U.S. Department of Health and Human Services
Public Health Service
National Institutes of Health
National Institute of Mental Health
National Advisory Mental Health Council
Minutes of the 223rd Meeting
September 24, 2009
Minutes of the 223rd Meeting of the
National Advisory Mental Health Council
The National Advisory Mental Health Council (NAMHC) convened the open policy session of its 223rd meeting at 10 a.m. on September 24, 2009 at the Neuroscience Center in Rockville, Maryland, and adjourned at approximately 12:00 p.m. The NAMHC reconvened for a closed session to review grant applications at 1 p.m. and adjourned at 5 p.m. (see Appendix A: Review of Applications). In accordance with Public Law 92-463, the open policy session was open to the public. Thomas R. Insel, M.D., Director, National Institute of Mental Health (NIMH), chaired the meeting.
Council Members Present at the Grant Review and/or Open Policy Sessions
(See Appendix B: Council Roster)
Chairperson: Thomas R. Insel, M.D.
Executive Secretary: Jane A. Steinberg, Ph.D.
David G. Amaral, Ph.D.
Carl C. Bell, M.D.
Glorisa J. Canino, Ph.D.
Elizabeth Childs, M.D., M.P.A.
Robert Desimone, Ph.D.
Ralph J. DiClemente, Ph.D.
Howard B. Eichenbaum, Ph.D.
Daniel H. Geschwind, M.D., Ph.D.
Portia E. Iversen
Dilip V. Jeste, M.D.
Norwood Knight‑Richardson, M.D.
Pat R. Levitt, Ph.D.
David A. Lewis, M.D.
Thomas H. Mcglashan, M.D.
Steven M. Paul, M.D.
Enola K. Proctor, Ph.D.
Ex Officio Member:
John A. Ralph, Ph.D., National Naval Medical Center
Liaison Representative Present at the Open Policy Session:
A. Kathryn Power, M.Ed., Center for Mental Health Services
Rahn Bailey, National Medical Association
Andrea Barnes, National Foundation of Families for Children’s Mental Health
Stephanie Bernstein, Institute for the Advancement of Social Work Research
Alissa Bronsteen, Juvenile Bipolar Research Foundation
Thomas Bryant, National Foundation on Mental Health
Reuven Ferziger, Ortho-McNeil Janssen Scientific Affairs
Wendy Greene, European Congress on Radiology
Jim McNulty, Depression and Bipolar Support Alliance
Ann Michaels, National Foundation on Mental Health
Diana Morales, Mental Health America
Amy Pollick, Association for Psychological Science
Darrel Regier, American Psychiatric Association
Jon Retzlaff, Council on Social Work Education
Bette Runck, Science Writer
Candice Tate, National Coalition on Mental Health and Deaf Individuals
Brad Trotter, National Coalition on Mental Health and Deaf Individuals
Jill Wetzel, Infinity Conference Group
Open Policy Session: Call to Order and Opening Remarks
NIMH Director Thomas R. Insel, M.D. called the open policy session to order, welcoming all in attendance.
Approval of the Minutes of the Previous Council Meetings
Turning to the minutes of the May and July 2009 Council sessions, Dr. Insel asked if Council members had revisions or comments on the minutes. Carl Bell, M.D. asked for two minor revisions to the summary minutes of his presentation which he felt would more clearly represent his statements. With these revisions, the minutes were unanimously approved.
NIMH Director’s Report
The most significant agency-level news was that Francis Collins, M.D., Ph.D. has been appointed as the new NIH Director. Dr. Collins served as the director of the National Human Genome Research Institute (NHGRI) at the NIH from 1993-2008. With Dr. Collins at the helm, the Human Genome Project consistently met projected milestones ahead of schedule and under budget. This remarkable international project culminated in April 2003 with the completion of a finished sequence of the human genome. In addition to his achievements as the NHGRI director, Dr. Collins' own intramural research laboratory has discovered a number of genes with important therapeutic potential, including those responsible for cystic fibrosis, neurofibromatosis, Huntington's disease, a familial endocrine cancer syndrome, and, most recently, genes for type 2 diabetes and the gene that causes Hutchinson-Gilford progeria syndrome.
