Minutes of the Interagency Autism Coordinating Committee (IACC) Meeting on January 14, 2009
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened at 9:00 a.m. on January 14, 2009, in Conference Room A of the Neuroscience Center Building at the National Institutes of Health in Rockville, Maryland, and adjourned at 1:00 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; James F. Battey, M.D., Ph.D., National Institute on Deafness and Other Communication Disorders (NIDCD); David DeVoursney, MPP, Substance Abuse and Mental Health Services Administration, (Representing Larke N. Huang, Ph.D.); Lee Grossman, Autism Society of America; Jim Hanson, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (Representing Duane F. Alexander, M.D.); Susan Hill, Centers for Medicare & Medicaid Services (CMS) (Representing Ellen W. Blackwell, M.S.W.); Gail R. Houle, Ph.D., U.S. Department of Education (ED); Yvette M. Janvier, M.D., Children's Specialized Hospital; Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS); Cindy Lawler, Ph.D., National Institute of Environmental Health Sciences (NIEHS); Michael Marge, Ed.D., Office on Disability, U.S. Department of Health and Human Services (Representing Margaret Giannini, M.D.); Christine M. McKee, J.D.; Lyn Redwood, R.N., M.S.N., C.R.N.P., Coalition for SafeMinds; Alison Tepper-Singer, M.B.A.; 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).
In attendance (non-voting):
Jennifer Johnson, Ed.D., Administration for Children and Families
Call to Order and Opening Remarks
Dr. Thomas Insel, IACC Chairman, welcomed the committee members to the first meeting of the committee in 2009 and described the objectives of the meeting: to finish reviewing the Strategic Plan, approve budgetary requirements, and talk about next steps. Dr. Della Hann informed the committee that the next meeting was scheduled for February 4, 2009 and the following meeting had been rescheduled for May 4, due to a conflicting conference that some of the committee members would be attending. It was stated that the IACC was again scheduled to meet on July 29 and October 23, 2009. Dr. Hann also asked that the committee members from then forward schedule their travel arrangements and lodging through Omega World Travel.
Dr. Insel then introduced new members to the committee. Due to the change in presidential administrations, he announced that Dr. Margaret Giannini, appointed Director of the Health and Human Service (HHS) Office on Disability by former President George W. Bush, would be stepping down on January 20, 2009 and that Dr. Michael Marge was going to serve as her replacement for the day. Dr. Insel also announced that Dr. Patricia Morrissey had retired since the previous meeting of the IACC on December 12, 2008 and would be replaced by Dr. Jennifer Johnson (whose official appointment was pending). Dr. Morrissey had served as Commissioner of the Administration on Developmental Disabilities within the Administration for Children and Families in the U.S. Department of Health and Human Services. Ms. Ellen Blackwell was unable to attend the meeting; in her place, Ms. Susan Hill was representing the Centers for Medicare & Medicaid Services (CMS) and would participate by phone. Dr. Insel informed the committee that Mr. David DeVoursney would be representing Dr. Larke Huang, Senior Advisor on Children for the Office of the Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA), who was currently on detail to the Centers for Disease Control and Prevention (CDC).
Dr. Insel reassured the committee that many of the new members had been deeply involved in autism-related issues and all had been briefed by others within their agency. The IACC committee members then introduced themselves and Dr. Insel restated the aim of the meeting - to complete the first version of the Strategic Plan, including budgetary requirements. He reminded the committee that the Strategic Plan is meant to be advisory to the HHS Secretary, Congress, and the NIH Director and must be updated annually. Dr. Insel then restated the "shared values" agreed upon by the committee to be included in the Plan - urgency, scientific excellence, spirit of collaboration, consumer focus, partnership between the public and private effort, and a sense of accountability.
Review and Decisions: IACC Strategic Plan for ASD Research - Introduction
The committee returned to the Introduction's Crosscutting themes, where they had left off at the December 12, 2008 meeting. In addition to the potential changes to the section based on public responses to the Request For Information (RFI) issued on August 20, 2008, the committee was also given revision suggestions by IACC members Ms. Ellen Blackwell and Ms. Lyn Redwood.
