[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
THE AUTISM EPIDEMIC--IS THE NIH AND CDC RESPONSE ADEQUATE?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
APRIL 18, 2002
__________
Serial No. 107-74
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
-------
80-356 U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2002
____________________________________________________________________________
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Internet: bookstore.gpr.gov Phone: toll free (866) 512-1800; (202) 512�091800
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COMMITTEE ON GOVERNMENT REFORM
DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York
ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York
JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania
STEPHEN HORN, California PATSY T. MINK, Hawaii
JOHN L. MICA, Florida CAROLYN B. MALONEY, New York
THOMAS M. DAVIS, Virginia ELEANOR HOLMES NORTON, Washington,
MARK E. SOUDER, Indiana DC
STEVEN C. LaTOURETTE, Ohio ELIJAH E. CUMMINGS, Maryland
BOB BARR, Georgia DENNIS J. KUCINICH, Ohio
DAN MILLER, Florida ROD R. BLAGOJEVICH, Illinois
DOUG OSE, California DANNY K. DAVIS, Illinois
RON LEWIS, Kentucky JOHN F. TIERNEY, Massachusetts
JO ANN DAVIS, Virginia JIM TURNER, Texas
TODD RUSSELL PLATTS, Pennsylvania THOMAS H. ALLEN, Maine
DAVE WELDON, Florida JANICE D. SCHAKOWSKY, Illinois
CHRIS CANNON, Utah WM. LACY CLAY, Missouri
ADAM H. PUTNAM, Florida DIANE E. WATSON, California
C.L. ``BUTCH'' OTTER, Idaho STEPHEN F. LYNCH, Massachusetts
EDWARD L. SCHROCK, Virginia ------
JOHN J. DUNCAN, Jr., Tennessee BERNARD SANDERS, Vermont
------ ------ (Independent)
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
James C. Wilson, Chief Counsel
Robert A. Briggs, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
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Page
Hearing held on April 18, 2002................................... 1
Statement of:
Boyle, Coleen, Associate Director for Science and Public
Health, National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention,
U.S. Department of Health and Human Services, accompanied
by Melinda Wharton, Director, Epidemiology and Surveillance
Division, National Immunization Program, Centers for
Disease Control and Prevention; Stephen Foote, Director,
Division of Neuroscience and Basic Behavioral Science,
National Institute of Mental Health, National Institutes of
Health, U.S. Department of Health and Human Services; and
Ann Willoughby, Director, Center for Research for Mothers
and Children, National Institute of Child Health and Human
Development................................................ 85
Grossman, Lee, president, Autism Society of America, and an
autism parent, Honolulu, HI; Belinda Lerner, member, Autism
Coalition, and an autism parent, New York, NY; Stephen
Shore, board member, Unlocking Autism, Brookline, MA; and
Doug Compton, scientific director, Cure Autism now
Foundation, New Jersey..................................... 27
Letters, statements, etc., submitted for the record by:
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana:
Information concerning thimerosal........................ 76
Prepared statement of.................................... 6
Boyle, Coleen, Associate Director for Science and Public
Health, National Center on Birth Defects and Developmental
Disabilities, Centers for Disease Control and Prevention,
U.S. Department of Health and Human Services, prepared
statement of............................................... 88
Clay, Hon. Wm. Lacy, a Representative in Congress from the
State of Missouri, prepared statement of................... 146
Compton, Doug, scientific director, Cure Autism now
Foundation, New Jersey, prepared statement of.............. 59
Davis, Hon. Thomas M., a Representative in Congress from the
State of Virginia, prepared statement of................... 145
Foote, Stephen, Director, Division of Neuroscience and Basic
Behavioral Science, National Institute of Mental Health,
National Institutes of Health, U.S. Department of Health
and Human Services, prepared statement of.................. 104
Grossman, Lee, president, Autism Society of America, and an
autism parent, Honolulu, HI, prepared statement of......... 31
Horn, Hon. Stephen, a Representative in Congress from the
State of California, ``For the Love of Zachary''........... 19
Lerner, Belinda, member, Autism Coalition, and an autism
parent, New York, NY, prepared statement of................ 41
Morella, Hon. Constance A., a Representative in Congress from
the State of Maryland, prepared statement of............... 68
Shore, Stephen, board member, Unlocking Autism, Brookline,
MA, prepared statement of.................................. 50
Smith, Hon. Christopher H. Smith, a Representative in
Congress from the State of New Jersey, prepared statement
of......................................................... 148
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 81
THE AUTISM EPIDEMIC--IS THE NIH AND CDC RESPONSE ADEQUATE?
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THURSDAY, APRIL 18, 2002
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 1 p.m., in room
2154, Rayburn House Office Building, Hon. Dan Burton (chairman
of the committee) presiding.
Present: Representatives Burton, Gilman, Morella, Shays,
Horn, Jo Ann Davis of Virginia, Weldon, Waxman, Maloney,
Norton, Cummings, Kucinich, and Watson.
Staff present: James C. Wilson, chief counsel; S. Elizabeth
Clay, Scott Feeney, and John Rowe, professional staff members;
Jennifer Klute, counsel; Robert A. Briggs, chief clerk; Robin
Butler, office manager; Elizabeth Crane, legislative assistant;
Elizabeth Frigola, deputy communications director; Joshua
Gillespie, deputy chief clerk; Susie Schulte, staff assistant;
Leneal Scott, computer systems manager; Corinne Zaccagnini,
systems administrator; Sarah Despres, minority counsel; Josh
Sharfstein, minority professional staff member; Jean Gosa and
Earley Green, minority assistant clerks; and Teresa Coufal,
minority staff assistant.
Mr. Burton. Good afternoon. A quorum being present, the
Committee on Government Reform will come to order.
I ask unanimous consent that all Members' and witnesses'
written and opening statements be put in the record. Without
objection, so ordered.
I ask unanimous consent that all articles, exhibits, and
extraneous and tabular material referred to be included in the
record. Without objection, so ordered.
Today we are here to talk about the autism epidemic. I use
the word ``epidemic'' for a good reason. Typically, we think
about epidemics in terms of infectious diseases. However, a
condition is considered epidemic when it occurs suddenly in
numbers that are clearly higher than normal.
Ten years ago only 1 in 10,000 children were thought to be
autistic. When we began our investigation in 1999, that number
was estimated to be 1 in 500. That is a 20 times increase.
However, the number today appears to be even higher.
The Center for Disease Control [CDC], conducted two
prevalence studies. The study in Brick Township, NJ, found that
1 in 181 children between the ages of 3 and 10 were diagnosed
with autism, and 1 in 128 were diagnosed with autism spectrum
disorders. An as yet unpublished study conducted in 1996 in
Atlanta, GA, found that 1 in 294 children ages 3 to 10 had
autism.
The National Institutes of Health [NIH], places the
estimate at 1 in 250 children, and boys are affected four times
more often than girls. That means that about 1 in every 156
boys in this country between the ages of 1 and 10 are autistic.
Unfortunately, the unexpectedly high rates in Georgia and
New Jersey are not isolated examples. This school year there
are 3,789 individuals with autism in Indiana schools. This is
up from 116 just 12 years ago, 116 to 3,789.
A recent news article out of Thailand indicates that there
are 100,000 children in Thailand with autism. In 1999, the East
Surrey Health Authority in the United Kingdom stated that the
prevalence of autism in their district was 1 in every 69 boys.
In the 60 years since autism was first described, we have
not yet figured out what causes it. We do not know if classical
autism and late-onset autism are the same conditions or two
different conditions with similar symptoms. We have come a long
way in 60 years. Doctors no longer blame the condition on bad
mothering. But we have a lot more work to do before we can pat
ourselves on the back for our accomplishments.
Is our investment in research on autism on a comparable
level with other epidemics? This is very interesting. Are the
CDC and NIH funding studies that will help prevent or cure
autism? Is their research adequately addressing the medical
issues associated with autism such as food allergies, chemical
sensitivities, and autistic enterocolitis? Is the information
about autism provided by our government adequate and useful to
families?
The CDC will testify today that they plan on spending $11.3
million on autism this year and $10.2 million on autism next
year. We compared that to two other conditions that have been
declared epidemics: diabetes and AIDS. Both of these conditions
can be devastating. Both deserve sufficient research dollars to
develop treatments and look for cures.
The CDC is spending over $932 million on the AIDS epidemic
this fiscal year. Compare that to $11 million for autism. AIDS
deserves attention--don't get me wrong--and so does diabetes,
which both Secretary Thompson and the former Surgeon General
declared an epidemic. CDC this year will spend just over $62
million on diabetes. The autism epidemic, just like the
diabetes and AIDS epidemics, is no less deserving. Yet, the
CDC's spending for autism is almost 80 times less than that for
AIDS. And CDC's spending for autism is five times less than
that of diabetes. CDC should be committing more research money
for autism, and we are going to work on that.
Now let's look at the National Institutes of Health. We
have got some charts up there on the wall which you can look
at. The NIH is the premier biomedical research institution in
the world. Congress has worked hard to double the NIH's budget.
Their total budget this year is $27 billion. We are committed
to funding research to help cure crippling diseases.
The NIH will testify today that their commitment to
researching autism has grown dramatically in the last few
years. In fiscal year 1997, the NIH investment in autism
research was only $22 million. Last year that number had grown
to $56 million, in large part because of the Congress.
That's good, but let's put that into perspective. At the
same time the NIH is spending $56 million on autism, a
condition that affects 1 in every 250 children in this country,
they are investing over $2.2 billion in AIDS research. The
rates of diabetes increased by 49 percent between 1990 and the
year 2000. Diabetes is a devastating condition in the Native
American community and of increasing concern in the African
American and pediatric populations. This year the NIH
investment for diabetes is $688 million, and compare that to
the $56 million that they are going to spend on autism, and
compare that to the huge money that is being spent on the AIDS
research.
I believe these numbers speak for themselves. Funding in
basic and clinical research into autism needs to be expanded
dramatically. We have an epidemic on our hands, and we in
Congress need to make sure that the NIH and CDC treat this
condition like an epidemic and put their efforts into doing
several things: First, to find out the causes of the epidemic.
Second, determine how to stop the epidemic in its tracks.
Third, to evaluate treatment options. And, fourth, to look for
a cure.
When we first began looking at this issue, we heard from
thousands of families. Many told us their children were
absolutely normal until they were vaccinated, and that just a
few days or weeks after they became vaccinated they became
autistic. We also heard about a dramatic similarity in these
late-onset autism cases. Many of these children have unusually
high levels of heavy metals in their systems. They have immune
system irregularities. They have unresolved yeast infections.
Eating foods that contain wheat or dairy may result in a rapid
deterioration of behavior. Exposure to many chemicals, even
perfumes, can have the same adverse effect. Many have chronic
diarrhea. NIH and CDC need to fund research to get answers to
all these issues.
One of the things that concerns me is that it seems that
many of these children, if we tested hair samples, urine
samples, blood samples, could give us an idea of whether or not
they have mercury in their systems, and to what degree, and
whether or not there are other toxic chemicals that may be in
their systems that could be found through these tests.
Autism has personally affected my family, and many of you
already know that. My grandson Christian was normal and healthy
until his second year of life. He walked, he talked, he made
eye contact, he enjoyed going to the mall, and all the other
things that 2-year-olds do. And then suddenly, shortly after
receiving his mandated immunizations, he became a different
child. He no longer spoke. He would not look anyone in the eye.
He cried endlessly. He banged his head against the wall. He
began running around flapping his hands, and he had chronic
diarrhea and severe bowel problems. We now know that he was
suffering from an adverse reaction to his vaccines. We also
know that he may have received more mercury in his vaccines
than is considered safe, way more than safe, by Federal
standards. This mercury toxicity was contributing to the
adverse reaction.
So far, the NIH and the CDC discount any potential
connection. The Institute of Medicine has stated that the
available research data is insufficient to prove or disprove a
connection between autism and either the MMR vaccine or
thimerosal, which is the preservative put in most children's
vaccines. But they say the link is biologically plausible. The
IOM called for more research in this area. One of the reasons
we are here today is to make sure that research gets done, and
gets done now rather than 10 years from now, when many more
thousands of children become autistic.
When you are a parent, whether your son or daughter is
autistic from birth, because of genetics, or because of some
environmental exposure such as vaccines or maybe something
else, you are facing a challenge more difficult than a 500-
piece puzzle. You are faced with putting the puzzle of your
child's life together one piece at a time.
Do you put special locks on your doors and windows and add
an alarm system because you're afraid the child will wander
away from your home? Do you need to put a lock on a cabinet in
your kitchen to keep the foods that set your children into a
spiral out of their reach? What medicines or dietary
supplements will your child need? How do you find services?
Does your child need to learn sign language? Do you need ABA or
other behavioral therapy? Where can you find a qualified speech
therapist? How are you going to pay for all of this? How are
you going to get through the school services maze? How will you
find time for your other children?
What happens when the child grows up? And that's something
our government needs to think about. One in 250 children are
becoming autistic, and we are not doing a great deal of dealing
with that problem right now, but they are going to grow up and
then they are going to be adults with autism. Now if you have 1
in 250 people in this society that's autistic down the road,
because we haven't done our job now, how are we going to take
care of it? How are we going to take care of all the health
care needs besides autism at the same time as taking care of
the burden they are going to be on society? And our medical and
research people need to address that issue. These are all
dilemmas that parents face now.
In addition to witnesses from the NIMH and CDC, I am
pleased that we have several autism organizations represented
here today. We were not able to have all of the organizations
testify at the table, but I hope that each will submit written
statements for the record.
Mr. Lee Grossman of Hawaii is our first witness. He is the
president of the Autism Society of America and has a son with
autism.
Ms. Belinda Lerner of New York is a member of the Autism
Coalition and has a son with autism. While having a child with
autism may be her toughest battle, Ms. Lerner is not a stranger
to tough battles; she is the first female attorney to work for
the National Football League. Those are big guys. [Laughter.]
Mr. Stephen Shore of Brookline, MA, is a board member of
Unlocking Autism. Mr. Shore, who did not speak the first 4
years of his life, has Asperger's disease, a condition on the
autism spectrum. Mr. Shore is a success story. Because of his
mother's drive and dedication, Mr. Shore is a doctoral
candidate at Boston University. That's very commendable. He
gives all families with autistic children hope.
Mr. Doug Compton is the science program director of Cure
Autism Now and the father of an autistic child.
I look forward to hearing from our witnesses today. Our
hearing record will remain open until May 3rd.
[The prepared statement of Hon. Dan Burton follows:]
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Mr. Burton. Mr. Waxman is not yet here.
Mr. Gilman, do you have a statement you would like to make?
Mr. Gilman. I do. Thank you, Mr. Chairman. I want to thank
Chairman Burton for conducting this important hearing regarding
NIH and CDC's response to the rising rate of autism in our
Nation.
I recently met in my constituency with Jeanine Conklin, a
mother to Daniel, her 5-year-old autistic son. Listening to her
explain the obstacles that her family must face each and every
day reaffirmed by commitment to this issue. It is essential
that there be continued research of and funding for learning
more about how this affliction manifests itself and how it can
be prevented, and how to properly educate the public. It is
important to understand how we define autism, why the autism
rate is increasing, and how we can support effective research
that will benefit those who are already afflicted by autism.
Autism makes it difficult for an individual to interact
with people and their environment. In some cases those with the
illness may behave in an aggressive or self-injurious manner.
It occurs in people of all races, ethnicities, and
socioeconomic backgrounds. A better understanding of the
origins of the disease is crucial to introducing new and
effective treatments.
As Chairman Burton noted, autism has afflicted 1 in 500
children in the United States. However, the CDC shows that even
higher rates occur in some specific locales such as Atlanta,
GA, Brick Township, NJ, where the autism rates are 1 in 94 and
1 in 128, respectively.
These alarmingly high rates have lead to several inquiries
into the contributing factor of the disease, including, but not
limited to, childhood vaccines and some of the environmental
factors. Many of the symptoms of autism are the same as mercury
toxicity. Through an FDA review, it was learned that the amount
of mercury in mandated vaccines that children were receiving in
the first 6 months of their lives exceeded guidelines that were
established by the Environmental Protection Agency and
validated through an Institute of Medicine review.
We have convened here today to monitor whether NIH and the
CDC have satisfactorily responded to the challenge of autism
research. More specifically, we would like to know if they made
headway into IOM's research recommendations, research to
determine how children metabolize and excrete metals,
particularly mercury; continued research on theoretical
modeling of ethyl-mercury exposures and careful, rigorous, and
scientific evaluations of chelation, when used in children with
neurodevelopmental disorders, especially autism.
Our committee's oversight is an essential component to
increasing communication. Autism is a disease that paralyzes
communication. We cannot afford to paralyze the communication
between our medical community, our government sector, and those
families who have been affected by autism. We owe it to the
American families like the Conklins in my area to do everything
in our power to ensure that the Federal Government continues
its commitment to autism, to research and discovery.
As a member of our Congressional Caucus on Autism, I am
extremely interested in the testimony that our witnesses will
have to present to us today. I want to thank Chairman Burton
again for his dedication to the health and safety of our
Nation's children.
Mr. Burton. Thank you, Mr. Gilman.
Let's see, Dr. Weldon.
Dr. Weldon. Hi, Mr. Chairman. I do not have an opening
statement, but I just want to again thank you for bringing the
spotlight of congressional scrutiny onto this very critical
issue of autism in America. I believe it to be a forgotten and
neglected disease for too long. Thank you for your leadership
on this.
Mr. Burton. Thank you, Dr. Weldon. Mr. Shays.
Mr. Shays. Thank you, Mr. Chairman. Mr. Chairman, no
prepared statement other than to thank you for having this
hearing and to say that, like a number of Members of Congress,
I have a very sizable number of autistic young and old in my
district. It is far more noticeable than in the past, and I am
deeply concerned about it. I can't imagine what it must be like
for a parent to hold a child and just be hungry for some type
of response of recognition. So I just thank you.
I know we are all wrestling with this. I know nobody has
the answers, but together I hope we are able to find some.
Mr. Burton. Thank you, Mr. Shays. Ms. Davis. Mr. Horn.
