By Jim Moody
In a surprise and deeply disappointing move, NIH announced in the Federal Register http://www.ageofautism.com/2008/01/nih-to-hold-clo.html#more on Monday that it will be holding four science workshops January 15-18 “to generate research priorities that will be used to develop the IACC strategic plan” that (without explanation or justification) will be “closed to the public.”
These workshops play an essential role in the development of the strategic plan required by the Combating Autism Act of 2006 Click here. that will guide the spending of over $600 million on federally funded autism research during the next several years. The agenda includes: “Review of research accomplishments, funding initiatives and research resources for ASD by scientists and other ASD stakeholders; discussion and generation of high priority research areas and initiatives for developing the IACC strategic plan for ASD research.”
A consensus group in the community worked very hard to get the CAA passed, an extraordinary legislative effort given that single-disorder bills are exceedingly rare. The group pushed hard to include mechanisms designed to ensure improved oversight and accountability. Among these were: the inclusion of six community representatives on the newly constituted IACC, the strategic plan, a mandate expressed in the legislative history that research include vaccines and their preservatives as a possible cause, reports to Congress, authority for an Autism Advisory Board composed of scientists, clinicians, and community representatives, and a specific requirement to expand and focus research into 13 broad subject areas with clearly stated goals:
“The Director of NIH (in this section referred to as the ‘Director') SHALL, subject to the availability of appropriations, EXPAND, INTENSIFY, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including basic and clinical research in fields including pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, and toxicology. Such research shall investigate the CAUSE (INCLUDING POSSIBLE ENVIRONMENTAL CAUSES), diagnosis or rule out, early detection, PREVENTION, services, supports, intervention, and TREATMENT of autism spectrum disorder.”
Senators McCain and Lieberman stated their intent to seek oversight in a December 7 letter to the HELP Committee, requesting hearings on “federal research efforts regarding factors affecting the incidence and treatment of autism spectrum disorders. . . . We have heard the concerns of many Americans that a number of environmental exposures . . . may be linked to autism. Our research efforts should support broad approaches to understanding the wide range of etiological factors in our environment that may be related to autism for both prevention and treatment purposes.”
The announcement of this process at the November 30 meeting of the Interagency Autism Coordinating Committee [IACC, http://www.nimh.nih.gov/research-funding/scientific-meetings/recurring-meetings/iacc/index.shtml appeared like a good first step to reprioritize and rationalize the federal research agenda. NIH touted its openness, transparency, accountability, and perhaps most important, the need for haste to respond effectively to what the data show to be a rapidly rising autism epidemic. In a good first move, NIH sought public comment http://grants.nih.gov/grants/guide/notice-files/NOT-MH-08-003.html research priorities in areas to be covered by the four workshops: treatment, diagnosis, risk factors, and biology. Over 500 responses were received, including a submission by SafeMinds and NAA.
The process will be overseen by a nine-member workgroup composed thus far of the four workshop chairs (David Amaral, MIND Institute (biology), Geraldine Dawson, CSO, Autism Speaks (treatment), Catherine Lord, author of Educating Children of Autism (diagnosis), and Dan Geschwind, UCLA, Center for Autism Research and Treatment (risk factors)), two feds (Thomas Insel, Director NIMH and Ed Trevathan, Director of Birth Defects, CDC plus the NIH’s staff on the “autism team”), and the major private funders of autism research (Peter Bell and Geraldine Dawson, Autism Speaks, Autism Speaks ; Gerald Fischbach, Simons Foundation, Simons Foundation; Denise Resnick, SARC), but no “consumers” of this research. While CDC has a seat on the workgroup in addition to IACC Chairman Insel from NIMH, the National Institute for Child Health and Development (NICHD) and especially the National Institute for Environmental Health Science (NIEHS) do not. The assigned mission of these agencies has in the past and should in the future give these agencies a significant, if not leading, role in research funding.
Approximately 70 scientists and a handful of “public” members and community observers have been specially invited to attend the closed workshops. NIH Guidelines http://www1.od.nih.gov/cmo/committee/SelectionCriteria2007.pdf for advice call for demonstrated proficiency in the relevant subject disciplines, an absence of conflicts, and open-mindedness with respect to the scientific inquiry at issue, and diversity from the relevant community for public members. “The Federal Advisory Committee Act (FACA) and a number of Federal regulations and policies govern NIH’s use and management of its advisory committees. The FACA requires that membership be fairly balanced\ in terms of points of view represented and the functions to be performed by the advisory committee. . . . Service on NIH advisory committees also demands mature judgment, balanced perspective, objectivity, [and] ability to work effectively in a group.” While NIH has invited a handful of scientists representing the environmental/biomedical view of autism, the majority seem steeped in the old paradigm of autism and recipients of legacy funding mechanisms. Several of the 13 subject areas are under-represented and some (gastroenterology, for example) seems to have no voice. Worse, some of those invited are publicly and actively hostile to looking at environmental causes, including vaccines, and to biomedical treatments.
