By Jim Moody
It has taken over a year to write the first-ever strategic plan for federal autism research, but this long and tedious ordeal may come to an end at the meeting of the Interagency Autism Coordinating Committee (IACC) this Wednesday in Washington. The public meeting will be held today 9-2:30 at the Neuroscience Center (NIMH), Conference Room C, 6001 Executive Blvd., Rockville, Md.
In-person attendees should register (HERE), and the meeting will be telecast on 888-455-2920, access code 3857872.
Slides can be viewed on a webinar (HERE).
The agenda (HERE) includes final decisions on the content of the Plan and the autism research budget, both of which are required under the Combating Autism Act of 2006. General information about IACC, including charter, members, and documents can be found on its home page (HERE).
This is a crucial meeting as many of the topics to be discussed will determine whether the research spending will actually make a differencer in finding the cause and effective treatments for autism. The draft strategic plan (HERE), backgrounddocuments relating to development of the plan (HERE), and the 148 public comments (HERE) received in September can be reviewed online.
Most of the revisions and additions to be discussed will make the plan an aggressive response to the national health emergency presented by the autism epidemic. The present draft basically continues business as usual and failed to even propose spending the minimum authorized by Congress in the CAA, about $640 million over the next three years.
The two topics on the agenda are completion of the edits to the Introduction for the Plan and assignment of budgetary amounts to the 35 research projects grouped into six broad categories with short- and long-term objectives for each.
Autism Must Be Declared a National Health Emergency.
The necessary changes in the Introduction primarily relate to the themes that impact the entire research enterprise. The Plan must declare autism a national health emergency driven by the rapid rise in prevalence, the burden on individuals, families, and society, and the opportunity that answers provided through research can have an immediate impact on function, quality of life and prevention of disability. The autism epidemic deserves a crisis-level response with direct leadership from the White House, as promised by President-Elect Obama. Why is CDC so quick to deny the epidemic of autism cases when it is reasonably competent at tracking down SARS, salmonella, pet food and toys from China, E. Coli outbreaks, and even 131 cases of measles? The recently released study from the MIND Institute (HERE) demonstrated with rigorous analysis that the rapid rise in cases reported in California data was real and not simply the result of better counting, awareness, and changes in diagnostic practices. CDC remains awash in ignorance about autism, claiming “it is unclear how much of this increase is due to changes in how we identify and classify ASDs in people, and how much is due to a true increase in prevalence,” although CDC does concede that ASDs are “urgent public health concern.” This deliberate ignorance must be replaced by concerted action.
The ability of basic and clinical research to have an immediate impact justifies a research agenda responsive to crisis. To the extent that services, interventions and treatments promise real hope for recovery or gain of functionality, improvement in behavioral symptoms, and restoration of physiological health, these must be developed through research and implemented with all deliberate speed. To the extent that autism is triggered by particular environmental factors, their identification and elimination offers the hope of a significant reduction in new cases.
Autism Is a Complex Biological Disorder.
The Plan must acknowledge that autism is a disorder of the whole body. Autism is at present defined and diagnosed behaviorally, but it is driven by biological mechanisms that we need to better understand. We therefore need to consider the wide range of dysfunction in multiple bodily systems as potential targets for research and treatment. Areas deserving further research focus include unusual brain growth, widely and unevenly distributed patterns of lasting neurogliosis and pervasive disruption in connectivity, mitochondrial dysfunction, immune system disregulation, sleep disturbances, gastrointestinal pathology, and disruption of metabolism. Making rapid progress in elaborating the mechanisms for these pervasive problems will require collaborative efforts across disciplines. We need to focus research on the real-time development of this disorder in the brain and in other body systems.
Environmental Factors Play a Crucial Role in Causation.
The rapid increases in autism rates demands a high priority on investigating the etiological role of environmental factors. These factors can interact with susceptibility genes. We need to take on a more innovative view of the interactions between genes and the environment in order to make research on both genes and the environment more productive. Timing of exposure during development is also an important consideration, and relevant environmental exposures can occur from the preconception, prenatal, and infancy periods with the changes in the brain and other bodily systems being most notable after infancy. Some show early signs of autism but others develop normally as infants and then regress. In light of the increases and the observations seen in children, it’s important to leave no stone unturned in the investigation of environmental exposures. Research on environmental factors must include the potential role of vaccines (including components such as mercury and aluminum) in the etiology of autism. Studies of vaccines in animals and in humans (especially the crucial vax/unvax comparison) were added to the research projects set forth in the Plan at last month’s IACC meeting (HERE).