Dr. Insel noted that Ms. Christine McKee and Dr. Cindy Lawler had since arrived to the meeting and welcomed them. Dr. Insel suggested that the committee review the Strategic Plan by first looking at specific comments from the public, then reviewing the small wording changes submitted by Ms. Blackwell, and then considering whether to insert new themes proposed by Ms. Redwood.
In the Heterogeneity section of the Introduction, the committee reviewed the suggestion to include "those who use augmentative communication systems and live somewhat independently" in a sentence describing who is represented on the autism spectrum. Dr. Jim Battey said that he did not think that the revision added very much of value and that he was concerned the Strategic Plan was getting too long, diluting the core messages. The committee voted 12-2 not to include the new language. Dr. Stephen Shore joined the meeting by phone during the discussion.
The committee then discussed Ms. Blackwell's proposed revision that "individuals" be changed to "people" in the first sentence. Dr. Story Landis suggested that a policy regarding the use of the term "individuals" versus "people" be agreed upon for the Strategic Plan as a whole. Dr. Marge reported that the Office of Disabilities referred to "persons with disabilities" in all of their documents and Ms. Susan Hill reported that CMS had a policy of using the term "people" to reflect the dignity of the individual. Ms. McKee said that the legal language referred to "individuals," as in the Individuals with Disabilities Education Act (IDEA), but that she had no personal preference. Dr. Landis made a motion to use the term "people" throughout the Strategic Plan, except where it created awkwardness, and the committee unanimously agreed.
The committee voted not to delete the term "gainful" in the sentence about people with ASD who find gainful employment, as had been suggested by Ms. Blackwell. In the Heterogeneity section, the committee discussed adding the sentence: "Also, single-subject experiments may be useful to test and gain preliminary data on possible treatments." Dr. Battey said that he would not be in favor of the addition as most single-subject studies are fraught with peril and misinterpretation. Dr. Edwin Trevathan agreed with him, saying that the scientists included in the IACC Work Groups had identified the need for more clinical trials. He recommended moving away from single case anecdotes and small series in favor of more rigorous science. The committee moved not to include the sentence, by a vote of 10-2.
Moving ahead in the Introduction, the committee discussed this additional language based on public comment: "Additionally, if one views ASD as a biological disorder triggered in genetically susceptible individuals by environmental factors, then prevention can include prevention of new cases of ASD through the identification and elimination of environmental causes." Dr. Battey said he thought the sentence was unnecessary, while Ms. Redwood countered that she felt the language highlighted the potential that autism could be prevented. Dr. Yvette Janvier and Mr. Lee Grossman encouraged including the sentence in order to raise awareness of environmental issues. The additional language was included by a vote of 12-4. The committee reworked the final sentence of the paragraph on Prevention, opting not to include Ms. Blackwell's descriptor of sound, "well-funded" research and her suggested mention of "experiential triggers."
Introduction: Earlier Detection
The committee then moved to the Earlier Detection section and discussed a comment from the public calling to enhance methods for detecting ASD earlier in life and "across diverse populations" and additional language calling for more programs for training service providers. The committee unanimously voted to include the language about diverse populations and exclude the language about training. The committee discussed a suggested addition from public comment, calling for efforts to promote earlier detection to be guided by sound bioethical principles. Dr. Janvier said that she hoped such a statement was not necessary and Dr. Landis said the language raised the specter of unethical scientists meddling with children. The committee voted not to include this additional language.
Introduction: Lifespan Perspective
Moving to the "Lifespan Perspective" section, the committee discussed the suggested addition from public comment: "Some suggest that greater priority be given to research on treatment and services rather than causes and prevention," and voted not to include it. Ms. Blackwell suggested that a sentence characterizing autism as a childhood disorder be revised, but the committee chose to retain the existing language.
