IACC Full Committee Meeting - April 30, 2010
|Date:||Friday, April 30, 2010|
|Time:||10:00 a.m. to 5:00 p.m. Eastern|
|Agenda:||The purpose of this IACC meeting is to welcome the new members of the IACC and to discuss IACC activities including the 2009 IACC Summary of Advances and the 2009 Portfolio Analysis. There will also be presentations on the Autism Treatment Network, autism in the DSM-V, stem cell research, nonverbal autism and comparative effectiveness research.|
|Place:||The Ronald Reagan Building and International Trade Center
1300 Pennsylvania Avenue, N.W.
Washington, DC 20004
|Conference Call:||USA/Canada Phone Number: 888-577-8995
Access code: 1991506
|Access:||Metro accessible - Federal Triangle Metro (Orange/Blue Line)|
|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
|Please Note:||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 Thursday, April 22, 2010 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 presentation/statement including a brief description of the organization represented (where applicable) by 5:00 p.m. Eastern on Friday, April 23, 2010. Statements submitted will become a part of the public record. Only one representative of a given 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 Monday, April 26, 2010. The comments should include the name and when applicable, the business or professional affiliation of the interested person. All written statements 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 webcast live or conference call, please e-mail IACCTechSupport@acclaroresearch.com.
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.
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).
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. Online 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. Please note: Online pre-registration will close by 5:00p.m. the day before the meeting. After that time, registration will have to be done onsite the day of the meeting.
Meeting schedule subject to change.
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This meeting will also be available to the public by live videocast. 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
|10:05 a.m.||Kathleen Sebelius
Secretary, Department of Health and Human Services
|10:20 a.m.||Welcome and Introductions of IACC Members|
|10:55 a.m.||Francis Collins, M.D., Ph.D.
Director, National Institutes of Health
|11:25 a.m.||Research Update: Autism Treatment Network
Geraldine Dawson, Ph.D.
Chief Science Officer, Autism Speaks
|11:50 a.m.||Research Update: Autism in the DSM-V
Susan E. Swedo, M.D.
Senior Investigator, Behavioral Pediatrics Section, Pediatrics and Developmental Neurospsychiatry Branch, NIMH
|1:30 p.m.||Public Comments|
|2:00 p.m.||Research Update: Stem Cell Research
James Battey, M.D.
Director, National Institute on Deafness and Other Communication Disorders
|2:25 p.m.||Research Update: NIH Nonverbal ASD Workshop
Helen Tager-Flusberg, Ph.D.
Director, Laboratory of Developmental Cognitive Neuroscience, Boston University
Ann Wagner, Ph.D.
Chief, Neurobehavioral Mechanisms and Mental Disorders Branch, NIMH
|2:50 p.m.||Research Update: Building the Infrastructure for Comparative Effectiveness Research on Disability Issues
Rosaly Correa-de-Araujo, M.D., MSc, Ph.D.
Deputy Director, Office on Disability, Office of the Secretary
|3:15 p.m.||Approval of January 19, 2010 IACC Committee Minutes|
|3:20 p.m.||Update: Planning Subcommittee
Thomas Insel, M.D.
Director, National Institute of Mental Health
|4:00 p.m.||OARC Update
|4:20 p.m.||Public Comments Discussion Period|
|4:50 p.m.||Closing Comments|
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- Welcome and Introductions
- Remarks by Kathleen Sebelius, Secretary of Health and Human Services
- Remarks by Francis Collins, M.D., Ph.D.
- Presentation on the Autism Treatment Network – Geraldine Dawson, Ph.D.
- Presentation on Changes to Autism in the DSM-5 – Susan E. Swedo, M.D.
- Public Comments
- Presentation on Stem Cell Research – James Battey, M.D., Ph.D.
- Presentation on the NIH Non-Verbal ASD Workshop – Helen Tager-Flusberg, Ph.D.
- Building the Infrastructure for Comparative Effectiveness Research on Disability
Issues – Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D.
- Approval of the January 19, 2010 IACC Meeting Minutes
- Discussion of IACC Planning Subcommittee Activities
- Update on the Office of Autism Research Coordination (OARC) – Della Hann, Ph.D.
