NAMHC Minutes of the 252nd Meeting

January 25, 2018

Department of Health and Human Services
Public Health Service
National Institutes of Health

Introduction

The National Advisory Mental Health Council (NAMHC) convened for its 252^nd meeting at 9:00 a.m. on January 25, 2018, at the Neuroscience Center in Rockville, Maryland. In accordance with Public Law 92-463, the policy session was open to the public until 1:10 p.m. The meeting was closed to the public from 2 p.m. to 5 p.m. for the consideration of grant applications (See Appendix A: Review of Applications). Joshua Gordon, M.D., Ph.D., Director, National Institute of Mental Health (NIMH), presided as Chair.

Council Members Present

(Appendix B, Council Roster)

Chairperson

Joshua Gordon, M.D., Ph.D.

Executive Secretary

Jean Noronha, Ph.D.

Council Members

• Rhonda Robinson Beale, M.D.
• Tami D. Benton, M.D.
• Randy D. Blakely, Ph.D.
• David A. Brent, M.D.
• Benjamin G. Druss, M.D., M.P.H.
• Ian H. Gotlib, Ph.D.
• Alan E. Greenberg, M.D., M.P.H.
• David C. Henderson, M.D.
• Michael F. Hogan, Ph.D.
• Richard L. Huganir, Ph.D.
• Lisa H. Jaycox, Ph.D.
• John H. Krystal, M.D.
• Marsha M. Linehan, Ph.D.
• Gregory A. Miller, Ph.D.
• Maria A. Oquendo, M.D., Ph.D.
• Elyn R. Saks, J.D., Ph.D.
• Hyong Un, M.D.

Ad Hoc Members

• Ricardo E. Dolmetsch, Ph.D.
• Cheryl A. King, Ph.D.
• Yael Niv, Ph.D.
• Neil J. Risch, Ph.D.
• Brandon Staglin

Ex Officio Members

Department of Defense

• Steven E. Pflanz, M.D.

Liaison Representatives

• Paolo del Vecchio, M.S.W.

Department of Veterans Affairs

• Amy M. Kilbourne, Ph.D., M.P.H.

NIH Staff

• Shelli Avenevoli, Ph.D.
• George Koob, Ph.D.
• David Murray, Ph.D

Others Present at the Open Policy Session

• Nancy Burke, Something for Kelly Foundation
• Randy Burke, Something for Kelly Foundation
• Elissa Chesler, The Jackson Laboratory
• Diana Clark, American Psychological Association
• Craig Fisher, American Psychological Association
• Dawn Gannon, Academy for Eating Disorders
• Patti Geolat, Something for Kelly Foundation
• Karen Gibson-Serrette, Longevity Consulting
• Steven Hyman, Presenter
• Michael Knopp, NIH Transcriber
• George Koob, Presenter
• Margie Lemay, NAMI, Vermont
• David Murray, Speaker
• Colleen Reilly, The Reilly Group, Inc.
• Kevin Roy, Autism Speaks
• Anika Smith, Longevity Consulting
• Stuart Spielman, Autism Speaks
• Claire Stroud, National Academy of Sciences
• Michelle Wagner, Science Writer
• Tracy Waldeck, Association for Psychological Science
• A.J. Walker, National Assoc. of State Mental Health Program Directors

Open Policy Session Call to Order and Opening Remarks

Joshua Gordon, M.D., Ph.D

Dr. Gordon welcomed the attendees to the NAMHC meeting and reminded everyone that the morning session was open to the public and members of the press. The Council then unanimously passed a motion to approve the final Summary Minutes of the September 14, 2017, NAMHC meeting.

NIMH Director's Report

Joshua Gordon, M.D., Ph.D.

Dr. Gordon stated that the 21^st Century Cures Act  that was signed into law in December 2016 provided multi-year funding through the NIH Innovation Fund for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN ) Initiative, the All of Us  Research Program, the Cancer Moonshot , and the Regenerative Medicine Program . The All of Us Research Program is currently recruiting participants through specific healthcare organizations. The NIMH Deputy Director, Dr. Shelli Avenevoli, is working to develop large-scale phenotyping in the Program to categorize behavior to evaluate the use of Research Domain Criteria (RDoC).