Moving to the Resources section, the committee reviewed a long passage suggested through public comment that addressed partnerships between school and intervention research programs. The additional language also called for increased donations of post-mortem biospecimens. Dr. Landis said that these were two separate ideas and should be voted on separately. Dr. Trevathan raised concerns that the level of specificity for this addition might imply that it was more important than other issues. The committee voted to not to include any of the suggested language, retaining the original text.
The committee voted to include the "collection of biospecimens" in the list of important resources for comparing people with ASD to people without the disorders. The term "individuals" was changed to "people." The committee reviewed and voted to include the suggested addition: "Attracting a cadre of rigorously trained researchers, including those outside the ASD research field, will foster innovative ideas and inter-disciplinary approaches," after removing, "and should be viewed as a priority. The need cannot be overstated."
Introduction: Community Engagement in ASD Research
In the Community Engagement in ASD Research section, the committee voted to change "care providers" to "care givers," as suggested by Ms. Susan Hill, in the list of people who play a vital role in the research process. "Advocacy organizations" were also added. The committee rejected suggested additional language about finding ways to capture and balance the diverse viewpoints of stakeholders being fundamental to the success of the Strategic Plan.
The committee voted to include a sentence at the end of the section: "Strategies are needed to gain and use first-hand experience of people with ASD their families, and caregivers." Ms. Redwood supported the addition, saying that many success stories from parents of children with ASD have been overlooked. The committee voted not to include the rest of the suggested language: "as well as strategies whereby people can request specific research and share first-hand experience relevant to research. Community engagement should also include greater public participation in discussing the relevance of research during the grant-making process." Ms. Hill said that service organizations wanted to ensure that the public could participate in the policy-making process, but that requesting specific research would be difficult to operationalize. Dr. Trevathan said the language might raise concerns that people were circumventing or conflicting with the scientific peer-review process. Ms. Redwood said that many parents' criticism of current research was that it focused on the "nice to know" rather than the "need to know" science. She described the Department of Defense panel for Congressionally-mandated research where members of the advocacy community participate in the decision-making process after the grant is peer-reviewed. Dr. Insel said that he would have reservations about putting a statement into the Plan about increasing public participation in the grant-making process without explaining the current process or having data to support the recommendation.
After finishing the review of public comments on the Strategic Plan, Dr. Insel asked the committee to consider whether they wanted to review Ms. Redwood's extensive additions to the Plan's Crosscutting Themes. Dr. Janvier said she was perplexed as to why the committee was reviewing these substantial changes after working together as a committee for so many months. She said that she felt the sense of urgency to address autism was being undermined by one committee member's attempts to rewrite the Plan. Ms. Redwood said that she was sorry her actions had been perceived that way but that she was simply responding to Dr. Della Hann's request for additional language from the committee members, sent in an e-mail several months prior. Ms. Redwood quickly presented her four new crosscutting themes: the first focused on autism as a national health emergency; the next focused on autism affecting more than the brain; her third addition called for balancing gene-environment causation research; and her final theme focused on the need for treatment and recognizing the uniqueness of people with ASD.
Dr. Battey and Ms. Singer said that they did not think new crosscutting themes were appropriate to add at that time. Dr. Trevathan said that it was too much material too late in the process and that these concepts could be considered in the next version of the Plan. In response, Ms. Redwood said that she felt this was actually the first opportunity she had been given to go through and comment in detail on the Plan, as much of the early document was written by the Office of Autism Research Coordination (OARC). Incorporating Ms. Redwood's suggested new themes was put to a vote and the majority of the committee (13-4) did not want to review the suggested additional language.
During the discussion of the additional themes proposed by Ms. Redwood, the committee expressed the desire to rewrite the introductory paragraph of the Strategic Plan to make it more compelling and convey the urgency of autism as a national health crisis. The committee instructed the OARC to revise the beginning of the Introduction to reflect this urgency.