- Public Comments Discussion Period
- Closing Comments and Adjournment
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened a meeting on April 30, 2010, from 10:00 a.m. to 5:00 p.m. at the Ronald Reagan Building in Washington, DC.
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.
Special Guests: Kathleen Sebelius, M.P.A., Department of Health and Human Services; Francis S. Collins, M.D., Ph.D., National Institutes of Health (NIH); Kareem Dale, J.D., M.B.A., White House Office of Public Engagement; Michael Strautmanis, J.D.,White House Office of Public Engagement; Howard Koh, M.D., Department of Health and Human Services.
Committee and Staff: Thomas R. Insel, M.D., National Institute of Mental Health (NIMH), Chair; 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 Communication Disorders (NIDCD); Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); Cindy Lawler, Ph.D., (representing Linda Birnbaum, Ph.D.), National Institute of Environmental Health Sciences (NIEHS); Josephine Briggs, M.D., (representing Francis Collins, M.D., Ph.D.), National Center for Complementary and Alternative Medicine (NCCAM); Henry Claypool, HHS Office on Disability; Geraldine Dawson, Ph.D., Autism Speaks; Gerald D. 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); Gail R. Houle, Ph.D., U.S. Department of Education (ED); Larke N. Huang, Ph.D., Substance Abuse and Mental Health Services Administration (SAMHSA); Yvette M. Janvier, M.D., Children's Specialized Hospital, Walter J. Koroshetz, M.D., National Institute of Neurological Disorders and Stroke (NINDS); Sharon Lewis, (representing Jennifer G. Johnson, Ed.D.), Administration for Children and Families (ACF); Christine M. McKee, J.D.; Ari Ne'eman, Autistic Self Advocacy Network (ASAN); Lyn Redwood, R.N., M.S.N., Coalition for SafeMinds; Denise D. Resnik, Southwest Autism Research & Resource Center; Stephen M. Shore, Ed.D., Autism Spectrum Consulting; Alison Tepper Singer, M.B.A., Autism Science Foundation; Marjorie Solomon, Ph.D., M.B.A., University of California, Davis; Edwin Trevathan, M.D., M.P.H., Centers for Disease Control and Prevention (CDC); Peter van Dyck, M.D., M.P.H., Health Resources and Services Administration (HRSA).
Welcome and Introductions
Dr. Insel opened the meeting and noted that new members and special guests were in attendance. He reviewed the charge of the IACC – to advise the Secretary of Health and Human Services on autism research needs and opportunities – and emphasized that the committee has no budget of its own with which to fund ASD research. He thanked the IACC for its work during Autism Awareness month, held during April, and noted the passing of Dr. Stanley Greenspan, a founding member of the autism treatment community.
Remarks by Kathleen Sebelius, Secretary of Health and Human Services
HHS Secretary Kathleen Sebelius then spoke before the committee, welcoming the new members and thanking the existing members for their service. Members then had the opportunity to introduce themselves and speak briefly about their agency or organization. This included the five new public members: Geraldine Dawson, Ph.D., Autism Speaks; Gerald Fischbach, M.D., Simons Foundation; Ari Ne'eman, Autistic Self-Advocacy Network; Denise Resnik, Southwest Autism Research & Resource Center; and Marjorie Solomon, Ph.D., MIND Institute, University of California, Davis.
Secretary Sebelius thanked the committee for its dedicated work and said that it greatly informed the Department's efforts on autism. She noted the need for collaboration across the government and in partnership with private organizations to address the alarming increase in ASD prevalence. She assured the committee that although she would not be able to attend IACC meetings, she would be informed of the committee's progress. Secretary Sebelius then outlined the advances that have already taken place during Barack Obama's presidency – the passage of the American Recovery and Reinvestment Act, the substantial increase in the NIH budget, and a healthcare overhaul that will ensure that companies cannot deny coverage for people with preexisting conditions. She stated that the committee had the attention of the president and the White House and urged the committee to continue its important work.