Dr. Gordon remarked that the overall NIH budget for 2017 increased by $2 billion, which translated into a modest budget increase at NIMH for funding of grant awards. NIMH was able to fund almost 600 awards with a success rate for applications of 21 percent. Funding early-stage investigators is a current NIMH priority.

Dr. Gordon provided a recap of some of the top leadership changes: Alex Azar was confirmed as the United States Secretary of Health and Human Services; Dr. Ned Sharpless is the new Director of the National Cancer Institute; Dr. Roderic Pettigrew resigned as the Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB); and Dr. Jill Heemskerk is currently serving as Acting Director of NIBIB. Dr. Pamela Collins left the NIMH Office for Research on Disparities and Global Mental Health to pursue her own research interests at the University of Washington. NIMH is currently considering applications to fill this director role. New positions are also opening for Extramural Program Officers that will be listed on the NIMH website.

Dr. Gordon noted that a number of NIMH staff have received awards and recognition. Dr. Bruce Cuthbert received the Society for Psychophysiological Research’s Award for Distinguished Contribution to Psychophysiology. Dr. Anna Ordoñez was elected to the rank of Distinguished Fellow by the American Academy of Child and Adolescent Psychiatry. 

Dr. Gordon announced the passing of a number of individuals from the NIMH community, including Dr. Dennis Murphy, Dr. Chuck Schulz, Dr. Pamela Sklar, and Dr. Ben Barres.

Dr. Gordon stated that in September 2017, NIMH’s Strategic Research Priorities were updated to include computational approaches, animal models and behavioral tests, and data sharing in human subjects grants, and emphasize rigor and reproducibility. In addition, the Interagency Autism Coordinating Committee released the 2016-2017 IACC Strategic Plan for Autism Spectrum Disorder  with 23 new objectives and a recommended autism research budget. 

Dr. Gordon discussed some policy changes to the NIH grant application process for clinical trial applications. NIMH now accepts “mechanistic clinical trials” under the NIH parent announcement and specific Funding Opportunity Announcements (FOAs). Investigators should consult with program officers to determine if their human subjects research qualifies as a mechanistic clinical trial by the NIH definition. 

The Office of Science Policy, Planning, and Communications (OSPPC) updated the NIMH website for the United States mental health statistics. Dr. Gordon encouraged participants to access the pages for customizable data that can be downloaded for use in presentations and publications including interactive graphs. 

Dr. Gordon then provided updates on the BRAIN Initiative. In Fiscal Year 2017, 110 BRAIN Initiative awards were made to over 178 investigators at 56 institutions. One particularly large effort is the BRAIN Initiative Cell Census Network , a project to create a census of all the cells in the brain and build an online atlas of their locations and physiological makeup that will enable research on the effects of disease on gene expression in particular cell types. Dr. Gordon noted that NIH is in search of a director for the BRAIN Initiative.

Dr. Gordon presented observations from an evaluation of the NIMH portfolio: (1) the balance has shifted in the past 10 years, (2) changing scientific priorities likely played a role, and (3) there are early signs of a reversal at least for some of those unintended consequences. Funding for the Division of Neuroscience and Basic Behavioral Science (DNBBS) that conducts mainly long-term investment research has gone up since 2007 while funding for medium- and short-term investment research in the Division of Translational Research (DTR) and the Division of Services and Intervention Research (DSIR) has slightly decreased. Dr. Gordon believes that this was a response to a shift to an experimental therapeutics approach, the launch of RDoC, and the completion of a number of large-scale trials. NIMH has since specifically requested applications for DSIR and has tailored new FOAs for the experimental therapeutics framework now including a separate FOA that invites research on behavioral and psychosocial interventions.

Discussion

Dr. Lisa Jaycox was concerned that as grants get more expensive due to rigor and reproducibility, the budget for funding other projects is cut. Dr. Gordon replied that in human subjects research grants are expensive as they have a per subject cost. Cutting their budgets would result in a reduction in the number of subjects. Therefore, when reviewing these types of grants, factors such as the number of senior collaborators should be considered as a potential way to reduce costs. Dr. Rhonda Robinson Beale suggested that metrics be developed to evaluate research impact and that NIMH needs to have partnerships and cross-accountability with agencies such as the Substance Abuse and Mental Health Services Administration (SAMHSA) that can help communicate research needs to the provider community. Dr. Gordon appreciated her comments and believed that metrics could be developed from an NIH-wide initiative to use natural language processing methods to evaluate grants. Drs. Neil Risch and Benjamin Druss also commented on the need for metrics. 