Review and Decisions: IACC Strategic Plan for ASD Research - Question 3
After finishing the Introduction, Dr. Insel reminded Ms. Redwood that she had requested that the committee revisit a portion of Chapter 3 after they were unable to do so at the December 12, 2008 meeting due to time constraints. Ms. Redwood said she had not prepared to re-address the language and Dr. Hann directed her to the portion of the document where Ms. Redwood had requested to return. Dr. Insel summarized the decisions on vaccine language made at the November 21 meeting while reviewing the "What do we know?" section.
On November 21, Ms. Redwood had requested that the committee revisit the language, but the committee had opted to advance forward in the Plan and return at a later date. Dr. Insel also asked the committee to address questions from the OARC about language revisions to the "What do we need?" section of Chapter 3 that the committee had requested at the December 12 meeting. Dr. Hann explained that the committee's recommendations on revising the language in this section had sometimes not been specific so the OARC wanted to verify that the revisions reflected committee opinion. Dr. Insel asked Ms. Redwood if she wished to return to the vaccine language in the "What do we know?" section. Ms. Redwood said that she and Lee Grossman had concerns with the passage: "Some do not agree and remain concerned that ASD is linked or caused by vaccination through exposure to Measles Mumps Rubella (MMR), challenges to a weakened immune system or possibly due to a mitochondrial disorder."
Ms. Redwood asked if the OARC could rework the sentence and have the committee return to it. Dr. Hann said that changes to the section should be handled by the committee, because of the difficulty for the OARC to interpret the variety of opinions on the topic matter. Ms. Redwood said that she was not aware they were going to revisit this material at the current meeting and so had not brought the sentence she had drafted and submitted previously. A member of the OARC went to retrieve a copy of Ms. Redwood's suggested language. Dr. Insel then reviewed the portion of the "What do we need?" section where the OARC team had questions about how the committee wished to revise the section summarizing the differing views on autism and vaccines.
Ms. Singer, who had made the revision suggestion at the December 12 meeting, said that she had intended for the passage outlining the different viewpoints on autism and vaccines to be moved from "What do we need?" to "What do we know?" Dr. Landis suggested replacing the existing passage in the "What do we know?" sections with the passage written by the OARC in the "What do we need?" section to eliminate the redundancy. The committee voted unanimously to make the change.
Dr. Insel told the committee that several issues had been raised regarding the two vaccine objectives that had been added to Question 3 at the December 12 meeting:
- 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.
- 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.
Dr. Insel said that, unlike the rest of the objectives included in the Plan, these two vaccine objectives had not arisen from the four one-day Scientific Workgroups held in January 2008. During these Workgroups, stakeholders had collaborated to generate a list of 41 potential research opportunities for ASD focused on the areas of biology, treatment, diagnosis, and risk factors. Workshop participants considered the strengths and weaknesses underlying the current state of the science and identified opportunities, unanswered questions, and research resources needed to find solutions. Participants included domestic and international scientific experts, representatives from private autism funding organizations and advocacy groups, clinicians, and individuals with ASD.
Because the vaccine objectives being discussed had not been generated by the Scientific Workgroups, the IACC had not received input from research program officers about budgetary requirements. Dr. Insel asked the committee members whether they wanted to revisit the initiatives, which lacked budgetary information, or choose to move on. He reminded the committee that the objectives had been discussed at length during the Dec. 12 meeting and that the vote to include had been very close. (The vaccine objective calling for cell and animal studies was included by a vote of 7 to 6, with two members abstaining. The objective to determine feasibility for the epidemiological study was included in the Strategic Plan with the support of eight committee members. Four members voted for language calling to initiate the study, one member voted not to include the objective at all, and two members abstained.) Dr. Insel said that there had also been some confusion because Ms. Singer had recommended combining the objectives and that this option had inadvertently never been put to a vote. Dr. Insel stated that if the committee wished to include these vaccine objectives, it would be so; he simply wanted to confirm that the Strategic Plan accurately reflected the wishes of the IACC.
