IACC Full Committee Meeting - November 10, 2009
|Date:||Tuesday, November 10, 2009|
|Time:||9:00 a.m. to 5:00 p.m. Eastern|
|Agenda:||To discuss recommendations for the annual update of the IACC Strategic Plan for Autism Spectrum Disorder Research.|
|Place:||The National Institutes of Mental Health
6001 Executive Boulevard
Conference Room A1/A2
Rockville, Maryland 20852
|Conference Call:||USA/Canada Phone Number: 888-577-8995
Access code: 1991506
|Access:||Metro accessible - White Flint Metro Station|
|Contact Person:||Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC, Room 8185A
Rockville, Maryland 20892-9669
Any member of the public interested in presenting oral comments to the Committee must notify the Contact Person listed on this notice at least 5 days in advance of the meeting (Deadline: 5:00 p.m. Eastern, November 5, 2009). Interested individuals and representatives of organizations must submit a letter of intent, a brief description of the organization represented, and a written/electronic copy of the oral presentation/statement by 5:00 p.m. Eastern, November 6, 2009. A printed/ electronic copy of the comment/statement provided by the deadline is required prior to the oral presentation; the document will become a part of the public record. Only one representative of an organization will be allowed to present oral comments and presentations will be limited to three to five minutes per speaker, depending on number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in order of the date and time when their request to speak is received, along with the required written statement submitted in advance of the meeting by November 6 at 5:00 p.m. Eastern.
In addition, any interested person may submit written comments to the IACC prior to the meeting by sending the statement to the Contact Person listed on this notice at least by 5:00 p.m. Eastern, November 6, 2009. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. All written statements received by the deadline for both oral and written public comment will be provided to the IACC for their consideration.
The meeting will be open to the public through a conference call phone number and webcast live on the Internet. Individuals who participate in person or by using these electronic services and who need special assistance, such as captioning of the conference call or other reasonable accommodations, should submit a request at least 7 days prior to the meeting.
As a part of security procedures, attendees should be prepared to present a photo ID at the meeting registration desk during the check-in process. Pre-registration is recommended. Seating will be limited to the room capacity and seats will be on a first come, first served basis, with expedited check-in for those who are pre-registered.
Members of the public who participate using the conference call phone number will be able to listen to the meeting but will not be heard.
To access the webcast live on the Internet the following computer capabilities are required: A) Internet Explorer 5.0 or later, Netscape Navigator 6.0 or later or Mozilla Firefox 1.0 or later; B) Windows® 2000, XP Home, XP Pro, 2003 Server or Vista; C) Stable 56k, cable modem, ISDN, DSL or better Internet connection; D) Minimum of Pentium 400 with 256 MB of RAM (Recommended); E) Java Virtual Machine enabled (Recommended).
Meeting schedule subject to change.
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This meeting will also be available to the public by live videocast.
|9:00 a.m.||Call to Order and Opening Remarks
Thomas Insel, M.D.
Director, National Institute of Mental Health
|9:10 a.m.||Public Comments|
|9:30 a.m.||Approval of October 23, 2009 IACC Full Committee Minutes|
|9:40 a.m.||Consideration of Strategies for Updating the Strategic Plan
Thomas Insel, M.D.
Director, National Institute of Mental Health (NIMH)
How much change to make to the current Strategic Plan?
Examples of Questions for Discussion:
|9:50 a.m.||IACC Discussion of Strategies for Updating the Strategic Plan|
|10:45 a.m.||Recommendations for Updating the Strategic Plan: Discussion and Votes
|1:00 p.m.||Recommendations for Updating the Strategic Plan: Discussion and Votes - Continued
|3:15 p.m.||Recommendations for Updating the Strategic Plan: Discussion and Votes - Continued|
|5:00 p.m.||Closing Comments and Adjournment|
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- Call to Order and Opening Remarks
- Public Comment
- Approval of October 23, 2009 Meeting Minutes
- Consideration of Strategies for Updating the Strategic Plan
- IACC Discussion of Strategies for Updating the Strategic Plan
- Question III: What Caused This to Happen and Can It Be Prevented?