Dr. Marsha Linehan commented on the need to address psychology in addition to the biology. Dr. Gordon noted that many NIMH grants are focused on psychosocial interventions. 

Dr. Randy Blakely commented that the general public needs a clearinghouse for useful therapy treatment approaches. Dr. Gordon thought it would be a useful resource but noted that it would be challenging for a government institution to develop a list of approaches that work, not to mention a list of those that do not work.

Final Report: Council Workgroup on Genomics

Steven Hyman, M.D.

Dr. Steven Hyman remarked that the key issue the Council Workgroup on Genomics addressed is the application of the results of genomics studies to neurobiology and other uses such as the stratification of patients for psychotherapy trials. He stated that one of the hopeful outcomes of the report is to break down cross-disciplinary barriers in the translation of genetics to neurobiology and psychology and to help inform grant decisions in the future. Dr. Hyman stated that genes are highly influential in risk of mental illness. Schizophrenia, bipolar, major depression, and autism spectrum disorders are among the most genetically influenced of all non-Mendelian human disorders. However, the field has struggled to determine how to connect experimental models to the human disease. This results in the need for very large clinical trials which includes people who may not actually have the same illness or who never had a chance of responding to treatment. 

Since the last NIMH Genomics Workgroup convened in 1997, there have been significant technological advancements such as the development of inexpensive microarrays for the sequencing of millions of alleles and the study of rare variants. Schizophrenia was identified as a polygenic disease as discussed in the well-known 2014 Nature paper  in which 108 genome-wide significant loci were found. The authors have since studied close to 100,000 subjects and discovered about 280 significant loci, demonstrating how much is yet to be discovered. Dr. Hyman commented that this raises the question for NIMH of how far they want to push the science considering the cost. Another important question for genetic researchers is that many of our disorders have both shared and unshared genetic components. Dr. Hyman added that polygenetic risk analysis can assist in the identification of the brain cell types involved in different mental illnesses depending on which cell types express the high-risk alleles. Dr. Hyman explained that the Workgroup focused on genes of small effect because they hypothesize that polygenic risk converges on a far smaller number of pathways, molecular complexes, and cell types.

Dr. Hyman stated the first Genomics Workgroup recommendation is to continue the genetic analyses of serious prevalent mental illnesses to the point of significantly better informing biological follow-up studies, elucidating genotype-phenotype relationships, and providing tools to improve stratification in epidemiologic, basic behavioral, and clinical studies. The Workgroup does not expect the genome to map onto the Diagnostic and Statistical Manual of Mental Disorders (DSM). The second recommendation is to achieve a greater understanding of the non-coding genome considering that approximately 90 percent of common variation across genome-wide association studies (GWAS) is noncoding. The third recommendation is for NIMH to adopt shared, high statistical standards for significance across all NIMH-supported genetics research and its applications. The Workgroup recommended the abandonment of candidate gene and gene–environment interaction (G×E) studies of illness, cognitive, and behavioral phenotypes in favor of well-powered, unbiased association studies. All forms of genetic variation should be tested, including common and rare, high and low penetrance, coding and noncoding, single nucleotide variants, indels, copy number variations, and more complex forms of structural variation. 

The Workgroup also thought it was important to emphasize the need to capture both genetic and phenotypic variation across diverse populations both within the United States and internationally. The Workgroup believes that resources for the storage and sharing of diverse cellular systems such as induced pluripotent stem cells and embryonic cell stem lines, and organoids and animals are critical for genetics research. The Workgroup uniformly supports the need for animal studies in the investigation of gene function and the contributions of disease-associated alleles to pathophysiological processes. Finally, the Workgroup suggests the use of the term “experimental system” in place of “animal model of disease.”

Dr. John Krystal highlighted the point made by Dr. Hyman on the need to end candidate gene research. He added that the translation of polygenic risk into biology is in its early stages in many respects. The Workgroup therefore focused on infrastructure and methods development.