Kareem Dale, Special Assistant to the President for Disability Policy, reiterated that the White House was strongly committed to addressing autism and said that the addition of the new members would bring fresh energy and additional perspectives. Secretary Sebelius thanked the Assistant Secretary of Health, Dr. Howard Koh, for his work increasing awareness of ASD.
Remarks by Francis Collins, M.D., Director of the National Institutes of Health
NIH Director Dr. Francis Collins welcomed the new members and said that after talking with parents of children with ASD, he could empathize with their sense of urgency. This meeting, held earlier in April, also gave him a sense of the variety of views on how NIH should invest research resources. He noted that autism had been given high priority, with NIH funding growing from $40 million in 1999 to $196 million in 2009, and that the use of the human genome will be important to identify factors that contribute to ASD. Acknowledging that ASD undoubtedly had an environmental component as well, he emphasized the importance of research into environmental factors and gene-environment interaction. Technological advances make personal genome sequencing more efficient than ever and a study is underway to sequence the genomes of 300 people with ASD. Dr. Collins cited an article that had appeared in the morning edition of the New York Times describing an exciting breakthrough in the treatment of Fragile X, a genetic disorder related to autism that is due, in part, to problems at the synapse. Much recent evidence has suggested that autism may be related to dysfunction of synapses, so the finding may have implications for treating autism as well. He said a group of NIH directors had met at a recent retreat to discuss how NIH could play a larger role in developing pharmaceuticals, a process that had typically been left to the private sector. They agreed that more investments are needed from the public sector to help develop drugs for rare disorders and those without a known biological target. These disorders generally receive little interest from pharmaceutical companies because they have less potential profitability. He then described the importance of the National Children's Study, the largest pediatric study ever undertaken, to study ASD and early environmental exposures as researchers track 100,000 children from before birth into adulthood. Dr. Collins discussed how ASD research could fit into larger NIH research themes like comparative effectiveness research and global opportunities. He described the tendency to fund less risky and innovative grants during tough financial times; to combat this, a number of programs to fund high-risk, high-reward grants have been put in place. He said that innovation is needed to continue to drive ASD research and asked the committee to keep pushing forward.
Presentation on the Autism Treatment Network – Geraldine Dawson, Ph.D., Autism Speaks
Dr. Geraldine Dawson spoke about the Autism Treatment Network (ATN), a network of hospitals and physicians supported by Autism Speaks that provides comprehensive medical care for children and adolescents with ASD. The ATN also conducts clinical research to better understand how to manage and treat co-occurring physical and mental health conditions, such as sleep and gastrointestinal disorders and various psychiatric conditions. Dr. Dawson reported that families with ASD have a significantly more difficult time getting services than do families with other special needs. Families with ASD generally do not get the appropriate services and have difficulty getting necessary referrals. General practitioners may not be trained to treat children with ASD, many of whom face a variety of medical issues and co-morbid psychiatric disorders. Research has shown that 75 percent of children with ASD have three or more psychiatric issues, often related to anxiety, she said. The ATN serves as a network to learn about treatment and conduct clinical research while providing needed care. Based on the model used by the cystic fibrosis network and the children's cancer network, the ATN works to improve quality of care and access. The ATN also provides education and training for physicians and collaborates with federal agencies such as the Healthcare Resources and Services Administration (HRSA). Based on studies coming out of the ATN, 50 percent of children with ASD report gastro-intestinal (GI) issues and these children are more likely to have sleep disturbances, behavioral problems, and indicate a lower quality of life. The ATN is also studying the use of psychotropic medications in children with ASD, as well as complementary treatment, and special diets. Dr. Dawson said that the goal was to expand beyond the 14 existing centers and develop a bio-repository to help identify biomarkers. Expanded funds are needed, she said, noting that President Obama had pledged that funding for ASD research, treatment, and services would increase to $1 billion annually.
