The Status of Research into Vaccine Safety and Autism

Opening Statement – June 19, 2002
Chairman Dan Burton
Committee on Government Reform
The Status of Research into Vaccine Safety and Autism

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.

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. @ 11:49 am | Article ID: 1024685344