Such research should resolve remaining uncertainty while preserving confidence in the vaccine program. Even low level exposures can result in alterations to development that can lead to symptoms of autism. Research on the role of environmental agents can be a fruitful approach for both treatment and prevention. The Plan must consider the best ways to inform epidemiology with toxicology, while also developing the disciplines of predictive toxicology, in order to get answers rapidly.
The Plan should emphasize a broad range of treatments (biomedical and behavoiral/educational) leading to recovery of function and loss of diagnosis. Individuals with an ASD diagnosis are unique. Children and adults with ASD can lead independent lives; expand their capacity to learn, grow and develop; play a productive role in society; and enjoy mutually satisfying and loving relationships as they desire. Individuals diagnosed with autism have biologically-based differences that can lead to both disability and superior ability, and that cannot be viewed purely as behavioral or psychiatric in nature. Substantial gains in function, quality of life, and health are possible across the lifespan through targeted interventions developed through careful assessment of each person. Thus personalized treatment parity across all domains, including medical, educational, and behavioral, must be made a high priority for research in the Plan.
The value of this Plan will be lost without proper implementation, even if the Plan succeeds in adopting good doctrine and a comprehensive list of research projects. Key features of this implementation include mechanisms for accountability and oversight, a substantially increased research budget, and community involvement in decisions relating to scientific merit and programatic relevance.
Public Participation in Research.
The CAA instructed IACC to increase public participation in all decisions relating to autism; therefore, this must be an express goal of the Plan. Such participation is consistent with the Plan’s goals of consumer focus, partnerships, and accountability. Close collaboration between parents, scientists, and clinicians, working through private organizations and providing input to public agencies, has been a hallmark of rapid progress of ASD research and in the development and deployment of both behavioral and biomedical interventions.
As an example, the Autism Research Program as recommended by the Institute of Medicine and administered by the Department of Defense Congressionally Directed Medical Research Program incorporates significant community participation in decisions relating to both scientific merit and programmatic relevance. Community participation in that program has been instrumental in serving to remind basic scientists of the human component of disease and to focus research toward projects with high impact and leverage. A similar process must be implemented with respect to research under the Plan.
Autism Advisory Board.
The CAA requires that the Plan be updated annually. This process will require evaluation of completed and ongoing projects, reallocation of resources among existing initiatives, the creation of new initiatives, and the preparation of annual updates to the Plan. In passing the CAA, Congress encouraged the establishment of an Autism Advisory Board comprised of scientists, clinicians, and advocates. Working together both formally and informally, collaboration among these groups has already proven an effective tool in advancing research and treatments for autism. The community has repeatedly asked for an AAB in comments and letters. The Plan should establish an AAB immediately.
Consistent with the demand for an urgent response to this crisis and the cross-cutting nature of much of the ASD research portfolio, IACC should immediately convene a workgroup to re-engineer the funding process to meet this crisis. Subjects to be addressed include allocation of the research initiatives among a limited number of special interest panels who will provide funding on a continuous basis through program announcements and other innovative grant-making initiatives, and an “innovation fund” and process for immediately responding to new research and treatment opportunities. Accountability, transparency, and oversight must be hallmarks of this process to ensure that progress on the research objectives is timely and effective.
The autism research budget set forth in the Plan has been increased during the past few months to approximately reflect the amounts authorized during the three years remaining under the CAA. However, the rapid rise in prevalence, the necessity of an urgent and coordinated response to this national health crisis, and the time-sensitive opportunities for prevention and treatment demand a considerable and immediate increase in the research budget. The CAA authorizations must be regarded as a floor, not a ceiling. IACC should immediately convene a workgroup and appropriate workshops to (1) increase funding for the research initiatives (with emphasis on increased priority for environmental and treatment research which has been under funded in the past) at least to the level of the CAA authorizations; and (2) develop a coherent justification for a substantial increase in the research budget based upon a “cost of disease” model and on the opportunity in the scientific and clinical communities (measured in part by grant proposals that have merit but remain unfunded) to perform high-quality research in support of the mission and vision of this Plan.
