SAFEMINDS SUPPORTS COMBATING AUTISM ACT PASSED BY SENATE DESPITE SPECIFIC CONCERNS

Strong Benefits of the Bill Outweigh Some Major Drawbacks

August 23, 2006. SafeMinds endorses the Combating Autism Act passed by the Senate on August 3, 2006. We would like to express our gratitude to the members of the Health, Education, Labor and Pensions (HELP) Committee and their staff for their hard work in drafting, refining and supporting this historic piece of legislation. We thank Senators Santorum and Dodd in particular for their leadership in bringing this legislation to the floor in collaboration with so many autism organizations. We urge the autism community to reach out to their representatives in the House of Representatives to make sure that Congress passes the bill so that the critical benefits it provides can be codified in law and implemented as rapidly as possible.

SafeMinds, working in collaboration with our fellow organizations in the autism community and especially with our close friends in the National Autism Association (NAA) worked very hard to make CAA the best bill it could possibly be. We worked closely with HELP Committee up until the final vote, analyzing and offering wording changes in the bill's provisions and language for the bill's legislative history in order to maximize the effectiveness of the bill and minimize its weaknesses. Along the way, we had many internal discussions on specific provisions, including much debate and some areas where there was substantive disagreement. On balance, we support the bill that passed the Senate and urge parents to advocate its passage.

That said, we want the autism community to know that, in our view, CAA is not a perfect bill and has some important weaknesses. SafeMinds and NAA were not satisfied with earlier drafts of CAA and our members were instrumental in developing the so-called Consensus Bill that was endorsed by the entire autism community and presented to the lead sponsors November 10, 2005. The Consensus Bill is the bill we would have preferred the Senate to pass. We recognize that compromise is essential in any political process, and the bill that finally passed the Senate was a result of many painful compromises and significant concessions. And although we were able to reach agreement on many of the improvements that we sought following the first release of the HELP staff version on July 12, we must acknowledge that we did not achieve everything that we had hoped. We worked long and hard with Senate staffers trying to devise solutions that allowed us to achieve the goals embodied in the Consensus Bill while working within the constraints of the political process. Stepping back from the intense and challenging process, we want to share with the broader parent community our general views on the outcome of the CAA negotiations and, more specifically, explain why we support the bill and where we think it comes up short.

We believe deeply that a profound transformation is required in the way our nation addresses the autism epidemic. CAA provides an unprecedented opportunity to effect that transformation. We had five goals in mind as we conducted all of our discussions surrounding the bill and hope that, as a nation, we can collectively pursue these five goals.

We need to recognize that autism is a national public health emergency.
We therefore need to sharply increase funding for autism research.
We also need to significantly increase the proportion of autism research funding that is directed towards environmental factors, including vaccines, thimerosal and mercury.
We need, in parallel, to promote the development and further adoption of effective medical treatments for our children.
We need to improve the effectiveness of federal government autism spending by increasing the accountability of government agencies and by increasing community participation in the strategic planning, oversight and evaluation process.

CAA makes some important progress toward all five of these goals. Yet we remain concerned that some features of the bill do not go far enough. Consequently, our decision to support the bill was not reached easily or unanimously. Here is our view of the major pros and cons and why we conclude the positives outweigh the negatives

Recognizing autism as a national public health emergency. More than any other accomplishment, we all need to celebrate the simple fact of the passage of CAA. The bill is an extraordinary achievement in terms of promoting a social consensus and priority for autism. Single disease bills have almost never been endorsed by Congress: the only current example is the Ryan White CARE Act first passed in 1990. Many in Congress have reservations about disease specific bills and so the mere fact that CAA has developed the momentum it has provides an unprecedented boost to our efforts to face the reality of the autism epidemic. Beyond the direct funding benefits that CAA provides, our community's success in uniting behind a bill and gaining broad support for CAA will have additional benefits as we continue to work with federal agencies such as NIH, FDA and CDC.
Increasing overall research funding. One of our most important accomplishments during our discussions with the Senate was the increase in priority for research into autism's causes. The first step in dealing with the autism epidemic simply must be a greater emphasis on understanding the cause of the epidemic and developing treatments for the affected children. As first introduced in the spring of 2005, CAA had no specific provisions for general research spending; as passed, CAA will mandate over $405 million in general research spending and $635 million including the new Centers of Excellence. As introduced, less than 30% of total CAA spending went to research; as passed approximately 70% went to research. We were especially grateful to the HELP Committee for embracing this priority for research, as the bill that passed the HELP committee proposed $740 million in research funding over 5 years, a meaningful step change over an uncertain baseline.