During his first few weeks as Director, Dr. Collins underlined five priority areas presenting exceptional opportunities for NIH-funded research:
- Applying unprecedented opportunities in genomics and other high throughput technologies to understand fundamental biology and to uncover the causes of specific diseases. Beginning this year, high-throughput technology will become widely available to enable the next generation of DNA sequencing, and extending from expression studies to epigenetics to small molecule screening and imaging. Dr. Collins emphasized the need for comprehensive approaches and stressed the need for developing improved computational technology, as well as a work force that draws from engineering, mathematics, and computational science.
- Translating basic science discoveries into new and better treatments. NIH is poised to play a greatly expanded role in translation. Dr. Collins advocates using public‑private partnerships and other mechanisms to enable and empower academic researchers to translate discoveries into interventions. Attention will also be directed to translating the anticipated explosion of new information garnered from stem cell research [including induced pluripotent stem cells (iPS cells), for which NIMH has led the way in funding].
- Putting science to work for the benefit of health care reform. Dr. Collins is interested in harnessing NIH infrastructure and expertise to contribute to improving the delivery of health care through several types of research: e.g., comparative effectiveness research; prevention and personalized medicine; health disparities research; pharmacogenomics; large-scale prospective studies; health information technology; and health research economics. The goal is to devise interventions that are more efficient, more accessible, and more effective than those available at present.
- Encouraging a greater focus on global health. Although already a priority at NIH, Dr. Collins intends to promote global health even more forcefully. The global health agenda is increasingly shifting from preventing acute infectious diseases to neglected tropical diseases and chronic non-communicable diseases and injuries, the latter of which are now responsible for more than half of all deaths in the developing world.
- Reinvigorating and empowering the biomedical research community. Dr. Collins will continue to develop his predecessor’s programs for stimulating innovation through multiple mechanisms, including the pioneer awards, new innovator awards, Exceptional, Unconventional Research Enabling Knowledge Acceleration (EUREKA) awards, and transformative research project grants. He has plans to reinvigorate the Common Fund, which supports the NIH Roadmap, among other projects, out of the Office of the Director. Dr. Collins also envisions programs to promote early career success, increased minority investigator participation, and the needs of the future scientific work force.
Enhancing Peer Review: Several of the planned changes to the NIH peer review process have already been implemented, notably the new 1-to-9 scoring system, where reviewers are asked to rate the overall impact of the application as well as each of the individual review criteria. The January submission due dates will reflect the next big change—that is, the shortening and restructuring of the application by aligning the structure and content of the application with the review criteria (e.g., 12-page R01 applications). More information on the new enhancements to peer review can be found at http://enhancing-peer-review.nih.gov/index.html .
Stem Cell Policy: The recently revised NIH stem cell policy has established clear guidelines that delineate how stem cells can be used and what types of research can be done. There are also guidelines in place detailing procedures for addressing specific concerns, and an advisory board has been convened to negotiate such issues. More information on these policies can be found at http://stemcells.nih.gov/Pages/Default.aspx .
Leadership changes: Bruce Cuthbert, Ph.D., recently accepted the position of Director of the Division of Adult Translational Research and Treatment Development. Before coming to NIMH, Dr. Cuthbert served as Professor of Psychology at the University of Minnesota. Prior to that, he had served as a program officer in the NIMH extramural program and is an expert on anxiety disorders and psychophysiology.
AIDS Prevention Summit: On September 20-21, 2009, NIMH invited experts to discuss how NIMH-funded research can help to reduce the incidence and spread of HIV/AIDS. This brainstorming summit was motivated by the reality that after 20 years of research and many successes, the overall incidence of HIV does not seem to be decreasing, making it imperative to find new approaches. Experts included scientific leaders already involved in HIV/AIDS research, leaders from potentially relevant fields (such as cognitive science and behavior change) not yet involved in the HIV/AIDS field, and advocates for people living with HIV/AIDS. The ultimate goal of the summit was to gather suggestions for new research opportunities and directions that will positively affect the current HIV/AIDS epidemic.
