By Jim Moody, Esq.
If you don’t like the way your tax dollars are being spent, or not spent, on autism research, this is your chance to speak up and take action. The strategic plan (SP) for autism research will guide federal spending on autism research for the next five years, subject to annual updates. The draft plan (HERE) was released for comment August 20 (HERE) .
Comments are due by Tuesday, September 30, and should be emailed to firstname.lastname@example.org. There is a suggested limitation of two pages. See the above request for further details. A few thoughts on possible subjects for comment are summarized below.
It is extremely important for groups and individuals to file comments. Over 500 comments were submitted in response to last January’s request, many of which were from our friends in the “neurodiversity” (ND) community.
The process for developing the SP began at a meeting of the Interagency Autism Coordinating Committee (IACC) last November 30. A summary of the major events in the development of the SP is here (HERE). Age of Autism reported on the process, “What’s So Secret About Autism Science” (HERE), January 12, “The Strategic Plan for the Combating Autism Act” (HERE), July 8, and “The Strategic Plan for the Combating Autism Act” (HERE), July 14. Consult these articles and information on the IACC website (HERE) for more background. Information on deficiencies in the plan can also be found in Safeminds’ July 7 letter to Secretary Leavitt (HERE) , IACC member Lyn Redwood’s August 5 letter to Dr. Hann (current head of the Autism Team) (HERE) and Autism Speaks’ August 14 letter to IACC Chair Insel (HERE) .
What’s Wrong With the Plan.
Where to start? There’s so much wrong with the plan that it is probably best to just start over. Basically it is a rehash of the 2004 “autism matrix” or research roadmap (HERE). The plan proposes 35 broad research initiatives grouped into six categories, and is organized as follows:
Introductory Material (including the Introduction, Vision Statement, Mission Statement, Core Values and Cross-Cutting Themes)
I: When Should I Be Concerned?
II: How Can I Understand What Is Happening?
III: What Caused This To Happen And Can This Be Prevented?
IV: Which Treatments And Interventions Will Help?
V: Where Can I Turn For Services?
VI: What Does The Future Hold?
Development Process for the IACC Strategic Plan for Autism Spectrum Disorder Research
Although Congress asked for a plan leading to cause (prevention) and treatment, the draft has all the urgency of molasses on a cold day. It fails to recognize the paradigm shift from autism as a psychiatric disorder to autism as a whole-body disease caused by environmental exposures and treatable. Set forth below are some ideas that might help your comments.
The Plan Must Articulate Adequate Doctrine to Guide Research.
The most crucial flaw is failure to adequately set forth guiding principles and doctrine. The plan must recognize that autism is a national health emergency and propose research with a genuine sense of urgency, similar to our response to threats like SARS and bird flu. The plan must recognize that the ten-fold increase in diagnosed cases over the past two decades represents a real increase in the frequency of this disorder – a genuine epidemic – rather than simply better labeling or increased public awareness. The research agenda responsive to an epidemic is much different than research directed against a disorder that has been here since the beginning of time, especially since it would focus aggressively on identifying and removing environmental triggers and on treatment of those already affected. The plan must expressly state a strategic goal of preventing new cases of autism. Without such a goal and research focused on identifying and eliminating environmental triggers, the over-emphasis on gene research in the current draft risks future reliance on eugenic abortions as the government’s “solution” to the autism problem rather than a genuine effort to identify and eliminate etiologic environmental triggers.
The plan largely embodies the old paradigm of autism as an inherited genetic disorder. Recent research has failed to provide evidence supporting the heritability hypothesis. While investigation of inherited factors in autism have contributed to some interesting hypotheses about the biology of ASD, and there continue to be extensive privately funded research projects in this area, this research is unlikely to lead to meaningful interventions for many years and therefore don't deserve the funding priority they have heretofore received.. The plan must state a strategic goal that research be conducted provide benefits to children and adults living with autism.
