IACC Full Committee Meeting - December 12, 2008
|Date:||Friday, December 12, 2008|
|Time:||9:00 a.m. to 4:00 p.m. Eastern|
|Agenda:||To review and make decisions about the IACC Strategic Plan for Autism Spectrum Disorder (ASD) Research|
|Place:||In Person: National Institutes of Health
Conference Room A
6001 Executive Boulevard
Rockville, Maryland 20892
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|Contact Person:||Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC, Room 8204A
Rockville, Maryland 20892-9669
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|9:00 a.m.||Call to Order and Opening Remarks
Thomas Insel, M.D.
Director, National Institute of Mental Health
|9:05 a.m.||Brief Introductions of IACC Members|
|9:10 a.m.||Review and Decisions: IACC Strategic Plan for ASD Research: Question 3
Thomas Insel, M.D.
Director, National Institute of Mental Health (NIMH)
|10:45 a.m.||Continuation - Review and Decisions: IACC Strategic Plan: Question 4
|12:45 p.m.||Continuation - Review and Decisions: IACC Strategic Plan: Question 5|
|1:30 p.m.||Continuation - Review and Decisions: IACC Strategic Plan: Question 6
|2:20 p.m.||Continuation - Review and Decisions: IACC Strategic Plan: Introduction and Cost Estimates
|3:45 p.m.||Open Session for Public Comment|
|4:00 p.m.||Closing Comments and Adjournment|
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- Call to Order and Opening Remarks
- Review and Decisions: Question 3
- Review and Decisions: Question 4
- Review and Decisions: Question 5
- Review and Decisions: Question 6
- Review and Decisions: Introduction
- Open Session for Public Comment
- Closing Comments and Adjournment
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened at 9:00 a.m. on December 12, 2008, in Conference Room A of the Neuroscience Center Building at the National Institutes of Health in Rockville, Maryland, and adjourned at 4:00 p.m.
In accordance with Public Law 92-463, the meeting was open to the public. Thomas R. Insel, M.D., Director, National Institute of Mental Health, chaired the meeting.
Committee Members Present at the Meeting: Thomas R. Insel, M.D., IACC Chair, National Institute of Mental Health (NIMH); Della Hann, Ph.D., Executive Secretary, Office of Autism Research Coordination (OARC), NIMH; Duane F. Alexander, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Judith Cooper, Ph.D. (representing James F. Battey), National Institute on Deafness and Other Communication Disorders (NIDCD); Lee Grossman, Autism Society of America; Gail R. Houle, Ph.D., U.S. Department of Education (ED); Walter J. Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS) (Representing Story Landis); Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS); Cindy Lawler, Ph.D., National Institute of Environmental Health Sciences (NIEHS); Christine M. McKee, J.D.; Patricia A. Morrissey, Ph.D., Administration for Children and Families; Lyn Redwood, R.N., M.S.N., Coalition for SafeMinds; Alison Tepper-Singer, M.B.A., Autism Speaks; Stephen M. Shore, Ed.D., Autism Spectrum Consulting; Edwin Trevathan, M.D., M.P.H., Centers for Disease Control and Prevention (CDC); Peter van Dyck, M.D., M.P.H., Health Resources and Services Administration (HRSA)."call">Call to Order and Opening Remarks
Dr. Insel welcomed the members of the IACC to the follow-up meeting to complete their review of the draft Strategic Plan for Autism Spectrum Disorder (ASD) Research. The committee members introduced themselves and Dr. Insel informed the group that the November 21, 2008 meeting of the IACC full committee had drawn 123 in-person attendees, 92 people who logged into the webinar, and 219 who listened in by phone.
Review and Decisions: Question 3
What Caused This to Happen and How Can It Be Prevented?
Dr. Insel reviewed the contents of the folders provided to the committee before beginning to edit the Strategic Plan. He reiterated the need for the committee to produce a document that will serve as an advisory plan to the new HHS Secretary, NIH Director, and members of Congress. Dr. Insel said that while the Plan produced may not please everyone on the committee, it needs to be a document that reflects the range of views and gives a sense of autism research needs and priorities.
The committee then resumed editing the Strategic Plan in the "What do we know?" section of Question 3, where they had left off at the November 21 meeting. Dr. Insel asked the committee whether they wanted to progress from that point or revisit sections of the Plan that had already been discussed, as requested in writing by IACC member, Ms. Lyn Redwood. The majority of the committee voted to move forward from where they had left off in Question 3 at the previous meeting.
