[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
THE DEPARTMENT OF HOMELAND SECURITY
SECOND STAGE REVIEW: THE ROLE OF THE CHIEF MEDICAL OFFICER
=======================================================================
HEARING
before the
SUBCOMMITTEE ON MANAGEMENT,
INTEGRATION AND OVERSIGHT
of the
COMMITTEE ON HOMELAND SECURITY
HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
OCTOBER 27, 2005
__________
Serial No. 109-51
__________
Printed for the use of the Committee on Homeland Security
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__________
COMMITTEE ON HOMELAND SECURITY
Peter T. King, New York, Chairman
Don Young, Alaska Bennie G. Thompson, Mississippi
Lamar S. Smith, Texas Loretta Sanchez, California
Curt Weldon, Pennsylvania Edward J. Markey, Massachusetts
Christopher Shays, Connecticut Norman D. Dicks, Washington
John Linder, Georgia Jane Harman, California
Mark E. Souder, Indiana Peter A. DeFazio, Oregon
Tom Davis, Virginia Nita M. Lowey, New York
Daniel E. Lungren, California Eleanor Holmes Norton, District of
Jim Gibbons, Nevada Columbia
Rob Simmons, Connecticut Zoe Lofgren, California
Mike Rogers, Alabama Sheila Jackson-Lee, Texas
Stevan Pearce, New Mexico Bill Pascrell, Jr., New Jersey
Katherine Harris, Florida Donna M. Christensen, U.S. Virgin
Bobby Jindal, Louisiana Islands
Dave G. Reichert, Washington Bob Etheridge, North Carolina
Michael McCaul, Texas James R. Langevin, Rhode Island
Charlie Dent, Pennsylvania Kendrick B. Meek, Florida
Ginny Brown-Waite, Florida
______
Subcommittee on Management, Integration, and Oversight
Mike Rogers, Alabama, Chairman
John Linder, Georgia Kendrick B. Meek, Florida
Mark E. Souder, Indiana Edward J. Markey, Massachusetts
Tom Davis, Virginia Zoe Lofgren, California
Katherine Harris, Florida Sheila Jackson-Lee, Texas
Dave G. Reichert, Washington Bill Pascrell, Jr., New Jersey
Michael McCaul, Texas Bennie G. Thompson, Mississippi
Peter T. King, New York (Ex (Ex Officio)
Officio)
(II)
C O N T E N T S
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Page
STATEMENTS
The Honorable Mike Rogers, a Representative in Congress From the
State of Alabama............................................... 1
The Honorable Kendrick B. Meek, a Representative in Congress From
the State of Florida, and Ranking Member, Subcommittee on
Management, Integration and Oversight.......................... 3
The Honorable Bennie G. Thompson, a Representative in Congress
From the State of Mississippi, and Ranking Member, Committee on
Homeland Security.............................................. 14
The Honorable Donna M. Christensen, a Representative in Congress
From the U.S. Virgin Islands................................... 16
The Honorable Sheila Jackson-Lee, a Representative in Congress
From the State of Texas:
Prepared Statement............................................. 4
The Honorable Michael T. McCaul, a Representative in Congress
From the State of Texas........................................ 12
Witnesses
Panel I
Dr. Jeffrey W. Runge, Chief Medical Officer, Department of
Homeland Security:
Oral Statement................................................. 5
Prepared Statement............................................. 7
Panel II
Mr. David Heyman, Director and Senior Fellow, Homeland Security
Program, Center for Strategic and International Studies:
Oral Statement................................................. 32
Prepared Statement............................................. 34
Dr. Jeffrey A. Lowell, Professor of Surgery and Pediatrics,
Washington University School of Medicine:
Oral Statement................................................. 28
Prepared Statmen............................................... 30
Mr. Timothy Moore, Director of Federal Programs, National
Agricultural Biosecurity Center, Kansas State University:
Oral Statement................................................. 23
Prepared Statement............................................. 24
For the Record
Dr. Michael Moriarty, Vice President of Research, Auburn
University:
Prepared Statement............................................. 49
APPENDIX
Questions and Responses for the Record
Questions for Mr. Jeffrey A. Lowell, MD, FACS.................... 53
Questions for Mr. Timothy E. Moore............................... 54
Questions for Dr. Jeffrey W. Runge............................... 56
THE DEPARTMENT OF HOMELAND
SECURITY SECOND STAGE REVIEW:
THE ROLE OF THE CHIEF MEDICAL OFFICER
----------
Thursday, October 27, 2005
U.S. House of Representatives,
Committee on Homeland Security,
Subcommittee on Management,
Integration, and Oversight,
Washington, DC.
The Subcommittee met, pursuant to call, at 2:03 p.m., in
Room 311, Cannon House Office Building, Hon. Mike Rogers
[Chairman of the Subcommittee] presiding.
Present: Representatives Rogers, McCaul, Meek, and Thompson
(ex officio).
Also Present: Representative Christensen
Mr. Rogers. I would like to call the meeting of the
Subcommittee on Management, Integration, and Oversight to
order.
Before I do anything, I would like to ask unanimous consent
that Dr. Christensen be allowed to sit on the dais and question
the witnesses. Without objection.
We are holding this hearing today to examine the role of
the new Chief Medical Officer in the Department of Homeland
Security, and I would like to thank our witness for being here,
taking time out of his full schedule to be with us, as well as
the other witnesses we are going to have on the second panel.
Shortly after Department of Homeland Security Secretary
Michael Chertoff assumed the office earlier this year, he
launched a top-to-bottom review of the Department's policies,
programs, and procedures. The review was referred to as the
Second Stage Review, or 2SR. It was completed at the end of
June. On July 13th, Secretary Chertoff sent his reorganization
proposal to the Congress, as required by section 872 of the
Homeland Security Act.
As part of the reorganization, Secretary Chertoff proposed
a new position of Chief Medical Officer. In his letter of July
13th to Congress, Secretary Chertoff stated, quote, ``The new
Chief Medical Officer will be responsible for coordinating
medical issues, including BioShield, throughout the Department,
and working especially with officials at the Department of
Health and Human Services and the Department of Agriculture to
improve coordination of the Federal Government's medical
preparedness efforts.''
The following day, on July 14th, Secretary Chertoff
announced the appointment of Dr. Jeffrey Runge to serve in this
position. At that time the Department indicated, quote, ``The
new Chief Medical Officer will provide the Federal Government
with a much greater capacity to be prepared for, to respond to,
and recover from catastrophic attack.'' Also, as a part of the
Second Stage Review, Secretary Chertoff proposed the creation
of a new Preparedness Directorate, which will be headed by the
Under Secretary for Preparedness. The office of Chief Medical
Officer will be located in this Preparedness Directorate.
Congress provided $2 million for the Office of Chief
Medical Officer in the fiscal 2006 Department of Homeland
Security Appropriations Act, which the President signed into
law 9 days ago, on October 18th. As one can readily see, the
Chief Medical Officer is a brand new position.
Therefore, we are pleased to have Dr. Runge here today in
his first appearance before Congress in this role to share his
vision with us. And from my perspective, there are three main
issues that we would like to explore with Dr. Runge: first, a
broad description of the role of Chief Medical Officer; second,
the relationship between the Chief Medical Officer and the
Department of Health and Human Services, the Centers for
Disease Control and Prevention, the Department of Agriculture,
and the Department of Defense, as well as State public health
officials and local hospitals; and third, the timeline for
fully staffing this office.
After September 11, 2001, and the anthrax attacks that
immediately followed, the Congress and this Administration have
made an unprecedented investment in building up the Federal,
State, and local public health infrastructures to deal with
potential public health emergencies to the tune of billions of
dollars. It will be the job of the new Chief Medical Officer to
work with his counterparts in the other Federal, State, and
local public health agencies to ensure that this massive
investment is achieving measurable success.
In addition, in my hometown of Anniston, Alabama, we have
the Noble Training Center which is operated by the Department
of Homeland Security. This Center is unique because it is the
only hospital facility in the United States that is dedicated
to training emergency managers and health care professionals to
respond to natural disasters and acts of terrorism. Therefore,
I am particularly interested to hear about the relationship
between the Chief Medical Officer and the Noble Training
Center. I am also interested in hearing what will be done to
ensure the Center has the support it needs to provide the best
training to medical professionals across the country.
On our second panel, we will hear from experts on what
responsibilities the new Chief Medical Officer should
undertake. We will also hear views on the role of the
Department of Homeland Security in medical emergencies, and
what steps the Department should take to help prepare the
Nation for a public health emergency--whether it is the result
of a bioterrorist attack or the naturally-occurring pandemic
flu.
Once again, I want to thank the witness for joining us
today and look forward to his testimony on this important and
timely subject.
And I now recognize the Ranking Member, my friend and
colleague from Florida, Mr. Meek, for any statement he may
have.
Mr. Meek. Thank you, Mr. Chairman. And I want to commend
you on having the hearing I think it is very important as it
relates to the country.
Dr. Runge, I want to thank you for coming before us here. I
know you are very new in the job, but this is not your first
time coming to the Hill, but under your new capacity, yes.
I think the Chairman has pretty much summed it up on what
we need to know as a subcommittee, but I think that some of the
issues that we are facing, to be able to truly understand your
role as it relates to BioShield, as it relates to dealing with
some of the other agencies like DHS. And I just wanted to tell
you what folks in your profession say all the time, you know;
this won't hurt a bit as it relates to us finding out what we
need to know.
And the reason why this is important, as you know, many
Members of Congress and folks throughout the medical emergency
services community have been calling for the establishment of
your office for some time now, and I was glad to hear that the
Department saw fit, especially in the Second Stage Review, to
find some of the findings that we have arrived at here in
Congress of saying it is important.
At present, there are various administration policies and
directives for biosurveillance and a few grant programs to help
States and counties and local medical systems prepare for a
response to an attack. The Department of Health and Human
Services and the Center for Disease Control and DHS Science and
Technology Directorate are the main players in this effort.
Absent in this whole role is a central Federal official or
leader who is responsible for making sure that all of the
moving parts work together.
I will be interested in knowing whether you see yourself as
filling that role; and, if so, how do you intend to accomplish
the goals of making sure that everyone is working together
within the Preparedness Directorate at DHS? Specifically, how
do you see yourself commanding authority on biopreparedness
issues in the Federal Government when you don't even have the
line authority, like the head of DHS on the BioShield program?
According to the Department of Homeland Security Policy
Directive 10, DHS is the leading Federal agency when there is a
massive casualty incident, like a BioShield--like a biological
attack that requires parallel departments of Federal assets and
other function areas like transportation or law enforcement. Do
you need to have a seat at the table earlier than versus later?
Like the DHS--like HHS's stated directive as it relates to
directing an outbreak, how do you find yourself working with
DHS? How do you find yourself working with the Center for
Disease Control? Because I think this is very, very important.
To date, the Department has done a very good job in laying
out what exactly you will be doing as a CMO. But as it relates
to staff, direct line to the Secretary, those are the kinds of
questions I think we need answered in this hearing. And it is
not mainly a reflection upon you and your leadership; it is
making sure that we can find ourselves in a situation that we
know, A, who is in charge; B, that we are prepared because you
have taken a command role in making sure that we are prepared,
because we would hate to see you in a position like we have
seen other DHS officials who the country thought was in charge
of overseeing the coordination, and we really don't have
coordination.
Just as part of my opening statement, and this is like a
question, but I want you thinking about this because I have
read your statement--and I must say, Mr. Chairman, we have to
really work on getting the statements of our witnesses. I
received it 2 hours prior to this hearing, and I think it is
not--it won't serve you good for us to be prepared of what you
have to say here if we get them 2 hours in advance of the
hearing when we knew the hearing was scheduled for some time.
But you really need to address this issue of how do you think
that you will be able to carry out your goals and objectives
and making sure that departments outside of DHS understand that
you are in charge as Chief Medical Officer of overseeing
emergency--overseeing when we have a bioattack or overseeing
the response and also coordination of EMS personnel. I think
that is very important, and I would appreciate if you can try
to answer that in your opening statement. I have read your
opening statement as best I could, but those are questions that
really need to be answered. And it is good to be able to answer
them now versus in a time of an emergency.
Thank you, Mr. Chairman.
Mr. Rogers. Thank you.
Dr. Christensen, did you want to make an opening statement?
Mrs. Christensen. No.
Prepared Statement of the Honorable Sheila Jackson-Lee
Chairman Rogers and Ranking Member Meek, today's hearing affords
this body the important opportunity to lay the foundation of
ascertaining the gaps in responsibility that exist outside the scope of
the authority to be assumed by the new Chief Medical Officer, to be
established pursuant to Secretary Chertoff's Second Stage Review (2SR).
According to 2SR, ``The new Chief Medical Officer will provide the
federal government with a much greater capacity to be prepared for,
respond and recover from a catastrophic attack.''
At the University of Houston, the ``Tools for Ultraspecific Probe/
Primer Design'' project was awarded a $500,000 grant for purpose of
developing better methods of diagnosing bacteria or viruses that could
be used in a bioterrorism attack.\1\ These dollars came from an
appropriation through the Homeland Security Advanced Research Projects
Agency account. I would query the new Chief Medical Officer whether he
would establish an entity or a body within your office to vet and
assess this kind of research data for national use. It is critically
important for this body to understand how this and other similar
projects will be monitored and put to maximum use.
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\1\Matt Cooper, ``U. Houston given $500K grant for bioterror
research,'' The Daily Cougar, June 2, 2005.
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Our primary witness today, Dr. Runge, was cited in the Associated
Press on September 24, 2005 as stating that he would ``like to improve
the government's medical response to disasters by creating a network of
trained volunteers,'' and that he would ``take advantage of volunteers
and make it easy for them to volunteer their service, lowering barriers
with liability issues and logistical issues to that kind of things
could take place without further burden on the taxpayers.''
Given my past ardent advocating of the use of local galvanization
in the effort to keep our homeland safe, I will encourage a response to
the question of whether he recommends utilizing the current volunteer
groups such as the Citizen Corps in actuating this endeavor. In
crafting an intelligent and efficient response to the threat of
biological attack, it is critical that the people--the ``second
responders,'' play a significant role.
I hope that the new CMO and Secretary Chertoff will work closely
with Members of this Committee to craft legislation to further define
and delineate the role of this new post. Thank you, Messrs. Chairman
and Ranking Member, for your effort and leadership in this matter. I
yield back.
Mr. Rogers. Okay. I would like to call up Dr. Runge, and I
would remind all of our witnesses on this panel and then in the
second panel, that your full statement will be submitted for
the record, so if you don't want to deliver the whole thing,
try to keep it to 5 minutes and we will get to the questions
and hopefully have some good interaction. But now I would like
to call up Dr. Runge, the Chief Medical Officer from the
Department of Homeland Security, for any statement he may have.
STATEMENT OF JEFFREY W. RUNGE, M.D., CHIEF MEDICAL OFFICER,
DEPARTMENT OF HOMELAND SECURITY
Dr. Runge. Thank you, Chairman Rogers, Ranking Member Meek,
Congressman Christensen, thank you very much for the chance to
be with you this afternoon. I will just hit the highlights of
my written statement, and hopefully I can address the Ranking
Member's concerns; and if we haven't, we can do that in the
question and answer time.
Secretary Chertoff did create the position of Chief Medical
Officer in mid-July as part of the Second Stage Review process.
Prior to that, DHS had no centralized medical structure to
coordinate medical preparedness activities inside DHS or to be
a coordinator with other departments of the administration. I
joined DHS the day after Labor Day, last month. I am honored
that Secretary Chertoff has picked me to be the first CMO for
the Department.
As the Chief Medical Officer, I serve as the Secretary's
principal adviser on medical issues, and the goal is to provide
the Secretary with the best possible advice on medical issues
to help ensure that he makes the best policy decisions. But
this job entails full engagement with other Federal agencies,
with State and local authorities, associations of medical
professionals, hospitals, and a lot of other stakeholders that
also deal with the medical consequences of natural disasters or
terrorist attack. In fact, it is our Nation's local assets,
first responders, emergency departments, trauma centers and
local practitioners that really represent the front line for
the health and security of our Nation in the event of a
catastrophic event.
Secretary Chertoff has charged our office with filling the
gaps in the Department's medical readiness, and so we are
actively working to develop a strategic plan to do so. Also,
under Second Stage Review, the DHS medical office is located in
that Preparedness Directorate, as you mentioned earlier, and
the CMO therefore reports to the new Under Secretary for
Preparedness. But I also have a direct reporting relationship
with the Secretary and the Deputy Secretary to provide them
that direct and unfiltered medical advice and consultation.
Central to this mission is to support the Secretary and the
Department's incident management needs. So I have the
obligation to provide sound medical advice and policy counsel
to help define risk and then mitigate risk.
My team will not replicate the deep knowledge base and the
operational role of other Federal departments, but I will help
the Secretary and his team have ready access to timely and
complete medical data to help drive those core incident
management decisions that he will make.
And under the Chief Medical Officer, we anticipate having a
Deputy Chief Medical Officer with an appropriate doctoral
degree in medicine or veterinary medicine, and expertise at the
State and local level in emergency management, public health
and other skills. Reporting to the CMO and the deputy would be
some associate chief medical officers for science and policy,
medical preparedness, operations and response, and mission
support.
With respect to science and policy, we need to achieve a
full integration of our available research and technology and
our intelligence to formulate policies that will then drive our
strategic plan and our actions. I intend for this office to be
a data-driven, science-based organization which will provide
the doctrine from which we coordinate our activities with HHS
and Agriculture and other stakeholders. This plan will
determine our success, and it would also drive future budget
requests which you also alluded to earlier.
We do have strong interdepartmental alliances with the DOD,
with HHS, and the intelligence community. Our Science and
Policy Office will lay the foundation for those activities of
our other offices to carry out Secretary Chertoff'S vision for
threat-based programs and countermeasures. Likewise,
Preparedness will be policy driven; they will create
initiatives to make sure that the Nation and its critical
infrastructure are all medically prepared for catastrophic
events.
Now, one of the great things about Second Stage Review is
that it has given us access to all the other important elements
of preparedness in this directorate. And in fact, Secretary
Jackson calls this the Preparedness Board of Directors: The
infrastructure protection and the State and local grants, the
U.S. Fire Administration and so forth. And we really believe
that we can leverage resources and apply programs of planning
across that entire Preparedness Board of Directors.
Now, we have got many customers and stakeholders, and I
intend to make sure that our partners understand that they have
a vital role to play in national medical preparedness and a
voice within DHS, and that is me. Our medical office will work
very closely with State and local governments to help support
that medical preparedness.
My time is running short, Mr. Chairman, I can probably
answer much of this in the Q and A. We do believe that we have
a role in operations and response to make sure that assets are
in place to support the National Response Plan, including ESF-
8, which is HHS's responsibility. Our goal is to ensure that
our assets are aligned to support ESF-8 and the National
Response Plan, the Interagency Incident Management Group, and
the command centers both at HHS and at Homeland Security.
And just real quickly, the fourth area is mission support.
I think I shared with you and your office that I think that one
of our most important responsibilities is to care for our most
valuable assets, and that is our workforce. We believe that our
Nation will only be secure if those entrusted with its security
are in fact cared for. And right now, every agency and
directorate do not have equal access to workforce protection, I
want to make sure that protocols and resources are in place to
do so.
So thank you, Mr. Chairman. I can't emphasize enough how
much I appreciate being here. And I want to remind everybody
this is a brand new vision, we are in our formulative stages.
Thank you.
[The statement of Dr. Runge follows:]
Prepared Statement of Dr. Jeffrey W. Runge
Chairman Rogers, Ranking Member Meek, and Members of the
Subcommittee. Thank you for the opportunity to be here with you this
afternoon. I appreciate the opportunity to discuss the position of
Chief Medical Officer (CMO) at the Department of Homeland Security (DHS
or the Department) and the responsibilities of this new office.
Secretary Chertoff created the position of CMO in mid-July as part
of the Second Stage Review process that he initiated at DHS. Prior to
the Secretary's Second Stage Review, DHS had no centralized medical
structure to coordinate medical preparedness activities inside DHS or
with other Departments in the Administration. I joined DHS last month,
and I am honored that Secretary Chertoff selected me to serve as the
first CMO for the Department.
As the CMO, I serve as the principal advisor to the Secretary for
medical issues within the Department. My goal is to provide the
Secretary with the best possible advice on medical issues to help
ensure that the best policy decisions are made. The DHS Medical Office
is located within the new Preparedness Directorate, but my
responsibility for medical issues stretches across the entire
Department. I am also responsible for representing DHS when it comes to
coordinating medical issues with other Departments in the executive
branch and the Homeland Security Council.
As we have all seen in the aftermath of catastrophic events--
whether natural or as a result of a terrorist incident--there will be
significant medical issues for DHS that arise and must be addressed.
Secretary Chertoff believes that a comprehensive approach to
preparedness must include coordinated and highly skilled medical
support. This preparation includes full engagement with other Federal
agencies, state and local authorities, associations of medical
professionals, hospitals, and other stakeholders that also deal with
the medical consequences of natural disasters or terrorist attacks. It
is our Nation's local assets--first-responders, emergency departments,
and trauma centers and local practitioners--that represent the front
lines for the health and security of our Nation.