- Question I: When Should I Be Concerned?
- Question II: How Can I Understand What Is Happening?
- Question IV: Which Treatments and Interventions Will Help?
- Question V: Where Can I Turn For Services?
- Question VI: What Does the Future Hold, Particularly For Adults?
- Question I – Continued
- Closing Comments and Adjournment
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened on November 10, 2009, from 9:00 a.m. to 5:00 p.m., in Conference Room A of the NIH Neuroscience Center Building in Rockville, MD.
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 and Staff 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; Susan Daniels, Ph.D., Office of Autism Research Coordination (OARC), NIMH; James F. Battey, M.D., Ph.D., National Institute on Deafness and Other Communication Disorders (NIDCD); Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Chris DeGraw, M.D., M.P.H. (representing Peter van Dyck, M.D., M.P.H.), Health Resources and Services Administration (HRSA); Lee Grossman, Autism Society; Alan Guttmacher, M.D., National Human Genome Research Institute (representing Francis Collins, M.D., Ph.D.); Deborah Hirtz, M.D., National Institute of Neurological Disorders and Stroke; Gail R. Houle, Ph.D., U.S. Department of Education (ED); Jennifer Johnson, Ed.D., Administration for Children and Families (ACF); Walter J. Koroshetz, M.D., National Institute of Neurological Disorders and Stroke; Cindy Lawler, Ph.D., (representing Linda Birnbaum, Ph.D.), National Institute of Environmental Health Sciences (NIEHS); Christine M. McKee, J.D.; Lyn Redwood, R.N., M.S.N., Coalition for SafeMinds; Susan Shurin, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development; Edwin Trevathan, M.D., M.P.H., Centers for Disease Control and Prevention (CDC); Alison Tepper-Singer, M.B.A., Autism Science Foundation.
Call to Order and Opening Remarks
Dr. Thomas Insel, Chair, welcomed the IACC members to the meeting held to review edits to the Strategic Plan for ASD Research. He announced that NIH Director Francis Collins would be unable to attend the IACC meetings on a regular basis, so Dr. Alan Guttmacher would be attending in his place. Dr. Guttmacher introduced himself to the group and noted that he had the unique distinction of knowing Dr. Leo Kanner, the physician who first identified autism.
The committee then heard comments from members of the public. Mr. Jim Moody, representing SafeMinds, stated the urgent need to identify environmental triggers and launch a response to the public health crisis on the same scale as reactions to the H1N1 flu, E. coli tainted spinach, and SARS (Severe Acute Respiratory Syndrome). He asked for increased public participation and the creation of an autism advisory board. He stated that the politics must be taken out of vaccine research and that studies must be conducted to prevent new cases of ASD caused by vaccines. Finally, he asked the IACC support an immediate and ongoing comparison of ASD in vaccinated and unvaccinated children.
Ms. Paula Durbin-Westby, representing the Autistic Self-Advocacy Network (ASAN), presented language suggestions she would like to see used throughout the 2010 plan. These included the use of "high likelihood" rather than "high risk" when describing siblings of children with ASD, changing "abnormal" to "atypical," and inserting the qualifier "appropriate" before any mention of interventions. She recommended using "early indicators" rather than "early warning signs" to avoid negative value judgments and using the terms "characteristics" or "conditions" instead of "symptoms." She also suggested using "variability" rather than "severity" and changing "pathology" to "differences in neurobiology and cognition." She then presented her specific recommendations for the language in Question I. Ms. Durbin-Westby asked that research promoting the use of seclusion and restraints not be funded and recommended that research on communication differences be given higher priority in the Plan. Finally, she asked that people across the spectrum be involved in all aspects of ASD research.