NIMH sought a range of new ideas from participants, such as their vision for new targets for robust behavioral interventions and ways to ensure widespread uptake of effective ones in the community. Participants shared their thoughts on how NIMH could optimally invest its research resources to rapidly achieve improved HIV/AIDS public health outcomes. Going forward, NIMH intends to focus its Division of AIDS and Health and Behavior Research specifically on AIDS, moving its portfolio on health and behavior research (including co-morbidity of mental and medical disorders, adherence, and stigma) to other divisions with related interests.
American Recovery and Reinvestment Act of 2009 (Recovery Act): The Recovery Act included an allocation of $10.4 billion in funds to NIH, $366 million of which has come directly to NIMH, approximately 90 percent of which has been committed. This infusion of money represents a unique opportunity to stimulate the economy by creating and preserving jobs, while advancing biomedical research. Additionally, Recovery Act funds will help jumpstart the research objectives laid out in the NIMH Strategic Plan, the Interagency Autism Coordinating Committee (IACC) Strategic Plan for Autism Spectrum Disorder (ASD) Research, and the Trans-NIH Plan for HIV-Related Research.
Dr. Insel reviewed how the Institute’s Recovery Act allocation was being spent, noting that approximately $16 million remains for new initiatives in fiscal year (FY) 2010. In terms of projects that have been funded or will be funded in FY 2009, approximately $72 million went to expand the payline for current projects; $30 million to supplements for other current projects; $65 million for Challenge Grants; $102 million for Grand Opportunity grants; $37 million for the ASD request for applications (RFA) on heterogeneity of the disorder; $11 million for the faculty recruitment initiative; and, $30 million to supplement contracts and to support the NIMH Division of Intramural Research Programs (DIRP). Dr. Insel noted that the NIH Office of the Director provided an additional $17 million for several of the best-scoring Challenge Grant awards and also contributed funds for comparative effectiveness research. Despite the new funding, the success rate for the Challenge Grants was below the 10th percentile; of the 890 applications assigned to NIMH, only about 82 were funded. The Institute looked to the Grand Opportunity grants to make a difference in three areas: very rapid sequencing efforts to explore the genetic architecture of mental illnesses; neurodevelopment genomics; and development of the first transcriptional atlas of the human brain, a historic effort that will enable molecular-level examination of how the human brain develops.
Other Recovery Act initiatives included a $10 million supplement to the U.S. Army Study to Assess Risk and Resilience in Soldiers (Army STARRS), the largest study of suicide and mental health among military personnel ever undertaken. Army STARRS investigators will identify modifiable risk and protective factors related to mental health and suicide. It also will support the Army's ongoing efforts to prevent suicide and improve soldiers' overall wellbeing. Another large contract seeks to fundamentally change the way schizophrenia is treated: the Recovery After an Initial Schizophrenia Episode (RAISE) project. The RAISE project will develop and test innovative and coordinated intervention approaches in the early stages of the illness when symptoms may be most responsive to treatment. Finally, the DIRP received Recovery Act funds to complete the construction of the Porter Neuroscience Building located on the NIH Bethesda campus.
Dr. Insel emphasized that the unusually large outlay of money over 2 years will be used to build needed infrastructure. It will also jumpstart initiatives and provide the framework for future research. The timing of the Recovery Act was fortuitous, since it came just as NIMH was implementing its Strategic Plan and as it was joining other Institutes and agencies in implementing the IACC Strategic Plan for ASD Research. He noted that he and other NIH leaders are concerned about what will happen when the stimulus funding ends.
FY 2009 Budget: Dr. Insel reviewed how the base budget expenditures in FY 2009 address the objectives of the Strategic Plan. Of the new and competing grants funded in FY 2009, 58 percent went to Objective 1: promote discovery in the brain and behavioral sciences to fuel research on the causes of mental disorders; 12 percent went to Objective 2: chart illness trajectories to determine when, where, and how to intervene; and 24 percent went to Objective 3: develop new and better interventions that incorporate the diverse needs and circumstances of people with mental illnesses. He noted that the smallest amount (6 percent) of funding went to Objective 4: strengthen the public health impact of NIMH-supported research. This area is a challenge to NIMH, and efforts will be made to increase funding of this objective.