Since I arrived last month, I have been focusing on preparation for
the likelihood of an avian influenza pandemic. This is a public health
and medical issue that many of us, both in and out of government,
believe could have devastating effects in the United States and around
the world. In this regard, I have been working very closely with my
colleagues at the Department of Health and Human Services (HHS), the
U.S. Department of Agriculture, and the Homeland Security Council to
plan for the government's response to contain this disease and protect
our Nation's critical infrastructure.
Secretary Chertoff has charged our Office with filling gaps in the
Department's medical readiness, and we are actively working to develop
a strategic plan for doing so. Under the Second Stage Review, the DHS
Medical Office is located in the Preparedness Directorate, and the CMO
reports to the Undersecretary for Preparedness. There is also a direct
reporting relationship between the Chief Medical Officer and the
Secretary and Deputy Secretary to provide direct and unfiltered medical
advice and consultation. Central to our mission is to support the
Secretary's and the Department's incident management needs. I have the
obligation to provide sound medical advice and policy counsel to help
define and mitigate risk. My team will not replicate the deep knowledge
base and operational role of other Federal departments, but I will help
the Secretary and his team access timely and complete medical data to
help drive core incident management decisions.
To accomplish our mission, we will need talented, highly skilled
leaders. Under the Chief Medical Officer, we anticipate a Deputy Chief
Medical Officer with the appropriate doctoral degree in medicine and
expertise at the state and local level in emergency management, public
health, and other relevant skills. Reporting to the CMO and the Deputy
CMO will be Associate Chief Medical Officers for science and policy,
medical preparedness, operations and response, and mission support. Let
me address each of these needs separately.
Rather than responding crisis-to-crisis, the DHS Medical Office
needs to be a data-driven, science-based organization that brings
cutting-edge science, technology, and intelligence to bear on the
Department's policy-making. We anticipate that this function will be
overseen by the Associate Chief Medical Officer for Science and Policy.
Sound science-based policy will provide the doctrine from which we
coordinate our activities with other agencies such as HHS, The
Department of Agriculture and the Department of Defense (DoD), interact
with other stakeholders, and bring together resources within the
Department. How we set our strategic plan, goals, and objectives will
determine our success in carrying out our mission, and will also drive
future budget requests.
For the last four years, I have run the National Highway Traffic
Safety Administration as its Administrator, and I believe the Nation
has reaped the benefits of having its highway safety programs
completely data driven, its budget directed by programs that have
proven to be effective--even to the exclusion of good ideas that have
no basis in the data. I intend to run the DHS Medical Office based on
the best information from the service elements of DHS, including our
Science and Technology and Information Analysis Directorates. We also
have strong interdepartmental alliances with the DOD, HHS and the
intelligence community. It is vital that our preparedness, operations
and response, and mission support functions carry out Secretary
Chertoff's vision for threat-based programs and countermeasures, which
can only be done through the integration of these various knowledge
bases.
Our Associate Chief Medical Officer for Preparedness will be
responsible for policy driven initiatives to ensure that the Nation and
its critical infrastructures are medically prepared for catastrophic
events, whether man-made or natural in origin. The Second Stage Review
process has given us access to all the important elements of
preparedness necessary to carry out this function. Full integration
with the other offices in the Preparedness--Infrastructure Protection,
the training assets of the U.S. Fire Administration, the relationships
of the Office of State and Local Preparedness, and the financial assets
of the Metropolitan Medical Response System--will allow our
``Preparedness Board of Directors'' to leverage resources and
strategically apply programs and planning to meet our medical readiness
needs. The Associate Chief Medical Officer for Preparedness will also
be charged with examining medically-related grants and contracts from
DHS to state and local governments and the private sector to ensure
these resources are used strategically. Some of these grants and
contracts are currently outside of the Preparedness Directorate, but
the cross-cutting nature of my position dictates that this
intradepartmental coordination takes place.
For the last month I have been meeting with representatives of many
organizations in our Nation that are key players in our medical
preparedness. I have been asking for ``to do lists'' from organizations
that will be our key partners for us in the future, including the
Association of State Health Directors, the American College of
Emergency Physicians, the American Hospital Association, the American
Ambulance Association, and the Federation of State Licensing Boards.
Our Department has many customers and stakeholders, and I intend to
make sure that our partners understand that they have a vital role to
play in national medical preparedness. The Medical Office will work
very closely with state and local governments to help support their
medical preparedness.
The Associate Chief Medical Officer for Operations and Response
will help ensure that assets are in place to support medical response
under the National Response Plan. This part of our operation requires
close collaboration with our Federal partners, most notably HHS. Our
goal is to ensure that our assets are aligned to support Emergency
Support Function 8 under the National Response Plan, the Interagency
Incident Management Group, and the command centers of both Homeland
Security and HHS. This office will also support the DHS Continuity of
Operations (COOP) function when medical advice and consultation are
needed. We are now receiving comments from our stakeholders about the
best way to approach this operations-and-response function, and our
goal is to make it a fully coordinated effort. We believe that the
Secretary needs a medical response element under his control to ensure
a medical support function for the Nation. It is clear that state and
local medical resources make up the ``front lines'' of national medical
response, and they must be fully integrated into preparedness planning.
The fourth element of our mission in the Medical Office is to
support the mission of the Department in terms of its most valuable
assets--its workforce. As the various operating elements of DHS were
put together two years ago, they brought with them existing legacy
workforce protection and occupational health programs. Some operating
elements, such as the Coast Guard, have very sophisticated programs
with a long legacy of workforce safety and security programs. Others
have none at all or rely on contracted entities to provide some
preventive health care. I believe that our Nation will only be secure
if those who are entrusted with its security are likewise cared for. We
will recruit an Associate Chief Medical Officer for Mission Support to
ensure that every agency and directorate in the Department has
appropriate workforce protection, protocols, and resources in place
whether they are protecting our Nation's borders, ensuring that our
airlines are secure, or engaged in critical planning activities. We
also intend, through this office, to build a network of all DHS medical
assets to ensure that they are likewise supported with training and
education, and that we have access to the various specialized skills
available from the medical workforce within DHS.
In conclusion, Mr. Chairman, although we have a strong vision of
what we would like to accomplish through our Office, we are in the very
early stages of trying to realize that vision. We look forward to
working with the Committee to incorporate your suggestions and advice
into how we can better serve our Nation. I am confident that with my
experience as a clinician, researcher, and as a Federal manager, my
team and I can bring this vision into reality if we have the necessary
support to do so. Our support from senior management in the Department
has been excellent, and I look forward to working with you closely to
ensure similar support from our leaders in the Congress.
Thank you, again, for this opportunity to introduce my office to
you and your colleagues.
Mr. Rogers. Thank you. I would like to ask some questions
now.
I noted in my opening statement that you currently are
starting off with a $2 million budget. And, as I understand,
you currently--including yourself--have 3 people in your
office, and I think you are budgeted to have 10 or 11. My
question is: Do you expect, since this is so new, do you expect
when you are fashioning the next fiscal year's budget, to play
an active role in formulating what that budget should be, or do
you expect to be total what it would be?
Dr. Runge. Well, we are already involved in 2007 budget
planning. Unfortunately, in the 2006 budget planning time, I
was planning the budget for the National Highway Traffic Safety
Administration. I did a really good job of that.
Mr. Rogers. Which is not helping you now.
Dr. Runge. That is correct. So we are grateful for what we
have got and I think it is a good building point.
Mr. Rogers. What is the exact number of people that you are
budgeted for now under your $2 million?
Dr. Runge. Well, the FTE numbers are cited at 10. The
executive-level slots have not yet been allocated, but I think
the bottom line is that we can't spend more than what we have
got this year. And I do think we will be able to leverage some
resources across the other offices in the Preparedness
Directorate, and I have been assured by the acting Under
Secretary he is going to do everything he can to get that done.
Mr. Rogers. Given that statement, do you think your
staffing allocation for this year is going to be sufficient?
Dr. Runge. We will be able to accomplish a lot. We will not
achieve the vision completely for the office until we have an
opportunity to present justifications for these positions, what
the mission requirements are, and present them to the Secretary
in the budgeting process.
Mr. Rogers. Could you share with the Committee, who fills
the current three positions and what would you expect the
remainder of positions to be filled with, what titles?
Dr. Runge. Well, I have brought over my office manager with
me to do logistics. That is sort of an essential function. And
my chief of staff joins us as the guy who is trying to get us
staff and working on our budget. I did bring one technical
person, Laura McClure, who is behind me. I was able to steal
her away from DOT, where she served the Secretary as his
security adviser, and has lots of tentacles out in the security
parts of the Federal Government.
Mr. Rogers. What about the remainder of positions that you
have budgeted?
Dr. Runge. In my written statement I talked about four main
buckets of activity. Each of those I would anticipate being
headed by an Associate Chief Medical Officer, although I have
not yet gotten sign-off for the executive-level slots necessary
to do that.
Mr. Rogers. Do you plan to have a veterinarian on your
staff?
Dr. Runge. We have two veterinarians that we work with very
closely. You know, one of the beauties of DHS is that resources
abound, and we just have to be smart about how we access those.
I have got two of the finest veterinarians who have been
working with us on the Avian Flu Task Force, who are also
readily available for consultation for just about anything that
we ask. We have not ruled out or ruled in having a vet actually
as part of the CMO.
Mr. Rogers. Also, as I represented in my opening statement,
the Noble facility is in my hometown, and it is near and dear
to my heart, and is the only hospital in the country that
serves that mission. Can you tell us a little bit about your
relationship with that facility?
Dr. Runge. Well, as you know, Mr. Chairman, it is under the
auspices of the U.S. Fire Administrator, and one of the first
things--actually, before I came to DHS I met with Dave Paulison
before he--obviously before acting FEMA administrator--and we
talked about that and how to better utilize Noble.
I also did some research since I met with you and looked at
the inventory of activities going on down there. They are quite
busy, but I think we can--my interest is in making sure that
everybody who touches a patient out there, whether they are a
paramedic, an EMT, an emergency position, a trauma surgeon, an
infectious disease doc, is adequately prepared. And I think
that we can use Noble in a bit smarter way to help accomplish
that. And I intend to work with the USFA and the U.S.
preparedness effort to coordinate all of our training efforts
to make sure they are strategically applied.
Mr. Rogers. You mentioned it is under Fire Services; is
that going to be a problem for you?
Dr. Runge. I don't think so.
Mr. Rogers. Or is it positioned where it should be? Do you
anticipate making some recommendations that may change that?
Dr. Runge. I don't believe so. If it is not broken, don't
fix it is one of my mottos. And I do believe that with the
collegiality that we have developed across this Preparedness
Board, these six people, the Office of Domestic Preparedness is
now State and local grants and training, and it is sort of all
on the same level and it is all in the same basket. So I
understand already that the Center for Domestic Preparedness
and Noble are sharing some administrative assets, and those are
the kind of efficiencies we need to look for.
Mr. Rogers. Well, thank you, I see my time is up. I would
now like to recognize the Ranking Member of the Subcommittee
for any questions he may have.
Mr. Meek. Dr. Runge, I know that you are new to the
Department, but you are aware of the Chief Information Officer
that is also there at the Department. We have been having
quite--a very difficult time with the Chief Information Officer
working with the 22 legacy agencies within the Department. It
is all thank you and please. You have a great title, Chief
Medical Officer, but the question is, chief of what? And who is
going to listen?
You know, when it comes down to the whole issue of the
incident of national significance, are you the person that
says, Mr. Secretary, you need to designate that; or is that
Department of--Secretary of HHS? That is the reason why I am
asking these questions, because either we need to legislate
that authority of who is in charge, because the last thing that
we want to find ourselves is in a situation where we have
Homeland Security saying one thing--and it has happened
before--Department of Justice; it was an event once before when
Justice Department said something, Homeland Security said
something, first responders were confused and States. You are
going to be working with States, HHS is going to be working
with states, Center for Disease Control are going to be working
with States. So how are you--what do you envision in your
capacity as Chief Medical Officer in the Department of Homeland
Security that, you know, in one place you read the overall
authority on this, what kind of role, how do you see yourself
playing a role there as Chief Medical Officer? And do you feel
that your office needs more authority to be able to at least
put forth that recommendation to the Secretary and the
Secretary can make that decision?
Dr. Runge. Congressman, I really appreciate that insight.
And as a former administrator of an agency with 700 people
instead of 3, I have a great appreciation for organizational
charts. And I reorganized NITSA partially because there were
too many direct reports.
I am very sympathetic. If you look at the DHS work chart, I
am very sympathetic with the conundrum of needing direct access
to the top-level staff and with the inability to direct and
oversee the activities of more than 20 people at one time.
It doesn't hurt my feelings at all to be in the
Preparedness Directorate. And already there have been a couple
of occasions in which Secretary Chertoff has told me you are
the guy on this, and I need you to address this issue.
And let me just say one other thing, too. With respect to
roles--and I want to make sure this is very, very clear--there
is no ambiguity with me about who does what. I think that is
very well laid out in the National Response Plan. We will be
there to support and help the various agencies that are
responsible for taking the lead in the various emergency
support functions; for instance, HHS with ESF-8, and
Agriculture with their emergency support function, and
Transportation and so forth.
In the event of an incident of national significance, the
DHS Secretary has overall authority for making sure those
assets are coordinated. And I believe that the genesis of my--
Mr. Meek. I am sorry, Doctor, because my time is--I am
sorry, I know that you are trying to--and that is the heart of
it; how will be it coordinated? I mean, you are the person,
quote unquote, that will either be talking to the Under
Secretary or directly to the Secretary about this, and how do
we coordinate within the agency of Homeland Security and the
Chief Information Officer. I am just taking that position, just
as an example, they get an F year after year because they can't
get the agencies within the agency--departments within the
agency to respond to the Chief Information Officer. And so I am
trying to get down to the bottom of it because really that, if
we are going to do something, let's do it for real, especially
as it relates to your position, to be able to give either you
or someone authority who is going to be the person that is in
charge of that. We have conflicting views here.
And if I get an opportunity later on I will, you know, as
it relates to the National Preparedness Plan versus some
statutory language that is out there, of who is going to
coordinate that. And that is pretty much the question that it
comes down to. If you are going to be talking to the Secretary,
you have no authority over these other departments. And also,
you are parallel on the third tier of the Department chart as
it relates to the Department of Homeland Security. How is your
office going to command that with 10 employees and a limited
budget?
Dr. Runge. That is a very pregnant question, and I hope
that over time I can satisfy you, Congressman, with being able
to do those support functions with diplomacy. I spent a lot of
time in the last month making a lot of house calls. I have been
with the CDC. I met with Dr. Besser, who is the Bioterrorism
and Emergency Response Director; with Dr. Gerberding; with Stu
Simonson and his staff; Jerry Parker at HHS. And, in fact, if
you look at my e-mails, there are a lot of them coming from HHS
in collaboration with what we are trying to do.
Mr. Meek. Doctor, let me say this. I am well over 10
seconds over my time. I just want to tell you, it is not to
satisfy me, it is to make sure that we are doing what we are
supposed to do. And it is not a criticism of you either. It is,
legislatively, we are going to respond to some of this and we
want to respond to it in an appropriate way, especially with
your consultation, and also realize that we don't want folks
pointing in two different directions when it comes down to
lights, cameras, action, because one day very soon it may be
the case. And we want to know that you have what you need to
carry out your duties and the Department of Homeland Security
has what it needs.
Dr. Runge. Thanks. I look forward to working with you,
Congressman. I appreciate it.
Mr. Rogers. Thank you. The Chair now recognizes the
gentleman from Texas, Mr. McCaul, for any questions he may
have.
Mr. McCaul. Thank you, Mr. Chairman. And Dr. Runge, thank
you for being here today.
As you know, DHS has been tasked with the responsibility to
do material threat assessments and determinations. It is the 1-
year anniversary of BioShield, and we have issued, I believe, 4
of the 60 of these hot agents. And I wanted to know--and I know
you are relatively new to the job--have you thought about how
you want to try to speed up that process? That is my first
question.
And my second one is with respect to the Avian Flu Task
Force. When we go back home, that is an issue of great concern
to our constituents. Now that it has jumped from bird to the
human species, I believe in Europe and in Indonesia, it is of
great concern to us. How are we going to handle that situation?
And God forbid it breaks out in the United States; what is our
level of preparedness and strategy to deal with that type of
situation?
Dr. Runge. Thank you, Mr. McCaul. Let me just address the
first part of this first.
These material threat assessments and determination, there
is a very fixed protocol for how that is done. The material
threat assessment is managed by the Science and Technology
Directorate, using intelligence functions as well as the best
possible science. I believe that we have five, now, material
threat determinations done, and I have been talking to them
about the process. I do not expect to insert myself into the
material threat assessments. That is very much of a scientific
and intelligence function; however, when it comes to a
determination, we will be there in the consultative process,
and I will advise the Secretary accordingly.
With respect to the speed, I believe that a report is due
in January for another sort of omnibus bunch of the
assessments. I was told that by the Director of R&D a couple
days ago, and we will be following up on that with you.
Mr. McCaul. Would it be helpful if we provided some limited
form of immunity from lawsuits? I know a lot of the major
pharmaceutical companies are not involved because they are
concerned about lawsuits.
Dr. Runge. I really can't speak to that, Congressman. We
would be happy to reply back to you in writing. I can tell you
as a physician I love the idea in general. But with respect to
this particular thing, I can't answer that question, sir.
Mr. McCaul. As to the Avian Flu Task Force.
Dr. Runge. When I walked in the door, I was given
responsibility to come up with a DHS plan. The first call was
to HHS because they have the lead in avian flu, wanting to make
sure that whatever planning function we did would dovetail with
the HHS plan so that they could give a national plan for avian
flu. That work is ongoing.
We also completed a memorandum of understanding with HHS
with regarding border protection for infectious diseases--it
would specifically apply in this case--which took a little bit
of doing. That involves quarantine and data sharing, passenger
information. It is important to know where someone is sitting
on a plane if someone actually shows to be positive. So work is
going on. This has gotten attention throughout the executive
branch at the very highest levels, and we are working
diligently to make sure that our plans are in place.
Mr. McCaul. I know we have antiviral medication to treat
the symptoms, but where are we with the vaccine for avian flu?
Dr. Runge. HHS, of course, has the lead for vaccines. You
know, the vaccine makers all came and met with the President a
few weeks ago, and I think the results of that meeting have
been reported in the press. There is no question that we as a
country need to ramp up our vaccine research, our vaccine
production. And frankly, Americans need to take flu vaccines.
It is very hard to generate a profit if you are a company, if
you can't sell your product. So one of the public health
messages that I think should be incumbent upon all physicians
is to make sure that everybody who is supposed to get a flu
shot should get a flu shot.
Mr. McCaul. It is very timely; I just took mine today,
actually. Do we have a vaccine for the avian flu is, I guess,
is my--
Dr. Runge. That is under study. And again, HHS is all over
that. Secretary Leavitt personally has become engaged with the
vaccine makers themselves and Deputy Secretary Azar. I am
confident that they are on the case.
Mr. McCaul. Okay. Thank you, Mr. Chairman.
Mr. Rogers. Thank you. And the Chair now is proud to
welcome and recognize the Ranking Member of the full committee,
my friend and colleague from Mississippi, Mr. Thompson, for any
questions he may have.
Mr. Thompson. Thank you very much, Mr. Chairman. Welcome
Dr. Runge. We are happy to see you, glad you are on board.
I want to take off on some of the other comments that I
have heard. You are looking to the Department to have 10
employees--
Dr. Runge. Yes, sir, that is the current configuration.
Mr. Thompson. Now your testimony talks about hiring, I
would assume, four senior people that you have presented to us
today. And, I would assume, somewhere around 150,000 annual
salary or something like that for them?
Dr. Runge. That would be correct.
Mr. Thompson. And your budget is $2 million.
Dr. Runge. Your arithmetic is bearing right down on it,
sir.
Mr. Thompson. Do you think you can do your job, hiring that
many people with just $2 million?
Dr. Runge. Well, as I told the Chairman, I believe before
you walked in, sir, I was not here during the 2006 budget
planning process, and this was the number that I was given when
I came in. And we will have a transition team in place with
that amount of money. Meanwhile, we are diligently working on
the 2007 budget planning. We have been given a little bit of a
grace period to provide some numbers and some rationale. And we
will be talking with the powers that be over there, including
the Secretary, on making sure that we are staffed up to an
appropriate level.
Mr. Thompson. So what is your staffing expectations if you
had your druthers?
Dr. Runge. Well, I haven't got a number for you right now.
I would be happy to come back and we can sit down and go
through the functions. Part of the problem is that having just
received sign-off on the organizational plan, we really need to
develop personnel requirements for the jobs necessary, and we
have not yet done that.
Mr. Thompson. Do you plan to use any contract employees?
Dr. Runge. Yes, sir, we do.
Mr. Thompson. Why would you want to use contract employees
rather than full-time people?
Dr. Runge. Well, for one reason, we can get them quicker;
they are a little bit more nimble, mobile. We can select them
for jobs that require a kind of a quick hit. And the other
process actually is going to take some more time, and time is
my enemy right now.
Mr. Thompson. One of the things some of us are concerned
about is the inordinate price tag that we pay for contract
employees. Do you anticipate paying more for contract employees
than you would for full-time employees?
Dr. Runge. I would think not. Our objective, the one
contract we have got pending right now for our next person to
bring in is right in line with a senior-level salary.
Mr. Thompson. That is a full-time contract person?