Dr. Trevathan stated that he was concerned that the objectives in question had bypassed the experts in the Scientific Workgroups. He was also concerned that the IACC lacked any vaccine research experts on the committee and recommended that the committee coordinate with HHS' National Vaccine Advisory Committee (NVAC) Vaccine Safety Working Group; the charge of the NVAC committee is to draft a research agenda on vaccine safety. Dr. Trevathan said that the committee had a large number of experts, community representation, and a plan for nationwide community input. He stated that the NVAC committee could provide expertise on the feasibility of a large-scale epidemiological study of vaccinated and unvaccinated groups. Dr. Trevathan stated that experts at the CDC were unable to give him a budget estimate for such an epidemiological study because there was not enough detail to define the study's testable hypotheses. Dr. Trevathan warned against working in parallel with the NVAC without being properly informed of their actions and suggested collaborating with the committee. While the NVAC is clearly charged with investigating vaccine safety, he questioned whether that was also the charge of the IACC.
Ms. Redwood stated that she was disappointed that the committee was returning to these vaccine objectives because they had spent a significant amount of time deliberating over them. She strongly objected to returning to the objectives after they had been voted on and approved. Dr. Landis asked whether the NVAC would give appropriate consideration to autism as a vaccine safety issue.
Dr. Insel said he was sensitive to Ms. Redwood's concerns about reopening portions of the Plan that had already been voted on. He raised an additional consideration about including the objectives, saying that he was concerned about the potential perception of impropriety due to ongoing litigation around the vaccine-autism question involving the Health Resources and Services Administration (HRSA). He was concerned with the appearance of having members, who could be perceived to have financial investments in the issue, vote on matters related to autism and vaccines during a large ongoing court case related to the subject. Dr. Insel said that committee comments on these vaccine objectives had the potential to be interpreted as being biased by non-scientific issues.
Ms. Redwood said that she did not feel that considering litigation with regard to research was appropriate and she remarked that she did not feel the same issues would be raised if the committee was considering breast cancer and hormone replacement therapy while litigation was ongoing.
Dr. Insel said that the process by which the two vaccine objectives were added to the Strategic Plan, coming directly from the committee instead of being generated by the Workgroups, in addition to the $10 million budgetary requirement assigned, may give the appearance that the committee is putting a high priority on demonstrating the connection between vaccines and autism. He advised the members to carefully consider what including these objectives might express about an issue that is both scientific and legal.
Dr. Landis suggested adding language to the "What do we know?" section about the existence of the NVAC and encouraging the committee to consider autism issues during their evaluation of vaccine safety. Dr. Lawler recommended including a short-term objective calling for coordination with the NVAC committee while working to assess the feasibility of the proposed vaccine studies.
Dr. Jim Hanson said that after speaking with Dr. Alexander, whom he was representing, they felt that the issue of vaccines and autism should remain in the Plan but that the IACC should coordinate with the National Vaccine Program Office and the NVAC. He said that the $10 million budget for the feasibility study no longer seemed appropriate but that he and Dr. Alexander agreed that some significant funds should be included for research involving vaccine safety of all types.
Dr. Landis said that without adequate information about the activities of the NVAC, vaccine objectives in the Strategic Plan should be tabled. She warned that the scientific community would suffer a setback if the NVAC and IACC, working in parallel without knowledge of the other's activities, designed studies that then produced conflicting results about vaccines and autism. She suggested language in the Plan that would "ensure that the National Vaccine Advisory Committee consider autism in any studies proposed to test vaccine safety." Dr. Trevathan and Dr. Landis noted that Dr. Ben Schaywitz, Chief of Pediatric Neurology at Yale University, represented an expert on the NVAC's Vaccine Safety Working Group that was informed about autism issues.
Dr. Trevathan made a motion to take out the objective calling to determine the feasibility of an epidemiological study of vaccines and health outcomes and put information regarding vaccines into the "What do we need?" section. New vaccine-related language would call for coordination of the IACC with the NVAC. Ms. Singer expanded the recommendation to include language on coordinating with the NVAC on the vaccine objective focused on cell biology, as well. In response to Ms. Singer's recommendation, Dr. Trevathan made a motion to remove both vaccine objectives from the Short-Term Objectives and include them in language under "What do we need?" urging cooperation between the IACC and the NVAC. Dr. Landis noted that the NVAC was currently in the process of accepting public comment to help draft their scientific agenda. Ms. Redwood made an alternate motion that the two vaccine objectives be voted on separately. In response, the committee first voted on moving the epidemiological initiative to the "What do we need?" section, which passed by a vote of 13 to 4.