The plan should focus research on environmental causation. Such research must include “controversial” topics such as vaccines as a potential cause. The legislative history of CAA singled out vaccine research for special emphasis yet the draft plan lumps this (without specific mention) into the general category of environmental research. An environmental factor or combination of factors contributes to disease causality. These factors can interact with susceptibility genes. Timing of exposure during development is also an important consideration, and relevant exposures may occur pre- or post-natally. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents must be the priority for understanding the new case rates, and can be a fruitful approach for both treatment and prevention. The plan must state a strategic goal of identifying the preventable environmental causes of autism and promising areas of intervention to improve function in affected individuals while also preventing new cases. While there may be no “cure” for autism, we cannot turn back the clock to reclaim the time lost to developmental injury. We also embrace the unique personality of autistic individuals and, for a few, their unique aptitudes and gifts. Our hopes for children with autism are that they: may lead independent lives; otherwise expand their capacity to learn, grow and develop; play a productive role in society; and the ability to enjoy mutually satisfying and loving relationships. Individuals diagnosed with autism are physically sick and disabled; they are not genetically defective. While they may have unusual talents, their condition is not purely behavioral or psychiatric. Substantial recovery from their deficits is possible and there is evidence in case studies of effectively complete recovery from the symptoms of autism. Autism and related disorders and their associated conditions are amenable to treatments which, if applied correctly, can result in significant improvements in function. Treatments and recovery mechanisms can be identified through systematic and thoughtful clinical practice, use of basic science, and comprehensive data analysis. With better science applied and more training of clinicians, significant improvement in function is likely. Recovery and improvement can be measured with the appropriate tools and methods. In order to accomplish meaningful recovery, however, medical intervention should be an integral component of autism support services, which also include specialized education, traditional therapies like speech and OT, innovative neural systems challenge approaches, accommodations, and life choice opportunities (housing, employment, recreation). The plan should expressly recognize that recovery of function is possible with early and effective treatment. The plan must state a strategic goal of expanding therapy and treatment options for all individuals with autism and identifying the most effective interventions in current use.
The Plan Must Include Community Participation in All Decisions Relating to Autism Research.
A second major flaw is that it completely fails to re-engineer the grant-making process. Crucial here is the inclusion of community participation at all levels of decisions relating to autism research, especially on matters of scientific merit and program relevance. The Congressionally-mandated program for autism research conducted by the Defense Department (HERE) does a much better job of incorporating meaningful community participation. Greater participation ha been encouraged by IOM and by Congress in the CAA. Also, the old “study section” model must be abandoned in favor of targeted funding opportunities with review by special emphasis panels. The plan should also include the establishment of an permanent Autism Advisory Board, as recommended by Congress in the CAA. Composed of scientists, clinicians, and advocates, the AAB be in a better position than ad hoc workgroups to monitor the plan and provide the annual updates required by Congress.
The Budget is Woefully Inadequate to Solve the Challenges Posed by the ASD Epidemic.
Although initially reluctant, the Autism Team eventually accepted the requirement in the CAA that it provide a research budget as part of the SP. How much should be spent on autism research? Not to be flip, but the answer is simple: as much money as is needed to effectively treat existing cases and prevent new ones. Given the enormous direct and indirect financial burden of autism on society, now growing exponentially, a “cost of disease” analysis should be performed and included in the plan to determine how much “should” be spent. Ironically, the same general sort of analysis is used to “justify” each new vaccine in terms of the “benefits” of preventing an infectious disease. The budget must also consider the demand from the scientific community for funding for autism-related research. Such an analysis would require, at a minimum, a review of proposals submitted to NIH during recent years that were not funded due to lack of money. This information was requested but never provided to IACC.
A couple of examples will illustrate the inadequacy of the funding. A list of the proposed initiatives with proposed funding as of August 8 is here (HERE). Five projects relating to environmental cause are proposed for the next five years at a funding level of $24 million. Why limit these studies to only five (without even specifically mentioning vaccines)? The plan should propose as many as are needed to identify the pre-natal and post-natal exposures that trigger ASD without arbitrary limits. The budget proposes a handful of treatment studies and clinical trials over five years. But this falls far short of studying the effectiveness of the dozens of behavioral and medical interventions currently used by parents. It’s hard to have confidence in NIH’s treatment research agenda in light of the recent cancellation of a clinical trial of chelation. Although thousands of parents are using various forms of chelation, NIH had its own trial on the books for two years and finally dropped it allegedly for safety reasons. Although most likely a pretext, the fact that so many parents are using chelation more than justifies rigorous study of this intervention especially if there are legitimate safety concerns.
Process Failures Contributed to a Deficient Plan.
You might also wish to comment on the many errors that have infected the planning process. The details are too numerous to discuss here, but, without major revision, anything approved by IACC is subject to legal challenge and a restart of the process. Some of the more serious examples include: appointment of Joyce Chung, wife of legendary epidemic-denier Roy Grinker, as head of the Autism Team (see “Grinker’s Stinker: His Wife Runs the IACC” (HERE), January 15); members of science workshops and workgroups were not appointed by IACC, the six c ommunity members of IACC were prohibited from collaborating outside formal meetings; secret email voting and discussions; “public” comments not made public; refusal to provide background information necessary to formulate the plan; community input was ignored; selection of workshop and workgroup members with disqualifying bias and lack of diversity; abrogation of IACC’s obligation to make key decisions to an internal bureaucracy; and “community” participation in making crucial decisions regarding funding priorities and specific initiatives was limited to organizations and interests that privately fund autism research (especially relating to genetics).
The next meeting of IACC will be held November 21 in Washington (HERE). As has been the case for three of the SP workgroup meetings, hopefully this will be available on a conference call and on the web (slides) so that the broader community can listen. Hundreds of millions in research funding are at stake. It is also important that the broader community have the first-hand opportunity to assess how effectively the six IACC “community” members are representing the community.