We were extremely disappointed, however, that the 5 year research spending total was cut back (we understand this was due to the intervention of a single Senator) to $635 million, reducing the increase in funding by over $100 million. We were also disappointed that the HELP Committee chose to increase research funding in a gradual way, reaching its peak only in 2011. This pattern of spending does not reflect the sense of urgency, and treats autism as an inevitability rather than a preventable crisis. So although we applaud and support CAA's strong research focus, we oppose the delays in getting the research started and the arbitrary reduction of $100 million in desperately needed funding. Some in Congress, perhaps few enough, called "budget hawks," are increasingly sensitive to the rising federal budget deficit. Yet the rapidly multiplying real and opportunity costs of the autism epidemic more than justify a crash program of research spending (as Congress did for the as yet purely theoretical "bird flu" epidemic) as it will likely lead to a dramatic reduction of new cases and treatments to help affected children fully participate in society.
Increasing spending on environmental factors research, including vaccines, thimerosal and mercury. The bill authorizes specific funding for environmental health research centers and the bill as passed increased the funding for these centers by 50%, to $45 million over five years, as compared to the bill as introduced. There were numerous occasions during the HELP Committee drafting process when the environmental centers were placed at risk, either through possible consolidation into the general pool or through language that gave the environmental centers a lesser priority for funding appropriations. We support the final bill's approach to retaining the priority for environmental research.

SafeMinds opposes restrictions of any kind on research into the role of environmental factors in autism, especially vaccines, thimerosal and mercury. In the Consensus Bill, this research was specifically mandated in statutory text. Senate staffers informed us early on that they hoped to respond to our interest in the "words that must not be named" by including support for such research in the bill's legislative history rather than the bill itself. . The intelligence we and others in the community were able to gather was that the inclusion of the vaccine research mandate in the statutory text would raise such a "red flag" that the bill could not pass under the rules for "unanimous consent." This seemed the only viable process for passage in time for House consideration before the end of this Congress given the political reality that the Senate leadership allocated so much floor time to more "pressing" issues.

Although we preferred the approach of the Consensus Bill, we support the Senate's endorsement of biomedical research into vaccines and their preservatives. We also appreciate that the legislative history points out the inconsistency in the Institute of Medicine's 2004 report on vaccines and autism. These are important accomplishments and helpful steps forward. We worked hard for them.

That said, the Senate could have and should have done more. We were disappointed that the colloquy (a scripted exchange of views about the purpose and meaning of the bill between HELP Chairman Enzi, lead sponsors Santorum and Dodd, and Kennedy published in the Congressional Record and part of the bill's legislative history) language on vaccines and preservatives only made reference to biomedical research, implicitly endorsing the IOM's restriction on further epidemiological research into autism. Scientific discovery should not be restricted simply because the research is controversial. We were also disappointed in the excessive deference paid to the IOM in the legislative history. In our view, the 2004 IOM report was outrageous and irresponsible, deserving criticism not deference. The failure of CAA to remove all research restrictions in autism was what made our decision to support CAA not unanimous.

On the other hand, it may be that we were so successful in convincing staff that the CDC-funded epi research relied upon by IOM was so untrustworthy that staff thought they were doing the community a favor by trying to prevent further "bad" epidemiology work. "[T]here is currently no expectation that the [CDC] should further pursue additional [epidemiologic] research regarding the link between [ASD] and vaccines or vaccine components, unless new biomedical research provides additional information about specific at-risk subpopulations." Thus, the prohibition on further epi research arguably applies only to CDC, not NIH. In any event, there has been more than enough "new biomedical research" since the IOM's 2004 report to justify further epidemiologic research now, including, for example, a comparison of vaccinated and unvaccinated populations, and competent studies of CDC's vaccine safety datalink database. Even with the potential trigger, the admonition that "[a]t this point . . . no new epidemiological research is required" is very troubling because it risks elevating political expediency over sound science.

The original CAA did not mandate any vaccine-specific research. The Consensus Bill called for "research on a broad array of environmental factors that have a possible role in autism, including but not limited to vaccines, other biological and pharmaceutical products, and their components (including preservatives)." This research mandate was not included in the final bill text but was included in the colloquy: " 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. . . . No stone should remain unturned in trying to learn more about this baffling disorder, especially given how little we know. . . . 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." We view this mandate for research into the link between vaccines and ASD as historic and a major achievement of the CAA
Promoting expanded biomedical treatments for our kids. CAA provides important support for treatment and interventions. The text and report make clear that this funding includes support for biomedical treatments. This funding support more than doubled when one compares the bill as introduced to the bill that passed. We worked hard with Senate staffers to clarify and improve the language in the bill so that misinterpretations of the bill's intent would not be possible and the freedom of parents to choose the best possible care for their children would not be restricted in any way. We helped to specify definitions for terms such as "evidence-based medicine", "diagnosis", "ruling out" a diagnosis, and "intervention" so that these terms could not be used in ways that might obstruct our right to obtain treatment for our children.

