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April 18, 2002
Good afternoon, I am Dr. Steve Foote, the Director of the Division of Neuroscience and Basic Behavioral Science at the National Institute of Mental Health (NIMH), a component of the National Institutes of Health (NIH). Also, currently I serve as the interim Executive Secretary of the Department of Health and Human Services (HHS), Interagency Autism Coordinating Committee (IACC) created under a provision of the Children's Health Act of 2000. I am also a member of the NIH's long-standing Autism Coordinating Committee (NIH/ACC). Today, I am accompanied by Anne Willoughby, M.D., M.P.H., Director of the Center for Research for Mothers and Children at the National Institute for Child Health and Human Development at the NIH.
Thank you for the opportunity to participate in this important and timely hearing on autism, a disorder that causes so much pain for too many families. The NIH is genuinely appreciative of the sustained attention that this committee has directed to the issue of autism research and I thank the Committee for its interest in the topic.
Current estimates indicate large increases in recent years in the numbers of individuals being diagnosed and receiving public services for autism spectrum disorders. Autism is a complex neurobiological disorder that persists throughout a person's lifetime, impairs ability to communicate and to relate to others, and is often associated with rigid routines or repetitive behaviors such as obsessively following schedules or arranging belongings in very specific ways. Current surveys show that autism occurs in all racial, ethnic, and social groups. Autism is heartbreaking, not only for the affected individual, but also for the impacted family. Families coping with this devastating illness are searching for answers about its causes, diagnosis, prevention, and treatment. Presently, there is no effective means to prevent the disorder, no fully effective treatment, and no cure. Research indicates that early intervention is critical for children with autism to gain maximum benefit from current therapies.
NIH has a long history of funding research on autism. Within NIH, five institutes are members of the NIH Autism Coordinating Committee (NIH/ACC), a long-standing internal body made up of all of the institutes that are conducting autism-related research. Members of the NIH/ACC include NIMH, the National Institute of Child Health and Human Development (NICHD), the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Deafness and Other Communication Disorders (NIDCD), and the National Institute of Environmental Health Sciences (NIEHS). In addition, a staff representative from the National Institute of Allergy and Infectious Diseases participates in NIH/ACC meetings. The NIH/ACC functions in a coordinating role for autism research activities funded and conducted by the NIH Institutes. Representatives from the NIH/ACC attend meetings of the IACC and conduct liaison activities between the two committees to ensure that IACC concerns and issues are addressed by NIH program staff. The NIMH and NICHD Directors, as co-chairs, provide oversight for NIH/ACC activities. Because NIMH has been designated to lead the implementation of the IACC, the NIMH Director also serves as chair of the IACC.
The main message of my testimony today is that the NIH has made substantial progress since the enactment of the Children's Health Act in further expanding and intensifying our autism research activities, and is on schedule for meeting the other responsibilities assigned to it through the Act.
The Children's Health Act of 2000, P.L. 106-310, signed into law on October 17, 2000, authorized the Secretary of HHS to conduct additional activities relevant to autism and pervasive developmental disorders, including expansion, intensification, and coordination of activities of the NIH with respect to research on autism; developmental disabilities surveillance and research programs; expanded information and education activities; and, establishment of an Interagency Autism Coordinating Committee. The Act also requires that an annual report be prepared and submitted to the Congress. The Secretary submitted the first such annual report in mid-2001, and the second annual report last month. The report summarizes the scope and intensity of autism-related activities across the HHS. My testimony will summarize and clarify the information within that comprehensive report.
Over the past few years, NIH has expanded autism research considerably and enhanced its coordination. The amount of NIH funding for autism research grew from $22 million in FY 1997 to $56 million in FY 2001. Specifically, the NIH spent the following amounts on autism research: $40 million in FY 1999, $52 million in FY 2000, $56 million in FY 2001, and plans to spend $65 million in FY 2002. In FY 2003, the President's Budget includes $70 million for autism funding. Plans for FY 2004 have not yet been developed. Thus, NIH is committed to the broad intensification of autism research efforts called for in the Act. This effort encompasses a large number of grants, contracts, and intramural research programs distributed across the NIH. From this broad spectrum of research activities, I have chosen a select few to emphasize today.