Dr. Insel briefly described the working draft of the Strategic Plan for those members that had not attended the last meeting. The left hand column contained the previous version of the Plan from August 15, 2008 that had been posted for public comment and could be considered the default option if the committee wanted to reject all subsequent edits. The right hand column contained the draft Plan with edits incorporated from public comments drawn from the Request for Information (RFI) issued August 20, 2008 and/or input from the Implementation Workgroup that met on September 10, 2008. Additionally, members of the committee had provided a list of their recommendations for revising the Plan.
"What do we know?"
Within "What do we know?," the committee discussed Ms. Redwood's proposal to add language about the Congressional wish for researchers to conduct studies on vaccines, mercury, and autism. Dr. Story Landis questioned whether it was appropriate for a forward-looking research plan to place such an emphasis on thimerosal research when the preservative had been eliminated from virtually all vaccines. Dr. Ed Trevathan, of the CDC, described the various immunization safety committees within the agency and stated that these were probably more appropriate forums for investigating any relationship between vaccines and autism. Ms. Redwood disagreed, maintaining that the responsibility for conducting these studies should not be deferred to the CDC. She brought the committee's attention to a letter from a number of advocacy groups calling for more vaccine research in the Strategic Plan.
At this point, Dr. Insel recommended that the group use more general language to express the variety of views in the sections about current knowledge and instead focus on reviewing the specific objectives proposed in the Plan. Mr. Lee Grossman went on record as strongly advocating that language on vaccine research be incorporated in the Strategic Plan. Dr. Cindy Lawler said that she felt that it was appropriate to address the different viewpoints on autism and vaccine in the introductory section describing current knowledge, but that the committee lacked the right kind of expertise to recommend specific objectives related to vaccine research.
Ms. Alison Singer then suggested extricating the material that related to the different views about vaccine-related research from the subsection "What do we know?" from material focusing on "What do we need?" She also supported the idea of doing a retrospective study of vaccinated and unvaccinated children. Dr. Trevathan brought up potential problems with study design and selection bias when putting together such a study and questioned whether the sample size from the National Children's Study would be adequate for prospective observational research. After more discussion, the committee voted to revise the document using Ms. Singer's suggestion to move language about opposing views and insert it into "What do we know?"
The committee then examined a list of factors that may confer environmental risk. The group voted to include a more general list that included parental age, exposure to infections, toxins, and other biological agents.
"What do we need?"
Under "What do we need?" the majority of the committee voted to include the language from public comment describing the debate over which category of ASD risk factors should receive research priority (environmental causes/genetic precursors/gene-environment interactions). The committee also voted to include language suggested by Ms. Redwood on how greater resources could be used to focus studies on environmental factors that potentially contribute to autism.
The committee then voted to include genetics in the statement about developing sound standards for identifying environmental factors that contribute to ASD. They rejected Ms. Redwood's suggested insertion about the need for a large-scale study comparing vaccinated to unvaccinated groups. The group accepted the proposed language on research studies of risk factors and generalized the list of specific co-occurring conditions. Language about specific subgroups that may be at higher risk was changed and specific examples were removed. Dr. Trevathan discussed a current study in Minnesota investigating whether Somali immigrants had higher rates of autism. Educational data from the state suggested a possible increased prevalence among the group. Dr. Insel also noted that unpublished study results had shown geographic clusters of autism when examining prevalence by zip code.
Moving to the Research Opportunities section, the group voted to retain language about studying "unique subpopulations" of people with ASD to identify novel risk factors. Several comments from the public indicated that the phrase may be too restrictive, but the majority of the committee felt the phrase "unique subpopulations" should be included. The group rejected the alternative suggestions on language for the section received through public comment: one alternative suggested making no mention of vaccine research and the other conflicting suggestion recommended including a focus on the role of vaccines in ASD.
Dr. Insel suggested that the phrase "genetic sequence variations" be changed to "genomic variations" in this section to reflect that structural changes in the genome also were important to understanding autism. In addition to this change, the committee also modified language suggested by Ms. Redwood to include the study of environmental influences in ASD. Ms. Redwood's suggested addition about studying "simplex families to inform and define de novo gene differences and the role of the environment" was added to the Plan. Ms. Redwood said that these additions were her attempt to include more genetics research that incorporated a focus on environmental factors into the Strategic Plan.
