August 11, 2006


BL Fisher Note:

For the past six months, representatives of autism advocacy organizations have been working with Congress on federal legislation which will allocate nearly one billion dollars in congressional appropriations to autism research and educational and social service support for autistic children. Some of the autism advocacy organizations represent parents who believe their children's autism was vaccine-induced and other advocacy organizations either take no position on the hypothesis that autism is vaccine-related or disagree that vaccines play a role in development of autism in some children.

On August 3, 2006, the Combating Autism Act (S. 843) was passed by the U.S. Senate. It still must pass the House and then be signed into law by President Bush.

According to Shelley Reynolds, co-founder and president of Unlocking Autism, who has been working on the legislation, "Politics is a tricky business. Sometimes things must be positioned in a certain way to get the end result passed. It is a constant procedure of negotiation until the bill is signed into law. In this case, the word vaccine had to be removed from the bill itself and substituted with the less inflammatory word, "environmental." Senator Enzi assured the organizations concerned that he would submit what is called a colloquy when the bill was passed that would define that the intention of the use of the word "environmental."

Below are statements by Senators Enzi (R- WY) Rich Santorum (R-PA), Edward Kennedy (D-MS) and Christopher Dodd (D-CT) made on the floor of the U.S. Senate on Aug. 3 explaining the intention of the language in the bill.

Colloquy of Sen. Enzi, Santorum, Sen. Kennedy, and Sen. Dodd
Senate passage of S 843, Combating Autism Act

August 3, 2006

Mr. ENZI: Mr. President, I rise today in support of S 843, the Combating Autism Act. I’m pleased to note that the Senate will pass this bill today.

This legislation, which was recently reported out of the Senate Health, Education, Labor, and Pensions Committee, focuses on expanding autism spectrum disorder research and coordination at the National Institutes of Health (NIH). It also increases awareness of autism spectrum disorder and its symptoms through the Centers of Disease Control and Prevention (CDC). Additionally, the bill integrates our various health, education, and disability programs that serve individuals and families affected by autism spectrum disorder and ensures that the community of people affected by this disorder have a voice in all of this.

No one knows exactly how many individuals are affected by autism spectrum disorder, but some studies suggest it could be as high as 1 out of every 166 American individuals.

But there are many things we do know about autism spectrum disorder. We know we need to begin intervention as early as possible to help individuals with autism spectrum disorder reach their full potential. And given the importance of early intervention, we need further research into the possible causes of autism spectrum disorder.

We need to understand more about the various forms of autism spectrum disorder to improve our ability to provide the right kinds of intervention and support. And, we need to provide better integration of the health, education, and disability programs already available to meet the increased demand for these interventions, supports and services.

I believe the “Combating Autism Act” is an important step toward addressing these needs and finding some solutions that will improve the lives of individuals and families whose daily lives have been turned upside down by autism spectrum disorder.

This bill is the result of a tremendous amount of work across party lines. I want to thank the original bill cosponsors, Senators Santorum and Dodd for introducing this legislation and for working with me to fine-tune it. I would also like to express my deep appreciation and thanks to the Ranking Member, Senator Kennedy, for his hard work during this process. Of course, in providing thanks to the members, I would be remiss if I did not mention the staff. Specifically, I want to thank Jen Vesey with Sen. Santorum; Jim Fenton, Ben Berwick, Tamar Magarik, and Elizabeth Hoffman with Sen. Dodd, and Caya Lewis with Sen. Kennedy’s office, as well as my staff – Steve Northrup, Aaron Bishop, Tec Chapman, Martina Bebin, and Shana Christrup.

I also want to thank the various groups and individuals who work on behalf of individuals and families affected by autism spectrum disorder. I appreciate the way in which this community of advocates has come together to work with me and my colleagues on this. If they had not worked together so well -- with each other and with us as our Committee worked on this bill -- I doubt we would be here today.

Mr. SANTORUM: Chairman Enzi, first let me express my sincere gratitude to you and your staff for investing so much time and thoughtful effort in this important legislation, as well as thank Senators Dodd and Kennedy, and their staffs. Few things are more important than the health and happiness of our nation’s children, and the Combating Autism Act will go a long way to helping those diagnosed with Autism live up to their full potential. We have a tremendous opportunity to make a real difference in the lives of children with autism and their families. This federal investment will lead to better understanding of autism, increase awareness, diagnosis and intervention - all things that will make a profound impact on families struggling for answers and hope.