Ms. Katherine Walker, mother of a 7-year-old boy with Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), spoke on behalf of SafeMinds and asked that the IACC recommend conducting vaccine research with independent oversight. She asked the committee to act with greater urgency in light of the recent rise in ASD to an estimated 1 in 100 children and recommended expanding research objectives related to identifying environmental factors, biomarkers, and treatments. Ms. Walker asked that the IACC incorporate the two vaccine initiatives (calling for animal and cellular models to investigate potential mechanisms of vaccine injury and a comparative study of ASD prevalence in vaccinated and unvaccinated children) into the final strategic plan. She asked that funding be granted to collect medical records (including vaccination information) during the National Children's Study (NCS) and said that Dr. Duane Alexander had estimated the cost at $28 million.
Dr. Kerry Lane spoke before the committee about his theory that children with inadequate glutathione levels develop regressive autism subsequent to taking acetaminophen soon after vaccination. He said that acetaminophen alone is not enough to cause autism and that the co-occurring gastro-intestinal disorders with ASD are caused by antibiotics used during infancy. He noted that AIDS also involves the depletion of glutathione.
Dr. Anita Miller Sostek spoke on behalf of Autism Speaks and cited Sen. Mike Enzi and Rep. Joe Barton's remarks during the passage of the Combating Autism Act (CAA) calling for additional vaccine research. She asked that rigorous, evidence-based studies of vaccine safety be included in the strategic plan.
Approval of October 23, 2009 Meeting Minutes
Ms. Ellen Blackwell asked that the minutes be corrected to reflect that she wished to substitute "person" for "patient" in Question IV. With this edit, the minutes were approved by the committee.
Consideration of Strategies for Updating the Strategic Plan
Dr. Insel spoke about the process for annually updating the strategic plan and reminded the committee that the plan's goal was to focus and accelerate research. The plan is intended to guide the research community and he noted that deciding which items to omit from the plan can be as important as deciding which to include. By law, the plan must be updated annually and suggestions for the most recent revision came from a two-day scientific workshop attended by researchers, clinicians, and personal stakeholders. These workshop participants considered the recent scientific discoveries on ASD, the portfolio analysis of ASD research conducted by major funders in 2008, and input from the public. The panelists were also asked to consider the items deferred during the drafting of the 2009 plan. Dr. Insel noted the importance of developing a standard updating process to use every year.
He presented the committee with issues to consider when developing a process, including whether edits should be minor tweaks or major re-writes, whether adding and deleting objectives would be helpful or confusing, and whether the annual portfolio analysis should be used as a measure of progress on the plan. He also asked the committee to consider how detailed objectives should be, how they should be prioritized, and how to find a balance between science and services. He recommended that objectives be specific, measurable, achievable, realistic, and time-bound ("SMART"). Dr. Insel also asked the committee to consider whether they should develop a separate strategic plan for ASD services.
IACC Discussion of Strategies for Updating the Strategic Plan
Dr. Walter Koroshetz stated that the committee's responsibility was to evaluate the plan and make minor modifications, rather than to completely rewrite it. He cautioned that majorly rewriting the plan yearly reduces the message and warned against the plan becoming a political document rather than a research plan. Dr. Susan Shurin suggested that a strategic plan should be written at a high enough level to give general direction while allowing for different methods of implementation. As a result, the plan does not require constant reworking. Mr. Lee Grossman described his experiences developing business strategic plans, which work backwards from defined, time-limited goals. Dr. Insel asked if the aspirational goals should be time-bound, and Mr. Grossman recommended doing so, much as NIH had while defining HIV/AIDS goals.
