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Committee on Government Reform
"The Status of Research into Vaccine Safety and Autism"
June 19, 2002
2154 Rayburn House Office Building
11:00 a.m.
In April the Committee conducted a hearing reviewing the epidemic
of autism and the Department of Health and Human Service's (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 CDC's 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 parent's 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 today's 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 CDC's 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. Wakefield's 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 public's 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 boy's 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 today's 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 didn't inform anybody but this
Committee of the data's availability.
That doesn't 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. That's not acceptable. That's why I insisted that Dr.
Chen be here today. I just want to ask him why they didn't tell
anyone about the database being available. I'd like to know how he
expects researchers to use this data if nobody tells them it's
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.
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