Institute of Medicine (IOM) Prevention Report: Dr. Insel briefly summarized NIMH activities that address the recommendations of the 2009 IOM’s report, “Preventing Mental, Emotional, and Behavioral Disorders Among Young People: Progress and Possibilities.” One recommendation called for data collection and monitoring; the longitudinal mental health tracking system is underway, in collaboration with Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Disease Control. Another recommendation was to link neuroscience findings across the life span. Applications received in response to a NIMH RFA on the identification and characterization of sensitive periods in neurodevelopment, knowledge critical for personalizing prevention, are now being considered for funding. Major gaps in prevention science approaches and the study of dissemination and implementation of successful interventions, the topic of a third recommendation, are also being addressed by NIMH in collaboration with SAMHSA. New technologies to study the effectiveness of mass media and the Internet, a fourth recommendation, are also of concern to NIMH. In 2010, NIMH has plans to co-sponsor a workshop with the Agency for Healthcare Research and Quality to examine the effectiveness of new technologies, particularly for adherence to treatment. Finally, addressing a fifth recommendation, Recovery Act funds have provided opportunities to study comparative effectiveness and the economics of preventive interventions.
Discussion: Steven Paul, M.D., said he was most concerned with the issue of sustained funding after the Recovery Act funding ends. He asked what ideas have been proposed to soften the blow of reduced levels of funding. Dr. Insel said that he and other NIH leaders assume that 70 to 80 percent of the unfunded grants will be resubmitted in 2010, and then in 2011, both the unfunded and funded grants will come back. Unless the budget is increased, success rates are likely to be down to about the 13th percentile. To avoid that reduction in success rate, it may be necessary for NIMH to reduce the number of RFAs that are issued in 2011.
Elizabeth Childs, M.D., M.P.A., said that in addition to health care disparities among racial, ethnic, and socioeconomic subgroups, individuals with mental illnesses are another subgroup to be considered because they are not only disabled, they also die 25 years prematurely, on average. Very few subgroups have such a shortened life expectancy. She asked Dr. Insel to advocate that individuals with mental illnesses be recognized as a subgroup with major health care disparities in and of themselves. Dr. Insel mentioned that a public service announcement would be published and aired on the Internet and television, beginning in October 2009. Actress Glenn Close was involved in its production; Ron Howard produced it, and John Mayer provided the music.
Sharing Imaging Data in NIMH‑Sponsored Research Projects
Following a suggestion made at a previous meeting, Daniel Geschwind, M.D., Ph.D., summarized the issues pertinent to sharing imaging data generated through NIMH-supported research and suggested ways to improve how data are shared. Brain imaging data can contribute significantly towards achieving the goal of developing personalized medicine, and the NIMH Strategic Plan proposes a large investment in imaging research. However, few imaging studies in patient populations actually replicate each other.
In order to utilize imaging data better, combined data analysis and large cohorts are needed. Dr. Geschwind suggested that one approach to creating such cohorts is through establishing large networks of imaging research—a proactive, top-down approach. If not practical, an alternative is to make existing data available for secondary analyses. Such data sharing could open up an entire field, and he cited the genetics of ASD as one example where data sharing has had a major impact. Data sharing increases interaction among distinct fields that might not otherwise intersect, because data collected to test one specific hypothesis are often valuable for other purposes. There are many success stories and many examples, and although there are definitely some hurdles, they can be overcome, as they have been in other fields.
David Amaral, Ph.D., endorsed the need for larger sample sizes and emphasized the need for better quality imaging techniques and quality control procedures. Glorisa Canino, Ph.D., said there are several parallels with genetics that support the idea of data sharing. In terms of larger sample sizes, there also needs to be greater efforts toward inclusion of minority populations as research on multi-ethnic groups introduces additional heterogeneity that can lead to new and interesting findings. For example, new and rare genes have been found in some Mexican-American populations.
Dr. Paul suggested that NIMH consult with the National Institute on Aging, which for the last few years has sponsored the Alzheimer's Disease Neuroimaging Initiative, which has been very successful. Many of the issues identified in Dr. Geschwind’s presentation have been addressed by that group. Multiple scanner technologies, standard operating procedures, and quality control have been built in. So far, some 500 subjects have been followed longitudinally. Genetics data are now being overlaid on the imaging data. Dr. Paul noted that the consortium was funded through a public-private partnership. He advocated doing the same with an imaging sharing program at NIMH.