Mr. Horn. Thank you, Mr. Chairman, for this continuing
effort to get at autism. I would like to have in the record a
piece called ``Medicine for the Love of Zachary,'' which was
Zach and Karen London, and she affected 400,000 people
nationwide with her crusade. I think you would find it very
inspiring.
Mr. Burton. Thank you, Mr. Horn. We will put that in the
record, without objection.
[The information referred to follows:]
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Mr. Burton. Are any of the minority members going to be
here?
[No response.]
Mr. Burton. We will now ask the first panel to come
forward. Mr. Grossman, Ms. Lerner, Mr. Shore, and Mr. Compton,
would you please approach the witness table and stand up so we
can swear you in?
[Witnesses sworn.]
Mr. Burton. Be seated.
We will start with you, Mr. Grossman. I guess we will just
go right down the line. Do you have an opening statement?
STATEMENTS OF LEE GROSSMAN, PRESIDENT, AUTISM SOCIETY OF
AMERICA, AND AN AUTISM PARENT, HONOLULU, HI; BELINDA LERNER,
MEMBER, AUTISM COALITION, AND AN AUTISM PARENT, NEW YORK, NY;
STEPHEN SHORE, BOARD MEMBER, UNLOCKING AUTISM, BROOKLINE, MA;
AND DOUG COMPTON, SCIENTIFIC DIRECTOR, CURE AUTISM NOW
FOUNDATION, NEW JERSEY
Mr. Grossman. Yes, I do, Mr. Chairman.
Mr. Burton. If we could, we would like to try to keep our
opening statements to 5 minutes, if we can, so we can get
through everybody and have time for questions.
Mr. Grossman. Good afternoon. My name is Lee Grossman and I
am president of the Autism Society of America, chair of the
Autism Society of America Foundation, a member of the Federal
Government's Interagency Autism Coordinating Committee, a
resident of Honolulu, HI, a small business owner for over 20
years in the medical industry, and, most importantly, a father
of a child with autism whose name is Vance.
Mr. Chairman, I would like to thank you and your colleagues
on the Committee on Government Reform for this opportunity to
present testimony on the issue of autism, the fastest-growing
disability in our country today. As President of the Autism
Society of America, I can tell you that hearings such as this
offer hope to hundreds of thousands of individuals and families
affected by autism.
I am going to deviate from my testimony a little bit to
respond to your opening statements. They're very moving to me
in that it truly represents what all of the families are going
through, our experiences, our frustrations in dealing with this
dilemma that we're faced with.
I want to thank you very much for acknowledging for the
first time, that I am aware of, that the Federal Government is
now acknowledging in this country that autism is an emergency,
and it is a national health crisis. It is something that has
not evaded the advocates and the families to this point. It is
reassuring to all of us to know that the government is finally
recognizing this as an epidemic.
There are a number of factors and figures that I would like
to present here before I get into what I believe that we need
to do and what ASA believes that we should do to correct this
problem over the near short-term. Currently, it is easy to say
that this is a national health crisis. There are as few as a
half million to perhaps 1.5 million people with autism in the
United States today. Estimates are as high as for every 1,000
children that are born today 6 will have autism.
The annual cost of treating autism in the United States is
anywhere from $20 billion to $60 billion every year. Autism is
growing at a rate of 10 to 17 percent each year. Based on these
figures, in 10 years the annual costs associated with autism
could be as much as $50 to $300 billion per year. After 60
years of dealing with this problem, the Federal Government is
currently spending $75 million on research when the problem is
in actuality conservatively a $20 billion problem. After 60
years of this approach, we have no identified causes of autism
or any proven treatments or therapies. Something substantially
greater has to be done to address this national emergency, and
we have to spend substantially more money to find causes and
effective treatments.
The Autism Society of America believes there are four
critical areas that need to be addressed, and these four areas
are in autism research, early identification intervention,
secondary school education, and adult issues. Here are our
immediate recommendations.
Current funding levels in biomedical research at NIH are
terribly low in relation to the disorders population and
economic impact. We are recommending that the Federal
Government increase the funding available for research over the
next 3 years to a level of $500 million per year devoted to
basic science, environmental science, tissue and genetic
collection, and all aspects of biomedical research related to
autism. When compared to the annual growing rate of autism in
our Nation, this is substantially below the funding to keep
pace with the projected growth.
In the area of applied science, we must find new and
innovative ways to develop and implement therapeutic and clinic
interventions and effective treatments. There has been to date
virtually no activity and support from Federal agencies in
these vital areas. We recommend that applied research funding
be increased over the next 5 years to a level of $100 million
per year. This increase is needed in the case of autism because
we are building from a zero base.
ASA also recommends that there is a need to increase the
number of scientists involved with research and treatment
grants. We request that NIH develop programs and encourage
researchers to enter into fields associated with autism
research and to stimulate new research protocols.
The CDC surveillance programs need to be implemented and
then expanded immediately so that more exact figures on the
prevalence and population of those with autism are established.
In our discussions with CDC, we recognize that data from a
substantial number of State or other geographic areas will be
needed to better identify those who have autism and what scope
of services will be needed. We, therefore, recommend that the
CDC budget in this area be increased to $8 million to expand
the number of regional centers and State surveillance programs
from 9 States to 20 States. These 20 States should represent a
statistically significant data base to allow CDC to better
identify those who have autism, and then start looking for root
causes and trends.
As we must find the causes and best treatments for those
with autism, there is also a need to fund areas which could
identify possible causes of autism created by our society. A
substantial number of families within our autism community
believe some forms of autism may be caused by some use of
vaccines. While we do not know this to be specifically proved
at this time, we should not ignore the body of evidence that
calls into question the source of many children with autism. If
causation is found, those injured must be provided recourse and
compensation.
This is why ASA supports and asks for early adoption by
Congress of the Burton-Waxman bill, H.R. 3741, which improves
the National Vaccine Injury Compensation Program by extending
the statute of limitations for individuals to file claims and
provides a 2-year look-back provision for the families that are
presently prevented from filing under the program, through no
fault of their own.
Now under early diagnosis and early intervention, ASA
strongly supports the general consensus that the most effective
means for a successful result in the life of an individual with
autism is through early diagnosis and early intense and
appropriate intervention. Therefore, we recommend that a
national awareness campaign be established through the U.S.
Department of Health and Human Services, national physician
organizations, and community health centers to provide
education and identification programs to pediatricians, child
care providers, and to the population at large.
ASA has expressed its willingness to act in concert with
the Department to make this happen by drawing upon its unique
membership and chapter base with the entire autism community.
ASA also seeks increased funds for States to Early Head Start,
or zero to 3, programs administered by the Administration for
Children and Families to provide.
For education for children with autism, ASA recommends to
the committee that it supports and develops legislation to
implement the recommendations and plans detailed in the
National Research Council's report, ``Educating Children with
Autism.'' This report precisely addresses the education
interventional needs of secondary school age children with
autism.
ASA further recommends that Congress immediately
reauthorize the Individuals with Disabilities Education Act and
fulfills the long overdue commitment to the full funding of
IDEA, and, last, support services for adults with autism. The
current availability of services, support, employment, and
residential options available to adults with autism can only be
described as almost non-existent. For too long the service
supports for these people has dramatically dropped once the
person passes through the secondary education system. A
comprehensive program must be developed and implemented to
address the tremendous needs of this growing and immense
population.
ASA has developed a white paper on this subject and has
posted it on our Web site to help develop interest in having it
implemented. We have also joined with coalitions and formed
coalitions of adult service providers, and are now doing
assessments of the needs of the adults with autism community to
formulate initiatives and legislation to address this problem.
We ask the Congress and this committee to join in supporting
the development of legislation and funding that will be
necessary to deal with this current and ever-growing dilemma.
In closing, Mr. Chairman, I would be terribly remiss if I
did not address the relevance and significance of this hearing.
As I stated, this is the first time that I am aware of that the
U.S. Government has acknowledged the autism epidemic and
attendant national health crisis. And with your acknowledgment,
ASA stands firm and ardent in requesting that this Nation take
real and measurable actions today to stop this national
economic, social, and health emergency.
I have described in my testimony what needs to be done now
in terms of money and autism. However, there is something just
as important to be added; that is hope. The autism community
has endured 60 years of unfulfilled hope.
Congressman Burton, I know you have waited with hope for
your grandson over the last 5 years. I have waited and hoped
for the last 14 years, and the community has waited 60 years.
If we will take the actions I have offered to you today, all of
our hopes can be translated into fulfillment. Please let us
help each other give meaningful hope to the millions of people
affected by autism.
Thank you, Mr. Chairman, and I will stand ready to answer
any questions you may have.
[The prepared statement of Mr. Grossman follows:]
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Mr. Burton. Thank you for that statement, Mr. Grossman.
Your recommendations, along with the others that we will hear
today, will be given to the officials at NIH and CDC and the
FDA. We have some of them here who are going to be testifying
in a little bit, and they are, I am sure, taking all this in.
Ms. Lerner.
Ms. Lerner. Thank you, Chairman Burton and distinguished
members of the committee.
I am here to speak to you today about my personal
experiences with the heartbreak and frustrations of autism. By
way of history, you should know, and as Chairman Burton has
already said, that professionally I am an attorney with the
National Football League. My job has presented me with many
interesting challenges, including cross examining 6-foot 5-
inch, 300-plus pound professional football players. I was the
first female attorney hired in that role, and so my challenges
were not limited to my interactions with football players, but
in winning the confidence and respect of my male colleagues in
the league and at the NFL clubs. However, those challenges,
while daunting at the time, pale in comparison to the
challenges I have faced, and continue to face, as a mother of
an autistic son.
My son, Benjamin, was diagnosed when he was 2 years old,
and when I received the news, I was relieved--yes, relieved.
Prior to his diagnosis, I was the mother of a screaming,
inconsolable, non-communicative little boy, who seemed to
reject all my attempts to love him and was incapable of
demonstrating his love for me. At a time when I should have
been awash in feelings of love, I was overwhelmed by feelings
of inadequacy, failure, and shame.
Now the enemy that had overtaken my son had a name--
autism--and like any lawyer worth her salt, I was going to
defeat my adversary by researching and understanding its
characteristics. I remember bombarding the psychologist, who
had diagnosed Ben, with questions: What causes autism? No one
knows. How prevalent is it? Undetermined, last count, 1 in 500.
What treatments are most effective? It is unclear. There have
been no reliable studies. Most importantly, what are my son's
chances for a normal life? Hard to say, but not particularly
good.
I refused to be cowed, but little did I know at the time
the journey I was embarking on. I was able to secure a spot for
Ben in a wonderful school dedicated to children with
developmental disorders, where by the age of 3 he began to
master basic language and other life skills. Finally, the
wonderful, charming little boy hidden beneath the disorder
began to emerge, and so did this incredible bond between Ben
and me.
Although Ben was making progress, he, nonetheless, still
had substantial and pervasive deficits. And so each time a new
problem arose that required additional therapy, we needed to
get permission from the school district's Committee on Pre-
School Education to amend his individual education plan [IEP],
to address this problem. Although I had my share of battles
with the CPSE to get appropriate services for Ben, it wasn't
until Ben turned 5 and was transitioned from the CPSE to the
CSE, Committee on Special Education, that the hostilities
elevated to an all-out war.
At that point Ben was to graduate from his special
education school. So my husband and I evaluated the school
district's inclusion kindergarten program, and we both agreed
that the curriculum and behavioral requirements were far too
advanced for Ben at that time. However, the school district
refused to provide us with any alternatives. So even though the
law requires that a ``free and appropriate education in the
least restrictive environment'' be provided to each child, we
were left with the choice of putting him in the school
district's program or pay out of pocket for any alternative.
We knew that following the district's mandate would be
setting Ben up for failure, in our experience a sure-fire
recipe for disaster and regression. If we sued the school
district, it would cost us as much as a year's tuition. So we
bit the bullet and sent Ben to a private pre-kindergarten
program at our expense.
This private school was initially a godsend for us, and Ben
continued to make small, but steady progress. But as Ben went
from pre-K to the typical kindergarten program, it was clear
that his developmental problems were too severe to be handled
by a well-intentioned but untrained and underequipped staff.
Because the school district would not provide additional
support for Ben at his private school, his failure to get the
appropriate interventions resulted in his lashing out and
shutting down. Once again, the shadow of autism was eclipsing
my sweet, charming little boy who had been showing so much
promise.
My husband and I pulled Ben from the private school,
obtained additional therapy and additional evaluations at our
own expense, and put him in our only other alternative, the
school district's kindergarten program, which we had rejected 2
years earlier. Ben is no longer regressing, but he is still
significantly delayed in all developmental categories.
Our most recent round of evaluations have revealed that,
unless Ben receives intensive interventions this summer to make
up for the losses he experienced this school year, he has
absolutely no chance of surviving first grade. However, because
the CSE has refused to classify Ben as a child who needs year-
round services, the job of securing the right therapists, as
well as the financial burden of providing them, will fall to
us.
Based on my unwavering love for my little boy, I am
determined to do what is in his best interest so that he may
have a chance for a happy, independent life. However, I and
similarly situated parents are faced with many obstacles, and
it is time for the Federal Government to share the burden and
the shame that has dogged the parents of the autistic, and the
lack of government assistance in autism to date is shameful. It
is shameful that this country, the greatest nation in the
world, has conducted no concerted nationwide prevalence study.
Funding Centers of Excellence, pursuant to the Children's
Health Care Act, would give us a vehicle to conduct a proper
nationwide tracking program. It is shameful that there has not
been significant funding into biomedical research. Less than
two generations ago, the disorder was thought to be a mental
illness caused by cold and detached mothers. Although we now
know it is a neurological disorder, we have yet to determine
what causes the autism and how it impairs the brain's
functioning.
It is shameful that this country has not conducted
meaningful and concerted applied research to determine what
therapies are most effective in countering the horrific effects
of autism. Our schools have been besieged by this growing
population, and while required by law to educate and treat the
autistic, they lack funding and training to handle this
enormous responsibility. Fully funding the IDEA statute would
alleviate some of that burden.
Finally, it is shameful that our Nation, either through
willful ignorance or benign neglect, has allowed this insidious
and pervasive health care crisis to rise to epidemic
proportions.
I began my testimony by presenting to you the challenges I
have faced professionally and personally as a mother of an
autistic son, and I would like to conclude by asking that you
adopt these challenges and support the funding for the five
Centers of Excellence and IDEA. Past generations were damned to
institutionalization. Let's not condemn our present and future
generations to the same fate.
I speak on behalf of the exhausted, voiceless, and
desperate parents of autistic children, the children that
without the proper government intervention will become adults
doomed to be a financial burden rather than a contributing
member of society. So please give full force and effect to the
Children's Healthcare Act and the IDEA statute. Thank you.
[The prepared statement of Ms. Lerner follows:]
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Mr. Burton. Thank you for that statement. I would urge all
of you who are interested and who are leaders in the autistic
community to write your Congressmen and to write the White
House and to tell them that you want these changes made and
that there be appropriate funding for all of these research
programs that you talked about, because the squeaky wheel in
this town gets the oil.
You talk about the AIDS research, and I am taking a little
liberty here, so forgive me. The AIDS research moneys that are
being spent are huge. I don't fault them for giving that money
to AIDS research. I think it is important. But autism is
equally important. Because they have been very outspoken in the
AIDS community, they have gotten a great deal of results from
the health officials of this country, and from the Congress,
and from the administrations, $700 million; I believe it was
pretty close to that. If we had that kind of money being given
for autism research, we could probably get a lot more
accomplished.
So write your Congressmen. Don't write me. I am already on
board. [Laughter.]
But write your Congressman and write the White House and
Senators and tell them that you want something done.
Dr. Weldon. Mr. Chairman.
Mr. Burton. Yes?
Dr. Weldon. Could you yield to me on this issue?
Mr. Burton. I will be glad to yield.
Dr. Weldon. Just for a minute?
Mr. Burton. Sure.
Dr. Weldon. I was going to say this in my question period.
If you add up--comparing to AIDS is a good thing because the
prevalence is somewhat similar. It is estimated 500,000 to a
million with autism and there's 500,000 people with AIDS, about
900,000 if you add AIDS and HIV-positive status.
If you add up the money that is spent by NIH, CDC,
Medicare, Medicaid, the housing money, the drug money, the
Federal Government is spending $12 billion on AIDS. That is why
I refer to this as a forgotten disease. You know, Mr. Grossman,
you laid out a really nice strategy. I mean it was great. I was
really glad to hear you do all that.
You've got a bunch of people here that are going to be
foursquare behind you, but you have got to develop a very
sophisticated lobbying effort. You are a 600-pound gorilla that
has been asleep for years. I can tell you, if you get your act
together and start working this town aggressively--and you
ought to meet with the AIDS people and just have them brief you
on how they did it. I mean, we are going to double the NIH
budget, and everybody is going to be out there to take a piece
of it: the kidney people, the heart people, the Parkinson's
people. But they've already got a big chunk, and the time is
really ripe. I apologize for rambling on here.
Mr. Burton. No, that is all right.
Dr. Weldon. You brought it up, Mr. Chairman.
Mr. Burton. It adds to the discussion.
Dr. Weldon. It is a two-way street. You know, you've got to
work this town, and you've got to be really slick and really
sophisticated, and you've got to put money into it, too. There
are a lot of people, NFL football players, businessmen with
money who will write checks, and you've got to hire
consultants. You've got to do a whole 9 yards, but you ought to
do it because I think you can cure autism. I really do.
Mr. Burton. Thank you, Dr. Weldon.
Mr. Shore.
Mr. Shore. Chairman Burton, I thank you and your colleagues
on the Committee on Government Reform for this opportunity to
present testimony, this historic opportunity to present
testimony on the issue of autism.
I am Stephen Shore and reside in Brookline, MA with my wife
Leawee, where I am completing a doctoral degree in special
education from Boston University with an emphasis on helping
those with autism reach their fullest potential. I am the
author of ``Beyond the Wall: Personal Experiences with Autism
and Asperger's Syndrome,'' consult internationally for autism-
related issues, teach college-level courses in special
education at both Boston University and Lesley University, as
well as work with people that have autism. I am very fortunate
to be leading a fulfilling and productive life.
