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My comment to the IACC

19 Jul

The IACC seeks public comment, both in-person and in writing. Below is my comment submitted for today’s meeting. I didn’t get this out until late, so it may not be included with the packets for the IACC members today, but it concerns an issue I find very important:

Dear Interagency Autism Coordinating Committee members:

I would like to thank the IACC members for their work over the recent years. It is my sincere hope that the Combating Autism Act will be reauthorized, allowing this committee to continue to guide autism research goals.

One goal I would hope that would be addressed in future Strategic Plans is the need for adequate medical care for autistics. It is my belief that the current medical system in the U.S. does not incentivize doctors for the care that is required by the disabled. One doctor told me that 70% or more of the information needed to come to a preliminary diagnosis comes from direct communication with the patient. It seems highly likely that individuals with difficulties in communication and sensory issues will require additional effort on the part of physicians. And, yet, insurance assumes that an office visit will be the same time for an autistic individual as for a non-autistic individual.

The questions that I would like to see addressed are straightforward. First, what is the appropriate amount of time doctors need to take to adequately address the needs of their autistic patients? This information could be used to allow for an additional or a different billing code for doctors to use with this population. Second, does the current system disincentivize doctors from taking on disabled patients in general, and autistic patients in specific?

A recent paper gives a view of the importance of these issues: Parenting aggravation and autism spectrum disorders: 2007 National Survey of Children’s Health. Parents without a medical home show much higher levels of aggravation. Addressing this one area could provide much benefit to not only the autistic children, but to the parents as well.

Again, I thank you for your time serving the needs of autistics.

Respectfully submitted

IACC Chairman Insel Testifies Before House Committee on the Combating Autism Act and the Accomplishments of the IACC

19 Jul

The Combating Autism Act (CAA) is set to “sunset” at the end of September of this year. With that would be the sunset of the Interagency Autism Coordinating Committee (IACC). The U.S. legislature is considering a re-authorization of the Act. Below is an announcement from the IACC about a congressional hearing, with testimony from Dr. Tom Insel, chair of the IACC and director of the National Institute of Mental Health (NIMH).

Testifying before the U.S. House of Representatives Energy and Commerce Subcommittee on Health on July 11, Dr. Thomas Insel spoke about the Combating Autism Act of 2006 and the successful federal coordination and public-private partnership efforts that have resulted from the Interagency Autism Coordinating Committee (IACC) that was created as part of the legislation. Without reauthorization of the Combating Autism Act, the IACC will sunset in September 2011. Representatives Christopher Smith (R-NJ) and Michael Doyle (D-PA) introduced the Combating Autism Reauthorization Act of 2011 (H.R. 2005) on May 26, 2011, a bill that, if enacted, would reauthorize the IACC and other federal programs that conduct research and provide services for people with autism spectrum disorders (ASD) and their families.

During his testimony, Dr. Insel, who is the director of the National Institute of Mental Health and chair of the IACC, focused on the work of the IACC in the five years since the Act was enacted, noting that the committee has “really served to focus efforts across the federal government by bringing federal agency representatives for research, services, and education, as well as parents, people with ASD, scientists, clinicians, and others together to work as a team…”

He praised the dedication of the members and noted that the collaboration between public and private members has fostered important partnerships and ensured that a range of voices and perspectives were heard. The committee’s strategic plan has guided national research efforts by creating a comprehensive blueprint for autism spectrum disorders (ASD) research.

Since the Combating Autism Act was enacted in 2006, there has been remarkable progress in the identifying symptoms of autism early, in understanding how commonly autism occurs in the community, and in developing effective interventions, particularly for very young children. This research is “moving rapidly toward translation into practical tools that can be used in clinics and community settings to change outcomes for people with ASD,” Dr. Insel said.

Health Subcommittee Members asked Dr. Insel a variety of questions, ranging from estimates of autism’s economic impact on families and society to racial disparities in diagnosis and recent research advances in the field. Asked about a recent study that suggests environmental risk factors may play a greater role in autism risk than previously thought, Dr. Insel stressed the importance of understanding how both genetics and environment interact to influence risk. He noted that, while less is known about environmental risk factors for autism than genetic factors, a number of projects were underway to follow children from before birth to early childhood to study potential environmental exposures.

When asked about the most significant gaps in ASD research, Dr. Insel cited the lack of knowledge on effectively supporting the transition from adolescence to adulthood and fixing the inconsistent service delivery systems across the country.

During the hearing, Dr. Insel was also asked how the IACC has been successful. He pointed to the committee’s achievement in improving coordination between federal agencies as well as between federal agencies and private foundations. He noted the importance of creating specific public-private partnerships around key areas of research interest and community need, citing the Autism Treatment Network (ATN) as an excellent example. The ATN is a partnership between Autism Speaks, the National Institutes of Health (NIH), and the Health Resources and Services Administration (HRSA) that creates a comprehensive model of care for children and adolescents with autism. This network helps involve families in research and provides the latest treatments directly to the community.

In addition, he pointed to the importance of public participation in the committee’s activities, creating a public forum for the community’s needs to be heard. He credited the families of people with ASD for their tireless work on behalf of the autism community, saying , “There’s no group of people that I’ve met that are more inspiring than the families of people with autism. These are really dedicated parents, who make things happen.”

While much has been accomplished, Dr. Insel emphasized the importance of continued Congressional support to build on the advances enabled by the Combating Autism Act of 2006. “While there’s been unequivocal progress, much work remains to be done. The reauthorization will be critical for continuing this momentum and the stability of the IACC over the next three years,” he said. Dr. Insel stated that reauthorization was only one step and that appropriations were critical for continued progress. He likened the reauthorization to obtaining a driver’s license, noting, “The agencies serve as our vehicle. We’ve got a great road map through this strategic plan that the IACC has put together, but at the end of the day, whether we have gas in the car or not depends on [the availability of funds appropriated by Congress].” If enacted, the Combating Autism Reauthorization Act of 2011 (H.R. 2005) would enable the committee to continue coordinating federal agency and private efforts to advance ASD research and enhance services to meet the needs of people with ASD and their families.

