IACC Full Committee Meeting - January 18, 2011
|Date:||Tuesday, January 18, 2011|
|Time:||10:00 a.m. to 5:00 p.m. Eastern|
|Agenda:||The purpose of the IACC meeting is to review and approve the final 2011 update of the IACC Strategic Plan for Autism Spectrum Disorder Research.|
|Place:||The Neuroscience Center
6001 Executive Boulevard
Conference Rooms C and D
Rockville, Maryland 20852
|Cost:||The meeting is free and open to the public.|
|Conference Call:||Dial: (888) 577-8995
Access code: 1991506
Pre-registration is recommended to expedite check-in. Seating in the meeting room is limited to room capacity and on a first come, first served basis.
|Access:||White Flint Metro (Red Line) - approximately 1/2 mile walk
On-site parking with parking validation available
|Deadlines:||Notification of intent to present oral comments: January 10th by 5:00 p.m. Eastern
Submission of written/electronic statement for oral comments: January 11th by 5:00 p.m. Eastern
Submission of written comments: January 14th by 5:00 p.m. Eastern
|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
Phone: (301) 443-6040
Any member of the public interested in presenting oral comments to the Committee must notify the Contact Person listed on this notice by 5:00 p.m. Eastern on Monday, January 10, 2011, with their request to present oral comments at the meeting. Interested individuals and representatives of organizations must submit a written/electronic copy of the oral statement/comments including a brief description of the organization represented by 5:00 p.m. Eastern on Tuesday, January 11, 2011.
Statements submitted 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 the order of the date and time when their request to speak is received, along with the required submission of the written/electronic statement by the specified deadline.
In addition, any interested person may submit written comments to the IACC prior to the meeting by sending the comments to the Contact Person listed on this notice by 5:00 p.m. Eastern, Friday, January 14, 2011. The comments should include the name and, when applicable, the business or professional affiliation of the interested person. All written comments received by the deadlines for both oral and written public comments will be provided to the IACC for their consideration and will become part of the public record. The meeting will be open to the public through a conference call phone number and webcast live on the Internet. 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. If you experience any technical problems with the conference call or webcast, please e-mail IACCTechSupport@acclaroresearch.com or call the IACC Technical Support Help Line at (443) 680-0098.
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).
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 to the Contact Person listed on this notice 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.
Meeting schedule subject to change.
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The registration desk opens at 9:00 a.m. Eastern for members of the public attending in person, and the meeting will also be available to the public by live videocast and conference call. The materials for the meeting can be found here.
|10:00 a.m.||Call to Order and Opening Remarks
Thomas Insel, M.D.
Director, National Institute of Mental Health
|10:10 a.m.||Review and Approval of December 14, 2010 Minutes|
|10:15 a.m.|| Round Robin
Geri Dawson, Ph.D.
Chief Science Officer, Autism Speaks
President and CEO, Autism Society
Walter Koroshetz, M.D.
Deputy Director, National Institute of Neurological Disorders and Stroke
Alison Singer, M.B.A.
President, Autism Science Foundation
|10:30 a.m.||Update on the Affordable Care Act and Health Insurance Coverage
Study Director, "Determination of Essential Health Benefits" Study, Institute of Medicine
Stuart Spielman, Esq.
Senior Policy Advisor, Autism Speaks
Jeffrey Sell, Esq.
Vice President for Public Policy, Autism Society
|11:30 a.m.||Strategic Plan Update – Discussion and Votes|
|1:30 p.m.||Public Comments|
|1:45 p.m.||Strategic Plan Update – Discussion and Votes (continued)|
|3:00||Update: IACC Subcommittee on Safety
Commissioner, Administration on Developmental Disabilities Administration on Children and Families
Co-Chair, Safety Subcommittee
Lyn Redwood, R.N., M.S.N.
Co-Founder and Vice President, Coalition for SafeMinds
Co-Chair, Safety Subcommittee
Alison Singer, M.B.A.
President, Autism Science Foundation
Co-Chair, Safety Subcommittee
|3:45 p.m.||OARC Update and IACC Planning Activities for 2011
Susan Daniels, Ph.D.
Deputy Director, Office of Autism Research Coordination, NIMH
|4:30 p.m.||Public Comments Discussion Period|
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- Call to Order and Opening Remarks
- Review and Approval of the December 14, 2010 Minutes
- Round Robin – Lee Grossman, Autism Society
- Round Robin – Dr. Walter Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
- Update on the Affordable Care Act and Insurance Coverage
- Strategic Plan Update – Introduction
- Public Comment
- Comments from Mr. Henry Claypool, Office on Disability
- Strategic Plan Update – Budget Estimate Approval
- Round Robin – Dr. Geraldine Dawson, Ph.D., Autism Speaks
- Round Robin – Ms. Alison Singer, M.B.A., Autism Science Foundation
- Update: IACC Subcommittee on Safety
- Office of Autism Research Coordination (OARC) Update and IACC Planning Activities for 2011
- Discussion of Public Comment
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened a meeting on Tuesday, January 18, 2011, from 10:00 a.m. to 4:30 p.m. at the Neuroscience Center in Rockville, Maryland.