Questions from the Committee
Dr. Peter van Dyck discussed HRSA's involvement with the ATN through Leadership Education in Neurodevelopment and Related Disabilities (LEND) projects created to teach professionals to better diagnose and treat people with developmental disabilities like ASD. Mr. Ne'eman raised his concern that medications can be used as "chemical restraint" and asked whether the ATN collected data on when a psychiatric illness was diagnosed and when medication started. Dr. Dawson said that this was an important concern along with the severe side-effects like obesity that often accompany psychoactive medications. She said that the use of multiple medications also needs better study. Dr. Fischbach said that many parents report that autistic symptoms improve when their child has a low fever and that this suggests involvement of the nervous system – a question that could be investigated through the ATN. Dr. Marjorie Solomon asked how children were selected to participate in the ATN and Dr. Dawson said that children initially come to the network for clinical evaluation; participants have received an autism diagnosis based on the DSM-IV and have been characterized using the Autism Diagnostic Observation Schedule (ADOS).
Presentation on Changes to Autism in the DSM-5 – Susan E. Swedo, M.D., National Institute of Mental Health (NIMH)
Dr. Susan Swedo, an NIMH intramural investigator and a member of the Diagnostic and Statistical Manual of Mental Health Disorders (DSM-5) Autism Workgroup, then presented on potential changes to autism criteria in the, DSM-5 which is expected to be released in 2013. Developed by the American Psychiatric Association, the DSM is the official guide for diagnosing psychiatric illnesses. Dr. Swedo explained that separate workgroups for each psychiatric illness had been established during the revision process that started in 2007. These groups of consultants and advisors were charged with recommending changes that would influence accurate diagnosis and reflect the additional knowledge about the disorder gained in recent years. Dr. Swedo commented that the decision had been made to change the naming convention from Roman to Arabic numerals to allow for online updates from "Version 5.1" onward. The draft changes proposed in the DSM-5 were posted online for public review. The workgroup recommended that PDD-NOS (pervasive developmental disorder not otherwise specified) and Asperger's syndrome be eliminated as stand-alone diagnoses and subsumed by the single diagnosis of autism spectrum disorder. There was some concern from members of the public who worried about losing the Asperger's identity and feared that they would also lose services. Dr. Swedo said that people who are currently diagnosed with ASD will not lose access to services and noted that separate scales to measure symptom domains may be included to define subgroups within ASD. The workgroup recommended that Rett syndrome be removed because it has a known neurological cause and diagnosis is not based on behaviors. Child disintegrative disorder has also been recommended for elimination because it has only been authenticated in a handful of cases. The workgroup found that ADHD may overlap with ASD and recommended that children could receive co-occurring diagnosis (in the past, the two disorders were mutually exclusive). Another draft of recommended changes to the DSM-5 will be available for public comment in the coming months.
Questions from the Committee
Mr. Lee Grossman said that parents were concerned that the new DSM criteria would be used to deny services to people with PDD-NOS or Asperger's. The Autism Society is discussing these concerns with state service agencies and will hold a public town hall on the issue on July 9, 2010 at their annual conference. Dr. Insel noted that there would be field trials of the new diagnostic criteria for ASD and asked whether effects on prevalence would be addressed. Dr. Trevathan noted that the measure of impairment to peer-relationships has poor specificity and could confuse diagnosis at a younger age. Dr. Dawson asked whether a web-based survey could be developed for states to anticipate how changes to the DSM may affect service utilization. Dr. Fischbach also recommended including an educational component to the survey to inform state agencies about the diagnostic changes. Mr. Ne'eman noted that the draft of the DSM-5 included a severity scale and asked how changes over the lifespan would be measured. He also expressed his concern that the DSM-5 might encourage eliminating adaptive behaviors in people with ASD. Mr. Grossman said that the Autism Society was in the process of working with state agencies to ensure that the new criteria not be used to deny services, which has happened in the past after DSM revisions. Dr. Insel encouraged the committee to pull together and try to ensure that preemptive measures are taken.
Ms. Eileen Nicole Simon advocated including recommendations for research into whether birth trauma or neonatal procedures contribute to ASD risk. She hypothesized that umbilical cord clamping may result in oxygen deficiency and damage the auditory system. She also asked that insurance cover the cost of lifespan care for people with ASD.
Mr. Jim Moody detailed the recent rash of accidental deaths among people with ASD – children have drowned, succumbed to freezing temperatures, and been struck by cars after wandering away from their families. He said that there was a lack of preventative measures to avoid such deaths and urged that materials on ASD and wandering be developed and distributed by pediatricians. He also asked that the amber alert criteria be revised to include children with life-threatening conditions. He said that help was needed to raise awareness about this danger and to prevent more deaths.