Dr. Insel starts at minute 21 in this video:

Here is his testimony:

Good morning Chairman Pitts, Ranking Member Pallone and members of the Committee. I am Tom Insel, Director of the National Institute of Mental Health (NIMH) at the National Institutes of Health (NIH). I have served as the Chair of the Interagency Autism Coordinating Committee (IACC), created by the Children’s Health Act of 2000 and re-established by the Combating Autism Act of 2006 (CAA), since my arrival at NIMH in 2002.

First, let me express my sincere appreciation for the opportunity to give you some background on how the existing CAA has facilitated unprecedented collaboration between federal agencies and private organizations, enabling amazing progress in the field of autism research and serving to sharpen our focus on the need for better services for people with autism and their families. We at NIH are very grateful for the strong support that you in Congress have always shown for NIH and the thousands of researchers around the country that it funds. As chair of the IACC, I’d like to express the gratitude of all the federal agencies that are members for your continued interest and encouragement.

The CAA dealt with five general provisions: centers of excellence, surveillance, education for early detection and intervention, the IACC, and authorization of funding. The 11 Autism Centers of Excellence, surveillance efforts at the Centers for Disease Control and Prevention (CDC), programs for early detection and intervention, and funding for all of these programs is authorized to continue with or without reauthorization of the CAA. The one provision that requires reauthorization to continue is the IACC, which is scheduled to sunset on September 30, 2011. For this reason, I will focus my remarks today on the IACC, but I welcome your questions about other provisions of the CAA.

In order to give you the most comprehensive yet concise background, I’ll briefly describe the IACC, its membership, its transparent process, its collaborative activities, the influential Strategic Plans that it has developed, and its various areas of intense interest. In short, this description will let you know that the IACC has fulfilled each and every requirement of the CAA. It has provided both an important forum for public discussion of autism issues and a framework for a research agenda that is optimized to take full advantage of scientific opportunities. As time permits, I also hope to share some examples of the very recent research advances that are so exciting in this field, and how these advances have been facilitated by the existence of the Strategic Plans developed by the IACC with considerable public input. Finally, I’ll discuss how the IACC has focused on the need to enhance services for people with autism.

Autism spectrum disorder (ASD) is a diverse collection of disorders that share in common impairments in verbal and nonverbal communication skills and social interactions, as well as restricted, repetitive, and stereotyped patterns of behavior. The degree and specific combination of impairments can vary from one individual to the next, creating a heterogeneous disorder that can range in impact from mild to significantly disabling. Two decades ago, ASD was considered a rare disorder. Today, with CDC’s latest prevalence estimates of 1 in 110 children in the U.S. being diagnosed with ASD, this disorder has become an urgent national health priority. In 2006, Congress passed the CAA to strengthen federal coordination around this issue and, to enhance public-private collaborations in order to accelerate research to improve the lives of people with ASD and their families.
The CAA outlines the membership of the IACC, which includes both representatives of federal agencies and public members representing a diverse set of stakeholder groups within the autism community. Currently, the IACC includes two people with ASD, several parents of children and adults with ASD, members of the advocacy, research, and service provider communities, and officials from the following federal agencies and offices that are involved in ASD research or services provision: Department of Education (ED), HHS’s CDC, Centers for Medicare & Medicaid Services (CMS), Office on Disability (OD), Substance Abuse and Mental Health Services Administration (SAMHSA), Administration on Developmental Disabilities (ADD) in the Administration for Children and Families (ACF) , Health Resources and Services Administration (HRSA), five institutes of NIH, and the NIH Director. Major autism research and services organizations represented on the IACC include Autism Science Foundation, Autistic Self Advocacy Network, Autism Speaks, SafeMinds, Simons Foundation, Southwest Autism Research & Resource Center, and the U.C. Davis M.I.N.D Institute.

In addition to the voices and perspectives added by the members of the IACC, the IACC has fostered public participation by having public comment periods at every full IACC meeting, regularly inviting written public comment, conducting formal requests for information from the public and holding town hall meetings, and has provided a high level of transparency for the public by actively disseminating information about IACC activities via e-mail, the IACC website, webcasts and even Twitter. By including both federal and public members on the committee, and by fostering public engagement through a variety of means, the IACC ensures that a diversity of ideas and perspectives on ASD are brought to the table to inform the IACC’s activities and recommendations. The IACC is a committed group—while the law only requires the committee to meet twice a year, since 2007, the committee has met around 16 times per year, including full committee and subcommittee meetings, workshops and town hall meetings.
Under the CAA, the IACC is charged with developing and annually updating a strategic plan for ASD research. In fulfilling these requirements, the committee produced its first strategic plan in January 2009 and has issued updates in 2010 and 2011. The IACC developed its Strategic Plan with a great deal of input from the public, gathered through planning meetings, town hall meetings, and requests for information. This tremendous public input, combined with that of scientific and subject matter experts and all the major federal agencies and private funders resulted in a plan that provided a clear path to move autism research forward in targeted, innovative ways to help public and private agencies prioritize activities as soon as it was released. The first IACC Strategic Plan was organized into six chapters that reflect the needs expressed by the community: early and accurate diagnosis, better understanding how autism develops, enhanced ability to identify risk factors, development of new and more effective interventions and treatments, more research needed to inform and enhance services, and the development of better approaches to meet the changing needs of people with ASD over the entire lifespan. In 2010, the committee also added a chapter on the infrastructure needed to support a robust research effort. As you can tell, our strategic plan has a broad scope, in part because it was developed through the cooperation of both research and services-focused agencies and private organizations. While the Plan is a research plan, as the law directs, it encompasses a range of research that goes from fundamental biology of ASD to inform new diagnostics and therapies, to the actual development of those needed tools and approaches, and finally to research that can inform and enhance services programs to meet the needs of people with autism across the lifespan.

