The requirement in the Combating Autism Act (CAA) for a Strategic Plan (SP) with a budget for autism research gives the community a unique and unprecedented opportunity to influence the conduct of federal autism research. The future of NIH-funded autism research will be decided in the next couple months as the strategic plan nears completion and submission to Congress. The entire autism community must again unite to fight for an effective plan. An “early draft” of the SP has been completed and will be presented Tuesday morning 10 AM - 1 PM EDT at a teleconference meeting of an outside “workgroup” for review (register HERE) and listen here [888-455-2920, code 3857872], and at a public meeting on the NIH campus in Bethesda on July 15 9 AM - 4 PM of the Inter-Agency Autism Coordinating Committee (IACC), register HERE.
The community must act quickly and in unity to ensure that the CAA research money is spent in a way that will be of greatest benefit to families already dealing with ASD and to the prevention of future cases.
The autism community worked tirelessly to enact the unprecedented Combating Autism Act (CAA) of 2006, P.L. 109-416. The CAA authorized $640 million over five years to expand and intensify autism basic and clinical research conducted by NIH to “investigate the cause (including possible environmental causes), diagnosis or rule out, early detection, prevention, services, supports, intervention, and treatment of autism spectrum disorder.” Congress directed the IACC to develop, submit, and annually update a comprehensive Strategic Plan (SP) with a budget for the conduct of this research. But appropriations to carry out this plan must be passed by Congress each year, especially reserved for autism, so that the research set forth in the plan doesn’t get ignored amidst the cockfight over the $28 billion or so allocated generally to NIH.
The process for development of the SP began at the IACC meeting November 30. See AOA: What’s So Secret About Autism Science? (HERE.) Unfortunately, serious process failures and a cloak of secrecy shrouding the development of the SP violate both the letter and spirit of the CAA. Based on what’s happened so far at IACC this spring, the SP will: be little more than a listing of general research projects (similar to the 2003 roadmap); NOT present a research plan and implementation strategy with any sense of urgency justified by the size and cost of the autism epidemic; NOT contain the research budget that Congress demanded; NOT contain a specific plan for vaccine research, even though mandated by CAA; NOT propose a funding process that is accountable and provides for considerably greater community participation (also required by CAA and used successfully in the tiny but highly regarded autism research program conducted by DoD and separately funded by Congress); and NOT reprioritize research in favor of effective treatments and eliminating environmental triggers (despite suggestions from IOM and a previous evaluation of the “roadmap”).
The Process So Far.
Briefly, the process to date has been as follows: The IACC, newly reauthorized by CAA, held its first meeting November 30. The NIMH staff presented a tentative plan to gather public and scientific input for the SP with over 500 comments filed by January 5. However, comments and/or summaries have not been made public. Over seventy scientists met in groups January 15-18 and generated 41 general research topics. These meetings were closed to the public and the 41 initiatives have not been made available to the public. An initial workgroup met on February 21. The IACC met again on March 14 and expressed a need for historical funding information and a consensus for a new workgroup to conduct detailed analysis and begin the process of drafting the SP. The newly organized workgroup met on April 21 with public access available via telephone. The workgroup reached a consensus that it needed clarification of its mandate from IACC and several more meetings to complete the task of drafting the SP. A huge townhall meeting was held in Sacramento on May 3.
During their most recent meeting on May 12, the IACC again expressed a strong consensus that the workgroup should reconvene for further analysis and development of the SP, as well as expanding the workgroup as an ongoing subcommittee similar to the Services Subcommittee. Despite repeated requests by the IACC for more information and for a continued role for the workgroup in drafting the SP, most of the drafting has been captured by NIMH staff with little practical input from the IACC, or the workgroup. The NIMH has consistently failed to follow the guidance of the IACC and the workgroup regarding ways to improve the quality and oversight of the SP. The “early draft” was sent to IACC and the workgroup, but only a brief opportunity for “review” (with insufficient time for real collaboration or drafting) has been scheduled for July 8. The draft SP will be presented to the IACC on July 15.
What Should Be In The SP?
The community can enthusiastically support a SP that ensures progress toward Congressional goals with all deliberate speed. Therefore, the SP must be much more than an unprioritized listing of interesting research topics relating to autism (as was the “autism roadmap” developed in 2003).
The SP must address at a minimum: (1) a mission statement incorporating the goals set by Congress; (2) specific goals; (3) analysis of past and present research, accomplishments, and gaps (including unfunded projects as a measure of demand); (4) a prioritized plan for present and future research initiatives that specifically includes a focus on environmental causes including vaccines; (5) changes to the funding process to reduce delay, rely on mechanisms such as special emphasis panels with defined budgets and research targets, and increase community participation in funding decisions; (6) transparency, accountability and performance metrics; (7) a justified research budget driven by scientific opportunity and demand; and (8) collaboration and partnerships with non-NIH public and private research funders.
The SP must strategically justify necessary resources, prioritize research questions, is accountable and transparent. The community must have an effective plan to take back to Congress to obtain the necessary appropriations.
Why Is The Strategic Plan Important?
This particular battle might seem like a small and irrelevant silliness, just a piece of paper, but it is of the utmost importance. Advances in treatment and prevention depend on sound science in biomedical/environmental and behavioral areas. Much of the really useful science to date has been funded by parents and private philanthropy and is being conducted “informally” (one kid at a time) in tens of thousands of households and in the offices of courageous, dedicated, and over-stressed DAN! docs and in leading institutions such as MIND, Thoughtful House, and the Rimland Center. Success in vaccine court depends absolutely on science to show a biologically plausible connection between vaccines and autism. Sound science must inevitably defeat the Government’s now tiresome refrain is that the kids’ case isn’t even close to this standard of proof, and is based on little more than “junk science” and mere speculation put forth by Sallie Bernard, et al, with respect to mercury, and by Wakefield, with respect to MMR. The SP sets the “official” agenda for what’s important (for example, spending a gazilion on the search for the elusive autism gene) and what’s unimportant (spending money on vaccine safety research or to determine whether there’s an association between vaccines and autism) which will drive both public spending and private philanthropy. The future (recovering kids and preventing new cases) depends on the research funded under this plan as well as that privately funded. If the Government refuses to look for possible triggers for autism in vaccines, then, obviously, they won’t find them and squander millions looking elsewhere. New cases will continue to skyrocket. In one example of stalled but crucial research, NIH has had a chelation clinical trial on the books for two years but hasn’t enrolled a single child; implementation has been held up for “political” reasons masquerading as safety concerns.
Time to Act Up!
The SP is an unprecedented opportunity to influence federally funded research that can make a difference. The community risks having little influence over federally funded autism research if we end up with a lame SP because it will have the imprimatur of the CAA, the IACC (with its six voting members from the community), and the blessing of an outside workgroup. The community must come together, once again, to fight for a strategic plan that will actually matter in the treatment and prevention of autism. We fought hard for this money and will have to fight again in the appropriations process to actually get the money allocated for autism. The SP must be an effective marketing document, justifying why we need hundreds of millions for autism research and how it will be spent in a manner that is both effective and accountable. Stay tuned here following the Workgroup meeting today for a further report and an action plan to include community-wide and individual letters. Working together, we can craft a plan that will make a difference.
Jim Moody is a Board Member of SafeMinds and the National Autism Association and chairs the government affairs committee of SafeMinds. He is the founder of Citizens for a Competitive Economy. Jim is a practicing attorney and is active in cause-related advocacy for children with autism