approximately 15 million doses of the FDA-approved ``Dryvax'' vaccine
have been stored since production stopped in 1983. This clearly would
not be enough to respond to a national smallpox epidemic. As a
response, NIAID last year initiated a study to determine the
feasibility of expanding the use of the existing stores of the Dryvax
vaccine by dilution. In this study, investigators examined the skin and
immune system responses of normal unimmunized adult volunteers who were
given a 1:10 dilution (10 percent) or a 1:100 dilution (1 percent) of
off-the-shelf Dryvax vaccine They compared responses to those from
other volunteers who had received the full-strength vaccine. The
results showed that the full- strength vaccine had maintained its
potency, and that 70 percent of people who received a single dose of
the 10-percent vaccine developed a sore followed by a scab at the
injection site and antibodies in their blood, indicating protection.
Even though the 10-percent vaccine was capable of stimulating an immune
response in most people in the study, it is unlikely that it would
protect enough people in a large population to sufficiently stop the
spread of smallpox. Based on these findings, a new study was designed
to determine if a diluted vaccine combined with an alternative
vaccination schedule could protect a greater number of people than did
the standard dose and regimen.
This study, which will enroll up to 684 people, is evaluating three
different doses of Dryvax. Researchers will study the ability of the
various vaccine formulations to stimulate a scab, or ``take,'' at the
vaccination site and to produce antibodies in the blood. If
participants have not developed a scab in seven to nine days after
vaccination, they will be revaccinated with the same vaccine they
received the first time. By that strategy, researchers hope to learn
which vaccine dose given in a single injection elicits the best
response among the largest number of people and whether ``boosters''
can fortify the immune response in those who did not react to the first
vaccination. This study is being conducted at several NIH Vaccine and
Treatment Evaluation Units around the United States, including Saint
Louis University, Baylor College of Medicine, the University of
Maryland, and the University of Rochester. Recruitment of study
participants began on Oct. 26, 2001.
NIAID-intermediate-term plans include development of a new smallpox
vaccine: a safe, sterile product grown in cell cultures using modern
technology. This vaccine will be rapidly tested in human clinical
trials; 250 million doses will be produced and delivered to the federal
government by the end of 2002. In the long-term, basic research
promises to provide a third generation of smallpox vaccines that could
be used in all segments of the population, including pregnant women and
people with weakened immune systems. As the research evolves, NIAID
continues to be actively involved in the development and testing of new
vaccines, including the initiation of clinical trials to determine
vaccine safety and efficacy, particularly in special populations.
therapeutics research
NIH therapeutics research focuses on the development of new
antimicrobials and antitoxins, as well as the screening of existing
antimicrobial agents to determine whether they have activity against
organisms that might be employed by bioterrorists. For example, in
collaboration with DOD, NIH has rigorously screened a large number of
antiviral drugs against smallpox and related viruses. One of these
agents is an antiviral called cidofovir, which is approved by the Food
and Drug Administration (FDA) for treating certain AIDS-related viral
infections. Cidofovir has shown potent activity against smallpox and
related viruses in test tube studies and in animal models. NIH has
taken the lead in developing a protocol that would allow cidofovir to
be used in emergency situations for the treatment of smallpox.
Concurrently, other anti-smallpox agents are being investigated. NIAID
and the U.S. Army Medical Research Institute of Infectious Diseases
(USAMRIID) funded initial screening of approximately 500 compounds for
potential antiviral activity against smallpox. Compounds were selected
for antiviral testing from the following categories: FDA approved drugs
effective against other viruses; antiviral compounds in clinical
development for other viruses; known experimental antiviral compounds;
and new chemical entities. Several drugs tested in these screening
studies, including several cidofovir derivatives, have been shown to be
active against both vaccinia and cowpox by in vitro evaluation.
Promising leads will be further tested with additional in vitro
studies, animal model testing, or combination therapy studies. In
addition, the design of medications active against known drug-resistant
variants of microbes and the development of broad-spectrum agents are
important NIH research priorities.
Together with our many research partners, NIH has made substantial
progress in the research effort that is critical to our Nation's fight
against terrorism. Much remains to be accomplished, however, and the
challenges posed by bioterrorism will require a protracted and
sustained commitment. With a strong research base, talented
investigators throughout the country, and the availability of powerful
new research tools, we fully expect that our basic and applied research
programs will provide the essential elements that will help enhance our
defenses against those who attempt to harm us with bioterrorism.
This concludes my testimony. I would be happy to answer any
questions which you or members of the Subcommittee may have.
Senator Harkin. Dr. Fauci, thank you very much for a very
straightforward presentation.
Dr. LeDuc.
STATEMENT OF JAMES W. LeDUC, Ph.D., ACTING DIRECTOR,
DIVISION OF VIRAL AND RICKETTSIAL DISEASES,
NATIONAL CENTER FOR INFECTIOUS DISEASES,
CENTERS FOR DISEASE CONTROL AND PREVENTION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. LeDuc. Good morning, sir, and thank you for the
invitation. I will proceed to brief you on our response to
smallpox.
It is CDC's responsibility to provide national leadership
for the public health and medical communities to detect,
diagnose, and respond and prevent illnesses, including those
that are a result of intentional release of agents. This task
is an integral part of CDC's overall mission, which is to
monitor and protect the health of the United States.
It is within this context that CDC is preparing our Nation
to respond to biological terrorism. Last year CDC issued a
strategy outlining steps in five areas to protect the Nation
against these threats. The first priority area is preparedness
and prevention. CDC is working to ensure that all Federal,
State, and local public health officials are prepared to work
with medical and emergency response communities to address the
consequences of biological and chemical terrorism.
We are developing performance standards and we are helping
States to conduct exercises to assess local readiness for these
issues. As Dr. Fauci just said, we are working in collaboration
with scientists at NIH, the Department of Defense, and other
agencies to actively research issues on smallpox virus,
including anti-viral drugs. We are producing additional
smallpox vaccine and we are making sure that the vaccine we now
have, the 15 million doses that Dr. Fauci mentioned, are safe
and ready for immediate use.
The second priority area is disease surveillance. As was
seen recently in Florida, the initial detection of a biological
terrorist act will most likely occur at the local level. This
is the area that we need to focus our attentions. To do this,
we must upgrade surveillance systems of State and local health
departments and strengthen their linkages with health care
providers so that unusual patterns of disease can be promptly
recognized and responded to.
In preparing to respond to smallpox, CDC is building
dedicated response teams and we will be offering specialized
training both to State and local health officials and
clinicians to better prepare them to handle this tragedy.
Third, to ensure that the control strategies and treatment
measures can be implemented promptly, we need to focus on rapid
diagnostic capabilities.
Fourth, a timely response to a biological terrorism event
involves a well-rehearsed plan to detect, to investigate, and
treat. We are assisting State and local health agencies to
develop these tests. Because hospitals play a critical role in
the response to bioterrorism activities, we are working closely
with the various health care institutions and associations to
better prepare them for potential bioterrorism events.
The fifth priority area deals with communications. Rapid
and secure communications are crucial to ensure a prompt and
coordinated response. CDC is building the Nation's public
health communications infrastructure through an effort called
Health Alert Network. We communicate with the public directly
through our web site and through a telephone and email system
which since the recent attacks has literally responded to
hundreds of inquiries every day.
As has been highlighted recently, increased vigilance and
preparedness for unexplained illnesses are an essential part of
the public health effort to protect the American people against
bioterrorism. Prior to September 11, CDC was making substantial
progress towards developing and implementing a nationwide
public health response network to help public health officials
respond to deliberate attacks.
The events of September 11 were a defining moment for all
of us. Since then, we have dramatically increased our levels of
preparedness and we are continuing to do so.
prepared statement
In conclusion, the best public health strategy to protect
the Nation against biological terrorism is strengthening the
public health surveillance and prevention systems. Priorities
include improved laboratory capacity, increased surveillance
and outbreak response capabilities, and better health
communications, education, and training. Not only will this
approach ensure that we are prepared for a deliberate
biological terrorism attack, but it will also improve our
national ability to promptly detect and control naturally
occurring outbreaks of infectious diseases.
Thank you very much, sir, for your attention. We will be
happy to answer any questions.
[The statement follows:]
Prepared Statement of Dr. James LeDuc
Good morning, Mr. Chairman and Members of the Subcommittee. I am
Dr. James LeDuc, Acting Director, Division of Viral and Rickettsial
Diseases, National Center for Infectious Diseases (NCID), Centers for
Disease Control and Prevention (CDC). Thank you for the invitation to
update you on CDC's public health response to the threat of smallpox. I
will address specific activities aimed at preparedness for a deliberate
release of variola virus, the pathogen responsible for smallpox.
As you are aware, many facilities in communities around the country
have received anthrax threat letters. Most were received as empty
envelopes; some have contained powdery substances. However, in some
cases, actual anthrax exposures have occurred. As of Wednesday, October
31, 10 cases of inhalational anthrax and 10 cases of cutaneous anthrax
have been identified in Florida, New Jersey, New York, and Washington,
DC. This is the first bioterrorism-related anthrax attack in the United
States, and the public health ramifications of this attack continue to
evolve. In collaboration with state and local health and law
enforcement officials, CDC and the FBI are continuing to conduct
investigations related to anthrax exposures. During this heightened
surveillance, cases of illness that may reasonably resemble symptoms of
anthrax will be thoroughly reviewed. The public health and medical
communities continue to be on a heightened level of disease monitoring
to ensure that any potential exposure is recognized and that
appropriate medical evaluations are given. This is an example of the
disease monitoring system in action, and that system is working.
public health leadership
The Department of Health and Human Services' (DHHS) anti-
bioterrorism efforts are focused on improving the nation's public
health surveillance network to quickly detect and identify the
biological agent that has been released; strengthening the capacities
for medical response, especially at the local level; expanding the
stockpile of pharmaceuticals for use when needed; expanding research on
disease agents that might be released, rapid methods for identifying
biological agents, and improved treatments and vaccines; and regulating
the shipment of hazardous biological agents or toxins.
As the Nation's disease prevention and control agency, it is CDC's
responsibility on behalf of DHHS to provide national leadership in the
public health and medical communities in a concerted effort to detect,
diagnose, respond to, and prevent illnesses, including those that occur
as a result of a deliberate release of biological agents. This task is
an integral part of CDC's overall mission to monitor and protect the
health of the U.S. population.
In 1998, CDC issued ``Preventing Emerging Infectious Diseases: A
Strategy for the 21st Century,'' which describes CDC's plan for
combating today's emerging diseases and preventing those of tomorrow.
It focuses on four goals, each of which has direct relevance to
preparedness for bioterrorism: disease surveillance and outbreak
response; applied research to develop diagnostic tests, drugs,
vaccines, and surveillance tools; infrastructure and training; and
disease prevention and control. This plan was developed with input from
state and local health departments, disease experts, and partner
organizations such as the American Society for Microbiology, the
Association of Public Health Laboratories, the Council of State and
Territorial Epidemiologists, and the Infectious Disease Society of
America. It emphasizes the need to be prepared for the unexpected--
whether it is a naturally occurring influenza pandemic or the
deliberate release of smallpox by a terrorist. It is within the context
of these overall goals that CDC is preparing our Nation's public health
infrastructure to respond to potential future acts of biological
terrorism. Copies of this CDC plan have been provided previously to the
Subcommittee. In addition, CDC presented in March a report to the
Senate entitled ``Public Health's Infrastructure: A Status Report.''
Recommendations in this report complement the strategies outlined for
emerging infectious diseases and preparedness and response to
bioterrorism. These recommendations include training of the public
health workforce, strengthening of data and communications systems, and
improving the public health systems at the state and local level.
cdc's strategic plan for bioterrorism
On April 21, 2000, CDC issued a Morbidity and Mortality Weekly
Report (MMWR), Biological and Chemical Terrorism: Strategic Plan for
Preparedness and Response--Recommendations of the CDC Strategic
Planning Workgroup, which outlines steps for strengthening public
health and healthcare capacity to protect the nation against these
threats. This report reinforces the work CDC has been contributing to
this effort since 1998 and lays a framework from which to enhance
public health infrastructure. In keeping with the message of this
report, five key focus areas have been identified which provide the
foundation for local, state, and federal planning efforts: Preparedness
and Prevention, Detection and Surveillance, Diagnosis and
Characterization of Biological and Chemical Agents, Response, and
Communication. These areas capture the goals of CDC's Bioterrorism
Preparedness and Response Program for general bioterrorism
preparedness, as well as the more specific goals targeted towards
preparing for the potential intentional reintroduction of smallpox.
Preparedness and prevention
CDC is working to ensure that all levels of the public health
community--federal, state, and local--coordinate with the medical and
emergency response communities to deal with the public health
consequences of biological and chemical terrorism.
CDC is creating diagnostic and epidemiological performance
standards for state and local health departments and will help states
conduct drills and exercises to assess local readiness for
bioterrorism. In addition, CDC, the National Institutes of Health
(NIH), the Department of Defense (DOD), and other agencies are
supporting and encouraging research to address scientific issues
related to bioterrorism. In some cases, new vaccines, antitoxins, or
innovative drug treatments need to be developed or stocked. Moreover,
we need to learn more about the pathogenesis, epidemiology, and
clinical features of the infectious diseases which do not affect the
U.S. population currently. We have only limited knowledge about how
artificial methods of dispersion may affect the infection rate,
virulence, or impact of these biological agents.
In 1999, the Institute of Medicine released its Assessment of
Future Scientific Needs for Live Variola Virus, which formed the basis
for a phased research agenda to address several scientific issues
related to smallpox. This research agenda is a collaboration between
CDC, NIH, DOD, and international partners, and is being undertaken in
the high-containment laboratory at CDC with the concurrence of WHO. The
research addresses: 1) the use of modern serologic and molecular
diagnostic techniques to improve diagnostic capabilities for smallpox,
2) the evaluation of antiviral compounds for activity against the
smallpox virus, and 3) further study of the pathogenesis of smallpox by
the development of an animal model that mimics human smallpox
infection. To date, genetic material from 45 different strains of
smallpox virus has been extracted and is being evaluated to determine
the genetic diversity of different strains of the virus. The NIH, with
CDC and DOD collaborators, has funded a Poxvirus Bioinformatics
Resource Center (www.poxvirus.org) to facilitate the analysis of
sequence data to aid the development of rapid and specific diagnostic
assays, antiviral medicines and vaccines. A dedicated sequencing and
bio-informatics laboratory has been developed at CDC to help further
these efforts. This laboratory will also be used to help characterize
other potential bioterrorism pathogens. A team of collaborating
scientists has screened over 700 compounds for antiviral activity
against isolates of variola (smallpox) virus and other related
orthopoxviruses and have found several compounds which merit further
evaluation in animal models. Over 20 of the most promising compounds
will be further tested for antiviral activity in animal model systems.
The identification of one currently licensed compound with in vitro and
in vivo efficacy against the smallpox virus has led to the development
of an Investigational New Drug (IND) application by NIH and CDC to the
FDA for use of this drug, cidofovir, in an emergency situation for
treating persons who are diagnosed with smallpox. In addition, CDC has
included the use of cidofovir in an existing IND to allow the emergency
use of this medication in the treatment of adverse reactions to
smallpox vaccination. Researchers also have been funded by NIH to
design new anti-smallpox medicines and to create human monoclonal
antibodies to replace the limited supply of vaccinia immune globulin
that is needed to treat vaccine complications that arise during
immunization campaigns.
The Advisory Committee for Immunization Practices (ACIP) worked
with CDC to develop updated guidelines for the use of smallpox vaccine.
These guidelines were published in the MMWR in June 2001 and serve to
educate the medical and state and local public health community
regarding the recommended routine and emergency uses and medical
aspects of the vaccine, as well as the medical aspects of smallpox
itself. Several infection control and worker safety issues were also
addressed by the ACIP within the updated guidelines.
We are pursuing the development of additional smallpox vaccine with
multiple manufacturers in order to rapidly enhance our vaccine resource
capabilities to respond to a smallpox outbreak. We are also working to
ensure that the stores of vaccine that we have in the United States
currently are ready for use, including protocols for emergency release
and transportation of the vaccine. We have conducted potency testing to
and have confirmed that all currently existing lots are still potent.
On October 26, NIH began recruitment for a study to test Dryvax vaccine
efficacy undiluted, at 1:5 dilution, and at 1:10 dilution. Depending on
the results of this study, CDC will ensure availability of enough
diluent to allow for the appropriate dilution of vaccine. One study has
already been completed which found that undiluted vaccine was effective
95 percent of the time, 1:10 dilution was effective 70 percent of the
time, and 1:100 was effective 20 percent of the time. CDC is in the
process of contracting with additional manufacturers to produce a total
of 300 million doses of vaccine by the end of next year. The President
recently signed an Executive Order that allows HHS to provide
indemnification for the smallpox manufacturers.
Detection and surveillance
Because the initial detection of a biological terrorist attack will
most likely occur at the local level, it is essential to educate and
train members of the medical community--both public and private--who
may be the first to examine and treat the victims. For example, the
Florida physician's ability to recognize a suspected case of anthrax
and his awareness of his role in reporting it to the local health
department was critical to our initial recognition of the current
bioterrorist events. It is also necessary to upgrade the surveillance
systems of state and local health departments, as well as within
healthcare facilities such as hospitals, which will be relied upon to
spot unusual patterns of disease occurrence and to identify any
additional cases of illness.
CDC is enhancing its national surveillance system for hospital-
acquired infections, dialysis surveillance, and healthcare worker
safety surveillance into the National Healthcare Safety Network (NHSN).
NHSN, is a web-based tool for collecting and communicating important
clinical findings with healthcare facilities. Other partnerships with
managed care and provider groups have proved invaluable for
communicating recommendations during the recent bioterrorism response,
and further activities to improve detection of potential bioterrorist
attacks through these partners is planned.
CDC will provide terrorism-related training to epidemiologists and
laboratorians, emergency responders, emergency department personnel and
other front-line health-care providers, and health and safety
personnel. CDC is working to provide educational materials regarding
potential bioterrorism agents to the medical and public health
communities on its bioterrorism website at www.bt.cdc.gov.
Preparing CDC, state, and other professionals to respond to a
smallpox bioterrorist threat or incident will revolve primarily around
training three groups:
--CDC Response Teams.--CDC will begin conducting a 3-day course this
month for personnel comprising teams that will be deployed to
respond to an incident. Training will cover technical issues
regarding the disease and the vaccine, operational issues such
as isolation and quarantine, surveillance, and communications,
and an introduction to CDC's response plan. A scenario-based
exercise will be included.
--State Health Representatives.--CDC is developing a 3-4 day training
course for health representatives from U.S. states and
territories who would be involved in responding to a smallpox
bioterrorist incident. The objective of this training is that
each state/territory produce a Smallpox Response Plan that will
be compatible with CDC's national plan. Approximately 150
representatives (up to 3 from each state/territory) will be
trained.
--Clinicians.--On December 13, CDC will conduct a live satellite
broadcast titled Smallpox: What Every Clinician Should Know.
This training session is targeted toward physicians, nurses,
and others who may be called on to identify and handle smallpox
cases and to deliver smallpox vaccine. It will cover topics
such as smallpox epidemiology, diagnosis, laboratory
confirmation, vaccination, and management of suspected cases.
After the broadcast, the course will be converted to a web-
based format and self-instructional videotapes.
Concurrent with the satellite broadcast, a ``train the trainer''
session will be held for infectious disease experts at academic
institutions and staff at national provider organizations. The
goal is to enable representatives from these groups to
disseminate smallpox response training to their peers
throughout the medical community. Followup sessions will be
held through April/May 2002.
CDC is also producing a variety of educational materials to be
used by clinicians who may be involved in smallpox
identification, care, or vaccination. These materials include
an interactive CD-ROM that will contain technical information
and practice exercises, fact sheets, aids to smallpox
diagnosis, and a smallpox Vaccine Information Statement.
Diagnosis and Characterization of Biological and Chemical Agents
To ensure that prevention and treatment measures can be implemented
quickly in the event of a biological or chemical terrorist attack,
rapid diagnosis is critical. CDC has developed guidelines and quality
assurance standards for the safe and secure collection, storage,
transport, and processing of biologic and environmental samples. In
collaboration with other federal and non-federal partners, CDC is co-
sponsoring a series of training exercises for state public health
laboratory personnel on requirements for the safe use, containment, and
transport of dangerous biological agents and toxins. CDC, also in
cooperation with the Association of Public Health Laboratories (APHL)
and the National Laboratory Training Network (NLTN) have sponsored a
``hands-on'' laboratory course for public health microbiologists. In
conjunction with the course, CDC produced two videos that were
distributed to the participants as well as to members of the NLTN. The
participants in this course are now using these videos and the other
materials developed by CDC to train other laboratorians in their
states. CDC is also enhancing its efforts to foster the safe design and
operation of Biosafety Level 3 laboratories, which are required for
handling many highly dangerous pathogens. Furthermore, CDC is
developing a Rapid Toxic Screen to detect people's exposure to 150
chemical agents using blood or urine samples.
Response
A decisive and timely response to a biological terrorist event
involves a fully documented and well rehearsed plan of detection,
epidemiologic investigation, and medical treatment for affected
persons, and the initiation of disease prevention measures to minimize
illness, injury and death. CDC is addressing this by (1) assisting
state and local health agencies in developing their plans for
investigating and responding to unusual events and unexplained
illnesses and (2) bolstering CDC's capacities within the overall
federal bioterrorism response effort. CDC has formed and trained
multiple outbreak response teams that are available for rapid
deployment to assist state and local authorities deal with outbreaks
due to any potential bioterrorism agent including smallpox. CDC is
formalizing current draft plans for the notification and mobilization
of personnel and laboratory resources in response to a bioterrorism
emergency such as smallpox, as well as overall strategies for
vaccination, and development and implementation of other outbreak
control measures such as isolation and quarantine measures. In
addition, CDC is developing national standards to ensure that
respirators used by first responders and by other healthcare providers
responding to terrorist acts provide adequate protection against
weapons of terrorism.
Hospitals are critical in the response to bioterrorist attacks. CDC
is collaborating with various healthcare associations and infection
control societies to better prepare for potential bioterrorist events.
Various hospital-based syndromic surveillance activities in regions
affected by anthrax exposures have provided critical information on
possible cases. Through provider-based sentinel networks, CDC has been
able to communicate with infectious disease clinicians, infection
control professionals, and other key clinical participants in
bioterrorism preparedness and response.
Communication Systems
Rapid and secure communications are crucial to ensure a prompt and
coordinated response. Thus, strengthening communication among
clinicians, emergency rooms, infection control practitioners,
hospitals, pharmaceutical companies, and public health personnel is of
paramount importance. To this end, CDC is making a significant
investment in building the nation's public health communications
infrastructure through the Health Alert Network (HAN). HAN is a
nationwide program to establish the communications, information,
distance-learning, and organizational infrastructure for a new level of
defense against health threats, including bioterrorism. Currently, 13
states are connected to all of their local health jurisdictions; 50
states have begun connecting to local providers as well; and CDC is
also directly connecting to groups, such as the American Medical
Association, to cast a broad net of coverage. CDC has also established
the Epidemic Information Exchange (Epi-X), a secure, Web-based
communications system that provides information sharing capabilities to
state and local health officials. CDC also provides timely satellite
broadcast and web-broadcast training through the Public Health Training
Network. For example, on October 18, CDC experts shared information on
anthrax with physicians, hospitals, and other healthcare providers
across the country via a satellite broadcast, Anthrax: What Every
Clinician Should Know. Part II of this program is scheduled for this
week and will present an update on clinical guidelines and procedures
for the early recognition, diagnosis, treatment, and reporting of
anthrax exposure.
Accurate and up-to-date information helps calm public fears and
limit collateral effects of the attack. CDC communicates with the
public directly through its website on emergency preparedness and
through a public inquiry telephone and email system, which, since the
recent attacks, has responded to hundreds of questions daily. In
addition, CDC communicates to the public by releasing daily updates to
the news media, answering inquiries from the press and providing
medical experts for interviews.
the national pharmaceutical stockpile
Another integral component of public health preparedness at CDC has
been the development of a National Pharmaceutical Stockpile (NPS),
which is mobilized in response to an episode caused by a biological or
chemical agent. The role of the CDC's NPS program is to maintain a
national repository of life-saving pharmaceuticals and medical material
that can be delivered to the site or sites of a biological or chemical
terrorism event in order to reduce morbidity and mortality in a
civilian population. The NPS is a backup and means of support to state
and local first responders, healthcare providers, and public health
officials. The NPS program consists of a two-tier response: (1) 12-hour
push packages, which are pre-assembled arrays of pharmaceuticals and
medical supplies that can be delivered to the scene of a terrorism
event within 12 hours of the federal decision to deploy the assets and
that will make possible the treatment or prophylaxis of disease caused
by a variety of threat agents; and (2) a Vendor-Managed Inventory (VMI)
that can be tailored to a specific threat agent. Components of the VMI
will arrive at the scene 24 to 36 hours after activation. The NPS was
mobilized for the first time on September 11, when a 12-hour push pack
was deployed to New York City, delivering 50 tons of medical supplies
to the site of the disaster in 7 hours. In addition, substantial
quantities of VMI were delivered to New York City within 24 hours.
Components of the VMI were deployed to various locations along the East
coast to provide adequate supplies of antibiotics as prophylaxis to
individuals who were potentially exposed to anthrax. CDC has developed
this program in collaboration with federal and private sector partners
and with input from the states.
challenges
As has been highlighted recently, increased vigilance and
preparedness for unexplained illnesses and injuries are an essential
part of the public health effort to protect the American people against
bioterrorism. Prior to the September 11 attack on the United States,
CDC was making substantial progress toward defining, developing, and
implementing a nationwide public health response network to increase
the capacity of public health officials at all levels--federal, state,
and local--to prepare for and respond to deliberate attacks on the
health of our citizens. The events of September 11 were a defining
moment for all of us, and since then we have dramatically increased our
levels of preparedness and are implementing plans to increase it even
further.
CDC has been addressing issues of detection, epidemiologic
investigation, diagnostics, and enhanced infrastructure and
communications as part of its overall bioterrorism preparedness
strategies. Based on federal, state, and local response in the weeks
following the events of September 11, and on recent training
experiences, such as the National TOPOFF event and the Dark Winter
exercise--which simulated a terrorist release of smallpox virus, CDC
has learned valuable lessons and identified gaps that exist in
bioterrorism preparedness and response at federal, state, and local
levels. CDC will continue to work with partners to address challenges
such as improving coordination among other federal agencies during a
response and understanding the necessary relationship needed between
conducting a criminal investigation versus an epidemiologic case
investigation. These issues, as well as overall preparedness planning
at federal, state, and local levels, require additional action to
ensure that the nation is fully prepared to respond to acts of
biological and chemical terrorism.
Disease experts at CDC are developing strategies to prevent the
spread of disease during and after bioterrorist attacks. Specific
components include (1) creating protocols for immunizing at-risk
populations; (2) isolating large numbers of exposed individuals; (3)
reducing occupational exposures; (4) assessing methods of safeguarding
food and water from deliberate contamination; and (5) exploring ways to
improve linkages between animal and human disease surveillance networks
since threat agents that affect both humans and animals may first be
detected in animals.
conclusion
In conclusion, CDC is committed to working with other federal
agencies and partners as well as state and local public health
departments to ensure the health and medical care of our citizens. We
have made substantial progress to date in enhancing the nation's
capability to prepare for and respond to a bioterrorist event, but
there is much more to be done. The best public health strategy to
protect the health of civilians against biological terrorism is the
development, organization, and enhancement of public health prevention
systems and tools. Priorities include strengthened public health
laboratory capacity, increased surveillance and outbreak investigation
capacity, and health communications, education, and training at the
federal, state, and local levels. Not only will this approach ensure
that we are better prepared for deliberate bioterrorist threats, but it
will also enable us to recognize and control naturally occurring new or
re-emerging infectious diseases. A strong and flexible public health
infrastructure is the best defense against any disease outbreak.
Thank you very much for your attention. I will be happy to answer
any questions you may have.
Senator Harkin. Dr. LeDuc, thank you very much for your
testimony.
Now we turn to Dr. Friedman. Dr. Friedman.
STATEMENT OF MICHAEL FRIEDMAN, M.D., CHIEF MEDICAL
OFFICER FOR BIOMEDICAL PREPAREDNESS,
PHARMACEUTICAL RESEARCH AND MANUFACTURERS
OF AMERICA
Dr. Friedman. Thank you, Mr. Chairman, Senator Byrd,
Senator Specter, Senator Stevens. On behalf of the men and
women who are the member companies in the Pharmaceutical
Research and Manufacturers of America, I thank you for this
opportunity to describe our deep commitment to the national
effort to counter bioterrorism and specifically our response to
smallpox.
In my new position I am focusing on ways in which we can
coordinate and facilitate the pharmaceutical industry's efforts
with government and with others to protect the public health.
This is a time of unprecedented public health threats and the
pharmaceutical industry is completely committed to the
government and to the American people to counter this threat.
We are already working in a variety of ways to address these
issues.
We are uniquely qualified to do so. Our scientists have the
ingenuity, the energy, the knowledge, the capability, and the
commitment to meet the threat. We are providing antibiotics. We
will be providing vaccines. We are making our company
scientists available. We are offering government all the
tangible resources that we can to assist. The reason we are
doing this is because it's our clear duty as American citizens.
We have made many tangible and important contributions, and
that is outlined in my written testimony and in the interest of
time I will not go through all of those here. Suffice it to say
that within hours of the terrorist attack on September 11 our
companies began responding in a variety of tangible ways to try
and help, and that continues today.
In addition, we reached out to the President, to the
Secretary of Health and Human Services, to Governor Ridge and
the Office of Homeland Security, to ask them what can we do to
complement government activities and to make a more integral
overall defense of the Nation. We formed within our
organization our own emergency preparedness task force to
direct our efforts at bioterrorism, both from an administrative
point of view and a separate committee on a scientific level to
try and do that.
We have had the privilege of meeting twice with Secretary
Thompson very recently, once with Governor Ridge, to discuss
very specifically identifying the priority needs that the
government has and how we can help address those things. We are
committed to working with organizations represented on this
panel and other organizations within the government to fully
address these issues.
It has been pointed out to you that the global success of
vaccination has caused the smallpox threat to diminish until
just very recently. Let me outline, if I may, very quickly what
several of our companies are engaged in at this moment.
Initially, several of our companies were contacted by the
government in late September about the feasibility of
manufacturing a new version of smallpox vaccine. Today I am
pleased to report that they have made really extraordinary
efforts to respond in record time.
Even before the formal request for information was issued,
they had brought to bear considerable resources to this
project, redirecting other priorities and surveying their
existing technical capabilities, recognizing what would be
needed. They put in place their efforts to respond. Within a
week of receiving the initial request, our companies were here
in Washington, presenting to a distinguished panel of experts
formed by the government what our capabilities for each of
those companies might be in the response to that initial
request.
This has been a herculean effort. Normally it takes many
years to produce a new vaccine, but the government needs it
more quickly. They have said that their expectation is 300
million doses, as Dr. Fauci has mentioned, produced within 1
year. This is an extraordinary effort. We are up to this effort
and our individual companies are prepared to do what is
necessary.
A new vaccine will be needed. New technology will be
employed. It will not be the old vaccine produced in the old
way. That represents a number of challenges. But I was
astonished to learn that if you just add up the number of years
of experience that the four companies within our organization
bring to this problem, it is 400 years of combined experience,
and that is a tremendous resource that we can offer to the
American public.
We recognize that there are a number of specific issues and
problems that will need to be dealt with. This contracting
process is still ongoing and so I cannot speak to any of the
specifics. But our companies are fully committed to this and we
are working well with government agencies.
The government is best able to assess and identify the
risks of various possible agents. Our responsibility, as
vibrant and vigorous research organizations, is to bring about
those treatments to address those specific needs. We feel it is
a privilege to be able to serve in that capacity.
prepared statement
I understand that there may be a number of questions that
you would like to ask. We would be very pleased to try and
answer those. Uniquely, the pharmaceutical industry has what it
takes to win this bioterrorism war, and we are fully engaged in
this.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Dr. Michael Friedman
Mr. Chairman and Members of the Subcommittee: On behalf of the
Member companies of the Pharmaceutical Research and Manufacturers of
America (PhRMA), I want to thank you for providing me the opportunity
to testify on the pharmaceutical industry's response to bioterrorism,
and specifically its response to small pox. My name is Michael Friedman
and I am the Chief Medical Officer for Biomedical Preparedness at
PhRMA, a new position created to help coordinate the pharmaceutical
industry's efforts to protect public health. I am a board certified
internist and medical oncologist and am currently a Senior Vice
President at Pharmacia Corporation. Prior to joining Pharmacia, I spent
four years at the Food and Drug Administration (FDA), including more
than a year's service as Acting Commissioner. In addition to my time at
the FDA, I also spent 12 years at the National Cancer Institute, and 8
years as a faculty member teaching and conducting research at the
University of California, San Francisco Medical School. I also served
on active duty for many years in the Public Health Service, holding the
rank of Rear Admiral and Assistant Surgeon General, and continue today
as a reserve officer.