Fortuitously, the first strategic plan was completed just as NIH received significant additional funding from the American Recovery and Reinvestment Act to help stimulate the economy through the support and advancement of scientific research. With a strategic plan in place to guide priorities, NIH allocated over $122 million of additional funding between FY09 ($64 million) and FY10 ($58 million) to autism research, supporting a variety of projects addressing the most critical research needs highlighted by the IACC. This was in addition to NIH’s investment of base annually appropriated funds for autism research, which was $160 million in 2010. The overall NIH investment in autism research was an unprecedented $218 million in 2010, more than double the funding prior to the CAA.

The IACC has also fulfilled the CAA requirements to produce an annual summary of advances in research and to monitor federal research activities. Since 2007, the IACC has issued four Summary of Advances documents, which describe what the committee felt were some of the most exciting advances in autism biomedical and services research each year. The IACC has also been actively monitoring not only federally-funded research, as the CAA requires, but has also tracked the research funded through private organizations, making for a much more complete picture of the research landscape across the U.S. All of the private organizations on the IACC that conduct research provided their data, and we have also collected data from all U.S. federal agencies and additional private groups. The result has been the IACC’s annual “portfolio analysis.” The first year, the data were presented at IACC meetings, but in subsequent years the IACC issued full reports on fiscal years 2008 and 2009 funding; the analysis of 2010 data is currently underway. These portfolio analysis reports have provided the first comprehensive look at autism research being conducted in the U.S. They also have facilitated a better understanding of how current research aligns with the IACC Strategic Plan. The committee has found both the summary of advances and portfolio analysis reports to be valuable tools for updating the Strategic Research Plan and determining the greatest areas of need for further action.

This year, the HHS/NIH office that supports the IACC, the Office of Autism Research Coordination (OARC), published a comprehensive Report to Congress, as required in the CAA, on federal activities that have taken place since the passage of the CAA. That report contains rich information about the programs and projects going on across HHS and the ED to meet the needs of people with autism. I urge you to take a look at this report because it provides the most comprehensive picture to date of how federal agencies are responding to the urgent needs of the autism community. The report contains details of the wide array of autism research, services and supports activities conducted by federal agencies, including biomedical and services research, public health activities, education initiatives, early screening, diagnosis and intervention services, provider training, healthcare delivery, social supports, and vocational training. We have copies of this and the other most recent reports mentioned with us and will be happy to give you copies.

Now I’d like to share with you some of the exciting advances we have seen in ASD research. Since the passage of the CAA in 2006, there has been a groundswell of activity on multiple fronts, from game-changing scientific discoveries reshaping the field of autism research to real-world applications that can help people with ASD and their families now.

As I mentioned earlier, one of the main provisions of the CAA was support for early diagnosis and intervention. CDC reports that the median age for autism diagnosis is 4 and half years of age and varies widely by sociodemographic group and geographic location. With recent advances, diagnosis by age 14 months is now a realistic possibility, and researchers are actively pushing the detection window to even younger ages. In April 2011, NIH-funded researchers demonstrated that a simple, low-cost, practical screening tool that takes only five minutes to administer can be implemented by doctors’ offices to detect ASD around one year of age for many children. More than 100 pediatricians in San Diego County, CA participated and screened over 10,000 one year old children using the checklists. Impressively, all pediatricians who participated in the study are continuing to use the tool because they recognized the tremendous potential it provides to identify autism earlier and direct families toward interventions that can result in significant positive outcomes earlier in life. Another promising diagnostic tool is a simple test that detects eye gaze patterns specific to infants with autism. A group of researchers at University of California, San Diego who have received funding from NIH to develop such a test recently reported that they could identify 1-3 year old children with autism with nearly 100 percent specificity. These promising diagnostic tools, combined with CDC’s health education campaign, “Learn the Signs. Act Early.”, to improve early identification, provide great potential for reducing the age of diagnosis and allowing children and their families to get the services and support they need when it can help the most.

Of course, early diagnosis is only valuable if effective interventions are available. Recently published results from several successful trials of early interventions have validated approaches that are effective in young children, creating real promise of improved health outcomes, and quality of life for children with ASD. In 2010, NIH investigators reported that children with ASD who receive a high intensity behavioral intervention starting by age 18-30 months show improvements in IQ, language, and adaptive behavior, to the point where the autism diagnosis no longer applies to some children who receive treatment. Soon after that groundbreaking study, a group of investigators jointly funded by HRSA and NIH reported that an intervention designed to enhance social engagement in toddlers indeed improved social, language, and cognitive outcomes. Early interventionists have noted an encouraging “problem” – new approaches that are being proven effective are being taken up so quickly by the community that it is difficult to find “control groups” for behavioral intervention trials. While this can complicate efforts to conduct randomized control trials, the real story is that parents and community practitioners are putting innovative strategies into practice quickly. Many of these recent advances in early diagnosis and intervention can be credited to NIH’s Autism Centers of Excellence (ACE), which were expanded under the CAA and now comprise 11 research centers at major research institutions across the country.

