Minutes of the Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process Conference Call on October 15, 2009
The Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process held a conference call on October 15, 2009, to discuss the proceedings of the 2009 Scientific Workshop to update the Strategic Plan for ASD Research. The call was held from 2:00 to 4:00 p.m. EDT.
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.
Planning Subcommittee Participants: 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; Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Lee Grossman, Autism Society; Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS); Lyn Redwood, R.N., M.S.N., C.R.N.P., Coalition for SafeMinds; Cathy Rice, Ph.D., (Representing Ed Trevathan, M.D., M.P.H.) Centers for Disease Control and Prevention (CDC); and Alison Tepper-Singer, M.B.A., Autism Science Foundation.
Liaison Participants (not members of the Planning subcommittee): Jennifer G. Johnson, Ed.D., Administration for Children and Families; and Yvette M. Janvier, M.D., Children's Specialized Hospital
Welcome and Introductions
Dr. Insel welcomed the planning subcommittee members to the conference call held to follow up on the events of the Scientific Workshop. The attending members introduced themselves and Dr. Story Landis asked to address the subcommittee. Dr. Landis noted that something she had written privately during the Workshop had been posted on a blog and she apologized for the upset and concerns that it had raised.
At the request of Ms. Lyn Redwood, approval of the June 16, 2009 and August 5, 2009 Planning Subcommittee meeting minutes was deferred until the end of the call.
In order to generate recommendations for updating the Strategic Plan for Austim Spectrum Disorder (ASD) Research, the panel liaisons were asked to review ideas raised at the Workshop, items deferred from last year's discussions, and any other issues the subcommittee felt should be considered. The panel's recommendations would be presented at the October 23, 2009 meeting of the full IACC. Dr. Insel recommended generating the suggested line edits to review with the committee. The liaisons then shared an overview of their recommendations, starting with Panel 2. (Panel 1 liaison Jennifer Johnson joined later in the call.)
Panel 2 – Overview and Discussion
Ms. Alison Singer said that Panel 2 had identified the use of new technology to induce pluripotent stem cells for neuronal differentiation from skin fibroblasts as an important research opportunity. They identified the need to develop protocol for working with skin fibroblasts and the need to study nonverbal forms of ASD and those with cognitive disabilities. The panel also recommended studying genotypic association with structural or functional phenotype and targeting underlying biology by identifying co-occurring pathways and conditions (such as familial autoimmune disorders, seizures, and sleep disorders).
She said that the panelists felt satisfied with the existing content in Question 2 and hoped that their recommendations would be used to develop additional objectives. She noted that the objectives were the only measure used to assess their progress in fulfilling the Strategic Plan (items listed as "Research Opportunities" were not considered). Dr. Insel asked Ms. Singer if the panelists would be able to provide enough detail to help generate the recommended budgetary requirements for these new objectives.
The subcommittee members asked if chapters of the Plan could be distributed in Word format for editing and were told that they could be provided. Dr. Hann noted that the planning subcommittee would have to determine if all subcommittee members could be involved in generating line edits, or solely the panel liaisons. Ms. Redwood asked if any member of the Planning Subcommittee could contribute to edits and Dr. Hann said that any contributions would have to be made in conjunction with the panel liaisons. The subcommittee members noted that edits should reflect what the panelists recommended at the Workshop and that any additional comments could be discussed with the committee after the initial review. Dr. Insel reminded the subcommittee that they were working toward creating final language for the IACC to review. Ms. Redwood said that she was not a panelist but wanted the opportunity to have input. She was told that she would have the opportunity to comment at the full committee meeting on October 23rd.
Ms. Blackwell asked when line edits were needed to the Office of Autism Research Coordination (OARC) and Dr. Hann asked that the documents be submitted by Wednesday, October 21st at 10:00 a.m. The liaisons were told that Dr. Hann or Dr. Susan Daniels should be copied on all e-mail conversations about generating the line edits. The subcommittee was told to note any changes to the "What do we need?" and "What do we know?" sections that they wished to include. Dr. Landis said that edits to these sections were the opportunity to reflect recent scientific advances in the Plan. Dr. Insel asked if panel liaisons had considered the list of deferred items when making recommendations. Ms. Singer said that they had reviewed the items and felt that they did not warrant inclusion.
Panel 3 – Overview and Discussion
Dr. Landis said that Panel 3 had discussed at length how to approach issues of immune response and sensitivity to vaccines. Mr. Lee Grossman noted that there had been more discussion of vaccines during the Workshop than on the preparatory calls and he was still unsure as to what related recommendations were being made. Mr. Grossman said that the panel had agreed upon the need to understand heterogeneity across the spectrum. Dr. Landis said that the panel would need to look at the previous objectives to determine recommended edits or additions. Mr. Grossman asked for feedback from the subcommittee about discussion at the Workshop on Panel 3. Ms. Singer said that she heard the group talk about the need to study heterogeneity conferred by genetic risk and the need to focus on reducing the disability associated with ASD. She felt that the panel recommended maintaining the existing language in the Plan and did not find any new evidence that would support adding additional objectives related to vaccine research. Ms. Blackwell said that the panel talked less about limiting disability and more about maximizing quality of life and health outcomes.
Ms. Redwood recommended prioritizing the study of environmental toxicants and using more sophisticated testing to identify environmental targets. She also recommended using animal and cellular models to assess environmental risk factors. Dr. Landis said that the panel had discussed broadening the scope of the search for environmental risk factors and mentioned using biological samples from the epidemiologic study being conducted by the National Institute of Neurological Disorders and Stroke (NINDS) in Norway. Researchers are tracking women before, during, and after their pregnancy in the hopes of linking environmental exposures to their children's outcomes. Ms. Redwood stated that it was difficult to draw parallels between studies conducted in other countries and Dr. Landis said that results could help guide studies conducted in the United States. Ms. Blackwell noted that the "What do we need?" section should be updated to reflect that the IACC had already met with the National Vaccine Advisory Committee.