Behavioral Interventions Research
All of the NIH/ACC institutes conduct and fund behavioral research. Research to develop and test behavioral (i.e., psychosocial as opposed to pharmacological or biomedical) interventions for children with autism is an essential part of NIH's efforts to expand research programs in autism. At NIMH alone, funding devoted to testing psychosocial preventive and treatment interventions accounts for about three-fourths of the entire budget of the branch devoted to child and adolescent treatment and preventive intervention research. In 2001, of 18 funded grants in this branch, 14 involve research on psychosocial interventions. Behavioral interventions research in autism has also been expanded. In November 1999, a major workshop on treatment of autism was organized by the NIH/ACC and the U.S. Department of Education. A prominent part of the meeting was devoted to intensive behavioral and psychoeducational treatment in autism. The proceedings of the meeting were published in the Journal of Autism and Developmental Disorders (October 2000 issue), and the first three reports are entirely focused on behavioral research. In 2001, the NIH/ACC published a Request for Applications (RFA) with dedicated funding for "Development of Innovative Treatment Approaches to Autism" (MH-01-101). This initiative grew out of the 1999 meeting. As a result of this RFA, NIH awarded seven grants to institutions across the country in September 2001 to support the development and/or refinement of treatments for core and secondary symptoms of autism. Three of these grants focused on behavioral/psychosocial treatment approaches. The grants were funded through the NIH/ACC, with four Institutes contributing funds: NIMH, NICHD, NINDS, and NIDCD. The grants are for three years each, totaling $2.9 million dollars over the three years. The funded grants address psychosocial treatments for teaching speech, imitation, and joint attention skills; psychopharmacology for behavioral problems, emotional dysregulation, and cognitive deficits; and testing of an animal model of self-injurious behavior. Currently in the planning stages is a follow-up workshop for investigators, which will focus on progress in the field since the 1999 meeting. Methodological issues related to conducting behavioral and psychosocial interventions for children with autism, and potential solutions to barriers to conducting this research will be addressed. The workshop is being planned for the fall of 2002.
In addition to supporting the development of new and innovative treatments, NIH is also supporting research focused on studying the efficacy and safety of treatment interventions that are promising and that are commonly used in the community without adequate testing, or that are aimed at specific impairing symptoms such as compulsions, stereotypies, overactivity, and self-injurious and aggressive behavior. Both psychosocial and pharmacological interventions are being studied. Included in the research on psychosocial treatments, NIMH is currently supporting studies to test the effectiveness of a parent-delivered technique to teach joint attention skills, the use of visual stimuli to teach language to nonverbal children, and the impact on parents of involvement in an intensive parent training early intervention program. Similarly, NICHD is supporting work on treatment interventions through its Collaborative Programs of Excellence and several other research projects.
Medications trials in autism are ongoing in the autism Research Units on Pediatric Psychopharmacology (RUPP), a research network supported by NIMH contracts and devoted to testing promising pharmacological agents for the treatment of children and adolescents with autism and other pervasive developmental disorders.
The NICHD/NIDCD Network on the Neurobiology and Genetics of Autism
The NICHD/NIDCD Network on the Neurobiology and Genetics of Autism consists of 10 Collaborative Programs of Excellence in Autism (CPEAs) that link together more than 75 researchers in 26 universities and more than 2500 families of people with autism. This Network requires each CPEA both to conduct a cohesive, site-specific, multidisciplinary research program on the causes, brain structure and function, and clinical development in autism disorders and to participate in some trans-Network collaborative studies that no one project has the needed expertise and/or subject population to investigate individually. The CPEA Network is in turn linked to a six-nation European autism consortium. The CPEA Network is now studying the world's largest group of well-diagnosed people with autism for whom both genotype and extensive phenotype data will be available. In addition, because of their combined clinical and scientific resources, the CPEAs address urgent public health questions when appropriate, including the study of the neuropeptide secretin for treatment of autism and the study of regression or late onset autism. In November 2001, the results of another CPEA study on secretin were published, finding that patients with autism who received a form of secretin showed no statistically significant improvements in the core symptoms of the disorder when compared to those same patients receiving a placebo. NIH has solicited applications from CPEA sites for an additional 5 years of funding; these applications are currently undergoing competitive peer review. In addition, NIH will establish a data-coordinating center, designed specifically to expedite and maximize analysis of the data generated by the CPEA research projects and, where appropriate, other NIH-supported research activities. The NICHD and NIDCD plan to allocate $60 million over the next five-year period to sustain and enhance the CPEAs.