In this time of unprecedented public health threats, the
pharmaceutical industry is united with the American people and with our
government. We are committed to doing everything possible to help
protect the public health. Our scientists have the innovation, the
energy, the cutting-edge knowledge, the capability, and the commitment
necessary to meet the bioterrorist threat. From providing antibiotics
and vaccines, to making available scientists within our companies, we
are offering the government our resources to meet the public health
threats of bioterrorism. We are here to continue our partnership with
the federal government and with the American people in meeting these
challenges. This is our first duty as Americans.
industry's response to events of september 11
Let me briefly summarize the pharmaceutical industry's initial
response to the tragic events of September 11, a day that none of us
will ever forget. Within hours of the terrorist attacks, our companies
responded by supplying:
--Transportation/Delivery Support to Hospitals and Medical
Facilities--Refrigerated Trucks
--Helicopter Support
--18-wheeler transports for military and medical supplies
--Fire Trucks
--Ambulances
--Medicines
--Pain medication
--Antibiotics
--Analgesics
--Anti-fungals
--Eye lubricants
--Saline
--Infant Formula
--Anesthesia products
--Alcohol swabs
--Bags of dextrose solution and sodium chloride
--Wound care and personal care products in disaster-care modules
delivered by mid-afternoon Tuesday to New York area
hospitals
--Medical Equipment
--Masks
--Tyvek suits
--Respirators with cartridges
--IV's
--Tubing
--Work gloves
--Latex gloves
--Aid for burn victims
--On the night of September 11th, Novartis made a donation of their
artificial human skin, Apligraf Graftskin, for burn
victims. Working closely with officials in New York and at
the Department of Health and Human Services (HHS) in
Washington, they have provided technical medical support
and enlisted cars, vans and trucks to ship the skin to
medical facilities. Additionally, Novartis sent 20,000
bottles of eye solution for rescue workers.
--In the immediate hours after the attack, Solvay obtained special
Food and Drug Administration (FDA) ``compassionate use''
approval to provide 2,088 bottles of burn cream that is
currently in Phase III trials. Solvay worked through the
Centers for Disease Control and Prevention (CDC) in Atlanta
to arrange for shipment to New York's Presbyterian Hospital
Burn Center by Special FedEx truck and state police escort.
--Blood supplies and blood donations
--With the help of National Guard and police escorts, Abbott
delivered critical medical products throughout the day to
all of the hospitals in the affected areas that placed
emergency orders. To address the blood shortage, Abbott
transported (by refrigerated truck) a supply of blood from
the Chicago area and Wisconsin blood banks to hospitals and
medical centers in New Jersey and New York area.
--Clothing
--To fire, police and other rescue workers
--Financial Contributions
--Our companies have donated over $80 million in cash to a variety
of relief efforts.
Immediately, our companies reached out to President Bush, Secretary
Thompson, Governor Ridge and others in government to ask what we could
do. In addition, PhRMA and its member companies quickly formed an
industry Board-level Emergency Preparedness Task Force to direct
PhRMA's efforts on bioterrorism.
industry's response to anthrax
Just weeks ago, when stories first began breaking about cases of
anthrax exposure in Florida, the nation quickly became aware that
Cipro, manufactured by a PhRMA Member Company, Bayer, was the initial
treatment of choice for anthrax exposure. Let me briefly explain what
several of our companies have done to specifically respond to fight
anthrax:
--Bayer has donated four million tablets of Cipro to HHS for
emergency workers on the frontlines and the postal workers who
may have been exposed to anthrax-laden mail. They have also
tripled production of Cipro to 15 million tablets a week,
ensuring that an ample supply of Cipro is available. They have
pledged to the U.S. government that they will produce 200
million tablets in the next 90 days for its stockpile. Last,
Bayer will sell Cipro to the government at deeply reduced
prices.
--Abbott will supply the antibiotics Biaxin and erythomycin, if
approved by the FDA for the treatment of anthrax, free to the
government for any victims. Abbott is also sending shipments of
its antibiotics to the Department of Defense for U.S. military
troops involved in the current effort.
--Bristol-Myers Squibb will make its antibiotic Tequin available free
to people infected by or exposed to anthrax if the FDA approves
its use against anthrax. It will also consider sharing the
Tequin license with the government or other companies in the
unlikely event the need should exceed the supply.
--GlaxoSmithKline is working with the government on expeditious
review of two antibiotics, Amoxil and Augmentin, to be used in
the treatment of anthrax. It will make these medicines
available to the government free of charge for individuals
exposed to, or diagnosed with, anthrax.
--Johnson & Johnson is seeking FDA approval of an existing
antibiotic, Levaquin, for the treatment of anthrax and will
make up to 100 million tablets of the medicine available to the
government free of charge.
--Pharmacia Corporation will make available to the government free of
charge an antibiotic, Cleocin HCl, to treat anthrax infection,
pending FDA approval for the treatment of anthrax. Other
Pharmacia antibiotics are also in laboratory testing to
determine efficacy against anthrax and other biological agents.
--Pfizer has increased production of an antibiotic, Vibramycin, which
is indicated for the treatment of the cutaneous and inhalation
forms of anthrax. Pfizer is also in discussions with public
health authorities regarding the possible utility of the
company's other human antibiotics. It has also pledged that it
will make no profit on medicines supplied to the government to
fight bioterrorism.
--Eli Lilly and Company will provide any of its antibiotics that are
found to be effective against anthrax at cost to victims of
bioterrorism.
ph rma's emergency preparedness task force action
On October 19, 2001, PhRMA's Emergency Preparedness Task Force met
with Secretary Thompson to offer the industry's assistance in
responding to the national bioterrorism threats. By October 26, 2001, a
follow-up meeting was held with Secretary Thompson to continue sharing
information and offering assistance.
As part of this meeting, we pledged to Secretary Thompson a wide
array of support. In addition to the Task Force on Emergency
Preparedness composed of industry leaders, we also established a
Bioterrorism Group of Scientific Experts composed of leading
scientists. Through the Task Force, the Bioterrorism Group of
Scientific Experts, and myself, we are offering our assistance to the
United States Office of Homeland Security, HHS, CDC and any other
government agency that we are asked to serve.
On October 31, 2001, our Emergency Preparedness Task Force met with
Governor Ridge to offer the industry's support in responding to
bioterrorism threats.
In addition to pledging our leading scientists, several companies
have stepped forward with other offers of assistance, including:
--Bristol Myers-Squibb will provide a dedicated antibioterrorism team
of 20-25 scientists specialized in anti-bacterial research who
will initiate a multiprong attack on the microbial weapons of
bioterrorism. This team will purse research under government
direction and be fully funded by Bristol Myers-Squibb.
--Merck-Medco will help state and federal authorities distribute
antibiotics as needed and will use its technology and expertise
to transform stockpiles of medicines into individual
prescriptions. In New Jersey, Merck-Medco is ``on call'' to
assist the state in dispensing antibiotics to approximately
1,500 postal workers, if needed.
--Pfizer will put its extensive distribution network and warehouses
at the disposal of the government to ship medicines as needed.
--Abbott is testing existing antibiotics to see if they would be
effective against bioterrorism organisms and offering the
assistance of its experts in infectious diseases.
--Johnson & Johnson will makes its scientific and research
capabilities, manufacturing facilities, distribution channels
and public information and education capabilities available to
the government to deal with the crisis.
--Aventis is offering technical and scientific support to the
government in the development of new vaccines and antibiotics
manufacturing.
--Pharmacia will provide confidential access to its internal
scientific information, animal model systems and chemical
libraries to government officials.
--The industry will make many of its manufacturing facilities and
delivery systems available to the government, upon request.
industry's response to small pox threat
In addition to concerns over anthrax exposure, attention and
concern is now being focused on other diseases, such as small pox. As
you know, the small pox vaccine was credited with eradicating the
disease on a global basis. As a result, public health officials
terminated the vaccination program within the U.S. in the 1970's.
Several of our companies were initially contacted by the U.S.
government in late September about the feasibility of manufacturing a
new version of the small pox vaccine. I am pleased to report that they
have each made an extraordinary and unprecedented effort, to respond in
record time.
Even before the formal Request for Information (RFI), they brought
resources to bear on this project, redirecting priorities and surveying
existing technical capabilities that could be put into place to address
this prospective public health emergency. Within a week of receiving
the RFI, our companies were here in Washington making presentations to
our nation's public health authorities as to their individual
capabilities to produce the necessary amount of small pox vaccine.
This is no small task as the normal course of vaccine manufacturing
scale-up is a process than can take 5-8 years.
Our government has requested enough doses of vaccine for the entire
U.S. populace (300 million doses) and to have this vaccine available
within one year. Our industry stands ready to meet this request.
Since the vaccine has not been produced in nearly a quarter of a
century, the United States only has a relatively small amount of this
vaccine on hand. In addition, the manufacturing process by which that
vaccine was made is not deemed acceptable by modern day standards.
Rather than growing Vaccinia (the virus that the small pox vaccine is
based on) in cows, a new process of growing it in cell culture must be
scaled-up. Developing the appropriate cell culture system and
manufacturing capabilities present challenges. However, our vaccine
companies can and will meet this challenge. Collectively they have
hundreds of company-years of experience in research, scaling up
production, and manufacturing and distributing vaccines against many
major public health threats.
It is the pharmaceutical industry that manufactured the original
small pox vaccine. They have developed numerous viral vaccines for
prophylaxis against diseases such as mumps, measles, rubella, polio,
and hepatitis and have extraordinary experience in the type of large
scale manufacturing operations that lead me to be optimistic that this
challenge can be met.
An initial assessment suggests that with extraordinary efforts and
an unprecedented crash program, 300 million doses of Vaccinia could be
available by the middle of next year. Of course, many tens of millions
of doses could be available considerably earlier.
There is no doubt that developing the capabilities to produce
enough quantity in a quick time frame will be a massive, unprecedented
undertaking requiring companies to retool their production processes on
a scale never previously contemplated. Clearly a number of the critical
issues will be addressed when the government issues its formal Request
for Proposal (RFP) that we understand will be forthcoming shortly.
It is also vital that there be a concerted effort on the part of
the FDA to work with industry as this new vaccine is developed. FDA
must provide swift and clear guidance to any of the prospective
manufacturers of this new small pox vaccine as to the expected
requirements for licensure. This is critical as the new process for
producing this vaccine is markedly different than the process used in
the past. There are two components to this. First, the new vaccine must
be evaluated to ensure that it is as efficacious as the older, animal-
sourced vaccine. This will require some comparative clinical trials,
which should be conducted on an expedited basis. Second, the
manufacturing facility or facilities will have to be inspected for
manufacturing compliance. It is our assessment that the FDA has all of
the requisite authority to make this a priority.
next steps
The U.S. government and the pharmaceutical companies have the same
goal--protecting the public health. We will assist the government in
any way we can to protect the health of our nation's citizens.
We are offering our assistance to the government to help educate
consumers and the medical community. We are in the process of
establishing a consumer-friendly web site to educate and inform the
public. In a meeting with Governor Ridge earlier this week, our
companies also offered the use of their work forces, who meet and visit
with doctors on a regular basis, to be a tool the government can use to
educate doctors about potential public health threats related to
bioterrorism.
We will also continue to do what we do--develop new medicines.
Today, there are 19 antibiotics and 42 vaccines currently in
development, including vaccines for AIDS, malaria and tuberculosis.
Continuing research and development of new medicines, both to conquer
natural diseases and to assure that our country's citizens have the
best possible defenses against bioterrorism. Our armed forces and
public safety workers are the nation's first defense. Our country's
unparalleled scientific capabilities--characterized by innovation,
nimbleness and extraordinary creativity in fighting disease--stand
immediately behind them in protecting the public health.
Our government is in the best position to assess the risk of the
use of threat agents. This is a difficult task and I know that the
health and defense authorities are hard at work on it. We will make our
expertise available to assist in designing the right responses to
threats. As needed steps are identified, we will do what is necessary
to respond, including making the best treatment options available.
conclusion
As I said in the beginning of my testimony, the pharmaceutical
industry is prepared to do whatever it takes to win this war. We stand
ready to work with the government to identify and respond to threats.
Our companies are eager to make contributions to this effort, and we
stand ready to be of service.
America's pharmaceutical companies have always been there for our
country at times of national crisis. We provided Penicillin for our
soldiers in WWII. We responded to the AIDS epidemic, and since the mid-
1990's, when the first protease inhibitor drugs were launched and
combination drug therapy was introduced, the U.S. death rate from AIDS
has dropped 80 percent. We offered medicines, supplies, and financial
assistance within hours of the tragic events of September 11th. And
we're here for our country again in this time of crisis.
We're in unchartered waters here. We anticipate that this is going
to be a long war. And we'll be here for the American people every step
of the way. We have what it takes to win this war on bioterrorism--in
terms of the innovation, the research, the cutting-edge knowledge, and
we'll do whatever it takes to get the job done.
Thank you.
Senator Harkin. Thank you, Dr. Friedman.
Now we turn to Dr. Barry. Dr. Barry.
STATEMENT OF M. ANITA BARRY, M.D., M.P.H., DIRECTOR,
COMMUNICABLE DISEASE CONTROL, BOSTON PUBLIC
HEALTH COMMISSION, AND MEMBER, NATIONAL
ASSOCIATION OF COUNTY AND CITY HEALTH
OFFICIALS
Dr. Barry. Good morning. Chairman Harkin, honorable
committee members, thank you for inviting me to speak to you
today from the perspective of a major urban health department.
My name is Dr. Anita Barry and I am the Director of
Communicable Disease Control for the Boston Public Health
Commission, in the City of Boston, under the leadership of
Mayor Thomas Menino.
I am speaking to you today on behalf of the Boston Public
Health Commission and also the National Association of County
and City Health Officials, or NACCHO. NACCHO represents the
Nation's 3,000 local health agencies and NACCHO members serve
every day on the front lines to protect the health of their
local communities.
As you consider legislation related to bioterrorism and
smallpox, I offer you the realities of what dealing with
smallpox on a local level would entail. While we have all
learned a great deal in responding to anthrax-related
bioterrorism, smallpox would be very different. It is highly
infectious and can be spread person to person, making it a
global as well as a local public health threat.
Thus far, proposals put forward by the administration have
focused primarily on creating more vaccines. With smallpox, all
the vaccine in the world is not going to do any good without
the capacity to distribute and administer this vaccine locally.
One thing is very clear. The current levels of staffing,
planning, and preparedness at the local level are not enough,
even in cities that have initiated bioterrorism preparedness.
Well before September 11, Boston began to prepare for the
possibility of a bioterrorist event. City public health
officials and safety personnel have participated in Federal
emergency planning efforts and have held tabletop exercises to
develop city-specific plans. But the recent cluster of anthrax
cases, despite the fact that there have been no anthrax cases
in Boston, has illustrated the many challenges that
bioterrorism presents. These challenges will be magnified
manyfold if the disease in question is smallpox, which can be
transmitted from person to person, instead of anthrax, which
cannot.
If presented with a smallpox case, what would a local
health department do? We would first confirm the diagnosis as
quickly as possible. But once that happened, we would be faced
with a myriad of issues, such as appropriate care for and
isolation of the infected individual, identification of the
source of infection to determine if others were at immediate
risk, identification of exposed individuals who need smallpox
vaccination to prevent disease, provision of clinical
guidelines for other health care providers in the area to
enable them to provide both the best individual and public
health care, and the launching of a massive educational
campaign for both the public and the health care community.
The local health department would quickly be contacted by
the hospital for advice on infection control. We would be asked
to perform epidemiologic analysis to identify those at risk in
the community. We would have a flood of calls from health care
providers concerned that they have the next smallpox case.
Citizens would turn to their local health department with the
expectation that vaccination clinics would be widely available
ASAP. And all the while, the media would be contacting us to
report to the waiting public.
Can a local public health department meet this challenge? I
believe that it can, but this smallpox threat highlights the
fact that local health departments desperately need increased
Federal support in order to plan for and respond to a major
infectious disease event like smallpox.
In the communicable disease control program in Boston, we
have currently one infectious disease physician and a few
nurses, which is not enough for a city with a population of
600,000 residents and a weekday work force of 1.2 million
people. Many times this number of clinical and public health
personnel would be needed to deal with smallpox, as well as
other infections such as meningitis that also urgently demand
our attention.
At the most recent Boston Surveillance Task Force on
Bioterrorism meeting held last Monday, hospitals were already
asking for infection control guidelines related to smallpox.
Questions about the imposition and enforcement of quarantine
have already surfaced. From my perspective, voluntary in-home
quarantine with appropriate support, such as the delivery of
medical information, food, and medication, is our most
realistic option. But depending on the number of cases, a
quarantine facility may need to be set up and staffed as an
option for those unable to stay at home.
The Federal Centers for Disease Control and Prevention
plays a key role in providing technical assistance of the
highest quality. However, expediting direct access to this
expertise for local health departments should be a top
priority. Already strained State health departments should not
have to act as a liaison in this process.
Last week, Boston Mayor Thomas Menino and city public
health and safety officials joined mayors from across the
country to discuss local preparedness at the U.S. Conference of
Mayors Emergency Safety and Security Summit. The following
recommendations include public health steps urged by the U.S.
Conference of Mayors. These action steps will go a long way to
help local public health departments effectively carry out our
jobs to protect public health in the event of smallpox or
another bioterrorist event.
First, local health departments should be represented at
the table at national emergency planning. The Director of
Homeland Security should immediately establish a permanent
commission including mayors, local public health officials, and
local safety officials. Local officials are on the front lines
of homeland security and it is essential to forge direct lines
of communication.
Second, the technical capabilities and communications
infrastructure of local health departments need to be improved.
All local health departments should have access to
communications systems to receive accurate and timely
information from State and Federal authorities. We strongly
support full funding and expansion of the Health Alert Network.
Third, Federal agencies should direct significant----
Senator Harkin. Dr. Barry, could you please sum up, please.
Dr. Barry. I am. Direct more funding to local communities.
Too often, local health departments are left out of the
equation, but we bear the burden of the front line response.
prepared statement
In closing, I would like to thank Senators Harkin, Specter,
Byrd, and their colleagues, including Senator Kennedy, for
recognizing the importance of funding for bioterrorism
preparedness, and I would encourage you, as you go forward, to
direct funding to those on the front lines, the local health
departments.
[The statement follows:]
Prepared Statement Dr. Anita Barry
Chairman Harkin, Honorable Committee Members, thank you for
inviting me here to speak to you today from the perspective of a major
urban health department. My name is Dr. Anita Barry. I am the Director
of Communicable Disease Control for the Boston Public Health
Commission, the health department for the City of Boston, under the
leadership of Mayor Thomas Menino. I am speaking today on behalf of the
Boston Public Health Commission and also the National Association of
County and City Health Officials (NACCHO). NACCHO represents the
nation's 3,000 local public health agencies. NACCHO members serve every
day on the front lines to protect the health of their communities.
As you consider legislation related to bioterrorism and smallpox, I
offer you the realities of what dealing with smallpox at the local
level would entail. While we have all learned a great deal in
responding to anthrax related bioterrorism, smallpox would be very
different. It is highly infectious and can be spread person-to-person,
making it a global as well as a local health issue. Thus far, the
proposals put forth by the Administration have focused primarily on
creating more vaccines. With smallpox, all the vaccine in the world
isn't going to do any good without the capacity to distribute and
administer vaccine locally. And one thing is very clear: the current
levels of staffing, planning, and preparedness at the local level are
not enough, even in cities that have initiated bioterrorism
preparedness.
Well before September 11, Boston began to prepare for the
possibility of a bioterrorist event. City public health and safety
personnel have participated in federal emergency planning efforts and
have held tabletop exercises to develop city specific plans. But the
recent cluster of anthrax cases--despite the fact that there have been
no anthrax cases in Boston--has illustrated the many challenges that
bioterrorism presents. These challenges will be magnified many fold if
the disease in question is smallpox--which can be transmitted from
person--instead of anthrax--which cannot.
If presented with a smallpox case, what would a local health
department do? We would first confirm the diagnosis as quickly as
possible. But once that happened, we would be quickly faced with a
myriad of issues, such as:
--appropriate care for and isolation of the infected individual;
--identification of the source of infection to determine if others
were at immediate risk;
--identification of exposed individuals who need smallpox vaccination
to prevent disease;
--provision of clinical guidelines for other health care providers in
the area to enable them to provide the best individual and
public health care;
--launching of a massive educational campaign both for the public and
the health care community.
The local health department would quickly be contacted by the
hospital for advice on infection control. We would be asked to perform
epidemiologic analysis to identify those at risk in the community. We
would have a flood of calls from health care providers concerned that
they have ``the next smallpox case.'' Citizens would turn to their
local health department with the expectation that vaccination clinics
would be widely available ASAP. And all the while, the media would be
contacting us to report to the waiting public.
Can a local public health department meet this challenge? I believe
it can, but the smallpox threat highlights the fact that local health
departments desperately need increased federal support in order to plan
for and respond to a major infectious disease event such as smallpox.
In the Communicable Disease Control Program at the Boston Public Health
Commission, we currently have one Infectious Disease physician and a
few nurses--not enough to address a major infectious disease emergency
in a city with 600,000 residents and a workday population of 1.2
million. Many times this number of clinical and public health personnel
would be needed to deal with smallpox as well as other infections such
as meningitis that urgently demand our attention.
At the most recent Boston Surveillance Task Force meeting held last
Monday, hospitals were already asking for infection control guidelines
related to smallpox. Questions about the imposition and enforcement of
quarantine have already surfaced. From my perspective, voluntary-in
home quarantine with appropriate support (such as delivery of health
information, food, and medication) is the most realistic option. But
depending on the number of cases, a quarantine facility may need to be
set up and staffed as an option for those unable to stay at home.
The federal Centers for Disease Control and Prevention plays a key
role in providing technical assistance of the highest quality. However,
expediting direct access to this expertise for local health departments
should be a top priority. Already strained state health departments
should not have to act as a linkage in this process.
Last week, Boston Mayor Thomas Menino and City public health and
safety officials joined mayors from across the country to discuss local
preparedness at the U.S. Conference of Mayors Emergency, Safety, and
Security Summit. The following recommendations include public health
steps urged in the U.S. Conference of Mayors National Action Plan for
Safety and Security in America's Cities. These action steps will go a
long way to help local health departments effectively carry out our
jobs to protect the public health in the event of smallpox or other
bioterrorist incident:
1. Local public health departments should be represented at the
table in national emergency planning. The Director of Homeland Security
should immediately establish a permanent commission including mayors,
local public health officials, and local public safety officials. Local
officials are on the frontlines of homeland security, and it is
essential to forge direct lines of communication among the Office of
Homeland Security, federal agencies, and local governments.
2. The technical capabilities and communication infrastructure of
local health departments need to be improved. All local health
departments should have access to communications systems to receive
accurate and timely information from state and federal authorities. We
strongly support full funding and expansion of the Health Alert
Network.
3. Federal agencies should direct significantly more funding to
local communities. National public health organizations recommend that
at least $835 million of the emergency bioterrorism funding request go
directly to local and state health departments. Local communities must
receive a significant portion of that funding. Too often, local health
departments are left out of the equation, but we bear the major burden
of front line response. For example, in Boston, the health department
anticipates spending at least $700,000 by the end of this fiscal year
on bioterrorism-related emergency medical service response and the
surveillance, communication, and coordination activities of the
communicable disease program.
4. Federal funding should be flexible--we need to track and respond
to a range of public health concerns, including bioterrorist agents as
well as influenza and other emerging problems.
In closing, I again thank Chairman Harkin and the Committee for
inviting me to speak on behalf of local health departments and NACCHO.
I would be pleased to provide any further information in the future.
Senator Harkin. Thank you, Dr. Barry. Thank you all.
I will turn to Senator Byrd first for questions and then
Senator Stevens. But before I do, Senator Byrd, just listening
to these witnesses, I thought of comparing our public health
officials and our public health infrastructure in America, to
our military overseas. If I were to do so, after listening to
these people, I would say that if you put it in military terms,
our troops are ill-trained, our radar is out of date, and we
are short on ammunition with our public health in America. That
just seems to me what I am hearing here.
I turn to you, Senator Byrd, for your comments.
Senator Byrd. In other words, as Oliver Twist said,
``Heaven is a long way off.'' We are coming up pretty short.
Well, I thank you, Mr. Chairman, again. I thank Senator
Stevens. I am the 23rd chairman of the Senate Appropriations
Committee. Now, remember that. There is the best chairman. I
have served with a lot of good chairmen on the Appropriations
Committee. Where MacDonald sits, there is the head of the
table. There is MacDonald, Senator Stevens, my colleague. As
far as I am personally concerned, he is the best chairman I
have ever served with.
Now, this is a fine panel, an extraordinarily fine panel.
It seems to me that the emphasis here mostly is on building our
State and local health departments so that they will be able to
respond, so that they will be able to--their labs, building
their labs, enhancing their labs, so that they will be able to
recognize a variety of pathogens, be able to recognize these
pathogens.
I would wager that there are very, very few doctors in the
United States who have ever seen a case of smallpox, very few.
Therein lies a great need here, a need to be able to recognize
smallpox and other bioterrorism pathogens quickly and then, as
has been said here, be able to spread the word and be able to
take action, be able to isolate and so on.
So let me ask my questions all at once. I have about three
or four questions. I will make it easy for you on the panel to
answer these questions. I am from a rural State. I say to Dr.
Barry, with all respect to the great urban communities of this
country: God made the country and man made the town. Now, I am
from a rural State. Thank God for that. A small State, a rural
people, and my problems--my questions concentrate perhaps on
the rural areas.
We all recognize the need, the desperate need, to
strengthen the resources of our State and local health
agencies. But I fear that one problem may severely limit that
effort, namely the critical shortage of well-trained doctors
and nurses in our rural areas. So what can NIH or CDC do to
bridge this gap in times of medical emergencies? That is
question No. 1.
Question No. 2, particularly to Dr. LeDuc. You spoke of the
CDC's high tech communications tools--the Internet, email, and
so forth. But so many rural health departments do not have
access to these communications resources. What is the CDC going
to do, and what does it recommend that we do, as members of
this panel to overcome this gap?
As we contemplate the dark winter of our discontent, should
some medical or emergency workers be vaccinated immediately?
Finally, will the decision to produce so many doses of the
vaccine fuel public demand for a potentially hazardous mass
immunization campaign? You have indicated that there is some
toxicity side effects. Let me speak of one. What happens to
those who have asthma, who already have lung diseases, and
shortage of capacity, and so on?
That is my contribution, Mr. Chairman. I hope that Dr.
LeDuc would begin because I mentioned him specifically.
Dr. LeDuc. Thank you, sir, for those very thoughtful
questions. Let me address the specific question you asked about
communications in the rural area. It is our plan to develop the
Health Alert Network to the local area, to the county level, in
all States, and I think we are well on the way to doing that.
I can get back to you for the record--well, maybe I can get
to you right now. We are making progress in getting that to all
the local county levels. I do not know exactly what the
implementation scale is today, but that clearly is one of our
highest priorities, especially now that the need is so
apparent.
Senator Byrd. Dr. Fauci.
Dr. Fauci. The question that I could address, Senator Byrd,
of the few that you asked is one that is quite relevant and we
do need to address it. It is the question of what we call
preemptive vaccination, because a lot of people are asking
that. We are now on a crash course, as it were, to get enough
vaccine to be able to vaccinate the entire population of the
United States if necessary.
The public health approach to the identification of a case
or cases of smallpox in West Virginia, for example, if that
happened, would be to do the approach that you heard mentioned
here: you identify, isolate, quarantine if necessary, contact,
trace, and vaccinate people in an area that could have come
into contact with smallpox virus. That is the classic public
health approach to smallpox and is the way that eradication of
smallpox was actually accomplished, particularly in developing
nations, the strategy that Dr. Bill Foege and others had
developed many years ago.
If you have multifocal involvement, where you have many
cases in many different places, then you think in terms of a
broader, more massive vaccination. I can tell you here today
that when we get, and even before we get, enough vaccine to
execute something like a preemptive vaccination, a decision
needs to be made in a way that is serious and well thought out.
The American public needs to hear about this and it needs to be
transparent.
Senator Byrd. But what are some of the toxicities that I
have heard about?
Dr. Fauci. The toxicities are as follows, and then perhaps
Dr. LeDuc can amplify on them. The toxicities we know come from
experience decades ago with vaccination, and there are a few
studies that vary with regard to toxicities. For example, the
most recent study that we have from 1968 data indicates that
for every million people who are vaccinated there will be
anywhere from one to four or five deaths associated with the
vaccine.
That is generally due to a fulminant response such as
encephalitis associated with the vaccination or generalized
vaccinia. They are uncommon, but when they occur they are
serious. This is relevant to the point that I mention, that if
you decide to preemptively vaccinate you must weigh the risk-
benefits. I believe this debate is going to occur and it might
even occur right here before this committee when that time
comes, about whether to do the classic public health approach
of trying to isolate the index cases or to think ahead and
preemptively vaccinate.
That is a debate that needs to occur in a transparent way
for the American people to understand it.
Senator Byrd. I thank you. I do not want to press this
further. I am sure that through the questioning of my
colleagues here the answers to some of the other questions
about the need for more nurses, more doctors, more emergency
health responders who will be able to recognize these various
pathogens and laboratories enhanced so that they can recognize
the early symptoms of these bioterrorist weapons.
Thank you very much.
Senator Harkin. Thank you, Mr. Chairman.
Senator Stevens.
Senator Stevens. Thank you very much, ladies and gentlemen.
My role here has predominantly been in defense, as I think you
all know. But my basic interests have been in medical research.
I am pleased to say Dr. Fauci spent one evening and tried to
help educate me. I thank you for that.
But I am constrained to say that if we look at the recent
history, the Soviet Union imploded because of the fear of
weapons we did not have. I would hate to see us implode because
we finance a whole series of actions against fears that could
not or would not materialize.
Now, having said that, I would hope that we keep in mind we
are into some things that are not detectable. This is a
detectable, readily detectable disease if it comes to our
community, is it not? It will be readily detectable?
Senator Byrd. The record will not show the nodding of
heads.
Dr. LeDuc. Yes, sir. There are virtually no clinically
inapparent infections. All infected people will be overt.
Senator Stevens. I do not want to underestimate the
severity of this disease.
Senator Harkin. Senator Stevens.
Senator Stevens. Yes?
Senator Harkin. Could you just yield on that for a little
bit of enlightenment on that?
People today do get chickenpox. Do you believe that there
are enough health professionals out there that would recognize
the difference between smallpox and chickenpox before it got
out of hand?
Dr. LeDuc. We have had experience addressing this very
issue quite recently and I can tell you that severe chickenpox
is extremely difficult to differentiate from classic smallpox.
This would be a diagnostic dilemma.
Senator Harkin. So then your question to Senator Stevens
has to be modified a little bit. You nodded your head and said
yes, that this is something that would be readily identifiable.
But if it is confused with chickenpox, which is rather benign,
and is not treated immediately as smallpox, then it could
spread out of control very rapidly.
Dr. LeDuc. Well, in fact we are approaching this problem
from two perspectives. There is an effective vaccine for
chickenpox and we are encouraging health providers to use this,
so that we maintain a very high level of coverage for
chickenpox immunization, so that we have reduced the risk of
having outbreaks of chickenpox.
Senator Stevens. To show my age, although my senior
colleague is not very far off----
Senator Byrd. Do not worry about it.
Senator Stevens [continuing]. I recall very well both
chickenpox and smallpox in my community when I was a boy, and
we all got our vaccinations in school and they were automatic.
That is another subject, because I was raised by a Christian
Science family. So it was a real interesting life that I had.
But as a practical matter I would like to ask you just a
couple of questions and see if you can give us the answer--
those of us who are old enough to have lived through the
seventies were vaccinated for smallpox and I was vaccinated
several times. None of those vaccinations have any effect
today, is that correct? They are all expired?
Dr. Fauci. I do not think we can say that, Senator Stevens.