They then moved to vote on giving similar treatment to the second vaccine initiative. Before they voted, Ms. Redwood expressed her concern with the CDC's leadership role on the NVAC because their vaccine patents and role in promoting vaccines represented an inherent conflict of interest. She said that the autism community would view vaccine research done under the auspices of NIH much more favorably. Dr. Insel said that none of the committee members from the NIH possessed the necessary expertise in vaccine safety.
Dr. Landis said that coordinating with the NVAC would make the IACC better prepared to make informed recommendations on vaccine studies during the next iteration of the Strategic Plan. Dr. Janvier said that as a pediatrician she saw immense concern from the public about the potential link between autism and vaccines. She said that it was inadequate to simply remit the responsibility to examine vaccines and autism to another committee in the face of huge public concern. Dr. Insel questioned whether studies of cell biology would ultimately ever reassure the public. Dr. Trevathan clarified that the NVAC Vaccine Safety Working Group is not a CDC committee, but rather an HHS committee.
Dr. Insel then informed the committee that Dr. Bruce Gellin, M.D., M.P.H., Director of the National Vaccine Program Office, could be invited to attend the next IACC meeting. The committee then voted on the motion to shift the issue around vaccine components and vaccine safety to the "What do we need?" section and the measure was approved by a 10-5 margin. Two IACC members abstained. Ms. Redwood asked that a roll call vote be conducted because voting reflected a split between public and federal members of the committee. Dr. Insel did not agree with the characterization of the voting division. Dr. Hanson said that he had abstained from voting because the viewpoint of NICHD was not reflected entirely in either option. He said that NICHD conducts vaccine safety research in coordination with the CDC that helps inform the NVAC.
Dr. Insel clarified to the committee that the NVAC is not in the CDC but rather out of the Office of the Secretary and that if Dr. Gellin presented he would do so as a representative of the HHS Secretary. Dr. Houle wanted to reinforce that the IACC committee is not voting against the vaccine research but rather voting for an informed and coordinated effort with another advisory committee potentially working in parallel. Dr. Landis recommended that the IACC write in to the NVAC during their public comment period to request their cooperation in coordinating autism-vaccine issues. The committee agreed to have the OARC draft a letter to the NVAC to be approved by the IACC via e-mail. Dr. Insel commented that he did not want the focus on vaccines to overshadow the other potential environmental risk factors that had not received significant study.
Review and Decisions: IACC Strategic Plan: Budget Recommendations
The committee then discussed the budget recommendations for the objectives in the Strategic Plan. They were given a chart to review with the objectives, the proposed number of years the objective would be ongoing, and the proposed budget recommendations. The chart also included new budget estimates if the objective had been substantially changed during committee deliberations from the version reviewed by the Workgroups and a figure for the total budget of the objective, adjusted for inflation. For any objectives that included a recommendation for "at least" a set number of studies or outcomes/deliverables (e.g., at least one efficient diagnostic instrument), the budget estimate reflected the base number plus 50 percent. For example, the budget for standardizing and validating 20 robust model systems would be calculated for 30 models.
Dr. Insel reminded the committee that they were not making funding decisions but were instead providing professional judgment - an advisory estimate of the cost if funds were available for the proposed objective. Dr. Van Dyck asked whether the number used to provide the budget requirements for initiatives calling for "at least" a certain number of studies would be included. (For example, an initiative calling for at least 10 studies would be given an estimate based on 15 studies). Dr. Insel clarified that only the original language ("at least 10 studies") would be included. Dr. Trevathan wished to emphasize that the figures were a professional judgment exercise and that the IACC was not making decisions about where funds would be allocated. He asked whether a budget range could be used. Dr. Battey said that because the figures were merely an estimate, adding a range probably would not give any more useful information. He also suggested that the budgetary requirement figures be rounded because specifying them to a single dollar amount implied a level of accuracy that was misleading. The committee agreed that the figures be rounded to the nearest million, unless they were under $1 million and would then be rounded to the nearest hundred thousand.