Autism raises complex and emotional issues. All of us who worked so hard on this legislation sought to keep the primary focus of the bill on autism research and awareness. However, in addressing the key issues within S 843, some have raised concerns regarding a potential link between vaccines, vaccine components (such as thimerosal), and autism. Mr. Chairman, can you clarify your position on this issue?

Mr. ENZI: I’m happy to do so. In 2004 the Institute of Medicine’s Immunization Safety Review Committee concluded that the body of epidemiological evidence “favors rejection of a causal relationship between the MMR vaccine and autism spectrum disorder” and also “favors rejection of a causal relationship between thimerosal-containing vaccines and autism spectrum disorder.” The IOM committee also found that “potential biological mechanisms for vaccine-induced autism spectrum disorder that have been generated to date are theoretical only.”

However, the IOM committee also acknowledged that “[a]bsent biomarkers, well-defined risk factors, or large effect sizes, the committee cannot rule out, based on the epidemiological evidence, the possibility that vaccines contribute to autism spectrum disorder in some small subset or very unusual circumstances.” The IOM committee also noted that “experiments showing effects of thimerosal on biochemical pathways in cell culture systems and showing abnormalities in the immune system or metal metabolism in people with autism spectrum disorder are provocative,” and suggested that “the autism spectrum disorder research community should consider the appropriate composition of the autism spectrum disorder research portfolio with some of these new findings in mind.”

I agree with the IOM committee’s recommendation that “available funding for autism spectrum disorder research be channeled to the most promising areas.” The HELP Committee reported this bill without making the determination for the autism spectrum disorder research community of what are the “most promising areas” for investigation. Instead, the bill reported by the HELP Committee contemplates key research activities, including environmental research, that focus on a broad range of potential contributing factors, with meaningful public involvement and advice in setting the research agenda.

However, I want to be clear that, for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder. Thus, I hope that the National Institutes of Health will consider broad research avenues into this critical area, within the Autism Centers of Excellence as well as the Centers of Excellence for Environmental Health and Autism. No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know.

I also want to note that this broad statement is appropriately limited to biomedical and not epidemiological research. Although S 843 provides for specific centers of excellence to examine epidemiological issues related to autism spectrum disorder, there is currently no expectation that the Centers for Disease Control and Prevention should further pursue additional epidemiological research regarding the link between autism spectrum disorder and vaccines or vaccine components, unless new biomedical research provides additional information about specific at-risk subpopulations. At this point, given what we know and what has already been done in this area, no new epidemiological research is required.

Mr. SANTORUM: I agree with your comments, Mr. Chairman. Thank you for clarifying, and again for all of your hard work on this legislation.

Mr. KENNEDY: I also agree with your comments, Mr. Chairman.

Mr. DODD: As my colleagues are well aware, the prevalence of ASD in the U.S. is 10 times greater than a decade ago. In my own state of Connecticut, ASD diagnoses have increased by close to 1100 percent since 1993. What these numbers tell us is that ASD diagnoses are rising at truly alarming rates and we simply must provide more answers to all those affected by this devastating condition.

We must also create a larger pool of experts in the field so that families can be directed to nearby specialty clinics for confirmation of diagnosis, care and services. Waiting lists at the nation’s top developmental disability centers are as long as 2 to 3 years, and families are often forced to travel far from home to receive needed care and to participate in clinical research studies. Increasing the number of trained physicians and allied health professionals who can provide a medical home for individuals with ASD will enable all those affected to receive the optimal and timely care that they deserve.

It is my sincere hope and expectation that by expanding the federal response to ASD and other developmental disabilities through the Combating Autism Act, we will see improved research on ASD, including its causes, and families across America will get the services they so urgently need. In our search for the cause of this growing developmental disability, we should close no doors on promising avenues of research. Through the Combating Autism Act, all biomedical research opportunities on ASD can be pursued, and they include environmental research examining potential links between vaccines, vaccine components and ASD.

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