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.
Thomas Insel, M.D., 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 Battey, M.D., Ph.D., National Institute on Deafness and Other Communication Disorders (NIDCD); Ellen Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Coleen Boyle, Ph.D., Centers for Disease Control and Prevention (CDC); Josephine Briggs, M.D., (representing Dr. Francis Collins), National Center for Complementary and Alternative Medicine (NCCAM); Henry Claypool, HHS Office on Disability; Geraldine Dawson, Ph.D., Autism Speaks; Gerald Fischbach, M.D., Simons Foundation; Lee Grossman, Autism Society; Alan Guttmacher, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Walter Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS); Cindy Lawler, Ph.D., (representing Dr. Linda Birnbaum), National Institute of Environmental Health Sciences (NIEHS); Sharon Lewis, Administration for Children and Families (ACF); Christine McKee, J.D.; Ari Ne'eman, Autistic Self Advocacy Network (ASAN); Lyn Redwood, R.N., M.S.N., Coalition for SafeMinds; Denise Resnik, Southwest Autism Research & Resource Center (SARRC); Stephen Shore,* Ed.D., Autism Spectrum Consulting; Alison Tepper Singer, M.B.A., Autism Science Foundation (ASF); Peter van Dyck, M.D., M.P.H., Health Resources and Services Administration (HRSA).
*Note: Attended by phone.
Call to Order and Opening Remarks
Dr. Insel welcomed the committee members and conducted roll call. He summarized the day's agenda and gave an overview of several recent research advances. He first spoke about a recent finding that children with ASD were more likely to have a specific autoantibody found in the cerebellum. The autoantibody was present in 9.7 percent of the children with ASD and 3.6 percent of controls.1 The study was based on a previous finding about maternal autoantibodies that seemed to create autistic-like symptoms when transferred to primates.2 Dr. Insel noted that a relatively large number of controls also had the autoantibody and deemed the research a work in progress. Ms. Redwood asked whether the controls were screened for disorders associated with ASD, such as attention deficit disorder (ADD), and was told that the controls had no diagnosable disorders. Dr. Insel noted that ongoing research into rare anti-NMDA antibodies seemed to link the antibodies with a specific subtype of ASD.
Dr. Insel then summarized research showing hyperconnectivity in many subcortical regions of the brain in people with ASD. The study, published in Biological Psychiatry, found that the pons was particularly overconnected.3 Dr. Insel said that the idea of the overwired brain in ASD would need further exploration, particularly to determine which pathways seem to link to particular aspects of the disorder. He then spoke about two papers coming out of the CHARGE study. The first found that levels of flame retardant, polybrominated diphenyl ethers (PBDEs), was no higher in children with ASD when compared to controls.4 PBDEs are known endocrine disruptors that are prevalent in the environment, particularly California. The other study found that mothers who lived in close proximity to a highway (less than 300 meters) during the last trimester of their pregnancy were twice as likely to give birth to a child with ASD.5 The reason for this association is unclear but one hypothesis is that it may relate to air pollution.
Dr. Insel spoke about the recent finding that closely spaced pregnancies increased the risk of ASD. Using data from California's Department of Developmental Services, Dr. Peter Bearman calculated that women who became pregnant again within 12 months of having a child were three times more likely to have a child with ASD, compared to women who waited three years or more to become pregnant again.6 The reason for the increased risk is unclear and numerous other factors such as birth weight and pregnancy complications were ruled out. In a study of Danish children, those born in the winter months with neonatal jaundice were more likely to have ASD, but only when the child was not the first-born.7 Dr. Insel said that these results were hard to interpret and were not as statistically significant as those in Dr. Bearman's study.
Finally, Dr. Insel summarized a recent study showing promising results from an early behavioral intervention for toddlers with ASD. Fifty toddlers, 22- to 33-months of age, were given an intervention focused on improving joint attention skills and social engagement. At the end of the trial significantly more of the toddlers were engaging in aspects of interpersonal synchrony and importantly, their skills continued to grow outside the classroom.8
Dr. Insel mentioned that a report had been sent to Congress on behalf of the Office of the Secretary of Health and Human Services describing federal activities related to the Combating Autism Act of 2006.9 The committee was given copies of the report for reference.
Review and Approval of the December 14, 2010 Minutes
The committee moved to accept the minutes from their December 14, 2010 meeting, after one correction to an attribution in the document had been made.