Ms. Caroline Rodgers asked that the Strategic Plan be modified to include research into the risk posed by prenatal ultrasound. Citing the decreased prevalence of ASD in the children of Hispanic women – a group that receives fewer scans - Ms. Rodgers asked that ultrasound use be further scrutinized. She quoted a 1982 report from the World Health Organization that suggested that neural and behavioral changes could be caused by ultrasound.
Ms. Lindsey Nebeker, a woman on the spectrum, told the committee about her personal experience as a woman with autism and how it differed from that of her non-verbal brother. While she was mainstreamed, her brother was put in a special education setting, and while she was fully verbal, her brother had limited means of communication. She asked that the majority of research be directed towards interventions and the current service needs of people with ASD. She noted that there was very little middle ground between a path of full independence and no supports or complete dependence with full supports. She also described feeling alone as a girl on the spectrum and asked for more research on females with ASD.
Ms. Paula Durbin-Westby applauded the addition of another person with ASD on the committee, but asked that the language of burden and sadness in the Strategic Plan be replaced with more neutral language. She asked that the committee focus on services across the lifespan and the development of functional communication systems. She also raised ethical concerns over developing prenatal tests for ASD and asked that people with ASD collaborate with researchers while designing studies.
Presentation on Stem Cell Research – James Battey, M.D., Ph.D., National Institute on Deafness and Communication Disorders (NIDCD)
Dr. James Battey gave a presentation on stem cell research, explaining the basic science of stem cells and how they could potentially be used therapeutically. Stem cells have unique potential because they can develop into many different cell types during early life. In many of the body's tissues or organs, adult stem cells can continue to divide to repair damaged or worn out tissue. Embryonic stem cells have more versatility because they are capable of differentiating into many different cell types (unlike adult stem cells in tissues or organs that can only yield similar cell types). It may one day be possible to treat diseases like Parkinson's disease, diabetes, and traumatic spinal cord injury using stem cell transplantation, however, Dr. Battey cautioned that this probably will not be the first therapeutic use of stem cells. While embryonic stem cells seem to offer exciting potential, there are a host of ethical issues that surround them because harvesting requires the destruction of a blastocyst (formed about five days after fertilization). Currently, all embryonic stem cells used in federally funded research come from surplus embryos from clinics that perform in vitro fertilization. Since 2007, scientists have also been able to artificially create pluripotent stem cells without destroying an embryo. These induced pluripotent stem cells (iPSC) are created by reprogramming genes in an adult cell (such as a skin fibroblast) to return to its pluripotent state. While they are similar to human embryonic stem cells, Dr. Battey said that it is becoming evident that they are not completely identical. Induced pluripotent stem cells offer the possibility to generate patient specific stem cells which may reduce the risk of rejection after implantation. However, there are fears that the retroviruses used to produce iPSC may trigger cancer-causing genes and more research is needed to understand cell cycle control after transplantation. Dr. Battey said that stem cell therapy would not be used to treat autism in the near future because of the range of systems affected by the disorder and the general lack of understanding of ASD causation. He also pointed out that due to the developmental nature of ASD, there may be a limited critical period in which the intervention would be effective. However, induced pluripotent stem cells can be used to model the cellular properties of the disease and investigate potential causes, he said. For more information about stem cells and their potential uses visit http://stemcells.nih.gov.
Questions from the Committee
Dr. Insel asked whether biorepositories should include fibroblasts in order to create induced pluripotent stem cells and Dr. Battey answered that lymphoblasts, which are currently collected, can also be used. Ms. Singer asked about the procedures for collecting skin fibroblasts and Dr. Battey said that a skin biopsy was all that was necessary. Dr. Fischbach recommended collecting fibroblasts as well because multiple cell types may be involved in ASD, such as glial cells, in addition to neurons.
