Minutes of the Interagency Autism Coordinating Committee (IACC) Meeting on February 4, 2009
The Interagency Autism Coordinating Committee (IACC, also referred to as "the committee") convened at 9:00 a.m. on February 4, 2009, in the Rotunda Room of the Ronald Reagan Building in Washington, DC, and adjourned at 4:00 p.m.
In accordance with Public Law 92-463, the meeting was open to the public. Thomas R. Insel, M.D., Director, National Institute of Mental Health, chaired the meeting.
Committee Members Present at the Meeting: Thomas R. Insel, M.D., IACC Chair, National Institute of Mental Health (NIMH); Della Hann, Ph.D., Executive Secretary, Office of Autism Research Coordination (OARC), NIMH; Duane F. Alexander, M.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Linda Birnbaum, Ph.D., National Institute of Environmental Health Sciences (NIEHS) (Representaing Cindy Lawler Ph.D.); Ellen W. Blackwell, M.S.W., Centers for Medicare & Medicaid Services (CMS); James F. Battey, M.D, Ph.D., National Institute on Deafness and Other Communication Disorders (NIDCD); David DeVoursney (Representing Larke N. Huang, Ph.D.), Substance Abuse and Mental Health Services Administration (SAMHSA); Lee Grossman, Autism Society of America; Gail R. Houle, Ph.D., U.S. Department of Education (ED); Yvette M. Janvier, M.D., Children's Specialized Hospital; Story C. Landis, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS); Christine M. McKee, J.D.; Lyn Redwood, R.N., M.S.N., Coalition for SafeMinds; Alison Tepper-Singer, M.B.A.; Stephen M. Shore, Ed.D., Autism Spectrum Consulting; Edwin Trevathan, M.D., M.P.H., Centers for Disease Control and Prevention (CDC); and Peter van Dyck, M.D., M.P.H., Health Resources and Services Administration (HRSA).
Call to Order and Opening Remarks
Committee Chairman Thomas Insel welcomed the IACC and presented a set of slides on President Barack Obama's Agenda for Disabilities posted on the White House Web site.1 Dr. Insel noted that autism was the only disorder specifically mentioned in the President's agenda, indicating that the new administration placed increased priority on autism research. Dr. Insel mentioned that the positions of HHS Secretary, NIH Director, and CDC Director had yet to be filled and discussed the impending approval of the federal stimulus package. Dr. Insel said that the research funding provided by the stimulus plan may serve to jump-start the objectives recommended in the Strategic Plan for ASD Research.2 He noted that the Strategic Plan had been completed at an opportune time, just as a large infusion of funds could become available for ASD research. Dr. Insel addressed recent concerns raised in the blogosphere about the IACC's process and recapped the committee's actions on the vaccine objectives at the January 14, 2009 meeting. The committee had taken two previously-discussed vaccine objectives in Chapter 3 and moved them to the "What do we need?" section. In addition, the IACC voted to collaborate with the National Vaccine Advisory Committee (NVAC) to get more information on the feasibility of vaccinated/unvaccinated population studies and make use of the committee's expertise on vaccine safety. Dr. Insel indicated that for this purpose, Dr. Bruce Gellin, M.D., Director of the National Vaccine Program Office, was scheduled to speak during the afternoon session of the meeting.
Dr. Insel discussed the significant disagreement between those who felt that vaccines had been sufficiently investigated as a potential cause of autism and those who pressed for continued research in the area. He asked to improve trust within the committee and the general public so that the vaccine issue could be discussed in an open, rational, and scientifically-based way. He announced that Ms. Lyn Redwood had invited Dr. Mark Noble as a guest presenter on the vaccine issue. Additionally, committee member Ms. Ellen Blackwell and her guest, Ms. Ann Clemency Kohler, were slated to present in the afternoon on how the national financial crisis may impact ASD services provided by states.
The IACC members then introduced themselves, including Dr. Linda Birnbaum, the newly appointed Director of the National Institute of Environmental Health Sciences (NIEHS) and would be substituting for Dr. Cindy Lawler until her official appointment to the IACC was finalized. Dr. Insel noted that a team from ABC News would be filming the meeting. Next, the committee members proceeded to present updates on current ASD research at each of their agencies or organizations.
National Institute of Disorders and Stroke (NINDS) - Dr. Story Landis
Dr. Story Landis reported that the National Institute of Neurological Disorders and Stroke (NINDS) contributed around $9 million dollars last year to autism research, according to the NIH accounting system - Research, Condition, and Disease Categorization (RCDC). This represents about 10 percent of the total NIH spending on autism research. Dr. Landis outlined several ASD studies being conducted by NINDS, including a neuroepidemiological study in Norway examining multiple potential risk factors. During the study, 100,000 mothers and infants will be enrolled to explore how various genetic and environmental factors contribute to the development of autism and other neurodevelopmental disorders. Researchers will explore genetic risk factors, infection history, low birth weight, dietary and environmental exposure (including methylmercury and vaccination history). Dr. Landis said that biological samples will be obtained from all potential cases and controls.
Dr. Landis also reported on a clinical trial being conducted through the Autism Centers of Excellence (ACE) network, examining buspirone, a drug thought to alter the brain's serotonin system, as a potential intervention for people with ASD. The trial will begin enrollment shortly. Dr. Landis described research being conducted by Dr. Margaret Pericak-Vance on the cognitive and anatomical characteristics of a new candidate gene on Chromosome 2.