I think we can say that from what we classically know about
immunology and response to vaccinations, that the immunity that
you and I got when we were children and vaccinated is almost
certainly diminished. We say ``waning immunity.'' I doubt, as
an immunologist and as an infectious disease person, that that
immunity is gone, namely zero.
Senator Stevens. That is my question, doctor. Can those
that were previously vaccinated be given a booster, as opposed
to those that have never been?
Dr. Fauci. Yes.
Senator Stevens. Can you stretch that supply out by saying,
you people that were vaccinated before, you get this vaccine;
those that have not, you get another?
Dr. Fauci. No, because the booster for an already
vaccinated person, Senator, is exactly the same as a primary
for a person who has never been vaccinated.
Senator Stevens. Then answer another question on an
entirely different subject. If an exposure of a community
occurred on Monday, how long would it be before a vaccination
would not be effective on the populace? How soon do we have
this vaccine available to a community after exposure?
Dr. Fauci. It is approximately 4 days, between 3 and 4
days. Experience tells you that, if you vaccinate an exposed
person, you could either prevent infection or significantly
modify the disease that that person has.
Senator Stevens. My other question would be, how effective
is real quarantine of a community that has it?
Dr. LeDuc. I think quarantine would be very effective.
Isolating patients is what we do, for example, to control ebola
outbreaks, where we have no other tools. This interrupts
transmission. If you could isolate patients so that they do not
come into contact with susceptible individuals, then you can
interrupt transmission. We have lots of tools to do that. We
can isolate them within established hospital rooms under
isolation conditions. We can vaccinate staff even after, as Dr.
Fauci said, even after they have been exposed.
So for example, the patient comes into the emergency room
and it is determined that that individual has smallpox; we
could immunize the attending physician and all those in contact
with that patient within four days and certainly alleviate the
symptoms and in many cases protect from infection completely.
Senator Stevens. About the exposure of our community in the
case of anthrax, it has obviously taken highly trained people
who can refine that product, deliver it without themselves
being infected. I have not seen any reports that people who
handle it and deliver it have been infected. This process
involves a human being with smallpox. Can it be delivered other
than by a human being who is infected?
Dr. LeDuc. I do not really have any information on delivery
systems. Perhaps others do.
Senator Stevens. Well, if you had a petri dish here and it
spilled, would I get exposed? Or does it take an infectious
person who breathes into the air that I breathe?
Dr. LeDuc. You could certainly get it from the virus itself
in the equivalent of a petri dish or from a clinically ill
individual, that is true. It could be concentrated. It could be
disseminated by air.
Senator Stevens. But I am looking to the question, how can
we protect the community against exposure? We have immigrants
coming in, we have people coming with visas. To our knowledge,
we have no cases of smallpox in the United States today, so
this would be something that would have to be imported, right?
Dr. LeDuc. There are no cases anywhere in the world today.
The disease has been eradicated, so the virus that causes the
illness only occurs in test tubes in stored stocks.
Senator Stevens. I do not want to prolong it, either, but I
think we have a real problem in trying to assess as we go
forward now with this money we have available this year the
priorities of where we put the money. Very clearly, one of the
basic priorities that I have had is the research to determine
what substances might be used as weapons.
Dr. Fauci.
Dr. Fauci. Senator Stevens, let me address directly the
direction I believe you were going in, about what we need to
do, be it easily recognizable or not, even if we were
absolutely correct and expert in recognizing a case of smallpox
in this country. That would immediately trigger the need and
justification for having vaccine available, because just one
case, even if you recognize it totally accurately, tells you
that smallpox has been introduced to our society and we need to
be prepared with a vaccine.
Senator Stevens. How about a timetable on that, doctor? If
you have an exposure in West Virginia, how soon thereafter with
the community at large, the whole country, have to have vaccine
if they desired to have vaccine?
Dr. Fauci. If you fulfilled the strategy of isolating the
case and it is only a West Virginia case, and do what I
mentioned before about identification, isolation, contact,
tracing and vaccination around the case, you can do that at the
local level. If you had multifocal cases, then it becomes very
complicated.
There was an experiment done that I, interestingly, as a
child was part of. That was in 1947 in New York City. There was
a misdiagnosis of a case of smallpox that was felt to be
chickenpox. An individual went into a hospital and exposed a
number of people. Twelve people were infected, 2 people died.
The public health approach to that was exactly what we said.
There was isolation, quarantine, and vaccination within a 2-
week period of 6.3 million New Yorkers, one of which was me at
that time. That is how that potential epidemic was curtailed.
That is exactly what the first-line approach would be. The
critical issue is if it is a multifocal outbreak, where it is
not just New York City or West Virginia, that is the reason why
we are talking about the need to have smallpox vaccination on
hand.
Dr. Barry. Could I just clarify for my perspective as a
local health person. Let us say we have a case come in the
Massachusetts General Emergency Room and the docs there
immediately recognize that this is smallpox and they call us at
the local health department. First of all, you have to realize
that person has been wandering around the city of Boston now
for a number of days and is infectious. So we on a local level
are not only going to have to be advising the hospital on types
of isolation, but somehow we are going to have to find the
staff to try to interview and find out where this person has
been in the city.
So you have 4 days from the time you are exposed to get the
vaccine and be protected. But we are not going to know where
those people are. We are going to have to find those people and
we are going to have to have pretrained staff who are going to
know how to deliver that vaccine. That is going to be a very
challenging task for a local health department.
Also, I have to comment on the issue of community-wide
quarantine. I think that is going to be very difficult to do. I
think we are really going to have to look at building support
structures for people, allowing them to stay for the most part
in their own homes.
Senator Stevens. Doctor, respectfully, I have to tell you
that if someone is going to use this as a weapon, you are going
to have a peripatetic agent that will probably visit about 10
or 11 terminals in 1 day or 2. I do not think that, if this is
to be used as a weapon, we can say it is going to be contained
in Boston or Anchorage or somewhere in West Virginia. A weapon
is a weapon.
I go back where Dr. Fauci came. I believe in fully
available vaccines, but I do not suspect this is going to be
some disease that springs out of someone having visited
someplace in the world and coming back with smallpox. This
comes to us as a weapon and I think we have to think of it as a
weapon, not think of it as a public health problem,
respectfully. It will be dealing with a weapon, a weapon
delivered to our system which we must react to immediately.
That does not mean just one community; it means that the Nation
is the community.
Dr. Barry. Oh, I certainly understand that, Senator. But I
am just trying to figure out literally step A to step B what is
going to happen to get us into that responding to, as you call
it, weapons mode. It is going to take a lot.
Senator Stevens. It will, yes.
Thank you very much. I appreciate your courtesy to me. I am
late for another meeting, but I appreciate what you are doing.
Thank you.
Senator Harkin. Thank you, Senator Stevens.
Senator Specter.
Senator Specter. Thank you, Mr. Chairman.
With respect to the issue of our preparedness, the
testimony and written statements point out that the vaccine
will be available by the end of next year, but what do we do
now if something should happen immediately? Dr. Friedman?
Dr. Friedman. If you will, sir, I think that the current
stocks of vaccines are the responsibility of the Centers for
Disease Control.
Dr. LeDuc. Yes, sir, let me try to answer that for you. As
Dr. Fauci said, we have in place a little over 15 million doses
of vaccine. That represents our immediate response capability.
We have already explored the possibility of diluting that and,
for example, as Senator Stevens said, if we think of this as
being a formal military attack, I think one of the first
challenges or first requests we are going to have is from the
Department of Defense.
Senator Specter. Let me ask you if there is a way to dilute
it, which has been testified to, to increase it substantially,
but what can be done now to deal with the population in this
country of 280 million people? This subcommittee is prepared to
recommend, and I think the Congress will accept, funding for
whatever it takes. So what can be done now to have enough
vaccines for our entire population?
Dr. LeDuc. We have already begun that process. As Dr.
Friedman said, we have met with the major manufacturers. I can
tell you, it is a heartwarming experience to have each and
every one of these major firms come and say, we recognize this
as a major national crisis, we are here to help.
Senator Specter. Dr. LeDuc, we understand that the people
are willing to cooperate. The question is how fast can it be
done. If money were no object--if it was no object; we will
make it subjective. If money was no object, how fast can it be
done?
Dr. LeDuc. The fastest that we will have a full 300 million
doses for the entire population is roughly by the end of next
year. Actually, it will be more towards the middle, third
quarter of next year, those vaccines.
Senator Specter. By the third quarter of 2001?
Dr. LeDuc. 2002.
Senator Specter. 2002.
Dr. LeDuc. Calendar year.
Senator Specter. Dr. LeDuc, that is not adequate.
Dr. LeDuc. That is as fast as it can be made. Now, let me
explain also that this will be an increasing slope. In fact, we
are already producing the vaccine, the new vaccine----
Senator Specter. How soon can we have it, if not for 300
million people, for 100 million people?
Dr. LeDuc. We are talking with the major manufacturers.
Their lot sizes are roughly 20 million doses. When they get
going, they produce these in a matter of a couple of weeks. It
takes----
Senator Specter. Dr. LeDuc, let me ask you to go back to
the drawing boards and you, Dr. Friedman, as to what can be
done to expedite it.
Dr. LeDuc. Sir, I think that we have pushed this system
absolutely as much as we can. I do not think that we can make
it go any faster than we already are.
Senator Specter. Well, let me ask you, notwithstanding
that, to go back to the drawing boards and let this
subcommittee know within a week what can be done with more
intensity. We have found a lot of lines that we can do more if
cost is no object, a life and death situation.
Dr. Friedman. Senator Specter, may I just interrupt for one
moment, because I wanted to just give some amplifying remarks,
if I may, sir. Something unprecedented is being offered by our
pharmaceutical companies. What they have said is, irrespective
of the contracting process, whoever gets that contract, the
other companies are willing to dedicate their scientists and
their production facilities in order to meet this need.
Now, there are other legal implications of that that have
not been fully explored. But when I say that our companies are
prepared to do things that have never been done before, that is
what I am talking about.
Senator Specter. Dr. Friedman, I understand that. I
understand that they understand it is an emergency. But the
question is how soon for 100 million people or how soon for 200
million people and how soon for 280 million people. We know
they are prepared to move ahead, but how soon if cost is no
object.
I want to turn now to the question of vaccination. Under
normal circumstances, you do not vaccinate because the risks of
vaccination are higher than the risks of contracting smallpox.
The Washington Post had last Sunday characterizing ``Smallpox
may be the scariest thing in the biowarfare arsenal.''
Specifically when the Post writer Shannon Brownley comes down
to the issue of vaccination, the statement is made: ``A
biological attack with smallpox virus, though perhaps not as
unlikely as it was just weeks ago, is still a low probability,
high impact event.''
The experts are said to be opposed to vaccination because
of the adverse consequences. Well, it seems to me that that is
a valid conclusion under normal circumstances, when you take
the likelihood of bad reaction or even death. But I question
that in the context of a bioterrorist attack. Now, that is
very, very hard to quantify, but it seems to me as a matter of
common sense that vaccination may be preferable. But those odds
are totally changed.
What about that, Dr. LeDuc? First of all, what are the
risks with vaccination? I had heard one out of 4,000 would
result in death. Dr. Fauci says no. What are the risks, Dr.
Fauci?
Dr. Fauci. There is a bracket depending on the study and
the bracket goes anywhere from one to six per million deaths.
There are a lot of serious complications that do not
necessarily result in death, but mortality is anywhere from one
if you look at the 1968 study, or an early study, it goes up to
six or so per million.
Senator Specter. So why not vaccinate if the risks are that
proportioned? Dr. Fauci?
Dr. Fauci. As I said before, Senator Specter, I believe
that we should seriously consider that, depending upon what the
risks are. Right now the risk is unclear with regard to the
unleashing of a smallpox bioterrorism attack.
Senator Specter. Dr. Fauci, are the risks ever going to be
other than unclear?
Dr. Fauci. If you have good intelligence or an index case--
let me, if you would permit me, Senator, to just very quickly
go through some scenarios. If you have very good intelligence
and we know there clearly is smallpox available and it will be
used as a bioterrorism weapon, that weighs toward what you are
alluding to. If there is an index case, even if it is not in
the United States, that weighs a little bit more. If we have an
index case, that makes it very, very heavy.
So myself as a physician, as an infectious disease person,
am not at all against vaccination. But we need to weigh the
risk-benefits as they evolve. There is a risk, but it may be
that those risks should be acceptable. I would not deny that at
all. It is entirely conceivable that we will have to accept
those risks and vaccinate people. But at this point in time,
given the uncertainty as to whether or not there is even
material available to mount a bioterrorism attack, we do not
have the material yet, so we do not have enough even if we
wanted to vaccinate everyone.
As we get it, we need to sharpen the debate about whether
or not we should preemptively do it. So I think we are on the
same channel. You are not hearing me say that we should not do
that.
Senator Specter. Well, I do not think that we are ever
going to have intelligence to tell us that a bioterrorist
attack with smallpox is imminent. If we could not find out that
they were about to crash into the World Trade Center and the
Pentagon, we are not going to find that out. Our intelligence,
we just cannot rely upon our intelligence. So I think the time
is upon us now to get the maximum amount of vaccine available,
which we have already discussed, and then at a minimum to leave
it up to people to make the decision as to whether they want to
be vaccinated.
That is not really a governmental decision. Tell the
American people what the risks are, have the vaccine available,
and let them make the decision.
Dr. Fauci. That is an entirely reasonable approach.
Senator Specter. My judgment would be to have my four
granddaughters vaccinated. It is one in a million that they are
going to have an adverse reaction. It is our job to get the
vaccine available. I do not think that--it is not your province
to decide what the risk factor is of bioterrorism. That is the
province of the Department of Defense or the Central
Intelligence Agency, with perhaps some inputs from the
Congress.
But you tell us what the risks are and get us the vaccine
and let us leave it up to the American people to make their
choice.
Dr. Fauci. What you say makes very good sense, Senator, and
as a matter of fact, my own children, I would take the risk of
having them vaccinated if given the choice of having it. So I
agree with you. I think that is something that should be
discussed in detail because it makes sense.
Senator Specter. Now we are on the same wavelength.
Dr. Fauci. Yes, okay.
Senator Specter. Put aside the risk factor. We are not
going to figure that out any better than we know it now. Let us
get the vaccine available and let us have the fathers and maybe
even some of the grandfathers make choices.
One more question to you, Dr. Barry. One infectious disease
doctor in Boston. How many in Philadelphia? I know you do not
know the answer to that, but what can you do? Or Pittsburgh or
Harrisburg or Russell, Kansas. What can you do to make more
infectious disease doctors available?
Dr. Barry. Well, the issue is within the city health
department. There is one infectious disease doctor within the
city health department to deal with bioterrorism, meningitis,
hepatitis, tuberculosis, and what can you do? You can increase
funding for local health departments so they can hire people.
Senator Specter. Okay, that is the city health department,
but how about the medical personnel generally in Boston? There
are more infectious disease doctors?
Dr. Barry. There are many excellent infectious disease
doctors in the city of Boston and they have been wonderfully
cooperative in working with us in our planning efforts.
However, their focus is not on public health. Their focus is
dealing with their patients in the hospital or in their
practice.
Senator Specter. Have they been organized in the event of
an infectious disease bioterrorist attack?
Dr. Barry. Yes. In fact, in 1999 we got about a $1 million
grant over 5 years from the Centers for Disease Control to
develop a specialized surveillance system and to develop that
system we created a citywide task force that included emergency
department and infectious disease personnel from all the
hospitals in Boston.
Senator Specter. Dr. Barry, would you provide to this
committee just what you have done there, how many infectious
disease doctors there are, what organization there is to pull
them into a coordinated response to an attack? I think that is
something that we will inquire of other cities, to see what
assistance may be necessary.
Dr. Barry. Sure, no problem. There are infectious disease
societies.
[The information follows:]
Emergency Coordination Among Physicians in Boston
Emergency Department and Infectious Disease physicians from 9
Boston hospitals as well as physicians from Boston Emergency Medical
Services and the Massachusetts Department of Public Health are members
of the Commission's Surveillance Task Force. These doctors receive
daily reports on emergency department and acute care site volume,
frequent clinical advisories from the Boston Public Health Commission,
and participate in regular Task Force meetings to monitor and improve
the Special Surveillance System.
The Boston Public Health Commission is also in close communication
with the Conference of Boston Teaching Hospitals, which receives the
regular clinical advisories and forwards these to member hospitals.
Surveillance Task Force physicians have worked with the Commission
to develop a ``train the trainer'' curriculum and implement a program
to teach other physicians, nurses and other health care workers about
bioterrorism.
Despite intensive education, healthcare providers have relied on
Dr. Barry, and the Boston Public Health Commission for guidance on
anthrax and other bioterrorism related issues. For example, physicians
consult Dr. Barry regarding whether a patient's symptoms and exposure
to a ``suspicious substance'' require antibiotic treatment. In another
case, a doctor called the Commission for guidance regarding appropriate
measures for a patient complaining of fever and pox. The Boston Public
Health Commission assisted in determining that the patient was
suffering only from chicken pox.
Dr. Barry also serves on the Public Health Executive Council of the
Massachusetts Medical Society and has contributed to the development of
educational materials as part of their education group.
We are continuing to discuss ways to better coordinate
communication and response efforts among the hospital and public health
and public safety agencies of the City. However in the event of a
public health emergency, the Boston Public Health Commission will have
the primary responsibility for centrally coordinating communication and
response efforts.
Therefore, we need more clinical personnel in Boston Public Health
Commission, specifically the Communicable Disease Control program,
which has played a unique role in a public health crisis. To increase
clinical personnel at a large city health department, what is needed is
simply additional funding.
Senator Specter. Do you have access to the information
which is in the hands of Federal authorities, or do you have a
problem? Local police departments are complaining that the FBI
will not share information.
Dr. Barry. We have a lot of information available. I think
sometimes it would be a little easier for local health
departments to be able to deal directly with the technical
expertise available at CDC, as opposed to having to almost
always work through the State health departments.
Senator Specter. Would you say in the event of bioterrorist
attacks with smallpox we need a massive education program?
Dr. Barry. Yes.
Senator Specter. Should we not start that now?
Dr. Barry. Yes. In fact, we have, as well as we can with
our resources, started. We have fact sheets developed on
smallpox. We have started to talk to health care providers as
part of an educational series. But again, we have limited
staff. We have started this process, but we clearly need more
to be able to finish it.
Senator Specter. Would you provide the information as to
what your educational program is?
Dr. Barry. Certainly.
Senator Specter. That is something the subcommittee would
like to look at----
Dr. Barry. Certainly.
Senator Specter [continuing]. To see what funding is
appropriate for you and for other similarly situated health
departments.
[The information follows:]
Bioterrorism Education in Boston
The Boston Public Health Commission (BPHC) has engaged in several
initiatives to educate providers and the general public about
bioterrorism. In addition, we have conducted trainings and disseminated
information on workplace mail safety procedures for other City agencies
and a number of major businesses.
Train the Trainer for Health Care Providers
As mentioned previously, the Surveillance Task Force has developed
a bioterrorism lecture. BPHC also operates a ``train the trainer''
program for lecturers. BPHC provides the lecture in a CD-ROM format and
also provides written materials for dissemination at lectures. BPHC
updates the lecture regularly. To date the lecture has been delivered
at Boston hospitals, university health centers, a major HMO, and at
schools of public health and nursing.
Clinical Advisories
The Commission's Communicable Disease Control Program develops
regular clinical advisories for health care providers with guidance on
the latest national and/or local incidents, symptoms, diagnosis,
treatment, and any other recommendations from the U.S. Centers for
Disease Control and Prevention. These advisories are sent out to all
members of the Surveillance Task Force, community health centers,
Conference of Boston Teaching Hospitals, university health centers,
hospital-based internal/primary care providers and school based health
services as well as posted on the BPHC website.
Training Commission Staff
The Commission has identified key clinical staff from all its
programs as well as key non-clinical staff with the capacity to serve
as public educators and staff the hotline in the event of a major
mobilization. These staff have received in-depth training regarding
bioterrorism issues and response plans.
General Public
In addition to regular media appearances by BPHC staff, the
Commission web site is regularly updated with the latest news and
recommendations, in addition to fact sheets about bioterrorism in many
languages. See www.bphc.org for this information. This information can
also be accessed through the City of Boston website at: http://
www.cityofboston.com/.
A dedicated phoneline has been established with a recording in
Spanish and English. Staff is available to answer questions in both
languages during usual business hours. A manager on call is available
by pager to answer urgent questions after hours.
The Commission also partnered with the state health department to
develop a supplement on bioterrorism for a major daily newspaper
offering practical information for readers, and a monthly health
education column in community papers provides similar practical
information.
Senator Specter. Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter.
Well, this has been a very informative gathering. I thought
I would start my line of questioning by responding a little bit
to what Senator Stevens had said. I had interrupted him once. I
did not want to interrupt him again. But regarding the point
that Senator Stevens made about building up and spending all
this money against a nonexistent threat, let me put a different
face on it.
I remember the farewell speech that another former chairman
of this full committee gave when he left the Senate, Senator
Mark Hatfield. I was sitting on the floor listening to that,
and I remember he was talking about where we ought to be
focusing our attention in terms of governmental spending. I
think that is sort of the gist of what it was.
He said: No longer is the threat that the Russians are
coming, the Russians are coming. He said: The threat is the
viruses are coming, the viruses are coming. I will never forget
that. Now, he was not talking about it in terms of a
bioterrorist threat. That was not even on the horizon. He was
talking about it in terms of the naturally occurring viruses
that mutate over time, that evolve and threaten us
periodically, the new pathogens that arise. Maybe we dealt with
one, but over time they mutate, they become stronger, they
develop different strains that we have to attack.
Sometimes, as we know, they can become very virulent, HIV
for example. We still do not know how to attack the HIV virus,
but it has killed millions and millions of people.
So building up against a nonexistent threat. Well, maybe in
terms of the bioterrorist threat, it may be so. But if we build
up, we protect ourselves against the naturally occurring
disease threats that also may come down the pike in the future.
There is an old saying, there is no dark cloud but what has
a silver lining. Perhaps out of what is happening to us in this
country may come a silver lining. Now we recognize the need to
bolster our public health system in this country and around the
world.
I just think for too long we have just sort of skimmed by,
and now we recognize in this hour of darkness that we have in
our country right now the need to respond to the possibility of
man-made threats. But out of that comes the possibility that we
will also build up our defenses against the non-man-made
threats that come down the pike in the future.
So I see it a little bit differently, that it is an
existing threat. As long as there are viruses and pathogens in
the world, there is that threat. Regarding food safety, we lost
about 5,000 people I think in New York in the World Trade
Center buildings, but last year there were about 5,000 who
people died of food-borne illnesses in the country. Millions
more got deathly sick and lived. So we are finding that some of
these strains in our food are becoming more virulent than they
were in the past, strains of salmonella, botulism, things that
we have attacked with antibiotics over time, but they have
become more resistant and they have become harder to attack.
So our public health system needs to be beefed up.
Regarding communications, Dr. LeDuc, I believe it was in your
statement that only 13 States, 13 States, have connections from
their central State public health office to all of the local
public health offices. Is that right?
Dr. LeDuc. That is correct, sir.
Senator Harkin. That is abysmal. I found out that there are
some States that do not even have 24-hour, 7 day a week
response from their hygienic labs. Some States do, some States
do not. I do not know how many there is like that.
You talked about the Health Alert Network. Senator Byrd
said in his opening statement that there are some of them are
not even hooked up to the Internet. They do not even have a fax
machine to be able to respond. Right, Dr. Barry?
Dr. Barry. That is absolutely true. There are some small
community health departments that do not have fax machine,
Internet access, that is true.
Senator Harkin. I will bet you they are mostly in our rural
areas. That is where they mostly are. There may be some in
cities too, but I bet you in rural areas there are even less.
So I make those points again just to say that we are all on
the right track, Senator Byrd. You are on the right track in
getting this money out there to beef up our public health
system in America. Certainly there are different priorities.
Right away, I think the first priority is to ensure that we
have adequate vaccines against smallpox. We are on the way to
that, and I am going to ask a couple of questions about it. But
then we need other kinds of responses for the other type of
weapons of mass destruction that might be introduced by a
terrorist.
But then beyond that, I think we have to do other things.
By the way, Dr. LeDuc, I was a little remiss in not thanking
you for the phone call last week. I had a lot of my colleagues
asking me all these questions about smallpox and I did not have
the answers, so I had to get some answers, and I appreciate
that.
Dr. LeDuc. It was my pleasure, sir. Thank you.
Senator Harkin. I listened to Dr. Barry speak about the
lack of coordination and the Health Alert Network. Is there a
manual, is there a blueprint, is there something that a local
health department could go to and say, we have got something
here, open the book, here is what we do? Is there such a
blueprint, is there such a manual from CDC?
Dr. LeDuc. Yes, sir, there is. It is just in final review
stage. That will be sent out in the next couple of weeks as a
draft, with ``Draft'' on the top, so that we can get more
active feedback from the local level. That is, a very
comprehensive plan, and is ready to go.
Senator Harkin. Will that be made available on the CDC
website? How will local health departments get this? You have
got to get it out there in a hurry.
Dr. LeDuc. Well, we will certainly use the Health Alert
Network as part of that distribution process. I can get back
with you for the details of how else we will get it out. I do
not have that off the top of my head, but I will.
Senator Harkin. That needs to be gotten out there in a
hurry, because as I understand it there really is no blueprint
right now. There is not a cookie-cutter type of an approach
that you can go to and say, here is what we do if this happens.
Dr. LeDuc. It is virtually done.
Senator Harkin. Now, let us get back to smallpox again. It
is my understanding that there are some 400 different strains
of smallpox. Is that true or is someone telling me a story
here? Dr. Fauci or Dr. LeDuc?
Dr. LeDuc. We have over 400 different isolates from
individual patients that are in the CDC collection. That
collection was accumulated as the global eradication campaign
proceeded. They were put into two different repositories, one
at CDC and one in Russia. There are about over 400, about 450
isolates.
Senator Harkin. Will the vaccines that we have on hand, the
15.4 million doses that we have on hand, that was developed
through the old methodology, will that protect against all
those strains?
Dr. LeDuc. Yes, sir. This vaccine was used in the global
eradication campaign and did protect against wild-type
smallpox.
Senator Harkin. That is comforting to know.
Now let me ask the follow-up question. Regarding the
vaccines that you are now developing that are not based upon
the old methodology, how confident are you that those will also
protect against all those strains?
Dr. LeDuc. We are working very closely with the Food and
Drug Administration to develop a strategy to show that the
vaccine is not inferior, the new vaccine is not inferior to the
old one.
Senator Harkin. Tell us how you will do that and how long
will it take?
Dr. LeDuc. It is being done now. In fact, there is a number
of pre-clinical tests have already been done, animal
experiments, cell culture experiments, these sorts of things,
and at every point we have shown that the new vaccine is
identical to the old vaccine.
Senator Harkin. But you do have to go through some clinical
trials, do you not?
Dr. LeDuc. The clinical trials that we will look at are
primarily focused on safety--well, making sure that it does not
make people sick, then making sure that it produces the kind of
immune reaction that we know is protective.
Senator Harkin. Now, you are absolutely certain, 100
percent certain, that the stored vaccines will protect against
all of them because it was used in the worldwide eradication?
Dr. LeDuc. Yes, sir, we are.
Senator Harkin. Give me your level of confidence in the new
vaccines and the ones that are developed in the petri dishes?
Dr. LeDuc. I am very, very confident that this will be
equally as effective. There is a very small difference in the
new vaccine versus the old one. It is only in the method of
manufacture. We no longer make it in calves; we make it in cell
culture, which is the way we make virtually all of our other
viral vaccines.
Senator Harkin. As confident? Are you as confident as the
old ones?
Dr. LeDuc. You said 100 percent. I am 99.9 percent.
Senator Harkin. That is pretty good.
Dr. Fauci, in your prepared statement you mentioned there
is an anti-viral, I cannot even pronounce it, called Cidofovir.
Dr. Fauci. Cidofovir.
Senator Harkin. What?
Dr. Fauci. Cidofovir.
Senator Harkin. Cidofovir has been found effective against
smallpox. Can you tell us more about this, and will it work?
Dr. Fauci. Yes. As I mentioned in my oral statement also,
Senator, cidofovir was originally developed as an anti-viral
against cytomegalovirus for the purpose of treating that
complication in HIV-infected individuals. In studies that have
been performed in an animal model in which animals were
challenged with pox viruses with strong resemblances to
smallpox, a variety of viruses, it proved to be highly
effective in treating in that animal model, primate monkey
model.
Based on that, an investigational new drug application has
been taken out to determine, as a secondary backup, if
cidofovir could be used in our vaccination programs when people
get a reaction against the vaccine. The first thing you would
do is to give vaccinia immune globulin. We are going to use
cidofovir as a backup. We are also pursuing developing or
getting an IND for its use in the treatment of smallpox.
The animal model data are very impressive, but, as is
always the case with an animal model, there is a leap from the
animal model to the humans. So you cannot say, as Dr. LeDuc
mentioned with regard to his confidence in the smallpox
vaccine, you cannot have that same confidence in an anti-viral
since it has not been tested in humans with smallpox.
But if you look at the data that emanated from the animal
studies with similar pox viruses, it is quite impressive, the
data. That is the reason why investigators are not only
pursuing cidofovir itself, but they are doing a large screening
on drugs that are of the class of cidofovir to see if you could
come up with even a better one.
Senator Harkin. That is being aggressively pursued?
Dr. Fauci. Quite aggressively, yes.
Senator Harkin. Is that under your guidance?
Dr. Fauci. It is a combination of ourselves and the
Department of Defense USAMRIID.
Dr. LeDuc. And the CDC.
Dr. Fauci. I am sorry, I am sorry. When I say ``us,'' we do
everything together. I take it for granted. It is the CDC, NIH,
and USAMRIID.
Dr. LeDuc. Let me just add to that, sir, for clarity. We
are actually, and have been for the past 2 years, working with
live Variola virus, the virus that causes smallpox, at CDC in
our maximum containment laboratory. Senator Specter saw the
space suit laboratories. We are actually doing the testing of
the drugs that Dr. Fauci mentions against the virus itself.
Senator Specter. I saw those when I made the trip down
there.
Dr. LeDuc. Yes, sir, you did.
Senator Specter. Are you improving those conditions? We
have got $170 million last year, $250 million this year, long
before this was a focus of attention.
Dr. LeDuc. We are indeed. Thank you very much for that. We
thank you for that.
Senator Specter. All you had to do was ask.
Dr. LeDuc. Thank you.
Senator Harkin. I just might say to Senator Byrd, both of
us have been down there and looked at CDC. We paid a lot of
attention to NIH, rightfully so. We doubled their funding in
about 5 years, Senator Specter and I.
Senator Specter. May I interject at this point, Mr.
Chairman, just for a comment or two?
Senator Harkin. Let me just finish my statement. I was just
going to say that we both visited CDC. The CDC is our front-
line defense in America against illnesses and public health.
They are spread out all over the place. Some of their labs date
back to World War II buildings, really, literally. I could not
believe it when I saw how out of date they are.
In fact, I learned when I was down there, they made a
movie, one of these scary movies.
Dr. LeDuc. ``Outbreak,'' I think, ``Outbreak.''
Senator Harkin. ``Outbreak.'' I saw it. It is one of those
movies about an outbreak of disease. They wanted to film a
movie, they wanted to film at CDC to show the buildings and how
they do all of this. I was told that the buildings were so
decrepit and old that the movie producers decided to build
their own set because the people would not believe it.
Is that true?
Dr. LeDuc. Yes, sir, that is true. But we are getting
better and we appreciate your help.
Senator Harkin. I am just saying that is why we need to
rebuild that. Can we use the movie set? No?
Senator Specter. I wanted to make a comment about our level
of preparedness and it ties in to what happened with the Center
for Disease Control. There had never been a request by the
Department of Health and Human Services to improve the physical
plant there. Senator Harkin and I heard about it from the
people in Atlanta and we took the initiative to go down there.
I spent a Sunday taking a look at it and had a hard time. I had
heard that it was awful, but what I had heard was wrong. It was
worse.
On the initiative of this subcommittee, last year we put in
$170 million. That is hard to find in our budget, but we did it
because of the importance. This year we put $250 million in
before September 11 occurred. But to be candid or really blunt,
I do not like what I am hearing today. Senator Harkin says we
are on the right track and I think we are, but we are a long
way from the station, just a long way from the station.
Now, when it came to the National Institutes of Health this
subcommittee took the lead 6 years ago to ask a lot of hard
questions. We saw what NIH could do on Parkinson's and
Alzheimer's and heart disease and cancer, and every year we
brought in the 25 directors of NIH--you were always here, Dr.