Ms. Lyn Redwood stated that the committee had been told that they would return to items that they had struggled with during the drafting of the 2009 plan, so there was the expectation of significant changes in the next version. She said that the 33 additional objectives proposed for the 2010 plan were not excessive and reflected the urgency needed to address ASD. Dr. Insel said that a "laundry list" of objectives may obscure the focus and priority of the plan. Ultimately, a measurable and focused list of priorities will be most useful. Dr. Shurin recommended grouping priorities into categories and receiving input to identify key scientific opportunities. Ms. Alison Singer said she was concerned that the revised plan did not read cohesively because each chapter had been looked at by separate groups of panelists during the process of developing recommendations for revisions. Dr. Insel said that there had been a push to develop the 2009 plan for the new Administration and as a result, some topics had been tabled. He said that these deferred items needed due consideration. Dr. Koroshetz stated that the way new objectives were presented could prevent confusion. Rather than revamping the plan so that it looks completely different, new items should be marked and measurements of progress should be included. Dr. Guttmacher noted that the 2009 plan was impressive in its current form and warned against reviving contentious issues that had been resolved if no new evidence had arisen. Ms. Blackwell said that while revising Questions V & VI, they had incorporated input from a large number of recent public comments. Dr. Jim Battey agreed that many new objectives should not be added to the plan, because it would lose focus. Dr. Cindy Lawler suggested having one major revision and then only minor annual tweaking based on new scientific opportunities and the progress fulfilling objectives. Ms. Christine McKee said that the plan needs to be more integrated and to adopt a common voice before it can become the foundation for minor edits in the future.
Dr. Insel said that most text revisions would be to the "What do we need?" section rather than the "What do we know?" section, because more progress had been made in understanding needs versus discovering new scientific opportunities. Dr. Shurin said that the new plan will increase emphasis on adults with ASD which will impact prioritization. Mr. Grossman supported the idea of having a separate plan for services in order to include other stakeholders (e.g., educators, language and speech pathologists, members of the justice system, representation from the Department of Labor and the Department of Transportation, etc.). Ms. Blackwell was concerned that taking the chapters on services out of the strategic plan may disassociate the importance of services to research. Dr. Insel clarified that the suggestions was not to take services research out of the plan but to create a separate document addressing service provision and policy. Dr. Ed Trevathan said that he was worried that completely rewriting the plan every few years would make the document less relevant. The committee then reviewed the proposed line edits, starting with Question III: What Caused This to Happen and Can It Be Prevented?
Question III: What Caused This to Happen and Can It Be Prevented?
Mr. Grossman thanked his panelists and noted that some parts of the draft reflected division within the group. The committee reviewed the proposed edits to the introductory questions and Ms. Singer noted the style inconsistencies that arose from editing each chapter separately. She recommended removing the clause "or the consequences of ASD that impact quality of life" that had been added to the first three introductory questions, and striking the second new question added because of its excessive detail. Ms. Blackwell said that the question of whether some individuals or groups were "more susceptible to these environmental influences" should be categorized as a research question and suggested possibly adding a bullet on potential risk factors. The committee voted to retain the original language of the first sub-question, change the second to reflect the influence of gene-environment interaction and change the third to question which environmental factors contribute to ASD, rather than whether environmental factors are involved at all. They also flipped the position of the second and third sub-question. The proposed additional sub-questions were not adopted.
The committee reviewed a proposed addition in the "What do we know" section stating that NIH has historically placed more of an emphasis on genetic research. They decided not to accept the addition, and moved to suggested language about the importance of studying genetic variants associated with disorders that frequently co-occur with ASD. Dr. Insel suggested revising the language to reflect the importance of identifying subjects who have genetic variants associated with ASD but have not developed the disorder. These individuals may have protective factors that are valuable to understand when developing medications and other interventions. The committee voted to accept this language and discussed the appropriate use of "medications" versus "therapeutics," eventually settling on "medications" upon first reference and "intervention targets" later in the sentence.
The committee reviewed proposed language about the recent identification of common genetic variants and recommended removing the editorializing about recent genetics research being "highly productive." Dr. Koroshetz recommended that they highlight that the findings were exciting because they all involved mutations in genes associated with synaptic connectivity. Dr. Battey suggested removing the parenthetical references to specific genes, because more genes would undoubtedly be found, thus dating the plan. The committee voted to accept these language changes.
The members then discussed the prevalence of these genetic variants in people with ASD. The 2009 plan cited 10 to 20 percent, but the committee felt that the upper range could not be reliably defined. The committee voted to cite "at least 10 percent" and changed the next suggested passage stating that the risk conferred by these variants was modest to specify that ASD may involve many different genes, environmental factors, and the interplay between the two. Dr. Insel said that he was concerned that the chapter often overlooked gene-environment interaction and the importance of understanding epigenetic changes to explain the effect of environmental exposures.