Dr. Elissa Chesler highlighted the critical role that animal genetics and cross-species bioinformatics offers, providing complementary strategies necessary to discover and characterize bio-behavioral mechanisms of psychiatric disorders and behavioral change. She felt that the Workgroup report should have better emphasized advances in animal behavioral systems genetics and its critical utility in the search for mechanisms of behavioral disorder. The diathesis-stress model implies that multiple genetic and non-genetic ideologies exist, particularly for heterogeneous diagnostic categories. It has become more widely appreciated that GWAS is not necessarily aimed at discovering causal variants in drug targets per se, but rather of discovering the major molecular networks predictive of pathological states. Discovery approaches in model organism genetic populations are cost-effective, provide mechanistic depth not limited to the association of genome and disease, and enable controlled characterization of phenotypes across developmental time and environmental exposures. She remarked that advances in animal models were insufficiently incorporated into the report. She stressed that although some historic animal models were built on face similarity to ill-defined human psychiatric conditions, construct-valid animal models do exist. Dr. Chesler concluded that advances in bioinformatics allow for the validation and generation of advanced models through comparative behavioral genomics. Elimination of model development may close a critical path to the translation of human genetic findings due to the important role of these models in preclinical efficacy testing. Dr. Chesler stated that in summary, the report lays out a compelling yet incommensurate strategy for harnessing genetics to discover and characterize the basis of psychiatric disorders.

Discussion

Dr. Risch remarked that there is still a need to be careful about the notion of high penetrant genes causing psychiatric disorders. He also cautioned against dismissing G×E studies entirely. Dr. Gordon confirmed that the report specifies that only "candidate gene by environment interaction" studies should be abandoned. Dr. Risch stated that the demand for a replication cohort has been filtering through the field, and although he felt that it was important, in his experience when the sample size is 10 times larger than any replication sample, there is no need to replicate. Dr. Risch’s final comment was that he still believes it is important to tie the diagnostic boundaries to treatment.  

Dr. Richard Huganir, a member of the Workgroup, agreed with the written report but has concerns regarding how the recommendations could be implemented at the program and study section level.

Dr. Ricardo Dolmetsch commented that it’s important to group genetic hits into clusters and hubs as a priority for polygenic disease. There is also a need to understand the natural history of people with specific kinds of variants, because the impact of that research will be more immediate. Dr. Dolmetsch added that his experience had taught him that the real issue with animal models is over-interpretation.

One Council member abstained from voting to approve. The remaining Council members voted to approve the report, and the motion to approve was passed.

National Institute on Alcohol Abuse and Alcoholism (NIAAA) Updates

George Koob, Ph.D.

Dr. George Koob, director NIAAA, began his presentation with a slide outlining the $250 billion a year that alcohol-related problems cost the United States. About 90,000 people die annually from alcohol-related causes ranging from drunk driving to drug interactions. Less than 20 percent of individuals with an alcohol use disorder receive treatment, and less than one in 10 receives a pharmacotherapy. The NIAAA funds 686 research project grants, 20 centers, 109 research career awards, and 305 training grants. The NIAAA Strategic Plan for 2017 - 2021 aims to identify mechanisms of alcohol action, pathology, and recovery; improve diagnosis and tracking; develop and improve prevention strategies; develop and improve treatments; and enhance the public health impact of NIAAA research. 

To highlight some current NIAAA research, Dr. Koob discussed new ways of diagnosing fetal alcohol spectrum disorder (FASD) with 3-D photography and image analysis techniques. NIAAA’s intramural research program is building off NIMH’s RDoC approach with domains within an alcohol use disorder. The domains are incentive salience for the binge-intoxication stage, negative emotionality for the withdrawal-negative affect stage, and executive function for the preoccupation- anticipation stage. He also presented research on an addiction neuroclinical assessment exploring associations of functional domains with neurocircuits. The results of the National Consortium on Alcohol and Neurodevelopment in Adolescence prospective cross-sectional study of about 800 adolescents are now being released. A high-risk enhanced community sample of adolescents from age 12 to 21 underwent annual assessments that included brain imaging, a comprehensive neuropsychological battery, and assessment of alcohol use and related problems. Individuals who during admission and the original screening were identified as excessive drinkers show weaker functional amygdala-precuneus connectivity than youth who were abstinent or low drinkers at entry. 

Dr. Koob stated that NIAAA’s Division of Medications Development conducts human laboratory screening studies to bridge the gap between preclinical and clinical trials. NIAAA changed their Small Business Innovation Research/Small Business Technology Transfer program to bridge the gap between basic and clinical research by facilitating studies leading to an FDA Investigational New Drug application. NIAAA also funded a challenge award for the development of an online, real-time, blood alcohol level monitoring system that is less bulky than the system currently used by the criminal justice system. The winning prototype can be worn on the wrist and detects alcohol in sweat. 