Robert Desimone, Ph.D., noted that some in the imaging community have argued that imaging results reported in the literature may contain false positives; the analyses are underpowered, resulting in inflated estimates and correlations. In addition to pooling data, greater emphasis should be given at the study-section level to power analyses and replication groups at the imaging site. Larger sample sizes are needed to achieve any kind of meaningful result. Dr. Geschwind agreed. He said that he would also like to see studies across diseases, as are being done in genetics. Pooling across disorders may uncover common etiologies.
Dr. Insel warned that the problem of heterogeneity cannot always be solved simply by increasing sample sizes. Genomics has demonstrated that as sample sizes grow larger, heterogeneity increases and signal can be lost. The lesson may be to stay with known pedigrees, stay within families, and preserve signals before making comparisons. This point is illustrated by the findings of as much as a 15-fold increase in the risk for Alzheimer’s disease among individuals with the ApoE4 gene, and yet that risk does not hold true for African Americans.
Dr. Insel also pointed out that preserving the original investigator’s rights to data for an embargoed period is a source of contention among genetics researchers. Some say that the data should be made public as soon as they are produced, while others argue for an embargo period of at least 9 months and up to 2 years. This is another issue that needs to be thought through in any plan for sharing imaging data.
Jean Noronha, Ph.D., Chief of Extramural Policy in NIMH’s Division of Extramural Activities (DEA), reported on the issues discussed at a meeting she convened of NIMH program staff who have portfolios with imaging studies, as well as others with experience administering databases. The group’s objectives were to consider ways to encourage and enable the secure sharing of imaging data from NIMH grants and clarify the considerations in developing a sharing plan for projects in which imaging data are collected.
The group identified three types of challenges in undertaking a plan for secure sharing of imaging data:
- There are costs incurred by either the investigator or the centralized data storage facility into which the data are entered.
- There are issues related to comparability of data and how they can be standardized given the complexities and variations in data.
- There are human-subjects issues, related to ensuring privacy and confidentiality of the data.
In an effort to address these challenges, the NIMH working group proposed an initial set of best practices, which Dr. Noronha summarized.
- Investigators should include sufficient funds in their applications to support data sharing.
- Existing databases may be used, and database managers should advise investigators on their costs.
- Standardization issues:
- Use standardized phantoms to allow comparability.
- Use a data dictionary (databases can share theirs).
- Establish quality control procedures.
- Provide documentation of imaging modalities, scanner specifications, and other relevant information.
- Human subjects issues:
- Consent forms need to address sharing of data beyond original research site.
- Establish de-identification procedures (e.g., how to de-identify facial image).
- Prepare a data use certification document and related policies.
Dr. Noronha concluded her report by describing the group’s ongoing work. Dr. Insel said he expected the data-sharing ideas to be helpful to Council members, particularly during the closed grant review session.
National Advisory Mental Health Council Interventions Workgroup Update
David Lewis, M.D., co-chair of the NAMHC Interventions Workgroup, said that the group’s mission is to address Strategic Objective 3 of the NIMH Strategic Plan, Develop New and Better Interventions for Mental Disorders that Incorporate the Diverse Needs and Circumstances of People with Mental Illness. It is the Council’s view that NIMH needs a coherent plan for new intervention development across the lifespan. The workgroup’s charge is to lay the foundation for developing the next generation of interventions for mental disorders, especially those that are preemptive and personalized. Dr. Lewis said that the group has broken down that charge into three sets of issues and tasks:
- Identify novel treatment targets and assess the efficacy of interventions directed against those targets from preclinical studies through phase III clinical trials. Targets should be defined broadly, to extend from molecules to neural circuits, to domains of function. Interventions are also conceived broadly to include medications, biologics, devices, and behavioral approaches.
- Determine how new interventions can be effective. Because the emphasis will be on personalized interventions, it will be necessary to pinpoint biomarkers or biosignatures that can be used to identify individuals who are most likely to benefit from the intervention. Preemptive interventions will also be sought, particularly those that can be introduced before symptoms appear. Such interventions must be assessed not only for their effectiveness but also for their potential risk of disrupting important developmental processes.