The NICHD/CDC Study on the Relationship between Autism and Vaccines
The NICHD and CDC are co-sponsoring a study of the possible association of symptoms of regressive autism with measles, mumps, and rubella (MMR) vaccinations. Regressive autism involves a relatively rapid onset of loss of a child's skills, typically involving loss of speech or words, but can include changes in social behavior or the onset of repetitive behaviors that can interfere with development. Regressive autism usually occurs during the second year of life. Among children diagnosed with autism, it is estimated that between 20-39 percent experienced regressive autism. The remainder of these children experience a more gradual development of symptoms related to autism. The MMR study, which began in September 2000, is examining the medical and developmental records of 1,600 well-diagnosed cases of autism (including regressive and non-regressive) and a large number of healthy controls to assess whether there is a temporal relation between receipt of the MMR vaccine (and possibly other vaccines) and the beginning of symptoms in early onset autism and regressive autism. The next phase of the study will use laboratory tests to assess the levels of measles antibody titers and to search for evidence of persistent measles infection in blood that could be attributed to the MMR vaccine in early onset and regressive autism cases and matched controls. Data have been collected on regressive vs. nonregressive autism at all of the CPEA sites. Those data are undergoing analysis; they are necessary to establish whether regressive autism differs from nonregressive autism, and along what dimensions, to ensure scientifically valid comparisons to normal controls.
Children's Centers for Environmental Health and Disease Prevention
The National Institute of Environmental Health Sciences (NIEHS) and the Environmental Protection Agency (EPA) have funded two new Children's Centers for Environmental Health and Disease Prevention that will focus research on potential environmental factors that may be related to autism. The centers each have been funded at $5 million, or approximately $1 million per year for five years beginning in August 2001. The new Children's Center at the University of California at Davis (UC Davis) will investigate how environmental risk factors may contribute to childhood autism. There has been speculation among both parents and health professionals that prenatal or early postnatal exposure to various metals or chemicals or even vaccines may trigger autism. To help address this concern, the Center's research will include a large case-control epidemiological study of various exposures and the development of autism. This Center will also conduct research to develop new animal models for studying social interaction and the impact of neurotoxicants on social behavior. Additional studies will focus on elucidating the cellular and molecular mechanisms by which specific neurotoxicants can perturb critical neuronal functions during development. The team of investigators will include scientists from the NIEHS Environmental Health Sciences Center at UC Davis and the NIEHS Superfund Basic Research program, also at UC Davis. The work will be carried out within the infrastructure of the UC Davis M.I.N.D. (Medical Investigation of Neurodevelopmental Disorders) Institute, which has a strong relationship with the autism advocacy community.
The newly funded Children's Center at the Robert Wood Johnson Medical School of the University of Medicine and Dentistry of New Jersey will seek to determine the possible influence of mercury, lead, and valproic acid (a drug commonly used to control seizures) on autism, learning disabilities, and regression. Studies to be conducted will look at critical windows for brain development in the forebrain and hindbrain and will attempt to link exposures or disturbances at these times to subsequent behavior. Researchers also will look for differences in genetic susceptibility of children to environmental toxicants. Researchers will use brain imaging to determine whether children with higher exposures to environmental toxicants have different patterns of brain growth and development.
Centers of Excellence
The Children's Health Act of 2000 also called for NIH to establish at least five Centers of Excellence in Autism Research. NIH took several steps in 2001 to begin implementing a program that will meet all of the specifications of the Act regarding the organization, scientific goals, and other activities of these centers.