Fauci--and we said, if we give you a billion dollars more next
year, what can you do with it? Then we put a billion in 5 years
ago.
We had to take it out of the budget that we had because the
Budget Committee would not give us more. $2 billion the year
after and $2.3 billion. Every year we brought in the experts
and said, what did you do with the extra money last year and if
you get more money what will you do with it next year.
But we did not have the foresight to ask you about
diseases. Candidly, Dr. LeDuc, I think the Center for Disease
Control should have come to this subcommittee and should have
said, smallpox is a problem, we have only got 15 million
vaccines, maybe we can dilute them one to five.
Now, I asked Dr. Koplan, the head of CDC, on October 23 to
give us a list of all the possibilities of bioterrorism and
what it would cost. But I think the American people have the
standing to be very dissatisfied with what their government has
done. The first responsibility of government is security of the
people, and we have so hamstrung the CIA when we had people who
were informants that were not Boy Scouts that we precluded the
CIA from having those informants to deal with intelligence. So
we are vastly unprepared on intelligence.
Now you could itemize the dangers of smallpox which we are
talking about today, and as we took the initiative on NIH
because we understood that, and we talked about bioterrorism,
we put a lot of money into it, but not nearly enough. So I
think what we really have to do is face up to the failures and
find out how fast it can be done.
I think the American people have a right to be very
dissatisfied with what we have done for them.
Dr. LeDuc. Sir, I will relay that message.
Senator Harkin. Dr. Friedman, did you have something you
want to add?
Dr. Friedman. Not directly to Senator Specter's point, but
if you will allow me to go back to the point you were making,
Mr. Chairman, if you would allow me to make just a brief
comment on the military metaphor that you talked about. Senator
Specter was talking about it, Senator Byrd as well. There are
differences between wars. You make a mistake if you compare one
with the other. But if you think that we were not well prepared
when World War II started, the country had to do a lot of work
and there were a lot of mistakes made in terms of how quickly
we came up to speed, it is not inappropriate to make that
comparison.
From my point of view, if you think that our industrial
might really helped us to win World War II, and I think that
most people would say that it did, what I would suggest to you
this morning is that for this war the pharmaceutical industry
is the most pertinent power for helping us to defend our
freedom. We are not going to do it alone, but we are going to
provide the weapons for the public health infrastructure that
everyone is talking about here today and which absolutely needs
to be improved.
We can provide those weapons and we want to be the
industrial might that helps win this war.
Senator Harkin. Dr. Friedman, as a matter of fact I had a
question here. Dr. Friedman, what do we need to do to move this
forward more rapidly? I made a note here about joint
government-industry effort like World War II.
Dr. Friedman. Yes, sir.
Senator Harkin. Just like what we did in World War II. The
government joined with the auto industry, it joined with the
aircraft industry, it joined with all kinds of industries in a
joint effort. I think we can use that.
You are right, not every war is the same. But it seems to
me that you are right, the pharmaceutical industry in this
country is the best in the world. We take a back seat to no
one. Our pharmaceutical industry, our research scientists, our
ability to develop and bring to market new drugs and new
remedies is unparalleled anywhere in the world, anywhere in
history, any time in history.
Dr. Friedman. That is right, sir.
Senator Harkin. It seems to me this is the group we have
got to go to now to ramp up and to provide the kind of
protections our people need. I hope that with this committee
and with other committees of the Congress that we could have
that kind of joint government-industry cooperation. I see no
reason why we cannot.
Dr. Friedman. We appreciate that, sir. Thank you.
Senator Harkin. Senator Byrd, I know I wanted to recognize
you. You said you wanted to say something?
Senator Byrd. Mr. Chairman, I found so interesting your
questions and the questions of others on the panel. I feel that
I have gained a great deal of knowledge here today and I think
that we four, you and Senator Specter and Senator Stevens and
I, are in a position here on this Appropriations Committee to
do something about this war and I believe we will.
Now, my mother died in the great influenza epidemic in
1918, and people contracted the disease one day and were buried
the next or perhaps died the same afternoon. That epidemic
killed 20 million people around the world, 12 million in India
and probably 750,000 in this country.
My question would be this. I hardly know how to phrase it.
In the context of today's circumstances, today's treatments,
today's abilities to recognize anthrax, smallpox, and
influenza, and all of the various aspects, if an enemy were to
seek to somehow spread any one of these three pathogens, how
would you rate the one most dangerous, the one most dangerous
to us as a Nation, the one perhaps most easily spread by an
enemy?
Which would be worse--I will narrow it down--between
anthrax and smallpox? If you were the enemy, which would you
think could cause the greatest damage to our country--that is
No. 1.
No. 2, what is the lifespan of the smallpox virus? If it
were released into the air over in McLean where I live and if
the wind is blowing this way, how long, how far would that
virus be potent? What is its lifespan?
That leads me to think that if an enemy sought to diffuse
this smallpox virus in the air somehow, if he were of a nation
across the Atlantic, would he need to be cautious lest this
wind drive this virus across the sea to his own country?
Dr. LeDuc. I do not have accurate information on the
stability of smallpox virus. I know it is a rather stable
virus, especially in the crust after a person has been
infected. As an airborne particle, I would assume, like many
viruses, that it would be degraded over time by UV, sunlight,
radiation. I do not think it would be crossing any oceans. It
would be a matter of hours, I suspect, before it is
inactivated. But that is strictly my personal guess.
Senator Byrd. All right. As between this and that, as I
said earlier, which would you----
Dr. LeDuc. Well, I certainly do not want to place public
challenges on which is better.
Senator Byrd. No, not which is better, but----
Dr. LeDuc. Which is worse, exactly. Actually, we know that
there will be influenza outbreaks and I think that this is an
area in which we need to remain vigilant. Regarding the
comparison between smallpox and anthrax, anthrax is no longer a
theoretical risk. I think we need to be very prudent in our
approach to this, and I think likewise the steps that we are
proposing to take in preparing the Nation for smallpox are
equally prudent and essential.
Dr. Fauci. Senator, as a fundamental principle a microbe
that could be transmitted from one person to the other is
inherently more dangerous than a microbe that cannot, that does
not have that characteristic of transmissabiltiy. So smallpox,
being able to be easily transmitted, as well as an aberrant
form of influenza like we experienced in 1918, is inherently
more dangerous than an agent, regardless of how virulent it is,
that can only attack the person exposed to the agent.
Senator Byrd. Mr. Chairman, this is the first line of
defense.
Senator Harkin. You are right, this is it, and we will do
our utmost to meet our obligations to give you all the tools
you need to work with industry and to work with our local
public health departments, to try to get them up to speed,
trained, equipped, and working closely with the Center for
Disease Control.
We have an opportunity now. We have an opportunity to build
the kind of public health system in the United States that we
should have done 20, 30 years ago. I believe by doing so we
will not only protect our people against the man-made threats,
but against the naturally occurring threats that may be coming
down the pike also. So out of the dark cloud that is what I see
as our silver lining. That is what we will do.
Senator Specter. I have another question or two, Mr.
Chairman.
Dr. Fauci, in 1994 the budget for the National Institute
for Infectious Diseases was $1.063 billion and the current is
$2.063 billion. With the increases which this subcommittee has
proposed, next year it is going to be $2.375 billion. My
question to you is, when we have doubled it and now projecting
more than doubling it, has your department in NIH on infectious
diseases directed a significant amount of that increase to
bioterrorism?
Dr. Fauci. The increase, yes, Senator. The relative
increase of bioterrorism resources compared to the relative
increase of other infections, it is on a steep----
Senator Specter. Could you give us a ballpark figure?
Dr. Fauci. Yes, I can do that. If you look at--I can just
give you some numbers on bioterrorism from our Institute. In
year fiscal 2000--excuse me--fiscal 1999, it was $23.8 million.
In the year 2000, $32.6 million. Then it jumps up in 2002 to
President's budget of $81.5 million.
Senator Specter. Well, I suggest to you that $23.8 million
and $32 million are a very, very small part of $2 billion.
Dr. Fauci. I agree with you.
Senator Specter. I think you need to do better.
Dr. Fauci. We will. I agree with you.
Senator Byrd. Would the Senator yield?
Of the $81.5 million in the budget, how much did you ask
for? You have standing between you and the budget the Office of
the OMB.
Dr. Fauci. Right.
Senator Byrd. And they generally cut what you request. How
much did you request?
Dr. Fauci. The initial request was about that ballpark,
Senator. But a lot of things happened between the original
request and where we are standing right now vis a vis the
assessment of that.
Senator Specter. Senator Byrd, this subcommittee has seen
to it that OMB does not stand between NIH and funding.
Senator Byrd. Hallelujia.
Senator Specter. Last year the President asked for a
billion dollars. Senator Harkin and I took the lead and put in
$2.8 billion. We have made a determination on priorities as to
how important NIH was.
But I am a little disappointed, Dr. Fauci, that you only
used $32 million of that money for bioterrorism.
Let me say this to you, Dr. LeDuc. I already asked Dr.
Koplan, the head of the Center of Disease Control on October
23rd for a list of agency problems in bioterrorism and what it
would cost. Go back and give us a figure as to what it would
take, what would it take on smallpox to have the vaccine for
280 million Americans. Then go down the list and tell us what
it would take, and let us make the decision as to whether we
are going to fund it or not. That is a decision for Congress.
That is Congress' job. Your job is to tell us what it takes.
You listened to the Boston Public Health Service and Dr.
Barry who is struggling under circumstances which are
disgraceful--one infectious disease doctor. So if there is
going to be follow-up here, let it rest with the Congress. You
tell us what it takes and I think we will provide the
resources.
Dr. LeDuc. Well, I will certainly relay that message.
Senator Harkin. With that, we thank you all very much, and
thank Senator Byrd for gracing us with his presence and for his
interest and leadership in this area. We thank you so much.
Thank you all for your leadership in your respective areas. We
look forward to working with you.
subcommittee recess
Thank you all very much for being here, that concludes our
hearing.
[Whereupon, at 11:01 a.m., Friday, November 2, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
FUNDING FOR BIOTERRORISM PREPAREDNESS
----------
THURSDAY, NOVEMBER 29, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human,
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met, pursuant to notice, at 9:08 a.m. in
room SD-192, Dirksen Senate Office Building, Hon. Tom Harkin
[chairman] presiding.
Present: Senators Harkin [presiding], Kohl, Landrieu,
Specter, and Stevens.
OPENING STATEMENT OF SENATOR TOM HARKIN
Senator Harkin. The Subcommittee on Labor, Health, Human
Services, and Education will come to order. Today marks the
subcommittee's fourth hearing this year on bioterrorism. This
morning we will focus on the resources required to improve our
public health infrastructure and protect Americans from a
possible biological weapons attack.
In recent years this subcommittee made significant new
investments in our public health system. We have made progress,
but we know it is not enough. Recent events and expert
testimony before this subcommittee have made one thing
perfectly clear: Our Nation's public health system is not
adequately prepared to either prevent or respond to a
biological weapons attack. To properly prepare, we must begin
to think of our Nation's public health system as the front
lines in our battle against terrorism.
Right now we do not have enough vaccines to protect every
American. We will be discussing that this morning. But public
health officials are without the tools and training they need
to detect an outbreak and rapidly respond. Prudence demands
action and that is why Senator Specter, Senator Byrd, and I
have crafted a $4 billion bioterrorism initiative. We plan to
press ahead with this initiative and we should not end this
session without acting to protect the American people.
Last week Director of Homeland Security Tom Ridge stated
that the administration intends to request substantial new
funding for bioterrorism as part of the 2003 budget request.
With all due respect to Mr. Ridge and the administration, these
funds would come much too late. Safeguarding this Nation
against public health threats demands immediate action. If a
nation declared war on the United States, we would not wait
until next fiscal year to prepare. We would act and get
prepared now, and that is what we have to do in the public
health sector.
That is why Senator Specter and I are finalizing
legislation that we will introduce later today hopefully, much
of it based on this morning's testimony. Our plan would be to
boost our Nation's defenses against bioterrorism. Among other
things, we would put the bulk of the funding, $1.3 billion,
into improving our public health departments, shoring up local
lab capacity, and expanding the health alert network. Our
proposal would also allocate $200 million for research at NIH
on new vaccines.
Earlier this month our subcommittee heard testimony from
Dr. Fauci, who is with us this morning, about the promising
future of antivirals against smallpox, and so we want to see
again how much more we need to invest in that area.
Our plan also provides substantially more money to boost
the work of the Centers for Disease Control and Prevention. We
need to upgrade their overburdened lab capacity and their
disease surveillance systems.
We need to do more this year to make sure that Americans
are fully protected against anthrax, smallpox, other types of
pathogens that might be used in a bioterrorist attack. We have
a distinguished panel of witnesses before us today. I really
want to thank them for joining us. I would, before I yield to
Senator Specter, again just pay my respects and my accolades to
you, Dr. Koplan especially, and for the Centers for Disease
Control and Prevention for all of the great work that you have
done out there in responding to the anthrax attacks that have
been bedeviling us around the country. I know you have got your
investigators hot on the trail. I know they are working hard.
I think Americans everywhere ought to understand that these
soldiers working for the Centers for Disease Control are
putting their lives at risk every day, in much the same way as
our soldiers in Afghanistan are putting their lives at risk.
These are the people that go out, that have to expose
themselves openly to anthrax, as the case may be right now.
They are doing the lab work and they are exposing themselves to
the possibility that they too might get infected.
So I just wanted to point that out that they have been
doing a great job under very trying circumstances. I hope, Dr.
Koplan, you will pass on to all of the people that work in the
Centers for Disease Control our high esteem and our genuine
thanks and appreciation for all of the hard work that they are
doing and the risks that they are taking on themselves for
tracking down this anthrax scare.
Dr. Koplan. Thank you. That means a lot to us.
Senator Harkin. Senator Specter.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Thank you, Mr. Chairman.
There is no more important subject for America today than
the subject matter of this hearing. The American people face
the potential of an imminent threat of bioterrorism. We have
had in the past several weeks two high alerts from the
administration and the imports of those alerts is the potential
for a bioterrorist attack. It is indispensable that we address
the subject now before the Congress adjourns for whatever
funding is necessary to meet this danger.
An administration report published in last Friday's New
York Times talked about including this funding in next year's
budget. That appears to mean for the budget beginning October
1st, 2002, and we know the reality of that is later than the
end of the fiscal year and into 2003 before the funding could
be started. That, simply stated, is too late.
This subcommittee had an earlier hearing where Dr. Koplan
testified when we were ousted from this building because of
bioterrorism, because of anthrax, and we asked at that time to
have a comprehensive list of all the threats and what it would
take in dollars and cents to meet them. Then we had a hearing
in this room a couple of weeks ago where Dr. Fauci and others
testified about what needed to be done with respect to the
focus on smallpox. At that time the debate centered on the
issue that vaccinations were not really necessary, that there
would be time to inoculate after exposure.
My rejoinder was that the government has the responsibility
to have the vaccines available and then the citizens can make a
decision as to whether they want to undertake the risks, which
were identified as one to six out of a million. Dr. Fauci and I
had a little discussion about our grandchildren and I said I
wanted my grandchildren inoculated. It is not my decision, by
the way. It is my son and daughter-in-law's decision. They are
the people to determine what their children will have. I think
Dr. Fauci came around to my way of thinking and he wanted his
grandchildren immunized, vaccinated, too.
The point is that it is government's responsibility to have
it available. I made the point that this subcommittee, with
Senator Harkin's leadership and my joinder, has provided
enormous funding for NIH. We saw the needs there. NIH did not
come forward and ask us to double the money, because NIH is
controlled by HHS, and HHS is controlled by OMB, and by the
time you finish the alphabet soup Congress cannot find out what
is going on, unless we use back channels to find out.
But we saw the potential for NIH ourselves and we took a
budget of $12 billion and with this year's appropriation it
will be $11 billion more. That is a great tribute to America
for what NIH has been doing on Parkinson's and Alzheimer's and
heart attacks and cancer and a whole litany of ailments.
When we heard that the CDC needed additional capital
improvements--and we did not hear it from the Secretary of
HHS--Senator Harkin and I made trips down there on our own to
take a look at the facilities. Before we had this emergency of
September 11th, more than a year ago we added $170 million to
their capital program, because this subcommittee is determined
to see to it that the medical needs of America are taken care
of.
This year we have added $255 million on our way to a
billion dollar program. I think this is a lesson for government
generally. You professionals need to tell us what you need, and
if we do not fund it then it is our responsibility.
So I am glad that we are going to get the figures today and
we are talking about ways to include it in the budget to make
sure that it does get done.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter.
We have been joined by our distinguished ranking member of
the full committee, Senator Stevens.
Senator Stevens. Senator Kohl.
Senator Harkin. Senator Kohl, did you want to make an
opening statement?
Senator Kohl. No.
Senator Harkin. Senator Kohl is deferring, Senator Stevens.
OPENING STATEMENT OF SENATOR TED STEVENS
Senator Stevens. I intend to stay, Senator, so I would be
happy to--thank you very much.
It is nice to see you again, Dr. Fauci and Dr. Koplan. I am
pleased to have a chance to be with you today for a little
while. I thank the chairman and the ranking member for holding
this hearing.
Yesterday at another subcommittee I had an exchange with
regard to the safety of our business, our buildings here, and
the mail. We were told it is the responsibility of CDC to set
the standards for safety and the standards for the ultimate
decision that our buildings are safe for our staff and the
public. I am going to have some questions about that later if I
may, but for now I would say this, that I do think that we have
got a real problem here and the problem is that, at least as
far as I am concerned, there are still some areas of great
misunderstanding about anthrax.
The front page of the Post today talked about how they had
to use a paraffin sheet to capture the anthrax because it is so
finely refined into such small units. We are having to face our
staff to tell them we are going back into that building. I do
not know if you know about it. I asked some questions, for
instance, whether the plants were still there. Friends of mine
told me all the plants should have been destroyed immediately.
But in any event, they said that is where the anthrax spores go
around the ranch, into dirt and into manure; they do not go to
books and tables, they go into the ground.
Apparently there is a difference of opinion here. We have
some real problems ahead of us here now. Dr. Fauci, one of the
greatest ones is that in the years that we have doubled NIH,
and this is the last year, we have decided not to earmark. Yet
now that apparently money should be plentiful at NIH, some of
the priorities that the people are screaming at us to get onto
the list of these research agencies are being ignored.
So I want to tell the subcommittee, as far as I am
concerned this is the last year we do not earmark unless we see
some action dealing with some of the issues the public is
clamoring for details on. Just for instance, I asked the
question, do we know anything about the anthrax spores? What do
they do? What is their range? How far can they travel without
some type of assistance, either by carrier or by wind,
etcetera? We do not know, apparently.
I asked questions about the files and the books in our
offices and I was told, no, they did not open those. They did
not open the files and they did not open the books, because
they do not believe the spores would go there. Well, you try to
tell that to a bunch of young college graduates. Yesterday I
tried. It was not acceptable.
I think we have to have some answers and we have to have
them pretty quick. But we have not had that kind of answer. I
would assume someone had tried to determine the characteristics
of this anthrax that was headed toward the Senate and the
House, but particularly the Senate.
So I am going to have some questions about that. I hope
that that is all right with the committee, when we get to that
time.
But I do welcome you. Again, we have not spent much time
together, Dr. Koplan, but I had some interesting education with
Dr. Fauci and I hope to get more today.
Thank you very much.
Senator Harkin. Thank you, Senator Stevens.
We will turn to our first panel: Dr. Jeffrey Koplan,
Director of the Centers for Disease Control and Prevention.
After him we will then turn without interruption and without
questions to Dr. Fauci, who is the Director of the National
Institute of Allergy and Infectious Diseases at NIH. So
welcome. Your statements will be made a part of the record in
their entirety. Dr. Koplan, we will turn to you first.
STATEMENT OF JEFFREY P. KOPLAN, M.D., M.P.H., DIRECTOR,
CENTERS FOR DISEASE CONTROL AND PREVENTION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Koplan. Good morning and thank you, Mr. Chairman,
Senator Specter, Senator Kohl, Senator Stevens. I am pleased to
appear before you today on behalf of the Centers for Disease
Control and Prevention, the CDC, and thank you for the
invitation to discuss CDC's public health response to the
threat of bioterrorism.
The terrorist events on and since September 11th have been
defining moments for all of us and they have greatly sharpened
the Nation's focus on public health. But even before the
September 11th attack on the United States, CDC with the
support of this subcommittee was making substantial progress to
define, develop, and implement a nationwide public health
response network to increase public health capacity at local,
State and Federal level.
Since September 11th we have dramatically increased our
efforts, resulting in a heightened level of preparedness which
we are committed to increase even further based on lessons
learned in recent months.
CDC has used funds provided by the Congress to begin the
process of improving the expertise, facilities, and procedures
at State and local health departments and then within CDC
itself related to bioterrorism. We have established a
bioterrorism preparedness and response program to direct and
coordinate our efforts. We have over 100 full-time
professionals comprising expertise in epidemiology, laboratory
science, surveillance. Over the last 3 years we have awarded
over $130 million in cooperative agreements to 50 States, a
territory, and 4 major metropolitan health departments to
support preparedness, planning and readiness, epidemiology and
surveillance, laboratory capacity, and improved communications.
Since September 11th, we have sent over 500 CDC staff to
the field. For example, at the height of the anthrax response
here in the Washington, D.C., area, we had 85 staff present.
Currently in Connecticut in the investigation we have over 25
staff present working with the Connecticut State Health
Department. These experts include epidemiologists, industrial
hygienists involved in environmental sampling, laboratorians,
communications specialists, logisticians, management staff.
CDC has also been working with many of the States where
there have not been documented anthrax cases because there have
been threats and hoaxes and hundreds of thousands of laboratory
specimens sent to these States, putting a tremendous burden on
every State in the country. In some instances we have augmented
their staff with staff of our own to assist them in getting
through the work load that they had.
We have launched an effort to improve health laboratories
across the country in a network, a laboratory response network,
improving our capability of detecting bioterrorist agents
quickly and accurately, and we have done that in partnership
with a number of other groups and laboratories.
We have tried to improve communications systems which are
antiquated and in which, for example, less than half of the
health departments in this country have direct, secure Internet
linkage in a national communications system for public health.
We have worked to get pharmaceutical materials available to
places in need and we have in place large amounts of materials
that include antibiotics, antidotes, vaccines, materials for
blood loss and trauma, available to any site in the country
within 12 hours of a request for deployment. As an example, in
New York the materials were provided within 7 hours of the
request and being distributed for use.
A critical issue is preparedness of State and local health
departments in this effort. They need to have plans in place to
deal with terrorism. Those plans need to include distribution
of supplies, such as pharmaceuticals, vaccines, antibiotics.
Currently CDC funds only nine States and two cities to do such
planning.
Security is a major issue, for facilities in particular,
and at CDC we pay particular attention and effort to this, but
have more to do to increase the quality and status of our
security at several sites.
Our challenges for the future. While we have accomplished a
great deal in the past 10 weeks, several challenges remain.
One, it is critical that we bolster the infrastructure of State
and local health departments in the areas such as early
detection, laboratory analysis, crisis communications, and
epidemiologic capability.
In addition, we need to forge closer working relationships
between clinical medicine and public health, between hospitals
in our communities, local health departments, law enforcement,
other first responders.
Another important opportunity is to strengthen our
relationship with other Federal agencies. While institutions
such as the National Institutes of Health and the CDC and the
FDA work closely together many, many times a day, we need to
broaden that to include the law enforcement community. As we
have seen in recent events, a close working relationship can be
very helpful in dealing with an event such as bioterrorism,
which includes a public health investigation component and a
criminal investigation component. To facilitate that, we have
assigned a senior staff member from CDC to work at the FBI to
improve and assure an optimal interchange between the two
agencies.
Finally, we need to redouble our efforts to enhance our own
capacity at CDC to respond to future threats. Since October 4th
we have tested over 5,500 laboratory specimens. Our labs are
working 24 hours a day. Scientists sleep in their office to
avoid losing time. We need to expand that scientific capacity
in the areas of epidemiology, surveillance, and laboratory, as
well as accelerating our plans to improve our physical
facilities and enhance security at all our locations.
In conclusion, the strength of our Nation to deal with
bioterrorism is only as strong as our weakest links. That means
every local health department, every State health department,
and the Federal capacity have got to all be optimal and they
have to be optimal in a variety of different capacities:
laboratory, ability to investigate quickly and accurately,
communication--the range of what modern public health is about.
PREPARED STATEMENT
When that playing field is level, when there are no weak
spots, then we will be truly capable of dealing with a wide
range of threats as they come to us. But a strong and flexible
public health infrastructure is our best defense.
[The statement follows:]
Prepared Statement of Jeffrey P. Koplan, M.D.,
Good morning, Mr. Chairman and Members of the Subcommittee. I am
pleased to appear before you on behalf of the Centers for Disease
Control and Prevention (CDC). Thank you for the invitation to discuss
CDC's public health response to the threat of bioterrorism.
The terrorist events on and since September 11th have been defining
moments for all of us-and they have greatly sharpened the Nation's
focus on public health. Even before the September 11th attack on the
United States, CDC was making substantial progress to define, develop,
and implement a nationwide public health response network to increase
the capacity of public health officials at all levels-local, State, and
Federal-to prepare for and respond to deliberate attacks on the health
of our citizens. Since September 11th we have dramatically increased
our efforts, resulting in a heightened level of preparedness, which we
are committed to increase even further based on lessons learned in
recent months.
CDC's top priority is to protect the Nation's health. To do this,
CDC focuses on building a solid public health infrastructure--at CDC,
as well as at the State and local level to protect the health of all
citizens. As recent events have shown so dramatically, we must be
constantly vigilant to protect our nation's health and security. The
war on terrorism is being fought on many fronts, and we must ensure a
strong, robust public health system to be on guard at all times to
prevent and respond to multiple and simultaneous terrorist acts. The
arsenal of terrorism may include biological, chemical, and radiological
agents as well as conventional and non-conventional weapons, as the
attack on the World Trade Center so vividly attests.
bioterrorism preparedness
CDC has used funds provided by Congress to begin the process of
improving the expertise, facilities and procedures of State and local
health departments and within CDC itself related to bioterrorism. CDC
has established a Bioterrorism Preparedness and Response Program to
direct and coordinate our activities. CDC has a dedicated anti-
bioterrorism staff of more than 100 full-time professionals comprising
expertise in epidemiology, surveillance, and laboratory diagnostics.
Over the last three years, we have awarded more than $130 million
in cooperative agreements to 50 States, one territory and four major
metropolitan health departments to support,
(1) Preparedness planning and readiness assessment;
(2) Epidemiology and surveillance
(3) Laboratory capacity for biological or chemical agents; and
(4) The Health Alert Network (a nationwide, integrated, electronic
communications system).
Since September 11, we have sent almost 500 CDC staff to the field.
For Example, at the height of the anthrax response in the Nation's
Capital, there were 85 staff in Washington, DC alone. These experts
included epidemiologists, industrial hygienists involved in
environmental sampling and clean up, laboratorians, communications
specialist to assist with media relations, and logistics and management
staff. CDC not only investigated cases that proved to be anthrax in
four States and the District of Columbia, but also investigated
suspicious cases in six other States. These cases proved not to be
anthrax, but required CDC assistance to go through the process of
ruling them out. CDC experts were needed to augment the staff of State
and local health departments, who would have been severely overtaxed
without our help. The Administration has requested $20 million through
the Emergency Response Fund to create additional specialized Federal
teams and place additional Epidemic Intelligence Service (EIS) officers
in more States.
CDC has launched an effort to improve health laboratories that
likely would be called upon to identify a biological or chemical
attack. The Laboratory Response Network (LRN), a partnership among the
Association of Public Health Laboratories (APHL), CDC, FBI, State
Public Health Laboratories, DOD and the Nation's clinical laboratories,
will help ensure that the highest level of containment and expertise in
the identification of rare and lethal biological agents is available in
an emergency event. The LRN also includes the Rapid Response and
Advanced Technology Laboratory at CDC, which has the responsibility of
providing rapid and accurate triage and subsequent analysis of
biological agents suspected of being terrorist weapons. The
Administration has requested $35 million under the Emergency Response
Fund to improve State and local health departments' laboratory capacity
and improve CDC's internal laboratory capacity.
The CDC is also working to provide coordinated communications in
the public health system, between Federal agencies and between public
health officials and the public itself. To this end, CDC has the
Epidemic Information Exchange (EPI-X). The EPI-X is a secure, Web-based
communications network that will strengthen bioterrorism preparedness
efforts by facilitating the sharing of preliminary information about
disease outbreaks and other health events among officials across
jurisdictions and provide experience in the use of a secure
communication system.
CDC has invested $90 million in the Health Alert Network (HAN), a
nationwide system that will distribute health advisories, prevention
guidelines, distance learning, national disease surveillance
information, laboratory findings and other information relevant to
State and local readiness for handling disease outbreaks. HAN provides
high-speed Internet connections for local health officials; rapid
communications with first responder agencies and others; transmission
of surveillance, laboratory and other sensitive data; and on-line,
Internet- and satellite-based distance learning. With the addition of
several recent awards, CDC has provided HAN funding and technical
assistance to 50 State health agencies, Guam, the District of Columbia,
three metropolitan health departments and three exemplar Centers for
Public Health Preparedness. The Administration has requested an
additional $40 million through the Emergency Response Fund to improve
and expand these systems.
CDC also manages the National Pharmaceutical Stockpile (NPS), which
provides us with the ability to rapidly respond to a domestic
biological or chemical terrorist event with antibiotics, antidotes,
vaccines and medical materiel to help save lives and prevent further
spread of disease resulting from the terrorist threat agent. The NPS
Program provides an initial, broad-based response within 12 hours of
the Federal authorization to deploy, followed by a prompt and more
targeted response as dictated by the specific nature of the biological
or chemical agent that is used. The first emergency deployment of the
NPS occurred in response to the tragedy in New York City.
We saw just how critical local planning is--each State and
community needs to plan for terrorism. The planning process builds
essential relationships among public health, emergency management, and
health care providers. And this coordination, especially with law
enforcement must be strong--at the Federal, State, and local level--as
the anthrax investigations have highlighted. Currently, CDC funds only
nine States and two cities to do this planning. Under the
Administration's Emergency Response Fund request, an additional $10
million will allow all States and territories to receive funding for
planning and preparedness activities.
In light of the recent terrorist attacks, it is important for CDC
to improve security in its facilities. CDC received an additional $3
million in the initial Administration release of Emergency Response
Funds, and the Administration's Emergency Response Fund request also
includes an additional $30 million to secure CDC facilities,
particularly where special pathogens may be stored. Also, as mentioned
earlier, there is an additional $20 million to improve and upgrade
CDC's internal laboratory capacity.
challenges for the future
Although we have accomplished a great deal in the past 10 weeks, we
have several remaining challenges .
First, it is critical that we bolster infrastructure in State and
local health departments. As evidenced by our experiences following the
September 11th and anthrax incidents, public health departments are at
the frontlines of emergency response. State and local health
departments need expanded capacities and resources for key preparedness
and response functions such as early detection, laboratory analysis,
and crisis communications.
In addition, we must continue to forge relationships between
clinical care and public health. It was through the efforts of
clinicians that we were able to identify the cases of anthrax. These
physicians reported the cases to their local public health authorities
and obtained laboratory specimens for analysis at State laboratories
and CDC. The closer the relationship between clinical medicine and
public health the faster we are able to identify potential bioterrorist
threats and other outbreaks, identify the cause of the illness, and
provide early treatment to save lives.
Another important opportunity is to strengthen our relationships
with other Federal agencies, and State and local agencies outside the
field of public health. Since September 11th, we have created stronger
partnerships with a wide range of agencies, particularly the law
enforcement community. For example, in response to the recent events,
CDC assigned an individual to work at the FBI to assure optimal
information exchange between the two agencies. As we prepare for any
future threats, we need to maintain and enhance our ties with a much
larger range of agencies.