NIAAA has acknowledged emerging issues including that of alcohol and women's health, an increase in alcohol-related emergency department visits, a trend towards more binge drinking among individuals aged 65 and older, and the urgent need to grow the addiction medicine workforce. An FOA has been issued for alcohol-post traumatic stress disorder (PTSD) co-morbidity studies on models and mechanisms in collaboration with Cohen Veteran's Bioscience. In October 2017, the NIAAA Treatment Navigator ℠ was developed to help people find alcohol use disorder treatments. It outlines the features of an evidence-based alcohol use disorder treatment and describes the various routes to recovery.

Discussion

Dr. Robinson Beale questioned what criteria certified treatment specialists need to meet and how their success was measured. Dr. Koob indicated that NIAAA has objective measures for these specialists and they are identified on the SAMHSA and Psychology Today locators. Dr. Linehan commented that although a good therapist can treat those with alcohol use disorders, in her program they ask patients if they would rather talk to a computer. Dr. Koob concurred that motivational interviewing and cognitive behavioral therapy (CBT) are effective treatments for alcohol use disorder. 

Dr. Michael Hogan noted that alcohol and suicide combined kill more people than opioids. He asked what efforts have been made at NIH to increase the understanding of the opioid crisis and if there were any actions underway. Dr. Koob remarked that there is a big effort to address the crisis at NIH and a workgroup is being convened to evaluate research on the increasing national death rate resulting from alcohol poisoning, suicide, and opioid use.  

Concept Clearances

NIMH staff presented two initiatives to Council. Members were generally supportive during detailed discussions and asked a number of questions.

Lisa Gilotty, Ph.D.

Early Screening for Autism Spectrum Disorder

Dr. Lisa Gilotty stated that the goal of this concept is to develop and validate new screening methods for autism spectrum disorders (ASDs) that can be used in infancy. Evidence from NIH-funded research indicates that subtle signs of ASD can be detected in the first year of life. Despite these findings, the average age of diagnosis for ASD in the United States remains at approximately four years of age. Early intervention has been demonstrated to improve cognitive and behavioral outcomes for young children with ASD. 

The concept proposes to evaluate the sensitivity, specificity, and other psychometric properties of tools or methods to identify ASD risk in infants from birth to 12 months of age. While early stages of testing and development would likely be conducted in laboratory settings, demonstrating feasibility for future implementation in the general population and within the general pediatric clinical care setting are key. Applicants would be encouraged to utilize multimodal methods of determining ASD risk as well as to construct risk algorithms using single or multiple parameters using computational approaches.

Discussion

Dr. Ian Gotlib commented that it is not surprising that subtle signs of autism can be detected in the first year of life but not diagnosed until age four and that this may not be a reflection of the accuracy of the screening but rather the signs of a manifested disorder do not come out until age four or later. This raises the question of who should be screened. Dr. Walsh had mentioned siblings. A screening instrument will need to have more value than to provide a family history as two healthy parents can have an autistic child. 

Dr. Gotlib stressed that any tools that are developed for infants should be scalable to make basic correlations between brain and other markers and indicated that once autistic children are identified, steps towards prevention can be taken. 

Dr. Hogan questioned whether there is truly a lack of screening tools for ASD in infants considering that available screening tools are not widely used. Dr. Gilotty agreed that good screening tools are available to identify children at risk at 18 and 24 months of age but pediatricians and other practitioners do not routinely use them, even though they are recommended by the American Academy of Pediatrics. She pointed out, however, that screening methods for the first year of life are still needed. 

Dr. Tami Benton remarked that this work was extremely important. Pediatricians evaluate any new child that comes into their practice. Although there are screening tools to identify kids with a developmental risk, not all pediatricians are consistently trained to use those instruments. If the first time they see a patient is at age four, a couple of years of early intervention opportunities are missed. 

Dr. Dolmetsch suggested phrasing the concept as a means to prevent a specific set of symptoms as the diagnostic criteria for autism is so broad. Dr. Gordon clarified that the concept is an attempt to generate a screening tool. High risk children identified from the general population could then be entered into a research study and followed longitudinally. Dr. Gotlib imagined that multi-site machine learning could really make an impact. Dr. Risch suggested reviewing principles of newborn screening for metabolic disorders that have very high sensitivity. 