Presentation on the NIH Non-Verbal ASD Workshop – Helen Tager-Flusberg, Ph.D., Boston University
Dr. Ann Wagner introduced Dr. Helen Tager-Flusberg, who spoke about the recent "NIH Workshop on Nonverbal School-Aged Children with Autism" that took place in April 2010 in Bethesda, MD. The meeting was convened by NIDCD, NIMH and NICHD to address the lack of research on non-verbal people with ASD, a concern that was expressed by many members of the public in response to the Request for Information (RFI) issued by the IACC in 2009. Dr. Tager-Flusberg said that the meeting had been held to discuss non-speaking school-age children who had gone through many different types of interventions but still had limited or non-existent communication. She noted that it was a hard group to study because of its diversity and difficulty in assessing skills and knowledge. The current measurement tools have limited validity for this group and very little reliability. While it is possible to gain speech after five years of age, almost all people with ASD who have verbal ability begin speaking before the age of seven. The workshop participants had discussed several potential explanations for lack of speech including lack of motivation, symbolic deficits, intellectual disability, and motor/movement factors. It is difficult to study children who are non-verbal because they often cannot comply with MRI protocols, she explained. While many non-verbal children have sensory issues, there are no published studies on sensory sensitivities in the population. The workshop participants had an extended discussion on how research could incorporate novel assessment of non-verbal children with ASD. While augmentative therapies (e.g., voice-generating devices, sign language, Picture Exchange Communication System – PECS) can be effective in increasing communication and can lead to speech, the use of these techniques appears to be very limited even after they have been introduced.
Dr. Tager-Flusberg said that the workshop attendees agreed that there was an urgent need for novel interventions and to include non-verbal children in studies of early interventions. There is also the need to establish what percentage of people with ASD is non-verbal. She noted that having even one spoken word is a significant predictor of future success with treatment and ended by reiterating that communication is a basic human right.
Questions from the Committee
Ms. McKee asked if the type of word expressed by a child with limited verbal skills mattered (e.g., comment vs. request) and Dr. Tager-Flusberg said that using any sort of word predicted progress developing language. Mr. Ne'eman said that the lack of use of augmentative communication devices concerned him and asked whether the Services Subcommittee could address the lack of access. The committee discussed obstacles to using these devices and Dr. Yvette Janvier explained that a referral was needed to get an augmentative device and that the cost of the device itself was often prohibitive. Dr. Gail Houle noted that a lot of personnel training is needed to work with a child using an augmentative device and that the family must be trained as well to continue use at home. She noted that the Department of Education was using funds from the American Recovery and Reinvestment Act (ARRA) to pay for the device, training, and oversight. Progress will be tracked to see if use of these devices increases. Mr. Grossman emphasized that programs to encourage the use of augmentative devices do work, as he saw in a school in Cape Town, South Africa. Dr. Tager-Flusberg said that a report summarizing the workshop, including a discussion of obstacles to the use of augmentative communication devices, would be written up and distributed.
Building the Infrastructure for Comparative Effectiveness Research on Disability Issues – Rosaly Correa-de-Araujo, M.D., M.Sc., Ph.D., HHS Office on Disability
Dr. Correa-de-Araujo explained that comparative effectiveness research (CER) is designed to gather evidence about the effectiveness, benefits, and drawbacks of different treatment options. The American Recovery and Reinvestment Act allocated $1.1 billion to comparative effectiveness research in an effort to improve the quality and efficiency of patient care. Using ARRA funds, the HHS Office on Disability established a Center of Excellence in Research and Disability Services, Care Coordination and Integration. The Center is currently developing the infrastructure necessary to carry out CER for people with disabilities, a group often excluded from clinical trials. The Center will identify and systematically review published and unpublished data on the effectiveness of health support services. One of the major sources of data will be the Center for Medicare and Medicaid Services' Chronic Conditions Warehouse (CCW), as well as Medicaid data provided by states. Consumer input will also be used. The challenge is to assess the accuracy and reliability of the different data sets and to link data sets while ensuring patient privacy and confidentiality, Dr. Correa-de-Araujo said. She detailed other potential data sets that could be linked including the Medicaid Analytic Extract Files from CMS, the Medical Expenditure Panel Survey from the Agency for Healthcare Research and Quality (AHRQ), the National Survey of Children with Special Health Care Needs from the Health Resources and Services Administration (HRSA), several CDC datasets, and the NIH's National Database for Autism Research (NDAR). She detailed the services and supports that could be examined for autism spectrum disorders including personal care, medical interventions, behavioral therapy, assistive technology, supportive employment, and independent living skills training. Dr. Correa-de-Araujo stated that there are plenty of opportunities to increase data availability for health services research, which will ultimately help to better understand which treatments, interventions, and models of care work best for people with disabilities, including those with ASD. She said that the work should not be viewed as a short-term effort, but instead a long-term partnership among Federal, state, and private entities.