Finally, we must redouble our efforts to enhance our own capacity
at CDC to respond to future threats. For example CDC has tested over
5400 human and environmental samples since October 4, our labs have
worked around the clock, with scientist sleeping in their offices to
avoid losing time. We need to expand our scientific capacity in the
areas of epidemiology, surveillance, and laboratory, as well as
accelerating our plans to improve our physical facilities and enhance
security in all CDC locations.
conclusion
In conclusion, CDC is committed to working with other Federal
agencies as well as State and local public health partners to ensure
the health and medical care of our citizens. We have made substantial
progress to date in enhancing the nation's capability to prepare for
and respond to public health threats and emergencies, including
bioterrorism events. The best public health strategy to protect
civilians against any health threat is the development, organization,
and enhancement of public health systems and tools. Priorities include
a fully staffed, fully trained, and properly protected public health
workforce, strengthened public health laboratory capacity, increased
surveillance and epidemiological capacity, secure up-to-date
information systems, solid health communications capabilities--all
supported by flexible policies and preparedness plans that enable the
public health system to prepare for and respond to any type of health
emergency at the Federal, State, and local level. Not only will this
approach ensure that we are prepared for deliberate bioterrorism
threats, but it will also ensure that we will be able to recognize and
control any threat to the public's health. A strong and flexible public
health infrastructure is our best defense. The Administration's
Emergency Response Fund request is an important step in this process
and we encourage you to support it.
At this time, I would be happy to answer questions from you and
Members of the Committee.
Senator Harkin. Thank you very much, Dr. Koplan.
Dr. Fauci.
STATEMENT OF ANTHONY S. FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS
DISEASES, NATIONAL INSTITUTES OF HEALTH
Dr. Fauci. Mr. Chairman, Senators Specter, Stevens, Kohl:
Thank you for calling this hearing and thank you for giving me
the opportunity to testify before you. As you have just heard
from Dr. Koplan, the effort to address bioterrorism is out of
necessity a comprehensive and multi-faceted endeavor involving
multiple Federal agencies, several sister agencies within the
Department of Health and Human Services, as well as other
agencies such as the Departments of Defense and State, local
health departments, and, importantly, private industry.
The NIH's role in this important comprehensive approach is
a very specific one and that is addressing the biomedical
research component of the counter-bioterrorism effort. We do
that with basic research--I will talk about that very briefly
in a moment--and we aim to develop and apply basic research to
the production of diagnostics, therapeutics, and ultimately
vaccines.
We have emphasized, together with the CDC, a number of
microbes that we call Category A microbes that are, in our
estimation, of the highest risk and greatest impact. Among
these are anthrax, smallpox, plague, botulism, tularemia and
the hemorrhagic fevers. In the interest of time, I am going to
focus my very brief discussion on the NIH research efforts
addressing smallpox and anthrax.
First with regard to smallpox, as I testified a short time
ago before this committee, we have embarked on dilutional
studies to look at the already-owned stock that the Federal
Government has under the auspices of the CDC, the 15 million
doses, to determine if by diluting them one-to-five or one-to-
ten we can preserve the potency as well as expand the numbers.
This study is proceeding extraordinarily well. We have an
encouraging high rate of ``takes.'' A ``take'' is an indication
that the potency still remains, even when the vaccine is
diluted. I will be happy to discuss this a little bit later.
You heard yesterday the announcement of the letting of the
contract by Secretary Thompson to Acambis and Acambis-Baxter to
have 155 additional million doses of a second-generation
vaccine to supplement those that we already have contracted
for. Together with the dilutional group, this will allow us to
have vaccine available if necessary to give to everyone and
anyone in the country.
Importantly the NIH research effort also includes third-
generation vaccines, namely the molecular biological approach
of looking at purified sub-units that would obviate the concern
regarding toxicities of using a live virus. This is years away,
but it is one of those future things that we need to approach
because this would make it safe for all populations.
We also have an antiviral screening and development
program. You have heard of the drug Cidofovir. I mentioned this
at the last hearing. It is a drug that we originally developed
for the purpose of treating cytomegalovirus infection in HIV-
infected individuals. It is now shown in the test tube and in
animal models to be highly effective against a variety of pox
viruses. We are pursuing this in investigational new drug
applications to determine its capability against disseminated
vaccinia and ultimately smallpox.
Moving on to anthrax, the NIH's role is to cooperate with
our sister agencies, CDC, USAMRIID, and others, together with
the FDA to develop a recombinant protective antigen anthrax
vaccine that we could use as a second- and third-generation
vaccine. Also, there is a considerable amount of basic research
done on the anthrax microbe itself to answer some--not all but
some--of the questions that Senator Stevens just brought up.
Integral to our research effort again is another area that
we have been working on for a considerable period of time that
significantly antedated the September the 11th tragedy. That is
the sequencing of the full genomes of pathogenic microbes,
including smallpox, anthrax, and several others. The reason
that this is important is because this approach gives us a very
specific target for the development of diagnostics,
therapeutics, and vaccines.
Very briefly, there are other agents that I alluded to. We
do not have time to go into them right now, but one of them in
particular is the group of hemorrhagic fevers, including Ebola.
We have a program at the NIH in the Vaccine Research Center of
the NIAID that has shown very convincingly in a non-human
primate model that a recombinant type of second-third-
generation vaccine was able to protect these non-human primates
against Ebola. We are moving as rapidly as we can to get that
into phase one trials.
Having said all of this, much still needs to be done
because there are many unanswered questions and we need to
address these as quickly as we possibly can.
In summary, the NIH is focusing our basic and applied
research resources on bioterrorism. We have at the intramural
research program at NIH, and in our extramural community of
very talented investigators whom we support with grants and
contracts, the world's experts in the science of countering
bioterrorism. Together with our sister agencies such as the
Centers for Disease Control and Prevention, we commit ourselves
to meeting this most extraordinary and historic challenge to
the health of our Nation.
PREPARED STATEMENT
I would be happy to answer any questions, Mr. Chairman.
Thank you.
[The statement follows:]
Prepared Statement of Anthony S. Fauci, M.D.
Mr. Chairman and Members of the Subcommittee, thank you for
inviting me here today to provide an update on the current bioterrorism
research activities of the National Institutes of Health (NIH) and our
plans for the future. Any program that will effectively counter
bioterrorism out of necessity would be a comprehensive program
involving multiple government agencies, local and State health
departments, and private industry. An important component of such a
comprehensive effort is biomedical research. The role of the NIH in the
overall government effort against bioterrorism is to conduct and
support such research.
The NIH bioterrorism research program is spearheaded by the
National Institute of Allergy and Infectious Diseases (NIAID) and
encompasses four broad areas: basic research, diagnostics, vaccines and
therapeutics. I would like to briefly describe our research in these
broad areas as well as summarize several specific NIAID-supported
smallpox and anthrax studies.
Research into the basic biology and disease-causing mechanisms of
pathogens underpins efforts to develop interventions against agents of
bioterrorism. NIH supports research to better understand the factors
that influence a pathogen's virulence and invasiveness, as well as
those that determine antibiotic resistance. NIH also supports research
on the host/pathogen interactions. Knowledge from basic research
findings is crucial to the development of preventative and therapeutic
strategies.
One of the most important basic research tools that has evolved in
recent years is the ability to rapidly sequence the entire genomes of
microbial pathogens, including potential agents of bioterrorism. Some
agents, such as smallpox and other orthopoxviruses related to smallpox,
have already been sequenced; the sequences of others, such as Bacillus
anthracis (the anthrax bacterium) and other bacteria relevant to
bioterrorism are in progress and close to completion. The fruits of
genomics research, coupled with other biochemical and microbiological
information, are expected to facilitate the achievement of critical new
goals, including the discovery of new targets for drugs and vaccines.
In particular, comparative genomics (comparing the sequences of
different strains of particular organisms) will be an important
component of future research, helping us to understand what makes a
particular organism either harmful or benign.
NIH also supports research leading to the development of new and
improved diagnostics. The goal of this research is to establish methods
for the rapid, sensitive, and specific identification of natural and
bioengineered microbes as well as the determination of the microbe's
sensitivity to drug therapy. These scientific advances will allow
health care workers to diagnose and treat patients more accurately and
quickly.
NIH-supported researchers are developing vaccines that are
effective against many infectious agents, including those considered to
be bioterrorism threats, with the intention of developing products that
are safe and effective in civilian populations of varying ages and
health status. Vaccines against pathogens are being developed using
both traditional and novel technologies. Some novel technologies
include the development of ``DNA vaccines'', various vector vaccines,
and innovative systems for the rapid creation of vaccines against
unfamiliar or genetically altered pathogens; these technologies are in
various stages of development.
NIH therapeutics research focuses on the development of new
antimicrobials and antitoxins, as well as the screening of existing
antimicrobial agents to determine whether they have activity against
organisms that might be employed by bioterrorists. Knowledge gained
from basic and applied research is helping to identify additional
targets for medications against agents of bioterrorism. The design of
therapeutic drugs active against known drug-resistant variants of
microbes, and the development of broad-spectrum agents are also
important NIH research priorities.
Together, these efforts create the strong foundation from which the
NIH carries out bioterrorism research activities. Two cogent examples
of this multifaceted research approach are the specific NIH projects in
the areas of smallpox and anthrax. Smallpox is considered one of the
most dangerous, potential biological weapons because it is easily
transmitted from person-to-person, and very few people carry full
immunity to the virus. Historically, the mortality of smallpox
infection has been approximately 30 percent; those patients who recover
frequently have disfiguring scars.
NIAID research on smallpox focuses primarily on extending existing
vaccine stocks to increase the number of available doses, and
developing new vaccines and treatments for the entire population, as
well as diagnostic tools to detect the disease quickly.
At present, the approximately 15 million doses of the traditionally
employed and highly effective ``Dryvax'' vaccine that have been stored
since production stopped in 1983 would not be enough to respond to a
national smallpox epidemic. In response to this shortage, NIAID
initiated a study last year to determine the feasibility of expanding
the use of the existing stores of the Dryvax vaccine by dilution. In
this study, investigators examined and compared the skin and immune
system responses of normal unimmunized adult volunteers who were given
undiluted Dryvax vaccine, a 1:10 dilution (10 percent) of vaccine or a
1:100 dilution (1 percent) of vaccine. The results showed that the
full-strength vaccine had maintained its potency, and that 70 percent
of people who received a single dose of the 10-percent diluted vaccine
developed a sore followed by a scab at the injection site and
antibodies in their blood, strongly suggesting protection. The 1:100
dilution had an unacceptably low take rate.
Based on these findings, a larger study is underway to determine
the best strategy for optimal use of available vaccine. This study,
which will enroll up to 684 people, is evaluating three different doses
(undiluted, 1:5, 1:10) of Dryvax. Researchers will study the ability of
the various vaccine formulations to stimulate a scab, or ``take,'' at
the vaccination site and to produce neutralizing antibodies in the
blood. If participants have not developed a scab in seven to nine days
after vaccination, they will be revaccinated with the same vaccine dose
they received the first time. By that strategy, researchers hope to
learn which vaccine dose given in a single injection elicits the
desirable response among the largest number of people and whether
``boosters'' can increase the take rate on a population basis.
NIAID is also designing clinical protocols for testing of Dryvax in
previously immunized adults and in children. At the same time, we are
investigating the newer cell culture based smallpox vaccines as well as
alternative vaccination strategies with the goal of designing safer and
more effective vaccines.
NIAID/NIH also supports long-established contracts that conduct in
vitro and in vivo screening of known antiviral compounds to determine
if they are effective against viruses that are similar to smallpox
(vaccinia virus and cowpox virus). Compounds with promising in vitro
activity are further evaluated in animal models of orthopoxvirus
infection by both United States Army Medical Research Institute of
Infectious Diseases (USAMRIID) and NIAID-supported investigators. To
date, NIAID and USAMRIID have screened approximately 500 compounds. The
drug cidofovir has been shown in multiple test systems to have activity
against all orthopoxviruses tested in vitro and in vivo. NIAID
submitted an Investigational New Drug (IND) application for use of this
drug as a backup to vaccinia immune globulin (VIG) in our dilutional
vaccine studies and possibly for the emergency treatment of smallpox
should a bioterrorism attack occur.
One key collaborative activity that will accelerate the development
of new treatments and vaccines for smallpox is the recent establishment
of the ``Orthopoxvirus Genomics and Bioinformatics Resource Center.''
NIAID, the Defense Advanced Research Projects Agency (DARPA), the
Centers for Disease Control and Prevention (CDC), USAMRIID and the
American Type Culture Collection have all contributed toward this
Center, which will conduct sequence and functional comparisons of genes
to provide insights for the selection of targets for the design of
antivirals and vaccines.
With regard to anthrax research, NIAID has been collaborating with
the Department of Defense (DOD) to support the development of the next
generation of anthrax vaccines that may be more appropriate than the
current anthrax vaccine for use in the civilian population. At present,
we are currently planning Phase 1 safety and immunogenicity trial for
the USAMRIID recombinant protective antigen (rPA), one of the leading
anthrax vaccine candidates. In addition, NIAID is utilizing its vaccine
production and support contractor, Science Applications International
Corporation (SAIC) to facilitate and expedite the development of
additional rPA vaccines.
NIAID is also exploring rapid diagnosis of anthrax and the utility
of available antimicrobial or antitoxin therapies. Together with the
Food and Drug Administration (FDA), CDC, and USAMRIID, NIH is working
to prioritize and accelerate testing of existing antimicrobials for use
against anthrax. Last month, NIAID-supported investigators published
two studies in the scientific journal Nature that help to explain how
anthrax toxin destroys cells. In the first study, researchers have
identified the site on the cell that binds the anthrax toxin and have
developed a compound that may disable it. Another group of
investigators has characterized the structure of a major component of
the anthrax toxin. The information gained through these studies will
likely hasten the development of new drugs to treat anthrax.
In addition, the NIAID, through an Inter-Agency Agreement with the
Office of Naval Research, has provided funds to help complete work on
sequencing the genome of B. anthracis. The information derived from
this genome-sequencing project should be of great value in developing
rapid diagnostic tests, as well as new vaccines and antibiotics
therapies against mutant strains of B. anthracis.
Although the focus of national attention has been on smallpox and
anthrax, we must not overlook other organisms of bioterrorism,
including agents that cause plague, tularemia, botulism, and viral
hemorrhagic fevers. NIH-supported research is yielding insights in
these areas. For example, intramural investigators at NIAID's Dale and
Betty Bumpers Vaccine Research Center have developed a DNA vaccine that
has protected monkeys from infection with Ebola virus; this vaccine
could soon enter human trials.
Together with our many research partners, NIH has made substantial
progress in the research effort that is critical to our Nation's fight
against emerging diseases, including those that are intentionally
released as agents of terrorism. In addition to previously mentioned
collaborations with other government agencies, NIAID maintains
important partnerships with industry that are essential to the
development of new technologies and treatments in the arena of
infectious diseases.
Much remains to be accomplished, however, and the challenges posed
by bioterrorism will require a sustained commitment over the years to
come. Within the next few weeks, NIH will announce new initiatives for
funding in fiscal year 2002 to provide the academic and industrial
research communities with an opportunity to propose studies targeting
new approaches to research on agents of bioterrorism. For example, we
will unveil an initiative entitled ``Partnerships for Novel
Therapeutic, Diagnostic and Vector Control Strategies in Infectious
Diseases,'' which will involve substantive involvement by a private
sector partner and focus on areas that are currently not a high
priority or that may be too financially risky for industry to pursue
alone, but are likely to have a high impact on public health. The
submission, review, and funding of these proposals will be expedited in
order to facilitate the rapid advance of these important research
endeavors. This information is being made available to the public and
the research community through our website.
With a strong research base, talented investigators throughout the
country, and the availability of powerful new research tools, we fully
expect that our basic and applied research programs will provide the
essential elements that will greatly enhance our defenses against those
who attempt to harm us with bioterrorism.
That concludes my testimony. I would be happy to respond to any
questions that you might have.
Senator Harkin. Thank you, Dr. Fauci.
I wonder if I could start with you, Dr. Fauci. To go back
over smallpox, I would like you to, if you could, in just a
little more detail outline for us the proposal that Secretary
Thompson made late yesterday afternoon. I spoke with him
personally myself yesterday. As I understand it, negotiations
have been finished, and there will be, what, three companies
that will be supplying the smallpox vaccine?
I am not so much interested in all the minute details. What
I really want to know is, give us a time line and let us know,
how soon will you be able to tell us whether the 15.4 million
doses that we have stockpiled now could be used for, let us
say, up to maybe seven, eight times that much, depending on the
dilution? How soon will we know that?
How soon will we have enough vaccines available for every
person in America? How soon we will have that built up under
the agreement that was made yesterday?
Dr. Fauci. First of all, it is not three companies, Mr.
Chairman. The companies involved are the company Acambis that
we had already contracted with initially to make 40, but then
changed to over 50 million doses of the second-generation
vaccine. They have combined with a large company called Baxter.
So to avoid confusion, there is the Acambis contract that had
already been let, and then there is the Acambis-Baxter contract
which was announced by Secretary Thompson yesterday.
So let me run through your questions briefly and tell you
how we are going to get to the total number of doses that you
refer to. The dilutional study that started at the end of
October, in which we are looking at that 15 million doses to
see if we could stretch them out, we are doing a one-to-five
and a one-to-ten dilution. We have vaccinated essentially
everyone with just a few to go in the original 684. The take
rate is extraordinarily high.
Senator Harkin. That is undiluted?
Dr. Fauci. That is, no, on all of them.
Senator Harkin. All of them.
Dr. Fauci. We cannot tell you exactly and I do not want to
make any announcement of results because you have to
scientifically examine them, put them to peer review, look at
the antibody titers that we do not have yet. We are just
looking at take rate, and our experiments over the years tell
us that take rates coincide very well with the production of
the antibodies that you would like to induce.
So it is not final yet, but things are looking quite good.
We will have those results in their final form by the end of
January, the very beginning of February. Let us assume that the
dilution one-to-five does in fact give you a high rate of
induction of immunity. That then would provide us with about
75-plus million doses. So that is one component of the totality
of doses.
We have a contract with the CDC and Acambis, that has been
going on for a considerable period of time, with the original
target to get 40 million doses by the beginning of the year
2004. That has been markedly upscaled to now deliver 54 million
doses by the end of the year 2002. That is another 54 million.
So it is 75 and 54 million.
Then you have what you heard about yesterday, the 155
million doses in which Acambis and Baxter together are going to
give us that second generation smallpox vaccine. They are now
going to be having pilot lots probably by the beginning of the
year, later winter or so. Then there will be an accrual, that
each month that goes by there will be that many more tens of
millions of doses, so that by the time we get to late fall,
perhaps early winter of 2002, we will have the totality of
doses that you referred to, which would be about 280 million
some odd doses.
Senator Harkin. Do you know--I do not know if you are the
right person to ask this question, but is the idea then that
these vaccines would be distributed around the United States at
various locations? Is that the idea?
Dr. Fauci. The idea is to have them in reserve. I will
defer to Dr. Koplan, since the CDC plays such a major role, not
only in the advice about how and when and where to vaccinate,
but also in the distribution. So if I could pass that over to
Dr. Koplan, he could answer that.
Dr. Koplan. Thanks.
We have already begun discussions on the appropriate
deployment of amounts of vaccine as they become available. What
will happen is in the coming months we will have broad public
discussions with academicians and scientists from both within
the government and outside the government, from academia,
elected officials, Congress, and discuss the pros and cons of
the various alternative ways of dealing with having a vaccine
for which currently there is no naturally occurring infection,
but for which there might be a threat of its use as a
bioterrorism agent, and the level of that threat is quite
unknown at this time.
The issues that will be involved in that discussion are
complex and they involve: one, the issue of should there be a
mandatory vaccination, should everyone have it? If that were
true, does it then get repeated every year for new people who
have not been vaccinated?
This is a vaccine which has a low rate of side reactions to
it, but a real and a predictable rate of side reactions to it.
Some of them are not just significant reactions. Some of them
are severely damaging and some of them result in death. So if
you use this vaccine in a million people, you can expect a half
dozen or more to be severely enough injured from the vaccine to
be hospitalized and some number of those to die from it.
So in a widespread use of the vaccine, there will be
hospitalizations, there will be people with permanent damage,
and there will be deaths. So that has to get balanced with what
one considers the threat of an introduction of smallpox. This
will take place over the coming months as the amount of vaccine
is increased in the country.
We have a mechanism for determining immunization policy in
this country using the ACIP, the Advisory Committee on
Immunization Practices, which has served us well over decades
now and has resulted in the lowest rates of disease from
immunizable illnesses that has ever been seen in the world. So
they would I think play a major role as well in this.
Senator Harkin. Thank you, Dr. Koplan. I want to come back
and ask you about that later. I see my time is up right now,
but I want to ask about Cidofovir and the stockpile, if we are
going to stockpile that drug, later on.
Senator Specter.
Senator Specter. Thank you, Mr. Chairman.
Dr. Koplan, on October 23rd at our bioterrorism hearing I
asked you to furnish a list of all the threats and the costs
involved. I would like now your professional judgment on what
we need to appropriate now to meet all the bioterrorism
threats.
Dr. Koplan. Thank you, Senator Specter. I am happy to offer
my professional judgment. Of course, you will all recognize
that it is not constrained by the competing priorities that the
President and his advisors must consider.
Having said that, a major area for upgrade is State and
local health capacity. You have heard that from, I think, your
own respective States, wherever they are, and that this is
really where things start in a bioterrorist event. It started
in Palm Beach County, Florida; it started in New York City.
Senator Specter. Dr. Koplan, I have got 5 minutes. What is
the cost?
Dr. Koplan. Okay. Basically, roughly between $15 and $20
million per State is needed to get them up to running speed for
this.
Senator Specter. Total national?
Dr. Koplan. For a total of about $1.050 billion for States.
Senator Specter. What is next?
Dr. Koplan. Upgrading CDC capacity, including our
biological capabilities and laboratories and chemical needs, is
roughly $150 million.
Senator Specter. I am convinced of that. I have seen it
myself. Next?
Dr. Koplan. The national pharmaceutical stockpile we want
to enlarge. We want to add anti-botulism items. We want to
increase trauma supplies, etcetera. That is about $640 million.
We will add four more pushpacks to bring the total to 12 from 8
that we had before.
For the vaccine purchase that you have heard Dr. Fauci just
describe, there are also some implementation figures that might
be helpful for States. In other words, it is not just having
the vaccine present in a warehouse. It is how do they get them
out to communities. We can work with your staff to give an
estimate of that number, but that will require a little more
research.
Senator Specter. What is your professional estimate at the
moment?
Dr. Koplan. I would guess it is probably somewhere between
$600 and $700 million for the extra expenses beyond just
producing the vaccine.
For laboratory security, principally at CDC, at four of our
campuses that have biological agents present, roughly $96
million would be required for laboratory security improvement.
Then finally, for efforts related to the events of the last
several months, where lots of expenditures have been made and
lots of needs have been accrued by the localities in which
these bioterrorist and terrorist events have occurred, roughly
$50 million.
Senator Specter. Did you cover smallpox?
Dr. Koplan. Smallpox is handled within that vaccine, the
area that I just mentioned, $600 to $700 million.
Senator Harkin. $600 to $700 million.
Dr. Koplan. Plus the purchase, not including the purchase
cost.
Senator Specter. So what would the total need be for the
purchase of vaccines?
Dr. Koplan. Well, the purchase of vaccines, as Dr. Fauci
just indicated, is the $500 million figure for purchasing these
new vaccines.
Senator Specter. I had been informed that the smallpox
vaccine would cost $1.4 billion.
Dr. Koplan. I am saying the purchase of the vaccine itself
is roughly $500 million, but then there are other expenses in
terms of getting it out to States and localities, having people
prepared to use it, and having training for those people. There
also has to be vaccinia-immune globulin.
Senator Specter. Then is the $1.4 billion figure accurate
or not?
Dr. Koplan. I think that is a little high because of the
negotiation and the lower price we got on the vaccine that was
announced yesterday.
Senator Specter. How much would you take off the figure
then?
Dr. Koplan. I would probably take off $600 million off of
that, based on the way we have been able to package vaccine and
get it up to 300 million doses.
Senator Specter. So $800 million instead of $1.4 billion?
Dr. Koplan. Exactly.
Senator Specter. The release by the Secretary yesterday on
the expenditure of some $428 million, that has to be
appropriated. The Department does not have that money, correct?
Dr. Koplan. I believe that has to be appropriated, correct.
Senator Specter. So he is contracting for it without
authorization, without an appropriation from Congress, and I
congratulate him for doing so.
You did not answer the question, Dr. Koplan, and you do not
have to.
Dr. Fauci, the same question was put to you. What are the
needs for NIH to have adequate funding for bioterrorism?
Dr. Fauci. In our original request that is contained in the
President's budget, Senator Specter, we had accelerated up to
$92.7 million. As things have evolved since the time of that
submission I would have to give you my professional judgment of
what we would need to meet what I feel are the scientific and
public health needs that the NIH can address. As Dr. Koplan
said, I would have to say that this judgment is not constrained
by those other priorities of the President and his advisers.
But in my professional judgment we would have to do
significantly more than that. If you look at bioterrorism
prevention, treatment, vaccine and other basic research, not
only in smallpox, anthrax, and other microbes, together with
the secure facilities that we would need, what we call BL-4
facilities, to work with the material that we would ultimately
have to work with, as well as other physical security measures
and continuation of part of the smallpox vaccine program, it is
going to depend on when we get it. But I will give you specific
numbers, because if we could do it immediately it would be
something that would be more front-loaded.
If you are talking about the number that we could clearly
do--the kinds of research that I think are implementable right
now--we are talking about a total additional number above the
$92.7 million that ranges from $175 million to more than $200
million, again depending on when and how we get it.
If you add the kinds of things that we need----
Senator Specter. The question is how much do you need and
can you put it to use now?
Dr. Fauci. Right now, we could put to good use between $175
million and $200 million, in addition to the $92.7 million that
we asked for.
Senator Specter. That sounds to an appropriator like $175
million. Will that meet your needs? If you are going to give us
a range of $175 million to $200 million, we are not going to
give you the top figure; we are going to give you the bottom
figure. I just want to be sure that is what you need.
Dr. Fauci. We could adequately spend up to $200 million.
Senator Specter. Dr. Koplan, on the figures you have given,
is there room for a first installment or is that the money you
need now to move ahead with an adequate response to
bioterrorism?
Dr. Koplan. I think we are facing risks now and the sooner
these funds beef up State and local health departments, the
sooner we are better prepared.
Senator Specter. So you have a need to expend them now?
Dr. Koplan. Yes.
Senator Specter. Thank you.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Specter.
Senator Kohl.
OPENING STATEMENT OF SENATOR HERB KOHL
Senator Kohl. Thank you, Senator Harkin.
Dr. Koplan, I would like to talk with you about the
immunization program for the vast number of people who we would
describe as the caregivers in the event of an outbreak--
physicians, nurses, people who work in hospitals around the
country, other local public health officials. I am assuming
that in order for them to provide the kind of service that
would be necessary in the event of an outbreak they would need
to be immunized beforehand.
Number one, is that true? Number two, what is the program
that is on the table to immunize the caregivers of this
country? Number three, how long does it take to provide that
immunization to an individual, a day, a week, a month? How is
this going to unfold and how quickly is this going to unfold?
Dr. Koplan. Thank you, Senator Kohl. We are trying to
determine who would most benefit from vaccine. There are a
range of both caregivers and non-caregivers who could
potentially be exposed. One of the aspects of smallpox is that
in the first 4 days after exposure to the disease you can still
get the vaccine and be fully protected from it. So, unlike some
other diseases where you have to get the vaccine days, weeks,
or months ahead of time, smallpox is different. You begin to
produce antibodies right away.
Another method of protection against smallpox is not just
vaccine, but the type of isolation procedures that hospitals
routinely use for a wide variety of other diseases and that can
protect their staff, including the use of face masks protective
against smallpox dissemination.
Nevertheless, having said those two things, what we are in
the process of now, we have just put out a draft version of a
national smallpox bioterrorism plan, if you will. That was
created in cooperation with State and local health partners.
What we are going to be doing is meeting, talking with them,
with physician groups, nursing groups, etcetera, to determine
just what you said, who are the groups that would most benefit
from early vaccination with smallpox vaccine.
Senator Kohl. All right, I appreciate that. But if we have
an outbreak tomorrow or next week, are the caregivers of this
country prepared to provide their services?
Dr. Koplan. Yes. If we have an outbreak today--first of
all, the outbreak begins with the recognition of a case or two,
that is the way all outbreaks begin. At that point, local and
State investigators would be on the spot, getting specimens,
determining what is going on, and also identifying what had
been exposed to that individual. All those individuals would be
getting vaccine and we would go in increasing rings around that
individual who had been exposed.
Senator Kohl. Yes, but don't those people need to be
immunized in order to provide the kind of services that will be
necessary?
Dr. Koplan. No, they do not. They can provide those
services. I am not currently immunized and I would not hesitate
to provide service to someone who came in with a rash or an
illness, as long as I know that within 4 days after I have had
that exposure I can get vaccinated.
Senator Kohl. You said that is true with respect to
smallpox?
Dr. Koplan. That is true for smallpox.
Senator Kohl. What about other communicable diseases?
Dr. Koplan. Some of the other diseases that we worry about,
rather than vaccines, we have antibiotics that are effective
against them. But I think the key item in every one of these
things that you are raising and appropriately raising is the
speed of diagnosis. That is what makes all the difference in
every one of these outbreaks. It is how quickly you could
identify those first cases, because particularly in diseases,
unlike anthrax which cannot be spread from person to person.
But some of the other diseases that we would worry about, such
as smallpox and some others, are spread from person to person.
So the speed of that first diagnosis is crucial in limiting
the amount of spread of disease.
Senator Kohl. Well, do we intend to immunize in advance
those several hundred thousand primary caregivers around the
country?
Dr. Koplan. I think that is a subject for discussion. As we
get more doses of vaccine available, certainly more and more
people can and ought to be considered. It is not just the
primary caregivers. Once you get into a hospital emergency
room, it includes maintenance staff and cleanup crews and
people that come in and out, and there is turnover of all these
individuals.
As I indicated before, the thing one has to keep in mind
with something like smallpox vaccine is it is a live vaccine
which is present on the skin surface. With its rates of side
reactions, people who are immunosuppressed, who are HIV-
positive, may have severe reactions to this vaccine. In
addition, people working in hospital environments where there
are sick people around may have to leave work for a period of
time while that vaccination takes place because of the live
virus present; they may not have to, but some may.
So these are all complicating issues when you talk about
health care providers getting the vaccine. There is a tradeoff.
If they absolutely need it, then they need to get it. But where
the risk is unclear, there are also dangers attached to
providing the vaccination, and it is these benefits and risks
that have to be taken into balance and will be discussed with
both clinicians and clinician groups and with public health
people in the States.
Senator Kohl. Are you prepared to recommend that this group
be immunized in advance at this time, next week, next month?
Dr. Koplan. No, I am not prepared to make that
recommendation. But we are certainly eager to have discussions
with both these people who would be involved and the people in
the States and see what the consensus is on what policy would
be best.
Senator Kohl. Thank you.
Thank you, Senator.
Senator Harkin. Thank you, Senator Kohl.
Senator Stevens.
Senator Stevens. Doctors, let me first start by making a
short statement, and that is this. We are dealing with bills
now that will probably not be signed until Christmas. Monies
could not be released until at least January. We will be
through at least one quarter of the fiscal year.
The figures you have just given the chairman and Senator
Specter I assume were annual expenditures, or were they
expenditures for several years?
Dr. Koplan. Those were annual.
Senator Stevens. Could you give us a statement of how much
you believe you need to pay out, not commit, pay out between
now and May and between now and the end of September? I do not
want it right now, but we are dealing with a lot of tight money
right now and we have got to stage it if we are going to get
the money we need to you as it is needed. There is great fear
that we are just dumping money out the window and people do not
know exactly what it is for and therefore people are afraid
that we are going to waste money. We all read the papers about
the terrible big spenders around here and I usually head the
list, but I do not believe we are. But we want to be very
specific.
Now, my first question to you is, we have been visited, I
think most of us have been visited, by a group that believes
that they can develop a heteropolymer system that uses
monoclonal antibodies to bind pathogens in the blood and
transport them to the liver, where they can be cleansed and
removed from the body.
Now, I do not know enough about the science, and I assume
you do. But we have been told there is money in the budget,
there has been money in the budget the last 2 years dealing
with this. But we have been told that that process might be
accelerated. I am particularly concerned with the people we
send in harm's way, our military, and they said they could
prepare what could be called a cocktail of such heteropolymers
that could provide broad spectrum protection for people against
a series of substances.
Now, do you know about this research and are either of you
pursuing funding it?
Dr. Fauci. The principle that you are referring to is a
mechanical and physical chemical way, as you mentioned
correctly, to bind to any organism, essentially, and get it
cleared out of the body. The NIH, as in the past,
enthusiastically now and in the future, will be happy to
examine any proposal in the classical peer-reviewed way to
determine if in fact it is something that can be and should be
funded.
If we do not have a proposal in front of us, we cannot
evaluate it. To my knowledge, that proposal has not reached us.