Round Robin – Lee Grossman, Autism Society
The members then conducted a round-robin update on the activities of their parent agency or organization. Mr. Lee Grossman noted that the Autism Society was preparing for their annual meeting, July 6-10, 2011, in Orlando, FL. The event is expected to attract about 2,000 people. Mr. Grossman spoke about the Autism Society's collaboration with the Coalition to Promote Self-Determination to improve adult service provision and enhance employment opportunities. The Autism Society also works with the Safer Chemicals, Health Families Coalition to conduct research and promote legislation limiting toxic chemicals. Mr. Grossman said the Autism Society is also working to develop accreditation standards for residential providers and create standards in education for children with ASD. Many of the families that the organization serves will be impacted by impending state budget cuts and he emphasized the seriousness of the situation.
Round Robin – Dr. Walter Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
Dr. Walter Koroshetz spoke about the mission of the National Institute of Neurological Disorders and Stroke, noting that the Institute mainly focuses on understanding the biological mechanisms of the neurological issues leading to ASD. NINDS funds research into brain connectivity, synaptic function, and potential triggers that cause the brain to go awry in the disorder. Recently, the Institute has been able to use advances in imaging technology to better understand brain anatomy associated with ASD. NINDS also studies other conditions on the autism spectrum such as tuberous sclerosis, Rett syndrome, mitochondrial disorders, and related conditions like epilepsy. Dr. Koroshetz described several projects supported by NINDS, including the large prospective study of pregnant mothers – the Norway Birth Cohort Study. Dr. Insel asked Dr. Koroshetz about NINDS funding in FY2012 and he said that they could experience significant budget cuts.
Update on the Affordable Care Act and Insurance Coverage
Ms. Cheryl Ulmer, Study Director at the Institute of Medicine (IOM), then spoke to the committee about the Essential Health Benefits Study, which was set up to help define the package of health benefits to be offered by states participating in health insurance exchanges. The Affordable Care Act requires that the Secretary of Health and Human Services define the package of benefits – the IOM panel will provide the Secretary with general recommendations on how to define and update this package. Ms. Ulmer noted that the IOM serves in an advisory role only, and that the Secretary is not obligated to follow the IOM recommendations. The IOM recently selected the committee members that will serve on the panel – they include a state insurance commissioner, a health insurance medical director, several healthcare services researchers, and multiple consumers. The committee also recently held an open period for written public comment during which 300 people responded. The committee's first meeting of four was held on January 12 - 14, 2011.10 Ms. Ulmer described the ten categories of care to be included in the benefits package, specifically singling out the mental health category. She explained that it was still unclear what level of detail would be specified by the Federal government. There will be many other considerations when defining a benefits package including whether current state mandates should be included, how to best balance increased coverage with affordability, and whether individual states should define "medical necessity." They must also decide what kind of safeguards should be built to monitor coverage decisions and reimbursement rates. The legislation states that the benefits package should be similar in scope to a "typical employer plan," and the committee must also determine the size of such a "typical" plan. Ms. Ulmer asked for input from the autism community about which services are hard to access and how to best differentiate between medical and non-medical services (if such a distinction can be made). She said that the committee would produce a draft report for confidential review in June.
Mr. Ne'eman asked Ms. Ulmer to speak further about the process determining the scope of a typical employer plan. Ms. Ulmer said that a representative from the Department of Labor (DOL) had spoken to the IOM committee at their recent meeting about the Department's National Compensation Survey, which collects information about employer size and medical coverage. The DOL is also examining individual plans to determine services that are commonly covered or excluded. Ms. Ulmer said that they had found relative consistency in what services were excluded from plans but little consistency in covered services.
Mr. Stuart Spielman, Senior Policy Advisor and Counsel for Autism Speaks, then spoke about private insurance coverage for ASD. Mr. Spielman said that coverage for ASD services was an economic issue as well as a medical one because of the crushing financial burden it often placed on families. The Health Resources and Services Administration's (HRSA) National Survey of Children with Special Healthcare Needs found that families affected by ASD are much more likely to report that their insurance is inadequate and are more likely to use Medicaid or other insurance. In positive news, the number of states that mandate comprehensive coverage of ASD has grown from one state (Indiana) in 2001, to 23 states in 2011. This is in part due to a nationwide campaign launched by Autism Speaks to improve coverage for habilitative care (including speech and occupational therapy), applied behavioral analysis (ABA), and other services rendered under IDEA.
Mr. Spielman stressed that their intention was not to shift the burden from the educational system to the healthcare system but to enhance overall healthcare system involvement. He directed the IACC members to visit autismvotes.com to follow current state and Federal autism legislation. Based on estimates from the actuarial firm of Oliver Wyman, laws enforcing comprehensive coverage of ASD services would only increase premiums by 0.42 percent, he said, and this modest increase would result in long-term savings as well. He explained that many people would not be affected by state autism laws because they belong to a self-funded plan, a Federal plan like FEHB or Medicaid, or are unemployed. Because of this, Federal legislation is also critical. The Autism Treatment Acceleration Act was introduced to Congress in 2009, but ultimately failed to be enacted into law.