Participation by the community (including scientists and clinicians), the “consumers” of the research output, is vital at early and every stage of the process of developing the plan. The four workshops are overseen by the workgroup. Ultimately the plan will be submitted for approval to the full IACC, which by law is a public meeting. But by that time it will be far too late for meaningful input and changes. Rejection of the plan at that point would only result in further delay in the urgent mission of reorienting federal autism research. A “no” or “try again” vote at IACC is unlikely since it is dominated by federal employees who can easily outvote the six “community” members, at least one of whom has already expressed open hostility to biomedical treatments. The community consensus group proposed an Autism Advisory Board in the CAA, composed of scientists, clinicians, and advocates, for precisely this reason, to ensure that there was community input and oversight at a much lower level than the full IACC. Congress supported the AAB in the CAA’s legislative history, but left it up to IACC and NIH to formally establish it. Such non-federal advisory boards are routine, and highly valued, e.g. at FDA, NIH, and as part of the process of formulating DOD-funded autism research pursuant to a special Congressional earmark of $7 million for FY08.
Openness and oversight are essential to ensure a plan that effectively meets the needs of the community. Who gets to be “at the table” drafting the plan matters because of the tension between “old” and “new” paradigms of autism and therefore what research is important. The classic view of autism is that it is an inherited or gene-based disorder diagnosed as a psychiatric condition for which there is no effective treatment (except for reduction of symptoms). The emerging paradigm is that it is a disorder of the whole body triggered in genetically susceptible individuals by factors in the environment that is both preventable and treatable. There is a profound but all too slow shift to the new paradigm. For example, the IOM held a two-day workshop on “Autism and the Environment: Challenges and Opportunities for Research” last April and published the full transcript http://www.nap.edu/catalog.php?record_id=11946#toc, including an Appendix of crucial research topics http://books.nap.edu/openbook.php?record_id=11946&page=285 . Perhaps a third paradigm from the neurodiversity community looks at autism as a natural evolution that should not be thought of as a disease or disorder and should not be the focus of treatment, prevention, or cure. The model of autism has a profound impact on the research agenda and its priorities. It also has profound policy implications for the Congressional goal of “prevention” of new cases. Seeing autism as a genetic disorder will lead to genetic tests and the “prevention” of new cases through abortion. On the other hand, viewing autism as primarily an environmentally triggered highly treatable disorder will lead to identifying and simply eliminating the responsible environmental agents.
One of the biggest impediments to acceptance of the new paradigm is denial of the epidemic. If, as the data clearly demonstrate, this country is facing a rapidly rising autism epidemic, there must be an environmental cause, and autism can be treated and prevented. If, on the other hand, the cause is purely genetic, then the research focus should be on the search for the elusive “autism gene” and on relief of symptoms. While the labeling of previously undetected cases or the re-labeling of other diagnoses as autistic may account for a tiny fraction of the 1 in 150 prevalence (CDC data for the 1994 birth cohort), the rapid rise in diagnosed cases must be treated as an epidemic (especially in driving an urgent response from federal heal authorities to this national health emergency) until its deniers can demonstrate otherwise with persuasive evidence.
SafeMinds and NAA have asked that the workshops be open, have proposed 17 scientists (3 have been included so far) and 21 community representatives (2 have been included so far), and have asked that the workgroup be expanded to include a voice for consumers of the research and for the part of the community that funds primarily biomedical research and strategic planning expertise. The only community funding included on the workgroup thus far are Autism Speaks (Peter Bell and new Chief Science Officer Geraldine Dawson) and the Simons Foundation (Gerald Fischbach). In expressing hope for a dramatic reorientation of AS research funding, Katie Wright in a recent AOA post chastised AS research policies as “wedded to the past and are non-responsive to what parents want and the immediate needs of our children.” Including stakeholder “beneficiaries” of the research as part of the oversight would be a significant improvement.
Important questions remain: What could possibly justify the secret development of research policy of such vital importance to the community? Who had the final say (including veto power) over those invited to the workshops? To what extent will the development of the strategic plan go forward with meaningful community feedback and input? Will the Congressional goal of expanding and reprioritizing autism research to achieve the goals of finding the cause, prevention, and treatment be achieved?
The next meeting of the IACC will be March 14 in Washington. This must be public by law and there will be opportunity for the public to speak and make written submissions.
NAA and SafeMinds strongly support the urgency of the strategic planning process and of reorienting the federal research effort to more effectively address cause, treatment, and prevention of autism. We want to work with NIH and the rest of the community to ensure the most effective and legitimate process possible, that will be respected and supported by all segments of the autism community.
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