We do not know the causes of ASD, but very recent findings comparing identical and fraternal twins suggest the importance of focusing on both environmental and genetics factors. NIH and CDC are continuing to strengthen research investigations into possible environmental causes of autism, establishing expansive research networks with the capability to collect large sets of data on environmental exposures and health outcomes, and to conduct powerful analyses to determine which risk factors may be contributing to the development of autism. Population-based studies are the gold standard in epidemiology research. Large sample sizes and rigorous study designs allow researchers to examine many variables at once. Such networks, like NIH’s Childhood Autism Risks from Genetics and the Environment (CHARGE) and Early Autism Risk Longitudinal Investigation (EARLI) and CDC’s Study to Explore Early Development (SEED), will utilize data from medical records, interviews, questionnaires, developmental assessments, and physical exams to explore a host of possible risk factors, focusing heavily on factors in the environment before, during, and after pregnancy. It will take a few more years for these research networks to fully mature, but already, published findings are helping establish the evidence-base for ruling in and ruling out possible environmental triggers. In the first half of 2011 alone, the CHARGE study has implicated air pollution, mitochondrial dysfunction, and immune dysfunction as potential mechanisms for ASD. Just this month, CHARGE investigators reported that use of prenatal vitamins may reduce the risk of having children with autism. In the past week, another study, funded by CDC and a private group, showed that widely-used antidepressant medications taken during pregnancy can significantly raise the risk of having children with autism. In addition to their work on identifying risk factors for ASD, CDC also continues to provide the most comprehensive estimates to date of the prevalence of ASD in multiple areas of the U.S. through its Autism and Developmental Disabilities Monitoring (ADDM) Network. While great progress is being made for autism, CDC’s prevalence estimates have documented significant increases in autism in the US, which highlights the need to continue research efforts and service advances being made with facilitation by the IACC activities.

With the pace of research moving so rapidly, I am confident that our continued investments in novel and innovative biomedical research in ASD will pay large dividends in the future. But there’s a strong imperative to push the best of what we know now out into the community as rapidly as possible.

HHS’s OD and the Assistant Secretary for Planning and Evaluation are creating the infrastructure to support and conduct patient centered research on health services and supports for people with disabilities, including autism. Their new Center of Excellence, authorized under the American Recovery and Reinvestment Act, is part of a national strategy for quality improvement in health care and the expansion of health care delivery system research with a focus on person-centered outcomes research. Expanding on that effort, CMS is testing and implementing family-driven, person-centered and home and community-based service provision models for people with autism.

A common goal across many federal agencies is to support and empower people with autism to live more independently and enjoy an enhanced quality of life. Informed by the IACC Strategic Plan, NIH is making non-traditional investments in novel service and health delivery models, aided by the infusion of additional funds from the Recovery Act. Both the ED’s Rehabilitation Services Administration (RSA) and HHS’s SAMHSA “Supported Employment Toolkit” are helping people with autism secure and maintain jobs in the community. Medicaid continues to fund supported employment and habilitation services through States’ home and community-based waiver programs, which pay for such services for many people with intellectual and developmental disabilities across the nation.

There are also interventions and supports that can help people with autism and their families today. HRSA is helping to pave the road from research to practice. Through funds provided by the Combating Autism Act Initiative (CAAI) under the CAA, HRSA has invested substantially in autism interventions to improve physical and behavioral health of people with ASD, practitioner training, and service provision models. HRSA-funded investigators are examining critical questions, such as the impact of co-occurring health conditions in autistic individuals and the effectiveness of parent-mediated and peer-mediated behavioral interventions. HRSA’s health professionals’ training programs are designed to reduce barriers to screening and diagnosis by increasing professional capacity and raising awareness about ASD among providers in the community. HRSA’s State Implementation Grants represent nearly $2.7 million in funds to assist nine States with improving services for people with ASD. These grants promise to help identify best-practices at the individual, community, and policy level. When possible, partnerships between agencies are being formed – HRSA and CDC have joined to sponsor “Act Early” Summits in all regions of the US and to facilitate the development of professional and community teams to improve the early identification of children with autism at a local level.

The coordination in the autism research community is unparalleled, and the IACC has played a critical role in fostering the growing list of promising public-private partnerships. Last fall, the mother of a child with autism spoke at an IACC meeting about the need to examine the high prevalence of autism in the Somali community in Minnesota reported in a state-funded study based on school data. Working collaboratively, several NIH Institutes, CDC, and Autism Speaks put together a research initiative to support investigation of the reported increase in ASD prevalence in the Minnesota Somali community and to identify the diverse service needs of these Somali-American children and their families.
As the Somali study illustrates, federal agencies recognize the autism challenge is not one we can tackle alone. There are a host of private organizations funding cutting-edge research, including four that hold a seat on the IACC – Autism Science Foundation, the Southwest Autism Research & Resources Center (SARRC) and the organizations identified by the recent IACC Portfolio Analysis as being the 2nd and 3rd largest private funders of research after NIH, Simons Foundation and Autism Speaks. Jointly, NIH, Autism Speaks, and Simons Foundation are driving several significant initiatives poised to accelerate the pace and quality of autism research. By developing the infrastructure and appropriate incentives, these public-private partnerships are encouraging data-sharing on an impressive scale, enabling scientists to do more with less. Additionally, NIH’s National Database for Autism Research (NDAR) is federating with several other autism data repositories such as the Autism Speaks’ Autism Genetic Resource Exchange (AGRE) and the public/private-funded Interactive Autism Network (IAN) to enhance researchers’ access to data. And in the community, programs like AGRE, IAN and the Autism Treatment Network (ATN), that involve direct outreach to and collaboration with the patient community, are bringing together hundreds of researchers and clinicians with tens of thousands of people nationwide affected by ASD in a search for answers.

Federal IACC member, ADD, with the help of non-profit organizations, including the Arc of the United States, the Autistic Self Advocacy Network (ASAN), and the Autism Society, recently launched the AutismNOW Project, an innovative dissemination network to provide access to high-quality resources and information on community-based services and interventions for people with ASD and their families. AutismNOW offers a call center, web-based clearinghouse of resources, twice-weekly webinars on a variety of topics related to autism, and regional events for the community to connect in-person.