But if it has, we would be more than happy to expedite looking
at it.
Senator Stevens. Well, I have been specifically requested
to allocate portions of the defense budget to that immediately,
because we still have the defense bill with us. I think that is
why they are looking at the defense budget.
But we are also told that that research, with sufficient
funding, now could be accelerated so that those substances
might be available by 2003. If that is possible, we were
further told that these substances could protect an individual
for up to 60 days against the substance that might otherwise
seriously harm or kill them.
I think we need to know about things like this because if
this has less risk to the populace by using a temporary
substance it might even bypass the problem we previously
discussed of the risk to people with HIV or damaged immune
systems from even things like smallpox.
All I can tell you is I hope you will look into it. I do
not know what the cost would be, but clearly it would be much
better to have people in the service have a vial that they
could use, like we used to use morphine, and just self-
administer it and have protection in the event they were told
that substances had been released at them that might otherwise
kill them.
I really think we are in a crisis period as far as they are
concerned. Our people up here at home, we might have a better
way for civil defense than they do for defense militarily. So I
would urge you to take a look at it.
Dr. Fauci. If I can get something to look at, I would be
happy to look at it, Senator.
Senator Stevens. I will see that they get to you.
Dr. Fauci. Thank you.
Senator Stevens. I think we need someone's judgment before
we move to earmark defense money for this. There is just not
enough available to me so far.
Secondly, let me ask you this. I am running out of time.
Could I have another minute?
Senator Harkin. Yes, sure.
Senator Stevens. I asked yesterday a series of questions
about these substances in our building, about how far these
spores can travel, have traveled, whether they have traveled
further as minute particles than they would in the normal run
of the mill anthrax, and what exposure we could expect our
people to have if they go back into offices that may or may not
have been exposed to this anthrax.
Now, my offices are on the fifth and sixth floor of the
Hart Building. They are at the other end of the building from
Senator Daschle. But clearly the question is what does the air
system distribute and where do these things go. My friends from
ranch country tell me they go to the ground. But these people
have been leaving petri dishes around to see if spores are
there. Everyone I have talked to says they may go to petri
dishes, but they are going into the ground if it is there, and
if it is not they are going where it is dark and dirty.
Now, we have not been looking where it is dark and dirty.
We have been putting petri dishes out on the tables, as I
understand it.
Can you clear that up for us? We really seriously have a
group of young people who are going back into these buildings
before Christmas probably and they are not satisfied with our
explanations.
Dr. Koplan. Let me try. For one, I think there is
frustration for all of us because we do not have all the
answers and we do not have all the science for this. But for
one, the EPA is responsible for the cleanup of the Hart
Building and we are providing technical consultation.
Senator Stevens. Doctor, they say you are responsible for
the degree of safety in the buildings and determining whether
it is clean or not.
Dr. Koplan. We are providing technical support to the EPA,
and I will tell you everything I know.
Senator Stevens. Do you accept responsibility for saying if
the Hart Building is clean or not? Are you going to be the one
that determines that?
Dr. Koplan. I think by statute the EPA is. We are working
with them on a daily basis and this is an area that they have
got longstanding expertise in, which is building cleanup and
safety. We are involved in this to provide information on the
anthrax.
Senator Stevens. I am talking about the standards of what
is clean.
Dr. Koplan. There are no standards, Senator.
Senator Stevens. They are telling us that you are going to
set them.
Dr. Koplan. Well, it is hard to set them in the absence of
scientific information. This is why it is frustrating for all
of us. But if I can continue, the issue here is to get rid of
all the anthrax spores that we can through some process that
gets rid of them. Your question is, well, how do you know where
they are and how do you measure that?
The putting around of those petri dishes is appropriate
because if you are on a ranch or you are on a farm, you look
for anthrax in the soil or on cattle, but if you are in a room
like this or in our homes or anywhere you might go, the spores
exhibit a physical phenomenon: they drop to wherever they drop.
They can drop in the plants and in the soil, yes. But they can
also drop on a desk, and if there is a crevice on a piece of
furniture they are as likely to be there as anywhere else.
It is not that they gravitate to soil. That is where they
are found naturally. So when your folks outside talk about
where you find it outside, yes, that is where it is naturally
found, but not when it has been purposely spread in an office
building.
Yes, it does spread through air ventilation systems and one
of the things that has been done in Hart and other buildings
has been to put petri dishes around in other places in the
building to see where it has spread and to take specimens from
walls, vents, filters, et cetera, to see where it has gone.
Really, the best measure of your first question of how far
does it go, how do we know how fast it travels someplace, and
where it goes, is to do that measurement in different parts of
the building. That is what EPA and we have been working to do;
to get those measures and see if it is there.
If you go and do a cleanup and it is still in places, then
you have got to come back and do the cleanup again. I think
none of us, whether it is CDC or EPA or the Capitol Physician,
want to see you or any of your staff exposed to anything that
can cause them harm. We have got to come to some determination
of what is a safe level. Yes, we are working with our partners
there to determine what is a safe level. We will come visit you
in the Hart Building, too. We care about it for everybody. So
we want a safe environment, a safe work environment.
The place will not be opened until it is deemed safe. You
asked a question earlier of where these things line up and how
you can find the spores; these petri dishes are the best route
because that is what they grow on. But we will keep working
with EPA until we can determine that you have got a safe work
environment to go back into.
Senator Stevens. I am overdoing it, but let us take the
Daschle envelope. Air could carry that, it could go to the
floor, people could walk on it and they could carry that. The
cart that it was on could have carried it. A lot of things
could have carried it around the building.
Let me say, I stayed in the building almost three days
after I was there and I am one who believes it is clean now.
Beyond that, the question is assuring other people it is clean.
I still do not know why other things were excluded. Petri
dishes are one thing. Are you saying that you have tested some
of the soils and the plants, you have tested some of the files
and the drawers, you have pulled books off the shelf and tested
them? That is not what we learned yesterday.
Dr. Koplan. Let me ask and I will get back to you on that.
I will see exactly what they have tested, where they have done
their swabs. If they have missed things that should be tested,
they will have to be tested.
Senator Stevens. Thank you very much. Thank you for your
patience.
Senator Harkin. Thank you, Senator Stevens.
Senator Landrieu.
OPENING STATEMENT OF SENATOR MARY L. LANDRIEU
Senator Landrieu. Thank you, Mr. Chairman. I appreciate you
calling this hearing. I have prepared a statement that I will
submit for the record, but I would like to take this
opportunity to say a few things on the subject.
I realize that we are all on a learning curve here and
really struggling to deal with something that is in some ways
unprecedented in our Nation. Both of you have been wonderful to
testify before our committees on several occasions and have
been doing a very good job in helping the country prepare in
the event of another attack.
Following up on what Senator Stevens said, could you just
describe for the committee the link, the relationship or the
communications you are having with our military infrastructure?
While I appreciate that this is a public health issue, it is
more than just a public health issue. It is not just your
regular outbreak, obviously. It is not just an infection that
has taken over the country. This is a purposeful attack with
agents that we have had very limited experience with.
The questions that Senator Stevens asked are very much on
point, I think: how clean is clean, how dangerous is the
substance? Our military for many years has had a great deal of
experience in bioterrorism, directed at protecting its own
forces. All the information that the military has about
protecting its own forces from this attack could be used very
effectively in protecting the citizens of our Nation.
So my question would be, could you both describe for the
committee your current communications and relations with the
military and the Pentagon, so that we can both benefit from the
expertise of the military and the CDC can try to come up with a
plan that really works for the country? Dr. Koplan?
Dr. Koplan. Thank you. Thank you, Senator Landrieu. By the
way, on your recent visit you advised us that it really is an
anthrax attack, not an outbreak. I would like to let you know
we use that expression now regularly ourselves, because it is
not a naturally occurring disease outbreak.
Our links with the military actually go back some ways and
so we have got a very good and close working relationship
scientist-to-scientist and then at higher levels as well. The
new Assistant Secretary of Defense for Health Bill Winkenwerter
and I have had regular discussions over this.
Our close ties are with USAMRIID, the Army Medical Research
Institute for Infectious Diseases. In the earliest days of this
anthrax outbreak, when our staff had to go to a 24-hour, 3
shift a day, round the clock cycle, they actually lent us some
of their staff, came down, worked side by side with our people
in our lab to get the job done. That is just an example. There
is a close daily working relationship with USAMRIID, and we
know the folks well and there is good communication and
information gets exchanged.
As this thing progresses, there may well be the need for
even more and broader interchange for information and for staff
and for learning how things work.
Senator Landrieu. Mr. Chairman, the reason I raise this is
as chair of the Emerging Threats Subcommittee, our jurisdiction
is about helping the military be more prepared for these new
asymmetrical attacks. So there may be a way for us to explore a
more formal relationship between CDC and some of the experts
within the Pentagon to really help step up this homeland
defense so that these substances can be detected quickly, they
can be analyzed more quickly, the communications can be made
more effectively, and questions like Senator Stevens had can be
answered in a much more urgent fashion, so that we can counter
what we hope will be fewer attacks, but we are fairly confident
there are going to be other attacks.
So I think a more formal relationship with the military and
using their expertise, as well as leveraging the expertise of
the CDC, is something I would like to pursue with you. I do not
have a specific suggestion for this morning, but I just wanted
to get that information.
Doctor, do you have anything to add?
Dr. Fauci. Yes. Since we are a research institution, we
have very good scientist-to-scientist interactions,
particularly with individuals at USAMRIID and other groups that
do biomedical research, prevention and public health out of the
Department of Defense. It has been really quite good.
In fact, before you came in, Senator, I had mentioned that
some of the collaborations, particularly in the arena of the
development of the next-generation anthrax vaccine, is done in
very close collaboration and cooperation with the Department of
Defense. So from the scientific standpoint there is good
collaboration.
I just might mention something that might be helpful to you
in your formulation about the relationship between the military
and civilian situations. Though we can learn an awful lot from
them and I encourage us all to continue to make sure that the
lines of communication are open, one of the things that is not
fully appreciated is the rather significant difference in the
populations that the military needs to think about and worry
about when you are talking about bioweapons, strategic and
tactical, versus bioterror in a very diverse civilian
population.
If this were a theater of military operation and there was
an anthrax attack and the attack was taken care of, you would
have had very, very healthy young men and women between the
ages of 18 and mid-forties or what have you. They would have
been vaccinated, they would be very robust individuals. Whether
or not there were two or three spores lying around, no one
would care because of their mission.
Whereas in a situation in which you have civilians, where
you have children coming into the building, pregnant women,
older individuals, that is an entirely different ballgame. So
that is really the reason why there is the frustration that Dr.
Koplan alluded to, because there really is not any experience
about what is totally safe in the setting that we are in right
now.
Senator Landrieu. I appreciate that and I thank you. I will
just close with this, that your points about the differences
are well taken and I acknowledge that and I think it was well
spoken.
prepared statement
But even given that, I think there are still, as we
mentioned, some great leveraging that can be done between the
military and the CDC as we stand up to this sort of new attack,
or whatever we are going to sort of call it, to get the kind of
information to the American people and get treatment and
vaccines and deal with it in a much more expedited fashion. So
I thank you and look forward to continuing to work with you on
that.
[The statement follows:]
Prepared Statement of Senator Mary L. Landrieu
Mr. Chairman, again, I would like to thank you for your leadership
in holding this important hearing. As you well know, the subject of
bioterrorism preparedness has been on the minds of all Americans. Stop
at any newsstand in America and you will surely find the racks covered
in newspapers and magazines with headlines that read, ``How real is the
threat?'' or ``Is America Ready?'' Stop any American on the street and
ask them to detail the symptoms and remedies for Anthrax or small pox
and no doubt they will be able to. In this new world we live in, sights
of HAZMAT suits and Cipro bottles are common.
The concern about the risk of exposure to deadly biological weapons
is not just something we have read about or seen on television. For
most of us here on the hill, our present circumstances remind us of how
very real this threat is. From the time that the letter containing
Anthrax was discovered in Senator Daschle's office, we ourselves, have
had first hand experiences with nasal swabs, mail tests, fumigation
procedures and antibiotic treatments. This experience forced us to
question how prepared are we not only to respond to a bioterrorist
attack but also to prevent against it. Finding the answers to these
questions has not been easy. Like most other places in America, we were
not unprepared, but we certainly were under prepared. We have made some
good decisions and some not so good decisions, but most importantly, we
have learned some important lessons. Our task now is to take those
lessons learned and convert them into a plan for the next time, God
forbid there ever is a next time.
Webster's dictionary defines the word preparation as ``the process
of making something ready for use or service or of getting ready for an
occasion, test or duty.'' I mention this only because while we all use
this word often, especially lately, it is important that we focus on
what being prepared really means. In the event of a bioterrorist
attack, our public health system must be ready to serve. This system
has a duty to protect and preserve the lives of the American people. To
be ready to perform that duty and that service, they will need
guidance, assistance and resources.
Perhaps the first and most important step in the process of
preparation is assessing the need for improvement. A recent article in
the Washington Post asked this very question and what they found was
this. A recent survey of city and county health departments found that
80 percent of them do not have comprehensive bioterror response plans.
A little more than half of them have plans under development. Sixty-Two
percent of these health centers responded that they were only
``somewhat prepared'' or not prepared at all to answer the public's
bioterror questions since the September 11th attacks. A 1999 survey of
the city and county health departments found serious gaps in the
communication process between them and the CDC. Sixty-Five percent of
the CDC's e-mails were not successfully delivered to the departments.
What's more, 55 percent of these public health agencies did not have
the capacity to send alerts to multiple recipients like health
agencies, the CDC and doctors. Finally, a 1998 study of 186 hospitals
in Washington, Oregon, and Idaho found that 88 percent of them had no
plan for attacks involving biological weapons.
These statistics show a collection of gaps that must be filled if
we are to fulfill our promise to protect the American people from harm.
Filling these gaps will require time, expertise and first and foremost,
resources. In fiscal year 2001, the bioterrorism portion of the $3.9
billion CDC budget was a mere $181 million dollars. That is less than
half of one percent. In this new world in which we now live, this is
not enough. Yet just investing more money is not the answer. We must
use these funds to make strategic investments in our public health
infrastucture, national communication and coordination systems and
disease and vaccine research.
Last year, Congress passed the Public Health Threats and
Emergencies Act. This law, which I was proud to support, laid out a
series of important initiatives to strengthen the nation's public
health system, improve hospital response capabilities, assure adequate
staffing and training of health professionals to diagnose and care for
victims of bioterrorism, enhance our research and development
capabilities and take additional steps to prevent, prepare and respond
to the threat of a bioterrorist attack. While this bill became law,
none of the programs it outlined were funded in fiscal year 2001. At
the very least, we must invest the $1.4 billion authorized by this
bill.
Mr. Chairman, as Chairman of the Armed Services' Subcommittee on
Emerging Threats, I look forward to working with you, other members of
this committee, members of the House and the Administration toward
ensuring that the funding level for bioterrorism preparedness reflects
its importance as a national priority. I am interested to hear from the
witnesses today, especially those from the CDC and NIH about the extent
to which they are collaborating with the Department of Defense and
their experts in the area of bioterrorism. This threat of a biological
weapons war is not new to them, they have had to have been prepared for
such an attack, albeit under different circumstances, for quite some
time. The resources, procedures and information that the DOD has to
offer in this area are invaluable. I encourage members of this first
panel to make use of this resource. Most importantly, I hope that they
will work together with the DOD to reduce any duplication of effort and
thereby maximize the potential of the resources and skill offered by
all the relevant federal agencies.
Thank you.
Senator Harkin. Thank you, Senator Landrieu.
Just a couple of follow-ups. I mentioned earlier--I do not
know which one of you want to respond to this, but on the
national pharmaceutical stockpile, are you planning to include
Cidofovir in that? I do not know who is the proper person to
ask that?
Dr. Koplan. Yes, there is a budget for Cidofovir in that.
Senator Harkin. In the stockpile?
Dr. Koplan. Yes.
Senator Harkin. Secondly, Senator Specter apologized; he
had to leave to go to the Judiciary Committee. Both of us were
discussing here the figures, Dr. Koplan, that you went over
with him. There is just a little bit of confusion here on the
smallpox development versus the smallpox vaccine, and we are
trying to get a handle on that.
Without going into it because we want to move to our next
panel, could you just submit to us again the details of what
you just discussed with Senator Specter?
Dr. Koplan. Can I do that for the record?
Senator Harkin. You want to do that now or do you want to
submit it for the record?
Dr. Koplan. Can I submit it for the record?
Senator Harkin. Please submit it for the record.
Dr. Koplan. Okay.
Senator Harkin. Well, I am told by staff that we need to
get this budget today.
Dr. Koplan. We will have it to you before the day is over.
It is easier to see it written out on a line, and we will have
it for you today.
Senator Harkin. There is just a little bit of confusion on
this, on a couple of those figures.
Dr. Koplan. We will have it on paper before the hearing is
over, how is that?
Senator Harkin. Rather than sitting here going back and
forth, just give it to the staff afterwards.
Dr. Koplan. Great.
Senator Harkin. Also, with those figures, Senator Specter
also needed to know, just again we need to know time lines--how
much now, how much you need later on, so we know the flow of
the money.
Dr. Koplan. Will do.
Senator Harkin. Lastly, do we have to provide money each
year for upgrading State and local public health? You mentioned
the figure of $1.050 billion. That was for upgrading State and
local capacity. We are going to be hearing from some of the
hospitals here on the next panel, but obviously there is a one-
time up-front cost for training and that type of thing. But
then there is going to have to be some ongoing costs.
Dr. Koplan. Actually, there is very little up-front cost
for training because the training is ongoing for all these
individuals. Yes, we would start right off with training, but
the nature of the turnover in local and State health
departments and the nature of new knowledge being imparted is
such that training goes on literally 365 days a year for
laboratorians and epidemiologists. So that is an ongoing thing.
Senator Harkin. So you are looking at that $1.050 billion
as----
Dr. Koplan. This is a yearly cost to keep our local and
State health departments up to speed.
Senator Harkin. So you are saying this committee has got to
come up with an extra billion every year?
Dr. Koplan. Yes.
Senator Harkin. Okay.
Dr. Koplan. In my professional judgment.
Senator Harkin. I am sorry that Mr. Stevens left before
that one. But anyway, we will make sure he hears that.
Thank you both very much again from a personal standpoint,
but also speaking for this committee, we thank you both for
your great leadership that you have shown in these trying
times.
Barring any unforeseen circumstances, I doubt that we will
be having you here again before the end of the year, but
certainly when we come back in January we will want to have you
back again to see where we are at that point in time, probably
at the end of January, early February, come back and see if we
need to make any adjustments in our budgets at that time.
Dr. Koplan. Thank you.
Senator Harkin. We will be having supplementals.
Dr. Fauci. Thank you very much, Mr. Chairman.
Senator Harkin. Thank you very much, Dr. Fauci, Dr. Koplan.
Next, we have a vote coming up at 10:30. I am going to try
to see if we can bring this next panel up: Dr. Ken Alibek,
President of Advanced Biosystems; Dr. Joseph Barbera, Associate
Professor and Co-Director of the Institute for Crisis,
Disaster, and Risk Management at the George Washington
University; and Joseph LeValley, Senior Vice President for
Planning and Systems Development, Mercy Medical Center of Des
Moines, Iowa.
We will start off in the way I have introduced: Dr. Alibek,
President of Advanced Biosystems. Dr. Alibek, I might inform
the audience, defected to the United States from the Soviet
Union in 1992. Prior to that he was the Deputy Director of
Biopreparat, the civilian arm of the Soviets' biological
weapons program. Dr. Alibek frequently briefs U.S. military,
intelligence, and medical officials about biological weapons
and defenses. He is the author of ``Biohazard,'' which
describes his experiences running the Soviet bioweapons
program. He holds M.D., Ph.D., and Doctor of Science degrees
which he has received in the Soviet Union.
Dr. Alibek, welcome to the committee. Your testimony will
be made part of the record and just please proceed as you
desire.
STATEMENT OF KEN ALIBEK, M.D., PRESIDENT, ADVANCED
BIOSYSTEMS, INC.
Dr. Alibek. Thank you. Mr. Chairman, thank you for inviting
me to speak today. I know I have not much time, but I will try
just to be absolutely short.
In my opinion, one of the biggest issues we need to resolve
as soon as possible is what kind of research do we need to do
in the field of weapons threat analysis and development of
medical defense against biological weapons threat agents. I
know we are focusing now on anthrax and smallpox. I fully
support this work and I believe that anthrax and smallpox could
be considered as an imminent threat to our Nation.
But at the same time, we need to keep in mind,
unfortunately, the number of biological agents that could be
used in biological weapons is very large. Just a short analysis
done in the former Soviet Union showed that several dozen
different biological agents could be used in biological
weapons. Many of them have been developed in the form of
biological weapons. For example, just a short enumeration
probably would show you what is the real biological weapons
threat.
In addition to anthrax, bacterial agents like plague,
tularemia, brucellosis, glanders, melioidosis have been
developed as biological weapons. Viral biological agents
include smallpox, Ebola, Marburg, various encephalitis, and
some other viral hemorrhagic fevers. There is a group of
biological weapons based on so-called rickettsial agents:
epidemic typhus, and so on and so forth. There is a group of
so-called fungi biological weapons, including blastomycosis and
toxidiumicosis.
Of course, I realize that if we start taking care of all
these agents probably it would not be possible to find such a
huge amount of money. But at the same time, we need to start
doing some work to understand what is the real biological
weapons threat. In my opinion, we need to rectify our
knowledge, our understanding of the biological weapons threat.
It would help us to develop a new concept of biological weapons
defense. When we work in the field of biological weapons
defense or medical defense against biological weapons, we
usually work in three major fields.
One field is so-called prophylaxis, or vaccine development;
another field, so-called emergency prophylaxis is when we
develop some medical means and approaches just to use for pre-
exposure or post-exposure prophylaxis. I mean immediate pre-
exposure, post-exposure. Then there is a third field, so-called
treatment.
But when we discuss this issue, we focus very much on
vaccines. I have nothing against vaccines, but what we need to
keep in mind is that vaccines have been considered as the best
defense against biological weapons by many countries to protect
troops. Nobody considered vaccines for use in protecting
civilian populations, because of some important reasons.
What we need to keep in mind is that vaccines usually take
weeks and months just to take effect. In this case, for
example, the just recent anthrax event, nobody discussed the
necessity of using anthrax vaccine to vaccinate people who got
infected.
In this case, of course, we need to spend more time just to
see what kind of emergency prophylaxis means we could develop
and use to take care of these infected individuals. We need to
pay much attention to our treatment options and see what we can
use to treat these individuals.
There are many other issues, but what I would like to say,
when again we discuss the smallpox vaccine--I fully support
this effort. We need to develop this vaccine because of two
important reasons: because this infection is a very
threatening, contagious infection and could cause epidemics and
pandemics; but at the same time, this infection--this vaccine,
I mean, this vaccine could be used not just for containing
outbreaks and epidemics. It could be used for treatment, for
so-called post-exposure prophylaxis. This vaccine is the only
means we have got now just to protect against smallpox.
But at the same time we need to think what else we can do,
because I do not envision any situation in which we are going
to vaccinate the entire population of the United States against
anthrax, for example, prior to any anthrax incident. I do not
envision a situation in which you are going to vaccinate the
entire population of the United States against many different
infections.
In this case, of course it does not mean we do not have to
work in this field of vaccines, but it means we need to focus
much effort in the field of emergency prophylaxis and
treatment, because there's not just a single way to protect,
such as to develop and deploy vaccines.
One more issue I would like to touch on here. You know, the
Soviet Union as a country has spent decades and decades
researching and developing new biological weapons. My knowledge
is coming from the Soviet Union, and my expertise in this
field. Since I came to the United States in 1992, I have spent
years and years discussing these biological weapons threat
issues and possible approaches to biological and medical
defense against biological weapons with many experts here in
the United States--military experts, civilian experts. We
discussed the different aspects of this problem.
You know what is getting obvious? Unfortunately, we have
lost the knowledge and understanding of biological weapons
threat some time in the sixties and seventies. Since the
seventies a lot has changed. We need to keep in mind two
important things. Now when we discuss a biological weapon, or
let me say medical defense against biological weapons, we are
working in the field of developing protection against
biological weapons developed in the seventies, early seventies
and late seventies.
But you know, starting from the eighties a lot of new
biological weapons have been developed. A lot of new
genetically engineered agents and weapons have been developed.
We are not addressing these issues now.
There is another problem when we talk about developing
protection against biological weapons. In my opinion it is a
major point. When we develop a new vaccine, it usually takes
from 8 to 12 years to develop and get a new vaccine approved.
But you know, my personal experience is that the development of
biological weapons--I knew about many biological weapons
developed in the former Soviet Union--usually takes from 3 to 4
years.
You can imagine in this case it is a sort of a race, with
biological weapons appearing that are genetically engineered,
antibiotic resistant, new agents, and so on and so forth. If
you have got this time range for the development of protection,
8, 12 years, we will be increasing, widening the gap between
our knowledge in the field of biological weapons defense and an
actual situation in the field of biological weapons threat
agents. In my opinion, this is important to address.
At the same time there is a group of scientists still in
Russia. Some of them from the former Soviet Union are in the
United States, in some European countries, Asian countries.
PREPARED STATEMENT
I am finalizing my talk. What we need to do in my opinion,
we need to use the knowledge of these people, because many of
them are underemployed now. Useing their tremendous knowledge
in the field of biological weapons threat and defense probably
would give us a lot of benefits here in developing a defense
against biological weapons.
[The statement follows:]
Prepared Statement of Dr. Kenneth Alibek
topic: bioterrorism
Thank you, Senator Harkin and members of the Committee, for
inviting me to testify for you today on the topic of bioterrorism. I am
in a rather unique position to discuss these issues, since I developed
biological weapons for the Soviet Union for nearly twenty years, until
my defection in 1992. When I left the Russian biological warfare
program, I had been serving as First Deputy Director of Biopreparat,
the civilian arm of the biological weapons program, for four years. At
that time, I was responsible for approximately 32,000 employees and 40
facilities, comprising over half of the entire Russian program's
personnel and facilities. Since arriving to the United States, my
personal and professional goal has been to make the greatest
contribution I can to the elimination of the danger of biological
weapons.
Biological Weapons Threat of Proliferation and Terrorism Following
the breakup of the Soviet Union and the end of the Cold War, the threat
of proliferation of mass casualty weapons has grown dramatically. In
some ways, the danger posed by the proliferation of biological weapons
and biotechnology is greater than that of nuclear proliferation. For
example, the acquisition, manufacture, deployment, and movement of
nuclear components or weapons is much more expensive and difficult to
achieve than that of biological agents. A freeze-dried vial of anthrax
can easily be obtained and concealed, and the knowledge of how to turn
that vial of anthrax into a biological weapon is in the possession of
hundreds of scientists and technicians. The recent incidents of anthrax
dissemination through the Postal Service have only served to
demonstrate the reality of this threat.
The growing frustrations among scientists within the former Soviet
bioweapons community add to the risks of proliferation. Despite
initiatives directed by the United States government to employ some of
these scientists and to shift the focus of their research to peaceful
projects, more needs to be done. Many of these scientists are highly
trained in biotechnology and their talents could be directed toward
finding new methods of preventing or treating the diseases caused by
these pathogens. Several former bioweapons scientists have emigrated to
the West and are currently under-employed. We fear that in order to
feed their families, others may offer their technical skills on the
open market, which could provide our enemies with technical expertise
or ready-made, engineered organisms. Some Russian microbiologists are
reportedly teaching students from rogue states that are interested in
this expertise. Other prominent scientists have simply dropped out of
sight.
In a report to the Senate Permanent Subcommittee on Investigations
in 1995, the U.S. Office of Technological Assessment identified 17
nations believed to possess biological weapons. It is estimated that at
least 20 countries either have active research programs or were
formerly involved in biological weapons research and production. In
many cases, these are nations that are also engaged in chemical and
nuclear programs, since they feel the necessity to protect themselves
from hostile neighbors by any means necessary.
biological defense and treatment options
In the U.S. and other countries, growing fears of a biological
attack by a hostile country or a terrorist group have prompted
intensive efforts in the areas of consequence management, response
planning, intelligence gathering, and nonproliferation of expertise.
However, little effort has focused on new methods for treatment or
prophylaxis of biological threat agents.
Unfortunately, the diseases caused by many biological threat
agents, such as smallpox, Ebola, and Marburg are currently untreatable.
For so-called treatable diseases, such as anthrax, plague and
tularemia, current methods of treatment or medical prophylaxis are
often ineffective. Antibiotic resistance is on the rise, and in many
cases biological threat agents have been genetically engineered to
increase their resistance to drugs.
Similarly, vaccines do not exist for the majority of biological
threat agents. This situation is unlikely to change when we consider
that it takes 3-4 years to engineer a new drug resistant or more
virulent bioweapons, but it takes 10-12 years to develop and get Food
and Drug Administration approval for a new vaccine. Even the few
available vaccines are often ineffective against biological weapons for
three reasons:
--Vaccines often require weeks to months to take effect;
--Vaccination of large portions of the population against numerous
threat agents in advance of a biological incident is not
feasible
--Biological threat agents can be engineered to circumvent the action
of vaccines
new paradigm
We need to develop a broader appreciation of the scope of the
threat posed by the major biological threat agents and possible medical
and public health responses to them. This can only be achieved through
extensive biomedical research aimed at developing new prophylaxis and
treatment strategies.
New approaches are needed to both prevent and treat these
pathogens, and our country needs to be at the forefront of medical
research aimed at studying and developing novel approaches to combat
disease. Recent advances in our understanding of the immune system are
making it possible to create new tools to defeat invading organisms by
boosting the immune response. These new means and approaches would
supplement or replace drugs used to attack the invader. Tools to boost
the immune system are not limited to infectious diseases, but can also
be applied to the treatment of cancer, cardiovascular, autoimmune, and
age-related diseases.
Research in this area should include investigations of the etiology
and pathogenesis of infections caused by biological weapons, specific
and nonspecific immunomodulation as a means of eliminating pathogens,
and new antiviral and antibacterial drugs. Many of the treatments that
could be developed based on this research could be useful not only for
the purpose of medical defense, but also for the greater purpose of
improving the general health of mankind.
international collaboration to catalyze the development of effective
responses to bioterrorism
Countering bioterrorism will require efforts on an international
scale. We should establish and maintain international collaborations of
experts on bioterrorism and biodefense. The following research areas
would greatly benefit from international collaboration:
--The potential of various biological threat agents
--Possible production and deployment methods used by terrorists
--Technical countermeasures to biological aerosols
--Analysis of possible genetic engineering of biological threat
agents
--Epidemiology of infections caused by biological weapons
--Disinfection of large contaminated areas and buildings
--Medical microbiological, molecular biological, and immunological
methods for the development of protection against biological
weapons
--Research and development of novel therapeutic and prophylactic
regimens for infections caused by biological weapons
--Signatures of possible production facilities
Addressing these issues will greatly enhance the international
community's preparedness for a biological attack.
Senator Harkin. Thank you, Dr. Alibek. That is a great
suggestion. I read it in your testimony and that needs to be
followed up on and I intend to follow up and find out what the
administration is doing on that.
Dr. Barbera, welcome to the subcommittee. Dr. Barbera, your
testimony will be made a part of the record in its entirety and
I will ask you to summarize it if you could.
I just want to say again that Dr. Barbera is Associate
Professor and Co-Director of the Institute for Crisis,
Disaster, and Risk Management at GW University. Dr. Barbera.
STATEMENT OF JOSEPH BARBERA, M.D., ASSOCIATE PROFESSOR
AND CO-DIRECTOR, INSTITUTE FOR CRISIS,
DISASTER, AND RISK MANAGEMENT, THE GEORGE
WASHINGTON UNIVERSITY
Dr. Barbera. Thank you very much, Mr. Chairman. I will try
to summarize. My statement is relatively short.
I have been an operational emergency medical responder to
major disasters for the past decade for the Urban Search and
Rescue system for the Office of Foreign Disaster Assistance. I
responded to the Oklahoma City bombing and after the September
11th events. I was a responder to both the Pentagon and World
Trade Centers.
I have additionally been involved through the hospital and
through local preparedness efforts with the bioterrorism events
that occurred recently here in Washington, D.C.
I am coming at this from a different angle than what we
have heard in the prior testimony and that is from the
operational medical perspective: how do we actually address
bioterrorism and other types of mass casualty terrorism at the
operational level, how do we institute medical care, how do we
apply the principles, the scientific principles that you have
heard talked about earlier?