The committee briefly discussed a suggested addition to the section stating that research with the goal of eliminating people with ASD was not supported. Dr. Stephen Shore discussed focusing on ameliorating the debilitating aspects of autism rather than the goal to eliminate people with autism. Dr. Insel said that the addition reflected some of the public concern that genetics research would devolve into eugenics. The committee agreed that the suggested addition was not appropriate for the Research Opportunities section.
In Short-Term Objectives, the committee discussed the scale of the number of studies on environmental factors to be included in the first objective. Public comment recommended that the number of studies be increased to 10 or 20 from the initially recommended five. Dr. Patricia Morrisey and Dr. Lawler were among the committee members that supported increasing the number to 10. Ms. Redwood recommended going to 20, but said that she would support 10 studies if 20 had no other supporters. Dr. Gail Houle commented that the size and complexity of the studies might have more meaning than simply the number. The committee voted 8 to 7 in favor of remaining with the original language recommending at least five studies. Dr. Insel commented that public members of the committee were, in large part, the ones voting to increase the number of studies. Ms. Alison Singer suggested that additional funding be devoted to the studies to reflect the split within the committee. Dr. Trevathan suggested an increase budget as well and Dr. Insel recommended that the objective be flagged for future budget discussion. He reminded the committee that budget figures would be agreed upon at a later meeting.
The committee chose to retain the next objective on a genome-wide association study with a vote of 12 to 3, despite public comment that enough genetics research was ongoing. The committee then reviewed the next objective: "to identify and standardize at least three biomarkers by 2011." The suggested alternative was to increase the number of biomarkers to 10. Dr. Lawler said that identifying 10 biomarkers by 2011 was not feasible and that another alternative was to increase the amount of time to accomplish the task and define the new goal as a long-term objective. Dr. Walter Koroshetz cautioned that the current objective would be hard to meet. Dr. Lawler clarified that the committee was using the term "biomarker" loosely to include methods for measuring markers of exposure in order to harmonize studies, not simply biomarkers of the disease itself. In a vote of 9 to 4, with two abstaining, the committee chose to retain the original recommendation of at least three measures and the objective was flagged for budget review.
The committee then discussed the feasibility of a potential new objective received via public comment:
"Study the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and understand whether and how certain subpopulations in humans may be more susceptible to adverse effects of vaccines."
Alison Singer suggested that this objective be combined with the next proposed objective: "Initiate an epidemiology study to determine the health outcomes, including ASD, among various populations with vaccinated, unvaccinated, and alternatively vaccinated groups." Ms. Singer suggested that a combined objective would also call for the initiation of a large-scale retrospective study of vaccinated, unvaccinated, and alternatively vaccinated groups. Dr. Duane Alexander discussed sample size problems and issues with the composition of the unvaccinated control group when designing such a study. He said that the National Children's Study might not provide a large enough sample of unvaccinated children to give significant data for a relatively rare outcome like autism.
Dr. Koroshetz recommended assessing the feasibility of conducting a large-scale study examining the association between vaccines and autism. He stated he was uncomfortable committing to initiating a study because it was still questionable whether a sufficiently powered study could be designed. He recommended that the short-term objective calling for the initiation of a vaccine study be replaced with a call for a feasibility study.
Ms. Redwood asked Dr. Alexander for an estimate of how many unvaccinated children would be included in the National Children's Study. Dr. Alexander estimated that there would be 5,000 to 10,000 unvaccinated children in the study. Ms. Redwood then asked whether these unvaccinated children could be compared with age-matched children who were fully vaccinated. Dr. Alexander said that, while this was possible, the problem with such a design is that autism is a rare outcome and therefore requires a very large population. He said that this issue has hampered vaccine studies all along. Additionally, the sample of unvaccinated children may be dramatically different in composition from the sample of vaccinated children. Dr. Alexander stated that better methodologies need to be developed to overcome insufficient study populations. He explained that certain rare diseases can be studied in small groups when a target has been identified. Dr. Alexander pointed to post-vaccine encephalopathy as an example of a disease where researchers had identified a specific genetic mutation that could then be targeted in a small subset. Unfortunately, no such target has been identified in autism. He said he could support an initial push to design a study investigating vaccines and autism but did not think they were at a point to initiate such a study because of its complexity.
Ms. Redwood said she felt that feasibility questions about large-scale vaccine studies had been answered by a report from HHS, headed by NIEHS, CDC, and Dr. Irva Hertz-Picciotto. Dr. Lawler said that the study designs cited in the report played to the strengths of the database used and were slightly different than the type of studies that the IACC was currently discussing.