Looking back over the past five years since the passage of the CAA, we can see how the establishment of the IACC has served to focus efforts across the federal government, bringing federal agency representatives (research, services, and education), parents, people with ASD, scientists, clinicians and others together to work as a team to address the issues, and bringing a wide variety of expertise to a difficult area. In doing so, it has produced a strategic plan to guide and focus federal research efforts and catalyze public private partnerships, while also providing a forum for public discussion and identification of additional needs from the community.

We have also seen some remarkable progress in the identification of how common ASD is within communities, how ASD develops, how we can detect it at increasingly earlier ages and what types of interventions are most effective, especially in young children. This research is rapidly moving toward translation into practical tools that can be used in the clinic and community settings to change outcomes for people with ASD. In this time span, federal agencies have coordinated efforts to enhance critical services programs, identify best practices to support the education, health and employment needs of people on the spectrum, and develop new mechanisms and strategies to enable broad access to healthcare, services and supports – all leading toward improvement in quality of life for people with ASD and their families.

The CAA established the IACC, to provide advice to the Secretary HHS regarding matters related to ASD, to create a forum where the public could be actively involved in the process, and to develop a strategy to guide national research efforts. While there has been unequivocal progress, much work remains to be done. The reauthorization will be critical for continuing the momentum and stability of the IACC over the next 3 years. It is crucial that members of the IACC—individuals, federal agencies and member private organizations—have stable support to continue their efforts to work together on autism issues.

I thank you for this opportunity to speak with you and look forward to addressing any questions that you may have.

Funding Science in a Time of Austerity

12 Mar

Funding Science in a Time of Austerity is a blog post by Tom Insel, director of the National Institute of Mental Health (NIMH) in the US.

I’ve discussed many news stories of late which discuss special education in these tight fiscal times. Naturally research will be impacted as well. While the article by Tom Insel does not discuss autism specifically, it is worth a read. NIMH has not had a final appropriation from the government for this fiscal year (which started in Oct. 2010). And they are expecting cuts for fiscal year 2012.

Following is a post by Tom Insel, director of the NIMH:

C. S. Lewis once said that the “task of a modern educator is not to cut down jungles but to irrigate deserts.” The same might be said of an NIH institute today. But our ability to irrigate deserts may be compromised as we appear to be facing an austere funding future. As the Nation struggles to regain its economic footing, the final budgets for NIH in 2011 and 2012 remain uncertain. But there is little doubt that these will be tough years for NIMH funding.

Here is a quick synopsis. Following the doubling of the NIH budget from 1998-2003, NIMH has received budgets with sub-inflationary increases each year. By 2009, we had lost about 18 percent of our purchasing power relative to 2003, but through strategic cuts in awards, reductions in the out-years of multi-year grants, and elimination of programs, NIMH was able to maintain relatively stable funding throughout this period. By stable funding, I mean that we continued to support roughly 550 new research grants (R01 and R21-type grants) each year, representing at least 15 percent of proposals.

In 2009 and 2010, the American Recovery and Reinvestment Act (ARRA) brought a surge in funding to create jobs. With over $370M, NIMH was able to support several innovative projects, create or retain jobs, and fund some additional R01-type grants (for 2 years) on top of our regular appropriated budget. But this one-time surge from ARRA obscured the longer-term pattern of flat budgets that continued in 2009 and 2010 beneath the ARRA bubble. In 2010, the NIMH budget was 2.6 percent higher than 2009, still losing ground to inflation.

What about 2011? Although our budget year began October 1, 2010, we are still awaiting a final appropriation. Last week, Congress passed a continuing resolution until March 18, which means we will continue to operate under our 2010 budget rather than the President’s 2011 budget proposed last February. Prior to March 18th, Congress must vote either to extend the continuing resolution or to appropriate a budget for the remainder of the year. Both houses of Congress are concerned about the growing deficit and are committed to reining in spending, especially within the 12 percent of the budget labeled as “discretionary.” This will almost certainly mean a reduction in the NIH and NIMH budgets, but we do not know the extent of this reduction. The House voted for a $1.6B reduction below the 2010 NIH budget for 2011, including a 4.1 percent reduction (-$60M from 2010) for NIMH, but this budget still needs to be considered by the Senate.

In the absence of a final budget for this year and with expectations that we will likely see reductions in 2012, NIMH has been cautious about funding grants. We have a few principles that have guided us: prioritize research relevant to our strategic plan, support innovation, maximize the number of R01 grants, and protect early stage scientists. In support of these principles, we have reduced our intramural program, funded fewer centers, and reduced support of some large programs.

But even with these changes, the 2010 budget leaves us short in 2011. Partly because of the number of continuing grants and partly because of the increasing average cost of new awards, if we receive the full 2010 budget for 2011, we are projecting 481 new grants, representing roughly 10 percent of proposals. This would be the first time since 1999 that we would fund fewer than 500 new grants and would mark the lowest success rate in over 15 years. If the 2011 appropriation is 4.1 percent less than the 2010 budget, the actual number of new grants funded will likely be below 400.

Not surprisingly, this situation is creating anxiety in the scientific community. Basic scientists believe that the money has been shifted to translation. Clinical researchers say that funds are only going to basic science. But in fact, the Division of Neuroscience and Basic Behavioral Science, which was 27 percent of the total NIMH budget in 2005, was 29 percent in 2010 and will likely be close to this portion again in 2011.

Some have suggested that the funds are going to Centers or the intramural program instead of investigator-initiated R01 grants. But the percentage of R01s has only increased over the past decade.

A few scientists have suggested that the problem is a recent change in the review policy, allowing only a single re-submission. While this policy must seem catastrophic for someone who just missed the payline with a re-submitted grant, re-instating the “A2” would only delay funding for those within the payline. It may not increase the number of grants funded or the success rate.