To help interested groups of investigators prepare to submit high-quality applications to become autism centers, the NIH issued an RFA on "Developmental Grants for Autism Centers of Excellence" (see grants.nih.gov/grants/guide/rfa-files/RFA-MH-01-013.html). The NIH/ACC institutes jointly sponsored the RFA which was issued in April 2001 and was designed to provide developmental grants to teams of investigators to enhance their ability to plan, organize, and demonstrate the feasibility of their autism research efforts as they prepared applications for comprehensive center support over the following year. Through this method, NIH sought to optimize the chances that investigators who want to do research on autism would be successful in the highly competitive NIH peer review process. Each award under this RFA was for one year and a maximum of $100,000 for direct costs ($125,000 if multiple institutions were involved; thus, the total cost -- direct costs and facilities and administration costs -- of each grant would range from about $150,000 to $175,000). NIH anticipates that the developmental grants RFA will be a one-time solicitation. These developmental grants were intended for investigators who will submit grant applications later (by an August 2002 deadline) to support full autism centers of excellence. Six developmental grants were awarded by the targeted funding date of October 1, 2001.
NIH also implemented a parallel funding initiative intended for applicants who wished to apply immediately for full autism center of excellence support on an earlier timeline, without participating in the developmental grant process. To this end, NIH released, in mid-June 2001, an RFA (see grants.nih.gov/grants/guide/rfa-files/RFA-MH-02-001.html) that formally solicited proposals for comprehensive centers of excellence in autism research. These comprehensive centers will be called STAART (Studies to Advance Autism Research and Treatment) Centers. The RFA had a deadline for applications of November 29, 2001, and a number of applications were received. These applications underwent peer review in March 2002, and NIH anticipates beginning funding of successful STAART applications from this first round of competition in June 2002, with contributions from the NIMH, NICHD, NINDS, NIDCD and NIEHS. In addition, researchers who unsuccessfully applied for developmental grants or comprehensive center grants may submit a revised application for STAART center support by the August 2002 deadline. New applicants also may apply for STAART center support. Thus, applicants could compete for STAART support in one of three ways: (1) applying for a developmental grant in July 2001, with the intention of then applying for a comprehensive center grant in August 2002; (2) applying for a comprehensive center grant in November 2001, with the option to re-apply in August 2002 if unsuccessful; or (3) applying for a comprehensive center grant in August 2002.
NIH estimates that the total funds (direct costs and facilities and administration costs) available to support the STAART Centers Program when it is fully established in FY2003 will be $12 million per year. NIH will use this amount to fund the complement of at least five centers, a data coordination center, and collaborative projects among the centers. The Steering Committee of the STAART Centers Program will determine the exact nature of the cooperative studies.
Facilitation of Research
NIH has undertaken several activities to increase the quality and availability of genetic and tissue resources to the autism research community. The NIMH Genetics Repository has expanded its activities in the domain of collecting blood samples, creating cell lines, and distributing genetic materials to be used in autism research. This is a national resource that collects, stores, and distributes such materials very broadly across the scientific community. NIMH has also worked with a genetics data bank supported by an autism advocacy group, which resulted in a grant application that received high marks in peer review and has now been funded. This grant will support the continued activities of the genetic data bank, a resource that distributes genetic materials broadly to the autism research community. Also, NIH structured the RFA for the STAART Centers Program so that these centers, when funded, will become a national resource for genetics studies, greatly expanding available resources. The CPEA program also will continue its ongoing, extensive activities in the collection of genetic data within its research network. The NINDS continues to support promising research in the genetics of autism, including increased support for the development and expansion of genetics resources.
NIH Institutes have continued and expanded their support of existing tissue collection and distribution resources at several sites. Postmortem brain tissue offers a unique, high-resolution window into the inner workings of brain cells. Only with access to brain tissue can researchers uncover the underlying neuropathology of autism. NIH currently supports ongoing efforts at four tissue banks around the country to collect and make this vital resource available to researchers. Recently, NICHD awarded special supplements to target the acquisition of necessary biologic materials from individuals with autism for focused study. In addition, NIMH has just undertaken a funding initiative to enhance activities in this arena for several disorders, including autism. NIH also anticipates that the STAART Centers Program will provide resources for tissue-based research in autism.