He then discussed the sections of the Affordable Care Act that would directly apply to people with ASD including those related to rehabilitative and habilitative care. The IACC discussed the distinction between the two types of care and Dr. Yvette Janvier noted that in pediatric practice, rehabilitative care refers to regaining a lost skill while habilitative care is needed to attain a skill that has not yet been gained (e.g., delayed speech). Mr. Spielman said it was important to note that "behavioral health treatment" had been added to the mental health services category. He played a video clip showing Senator Robert Menendez recommending the language to the Senate Finance Committee. Mr. Spielman noted that this language in the Affordable Care Act demonstrated a commitment to providing better healthcare for people with ASD. He urged the IOM to consider the significance of healthcare laws on the ASD community when offering their recommendations.
Mr. Jeff Sell, Vice President for Public Policy at the Autism Society, spoke to the committee about the Affordable Care Act and gave a personal example of the distinction between habilitative and rehabilitative care. Mr. Sell has twin boys with ASD, one of whom is nonverbal. His insurance company refused to cover speech therapy because his son had never had speech, arguing that the service was habilitative and therefore not covered (rehabilitative services would, however, receive coverage). Mr. Sell said that the language of the Affordable Care Act makes clear that behavioral health treatments including habilitative care will be covered. The additional cost to consumers, based on actuarial reports, will be less than a cup of Starbuck's coffee a month, he said, and for every dollar spent on services now, roughly seven dollars will be saved in the future.
Questions from the Committee
The three speakers then took questions from the committee and Dr. Coleen Boyle asked how the Affordable Care Act would cover the 59 percent of worker who have self-funded plans. Mr. Spielman explained that most health insurance in the United States is provided by employers and 59 percent of employers use self-funded coverage, meaning that the company bears the full burden of paying out for healthcare costs. Self-funded insurance is not subject to state regulations. Dr. Insel commented that if neither the IOM nor the Secretary provided specific recommendations about behavioral services (type of therapy, number of hours, type of coverage), the private insurers would still be in control of these decisions. Mr. Spielman said that by including behavioral health treatment in the legislation, it was understood to mean treatments as they are shown to be effective in the research literature. Mr. Sell identified the 2001 report from the National Academy of Sciences: Educating Children with Autism as a source of specific treatment guidelines. He said he would prefer that the healthcare provider determine the specifics of each individual's treatment. Dr. Gerald Fischbach questioned whether it was time for a more recent scientific review of behavioral therapy practices. Dr. Dawson noted that the Agency for Healthcare Research and Quality (AHRQ) was required to conduct a review of interventions for children and adolescents with ASD as part of the Combating Autism Act. She also explained that in working with insurance companies for early intervention coverage, the prescribing physician would set up a program based on his professional judgment with specific therapeutic goals and methods. The physician would then provide updates on progress toward those goals to validate coverage. Mr. Spielman underscored the importance of defining clear healthcare needs as separate and distinct from educational needs. Mr. Grossman spoke about the importance of the Affordable Care Act in eliminating the ability for insurance companies to discriminate based on preexisting conditions. Dr. Fischbach asked how the Report to Congress on federal activities related to ASD would be used and Dr. Insel said that it had already caught the attention of Representative Mike Doyle who had posted it on his website. Dr. Janvier spoke about the issues distinguishing medical from non-medical services when both could be provided in school. Dr. Insel noted that they were currently at a critical junction as decisions about implementing the Affordable Care Act will be made in the coming months.
Strategic Plan Update – Introduction
Dr. Della Hann then led the committee through additional decisions that needed to be made to finalize the 2011 Strategic Plan for ASD Research. The committee was directed to consider additional crosscutting themes for the Plan Introduction and to review the proposed budget estimates for objectives. Ms. Redwood led the committee through the proposed changes to the Introduction, citing the need for a greater sense of urgency at the start of the document and including mention of President Obama's commitment to ASD research. She had taken language from the Autism Speaks website that noted "autism is more common than childhood cancer, juvenile diabetes, and pediatric AIDS combined." Dr. Guttmacher asked that it be clarified that these statistics were for the United States. Mr. Ne'eman objected to the language, saying that it drew unfair comparisons between autism and terminal medical conditions. After further discussion, 14 members of the committee voted in favor of the language recommended by the Planning Subcommittee with a clarification that these figures were in the United States. The committee then reviewed a passage that had been flagged for further discussion by members of the Planning Subcommittee because it stated that societal cost of ASD was estimated to be $35 - $90 billion annually. Mr. Ne'eman warned that this language could potentially alienate people on the spectrum. A majority of the committee (17 members) voted to keep the language. The committee also accepted a small recommended edit noting that progress had been made in accomplishing the objectives laid out in the Plan. Dr. Insel suggested alternative language describing what is meant by heterogeneity ("the severity of behavioral and medical conditions that comprise the disorder.") By accepting this language, the committee eliminated the following sentence describing the range of functionality for people on the spectrum. (The subcommittee had developed two versions of this sentence for discussion.) Ms. Redwood then reviewed a new crosscutting theme related to co-occurring conditions. The information in the passage came from Dr. Dawson's April 2010 presentation on the Autism Treatment Network (ATN).11 The committee voted to accept the theme and agreed that the Office of Autism Research Coordination would revise the passage for clarity and insert figures on the prevalence of seizure disorders in children with ASD. Ms. Redwood reviewed several other small changes to the Introduction emphasizing the role of public-private research collaboration and engaging stakeholders in the research process.