Most of us here today have involuntarily been inducted into
this community by the autism bug. What happens? A child is born
and develops typically until 18 to 24 months, suddenly hit with
a bomb that spreads its shrapnel from the child to the family,
to education, the community, and humanity at large. The child
loses verbal ability; withdrawal from the environment occurs.
We often see self-abusive and self-stimulatory behaviors,
tantrums.
I was hit with that very same bomb at age 18 months with
all those wonderful characteristics that we see going with it.
Despite the claim of being too sick to work with and
recommendations for institutionalization by diagnosing
professionals, it was my parents that were left to provide the
needed early intervention, and this was at a time when that
term had yet to be conceived. We are talking about the early
mid-sixties. My parents had no support.
However, fortunately, my mother was able to stay home all
day and provide the equivalent of what is known today, or would
be known today, as a home-based early intervention with an
emphasis on music, movement, sensory integration, narration,
and imitation--to at first make me aware of her presence, and
then to coax me out into her world. I was very lucky. Parents
and educators, we need to listen to the parents. They are the
experts on their children.
At this time I am before you as I continue my quest to help
those with autism and Asperger's disorder lead fulfilling and
productive lives. I continue to struggle with the residuals of
autism. While the uniform of a suit and tie that we find in
government and business may be a mere inconvenience to most
people, it is a major sensory violation for me. However,
helping my peers on the autism spectrum is way more important
than my discomfort.
I am very lucky and the rare exception of a child with an
early autism spectrum diagnosis. Here in the United States of
America, the wealthiest, most powerful Nation on Earth,
everyone on the autism spectrum has a right under IDEA to
receive critical services throughout their lifespan tailored to
their needs. This should not be a matter of luck or debate, but
it is a question of how.
These are some of my observations. As board president of
the Asperger's Association of New England, board member of the
Autism Society of America, Unlocking Autism, and other national
autism-related organizations, I see many others with autism
spectrum disorder who are vastly underserved: toddlers not
receiving vitally needed early intervention and school age
children in need of professionals educated in how to interact
with those on the autism spectrum.
We desperately need more educational research. Today we
know very little about the interventions that are effective
with individuals with high-functioning autism and Asperger's
syndrome. The implications are enormous. So many of my peers
living far below their potential, homelessness, other
substandard living conditions, unemployment, and serious
underemployment are all too common.
People with high-functioning autism and Asperger's syndrome
need to be taught more how to interact successfully with the
environment and people around them. Until medical terminology
can answer the questions it is pursuing, we have thousands of
individuals who are exposed to educational interventions that
are not validated or, perhaps even more tragic, not exposed at
all because the educational community doesn't know what to do.
We have some literature that supports best practice for
people with moderate to severe autism spectrum disorders, but
the same cannot be said for individuals with high-functioning
autism and Asperger's syndrome. We need to look at the
academic, cognitive, developmental, behavioral, social,
sensory, and other interventions.
As was mentioned before, the CDC estimates that 1 out of
250 children have autism right now. What are we going to do in
10 to 15 years when they become adults? This number, 1 in 250,
is actually much greater if we look at the people that are
affected by autism. What do I mean by that? We are talking
about the family. One child has autism. We have other siblings.
We have parents, grandparents, other relations, friends. Funds
devoted to research and early intervention now will pay huge
dividends later.
But what about the adults? There is very little literature
on this population also. What happens in the Commonwealth of
Massachusetts where I live is we see people with high-
functioning autism not being served by the Department of Mental
Retardation because they have an IQ over 70; thus, they are not
considered as having retardation. The Department of Mental
Health says autism is not a psychiatric disorder, so they don't
get services from the Department of Mental Health. As a result,
they fall in the crack, a big crack, and don't receive services
at all, and similar situations exist in many other States also.
What I have described, and what has been talked about by
you, by Lee, by Ms. Lerner, is a national emergency. They were
talking about up to 1.5 million individuals in the United
States having autism, and the numbers are rising. The U.S.
Department of Education, the California Department of
Developmental Services, and others, ASA, estimates autism is
growing at a rate of 10 to 17 percent annually. We are talking
about a rate of 100 to 400 percent over the next 10 years.
If we look at the Mind Institute, they estimate that the
conservative cost of a lifetime of care, and here we are
talking only transportation, day services, and residential
care, for every person with autism is $2 million. Multiply that
by 1 million and 1.5 million, and that doesn't even begin to
express the opportunity cost of lost wages and other
contributions to society such as charitable work and even
playing in musical ensembles. Every one of these persons must
be given the same chance that only a select few, often due to
luck, have had to succeed in life.
I would like to close with several concrete
recommendations. One is let's work with the Autism Society of
America by supporting their funding request and in developing
legislation regarding the autism spectrum, including
implementation of the National Research Council's Educating
Children with Autism Report recommendations.
Two, immediate and abundant funding for research and
education of those who work with people having autism.
Three, fund fellowships to increase the number of skilled
medical doctors, teachers, and other professionals in working
with people in the autism spectrum.
Four, mainstream autism as it relates to insurance
payments. We are dealing with a medical neurobiological
condition, and not a psychiatric one, and, thus, should not be
constrained by policy limits that we see on mental health
coverage.
Five, standardized payments for recognized methods of
interventions across the country. It is unfair that some
families are placed on long waiting lists, perhaps a year or
two, to access coverage.
No one particular approach can be required because
different children respond to different methodologies.
According to IDEA, we have to provide the child what they need
in order to get the education they need. Some sound approaches
include, but are not limited to, the Miller Method, Floor Time,
Hagashi, Teach, and applied behavioral analysis.
In summary, it is clear that we have some good
interventions and treatments for autism in place at this time,
but it is a travesty that the quantity and quality of these
services are lacking. The NIH needs to work with organizations
such as the Autism Society of America in developing national
policy for people within the autism community, so that all
those having autism have a fair shot at leading fulfilling,
productive, and independent lives to the limits of their
capacities.
Mr. Chairman and members of the Committee on Government
Reform, your providing this historic opportunity to present
testimony on this issue of autism today is very much
appreciated. I know you will do the right thing. Thank you, and
I am here to serve you.
[The prepared statement of Mr. Shore follows:]
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Mr. Burton. Thank you, Mr. Shore. Mr. Compton.
Mr. Compton. Good afternoon, Chairman Burton and members of
the committee. My name is Doug Compton, and I have been an
advocate for the autism community for 6 years while I was a
career scientist studying heart disease. I have recently become
the science program director for the Cure Autism Now
Foundation. My son, Daniel, who is now 9 years old, has autism.
I won't restate the prevalence estimates. As we all know,
they are high, and scientists are debating why these numbers
are changing, the extent to which the environmental factors are
playing, whether diagnosis is playing a role in the rise, or
whether genetics are playing a role in the rise with its
interaction with environmental factors.
What I will say is that we still do have hope. Four years
ago my family and I came from New Jersey to the Capital to help
introduce the Children's Health Act. We came with enthusiasm,
and it was a bright day. My son stood at a microphone such as
this and repeated his favorite script over and over, and he is
still doing that to this day.
During the years between the introduction of the bill and
its passage, groups such as Cure Autism Now, the National
Alliance for Autism Research, and the ASA formed partnerships
to establish genetic resources, brain resources, and alliances
with the NIH and other organizations studying autism. Together,
we funded research to try to identify the causes from genetics
to environment. We have funded brain imaging studies. We have
funded animal models and treatment trials. We have closed no
doors, as there is still no conclusive evidence as to what
causes this thing we call autism, nor are there any universally
effective treatments.
We continue to push the research agenda from the private
sector, but we need our government to push harder. While there
has been a large increase in funding from the Federal
Government from $5 million to $30 million a year, this is far
from sufficient. It is not commensurate with or ambitious
enough to address the depth of the human suffering and of the
economic hardship which the disorder is placing on affected
individuals.
The formula by which specific funding is allocated by the
NIH is a mystery to us. Far more money is spent on diseases, as
you said, which affect fewer people. We understand that the NIH
has to follow the scientific opportunity, but we ask that
decisions be linked directly to the real costs to society. We
invest vastly more money in Alzheimer's research, for example,
which has a much shorter course between diagnosis and death
than autism.
Autism is a lifelong disorder which has no apparent
inherent impact on longevity. Children diagnosed today with
autism will be an economic and emotional burden to the country
for the next 70 years.
Nearly 2 years after the passage of the Children's Health
Act, its conditions and goals are far from being met. A recent
report prepared by the National Institute of Mental Health in
February of this year contains what we consider to be several
inaccuracies. It reports that $56 million is spent each year on
autism, and we believe that these numbers are slightly
exaggerated due to accounting numbers of dollars that are spent
from related activities. We would like to see those numbers put
specifically toward direct research dollars that are focused on
autism.
We would also ask our friends at the NIH, when they put out
these reports, to show us where the numbers are coming from, so
that we continue to maintain a relationship of trust and
accountability between the public and the Federal Government.
We have been told by the NIH to anticipate the designation of
two of the five clinical centers mandated by the act this year.
Even this small step took a lot of effort on the advocacy
groups' part. The casual attitude of the NIH toward autism does
not reflect sufficient urgency in our minds. While it was
stated in an NIH report to Congress that there would be an
increase to $15 million per year for these centers, it became
clear that is not going to be happening in the near-term.
We would like to request that more than two Centers of
Excellence be designated in this cycle of funding and three to
four more in the next cycle, as the law provides for a minimum
of five centers. Time is of the essence. We realize that
scientific and medical research moves forward slowly, and I
know that from my own experience at the bench. We could double
or triple the pace if the NIH were to designate more centers in
this cycle now and then an additional number in the next cycle.
I know that there are qualified applicants and centers who
are anxious to get started. There have been minor activities by
the Federal Government in brain and gene banking, as required
by the act, but we expect a larger concerted effort, as
described in the legislation.
These brain and gene repositories are vital resources to be
able to understand all aspects of the disorder, including the
environmental interactions with these factors. The advocacy
groups have invested substantial dollars in these resources,
and we expect a larger effort from the government.
The NIH also needs to increase its intramural programs in
autism. We have been trying, since the beginning at CAN, to
develop field-building in which we recruit heavily at major
national neuroscience meetings to try to bring people to the
field of autism. I know that the NIH recognizes this and is
supporting intramural programs, but we believe that it is very
important that be one of the goals of the NIH, to develop
scientists who are maybe working in labs alongside with the
NIH, who are actually working on autism and don't realize that
they are because this is a complex disorder that affects many
biological systems in the body, including the GI tract and the
immune systems.
The Children's Health Act mandated that physician and
public education programs be developed to allow for earlier
diagnosis and intervention. It is well established that this is
currently the most effective means of changing a child's course
on the catastrophic course and possibly creating a productive,
independent person. The Department of Health and Human Services
has failed to move these programs forward.
In New Jersey the advocate groups came together and funded
a program called First Signs, which we launched last year at
the Autism Caucus. It has been piloted in New Jersey and seems
to be successful in training doctors.
It is unacceptable that 49 States do not have a formal
mandated training and education program for doctors and the
public. People are losing precious time. We lost lots of time
with my son because no one knew what he had.
Finally, we have heard that the CDC, also as part of the
Children's Health Act, has been prevented from fulfilling its
prevalence research studies due to the Family Education Rights
and Privacy Act. They have been working with the Department of
Education for over a year to allow access to the education
records that hold diagnostic information. We think that should
be able to be resolved so that the CDC can be allowed to do
their job.
The passage of the Children's Health Act was an incredible
first step in changing the course of this disease, and the
parents want to thank Congress for this. There is great
momentum, but it will take much more effort and money than the
not-for-profit advocacy groups could ever hope to sustain. We
ask Congress to continue to lead us forward and for the NIH and
CDC to show leadership in autism.
My son still has autism, of course, and so do hundreds of
thousands of other Americans. They need our government agencies
to be responsive.
I would like to close by thanking the members of the
committee for listening to us and for acting on our requests.
[The prepared statement of Mr. Compton follows:]
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Mr. Burton. Members of the committee, we are going to have
a vote in about 10 minutes. So what I will do is I will yield
to you right now for questions, and then I will stay here. Then
I guess, Dr. Weldon, if you can come back and take the Chair,
so I can rush over and vote, and then we will keep the hearing
going, if that's all right with the vice chair.
So let's start with you, Mrs. Morella. Do you have any
questions? I will ask my questions while you guys are running
over to vote.
Mrs. Morella. I was not the first to arrive here, if you
want me to yield to Mr. Horn.
Mr. Burton. Let's see, I think Dr. Weldon was the first to
arrive. So we will start with Dr. Weldon then. Then we will go
to you, Mr. Horn. Is that all right?
Dr. Weldon. Thank you, Mr. Chairman.
Mr. Grossman, the agenda that you put together, could you
just tell me a little bit about how you came to those
recommendations? You had some figures in there. Did you have a
committee that helped you work on that?
Mr. Grossman. These figures were actually put together in-
house at ASA. We have been inundated recently by numerous media
in the United States, as well as in Europe, to support the data
about explosion in the prevalence of autism. We were challenged
to find any good studies or any information out there. We
reviewed extensively all the literature that we had available.
We put it out to many people that are on our panel of
professional advisors, other consultants that we know,
professionals in the field, to provide us with information that
would support the data, show some meaning to the statistics
that we feel we need to support showing this increase.
Frankly, there is nothing out there. There are no good
studies. This is all anecdotal evidence. So basing what we know
on the ranges that exist that are commonly being bantered about
and accepted, we put together a formula of approximately what
it would take to fund at this point the research.
If you are specifically addressing the research and like
the $500 million, for example, we are looking at the cost of
autism, which is, we conservatively say, $20 billion annually.
That is based on what we figure is the prevailing--the numbers,
conservative numbers, of a half million times about $40,000 per
person for treatments per year, which is actually a low figure.
Dr. Weldon. Did you have any professionals help you put
this together? Tell me a little bit about ASA. How many members
do you have and how many staff?
Mr. Grossman. There's 200 chapters throughout the United
States. We have approximately 25,000 members throughout the
United States. We have a panel of professional advisors made up
of about 20 experts in the field. Our membership extends beyond
the 24,000. We don't exclude anybody that has an interest in
it. Our office here is located in Bethesda, MD. We have a staff
of, I believe, seven people.
The committee was made up of staff and people on our board,
as well as professionals that we were consulting with. We would
gather the information, extend it out through conversations,
and then come back to put that information together.
The $500 million, it is, to be frank with you, a drop in
the bucket compared to really what needs to be done to address
this. It is what we felt was a conservative number to approach
the government with.
We feel also that much has to be done. That is why there is
a 3-year ramping up of those figures, because the
infrastructure of what is available today in America to support
autism research is not there. It needs to be developed to get
us to that point.
Dr. Weldon. I am glad you raised that point because this is
one of the issues I have gotten into with the NIH. I was very
pleased that Mr.--is it ``Mr.'' or ``Dr.'' Compton--Mr.
Compton, he alluded to this issue, that if we were somehow able
to get an appropriation through this year for $500 million, the
NIH would be really hard-pressed to find a way to spend that
much money. There are not a lot of people prepared to do the
research studies.
I don't recall, did you say anything in your
recommendations about behavioral treatment at all? I know we
need to do a lot of basic science treatments in terms of the
pathophysiology and preventions, but dealing with all of these
older kids and adults, it seems to me there is really not a
good body of knowledge. Some of it seems to be emerging.
Mr. Grossman. Yes, I mentioned in my testimony that
virtually it is nonexistent today, the research that is going
on on the therapeutic aspect or the treatment aspect of autism,
and we specifically ask for a ramping-up over the next 5 years
to a level of about $100 million, based specifically on the
behavioral treatment, therapeutic, clinical aspects of autism.
Dr. Weldon. I am running out of time. I have one more
question. Your health insurance policies cover virtually
nothing, correct? You get a diagnosis of autism. Your typical
Blue Cross/Blue Shield, whatever, they will not cover any types
of therapies, treatments whatsoever, correct? So these families
are literally on their own? It is all out of pocket?
Mr. Grossman. Yes, essentially, it is all out of pocket.
The only avenue that is available to us is services provided to
us by the educational system.
It is funny that you brought this up because that is an
important issue that we are grappling with on the insurance
that would require a full hearing on its own. Recently,
California was able to pass legislation mandating that
developmental disabilities, and specifically autism, be covered
under the medical insurance plans in that State.
Dr. Weldon. Thank you, Mr. Chairman.
Mr. Burton. Mr. Horn.
Mr. Horn. Thank you, Mr. Chairman.
I have been very interested in what you had to say, and
there is a few simple things I need to know. Is it Asperger's?
What is this disease?
Mr. Shore. Asperger's syndrome.
Mr. Horn. Asperger's. Could you tell me the difference
between autism and that? I see in our lists here that, after
Mr. Shore's bit, that he is a doctoral candidate at Boston and
also has Asperger's disease, sometimes known as high-
functioning autism. I would like to just get a feel for what is
that particular part of this.
Mr. Shore. Well, the major difference between autism and
Asperger's syndrome, we talked about the autism spectrum,
ranging from severe to light. At the severe end that is what we
consider the classical canner's autism. That is what most of
society thinks of children with autism. These are the children
that we see being nonverbal, having tantrums whenever there is
a change in the environment, perhaps being self-abusive, a
strong, you might say, or severe lack of body-to-environmental
awareness.
As we move to, say, the moderate part of the spectrum, we
have more environmental awareness. These children have more
receptive language abilities. So they understand more than they
can speak. They may be considered being limited verbal, perhaps
having one or two-word phrases and not very many of them.
At the high-functioning end, and Asperger portion of the
spectrum, that is the lightest end of the spectrum, and we
actually see more people over there than at the severe end.
These children, particularly with Asperger's syndrome,
according to the DSM-4 revised, they don't have any delay in
communication, but the issues of socialization--I should say
verbal ability. There are still difficulties in communication.
So we see major issues in communication, socialization,
restricted interests, and repetitive motions.