I would like to say also that I think it is important that
at this point we start to focus very much on hospital
preparedness for mass casualties. This has not been something
we have done in the past. It is something the public and the
press have asked about: Why do we not have adequate
preparedness at the hospital level for mass casualties?
What we have right now is hospitals trying to do reasonable
preparedness for mass casualty events, and it is my belief that
there is a wide gap between what is adequate and what is
reasonable. The current medical economics are such that
hospitals have very little left over to spend on things that do
not have to do with the everyday practice of medicine. When I
have talked to hospital administrators in the past about
disaster preparedness, many of them have responded that their
main concern is not the terrorism that could occur 3 months
from now, it is whether or not their hospital will be in
business 3 months from now due to medical economic constraints.
It is important to recognize that preparedness for mass
casualty terrorism and mass casualty events from a hospital
perspective has very little to do with what hospitals do on an
everyday basis and what they do to prepare for the old-
fashioned definition of a disaster, which is 1 to 10 or 20
casualties from a trauma event. In order to prepare for these
things, I think it is time that we start to focus on how we
treat hospitals as part of the public safety function in the
American emergency response community.
As I have put into my testimony, right now when you need
fire suppression you call 911 and you get fire response, which
is a government entity. When you need law enforcement, you get
police and that is a government entity. When you need mass
casualty medical care, you get 911 and you get EMS, which is a
government entity. But the patients end up at hospital
facilities that are generally private, for-profit, not-for-
profit, even public hospitals, that do not have a budget for
mass casualty preparedness.
If we are going to adequately prepare for this, we need to
pay attention to that, start to treat at a public policy level
mass casualty medical care as a public safety function. We also
have to recognize that hospitals are very much a vital asset in
community emergency response and they deserve the same level of
security and other attention that other government emergency
response entities are given.
So how do we address this? I think you are taking a very
important step here and I congratulate you on focusing on
hospital preparedness for mass casualties. I think there are
models out there for public-private emergency response
partnerships that can be followed and I have referenced a paper
that I did for the Harvard Kennedy School that addressed this
specific subject.
I think that hospitals very much would be willing to
develop even a contractual relationship with local community
emergency response, to develop programs that include training
and maintenance of those programs for mass casualty care and
for specialty care, for true surge capacity for not just
bioterrorism events, but an all-hazards mass casualty
preparedness.
In closing, I would like to say very much that I think that
we have a very strong medical foundation here at the hospital
and the acute care medical communities across the United
States. I have been part of the bioterrorism response entity
here in Washington, D.C., over the past month and a half. I
chair the D.C. Hospital Association Emergency Preparedness
Committee. We have developed a mutual aid memorandum and a
hospital mutual aid system in Washington, D.C., between all of
the hospitals in Washington, D.C., and including the four
Federal hospitals in the D.C. area.
As part of our response, we established a daily conference
call that ended up encompassing most of the hospitals in the
National Capitol Region, most of the public health authorities
in the area, and the acute care medical community. As the
moderator of those conference calls, I was quite encouraged and
inspired at how hospitals came together and worked very hard
for community betterment during this.
PREPARED STATEMENT
I think that we have a possibility now or a very strong
probability to develop programs that promote operational
medical systems, not just the buying of equipment, not just
seed money that will start programs that will then be another
unfunded Federal mandate for hospitals to continue, but an
opportunity to develop operational systems of information
management, communication, true collaboration between the acute
care medicine and public health entities, things that will be
ongoing that will improve the medical care in the United
States, not just for terrorism response but for all-hazards
mass casualty events.
Thank you very much.
[The statement follows:]
Prepared Statement of Dr. Joseph A. Barbera
Mr. Chairman and Members of the Subcommittee, I am Joseph A.
Barbera, a residency trained, board certified emergency physician. I am
Co-Director of the Institute for Crisis, Disaster, and Risk Management
at the George Washington University, where I teach masters and doctoral
emergency management courses, and I provide emergency medicine services
through the George Washington University Hospital. One of my
professional volunteer activities is chair of the Emergency
Preparedness Committee of the District of Columbia Hospital Association
(DCHA), a position I have held since the committee's inception in 1995.
In this role, I have presided over the development and implementation
of a comprehensive Hospital Mutual Aid System that provides effective
coordination and communication between the District's hospitals in
emergency preparedness and response. The four Federal hospitals in the
National Capital Region, Walter Reed, National Naval, Malcom Grow, and
the Veterans Administration Medical Center are all very active and
vital participants in this process.
During my medical career, I have also had the privilege of
experiencing disaster response to major incidents. I have participated
in the FEMA and Office of Foreign Disaster Assistance Urban Search &
Rescue programs for over a decade, including earthquake responses to
Northridge California, Taiwan in 1999 and the Philippines in 1990. I
have responded to major terrorism incidents, providing medical
expertise to the search and rescue effort after the Oklahoma City
bombing and, after September 11, to both the Pentagon and the World
Trade Center incidents.
I have additionally experienced the specter of biological
terrorism. I was the emergency physician on duty at George Washington
University Hospital the day of the B'nai B'rith bioterrorism hoax in
1997. I was a medical controller for the TOPOFF bioterrorism exercise
in Denver in 2000. Most recently, I was heavily involved in the recent
anthrax dissemination incident here in the National Capitol Region. In
my role for DC Hospital Association, I established a daily conference
call that became the basis for information exchange between hospitals,
acute care providers, and the multiple public health authorities in the
National Capitol Region. We are currently developing a profession
review of that incident response to capture the views of the hospital-
based medical community.
I have been asked to speak to you today about the subject of
hospital preparedness for mass casualty response. I would like to note
that I provide this testimony from the medical perspective of a
hospital-based emergency physician with extensive experience in
emergency public health and emergency response. I have no remunerative
relationship representing hospitals, or hospital associations, in this
regard.
I would like to begin by congratulating and thanking you for
focusing on this vitally important subject. As we face the specter of
mass casualties from chemical, biological, incendiary or explosive
attacks, the press and the public are continuously asking why the
medical care community is not adequately prepared for these
possibilities. Many vague reasons have been put forth, but the cold
hard reality is that adequate preparedness is impossible without basic
changes in public policy attitudes towards funding medical
preparedness.
First, one must understand that the non-governmental medical system
must be viewed as a ``first responder'' in mass casualty care.
Next, one must understand what mass casualty care entails. The
medical infrastructure needed to care for one or ten injured or ill
individuals is completely different from that required to care for
hundreds or thousands of patients. The infrastructure for mass casualty
care also has very little to do with everyday hospital practice. This
is not a minor technicality to be recognized and understood only by
medical planners. This is a fundamental financial reality that must be
addressed by the highest level of political leadership at all levels of
government. It is also critically important to understand the following
key concepts:
--When you need firemen for fire suppression, you call 911 and the
municipal fire department responds with the needed assets. All
non-governmental assets are bit players. We stopped expecting
private fire insurance companies to fund municipal fire
services somewhere around two hundred years ago.
--When you need law enforcement to control a situation, you call 911.
Police respond and become the primary force that provides law
enforcement. Private security is only a bit player if involved
at all.
--When you need acute medical care for hundreds or thousands of
casualties, you call 911, but the response capabilities are
completely different. Municipal services have little
significant acute medical care capacity beyond triage and
transport of patients. Definitive medical care in Washington
DC, and most areas of the United States, is a function of
primarily private sector assets. As such, all hospitals should
be viewed as critical emergency response assets within a
community, and accorded security considerations similar to that
provided to governmental emergency response entities.
The next reality is that private medicine has been shaped by
medical economic forces beyond the control of the medical and hospital
community. Hospitals now survive by adopting ``modern business
practices'' such as just-in-time inventory, bare minimum staffing
patterns, closure of empty hospital beds. All these make smart business
sense, but they have severely impacted health care surge capacity for
both mass care and for specialty care of unusual victims such as
critical care patients, ventilator patients, burn patients, patients
requiring isolation, and so on. In an era of barely survivable medical
economics, the government and the public have expected private medicine
to pay on its own to cover the exorbitant costs of the community's mass
casualty preparedness. It hasn't happened, which is why we are here
today.
Mass casualty medical care must be recognized as a public safety
function, and therefore as a governmental responsibility equal in
importance to fire suppression, emergency medical services, public
works, and law enforcement. Until public policy changes to address this
financial reality, we have little chance of adequate preparedness for
mass casualties. Hospitals, in their current financial circumstances,
can at best make a good-faith effort at reasonable preparedness, and
indeed they are doing so. The difference between adequate and
reasonable is wide, and I believe it is unacceptable to the American
public.
How can we address this gap?
Begin with a fundamental change in governmental attitudes towards
hospitals, and I commend you for taking this important step. Government
must actively solicit the hospitals' planning input through hospital
group efforts such as the DC Hospital Association's Emergency
Preparedness Committee. Government agencies must understand that they
have an obligation to support hospitals in planning for mass
casualties--Hospital's are in fact in the driver's seat of providing
medical care. Government, including government public health entities,
must allow hospitals to have significant input in developing the most
effective ways for them to organize and to be assisted by governmental
assets in preparing for and responding to mass casualty events.
A major fact of emergency management is that the planning process
is far more important than any actual plan. The process must promote
the development of effective planning and response relationships
between key players, and this is even more important in areas such as
healthcare, where many of the key resources are non-governmental. It
again is a governmental obligation to assure that this objective is
accomplished, and I believe this should be a goal of your legislative
efforts.
Finally, government at all levels must accept that mass and
specialty casualty care is a public safety function and must have
adequate funding provided to hospitals who are willing to accept the
responsibility for this community need. Hospitals do not need, nor
should they accept, ``seed money'' that begins expensive emergency
preparedness programs that result in additional unfunded Federal
mandates. Hospitals need to become funded partners in community
emergency preparedness, fully integrated into emergency response.
Hospital mutual aid systems, effective collaboration between public
health and the hospital community, mass decontamination capabilities,
critical care surge capacity, improved information systems for
communicating between hospitals and with key health officials are only
a few of the requirements that would provide immense public benefit.
Public hospitals, including our Federal hospital partners here in the
Washington DC area, must receive the same financial attention.
Many hospitals, I believe, would be very willing to agree to a
contractual relationship with the local community that adequately funds
development, training, and maintenance of defined surge capacity and
other specialized resources. Medical realities, such as the twenty-
percent annual turnover in emergency department staff found in many
hospitals, must be addressed in the training aspect of system
maintenance. Many models exist for this type of public-private
emergency response partnership, and have been described more fully in
an article I co-authored for the Kennedy School of Government at
Harvard University, titled ``Ambulances to Nowhere: America's Critical
Shortfall in Medical Preparedness for Catastrophic Terrorism.''
In closing, I would like to emphatically state that this is not a
time for political maneuvering, and it is not a time for shaping public
perceptions of medical response competence through any route other than
actually becoming competent in a planning process that could mean life
or death for future terrorism victims in the United States. The coming
together and voluntary commitment to community well-being that I
witnessed by hospitals in the National Capital Region since September
11 have been both encouraging and inspiring. We have a very strong
medical foundation upon which to expand our mass casualty preparedness.
I urge you to thoughtfully develop a program that promotes creation of
operational medical response systems that are effective, sustainable,
and multi-use.
Mr. Chairman, that concludes my prepared remarks. I apologize that
they are not more detailed, but I was invited to furnish this testimony
only two days ago, and my schedule did not provide the amount of time I
would have liked to further shape my comments. I would be pleased to
answer any questions you or members of the Subcommittee may have at
this time.
Senator Harkin. Thank you very much, Dr. Barbera.
There is a vote on now. I think what I will do is I will
hear Dr. LeValley's testimony, then we will take a break. You
might get together with Dr. Koplan so he can get back and get
these figures. Then I will come back here for a round of
questioning. Senator Specter may come back with me at that time
also.
So now we will turn to Dr. Joe LeValley, Senior Vice
President for Planning and Systems Development, Mercy Medical
Center in Des Moines, Iowa, again, hearing from people out in
the field as to, again taking off from what you just talked
about, Dr. Barbera, what we need in our local hospitals to be
ready for any contingency like this. I am going to get into
that more later when I get back to my questions.
Dr. LeValley, welcome again to the committee.
STATEMENT OF JOSEPH LeVALLEY, SENIOR VICE PRESIDENT FOR
PLANNING AND SYSTEMS DEVELOPMENT, MERCY
MEDICAL CENTER OF DES MOINES, DES MOINES,
IOWA
Mr. LeValley. Thank you, Mr. Chairman. My name is Joe
LeValley. I serve as Senior Vice President for Planning and
System Development at Mercy Medical Center in Des Moines.
I want to begin by saying it is an honor for me to be here
representing our hospital and indirectly thousands of other
hospitals. Mr. Chairman, as an Iowan it is particularly a
pleasure to appear here before this committee. I and everyone
at Mercy have enjoyed the opportunity to work closely with you
and your staff for many years and appreciate your longstanding
support of health care in Iowa.
Mercy is a 691-bed tertiary hospital. We are involved in
providing care in more than 50 sites, including physician
clinics, nursing homes, hospice, and a dozen rural community
hospitals. So I am going to try to bring the perspective as a
non-clinician, the perspective of an administrator trying to
coordinate with many others the care of Iowans in these issues.
One of the questions that America's hospitals have been
asking since the national tragedy of September 11 is how ready
are we to respond to incidents of terrorism involving
biological, chemical, or nuclear materials. One answer is that
we currently are well prepared to decontaminate, triage,
diagnose, and treat a small number of victims of exposure to
these dangerous materials. Our medical center, as an example,
has one portable decontamination unit that can be utilized. We
have one negative air flow room in our emergency department
that prevents fumes and particulates from entering the rest of
the hospital. We have a large emergency department with 38 exam
and treatment rooms and a staff of more than 120 people. This
emergency department cares for 56,000 people a year, the most
of any in Iowa.
One reason we can claim to be ready for modest incidents is
that we recognized even before September 11th the need to do
more and we have implemented last spring an aggressive program
to increase our preparedness. It involved training, new
equipment, new haz-mat suits, new policies and procedures,
clinical guidelines, security measures, several education
programs, etcetera.
We also participate in the Metropolitan Medical Response
System, which is a community-wide effort we are very proud of,
that coordinates the planning for and response to these types
of things. We have five departments represented on different
committees of that collaborative effort.
Of course, Senator Harkin, we also hosted the community
forum that you sponsored and facilitated, which was attended by
people from throughout the community and the area in addition
to the general public.
Despite our obvious pride in Mercy's capabilities and
preparations, I do have to report that I do not believe we are
prepared, nor any hospital is prepared, for mass casualties in
the area of biological, nuclear, or chemical exposure. When you
ask, well, how prepared are we, what is our level of
preparedness overall, it is difficult to answer. It depends on
what scale of preparedness do we want to be ready for, what
scale of attack do we think is possible.
But, having said that, that it is almost an unanswerable
question, there is no question that hospitals need to do more.
An organization like ours, the largest trauma center in the
State, needs more than one portable decontamination booth. If
an attack were to occur, that booth takes care of one person
every 8 minutes. That may not be adequate, probably would not
be adequate in a mass exposure situation.
Many hospitals do not have even the basic level of the
capability that Mercy has. So we know hospitals do need to do
more and we are going to need the Federal Government's
assistance to do that.
Some of this is occurring. We are pleased that the Des
Moines area with this collaborative team has received a
$400,000 Federal grant to get it started. But it is not nearly
enough when you consider the number of providers and agencies
who need that money in order to improve their capabilities.
So it is imperative the Federal Government provide
additional assistance to America's hospitals, many of which
already are suffering from declining reimbursement, increasing
demands for care, and rising costs. Many of us have reached
those capacity limits of having full beds and long waiting
times in our emergency departments.
This problem is especially acute in Iowa, and the Senator
is very aware of this issue, where we are severely underpaid by
Medicare in a very unfair way. That constrains all types of
issues for us: our ability to recruit and retain staff, to have
adequate facilities, etcetera.
So I have included in my testimony a kind of a laundry list
of things I think hospitals need. For time's sake, I will not
repeat it here, but I think these are all critical things, not
only the ongoing education and training that Dr. Koplan
mentioned, but there are facility needs, there are equipment
needs, that we have to address.
I would ask the Federal Government to address these things
in two forms: an ongoing provision of fair and adequate payment
and in specific grants to health care organizations and
coalitions. Some of the bills that are being worked on include
especially the second half of that and we appreciate that.
PREPARED STATEMENT
In closing, I want to say thank you. We appreciate Senator
Harkin's and the committee's attention to this critical issue,
and we certainly appreciate any support you are able to provide
America's hospitals in dealing with these threats.
[The statement follows:]
Prepared Statement of Mr. Joseph LeValley
Mr. Chairman and members of the Committee, my name is Joe LeValley
and I serve as Senior Vice President for Planning and System
Development at Mercy Medical Center in Des Moines, Iowa. I want to
begin by saying that it is an honor for me to be here today,
representing our hospital and, indirectly, thousands of other hospitals
across our nation. Mr. Chairman, as an Iowan, it's a particular
pleasure to appear before this committee. I and everyone at Mercy have
enjoyed the opportunity to work closely with you for many years, and
appreciate your longstanding support of health care providers in Iowa,
and of the patients and families we serve.
Mercy Medical Center is a 691-bed tertiary medical center in
downtown Des Moines. However, our organization is involved in providing
care in more than 50 sites including physician clinics, nursing homes,
hospice and a dozen rural community hospitals in central and southern
Iowa. We are members of Catholic Health Initiatives, one of the
nation's largest not-for-profit health care systems, and are affiliated
with Mercy Health Network, a statewide network of hospitals and clinics
in Iowa.
I have worked for Mercy hospitals in Iowa for 18 years. In my
current role I am responsible for the strategic and facilities planning
for Mercy-Des Moines and I oversee our Network of community hospitals.
In contrast to several of the other witnesses, I am not a clinician.
The perspective I hope to provide to the committee is that of an
administrator who works closely with physicians, nurses and managers in
all areas of the organization to try to ensure that our programs,
services and facilities are adequate to meet the needs of more than
650,000 people living in the nine counties of central Iowa.
One of the questions that America's hospitals have been asking
since the national tragedy of September 11, is: how ready are we to
respond to incidents of terrorism involving biological, chemical or
nuclear materials? One answer is that we currently are well prepared to
decontaminate, triage, diagnose and treat a small number of victims of
exposure to these dangerous materials. Our medical center has one
portable decontamination unit that can be utilized in the Emergency
Department garage with just 12 minutes notice, and we have one
``negative air flow'' room that prevents fumes or particulates from
entering the rest of the hospital when caring for cases such as these.
We have a large Emergency Department, with 38 exam and treatment rooms
and a staff of more than 120 nurses, doctors and support staff. This ED
receives and cares for 56,000 patients a year--the most of any hospital
in Iowa.
One reason Mercy-Des Moines can claim to be ready for modest
incidents is that we recognized, even before September 11, that we and
the rest of the community needed to do more to prepare for the
possibility of mass exposure to biological, chemical or nuclear agents.
As a result, Mercy's clinical and safety leaders began an aggressive
program to increase our preparedness. Since last Spring Mercy has
provided hazardous materials training to all members of the staff of
the Emergency Department. This training has totaled more than 600
person-hours. In addition, we have added new equipment, such as the
decontamination booth, and about a dozen special ``Haz-mat'' suits to
protect staff as they decontaminate and care for these patients. We
have developed new policies and procedures, we have developed clinical
guidelines for dealing with specific agents, such as Anthrax, we have
stepped up our disaster drills, and we have increased our security
measures for the hospital and its ambulances and helicopter. We also
have hosted several educational programs for health care providers,
have been active participants in the Metro Medical Response System--a
community-wide effort to coordinate planning for, and response to,
disasters such as we're discussing today. Mercy currently has
representatives from Emergency Services, Infection Control, Safety and
Security, Laboratory and Pharmacy serving on committees for this
effort. In addition, Mercy representatives participate in the Iowa
Department of Public Health's Disaster Preparedness Initiative--a
statewide effort to create teams to respond to terrorist incidents.
Lastly, as you know, Senator Harkin, Mercy hosted a community forum in
October which you organized and facilitated, that was attended by
emergency personnel from every agency and organization, in addition to
the general public.
Despite our obvious pride in Mercy's capabilities, and the
leadership we have shown in this important arena, I must report to the
committee that we are NOT prepared--nor do I believe any hospital in
America is prepared--for large scale disasters involving biological,
chemical or nuclear agents. What is our level of preparedness overall?
That is a difficult question to answer specifically, without defining
the magnitude of the threat for which we want to be prepared. But I DO
believe a large trauma center such as Mercy needs more than one
decontamination room and one negative-air-flow treatment room. I know
that the many hospitals that do not have even that basic level of
capability must address this deficiency as well. There may be no upper
limit to the resources that could be committed to increasing the health
care system's preparedness. However, I believe the federal government
does need to commit additional funds to assist hospitals in doing more.
Some of this is being done. For example, the Metro Medical Response
System in Des Moines has received a $400,000 federal grant to improve
the surveillance, communications, response and treatment capabilities
related to potential terrorist acts. The Des Moines emergency workers
and health care providers very much appreciate this support. However,
it is not nearly enough, when you consider the multiple police
departments, fire departments, hospitals, first responders and other
agencies and organizations that are attempting to improve their
capabilities.
It is imperative that the federal government provide additional
assistance to America's hospitals, many of which already are suffering
from declining reimbursements, increased demands for care, and rising
costs of wages, supplies and pharmaceuticals. This is especially
critical in Iowa, which is one of the lowest paid states in the nation
by Medicare, and which cares for one of the highest percentages of
Medicare recipients. The latest data available shows that the average
hospital in Iowa has a negative Medicare margin of 6.5 percent. This
enormous challenge is being exacerbated by plans to reduce outpatient
payments to hospitals, and to reduce physician reimbursement by more
than 5 percent.
I respectfully submit that health care providers--and hospitals
specifically--need additional federal money to assist with the
following critical needs related to our disaster preparedness:
--Community education
--Clinical training
--Development of clinical protocols and responses
--Development and coordination of community disaster response plans
--Improved communication systems
--Improved disease surveillance and reporting systems
--Purchase of decontamination and protective equipment
--Improvement of decontamination and treatment facilities
--Pharmaceuticals and medical supplies
--Mental health resources
This federal support should come in two forms. First and foremost,
the ongoing provision of fair and adequate payment for the services
provided by hospitals and doctors. Secondly, grants to specific health
care organizations, to coalitions of providers, and to governmental
entities to support needed improvements.
Related to these needs in Iowa, Governor Tom Vilsack has submitted,
on behalf of the Iowa Department of Public Health, a request for a
``Medical/Disaster Grant.'' This grant would be used equipment,
vaccines, transportation support, communications improvements and many
other areas related to potential terrorist events. A portion of this
money would flow to hospitals, to assist them in their roles.
Also, as you may be aware, the American Hospital Association also
has done some analysis related to these issues. The AHA's work is
related more specifically to the needs of America's hospitals. Again,
for the record, I have attached the AHA's report entitled ``Hospital
Resources for Disaster Readiness'' to my printed statement.
In closing, on behalf of Mercy Medical Center, I want to say that
we appreciate Senator Harkin's and the Committee's attention to the
critical issue, and any support you provide to us in meeting these
crucial needs. Thank you very much for the opportunity to testify. I
would be happy to answer questions.
hospital resources for disaster readiness
The American Hospital Association has developed the following
overview of the needs of the nation's hospitals related to future mass
casualty events. Many experts agree that it is a matter of ``when'' and
not ``if' such an event will occur. Without warning, hospitals in New
York, Washington DC, Pennsylvania, Virginia, Maryland, New Jersey, and
Connecticut were prepared to answer the call when it came on the
morning of September 11th. America's hospitals will be there to do so
again. The September 11th attacks, unfortunately, resulted in high
mortality and few survivors. Hospitals were ready to respond but few
patients appeared. The more recent spate of anthrax cases in Florida,
New York, New Jersey and Washington, DC has been a further test of
hospitals' readiness to address the increasing possibility of future
mass casualty incidents.
However, the stakes have clearly been raised since the September
11th attack. Hospitals need to upgrade their capabilities. In a
nuclear, biological, or chemical (NBC) attack, hospitals would be
severely challenged without access to additional resources. The recent
anthrax scare has shown that hospitals can adequately respond to an
attack yielding a small numbers of patients, but questions remain about
their readiness to deal with larger scale attacks.
This paper will provide a rough estimate of what each of the
nations 4,900 acute care hospitals would require to increase their
ability to respond to a NBC attack. We will distinguish between
readiness resources required for the nation's approximately 2,700
metropolitan hospitals and 2,200 non-metropolitan hospitals. For
metropolitan hospitals, we estimate the average number of total full-
time equivalent (FTE) employees per hospital at 1,200, with 370
clinical staff. For a non-metropolitan hospital, we estimate the
average number of total FTE employees per hospital at 300, with 90
clinical staff. The source of these hospital statistics is the AHA's
Hospital Statistics database.
The resource estimates below are based on a scenario that includes
an event with casualties of 1,000 individuals seeking care at a
metropolitan hospital and 200 individuals seeking care at a non-
metropolitan hospital. We estimate what these hospitals would need in
order to sustain these intense demands for approximately 24 to 48
hours. After this period of time, we assume that the Centers for
Disease Control and Prevention (CDC) Bioterrorism Preparedness and
Response program, especially its National Pharmaceutical Stockpile
program, would be mobilized, and provide additional medical supplies to
the impacted community. It should be noted, however, that this program
is not fully implemented and concerns about its weaknesses have been
raised (See, Combating Terrorism: Accountability Over Medical Supplies
Needs Further Improvement, GAO-O1-666T).
The AHA is also exploring a number of other options related to
readiness, including the need for regional coordination of community-
wide efforts to deal with an incident of biological or chemical
terrorism; the need for educational efforts by Federal, State and local
government to help hospitals and other members of the healthcare
infrastructure best utilize the resources outlined below; and the need
to address changes in certain regulations, such as the Health Insurance
Portability and Accountability Act (HIPAA), the Emergency Medical
Treatment and Active Labor Act (EMTALA), and other requirements on
hospitals that may actually impede our ability to prepare for and
ultimately respond to acts of terrorism. Further, because health care
workers in hospitals would be first responders in an outbreak resulting
from biological terrorism, they may face a higher risk of infection
than the general population. Therefore, the AHA, in consultation with
public health authorities, will be addressing whether health care
workers should be given priority with regard to inoculation against
certain biological agents (such as smallpox and anthrax) that are
considered to be potential terrorist threats. These issues will become
agenda items for our readiness efforts.
In this document, we have included only those items that would be
essential for the shortterm (24 to 48 hours) disaster response.
However, we believe that what is ultimately needed, in both the short
and long-term, is an operationally effective response system and the
integration of hospitals into the community-wide response for mass
casualty events. Because mass casualty events will, by definition,
overwhelm the resources of a single hospital, they should be seen as
community-wide concerns likely to require a broad array of community
resources to supplement the health care system. Therefore, a
communitywide perspective and community-wide planning is essential for
readiness. Local government must be involved in such planning,
including the public health department, police and fire department.
Other community resources are likely to be called upon and should be
included in community-wide planning, including public transportation
officials, news media, telephone and communication systems, schools,
churches, voluntary disaster relief organizations, restaurants and food
suppliers.
In order to ensure the readiness of the nation's hospitals for such
events, this paper will attempt to provide a credible roadmap toward
that goal. Operationally effective response systems must be defined and
developed so as to be sustainable over time. All related training also
must be sustained over time.
The following key areas must be addressed to increase hospital
readiness:
--Communication and notification
--Disease surveillance, disease reporting and laboratory
identification
--Personal protective equipment
--Facility
--Dedicated decontamination facilities
--Medical/surgical and pharmaceutical supplies
--Training and drills
--Mental health resources
Communication and notification
Mass casualty incidents create a demand for public information and
multiple means for communication with community first responder
organizations. In most cases, at least some of the information will not
be readily available while the incident develops. In our mass media and
multi-media culture, every news and information source will seek access
to the latest and most up-to-date information. Absent clear and
credible information, speculation may reign, and increase the stress
and pressure of the incident, especially on the hospital and its staff.
Therefore, planned and structured arrangements for communication
throughout the incident and during its response are critical components
of hospital and community preparedness. For example, all organizations
involved in the community preparedness plan for mass casualties,
including hospitals, need to agree in advance on who will serve as the
single, regional spokesperson. If a government official is designated
as the spokesperson, health experts must be provided to assist the
official with responses to medical questions. To minimize disruption of
hospital patient care activities, press events should be conducted away
from health care facilities, using regularly scheduled and pre-
announced media briefing times.
Further, in a mass casualty incident, it is critical that hospitals
have an ongoing, open channel of communications with the public safety
community who may have first awareness of the incident. A community-
wide network using the same channel is necessary. The network should be
tested daily, with the test rotating across the various hospital and
emergency medical services (EMS) shifts. Members of the public safety
community, such as fire, EMS, public health departments, State, local
and Federal law enforcement, and hospitals, normally rely on effective
communications to provide emergency medical care, rescue accident
victims, respond to natural disasters and investigate crime. One of the
``lessons learned'' from the experiences in the recent New York City
attack, at Columbine High School in Colorado and in response to the
Oklahoma City bombing is the need for greater coordination of public
safety communications. These types of communications may become even
more critical in the case of an NBC attack.
One of the key issues regarding public safety communications is
``interoperability.'' Interoperability refers to the ability of
different public safety entities to communicate with each other, on
demand, in real time. Common problems experienced by the public safety
community include the failure of equipment in ``dead spots,''
interference, insufficient equipment, outdated equipment and channel
congestion. An array of technologies including pagers, cellular phones,
mobile data terminals and mobile laptop computers are currently used.
However, a recent report suggests that existing local land mobile radio
systems are, on average, nearly 10 years old, with State agencies
having considerably older infrastructures (See, Public Safety Wireless
Network Program Analysis of Fire and EMS Communications
Interoperability, April 1999).
Most public safety organizations, including hospitals, have
experienced problems with interoperability. There is a critical need
for funding to upgrade and modernize public safety communications
systems and to address interoperability problems. In addition, public
safety communications face a variety of issues related to spectrum.
These are serious interoperability problems that arise from the
fragmentation of public safety spectrum. The most effective way to
better ensure interoperability is to incorporate the fundamental
principles of the Incident Command System into each level of emergency
preparedness planning. Additional spectrum may be required, as well as
improved planning and management of the interoperability spectrum.
In case existing systems fail in an emergency, alternative and
redundant communications systems (e.g., cell phone, two-way radio, ham
radio, unlisted numbers, web-based, video conferencing, and use of
human couriers) will be required as back-up. Loudspeakers or bullhorns
for communicating with the public outside the facility may also be
required for the purposes of crowd control. Finally, translators and
translated patient resource documents for non-English speaking patients
will also be needed, as well as clear signage plans for directing
patients to appropriate locations within the facility.
The following are resources needed for increasing preparedness and
developing an adequate communications system for metropolitan and non-
metropolitan hospitals.
--Coordination of public safety communications (fire, EMS, public
health department, other hospitals, Federal Bureau of
Investigation, Office of Emergency Preparedness, etc.)
-- Alternative communications system if hospital communications fail/
overload (e.g., cell phone, two-way radio, ham radio, unlisted
numbers, web-based, video conferencing, courier system)
--Translators for non-English speaking patients and translated
patient resource documents
-- Loudspeakers/bullhoms for communicating with individuals outside
the facility
-- Signage for communicating instructions to patients and for
designating various emergency functional areas
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $75,000 $202,500,000
Non-metropolitan hospitals:.......... 37,500 82,500,000
------------------------------------------------------------------------
Disease surveillance, disease reporting and laboratory identification
A terrorist attack involving nuclear, biological or chemical agents
could occur in an overt or covert manner. Most typical of terrorist
actions to date is that of a sudden and highly localized event
producing immediate casualties, such as an explosion. This is also the
most likely scenario for an attack involving chemical weapons.
Scenarios involving the deployment of a biological agent are
expected to occur covertly, with increasing numbers of patients
presenting to hospitals and physicians offices over the course of hours
to weeks with signs and symptoms that may be common to many diseases
and conditions. Radiologic agents could be released in either a covert
or overt manner.
Improving hospital disease surveillance and disease reporting, and
the public health infrastructure will be critical to determining that a
cluster of disease may be related to the intentional release of a
biological or chemical agent. Particularly for biological agents, an
effective medical response will be critically dependent upon the
ability of individual clinicians, who may be widely scattered around a
large metropolitan area, to identify, accurately diagnose, and
effectively treat an uncommon disease. To facilitate this level of
readiness, laboratory diagnostic capability will need to be upgraded
and laboratory personnel will require additional training.