Mr. Ne'eman supplied language explaining the participatory action model, which was accepted by the committee. The committee then discussed an additional theme related to the ethical, legal, and social implications of autism research. Ms. Blackwell asked that "Autistic adult community" be changed to "people with ASD" to remain consistent with the "person-centric" language used throughout the Plan. Dr. Dawson suggested broadening the scope of the theme to include research outside of genetic studies and Dr. Insel recommended citing intervention research, as well. With these changes, the theme was accepted. The committee then reviewed a suggested crosscutting theme on self-determination drafted by Ms. Jennifer Johnson. Ms. Blackwell suggested edits to make the passage more positive by striking a reference to relying on others to make choices for them. Ms. Singer recommended using the term "supported self-determination" to include individuals with ASD who are more challenged, but was told that the term had fallen out of use. Ms. Lewis noted that self-determination was an accepted and valued concept in the services community and that it could be used by people with the most significant and profound needs. People with very significant communication and intellectual challenges can still make choices that help to work towards a self-determined goal. Ms. Dawson suggested having a speaker on self-determination at a future meeting. Ms. Blackwell noted that speakers had appeared at the November Services Workshop and that the presentations were available online.12 Dr. Hann suggested organizational changes to the passage for clarity. This version was accepted with 12 members voting for inclusion and 8 members voting to omit the theme entirely.
Ms. Caroline Rodgers spoke about her concern that prenatal ultrasound may contribute to ASD. She cited several major public health discoveries in history including the significant decrease in maternity ward deaths after hand-washing was mandated and the finding that rickets was caused by vitamin D deficiency. She asked for further study of the potential causative role of ultrasound in ASD. Mr. Jim Moody spoke on behalf of the National Autism Association (NAA) and urged the committee to act to prevent wandering-related fatalities among people with ASD. They noted that issues of independence and self-determination should not take priority over preventing death and asked the committee to act with the appropriate amount of urgency.
Comments from Mr. Henry Claypool, Office on Disability
Because Mr. Henry Claypool was leaving prior to the end of the meeting, he was given time to speak about his concerns related to sending a letter on wandering to the Secretary. He said that writing this letter was not the best use of the IACC and he asked that it be tabled until further research was conducted. Dr. Boyle asked whether developing better-defined actions would ease his resistance and Mr. Claypool said that more information would be necessary to understand the causes of wandering and to determine what types of services may be effective in preventing the behavior. He also cited the length of time it would take to make changes to the ICD codes. Ms. Redwood asked if he had been present during the NAA presentation and whether he read the letter that had been drafted. He said that he had not been present during the presentation but that he had read that letter and that his primary concern was that a letter to the Secretary would not make progress toward the goals desired by the committee. He offered to broker a meeting between the IACC and the Alzheimer's community to gather information on their related activities. Ms. Redwood said that the letter would fulfill the statutory obligation of the committee to make the Secretary aware of important issues brought to their attention. Mr. Claypool responded that the committee might be better served by identifying a few strategic activities and empowering the IACC to take those actions. They might also benefit by looking to other developmental disabilities groups to see what work has been done in the past.
Strategic Plan Update – Budget Estimate Approval
Dr. Hann led the committee through the Strategic Plan budget estimates and the group voted by chapters to accept the estimates. Ms. Redwood questioned the $35,000 figure for a workshop on bioinformatics and Dr. Insel noted that in this time of austerity they had to be more frugal. Moving to chapter five, Mr. Ne'eman noted that the Health Resources and Services Administration (HRSA) had changed the wording of the dental health objective for which they had been asked to provide an estimate. The committee agreed to return to the original language of the objective but keep the budget estimate. An objective calling for the development of programs to increase health and safety for people with ASD had not received a budget estimate. Dr. Boyle suggested providing $2 million over two years based on existing programs. This estimate was accepted by the committee. Dr. Koroshetz was concerned that the estimate of $50 million to add 50 people to a digital brain atlas was excessive, but Dr. Insel assured him that the process was very expensive and the estimate was accurate. The budget figures were then finalized.