We also pointed out that often those diagnosed with autism spectrum disorders suffer with other co-morbid conditions which are typically overlooked. As a result, language was included that stated that all health aspects of the individual including "developmental, psychosocial, behavioral, nutritional, immunological, endocrine, gastrointestinal, metabolic and toxicological" be explored. The addition of this language will go a long way in affording our children the help they need for their medical conditions which often results in marked improvement with regard to their autism diagnosis.
Increasing agency accountability and parent participation. In many respects, this is the area in which we worked the most diligently, since we believe firmly that it is not only the amount of funding but also the way that the money is spent that provides the most important opportunity for change. In CAA, we will see many improvements in accountability and participation. We will see improved reporting on the status and progress of NIH research into autism; we will see a new and more transparent strategic planning process in which we can participate more actively; and we will have at least two additional guaranteed community seats on the Inter-Agency Coordinating Committee (IACC), which provides a coordinating role for activities that cross different federal agencies. In addition, we asked for and received tentative support (although not a clear mandate) for an additional oversight mechanism: an Autism Advisory Board (AAB) that would play a stronger role in planning and evaluating all autism activities within the Department of Health and Human Services (DHHS) and not just in coordination. The report accompanying the CAA indicates that IACC may establish an advisory board or the Secretary may do this on his own. It would have been preferable to have this board mandated in the actual bill text, but we are reasonably confident that the strong suggestion in the report will be followed. We plan to continue to push for this additional level of oversight.

In the spirit of accountability, we also want to note that the CAA as passed included sharply decreased funding and involvement from the Centers for Disease Control and Prevention (CDC). We at SafeMinds remain highly critical of CDC's performance in sounding the alarm over the autism epidemic and managing research into the relationship between autism risk and mercury exposure from vaccines. We applaud the HELP Committee's decision to reduce CDC's role in managing autism projects.

In summary, like many other autism organizations, we view CAA as an important step forward for our children and we endorse its passage by the House. Also, like several other autism organizations, we oppose some key features of the bill, especially the possible research restrictions on epidemiology work that includes vaccines and preservatives and the reduced research funding. On balance, we believe that SafeMinds can accomplish the most for our children in the shortest period of time by supporting the direct benefits that CAA provides, including:

the increased attention to autism,
the increased funding for research,
the new emphasis on environmental research, including research on the link
between vaccines and autism,
the support for investments in interventions and biomedical treatments, and
an increased opportunity for active participation within the system.

In addition, we are optimistic that CAA will provide us all with a platform to continue to make the case for change with the good people in Congress, the NIH and the broader autism research and clinical community by means of constructive engagement at the highest level of the government, vigorous challenge to obsolete ideas and approaches and our ongoing body of professional contributions to the research process.

Given the immediacy and severe impact of this epidemic, we share the frustration of many in the community that progress toward a social consensus and a meaningful solution (stopping new cases and providing effective treatments for those already affected) is more glacial than expeditious. Mindful that we must not let the "perfect" be the enemy of the "good," the alternative of having no CAA seems clearly inferior. A political strategy that focuses on constructive engagement-passing CAA now, working for its effective implementation, working with staff and Members, now joining with the community as allies in seeking solutions, for additional legislation in the future, and building grassroots support for this and future legislation-is more likely to achieve the goals of our community than a demand for the Consensus Bill or nothing or a belief that the federal government is so untrustworthy and corrupted that no positive step forward will ever be fast enough or good enough.

As for next steps, we urge parents to contact their House members during the recess to educate them on the autism epidemic, introduce them to your kids (as part of NAA's Putting a Face on Autism campaign), urge their co-sponsorship for the CAA and passage of the Senate version, urge that they join the Autism Caucus, and urge passage of related legislation (such as H.R. 5887, the Weldon-Maloney vaccine safety bill, and H.R. 5940, the Osborne-Maloney vaccinated vs. unvaccinated study). Grassroots, one-to-one connections with federal and state legislators is the best means by which the community can advance its legislative agenda.

LINKS

CAA as originally introduced S. 843 (PDF 205KB)

Consensus Bill as of 11/10/05 (PDF 117KB)

Explanation of changes to CAA (PDF 41KB)

Explanation for changes presented in Consensus Bill (PDF 117KB)

HELP Committee draft substitute as of 7/12/06 (PDF 62KB)

SM/NAA Joint Statement on needed improvements, 7/14/06 (PDF 78KB)

Manager's Amendment as of 7/18/06 (PDF 67KB)

SM/NAA statement on needed improvements, 7/19/06 (PDF 33KB)

CAA as passed by HELP on 7/19/06 (PDF 212KB)

CAA as passed by the Senate on 8/3/06 (PDF 214KB)

Colloquy explaining CAA as passed by Senate (PDF 35KB)

Report accompanying CAA (PDF 115KB)