Now when we move to Asperger's syndrome, these are the
children that strictly, according to the DSM-4, have never lost
their verbal ability. Applied a little bit more loosely, these
are children, to need to be specific, who had have verbal
ability until 18 months, the bomb hits; we lost verbal ability
and we get it back. So usually by around the age of 4 or 5 or
so, maybe 6, the verbal ability is back. It is pretty much at
the level of most other people, but the language is used, you
might say, in a unique way and there is often difficulties with
dealing with abstract subjects, you might say reading between
the lines, which translates to difficulties in being able to
determine what other people's intents are, if it is not spoken
in a very concrete, clear way.
The important thing to keep in mind, though, is that with
both autism and Asperger's syndrome the issues are coming from
the same place. You are still dealing with the communication
issues in one way or another. The most severe end, lack of
verbal ability; the lighter end, Asperger end, verbal ability,
but difficulties in dealing with pragmatics or what is between
the words, you might say.
You still have restricted interests, special interests they
are called, as Tony Oustwich talks about them, interests that
are so strong that they actually interfere with daily
functioning. What the current educational--what people are
beginning to learn in education is to use these special
interests in order to facilitate learning.
Repetitive motions, that is often the self-stimulatory
behavior that we see, and an issue that the DSM-4 doesn't cover
that I find present throughout the autism spectrum, sensory
integration issues. In that case what we are talking about is
some of the senses are turned up too high, way too high. I know
people on the spectrum that if they were in a room like this, I
would see their eyes vibrating like this, and they would say,
``We've got to get out of here.'' Because they actually see the
cycling of the fluorescent lights above that screen there. Some
senses are up too high, some are too low, and other senses,
information that comes in from the senses is distorted or
unable to use the information, you might say, in a typical
manner that other people would.
Mr. Horn. Mr. Compton, is there anything you want to add to
this definition?
Mr. Compton. No, I think that Stephen described it fairly
well.
Mr. Horn. So I would be curious about what type of either
biochemical, chemical, or whatever, to work on some of these
things. Would you work with autism as well as Asperger's
approach or are there certain other ways that would call for a
different type of scientific approach?
Mr. Compton. Well, I would like to address one of the
aspects that Stephen brought up, which would be that,
obviously, people with Asperger's who have more communication
are more readily, I believe, have their symptoms remediated by
behavioral teaching and interventions.
In the area of I think what you are referring to as
pharmacotherapy, I would say that we are in the infancy of
that. I just returned from an autism clinical trial task force
that our foundation held in Los Angeles last week, and I
believe to this day there have only been seven well-controlled,
double-blind, placebo-control clinical trials in autism.
Because we don't know what the underlying neuroanatomical
substrates are that are aberrant or the biochemical pathways
that are aberrant across the spectrum, it is very difficult at
this point to design targeted therapeutics for the disease.
We are still not certain how many disorders are represented
under the umbrella of the autism spectrum. I would be certain
from the data that I heard last week that certain treatments
will actually give serious adverse effects to some patients,
increase their hyperactivity and motor stereotypies, cause
restlessness, decreased sleep, whereas in another subset of
patients we may see improvements with these types of therapies.
So I would say that it is too early in the field to generalize
about any of this.
When we think about treatments that go beyond the brain to
the GI tract or to immune dysfunction, they we have opened up
an even wider area that we need to study. All of this reflects
back on the fact that we need to cast a wide net and we need
more money, and we need more intramural programs, because
despite the fact that we have made tremendous progress in the
past 5 years through a lot of the advocacy groups funding
research and the NIH's efforts with the CPEA programs and the
newly funded research, we are far from having any clue as to
how to develop effective therapies.
Mr. Horn. Do you feel like the report to Congress is an
accurate representation of what is happening in autism
research?
Mr. Compton. Well, I would say, I was talking with Dr.
Foote before this, and we don't have a line-by-line itemization
of each dollar that is spent, but when we look at the directed
programs, which we are very happy that money is being spent
there, we don't see it add up to $56 million. Now that can be
due to something that as a scientist I firmly agree that we
need to field-build and we need to fund research in other
areas, but in the autism community I believe that we need to
focus on autism. When there are basic research questions being
addressed which could include development of brain imaging
techniques or genetic techniques, or what have you, for those
to be lumped under the category of spending on autism, if in
fact that is being done, I'm not certain if that is being done,
but we do see an inconsistency that could be explained by this
phenomenon. That is acceptable in the sense that the intramural
researcher, if it is being claimed as being money spent on
autism, that the intramural researcher is actually doing autism
research or at least collaborating with a researcher who is
doing autism.
I would suggest, if possible, that there be a detailed
report from the Public Information Officers, so that we would
feel as a community that there was an open dialog on this
issue.
Mr. Burton. Mr. Horn, can we go to Mrs. Morella, and we'll
come back to you in just a moment? We are going to have a vote
here, and I want to make sure she has an opportunity.
Mr. Horn. I have got to dump some stuff off for later
things, so I will try to come back.
Mr. Burton. That would be fine.
Mr. Horn. OK.
Mr. Burton. Mrs. Morella.
Mrs. Morella. Thank you, Mr. Chairman.
I think as people who are here assembled probably know, you
have had a real commitment to try to unlock those secrets of
autism. Had I thought about it earlier today, I would have worn
my autism ribbon, which is puzzle pieces, you know, seeking to
come together, but they have yet to do that. But we on this
committee have been seeking the data, wanting to know more
about what studies are being conducted, and are rather
frustrated about the fact that so much needs to be done and has
not been done yet. That is the purpose of the meeting. So I
thank you for this hearing, Mr. Chairman, and for your
commitment.
Mr. Grossman, you probably know that I represent Bethesda,
MD, where ASA is located, very proud of the fact that is your
national headquarters.
Mr. Shore, I am a graduate, as is my husband and a couple
of my kids, of Boston University. I congratulate you on
pursuing doctoral studies, and I thank Mr. Compton and Ms.
Lerner for being here.
Also, I represent the National Institutes of Health, and I
am very proud of the work that they do, and I am very proud of
the fact that in the budget that we approved on the House side,
and the President submitted, there is like a 16 percent
increase for NIH, which is going to bring it to that 5-year
plan of having doubled the budget of NIH during that 5 years,
by 2003.
Now the question I want to ask all of you, or however time
will allow, is: NIH is going to be at the table right after
you. If you had a chance to ask them a question or if you had a
chance to say to them, ``How do we work together''--I mean, are
they providing information? Is there a partnership? Does there
need to be more of
a partnership? I know their intent is very good. So it could be
that you want to say something for the record and that you
would like to ask them something or make a suggestion.
I would like to start off with you, Mr. Grossman.
[The prepared statement of Hon. Constance A. Morella
follows:]
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Mr. Grossman. The relationship that ASA has developed with
NIH over the last year has been very, very positive. The
communication has been----
Mrs. Morella. I would add CDC, too.
Mr. Grossman. Right, and the CDC has been very, very
positive. There's been much communication between us in terms
of us addressing our concerns with them, and them providing us
answers to those issues.
I am the representative on the Interagency Autism
Coordinating Committee also, which is a forum which started,
our first meeting was in November, which summarizes at that
first meeting all the activities of the Federal agencies and
will be an organization or committee going forward that,
hopefully, will be coming forward with more suggestions.
In looking at the report to Congress, for example, which
describes in detail what NIH and CDC is doing, it is pretty
much I believe they have been mandated at this point to do.
What we would need to do, and I don't have any specific
suggestions for them at this point, is that we need
collectively, the autism community, as well as the legislative
branch and the administration, needs to provide them with the
resources that they need specified for autism to expand their
research efforts, to expand the service delivery.
This incorporates a much broader base than just those two
agencies, NIH and CDC. This is a national emergency. It has
reached epidemic proportions. It is not only a two-Federal
agency issue. It is a national issue, and we need to bring it
forward as such.
Mrs. Morella. Would any of the other panelists like to
respond to that? Yes, Mr. Compton?
Mr. Compton. Yes, I would like to respond. Despite the fact
that I may have sounded critical about the NIH, I am absolutely
thrilled with what has been going on since my son was
diagnosed. When I first went to my first meeting and I saw Dr.
Bristol Powers speak, I was very impressed, and I still
maintain tremendous hope.
I think that the NIH and its subdivisions, the NIMH and
NICHD, etc., and the CDC need more money. It may sound
ridiculous, but $56 million is not very much money when you
look at the vast number of systems that are affected in
autistic individuals.
Beyond the medical research, at a biological level, there
is a need, for instance, to develop protocols, to measure
outcomes in clinical trials, and it does not just mean clinical
trials of pharmaceuticals or interventions. It means clinical
trials of educational interventions, which need to be held to
the same degree of scrutiny. A lot of families are wasting
money on therapies that are not biologically based, which are
probably also not helping their children.
I would like the NIH to break down any of the barriers
among the agencies and try to promote as much collaboration as
possible. When it comes down to it, I think it is all about
money and the prioritization and, as we talked about earlier,
the way that decisions are made to weigh the cost of the
disease to society versus the cost of investment. I think that
needs to be looked at critically, and to develop the intramural
programs such that there is true focus of related fields to
this disease. It not only gets you more bang for your buck, but
creates the cross-talk and the collaborative environment that I
think is going to be necessary to correct the situation.
Mr. Shore. I have something to add. I think it is a great
start. We need more. We need more work on collaborating, and I
see a lot of in-fighting between the autistic community. If we
just look at educational interventions, like some of the ones
that I have named, there is no--I haven't found any study where
anyone who has taken a serious look at comparative methodology.
What I find in looking at the different methodologies such as
the ones I have listed, a lot of them are doing similar things,
but they are calling them different names.
Also, because of such wide differences in people with
autism, it is a wide spectrum. There are some children where a
particular method works much better than another method. I
would like more research. Actually, that is going to be part of
my doctoral dissertation, but that is just a start. I am just
going to validate the instrument.
What I am talking about is something that will be able to
allow us to match the child to the method, because at this time
it is a bit like the Keystone Cops: ``Oh, this method is the
greatest; that's all there is. The other methods aren't worth
even thinking about.'' We should be kind of ashamed of that. We
should all be working together and corroborating.
Mr. Compton's suggestion of outcome studies, they are very,
very important, longitudinal studies, hard to do, but we need
them.
Mrs. Morella. Thank you. You have all been very helpful in
responding to that question. Thank you, Mr. Chairman.
Mr. Burton. Thank you, Mrs. Morella.
One of the things that has concerned me has been the large
incidence of autism being created, I believe, by things like
thimerosal, which includes mercury in that preservative. In
Russia, in the 1980's, they recognized problems. As a matter of
fact, we just got a letter that we received this week from a
professor of medicine at the Academy of Medical-Social
Management in Russia, and this letter details the history of
concern about thimerosal in vaccines and injury. This is a
concern, as I said, that reaches back to the eighties.
I would like to specifically note that Dr. Krashenyuk
states, ``starting vaccination against hepatitis B of premature
infants at age 2 months . . . when they reach a weight of 4
kilograms is recommended in the U.S. From our point of view,
this practice is undoubtedly harmful, since it does not take
elementary notions of the infant's immunity into account--up to
1.5 years of age the infant does not have its own immune
protection, and is protected only by the mother's passive
immunity.'' And then he goes on to say, ``It is impossible
today to deny the fact that this preservative,'' thimerosal,
``can cause severe post-vaccination complications in
children.''
[The information referred to follows:]
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Mr. Burton. That same conclusion has been reached in
countries like Norway, Sweden, and Denmark has not allowed any
thimerosal in any of their vaccinations since 1990.
Was there any connection when your children became
vaccinated and the onset of the autism? Did you notice it in
close proximity? Any of you at the table?
Ms. Lerner. Not me personally, but I can tell you that,
because of the controversies surrounding the MMR, I was very
concerned when my son had to get his second round of
vaccinations. So in New York State they allow you to get a
titers test to determine what the immunization level is for the
child and whether or not it necessitates a second vaccination.
As a result of that blood test, it showed my son still had very
high levels of the immunity in his system, which led me to
believe that, for whatever reason, based on his neurology, he
was not able to properly metabolize the original vaccination
that he got. Now Ben's symptoms date back to, I think, infancy,
but there is demonstration that obviously, based on their
compromised neurology, that they can't process these
vaccinations in the same way.
Mr. Burton. In the audience, how many have noticed a change
in your child after the vaccinations?
[Significant show of hands.]
Mr. Burton. OK, I just wanted to know that from the
audience.
Mr. Grossman. Mr. Chairman, if I can comment on that?
Mr. Burton. Yes, sure.
Mr. Grossman. Personally, I didn't recognize any change in
my son. We knew something was wrong, and it was about at the
time that he would have received his vaccination, but it took
us a while before we figured things out. It actually was my
sister, who is a practicing psychologist in Philadelphia, that
took a trip with him to the mainland, and she noticed that I
had to get some interventions for him, something was terribly
wrong, and she threatened to take my son away from me unless I
did.
But I think the stories that I have heard that many of our
members tell, that many of these people in the audience will
tell you, is that they believe that there is evidence that
there is a direct linkage, a direct causation of vaccines
causing their child's autism. I think it is imperative for us,
the advocates in the room, for ASA, and for Congress, for the
lay public, to stand together to get this question answered,
answered immediately.
We are perhaps creating generations of children that are
severely getting injured through vaccinations. We don't know
that, but there is a growing body of evidence such as what you
are reporting from Europe that really draws into question what
is going on. So whatever is necessary from you to give us
direction on what we need to do, we will support that.
Mr. Burton. How many members? You said you had 25,000
members in your organization?
Mr. Grossman. 25,000 members, and we have an extended
membership of people that are signed up as advocates that
actually don't pay a membership. Our reach, we believe, extends
into certainly 50,000 to 60,000 people at any one time.
Mr. Burton. Now the organization that you are connected
with, Ms. Lerner, how many members do you have? Do you know?
Ms. Lerner. It is hard to actually quantify that because we
are an umbrella organization, and organizations like ASA, CAN,
NAR, they are all part of our group. So we would be
collectively whatever their membership----
Mr. Burton. So it would be kind of included in the same?
Ms. Lerner. Yes.
Mr. Burton. How about you, Mr. Shore?
Mr. Shore. Yes, the Asperger's Syndrome Coalition of the
United States, I believe we have a reach of probably 2,000 to
3,000 by the time the mailing that is rebound all over the
place.
Mr. Burton. OK, and your organization?
Mr. Compton. CAN's membership, I am not sure if the
membership is completely autistic, for autistic families, runs
at about 35,000.
Mr. Burton. Around 35,000? Well, somewhere between 60,000
and 100,000 people can be reached by your organizations, and I
am sure there are other organizations here that I am familiar
with. I would like to just restate one more time what I said
earlier. That is that the squeaky wheel gets the oil in this
town.
I cited the amount of money that is being spent for the
various research projects including AIDS and diabetes, and so
forth, and the comparison of that with the money that is being
used for autism research. We are going to be funding at a much
higher level research at NIH in the coming years, and this is
the time for you to be proactive.
I cannot stress enough how important it is, and I will be
doing my part here as well, and other Members will, to contact
your Congressman, your Senators. Don't just write to one; write
to them all, if you can, in your State, and make sure and tell
your members, make sure to tell them how important it is that
there be an increase and an adequate amount of funding and the
proper research into rehabilitation for children and
prevention, to make sure that we find out what is causing this,
not just possibly things like mercury in vaccines, but other
things, maybe other toxic substances that may be in the
vaccines, maybe mixing too many at one time. The immune system
might not be able to handle that much. Maybe it is the MMR
vaccine. I don't know what all the circumstances are, but that
research needs to be done, and it is going to cost money. It is
going to take pressure to be exerted from folks like you folks.
Yes, go ahead.
Mr. Waxman. I want to join you in supporting more research
because there is still so much we don't know about autism. We
do not know how prevalent it is. We need to do the research in
order to understand what the actual prevalence of autism is and
whether the increases in cases is due to better diagnosis or to
environmental causes that can be prevented, or some combination
of factors.
We also don't understand the causes of autism, nor do we
have a cure. That is why Congress enacted the Children's Health
Act of 2000. This act, which I strongly supported, increased
funding for autism research. But we need to do more than wait
for the research. The National Academy of Sciences has made it
very clear in a report last year that early intervention is
critical for educating and treating autistic children. It is
incumbent on the medical and educational communities to
identify children in need of services as early as possible, and
it must be a high priority for Congress to assure that all
children with developmental delays, including autism, have
access to scientifically proven treatment and educational
services that can maximize their potential.
I appreciate the contribution of all the witnesses who have
testified at these hearings and educated us about what it is
like to live with a child with autism or to live with autism
themselves. I want you to know that the experiences you have
recounted are part of the record. They will be shared with our
colleagues, and they are going to have a genuine impact.
Thank you, Mr. Chairman.
[The prepared statement of Hon. Henry A. Waxman follows:]
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Mr. Burton. Thank you, Mr. Waxman. We do appreciate what
you have done in the past to help in this area.
Let me just say to this panel that we really appreciate
your testimony. We hope you stick around to hear what the NIH
people have to say and the people from our health agencies.
We are going to take a brief recess here. Dr. Weldon will
start the hearing, and I will be back as soon as I get a chance
to vote on the floor.
We stand in recess at the fall of the gavel.
[Recess.]
Dr. Weldon [assuming Chair]. Chairman Burton asked me to
reconvene the hearing.
So I would like to again convey his thanks to the first
panel, and I would like to ask our next panel to come forward
and take their seats.
The committee will now resume. On the second panel we have
Dr. Steven Foote, Director, Division of Neuroscience and Basic
Behavioral Science, National Institute of Mental Health, at the
National Institute of Health, and Dr. Coleen Boyle, Associate
Director of Science and Public Health, National Center on Birth
Defects and Developmental Disabilities. And we have a third
panelist, is that right? You are going to accompany Dr. Boyle,
OK. And your name is?
Ms. Wharton. Melinda Wharton.
Dr. Weldon. OK, could you all please rise?
[Witnesses sworn.]
Dr. Weldon. Let the record indicate that the witnesses
indicated in the affirmative.
I want to thank the panelists for being here. I would ask
you to try your best to summarize your comments to
approximately 5 minutes, and we will begin with you, Dr. Boyle.
Please proceed.