Dr. Insel asked about the Center's funding and was told that it was established using $7 million in ARRA funds, which must be spent by 2011. The committee asked about their progress and Dr. Correa-de-Araujo said that the data was not yet usable. Mr. Grossman said that they had the continuing support of the Autism Society. Dr. Dawson noted that the U.S. was in the process of passing insurance coverage reform for behavioral health and it would be a unique time to examine how this impacts the ASD community. Mr. Claypool noted that the Office on Disability was generating common reporting requirements in an attempt to standardize data in the future. Dr. Insel commented that the point of comparative effectiveness research is to change policy that influences provider and payer practices and asked if the Office on Disability had considered bringing these stakeholders in as partners at the outset. He noted that it was an exciting time to be conducting this research because of the health care reform and mental health parity going into effect and that it would be important to track data over the next five years.
Approval of the January 19, 2010 IACC Meeting Minutes
The minutes of the January 19, 2010 meeting were approved by the committee. The finalized minutes will include edits sent in by Ms. Redwood prior to the meeting but after an initial draft had been printed.
Discussion of IACC Planning Subcommittee Activities
Dr. Insel reported that the Planning Subcommittee had convened on April 19, 2010 to discuss the next update to the Strategic Plan for ASD Research. The plan was extensively reworked for the 2010 version and the subcommittee agreed that any objectives added to the 2011 plan should be the result of major new scientific discoveries. The Portfolio Analysis of ASD Research will be used to gauge progress fulfilling the plan objectives and the Summary of Advances should be used to update the "What do we know?" sections. The subcommittee recommended conducting a selection of articles for the Summary of Advances in the summer and fall to capture the most up-to-date research. They also recommended holding a workshop focused on a specific topic to inform the strategic plan in the fall.
Ms. Singer mentioned that Mr. Grossman had suggested a services research-themed workshop and noted that Autism Speaks was holding a conference on drug development and outcome measures in collaboration with the Federal Drug Administration and several pharmaceutical companies. Dr. Lawler mentioned that the National Institute of Environmental Health Sciences (NIEHS) was conducting a workshop around the role of the environment in ASD and promised to report back to the committee on the event. Mr. Grossman noted that the Autism Society was holding a consensus workshop in October to identify risk factors and individualized treatments. Dr. Fischbach said that the Simons Foundation holds many conferences throughout the year, mostly on neural circuits and synaptic biology, which would be open to members of the committee. He asked if it was possible to circulate a calendar of events among the committee.
Dr. Insel said that the committee had also recommended issuing a Request for Information (RFI) similar to the RFI issued in August 2009 for public responses to the strategic plan. Members of the public will be able to comment on each chapter of the plan, in addition to the introduction (which was not included in the 2009 RFI). After discussion among the committee, they decided that responses would have an overall character limit but responders would be able to apply the full number of characters allowed to a single response box if they wished.
The committee then discussed the composition of the subcommittees (limited to 12 members to stay below a quorum) in light of the new members and Ms. Singer voluntarily left the Services Subcommittee to create a vacancy for Ms. Resnik. Mr. Ne'eman also joined the Services Subcommittee. Dr. Dawson and Dr. Marjorie Solomon joined the Planning Subcommittee.
Ms. Redwood asked if IACC members could attend the Autism Speaks drug development workshop and Ms. Dawson said that well the sessions were designed to be small and interactive, they would welcome IACC members to attend. Dr. Lawler said that the NIEHS meeting was small and not intended to be open to a large number of people but could accommodate IACC members.