Dr. Runge. Yes, sir.
Mr. Thompson. For 12 months?
Dr. Runge. Yes, sir.
Mr. Thompson. What kind of conflict of interest form, or
anything that you would have a contract employee or a full-time
employee sign if they come work with your agency?
Dr. Runge. I hadn't really given that any thought. Can you
elaborate more on this issue?
Mr. Thompson. Well, I would assume that if you are going
out hiring contract people, they may or may not be in a
position to make a decision that would be favorable to the
company they work for. And if that is the case--
Dr. Runge. I see. Okay, I understand. The individual that
we bring on next is through an IPA with a university. And,
absolutely, they would be recused from any sort of financial
gain going back to that university.
Mr. Thompson. Can you provide the committee with whatever
document those individuals would be required to sign?
Dr. Runge. I would be happy to do that.
Mr. Thompson. So that we could know? The other thing I
would like is for you to provide the committee, if in fact the
contract employees cost more than a salaried employee, that
information.
Dr. Runge. We will be happy to give you the full rundown as
soon as we have it.
Mr. Thompson. Thank you. Mr. Chairman, I have one other
question.
Dr. Runge, you know, just before I guess you came, we
received notice that some information was for official use only
and that you couldn't testify to it. But I guess my problem is,
if I can get most of what you say off the Internet, off the AP
wires, off MSNBC, why would the Department prevent this
committee--prevent you from giving it to us?
Dr. Runge. Congressman Thompson, I don't set the
classification of documents. As they say, I just work there.
And I take my classification literally. And obviously--I think
the document you are referring to is Dr. Lowell's report to
Secretary Ridge, which has been in the press. And I think the
contents of that are certainly for official use only, but the
issues are fair game.
Mr. Thompson. But you know, it is the worst-kept secret in
town--
Dr. Runge. There are a lot worse ones than that,
Congressman Thompson.
Mr. Thompson. Well, it might be worse, but my question is,
I am concerned that the Department would label something ``for
official use only'' when we can get it off the Internet or off
the wire service already. And it appears to be a practice of
the Department to keep certain information hostage. And if it
was produced at public expense, I am convinced the public has a
right to know.
Dr. Runge. I will be happy to convey that sentiment to my
bosses. Thanks.
Mr. Thompson. Thank you.
Mr. Rogers. I thank the gentleman.
The Chair now recognizes my favorite physician on the
Homeland Security Committee, Dr. Christensen, for any questions
you have.
Mrs. Christensen. It has nothing to do with the fact that I
am the only one, but thank you, Mr. Chairman. And I would like
to welcome you.
We had some concerns about when we heard there was going to
be a Chief Medical Officer for the Department, but you come
with good credentials. We still have many concerns of how the
job is going to really work and what exactly your role will be.
But I have a specific question related to Katrina, because
you did come in after Katrina, but now in recovery. And I just
came from a meeting of AIDS advocates, People Living with AIDS,
and organizations, some of whom are in New Orleans, and some
from Mississippi, Texas, et cetera. And one of the concerns
that they raise is one that I have as well: What is being done
to restore the services? There are a lot of physicians and
other health providers who are working in New Orleans and some
of the other impacted areas in the gulf, and at least I am not
hearing that anything is being done to restore their practices
and help them to provide services to the people who are
remaining there, some of whom who are in desperate need.
Dr. Runge. I can probably best respond to that by
recounting a vignette. I was actually asked by Deputy Secretary
Azar to come over to HHS my first or second day on the job, to
sit around a table with a group of people about 6 o'clock at
night to talk about medical issues in Mississippi and
Louisiana. I was very, very impressed with the level of
strategy and response that the Health and Human Services folks
were putting into this challenge. And that was a question that
came up around the table: What are we going to do now to try to
ensure that physicians will come back after the initial exodus
is over? And number two, is it an opportunity to improve a
community health system that really wasn't working very well in
many parts of that region?
I know it is on HHS's radar screen. We have, through our
office in helping them facilitate, we have gotten FEMA funds
for some of those purposes to which you refer. And we would be
happy to give you an inventory of those. But that really does
fall under HHS' bailiwick.
Mrs. Christensen. See, we are still not clear. Hopefully as
we go through this, it will be clearer where you are.
You mentioned that you have been spending some time on
avian flu, and you don't seem to have much of a direct
responsibility for BioShield, but yet we are now looking at
BioShield, too. And I wanted to ask you a question about
another bill. I think we still call it Safe Cures bill, which
focuses more on shortening the time from the identification of
a bug to a cure or a vaccine. And we constantly hear about the
length of time it will take when it mutates and we know that we
have to develop a specific countermeasure.
Don't you think that we ought to be spending more time on
research that shortens the time to get from identification to
cure or vaccine?
Dr. Runge. I doubt that there is any disagreement about
that, Dr. Christensen. I think that that is a sentiment that is
shared everywhere. There is, I think they call it the ``valley
of death'' between initial drug or countermeasure development
and actual deployment, at which time it takes off and has
commercial viability. And I do know that there is some energy
over here, particularly in the Senate, about stimulating--
providing a catalyst between that initial point and the time
that it zips through until the time it is commercially viable.
We have had an opportunity to review a couple of bills, and
I am not sure they have been introduced, and I will be happy to
check that and make sure that you have access to that
information.
Mrs. Christensen. You said that you have been meeting with
representatives of organizations that are key players in
medical preparedness. Are you finding that the health
providers, doctors, public health people, emergency medical
services, are fully integrated into the first responder
systems?
Dr. Runge. That is a great question. I asked each of those
organizations to give me a ``to do'' list, and some of them
have come back right away, and I can tell you that answer
varies from organization to organization.
Mrs. Christensen. Can you do something about that; is that
your role?
Dr. Runge. I believe it is. And certainly we will
coordinate with HHS as much as we possibly can to make sure--my
interest in getting out there and making all these house calls
is to make sure they know they have a voice in DHS, and if
something is happening that they don't like, they have got a
place to call and we can circle back and try to fix the
problem.
Mrs. Christensen. But do you set standards and certain
criteria that have to be met--
Dr. Runge. I do think that is our role at DHS. And our
coordinating role for all the support functions is to make sure
we have a set of system requirements that will actually get the
job done. You know, with an office of 3 or 10, obviously I
can't operationalize that; but I think through the power of the
Secretary of DHS, we will in fact get those requirements
accomplished.
Mrs. Christensen. Thank you, Mr. Chairman.
Mr. Rogers. Thank you. I would like to ask a couple more
questions, and it has to do with BioShield. You heard in my
opening statement, I made reference to Secretary Chertoff's
announcement of the creation of the Chief Medical Officer. And
in that letter he said the chief medical officer would be,
quote, responsible for coordinating medical issues, including
BioShield, throughout the Department. Could you tell us about
this relationship with BioShield, what your role will be?
Dr. Runge. The Secretary and I have not discussed that. In
trying to get smart on BioShield, I have studied both the
material threat--first of all, the CDC's list and working its
way down through the material threat assessments and
determinations, trying my best to understand the process and
all the inputs. I really am still gearing up my knowledge on
this.
The expenditure of funds is, I think, really sort of where
the rubber hits the road. I believe $6 billion was initially
appropriated over 10 years for the acquisition of
countermeasures, and much of that has been spent, over half of
it has been spent; and I think that the next round of purchases
will put another dent in it. And I think the Secretary is very
interested in my--
Mr. Rogers. By the way, when do you expect that next round
of expenditures?
Dr. Runge. Let me withhold an answer on that. I know that
there is an agreement that is in process right now.
Mr. Rogers. But if you would follow up as soon as you can
let us know and get that to us, I would appreciate it.
Dr. Runge. There is some fiduciary responsibility here as
well as a prioritization that has to take place. And I think
that my role is basically one of overseeing and consulting. I
have no role in intelligence, and I certainly have not been in
a lab to look at the viability of countermeasures. I have
talked with the folks who do make those assessments and
determinations, and I think that the Secretary wants somebody
just to put the information all together for him in a package
that is all rolled up, and that he has confidence that when he
signs that memo that this in fact is a material threat, and
sends it to Secretary Leavitt that he has confidence that it
is.
Mr. Rogers. Can you tell us how you can ensure in your
capacity, if you can, ensure that our Nation has an adequate
supply of vaccines and other medication in the event that we do
have a bioterrorist attack or a pandemic in this country?
Dr. Runge. Well, I believe I will again just try to be very
clear about roles and responsibilities. This is an area that
HHS has complete jurisdiction over. And Secretary Leavitt and
the Deputy Secretary over there--in fact the whole team, Dr.
Fauci, they are very focused on getting that job done. It
clearly is an issue of national security as well as health, and
we are working together. They keep us abreast of what they are
doing. The need for investment, the need for a coordinated
approach has been shared with us. But they have the lead on it.
Mr. Rogers. See, that is--there is some confusion from my
perspective on that. I have read in some of the documents in
preparation for this hearing that DHS had envisioned your
position would be the lead in those situations with pandemic
outbreak, but you are telling us that is not the case.
Dr. Runge. Well, regarding vaccines, that is not the case.
There is a point at which in a pandemic--
Mr. Rogers. Who is in charge? In the event we have a
pandemic outbreak next year--
Dr. Runge. When critical infrastructures are threatened,
the Secretary of DHS is responsible for the preservation of
critical infrastructures. HHS will continue to have the lead in
prevention, containment, and treatment of avian flu, but if the
government surges and if the ESFs stand up and so forth, the
Secretary of DHS will be responsible for each of those
emergency support function's discharging of their duty. One of
the duties of HHS is containment, prevention and treatment of
Avian Flu.
Mr. Rogers. Well, as everybody knows, this is a very real
threat that our country faces, perhaps as early as next year,
and we need to make sure everybody understands who has got
which responsibility, and that is of some concern to me.
As we saw last year, the United States had difficulty
acquiring this sufficient supply of flu vaccines from foreign
providers. Do you think it is preferable to have domestic
providers of flu vaccines to ensure that Americans who want
treatment can get access and vaccines?
Dr. Runge. My opinion is that any time we can acquire
something domestically, it would be preferable to having it
acquired overseas; yes, sir.
Mr. Rogers. Are you at all concerned about the current
suppliers being foreign suppliers?
Dr. Runge. I do share Secretary Leavitt's concern with
that, and I do believe he has worked very hard on remedying
that situation.
Mr. Rogers. Thank you.
The Chairman recognizes the Ranking Member to see if he has
any additional questions.
Mr. Meek. Thank you, Mr. Chairman.
Dr. Runge, I want to pretty much--I know almost on the
heels of the Chairman's question, right now the military is the
only branch of government with the operational capacity to
respond to a large medical outbreak. And I want to know what
steps are you taking, the necessary steps to coordinate in such
an emergency, a time of emergency. Because when it comes down
to, quote unquote, the chain of command or when it comes down
to the chain of making sure that we are all--well, when it
comes down to operational issues in the time of an emergency, I
don't need to explain that. I mean, you just left the Highway
Safety, you know--like you said, operationally as a
professional and as a doctor, you know it is important to know
who is really coordinating here. And I see all the questions
kind of swarming around that question because this is a serious
question. I mean, we are in a committee hearing now and we
don't find ourselves under, quote unquote, the gun. But if we
are, are you coordinating with the military? Are you having
discussions with the military as it relates to the outbreak,
Northern Command?
Dr. Runge. Yes, sir.
Yes, sir, thus far, I have met with General Kelly in
medical affairs at the Pentagon and some of his staff as well
as his policy people. I have also met with the medical director
of NORTHCOM basically just to assess where we are. I have the
same questions that you have. And I want to make sure that I
understand what their capacity is, what their mission is, and
how they can contribute in the event that they are needed
domestically.
The President asked a very important question a few weeks
ago and it was a question. And he sort of threw it over to
Congress saying, you know, we need to talk about the role of
the Department of Defense in these domestic activities. I think
that the folks at Defense are working on solutions to that
question, as well. I do think it is worth our pondering.
I am sort of at the assessment stage. There is a quote that
sticks in my mind and that is: We are not as vast and fast as
people think we are. You know, they are a lean Department of
Defense with a mission to defend our country externally. And I
think it would be unfair of us to assume that they have
capacity to jump in domestically and save us. I don't think
that is fair.
So I think this coordination is extremely important. That
we have to understand our roles and our responsibilities and
our capacity.
Mr. Meek. Well, we need to know that ASAP. And I am glad
you have that concern already planted in your head of the
capabilities of the military, especially when it comes down to
bioterrorism. During Hurricane Katrina, speaking with a two-
star general in the 82nd Airborne, when they got on the ground,
they jumped right in the water and started carrying out their
rescue missions and found that his troops were getting a rash
here, a sore there. They had to go out and through a commercial
vendor with a credit card go out and buy--what is the thing you
wear--you know what I am talking about?
Dr. Runge. Waders.
Mr. Meek. Waders.
Dr. Runge. I am from North Carolina; I know what they are.
Mr. Meek. Very good. We do not wear too many of those on
South Beach. But they had to go out and buy those. And then the
discussion started with the Centers for Disease Control of what
the 82nd Airborne was going through.
I think it is important as we start talking about a
military response, because everything can't be the military
will handle it. There is more to that than just bodies out
there up front. I see your position, tell me if I am wrong.
Quote, unquote, as the Surgeon General for the Department of
Homeland Security, and also the public in terms of how they can
protect themselves in terms of a bioterrorism or biochemical
attack.
And I think it is also important what you have share with
them is almost identical of what the way HHS sees it, and the
way that the Centers for Disease Control sees it also. But you
are going to be the person that is designated for that. Have
you had a discussion with them about that role?
I do have some reports--you were talking about the issue of
getting volunteers involved, especially in the EMS field. That
is one question. But EMS field of looking at the issue of
lowering the barriers of liability issues that they may face.
And that is a real discussion, something that this committee,
subcommittee just passing this news report. I just got off the
Web on some statements that you have made, that is something is
that we need to talk about, because during Katrina, you had
folks from other States, docs that wanted to come down, EMS
personnel that wanted to come down, and there were some issues
as it relates to licensing and issues as it relates to foreign
countries that wanted to send doctors, Mexico, Pakistan of all
places, they are needing docs over there, but they wanted to
send doctors. But because of licensing issues, they could not
address those issues.
I think as it relates to your public information officer
role that you play, and also as it relates to foreign doctors
coming into the United States and helping us in our time of
need, is there some thinking going on there as it relates to
your office and how are you going to accomplish that?
Dr. Runge. I am a believer that public information and
public education is one of the three legs of the three-legged
stool, and without it, you can't sit up. I am also the guy that
took Click It Or Ticket nationwide. I believe in branding. And
Only You Can Prevent Forest Fires. We do not have a Smokey the
Bear for biologicals. We need that. And I have talked to our
marketing folks about that who are configured right now less
for marketing and more for handling press.
The head of our public affairs is well aware of that. And
he is actually hiring somebody who is going to be a health
specialist to start to coordinate these messages with HHS and
with others to make sure that we are saying the same thing in
government. That there is not an HHS message or a DHS message
or an ag message, but that all of our messaging is consistent
and coherent and it actually tells people what to do and what
to expect. Surprise is not a good thing for people. They want
to know--they can handle bad news if they know what is coming.
So I take your advice to heart. And I will do everything I
can to make sure that we do have a coherent message across
government for these issues.
Mr. Meek. The issue of these docs or EMS personnel that are
in other States that may run into licensing issues and going to
a State like Florida, someone coming from Illinois, medical
boards they do not recognize the Illinois license. You are
going to address that as you try to get volunteers in the
medical response?
Dr. Runge. Yes, sir, there are some systems out there in
place, there is something called ESAVIP. And I can't ever
remember what this stands for, but it is a precredentialing
mechanism. There is also MDMS credentialing. One of the
problems after Katrina hit, and there was such devastation,
people who are helpers by nature wanted to help. They had not
done their work ahead of time to make sure they were trained,
they were not going to get in the way as volunteers, that they
had credentialling issues. That is what I was talking about in
that article.
I would like to see every physician--and some States
actually have a place where you can--on your license
application, where you can be contacted about how you can
volunteer and be part of the Medical Reserve Corps that the
Surgeon General has stood up. And I met with the Federation of
State Licensing Boards, this is a group in Dallas that
coordinates every State medical licensing board in the country.
They think they have a solution to this. It is a matter of me
getting the right people together.
Again, talking about public information, to educate our
physicians, nurses, and paramedics, and how is it that they do
this ahead of time.
Mr. Meek. I am over my time. As someone who just left south
Florida yesterday, that we have issues from the top to the
bottom, getting ice and water to people, leave alone dealing
with the very technical issue that we are dealing with right
now. And the things that we have to work out as it relates to
authorization for docs to come in from other States and they
know from a liability standpoint they do not have to end up
sitting in a trial because they were sued because they were not
licensed in a particular State. I think it is something that we
need to work out more sooner rather than later.
I am a cheerleader for the Department, but I honestly feel
overall that a lot of places where we are saying we are ready,
we really are not. We really are not. And we do not want to
scare the public by saying that we are not. But I think we need
to start seeing it as leaders that we have a lot of work to do
to get us where we need to be so that the folks who are
listening to us, the folks under your command and the folks in
HHS, and the folks in the Centers for Disease Control and in
the military, we say that so that we can, number one, see that
we have a problem and then we can start working towards the
solution.
I would like to know more about that cross-State licensing,
because we do have, with the emergency compacts, with the
emergency management, with States, State emergency compacts. I
sponsored that bill on the floor of the legislature in Florida
making sure that you have a compact with the State and
automatically there are some things that come along with that.
We can use your National Guard, we can use your Department of
Transportation trucks, Bobcats or what have you.
We need that as it relates to the medical issue. And I am
going to tell you, as it relates to these medical boards, take
it from me in Florida, it is tough to get into a medical board
or barred in certain States. So we want to make sure that folks
recognize one another in a time of emergency and we want to
work with you on that.
Thank you for coming before the committee. We look forward
to seeing your role stronger and given the ability to
coordinate with other agencies and within the Department of
Homeland Security. So thank you.
Dr. Runge. Thank you very much.
Mr. Rogers. And I want to echo that sentiment. We very much
appreciate you taking time to be here, but we also look forward
to helping you and your employees fulfill the mission that is
set out by the Secretary and creating this Department.
We are now going to excuse this panel. I have just been
informed by staff that we are about to be called for a series
of four votes which will keep us away for about 40 minutes, I
would expect. The second panel, oh, and Dr. Rungnge, and I will
tell the second panel, too, the record will be kept open for 10
days. There may be some Members--there are a lot of markups
going on so members are having conflicts about coming over
here--but they may have questions that they want to submit, and
I would ask you, too, in writing, respond to those.
And the second panel will be the same deal, some members
may want to get questions in for a record, and I ask you to
respond to those in a timely manner in writing. Thank you, Dr.
Runge, and your panel is discharged.
Let's do this, the second panel, let's go ahead and seat
the second panel and try to get your opening statements in
before we break for votes then we will do questions after that.
Mr. Rogers. We turn now to Mr. Timothy Moore for any
statement that he may have.
STATEMENT OF TIMOTHY MOORE, DIRECTOR, FEDERAL PROGRAMS,
NATIONAL AGRICULTURAL BIOSECURITY CENTER, KANSAS STATE
UNIVERSITY
Mr. Moore. Mr. Chairman, thank you. Mr. Meek, thank you for
allowing me to be here today to testify before this committee.
I think that the work you are doing is very important. The role
of the chief medical officer, as you have noted in your earlier
panel, is evolving. One of the things I would like to make sure
that, in my role as a private citizen before this committee
today is this: the importance of the connection between the
chief medical officer's position and that of animal health,
veterinary health issues, because they are intertwined. As the
avian influenza issue is looming about, it is an animal issue,
it is human issue and they will have to be closely coordinated.
I would tell you today that I don't believe that that issue is
being as well addressed as it should be between DHS, USDA and
the Centers for Disease Control, HHS. There are some issues
there that I think this committee can lend some guidance to.
Sir, today we are vulnerable to issues involving animal
diseases, emerging diseases, one of which is avian influenza.
While the potential for a human pandemic is obviously of grave
concern, I ask this committee to consider the fact that even in
its current configuration, the H5N1 strain, if it were to
arrive in this country, it would have catastrophic effects upon
our poultry and agricultural sectors such that we may have a
cascade of economic events that would cause great harm to
States such as Alabama, Arkansas, North Carolina and Georgia
where we rely on these industries for a mainstay of our
agricultural sectors.
The chief medical officer's role needs to be clearly
defined, in my estimation, so that the veterinary issues are
front and center from the Homeland Security Department, because
there is a lot of confusion, Mr. Chairman, as to who will have
control. One of the issues of great concern is the issue of
quarantine. Agricultural quarantine, animal quarantine, human
quarantine issues are not one and the same. So if you have an
animal event break out and you have a human quarantine event
that follows on behind that, who exactly is in charge at what
time, what tripwires have to be initiated for these things to
occur to my mind have not been addressed.
As I stated, the agricultural sector is vulnerable to
emerging animal diseases. One of the reasons for this, Mr.
Chairman, is the fact that within the Federal sector we have
less than 3,000 Federal veterinarians in employment across all
Federal agencies. Within the next 18 months we will lose
approximately 50 percent of those individuals. With those
individuals going out, we will lose decades of hard-fought
experience that we will not be able to readily capture and
transfer to the next generation of Federal veterinarians.