STATEMENTS OF COLEEN BOYLE, ASSOCIATE DIRECTOR FOR SCIENCE AND
PUBLIC HEALTH, NATIONAL CENTER ON BIRTH DEFECTS AND
DEVELOPMENTAL DISABILITIES, CENTERS FOR DISEASE CONTROL AND
PREVENTION, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ACCOMPANIED BY MELINDA WHARTON, DIRECTOR, EPIDEMIOLOGY AND
SURVEILLANCE DIVISION, NATIONAL IMMUNIZATION PROGRAM, CENTERS
FOR DISEASE CONTROL AND PREVENTION; STEPHEN FOOTE, DIRECTOR,
DIVISION OF NEUROSCIENCE AND BASIC BEHAVIORAL SCIENCE, NATIONAL
INSTITUTE OF MENTAL HEALTH, NATIONAL INSTITUTES OF HEALTH, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND ANN WILLOUGHBY,
DIRECTOR, CENTER FOR RESEARCH FOR MOTHERS AND CHILDREN,
NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
Dr. Boyle. Good afternoon, Congressman Weldon and members
of the committee. I am Dr. Coleen Boyle, Associate Director for
Science at the National Center on Birth Defects and
Developmental Disabilities at the CDC, and I am accompanied by
Dr. Melinda Wharton, who is the Director of the Epidemiology
and Surveillance Division at the National Immunization Program
at CDC.
First, I would like to thank you for the opportunity to
update you today on CDC's activities related to autism that
have occurred during the year since your last hearing. I would
also like to thank the parents, the autism advocacy groups, and
Mr. Shore for sharing their concerns with us about autism.
The committee requested that CDC testify about the problems
of autism and what we know about the apparent increase in
rates. We were also asked to discuss the timeline for
implementation of the research recommendations from the IOM
evaluation of the autism vaccine-related issues as well as
CDC's funding for autism research. We are prepared to discuss
these issues.
The committee also requested that we address research
efforts conducted by the CDC into treatments for autism
spectrum disorder. CDC has not conducted research into the
treatment of autism spectrum disorders since the NIH is the
agency responsible for such clinical research.
Last year I told you about the report of a prevalence study
that has already been mentioned today in Brick Township, NJ.
That investigation found rates of 6.7 and 4.0 per thousand
children for autism spectrum disorder and for autistic
disorder, respectively.
This year we can report on the prevalence of autism
spectrum disorder in the metropolitan Atlanta Disabilities
Program. This report shows a prevalence of autism spectrum
disorder of 3.4 per thousand children, as you have already
heard. We believe this to be a minimum prevalence and that most
of the cases that we have included are actually autistic
disorder. In general, the Atlanta rate is similar to that which
we found in Brick Township. We cannot determine whether the
rates are increasing or not because we don't have comparable
data from earlier years, but we will continue to monitor the
current rate closely.
We can also not yet generalize for a prevalence for the
U.S. population. The population in Brick Township was very
small, about 9,000 children, and the population monitored in
metropolitan Atlanta is much larger, close to 300,000 children,
but we cannot assume that is representative of the U.S.
population. Determining if there are regional differences in
autism prevalence really requires data from other regions of
the country.
To address this need, we have implemented a State autism
monitoring program. In fiscal year 2000 we funded five States
to track autism. In fiscal year 2001 we funded four Centers on
Autism and Developmental Disabilities Research and Epidemiology
for the purpose of not only collecting prevalence data, but for
conducting collaborative epidemiologic studies to try to begin
to identify causes and preventable risk factors for autism.
With these programs, plus the one that CDC runs in Atlanta,
we have now nine States involved in monitoring the prevalence
of autism. With the new funding that we have received in fiscal
year 2002, we expect to add at least three programs, bringing
the total up to 12 States that will be tracking autism
prevalence.
Monitoring the prevalence of developmental disabilities
such as autism provides a number of challenges, including
identifying proper sources for case information. Unlike birth
defects that are more easily identified in the first year of
life, developmental disabilities are diagnosed later in
childhood and may require nontraditional sources for public
health monitoring.
Collecting data from these sources has proved challenging.
CDC will continue to work with colleagues in other agencies to
try to address this important issue.
In 2000, CDC and NIH contracted with the Institute of
Medicine to establish an independent expert committee to review
the hypotheses about existing and emerging immunization safety
concerns. Some researchers have suggested that the receipt of
either the MMR vaccine or thimerosal-containing vaccines has
been associated with various neurodevelopmental disabilities,
including autism.
The IOM was asked to review the available information on
these issues. In the March 2001 IOM report regarding the
association between MMR vaccine and autism spectrum disorder,
the committee concluded that the evidence favors rejection of a
causal relationship at the population level between the MMR
vaccine and ASD.
In October 2001 the IOM Immunization Safety Committee
published a report on the possible association between
thimerosal-containing vaccines and neurodevelopmental
disorders. In this report the IOM concluded that the evidence
is inadequate to accept or reject a causal relationship between
exposure to thimerosal vaccines and the neurodevelopmental
disorders of autism, ADHD, and speech and language delay.
In these reports IOM also made specific recommendations for
a number of epidemiologic studies. The CDC has initiated a
broad range of studies to better assess these findings as well
as to address recommendations by the IOM Immunization Safety
Review Committee. These studies are discussed and detailed in
my written summary.
CDC remains committed to collecting accurate data on the
prevalence of autism and to conducting studies to find its
causes. We want every child to be born healthy and to grow and
develop normally, so that they are able to lead productive
lives. We are dedicated to continuing our work to identify what
causes autism and how it can be prevented.
We appreciate your attention to this problem and we look
forward to working with you, Dr. Weldon, and other members of
the committee.
[The prepared statement of Dr. Boyle follows:]
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Dr. Weldon. Thank you very much, Dr. Boyle. We will now
hear from Dr. Foote. You may proceed.
Dr. Foote. Dr. Weldon, members of the committee, I am Dr.
Steve Foote, Director of the National Institute of Mental
Health's Division of Neuroscience and Basic Behavioral Science.
Entering on cue is Dr. Ann Willoughby, Director of the Center
for Research for Mothers and Children at the National Institute
of Child Health and Human Development, who is accompanying me
today.
The sustained attention that this committee has directed to
the issue of autism research has helped to focus and accelerate
our efforts at NIH. I appreciate the opportunity to talk with
you about NIH support of research on autism. I am a
neuroscientist who has been interested in the brain and its
disorders throughout my career. Like others, I have found
autism to be a particularly challenging mystery.
My view of this disorder has been broadened and deepened
recently by my continuing interactions with family members of
children and adults with autism. I feel their urgency. An
affected child cannot wait for research before growing up. Each
day, each potential improvement is crucial.
I would like to acknowledge the important role of family
and advocacy groups in our efforts. They have not only raised
the visibility of autism and challenged assumptions, they have
pushed for accelerated and expanded research activities.
Today I would like to report on progress that has been made
at NIH. Only a few years ago research on pervasive
developmental disorders, the autism spectrum disorders, was
fragmented and distributed across NIH institutes and other
agencies with little coordination. Today a more integrated, but
still appropriately specialized approach is in place.
The basic research on autism that is sorely needed is
moving forward at an accelerated pace, as is continued genetic
research and studies of the etiology of various symptoms, such
as communication disorders. I am a witness today because I play
several roles in this integration and overall comprehensive
planning. I am the Interim Executive Secretary of the
Department of Health and Human Services' Interagency Autism
Coordinating Committee that was created under a provision of
the Children's Health Act of 2000. In addition, I serve as a
scientific program staff member of the NIH Autism Coordinating
Committee, a longstanding body that serves to coordinate
research efforts within the NIH.
We have made much progress in implementing the provisions
of the Children's Health Act of 2000 that focused on NIH
research activities. The act authorized augmentation of autism
research activities at the National Institutes of Health and
the CDC.
First, with regard to the Interagency Autism Coordinating
Committee, the Secretary of the Department of Health and Human
Services delegated to NIH the authority to organize the IACC,
and NIMH was asked to lead this effort. The IACC has already
begun to enhance communication and effective interaction among
the several agencies that support or conduct autism-related
research, service, or educational activities, and it will
engage family and advocacy groups.
The NIH Autism Coordinating Committee has continued to act
within NIH to allow program scientists and directors of the
relevant institutes to come together to plan and conduct
research, and it communicates closely with the IACC. The
inaugural meeting of the IACC was held in November 2001 on the
NIH campus, and it included the public members selected by the
Secretary. Lee Grossman, for example, was one of the founding
public members of that committee. The date of the second
meeting has been set for next month, and we are on schedule, as
stipulated in the Children's Health Act, to have twice-a-year
meetings of that committee.
In terms of accelerated and expanded research activities,
NIH issued a Request for Applications to implement on a fast
track the requirement for new Centers of Excellence Programs
for autism research as specified in the Children's Health Act.
An RFA is a clear statement to the field, setting aside funds,
that NIH invites research applications in a particular area.
These comprehensive centers are to be called STAART Centers,
which stands for Studies to Advance Autism Research and
Treatment.
A number of applications were received in response to this
initial RFA. They were reviewed last month, and the successful
applicants will be funded this summer. A second round of
competition has already been posted. It will close in August of
this year, and those successful applicants will be funded in
2003. At that time the full network of at least five centers
stipulated by the law will be in place. The five participating
NIH institutes have established a funding pool of $12 million
per year.
This past year the NIH ACC also endorsed two other RFAs,
one for groups planning to submit center applications this year
in order to allow them to undertake planning activities, and
one for innovative research into treatments for autism.
In addition to these activities, NICHD and NIDCD will
competitively renew their longstanding Cooperative Program for
Excellence in Autism. This program will expand to be
essentially the same size as the STAART program. And in yet
another enhancement of the NIH autism research portfolio,
NIEHS, in collaboration with the EPA, has funded two new
centers focused on autism research.
We at NIH are in a heightened state of awareness concerning
the need for more research on autism, due to the clear
magnitude of this major public health problem and due to the
work of many people within and outside this room, and we have
been making progress. As mentioned earlier, our budget for
autism research has expanded rapidly over the past few years,
more than doubling. The research now in this portfolio, and to
be included in the near future, holds the promise of answers
not only for children with autism, but also for unlocking the
secrets of brain development, what its possibilities are, how
it goes wrong, and when to intervene, which will help all
children realize their potential.
In summary, NIH is on schedule in terms of implementing the
letter and the spirit of all aspects of Title I of the
Children's Health Act, including a broadly based increase in
autism research support,
the initiation of a new Centers of Excellence Program, the
extension of the CPEA Program, the enhancement of genetic and
other resources, and the establishment of the Interagency
Autism Coordinating Committee.
I would be happy to answer any questions.
[The prepared statement of Dr. Foote follows:]
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Mr. Burton. Thank you, Dr. Foote. Dr. Willoughby, does she
have any comments?
Dr. Willoughby. No, sir.
Mr. Burton. You are just there to hold him up if he falls
down. [Laughter.]
Dr. Willoughby. He doesn't need it.
Mr. Burton. OK. I would like to put a chart up there. Maybe
you can explain this to me. The chart on the comparisons,
please, the NIH one. Yes.
I don't know if you can see that. Do you have a slide that
you can put it on the slide machine, so that they can maybe see
it clearly?
What that says is that, for diabetes, the yellow line on
diabetes shows for fiscal year 2003 there's $845 million; in
fiscal year 2002, the blue line, it is $781.3 million, and in
fiscal year 2001, it is $688.1 million.
If you look at the middle set of lines, that concerns HIV
and AIDS. There is $2,770,000,000 in fiscal year 2003;
$2,000,515,000 in fiscal year 2002, and $2,247,000,000 in
fiscal year 2001.
Then that very last part that is very difficult to see,
that shows autism. In 2003 it will be $70 million, and in 2002
it will be $65 million, and in fiscal year 2001 it is $56
million.
Now, according to the statistical data we have, there is
about the same number of people who are autistic estimated as
there are HIV, and yet the amount of money that is projected to
be spent for HIV is going to be almost $3 billion as opposed to
$70 million for research. Can you explain that to me? Any of
you?
Dr. Foote. Well, I think you know better than I do that
these budget figures result from a complex state of affairs
that involves not only NIH, but Congress, public health issues,
and history. I don't think that I could adequately explain
exactly how those numbers came about.
Mr. Burton. Well, NIH, as I understand, they come up to the
Hill and they propose to the appropriators, the Appropriations
subcommittees, ``The College of Cardinals'' we call them up
here, they propose various amounts of spending or spending
levels for various things. Can you tell me, in the last 2 or 3
years, how much money has been requested for AIDS research or
for diabetes research or for autism research?
Dr. Foote. The short answer is no.
Mr. Burton. Well, could you get that for me?
Dr. Foote. Yes.
Mr. Burton. I would like to know what NIH is asking for.
Dr. Foote. We can obtain that information for you.
Mr. Burton. Now NIH receives unprogrammed, unallocated
funds for research, and I don't, how much is that? Do you know
how much money that is? Well, it is in the billions of dollars.
Can you tell us how the research spending levels are decided
over there, the unspecified, unprogrammed moneys?
Dr. Foote. Yes. NIH has several approaches to funding
research. One of the largest is to accept investigator-
initiated grant proposals, which are subjected to peer review.
Priority scores are assigned, and then program officials like
myself make final funding decisions and budgetary decisions.
There's a distribution of funds among basic research
funding pools, basic research that is applicable to biomedical
research. This issue has come up earlier today. For example, as
one of the earlier witnesses pointed out, in an area that is
relevant to autism, we support a number of studies of brain
development, imaging the brain in children, activities that are
relevant to understanding childhood disorders like autism or
attention deficit hyperactivity disorder. A certain fraction of
our funds goes into those basic research efforts. There are
other funds that are dedicated, in the case of clinical
neuroscience, to efforts to understand specifically brain
development in individuals affected with autism, and so forth.
Mr. Burton. Let me interrupt just a minute here. The NIH
estimates that now 1 in 250 children born will become autistic
between the ages of 3 and 8, I believe. Now that is your
estimate. That is NIH's estimate. That is an epidemic. That is
a major, major problem, and yet only $70 million is going to be
allocated for research in this area in 2003, and only--what did
I say--$65 million this fiscal year. I would suggest that it
might be wise to take a look at those unallocated funds and see
if more of that couldn't be appropriated or utilized for autism
research.
The other thing I want to point out to you, and you were
here, you have been here for the whole hearing. I am sorry you
had to wait so long, but they always take longer than we
anticipate, especially when we have votes.
I want you to look around. Everybody that has a child who
became autistic shortly after being vaccinated, hold your hands
up, please. I want you to look at that. Do you see that? I
didn't put them up to that. But every time we have a hearing--
and, incidentally, I will hold my hand up, too, because my
grandson was a perfectly normal child, was going to be 6-foot
10. I was planning on him in the NBA to take care of me in my
old age. Within just days after getting nine shots in 1 day he
was banging his head against the wall and running around the
wall.
And all these people tell you pretty much the same thing.
Yet, when we have people from NIH and CDC up here, they
continue to tell us, well, we don't have any information or
evidence that these vaccines have anything to do with it. Hold
your hands up again, will you, please?
[Significant show of hands.]
Mr. Burton. I want you to look at that. Now I don't know
what you want for evidence, but that ought to be enough to make
sure that there is very comprehensive studies done on
thimerosal, which has mercury in it, that is going into so many
children's vaccines. Now, granted, you are taking it out.
You have been up here before, I believe, but I have also
mentioned that every Congressman who gets a flu shot gets
thimerosal, too. I told the doctor today, Dr. Eisold, the
physician here on Capitol Hill, that I am going to inform every
single Congressman and Congresswoman and Senator before the
next shots are given for flu vaccine that they have mercury
being injected into their bodies. Now we all want to get the
flu shot, obviously, because we don't want to have that
confused with anthrax and maybe die or something, because the
anthrax scare was a real one, and the symptoms are similar. But
we want to make sure that everybody is informed about it.
I tell you, most people who had their children vaccinated
did not know that they were being injected with mercury. I
mentioned earlier I think five or six countries that have
stopped using thimerosal in their vaccines, and I read a letter
from this Russian doctor who says there is no doubt that it has
a bad effect on children who are being vaccinated. Yet, we
continue to put mercury into these children, not in one
vaccine, but in my grandson's case, I think it was seven or
eight of the nine in 1 day.
So I would urge you, and you will be getting a letter from
me and the head of the Autism Conference. We will be sending
you letters signed by probably 50 or 100 Congressman urging you
to do more extensive research into the vaccines and into the
causes of autism in the coming years. We're also going to be
contacting the members of the Appropriations Committee to try
to earmark funds for that, and the people in the audience are
going to be contacting everybody they know that lives and
breathes to write to their Congressmen and Senators about it as
well.
[Applause.]
Mr. Burton. Thank you. Thank you. I didn't request that,
either.
Dr. Weldon, do you have any questions you would like to
ask?
Dr. Weldon. Yes, thank you, Mr. Chairman. I have some
questions for Dr. Boyle.
Dr. Boyle, you mentioned several studies that the CDC is
undertaking in response to the recommendations of the recent
IOM. I have several questions regarding those studies.
First of all, as you know, many Americans are suspect over
the ability of the CDC to conduct an unbiased study. Rightly or
wrongly, these are legitimate concerns. Well, they are
concerns, whether you feel it is right or wrong. I certainly
hope that those concerns are being taken into account.
If the research you are doing is to have any real effect on
public perceptions, you must make every effort to ensure
independence. Otherwise, the CDC will have not achieved its
desired goal of restoring public confidence in the vaccine
program.
Specifically, to get to my questions, the first study you
mentioned using the MADDSP data appears to be an epidemiologic
study. Is that right? There are no biopsies done as part of
that study to look at the presence of measles in the intestinal
tracts of these children, correct?
Dr. Boyle. That is correct.
Dr. Weldon. The second study you mentioned is designed to
determine whether or not the timing of the MMR has any
association with the onset of regressive autism. Again, this is
another epidemiologic study, correct?
Dr. Boyle. Yes, and, actually, that one is being conducted
in conjunction with NIH.
Dr. Weldon. It is? OK. So, again, no biopsy specimens, no
tend to look at the gastrointestinal tract.