For scientists, this may feel like a funding desert. During this relative drought, there may be many reasons for complaints. But the bottom line is that funds for new grants are the lowest we have seen in several years and the average costs of new grants is higher than ever ($419K in 2010 vs $313K in 2005). NIMH is committed to funding the highest impact science with the available funds. But as much as we would like to “irrigate the desert,” some outstanding science will, unfortunately, not get funded. And those projects selected for funding may receive less than optimal support.

What makes this desert especially difficult is that the scientific opportunities have never been better. We have unprecedented traction in the science necessary to make progress for helping people with mental illness. However, in this period of austerity, we will not at this time be able to fund some of the science that will make a difference for those in greatest need.

Release of the 2011 IACC Strategic Plan for Autism Spectrum Disorder Research

28 Feb

The IACC has released the 2011 Strategic Plan. I have quoted the announcement below, which includes the links:

The Interagency Autism Coordinating Committee (IACC) and the Office of Autism Research Coordination (OARC) are pleased to announce the release of the 2011 IACC Strategic Plan for Autism Spectrum Disorder Research. The updated Strategic Plan contains 16 new research objectives covering a variety of issues, including use and accessibility of interventions for non-verbal people with ASD, health promotion for people with ASD, and issues related to safety for people on the spectrum. The HTML version of this year’s Strategic Plan is fully hyperlinked throughout to websites with information about funders, programs and over 180 ASD-related publications, which should make the Plan an especially useful resource for people with ASD, families, providers, research funders, researchers, policymakers, and the public. A formatted, downloadable PDF version of the Plan is also available. Links to the new Strategic Plan and related information, including a news update about the Plan, can be accessed from the IACC Home Page.

Increase in NIH autism projects over the past decade

18 Jan

We hear repeatedly how research interest in autism has climbed in the past decade. I was looking through the NIH database of autism research projects and I decided to check on the number of projects that the NIH has funded by year.

Here are those data: research projects by fiscal year. In the past 10 years, the number of projects funded per year has increased by about 3x or 4x.

Quantity isn’t the same thing as quality by a long shot. But I do find this very encouraging.

Stakeholder meeting October 29: Study of Health Outcomes in Children with ASD and Their Families

26 Oct

The United States National Institute of Mental Health has called a meeting to discuss a study on health outcomes on children with ASD and their families. The meeting will also be a chance for community input.

I don’t see an easy way to provide input in advance of the meeting.

There are many topics I can think of for input, but a big piece of information would be to question why this is limited to children with ASD?

Meeting Announcement

Study of Health Outcomes in Children with ASD and Their Families – Stakeholders’ Meeting

October 29, 2010
NIH Neuroscience Center
6001 Executive Blvd.
Conference Room C
Rockville, MD 20852

Sponsored by:

National Institute of Mental Health (NIMH)

NIMH recently awarded a two-year contract to The Lewin Group to conduct a study of health outcomes in children with autism spectrum disorders (ASD) and their families. The objective of this study is to advance our understanding of ASD, including variables related to diagnosis, health conditions, and health care outcomes, using existing administrative data.

NIMH will host an informational stakeholders’ meeting, inviting participation from individuals with ASD, parents of children with ASD, community care providers, ASD researchers, and patient advocates. The Health Outcomes research team will provide an overview of the goals, objectives, and methods of the study. The meeting is also a venue for input from the community about the particular health issues that are of the greatest concern, as well as ASD-specific challenges or complications related to health care service provision and utilization

The meeting will be open to the public, and will be held on October 29, 2010, 2:00pm to 4:00pm EDT at the NIH Neuroscience Center. Participation by webinar is also possible. To register for in-person attendance at the meeting, or for webinar participation, please go to: .

It seems likely that this study will address questions such as whether there is a higher incidence of gastrointestinal problems in autistics, and how GI issues evolve with time in those kids who have it. I would expect attention on questions such as whether autistic kids are more prone to infections and/or get more antibiotics, how medicated these kids are, the incidence of epilepsy, the incidence of apraxia, and how these conditions progress with time.

I hope a good method is made for input for this meeting, other than attendance.

GFCF of no benefit

19 May

This post is from Eureka Alert

A popular belief that specific dietary changes can improve the symptoms of children with autism was not supported by a tightly controlled University of Rochester study, which found that eliminating gluten and casein from the diets of children with autism had no impact on their behavior, sleep or bowel patterns.

The study is the most controlled diet research in autism to date. The researchers took on the difficult yet crucial task of ensuring participants received needed nutrients, as children on gluten-free, casein-free diets may eat inadequate amounts of vitamin D, calcium, iron and high quality protein. Unlike previous studies, they also controlled for other interventions, such as what type of behavioral treatments children received, to ensure all observed changes were due to dietary alterations. Past studies did not control for such factors. And although no improvements were demonstrated, the researchers acknowledged that some subgroups of children, particularly those with significant gastrointestinal (GI) symptoms, might receive some benefit from dietary changes.

“It would have been wonderful for children with autism and their families if we found that the GFCF diet could really help, but this small study didn’t show significant benefits,” said Susan Hyman, M.D., associate professor of Pediatrics at Golisano Children’s Hospital at the University of Rochester Medical Center (URMC) and principal investigator of the study which will be presented Saturday (May 22) at the International Meeting for Autism Research in Philadelphia. “However, the study didn’t include children with significant gastrointestinal disease. It’s possible those children and other specific groups might see a benefit.”

In response to widespread parent-reported benefits, URMC initiated the trial in 2003 to scientifically evaluate the effects of the gluten-free and casein-free diet, which eliminates wheat, rye, barley and milk proteins. Parent observation has played an important role in earlier treatment discoveries in children with autism, such as melatonin’s benefits for sleep.