Update on the Office of Autism Research Coordination (OARC) – Della Hann, Ph.D.
Dr. Della Hann gave an update on the activities of the Office for Autism Research Coordination, which has released printed copies of the 2009 Summary of Advances and the 2008 ASD Research Portfolio Analysis Report. Members of the office would be attending the International Meeting for Autism Research (IMFAR) on May 20 – 22, 2010, where the IACC would have a booth.
Public Comments Discussion Period
At the January meeting, the committee had decided to dedicate a period to discuss public comments heard earlier in the meeting. The members complimented the quality of that day's comments and Dr. Trevathan said that the CDC was working to address question about accidental deaths among people with ASD using the available datasets. Ms. Redwood noted that many families are not aware of the option to donate brain tissue of a family member with ASD and Dr. Insel said that bereavement services could be offered to give back to families that make brain donations. Dr. Dawson noted that Autism Speaks, Simons Foundation, and NIH had collaborated on an aggressive outreach program to inform families about autism tissue donation. The committee also noted that the Autism Safety Project is an important resource for educating first responders like law enforcement officials, firefighters, and emergency medical personnel. Mr. Grossman noted that the Autism Society has a similar project called the Safe and Sound Initiative. In light of this discussion on services, Ms. Ellen Blackwell recommended including a services item on the agenda of every committee meeting. She noted that the Centers for Medicare & Medicaid Services (CMS) recently issued an environmental scan report on autism services and asked that OARC distribute copies to the members. Dr. Dawson recommended hearing Dr. Lisa Gilotty and Dr. Joe Piven present on addressing large-scale service issues. Dr. Shore commended the quality of the public comment, saying that Ms. Nebeker and Ms. Durbin-Westby gave poignant commentary. Mr. Ne'eman recommended that the Services Subcommittee address the under-identification of women on the spectrum and the ethical safeguards that should be put in place for ASD research. Ms. Redwood said that risk factors brought up during public comment like ultrasound exposure, cord clamping, and brain stem injury warranted further exploration. Dr. Insel said that longitudinal studies like the National Children's Study will be mechanisms for looking at early prenatal factors such as these.
Closing Comments and Adjournment
Ms. Resnik said that she was interested in understanding how the service model for ASD could be tied to scientific research and Dr. Insel noted that the additional committee members made for a richer and more interesting discussion. He reminded the members that the next full committee meeting was scheduled for July 16, 2010 and the meeting was adjourned.
These minutes of the IACC Full Committee were approved by the Committee on July 16, 2010.
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 – 185 KB)
- Written Public Comments (PDF – 1.3 MB)
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- 2010 IACC Strategic Plan for Autism Spectrum Disorder Research
- 2009 IACC Summary of Advances in Autism Spectrum Disorder Research
- 2008 IACC Autism Spectrum Disorder Research Portfolio Analysis Report
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- Meeting Transcript (PDF - 625 KB)
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- IACC Meeting Slide Set (PDF – 73 KB)
Research Update: Autism Treatment Network (PDF – 985 KB)
Geraldine Dawson, Ph.D., Chief Science Officer, Autism Speaks
Research Update: Autism in the DSM-V
Susan E. Swedo, M.D., Senior Investigator, Behavioral Pediatrics Section Pediatrics and Developmental Neurospsychiatry Branch, National Institute of Mental Health (NIMH)
Research Update: Stem Cell Research
James Battey, M.D., Director, National Institute on Deafness and Other Communication Disorders
Research Update: NIH Nonverbal ASD Workshop (PDF – 188 KB)
Helen Tager-Flusberg, Ph.D., Director, Laboratory of Developmental Cognitive Neuroscience, Boston University
Research Update: Building the Infrastructure for Comparative Effectiveness Research on Disability Issues (PDF – 407 KB)
Rosaly Correa-de-Araujo, M.D., MSc, Ph.D., Deputy Director, Office on Disability, Office of the Secretary
Update: IACC Planning Subcommittee
Thomas Insel, M.D., Director, NIMH and Chair, IACC
Update: Office of Autism Research Coordination (OARC)
Della Hann, Ph.D., Director, OARC, NIMH, NIH
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