The NIH is committed to bringing public views to our activities, programs, and decision-making; to conveying information about NIH to a broad public; and to seeking comment about our efforts and help evaluating our performance. NIH offers many opportunities for public participation, including the NIH Director's Council of Public Representatives meetings, the individual Institute council meetings (every institute has public members on its Advisory Council), and specially conducted public forums around the country. In addition, some Institutes solicit public participant reviewers on Scientific Review Groups for treatment and services research grant applications. NIMH also widely disseminated an invitation with nomination procedures to patients, consumers, family members, service providers, policymakers, and educators regarding serving as public participants. NIMH staff reviewed the nominations and chose public participants after a rigorous review process. Members of the autism advocacy community are among the public participants currently serving and offering highly relevant consumer perspectives on NIMH scientific review committees. The commitment to involving the public is being carried over to NIH's newest activities -- the review groups for both the STAART Centers and the CPEAs included members of the public.
For the last two years, NIH has held a special meeting with members of the autism advocacy community to exchange information. As a result of the first meeting, NINDS developed a listserv (now maintained by NIMH) of the e-mail addresses of advocacy group members, which continues to update those who register with news of interest to the autism community. Also, the National Library of Medicine's Medline Plus website for autism became a significant topic of discussion and increased effort in response to the autism parents meeting last year (medlineplus.nlm.nih.gov/medlineplus/autism.html). This is a searchable site with numerous links. It provides the latest news, information about research (with the ability to do a Medline search of the relevant scientific literature), names of autism advocacy organizations, information on rehabilitation and treatment, news on specific conditions such as Asperger's, information on related issues such as vaccines (with a link to the CDC), and links to the specific NIH/ACC Institutes:
Interagency Autism Coordinating Committee (IACC)
The Children's Health Act of 2000 established the IACC. Secretary Tommy Thompson delegated the authority to establish the IACC to the NIH in April 2001; NIH subsequently asked NIMH to take the lead for coordinating the activity of this important committee, whose primary mission is to facilitate the effective and efficient exchange of information on autism activities among the relevant government agencies and with advocacy and other groups focused on autism and related disorders, and to coordinate autism-related activities.
The Children's Health Act also permits the Secretary to appoint parents or legal guardians of individuals with autism or other pervasive developmental disorders to the Committee. Such appointments are necessary and vital to the conduct of the Committee's mission. In particular, public members of the IACC will bring to HHS and its member agencies the concerns and interests of members of the autism community. This kind of interactive, two-way communication is critical. The IACC serves as a forum and helps to increase public understanding of the member agencies' activities, programs, policies, and research, brings important matters of interest forward for discussion, and ensures that the voices of the parents and others advocating for those with autism are clearly heard. The Secretary appointed four public members.
Governmental agencies represented include the following: NIH/ACC members (NIMH, NICHD, NIDCD, NIEHS, and NINDS), CDC [the National Center on Birth Defects and Developmental Disabilities], the Administration for Children and Families [(ACF) the Administration on Developmental Disabilities], the Food and Drug Administration (FDA), the Agency for Toxic Substances and Disease Registry (ATSDR), Health Resources and Services Administration (HRSA), the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Department of Education.
In November 2001, the inaugural meeting of the IACC was held on the NIH campus and included the public members selected by the Secretary of HHS. A summary of the first meeting is posted on the NIMH Web site (see www.nimh.nih.gov/events/interagencyautism.cfm). The date of the second meeting, May 24, 2002, has been set. The IACC is on schedule to meet twice a year as set forth in the Act.
Report to Congress
Section 105 of the Act requires the Secretary of HHS to submit an annual report to Congress "concerning the implementation of this title and the amendments made by this title." The first annual report was submitted in July 2001. The second annual report was signed by the Secretary on March 12, 2002 and submitted to Members of Congress.
The NIH/ACC institutes are currently implementing the STAART Centers Program, competitively renewing the CPEA program, and implementing the activities of the IACC. I have described several other ongoing activities with respect to further research on vaccines and their possible relationship to autism. Enhancing the quality and coordination of autism research activities across the NIH and with other Federal Agencies -- in a way that is open and readily discernable by Congress, members of parent groups and other interested organizations -- remains of the highest priority.
That concludes my prepared remarks. I would be happy to answer any questions.
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Last revised: April 29, 2002