Dr. Foote. There are blood samples to examine questions of
excretion and blood levels of mercury and immune parameters.
Dr. Weldon. The third study, I think it is a study out of
Denmark, again, an epidemiologic study, but then you mentioned
a fourth study?
Dr. Boyle. Actually, that one also has biological markers
in it as well.
Dr. Weldon. The third one?
Dr. Boyle. The Denmark study.
Dr. Weldon. The Denmark study? Is it serum specimens?
Dr. Boyle. This is done in collaboration with the Danish
National Research Study, and it actually looks at some
particular biomarkers.
Dr. Weldon. What are those biomarkers?
Dr. Boyle. Various neurotropins. There is a study that was
reported last year at the hearing by Dr. Cary Nelson at the NIH
that looked at some specific neurotropins that may, in fact, be
predictors of autism. So what we're trying to do with that
study is essentially look at whether or not these particular
children may be more vulnerable.
Dr. Weldon. What I really wanted to get though is in the
fourth study, you say you are in the early stages of planning
this study to investigate whether or not measles vaccine strain
virus is present in the intestines of some children with ASD.
So is that the one where you are going to try to look at the
issues raised by Dr. Wakefield in his reports and Dr. O'Leary?
Ms. Wharton. There is a study that is still in development.
No word has made yet to an investigator to do the study, but,
yes, there is a plan to look for the presence of measles virus
geno-meno-testinal tissue.
Dr. Weldon. One of the concerns that I have is that the
biological markers is a competent lab. As I understand it, the
standards and the techniques that Dr. O'Leary uses are not in
common use in most labs. They are relatively unique and there
are only a small handful of labs that are capable of
duplicating that work. Is that correct?
Ms. Wharton. Yes, similar methods to what Dr. O'Leary used
were being put in the study, and laboratory work will be done
simultaneously on blinded specimens by a number of different
independent laboratories.
Dr. Weldon. OK. The question I have for you, are you making
every effort to make sure that the virology sampling and
analysis is of the same quality and caliber as the work that is
done by Dr. O'Leary? I am saying this because, if you publish
something and if other scientists can nitpick it and say they
didn't use this technique and didn't use that technique, and
the techniques were faulty, then we are not going to restore
public confidence in the system and we are going to be back to
square one.
Ms. Wharton. Yes, I appreciate that, Dr. Weldon, and thank
you for making that point. There will be an effort made in this
study to use the best virologic techniques available, as well
as having specimens obtained from patients whose clinical
systems are well-characterized, whose vaccinations and disease
histories are ascertained with appropriate blinding of the
specimens.
Dr. Weldon. Thank you very much. I would like to be
notified as soon as possible when you are ready to--I guess you
do Request for Proposals associated with that study?
Ms. Wharton. Yes, as far as I know, no specific funding
mechanism has yet been identified, but we hope to be able to
make an award this fiscal year.
Dr. Weldon. Thank you. Well, please keep my office
informed.
Dr. Boyle, the epidemiologic study on thimerosal, the
preliminary data, as you know, did not show any link with
autism, but did show a statistically significant link with
speech development disorder, and then the final analysis that
statistically significant link disappeared.
There have been a number of people who have wanted to look
at that data, and the CDC has not released the datasets. Could
you explain to me why the CDC has not released the datasets on
that information? There is some concern that the sampling
techniques used may have diluted down the information.
Ms. Wharton. With your permission, Dr. Weldon, I will
respond to that question. There has been a lot of discussion
about the differences in the preliminary analyses of the
screening data from the Vaccine Safety Data Link with the
subsequent studies done.
The major differences between the preliminary analyses were
that they included followup through 1997. Because of the way
the Vaccine Safety Data Link works, we receive additional
information each year regarding subsequent followup on
patients. So what has happened since then is we now have
several years of additional followup on the children who were
initially part of the study cohort, which actually should
greatly enhance our ability to detect neurodevelopmental
problems which may not be diagnosed until the children are
older.
With extension of the study 2 years, from 1997 through
1999, there is an average increase in followup of 23 months. So
it is not that we have diluted it out by including younger
children, but we have extended followup, and that accounts
primarily for the differences in findings between the
preliminary analyses and the subsequent analyses.
Regarding your question about access to the information, as
you know, the Vaccine Safety Data Link essentially is
electronic medical information of a large number of
individuals. There is a strong obligation to maintain the
confidentiality of those data. That need has greatly
complicated the ability to make the information, the dataset,
available for independent review.
However, we appreciate this request and have worked very
hard with the individual health maintenance organizations that
participate in the Vaccine Safety Link Data Project to identify
mechanisms through which independent researchers can repeat
analyses from these sorts of vaccine safety studies while
maintaining the confidential nature of these private medical
records, as well as the proprietary interests of the health
maintenance organizations that participate in the project.
We have been able to develop a process that is quite
comparable to that used by the National Center for Health
Statistics, using their Research Data Center, so that a dataset
can be made available for re-analysis using a protocol that
could be developed by independent researchers. We have shared
this plan with Chairman Burton's staff. So, in fact, we have
been able to solve, I think, the most serious problems related
to re-analysis and will be prepared to receive protocols to----
Dr. Weldon. To release the data?
Ms. Wharton. It is making the data available for analysis
using a protocol that has been written. We can't release the
data because these are confidential medical records, but the
data can be made available in a secure setting, so that
analyses can be performed by independent researchers.
Dr. Boyle. I just may add as well, this is a prototype that
the National Center on Health Statistics has developed for
other types of confidential information, allowing people
access, allowing them to have availability of the resources to
actually analyze the data.
Dr. Weldon. Well, what I would like to see is the data made
available as soon as possible, so that an independent review--
so that the committee can look at the data. Certainly, I
understand the need to maintain patient confidentiality.
One other question I have: Dr. Boyle, you were in my office
about 2 years ago. We talked about incidence, and you talked
about the Atlanta study. It was just getting underway. So,
based on the information you have recently released, the
incidence rates that were being spoken of, 1 in 250, 1 in 500,
and many scientists were questioning that 2 years ago and 3
years ago, you are saying now, yea, verily, at least in Atlanta
that it is that high, and it is reasonable to speculate it may
be that high throughout the Nation? I know you are scientists
and you are going to say we have no proof of that, but I have
been in Atlanta and I have been to lots of other cities. I find
it hard to believe that this would be exclusive to Brick
Township and Atlanta. So the rates are really high?
Dr. Boyle. Based on what we found in Atlanta, they are very
comparable to what we found in New Jersey. The important part
of what we found in Atlanta is that most of, even though we
call it autism spectrum disorder, the way we find cases is
through access to school records, and we know that most of
those children are children who are in special education.
Higher-functioning children, children with Asperger's disorder,
or children with higher-functioning autism may not be captured
by those methods. So, in fact, the rate, if you look at the
whole spectrum, might be a little higher.
Dr. Weldon. Well, I know you are scientists and you won't
believe it is going to rain unless the weather balloons go up
and measure the humidity in the clouds and the barometric
pressure, etc., but, and I think I have said this before at
previous hearings, when I started medical school in the
seventies, I didn't know anybody with autism. I never saw any
kids with autism. I didn't know anybody on the faculty with
autism. I didn't know, I never saw a case as I went through all
the rotations. The thing that has really dramatically struck me
is I am starting to hear everywhere so-and-so's got a child
with autism. I think it is one of these things where the
scientists are the last to find out what is going on.
I am certainly glad your data verified what everybody has
been saying, that we've got a crisis, and I certainly would
encourage you to duplicate the analysis in other locations and
try to refine the data as much as possible, and then continue
to track it to see if the rate is increasing even further. I
certainly appreciate all the work you are doing.
I yield back to the gentleman from Connecticut.
Thank you very much. Thank you for your testimony.
Mr. Shays [assuming Chair]. I thank the gentleman.
I want to apologize. I don't usually take the Chair when I
haven't heard the testimony, but Mr. Burton is on the floor of
the House on an issue that he also cares deeply about, and as
we know, he is a very passionate person, thank goodness.
I want to ask you a question, Mr. Foote. ``Doctor,'' I'm
sorry. I just want to ask you, do you think the title of this
hearing is appropriate in terms of its being an epidemic or
would you qualify it in a certain way, and if you would qualify
it, how would you qualify it? It is not a trick question. It
sounds like it, but, honestly, it isn't.
Dr. Foote. I think it is clear, as Dr. Weldon was saying,
that there has been a change. It has been a change that has
involved a substantial increase, as in Chairman Burton's
definition of an epidemic as an unexpected large increase in
the prevalence of a disorder. Given that definition, I think it
is fair for him to use that term. I would call it a large
increase, and our response, I believe, has been appropriate;
that is, that we are mobilizing and we are assembling the
structure, and putting it in place, that will provide resources
for investigators to undertake large-scale studies that would
not previously have been possible that are necessary to address
a disorder that is occurring this commonly. That is our goal,
and that is what our actions have been: to establish centers
where young investigators who are interested in autism can be
trained to go on and develop the science that is going to be
necessary to have rational treatments for this disorder.
There is only so much we can do in a short period of time.
Science is an endeavor that takes a lot of training and a
certain amount of ramping-up to be able to use funding in an
appropriate and very high-quality way. So we are hoping that we
are putting in place the infrastructure that will allow that to
happen.
Mr. Shays. Thank you. That is a very helpful answer.
Dr. Boyle, how would you respond to that question?
Dr. Boyle. Well, I guess, rather than sort of fooling with
the semantics of it, I feel, based on the work that we have
done, the work that many other people have done, that the
prevalence of autism is clearly much higher than what we
previously thought, and that we need to have a concerted
response to that issue.
I think at CDC we have strived over the last 5 years to do
that, both in terms of trying to understand the magnitude of
the problem, who's affected, and then by actually setting up
sort of the research, epidemiologic capacity, to begin to
address why this is happening.
It is clearly hard to look retrospectively and say, what
was the rate 30 years ago, what was the rate 15 years ago. We
don't have that data assembled. But I think it really shows us
that in this country we need to understand that developmental
disabilities, including autism, are extremely important
conditions, and conditions that we all must take seriously.
Mr. Shays. Let me understand. It is my understanding that
CDC is going to actually be reducing its spending next year on
autism. Is this accurate, and if so, why would that be
happening?
Dr. Boyle. Well, actually, we were appropriated $9.7
million for autism in 2002. We also included additional funding
for autism-related activities from the Vaccine Safety Program.
I can actually let Melinda talk. We are still going to be
expending the $9.7 million for autism that is specifically
appropriated by Congress for those activities.
Mr. Shays. Let me just say something, just so I can put
this on the record. I don't fault administrators when we in
Congress don't appropriate the money, but where administrators
become responsible is when they see a need and they can fill a
need, they don't request the money, and then we in Congress
don't respond.
I am getting the sense that in the last years this has been
mostly generated by Congress kind of pushing NIH and others to
treat this as a more important effort. I may be wrong, and I am
happy to be corrected.
But, I'm sorry, you wanted to make your response?
Ms. Wharton. Well, I was going to elaborate on what Dr.
Boyle just said----
Mr. Shays. Sure.
Ms. Wharton [continuing]. About the small reduction that
you see in the projected CDC numbers for fiscal year 2003. As
Dr. Boyle said, there has been a certain amount of money
appropriated for autism activities, and that has been
supplemented by vaccine safety appropriations. There have been
a number of studies launched in response to different issues
that have come up related to autism that have been initiated in
the last couple of years. Some of those studies, the final
funding cycle is in fiscal year 2002. So that accounts for the
apparent reduction. In the fiscal year 2003 spending we have
only reported to you what we currently anticipate spending
based on the President's budget, but, of course, if additional
issues arise that require additional studies, those might very
well be the studies we would end up doing in fiscal year 2003,
in response to new concerns or problems that arise.
Mr. Shays. When a President submits a budget, and I don't
pretend to be a big spender, and I voted against spending, so I
am not suggesting where blame lies here, but what I am
interested in knowing, though, is if the President and the
Budget Director are not suggesting enough funds for either of
your agencies as it relates to this effort, have you gone on
record as saying you need more money, not just with Congress?
Let me start with the Budget Director, or are you basically
just accepting whatever has been allocated?
Dr. Boyle. This is really not done at my level. I clearly
feel like this is an important issue, but it is really done at
levels above me.
Mr. Shays. OK, Dr. Foote.
Dr. Foote. Well, the same is true for me, but, once again,
to point out the way NIH does business, we have to have
scientists who have the skills and the motivation to propose to
us, even if we publicize an RFA, the kind of science that is
necessary to address the issues. So we need to cultivate fields
and we need to develop the competence and the expertise and the
people and the resources to make the research possible. More
often, that is a matter of sustained investment over a period
of at least a few years to get fields really ready to take
advantage of opportunities. So, yes, we have consistently, I
think, advocated for that approach to biomedical research.
Mr. Shays. I used to chair the Human Resources Subcommittee
of Government Reform and for 4 years had oversight of NIH and
CDC, and so on, and FDA as well, and HHS. I am very familiar
with the point you are mentioning. I think it is important to
put on the record.
But would it be fair to say that you have a pretty good
comfort level that if the field was hearing your testimony,
that we wouldn't be flooded with people who say, ``I've come in
with proposals and I've been told there isn't the money''? Are
you pretty comfortable in suggesting to this committee that
there aren't a lot of people out there looking to do research
in this area, and that you have to cultivate this group? Is
this kind of what you are suggesting?
Dr. Foote. I think if there is appropriate training offered
and if the structure that we are establishing and that other
institutes at NIH have long supported, such as NICHD and NIDCD
with their CPEA Program, the field expands because this is an
interesting problem. This is a problem that scientists are
motivated to get into and to try to help. There will be growth.
As you know, once the seed is there, then sometimes growth can
be quite rapid. So I think that is the scenario we are looking
at, that in a few years, over the next few years, there will be
investigators coming in with applications, and so on, and we
will need to plan for some sustained growth in this area, so
that people don't get disappointed. So that is the scenario we
will be trying to plan for, sustained growth.
Mr. Shays. In our public life, just in our private life, we
may come in contact with families and friends who have children
that have different challenges, and autism being one of them,
but in our public life, we're obviously exposed to more
families. I find myself thinking, what if I was the parent? I
would find myself somewhat frustrated with traditional
medicine, given that it sometimes does seem to prod,
traditional research. I would be very fearful that there
weren't things that I was doing to my child, or had done, that
may have contributed; in other words, if they were allergic to
certain things, and so on.
So I have tremendous empathy as to why people don't want to
wait too long, because wouldn't it be amazing to think that,
when we discover something 5 or 10 years from now, we will
learn that there were things we were doing for our kids,
thinking we were helping them, when we were actually hurting
them, and there were things that we could have done at a
younger age that would have made them well, but at an older age
may not have the same impact. I know you all have to have that
sense as well.
I want to ask a few questions that the staff has prepared.
So I will be reading a few of these, but I would like to put
them on the record, and I would like the synergy of both of you
responding and making comment.
But, Dr. Foote, this is to you. It relates to Dr. Ruth
Kirchstein of NIH. I guess she is the Deputy Director, is that
correct?
Dr. Foote. She is currently the Acting Director of NIH.
Mr. Shays. She published research she conducted in the
1960's on thermara----
Dr. Foote. Thimerosal.
Mr. Shays [continuing]. Thimerosal, yes.
Dr. Foote. Yes.
Mr. Shays. Our staff has been seeking to speak to her about
this research and what other research she conducted relative to
this. I am interested if you or anyone else at NIH is looking
at this issue, and whether she will be getting back in touch
with our staff. We need some cooperation from her, frankly.
Dr. Foote. I can carry that message back.
[Applause.]
Mr. Shays. Let me just say something to our guests. In this
hearing it is truly a hearing, and so I want to respect your
interests, but it is important that we have decorum.
Dr. Foote. My understanding is that was an FDA research
effort. So I think probably it is also appropriate to request
of FDA whatever documentation they have.
Mr. Shays. Can we, given that you are before our committee,
can we anticipate that you will certainly try to help us in
this regard?
Dr. Foote. You can anticipate that we have heard what you
have said, and that we will carry the message back, yes. Thank
you, Mr. Chairman.
Mr. Shays. Isn't it going to be important to evaluate the
real-world treatment approach in autism and not just one
therapy at a time? Let me just repeat the whole question. And
don't you think it would be important to find a practice-based
research center that is providing care for individuals with
autism, so that we can track cutting-edge treatments in real-
world situations?
Dr. Foote. Well, the issue of treatment, obviously is a
primary one for families faced with an affected individual. As
we were just discussing, it may be some time before there is a
treatment founded and based on the pathophysiology of the
disorder and derived in some rational way that really has a
silver bullet approach to this disorder. In the meantime,
people, of course, need to be trying to help their children,
and doing it in as timely a way as possible, and in a way that
is guided as much as possible by reliable information.
So NIH has in place several research programs focused on
treatment. The CPEA networks have strong treatment components
utilizing treatments that families are making use of right now,
aimed at evaluation of their effectiveness and, as has been
mentioned many times, which subset of affected individuals that
treatment might be most appropriate for.
When we issued the RFA for the new STAART centers, the one
requirement, absolute requirement, we had was that each
application had to include a treatment component, a treatment
study, and for a center to be considered to be fundable it had
to have at least one treatment study that got strong ratings
from the Peer Review Committee. So it has been our intention
all the way along that in this major new effort treatment would
be an inherent and major part of the overall effort.
Then I might note, finally, that this past year the NIH
Autism Coordinating Committee issued an RFA as the result of
which we funded seven applications having to do with new
approaches to treatment, and we have funded those seven grants
to get them going. So we are trying to undertake an effort
where we are developing basic science for long-term treatment,
but we are also doing these very much more immediate efforts
where people have to find treatments; they have to use
treatments now. People look for evidence. They say, ``I want to
use the kind of treatment that has the best evidence supporting
it,'' and they often find that they go and look and the
evidence base is very fragmentary, anecdotal, highly variable.
It is not clear to them what to do when faced with this entire
array of possible treatments. So we have undertaken efforts to
try to help to deal with that as well.