Dr. Landis also described the work of NIH Pioneer award recipient, Dr. Ricardo Dolmetsch,3 who has been able to convert skin samples from patients diagnosed with ASD into cells essentially identical to embryonic stem cells. These induced stem cells are then treated with a cocktail of factors to convert them into nerve cells for study. Dr. Landis explained that this work is invaluable because it is not possible to take a brain biopsy from a child with autism to study his or her nerve cells. The research provides an opportunity to study how genetic risk factors relate to the behavior of the nerve cells. She noted that Dr. Dolmetsch's work was funded by the NIH Office of the Director, not NINDS.
Children's Specialized Hospital - Dr. Yvette Janvier
Dr. Yvette Janvier reported that she was involved in a project through the New Jersey Governor's Council for Autism Research and Treatment. The project supports a developmental screening clinic, run by nurse practitioners and supervised by Dr. Janvier, that has evaluated 228 children, mostly between the ages of 24 and 36 months. Close to half were found to have autism spectrum disorder. Dr. Janvier said that she was also working with pediatricians to implement the American Academy of Pediatrics guidelines on universal screening. She reported that of the 21 practices that had been observed, only about 20 percent were using the Modified Check-List for Autism in Toddlers (M-CHAT) and not one practice was using the tool according to its design.
Centers for Disease Control and Prevention (CDC) - Dr. Edwin Trevathan
Dr. Edwin Trevathan described three programs within the CDC's National Center on Birth Defects and Development Disabilities that are conducting ASD research. He reported that the CDC continues to monitor the prevalence estimates and population make-up of people with ASD and is now putting additional focus on early diagnosis and intervention. The ADDM Project for the Autism and Developmental Disabilities Monitoring Network is a group of population-based epidemiological centers around the country which provides prevalence estimates (currently 1 child in 150 is diagnosed with ASD). Dr. Trevathan also described the Study to Explore Early Development (SEED) study currently enrolling 2,700 children to examine potential ASD risk factors. He also described the Learn the Signs. Act Early. campaign which recommends that children be screened twice for ASD by the age of 2.4 The CDC is currently engaging stakeholders to examine how to translate early diagnosis into earlier access to services. The National Center for Environmental Health at the CDC serves as a biomonitoring lab for the National Children's Study (NCS) and is currently looking at potential immune markers for autism.
National Institute on Deafness and other Communication Disorders (NIDCD) - Dr. James Battey
Dr. James Battey reported that the National Institute on Deafness and other Communication Disorders (NIDCD) is currently conducting research on the communication disorders associated with autism. In Fiscal Year 2008, NIDCD invested approximately $6.3 million of its appropriated budget into roughly 40 research projects related to autism. NIDCD brought together a group of language development researchers who concluded that a more standardized approach was needed to evaluate the language skills of young children with ASD. Dr. Battey reported that a research paper is currently in press calling to standardize language evaluation for children with ASD in order to meaningfully assess intervention strategies. NIDCD also provides partial support for three of the Autism Centers of Excellence at the University of Washington, Yale University, and the University of California - Los Angeles.
Centers for Medicare & Medicaid Services (CMS) - Ms. Ellen Blackwell
Ms. Ellen Blackwell reported to the committee on the Centers for Medicare & Medicaid Services' (CMS) autism task order. Ms. Blackwell serves as the project officer for the task order, which includes an environmental scan of the research literature related to evidence-based services and supports available to people with ASD. Next year, the autism task order will conduct an assessment of the ASD services currently being provided by nine states. Ms. Blackwell described two other pieces which have not yet received funding. CMS will design model programs of services and supports for people with ASD and measure outcomes; and will create an HHS web-based ASD information portal.
Substance Abuse and Mental Health Services Administration (SAMHSA) - Mr. David DeVoursney
Mr. David DeVoursney described two programs supported by SAMHSA that could impact children with ASD. The first, the Children's Mental Health Initiative, creates local systems of care to support children with identified mental health issues. The second project, Linking Actions for Unmet Needs in Children's Health (LAUNCH), focuses on the mental health of children from birth to age 8 and emphasizes increased developmental assessments for young children.
Health Resources and Services Administration (HRSA) - Dr. Peter van Dyck
Dr. Peter van Dyck reported on the programs being funded by the approximately $16 million that had been granted to the Health Resources and Services Administration (HRSA) through the Combating Autism Act (CAA). HRSA is currently funding two autism intervention research networks working to evaluate the effectiveness of certain ASD treatments. The HRSA supports the Physical Health Intervention Network which receives about $4 million over the next three to four years and the Behavioral Health Intervention Network which receives about $2 million per year. Massachusetts General Hospital serves as the primary site for the physical health intervention network, while UCLA serves as the main hub for behavioral health research. Both networks have multiple sites across the country.
HRSA also provides Leadership Education Excellence in Caring for Children with Neurodevelopmental and Related Disabilities (LEND) grants which fund training programs for health professionals on neurological or neurodevelopmental disorders. The agency has funded four new LEND grants at universities that did not previously have the training program. Eighteen of the existing LEND programs, around half of the total number, expanded their training on autism. HRSA also funds ten developmental behavioral pediatric training programs around the country; six of those receive specific money for autism activities. Dr. van Dyck also reported on HRSA's efforts to develop statewide coordinated systems for early identification and treatment for children with ASD. HRSA recently held a national meeting to enable coordination among grantees. Speakers from the IACC were invited to illustrate how federal and public members could collaborate. Dr. van Dyck also reported working with the CDC on the Learn the Signs. Act Early. program, convening regional summits and quarterly coordination meetings.
Ms. Alison Singer mentioned that as private individual not representing an agency or organization, she personally was not currently funding any major research programs.
National Institute of Environmental Health Sciences (NIEHS) - Dr. Linda Birnbaum
Dr. Birnbaum thanked Dr. Cindy Lawler for her service on the IACC, and reported that NIEHS supported approximately $5 million in autism research. Most of the research focused on investigating the effects of environmental stressors on children's health, including studies of basic biological processes central to brain development. Some of NIEHS' work is funded through a joint program with the U.S. Environmental Protection Agency (EPA) Centers for Children's Environmental Health and Disease Prevention. On January 21, 2009, NIEHS released an announcement soliciting grant applications for the research centers. The ongoing Childhood Risk from Genetics and the Environment (CHARGE) program was recently launched as one of the center's programs.
A companion initiative was released to support the formation of new centers. Details of both these initiatives can be found on the NIH Guide Notice or through the EPA Web site.5 In addition to its efforts with the EPA, NIEHS also provides funding for joint activities with other NIH institutes, including management of the Autism Centers for Excellence (ACE) programs and the National Database for Autism Research (NDAR).
Coalition for SafeMinds - Ms. Lyn Redwood
Ms. Lyn Redwood informed the committee that SafeMinds has funded several small grants to investigators researching mercury-induced neurological disorders. One such study examined the differences between methylmercury and ethylmercury in infant primate macaques. Ms. Redwood reported that the results of the study had shown that methylmercury was inadequate to test the effects of ethylmercury in the body when attempting to replicate the vaccine schedule. The study had reportedly shown that the blood-brain ratio for ethylmercury was higher than that of methylmercury and resulted in twice as much ethylmercury being deposited in the brain. Ms. Redwood said they were funding further study of mercury deposition in other brain hemispheres. She also said that they were employing a cell-counting technique to investigate what type of effect ethyl and methylmercury had in the primates' brains. Ms. Redwood reported that SafeMinds was replicating the neuroimmune studies conducted in the Vargas study of children with autism. The study is expected to be completed in June.
National Institute of Child Health and Human Development (NICHD) - Dr. Duane Alexander
Dr. Alexander discussed the brain and tissue bank that has been funded by the National Institute of Child Health and Human Development (NICHD) for about two decades. He thought it would be of particular interest to the IACC because the Strategic Plan for ASD Research included objectives related to maintaining and expanding the bank. The biobank includes samples from a range of neurodevelopmental disorders outside of autism and also includes samples from neurotypical subjects.
In preparation for the 2009 competitive renewal of the brain and tissue bank, NICHD issued a Request for Information (RFI) in November 2008 to solicit public comment on the current activities of the bank.6 Dr. Alexander reported that they received over a hundred public responses, mostly from investigators who recounted positive experiences receiving samples from the bank. The RFI generated suggestions for improvement, but overall, the comments affirmed that the bank was a valuable resource. The RFI also requested comments on mechanisms for extending and enhancing the bank's role and supporting its ability to leverage its resources, as called for in the Strategic Plan. Dr. Alexander said that comments from the RFI were being incorporated into the Request for Proposals (RFP) which will soon be issued.
In addition to the brain and tissue bank, the Institute is involved in funding activities in four ACE centers and one ACE network.
Dr. Insel asked Dr. Landis whether current technology was advanced enough to begin collecting stem cells in a repository such as NICHD's brain and tissue bank. Dr. Landis described the current state of stem cell research. During his campaign, President Obama had promised to make new stem cell lines available to researchers using federal funds. Previously, former President George W. Bush had limited federally-funded stem cell research to existing lines generated before August 9, 2001. Dr. Landis said that as many as 600 new lines could be made available when Obama lifted the existing restrictions. In addition, skin cells can now be transformed into pluripotent stem cells which can then be differentiated to form different types of neurons. She asked whether NIH would want to add induced pluripotent (iPS) cells to a stem cell bank and if so, how the number of lines could be controlled.
Dr. Landis concluded that the current brain and tissue bank could not maintain pluripotent stem cells from any source as it was presently constituted. She said that NINDS might want to consider creating a stem cell bank for iPS cells in order to study neurological and psychiatric disorders. Dr. Insel questioned whether skin fibroblasts could be taken post-mortem and stored to be used later to generate iPS cells. Dr. Landis said that, to her knowledge, this procedure had not been done. Dr. Battey said that the process seemed feasible.
Autism Society of America (ASA) - Mr. Lee Grossman
Mr. Lee Grossman told that committee that the Autism Society of America continued to note the increasing prevalence of autism. He said that the ASA's call centers were hearing a unified cry from the community for an increase in services for people with ASD. As a result, ASA has been working with the presidential administration to design comprehensive service delivery legislation. Mr. Grossman reported that his organization has modeled legislation for several states. Unfortunately, autism insurance legislation recently failed to pass in Oklahoma and Virginia. He reported that ASA's model legislation is designed around quality of life across the lifespan, the need for systems change, and global human rights. On the research front, ASA will be hosting a series of key note sessions at their July conference focused on integrating biomedical, behavioral, and educational aspects of addressing autism.
National Institute of Mental Health (NIMH) - Dr. Thomas Insel
Dr. Insel then reported on NIMH activities. The Institute was the largest investor in autism research in 2008, contributing $55 million out of the $118 million invested by NIH. Dr. Insel briefly explained that when looking at RCDC, the new NIH research accounting system, spending estimates for previous years may not be comparable because of a new coding system that no longer took some basic research into account. Dr. Insel then described recent grants funded by NIMH. In extramural work, researchers are investigating new technology to examine brain connections and the development of cortical maturation. Others are studying peripheral cells and patterns of RNA expression. Dr. Insel mentioned work being done by Dr. Allan Reiss at Stanford, studying cortex development in children at risk for autism. Studies at U.C. Davis are focused on the importance of maternal antibodies to fetal brain proteins. Another extramural study is examining fetal movement of ASD siblings beginning in the second trimester to determine if detection in the womb may be possible. Dr. Cathy Lord at the University of Michigan is conducting studies to develop predictors of outcome in children with ASD. Dr. Insel also reported on the work of Dr. David Mandell, who is investigating two different school-based interventions for students with ASD.
In intramural research, investigators are examining different ASD subtypes in order to understand what causes regression. Researchers have also completed a phase one trial using minocycline as an anti-inflammatory medication for ASD. A trial of Donepezil is also underway - the medication increases REM sleep which is markedly reduced in children with ASD. The study will investigate whether the intervention has a positive behavioral impact. Dr. Insel described another NIMH study to examine children who had been diagnosed with autism and then lost the diagnosis. This study is set to begin recruiting recovered children on March 9, 2009. Dr. Insel reported that the National Database for Autism Research (NDAR) is also in the process of expanding the number of unique identifiers entered into the database from the ACE sites.
Dr. Stephen Shore stated that he was encouraged by the emphasis on services issues and adults on the autism spectrum. The committee then heard from Ms. Ellen Blackwell who presented on the state of ASD services and supports during the financial downturn.
ASD Services and Supports Presentation
Ellen W. Blackwell, M.S.W., Center for Medicaid & State Operations
Ms. Blackwell told the committee that CMS had recently met with a group that included state Medicaid directors, the association representing state directors of developmental disabilities, state units on aging, head state injury administrators, and state mental health program directors. During this meeting, the group discussed the heavy impact of the current economic conditions on people with disabilities. Ms. Nancy Thaler, the representative for state developmental disabilities directors, likened the impact of the current economic crisis on people with disabilities to Hurricane Katrina.
Ms. Blackwell outlined Medicaid provisions that are likely to impact people with ASD. She described the home and community-based waivers that serve people with mental retardation and developmental disabilities. Presently, CMS has approved about 350 waivers which serve an estimated one million people. Several states have a waiver that exclusively serves children with ASD. Pennsylvania is the only state with a waiver that exclusively serves adults with ASD. Ms. Blackwell described the state plans, submitted to CMS, that detail which recipients, services, and providers are included. Services must be medically-necessary, which is defined by the state and can vary in different locations. State plans are living documents which can be amended at any time. Many states have been amending their plans in response to state budget problems.
Ms. Blackwell described two demonstration projects which are currently underway. The first is designed to transition about 35,000 people out of institutions, as part of the Deficit Reduction Act. The second demo is designed to transition children with mental disorders from institutional to home and community-based care.
Dire economic conditions are causing state staff reductions and are threatening home and community-based services. Ms. Blackwell warned that changes to Medicaid are difficult to reinstate. Changes made to waivers may result in reductions to the amount of services. For example, day programs for adults with ASD may be eliminated. States are putting freezes on waiver enrollments and some may eliminate waivers entirely. States may also make it more difficult to get into an institution which is the measurement criteria against which home and community-based services are based. The end result is that people will find it more difficult to receive home and community-based services. Additionally, state plans are reducing the health and welfare services they provide. She warned that states may make it harder for people to qualify for Medicaid by dropping optional eligibility groups or counting income that was not previously considered. Ms. Blackwell said that recent state staff reductions may also make it harder for states to implement programs.
The fiscal stimulus package includes $87 billion to supplement state Medicaid programs and would increase the match states receive from the federal government.
Ann Clemency Kohler, Director of Health Services, National Association of State Medicaid Directors, American Public Human Services Association
Ms. Kohler, speaking on behalf of the National Association of State Medicaid Directors, emphasized the dire fiscal challenges for states. She said that 47 states reported experiencing severe fiscal constraints, an increase from 29 in July 2008. Thirty-one states have already made cuts during the middle of their budget year. Because states cannot deficit spend, some are looking to make significant cuts in Medicaid. The stimulus bill requires that states maintain their eligibility rates, but this does not preclude cutting services and provider rates. In order to reduce Medicaid cost, many states are putting effort into preventing fraud, waste, and abuse. Many states are trying to implement technology for electronic health records and e-prescribing to reduce cost. They are also expanding the use of evidence-based treatments to determine medical necessity.
Ms. Kohler then spoke about the federal stimulus package, the American Recovery and Reinvestment Act of 2009, which is expected to pass in the coming weeks. The package would extend six regulations that would reduce costs to the state and add outpatient regulations until 2009. She said that Medicaid directors were concerned because the regulation would significantly reduce Medicaid's ability to pay hospitals. The package would also extend transitional Medicaid for those going to work and provide a significant amount of money for health information technology. She concluded that states are in terrible fiscal conditions and are going to be making significant cuts. These reductions have heavy implications for people with autism, as community-based programs are optional under federal law.
Ms. Singer pointed out that cuts within the education budget may affect children with ASD, as well, because special education programs tend to be more expensive to implement than general education programs. Dr. Insel said that sky-rocketing unemployment may also put strain on parents trying to care for a child with ASD. Dr. Insel suggested that the committee bring the new Secretary of HHS to the next IACC meeting so that he or she could get a sense of the gravity of the situation. As an aside, Dr. Insel said he was a bit skeptical about using information technology as a cost-saving measure.
Ms. Kohler said that the state Medicaid directors advocated increased communication between Medicare and Medicaid and making community care the norm.
Planning for the IACC ASD Summary of Advances
Ms. Diane Buckley, M.A., a member of the Office of Autism Research Coordination (OARC), spoke to the committee about preparing the annual Summary of Advances. The Summary of Advances is a synopsis of autism research conducted during the year, mandated by the Combating Autism Act (CAA).
Ms. Buckley reminded the committee that the last Summary of Advances had been released on July 15, 2008. The report highlighted ten key scientific advances from the peer-reviewed literature in calendar year 2007 and is available on the IACC Web site.7
Ms. Buckley updated the committee on the status of the report for 2008. The NIH Library had conducted a literature search to identify original scientific findings published in peer-reviewed journals in 2008 using the search terms "autism" and "autistic." The search yielded more than 120 publications from over 80 journals. The search focused on scientific findings highlighted in major science news or rated databases. The OARC had begun to sort the publications into six broad topic areas which correspond to the six-question framework of the Strategic Plan. She asked the committee how they would like to proceed to produce the final Summary of Advances. She recommended finalizing the list, identifying the most significant findings, and producing a lay-friendly report. She asked the committee how they would like to review the publications (via webinar or email) and determine which were significant. She also asked that the committee think about a timeline for producing the next Summary of Advances. Dr. Landis asked whether the last report had looked solely at federally-funded advances and Ms. Buckley said that funding source had not been considered. Dr. Battey asked whether the citation index could be used as a criterion to establish impact. The committee discussed that citation index may be problematic because of the articles' newness. Dr. Birnbaum urged that review articles be included in the search. Dr. Janvier recommended that presentations from the International Meeting for Autism Research (IMFAR) be considered as advances. Dr. Battey recommended remaining with peer-reviewed publications and reviews, saying that IMFAR presentations would be captured the subsequent year if they evolved into peer-reviewed papers.
Ms. Redwood asked that the scope of the search be broadened to include Asperger's and Rett syndrome and requested that a research portfolio analysis be conducted. The committee agreed that funding source would be an interesting component to examine after identifying the highest impact advances. Ms. Singer suggested that a section on stakeholder impact also be included.
The committee discussed whether the categories of scientific advances should match directly with the questions in the Strategic Plan to monitor progress on the Plan. Ms. Buckley said that the same question had been raised last year and the committee ultimately felt that using the language from the Plan was confusing. Linking advances to the framework of the Plan might be misleading because the Plan had not yet been released. Mr. Grossman recommended that advances not be limited to peer-reviewed literature and the committee discussed the vulnerabilities introduced by including non peer-reviewed publications. Dr. Hann asked the committee to consider how inclusion of non-peer reviewed articles could be accomplished in practice. Dr. Trevathan said that the Summary of Advances could provide the opportunity to educate to the public on the meaning and value of peer review.
Dr. Landis suggested considering the development of an integrated database for all autism advances. She identified that some families may be interested in emerging ideas, particularly about interventions that were not scientifically-backed. However, this would be separate from the peer-reviewed high impact work highlighted in the Summary of Advances. She alluded to several well-controlled trials done by the National (NCCAM) that did not provide any support for the use of Echinacea, St. John's Wort, and other alternative therapies. She said that this illustrates the questions that are raised when taking anecdotal evidence as support.
Dr. Battey moved that the Summary of Advances be restricted to peer-reviewed articles and reviews and the committee accepted his recommendation. Dr. Janvier suggested collaborating with the NCCAM to discuss alternative therapies, but was concerned about the appearance of endorsing untested treatments. Ms. Redwood suggested that the Autism Research Institute and NCCAM present to the IACC on alternative therapies being used by children with ASD. Dr. Insel suggested possibly creating a category to capture new treatments as emerging trends for the next Strategic Plan. Ms. Singer said that the Interactive Autism Network at the Kennedy Krieger Center could also be a resource for parent-collected data on treatments.
The committee voted to include financial information on advances after they had been selected and to add links to the article in PubMed Central. The committee also voted to review the list of publications electronically and indicate which articles should be added, deleted, or resorted. The OARC will then send back the revised list and the committee will vote on which articles should be highlighted. Dr. Hann suggested that members vote for up to three articles in each topic area. Ms. Redwood asked that they not be limited to voting for a set number of articles, but the committee did not discuss the matter further. Dr. Hann said that the initial list could be sent in the next two weeks, the committee members would then have two weeks to review the list and give feedback. A draft write-up could potentially be circulated after the May meeting. Dr. Janvier stated that the Summary of Advances may be a good way to communicate with the Secretary.
Vaccine Studies Considerations
Mark Noble, Ph.D., University of Rochester Medical Center
Ms. Redwood introduced Dr. Mark Noble, Ph.D., University of Rochester Medical Center, who presented his ideas and opinions on vaccine safety research to the committee. Dr. Noble acknowledged that vaccine-autism research was an emotionally-charged area and described himself as one of the founders of stem cell biology in the central nervous system. He said that his laboratory was the first to repair the central nervous system and damaged spinal cord with purified progenitor cells. He said that his strong math background gave him particular insight into the epidemiological questions around autism and vaccines. Dr. Noble stated that he had no family members with autism and did not testify at trials.
Dr. Noble told the committee that he had examined thimerosal and concluded that it was just as toxic as methylmercury. He deconstructed the data graph from Madsen, et al. "An analysis of the Danish Registries," which showed an increase in the incidence rate of autism after thimerosal with removed from vaccines after 1990.8 Dr. Eric Fombonne's study of the Montreal School Board9 showed a similar increase, which was also seen in the United States and Sweden. He proposed two extreme hypotheses: that the increase in autism and related disorders is entirely diagnostic or that the increase was entirely due to biological factors. The answer, he said, lies somewhere in the middle. Dr. Noble adjusted the graph from the Danish registry using the estimate that new diagnostic criteria would increase the number of children identified with ASD by about five-fold. He cited that the study had used additional outpatient data without adjusting for the increased number of people after 1995. He reanalyzed the data and said that his results indicated that autism decreased after thimerosal was removed from vaccines. Dr. Noble reanalyzed Fombonne's data and reported that they showed similar decreases after thimerosal was removed, when correcting for different diagnosis.
He said that the recent Italian study by Dr. Alberto Tozzi10 confirming vaccine safety did not examine a representative sample as only one case of autism was identified out of 1400 children. He commented that emotional arguments were not helping to bolster confidence on either side of the vaccine issue, recommending that more studies be conducted and that the IACC convene a vaccine working group. He warned that more people would opt out of vaccines if they did not pursue solid evidence on vaccine safety.
Dr. Insel asked about Dr. Noble's interpretation of the data and whether he meant to imply that the prevalence of autism has been decreasing and going away. Dr. Noble said that he took no stance except to say that the data is insufficient to take a firm position.
Ms. Singer asked Dr. Noble if he had a hypothesis as to why multiple studies from multiple sources misinterpreted their data. Dr. Noble said that he tended to find things that other people did not and credited his strong mathematics background and interest in the psychology of magic. He pointed to Uri Geller and his spoon bending as proof that scientists are among the easiest to fool because they approach the world as though it were rational. He concluded that they would have to ask the other scientists to determine why they presented their data in that manner.
Information about the National Vaccine Policy Office
Bruce Gellin, M.D., M.P.H., National Vaccine Policy Office, DHHS
Dr. Gellin presented to the committee on the National Vaccine Advisory Committee (NVAC) and informed them that he had just come from an open session of the NVAC's safety committee in the morning. He described the National Vaccine Program Office (NVPO) and its variety of responsibilities ranging from early research, to financing and supply, to the use of vaccines and their impact. The committee is advisory to the Assistant Secretary of Health and was established over 20 years ago. In 2005, the Institute of Medicine recommended external review of the NVAC's process which now oversees CDC vaccine safety research. The Vaccine Safety Working Group was created, composed of members of the NVAC, the parent committee, other disciplines, and two public members. Dr. Gellin underscored that no one with autism-specific expertise sits on the working group. He presented the straw man scientific agenda document put forward by the CDC Immunization Safety Office (ISO).11, 12 He emphasized that the document addressed a wide range of immunization safety issues and diseases. A request for information on the ISO Scientific Agenda was issued recently and comments were presented at the NVAC meeting that morning.13 The office received 91 responses, including the letter drafted by the IACC after the January 14, 2009 meeting. Ten responses came from organizations while the rest were sent from individuals. Of the individual comments, 60 comments related to autism, 35 mentioned vaccine ingredients, and 32 called for a study comparing vaccinated and unvaccinated children. Dr. Gellin said that the Vaccine Safety Working Group will present its case to the full committee in June, after which they will recommend actions to the CDC's Immunization Safety Office.
He reported that the NVPO had also reached out to the public by organizing town hall meetings which were convened in Birmingham, Alabama, Ashland, Oregon, and Indianapolis, Indiana. Ashland, Oregon was selected because many parents there choose to exempt their children from vaccination. Currently, twenty-five percent of the city's kindergarten students are unvaccinated. During the town hall meetings, members of the public commented that they were concerned about ingredients in vaccines, the number of vaccines and schedule, the potential side effects, and interactions. People were also concerned about studies on the vaccination system and questioned why there had not been a study of autism prevalence in vaccinated and unvaccinated populations. Questions about critical subpopulations and the call for more independent research were also raised routinely.
Dr. Gellin informed the IACC that a Vaccine Safety Working Group Stakeholders Meeting will be held in Washington, D.C., in mid-March. Subsequently, the NVAC Vaccine Safety Working Group will release the revised draft ISO scientific agenda for public comment and the agenda will potentially be finalized at the June meeting of the full committee. The agenda will then be sent as an advisory document to the Assistant Secretary of Health.
Concurrently, the NVPO is updating the National Vaccine Plan, originally written in 1994.14 The National Vaccine Plan will act as a roadmap for vaccines and vaccination practices in the future. On April 14, 2009, the Institute of Medicine will convene a conference in Washington, D.C., to focus on the vaccine safety goals included in the National Vaccine Plan.
Dr. Gellin then addressed the letter sent to the NVAC by the IACC, saying that members of the working group were enthusiastic about collaborating in some manner. He said that the two committees had to discuss how to best coordinate to share their respective expertise.
IACC Discussion of Vaccine Studies and NVAC
The floor was then opened up for questions and Dr. Noble asked Dr. Gellin about his estimate of current vaccination exemption rates in the U.S. Dr. Gellin said that exact numbers were unknown and difficult to determine, but he did caution that the nation may be at a tipping point. Public opinion surveys have shown that even parents that do vaccinate their children have lingering concerns and he questioned when these concerns translate into behavior. Last year's measles outbreak and the recent outbreak of Haemophilus influenzae B (HIB) meningitis illustrate how community immunity levels drop when individuals choose not to be vaccinated.
Ms. Redwood questioned whether the NVPO had a budget to conduct research or whether the office looked to the CDC to conduct vaccine safety studies. Dr. Gellin responded that the NVAC was responsible for making recommendations about vaccine safety research to the government. Ms. Redwood commented that many parents in the community do not trust the CDC because of the inherent conflict of interest stemming from their vaccine patents and their role in vaccine development. The IACC members then discussed the fundamental issue of trust between the government and the public on questions of vaccine safety. Ms. Redwood suggested convening an independent committee to oversee vaccine safety research. Dr. Landis referred back to the tests of alternative therapies such as St. John's Wort and Echinacea, indicating that some people rejected the results of NCCAM's studies showing little efficacy because they said it was the wrong sort of Echinacea or the wrong strength of St. John's Wort. She suggested that it might be hard to ever design a set of studies that would prove definitive for certain people. Dr. Alexander asked whether the NVPO had thoughts about designing a better surveillance system for adverse events to vaccination and Dr. Gellin said that surveillance was addressed in the National Vaccine Plan.
Dr. Insel discussed further collaboration with the NVAC and mentioned possibly convening an working group to develop a set of actionable objectives. Mr. Grossman strongly supported such a working group, but Dr. Landis questioned how an appropriate working group could be formed because anyone with expertise would most probably have a conflict of interest. For example, researchers knowledgeable about toxicology using molecular systems would be the same people applying for grant money.
Dr. Birnbaum suggested bringing in consultants to confer with on the issue of bolstering public trust. Dr. Janvier mentioned that Googling "autism and vaccines" did not bring up many official documents that would support vaccine use for a parent. She said that she was concerned that many parents had lost sight of the benefit of vaccines to our culture. Many parents are not aware of the reality of the diseases vaccines guarded against because they had never been exposed to them in their lifetimes. Dr. Janvier said that parents needed to be reminded of where we would be without vaccines and she concluded by saying that fears about vaccines and autism will never truly be allayed until the cause of autism has been discovered.
Dr. Gellin and the members of the IACC agreed to schedule a future joint meeting between the IACC and the NVAC to continue forward by drawing on each other's expertise.
Planning for the Annual Update to IACC Strategic Plan for ASD Research
Dr. Hann described the options for updating the Strategic Plan for ASD Research and presented the committee with a series of issues. She reminded them that updating the Strategic Plan was a requirement based on the CAA and presented the committee with a diagram illustrating a potential process for updating the Strategic Plan. The four parts of the updating process could include monitoring progress; identifying the Plan's strengths, weaknesses, opportunities, and gaps (SWOG); analyzing information; and revising the draft (including budgetary requirements).
Dr. Hann asked the committee to decide whether the planning would be done by a subcommittee or a series of meetings of the whole committee. She proposed that the agreed upon group convene a meeting to work out mechanics and presented the options of conducting that meeting in person or via webinar.
Ms. Blackwell said that the RFI process worked well for gathering public comment on the initial Strategic Plan and Ms. Redwood asked whether a portfolio analysis would be conducted. Dr. Hann confirmed that a portfolio analysis would be part of the planning process. Ms. Redwood suggested convening an autism advisory board to aid in updating the Strategic Plan for ASD Research. Dr. Hann said that it was the charge of the IACC to update the Plan and that under the CAA this responsibility could not be delegated to a group outside the IACC. However, the committee could choose to convene a subcommittee to update the Plan. She noted the section in the CAA outlining rules for subcommittee membership: subcommittees can only be comprised of committee members and must be less than a quorum (eight members or less, based on the current committee size) or the subcommittee effectively becomes the whole committee.
Ms. Blackwell described following these rules for the Services and Supports subcommittee she co-chairs with Mr. Grossman. Dr. Insel recommended convening a subcommittee to plan the Strategic Plan updating. Dr. Landis recommended that smaller groups be given primary and secondary responsibility for different pieces of updating the Strategic Plan and then inform the full committee. The committee agreed to convene a subcommittee that would work closely with the OARC to plan the process for updating the Strategic Plan. Eight IACC members agreed to take part in the subcommittee:
Dr. Insel, Dr. Landis, Dr. Trevathan, Ms. Redwood, Ms. Singer, Mr. Grossman, Ms. Blackwell, and Dr. Shore
The subcommittee's charge is to develop a process for revising the Strategic Plan for ASD Research and report back to the full committee for approval of the methodology.
Open Session for Public Comment
Ms. Katherine Walker, a representative of SafeMinds and the mother of a five-year-old son with Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS), said that she was hopeful that the events of that day's IACC meeting would spur action on research into vaccines and autism. She said that individuals were playing a "game of hot potato" with vaccination safety research, shirking their duty by saying that the IACC lacked the expertise or may be duplicating another agency's efforts. She stated that her intention was to encourage the fiduciary duty of government to investigate the potential link between vaccines and autism.
Ms. Theresa Wrangham, President of SafeMinds and mother of 18-year-old daughter with autism, stated that many autism organizations were extremely dissatisfied with the IACC's actions to remove previously-approved vaccine objectives from the Strategic Plan. She said that her organization's concerns about vaccine risks were based in science and that the CAA carried an undeniable Congressional mandate to study vaccine-autism research. She said that despite statements to the contrary, the vaccine objectives that were removed from the Plan had been supported in the IACC science workshops and called for them to be reinstated.
Dr. Insel pointed out that vaccine research could still be conducted under several objectives in the Strategic Plan to investigate environmental risk factors for ASD. He said that the objective calling for research on gene-by-environment interactions would investigate populations specifically susceptible to environmental triggers. He reiterated that in removing the specific vaccine objectives, the IACC was acting on the wish of the majority of the committee to receive more information about current vaccine safety efforts.
Next, Mr. Peter Bell, Executive Vice President of Autism Speaks and father of a 16-year-old son with autism, spoke before the IACC. He said that Autism Speaks had played an integral role in getting Congressional approval for the Combating Autism Act. He and Dr. Geraldine Dawson, Chief Science Officer for Autism Speaks, were both members of the Strategic Plan Work Group that helped develop the list of objectives that are now part of the plan. He expressed concern with the process by which the changes were made to the plan and the substantive merits of those changes. Mr. Bell said that the process by which the vaccine objectives were reconsidered, without being listed on the agenda and without advanced notice to the public members, undermined the trust that had been developed over the past two years. Due to these breaches in process and trust, Mr. Bell informed the committee that Autism Speaks was withdrawing its support of the Strategic Plan for ASD Research. He stated that Autism Speaks advocates immediately addressing ongoing questions of vaccine safety through rigorous science. He requested that the IACC incorporate the vaccine objectives in the second version of the Strategic Plan.
Ms. Yvonne Hershey and her 17-year-old son Derrick, diagnosed with ASD, presented to the committee. Ms. Hershey spoke of the profound impact that mercury had on her son and attributed his early developmental delays and attention deficits to mercury poisoning. Ms. Hershey spoke of her son's early attention deficits, his abuse of prescription drugs, and his institutionalization in eighth grade after a suicide attempt. Derrick described his recovery using alternative treatments such as B12 and glutathione. Ms. Hershey asked for the committee to advocate funding research into the mercury-autism link.
Mr. John Erb, author of The Slow Poisoning of America, presented his theory that the food additive monosodium glutamate (MSG) was the cause of autism. He hypothesized that glutamate increases mercury in the body and causes many of the gastrointestinal issues seen in people with ASD. He indicated that several recent studies had shown that glutamate plays a role in the etiology of autism. Mr. Erb informed the committee that he had petitioned the FDA to remove MSG from the food supply. He announced that he was going to create the Global Autism Institute and Academy to bring together international autism researchers.
Ms. Maribel McIntyre, mother of a four-year-old child with autism, illustrated that there was often an exception to every scientific rule. She cited the folklore that Lake Superior does not give up its dead. In fact, there is a clear scientific explanation for the myth. Usually, cadavers sink into the water after their lungs fill with fluid and then rise to the surface from the gas produced by bacteria in the gut and chest. However, in Lake Superior the waters are so frigid that they slow down bacterial action, resulting in the myth. She said that the children who cannot clear the neurotoxins found in vaccines from their bodies, resulting in autism, may be the scientific exception. She urged the committee to support further research into vaccines and autism.
Ms. Paula Durbin-Westby, a representative from the Autism Self-Advocacy Network (ASAN), commended the IACC's efforts to develop the Strategic Plan for ASD Research but said that funding was skewed in the direction of finding causes and cures. She recommended a shift in focus to research on services and supports, which will help people with ASD and their families. She recommended that such research be measured using the World Health Organization (WHO) Quality of Life Instrument. Ms. Durbin-Westby said that the plan had included mention of picture exchange communication systems but failed to mention any other communications technologies and systems. She said that picture exchange cannot adequately represent the entire realm of augmentative and alternative communication and assisted technology and asked that the strategic plan recommend funding specific research initiative into emerging promising communication technologies. These include aided language simulation, story book aided language simulation, natural aided language, functional communication training with AAS and language acquisition through motor planning. Ms. Durbin-Westby said that autistic individuals must be consulted in order to develop effective communications tools.
Closing Comments and Adjournment
Dr. Janvier suggested having a presentation on alternative communication at a future meeting and suggested coordinating with NIDCD for resources. Dr. Insel recommended adding such a presentation to an upcoming agenda and the meeting was then adjourned at 4:00 p.m.
These minutes of the IACC full Committee Meeting on February 4, 2009 were approved by vote of the IACC on May 4, 2009.
I hereby certify that the foregoing meeting minutes are accurate and complete.
Thomas Insel /s/
Thomas Insel, M.D.
Chair, Interagency Autism Coordinating Committee
8 Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB. Thimerosal and the occurence of autism. Negative ecological evidence from Danish registry-data] Ugeskr Laeger. 2004 Sept 13; 166(38):3291-3. PMID:15496004
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