What does that mean? That means that that experience will
dissipate and that means that States and industries and regions
will have to bear a greater burden in the response to any kind
of agricultural disease incident.
I want you to consider, for example, the paucity with which
we have Federal resources to respond. In 2002 and 2003, the
United States experienced an exotic new castle disease in
California. It only affected poultry. At the height of the
outbreak, the U.S. Department of Agriculture was only able to
mobilize 1,800 personnel for the response. If we look at these
numbers in light of the 50 percent reduction due to retirement,
that means the pandemic flu that we are worried about, avian
flu, coming to this country we may have less than a thousand
individuals to respond at a given time. If it breaks out in
multiple States, we may find that we do not have the resources
to respond. As one Federal veterinarian said to me, avian flu
has the potential to be the Hurricane Katrina for the
agricultural sector.
Sir, one of the things I have tried to stress in the last 2
years of working in the agricultural response community is that
this is a blended response requirement. We have had these two
communicates operating in silos. They do not normally interact
and we need to make sure that they do so.
Things I would recommend this committee to consider, sir: I
would recommend that we credential graduating veterinarians
from the 28 veterinary schools in this Nation to be accredited
in the areas of incident command response, emergency
preparedness skills, so they are capable of helping this Nation
from the moment they graduate. At present no college does that.
Second of all, we need to reinforce within the Federal
agencies that preparedness for agricultural diseases is not an
unfunded mandate, it is not a ``nice to have,'' it is something
that is front and center in their primary mission.
Lastly, I think through the chief medical officer, Dr.
Runge, is what you can achieve is one medical voice for the
Federal Government as to what is going to happen in an
agricultural disease incident or heaven forbid a pandemic flu
incident.
The last thing I would have this committee consider is the
fact that the agricultural sector accounts for $1.25 trillion
of our annual U.S. economy. I would ask this committee to think
about the investment we put forth protecting that sector and
what will happen to our citizens is if we do not do that.
The 1918 pandemic was an avian strain as we have now
learned. At that time, America was much more compartmentalized.
We bought our bread, we bought our milk, we bought our meat
from local markets that were grown and harvested locally. Today
we are a global economy. If things begin to go awry, our
transportational sectors may collapse to the point where we may
not be able to feed our citizens and exacerbating the problems
and fears and concerns that Dr. Runge talked about.
That concludes my formal statement and I will yield to any
questions you may have, sir, thank you.
[The statement of Mr. Moore follows:]
Prepared Statement of Timothy Moore
Introduction
Mr. Chairman and distinguished Committee members, it is indeed my
pleasure to testify before you today regarding the clear need for
disease incident response training as it relates to the veterinary and
agricultural communities. I come before you today as a private citizen
with broad experience and knowledge of the threats against our
agricultural sector and the current status of preparedness and response
training efforts to mitigate these threats.
Background Information
This distinguished Committee has received previous testimony
regarding emerging and re-emerging diseases that threaten our nation's
agricultural sector. Current headlines are replete with information,
warnings and concerns over ``Avian Influenza.'' Yet, Avian Influenza is
but one of multitude of diseases that our nation must be prepared to
recognize, detect, respond to and, if necessary, recover from in the
coming years. Avian Influenza is particularly troublesome among
diseases due its unpredictability--its ability to ``jump species'' or
exhibit zoonotic tendencies and due to the fact that there are multiple
environmental or animal reservoirs that hinder our ability to eradicate
it. Currently Avian Influenza is concentrated within the poultry and
wild fowl populations in select areas/nations around the globe.
Unfortunately, we have no assurance that the disease will remain in
these areas. The combination of the unpredictable nature of the virus
coupled with the pressures associated with globalization of the
agricultural sector and the speed-to-market required to compete on the
international level have all strongly contributed to the conditions
that will most likely result in the continued spread of this disease.
Therefore, as a nation, we must be prepared to deal with this and other
emerging disease threats. In order to reduce the likihood of the
emergence of Avian Influenza in our counrty we are fortunate to have a
group of dedicated professionals who work at our federal, state and
local levels to protect us from and respond to these diseases:
Veterinarians.
As one measure of our veterinary population, let us examine the
current status of our federal veterinary community. At present, we have
fewer than 3,000 veterinarians spread amongst all agencies within the
federal sector. Accross the nation we have roughly 100,000
veterinarians. By contrast, the state of New York has more than 70,000
MDs. The nation generates fewer than 4,000 new Veterinarians from our
28 Colleges of Veterinary Medicine a each year. These numbers are
troubling, but they tell only part of the story.
At present, approximately 85% of all Veterinary graduates are
electing to enter exclusively into small animal practice with only 15%
electing to enter service within the food animal or mixed practice
(i.e. treatment of small and large animals). This represents an abrupt
change from 25 years ago when we witnessed approximately 50% of all
Veterinary graduates electing to enter into food animal or mixed animal
practice. The changes over the past 25 years reflect the economic
changes within the animal care sector of our country. Companion animals
represent the largest growth area within veterinary medicine. As we
move further away from individual farms and family agriculture we can
expect to see these trends continue. This is troubling because food
animal veterinarians have played a key role in securing the health of
our nation's animal populations for the past 100 years.
As vexing as these data are, they are only an indicator of the
challenges we will face in the future. Within the federal sector we are
witnessing a precipitous decline in the numbers of federal
veterinarians with direct experience in responding animal disease
incidents. This is not a trivial matter. For example within USDA's
Animal and Plant Health Inspection Service (APHIS), we find a federal
veterinary population that has done a magnificent job in preserving the
health of our pre-harvest animal population. However, we have fewer
than 500 USDA-APHIS veterinarians who are in the field conducting
important disease surveillance and response missions. This same group
of federal veterinarians serves as the backbone of our animal disease
incident response infrastructure - they led the 2002-2003 Exotic
Newcastle Disease response in California, Nevada and Arizona.
Currently, more than 50% of these veterinarians are scheduled to retire
from federal service before 2007. These retirees will, in effect,
remove hundreds of years of combined experience at the very moment that
we are witnessing the appearance of new and re-emerging diseases which
threaten our agricultural sector, our economy and perhaps our health.
As these key personnel retire, their replacements will be required to
master not only basic veterinary skills, but they will they will need
to master those skills required to effectively respond to disease
incidents. These emergency response skills may have to be learned
largely through trial and error. The nation's 28 Colleges of Veterinary
Medicine offer few, if any, programs of instruction geared toward the
role of veterinarians in disasters or emergency response. There is no
standard for instructing veterinary students in the art and craft
associated with the Incident Command System or in the proper selection
of personnal protective equipment or how to proper don or doff this
equipment. Further there is limited discussion of the relevant points
of self, equipment or structural decontamination procedures and limited
guidance on proper animal carcass disposal techniques that will be
needed to reduce the spread of infectious agents. As important as our
federal veterinary population is, we have little if any structured
process in place at the present time for the recruitment and training
of their replacements or any developed strategy to ``collect'' relevant
skills and best practices to ``pass'' on to the next generation of
federal veterinarians. Our current federal response strategy is
predicated on working closely with our state and industrial partners to
effect the eradication of a detected disease. This may become more
problemmatic in the coming years unless we have an agressive and
successful strategy to replace these individuals. If we are slow or
ineffectual in our attempts to replace these losses, we can anticipate
that the each state will bear a greater burden in the surveillance of
and response to animal infectious diseases.
In the past, animal disease response was largely handled within the
federal, state and local veterinary populations. However, Avian
Influenza presents a complication to this traditional response
strategy. Avian Influenza and other zoontic diseases, regardless of
origin (natural, accidental or deliberate) will require a coordinated
response by federal, state, and local veterinary AND non-veterinary
(i.e. traditional 1st responders) response personnel. Veterinary
responders and traditional 1st responders have limited experience in
working together--in many cases they do not know that the other exists.
This limited interaction could pose significant problems if the H5N1
strain of Avian Influenza is detected in the US. The detection of this
strain could cause significant disruption to our poultry production
regions of the country and neccessitate a close interaction between
local and state law enforcement for quarantine enforcement and local
fire departments to support individual and equipment decontamination
needs. Further, an animal only Avian Influenza strain will prompt close
involement and surveillance by local, state and national public health
entitites--something that has not occured in the past nor has it been a
standard component of public health or veterinary training. Ultimately
any Avian Influenza disease response will require agricultural and
traditional 1st responders to work together in ways that they have
never done so in the past. Due to the rapidly diminishing numbers of
experienced veterinarians at the federal level we must anticipate that
state and local authorities must be prepared to address wide spread
animal disease incidents largely on their own for an extended period of
time.
Presented below are some of the several activities underway to help
improve our readiness to combat agricultural disease incidents:
The first step in addressing any type of incident is achieved with
greater awareness on the part of veterinarians and traditional
responders alike of the various diseases, how they are manifested and
what must be done to contain and result in its eradication. Toward this
end, USDA-APHIS assembled and began distributing a CD entitled ``The
Threat to American Agriculture--Livestock Disease Awareness'' to the
nation's 28 Colleges of Veterinary Medicine, all 56 field offices of
the FBI , all state veterinarians and have made the CD available to
traditional responders. Furthermore, USDA-APHIS is working closely with
the Office for Domestic Preparedness in the development and validation
of didatic program regarding agricultural foreign animal disease
recognition that will capitalize upon the nation's community college
network to effectively spread this information. USDA-APHIS in concert
with the Department of Homeland Security has embarked on a cooperative
program to develop and deliver a beta version of an emergency response
training course (Individual performance--Defensive by the ODP
guideline) designed for federal, state and local veterinary AND
traditional 1st responders to train side-by-side to recognize and
respond to agricultural disease incidents. This new course is entitled
the Agricultural Emergency Response Training (AgERT) course and is
currently undergoing pilot delivery at the Center for Domestic
Preparedness located in Anniston, Alabama. The AgERT course teaches
agricultural responders in the proper skills required to safely respond
to ``all hazards'' incidents and provides traditional 1st responders
with basic animal disease information (e.g. introduction to
epidemiology priciples; overview of animal diseases; carcass disposal
considerations, etc.) This course offers promise and path forward as to
how the nation can train veterinarians and 1st responders to work
together during a disease incident. Upon completing the pilot phase,
discussions will begin as to how best to distribute this training
across the nation to meet the broader training audience. Lastly,
discussions are underway for the development of an advanced veterinary
response training course that will better prepare federal, state and
select local veterinarians to handle the difficult issues associated
with leading animal disease incident response.
Issues to Consider
The Committee is well aware of the looming potential for a pandemic
version of Avian Influenza to strike in the United States. The
Committee may not recognize that Avian Influenza is just one of
multitude of emerging or re-emerging diseases which either may
exclusively affect the agricultural sector or have the potential to
impact both animal and human health. Disease threats, regardless of
origin are a ``new normalcy'' that we must expect, plan for and react
to. If we are fortunate enough to ``dodge'' a pandemic involving this
particular strain of Avian Influenza, then we must be ready to deal the
next strain or the next disease that will almost assuredly come during
our lifetime. In short threats from new or re-emerging diseases will
not fade away.
The Committee must understand that steps must be taken to assure
Americans that we will have a sufficient number of properly trained
Veterinarians at the federal, state and local levels to meet the
response requirements associated with either an animal disease incident
or a zoonotic disease incident. Programs need to be considered to
reinforce and fund Veterinary Public Health Service-related positions
within the Agricultural and Public Health sectors. Without such
funding, the possibility of attracting our best and brightest into the
service of their country is remote. These positions would assist states
and resgions in the conduct of general and targeted disease
surveillance efforts.
An issue of concern surrounds the ambiguity of the issue of
Quarantine. The Committee understands that Agricultural/Animal
Quarantine and Human Quarantine measures are neither identical nor are
they imposed in similar fashion. Without a clear and concise
understanding within the federal, state and local levels as to how
these types of quarantine procedures should and must work together, we
can be assured of general confusion and increased apprhension regarding
these issues within the ranks of our fellow citizens. As such we must
work together as a community to identify where and how these types of
Quarantine procedures will interact and who is ultimately responsible
for Quarantine during a zoonotic disease event.
Suggested Next Steps for Consideration
Listed below are a few suggested next steps for the Committee to
consider when addressing the issues surrounding agricultural sector
preparedness.
The Committee has been instrumental in the creation of new position
within the Department of Homeland Security entitled the Chief Medical
Officer (CMO). I applaud this action as an important first step. I urge
the Committee to consider designating one of the CMO's permanent staff
positions for a Assistant CMO--Veterinary Emergency Response (VER).
This position would answer to the CMO on all issues pertaining to
effective and proper preparedness, to include the measurement and
validation of readiness as it relates to the directives contained in
HSPD 9 (Food and Agricultural Security). In this way, the nation will
have a veterinarian ``in the loop'' when it comes to all matters
pertaining to agricultural disease incident readiness and response
within the Department of Homeland Security who will coordinate with
USDA, CDC and any other relevant federal agencies.
Secondly, I urge the Committee to consider implementing a series of
federal, state and local, as well as ``joint'' assessment exercises, of
a similar nature to the ``Crimson Sky'' to clearly identify our gaps,
voids and needs so that our limited funding and staff time can be put
to best use. Further, the data arising from these exercises must be
placed into actionable formats so that key issues are identified and
coupled with a plan arising from the CMO's level to support
preparedness strategies.
Thirdly, I urge the Committee to direct DHS, USDA and HHS/CDC to
form a working group to examine the consequences of a pandemic
influenza. There are a number of issues related to who is in charge at
precisely what moment during a potential ``species jumping'' disease
incident that we have yet to work through at the national level. This
will be important to the security of our nation during any significant
disease outbreak.
Fourthly, I urge the Committee to explore mechanisms by which we
can train, certify and mobilize veterinarians on a national basis to
react to disease incidents. Currently within DHS we have the Veterinary
Medical Assistance Teams (VMAT) which have performed well in the
response to companion animal crises (e.g. Katrina) and we have the
Veterinary Services component of the USDA to deal with pre-harvest
animal disease events. While these groups are important, we must
consider methods to support their actions with greater numbers of
federally trained veterinarians so that we create some type of
veterinary surge capacity.
Lastly, I urge the Committee to consider its role in spelling out
specific national mandates with regad to animal disease incidents. We
live in a world at the federal, state and local levels with limited
personnel resources and funding. However, we are entering a period in
our nation's history in which we simply cannot afford to conduct our
activities in the manner which we have grown accustomed. Preparation to
effectively, swiftly and accurately respond to agricultural or zoonotic
disease events is too important to allow it to be mixed with other
``routine'' agency activities. Emergency response must emerge as a
``top of the list'' issue for our agency and prrogram personnel and it
cannot be allowed to viewed as an ``optional issue" or as an ``unfunded
mandate.'' Disease surveillance, detection, response and recovery need
to be at the top of our priorities to ensure that we have the staff and
with the proper training to ensure the continuity of our agricultural
sector.
Conclusions
Mr. Chairman, I want to take this opportunity to thank you and the
members of the Committee for allowing me the opportunity to testify
today. I hope that I have clearly conveyed that we have diseases that
are looming and which could potentially alter our agricultural
sector,our economy and even our health.
I would like to leave the Committee with two quotes to consider.
The first quote is from Alex Thierman, Office of International
Epizooties (i.e. the World Health Organization for Animals) who stated
in 2001 that ``Governments will no longer be judged on whether or not
they have incursions of [new] diseases, rather they will be judged on
how well they respond to them.'' The second quote was recently conveyed
to me by a veterinarian who stated that ``Avian Influenza has the
potential to become the agricultural sector's Hurricane Katrina.'' It
is my hope that we can avert disaster through our dedication to being
prepared. Thank you.
Mr. Rogers. What I would like to do, and I neglected to
cite your title--you are the Director of Federal Programs at
the National Agricultural Biosecurity Center at Kansas State
University. I thank you for that statement.
I am hoping that we can get Dr. Lowell's and Mr. Heyman's
statements in. Dr. Jeffrey Lowell is Professor of Surgery and
Pediatrics at Washington State University School of Medicine,
and you are recognized for any statement you might have.
STATEMENT OF JEFFREY A. LOWELL
Dr. Lowell. Thank you, Chairman Rogers, Ranking Member
Meek, and distinguished members, for the opportunity to testify
today. My name is Jeffrey Lowell. I am a surgeon at Washington
University School of Medicine, where I am a professor of
surgery and pediatrics and direct the transplant surgery
programs at St. Louis Children's Hospital. I am a liver and
kidney transplant surgeon and have held the position of
assistant vice chancellor in the School of Medicine. I have
also served as the police surgeon for the St. Louis Police
Department, I also served on the hostage response team and
senior advisor to the mayor for medical affairs and chief of
the St. Louis medical response system.
I am here to today to discuss medical readiness
responsibilities and capabilities in the Department of Homeland
Security and the role of the chief medical officer in relying
and strengthening the Federal medical response.
In September 2004, I was appointed by then-Secretary of
Homeland Security, Tom Ridge, to serve as the senior advisor to
the Secretary for medical affairs. In that capacity, I was the
principal adviser to the Secretary on medical issues relevant
to the Department, including medical response to disaster,
distribution and utilization of medical assets within the
Department, coordination with other departments and agencies on
medical issues and occupational health and safety issues
regarding DHS employees and support personnel.
Secretary Ridge, and now Secretary Chertoff, have
recognized that medical preparedness and response are critical
elements of the DHS mission. One of my tasks as senior advisor
to the secretary for medical affairs was to assess the
Department's capability to carry out its medical mission as
part of that task, I examined DHS's medical readiness
requirements and capabilities for addressing these
requirements. I reviewed the medical and health assets
activities resources and capabilities located in DHS and how
these assets and responsibilities are related to other Federal
departments or agencies at the executive branch with a focus on
mass casualty care.
I found that DHS lacked a clearly defined and unified
medical capability to support its mission of preventing
protecting responding to and recovering from major terrorist
attacks or natural disasters. The primary consequences of most
events of national significance are the impact on human health.
People get injured or they die. If we do not save lives, little
else matters.
Americans expect DHS to pass the readiness test. I found
the Department's medical readiness responsibilities,
capabilities, assets, personnel, and fiscal resources needed to
be realigned and consolidated in order for the Department to
pass the medical readiness test and I make recommendations on
how to do so.
In recognition of the importance of the medical mission,
Secretary Chertoff, after conducting the second stage review of
the department, established the position of DHS Chief Medical
Officer. And I applaud Secretary Chertoff for this decision.
Secretary Chertoff has stated that the CMO position is to be
housed within the proposed Preparedness Directorate; however, I
would respectfully suggest an alternative.
Instead, I recommended establishing an Office of Medical
Readiness in the Department of Homeland Security and would like
to provide a brief overview of the configuration
responsibilities and benefits of such an office. I would like
to discuss the role of the chief medical officer in leading
this office.
The DHS Chief Medical Officer should be charged to protect
the public, emergency responders, and affiliated medical
personnel from the range of manmade and naturally occurring
biological and environmental diseases, injuries and threats
that the Department will face and to serve as an information
and communication channel with the public, emergency
responders, and the medical profession regarding all aspects of
these issues.
The CMO should lead a centralized, coordinated
organizational structure within DHS and serve as the central
medical point of contact to coordinate with other Federal and
State and local agencies, and to provide the core architecture
for managing and coordinating the delivery of Federal emergency
medical support; deliver medical risk communications; and
provide medical and health support to DHS employees in the
workplace and on deployments.
The CMO should have the following responsibilities: To act
as the principal advisor to the Secretary on medically-related
issues. To direct the operational elements of the Federal
medical health threat response to a national critical incident.
To integrate relevant agencies and programs within DHS and
within the U.S. Government, such as CDC, Office of Public
Health and Emergency Preparedness of HHS, the Public Health
Service, Army Air National Guard Medical Corps, and the VA
Hospital System.
To act as a spokesperson for the Secretary on medically-
related issues, including threat risk assessment, preparation
and responses. To focus Federal resources on developing a
national medical surge capacity, including the integration and
coordination of existing Federal assets, including the National
Guard, NORTHCOM, and VA with civilian response systems. To
ensure effective integration among civilian medical providers
and facilities including developing systems to ensure intra/
inter regional coordination, interoperable equipment,
standardized practices and procedures including electronic
systems to track patients that may be transported from one
location to another, and robust intra--and inter-regional
exercises. And to coordinate relevant research and development
programs across agencies.
I would recommend that the CMO, in the immediate period,
address four critical problems in the Federal medical response
to an event of national significance.
First, people. There must be a trained, equipped mobile
medical workforce composed of the appropriate medical and
surgical disciplines capable of providing medical care in the
event of catastrophic threats or events. There are weaknesses
in the Federal medical response currently led by the national
disaster medical system, the NDMS. NDMS is currently assigned
to the Emergency Preparedness and Response Directorate in DHS,
where there are few qualified medical personnel available to
develop the requisite medical doctrine, policies and
procedures.
I would recommend that NDMS be moved to the proposed Office
of Medical Readiness and be substantially transformed to
include full-time Federal medical teams and a uniformed Reserve
corps supplemented by volunteer teams to satisfy casualty
requirements from existing planning scenarios.