Dr. Landis asked that an explanation of professional judgment be included in the Strategic Plan. Dr. Hann suggested putting the explanation in the beginning of the Introduction when explaining the role of the committee in providing proposed budgetary requirements; the committee agreed to have OARC add the additional language. The committee then voted unanimously to accept the proposed budgetary requirements for all initiatives in Question 1. The committee reviewed Question 2 and Ms. Singer said that she had consulted with the Ad Council, BBD&O, and McCann-Erickson to generate an estimate for a national campaign to increase awareness among the ASD community of the potential value of brain and tissue donation. She provided an estimate of $700,000 per year over two years. The committee then voted to accept Ms. Singer's estimate and all budget recommendations for Question 2.
The committee reviewed budgetary requirements for Question 3 objectives and Dr. Insel clarified that the vaccine objectives that had been moved to the "What do we need?" section would not include budgetary requirements. He also clarified that the budget table that the committee was using as an aid for their review would not be included in the Strategic Plan. The committee voted unanimously to accept the budgetary requirements for Question 3.
The committee reviewed the budget for initiatives in Question 4 and Dr. Hann explained that the large disparity between the original estimate for the Workgroup and the new estimate was due to the increase from three model systems to 20. Ms. Singer asked why the recommended budget for this objective had changed from $268.2 million in a previous draft of the Strategic Plan to the current figure of $50 million. Dr. Hann explained that the $268.2 million figure had been submitted through public comment and that the current estimate was derived from the Implementation Workgroup's recommendations. Ms. Singer said that she had understood that the committee was voting on the $268 million budget when they accepted the objective. Dr. Insel said that the committee had not been voting on budget estimates prior to the current meeting. Dr. Landis said that based on research with induced pluripotent stem cells, she estimated that $50 million was too low but that $268 million was too high. In her professional judgment, an estimate of $75 million would be more accurate. The committee voted to accept Dr. Landis' revised estimate and the remaining budget estimates for Question 4.
The committee considered the budgetary requirements for the objectives in Question 5. Ms. Singer said that she felt that the budget for the long-term objective to "test the efficacy and cost-effectiveness of at least four evidence-based services for people with ASD of all ages in community settings" did not reflect the objective's priority, as expressed by the committee. Dr. Landis suggested that this objective be rotated with the objective calling to "test four methods to improve dissemination of effective interventions in diverse community settings" and the committee accepted the switch. All budgetary requirements for Question 5 were approved.
The committee considered the budget for objectives in Question 6 and Dr. Trevathan recommended that the second short-term objective, to "launch at least two studies to assess and characterize variation and quality of life in adults living with ASD," be increased from $2.3 million to $5 million. Dr. Hann identified that the budget listed for the long-term objective to develop means by which to merge or link administrative databases was incorrect. The committee agreed to leave the budgetary requirement for this objective as "To Be Determined." The IACC then approved the budgetary requirements for Question 6, finishing all budget review for objectives in the Strategic Plan.
Review and Decisions: IACC Strategic Plan for ASD Research - Finalizing the Plan
Dr. Insel reviewed next steps: to have the OARC staff draft a more compelling introductory paragraph for the Plan, potentially using some of the proposed language from Ms. Redwood, and to insert language about professional judgment into the Introduction. Dr. Landis asked that the new introduction be circulated among the committee for approval. Dr. Battey requested that the person drafting the new introductory section be mindful that all assertions be supportable by fact. Dr. Hann spoke to the committee briefly about options for annually updating the Strategic Plan and monitoring the implementation of the objectives. She said that the committee would address potential strategies in more depth at the February 4, 2009 meeting. Ms. Redwood suggested creating a subcommittee to update the Strategic Plan.
Dr. Landis asked whether the recipients of the Plan - the HHS Secretary, NIH Director, and members of Congress - were likely to modify the Plan after it was sent to them. Dr. Insel said that the Plan was not likely to be modified; instead, the Secretary and others would look to the community to conduct the actions advised in the Plan and questions would be raised if elements of the Plan failed to be carried out. Dr. Insel said that it was the responsibility of the committee to determine how initiatives will be implemented and by whom. Dr. Hann said that while the committee itself could not provide implementation, the members' role was to provide advice, monitor, and ask questions.
Dr. Janvier asked about the source of the money to fund the objectives recommended in the Strategic Plan and Dr. Insel reiterated that the Plan is not a funding document. The Strategic Plan represents recommendations of what the IACC feels is the most important research to be done and includes estimates of what that research would cost. He said that the appropriations process would need to ensure that money is allotted for research new items recommended in the Plan. Dr. Battey inquired about the annual NIH investment in autism research and Dr. Insel informed the committee that NIH contributed $127 million in fiscal year 2007. Dr. Insel pointed out that this figure was not dissimilar to budgetary requirements included in the Plan and therefore did not represent an unrealistic increase in research funding.
Dr. Landis requested that a letter to the NVAC be drafted and reviewed by the IACC. Dr. Insel said that the letter could be circulated along with the revised introductory paragraph and that the IACC would plan to have Dr. Bruce Gellin attend the February 4 meeting. At this point, Dr. Insel congratulated the committee on finishing the Strategic Plan.
The committee then heard public comments from Ms. Katherine Walker and Ms. Paula Durbin-Westby.
Katherine Walker, a member of the Government Affairs Committee for SafeMinds and mother of an autistic son, addressed the committee. Ms. Walker commended the IACC on their progressive objectives, particularly those related to the role of the environment. However, she said that the Plan's continued emphasis on funding genetic research, significantly outpacing environmental research, was a concern. Ms. Walker cited research by Dr. Irva Hertz-Picciotto, published in the January edition of Epidemiology, that the rise in autism in California was real and not due to the inclusion of milder cases of autism or earlier diagnosis.1 Ms. Walker said that Dr. Hertz-Picciotto had called for research emphasis to shift from genetic to environmental threats. As a representative for SafeMinds, she requested that the NIH autism research portfolio reflect a preference for funding environmental risk factor research over genetic research. Additionally, she requested that the description of vaccine autism research in Question 3, which she deemed inaccurate, be corrected. She also asked that the agenda for the February 4th IACC meeting address mechanisms for oversight, review, and evaluation, and include establishing a strategic planning subcommittee and an autism advisory board.
Paula Durbin-Westby, representing the Autism Self-Advocacy Network (ASAN), spoke before the committee. She said that the autism research agenda had been focused almost exclusively on causation and cure when services research should be given higher priority. She cautioned that research focusing on discovering and eliminating autism entered the dangerous realm of eugenics and avoided addressing the social barriers that autistic people face which impact their quality of life. She recommended that at least half of the federal autism budget be allocated towards services research and requested that the IACC pursue quality of life research on issues such as improved service delivery methodologies.
She also requested that the IACC include representation from an autistic self-advocacy organization such as ASAN. Additionally, Ms. Durbin-Westby asked that the Strategic Plan include the perspective of autistic adults who do not want to be cured and recommended that the IACC fund research into augmentative and alternative communication options. She asked that at least one-third of federal autism research funds be dedicated to research on the needs of autistic adults and requested that student loan forgiveness be applied to researchers investigating services and quality of life for people with ASD. Finally, she recommended that the committee look to the National Institute on Disability and Rehabilitation Research as a model for establishing autism research priorities.
Closing Comments and Adjournment
Dr. Insel thanked the presenters and the IACC members, at which time the meeting was adjourned at 1:00 p.m.
These minutes of the IACC full Committee Meeting on January 14, 2009 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