A motion to approve the concept was passed.

Robert Heinssen, Ph.D.

Research to Improve the Care of Persons at Clinical High Risk for Psychotic Disorders

Dr. Robert Heinssen remarked that the goal of the concept is to encourage researchers to test the feasibility and effectiveness of stepped-care interventions for persons at heightened clinical risk for psychosis. To accomplish the goal, NIMH envisions a multi-site randomized control trial that would develop and test interventions of varying intensity and duration that target psychosis risk, mood and anxiety symptoms, substance use, and compromised functioning. One of the rationales for implementing and evaluating research-based procedures in community practice settings is that screening, diagnostic, and risk stratification tools that can be used to identify individuals at risk in community clinics are already available. In addition, the field has moved in the direction of clinical staging models for psychotic disorders where lower intensity and lower risk treatments would be offered as the first line intervention. 

Discussion

Mr. Paolo del Vecchio noted that the concept investigates the effectiveness of psychosocial interventions. However, outreach and engagement efforts may be a challenge. 

Dr. David Brent asked whether NIMH was proposing one multi-site randomized controlled trial or was soliciting research to test different aspects of feasibility. Dr. Heinssen stated that a multi-site randomized controlled trial offers the opportunity to conduct a study that is much better powered than previous studies and could provide a more definitive test of the most promising treatments that the early research has already identified. Dr. Brent remarked that this is a perfect example of the utility of a health economics approach to evaluate the cost efficacy of the different means of preventing the onset of psychotic disorders. He also suggested consulting with a statistician to determine the number of sites and the target enrollment to guide the investigative team. 

Mr. Staglin asked if there was an interest in exploring new types of medication as part of the concept project. He also asked if funding could be allotted to additional community programs for clinical high-risk populations such as the current first episode psychosis SAMHSA block grant. Dr. Gordon stated that the concept proposes to implement proven approaches, but once established, a learning healthcare system will be created out of the community networks for first episode psychosis to continuously test new ideas. Dr. Heinssen remarked that the concept was more of an effectiveness study to test the feasibility of implementing approaches from the research base. He believed that NIMH had mechanisms to support more upstream research in the intervention development phase that would be appropriate for trials involving new compounds. 

A motion to approve the concept was passed.

NIH Office of Disease Prevention (ODP) Strategic Planning

David Murray, Ph.D.

Dr. David Murray, director of ODP, stated that the Office of Disease Prevention (ODP), in the Office of the Director and works across all of the ICs has a mission is to improve the public health by increasing the scope, quality, dissemination, and impact of prevention research supported by NIH. Dr. Murray commented that ODP manages the $100 million dollar Tobacco Regulatory Science Program . ODP is also the NIH liaison for the United States Preventive Services Taskforce , the Community Preventive Services Taskforce , and Healthy People 2020 . ODP also offers training and education programs and co-funds research projects, meetings, and workshops that support prevention research or methods. 

Dr. Murray presented on the five strategic priorities ODP is proposing for FY19-FY23. The first is to systematically monitor NIH investments in prevention research and the progress and results of that research. The second priority area is to identify prevention research gaps that warrant additional investment or expanded effort by the NIH. The third priority area is to promote the use of the best available methods in prevention research and support the development of better methods. ODP intends to continue to provide resources for review staff, identify methodologists for their panels, and provide training for program officers, program directors, other staff at NIH so that they can respond to questions from investigators on the new clinical trial requirements and particularly how they relate to the methods that are used in prevention research. The fourth proposed strategic priority is to promote collaborative prevention research projects and facilitate coordination of such projects across the NIH and with other public and private entities. Dr. Murray stated that the last strategic priority is advancing the understanding of prevention research. 

Discussion

Dr. Brent wondered where return on investment fits into the plan. Dr. Murray replied that return on investment fits into their first strategic priority. ODP has spent the past four years developing methods to automate the portfolio analysis. Prevention research NIH has been funding can now be accurately identified in terms of the return on investment. This will be a primary focus of the next five years. 