Mr. Shays. Thank you. I am going to have the staff ask
these questions, and ask as many as you want. I am going to
listen to them. I might jump in, but I think that we might
cover this more quickly to do it that way, given that they are
going to be a little more familiar with your responses as well.
Ms. Clay. Dr. Foote, when can we expect the NIH intramural
program to replicate Dr. Wakefield's research?
Dr. Foote. I'm sorry, there was a distraction. When can we
expect the intramural research program? I'm sorry, is that what
you said?
Ms. Clay. Yes. When can we expect children to be able to be
seen at the NIH Clinical Center who have autism and who also
have gastrointestinal issues to be investigated in the same
manner that Dr. Wakefield did?
Dr. Foote. I don't know the answer to that. I would be glad
to find out the answer to that and furnish it to you.
Mr. Shays. That would be helpful. Thank you.
Ms. Clay. Yes.
Isn't it going to be important for the program at the NIH
Clinical Center to be expanded for autism?
Dr. Foote. It sounds to me like that is addressing
basically the same issue of what is happening on the NIH campus
in terms of the ability of people to access that facility and
get advice and potentially care, or enter into clinical trials,
through that particular facility. I am afraid I don't know the
answer to that. I will have to find out, but we will try to
provide an answer that encompasses both of those questions.
Ms. Clay. Dr. Boyle, we have talked about the CDC's Vaccine
Safety Data Link project today. You have been tracking for 10
years vaccine adverse events through several HMOs. The
committee asked for the raw data a couple of years ago, and we
were told we could not have it because the HMOs were
threatening to pull out of the project. We have learned that at
least one pharmaceutical company has had access to the data
through one of the HMOs and that other individuals have tried
to receive this data through Freedom of Information Act and
been denied.
Why has the pharmaceutical industry been given preferential
treatment?
Ms. Wharton. The study in question was actually done by one
of the participating HMOs and was not a Vaccine Safety Data
Link project. These individual HMOs each have their own
research organizations which make their own arrangements with
outside entities, including universities, pharmaceutical
companies, vaccine manufacturers, and others, to do research
using their patient population.
The particular study you are referring to, which I believe
was initially on the list of VSD studies actually shouldn't
have been on that list because it wasn't a VSD study. It was a
study engaged in by one of the individual organizations in
corroboration with a manufacturer, which they do many studies
in terms of post-licensure safety studies, for example, these
individual organizations.
Ms. Clay. So your position is that no pharmaceutical
company has had access to the Vaccine Safety Data Link project
tapes at all?
Ms. Wharton. That is my understanding.
Mr. Shays. Could you verify that? In other words, would you
check that out?
Ms. Wharton. Yes, we can get back to you on that, but that
is my understanding.
Mr. Shays. And would you, in getting back, confirm yes or
no? In other words, if your answer is the same, don't not get
back to us; say that you have confirmed your answers.
Ms. Wharton. Yes, I will do that. Thank you.
Mr. Shays. Thank you very much.
Ms. Clay. In reviewing the publications that were provided
to us from the CDC from this project, it appeared that an equal
or more number of these projects were not looking at vaccine
safety issues, but were looking at ways to increase
immunization rates. Is that an accurate assessment?
Ms. Wharton. I'm sorry, I can't answer your specific
question.
Ms. Clay. We were given about 45 published studies.
Fourteen of them were looking at potential adverse event
correlations doing vaccines. Another 14 or more were specific
studies looking at how to improve immunization rates. So, in
other words, how we were going to have increased uptake of
vaccine usage within the HMOs, not at all about vaccine safety.
Ms. Wharton. Well, the Vaccine Safety Data Link is used by
the participating investigators to answer a variety of
questions, including disease incidence, other issues beyond
those related to vaccine safety, but it is still done within
the same constraints of the system; that is, maintaining
confidentiality of the patient records.
Ms. Clay. Well, given the need to find out the issues of
vaccine safety and the lack of research looking at adverse
events, and that the creation of this project was specifically
to look at adverse events, wouldn't it be important to put our
focus there first?
Ms. Wharton. Well, I appreciate your comments, and I can
assure you that the people who are directly involved with the
VSD project share your concern that the primary focus of the
project has to be vaccine safety. The other projects that have
been done through the system have really been, in general,
smaller projects that have not required use of substantial
resources. This system was created for vaccine safety, and
vaccine safety continues to be its primary focus.
Ms. Clay. And who at the CDC makes the decision of what
projects can and cannot be conducted with the access to this
data?
Ms. Wharton. It actually is not CDC's decision. It is a
collaborative project involving a number of health maintenance
organizations, which, as I noted earlier, have their own
research structures and their own principal investigators. This
group collaboratively reviews protocols and makes decisions
about what are appropriate uses of VSD resources.
Ms. Clay. And as we move forward in having protocol
established for outside experts to have access to this data,
can we be assured that the data will be available fairly, and
that there will be no reduction of access to the projects that
they are requesting the data for?
Ms. Wharton. Well, clearly, it is our intent to make the
dataset available for re-analysis. A protocol will need to be
developed and will need to be approved by the institutional
review boards of the participating health maintenance
organizations, but, yes, the dataset will be made available,
the appropriate dataset will be made available for the re-
analysis.
Ms. Clay. Can we be assured then that if a researcher wants
to conduct an independent analysis of Dr. Verstraeten's study,
that can be done without bias?
Ms. Wharton. You have asked a difficult question, and I may
not be giving you quite the answer you are anticipating.
Actually, I think there are some real issues with Dr.
Verstraeten's study, and the epidemiological term for that is
``bias.'' But, yes, what needs to be done is a protocol
developed that will specify what data are needed for analysis,
and those data will be provided in this confidential, in this
secure setting of the Research Data Center at the National
Center for Health Statistics using the existing model,
following IRB approval.
Mr. Shays. Does the gentlelady, Ms. Watson, have questions
that she would like to ask? We are having staff just pursue
some questions, but if you have some questions or comments, I
would love to recognize you.
Ms. Watson. Let me just first thank the committee for
holding this hearing. Since I am so late, I am wondering if
there was a connection made between the fumes and the toxicity
from mercury in the amalgams and autism. All right, we had kind
of reached and bridged a gap. We thought there was some kind of
connection.
Mr. Shays. If you would like to just ask a question or two
about that, we would be happy to have you do that.
Ms. Watson. Yes. Let me ask those from CDC, I'm carrying a
piece of legislation that will prohibit the use of mercury in
dental fillings. Fifty percent of that silver that they call
silver is really mercury. The bill will outlaw eventually the
use of it at all, but we want people very well informed when
they go in to have fillings.
Can someone comment on whether there has been a connection
made between mercury fillings and autism? Does that ring a bell
with anyone?
Dr. Boyle. I'm Dr. Boyle from CDC.
Ms. Watson. Yes.
Dr. Boyle. As far as I know, there has been no study that
specifically addressed that issue in terms of dental fillings
and autism.
Ms. Watson. Yes.
Dr. Boyle. No, there has not been a connection, but also
there has not been specific studies.
Ms. Watson. In my literature that we have collected around
the bill, there has been some reference to not only autism, but
serious conditions of brain deterioration suspected coming from
that toxic substance that is emanating from the fillings. So I
would like to let you know that my door and mail is open. If
there is anything that you find in the literature that you
could share with our office, it would certainly help us.
My staff is just handing me a note that is saying in some
of the vaccines thimerosal contains mercury, and it is a kind
of preservative, and it goes into the filling. So what we are
looking for is any research, evidence, that would indicate a
connection. Thank you.
Mr. Shays. Does the gentlelady from California have any
other questions she would like to make?
Ms. Watson. No, Mr. Chairman.
Mr. Shays. I am going to have the staff continue to ask
questions. If you are still here and want to jump in, you could
do that.
Ms. Watson. Let me just ask one more question.
Mr. Shays. Sure. No, you have the floor.
Ms. Watson. In your research, is it true that autism
continues throughout a lifetime or can autism come to some
point where the person comes back to very normal growth? Can
someone comment on that?
Dr. Foote. Well, I think the observations are that it is a
lifetime disorder with sometimes quite striking remission in
certain symptom domains. The communication disorder, the
communication problems, for example, can improve substantially.
People have striking luck with certain kinds of treatments for
parts of the disorder in certain children. But these tend to be
sporadic, partial alleviation of the disorder rather than a
sustained and total remission.
Ms. Watson. Can the disorder be affected, say, for the good
through a change in nutrition? Is there any evidence?
Dr. Foote. There have been reports--we were just talking a
little bit earlier about the fact that the number of
appropriately blinded, placebo-controlled studies in autism are
several, literally several studies in the entire literature
that have been very well done. Nutritional changes haven't been
one of the domains in which there have been really careful
studies.
So there are examples of alleviation of symptoms with
dietary changes or nutritional supplements, but those tend to
be anecdotal; that is, stories about a few to several people
rather than carefully controlled clinical trials.
Ms. Watson. Are autism patients treated individually? The
condition can change for the better, but it still stays with
them for the rest of their life? So my question is, can they be
treated individually or is there a protocol?
Dr. Foote. Well, because we do not have broadly effective,
standardized, rigorously demonstrated treatments, and people
are confronted with serious difficulties in day-to-day life
with an autistic child, people search for treatments. So, given
that the typical story is that a given child will be exposed to
several different treatment regimes over a period of time, the
most broadly used treatments tend to be behavioral treatments
rather than drug or other kinds of treatments. There are
certain behavioral treatments, educational treatments, that
with sustained large investments of time and effort can show
substantial improvement in a large fraction of children. I
think that is a fair statement.
Ms. Watson. Institutionalization is one way to deal with
this disorder. What percentage of those identified during their
school years go into institutions, or do you have that
information?
Dr. Foote. I don't have that information.
Ms. Watson. Anyone?
Dr. Boyle. From our work in Atlanta and Brick, there were
no children who were currently institutionalized.
Ms. Watson. There are no children in Atlanta or no children
in your studies in the children that you know of?
Dr. Boyle. In our studies of trying to establish the
prevalence of autism, there are no children who were
institutionalized. However, the whole issue of
institutionalization in children, I mean there is clearly very
few children who are currently institutionalized.
Ms. Watson. Throughout the country?
Dr. Boyle. Again, this is just in Atlanta and New Jersey.
Ms. Watson. Just in Atlanta. So you don't have any
information countrywise? That is something I would like to
know. I know in California they do institutionalize. I know in
Massachusetts they institutionalize. I am just wondering how
prevalent it is across the country. Thank you.
Mr. Shays. Dr. Foote and Dr. Boyle, let me just say it is
our intention to let you get out pretty soon. You haven't had a
break or anything. Do you have 20 more minutes in you? Are you
OK?
I am going to do something that may seem a little unusual,
and I may have to just cut it off if it is not a good idea.
But, Dr. Foote and Dr. Boyle, if you can trust me in terms of
my ability to control a meeting, it is not lost on me that we
have a lot of people in the audience who have a keen direct
interest. There may be a question or two that none of us on the
panel here have asked that we should have. I am going to ask if
there is someone in the audience who may have a question that
says we should have addressed this. I will allow you to stand
up and tell the committee, and then we may choose, our
committee may choose to ask that question.
My motivation is that it would be a shame to have people
leave without you having the opportunity to respond and maybe
clear something up. Both of you have such a nice, friendly
smile. I figured I could get away with it. So we are going to
try it out, but I have the counsel--excuse me, the minority
counsel would like to ask you a few questions, the majority
professional staff would just like to ask a few more, and then
I am going to just throw it out to the audience, pick two or
three of you and ask you to stand and tell me if there is a
question you think we should have asked, loud enough so I can
repeat it to our witnesses.
There you go. So I will recognize the minority counsel.
Yes? Mrs. Morella, I had asked if there was any question, and I
had been told you didn't have any. Would you like the floor?
Mrs. Morella. I would love it.
Mr. Shays. You have the floor as long as you would like.
Mrs. Morella. Particularly because I represent the National
Institutes of Health, and, Dr. Foote, I am glad you are here,
and I work very closely with CDC, and I am glad you are here,
Dr. Boyle, too.
I was here for the first panel and heard the kinds of
questions or the points that they brought out. I think one of
the notes that I had jotted down was they felt there was a need
to develop a national policy, that we needed more
collaboration, that we needed to match the child to the method.
We pointed out the fact that there are just so many
questions that are still unanswered. Funding was stressed by I
think every member of that first panel. I am not sure--if you
would kind of comment on whether you see, what do you see is
really necessary? Is it the need for further collaboration?
Will funding alone do it? How do we get some of these questions
answered, particularly also with regard to vaccines and what
their connection is to autism? If any of you would like to
comment on that just general area? Dr. Boyle.
Dr. Boyle. I will start. I took some notes, too, during the
last panel. I would applaud the issue of collaboration. I think
we have made a good start across not just NIH and CDC, but all
the agencies involved. The Department of Education, the Health
Services and Resources Administration, all of these agencies
need to work together to address this issue.
Mrs. Morella. Should we do something about that? I mean, is
there direction we should be offering?
Dr. Boyle. I think the direction from Congress from the
Child Health Act clearly directed collaborations. It directed,
I think, to CDC and NIH, but other partners have clearly been
pulled into that. I think that we need to continue to make that
happen, as well as work with all of the parent groups that are
seated behind us here.
I applaud the effort of hearing from the parents at the end
of the committee hearing today. So I would definitely second
that notion.
The other thing I heard about was, though, the issue of
training.
Mrs. Morella. Yes.
Dr. Boyle. And this is training across the board. I think a
lot has happened in the last 5 years in terms of both
epidemiology researchers, diagnosticians, treatment issues. I
think that we have made clear progress, but I do think this is
an area that we need to put concerted energies into.
There is a lot of interest in autism and other
neurodevelopmental disorders, and we want to continue to have
that momentum happening it and growth in positive ways.
Mrs. Morella. Dr. Foote, I would love to give you an
opportunity to respond to any of those facets.
Dr. Foote. Well, the Children's Health Act called for the
establishment of an Interagency Autism Coordinating Committee.
We now have that up and running. There is, of course, always a
big distance between sitting down in the same room and talking
and converting that into something that resembles a national
policy or even a coherent picture of what it is that is being
done, which, of course, helps you identify what isn't being
done.
But I think at our first meeting, and I think on the agenda
for our second meeting of that committee, those are exactly the
jobs that we are taking on. I think we have the appropriate
representation on the committee to be able to do that in a
realistic way. So I think if there is going to be a national
agenda about autism, I think that there is a kernel for
starting that with the Interagency Autism Coordinating
Committee.
Mrs. Morella. Maybe this committee hearing will help to
spur that on.
Thank you, Mr. Chairman. I am pleased also to note your new
concept of involving the audience, involving the parents.
Mr. Shays. Well, we have done it before and it has worked,
but it does take cooperation.
Mrs. Morella. Right.
Mr. Shays. We will give it a try in a second. Excuse me for
not calling on you; I apologize. I think it was the nervousness
of thinking how we were going to do the latter. [Laughter.]
I recognize minority counsel.
Ms. Despres. Thank you. I have just a couple of questions
regarding that request for the Vaccine Safety Data Link data. I
was wondering if you could explain to us why the privacy
concerns are so important. I am particularly interested in what
could happen to the VSD if the participating HMOs didn't
believe that there was adequate control over patient
confidentiality.
Ms. Wharton. Well, in fact, I think just the fact that this
discussion has been ongoing for so long has convinced all of
them that there is no longer assurance that the data can be
maintained in a private way at CDC. The individual
participating organizations are no longer sending master
datasets to CDC. I think that unless these issues can be
resolved, the project is likely to no longer be possible to
continue.
What we have tried to do is develop a new way of doing
studies where, in fact, the data won't reside at CDC, but the
analyses will be done in a distributed way among the
participating organizations. This is something which is
theoretically possible to do, but operationally would clearly
require much more in the way of data management and statistical
support of the individual sites, as well as at CDC. So I think,
in effect, it will reduce the amount of work that will be
possible for us to accomplish within the VSD with existing
resources.
Ms. Despres. Can you explain to us, if the VSD is not able
to continue, what would be the implications for vaccine safety
research in the future? I am also curious about the
implications of the fact that the data currently is not at CDC.
What present implications on vaccine safety research has that
had and what implications could it have in the future.
Ms. Wharton. Well, at the moment we, as I understand it,
have not yet received any of the year 2000 data because none of
the organizations are currently willing to send it to us. So we
are not currently able to perform any studies easily in terms
of screening analysis that requires access to the year 2000
data. Now, again, the data do reside at the individual sites
and can be accessed in this distributed way, but it is far more
laborious.
Should the project cease to exist, I think it would
dramatically change--it would be a great loss for us. The VSD
has provided a mechanism through which vaccine safety concerns
could be rapidly addressed, and often reassurance provided in a
very prompt way when something comes up. Now many issues are
complex and do require more detailed investigation beyond what
can get from analyzing the automated data tape, and do require
chart review, and so forth. Those studies are more complicated
and take longer to perform, but the VSD has really been one of
the bedrocks of our vaccine safety system. I think its loss
would be a great one.
Dr. Boyle. Can I add a comment to that as well? I think
that this actually has had a ripple effect with the HMOs. We
are dealing with other issues where we would like to have a
rapid response and work with the HMOs because they are a wealth
of information and data, and they are reluctant to participate
because of these privacy issues.
Ms. Despres. So without having VSD data now and the
possibility that you won't have it at all in the future, would
that mean that it could take longer to detect vaccine adverse
effects?
Ms. Wharton. It clearly would take longer. It would clearly
be more laborious. It clearly would be more resource intensive,
and we would be unable to accomplish as much.
Ms. Despres. I don't have any more questions. Thank you.
Mr. Shays. I thank you very much. It is important to get on
the record. I appreciate it.
I recognize the majority professional staff.
Ms. Clay. Aren't some of the privacy concerns as a result
of the HIPAA regulations that are about to be implemented?
Ms. Wharton. Some of the privacy concerns do overlap with
HIPAA issues. There are additional State requirements in some
of the States in which these organizations persist. But it is a
general issue that we have to assure the confidentiality of
these data.
Ms. Clay. And is their not providing the tapes to you a
violation of the contract that you have with the association
that oversees these HMOs?
Ms. Wharton. We are in the process of trying to develop a
new procurement mechanism that will allow development of this
distributed model.
Ms. Clay. One of the correlations that we have looked at
between the issue of mercury in medicine and exposure for our
children is the same process that we went through in the 20th
century looking at lead in paint and its effect on children.
How does this issue correlate, the CDC and the NIH response
correlate for mercury as it did to lead in the paint 50 years
ago?
Dr. Boyle. Well, I will start first. One of the things that
we are hoping to be able to do with our State-based program is
to be able to monitor, and we call it, from an ecological
standpoint. The implications you have had were in terms of
looking at lead. But we are hoping to be able to look over time
at the prevalence of autism based on our State-based monitoring
program and how that prevalence may have been impacted based on
the removal of thimerosal from vaccines.
Dr. Foote. I think the NIH response to the thimerosal
issues has been to undertake a series of research projects
looking at metabolism, and distribution of ethyl-mercury in the
body, rates of clearance, and potential toxic effects. There
are several such research efforts now underway, some of which,
as we discussed earlier, and in collaboration with CDC. So I
think this is a serious and appropriate response to those
issues.
Ms. Clay. And, Dr. Foote, if a parent, when they have a
newly diagnosed child, goes to the NIH Web site and looks for
information on therapies for the child, will they find adequate
information?
Dr. Foote. Well, we have a joint linkage with the National
Library of Medicine in which there are large amounts of data
available. The real problem is one of the underlying science
and the underlying science not being adequately developed.
Anybody would be daunted right now in attempting to sift
through that information. I don't think it is as much a matter
of organizing the information as it is of literally developing
the information, and that is the effort that we have underway.
So, yes, we have taken seriously the task of having an
interface with the public that makes information accessible to
them, but our real job and the real effort that is going to
solve this problem is to have better information available.
Mr. Shays. Now let me state what I would like to do. I
would like to let our witnesses leave soon. I would like to
just say that this is a hearing of the House of
Representatives, of Congress, so the decorum needs to be done
well.
I am going to first ask how many people would like to ask
the question. I am going to invite five people to take each of
those five seats. I am going to invite you, Ma'am, in the front
row to come up to that seat up there, yes. I am going to invite
you in the very back to come up, the very back there. I am
going to invite you, sir, to come up. I am going to invite you,
Ma'am, in the middle, and I am going to invite you in the very
back there.
I am going to have you each take a seat. What I am going to
invite each of you to do, the committee is going to invite each
of you, you are just going to go down and you are going to
identify your name, as you ask the question, where you live. If
you have a loved one who is impacted, we are happy to have you
share the name of your child, but this is primarily for an
opportunity to ask a question. We will just see how it goes.
OK?
You all are nice--thank you--to let us do this.
Just turn the mic on, start at the very end, and ask your
question.
Ms. Mintz. Hi. My name is Sandy Mintz. I am from Anchorage,
AK. I am lucky enough not to have a child who has been injured
by a vaccine.
My question is, is NIH ever planning on doing a study using
the only proper control group, that is, never vaccinated
children?
Dr. Foote. I am not aware of--but note carefully what I
said, that I am not aware of--a proposed study to use a
suitably constructed group of never vaccinated children. Now
CDC would be more likely perhaps to be aware of such an
opportunity.
Dr. Boyle. The study that I mentioned earlier that we are
doing in collaboration with Denmark compares children who
received the MMR vaccine versus children who did not receive
MMR.
Ms. Mintz. But I am saying never vaccinated with any
vaccine. That assumes that other vaccines don't cause autism,
which is what needs to be studied, not assumed.
Mr. Shays. Let me just say that if you would turn off your
mic, I am happy to have you do the followup, if you would
respond to it.
Ms. Mintz. I'm sorry.
Mr. Shays. No, you don't need to apologize. And we will go
to the next. Do you have any other comment based on that? The
point that is being made, any vaccination. Could we just
suggest that you take this under advisement?
Ms. Wharton. The difficulty with doing such a study in the
United States, of course, is that a very small portion of
children have never received any vaccines, and these children
probably differ in other ways from vaccinated children. So
performing such a study would, in fact, be quite difficult.
The Denmark study was a study that, in fact, could not have
been done in the United States, although, of course, these
children did potentially receive some other vaccines, but
simply hadn't received MMR.
Mr. Shays. I will invite anyone who is here to speak to
staff or me afterwards if they want to augment a comment.
Let's go to the second person. I am sorry, I don't know
your name. So I can't call you by name. So you are going to be
a number to me.
Ms. Stewart. OK.
Mr. Shays. You are No. 2.
Ms. Stewart. OK. My name is Dr. Linda Stewart. I am from
New York. I am coming from Switzerland. I have been working in
Switzerland for 30 years in the political and internal affairs
international arena. I am also a mother of a son, my No. 2 son,
who has been recently diagnosed with autism spectrum disorder.
Mr. Shays. How old is your son now?
Ms. Stewart. He is 8.
Mr. Shays. OK.
Ms. Stewart. We returned to the United States, as he was
born and vaccinated in Florida. We had been to four or five
neurologists in Europe, the highest doctors we could find in
France, Switzerland, Italy, and we came to the United States to
find out if we could find any help for the boy since he was
born and vaccinated here.
All the tests, MRIs----
Mr. Shays. Let me ask you, can you do your question, if you
could, yes?
Ms. Stewart. Yes. All our tests showed normal, and we were
able to find a program by residents from NASA that showed the
child was full of mercury. My question to you, respectfully, as
scientists and researchers, what results, with all the millions
that I hear you mention back and forth today, what have been
your results in a pragmatic and functional level for the
millions of research that you have received in biological
autism?
Dr. Foote. The types of studies that happened and are
underway are studies about the levels of mercury that result
from vaccination and are about the timing of the onset of
autism symptoms in regressive and/or non-regressive autism and
how those may be or may not be systematically related to the
time of vaccination.
Some of those data are in; some of those studies are
currently being conducted, and some of those studies are still
being organized. The data are not yet in. But the money is on
the table. The studies have been funded and they are underway.
Ms. Stewart. Thank you.
Mr. Shays. No. 3.
Ms. Wedewer. Hi. My name is L.D. Wedewer. I am the U.S.
Autism Ambassador, and I have more titles than my arms, so I
will leave it at that.
But I have a two-part question actually. My daughter
received a hepatitis B shot at 2 days old, which I truly feel
was too young, but I was never given any information on the
cause and effect, what could happen to her. Do you feel that
there is a need to ensure that parents have the knowledge of
what the mercury could do to the individual, and how would we
assure that?
Ms. Wharton. Well, clearly, we do try to inform parents of
the known risks and benefits of vaccination through vaccine
information statements, which are required by the National
Vaccine Injury Compensation Act passed by Congress some time
ago.
The mercury is no longer contained in any of the hepatitis
B vaccines administered to infants or thimerosal is not, and
thimerosal--the vaccines now being routinely administered to
children, in fact, none of them contain thimerosal at this
point.
There are not data to--there are no established harms
associated with this. I know this is a subject of great
concern, and a number of studies are underway, but we do not
have data that support known hazards associated with thimerosal
contained in vaccines at this point.
Ms. Wedewer. OK, and my second part to the question is I
have, as the U.S. Ambassador, I have been receiving over the
last year numerous information and different amounts of proof
on the thimerosal connection, Ma'am, as my daughter is one of
them. I had found a recent CDC report that had never been
released that had birth to 6 months, and yet the release that
you released to the public and congressional hearings omitted
birth to 6 months. Is there a reason why the original report
and the second report do not match?
Ms. Wharton. Well, this is an issue that was addressed
earlier. I believe the study you are referring to is Dr. Thomas
Verstraeten's analysis of the VSD screening data.
Ms. Wedewer. I actually have it here today, if you would
like to have it in front of you, so you know----
Mr. Shays. No, but she is on target, right? She got the
study.
Ms. Wedewer. OK, go ahead.
Mr. Shays. Yes.
Ms. Wharton. And as I mentioned earlier, the initial
studies focused on a limited followup period. Since that time,
there has been more extensive followup which should actually
enhance the finding of children whose subsequent developmental
abnormalities were diagnosed later in life. So more extensive
followup should help us do a better study.
Ms. Wedewer. OK, my final, this is the final part to it,
and I promise I will let Mr. Horowitz go on. My last concern--
and, remember, I receive e-mails from many, many parents; I was
inducted by more than 245,000 people, so I----
Mr. Shays. Ask your question. Why don't you ask it.
Ms. Wedewer. I have U.S. knowledge. May I ask, why, then,
if you are so worried about releasing the statistics from the
parents to a congressional hearing, as I do work with
Democrats, etc., in Iowa, do you really think--as a parent of a
child with autism, I don't think that I would have a problem
with you releasing the information for someone else to look at.
Do you really think that other parents would have problem with
that, when everybody they see----
Mr. Shays. OK, you have asked your question. Now I am going
to have you move the mic, so I know you are not going to have a
fourth followup.
Ms. Wedewer. OK. [Laughter.]
Mr. Shays. OK.
Ms. Wharton. Well, it is not just parents of children who
have neurodevelopmental abnormalities. It is all the patients
participating in these health maintenance organizations, which
is a measurable proportion of the U.S. population, have data on
every medical encounter and every diagnosis they have received.
I think these are data which have to be maintained
confidentially. We have no choice about that.
Mr. Shays. Thank you. We have two more to go, and you all
have been wonderful. Yes, sir, you are No. 4. Turn the mic on,
if you would.
Mr. Horowitz. Thank you. My name is Dr. Len Horowitz. I am
here representing an organization nationwide called Vaccination
Liberation, as well as I am an Honorary Autism Ambassador, and
I appreciate this opportunity.
My question is not simply for the good representatives
here, but also for all of us to consider. We have currently in
the last several years particularly become very aware of the
tobacco industry and its infusion into what amounts to cancer
sticks, a variety of ingredients that the industry itself knew
was totally toxic. The evidence before this committee, I
understand, including the Verstraeten report, indicates clearly
the Centers for Disease Control and other industry officials
knew well in advance that mercury, as well as potentially
aluminum, formaldehyde, formalin derivatives, as well as
foreign species DNA, RNA, proteins, cause a horrific number of
injuries.
The question that I have is, how, as we begin to spend
millions of dollars and give to these same organizations who
have this knowledge, how can we assure that putting virtually
the fox in charge of the hen house do we expect this autism
pandemic or epidemic here in the United States to stop without
a full housecleaning within the NIH, CDC, NAID, NIMH, and FDA,
freeing this bureaucracy from special pharmaceutical industry
biases and influences, especially since the lives of our
children, our Nation's future is at great and grave risk?
Mr. Shays. OK, let me say, you are not going to have a
followup on that one because that was such a long question, and
it did have a sense of bias as well as a statement, but it is
an important question to put on the record.
I don't know if you all want to address it. It was thrown
out to all of us. Do you want to just make any response? I
mean, Dr. Foote, can you--let me try to narrow it down a little
bit.
Given that we did know that there are a lot of things that
we have allowed to happen where we knew they shouldn't, how do
we sort that out? In other words, in Congress, in the private
sector as well, I mean we could say with hindsight we know it
shouldn't have happened. We can say, well, some people in a
company may have known, but maybe not everyone. Just he
deserves some type of response.
Ms. Wharton. Well, I would call into question the initial
statement that we know that all these additives are in vaccines
and we know that they cause harm.
Mr. Shays. Right.
Ms. Wharton. In fact, that is not known. The Institute of
Medicine has reviewed the data regarding IOM and autism and has
found that the evidence favors rejection of a connection
between MMR vaccine and autism. As far as the thimerosal issue
is concerned, the evidence is too incomplete and fragmentary to
make any decisions about causation.
Of course, many substances are known to be dangerous when
administered in high concentrations, but the additives that are
included in vaccines are present in trace amounts, and even
when multiple vaccines are given, these are still very small
amounts of products. It is not established even that thimerosal
is associated with any harm as a vaccine additive.
That said, we have committed a large amount of staff time
and funding to try to further elaborate these issues and have
designed a whole series of studies that have been described in
our written testimony that we believe will help address these
issues and are responsive to the specific research
recommendations made to us by the Institute of Medicine.
Mr. Shays. Thank you. I am going to respond and say that
some of our most dedicated employees are in the very
institutions you have mentioned. So I would dispute that we
need a cleaning of the house, but I do think----
Mr. Horowitz. Just in terms of those biases by special
interests, currently, the waivers bother me, the fact that we
have CDC officials and ASIP officials in the vaccine----
Mr. Shays. You know what we are going to do----
Mr. Horowitz [continuing]. That get these waivers----
Mr. Shays [continuing]. We are going to allow you to have
dialog directly with the staff about this afterwards, and the
staff will stay.
Let me just go to No. 5, and then you all have been very
trustworthy, and I thank you, and I know it is tempting to jump
in, but you won't be given an opportunity. We are going to
five, and then you all are going to get home.
Ms. Bigelow. Hi. I am Rita Bigelow. I have an 11-year-old
boy with autism. I just want to say thank you to the
Congressmen and women who are here helping us with this cause,
and also to the people from the NIH. Thank you for listening to
us, answering our questions.
Mr. Shays. And CDC.
Ms. Bigelow. And CDC. Sorry.
Mr. Shays. Yes.
Ms. Bigelow. I am with the Autism Coalition and with other
groups. I see many of my friends who are here, too. So thanks
to all of them for making the trip down.
I have a question that is a little bit taking a different
tack, but I worked with several researchers in autism, tried to
raise money for them, and worked with them. It seems that most
scientists believe that autism is caused by a combination of
genetic and environmental triggers.
My specific question, and I don't have a part B, but, what
types of steps has the NIH taken to promote genetic studies?
You know, the genes may perhaps interact with environmental
triggers, with psycho-pharmacologic agents, things like that.
Dr. Foote. So the CPEA network that has been funded for the
past several years by NICHD and NIDCD has a coordinated
genetics program, their Centers of Excellence in Neurobiologic
and Genetics of Autism, where they have multiple sites at which
they collect genetic data from subjects. The advantage of
having multiple sites being that you can collect from them a
much larger cohort than you could ever do having individual
investigators operating just within their own spheres. So it
provides power to genetic analyses that couldn't otherwise be
obtained.
In the new STAART Centers Program, we will be doing the
same kind of thing, where there will be standardized diagnostic
protocols across all of the sites, standardized instruments, so
that then you can collect genetic data from a large number of
subjects distributed at various sites and have the numerical
power to do genetic analyses that wouldn't otherwise be
possible.
We have at NIMH a genetics repository where we collect
large amounts of genetic data and make it available to any
responsible investigator who applies to us to receive genetic
materials from rigorously diagnosed subjects about whom we have
large amounts of information.
So this is the future. This is what we are actively
implementing. We recently just gave a multimillion dollar grant
to the AGRE data base, which you may have heard of, which has
originated from advocacy groups, and really the grassroots,
generating genetic samples. So now we feel like we are in the
position where we can have a very large data base of genetic
information combined with very detailed behavioral and clinical
information from subjects, so that we can do powerful genetic
analyses.
Then just one final note, and then I will be quiet, because
you hit one of my buttons here, obviously. The other issue is
that some of these questions that come up, ``Why did my child
respond so dramatically to a particular vaccine when all the
other kids on the block didn't respond the same way?'' Well,
the genetics may well be a clue to that. The way we are going
to get the answer eventually is through these combined genetics
efforts where we have a large number of subjects, thorough
clinical histories, standardized genetic information, freely
available to a number of investigators who may well want to
look at exactly this question. So that is where we are going.
We are getting there.
Mr. Shays. Dr. Boyle.
Dr. Boyle. I was just going to be very brief. In our
centers' studies, these are epidemiologic studies that are done
collaboratively, sort of what we call gene environment
interaction. This is a very important issue, and it is clearly
one that is the basis for the studies, and that is what we are
addressing.
Mr. Shays. I thank all five of our----
Mrs. Morella. Mr. Chairman, may I just add something to
that?
Mr. Shays. Sure.
Mrs. Morella. That is where you are going to need the
passage of the Genetic Non-Discrimination in Employment and
Health Act, which has about 260 co-sponsors here on the House
side.
Mr. Shays. I hope I am on that bill. Good grief.
Mrs. Morella. I think you are, yes. [Laughter.]
Mr. Shays. Ms. Watson, do you have any last comments you
would like to make?
Ms. Watson. No, I don't except to thank the panel.
Mr. Shays. Yes. I am going to ask this question. I have one
other question.
Mrs. Morella, any comments?
Mrs. Morella. No, Mr. Chairman.
Mr. Shays. I had a question that I was asked to give, and I
think by the response to one that we are doing this. But the
question was, do the CDC and NIH recommend that the removal of
thimerosal from childhood vaccines--it appears that is the
case, that we are removing them from childhood vaccines? Is
that the case?
Ms. Wharton. That recommendation was actually made in 1999.
Mr. Shays. Great.
Ms. Wharton. And the vaccine manufacturers moved very
quickly to reformulate and relicensed all the routinely
administered childhood vaccines, so that they are now available
only in thimerosal--they are now marketed only in thimerosal--
in formulations that do not contain thimerosal as a
preservative.
Mr. Shays. Got you. Let me ask you this now: Is there any
question that you had prepared to answer that we never thought
to ask that you want to answer? [Laughter.]
[No response.]
Mr. Shays. I think that our guests would recognize that you
all have been very patient, and I think our witnesses would
recognize that you all, those of us who are our guests at this
hearing are dealing with some really tough issues. We want to
be helpful to you and want you to stay in touch with our
committee. Our committee record will be open until the 3rd, and
you are invited to submit anything in writing to the committee
that you would like to submit.
But I do thank all of you for participating here, and I
thank No. 1, 2, 3, 4, and 5 for being here and your patience in
not having the sixth or seventh followup.
This hearing is now adjourned. Thank you.
[Whereupon, at 5:10 p.m., the committee was adjourned, to
reconvene at the call of the Chair.]
[The prepared statements of Hon. Thomas M. Davis, Hon. Wm.
Lacy Clay, Hon. Christopher H. Smith, and additional
information submitted for the hearing record follow:]
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