- As these first two sets of tasks progress, consider how NIMH can best work with other groups to develop the infrastructure necessary for this type of translational research. It may be necessary to advance or re-conceptualize partnerships with industry and components of academia to accomplish this goal.
Dr. Lewis praised the efforts of the workgroup and noted that members include representatives from academia, industry, regulatory agencies, and public interest groups—individuals with experience in drug development, device development, and the development of behavioral interventions for treating mental disorders. The group will hold a 2-day meeting in early October 2009 to focus on the first two sets of issues. Two months later the group will meet again to address the issue of how to achieve the goals identified in the first meeting.
Dilip Jeste, M.D. asked whether complementary and alternative medicine interventions would be included. Dr. Lewis said that a broad range of interventions would be considered. Dr. Jeste noted that interventions that have been shown to be effective have not always been implemented. Dr. Insel said that the Council’s report, “The Road Ahead: Research Partnerships to Transform Services”, was focused on implementation and NIMH continues to work towards implementing the recommendations of that workgroup.
Dr. Paul said that the pharmaceutical industry still has tremendous interest in finding new drugs, whether they are small molecules or biologics, for psychiatric disorders. A majority of patients are not adequately treated with current drugs. The problem has been finding new targets, broadly defined. He suggested that NIMH could help early in the process with target identification, target validation, and the proof-of-concept stage in human testing.
Ralph DiClemente, Ph.D., asked whether a subgroup should focus on HIV interventions. Dr. Insel said he thinks this is an issue that should be considered by a separate committee. With the exception of the neurological aspects of AIDS, HIV-medication development is primarily explored by the National Institute of Allergy and Infectious Diseases. Once this workgroup’s initial recommendations are established, further work may be possible on HIV.
Comments from Retiring Council Members
Dr. Insel acknowledged the contributions of Council members whose tenure ends on October 1, 2009: Glorisa Canino, Ph.D., Norwood Knight-Richardson, M.D., M.B.A., and Pat Levitt, Ph.D. Dr. Insel invited the departing members to address the Council.
Dr. Canino said that the 4 years of her tenure have passed quickly and that she has learned a tremendous amount. She noted that she would like to see a greater emphasis in the NIMH portfolio on mental health care, focusing on reducing the disparities in mental health for children, the elderly, and minorities. These three populations appear to be underrepresented in the NIMH portfolio. Dr. Canino asserted that the Institute should do more to encourage applications in these areas. Dr. Canino also called for greater transparency in funding decisions and continued evaluation of the recommendations of Council’s workgroups to examine the extent to which they have been accomplished.
Dr. Knight‑Richardson thanked Dr. Insel and the NIMH staff for their dedication to science and scientific endeavors. He then issued a series of challenges to both Council members and NIMH staff to continue to question science and decision-making processes and to continue to hold high expectations for NIMH staff and leadership, investigators, and the pursuit of science.
Dr. Levitt said that on contemplating his remarks, he recognized that he could not top Dr. Canino’s passion or Dr. Knight-Richardson’s erudition. Instead, he expressed his gratitude for his experiences serving on Council in verse.
Mr. Jim McNulty, Vice President of Peer Services for the Depression and Bipolar Support Alliance and a former member of Council, said he is concerned that industry seems to be backing away from finding novel therapeutics for serious mental illnesses, specifically schizophrenia, bipolar disorder, depression, and anxiety disorders. Mr. McNulty said that genomics offers hope, but he is concerned that the field does not yet know how to use the latest tools. He urged NIMH to speed up translational work.
Dr. Candice Tate, President and Chief Executive Officer of the National Coalition on Mental Health and Deaf Individuals, spoke about the need for research on the mental health of the deaf population. She said that because deaf individuals have been deprived of full access to language, their symptoms may be somewhat different from hearing individuals. Treatment may also need to be different. She asked the Council to support research to clarify these issues. Dr. Insel assured her that NIMH would follow up on her request, and he asked Kathryn Power for SAMHSA’s collaboration. Ms. Power said that the National Association of State Mental Health Program Directors (NASMHPD) has identified the mental health of deaf people as a priority. A meeting is scheduled for December 2009 to discuss needed research and service interventions. Dr. Tate noted that her organization is formally affiliated with NASMHPD and looks forward to working with Ms. Powers and NIMH.