Hyman’s study enrolled 22 children between 2 ½- and 5 ½-years-old. Fourteen children completed the intervention, which was planned for 18 weeks for each family. The families had to strictly adhere to a gluten-free and casein-free diet and participate in early intensive behavioral intervention throughout the study. Children were screened for iron and vitamin D deficiency, milk and wheat allergies and celiac disease. One child was excluded because of a positive test for celiac disease and one was excluded for iron deficiency. Other volunteers who were excluded were unable to adhere to the study requirements. The children’s diets were carefully monitored throughout the study to make sure they were getting enough vitamin D, iron, calcium, protein and other nutrients.

After at least four weeks on the strict diet, the children were challenged with either gluten, casein, both or placebo in randomized order. They were given a snack once weekly with either 20 grams of wheat flour, 23 grams of non fat dried milk, both, or neither until every child received each snack three times. The type of snack was given in randomized order and presented so that no one observing – including the family, child, research staff and therapy team – knew what it contained. The snacks were carefully engineered to look, taste and feel the same, which was an exercise in innovative cooking. In addition, the nutrition staff worked closely with the families to make a snack that met their child’s preferences. Casein was disguised in pudding, yogurt or smoothies and gluten in banana bread, brownies, or cookies depending on the child’s food preferences.

Parents, teachers and a research assistant filled out standardized surveys about the child’s behavior the day before they received the snack, at two and 24 hours after the snack. (If the child’s behavior wasn’t usual at the scheduled snack time, the snack would be postponed until the child was back to baseline.) In addition, the parents kept a standard diary of food intake, sleep and bowel habits. Social interaction and language were evaluated through videotaped scoring of a standardized play session with a research assistant.

Following the gluten and casein snacks, study participants had no change in attention, activity, sleep or frequency or quality of bowel habits. Children demonstrated a small increase in social language and interest in interaction after the challenges with gluten or casein on the Ritvo Freeman Real Life Rating Scale; however, it did not reach statistical significance. That means because of the small difference and the small number of participants in the study, the finding may be due to chance alone.

The investigators note that this study was not designed to look at more restrictive diets or the effect of nutritional supplements on behavior. This study was designed to look at the effects of the removal of gluten and casein from the diet of children with autism (without celiac disease) and subsequent effect of challenges with these substances in a group of children getting early intensive behavioral intervention.

Hyman said, “This is really just the tip of the iceberg. There are many possible effects of diet including over- and under-nutrition, on behavior in children with ASD that need to be scientifically investigated so families can make informed decisions about the therapies they choose for their children.”

Dr. Tom Insel on Demystifying Autism

12 May

Dr. Tom Insel wears many hats, as they say. He is the director of the National Institute of Mental Health (NIMH), one of the National Institutes of Health run by the US Government. As part of his function there, he chairs the Interagency Autism Coordinating Committee (IACC). The IACC prepares the “Strategic Plan” for the government’s activities in autism research.

Dr. Insel has obviously taken autism research very seriously. He doesn’t just chair the IACC, he obviously spends a lot of time reviewing autism research. I doubt many people at the Director level at NIH would spend the amount of time Dr. Insel obviously spends on autism.

He has recently given a few talks on autism, the current state of knowledge and the directions for research. One such talk was at NIH and was titled Demystifying Autism . Another talk was given at MIT and was hosted by the Simons Foundation. (sorry, I can’t find embed code for those talks)

Dr. Insel talks about how there is a large diversity in the autism population. The “spectrum” is broad, as likely most readers to this blog will already know. In both talks, Dr. Insel uses video from Dov Shestak (son of Portia Iverson and Jon Shestak, founders of Cure Autism Now, which is now part of Autism Speaks). This is used to give an example of regression in autistics.

Of course one large section is devoted to the increasing autism prevalence. Dr. Insel mentions the epidemiological work of Peter Bearman, which shows that much of the increase in the California Department of Developmental Services autism caseload can be accounted for by diagnostic changes and social factors. But, not all of the increase has been accounted for. Dr. Insel uses the term that the burden of proof is on those who would say that the increase is not “real”. I would put it differently–that given the lack of definitive information on the causes of the rise, we should continue to look for possible environmental causes. Many use the term “environmental cause” to mean “vaccines”. That’s not what I, or it appears, Dr. Insel mean though.

Dr. Insel discusses one yet-unpublished study: the California Twin Study.

Here is his power point slide (which you can click to enlarge if you wish):

Slide showing results of yet unpublished twin study

Dr. Insel's slide on Twin Study


Narrow criteria:
monozygotic (“identical”)–80% concordance
dizygotic (“fraternal”)– 26% concordance
broad criteria
monozygotic–87% concordance
dizygotic– 39% concordance

This is consistent with a recent study from the Kennedy Kreiger Institute at Johns Hopkins. While this wasn’t discussed by Dr. Insel, I include the abstract for that study below:

OBJECTIVES: To examine patterns of autism spectrum disorder (ASD) inheritance and other features in twin pairs by zygosity, sex, and specific ASD diagnosis. DESIGN: Cross-sectional study. SETTING: Internet-based autism registry for US residents. PARTICIPANTS: Survey results from 277 twin pairs (210 dizygotic [DZ] and 67 monozygotic [MZ]) aged 18 years or younger with at least 1 affected twin. MAIN EXPOSURES: Zygosity and sex. OUTCOME MEASURES: Concordance within twin pairs of diagnosis, natural history, and results from standardized autism screening. RESULTS: Pairwise ASD concordance was 31% for DZ and 88% for MZ twins. Female and male MZ twins were 100% and 86% concordant, respectively, and DZ twin pairs with at least 1 female were less likely to be concordant (20%) than were male-male DZ twin pairs (40%). The hazard ratio for ASD diagnosis of the second twin after a first-twin diagnosis was 7.48 for MZ vs DZ twins (95% confidence interval, 3.8-14.7). Affected DZ individual twins had an earlier age at first parental concern and more frequent diagnoses of intellectual disability than did MZ twins; MZ twins had a higher prevalence of bipolar disorder and Asperger syndrome and higher concordance of the latter. Results of autism screening correlated with parent-reported ASD status in more than 90% of cases. CONCLUSIONS: Our data support greater ASD concordance in MZ vs DZ twins. Overall higher functioning, psychiatric comorbidity, and Asperger syndrome concordance among affected MZ vs DZ twins may also suggest differential heritability for different ASDs. For families in which one MZ twin is diagnosed with ASD, the second twin is unlikely to receive an ASD diagnosis after 12 months. In addition, Internet parent report of ASD status is valid.