The importance of this Plan cannot be over-emphasized. It (along with annual updates) will direct all federal autism research. Attendees and listeners should pay particular attention to how the six community members advocate and vote for the necessary improvements in the Plan.
In the end, the Plan is just words on paper. Its true value will depend on whether its implementation can be measured in new cases of autism prevented, in meaningful treatments for existing cases, and in services and supports that have a useful impact for those with ASD.
Previous AoA articles on the strategic planning process:
1/5/09: Kirby, Top Federal Autism Panel Votes for Millions in Vaccine Research http://www.huffingtonpost.com/david-kirby/top-federal-autism-panel_b_155293.html.
12/13/08: Walker, When Autism Leads to Advocacy http://www.ageofautism.com/2008/12/when-autism-lea.html.
12/11/08: Moody, IACC Meeting Friday to Finalize Federal Autism Research Plan http://www.ageofautism.com/2008/12/iacc-meeting-fr.html.
12/11/08: Community research organizations’ concensus statement “Concerns on IACC Strategic Plan Discussions” http://www.ageofautism.com/files/iacc_sp_community_concerns_121108_final.pdf.
11/20/08: Listen Live Friday to the Federal Plan for Autism Research http://www.ageofautism.com/2008/11/listen-live-fri.html#more.
11/13/08: Autism Community “United in Expressing Our Disapproval “ of the NIH Strategic Plan for Autism Research (first consensus letter urging that the plan communicate a sense of urgency driven by the rapid rise in prevalence, allocate sufficient resources to achieve its goals, increase resources devoted to environment and gene-environment research, provide for accountability and oversight, create an Autism Advisory Board, and represent the diverse views in the community) http://www.ageofautism.com/files/iacc_strategic_plan_community_concerns.pdf.
9/29/08: Moody, Reminder - This is Your Chance to Influence Federal Autism Spending - Comments Due Tuesday [http://www.ageofautism.com/2008/09/reminder---this.html].
09/10/08: Budget Recommendations from Aug. 8 and Sept. 10 strategic planning workgroup meetings http://www.ageofautism.com/files/iacc_funding.pdf.
9/9/08: Safeminds Reminds: IACC Budget Meeting Wed., Sept. 10 http://www.ageofautism.com/2008/09/safeminds-remin.html.
8/25/08: Davis, NIMH Flip-Flops on Pivotal IACC Workgroup Meeting http://www.ageofautism.com/2008/08/nimh-flip-flops.html.
8/14/08: Autism Speaks’ letter to Chairman Insel (urging clearly defined objectives tied to well-specified budget, greater emphasis on research into environmental factors and gene-environment relationships, potential role of vaccines in the etiology of autism, and inclusion of diverse viewpoints from the entire community) http://www.ageofautism.com/files/autism_speaks_letter.pdf.
8/12/08: Dunkle (Hanah Poling’s aunt), Boost Vaccine Safety http://www.ageofautism.com/2008/08/the-matter-is-u.html.
7/14/08: Davis, Congressional Oversight Committee Presses for Vaccine Research http://www.ageofautism.com/2008/07/congressional-o.html.
7/14/08: Letter from House Science and Technology Committee to IACC (noting concerns over process and calling for vaccine research) http://www.ageofautism.com/files/71408_miller_to_leavitt_re_iacc.pdf.
7/8/08: Moody, The Strategic Plan for the Combating Autism Act [http://www.ageofautism.com/2008/07/the-strategic-p.html].
7/7/08: Safeminds’ letter to Secretary Leavitt Download Safeminds leavitt letter
4/28/08: Invitation to California Autism Advocates (to attend town meeting to gather input for strategic plan) http://www.ageofautism.com/2008/04/nih-invitation.html.
4/20/08: IACC Meeting Listen In Via Conference Call http://www.ageofautism.com/2008/04/iacc-meeting-li.html.
1/15/08: Handley, Grinker’s Stinker: His Wife Runs the IACC http://www.ageofautism.com/2008/01/grinker.html.
1/12/08: Moody, What’s So Secret About Autism Science http://www.ageofautism.com/2008/01/whats-so-secret.html.