NAMHC Minutes of the 257th Meeting

September 19, 2019

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council

Introduction

The National Advisory Mental Health Council (NAMHC) held its 257^th meeting at 9:00 am, September 19, 2019 at the Neuroscience Center in Rockville, Maryland. In accordance with Public Law 92-463, the session was open to the public until approximately 1:30 pm, and closed thereafter from 2:30 pm for consideration of grant applications. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair.

Chairperson

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

Executive Secretary

Jean Noronha, Ph.D.

Council Members Present

• Laura Almasy, Ph.D.
• Marjorie Baldwin, Ph.D.
• Tami Benton, M.D.
• Randy Blakely, Ph.D.
• Ian Gotlib, Ph.D.
• Lisa Jaycox, Ph.D.
• Cheryl King, Ph.D.
• John Krystal, M.D.
• Gregory Miller, Ph.D.
• Neil Risch, Ph.D.
• Rhonda Robertson Beale, M.D.
• Elyn Saks, Ph.D.
• Brandon Staglin, M.S.
• Sophia Vinogradov, M.D.
• Christopher Walsh, M.D.

Department of Veteran Affairs

• Amy Kilbourne, M.D., Ph.D.

Department of Defense (Ex Officio Member)

• Captain Michael Colston, M.D.

Liaison Representative

• Anita Everett, M.D.

Others Present at the Open Policy Session (Others Roster)

Council Members (Appendix B, Council Roster )

Open Policy Session Call to Order & Opening Remarks

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

NIMH Director, Dr. Joshua Gordon, opened the NAMHC meeting by welcoming Current Council Members, and the public. Dr. Gordon welcomed a new ex-officio member, Captain Michael Colston from the Department of Defense Health Services and Policy office. Following introductions, the Council unanimously passed a motion approving the final Summary Minutes of the May 30, 2019 meeting.

NIMH Director’s Report

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

Legislative Updates

Dr. Gordon updated participants and attendees on recent NIMH congressional activities. In June, NIMH hosted a staff delegation from the Mental Health Caucus , and, in July, Dr. Gordon and directors from other National Institutes of Health (NIH) Institutes and Centers (ICs) met with two Senate Appropriation Clerks. In September, the Freshmen Working Group on Addiction visited NIH to meet with NIH Director Dr. Collins and tour select labs. The delegation of members and staff engaged in discussion with Institute directors, including Dr. Gordon, and received a demonstration of transcranial magnet stimulation (TMS) at Dr. Sarah Lisanby’s lab. Additionally, the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee toured the NIH Clinical Center and reviewed research efforts related to the antidepressant effects of ketamine. Other NIMH staff continue to brief members of Congress on topics including post-traumatic stress disorder (PTSD), the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN ) Initiative®, the opioid crisis, and child mental health.

NIMH also remains engaged with stakeholder groups. In June, the NIMH director and deputy director met with the Mental Health Liaison Group. Dr. Gordon also participated in the 2019 Mental Health of America Annual Conference  on “Dueling Diagnoses” in June, and the NIMH Outreach Partnership Program (OPP) in July. Dr. Gordon explained that the OPP will no longer hold annual conferences, opting instead to open up outreach activities to conferences hosted by constituencies.

NIH/NIMH Budget

Bipartisan Budget Act of 2019  raised discretionary spending limits for 2020 and 2021. Dr. Gordon explained that because this budget agreement extends to the end of the sequester, which was set to end in 2021, NIMH will not be affected by the sequester unless it is renewed. The House also passed a series of budget bills, including a minibus package that would increase NIH funding by $2 billion. The Senate Appropriations Committee released its own draft version of the bill that would increase NIH funding by $3 billion with $200 million set aside for NIMH. Dr. Gordon hopes that the House and Senate will compromise to pass a bill for 2020.

NIMH has received four consecutive years of budget increases, allowing for an increase in the success rate for investigator-initiated grants. As a result, NIMH anticipates that grant funding will have a success rate of approximately 26 percent. A large number of awards are also being made through the BRAIN  Initiative 21^st Century Cures funds.