Dr. Trevathan reiterated that other groups were looking at vaccine safety questions and that he was concerned that the IACC did not have the makeup or expertise to recommend large population vaccine research. He agreed with Dr. Landis' recommendation to have another committee address questions about potential vaccine-autism study design. Dr. Trevathan said that he also had reservations about the IACC's ability to recommend cell and animal studies of vaccines and vaccine components.
The committee discussed the possibility of merging the objectives about cell and animal studies with the objective on conducting an epidemiological study, as per Ms. Singer's recommendation. However, the committee decided that the two objectives were distinct and should remain separate. Dr. Alexander again asked that a feasibility study be conducted in lieu of calling to initiate the epidemiological study.
The committee first voted on the addition of the objective calling for the study of the effect of vaccines, vaccine components, and multiple vaccine administration in autism causation and severity through a variety of approaches, including cell and animal studies, and an investigation of how certain subpopulations in humans may be more susceptible to adverse effects of vaccines. The committee voted 7 to 6 to add the objective. Two members abstained.
The majority of the committee then voted to revise the next objective to focus on determining the feasibility of an epidemiological study on the health outcomes of vaccinated, unvaccinated, and alternatively vaccinated groups. The new objective, to "determine the feasibility and design of epidemiological studies to determine the health outcomes, including ASD, among various populations with vaccinate, unvaccinated, and alternatively vaccinated groups," was added. Eight members voted for this wording, four members voted for language calling to initiate the study, and one member voted not to include this objective at all. Two members abstained from voting.
The IACC then voted to include an objective initiating efforts to expand existing large case-control and other studies to enhance capabilities for targeted gene-environment research. Finally, the committee voted to include a recommendation to enhance existing case-control studies by enrolling broad ethnically-diverse populations affected by ASD. The committee agreed that these short-term objectives should be accomplished by 2011.
The committee then addressed Long-Term Objectives in the Strategic Plan, recommending that by 2015, researchers determine the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and postnatal period of development. This item was flagged for budget discussion. The committee voted to retain the original language of the August 15 draft on the long-term objective calling for the study of environmental factors in subsequent pregnancies of women who had a child with ASD. Responses to the RFI stated that this study should include a control group or use methods comparable to the National Children's Study (NCS). Dr. Alexander said that the NCS would not make deliberate attempts to recruit women who had children with autism, but that some would be included by chance through random sampling. The language around the NCS was not included in the draft.
The objective to identify genetic risk factors in at least 50 percent of people with ASD was kept and the time frame was not extended, as suggested by public comment. Language around large-scale population-based epidemiological studies was changed to explicitly include U.S. populations and this objective was flagged for budget consideration. Finally, the committee rejected a proposed objective to maintain and increase sample size of existing studies that address common genes and gene-environment interactions in ASD.
Review and Decisions: Question 4
Which Treatments and Interventions Will Help?
After a brief recess for lunch, the committee reconvened to review Question 4: Which Treatments and Interventions Will Help? The first paragraph of the "What do we know?" section was rewritten using language suggested by Ms. Redwood. Dr. Insel praised the new language for being more explicit and more conceptually advanced. Further down in the section, a sentence on occupational therapy was revised and a sentence on the cost savings of effective interventions was removed. Dr. Houle said she was in favor of taking the sentence out because she did not want to support the idea that a treatment must result in cost savings.
A suggested passage from public comment on specific behavioral interventions was not added to the document. Ms. Redwood said the passage was unnecessary and sounded like the Plan supported specific types of Applied Behavioral Analysis (ABA) therapies over others. The committee voted to add a section proposed through public comment on the different views of widely-used therapies that had not been studied in randomized controlled trials. A reference to chelation was stricken.
"What do we need?"
Within the "What do we need?" section, a passage suggested by Ms. Redwood about the identification of biomarkers was added and a reference to fully recovering from autism was taken out. Dr. Shore said that the language seemed to denote a cure or elimination of autism and supported the phrase being removed.
The committee then turned its attention to the Research Opportunities section. A specific list of widely-used therapies that had not been rigorously studied was removed from the objectives. The committee moved to expand an objective on interventions to extend across the lifespan and include adolescents in the list of people with ASD.