Dr. Darrel Regier, Director of Research at the American Psychiatric Association and Executive Director of the American Psychiatric Institute for Research and Education, noted that he is concerned about the slow pace of translation of basic science into treatments. Collaboration among academia, government, professional associations, and industry is essential to find new treatments, identify targets, and move forward. One of the bridges connecting basic science with treatments is the Bayh‑Dole Act of 1980, which gave small businesses and others intellectual property rights to discoveries they made with Federal funding. That law served well in its early days when treatments for HIV/AIDS were being developed, but it may not be working well now. Dr. Regier urged the Council and NIMH to consider how this Act might need to be modified.
Dr. Insel responded that financial conflict of interest, which is the other side of the issue raised by Dr. Regier, is very much on the agenda at NIH and would be discussed further at the Council’s February 2010 meeting. An advance notice of proposed rulemaking was issued in the spring of 2009, and public comments were received through mid-July. Those comments are now being reviewed, and the proposed rule will be issued and available for public comment. A new policy will ideally be in place by next summer. He said that the goal is to avoid unintended consequences in changing the existing policy, which everyone seems to agree is flawed.
Ms. Alissa Bronsteen, representing the Juvenile Bipolar Research Foundation (JBRF), said that the Foundation is very concerned about the controversy and delay in research on bipolar disorder among the juvenile population. The difficulty of dealing with mental illness is compounded by the use of powerful drugs in children. Regardless, she and others who have children with bipolar disorder are concerned that another decade could pass with little guidance or instruction for pediatricians, who are on the forefront of diagnosis. She urged NIMH to increase funding for research on juvenile bipolar disorder.
Dr. Insel responded that NIMH has robust programs in juvenile bipolar disorder. Ellen Leibenluft, M.D., leads these efforts in the NIMH DIRP. In addition, NIMH has a large extramural effort within the portfolio of the Division of Developmental Translational Research. Dr. Insel noted that the NIMH Office of Constituency Relations and Public Liaison, under the leadership of Gemma Weiblinger, will make sure that JBRF becomes involved in the Institute’s outreach program for advocacy organizations and other stakeholder groups.
Dr. Insel adjourned the open policy session of the 223rd meeting of the NAMHC at approximately 12:00 p.m. on September 24, 2009. The NAMHC met in closed session to review grant applications at 1 p.m. and the meeting was adjourned at 5 p.m. on Thursday, September 24, 2009.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Thomas R. Insel, M.D., Chairperson
Summary of Primary MH Applications Reviewed
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE OF MENTAL HEALTH
NATIONAL ADVISORY MENTAL HEALTH COUNCIL
(Terms end 9/30 of designated year)
|Thomas R. Insel, M.D.|
National Institute of Mental Health
|Jane A. Steinberg, Ph.D.|
Division of Extramural Activities
National Institute of Mental Health
Carl C. Bell, M.D. (11)
Glorisa J. Canino, Ph.D. (09)
Elizabeth Childs, M.D., P.C. (10)
Jonathan D. Cohen, M.D., Ph.D. (08)
Robert Desimone, Ph.D. (11)
Daniel H. Geschwind, M.D., Ph.D. (11)
Raquel E. Gur, M.D., Ph.D. (08)
Peter J. Hollenbeck, Ph.D. (08)
Dilip V. Jeste, M.D. (10)
Jeffrey A. Kelly, Ph.D. (08)
Norwood Knight-Richardson, M.D., M.B.A. (09)
Helena C. Kraemer, Ph.D. (08)
Pat R. Levitt, Ph.D. (09)
David A. Lewis, M.D. (11)
John S. March, M.D., M.P.H. (10)
Enola K. Proctor, Ph.D. (10)
Suzanne E. Vogel-Scibilia, M.D. (08)
Ex Officio Members
Office of the Secretary, DHHS
National Institutes of Health
A. Kathryn Power, M.Ed.