A full-time and uniformed reserve medical corps led by the
CMO would need to be recruited and supported as part of the
medical element of either the U.S. Coast Guard in DHS, the
National Guard or a new clinical readiness component of the
independent DHS medical corps. Just as our nation expects other
components of its emergency response systems, police, fire and
EMS, to be solely committed to its singular commission and
responsibility, the medical health components must be comprised
of solely committed specialized personnel. We do not expect our
Nation's largest estates to rely disproportionately on
volunteer firefighters and auxiliary police officers. There
needs to be a thorough analysis and transformation of NDMS by
the DHS CMO.
I think I am over my time here.
[The statement of Dr. Lowell follows:]
Prepared Statement of Jeffrey A. Lowell, MD, FACS
Good afternoon. Thank you Chairman Rogers, Ranking Member Meek, and
distinguished Members of the House Committee on Homeland Security, for
the opportunity to testify before the Committee.
My name is Jeffrey Lowell. I am a surgeon at Washington University
School of Medicine, where I am Professor of Surgery and Pediatrics and
direct the Transplant Surgery program at St. Louis Children's Hospital.
I am a liver and kidney transplant surgeon, and have held the position
of Assistant Vice Chancellor in the School of Medicine. I have also
served as the Police Surgeon for the St. Louis Metropolitan Police
Department (where I served on the Hostage Response Team), as Senior
Advisor to the Mayor for Medical Affairs, and Chief of the St. Louis
Metropolitan Medical Response System.
I'm here today to discuss medical readiness responsibilities and
capabilities in the Department of Homeland Security and the role of the
Chief Medical Officer in realigning and strengthening the Federal
Medical Response.
In the Summer of 2004, I was appointed by then Secretary of
Homeland Security Tom Ridge to serve as Senior Advisor to the Secretary
for Medical Affairs. In that capacity, I was the principal advisor to
the Secretary on medical issues relevant to the Department, including
medical response to disaster, distribution and utilization of medical
assets within the Department, coordination with other Departments and
agencies on medical issues, and occupational health and safety issues
affecting DHS employees and support personnel. Secretary Ridge, and now
Secretary Chertoff, have recognized that medical preparedness and
medical response are critical elements of the DHS mission.
One of my tasks as Senior Advisor to the Secretary for Medical
Affairs was to assess the Department's capability to carry out its
medical mission. As part of that task, I examined the Department of
Homeland Security's medical readiness requirements and its capabilities
for addressing these requirements.
I reviewed the medical and health assets, activities, resources and
capabilities, located in the Department of Homeland Security, and how
these assets and responsibilities related to other federal departments
or agencies of the executive branch, with a focus on mass casualty
care.
I found that the Department of Homeland Security lacked a clearly-
defined and unified medical capability to support its mission of
preventing, protecting, responding to, and recovering from major
terrorist attacks or natural disasters.
The primary consequences of most Events of National Significance
are the impact on human health--people get injured or die. If you don't
save lives, little else matters. Americans expect the Department of
Homeland Security to pass the medical readiness test. I found that the
Department's medical readiness responsibilities, capabilities, assets,
personnel, and fiscal resources need to be realigned and consolidated
in order for the Department to pass the medical readiness test, and I
made recommendations on how to do so.
In recognition of the importance of the medical mission, Secretary
Chertoff, after concluding the Second Stage Review of the Department,
has established the position of DHS Chief Medical Officer. I applaud
Secretary Chertoff for this decision. Among other issues, Secretary
Chertoff has recommended that the CMO position be housed within the new
proposed Preparedness Directorate. However, I respectfully suggest an
alternative.
Instead, I recommend establishing an Office of Medical Readiness in
the Department of Homeland Security, and would like to provide a brief
overview of the configuration, responsibilities, and benefits of such
an office. I would like to discuss the role of the Chief Medical
Officer in leading this Office.
The DHS Chief Medical Officer should be charged:
to protect the public, emergency responders, and
affiliated medical personnel from the range of manmade and
naturally occurring biological and environmental diseases,
injuries, and threats that the Department will face
to serve as an information and communication channel
with the public, emergency responders and the medical
profession regarding all medical aspects of these issues
The CMO should lead a centralized, coordinated medical
organizational structure within DHS, and serve as the central medical
point of contact to coordinate with other Federal, State, and local
agencies and to provide the core architecture for managing and
coordinating the delivery of Federal emergency medical support; deliver
medical risk communications; and, provide medical and health support to
DHS employees in the workplace and on deployments.
The CMO should have the responsibilities:
To act as the principal advisor to the Secretary on
medically related issues
To direct the operational elements of the federal
medical/health threat response to a national critical incident
To integrate relevant agencies and programs within DHS
and within USG (e.g., Centers for Disease Control and
Prevention (CDC)--Office of Public Health and Emergency
Preparedness (HHS), U.S. Public Health Service (HHS), Air/Army
National Guard Medical Corps (DOD), and VA Hospital System
(Department of Veterans' Affairs)).
To act as the spokesperson for the Secretary on
medically related issues, including threat/risk assessment,
preparation and responses
To focus federal resources on developing a national
medical surge capacity--including the integration and
coordination of existing federal assets (including the National
Guard, NORTHCOM, VA Hospital System) with civilian response
To ensure effective integration amongst civilian
medical providers and facilities, including developing systems
to ensure intra/inter regional coordination, interoperable
equipment, standardized practices and procedures (including
electronic systems to track patients that may be transported
from one location to another), and robust intra/inter regional
exercises
To coordinate relevant research and development
programs across federal agencies
I would recommend that the CMO, in the immediate period, address
four critical problems in the federal medical response to an event of
national significance.
First, people. There must be a trained, equipped, mobile, medical
work force composed of the appropriate medical and surgical
disciplines, capable of providing medical care in the event of
catastrophic threats or events. There are weaknesses in the federal
medical response to mass casualty events, which is currently led by the
National Disaster Medical System (NDMS). NDMS is currently assigned to
the Emergency Preparedness and Response Directorate in DHS, where there
are few qualified medical personnel available to develop the requisite
medical doctrine, policies, and procedures. I would recommend that NDMS
be moved to the proposed Office of Medical Readiness and be
substantially transformed to include full-time federal medical teams
and a uniformed reserve corps, supplemented by volunteer teams, to
satisfy casualty requirements from existing planning scenarios. A full-
time and uniformed reserve medical corps, led by the CMO, would need to
be recruited and supported as part of the medical element of either the
U.S. Coast Guard, the National Guard, as a new clinical readiness
component of the U.S. Public Health Service, or as an independent DHS
medical corps. Just as our Nation expects other components of its
emergency (first) response (e.g., police, fire, EMS) system to be
solely committed to its singular mission and responsibility, the
medical/health components must also be comprised of solely committed,
specialized personnel. We do not expect our Nation's largest cities to
rely disproportionately on volunteer fire fighters and auxiliary police
officers. There needs to be a thorough analysis and transformation of
NDMS by the DHS CMO.
Second, surge capacity. There is little surge capacity in U.S.
hospitals for catastrophic events. The surge capacity of a health care
system includes more than an accounting of staffed vs. licensed
hospital beds. Most hospitals in the U.S. function at or near capacity
on a daily basis. After action reviews of Hurricanes Katrina and Rita
will undoubtedly identify large gaps in the plans and systems to
redistribute, and track, patients regionally and nationally. DHS should
establish a standard for temporary, mobile medical facilities, and
staff requirements to support these facilities, that can serve as
alternative care sites or potentially sites for quarantine, to
supplement the already strained U.S. Hospitals.
Third, interagency coordination and leadership. There must be a
solution to the lack of interagency coordination. There are apparent
conflicts in the requirements of the Homeland Security Act of 2002 and
Emergency Support Function--8 of the National Response Plan and
Homeland Security Presidential Directive 10 that should be clarified
and resolved. There is a lack of a clear and effective public education
strategy for medical/health response to a critical incident, termed
``risk communication'' and a lack of an understanding of who (from
which USG Department and position) should be the risk communications
spokesperson.
Fourth, manage and coordinate the current medical/health programs
that reside within DHS, within the proposed Office of Medical
Readiness.
DHS was created to prevent, protect, respond to, and recover from
natural and man made disasters. Meeting the health and medical needs of
the nation at times of disaster is a core requirement in the mission of
DHS. Accordingly, to efficiently and effectively complete this mission,
DHS must re-evaluate and refine the medical component of its mission;
design, develop, and realign medical response capabilities within the
Department, under the direction of its Chief Medical Officer, and
collaborate with HHS and other Federal partners to ensure the seamless
integration of medical preparedness and response capabilities at the
Federal, Regional, State, and local levels.
Thank you again Mr. Chairman and Ranking Member Meek, as well as
the other Members of this distinguished Subcommittee for your continued
leadership and for the chance to appear before you today to discuss
medical readiness responsibilities and capabilities in DHS and the role
of its Chief Medical Officer in realigning and strengthening the
Federal Medical Response. I will be happy to answer any questions that
you have.
Mr. Rogers. Your full statement is in the record, that is
good. We will go to Mr. Heyman. And Mr. Heyman is a Senior
Fellow and Director of the Homeland Security Program Center for
Strategic and International Studies. The floor is yours.
STATEMENT OF DAVID HEYMAN
Mr. Heyman. Thank you, Mr. Chairman, and members of the
committee. I do have a full statement which I would like to be
included in the record.
First, I want to discuss the new context that shapes the
catastrophic health emergencies today so that I can set the
recommendations in context. Second, I want to touch on some
recommendations from a report we wrote on DHS 2.0, which looked
at the CMO function. And third, I am going to highlight four
areas of greater leadership we need in the Federal Government
that the CMO might be able to adopt. And finally, I have some
recommendations specifically for the CMO in light of the
possible pandemic flu.
To understand the challenges we face today in public
health, we must also appreciate the changes that evolved over
the past 50 or 70 years in terms of health risk or health care.
In the 20th century, we saw two important health care trends
and two health care risks evolve. We saw the rise of the era of
preventive medicine in which a number of techniques, including
vaccines and antibiotics, could employ not only to prevent
disease, but to reduce the lethal effects.
We also saw beginning in the 1980s the just-in-time
manufacturing principles applied in health care and hospitals
to reduce costs and increase revenue. This led to the reduction
in overall number on average of available beds and hospital
services. It also helped create a health infrastructure that
thrives on efficiency at the expensive surge capacity.
In terms of risks, we began witnessing the emergence of
novel infectious disease causing pathogens and increased
microbial resistance to antibiotics in some known pathogens.
This meant diseases that are now cropping up that are not
necessarily amenable to our sort of standard 20th century
interventions.
And finally, more recently, we have experienced the advent
of catastrophic terrorism, of deliberate release of Bacillus
anthracis, and the fear that the world's deadliest weapons,
nuclear, biological and chemical, may be acquired and used by
terrorists.
The implication of all of these developments is that
whereas preventive medicine and its aspirations to eliminate
infectious disease was the focus of the 20th century,
responsive health care may be increasingly required at the
beginning of the 21st century to manage new health risks.
What I mean by that is the ability to develop new vaccines
or medicine to apply to newly emerging diseases or, in
particular, rapidly deliver health care services to possibly
large populations in short order.
These trends are important to the preparedness and response
activities that may fall under the purview of the new chief
medical officer at DHS. Greater national leadership in
biodefense was one of the principal recommendations of our task
force report, DHS 2.0. And today I believe, despite a new
presidential directive and a preparedness directive describing
the administration's approach to biodefense, the need for
leadership is still great and confused.
There are four areas in particular where clear leadership
is needed today:
One, leadership in providing scientific, medical, and
public health advice at DHS. Two, leadership in developing
greater situational awareness of biothreats and health
preparedness. Those are threats and vulnerabilities that go
together. Three, leadership in integrating Federal, State,
local, and private sector preparedness and response functions.
We have had a number of comments on that today. And four,
leadership supporting public education through public
preparedness. They are really at the first line of response.
Let me conclude by turning to avian flu. The increased
concern and possible risk of pandemic flu provides a special
case that urgently needs leadership in preparing for biological
events. By any standard, we are not prepared should a pandemic
emerge today. Vaccines needed to protect us would take a
minimum of 6 months and might take longer to develop. Small
stockpiles of antiviral medication exist but not in sufficient
quantities. And without vaccines or medical countermeasures the
next best option--perhaps the only best option--is to put in
place disease exposure controls to reduce as much as possible
the likelihood that individuals will pass the disease from one
to another.
Disease exposure control is a process by which the spread
of disease is minimized by limiting contact between uninfected
individuals and other individuals who are potential spreaders
of disease. To be sure we do need medical supplies, vaccines
and antiviral drugs. We also need enhanced disease surveillance
networks for early warning and we need to put plans in place to
prioritize, move, and dispense medical countermeasures as well.
But in their absence, which is where we are today, with a
possible pandemic on the horizon, the chief medical officer's
yet to be defined role could be vital in helping delineate
these additional tools to limit exposure to disease and help
protect public health should a pandemic materialize. National
leadership is needed now. And I am happy to answer your
questions.
If I hadn't stumbled, I would have been right on 5 minutes.
[The statement of Mr. Heyman follows:]
Prepared Statement of David Heyman, Senior Fellow and Director,
Homeland Security Program, The Center for Strategic and International
Studies (CSIS) \1\
Mr. Chairman and other distinguished Members of the committee,
Thank you for the opportunity to testify before the committee today
to discuss improving the national response to catastrophic health
emergencies and, specifically, the role of the new chief medical
officer at the Department of Homeland Security.
---------------------------------------------------------------------------
\1\ The Center for Strategic and International Studies provides
strategic insights and practical policy solutions to decision makers
committed to advancing global security and prosperity. Founded in 1962
by David M. Abshire and Admiral Arleigh Burke, CSIS is a bipartisan,
non-profit organization headquartered in Washington, D.C with more than
220 employees. Former U.S. Senator Sam Nunn became chairman of the CSIS
Board of Trustees in 1999, and John J. Hamre has led CSIS as its
president and chief executive officer since April 2000. More
information is available at www.csis.org.
---------------------------------------------------------------------------
I also want to thank Ambassador Bob Stuart who had the foresight
and has generously helped support much of CSIS's work in this area.
Greater national leadership in biodefense was one of the
recommendations of the task force co-chaired by myself, on behalf of
The Center for Strategic and International Studies, and Jim Carafano,
of The Heritage Foundation. The task force's report, DHS 2.0:
Rethinking the Department of Homeland Security, evaluated the
department's capacity to fulfill its mandate as set out in the Homeland
Security Act of 2002.
In evaluating the new role of chief medical officer, I would like
to first discuss the new context that shapes catastrophic medical
emergencies today. Second, I will review the recommendations the task
force made related to the chief medical officer and our nation's
ability to respond to these type of emergencies. Third, I would like to
discuss the areas in which greater leadership in the federal government
would enhance our nation's ability to prepare for and respond to
catastrophic medical emergencies. Fourth, and finally, I would like to
recommend actions the Chief Medical Officer at DHS might consider in
regard to the possibility of a pandemic flu outbreak.
A New Context--Catastrophic Medical Emergencies
To understand the challenges we face protecting public health
today, we must appreciate some of the changes that have evolved over
the past fifty to seventy years in terms of health risks and health
care.
First, the 20th century was a period that ushered in the era of
preventive medicine. In this period, we saw the development of a number
of techniques and medicines including vaccines, antibiotics and other
medical interventions that could be employed not only to prevent
disease, but also to reduce its lethal effects. Preventive medicine has
become the dominant model within which health care is delivered today.
Second, beginning in the 1980s, we saw principles of ``just-in-
time'' manufacturing applied to health care and hospitals, to reduce
costs and increase revenue in increasingly privatized health care
systems. This led to a reduction in the overall number on average of
available beds and health care services. It also created a health
infrastructure that thrives on efficiency, at the expense however, of
surge capacity.
Coincidentally, at the same time, we began witnessing the emergence
of nearly two dozen novel infectious disease-causing pathogens, and
increased microbial resistance to antibiotics in some known pathogens.
This meant diseases are cropping up that are not necessarily amenable
to our standard twentieth-century interventions.
And finally, more recently, we have experienced the advent of
catastrophic terrorism, the deliberate release of Bacillus anthracis,
and the fear that the world's deadliest weapons--nuclear, biological,
and chemical--may be acquired and used by terrorists.
The implication of all of these developments is that whereas
preventive medicine and its aspirations to eliminate infectious disease
was the focus of the 20th century, responsive health care may be
increasingly required at the beginning of the 21st century to manage
new health risks.
What I mean by and what I am calling ``responsive health care'' is
the ability to quickly develop new vaccines or medicine to apply to
newly emerging diseases, combined with rapidly delivering health care
services to possibly large populations in short order. In a world of
newly emerging and possibly deliberately spread biological threats, we
may no longer aspire to eliminate these threats, we will have to manage
them.
We saw the seeds of responsive health care applied in New York in
September 2001; we see the need for it in large-scale hurricanes and
natural disasters; and we saw it in Washington DC when the city
government had to dispatch antibiotics to 40,000 individuals who were
potentially at risk of contracting anthrax. We may yet see the greatest
need for responsive health care if the H5N1 avian influenza virus
mutates to become transmissible among humans around the world.
Why DHS 2.0?
Before I discuss our recommendation for greater national leadership
in biodefense, I would like to share with the committee our rationale
for undertaking the CSIS/ Heritage study where this recommendation
comes from, and why the task force urged Congress and the department's
new leadership to consider adopting the recommendations of the report.
When we wrote the DHS2.0 report last year, we had learned much over
the intervening three years since the 9/11 attacks. We had come to
understand that the age when only great powers can bring great powers
to their knees is over and that the specter of catastrophic terrorism
that could threaten tens-ofthousands of lives and hundreds-of-billions
of dollars in destruction will be an enduring concern.
Our review of the initial conception for the DHS in the Homeland
Security Act suggested that the department's original organization did
not reflect these realities well. Additionally, since its creation,
whether one looks at the department's capacity to organize and mobilize
a response to a catastrophic terrorist attack or at the international
dimension of DHS programs, the department had been slow to overcome the
obstacles it faced in becoming an effective 21st century national
security instrument.
Fundamentally, a new threat environment requires a new approach to
security. A nimble, highly adaptive adversary necessitates a
bureaucracy that must also be flexible and responsive to a constantly
changing threat. Experience with the creation of the Department of
Defense reminds us that it takes only a few years for bureaucracies to
become entrenched. And thus we must attempt to correctly structure them
at the beginning or live with the mistakes for a long time.
The proposals related to biodefense were developed by a task force
with members from academia, research centers, the private sector, and
Congress and chaired by homeland security experts at The Center for
Strategic and International Studies and The Heritage Foundation. Based
on analysis, seminars, an extensive literature search, and interviews,
the task force developed 40 major recommendations for improving the
oversight, organization, and operation of DHS.
The findings and recommendations of the task force can be found on
CSIS' web site at: http://www.csis.org/media/csis/pubs/041213_dhsv2.pdf
The Need for National Leadership on Biopreparedness and Biodefense
One of the taskforce recommendations was for the government to
clarify authorities and national leadership roles for biodefense by
establishing and empowering a lead executive.
Today that need is still great. Despite a presidential directive
\2\ that provides a comprehensive framework \3\ to forge a national
system to protect us against future biological attacks; and despite
specific descriptions of roles and responsibilities for the multitude
of federal agencies involved in bio-defense, the directive fails to
resolve the largest shortcoming in our bio-defense strategy--lack of a
single authoritative federal entity to ensure national leadership and
coordination for biopreparedness and biodefense.
---------------------------------------------------------------------------
\2\ See ``Biodefense for the 21st Century'' at http://
www.whitehouse.gov/homeland/20040430.html
\3\ HSPD-10 describes four key elements of the president's
strategy: bolstering our nation's threat awareness, which includes
biological weapons-related intelligence, vulnerability assessments and
anticipation of future threats; strengthening prevention and protection
capabilities, which includes interdiction and critical-infrastructure
protection; improving surveillance and detection, which includes attack
warning and attribution; and expanding response and recovery capacity,
which includes response planning, mass casualty care, risk
communication, medical countermeasures and decontamination.
---------------------------------------------------------------------------
None of the federal entities discussed in the directive have
overall responsibility across all aspects of bio-defense, and none has
the mandate or authority to reconcile competing agendas and
capabilities across the entire spectrum of federal resources or
national interests. Without coordinated federal leadership, states lack
measures to assess their own readiness plans, our national surveillance
system devolves into a patchwork of state systems, surge capacity is
limited and international coordination becomes ad hoc, agency by
agency.
A key--and unique--mission of the Department of Homeland Security
is leading national--not just federal--efforts to protect, prepare for
and respond to possible attacks and other emergencies like the 9/11
terrorist attacks. National biodefense preparedness and response
includes naturally occurring and deliberate attacks and requires the
involvement of a wide range of Federal departments and agencies--the
Department of Health and Human Services (HHS, which includes the Public
Health Service, the Centers for Disease Control, and the National
Institutes of Health), the U.S. Department of Agriculture (USDA), and
the Department of Defense (DoD).
Until the recent adoption of a new Preparedness Directorate at the
DHS, even within just the Department of Homeland Security, the range of
departmental elements with some role in preparing for and responding to
biological attacks is widespread. Referring in some cases below to
their pre-Preparedness Directorate names, they include:
(1) The DHS Emergency Preparedness & Response (EP&R)
Directorate. This Directorate is primarily the Federal
Emergency Management Agency (FEMA), but it also includes within
it certain efforts to coordinate with state, local, and private
entities on preparing for disasters, including terrorist
attacks.
