Opening
Statement
Chairman Dan Burton
June 19, 2002
In April the Committee conducted a hearing reviewing the epidemic
of autism and the
Department of Health and Human Serviceïs (HHS) response. Ten years
ago, autism was
thought to affect 1 in 10,000 individuals in the United States. When
the Committee began its oversight investigation in 1999,
autism was thought to
affect 1 in 500 children. Today, the National Institutes of Health (NIH)
estimates that autism
affects 1 in 250 children.
In April we looked at the investment our Government has made into
autism as compared to
other epidemics. We showed in that hearing that the CDC and NIH have
not provided adequate funding to address the issues in the manner that
our Public Health Service agencies have used to address other
epidemics.
After our hearing, I joined with my colleagues on the Coalition on
Autism Research and
Education to request from our appropriators that at least 120 million
dollars be made available in FY 2003 for
autism research across the NIH and at that an
additional $8 million be added to the CDCïs budget for
autism research.
Giving more money to research is not the only answer though.
Oversight is needed to make sure that research that is funded will
sufficiently answer the questions regarding the epidemic, how to treat
autism, and how to
prevent the next ten years from seeing the statistic of 1 in 250 from
becoming 1 in 25 children.
High quality clinical and laboratory research is needed now, not
five or ten years from now. Independent analysis of previous
epidemiological and case control studies is needed as well.
We have learned that a majority of parents whose children have
late-onset or acquired autism
believe it is vaccine-related. They deserve answers. We have also
learned that the parents have been our best investigators in looking
for both causes of autism
and for treatments.
It has been parents who have formed non-profit organizations to
raise research dollars to conduct the research that the CDC, the FDA,
and the NIH have neglected to do. We have heard from many of these
parents in the past, Elizabeth Birt, Rick Rollens, Shelley Reynolds,
and Jeanna Smith, to name just a few. Each of these parents had
healthy babies who became autistic after vaccination.
I might have been like many of the officials within the public
health community - denying a connection - had I not witnessed this
tragedy in my own family. I might not have believed the reports from
parents like Scott and Laura Bono, Jeff Sell, Jeff and Shelly Segal,
and Ginger Brown, who came to me with pictures, videos and medical
records. I might have been like so many pediatricians who discounted
the correlation between vaccination and the onset of fever, crying,
and behavioral changes. Because both of my grandchildren suffered
adverse reactions to vaccines, I could not ignore the parentïs plea
for help. I could not ignore their evidence.
My only grandson became autistic right before my eyes - shortly
after receiving his federally recommended and state-mandated vaccines.
Without a full explanation of what was in the shots being given, my
talkative, playful, outgoing healthy grandson Christian was subjected
to very high levels of mercury through his vaccines. He also received
the MMR vaccine. Within a few days he was showing signs of
autism.
As part of our investigation, the Committee has reviewed ongoing
concerns about vaccine safety, vaccine adverse events tracking, the
Vaccine Safety Datalink (VSD) Project, and the National Vaccine Injury
Compensation Program. I have joined with Congressman Weldon,
Congressman Waxman and 32 other members of Congress in introducing HR
3741, the National Vaccine Injury Compensation Program Improvement Act
of 2002 to realign the compensation program with Congressional Intent.
In todayïs hearing, we will receive a research update from several
previous witnesses as well as new research findings that further
support a connection between autism
and vaccine adverse events. We will learn more about both the possible
link between the use of the mercury-containing preservative thimerosal
in vaccines and autism,
as well as autistic entercolitis resulting from the
Measles-Mumps-Rubella (MMR) vaccine.
Through a Congressional mandate to review thimerosal content in
medicines, the FDA learned that childhood vaccines, when given
according to the CDCïs recommendations exposed over 8,000 children a
day in the United States to levels of mercury that exceeded Federal
guidelines. Is there a connection between this toxic exposure to
mercury and the autism
epidemic? We will hear from Dr. James Bradstreet and Dr. Vera Stejskal
on this issue.
We have twice received testimony from Dr. Andrew Wakefield
regarding his clinical research into autistic entercolitis. We will
learn today that not only has he continued to conduct clinical
research, but that this research is confirming the presence of
vaccine-related measles RNA in the biopsies from autistic children.
Dr. Wakefield - like many scientists who blaze new trails - has been
attacked by his own profession. He has been forced out of his position
at the Royal Free Hospital in England. He and his colleagues have
fought an uphill battle to continue the research that has been a lone
ray of hope for parents whose children have autistic entercolitis. Dr.