Dr. Battey suggested removing a large passage about the collaborations between many public and private organizations on the grounds that it added unnecessary detail for researchers looking to the plan for guidance. The committee voted to remove the section.
The committee voted to retain proposed language about the need to invest in further research into environmental factors and suggested adding references to environmental findings such as the recent study of organophosphates. They voted to retain a section on the limitations of the existing population-based studies to detect subgroups susceptible to injury from environmental exposures, as detailed in the 2004 Institute of Medicine (IOM) report, but rejected additional language specific to vaccines saying that is seemed misplaced. Ms. Singer asked if there had been discussion among the Question III panelists subsequent to the Workshop, because her recollection was that they had not recommended any language changes around the vaccine issue. Mr. Grossman said that the panelists had participated in a call and that these edits reflected their discussion. The committee voted not to include the proposed statement explaining that the panelists differed in opinion about the extent of future vaccine research.
The committee expanded a list of potential environmental factors of interest and crafted language calling for early reports to be the subject of additional study. They moved a sentence about toxicology resources to the new infrastructure chapter and removed suggested language about establishing mechanisms for tracking risk factors being assessed in ongoing research.
The committee then discussed potential edits to the passage about coordinating with the National Vaccine Advisory Committee. Ms. Redwood did not feel that they needed continued coordination with the NVAC and should instead continue forward with their recommendations outlined in the ISO National Vaccine Plan. She stated that Dr. Insel had expressed reservations about convening a panel (such as the IOM) to consider the viability of a study comparing health outcomes in vaccinated and unvaccinated children. Dr. Insel stated that his personal feelings were that convening another panel might not address the urgency felt by the community. However, there would be no downside to continued communication with the NVAC to ensure that the best science on neurodevelopment and ASD risk was conducted. The committee voted to keep the sentence about continued coordination with the NVAC, but voted 10 to 4 to eliminate the proposed language detailing examples of topics that may be of mutual interest for ongoing discussions between the IACC and the NVAC, including additional studies of post-vaccine response, studies of susceptible subgroups and study of health outcomes in vaccinated, unvaccinated and alternatively vaccinated groups. They chose to leave possible topics of discussion open-ended rather than to articulate specifics, which may change over time.
They voted not to include specific mention of the ongoing Norwegian study as an example of a large birth cohort study and struck proposed language calling for investigation into potential windows of vulnerability and a description of the EARLI (Early Autism Risk Longitudinal Investigations) study. The committee voted 8 to 4 (with 2 abstaining) not to incorporate suggested language about accounting for heterogeneity when studying environmental risk factors. The committee felt that heterogeneity was discussed in detail elsewhere in the plan and wanted to avoid redundancy. They also voted to move a passage calling for greater coordination across studies to the new proposed infrastructure chapter.
The committee discussed the proposed edits to the aspirational goal which included adding mention of services and supports and changing the "prevention/preemption of the challenges and disabilities of ASD" to "improving the quality of life." Dr. Insel said he was concerned that the idea of prevention was being lost in the edited version. The committee voted to retain the original aspirational goal as it appeared in the 2009 strategic plan.
The committee reviewed the first research opportunity about genetic and epigenetic variations and Dr. Lawler noted that much progress had been made in the field of epigenetics and that it warranted more mention in the plan. The committee asked Dr. Lawler and Dr. Battey to draft some language defining epigenetics and explaining its importance to the field. The committee accepted additional language about speeding the replication of findings and studying variation across subgroups with common genetic factors. They also incorporated language calling for subgroup studies to examine common genetic and environmental factors.