(2) The Infrastructure Protection (IP) piece of the DHS
Information Analysis and Infrastructure Protection (IAIP)
Directorate. The job of IP is to identify critical
infrastructure warranting protection, prioritize efforts, and
work with state, local, and private entities to secure this
infrastructure.
(3) The DHS Office of State and Local Government Coordination
and Preparedness (OSLGCP). This entity--the product of merging
the Office of State and Local Coordination, and the Office of
Domestic Preparedness
--works with state and local governments on identifying needs,
coordinating efforts, and doling out DHS grant money for
critical infrastructure protection and preparedness.
(4) The Office of Private Sector Liaison. This office has
primarily been an ombudsman for private efforts to influence
DHS policy in various areas, but it conceivably could be a
forum for working with the private sector on critical
infrastructure protection and preparedness for attacks.
(5) The Science and Technology Directorate Office of WMD
Operations and Incident Management (WMDO-IM). This new office,
within the S&T Directorate, is intended to provide rapid
scientific and technical expertise and decision-making in
response to WMD attacks and incidents.
(6) The Assistant Secretary for Plans, Programs, and Budgets
develops the R&D agenda for biodefense countermeasures, which
is executed by the Office of Research and Development and the
Homeland Security Advanced Research Projects Agency.
The Secretary of Homeland Security, as the principal Federal
official for domestic incident management, is responsible for
coordinating domestic Federal operations to prepare for, respond to,
and recover from biological weapons attacks and natural disasters.
Nonetheless, the task force concluded that the ability of the DHS
Secretary to lead in this regard was hampered not only by the absence
of clear leadership in biodefense, but also by the fragmentation of key
responsibilities both within and outside DHS, among a number of
entities.
The task force recommended both a greater consolidation of
authorities for biodefense and medical response to catastrophic
terrorism to support a more efficient and coordinated federal response,
and also consolidation of a number of preparedness functions that were
fragmented across the department into one directorate. (These
recommendations have now been adopted by the Department and supported
by Congress.)
The Role of the New Chief Medical Officer
Following his second stage review,\4\ DHS Secretary Michael
Chertoff consolidated all the Department's existing preparedness
efforts--including planning, training, exercising and funding--into a
single directorate led by an under secretary for preparedness. Further,
as part of his consolidated preparedness team, he created the position
of a chief medical officer within the preparedness directorate to be
his principal advisor on medical preparedness and lead representative
to coordinate with DHS federal partners and state governments.
---------------------------------------------------------------------------
\4\ See Secretary Chertoff remarks on second stage review at:
http://www.dhs.gov/dhspublic/interapp/speech/speech_0255.xml
---------------------------------------------------------------------------
The chief medical officer and his team, the Secretary has said,
will have primary responsibility for working with HHS, Agriculture, and
other departments in completing comprehensive plans for executing our
responsibilities to prevent and mitigate biologically-based attacks on
human health or on our food supply.
First, let me commend Secretary Chertoff and the Department for
creating the position and those in Congress for supporting it. This is
clearly much-needed and well-founded.
The question is what specific roles will the CMO play.
As I have described earlier, the new chief medical officer faces a
number of challenges that will require urgent attention. I believe if
you consider the breath of responsibilities, however, that his role
should be more one of a Chief Health Officer than a medical officer, as
he must help guide the Department in far more than medical advice, to
include for example navigating health care systems, understanding
disease surveillance, or advising on waste disposal, sanitation and
decontamination.
As described by Secretary Chertoff, the role of Chief Medical
Officer is primarily to provide much-needed leadership at the
Department--and perhaps even more so across the federal government--to
prepare for catastrophic health emergencies, and to provide guidance to
leadership in times of crisis.
In particular, there are four specific areas where clear leadership
is needed today:
1. Leadership in Providing Sound Scientific, Medical, and Public Health
Advice
The chief medical officer should be the principle advisor to the
secretary, providing scientific, public health, and medical advice.
While DHS has responsibility for preparedness and response to
natural disasters, as well as biological, chemical, radiological, or
nuclear weapon attacks--all of which would require a health care
response--biological outbreaks, whether naturally occurring or
deliberate, present a special case. Occurrences of outbreaks are highly
variable and often unpredictable. They can originate from a diversity
of pathogens; they can be naturally occurring or deliberate; they can
crop up in cities of any size; and they can occur among peoples with
wide-ranging customs, social habits and lifestyles. Each of these
factors affect how a disease spreads, and thus, to the extent possible,
must also figure into strategies to detect and halt the transmission of
a disease.
Similarly, strategies for controlling the spread of disease must
rely on the medical countermeasures available, on the ability of our
health care systems to provide services, and on the coordinated support
of a number of federal, state, local, and private sector actors.
Decisions at DHS regarding preparedness and emergency response
programs must be based at a minimum on expert scientific advice; the
epidemiologic features of the disease; and knowledge of resources
available for deployment.
2. Leadership in Developing Greater Situational Awareness
The chief medical officer should be the principle architect for
providing the secretary with greater situational awareness of both
biological threats (threats) and health care preparedness
(vulnerabilities).
The speed at which a public health threat can be detected and
characterized, and health care services and/ or medical countermeasures
deployed is critically important. The faster and more effectively this
is accomplished, the quicker response and containment efforts can be
employed, resulting in fewer casualties.
Situational awareness, both of emerging biological threats and of
health care readiness, requires timely, complete actionable
information--both of our national and the international health
disposition, and of the state of health care preparedness (e.g.,
countermeasure inventories, protective gear, medical and isolation
services available, plans, etc). Greater situational awareness will
allow for better operational decision-making that is critical for
providing early-warning, deploying assets and protecting public health.
This capability, which largely does not exist even within a public
health community, will be critical to effective management of a
terrorist biological attack or a natural disease outbreak whose spread,
taking advantage of modern transportation systems, can be much more
rapid than previously in the past.
3. Leadership in Integrating Federal, State, Local, and Private
Sector Elements.
The chief medical officer should provide a focal point in the
federal government for development and implementation of a national
strategy to protect against biological events.
Homeland Security Presidential Directive-10 (HSPD-10) rightly says
that ``defending against biological weapons attacks requires us to
further sharpen our policy, coordination, and planning to integrate the
bio-defense capabilities that reside at the Federal, state, local, and
private sector levels.'' Who today is ultimately in charge of
developing and implementing the national strategy? Who makes sure that
all of the diverse components of bio-defense--from threat analysis to
research and development of countermeasures, to crisis detection,
response and recovery--are fully integrated? A clearly empowered
federal authority to provide national leadership and a focal point on
the spectrum of issues related to securing America against biological
events is needed today.
4. Leadership Supporting Public Education/Public Preparedness
The chief medical officer, in close coordination with HHS
officials, should establish and lead outreach efforts to educate
citizens on steps to prepare for and protect their health during
catastrophic health emergencies.
Public action in anticipation of and in response to a health crisis
can help mitigate casualties and speed recovery, or it can cause panic
and hasten the spread of disease. Today, the public has little to no
knowledge of when it is appropriate to shelter-in-place versus
evacuate. They have equally little knowledge of the steps they can take
to reduce the likelihood of exposure to disease. The public must be
engaged as a partner, particularly when it comes to protecting the
public health. Individuals empowered with the knowledge to enhance
their safety and help limit the spread of disease, can reduce the need
for admittedly scarce resources to be required for providing health
care to them, when and if an outbreak occurs.
The Special Case of Avian Flu
The increased concern and possible risk of a pandemic flu provides
a special case that urgently calls for leadership in preparing for
biological events.
We have witnessed three pandemic flu epidemics over the last
century, with the 1918 Spanish flu pandemic being the most severe,
causing over 500,000 deaths in the United States and more than
20,000,000 deaths worldwide. Given the disease patterns, historical
data indicate that a new pandemic is likely in the near term.
Recent studies suggest that a rapidly spreading strain of avian
influenza, which has become endemic in wild birds and poultry
populations in some countries, holds great potential of mutating to
cause severe disease in humans and possibly the next pandemic flu
outbreak.
In the past year, 8 nations--the Republic of Korea, Thailand,
China, Vietnam, Laos, Indonesia, and Japan--experienced outbreaks of
avian flu (H5N1) among poultry flocks. More recently Croatia, Russia,
and Greece have also started to see cases of avian flu in birds and
poultry.
There have also been over 100 confirmed human cases reported of
this strain of avian influenza (also H5N1), 60 of which resulted in
death. Of these cases, 91 were in Vietnam, 17 in Thailand (including
one possible human-to-human infection), 4 in Cambodia, and 4 in
Indonesia. With no natural immunity to this strain of influenza, which
differs from seasonal strains of influenza that have traditionally
infected human poulations, humans are vulnerable to a possible-mutated
version of this virus that would be capable of human-to-human
transmission.
By any standard, we are not prepared should a pandemic flu emerge
today.
Vaccines needed to protect Americans would take a minimum of six
months--and likely longer--to develop. Small stockpiles of anti-viral
medication exist, but not in sufficient quantities to protect the vast
numbers of people likely to get sick; and we lack a way of urgently
increasing production in a timely manner. Moreover, our cities, states,
our nation's healthcare delivery systems, hospitals, and managed care
organizations have yet to put together the plans for handling the
dramatic increase in patients, for determining priorities for scarce
resources and augmenting those for which demand will vastly exceed
supply, or for ensuring the delivery of services to the vast numbers of
individuals who may be affected.
Without vaccines or medical countermeasures, the next best option--
perhaps the only option--is to put in place disease exposure controls,
to reduce as much as possible the likelihood that individuals will pass
the disease from one to another.
Disease Exposure Control (DEC) is the process by which the spread
of disease is minimized by limiting contact between uninfected
individuals and other individuals who are potential spreaders \5\ of a
contagious disease. DEC programs could help confront possible large-
scale outbreaks of contagious diseases, in particular when vaccines or
antivirals do not exist, are unavailable, or are insufficient to halt a
fast-spreading disease.
---------------------------------------------------------------------------
\5\ The term ``potential spreaders'' refers to individuals who
either may have been exposed, are incubating, subclinically affected,
or are a carrier of a disease. It also includes individuals with active
disease.
---------------------------------------------------------------------------
DEC programs rely on the use of a number of tools--including
infection control, isolation, community restrictions, sheltering-in-
place, and even quarantine--that can slow down or perhaps stop the
spread of a fast-moving, contagious and potentially deadly disease, in
the absence of sufficient medical countermeasures.
Although vaccines and medical countermeasures are much needed, to
date, unfortunately, too large a fraction of our national attention has
been placed on developing them, and too little on putting into place
those disease exposure control programs that might be our only recourse
for slowing a pandemic flu.
To be sure, we do need medical supplies, vaccines, and antiviral
drugs. We also need to enhance disease surveillance networks for early
warning. And we need plans to prioritize, move, and dispense medical
countermeasures as well.
But in their absence, and with a possible pandemic on the horizon,
the chief medical officer's yet-to-be defined role could be vital in
helping delineate these additional tools and protecting public health
should a pandemic materialize.
National leadership is needed now.
CSIS is continuing to explore these important issues including how
to operationalize disease exposure controls.\6\ We would be happy to
work with the Committee as we go forward.
---------------------------------------------------------------------------
\6\ For more information, see CSIS Homeland Security Program,
Current and Ongoing Projects, Disease Exposure Control at
http://csis.org/index.php?option=com_csis_progj&task=view&id=294
---------------------------------------------------------------------------
Thank you.
Mr. Rogers. That is great. All three of those were very
interesting, thoughtful, and provocative statements, and I am
looking forward to the Q&A interchange after we go vote.
My expectation is that it will be approximately 4:15 when
we come back. At this time we will stand in recess subject to
the call of the Chair.
[Recess.]
Mr. Rogers. I would like to call the hearing back to order
and start off with the questions.
I really was impressed with those statements. They are
better than usual, but particularly provocative. Dr. Lowell, in
particular, when you were describing this new position of
readiness, as opposed to a CMO, tell me more about how you see
that being structured. Just kind of help me get a mental
picture of what you are--the leadership structure of that.
Dr. Lowell. Thank you, Mr. Chairman.
I had proposed four divisions within this readiness office,
one dealing with intelligence, to make sure that we are
consolidating all of the intelligence products from the
different intelligence agencies that deal with medical
intelligence, so that we can both develop policy and plans--
Mr. Rogers. Where is that intelligence component currently?
Dr. Lowell. It is spread out in a variety of different
places, in U.S. Government. It is in DAA. DHS has some at Fort
Detrick and MPACT. It is CIA. There are a variety of different
components to it. DHS also has, at least when I was there, it
was in the DIA IPNIA, but it was disjointed.
Mr. Rogers. Okay. In addition to the intelligence
component, what else? What would be the other three? And then
tell me, would they answer to the CMO?
Dr. Lowell. Yes. All of the medical and health assets, in
my opinion, in DHS should be consolidated in one office,
reporting to one person.
Mr. Rogers. Would anything be pulled from HHS?
Dr. Lowell. That is a good question. I think one thing I
would probably recommend is the stockpile--right now it is in
the CDC, and I am not sure that is necessarily the best place
for it. It probably deserves a separate answer. But right now
that would be the main thing I would move from HHS to DHS is
the stockpile and have that associated with the person who I
think should run the Federal medical response, which would be
the DHS Chief Medical Officer.
The second division in DHS I think the CMO should be
responsible for is preparedness, and that would include--
medical preparedness--that would include a variety of different
programs that currently organically exist in DHS now, such as
MRRS, Noble--you talked about before, the program called
CONTOMS, which is the Tactical Medical Training Center for the
United States, which used to be at DOD; now it is in BTS in
Immigration and Customs Enforcement is where it is located
now--and also to provide the reachback to State and local to
make sure that the Federal medical response is integrated as
part of the response to medical events of national
significance.
Mr. Rogers. Now, as I understand it, before you go to the
third and fourth components, what you are describing is a
readiness department that would answer directly to the
Secretary and would not be under the Preparedness Directorate.
Dr. Lowell. Yes, sir. To me that makes the most sense. I
mean, part of the--the primary mission I think for DHS is to
protect people. And in an event, whether it is from a bad guy
or Mother Nature, people are going to get hurt or they may die,
so I think that the medical and health primacy has to have the
appropriate place in the organizational structure.
The third piece is perhaps the most important. That is the
Federal medical response. Right now the Federal medical
response is the Natural Disaster Medical System, which is a 20-
year old system that was originally designed for natural
disasters, essentially all volunteer. Very few full-time people
work at NDMS. And the people that have been involved in NDMS,
the doctors, nurses and paramedics, and people who have been
volunteering their time for all these years, are incredibly
dedicated Americans and I think deserve a huge amount of
praise. However, it is not enough; it is nowhere near enough.
The size of it really is based on the number of people that
have volunteered to date. I mean, it is not how I think we
should be building our Federal medical response. And it
shouldn't be all volunteer. I mean the size of the Federal
medical response should be based on what missions we are asking
it to do.
So if the goal is to be able to take care of, as some of
the scenarios have been developed, 100,000 people concomitantly
hurt in four different geographic areas for a month, 2 months,
or 3 months, that is the mission. And then we have our planners
say this is what we need to accomplish that mission. We need
this number of doctors, nurses, paramedics, this number of
equipment, this number of logistics, people to get stuff to and
from the place, and that has to be a guarantee that it works,
it can't--we cannot just rely on a volunteer force. No other
piece in the U.S. Government that is so important relies solely
on volunteers.
And then the fourth division is the occupational health and
safety piece. DHS has 180,000 people in it. It doesn't really
have a unified occupation health and safety core in one office.
And there are a lot of people operating, some tactically
operating in a variety of different conditions where they need
or may need medical and health support, whether they are
deployed in a foreign country, they are working at the borders,
or trying to get a flu vaccine. Which is what I was dealing
with last year. I mean, all 180,000 people are very important
to the country, and all needed a flu vaccine, but we didn't
have enough flu vaccine. So we had no real single point of
contact to say this is what the 180,000 people that are
protecting our country need to have in order to get their job
done.
Mr. Rogers. My time is up, but I am looking forward to
coming back around.
The Chair recognizes the Ranking Member, Mr. Meek.
Mr. Meek. I want to thank all of you for your testimony,
and we do have it, and I had an opportunity to take a look at
it. And you got your testimony in before the Department, so if
there is anything to commend you on, that is one of them.
We have had three top-off exercises that have been
sponsored by the Department of Homeland Security. One simulated
an airborne release of the plague in Denver. Another top-off
took place, a dirty bomb in Seattle Washington. There was a
plague attack also in Chicago. And I can tell you that what
these top-off programs, they are sponsored by the Department of
Homeland Security, of course. They ask the Center for Disease
Control to participate, they ask HHS to participate. But this
is when we rehearse how we are going to respond.
But better yet, when you look at the National Response
Program and also a plan, and you look at some statutory
language, it is not necessarily putting the Department of
Homeland Security in the lead. And I don't know if you all have
any recommendations on what we should do legislatively to clear
some of this up, quote unquote, streamline some real line of
responsibility. Because I believe it is going to be like the
baseball game last night; the ball pops up in the air and the
catcher thinks that the infielder has--you understand it, the
short stop has it. And we can't afford that, especially with
these threats that are out there as it relates to bioterrorism.
Dr. Lowell. I will take the first crack at that one.
I agree 100 percent. I think we have--at least my view of
it, there is conflict as to who is in charge, at least with
regard to the medical and health component.
The Homeland Security Act of 2002 transferred over the
Natural Disaster Medical System, the stockpile MMRS programs,
and all of the responsibilities and authorities related to mass
casualty care from the Office of the Assistant Secretary for
Public Health and Emergency Preparedness from HHS to DHS. So I
think in my view, the sense of Congress was that DHS was
supposed to drive the medical and health response to the events
of national significance. That is why the law said stuff was
supposed to move, and the authorities and responsibilities were
supposed to move. I am not sure that everything that was
supposed to move did move, and I don't know if Congress has
ever taken a look at that. But that might be something that
would be worth doing, to make sure that all of the things that
were supposed to transfer over in the Homeland Security Act of
2002 did.
Mr. Meek. Doctor, do you have any recommendations on what
was left that should come over to the Department of Homeland
Security? And it can be the same expertise. I mean, obviously
you are changing the letterhead, but if it comes down to
responding to a Homeland Security bioterrorism attack, folks
don't--we need to not only know who to call, but know who is
responsible.
Dr. Lowell. Well, I agree 100 percent. I think there is
conflict because EFS-8 of the National Response Plan says that
HHS is responsible. So I think there is conflict between the
responsibilities and authorities that transferred over in the
Homeland Security Act of 2002 and ESF-8 of the National
Response Plan.
Also, HS PD-10, Homeland Security Presidential Directive
10, also says that HHS is responsible or has the lead for
medical and health response of mass care. That also I think is
in conflict with the Homeland Security Act of 2002, at least
the spirit of what Congress--at least my interpretation of what
the spirit of Congress wanted. So that I think those need to
get reconciled.
I think getting back to your original question, I think a
very important thing to do is figure out who is in charge,
because you have asked several times in this hearing--it is not
in my mind at least, and I think in many others, clear who is
in charge. And if it was to me, I would make the CMO in charge.
I would make that person the Operational Surgeon General of the
United States and leave public health issues to the Public
Health Surgeon General: Lead paint, stop smoking, lose weight;
and have the medical response to events of national
significance the responsibility of the DHS CMO.
Mr. Heyman. Just a couple of points to follow up on that
question. One is that the CMO has got to be broader than just
medical. It is health--as you heard from the testimony this
morning, you have got health care systems involved, you have
got disease surveillance, you have got agriculture and food
concerns. When we are talking about crisis in America and
homeland security and all things bio, it is much broader--waste
disposal, sanitation, decontamination--all of those things need
to be factored into it, so it is not just medical. And maybe he
or she should be responsible for operational management during
a crisis.
I would recommend that--if you look at HSPD-10, it
distributes the responsibilities and roles across the
government, but it doesn't tell you who is in charge of
managing strategy, reiterating strategy or making sure it is
being implemented, and I think you need a higher role for that.
And I am not sure it is CMO, but if it could be anybody,
perhaps him.
Finally, I will just make a recommendation to Congress,
this committee, other committees, Homeland Security and health
committees could join together, perhaps Agriculture, and have a
joint hearing with USDA, HHS, DHS and ask those questions about
who is in charge and walk them through the different scenarios
you are concerned about. I would like to see those witnesses
clarify that in front of you.
Mr. Moore. Mr. Meek, my position on this is simply that I
echo my copanelists here. It is unclear, it is ambiguous I
guess is the way I would put it. And the expectation is things
will happen, and when the expectations aren't met, aren't
managed, in essence chaos ensues.
One of my recommendations is that you form or compel these
agencies to sit down and work through when are you in charge,
what are the specific timelines and trip wires that will have
to be navigated for these things to occur.
You run the risk, of course, if you lump everything into
DHS, you have one Federal agency and that's all you have got.
You have to go through some type of unified command structure
like you have in an incident command system when you roll up to
one organization being in charge, how do the other
organizations statutorily roll in and what their roles and
responsibilities are.