The rapid identification of the chemical, biological or radiologic
agents involved in any such incident is vital to the protection of the
first responders and emergency medical personnel at local hospitals, as
well as to the most effective treatment of resulting casualties.
Further, readiness will require a special ability to track large
numbers of patients and handle and display comprehensive amounts of
real-time patient information, with the ability to integrate with
systems currently used by Federal, State, regional and local agencies.
What follows are some of the improvements, equipment and tests that
will be critical to ramping up hospital disease reporting, disease
surveillance and laboratory identification capacity.
--Improvement of hospital disease surveillance, disease reporting,
and public health infrastructure
--System to facilitate expedited disease reporting, dissemination of
real-time treatment guidelines and access to experts
--Informatics
--Patient tracking system
--Detection instruments/monitors for detecting radiation
--Tests/assays for detection of chemical agents and toxic industrial
materials
--Serologic/immunologic/nucleic acid tests for identification of
biologic agents
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $750,000 $2,025,000,000
Non-metropolitan hospitals........... 375,000 825,000,000
------------------------------------------------------------------------
Personal protective equipment
Personal protective equipment (PPE) refers to clothing and
respiratory apparatus designed to shield an individual from chemical,
biological or other physical hazards. The ``universal precautions''
(gloves, gown, mask, goggles, etc.) used by medical personnel to
prevent infections will generally provide protection from the
biological agents commonly considered to be threats. However, in the
event of a large-scale biological event, hospitals would have to
provide at least this level of protection to all staff. A hospital's
daily inventory of such items would be quickly exhausted and the
replacement of these supplies and equipment would be necessary. This is
particularly the case because hospitals would have to be prepared to
receive not only patients who would be decontaminated in the field, but
also patients who ``walk in'' without being decontaminated. Initial
triage must be performed by health care workers in appropriate PPE.
Today, hospitals generally are not stocked with suitable PPE to protect
clinicians and other health care workers from exposure in the event of
a biological or chemical attack, particularly one involving an unknown
agent.
The highest level of PPE provides the utmost protection for the
worker, but carries the disadvantages of being extremely costly to
purchase and train staff members in its use, and is a very awkward
ensemble in which to function. Other levels may provide appropriate
protection levels and yet overcome some of the disadvantages. All
levels of protection will fall under Occupational Health and Safety
Administration (OSHA) regulations for respiratory protection (29CFR
1910.134) and personal protective equipment (29CFR 1910.132). A
requirement for training hospital employees in the use of PPE also must
be included in disaster planning.
Level A protection provides the highest level of respiratory and
skin protection. The suit provides a fully enclosed environment for the
health care worker, being chemical resistant and impermeable to gases
and vapors. Chemical resistant boots and gloves also should be worn. It
is used with either a self-contained breathing apparatus (SCBA)
internal to the suit or a supplied-air respirator. According to OSHA
this is the level of protection to be used with an unidentified agent.
This level of protection is extremely cumbersome, hot to wear and may
hinder communication.
Level B protection provides slightly less skin protection than
level A, in that the suit does not provide a fully enclosed environment
for the worker, but still a high level of respiratory protection. It is
also chemical resistant, but does not fully protect against vapors,
which may be harmful to the skin. Chemical resistant boots and gloves
also would be required. At this level the SCBA tank would be worn
outside of the suit, or a supplied-air respirator may also be used.
Although less than level A, level B protection is still cumbersome and
warm, as well as limiting to communication.
Level C protection is also chemical resistant and splash proof,
with chemical resistant gloves and boots required. At level C, a full-
or half-face air-purifying respirator may be used. With this type of
respiratory protection, it is essential that the chemical agent be
identified, as the cartridges must filter that specific agent. There
are some respirators available with stacked cartridges to address
organic vapors and acid gas, and to provide high efficiency particulate
air (HEPA) filtration. This latter system may prove to be effective
against most agents expected to be utilized in a situation of chemical
terrorism.
Level B protection will be appropriate for front-line clinicians in
most health care applications. It provides a high level of protection,
yet provides more ease of movement and comfort for the health care
worker, while also being less costly than level A protection.
Additionally, with SCBA or air-purifying respirators with full head
cover, immediate knowledge of the specific identity of the agent is not
required. For most agents encountered in a hospital setting, level B
will be adequate, although not the highest level of available
protection. However, level C protection, with stacked cartridges may
also suffice. A health care organization must make its own
determination concerning appropriate PPE based on regulatory
requirements, evaluation of potential hazards, and consultation with
local emergency response agencies. If, during the course of an
incident, the contaminant is identified and determined to be a lesser
threat than originally assessed, the level of personal protective
equipment can be downgraded.
For metropolitan hospitals, we assume that a basic ``universal
precaution'' level protection would be required for 1,200 FTE
employees, with Level B protection available to 50 clinicians
functioning in a front-line capacity--decontamination, triage,
emergency room (ER), operating room (OR), laboratory, radiology, and
custodial personnel--over the course of 48 hours in an event involving
1,000 patients presenting to the hospital. For non-metropolitan
hospitals, we assume that the basic level of protection would be
required for 300 FTE employees, with Level B protection available for
20 front line clinicians--decontamination, triage, ER, OR--over the
course of 48 hours and in an event yielding 200 patients at the
hospital.
--Gloves, gowns, HEPA masks (OSHA/NIOSH-approved high efficiency
particulate), goggles, shoe covers--available to all employees
with allowances for frequent glove, gown and mask changes
(metro hospital $65,000, non-metro hospital $16,000)
--Fit-testing HEPA mask--at $75 per person for all employees (metro
hospital $90,000, non-metro hospital $22,500)
--Level B protection for front-line clinical staff includes:
--SCBA operated in positive pressure mode
--Fit-testing and maintenance requirements for SCBAs
--Hooded, two-piece chemical resistant suit
--Chemically resistant gloves and boots
--Estimated cost of $7,000 per person; metropolitan hospital
$350,000; nonmetropolitan hospital cost of $140,000
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $505,000 $1,363,500,000
Non-metropolitan hospitals........... 178,500 392,700,000
------------------------------------------------------------------------
Facility
Newly constructed and existing hospitals must comply with the Life
Safety Code (LSC) developed by the National Fire Protection
Association. The LSC is intended to provide a level of life and
occupancy safety necessary to protect patients, personnel, visitors and
property from fire, smoke and other products of combustion. It provides
a process for inspecting, testing and maintaining fire protection and
life safety systems, equipment and components on a regular basis. In
addition, each hospital must develop policies and procedures that
include written criteria evaluating various deficiencies and
construction hazards.
In the case of a NBC attack the following additional items and
capabilities must be contemplated:
--Lockdown capability to minimize access to facility and facilitate
direct patient flow to specific points
--Other security measures such as perimeter checks, hospital-issued
staff photo identification badges, visitor badging/
identification and package handling.
--Auxiliary power source
--Increased storage capacity for fossil fuels to provide
uninterrupted power
--Portable negative air machines and HEPA filters
--Large volume water purification equipment
--Expanded mortuary facilities to manage bodies with high
contamination or infectivity potential
--Designated hospital locations for personnel quarantine
--Expanded patient isolation facilities, including separate air
handling system
--Expanded storage space for stockpiles of PPE, pharmaceuticals and
supplies.
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $75,000 $202,500,000
Non-metropolitan hospitals........... 37,500 82,500,000
------------------------------------------------------------------------
Dedicated decontamination facility
Patient decontamination is the process of removing or neutralizing
hazardous chemical, biological or radiologic agents from an injured or
otherwise exposed individual in order to reduce the risk to the
individual and minimize secondary exposure to health care workers and
other patients in the facility. Hospitals should have a minimal level
decontamination facility for ambulatory and non-ambulatory patients for
small events; the ability to ramp-up quickly for a medium level event;
and access to a regional decontamination facility for a large-scale
event.
An outdoor facility or area can be effective, particularly to
prevent contaminants from entering a fixed health care facility. An
outdoor facility also is suitable for handling any large influx of
injured or exposed individuals. It also holds the advantage of not
requiring a dedicated air-handling and ventilation system, as would be
required in an indoor decontamination facility. There are several
drawbacks, including the requirement for providing protection from
inclement weather and providing additional lighting. Each hospital must
consider all such relevant factors in making a decision regarding
appropriate decontamination facilities.
--Hospital decontamination room, including:
--Dedicated entrance from the ambulance entrance
--Ventilation: negative pressure (minimum of 12 air changes per hour)
and dedicated exhaust with HEPA filter
--Water supply: emergency eyewash and shower (with hot and cold
water)
--Waste water containment: Floor drain directs decontamination water
to a commercially available, 500-gallon hazmat-compatible
(polypropylene) holding tank, with sample port, bypass valve
and extra holding tanks.
--Electrical: Two explosion-proof pendant fixtures (not affixed to
the ceiling), with two 48 x 1 inch 32W T8 tubes per fixture
with full electronic ballast; external light switch, and;
explosion-proof receptacles, protected by ground fault
interrupters.
--Decontamination tables
--Storage: PPE, medical and other decontamination room supplies
should be stored in a cabinet alcove outside the
decontamination room. A hazardous waste drum should be in the
room for contaminated patient clothing, etc.
--Provision for the storage and identification of patient clothing
and personal items/valuables, pending possible disposal
requirements.
--Provisions to extend decontamination into the parking lot or other
large area using portable units, including:
--Outdoor shower systems with hot and cold water supply, with
provision for separate showers for male and female patients
--Adequate containment for run-off waste water
--Separate tents for male and female patients
--Portable generator(s) for power and for heating/air conditioning
based on weather
--Portable lighting units for use during evening operations
--Soap, dispensers, brushes, etc.
--Facilities for safe collection, containment, storage and disposal
of contaminated materials
--Extra patient linen for decontaminated patients and hospital scrubs
as change of clothing for hospital staff working in the
decontamination room/area
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $500,000 $1,350,000,000
Non-metropolitan hospitals........... 250,000 550,000,000
------------------------------------------------------------------------
Pharmaceutical and medical/surgical supplies
Hospitals must be properly stocked with antibiotics, antitoxins,
antidotes, ventilators, respirators and other supplies and equipment
needed to treat patients in a mass casualty event. We assume that
external sources of drugs and related supplies (e.g. CDC's National
Pharmaceutical Stockpile) will be available within 24 hours of the
detection of a biological or chemical agent. Therefore, hospitals would
have to be prepared to sustain a 24-hour supply of pharmaceutical
products at the most common dosage for the estimated number of patients
and hospital personnel. Provisions and planning also must be made for
appropriate dosages and formulations for children who may be victims.
For medical/surgical supplies and equipment, a standardized formula
must be developed to adequately determine stock requirements.
In addition to needed pharmaceuticals and medical supplies that are
directly related to attacks using biological or chemical agents,
hospitals may need to increase their in-house inventory of routine
drugs, biologicals and medical supplies. As a cost containment
initiative, many, if not most, hospitals have very tight inventory
controls in place. If local transportation is disrupted or local
warehouses destroyed, hospitals will need to be able to survive for 24-
48 hours with on-hand pharmaceuticals and supplies for all purposes
until relief supplies arrive. The need to increase their on-hand stock
may be especially important for high-use items, such as insulin, that
are taken daily by large numbers of people with chronic conditions. If
local retail sources of such drugs become unavailable or local retail
sources are unable to replenish their stock, chronically ill
individuals who lose access to their home supplies are likely to turn
to their local hospitals to access needed drugs and biologicals.
For pharmaceutical and other supplies used rarely in the normal
course of hospital activity, particular attention must be paid to
appropriate dosing, shelf life and stock rotation issues. A plan for
pooling of resources through mutual aid agreements among area health
care facilities should be considered for such rarely used products and
supplies.
Suggested pharmaceuticals and related supplies
Bacterial agents: Ciprofloxacin, Doxycycline, Penicillin,
Chloramphenicol, Azithromycin, Rifampin, Streptomycin, and Gentamicin.
Botulism toxin: Mechanical respiratory ventilators, and other
associated supplies.
Cyanides: Cyanide antidote kits containing amyl nitrite, sodium
nitrite and sodium thiosulfate.
Lewisite: British anti-lewisite.
Nerve agents: Atropine, Pralidoxime chloride, and Diazepam (or
lorazepam).
Pulmonary agents: Oxygen ventilators, and Respiratory care
supplies.
All agents: Resuscitation equipment and supplies, Vasopressors and
vasopressin vials.
Other equipment and supplies
Mechanical respiratory ventilators (adult, pediatric, neonate), IV
pumps and poles, IV supplies (for 1,000 patients)--IV Fluids-D5W,
D5NaC1, D5 lactated Ringers (need one per initial patient) In-dwelling
catheters (need one per initial patient in each size), IV sets (enough
to handle one per initial patient)--Suction machines, Stretchers,
Wheelchairs, Linens, and Bandages and dressings.
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $600,000 $1,620,000,000
Non-metropolitan hospitals........... 300,000 660,000,000
------------------------------------------------------------------------
Training and drills
Staff training is needed at all levels of the organization for all
types of potential disasters: nuclear, biological, chemical and
conventional. The training needs to be stratified by educational level,
from general staff awareness to technician level. Further, drills must
be conducted at least twice a year, according to requirements of the
Joint Commission on the Accreditation of Healthcare Organizations,
(JCAHO), and involve all key staff. Additional disaster drills beyond
those required by JCAHO, particularly those integrated into local/
State/Federal disaster drills, would enhance the level of hospital
readiness and staff competence in the event of a mass casualty
incident.
--Training: Using Web-based format with hard copy materials for all
levels of staff on mass casualty event awareness and
preparedness (initial orientation, annually, periodic)
--Development of on-site disaster-response training courses
(equipment, supplies, course manuals, trainers). This would
include, but not be limited to, clinical training on biological
and chemical topics involving staff from ER, urgent care,
primary care, laboratory and others involved in emergency
response. Should include training on pediatric casualties.
-- At least two drills annually: Functional exercise, full disaster
drill, and additional hours on development of the scenarios and
logistics.
--Training on the use of personal protective equipment
--Training on set up and use of decontamination systems
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $500,000 $1,350,000,000
Non-metropolitan hospitals........... 250,000 550,000,000
------------------------------------------------------------------------
Mental health
Survivors of mass casualty events and responders to such incidents
(fire, police, rescue workers, health care professionals, etc.) will
suffer not only physical injury requiring medical care but also will
undoubtedly undergo extreme psychological trauma. Thus the deployment
of chemical, biological or nuclear agents against a population produces
both acute and chronic psychiatric problems. In a disaster, several
different groups would require mental health services, both direct and
indirect:
--Individuals presenting at the door or brought to the facility by
rescue personnel, including those who have specialized needs
such as pregnant women, children, elderly, or those who have an
underlying mental health problem that may or may not have been
previously treated;
--Fire, police and rescue workers injured while attempting to save a
life
--Injured individuals, including children, who have witnessed the
death or serious injury of a family member or colleague;
--Family and friends of the missing, injured or dead. This group may
suffer mental distress that may require immediate mental health
services or physical treatment;
--``Worried well'' individuals who may need reassurance that they are
not ill;
--Administrative staff responsible for making decisions that affect
the facility's ability to quickly respond to a mass casualty
disaster;
--Communication/professional staff to handle media inquiries and
present accurate and appropriate information so that the
general public and institutions will be able to process the
information; and
--Facility staff working the disaster to ensure they are mentally and
physically fit. There would be an immediate on-site need for
critical incident stress debriefing to be conducted for those
providing trauma and triage care.
Beyond physical injuries, individuals who have survived a disaster
also would be experiencing extreme emotional distress that could also
manifest in physical conditions. This could include, but not be limited
to, physical shock, hysteria, anxiety, fear, anger, frustration, and
guilt, as well as an inability to communicate information critical to
their treatment. For example, a survivor with a heart condition or
asthma may require both immediate physical help and crisis intervention
to be able to calm down and prevent further injury or distress.
Finally, some individuals also may want to leave facilities to find
loved ones or colleagues or to return to a safe place, whether or not
they are physically or mentally able to do so. This might require close
monitoring or short-term containment.
The following estimate was provided by the New York-Presbyterian
Healthcare System, 525 E. 68th Street, New York, NY, whose recent
experience provided some answers regarding this question. According to
their estimate, triage and initial evaluation for one day of 1,000
individuals (assuming an average salary of $75,000) would require that
31.25 FTEs provide four direct service evaluations per hour. This would
be a direct cost of $9,375 per day. In addition, administrative
services would cost $2,500 per day with total service personnel of
$11,875. Other costs would include additional security, medications and
administrative costs of $10,000, for a total of about $22,000 for a
metropolitan hospital. We assume that a non-metropolitan hospital would
bear about half the total cost of a metropolitan hospital.
------------------------------------------------------------------------
All hospitals in
Per hospital category
------------------------------------------------------------------------
Metropolitan hospitals............... $22,000 $59,400,000
Non-metropolitan hospitals........... 11,000 24,200,000
----------------------------------
Totals: Metropolitan Hosp...... 3,027,000 8,172,900,000
==================================
Totals: Non-metropolitan Hosp.. 1,439,500 3,166,900,000
----------------------------------
Totals......................... .............. 11,339,800,000
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Senator Harkin. Thank you, Dr. LeValley.
I want to call a brief recess here. When I come back I
would like to cover just the following things. Dr. Alibek, I
just want to ask you, do you think we are maybe overreacting? I
want to just delve into that a little bit with you. Are we
overreacting or not in this? We will get back to that when I
get back.
Dr. Barbera and Dr. LeValley, I want to talk about this
question you raised, Dr. LeValley, about what is the adequate
level of preparedness. We cannot prepare for every possible
contingency, so we have to prioritize. What is the first thing
that we have to do and what does that cost, and what level of
protection did we provide for the American people in our
hospital systems across the country? Obviously, we just cannot
cover everything, but we have to think about what is it that
gives the maximum amount of protection to the American people
in the realm in which we are working right now, and how much is
that going to cost and how soon do we need to do it? So I am
going to come back and ask you what the priorities are out
there, since we cannot fund everything.
So we will have a brief recess. Maybe, Dr. Koplan, you can
get those figures, because, as Senator Specter said, we have
got to get this budget put together before the end of the week.
So we will have a brief recess and the subcommittee will be
back in about 15 minutes.
[Recess from 10:42 a.m. to 11:04 a.m.]
Senator Harkin. The subcommittee will resume.
Dr. Alibek, before I left I said I wanted to ask you a
couple of questions. Again, I want to know if we are
overreacting, because a couple of years ago, we had this
Japanese cult that released some sarin gas in Tokyo in the
subways and it just did not work on a broad basis. Even with
the anthrax, it seems to be very difficult to do on a broad-
basis.
Now that the initial wave has hit, people are now thinking
about what we have to do. Are we overreacting? Is it very
likely that biological weapons that were manufactured in the
Soviet Union have been obtained by other nations?
You said that the former Soviet Union had genetically
modified smallpox and other agents. Would the smallpox vaccine
that we are talking about here, will it work against the
modified smallpox?
Dr. Alibek. It would.
Senator Harkin. It would.
Second, what do you think about this? Are we overreacting
or not?
Dr. Alibek. I would like to say we are overreacting, but
unfortunately I cannot say this. The problem is this: When we
discuss biological weapons, what is the difference between a
biological weapons threat, a bioterrorism threat, and some
other threats we have already faced? We noticed that this
anthrax threat was a long-term continuous threat. We saw how
people reacted. The entire population was in a state of fear or
scare.
What is important to say in this case is that this attack
was the least effective attack you could imagine, because
letter-borne deployment is not very effective. I would say it
is the least effective. In this case, think what could be done
if they are able to use some other techniques to deploy
biological agents. I am not going to elaborate what kind of
techniques they could use, but, believe me, there are many
different techniques.
I do not want to be a bad messenger, but in my opinion it
is sort of the beginning of the process. We will be seeing some
new attempts to deploy biological agents in the future.
But when we say it was not very effective, for example the
Japanese cult using sarin gas, and then the anthrax scare or
attack here in the United States, in my opinion it is a first
attempt. Even these first attempts showed how scary this thing
could be. In this case, in my opinion we need to put it on a
scale: What kind of consequences could we expect in case we
have a large biological weapons attack somewhere in the mall,
one of the malls, or metro systems, and so on and so forth. You
can imagine what kind of damage, psychological and economic
damage, this type of attack would bring to the United States.
In my opinion, we are not overreacting. We do what we need
to do, and in my opinion we need to do more to be better
prepared.
Senator Harkin. I appreciate that.
One last thing. You mentioned the scientists that have a
lot of expertise in this area. You mentioned in your testimony
and in your written testimony, that they have a lot of
expertise and that they could be used. Where are these
scientists now? Are they still in Russia, are they here? Where
are they?
What would it take to be able to enlist them? I think what
you said is, because of the knowledge base they have, that
knowledge could also be used to help develop defenses against
biological weapons. Is that not what you said?
Dr. Alibek. Yes.
Senator Harkin. Where are all these people?
Dr. Alibek. It is a very interesting question. Of course,
maybe I am not an appropriate person to answer this question
because I have never done intelligence work to find out where
these people are. My knowledge is coming from my talks with
some former Russian scientists and some discussions with some
other people. For example, I know that many of them are here
now in the United States. In my opinion, about between 70 and
100 scientists are in the United States.
Senator Harkin. Are here?
Dr. Alibek. Yes, in the United States. Quite a significant
number of people are in Europe, in Eastern and Western Europe;
some of them are in Asia, Japan and some other Asian countries.
We know about some scientists working as professors and faculty
in Iran, teaching Iranian students. There was a rumor that some
of them left for Iraq, but it was rumor. Of course, we cannot
prove this.
There are quite a significant number still in Russia, and
many of them are in the former Soviet Union countries, which
are independent countries now.
I would say these scientists are scattered all over the
world now. In my opinion it is important to discuss this issue
of Russian scientists. We discussed smallpox, for example, and
we know that in the United States we have got significant
knowledge of smallpox. At the same time, a huge study was done
on smallpox, regarding how to develop protection and how to
develop biological weapons, in the former Soviet Union. A lot
has been done with anthrax. These people have sophisticated
knowledge about how to work with anthrax.
But at the same time, for many diseases like glanders, like
melioidosis, brucellosis, tularemia, Ebola infection, Marburg
infection, and so on and so forth--I can continue this
enumeration endlessly--we have no sophisticated knowledge here
in the United States. But these people, they've got this
knowledge and they could be very good assets to help us
understand what kinds of protection we can develop and
understand the pathogenesis of these infections.
Just to prepare a good scientist in this field who is able
to work under BL-3, BL-4 conditions and do this necessary work,
it could take years and years or even decades, and it would
cost millions of dollars. But we have got ready-made scientists
and they are able to accumulate this knowledge here in the
United States. In my opinion, they could be a perfect asset to
help the United States develop protection against biological
weapons and against bioterrorism.
Senator Harkin. Thank you, Dr. Alibek. It seems to me we
could make agreements with Russia. It would seem that they have
as much interest in this as we do. But that is out of the realm
of my subcommittee.
Dr. Barbera and Mr. LeValley, I asked you when I left to
prioritize. Since we cannot do everything, what can we do now
to help our local hospitals be at least somewhat prepared for
what we know would be some of the major things that might
happen? We know we cannot do everything, but what are the first
things we need to do and ought to be paying attention to here
with the money that we are appropriating?
Either one of you. Mr. LeValley?
Mr. LeValley. Well, Senator, I think we all understand
that, as I mentioned in my testimony, it is an unanswerable
question. I think you are probably aware the American Hospital
Association has done some work on some broad-based estimates
using some pretty broad rules of thumb and came up with a
figure of over $11 billion that hospitals could use to better
prepare, based on the assumption that we would want large urban
centers like Mercy to be able to handle 1,000 casualties.
I think as we debate those kind of numbers, we can debate
how many hospitals need to be ready for what level of care and
what can the government afford, and all those are very
legitimate issues.
One thing I might suggest to try to get to your issue of
prioritizing. Rather than rely on my perspective, we may want
to convene a group with the Iowa Hospital Association, for
example, and get some clinicians and others together and
provide you a written response to that question of how would
hospitals prioritize. I might make that offer to you. I would
be happy to coordinate that on your behalf, to pull some people
together and get some additional minds other than mine in terms
of the priorities.
From Mercy's perspective, I can tell you that if you took
the American Hospital Association numbers, and I just did the
calculation quickly last night in Mr. Waters' office, roughly
about $3 million would flow to Mercy Medical Center. I can tell
you as we sit here today that we could spend that $3 million to
significantly improve our preparedness and not any of it would
be wasted.
We have very real needs to improve our emergency
department, to improve our security systems, to increase our
pharmaceutical supplies and vaccines and all those things. I
made kind of a laundry list here in my notes about laboratory
and diagnostic capability expansion.
Compounding this problem of the terrorist threat is the
fact that America's hospitals are experiencing capacity
problems all across the Nation already. We have a bit of a
crisis going on in hospital care to begin with. In Des Moines,
not just Mercy, but all Des Moines hospitals have had numerous
days in the last year or two where we have been full, with no
beds available. We have had numerous days where emergency
departments have been forced to turn away patients, divert
patients to other places, because they did not have the
capacity.
If an attack like this were to occur on a day when our beds
were full and people are already being diverted, we would have
a true catastrophe on our hands.
But to answer your question then, do we say as part of our
terrorist preparedness that we want to expand the bed capacity
and physical plants of all of our hospitals? That number would
be enormous. So I think it is a very difficult policy question
and we have lots of needs. Our commitment to you would be to
put to very good use whatever funds you can come up with for
hospitals to help us improve our preparedness.
Second, I would just hammer home this issue that, if we are
going to have nurses in the future, if we are going to have
physical capacity in the future to deal with our health care
needs, we have got to have adequate reimbursement day in and
day out. Think about trying to recruit nurses and the whole
smallpox issue. Think about what we are going to have to be
paying people in the future as these threats are elevated and
emergency staffs and nursing staffs are being asked to take
care of these kinds of risks. The costs of that are only going
to rise, and if the government keeps reducing what they pay us,
as currently proposed in the outpatient capital process and the
physician reimbursement process, we are really headed for
disaster.
Senator Harkin. That is on another track we are trying to
address right now.
Mr. LeValley. We appreciate it very much.
Senator Harkin. But I see what you are saying. I think, to
interpret what you just said, Mr. LeValley, it is hard to focus
on building this extra additional capacity when the basic
fundamental capacity and support structure is being eroded.
Mr. LeValley. Absolutely.
Senator Harkin. That is what we are facing.
Dr. Barbera, you spoke about what is adequate and
reasonable. I am not certain I could define what is adequate.
That is what I do not know. That is what we as appropriators
are trying to get a handle on: What is adequate and what is
reasonable?
You said in your testimony: ``The difference between
adequate and reasonable is wide and it is unacceptable to the
American public.'' What are those parameters? I just do not
know.
Dr. Barbera. I do not think we know what adequate is, but I
think what we need is an objective process to decide what we
think it is and whether or not we are going to make a conscious
decision whether we are going to try to reach that or not.
I can tell you somewhat what reasonable preparedness is. We
as the hospital community in the District of Columbia have
recognized for a while that mass terrorism is a possibility, a
very real possibility. In 1995 we developed a hospital mutual
aid system. We recognized from research and other things,
multiple things.
One thing is, in major mass casualty events 80 to 85
percent of patients get to hospitals without EMS, even in the
best-trained EMS system. So contaminated patients and others
are going to show up at hospitals no matter how well prepared
our hospital community is.
We recognize also that in most mass casualty events the
regional hospital capacity is rarely exceeded. It is a problem
of medical needs being in places where there are not the
medical resources. We saw that in Oklahoma City, where many of
the casualties arrived at St. Anthony's 5 minutes from the
Murrah Building, whereas hospitals were prepared and standing
by only a few minutes further on and got very few patients.
So we developed a mutual aid system so that we can call
each other for help and we can offer assistance, recognizing
that you can move medical staff, nursing staff, and equipment
better than you can move critically ill patients. So we have
tried to maximize what we have here in the District. Indeed,
when we had a fire in the Foggy Bottom Metro Station across the
street from George Washington University's main entrance and we
did not know whether it was accidental or terrorist, we
activated the system and had plenty of capabilities that could
have responded if we suddenly had 200 badly injured, smoke-
ingesting patients who came up from the Foggy Bottom Metro
stop.
That is part of what we would call reasonable. At George
Washington University Hospital, we developed a low budget mass
casualty decontamination system. We made some assumptions and
we moved forward, so that we can wash off a significant number
of patients quickly. Those are some of the things that are
reasonable.
But in terms of adequate, we truly need a surge capacity,
and a surge capacity is not regular business. If you are using
your surge capacity on a regular basis, it is not surge
capacity. Anyone who looks at the business of anything says if
you develop capacity and you are funding capacity that does not
bring you anything back that is a stupid business idea. And
medicine and hospitals can no longer afford any sort of those
types of ideas.
Senator Harkin. But if I might interrupt you, for surge
capacity you just need locations, sites, you need facilities
that can be requisitioned, is that not the idea for quarantine
purposes and treating purposes?
Dr. Barbera. On a regular day most hospitals are close to
their capacity for critical care patients.
Senator Harkin. I understand that.
Dr. Barbera. So you need locations, you need equipment, you
need staff that can provide critical care services. We saw with
September 11th in the D.C. area and I think in the New York
City that area hospitals stepped up. Hospitals from the
Baltimore area called our communications system and offered
their services de novo. Hospitals will do what they can. But if
these are bioterrorism events or things that are going to go
long term, we have to look at what you are going to do to
hospitals.
You can close down your operating rooms and use the post-
operative area, the post-anesthesia or recovery room area as a
critical care area, but you have just killed off your operating
income for the hospital. How long can you do that, and is there
a mechanism to recover that if you have done that for the
community's benefit?
What happens if you have accepted large numbers of
contagious patients potentially with contaminants on them? How
do you convince the public that it is time to come back to your
hospital, that it is clean? And do you recover in some manner
the business losses that you have for doing that? This is not
looking at profit. This is looking at maintaining an everyday
capacity in your community.
These are difficult questions. So I would say you would
like to prioritize these things, starting with what are
relatively cost-effective mechanisms to develop a surge
capacity across the region that is sustainable and multi-
hazard. That is why we used our mutual aid system. We also have
to prioritize the protection of hospitals, their staff and
current patients from patients who are coming in that could
inadvertently be a threat to the facility or staff.
We have to look at the security interests of hospitals. We
all recognize that the terrorism modus operandi is secondary
hits, and we also recognize that they are not like in the old
days, where there were some general rules, so the hospital
could very well be the secondary hit. Hospitals do not have
extra money to have standby security capacity.
So there are a lot of these issues. I think we can
prioritize them based on cost-effective considerations, such as
how do we maximize what we have using information systems and
communications systems, how do we have an integrated system
between public health and emergency medicine and the hospitals
and emergency management, how do we bring regional and Federal
resources in to assist the hospitals, how do we work closely
with the U.S. military medical capacity and the hospitals?
I think we have developed a model here in Washington, D.C.,
using the mutual aid system, with Walter Reed, Malcolm Growe,
the National Naval Medical Center, and the Veterans Hospital.
We have offered help to each other when we have had problems
internally at hospitals.
So there are things we can do, but there are adequate
things that we have not defined yet.
Senator Harkin. Thank you very much, Dr. Barbera, Mr.
LeValley, Dr. Alibek. Thank you very much for being here and
for your expert testimony. I appreciate it. You have given some
good suggestions we are going to follow up on.
One thing we have really got to work through with the
Centers for Disease Control and with hospitals around the
country is that there have to be plans in effect for these kind
of surge capacities. There has to be some plans in effect,
maybe not in every locality, but at least I think in major
metropolitan areas, where the rate of contagion can be more
rapid than, let us say, in a dispersed area. I am not certain
that we have those kind of plans in effect right now.
Mr. LeValley. If I might, Senator, I think every hospital
does have a disaster plan.
Senator Harkin. Oh, I understand that.
Mr. LeValley. I think at least in Iowa the coordination and
cooperation between hospitals is wonderful, as we saw in Sioux
City with the 232 crash. There is good response capability for
100, 200 casualties. I think it is when we get up into those
big numbers that everything is really at risk.
Thank you.
conclusion of hearingS
Senator Harkin. Thank you very much.
The subcommittee will stand in recess until Tuesday
morning, when we will have a hearing on cloning.
[Whereupon, at 11:26 p.m., the hearings were concluded, and
the subcommittee was recessed, to reconvene subject to the call
of the Chair.]
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