In the short-term objectives, the workshop panelists had recommended increasing the number of environmental factors identified by the IOM report to study as potential causes of ASD from five to 20. Dr. Battey questioned how many such studies the scientific community could take on at once and Dr. Hann noted that the panelists had discussed studying multiple factors in a single study. Dr. Insel stated that 12 studies of environmental factors were already being conducted, according to recent funding information which included the American Recovery and Reinvestment Act (ARRA) grants. Ms. Redwood asked that funding information be applied across the whole plan so the committee could get a sense of which objectives had been fulfilled. Dr. Hann noted that NIH funding information would not be available for several months because of the adherence to the fiscal year (running from October 1 – September 30). The committee decided on recommending 10 environmental factors for study and flagged the proposed budget for discussion later in the process. The committee decided that more information about phenotypic variation and identifying important clinical features for study was needed in the objective on genome-wide association studies. They directed the Office of Autism Research Coordination (OARC) to craft language from other proposed language in the plan.
The committee decided not to include proposed objectives on studies of exposures to immune challenges, such as vaccines and other environmental toxins or an objective on studies of phenotypic variation. They then reviewed proposed objectives calling for the investigation of the effect of vaccines and their components using animal and cellular models and an epidemiologic study of health outcomes in vaccinated, unvaccinated, and alternatively vaccinated groups. These same objectives had been proposed for but not included in the 2009 edition of the strategic plan. The draft provided to the committee noted that the majority of the Question III Workshop panelists did not recommend including vaccine-specific objectives, but that some panelists felt strongly that these two objectives should be reconsidered by the committee for possible inclusion in the 2010 plan.
Dr. Battey noted that while it was clear environmental issues warranted further study, it was unclear that vaccines should be specifically singled out. Ms. Blackwell noted that none of the researchers or clinicians on the panel supported the inclusion of the vaccine objectives. Dr. Lawler said that she had heard alternative recommendations put forth by the committee, including the study of vaccine response in children diagnosed with ASD. Mr. Grossman explained that, although the panelists could not agree on whether the vaccine objectives merited inclusion, he felt the group had agreed to have them put forward for discussion among the committee members. Dr. Lawler proposed using language calling for studies to better characterize response to immune challenges and studies measuring post-vaccine response in children already diagnosed with ASD, to replace the two vaccine objectives. Ms. Redwood stated that if studies of vaccines were not identified specifically in the plan and were instead referred to more generally as studies of environmental risk factors, they would not be funded. Dr. Insel told the committee that the NIMH was moving ahead with a study of health outcomes in families with ASD, and vaccination information would be collected. The committee agreed that it was important to determine whether subpopulations exist that are more susceptible to environmental exposures and proposed an objective:
"Support studies to determine if there are subpopulations that are more susceptible to environmental exposures (e.g., immune challenges related to infections, vaccinations, or underlying immune problems)."
The language for this new objective was unanimously accepted. The committee voted 12 to 1 not to include the proposed objective calling for animal and cellular models to investigate the effects of vaccines. They voted 9 to 4 (with 1 abstaining) not to include the objective on studies of health outcomes in vaccinated, unvaccinated, and alternative vaccinated groups.
The committee voted to accept the deletion of the phrase "nested, case-control" to describe the type of data to be collected on environmental factors in the final objective in Question III.
Question I: When Should I Be Concerned?
The committee then reviewed proposed edits to Question I: When should I be concerned? Dr. Jennifer Johnson, one of the panel liaisons, noted that the line edits had been made by the liaisons rather than the panelists themselves. She reviewed some of the panelists' general recommendations for language used throughout the plan: change "symptoms" to "characteristics of ASD" and "severity" to "variability." They recommended using the phrase "appropriate" interventions and changing language about "warning signs," "red flags," and "risks" of ASD to "indicators." Dr. Johnson explained that they had taken sections of text from "What do we need?" and put it into "What do we know?" The edits also reflected the increased emphasis on the issues of diversity, the need to study adults with ASD, the need to reach out to culturally and linguistically diverse populations, and the difficulty in diagnosing ASD when co-occurring disorders exist. They had changed the aspirational goal to catch children as soon as possible (before the 24 months that was the initial goal) and to diagnose adults that had been missed.