Round Robin – Dr. Geraldine Dawson, Ph.D., Autism Speaks
Dr. Dawson spoke about a recent meeting co-sponsored by Autism Speaks and Pfizer focused on development of outcome measures for clinical trials. The meeting is one in a series dedicated to translational medicine research. She said that 45 people attended including parents, scientists, academics, and NIH staff. The meeting was divided into four sessions: perspectives and lessons from industry and NIH-sponsored clinical trials, constructs for measuring core symptoms of ASD, very early interventions and brain plasticity, and outcome measures that address associated symptoms such as anxiety. The group developed several recommendations for accelerating research into outcome measures. This included forming a consensus working group, increasing collaboration between clinical researchers and individuals working at preclinical stages of drug discovery, and developing a white paper with recommendations. They also identified three areas in need of research funding: dedicated funds for measurement development, studies using innovative study design, and novel treatment approaches, particularly those combining behavioral treatments with drug interventions. Dr. Insel asked if the Food and Drug Administration (FDA) had attended and was told that they had not. Dr. Sue Swedo talked about the success of having the FDA involved in early working groups to determine outcome measures for schizophrenia. Dr. Insel echoed the sentiment and added that it was also important to transition quickly from experimental measures to real-world measures.
Round Robin – Ms. Alison Singer, M.B.A., Autism Science Foundation
Ms. Singer noted that the Autism Science Foundation was a relatively young parent-led organization dedicated to funding outstanding autism research. ASF is currently reviewing applicants for pre-doctoral grants and post-doctoral fellowships. The recipients are expected to be announced at the end of March 2011. The foundation also offers scholarships for individuals to attend the International Meeting for Autism Research (IMFAR). Recently, ASF has worked with other advocacy organizations to gather data on autism-related wandering through the Interactive Autism Network (IAN). The organization is also very active in disseminating science, Ms. Singer said, noting that they regularly host events to discuss the most recent science. These events are listed on the ASF website.
Update: IACC Subcommittee on Safety
Ms. Singer then presented the committee with the letter on ASD-related wandering to be delivered to the Health Secretary. The Subcommittee on Safety was created in October 2010 after hearing testimony about the dangers of wandering from the National Autism Association. The Subcommittee met to discuss the contents of the letter but was unable to reach consensus on a draft to bring before the IACC at the December meeting. After further discussion and revisions, the subcommittee developed two versions of the letter to present to the IACC for input at the present meeting. The key difference between the versions related to the recommendation on creating a medical subclassification or general medical coding for ASD-related wandering. Ms. Singer explained that this code would be similar to existing codes for dementia-related wandering. Such a code would help to collect better data and give families greater access to tracking devices and other technology that could aid in preventing wandering or recovering a lost child. Ms. Lewis, who serves as a co-chair for the Safety Subcommittee, together with Ms. Singer and Mr. Redwood, presented an alternate version of the letter that called for more data collection before developing specific action recommendations. Ms. Lewis registered her concern about elevating the issue of wandering above other issues that may be of equal or greater importance. She noted that this would be the first advisory letter ever sent to the Secretary by the IACC and questioned whether such a narrow issue should receive more attention than larger health and safety concerns or the numerous other issues discussed by the IACC. Ms. Blackwell shared her concern and recommended providing a broader focus on overall health and safety issues. Mr. Grossman asked which federal agency oversaw ICD (International Classification of Diseases) codes and was told that the CDC has input into the process but that it is ultimately overseen by the World Health Organization (WHO). Dr. Boyle said that the ICD-10 codes would not be released until 2014 so they had moved rapidly to be considered for an update to the ICD-9 codes. Mr. Ne'eman endorsed the second version of the draft, citing the lack of research into wandering and cautioning against using a medical approach to the issue when a services approach may be more appropriate.
Dr. Boyle noted that she sat on a committee that had made recommendations to the Secretary regarding reimbursement for medical foods for children with metabolic issues like phenylketonuria (PKU). She said that like wandering, there was little hard data on the issue, but that based on the urgency of the issue the committee was able to develop specific recommendations. Ms. Resnik recommended expanding the letter's introduction to include additional safety issues that could be written about in subsequent letters. Dr. Insel suggested framing the letter by reminding the Secretary of their mandate to bring forward important issues from the community. Dr. Dawson said she felt the letter should be sent forward to the Secretary to demonstrate the IACC's responsiveness to the public and due to the dire consequences of wandering. She noted that as a clinician she had seen how difficult it was for parents to deter wandering behavior. The committee discussed whether or not a letter should go forward to the Secretary and Ms. Lewis noted that while the topic was undoubtedly urgent, she was concerned about prioritizing this issue over others. She said that in meeting with hundreds of families with ASD across the country the issue of wandering had never been brought up. Mr. Ne'eman suggested working with the Services Subcommittee to broaden the letter to include other important services issues. Dr. Koroshetz supported pursuing an ICD-9 code and Ms. Singer noted that the Subcommittee on Safety had initially been created because the IACC felt that wandering was an urgent issue. Mr. Grossman said that he was sensitive to wandering – his own son with autism wandered often – but he questioned sending a letter to the Secretary recommending actions outside her purview. Dr. Dawson noted that the letter recommended "investigating the use of" the ICD-9 codes, rather demanding a change.