The committee removed a detailed list of co-existing medical conditions and revised an objective on early interventions by removing "early" and specifying "children, adolescents, and adults with ASD." The recommendation for outcome studies of the effectiveness of behavioral, developmental, and cognitive therapies was added to the research opportunities after removing the list of specific therapies. A call for observational studies to examine the effectiveness of occupational therapy was removed, as was a suggested addition to investigate sensory-based interventions. The committee voted to add an objective proposed via public comment pertaining to methods for measuring changes in core symptoms of ASD from treatment. The committee voted not to include suggested objectives related to testing antipsychotic medications, studying the effect of stress and stress hormones, and testing hair and bodily fluids for the presence of heavy metals.
The committee reviewed the Short-Term Objectives in Question 4 and approved the first recommendation: to "launch at least four research projects that seek to identify biological signatures that measure significant changes in ASD core symptoms across the lifespan by 2010." The committee considered the suggestion from public comment to quadruple the number of projects and budget. Dr. Alexander said that four projects would already by challenging and that16 projects by 2010 would be virtually impossible. Ms. Singer asked that the objective be flagged for budget discussion.
The language in the next short-term objective was changed to support "at least" three randomized controlled trials that address co-occurring medical conditions associated with ASD by 2010. The move to quadruple the number of projects and budget was struck down by committee vote. Ms. Redwood urged the committee to increase the number of trials beyond three but the committee voted for the wording of "at least three." The item was also flagged for budget discussion.
The committee then discussed the best number of robust model systems to recommend in the Plan. The document initially called for three which Dr. Insel said was not overly ambitious, as there were, in his estimate, probably more than 20 models currently in practice. The committee moved to recommend an objective calling for the development of at least 20 in vitro and animal models that could replicate features of ASD.
The next objective called for researchers to test the safety and efficacy of five widely used interventions that have not been rigorously studied for use in ASD by 2012. The suggested alternatives were to delete this objective or to quadruple the number of projects and the budget. The majority of the committee voted to change the language to "at least" five.
The committee deferred an addition about establishing a registry or consortium of registries to track seizure control, medication use, and adverse effects related to treatment. Dr. Trevathan said that in his experience, working with registries was often more expensive and harder to maintain than predicted. Dr. Morrissey suggested the possibility of adding people with ASD to an existing registry investigating seizure control medications and their effects. The committee decided to delete this objective from the current draft and reconsider it for a future version of the Plan.
The first long-term objective in Question 4 was reworded to clarify its meaning and the descriptor "scientifically rigorous" was dropped because the committee agreed that implicitly, all the research supported under the Strategic Plan should be rigorous. The group voted to recommend completing at least three randomized controlled trials of medications targeting core symptoms in people with ASD of all ages by 2014.
Ms. Redwood commented that the public members were consistently voting to increase the number of items to research but were not in the majority. She said that as a parent of a child with autism, she was disappointed that the bar was not being raised higher. Dr. Koroshetz responded that the scientists were assessing quality and feasibility issues which might limit the number of studies they could recommend, but that the federal members all supported doing the maximum number of high-quality studies. Dr. Trevathan agreed, saying that their recommendations on quantity must be a balancing act between not being ambitious enough and over-committing. Dr. Insel commented that tension between public members and researchers is often seen in forums around other diseases such as cancer and heart disease. He said that public members often want to push for the maximum resources to develop interventions while researchers voice concerns about going forward without specific molecular targets. Dr. Insel said that pharmaceutical companies he had spoken with had expressed similar reservations about working with autism before targets are identified.
A final objective on prospective trials of anti-epileptic medications was not added to the document because members felt it was encompassed by more general language in an earlier section of the Plan.
Review and Decisions: Question 5
Where can I turn for services?
The committee reviewed Question 5 and Ms. Ellen Blackwell led the group through revisions to the first paragraph of the "What do we know?" section. The committee rejected the proposed RFI wording for the second paragraph and accepted language indicating that the professional infrastructure is often inadequate to provide assurance of health and safety. Minor suggested changes to the third paragraph were unanimously accepted.
"What do we need?"
In the Question 5: "What do we need?" section, the committee revised the wording around navigating complex service systems and added "people with ASD" to the list of those who can be empowered by the participatory action model.
Within Research Opportunities, the committee voted to return to the original language on the Annual State of the State review of policies, services, and supports for individuals with ASD and their families. Specifics of these reviews were removed. The committee voted to retain the original, more general language around cost-effectiveness studies and voted to include language about evaluating services and intervention outcomes in the objective about studies of current ASD diagnostic and service use patterns. Dr. Morrissey said that outcomes were important when validating the use of government money.