Dr. Insel said he was confused about the movement of text between sections and asked that they be restored. He noted that the reference to identifying reliable biomarkers for diagnosis had been lost. Ms. Redwood said that the issue of recovery was important to highlight and Dr. Johnson said that the panelists had disagreed over how to frame "losing" a diagnosis. The committee felt that the draft version presented on October 23, 2009 represented a better reflection of the Workshop discussion and asked to return to the edits after that version was distributed.
Question II: How Can I Understand What Is Happening?
Ms. Alison Singer, Question II liaison, presented the panel's proposed edits. She said the panelists had highlighted the importance of collecting skin fibroblasts for creating induced pluripotent stem cells, studying non-verbal people with cognitive disabilities, and looking at the underlying pathways of co-occurring disorders such as Rett and Fragile X and co-occurring conditions such as epilepsy and gastro-intestinal issues. Since the discussion on October 23rd, the liaisons had clarified the language around co-occurring disorders and conditions, regression, and biomarkers.
The committee asked that language in the What do we need? section and an objective about biobanks be moved to the new infrastructure chapter. Ms. Blackwell asked if "intellectual disability" could be substituted for "cognitive impairment" and Dr. Trevathan said that he felt cognitive impairment was a broader term. Ms. McKee asked why the panelists had decided to include an objective specifically on nonverbal people with ASD who are cognitively impaired and Ms. Singer said that they were an understudied group. The committee decided to merge this objective with the next on the association between specific genotypes and functional or structural genotypes, citing nonverbal populations and those with cognitive impairments separately.
Dr. Deborah Hirtz asked about the redundancies in many of the chapters (focus on heterogeneity, adults) and Dr. Insel said that the plan would have to be read together and harmonized before it was finalized. Ms. Redwood asked that the language on regression from the previous draft be returned. The committee agreed and also asked that a sentence about co-occurring conditions also be returned. The group noted that a list of co-occurring conditions would be defined once in the introduction to avoid differing lists across the document. The committee voted en bloc to accept all discussed changes.
Question IV: Which Treatments and Interventions Will Help?
Dr. Insel described the edits proposed by for Question IV, which included more emphasis on the nonverbal population, new communication technology, and adult populations. He also noted the opportunity to include comparative effectiveness research, as it was an important concept in health care reform. He stated that he had supported reference to "n of 1" trials, where an individual tests the effects of an intervention on himself in a controlled, randomized way, but that members of the panel had outvoted him. Ms. Blackwell asked that mention of "autistic children" be changed to "children with ASD." Dr. Hirtz asked that a reference to combinations of interventions specific both pharmacological and behavioral interventions. Ms. Redwood asked to expand the list of interventions commonly used in the community to include mitochondrial cocktails, CoQ10, and carnitine. Dr. Insel noted that probiotics were also in common use. The committee unanimously voted to accept these changes.
Question V: Where Can I Turn For Services?
Ms. McKee reviewed the changes to Question 5 made since the October meeting. Ms. Singer noted that the goal of self-direction and self-determination is not appropriate for some segments of the population on the spectrum and asked that this language be balanced by discussing ongoing caregiving. Ms. Blackwell said that she did not want to stratify people with ASD and that future focus would be on principles of self-determination. Ms. Singer recommended including research on best practices for caregiving to adults with ASD. The committee inserted "families and support systems" to a list of people who should have access to needed services. The committee asked that the research opportunity relating to the "State of the States" report be moved to the infrastructure chapter, as well as an item related to methods for tracking trends in ASD prevalence across the lifespan, and objectives about "State of the States" and promising practices papers on innovative services and supports.
Dr. Hann noted that the promising practices called for in the chapter were important, but might not constitute a research objective. Ms. Redwood noted that the same issue might apply to demonstration projects. Dr. Trevathan said that demonstration projects conducted at CDC in collaboration were considered research and Dr. Chris DeGraw recommended framing these objectives as "implementing and evaluating models." A long-term objective was modified to include parents and legal guardians in service training strategies and include the idea of promoting interdisciplinary practice. The number of studies had been removed by the panel and the liaisons asked that they be restored. The committee voted unanimously to accept these edits.