Dr. Gordon presented an updated portfolio analysis and funding trends through fiscal year 2018. First, he reviewed the funding by Division and Office. The bulk of extramural NIMH funds are spent through the Division of Translational Research (DTR) and the Division of Neuroscience and Basic Behavioral Sciences (DNBBS). While funds for the Division of Services and Intervention Research (DSIR) have been relatively steady over the last few years, funds for DNBBS have been trending upwards and funds for DTR have been trending slightly downwards. Dr. Gordon explained that these trends are caused by a shift in spending allocation for genetics funding, which was previously administered through the Office of Genome Research Coordination. When administration of genetics funding was moved to DNBBS, the funding distribution changed.

Dr. Gordon also reviewed NIMH funding by research area. Disease-related basic research, such as new treatment protocols, animal models, device improvement, and early-stage translation, makes up approximately 40% of funded research. Similarly, about 45% of the funds are allocated to therapeutics development and services. Although spending in this area decreased in recent years, funding for therapeutics development and services has returned levels typically observed in the past. This is largely due to an increase in Requests for Application (RFAs). Basic, non-disease-focused neuroscience research remains a slowly increasing minority of NIMH’s budget. NIMH funds for clinical trials continue to represent about 11% of the overall budget.

Priorities and Updates

Dr. Gordon reviewed changes to the OPP, a program that united affiliate organizations across the country to conduct outreach and dissemination activities. After a year of deliberation and planning, NIMH has decided to end OPP in April 2020 and replace it with more widely available resources and outreach efforts that target a more diverse array of organizations. These include a new education and awareness portal through the NIMH website and a public e-newsletter called Discover NIMH. NIMH will continue to provide stakeholders access to NIMH scientific information and the kind of patient education materials that had been provided to these groups.

Motivated by a 2018 report  from the National Academies of Science, Engineering, and Medicine about the prevalence of harassment against women and other minorities in the science workforce, the NIH has implemented an anti-harassment policy  and personal relationship policy . NIMH offers targeted training to staff and supervisors, who are now required to report all suspected incidents of harassment to the NIH Civil Program . NIMH has designated an institute official (Ann Huston) and an employee relations designee (Nicole Martino), both of whom can be contacted with concerns.

Finally, Dr. Collins, the Director of NIH, made a statement that he will no longer attend panels or meetings that are not sufficiently representative or inclusive. Dr. Gordon has joined Dr. Collins in this effort and will decline to participate in panels, workshops, and conferences that lack diverse representation. In recognition that diversity is key to scientific excellence, NIMH is committed to changing the culture and climate of biomedical research to create an inclusive and diverse workforce. Dr. Gordon encouraged all members of the NIMH community to adopt a similar policy.

Dr. Gordon also reviewed the activities of the Interagency Autism Coordinating Committee  (IACC). In July, the IACC held a workshop  to address the housing needs of people with autism spectrum disorder (ASD). The IACC is awaiting Senate renewal of the act that will reauthorize their activities. Each incarnation of the IACC requires reconstitution of the committee and subsequent member approval. NIMH anticipates the process of appointing new members and reassembling meetings will begin in the coming months.

NIMH Staff and Leadership News and Awards

NIH and NIMH are welcoming new leadership. NIMH is pleased to announce that Dr. Andrea Beckel-Mitchener, Ph.D. was selected as the Director of the NIMH Office for Disparities Research and Workforce Diversity (ODWD), where she previously held the role of Acting Director. Dr. Beckel-Mitchener also serves as the Director of the Office of Rural Mental Health Research (ORMHR). NIH also welcomes Dr. Debara Tucci, who was appointed Director of the National Institute on Deafness and Other Communication Disorders.

Several leaders at NIH are retiring. Dr. Paul Sieving, the Director of the National Eye Institute, retired at the end of July. Dr. Ann Cashion, Acting Director of the National Institute of Nursing Research, retired in September. Additionally, Dr. Linda Birnbaum, Director of the National Institute of Environmental Health Sciences, will retire in early October.

Dr. Gordon was saddened to announce the passing of two NIH colleagues: Dr. Donald Lindberg (Director of the National Library of Medicine) and Dr. Carl Bell (NAMHC member from 2008 to 2011 and professor of psychiatry and public health at the University of Illinois at Chicago). Both of these individuals were powerful leaders at NIH and NIMH, and they will be missed.

Policies, Progress, and Initiatives

The All of Us Research Program  was recently awarded a combined $9.1 million in funding to two organizations to further the Program’s extensive community engagement efforts. Dr. Eric Dishman will transition from Director of the All of Us Research Program to become the Program’s Chief Innovation Officer, though he will continue to run the Program while they search for a new Director.

Recently, a group of extramural investigators updated the BRAIN Initiative ’s initial strategic plan. They presented the update to the Advisory Council of the Director and are anticipating revisions and approval of the final versions in fall 2019. The BRAIN Initiative Neuroethics Working Group and the Multi-Council Working Group both met in August. Planning is already underway for a BRAIN Initiative investigator meeting, which will take place in June 2020.

The Helping to End Addiction Long-term^SM (HEAL ), or NIH HEAL Initiative, addresses the opioid crisis. With support from the NIMH Division of Service Intervention Research, NIH has received applications for an initiative to manage dual-diagnosis individuals, opioid addiction, and mental health issues in primary care settings. A number of grants have already been awarded, including $155 million awarded to 12 grants through the Justice Community Opioid Innovation Network . This multi-year innovation network will support infrastructure to improve the treatment of individuals with opioid use disorder in criminal justice settings.

Science Highlights

Dr. Gordon concluded his report by briefly reviewing NIMH-funded research efforts in the extramural community. NIMH-funded researchers used cutting-edge technology to target specific neurons and observe neuronal activity across layers of cortex. They demonstrated that there are cortical layer-specific dynamics that underlie perceptual experiences. Further, with support from the BRAIN Initiative, these investigators are developing novel holography technology that can stimulate light in four dimensions (including time) to record and play back neuronal activity.

Dr. Gordon also shared the work of NIMH-funded researchers who have developed a novel form of antiretroviral therapy (ART) that may be more effective at eliminating the virus in central nervous system (CNS) reservoirs. Their work has provided proof of concept that permanent viral elimination may be possible and has the potential to profoundly impact HIV treatment and the HIV epidemic.

Finally, Dr. Gordon highlighted efforts to develop universal early screening to identify individuals who will go on to receive a diagnosis of autism. NIMH-funded researchers examined the age at which providers are able to reliably diagnose autism. They studied autism phenotypes in toddlers over the age of 12 months to determine if features of the disorder are reliably and stably observed early in life. The researchers found that diagnosis becomes stable by 14 months of age, suggesting that there may be opportunities to test the impact of very early-age treatment of ASD.

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Discussion

Capt. Michael Colston, who parents a child with autism, pointed out that housing needs for individuals with ASD differ significantly by location and socioeconomic status. He asked about research gaps in adults with autism, and Dr. Gordon replied that research efforts in ASD have primarily focused on child populations. The NIMH has attempted to address this gap by creating a career development initiative that focuses on autism in later life and during the transition to adulthood.

Dr. Randy Blakely added that although early intervention is important, animal studies reveal behavioral changes in key traits that can be analogized to adult human behavior. Dr. Gordon agreed that these activities will be complex but valuable, and he highlighted the Autism Biomarkers Consortium, which is working with the U.S. Food and Drug Administration (FDA) to develop an electrophysiological biomarker for autism treatment development. Although this effort is not yet aimed at adults, they hope to translate it to adult treatment in the future.

Dr. Rhonda Robinson Beale asked about the strategy of investigator initiated applications versus targeted opportunities such as BRAIN Initiative and Research Domain Criteria (RDoC). She wondered which of these methodologies is producing outcomes that are best translated into practical treatment. Dr. Gordon said that different Institutes address this problem very differently—some focus their efforts primarily on investigator-initiated research, while others choose to engage in more targeted research. He briefly spoke about two successful studies that operated through different pathways. The development of brexanolone, a recently FDA-approved hormonal treatment for post-partum depression, was entirely investigator-initiated and moved along an untargeted pathway. On the other hand, NIMH used a targeted pathway to successfully develop a coordinated care package for clinical treatment of first-episode psychosis, which was implemented nationwide after Congress allocated funds to the Substance Abuse and Mental Health Services Administration (SAMHSA). Dr. Gordon concluded that neither pathway is superior and that both are necessary to advance science.

2020 NIMH Strategic Plan for Research

Julie L. Mason, Ph.D., Meredith Fox, Ph.D., and Joshua Gordon, M.D., Ph.D.

Dr. Julie Mason reviewed recent efforts to update the current NIMH Strategic Plan for Research. The 2020 Strategic Plan (SP2020) will remain a vision-level document with updates to reflect the current state of the science and the current research landscape. SP2020 will also incorporate the Strategic Research Priorities into the main plan. The new Plan will also maintain the existing structure with four main goals as previously described: 1) Define the mechanisms of complex behaviors; 2) Chart mental illness trajectories across the lifespan; 3) Strive for prevention and cures; and 4) Strengthen the public health impact of NIMH-related research.

Dr. Mason reviewed the current structure of the Plan. The Plan will include a Director’s Message, an overview of NIMH, and a description of how the Institute serves as an efficient and effective steward of public resources (including priority setting, rigor and reproducibility, portfolio management, accountability, and collaborations with stakeholders). A new section of the plan will address challenges and opportunities in mental health research, such as suicide prevention, mental health equity, digital health technology, genetics, and neural circuits. In addition, cross-cutting research themes will cover areas such as prevention, environmental influences, translation, and the research workforce.

Dr. Mason also reviewed the SP2020 dissemination plan. NIMH aims to reach a wide audience using a multipronged approach of press releases, listserv messages, social media, video clips, live events, and other awareness campaigns. The community will be proactively engaged by distributing materials and presentations at national meetings and conferences. These resources will also be shared through a new education and awareness portal, which will be available on the NIMH website.

Dr. Mason concluded by thanking Dr. Rachel Scheinert and Dr. Collene Lawhorn, who have been instrumental in developing the SP2020.

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Discussion

In advance of this meeting, Council members were asked to provide feedback on a draft of the 2020 NIMH Strategic Plan for Research. Dr. Gordon led the discussion, which was divided into five topic sessions. In general, every commenter expressed approval and support for the SP2020 before providing specific feedback.

Topic 1: Overview of NIMH

Dr. Gordon asked Dr. John Krystal and Mr. Brandon Staglin to comment on this portion of the plan.

Dr. Krystal began by highlighting areas for improvement in the Overview section. First, he asked the Council to consider that a monitoring plan to ensure that NIMH effectively addresses the needs of diverse and underrepresented populations in the science workforce. He also pointed out challenges related to integrating genetics into biology. Dr. Krystal noted that although SP2020 highlights the value and activities of the intramural research program, it does not adequately clarify differences between the intramural and extramural research programs. Finally, he pointed out that SP2020 does not list biotechnology or pharmaceutical companies as potential partners, and he suggested considering partners outside of NIH, including Veterans Affairs, the Department of Defense, SAMHSA, and the FDA.

Mr. Staglin also provided his recommendations. He mentioned language in the SP2020 regarding NIMH’s goal to “enforce data-sharing” and wondered if investigators must commit to data sharing in order to receive funding. Mr. Staglin also pointed out that although language of “diagnosis, treatment, and prevention of mental illnesses” is appropriate in the short term, NIMH should also include “cures” for mental illness as a long-term goal. He suggested that the SP2020 should clarify the worldwide health burden of mental illness and the importance of improving cost-effectiveness and affordability of interventions. Mr. Staglin recommended including specific research opportunities, including neuromodulatory interventions and the role of microglia and the immune system.

Dr. Robinson Beale pointed out that although the SP2020 relies heavily on the term “mental illness,” there is a need to clarify the language by explicitly defining the terminology, with an emphasis on brain development, dysfunctional behaviors, and preventive strategies.

Dr. Blakely expressed the opinion that although the SP2020 clearly advocates for inclusivity among the NIH community, the Plan does not strongly emphasize the importance of gender and racial/ethnic diversity in the research subject pool. He pointed out the need to fund studies that consider broader genetic backgrounds and aim to understand how molecular- and circuit-level disease backgrounds vary by sex. He encouraged NIMH to add a section that addresses these issues.

Dr. Sophia Vinogradov suggested that cross-cutting research themes could also include development and resilience.

Dr. Anita Everett suggested that the SP2020 should include sophisticated statistical analyses to determine large-scale scalability of interventions, which would guide and accelerate states and large health systems towards successful implementation. Dr. Gordon noted that the section on accelerated public health impact should be amended to adequately address these issues. Dr. Everett pointed out that they could analyze data already generated by projects like PCORI. 

Topic 2: Goal 1. Define the Brain Mechanisms Underlying Complex Behaviors.

Dr. Gordon asked Dr. Laura Almasy and Dr. Randy Blakely to comment on this portion of the plan.

Dr. Almasy said that although some of the goals outlined in SP2020 are ambitious (in particular, analysis of genome-wide and phenome-wide environmental interactions), these goals support tool development in several areas, including statistical genetics. She suggested language related to inclusion and diversity also be included in multiple sections by adding language such as “in diverse populations.” She also recommended that the SP2020 should encourage investigators to examine sex-specific effects in genetic studies.

Dr. Gordon reminded the Council and extramural community members that NIMH routinely funds research that seeks to analyze existing data sets and build tools for data analysis.

Dr. Blakely recommended that the SP2020 should include a stronger statement on the need to utilize animal models in research. He also commented on the overall topic of genetic research and translation into mechanisms, suggesting that he would like to see an emphasis on complex questions related to ascertaining large scale populations of individuals who meet criteria for genome-wide studies. Dr. Blakely emphasized the importance of understanding mental illness as a complex, multi-variable phenomenon. To this end, he recommended that the SP2020 should discuss the complicated risk factors and the conditional genetic penetrance associated with mental illness.

Dr. Christopher Walsh said that this section of the SP2020 is vague about the species that will be used in animal models. He pointed out that the Genomics Work Group agreed that animals are good models of molecular changes but are ineffective for modeling human behavioral changes. For this reason, he recommended that the SP2020 clarify the importance of studying the human brain directly through postmortem brain collection.

Dr. Gordon asked Dr. Linda Brady to comment on the Councilmembers’ feedback about animal models. Dr. Brady agreed that animal models are important for understanding how underlying mechanisms in the brain inform the development of mental disorders.

Dr. Sarah Lisanby added that NIMH has significant investments in postmortem studies and is investing in noninvasive technologies to study the living brain.

Dr. Blakely said that in order to achieve these ambitious goals, NIH should address challenges related to training scientists to transition from animal to human models. Currently, the pipeline of clinical researchers who can work towards these goals is underpopulated. In response, the SP2020 could address these issues and incentivize early career training.

Topic 3: Goal 2. Chart Mental Illness Trajectories Across the Lifespan

Dr. Gordon asked Dr. Ian Gotlib and Dr. Lisa Jaycox to comment on this portion of the plan.

Dr. Gotlib presented three points for the Council to consider. First, he recognized that years may elapse between the presence of markers and the onset of a mental disorder, and he pointed out a need to invest in research that does not produce psychopathology outcomes within five years of the grant. He suggested that the SP2020 should emphasize the role of non-diagnostic biomarkers that precede the onset of mental disorders. Second, he recommended developing a plan to integrate domains of cognition and behavior, perhaps by developing Requests for Applications (RFAs) for integrating data across domains. Last, Dr. Gotlib suggested partnering with other institutes such as The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to strengthen studies related to normative development.

Dr. Jaycox expressed her concern that the title of the section, “Charting Mental Illness Trajectories,” does not adequately capture the complexities of these goals. She pointed out that the cross-cutting research theme of environmental factors fails to include important issues such as discrimination, gun violence, and natural disasters. Dr. Jaycox suggested that the SP2020 should more clearly define issues related to stress, trauma, risk, and resilience—and how these factors interplay with biological vulnerability to mental disorders.

Dr. Tami Benton pointed out that Goal 4 includes some of these psychosocial factors, and there might be an opportunity to integrate these issues in other sections. Dr. Robinson Beale noted that mental health is receiving increased attention in the field, so there is a need to increase the numbers of providers who can meet these needs in clinical settings.

Topic 4: Goal 3. Strive for Prevention and Cures

Dr. Gordon asked Dr. Cheryl King and Dr. Sophia Vinogradov to comment on this portion of the plan.

Dr. King commented on prevention versus intervention. She appreciated that the plan moves beyond diagnostic status and symptom severity to consider a broader range of impactful outcomes. She pointed out that approaches to public health, early prevention, and risk identification are mentioned at the beginning of the section but are not integrated in the remainder. Dr. King felt that this section of the SP2020 is targeted more specifically for patients and individual treatments rather than a general public health approach.

Dr. Vinogradov pointed out that clinical syndromes likely arise from multiple interacting circuit anomalies. As a result, treatments may need to engage several mechanisms simultaneously. She noted that computational modeling can be a valuable tool for developing these complex treatments. Dr. Vinogradov urged the Council to consider approaches that are matched to diagnostic categories, which should include input from patients and family members. There is also an ongoing need to incentivize patients to engage fully with the recommended treatment or intervention. She added that specific strategies to tailor treatments should include selection of clinical targets within specific age ranges, sex, gender, and neurotype.