The committee continued on to consider a proposed addition on training healthcare professionals, service providers, emergency responders, and educators. Dr. Morrissey said that she did not feel that training is a subset of research and therefore, it would not be appropriate to include a training objective in a research Strategic Plan. Dr. Houle suggested that the committee could modify the objective to make it more appropriate by calling for research identifying best practices for training. Dr. Insel commented that while building the capacity for providers is incredibly important, that an objective on this topic would take money from the research budget. He asked the committee to consider whether they wanted training to be included in the research Strategic Plan or put into the services effort. The committee voted to defer consideration of training to a future version of the Strategic Plan.
As there were no discussion points in the Question 5: Short-Term Objectives, the committee moved to the next section on Long-Term Objectives and voted to increase the number of evidence-based services to be tested for efficacy and cost-effectiveness to "at least four." The committee voted to defer an objective calling for the completion of randomized controlled studies of long-term effects of the intervention methods to discussion of future versions of the Strategic Plan. Dr. Insel said that there was a need for a better sense of the feasibility of such a study and it may be beneficial to have a future workgroup consider the proposal.
Review and Decisions: Question 6
What does the future hold?
The committee began reviewing Question 6 and voted to retain the original language in the first paragraph rather than insert a sentence, proposed by Ms. Redwood, on the increase in the prevalence of ASD. A reference to the support from "neighbors and communities" was reduced to simply "communities." The committee voted to adopt language suggested by Dr. Shore about improving public awareness and community supports to help foster acceptance, inclusion, and appreciation for people with ASD.
Within Question 6: Research Opportunities, the committee disliked the value judgment of "strengths and weaknesses" in the call to conduct "longitudinal studies of both people with ASD and their families to follow trajectories of strengths and weakness that account for clinical, psychosocial and biological heterogeneity," and did not include the phrase. The group discussed a potential addition to the language calling to improve the safety of people with ASD. Ms. Redwood said it was a very important issue but wondered if it was a research question. Dr. Insel questioned whether it was an article for study or whether it simply needed to be implemented. Mr. Grossman talked about his experience trying to set up disability safe houses for people in case of disaster. The committee voted on the proposed addition and moved to defer consideration of safety issues to discussions of future versions of the Strategic Plan. The group voted not to include a proposed addition to the language about creating models of financing to pay for services and provide long-term care when family is no longer available. The committee felt that this was a policy discussion rather than a research question.
The first short-term objective on harmonizing and integrating databases to track the involvement of individuals in ASD research was flagged for budget discussion.
The committee voted to change the wording of the next short-term objective on assessing and characterizing variation and quality of life in adults with ASD. The committee then removed the parenthetical listing specific interventions, services, and supports from the following short-term objective and opted not to increase the number of trials.
The group then moved on to Question 6: Long-Term Objectives and considered the recommendation to "develop and have available to the research community means by which to merge or link administrative databases that allow for tracking the involvement of individuals living with ASD research in health care, education, and social services." The committee decided that a needs assessment would be necessary before this objective could be implemented. The committee created a short-term objective focused on a needs assessment to be accomplished by 2009. Surveillance databases were also added to the objective, as per Dr. Trevathan's suggestion. The original long-term objective remained and was flagged for budget discussion.
The committee reworded and included an additional objective suggested through public comment to "conduct a cost/benefit analysis on provision of services and interventions over the lifespan with regards to long-term benefits including employment, productivity, and the need for federal/state assistance."
Review and Decisions: Introduction
Introduction and Cost Estimates
Dr. Insel reminded the group that the Introduction was intended to set the stage and to both try to inspire and command a sense of urgency. He then directed the committee to the draft introduction language prepared by the Office of Autism Research Coordination that listed symptoms associated with autism. The committee unanimously voted to include the new language at the beginning of the Introduction. Ms. Redwood then led the committee through her discussion points for the introduction. Ms. Blackwell registered her concern with having the Plan cite autism prevalence rates because she felt they were still unknown. Dr. Trevathan was asked to address the rumor that a yet-to-be-released CDC report would indicate higher prevalence estimates of autism than currently cited. Dr. Trevathan said that he could not comment because the data was not yet public.