Arthur Krigsman is joining us as well today to discuss his clinical
findings of inflammatory bowel disorder in autistic children. He will
share with us his initial findings as well as discuss his research
plans currently with his Institutional Review Board for approval.
Do the epidemiological and case control studies, which the CDC has
attempted to use to refute Dr. Wakefieldïs laboratory results, answer
the autism-vaccine
questions honestly? Epidemiologist Dr. Walter Spitzer is back today to
answer this question. What else is needed to prove or disprove a
connection?
Unfortunately, rather than considering the preliminary clinical
findings of Dr. Wakefield as a newly documented adverse reaction to a
vaccine, the CDC attempted to refute these clinical findings through
an epidemiological review. While epidemiological research is very
important, it cannot be used to disprove laboratory and clinical
findings. Valuable time was lost in replicating this research and
determining whether the hypothesis was accurate.
Officials at HHS have aggressively denied any possible connection
between vaccines and autism.
They have waged an information campaign endorsing one conclusion on an
issue where the science is still out. This has significantly
undermined public confidence in the career public service
professionals who are charged with balancing the dual roles of
assuring the safety of vaccines and increasing immunization rates.
Increasingly, parents come to us with concerns that integrity and an
honest public health response to a crisis have been left by the
wayside in lieu of protecting the public health agenda to fully
immunize children. Parents are increasingly concerned that the
Department may be inherently conflicted in its multiple roles of
promoting immunization, regulating manufacturers, looking for adverse
events, managing the vaccine injury compensation program, and
developing new vaccines. Families share my concern that vaccine
manufacturers have too much influence as well. How will HHS restore
the publicïs trust?
Access to the Vaccine Safety Datalink (VSD)
One of the primary topics to be discussed at this hearing is access
to the Vaccine Safety Datalink. (VSD). To help fill scientific gaps,
the CDC formed partnerships with eight large health maintenance
organizations through an agreement with the American Association of
Health Plans to continually evaluate vaccine safety. This project is
known as the Vaccine Safety Datalink (VSD) and includes medical
records on millions of children and adults. Up until this year, access
to data from the VSD has been limited to researchers affiliated with
the CDC and a few of their handpicked friends. This `good old boyïs
network" practice has predictably led to questions about the
objectivity of the research and the fairness of the results.
The VSD data should be made available to all legitimate scientific
researchers so that independent studies can be conducted and results
verified. This database contains a wealth of data involving millions
of patients over a ten-year period. If properly utilized, it can help
researchers study vitally important questions about the safety of
vaccines, the effects of mercury-based preservatives in childhood
vaccines, and many other questions.
The Committee first raised this issue with the CDC two years ago.
For two years the CDC delayed. Six months ago, we were informed that
the CDC was developing a plan to expand access to the database.
Finally, in February of this year, after a great deal of prompting
from the Committee, Dr. Robert Chen, Chief of Vaccine Safety and
Development at the National Immunization Program, informed Committee
staff that the CDC had finalized its plan and that it was poised to
put it into effect. Under this plan, any legitimate scientist could
submit a proposal to the CDC to conduct research using VSD data and
access to the data would be provided along with some basic safeguards.
In preparation for todayïs hearing, Committee staff asked the CDC
why the plan described to us in February had not yet been put into
effect. The staff was informed that the plan had been put into effect.
However, there had been no public announcement. How are researchers
supposed to know about the availability of the data if there is no
announcement? It took two years of prodding by this Committee to get
the CDC to open up access to the database. For four months it appears
that the CDC didnït inform anybody but this Committee of the dataïs
availability.
That doesnït make it appear that the CDC is making a good faith
effort to open up this database. It looks to me like the CDC is trying
to do the bare minimum that they have to do to get us off their backs.
Thatïs not acceptable. Thatïs why I insisted that Dr. Chen be here
today. I just want to ask him why they didnït tell anyone about the
database being available. Iïd like to know how he expects researchers
to use this data if nobody tells them itïs available.
Dr. Roger Bernier is here from the CDC to testify about these
issues. He is accompanied by both Dr. Chen, the creator of the VSD
Project and Dr. Frank DeStefano, the CDC official who is also a
co-author of the MMR - IBD study. They are here to address our
questions on the VSD project and the vaccine-
autism research.
The CDC employees are accompanied by Dr. Stephen Foote of the National
Institutes of Health and Dr. William Egan of the Food and Drug
Administration.
As representatives of the people, we have a responsibility to
ensure that our public health officials are adequately and honestly
addressing this epidemic and its possible links to vaccine injury.
I look forward to hearing from our witnesses today. Our hearing
record will remain open until July 3.
I now recognize the ranking minority member, Mr. Waxman for his
opening statement.
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