Question VI: What Does the Future Hold, Particularly For Adults?
Ms. Blackwell reviewed changes to Question VI and noted that the title had been changed to focus primarily on adults. Language about prevalence studies would be moved to the infrastructure chapter, as well as a passage about merging databases that include people with ASD. The committee reviewed the short-term objectives and asked that the number of studies be restored in order to estimate budgetary requirements. The committee modified the first short-term objective to "assess and characterize variation in the quality of life for adults on the ASD spectrum as it relates to components of the service delivery system," included safety in the list of factors, and added a call to determine best practices. The committee asked that "community-based" interventions be added to the second short-term objective and modified the language of the third objective to include parents and legal guardians. The committee reframed the objective on demonstration projects to call for evaluating models at the state and local level. The group discussed an objective to evaluate practices leading to the use of psychopharmaceutical medications in adults and modified it to address the safety and effectiveness of all medications for people with ASD. Ms. Blackwell questioned if the new objective should be moved to Question 4. The committee then voted en bloc to incorporate these changes.
Question I – Continued
The committee then returned to Question I using the October 23rd draft. Dr. Hann asked if the group was comfortable focusing on young children in this chapter now that Question VI focused on adults. The committee agreed but asked if specific age parameters should be specified. After discussion, they decided to keep the chapter generally aimed at "young children." The first subquestion was changed to "What are the early signs of ASD?" which corresponded with the CDC's language in the Learn the Signs campaign. The third subquestion was modified to ask: "How do variations in symptoms and severity create challenges in early diagnosis of ASD?"
The first sentence was modified to specify that a child's caregiver (rather than his "primary" caregiver) is often first to identify the signs of ASD. Ms. Singer noted that the intent of the sentence was to explain that doctors rarely are the first to notice indicators of autism in a child. Dr. Johnson asked whether the first paragraph should be revised based on updates to the DSM (Diagnostic and Statistical Manual of Mental Disorders) and Dr. Trevathan said that he and others did not expect the new criteria to be published until 2012 and that it would not yet be a consideration. Dr. Hirtz asked that language regarding parents missing a critical window of opportunity for early intervention not be included because it perpetuated guilt. The committee accepted language about assessments of co-occurring conditions being conducted regularly but struck "more." A sentence was clarified to explain that children were considered high-risk because of the presence of a sibling with ASD. The committee changed the language of a sentence about "losing" symptoms of ASD to cite "no longer exhibiting characteristics" and asked that a citation be added. Dr. Trevathan explained that the recently released HRSA phone survey was not an accurate indicator of recovery because the figure would include children who had been told by a health professional to get further evaluation, which ultimately did not lead to a diagnosis. "Severity" was changed to "variability" and the committee changed a sentence on a video glossary of "red flags" to state that it was one of several tools available for parents and caregivers.
Moving to "What do we need?" the committee modified language about culturally diverse children having limited access to assessment services, leading to delays in diagnosis and asked for a citation. The group removed a sentence about children who are slow to walk and talk probably catching up in the second year. The committee modified the language on the discovery of reliable biomarkers and changed the aspirational goal to identify children before ASD characteristics fully manifest. The committee began to review the research opportunities, changing "broad-band" screening to "general" developmental screening and "symptoms" to "characteristics" before having to stop due to time constraints.
Closing Comments and Adjournment
OARC was asked to add items related to infrastructure to the additional chapter and the committee agreed to meet again by teleconference on December 11, 2009. During this meeting, they would continue to review Question I and Question VII (Infrastructure). The meeting was then adjourned.
These minutes of the IACC Full Committee were approved by the Committee on December 11, 2009.
I hereby certify that this meeting summary is accurate and complete.
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee
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- Oral Public Comments (PDF – 195 KB)
- Written Public Comments (PDF – 529 KB)
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- Meeting Transcript (PDF - 838 KB)
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- IACC Meeting Slide Set (PDF – 52 KB)
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