Dr. Insel noted that some felt there was an imbalance between environmental and genetic research and that gene-environment interaction research was not a large focus at NIH. The Workshop members had different views on how much granularity should be included in the Plan. (For example, should specific genes/environmental factors be identified?) Ms. Redwood said that recommendations from NVAC on specific vaccine research should be included. Dr. Cathy Rice recommended specifying that other health outcomes, in addition to ASD, should be assessed when studying environmental factors. Ms. Redwood recommended a focus on developing mechanistic biomarkers and using animal models to identify such biomarkers.
Panel 1 – Overview and Discussion
Ms. Jennifer Johnson said that Panel 1 had not proposed significant changes to the chapter but endorsed focusing the objectives to include diagnosis across the lifespan. Dr. Janvier said that the panel wished to change the aspirational goal to detect ASD in the preclinical stages before any behavioral manifestations. Dr. Insel noted that the panel was recommending adding 11 new short-term objectives and stated that the IACC members had given a lot of consideration to the verbs used in the original objectives to ensure measurable accountability.
Dr. Janvier expressed her concern that some of the objectives were driven by the specific research of the panelists and Dr. Insel cautioned the subcommittee not to let the Strategic Plan turn into an entitlement for the research community that wrote it. He advised generalizing the recommendations to find themes and avoid targeting any one individual's research. Dr. Janvier summarized that the panelists had focused on implementation research related to diagnosis, identifying predictive biosignatures, studying co-morbid conditions, and improving adult detection (which she noted may overlap with other chapters). Ms. Blackwell said that she supported the shift to diagnosis over the lifespan. Ms. Singer stated she was concerned that children were not going to get enough emphasis if Question 6 is changed to focus solely on adults, while an emphasis on lifespan remains throughout the Plan.
Panel 4 – Overview and Discussion
Dr. Insel shared the recommendations of Panel 4, who noted that there was no discussion in the current Plan of interventions specific for adults or nonverbal people with ASD. They emphasized the importance of comparative effectiveness research in light of current healthcare reform and noted the need for trials comparing widely-used treatments. They identified the opportunity for research on molecular-based treatments, which Dr. Insel noted had only emerged as a new area in the last four to six months. The panel refined the language as a group and incorporated recommendations about the need for biomarkers to predict treatment response and focused outcome measures to assess quality of life and functional outcome. The panel discussed creating more powerful language to discuss the need for heterogeneity research and incorporated themes reiterated across the panels – focus on adults, lifespan approach, and the need to study heterogeneity. Dr. Insel said that the panel had considered one deferred item about seizure control but felt that it was too specific for the Plan.
Ms. Singer asked if the panel had discussed using treatment studies to elucidate mechanisms of action and Dr. Insel said that this related to the personalized medicine section.
Panel 5 & 6 – Overview and Discussion
Ms. Blackwell said that the panel had generated line edits together and shared them at the Workshop. They had recommended small wording changes to the aspirational goal in Question 5 and had added several research opportunities. The panelists felt that Question 5 was not as well-developed as other chapters and had clarified the objectives and added several additional ones.
The panelists felt that Question 6 may have served as a catch-all for items related to infrastructure that did not fit elsewhere in the Plan. They recommended changing the Question title to focus on the needs of adults and transitioning youth and recommended developing a separate infrastructure section or chapter for items related to data collection. The panelists expanded the Question 6 aspirational goal, expanded the research opportunities, and added additional short-term and long-term goals.
Ms. Singer questioned how creating a chapter specific to adult needs would affect the organization of the Plan and infrastructure themes. If a separate infrastructure chapter was developed, she recommended including the need to expand the research and service workforce, address ethical considerations and risk communication, convene a meeting or workshop identifying core symptoms to target, conduct prevalence studies, and speed replication studies.
Mr. Grossman stated his concern that vocational supports, residential services, and long-term care might be lost if they were lumped with other lifespan issues. Ms. Jennifer Johnson said that infrastructure might be best addressed in the cross-cutting themes. Ms. Singer noted that overarching themes were not accounted for in the metric assessing overall progress based on the Strategic Plan. The assessment either needed to be changed to incorporate cross-cutting themes or these items needed to become objectives, she said. Ms. Redwood agreed that infrastructure items needed to have funding attached and needed a way to be tracked. Dr. Landis stated that workforce development should not be tracked separately by Question. Ms. Singer said that decisions about cross-cutting themes and a potential seventh chapter should be brought back to the IACC. She reiterated her concern that the focus on early detection would be underemphasized if Question 6 became solely about adults, and Question 1 was not refocused to compensate.
Dr. Hann said that the revised Plan would have to be viewed as a whole to check for consistency and overlap across Questions. Ms. Blackwell asked if they were expected to present a PowerPoint summarizing their recommendation on October 23rd and Dr. Hann said that they would review their recommendations orally while their line edits were projected on-screen.
Approval of the August 5, 2009 and June 16, 2009 Planning Subcommittee Minutes
The subcommittee returned to the minutes and the subcommittee determined that a Workshop panelist recommendation in the August 5th minutes incorrectly attributed to Ms. Redwood should be changed to Ms. Blackwell. With these corrections, both sets of minutes were approved.
Dr. Landis noted that she would have led her Panel differently had she known that line edits were expected as an end product. Ms. Blackwell recommended starting earlier to allow the panelists more work time. The meeting was then adjourned.
These minutes of the IACC Services Subcommittee were unanimously approved by the IACC Subcommittee for Planning the Annual Strategic Plan Updating Process on April 19, 2010.
I hereby certify that this meeting summary is accurate and complete.
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee