Federal Activity - NIH
Scientific Workshops for National Autism Research Agenda Conclude: The Interagency Autism Coordinating Committee (IACC) has concluded their science workshops in preparation for updating of the nation's strategic plan for autism research and covered the six questions in the 2009 IACC Strategic Plan for Autism Spectrum Disorders Research. Disappointingly, SafeMinds Board Member and IACC Public Member Lyn Redwood, despite requests to participate on the science panels, was excluded from these proceedings, though she is the most knowledgable of the public members in understanding toxins and the role of the environment as it relates to autism and possible causation.
IACC Public Member and Autism Society of America CEO, Lee Grossman chaired the panel three on "What Caused This to Happen and Can It Be Prevented?" and failed to get reinstatement of previously approved vaccine research objectives removed from the agenda in January. The strategic planning meeting of October 15th when discussing prevention and causation was notably and erroneously bogged down in discussions of treatment which were to be addressed by panel four - "Which Treatments and Interventions Will Help?. Should questions on causation and prevention become irreparably entangled with treatment as opposed to recovery and prevention the message coming from the committee would change from pursuing an understanding of causation leading to additional effective treatments for autism as well as determining a means of preventing regressive autism. This entanglement is a step backward from NIH's mandate institute wide on preventing disease, as well as the mandate forming the IACC - the Combating Autism Act. Such a shift in the research paradigm would result in asking parents of children with autism to be satisfied with an autism diagnosis with little hope for improvement or recovery outside of what behavioral intervention may have to offer.
This month CDC announced that autism has increased in prevalence from 1 in 150 to 1 in 100 for the birth cohort of 1996 and underscores that urgency is needed in discovering the reasons behind the rise. The question of whether the rise in autism is real has been answered by an NIH-funded study at UC Davis M.I.N.D. Institute which found a 600-700 percent increase in the number of children born in California with autism since 1990. Lead author and respected epidemiologist Dr. Irva Hertz-Picciotto stated that “about 10 to 20 times more research dollars are spent on studies of the genetic causes of autism than on environmental ones. We need to even out the funding.” She went on to say, “We’re looking at the possible effects of metals, pesticides and infectious agents on neurodevelopment." The IACC continues to fail in designing a strategic plan that is suitably aggressive in response to the autism epidemic.
SafeMinds calls on the community to support the following research either by attending the upcomming Committee Meeting on the 23rd and participating in public comment and/ or sending your written request to the IACC.
- Vaccine Research: Vaccines can cause autism, as evidenced from compensation made to families since 1991from the Vaccine Injury Compensation Program. What remains unknown is how many individual have regressed into autism from vaccine adverse events. Congress has directed vaccine research be done in the 1986 Congressional Mandate for Safer Childhood Vaccines requiring research to reduce vaccine adverse events and the 2006 Combating Autism Act’s legislative history that specifically stated that, “...for the purposes of biomedical research, no research avenue should be eliminated, including biomedical research examining potential links between vaccines, vaccine components, and autism spectrum disorder,” as found in the Colloquy of Sen. Enzi, Santorum, Sen. Kennedy, and Sen. Dodd. The National Vaccine Advisory Committee (NVAC) in June identified comparison of vaccinated and unvaccinated populations in determining total health outcomes as a critical vaccine safety research gap, as well as identified additional autism specific outcome vaccine research as necessary. The IACC must restore the previously approved vaccine research objectives to the IACC's research agenda, which are now recommended by NVAC, as well as consider additions in this line of research as identified by the NVAC report. Objectives must be retrospective, as well as prospective and include a variety of studies (human, animal, cellular). Studies already underway, such as the National Children's Study and the Childhood Autism risks from Genetics and the Environment (CHARGE), can and should use medically verifiable vaccine records in their study design and actively seek to recruit unvaccinated (by choice) individuals to gain the robust sample size needed for reporting purposes.
- Environmental Factors: Below are additional improvements needed in the IACC's research agenda:
- Establish use by the National Institute of Environmental Health Sciences of existing data gathered by the National Center for Environmental Health and the National Health and Nutrition Examination Survey; the purpose of this would be to establish reference ranges to be used by physicians and scientists to determine unusually high toxicant exposure levels within individuals and/or groups, identify toxicity levels within the population, and determine environmental changes by tracking exposures over time.
- Conduct body burden studies on individuals with autism spectrum disorders that would investigate the toxic load of toxicants such as mercury and aluminum, their effects alone or in combination, and synergistic effects when combined with other toxins or viral or bacterial agents.
- In short-term objective 3.1, which addresses environmental factor investigation, only five factors are being pursued. Given the growing body of research that clearly indicates ASD growth to be predominately due to the environment, expansion of this objective is necessary with an added focus on the identification of comorbid disease states (immune system abnormalities, inflammatory bowel disease, oxidative stress, etc.). Last year the IACC public members voted for 20 factors to be investigated and were outvoted Federal IACC members who outnumber public members.
- Short-term objective 3.3 which addresses biomarkers in environmental exposure should also be expanded from 3 measures to 10 measures. Increase was again favored by IACC public members and failed due to federal members voting it down last year.
These measures would provide a cornerstone in understanding the effects of environmental toxins on human health as well as guide the prioritization of future research objectives. It would also provide insight into why biomedical treatments for autism effect positive behavioral outcomes. Investigation of the role of the environment in autism must include vaccine research guided by an independent panel with no conflicts of interest. At February's IACC meeting, Dr. Insel acknowledged that the Department of Health and Human Services has conflicts of interest.
IACC meetings are open to the publc! Please register to attend the meeting in person and give public comment. If you can't attend, submit your request to the commitee at iacc.publicquiries@mail.nih.gov
National Autism Research Agenda Overview
Interagency Autism Coordinating Committee (IACC) SummaryWith the passage of the Combating Autism Act (CAA), the National Institutes of Health Interagency Autism Coordinating Committee was reauthorized to spearhead the nation’s autism research agenda and allocated $645 million over five years to accomplish their task. Its chair is Dr. Tom Insel, Director of the National Institute of Mental Health (NIMH), which was designated at the lead agency by the Secretary of Health and Human Services (HHS). Unlike other Federal advisory committees, the IACC, as currently constructed by the prior Administration, has 12 government members and only 6 external or public members. SafeMinds Co-Founder and current Vice President, Lyn Redwood, is one of six public members of the IACC who is shaping the future of autism research leading to treatments, services and prevention.
The IACC is charged with coordinating all efforts within HHS concerning autism spectrum disorder to combat autism through research, screening, intervention and education. They are required to develop and annually update a summary of advances in autism spectrum disorder research; monitor Federal activities with respect to autism spectrum disorder; make recommendations to the Secretary regarding any appropriate changes to such activities; make recommendations to the Secretary regarding public participation in decisions relating to autism spectrum disorder; develop and annually update a strategic plan for the conduct of, and support for, autism spectrum disorder research, including proposed budgetary requirements; and submit to the Congress such strategic plan and any updates to such plan.
Approximately 40 research objectives were identified by NIMH staff in the current strategic plan adopted early this year. However, none are vaccine specific and the objectives remain weighted in genetics.
Recently the question of whether the rise in autism from 1 in 10, 000 to 1 in 150 is real has been answered by an NIH-funded study. Published this month in Epidemiology, researchers at UC Davis M.I.N.D. Institute found a 600-700 percent increase in the number of children born in California with autism since 1990. Lead author and respected epidemiologist Dr. Irva Hertz-Picciotto stated that “about 10 to 20 times more research dollars are spent on studies of the genetic causes of autism than on environmental ones. We need to even out the funding.” She went on to say, “We’re looking at the possible effects of metals, pesticides and infectious agents on neurodevelopment. If we’re going to stop the rise in autism in California, we need to keep these studies going and expand them to the extent possible.”
This most recent study found that increases in autism in California cannot be explained by either changes in how the condition is diagnosed or counted and suggested that research should shift from genetics to environmental factors and gene-environment interactions. As research has identified that children with Autism Spectrum Disorder (ASD) may be more vulnerable to environmental toxins due to impaired body chemistry and organ function, it is important to understand autism’s etiology and treatments currently used with success in improving outcomes in ASD children. A handful of studies are proving that ASD is a highly treatable multi-organ disease. SafeMind’s believes more treatment studies should commence as soon as possible. As autism continues to increase at an exponential rate, there is an urgent need to enact laws and policies in response to this current health crisis.
Environmental objectives in the IACC plan include investigation of the environmental factors identified in the recommendations from the 2007 IOM report as potential causes of ASD; identification and standardization of measures for identifying markers of environmental exposure in biospecimens; expansion of existing large case-control and other studies to enhance capabilities for targeted gene - environment research; determining the effect of at least five environmental factors on the risk for subtypes of ASD in the pre- and early postnatal period of development; and a multi-site study of the subsequent pregnancies of women with a child with ASD to assess the impact of environmental factors.
These objectives represent progress in creating the environmental research agenda necessary in gaining effective treatment for individuals affected by autism. However, there are significant deficits present in the strategic plan that require remedy. Congressional language accompanying the CAA asked that the research portfolio for autism include studies on potential links between vaccines and vaccine components and autism. During the development of the strategic plan, SafeMinds spearheaded a broad-based consensus of autism organizations formally and informally requested investigation of vaccines, as intended by the CAA. These requests have been consistently rebuffed by NIMH. The scientific workgroups and workshops convened as part of the SP drafting process also called for vaccine studies, but this information was not conveyed by NIMH staff to the IACC for its deliberations. The scientific meeting that discussed the issue most thoroughly (held in July 2008) was mysteriously not recorded properly and is the only IACC Strategic Planning meeting for which no transcript is available - see SafeMinds summary of July meeting.
At its December 2008 IACC meeting, the IACC approved two vaccine research objectives with budgets totaling $16 million, which is 2.5% of the $645 million Congress allocated to the IACC for autism research. The CDC representative on the IACC strenuously argued against these studies and during the January 2009 meeting reconsideration and re-vote on these studies was conducted on the false premise that the objectives did not come from the science workshops and that NIH did not have the expertise to conduct such research. The revote appears to violate standard advisory committee practices and some of the Federal members who had approved the two initiatives in December changed their vote in January to remove them. One Federal member of the IACC also commented during the meeting that he was instructed to vote a certain way on the studies, which appears to indicate that there were discussions among Federal members of the committee to vote against the vaccine objectives prior to the official meeting and in violation of the Federal Advisory Committee Act guidelines. Five of the 6 public members of the IACC, including a pediatrician who is an AAP member, argued unsuccessfully in favor of retaining the vaccine research. Autism Speaks, the organization of the single dissenting public member, is on record supporting the research, in contradiction to its IACC representative.
In addition, several important objectives within the strategic plan are missing, or are inaccurately worded. Definitions of success are also absent, as well as mechanisms to evaluate success, a process for accountability, and a process to modify the strategic plan over its 5 year life to reflect changes in needs and scientific progress. The NIH has attempted to assign responsibility or “leadership” objectives to various federal agencies and private organizations invited to be members of the Implementation Workgroup. Autism Speaks refused in principle to be assigned responsibility for objectives, saying that this was the government’s job, a position with which SafeMinds concurs. Similarly, many objectives remain unassigned, leaving objectives to be arbitrarily assigned to an NIH “Autism Coordinating Committee (ACC)” which has not been defined for the public.
SafeMinds believes that ultimate oversight of the implementation and evaluation of all research objectives should fall to an Autism Advisory Board comprised primarily of advocacy organizations and that such a panel would be more likely to ensure accountability of the federal agencies for producing productive research and be in the best position to define success in meeting the needs of individuals with autism and the public at large.
In general, the strategic plan would be greatly improved in meeting the aforementioned leveraged research agenda by implementing a higher allocation of the budget to environmental research; reinstatement of vaccine research objectives stripped from the agenda; removing NIMH as lead agency (our children are physically sick, not mentally ill); expansion of public members to equal Federal agency representation; creating of an advisory board to assure transparency and accountability and an analysis of the direct benefit of research already conducted (bang for buck). SafeMinds continues to work with Congress and the IACC, as well as other Federal agencies to assist our community in living the dream of no autism.
IACC meetings are open to the public and include presentations and discussions about member activities and projects of the IACC. The meetings also include scientific presentations from investigators in the field of ASD research. A portion of each meeting is reserved for public comment. A summary of each meeting is posted on the meetings & events page of the IACC website.