Dr. Janvier said that wandering was the only life-threatening issue that had ever come before the IACC and, thus, warranted action. She also said that as a clinician, using an additional ICD-9 symptom code would not be a burden. Mr. Ne'eman disagreed that wandering was the only life-threatening issue to ever come before the IACC, citing restraint and seclusion and homelessness. He also asked about the possibility of including a minority report if the letter were sent to the Secretary. Dr. Koroshetz noted that ICD-9 symptom codes were not associated with billing and would help to collect data on wandering. Ms. Blackwell stated her concern that the letter applied only to children and Ms. Lewis noted that the decision to focus on children was in part due to ethical issues related to adults and self-determination. The committee voted on the two versions of the letter and voted 11 to 7 to send version 1, after expanding the introduction to include mention of other safety issues and noting the IACC's role in bringing forward pertinent issues to the Secretary. A final vote to send the letter was taken with 14 in favor and 4 opposed. Six members were not present at the meeting at the time of the vote. The motion passed and OARC was charged with making final changes to the letter per the committee's recommendations and sending it to the Secretary.
Office of Autism Research Coordination (OARC) Update and IACC Planning Activities for 2011
OARC Deputy Director Dr. Susan Daniels gave updates from the Office of Autism Research Coordinating and thanked Dr. Hann for her guidance. Dr. Hann would be leaving her position as Acting Director of OARC for a position as Deputy Director of the NIH Office of Extramural Research and Dr. Daniels would be assuming the position of Acting Director after her departure. Dr. Daniels introduced two new members of the staff, Dr. Elizabeth Baden, Policy Analyst, and Dr. Sara Dodson, AAAS Science & Technology Policy Fellow/Health Scientist. She then updated the committee on the status of the yearly portfolio analysis of ASD research from major stakeholders. A draft of the 2009 Portfolio Analysis was presented to the committee in October 2010. Since that time, OARC had conducted a quality check of the coding as requested by the IACC and was in the process of completing the final analysis. They would then begin the process for the 2010 Portfolio Analysis if authorized by the committee. Dr. Lawler asked whether it would be possible to distinguish new grants from existing grants to track progress fulfilling the Strategic Plan. Dr. Daniels said that this could be indicated if the committee wished. Ms. Resnik asked if an analysis of the return on investment could be conducted and Dr. Daniels noted that it would be difficult for OARC to do such an assessment because it would involve an entirely different data set (including research results rather than just funded projects) and analysis. Dr. Insel noted that quantifying the value of information science was an intensive process that would require much additional information from funders. Dr. Dawson said that Autism Speaks had developed a software program that was distributed to their grantees to determine the impact of their investments. She offered to share it with any interested organizations. Ms. Redwood asked whether having information about publications resulting from grants would be useful to the committee. NIH already collects information on publications, which is available through the RePORTer tool. Dr. Boyle said that CDC collected publication information as well. Dr. Koroshetz asked about categorizing grants not specific to any objective and was told that OARC would try to develop additional categories to capture these grants in future reports. Dr. Daniels presented a proposed timeline for the 2010 Portfolio Analysis – data would be collected in spring and the data analysis would be completed in the summer with a draft presented at the July 2011 meeting. Dr. Janvier asked if funding from the New Jersey Governor's Council should be included and Dr. Daniels stated her concern about reaching out to a single state without contacting others.
She then reviewed the process for the annual Summary of Advances, a document describing the most important ASD research of the year. The committee had identified 10 advances for the mid-year selection and 10 more would be added in the final document. Members would be asked to nominate three to five articles and a ballot would then be distributed for voting. The IACC agreed to this process and Dr. Daniels moved to discussion of a potential workshop or town hall. Ms. Redwood asked Dr. Dawson if Autism Speaks had held a workshop on interventions and Dr. Dawson said that they would soon have a meeting on the preclinical phase of drug discovery. Mr. Ne'eman suggested holding another services workshop or holding the workshop on the ethical, legal, and social implications of ASD research called for in the Strategic Plan. Ms. Singer said she felt the committee had benefited from hearing comments from the community at town hall meetings. Dr. Insel noted that the Strategic Plan also called for a workshop on bioinformatic approaches to indentify environmental risk factors. Dr. Lawler noted that NIEHS and Autism Speaks were in the process of planning a bioinformatics workshop. Dr. Koroshetz presented the possibility of holding a workshop related to safety issues. Dr. Boyle noted that the CDC was sponsoring a workshop on ASD prevalence in Atlanta, GA. Mr. Grossman strongly endorsed holding another services workshop and Ms. Blackwell listed some of the topics that had not been included in the first: managed care delivery models for services, cultural sensitivity, health homes, infrastructure, person-centered planning and policies, recreational services, etc. The committee agreed to hold another services workshop and convene a town hall meeting during one of the major advocacy meetings during the summer. Ms. Blackwell recommended looking into electronic options to expand town hall participation.