One of the difficulties you have I think before you, one of
the challenges--I guess I better say it--is this: Homeland
Security understands that it has got a mission to protect
America from terrorism and bad things. Agriculture has a
mission to regulate and ensure safety of food and all these
other kinds of things, and terrorism as well. So you have to, I
believe, establish a clear mandate of what is the anticipation,
what are the expectations, what is the guidance from Congress
as to how they are supposed to apply funds and what results you
want.
The saying in science is the less the data, the more it is
speculation. If you give them money and expect them to do good
things, you need to have a way to check that. One of the ways I
think is--and one of my complaints, I guess, with the top-off
process, it is very valuable but the frequency was too
infrequent. It happens episodically every 2 years. We need to
be measuring more effectively on a smaller scale, more rapidly,
so that you have the ability to adjust course more often to
meet the needs. Otherwise, what it turns into is, in essence, a
large dog-and-pony show, that everybody doesn't want to look
bad and they try to massage the answer, as opposed to what is
exactly going on and where do we need to step in to fix the
problems. More non-attributional and more action-oriented, that
would be my point.
Dr. Lowell. Thank you, sir. There are, I think, two other
things that I think should be discussed on the topic of who is
in charge. When you have two different agencies that are in
charge, parallel systems will be built. And right now parallel
systems are being built both at DHS and HHS, and I think we run
the risk of creating interoperability issues within U.S.
Government on our watch, which I think would not be a good
thing and certainly would not be in the best interest of our
country.
And the second point is, I think it is very important to
decide up front who is going to talk to our country, who is
going to be the person that does the risk communication, both
before the event, as well as during and after the event;
because I think adlibbing that also would be a bad thing.
Having three or four different spokespersons in various
departments in the U.S. Government, which may or may not be
giving the same message, I think could be disastrous.
Mr. Rogers. I would like to go back and talk about who is
in charge of vaccines. You made reference to it a few minutes
ago. Who do you think should be--I would ask each one of you to
give me your answer to this--who should be in charge of making
sure that we have adequate stockpiles of vaccines and other
medications that would be necessary in the event of a pandemic
outbreak? Should that person be over at HHS, should that person
be at DHS or at the White House, or some other place? Dr.
Heyman, if you will start.
Mr. Heyman. The question of what to stockpile should be a
decision that is made amongst a number of agencies, so there
should be a Federal task force of sorts that is responsible for
making that judgment.
Who owns and operates the stockpile, in my opinion, should
be at this point now DHS. The Department, because the stockpile
would be used for dealing with catastrophic events perhaps or
response to large-scale events like a hurricane, stockpiles
today can include things like bandages and such. And since that
is largely a DHS or FEMA response requirement, I think it
should reside there.
Mr. Rogers. Dr. Lowell.
Dr. Lowell. I would advocate consolidating all this in one
department and putting it in the same place that has the
intelligence, just figure out what we should buy, and then
having the detectors out there to tell us where in real time we
should be.
Mr. Rogers. I am interested in who should own it. Who
should be the person that is responsible for making sure that
if we do have a task force that decides we need X, Y, and Z
vaccines or medications, that it is done, and that person is
who you roll up to and say where are they at this time?
Dr. Lowell. I am not sure of the answer to that. I think it
makes good sense to put it in the same department that is
making--that owns the primacy for the determination piece. And
I think that would be DHS, but I am not exactly sure.
Mr. Rogers. Okay. Mr. Moore.
Mr. Moore. Mr. Chairman, I would advocate that you have, in
essence, a single belly button inside of DHS that would
probably have to be, as we talked about today, the CMO. But the
CMO can't be buried down the organization. That individual has
to have the ability to have the authority and carry the weight
and execute.
Mr. Rogers. I was surprised to hear it from Dr. Runge, but
you may not have been surprised, when he said he has nothing to
do with whether or not we have enough vaccines or what we buy.
Were you already aware of that, and if not--
Mr. Moore. I was aware of it, sir. It is disconcerting is
the way I would put it, because we all have a role in this, and
we need to determine how this is going to function. I mean,
obviously it affects everyone in this room because if we have a
pandemic, this individual is going to have enormous
responsibilities. And to use Mr. Meek's analogy, we don't want
the pop-up to be dropped because we are assuming the other
fellow or other individual has the beat on it.
The other thing I would like to point out about strategic
stockpiles, the concern that I found following Katrina is the
stockpile isn't a stockpile. I assumed there were warehouses of
trucks ready to roll with materials available at a moment's
notice. Apparently there have been decisions made, as I
understand it--perhaps Dr. Lowell will have better information
than I--but the understanding that I have is the stockpile is
basically 10 percent loading and the rest of it is vendor
inventory management, we-will-get-to-you-when-we-get-to-you
kind of thing, as opposed to being at a moment's notice.
In response to Hurricane Katrina, there were calls for the
strategic stockpile to be released, and they were preparing for
warehouse loads of materials showing up, and what they got were
two trucks, and the rest of it was coming days later.
I would argue, sir, that having a single person involved
and then you go exercise and hold that person accountable for
the results of those exercises is probably the easiest way to
understand if we are prepared or not. Right now it is so spread
out that you are not going to get any leverage. One person will
say it is Dr. Lowell's, the other will say it is so-and-so's
responsibility. It needs to be unified in one location, sir, if
we are going to have any kind of positive reaction in a rapid
manner.
Mr. Rogers. And your initial thought is that that person
should be in DHS and may or may not be the CMO?
Mr. Moore. Yes, sir. That is something this committee will
have to discuss. You need a body, whether that is a CMO, or
something above the CMO or Assistant Secretary or Deputy
Secretary, I don't know. That is going to require some good
thought. However, it needs to be a single body.
In the military sense, where I came from, sir, you had to
know that you work for one individual. You had to know that
when he told you to do something or when she told you to do
something, it was an order, it would be carried out. What
concerns me, quite frankly, is if the stockpile is in one
agency's arms and they are responsible for preparing and
maintaining it, and yet I have got the ability over here to
pull the trigger to deploy it, what I am anticipating they have
done may not have occurred, and yet I have no control over
their actions. And so that is to me, that is a recipe for
heartbreak.
Mr. Rogers. One of my concerns after this morning's
testimony or--early afternoon's testimony--when I was talking
with Dr. Runge about it--which is why I was particularly
interested in Dr. Lowell's suggestion--I was talking to him
about who is responsible for coordinating or who has authority
over these different department heads and functions because in
Secretary Chertoff's letter, it says that the CMO would be
responsible for coordinating these responsibilities. And when I
read all these directives that outline these different
responsibilities, it was my impression that the CMO would be
the head guy that would be pulling resources within HHS, but
from hearing Dr. Runge, that is not the case. And it leads to
what you referenced, which is this ambiguity out there.
And what I can't stand about many of the circumstances we
find ourselves in, in Washington is when there is one guy
saying oh, you have to go to HHS for that, and then you go to
HHS and they say, you have to go to DHS for that. It always
allows finger-pointing, and that is why I am so interested in
seeing a single individual. When it comes to this purview, we
have got one person who is in charge and there is no finger-
pointing. The finger is pointed at that person.
So what you have suggested I think has some merit, and I
know we will be paying some more attention to it.
But before I let you all go, I wanted to go back to
something that Mr. Moore mentioned earlier, and that is this
issue of losing 50 percent of our veterinarians. Over what time
period was that?
Mr. Moore. Sir, within the next--before fiscal year 2007,
you are scheduled to lose--well, 50 percent of the Federal
workforce in total, sir, is eligible to retire. And most of
your veterinary population is older than the minimum retirement
age. And the forecasts that I have seen range anywhere from 50
to 60 percent of your field veterinary force that is out there
on the preharvest side--that is the Animal Health Inspection
Service component--is scheduled to go away. It is alarming
because of the skill.
You know, avian flu is new to a lot of members of this
committee perhaps because of its topical nature in the news,
but avian influenza is something that the agricultural
community has dealt with for 25 years on a recurring basis
because it occurs naturally in foul and poultry. It becomes
alarming from the health standpoint because it can sometimes
jump over to humans and mutate. And yet our youngest foreign
animal disease diagnostician, those that are specially trained
to deal with these things, is 11 months and change away from
retiring. And that is hard thought experience, sir. If you want
to ask me what keeps me up at night, that is what scares me.
Mr. Rogers. What is your proposed remedy?
Mr. Moore. Sir, I think there are two or three things that
need to be done. One is we need to engage the--there are a
couple of levers that this committee may have some ability to
influence. One is that all veterinarians that graduate from
veterinarian school, approximately 3,500 to 4,000 each year
from the 28 veterinary schools, almost 95 percent of them
obtain a Federal health accreditation certification, basically
the ability to write health certificates to move animals across
country, across State lines around the world. Right now, that
is a lifetime accreditation. I know the USDA is looking very
diligently at how to restructure that to make it a recurring or
a renewable kind of a process.
One of the things that needs to happen is these schools
need to be brought into the training focus to prepare these
veterinarians to deal with all sorts of calamity. So that is
one way you can do it. You can tie it to their ability to get a
health certificate, ability to write that health certificate;
they have to have these kinds of training. That is one.
Two, there needs to be a dedicated program to capture best
practices from these individuals. We have learned a lot. Why
reinvent the wheel and have a steep learning curve every time
we go to resolve the problem?
The third thing, sir, is we need to look at how we are
going to incentivize and try to attract the best and brightest.
Right now statistically within the veterinary community, 85 to
89 percent of all veterinary graduates go into small animal
practice. It is lucrative, it is a business, we all understand
that. Therefore, public health or public service kinds of roles
are diminishing.
We are requiring these people--we need these people, so we
are going to have to come up with a way to incentivize or
absolve a school debt or something to try to get them into
these roles that we need them to be in.
Quite frankly, Mr. Chairman, my concern is that the window
of vulnerability is open. With these retirement waves, that
sash will rise higher and the actions, I think, of this
committee are going to determine whether that sash remains in
an elevated state for 2 or 5 or 10 years. And with that, sir,
will go our vulnerability to basically all infectious disease
agents.
If you look at the category A, B, and C agents that the CDC
worries about, 75 percent of those are zoonotic, meaning they
can reside in animals and humans. We have to look at this as
one medicine. That is why I really endorse what Dr. Lowell has
espoused here today, because the way to do that is to unify the
command structure, the command structure that must respond. And
that is DHS, as this committee and Congress has mandated.
So that is what keeps me awake at night. So those would be
the off-the-cuff suggestions that I would recommend.
Mr. Rogers. Okay. And I appreciate that. What I would ask
is, is there something that I didn't ask about or one of the
Members didn't ask about that you really want to make sure is
on the record before we adjourn? Any of you?
Dr. Lowell.
Dr. Lowell. I think as a country we need to come to grips
with the fact that we do not have a rigorous, robust Federal
medical response to events of national significance, and our
reliance on volunteers isn't going to get us where we need to
get. And I think we need to rapidly look at building one,
building a professional medical Federal response system. It
could be mirrored after one of the existing ones that DOD has,
the Medical National Guard or Air Medical National Guard. But
we need to have organic medical assets that are under contract
to the government, and when we call them we know that they will
come, and that they are not volunteers. And this is going to
take a substantial amount of resources to get us there. But we
are so far away from where we need to be.
And we deployed, in Katrina, all of our assets. And the
actual number of people that were significantly hurt in
Katrina--while many, many people were taken care of--but the
number of actual people that were hurt by the storm, relatively
small compared to some of the scenarios that have been planned.
And it is likely--
Mr. Rogers. When you say scenarios that have been planned,
are you talking about pandemic or bioterrorist attack?
Dr. Lowell. I am talking about the planning scenarios that
came out of the White House Security Council, the 15 planning
scenarios.
And the number of people that were hurt and taken care of
in Katrina would likely also have to be dealt with in many of
those planning scenarios. But the delta of people that are hurt
either in an explosion or nuclear device or some sort of fire,
earthquake or something, would be substantial. And we threw
everything we had as a country at Katrina, so there is nothing
left.
So that what I would propose is some sort of uniformed
medical corps, a weekend a month, 2 weeks a year, which would
include both full-time as well as Reservists as well as
volunteers. But we cannot as a country rely solely on the
volunteer system that was designed 20 years ago to deal only
with natural disasters. Now we deploy for national special
security events, and we have all kinds of technological things.
And we are now starting to recognize that Mother Nature may be
a lot worse in terms of its ability to injure people than we
had originally planned 20 years ago.
Mr. Rogers. Thank you. Mr. Heyman, Mr. Moore.
Mr. Moore. Mr. Chairman, one thing I think that Dr. Runge
talked about was the ability for public information, what the
public should do.
One of the things I think that has to be broached, and I
don't know what branch of the government will do that, what
leader will do that, but the Federal Government is not a
panacea. We are not going to have instantaneous response to
disasters, particularly if they are bicoastal; and burning like
wildfire, we are going to have a lag period. My advice to local
responders has been plan; plan on the fact that you will not
have Federal assets available to you. You must be able to
respond with what you have for an extended period of time.
Subsequently, American citizens need to understand it is
their responsibility as well to be prepared, not alarming, but
be prepared. We have to do a better job at communicating that.
Telling somebody on the eve of the storm that they need to have
3 or 4 days' worth of food and water. It checks the box, but it
doesn't meet the moral requirement of leadership in my opinion.
If we have something that erupts within our agriculture sector,
our leadership of this country may be faced with the fact we
may have to shut down large portions of interstate commerce
just to get our arms around some diseases that are burning.
As a result, sir, you know the average city in the United
States has less than 5 days' food supply on hand. The world's
largest purchaser of food right now is Wal-Mart. If we are
relying on this system to be effective and have continuity of
operations at every component of our civilized society, we need
to tie our citizens into this and give them the no-kidding
advice of what they need to do, not just duct tape, but here is
how you build a kit, this is why you need a kit, this is how
you keep an inventory; because otherwise we are going to see
chaos ensue if we have a problem. And we have seen parts of
that. And probably the meltdown point, Dr. Lowell has probably
seen it better than anybody else, is probably 48 hours before
we see society become unglued.
So we need to have this whole piece tied together. So that,
I think, is the public campaign message that needs to get out
while we are busily trying to repair and fix and build what we
need to have, what we would like to have from the Federal
response side.
Mr. Rogers. Well, I thank all of you. This have been some
very informative presentations and Q and A, and I really
appreciate that.
I do want to remind you that the record is kept open for 10
days. Because of all the markups going on, Members are going to
have questions I know they will submit to you. I would ask you
to respond to those in writing in a timely manner.
Also, I would like--I am going to ask for unanimous
consent--I know I am going to get it--to include in the record
a statement from Auburn University that discusses Auburn's work
on a computer program model to do what you were just talking
about: to allow people to go through exercises, real-time
exercises to find out if we have the ability to respond
medically and in other ways to whatever the disaster might be.
So, since I did get unanimous consent, that is now in the
record.
[The information follows:]
For the Record
Prepared Statement of Dr. Michael Moriarty, Vice President of Research
Auburn University
Mr. Chairman, Members of the Committee, thank you for the
opportunity to present testimony on vaccine technology that can prevent
the spread of avian influenza in birds and the potential impact of
avian influenza on public health and the U.S. economy.
Vaxin Inc, with Auburn University, has developed vaccine technology
that allows it to produce influenza vaccines in large-scale cell
culture and can rapidly address genetic shifts in influenza viruses
including avian influenza. Working with Auburn University, this
technology has been shown to elicit specific antibody responses to
chickens in ovo and other routes, with the development of very high
serological titers. Once this vaccine has been demonstrated to be safe
and efficacious, it can be used to prevent avian influenza in the
poultry industry. Such a vaccine can be expected to interfere with the
potential spread of avian influenza strains into man, having a
significant impact on public health. The effect on the U.S. Poultry
industry would preserve both domestic and foreign markets.
Introduction
Recent reports from Southeast Asia concerning the transmission of
avian influenza from birds to man have caused alarm in both the public
health circles and in the poultry industry. Although the transmission
rate of avian influenza is very low, the virus is highly pathogenic in
man. The number of deaths has been few (108) while the mortality is
extremely high at over 50%. There is a public health concern that
through genetic reassortment between avian and human influenza strains,
this virus may acquire the genetic potential of infectivity (spreading)
from man to man, raising concerns about a potential pandemic that would
equal or exceed the flu pandemic of 1917-18 that killed from 50 to 100
million people world wide.
In 1997, an outbreak of H5N1 avian influenza in people in Hong Kong
caused alarm because people did not have immunity to this virus and
appropriate vaccines were not available. This outbreak led to fears
that the control of an H5N1 influenza virus pandemic would be difficult
to maintain by quarantine if the virus evolved to be transmitted from
chickens to man and from man to man. Prevention of infection by
immunization with vaccines prior to virus exposure is highly
desirable--for both man and chickens. Current methods of preparing
conventional inactivated vaccines against infections in man have
serious limitations. Both live and killed vaccines for chickens also
have significant drawbacks.
This avian influenza virus (H5N1) strain has long plagued the
poultry industry in various countries. In the USA, outbreaks in
chickens have been traditionally addressed by test and slaughter
methods. Once the disease avian influenza was diagnosed, federal
officials moved in, quarantined the area, and slaughtered all of the
poultry within a given radius of the initial infection. This
eradication procedure has cost U.S. taxpayers hundreds of millions of
dollars in the past two decades.
Vaccination has not been attempted in large measure because use of
existing killed avian influenza vaccines makes diagnosis of infected
birds difficult. This lack of differentiation interferes with
eradication efforts. The vaccine contains the same antigens as the
infective virus so that an infected bird cannot be differentiated
serologically from a vaccinated bird. Live recombinant vaccines are
based on a natural vector (fowl pox) to which the egg laying chickens
are immune and maternal antibodies interfere with this vaccine in newly
hatched chicks.
Almost all birds are susceptible to avian influenza. Migratory
birds are the chief carriers and spreaders of the infection. It is
imperative that all reasonable means of preventing the establishment of
this disease or its spread in the USA be pursued.
Significant Issues
Homeland Security has the charge to protect the United States
against unwanted foreign invaders--and that includes biological
invasion. The economic power of the poultry industry is based in the
Southeastern United States. This industry addresses domestic
production, use, and broiler export markets. According to the Economic
Research Service of the USDA (current web-site, updated Oct. 18, 2005)
the retail equivalent of the broiler industry in the US was $43 billion
in 2004. The top five producing States are all in the Southeast; these
are Georgia, Arkansas, Alabama, Mississippi and North Carolina.
Without proper control or prevention, an outbreak of avian
influenza in these States would be an economic disaster to the broiler
industry, while raising the possibility of transmission to man causing
pandemic influenza.
The Technology
Conventional flu vaccine technology: Most influenza vaccines
require that the influenza virus be adapted to grow in eggs. Once that
adaptation has occurred, the virus is propagated in embryonated eggs.
Fertile eggs are incubated for about 10 days, then the virus in
injected into the egg. The virus is allowed to propagate for 3 days,
after which the embryos are killed and the virus harvested. One dose of
vaccine requires approximately one egg. Sometimes the virus is to
pathogenic and virulent and cannot be adapted to eggs. It kills the
embryonating eggs before the virus can be propagated. Outbreaks of
avian influenza in the chickens producing the eggs for vaccine
production could significantly limit the availability of influenza
vaccine for humans in any given year.
Vaxin's technology: This technology has all the features needed for
rapid production of a safe and efficacious avian influenza vaccine. The
vaccines produced are non- replicating; impart an immune profile that
allows the vaccinated bird to be differentiated from an infected bird;
manufactured in tissue culture in 3 days; and can be administered by
various routes. Vaxin has developed a rapid method of making
recombinant constructs using a proprietary technology that allow
recombination of the selected gene(s) taken from the influenza virus.
To produce non-replicating vectored vaccines usually takes several
months of selective recombination to obtain the recombinant virus that
can be used as the vaccine. Vaxin can do this in one month.
The novel aspect of this application to birds is that the vector is
a human viral strain of adenovirus. The tissue culture cells upon which
the virus is replicated during manufacturing are genetically engineered
human cells that allow the virus to replicate in a defective manner so
that it cannot be transmitted among vaccinates nor can it contaminate
the environment. The gene inserted into the vector is a single gene,
the hemagglutinin gene (HA) from the avian influenza strain H5N1.
Auburn University has demonstrated that this non-replicating
adenovirus vaccine can be administered to chickens via a variety of
routes, resulting in antibody titers. The data presented in this paper
focus on the injection of the vaccine into the embryonating eggs,
resulting in immunity to the newly hatched bird. Serological data
obtained from birds vaccinated in ovo were derived by the USDA
Southeastern Poultry Laboratory in Athens, Georgia from serum submitted
by Auburn University.
Experimental Techniques and Results
Adenovirus Recombinant Construction was performed in the Vaxin
Laboratory using rapid methods for adenovirus recombination.
Techniques
Summary of Results: Preliminary results using the replication-
defective adenoviral-vectored influenza vaccine containing the human
influenza virus hemagglutinin gene by topical delivery have
demonstrated protection against a lethal influenza virus challenge in
mice, and antibody response in chickens, rabbits, monkeys and man.
Advantages of this novel replication defective adenovirus influenza
vaccine containing the avian influenza hemaggultinin in chickens
include the feasibility for large-scale administration; the fact that
vaccinal immunity can be differentiated from that of an infected bird;
and that the vaccine will not replicate in the bird.
Results--Preliminary Studies--Using Vectored Influenza Vaccine
Designed for Man
Trial 1: 100ml of the construct (1.3 x 107 pfu/ml) including the H1
hemagglutinin gene of the human influenza strain (A/PR/8/34) (H1N1) was
administered into nine 2-year-old hens via the nasal and ocular route.
Sera obtained at 13 days post inoculation showed two hens with
hemagglutination inhibition (HI) titers of 1:16 and 1:8 against human
influenza strain A/PR/8/34. Remaining hens maintained an antibody
negative status.
Trial 2: A construct containing the H3 gene of human influenza
strain A/Panama/2007/99 (H3N2) was inoculated into three 4-week-old
chickens via the intramuscular route.
All three chickens seroconverted achieving HI titers of 1:512.
Trial 3: The same Ad-H3 construct was inoculated in ovo at days 10
and 18 of incubation. Hatched chicks were bled at day 15 of age and
tested for seroconversion.
All chickens showed HI titers between 1:8 and 1:16 against A/
Panama/2007/99.
Results--Avian Influenza Studies
The HA gene of avian influenza strain A/Turkey/Wisconsin68 (H5N9)
(TK/WI/68) (genes kindly provided by Dr. D. Suarez, USDA SPRL) was
inserted into the adenovirus vector. The recombinant vaccine was
manufactured at Vaxin and sent to Auburn University for testing.
The following inoculation or vaccinations were administered into
eggs that were being incubated. Serological titers were determined 28
days after the chickens had hatched.
Group 1--in ovo vaccination at day 10 of incubation
In this group of newly hatched chickens, a single vaccination in
ovo resulted in seroconversion in all of the birds (12) with 11 of the
12 showing high titers. The mean titer for this group was between 4 and
5 log 2. The sera from which this data was obtained were sent to the
USDA Southeastern Poultry Laboratory for analysis in order to obtain
impartial results. It was surprising that a single inoculation of a
recombinant human adenovirus containing the gene encoding the
hemagglutinin gene from the avian influenza strain H5N9 could transfect
the tissues of the chicken, producing sufficient antigen to elicit such
a strong immune response, especially when inoculated at such an early
stage of embryonation.
Group 2--in ovo vaccination at 18 days of incubation
In this group of newly hatched chickens, a single vaccination in
ovo resulted in seroconversion of all sixteen (16) of the birds with 15
of the 16 demonstrating high titers. The mean HI titer for this group
was above 5 log 2. Again, the sera from these birds were sent to the
USDA Southeastern Poultry Laboratory to obtain impartial results. The
titers from the birds in this group were higher than those in Group 1,
suggesting that the positive serological response to the same vaccine
is stronger as the length of embryonation increases prior to
vaccination.
Conclusions
It is generally accepted in the avian influenza vaccine community
that high HI titer against the HA antigen will protect birds against
infection. The titers presented in these studies suggest outstanding
flock immunity. These data are exciting in that they demonstrate the
potential of using vaccination in ovo to protect the US poultry
industry against infection with this troublesome virus. By vaccinating
in the egg, those who handle the birds in all levels of processing will
also be protected against exposure to these potentially lethal viruses.
The mechanism to administer egg vaccination robotically already is in
use in the poultry industry.
The NIH has awarded Vaxin Inc. a $3 million grant to develop a non-
invasive vaccine against the avian influenza. The collaboration between
Vaxin and Auburn University has produced data that must be assessed
further in challenge studies using secure facilities and by
manufacturing the vaccine in large volumes for widespread
administration to poultry. This endeavor should be funded at a level to
allow our important collaboration to implement its findings. We believe
that all reasonable means should be undertaken to get the next
important and critical steps funded to complete initial challenge
studies in a high level secured containment environment, and
simultaneously to make proposals for the next levels of funding
necessary to prepare the vaccine for proliferation in America.
Thank you for the opportunity to present this testimony.
Mr. Rogers. And I want to thank you for your time. I know
you all are busy, and it was very generous of you to come here
and share your thoughts with us. And at this time this hearing
is adjourned.
[Whereupon, at 5:02 p.m., the Subcommittee was adjourned.]
A P P E N D I X
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Questions and Responses for the Record
For the Record
Committee's Additional Questions to Jeffrey A. Lowell, MD, FACS
1. Domestic Surge Production Capacity for Modern Smallpox Vaccine
Given the stated purpose of the CMO, how should the CMO coordinate
with HHS to ensure the timely implementation of domestic surge capacity
programs for necessary biodefense countermeasures?
The DHS CMO responsibilities for nation biodefense programs should
be to provide the leadership and coordination of the relevant federal
partner agencies (Department of Health and Human Services, Defense,
Veterans Affairs, Agriculture, State and Justice, the Intelligence
Community, etc.) in developing and executing the essential pillars of
the national biodefense program--assessments, critical infrastructure
protection, attack warning, attribution, response and recovery, and
risk communication (Homeland Security Presidential Directive-10). The
Secretary of DHS is the Principal Federal Official for domestic
incident management and is responsible for coordinating domestic
Federal operations to prepare for, respond to, and recover from
biological weapons attacks or disease outbreaks. The CMO is the senior
advisor to the secretary for medical and health affairs, and as such
should lead the effort to coordinate with the respective heads of the
other Federal departments and agencies to effectively accomplish this
mission.
The role of the CMO should be to lead and coordinate the USG multi-
agency effort to create policy and guidance that assures the nation has
a clearly articulated mission and executable biodefense plan. Each
participating USG department and agency should have clearly defined
roles/responsibilities and performance metrics which are defined in the
operational plan.
2. Development of Next Generation Technologies for Pandemic Flu
Preparedness
Is the Federal Government considering new technologies--such as
biotechnologies--that can cover a broad spectrum of flu strains and
enable mass production, on demand?
Numerous programs and agencies are currently engaged in addressing
this issue which includes: NIH/NIAID; DAROA/DSO Unconventional Pathogen
Countermeasures Program (http://www.darpa.mil/dso/thrust/biosci/
upathcm.htm); other offices in DOD, coordinated by the Deputy Assistant
to the Secretary of Defense for Chemical and Biological Defense; and
USDA.
What should be the role of the CMO in working with HHS to identify
and support the development of such new technologies?
The CMO should chair a multi-agency panel, which includes
participants from the Departments of Defense, Energy, Agriculture,
Veterans Affairs and Health and Human Services (NIH/NIAID and CDC) to
address these issues--both materiel and doctrinal.
3. Noble Training Center
1.(A) Do you believe the Noble Training Center is currently being
utilized effectively? If not, how would you increase its usage and
expand its programs?
Noble Training Center is a tremendous national asset that has most
recently been utilized primarily for training of emergency managers and
healthcare professionals. The Noble Center portfolio should also be
expanded to serve as a test bed for developing new technologies
(applied research and beta testing), new techniques (injury treatment,
protection of health care personnel and facility protection,
communications, HVAC operations and decontamination systems) and new
doctrine. Going beyond teaching current dogma, Noble should also have
the role of the Nation's learning lab--developing and testing new and
novel materiel and response techniques. To enhance these efforts, the
Noble Center should work closely with HSARPA and the Department of
Defense. In addition, the Noble Center should work with national
healthcare governing and licensing agencies (e.g., JCAHO, American
Hospital Association, American Medical Association, etc. . .) to
establish national training and response standards. In addition, the
Noble Campus might be considered for expansion as the primary base and
headquarters for the National Disaster Medical System. This could
significantly strength both programs. This campus might also be
considered as a home for national Emergency Medical Services (air and
ground transportation) programs--technologies, techniques and doctrine.
Though should also be given to evaluating whether Noble could be used
as an actual, functioning medical care facility, in the vent of a
national critical event, in which hospital surge capacity is needed.
(b) What training needs in the emergency medical community can you
identify that the Noble Training Center currently is meeting and could
meet if its programs were expanded?
Noble currently provides training for a cooperative local response
to a disaster in a medical facility. There are substantial
opportunities to expand the role of Noble to include: evaluating and
testing new technologies, techniques and doctrines; providing training
for the integration of the local, state and federal response; serving
as a home for national EMS programs; and, serving as a home for the
National Disaster Medical System, and the federal medical response
programs.
(c) How do you think this (the location of the CMO and Noble in the
new Preparedness Directorate) will impact the functions and
coordination of these entities with other medical preparedness programs
and resources in the Department.
As I have testified before the committee, I believe that all DHS
medical/health programs--Intelligence (e.g., National Biodefense
Analysis and Countermeasures Center (NBACC), BioWatch, etc. . .), NDMS,
Preparedness (Metropolitan Medical Response System (MMRS), Counter
Narcotics and Terrorism Programs (CONTOMS), etc. . .) and Mission
Support (e.g., medical logistics, commuications, information
technology, facilities and resource management and force health
protection (occupational health and safety), and risk communication)
should be consolidated into one Office, under the direction of the CMO.
The primary reason for this is to ensure, at a policy level, that these
various programs, as well as other complimentary ones in other agencies
and Departments, function in concert and in a coordinated manner.
Timothy E. Moore Responses to the Honorable Mike Rogers Questions
1: Domestic Surge Production Capacity for Modern Smallpox Vaccine
``Given the stated purpose of the CMO, how should the CMO
coordinate with HHS to ensure the timely implementation of domestic
surge capacity programs for necessary biodefense countermeasures?''
At present, I am not entirely certain as to the specific role of
the CMO. I am aware that the Department of Health and Human Services
serves as the primary lead agency on matters pertaining to domestic
surge production and capacity. Furthermore, with the advent of the
``Bioshield Program,'' which was developed in a coordinated manner
through Centers for Disease Control (CDC) and through the HRSA grant
process by which funding was supplied to state and local entities to
perform wide-spread vaccinations and delivery of prophylactic
medications in times of need, there appears to be a strong center of
gravity within HHS regarding this matter. Thus it would seem most
appropriate that the CMO meet with the leaders of these programs and
serve as a coordinator to ensure that DHS is fully aware of all
developments involving surge vaccine development, as well as surge
medical support. This should be done with the intent of seamless
interaction between these agencies in a time of crisis so that the
federal government speaks with one voice. I believe that one area that
the CMO can directly influence is in regards to development and
evaluation of major training exercises involving medical surge capacity
and the ability to project medical resources at a given time and place.
In this manner, the CMO can serve as an ``external'' evaluator of the
condition of readiness for large scale incidents requiring medical
surge. Other suggested roles for the CMO would include:
Assist in the development of the partnership of DHS
and HHS utilizing the Exercise division of Grants and Exercises
under the new DHS Preparedness Directorate. Incorporation of
field exercises by DHS HSEEP guidelines would allow local and
state authorities to test the plans to ensure their viability.
The role of the CMO would be to facilitate that interaction.
Work to coordinate DHS medical assets such as the
National Disaster Medical System and the Metropolitan Medical
Response System into the planning and execution of these plans.
2: Development of Next Generation Technologies for Pandemic Flu
Preparedness
I respectfully defer this matter to HHS/NIH, as well as to the CMO
and Secretary Chertoff.
3: Noble Training Center
1. A. Do you believe the Noble Training Center is currently being
utilized effectively? B. If not, how would you increase its usage and
expand its programs?
A. NO. As you stated in your question, the Noble Training Center
(referred to as ``Noble'') is truly a unique facility in the nation and
with the possible exception of the ER 1 facility (formerly D.C. General
Hospital), it is an intact hospital facility which can be utilized as a
field test site for training and technology development pertaining to
healthcare response to catastrophic, all-hazards events. It is unique
in its setting and physical location in close proximity to the US
Department of Homeland Security's Center for Domestic Preparedness and
the abundant unencroached property opportunities the old Fort McClellan
affords.
Response: B. I believe that there is a glaring need for curricula
to be developed or revised for healthcare and public health personnel
as it pertains to the medical response to mass casualties, terrorism,
WMD and naturally occurring events (e.g. Hurricane Katrina) which
prepares both those in the practice of healthcare delivery and those
professionals and paraprofessionals in training to meet the demands of
response.
I understand that currently work is in progress by the Office of
Grants and Exercises spearheaded by one of its training partners, The
University of Texas Health Science Center-Houston's Center for
Biosecurity and Public Heath Preparedness, that is based upon a
training matrix and needs assessment which was begun earlier this year
in the revision of the Target Capability List (TCL). The Senior Medical
Advisor to the Center for Domestic Preparedness (Dr. Mike Proctor) is
assigned to this position from the University of Texas HSC and works
very closely with the Office of Grants and Exercises who provide his
direct taskings.
A concept paper is currently in preparation which outlines a
program and process to revise current training offerings and develop
new training and educational offerings which will meet the needs of
healthcare delivery as well as augment the offerings of HHS / CDC/ HRSA
in preparing the Public Health sector to respond in all-hazards events.
Plans are to further utilize current DHS training partners and enlist
the assistance of new partners as needed as well as the healthcare and
public health professional organizations and entities. This program
would well benefit the merger of the Noble facility with the CDP to
fully encompass First Responder training as outlined in HSPD 8.
2. What training needs in the emergency medical community can you
identify that the Noble Center is meeting and could meet if its
programs were expanded?
A: The current Noble Training Center healthcare educational
offerings are follows:
B960--HEALTHCARE LEADERSHIP COURSE
FEMA Health Care (HC) MEPP Series--NEW FOR FISCAL 2006
B461--Hospital Emergency Response Training (HERT) for
Mass Casualty Incidents (MCI) Train-the-Trainer Course
Of the three courses listed above only the Healthcare Leadership
Course has been offered more than once. The remaining two courses are
to be offered in December 2005 and on into calendar year 2006. I have
found limited information on the new courses with regard to the course
content, course design, or authors other than the brief outline
contained on the NTC web site http://training.fema.gov/emiweb/NTC/
Further discussion of the needs and requirements for future courses
will be discussed in the concept paper mentioned under question number
1 above.
3.``A. As part of Secretary Chertoff's Second Stage Review, the
office of the Chief Medical Officer and the Noble Training Center are
located in the new Preparedness Directorate.
B. How do you think this will impact the functions and coordination
of these entities with other medical preparedness programs and
resources in the Department?
Response: A. I believe that this issue will need to be evaluated as
more details of the structure and organization of the new Preparedness
Directorate become available. There is still question of the specific
job functions of the CMO and where, within the new Preparedness
Directorate Noble Training Center will reside. There is pronounced
concern among the healthcare community that have been deeply involved
in disaster preparedness, weapons of mass effect and mass casualty
response by the lack of experience of the current CMO in these areas.
The current CMO is a capable administrator but his background lies
almost totally in motor vehicle related trauma and in the seat belt
initiative for the DOT with very little to no experience in WMD, mass
casualty events or disaster preparedness.
Response: B. I believe that is a wise decision to place both the
CMO and the NTC under the Preparedness Directorate, as it will serve to
place greater focus directly on the training and response to any mass
casualty event. All hazards and mass casualty response training for the
Healthcare Community has been to say the least, disorganized, with no
continuity or central theme or oversight. Some efforts have been
accomplished by HHS in the form of the CDC and HRSA grants process but
these efforts have dealt more with public health preparedness and not
actual healthcare delivery. As I understand it, further hampering this
educational and training effort is the lack of recognition that the
overwhelming majority of healthcare providers and the response
community actually reside in private industry and as such enjoy no
single entity that speaks for the healthcare delivery system or its
professional components. The single best example of a more unified
healthcare preparation, training and response can be found in the
nation's Chemical Stockpile Communities where unified efforts to
standardize training and response have been employed since the mid
1980's in preparation for the destruction of the unitary chemical
weapons (e.g. Sarin, VX, Distilled Mustard, etc.) via the Chemical
Stockpile Emergency Preparedness Program (CSEPP).
Another issue that I recommend that the Subcommittee consider
involves where the National Disaster Medical System (NDMS) and the
Metropolitan Medical Response System (MMRS) will reside and what role
they are to play in regards to response to catastrophic events. The
NDMS contains the Disaster Medical Assistance Teams (DMATs), Veterinary
Medical Assistance Teams (VMATs) and Mortuary Assistance Teams (DMORTs)
has fallen into disarray and in my opinion is in need of a major
restructuring and reorganization. I believe that one manner in which
this may be accomplished will be through the Noble Training Center
which could serve as the National Headquarters for this vital system.
The Noble Training Center could serve as the nexus for training and
retraining of the NDMS team members with the surrounding facilities of
the old Fort McClellan base being utilized house stockpiles of
equipment and supplies as well as utilize the expertise of the Center
for Domestic Preparedness (CDP).
I believe that the nation's healthcare response to the major
disasters has performed well due to the willingness and sacrifice of
the professionals involved and their humanitarian spirit. I believe
that we as a nation owe these professionals and their attendant systems
the same level of training opportunities we have afforded the
traditional responders of law enforcement and fire service. All
hazards, weapons of mass destruction / effect and mass casualties are
areas that the healthcare community is not familiar or comfortable with
as compared to their routine daily duties.
Questions from Chairman Mike Rogers For Jeffrey W. Runge, M.D.
Responses
(1) Domestic Surge Production Capacity for Modern Smallpox Vaccine
According to the Department of Homeland Security, the Chief Medical
Officer should ``provide the federal government with a much greater
capacity to be prepared for, respond and recover from a catastrophic
biological attack.'' One way to ensure biodefense preparedness is to
establish and maintain domestic surge production capacity for
biodefense countermeasures.
Given the stated purpose of the CMO, how should the CMO coordinate
with HHS to ensure the timely implementation of domestic surge capacity
programs for necessary biodefense countermeasures?
Response: ``Domestic surge capacity'' with respect to biological
attacks may refer to issues of capacity of hospitals, physicians, and
Emergency Medical Services (EMS), as well as provision of
countermeasures such as vaccines and antibiotics. Responsibility for
health care surge capacity falls within the responsibility of the
Office of Public Health Emergency Preparedness in the Department of
Health and Human Services (HHS). The Homeland Security Chief Medical
Officer (CMO) works with HHS in accordance with DHS' role as
coordinator of Federal assets. The CMO will work with his counterparts
in various agencies, including HHS, Agriculture, Department of Defense,
and Veterans Affairs to define the requirements and definitions for
medical preparedness in biological attacks. The CMO also has
responsibility for coordinating DHS medical assets, and is building a
network of all DHS medical assets to ensure that their activities are
strategically aligned, that they have necessary training and education,
and that the Secretary and his management team have ready access to the
various specialized skills available from the Department's medical
workforce. The CMO will also work with the Office of Grants & Training
and the US Fire Administration within DHS, as well as the Department of
Transportation, to ensure that EMS first responders have access to
training in response to biological attacks.
With respect to biological countermeasures, the CMO will support
processes already in place to perform material threat determinations
and assessments, and to advise the Secretary on issues necessary to
fulfill the Department's statutory role under the Project BioShield Act
of 2004. The CMO acts on behalf of the Department to inform the
procurement of BioShield funded countermeasures intended for additions
to the Strategic National Stockpile.
During a biological attack, the Department would operate as
directed by the National Response Plan. In addition to serving as the
DHS Secretary's principal medical advisor, the CMO and his staff will
assist with the Interagency Incident Management Group and support HHS'
role in the execution of Emergency Support Function #8, which
coordinates Public Health and Medical Services.
(2) Development of Next Generation Technologies for Pandemic Flu
Preparedness
The CMO's primary responsibility is to work with the Department of
Health and Human Services and other departments to prevent and mitigate
biological based attacks on our Nation's human health and food supply.
Pandemic flu, which poses a natural threat to our human population and
food supply, can also be weaponized by terrorists.
Whether in nature or in a bioterrorist attack, our Nation's level
of pandemic flu preparedness is hampered by the fact that the pandemic
strain spread from human to human is unknown. Even once the pandemic
strain is identified, both egg-derived and cell-culture-based vaccine
production methods may not be able to satisfy mass orders on demand.
Therefore, is the Federal Government considering new technologies--
such as biotechnologies--that can cover a broad spectrum of flu strains
and enable mass production, on demand?
Response: The broad issues of biotechnologies for influenza should
be addressed by HHS.
DHS also has research activity underway. The Science & Technology
Directorate funds development of biothreat agent assays at the Lawrence
Livermore National Laboratory for Avian Influenza/Flu strains and
research through a University Center of Excellence at Texas A&M's
National Center for Foreign-Animal and Zoonotic Disease Defense.
What should be the role of the CMO in working with HHS to identify
and support the development of such new technologies?
Response: The CMO would provide consultation on the clinical and
policy issues of any new technologies advanced by the Department.
Vaccine development, production, and administration protocols are the
responsibility of HHS.
Questions from Representative Steve Pearce For Jeffrey W. Runge, M.D.
Responses
(1) I understand that HHS has Title 42 authority, which allows them
to pay physicians above the normal GS pay schedule in order to recruit
and retain experienced medical clinicians.
Is there a need for a similar type of authority for your office in
order to attract and retain qualified doctors who are experts in
emergency medicine, preparedness and response?
Response: The Department of Health and Human Services (HHS)
informally advises that some HHS doctors are paid under Title 38
authority delegated by the Office of Personnel Management. The Title 38
authority, pertaining to the compensation of physicians, has recently
been expanded and offers attractive features. Presently, the Department
of Homeland Security (DHS) is exploring a range of options for
compensating physicians, including the use of the Title 38 authority
under an OPM delegation, the physicians' comparability allowance under
Title 5, United States Code, and, of course, the basic pay and pay
flexibilities that will be offered under DHS' own system, which is
currently being developed.