Dr. Hogan commented that developmental issues that lead to an inability to self-regulate coupled with early childhood trauma appear to be at the root of prevention problems. Dr. Murray replied that ODP has refrained from choosing content areas to focus on beyond the top 10 or 15 leading or actual causes of death. Dr. Gordon remarked that the issue is what research questions can be raised that might be of value to the policymakers. Dr. Krystal remarked that prevention efforts need to be directed at the parents before the children are born. Dr. Murray responded that the ODP Pathways to Prevention program is designed to prompt a literature and panel review of evidence and testimony on a specific topic and make recommendations for future research. 

Dr. Krystal remarked that prevention efforts need to be directed at the parents before the children are born. For example, through the identification and treatment of impaired, depressed, addicted, and violent mothers and fathers. 

Dr. Benton agreed that NIH needs to establish relationships between what they know broadly and more specifically. They know a lot about how trauma impacts people, but not everyone suffering from adversity and living in a dangerous neighborhood experiences trauma. She suggested a public health approach when investigating the mechanisms. Dr. Linehan recommended research into interventions for monitoring children in the home. 

Dr. Yael Niv asked whether NIMH defines abusive behavior as mental illness. Dr. Gordon replied that there is no DSM diagnosis for abuse. There are proven strategies to reduce an individual's risk of abusing their children intentionally or unintentionally.

Comments from Retiring Members

Retiring Council Members Dr. Brent, Dr. Huganir, Dr. Linehan, Dr. Oquendo, and Dr. Un expressed their appreciation for the opportunity to serve on the Council and thanked Dr. Gordon and NIMH staff.

Dr. Brent compared the Council to a requiem by composer Louis-Hector Berlioz that has four brass bands, one in each corner, plus the orchestra and the chorus. He praised the conductor for providing the leadership and listening to the discussions with a combination of humility and confidence. Dr. Huganir stated that he came to the Council with his own perspective on what direction the field should be moving in and has since learned from the diversity of approaches to address mental health. His parting advice was not to forget basic science. Dr. Linehan reflected on the Council’s interest in assisting younger researchers in their careers and thanked the Council for considering her comments on the need for psychological approaches. Dr. Oquendo praised NIH staff for their handling of contentious issues and making it easy for members to openly express their views. Dr. Un agreed that Dr. Brent’s metaphor of an orchestra was very apt. However, he challenged the Council and the staff with the issue that not everyone gets to hear the orchestra. In the community the orchestra is dissonant and disorganized.

Public Comment Period

Mr. Randy Burk of the Something for Kelly Foundation asked what the Council’s goal was in regard to eating disorders. Dr. Gordon answered that NIMH conducts research into eating disorders with the goal of better understanding and developing novel treatments to help sufferers reach recovery. He stated that he could further discuss this issue with Mr. Burk and referred him to the NIMH website for facts about eating disorders and their programs of study.

Adjournment

The open session of the NAMHC meeting adjourned at 1:10 p.m.

Closed Session

The grant application review portion of the meeting was closed to the public in accordance with provisions set forth in Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. appendix 2). The closed session was adjourned at 1:10 p.m.

Appendix A

Summary of Primary MH Applications Reviewed

Council: January 2018

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institutes of Health
National Advisory Mental Health Council
(Terms end 9/30 of designated year)

Chairperson

• Joshua A. Gordon, M.D., Ph.D.
  Director
  National Institute of Mental Health
  Bethesda, MD

Executive Secretary

• Jean Noronha, Ph.D.
  Director
  Division of Extramural Activities
  National Institute of Mental Health
  Bethesda, MD