Discussion of Public Comment
Dr. Lawler noted that many of the possible environmental risk factors mentioned in public comments were explored in ongoing studies such as the CHARGE (Childhood Autism Risks from Genetics and the Environment) study. She also discussed the need for bioinformatic approaches to prioritize classes of exposures for study. This would be discussed at the future meeting co-sponsored with Autism Speaks. Dr. Koroshetz noted that a recent CDC study using data from Kaiser Permanente found no association between ASD and prenatal ultrasound. Dr. Insel thanked the committee for their work and congratulated them on completing the 2011 Strategic Plan. He thanked Dr. Hann for her wisdom and guidance during her tenure with the IACC and Dr. Hann thanked the committee for the experience. She noted that the committee had made significant progress since it first convened 3½ years ago. The meeting was then adjourned.
These minutes of the IACC Full Committee were approved by the Committee on April 11, 2011.
I hereby certify that this meeting summary is accurate and complete.
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee
1 Goines P, Haapanen L, Boyce R, Duncanson P, Braunschweig D, Delwiche L, Hansen R, Hertz-Picciotto I, Ashwood P, Van de Water J. Autoantibodies to cerebellum in children with autism associate with behavior. Brain Behav Immun. 2011 Mar;25(3):514-23. Epub 2010 Dec 4. PMID: 21134442
2 Martin LA, Ashwood P, Braunschweig D, Cabanlit M, Van de Water J, Amaral DG. Stereotypies and hyperactivity in rhesus monkeys exposed to IgG from mothers of children with autism. Brain Behav Immun. 2008 Aug;22(6):806-16. Epub 2008 Feb 8. PMID: 18262386
3 Di Martino A, Kelly C, Grzadzinski R, Zuo XN, Mennes M, Mairena MA, Lord C, Castellanos FX, Milham MP. Aberrant Striatal Functional Connectivity in Children with Autism. Biol Psychiatry. 2010 Dec 31. [Epub ahead of print] PMID: 21195388
4 Hertz-Picciotto I, Bergman A, Fängström B, Rose M, Krakowiak P, Pessah I, Hansen R, Bennett DH. Polybrominated diphenyl ethers in relation to autism and developmental delay: a case-control study. Environ Health. 2011 Jan 5;10(1):1. PMID: 21205326
5 Volk HE, Hertz-Picciotto I, Delwiche L, Lurmann F, McConnell R. Residential Proximity to Freeways and Autism in the CHARGE study. Environ Health Perspect. 2010 Dec 13. [Epub ahead of print] PMID: 21156395
6 Cheslack-Postava K, Liu K, Bearman PS. Closely spaced pregnancies are associated with increased odds of autism in California sibling births. Pediatrics. 2011 Feb;127(2):246-53. Epub 2011 Jan 10. PMID: 21220394
7 Maimburg RD, Bech BH, Vaeth M, Møller-Madsen B, Olsen J. Neonatal jaundice, autism, and other disorders of psychological development. Pediatrics. 2010 Nov;126(5):872-8. Epub 2010 Oct 11. PMID: 20937652
8 Landa RJ, Holman KC, O'Neill AH, Stuart EA. Intervention targeting development of socially synchronous engagement in toddlers with autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2011 Jan;52(1):13-21. doi: 10.1111/j.1469-7610.2010.02288.x. Epub 2010 Dec 3. PMID: 21126245
9 U.S. Department of Health and Human Services, Office of Autism Research Coordination, National Institutes of Health (On behalf of the Office of the Secretary). Report to Congress on Activities Related to Autism Spectrum Disorder and Other Developmental Disabilities Under the Combating Autism Act of 2006 (FY 2006 – FY 2009). December 2010 (Rev. April 2011).
12 Mr. Michael Head (PDF – 168 KB) and Mr. James Conroy's Presentations on Self-Determination (PDF – 369 KB) – November 8, 2010 IACC
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- Draft: Letter to Secretary Sebelius (PDF – 84 KB)
- Draft: IACC Strategic Plan Introduction 2011 Update (PDF – 115 KB)
- Draft: 2011 IACC Strategic Plan (Question 1 - References) (PDF – 497 KB)
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- Meeting Transcript (PDF - 533 KB)
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- IACC Meeting Full Slide Set (PDF – 1.7 MB)
IACC Update (PDF – 385 KB)
Thomas Insel, M.D., Director, National Institute of Mental Health and Chair, IACC
Cheryl Ulmer, Study Director, "Determination of Essential Health Benefits" Study, Institute of Medicine
Stuart Spielman, Esq., Senior Policy Advisor, Autism Speaks
Jeffrey Sell, Esq., Vice President for Public Policy, Autism Society
Susan A. Daniels, Ph.D., Acting Director, OARC, National Institute of Mental Health
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