Ms. Redwood's suggested language for the Introduction was accepted by the committee with the exception of the last sentence which labeled existing ASD research efforts as "inadequate." The language drafted by the OARC on co-occurring symptoms was inserted into the new language suggested by Ms. Redwood with the additional mention of sleep disorders. The committee then voted to include language suggested by Ms. Redwood about the heightened societal concern over ASD, in addition to a description of the IACC and its activities from the Combating Autism Act.
Within the bulleted steps describing the development of the Strategic Plan, Ms. Redwood suggested including a mention of soliciting input from the public and non-government research sponsors during the four scientific workshops. The committee voted to include this language and continued on to review the Vision Statement.
The committee retained the language for the Vision Statement from the August 15, 2008 draft, rejecting additional language suggested through public comment to "seek understanding of the increased prevalence of ASD and identify ethical ways to prevent disability." The committee also rejected language suggested by Ms. Redwood which specified that the Strategic Plan was a U.S. government-based research agenda.
The committee rejected language proposed through public comment modifying the Mission Statement to include a call for research that "uncovers and curbs the causes of ASD." They also voted not to include suggested language from Ms. Redwood specifying that the research mission statement was solely that of the U.S. government.
Moving to the Core Values section, the committee decided to keep the values succinct and voted to retain the original language from the August 15, 2008 draft. The committee voted to include a mention of discussing submitted public comments in the Spirit of Collaboration core value. They also included a statement in the Consumer-Focused value on the importance of considering "the impact of research on human rights, dignity, and quality of life" for people with ASD. Finally, the committee voted to include "assessing impact" in the Accountability core requirement.
The committee then had to stop due to time constraints before addressing Crosscutting themes. They discussed potential dates for a future meeting to allow time to finish reviewing the Introduction section and budget recommendations, before moving to public comment.
Open Session for Public Comment
The committee then opened the floor for public comment. Ms. Karen Driscoll, a Marine Corps wife and parent of a child with autism, spoke to the committee about increased autism prevalence estimates in military children. She said that based on data collected through FOIA requests, autism affects one out of every 88 military dependents, making them a subpopulation at risk. She asked that more research be conducted to investigate the increased rate of autism in military children and suggested that factors such as higher vaccine compliance and additional environmental toxins may be indicated.
Ms. Paula Durbin-Westby from the Autism Self-Advocacy Network (ASAN) then presented to the IACC, calling for the committee to return to the Strategic Plan and add training and services objectives that had been removed because they were not considered appropriate for the research plan. She also asked that someone on the autism spectrum be available to sit on the committee when Dr. Shore is not present. Ms. Durbin-Westby recommended that the committee include representation from another agency with a focus on research across the lifespan and she asked that language urging cost savings as a goal of research be removed from the Strategic Plan.
Ms. Theresa Wrangham, President of Coalition for SafeMinds and parent of a daughter with autism, spoke to the committee about her organization's concerns that vaccine research would not be emphasized in the Strategic Plan. She cited Senator Enzi and Representative Smith as congressional members calling for more research examining the link between vaccines and autism spectrum disorders. She also recommended that the IACC adopt an oversight review and evaluation mechanism such as an autism advisory board and suggested using the Department of Defense grant review model. Ms. Wrangham requested that a workgroup be convened in January 2009 to focus on these recommendations.
Ms. Ann-Mari Pierotti, Associate Director of Clinical Issues in Speech-language Pathology at the American Speech, Language, and Hearing Association, spoke to the committee on behalf of Dr. Catherine Gottfred, President of ASHA. Ms. Pierotti presented on the critical role that speech-language pathologists play in providing programs and services to people with ASD. She drew the committee's attention to resources produced by an ASHA committee detailing the roles of speech-language pathologists in the diagnosis, assessment, and treatment of communication disorders associated with autism. She also recommended that the Strategic Plan include more emphasis on intervention research.
Closing Comments and Adjournment
Dr. Insel discussed the logistics of scheduling an additional meeting to finish reviewing the cross-cutting themes in the Introduction and budget recommendations. The committee agreed to schedule a meeting in January 2009 that would be broadcast in webinar with the option of attending in person. Dr. Insel commended the committee for a healthy discussion on areas of disagreement in the Plan and the meeting was then adjourned.
These minutes of the IACC full Committee Meeting on December 12, 2008 were approved by vote of the IACC on May 4, 2009.
I hereby certify that the foregoing meeting minutes are accurate and complete.
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee
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- Meeting Transcript (PDF - 2 MB)
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Autism and its Impact on the Military Family (PDF – 210 KB)
Karen Driscoll (Public Comment)
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