Concordance is when one child has an ASD, does the other one? 100% concordance would mean that if one twin has an ASD, the other twin does as well. That would indicate that autism is purely genetic.

Most people will concentrate on the monozygotic concordance. Even with the broad criteria, there is 87% concordance. That would indicate that at least some fraction of the cause of autism is not genetic. This is a very complicated question, as Joseph at the Autism Natural Variation blog has discussed.

What is astounding to me is the dyzogotic concordance. Take the 39% for the broad criteria. My recollection is that the concordance for siblings is about 4% if one sibling is male, and about 10% if one sibling is female. I’m trying to find the study on this. But, is there a higher concordance for dizygotic twins than for siblings in general?

Dr. Insel spends a fair amount of time on the genetic studies involved in autism. He attributes about 15% of the current autistic population as being linked to known genetic conditions. This is a pretty common estimate in the community.

One interesting fact: the known genes associated with autism are neurodevelopmental and involved with synapses. He even titles the slide as “Autism as a synaptic disease” and proposes that synaptic function might be the unifying feature of autism.

Dr. Insel notes that there are many chemicals whose neurotoxicity have not been determined. He also notes that there are some known chemicals which increase the risk of autism–valproic acid, Thalidomide and misoprostal. For all of these there is a critical window of time–in the first or early second trimester of pregnancy–where the autism risk is increased. Thalidomide, for example, is considered to be causal in a short period of time–from 20 to 24 days gestation.

If you want to see the direction Dr. Insel may take autism research in the future, these talks are worth listening to. I think it safe to say that autism research will continue to look for causes, genetic and environmental. Environmental cause research will likely focus on prenatal exposures. Study will continue on the physical structure of the brain, the “circuitry” to help define what autism is and what the phenotypes may be. Study will continue on interventions, with a look towards earlier interventions (before age 1, possibly before symptoms are visible). Intervention research will look to be tailored to the individual, which will require some way to phenotype autism.

As I noted above, I think Dr. Insel is taking a close interest in autism. He doesn’t dictate the goals for autism research, but I think listening to what he has to say gives in interesting insight into the directions it may be going.

Kathleen Sebelius and Francis Collins to speak at next IACC meeting

21 Apr

The Interagency Autism Coordinating Committee (IACC) will hold its next meeting on Friday, April 30. I checked the agenda for this meeting and found that Kathleen Sebelius, Secretary of Health and Human Services, and Francis Collins, Director of the NIH will be speaking.

The meeting will be videocast and available via telephone.

Here is the agenda for the next IACC meeting:

IACC Full Committee Meeting Agenda

Friday, April 30, 2010
9:00 a.m. – 5:00 p.m. Eastern

The Ronald Reagan Building and International Trade Center
Rotunda Room
1300 Pennsylvania Avenue, N.W.
Washington, DC 20004

Time Event
9:00 a.m. Registration

10:00 Call to Order and Opening Remarks

Thomas Insel, M.D.
Director, National Institute of Mental Health and Chair, IACC
10:05 Kathleen Sebelius
Secretary, Department of Health and Human Services

10:20 Welcome and Introductions of IACC Members

10:55 Francis Collins, M.D., Ph.D.
Director, National Institutes of Health

11:10 Break

11:25 Research Update: Autism Treatment Network
Geraldine Dawson, M.D.
Chief Science Officer, Autism Speaks

11:50 Research Update: Autism in the DSM-V
Susan E. Swedo, M.D.
Senior Investigator, Behavioral Pediatrics Section
Pediatrics and Developmental Neurospsychiatry Branch, NIMH

12:15 Lunch

1:30 Public Comments

2:00 Research Update: Stem Cell Talk

James Battey, M.D.
Director, National Institute on Deafness and Other Communication Disorders

2:25 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 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 Approval of January 19, 2010 IACC Committee Minutes

3:20 Update: Planning Subcommittee
Thomas Insel, M.D.
Director, National Institute of Mental Health and Chair, IACC

3:50 Break

4:00 OARC Update

* 2009 Summary of Advances
* IMFAR Update

4:20 Public Comments Discussion Period
4:50 Closing Comments
5:00 Adjournment

IACC conference call on the Strategic Plan

8 Apr

I just received this announcement from the IACC:

A Conference Call and Webinar of the Interagency Autism Coordinating Committee (IACC) Subcommittee for Planning the Annual Strategic Plan Updating Process

Please join us for a conference call and webinar of the IACC Subcommittee for Planning the Annual Strategic Plan Updating Process that will take place on Monday, April 19, 2009 from 10:00 a.m. to 12:00 p.m. ET.

No registration is required

Conference Call Access
USA/Canada Phone Number: 888-577-8995
Access code: 1991506

Webinar Access

The agenda for this conference call is to discuss plans for updating the 2010 IACC Strategic Plan for Autism Spectrum Disorder Research.

Please visit the IACC Events page for the latest information about the conference call, including access information, as well as all other IACC events.

For more information about the IACC, please visit

Now follow the IACC on Twitter (

The Contact Person for this conference call is:
Ms. Lina Perez
Office of Autism Research Coordination
National Institute of Mental Health, NIH
6001 Executive Boulevard, NSC
Room 8185a
Rockville, MD 20852
Phone: 301-443-6040
Please Note: This conference call may end before 12:00 PM if the discussion is completed ahead of schedule.