Members

• Tami D. Benton, M.D. (19)
  Psychiatrist-in-Chief
  Department of Child and Adolescent Psychiatry And Behavioral Sciences
  Children’s Hospital of Philadelphia
  Philadelphia, PA
• David A. Brent, M.D. (17)
  Academic Chief
  Child & Adolescent Psychiatry
  Endowed Chair in Suicide Studies
  Professor of Psychiatry, Pediatrics and Epidemiology
  Director, Services for Teens at Risk
  University of Pittsburgh School of Medicine
  Pittsburgh, PA
• Randy D. Blakely, Ph.D. (20)
  Professor
  Department of Biomedical Sciences
  Charles E. Schmidt College of Medicine
  Florida Atlantic University
  Jupiter, FL
• Ricardo E. Dolmetsch, Ph.D. (Pending)
  Global Head of Neuroscience
  Novartis Institutes for Biomedical Research
  Cambridge, MA
• Benjamin G. Druss, M.D., M.P.H. (18)
  Rosalynn Carter Chair in Mental Health and Professor
  Department of Health Policy and Management
  Rollins School of Public Health
  Emory University
  Atlanta, GA
• Ian H. Gotlib, Ph.D. (20)
  David Starr Jordan Professor and Chair
  Department of Psychology
  Stanford University
  Stanford, CA
• Alan E. Greenberg, M.D., M.P.H. (20)
  Professor and Chair
  Department of Epidemiology and Biostatistics
  School of Public Health
  George Washington University
  Washington, DC
• David C. Henderson, M.D. (20)
  Chair
  Department of Psychiatry
  Boston University School of Medicine
  Boston, MA
• Michael F. Hogan, Ph.D. (18)
  Consultant and Advisor
  Hogan Health Solutions LLC
  Delmar, NY
• Richard L. Huganir, Ph.D. (17)
  Professor and Director
  Department of Neuroscience
  Investigator, Howard Hughes Medical Institute
  Co-Director, Brain Science Institute
  The Johns Hopkins University School of Medicine
  Baltimore, MD
• Lisa H. Jaycox, Ph.D. (20)
  Senior Behavioral Scientist
  Health Program
  Rand Corporation
  Arlington, VA
• Cheryl A. King, Ph.D. (Pending)
  Director
  Mary A. Rackham Institute
  Professor, Department of Psychiatry and Psychology
  University of Michigan
  Ann Arbor, MI
• John H. Krystal, M.D. (19)
  Robert L. McNeil, Jr. Professor of Translational Research
  Chair, Professor of Neurobiology
  Chief of Psychiatry, Yale-New Haven Hospital
  Department of Psychiatry
  Yale University School of Medicine
  New Haven, CT
• Marsha M. Linehan, Ph.D. (17)
  Professor and Director
  Behavioral Research and Therapy Clinics
  Department of Psychology
  University of Washington
  Seattle, WA
• Gregory A. Miller, Ph.D. (20)
  Professor and Chair
  Department of Psychology
  University of California, Los Angeles
  Los Angeles, CA
• Yael Niv, Ph.D. (Pending)
  Associate Professor
  Princeton Neuroscience Institute
  Department of Psychology
  Princeton University
  Princeton, NJ
• Maria A. Oquendo, M.D. (17)
  Ruth Meltzer Professor of Psychiatry & Chairman
  Department of Psychiatry
  Perelman School of Medicine
  University of Pennsylvania
  Philadelphia, PA
• Rhonda Robinson Beale, M.D. (19)
  Senior Vice President and Chief Medical Officer
  Blue Cross of Idaho
  Meridian, ID
• Neil J. Risch, Ph.D. (Pending)
  Director
  Institute for Human Genetics, School of Medicine
  Lamond Family Foundation
  Distinguished Professor in Human Genetics
  University of California, San Francisco
  San Francisco, CA
• Elyn R. Saks, J.D., Ph.D. Ad Hoc (Pending)
  Orrin B. Evans Professor of Law
  Gould School of Law
  University of Southern California
  Los Angeles, CA
• Brandon Staglin (Pending)
  Director of Marketing and Communications
  One Mind Institute
  Rutherford, CA
• Hyong Un, M.D. (17)
  Head of EAP & Chief Psychiatric Officer
  AETNA
  Blue Bell, PA
• Christopher A. Walsh, M.D. (19)
  Chief, Division of Genetics and Genomics
  Boston Children’s Hospital
  Bullard Professor of Pediatrics and Neurology
  Harvard Medical School
  Boston, MA

Ex Officio Members

Office of the Secretary, DHHS

Alex Azar
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health

Francis Collins, M.D., Ph.D.
Director
National Institutes of Health
Bethesda, MD

Department of Veterans Affairs

Amy M. Kilbourne, Ph.D., M.P.H..
Director
Quality Enhancement Research Initiative
Health Services Research & Development
Department of Veterans Affairs, Ann Arbor
Ann Arbor, MI

Department of Defense

Steven E. Pflanz, M.D.
Air Force Director of Psychological Health
Mental Health Branch Chief
Air Force Medical Support Agency
Fall Church, VA

Liaison Representative

Paolo del Vecchio, M.S.W.
Director
Center for Mental Health Services
Rockville, MD