Dr. Krystal pointed out that focusing interventions at the early stages of the lifespan may have a larger impact than end-stage interventions. Dr. Lisanby agreed that the public health approach naturally integrates with new efforts to understand the precursors to end-stage illness. She said that although ending the suffering associated with mental illness remains a priority, there may be a need to rank priority.

Dr. Robert Heinssen suggested using new technologies to track populations longitudinally and use big data approaches to evaluate the broad impacts of early-stage interventions.

Dr. Robinson Beale pointed out that depression has widespread and devastating impact in terms of the large population it affects and the significant disability it can cause. She suggested adding depression to the list of priorities.

Mr. Staglin commented on the importance of tailoring interventions for patients and their families. Providers need to pay attention to the issues that interest families and impact patients’ daily functioning. Qualitative interviews may be a valuable tool to determine these areas of interest.

Dr. Marjorie Baldwin expressed surprise that the SP2020 does not mention families as part of its public health approach. Families supporting loved ones with mental illness experience disproportionate burden, causing health equity concerns. Dr. Vinogradov suggested that the SP2020 address these health equity issues by adding language about the burden of mental illness on families.

Topic 5: Goal 4. Strengthen the Public Health Impact of NIMH-Supported Research

Dr. Gordon asked Dr. Benton and Dr. Robinson Beale to comment on this portion of the plan.

Dr. Benton reviewed the topics under this goal, including health care financing, health care policy, health care delivery, payers, policy and financing, and community advocacy groups. She appreciated that the SP2020 recognizes that individuals with mental illness are overrepresented among minorities, disadvantaged populations, children, and the elderly. As a result, they experience additional barriers to access, recognition, and resources. She pointed out this goal may face implementation challenges because “strengthening public health impact” falls outside the purview of traditional scientific research. Dr. Benton said that the document will benefit from its focus on expanding implementation of evidence-based practices and their translation into existing systems of care, with an emphasis on identifying barriers to effective implementation. She also pointed out the importance of partnering with external organizations and using data analytics to support community practices. She suggested that the SP2020 should expand focus on disparate populations to include people experiencing instability in housing, income, employment, and food security. Additionally, there is a need to study low-cost providers, such as peer providers, to identify potentially effective interventions and components of care. All of these efforts can be supported by electronic tools and decision-making models, but smaller rural communities may not have access to online resources. Finally, this goal will be supported by mechanisms that improve access to care networks and promote activities with long-term cost benefits. There is a need to incentivize investments with long-term payoff, even if there are small up-front costs in the short-term. Dr. Gordon asked how to translate these many concerns about the health care system into research questions that could be substantiated in the SP2020. Dr. Benton suggested strengthening the strategies that are already proposed to capture issues of translation and implementation in community systems.

Dr. Robinson Beale suggested renaming this section to “Strengthen the Knowledge and Mechanisms for Public Health Impact of NIMH-Sponsored Research.” She agreed with Dr. Benton’s points about implementation and added that transition is another prominent challenge. Value-based contracting is another major consideration for provider payment. Capitated systems lack regulations and rules that contain costs, putting provider systems at risk by asking them to make decisions about cost of care. There is a need to consider if a given health system is operating on a fee-for-service structure, a capitation arrangement, or a per-member per-month (PMPM) structure. Payers recognize that these restrictions tend to limit not only the quality of care, but innovative thinking that can improve payment structures.

Dr. Robinson Beale emphasized the importance of population, partnerships, and repositioning roles during transitions. She noted that funder-organization relationships require cross-entity accountability in order to function. Dr. Robinson Beale also recommended that the SP2020 reinforce the importance of partnerships by shifting the language from “encouraging partnerships” to “requiring partnerships.” She pointed out that researcher-provider partnerships can be critical for data access, and can help to develop successful structures and outcomes.

Dr. Krystal briefly mentioned the relationship between mental illness and the criminal justice system, and pointed out a need for a research agenda to address gaps in the mental health workforce. Dr. Gordon responded that they will discuss two grants related to this topic during the closed discussion session. Dr. Robinson Beale expressed excitement that NIMH is capitalizing on its strengths to address these issues using existing technologies and methodologies.

Dr. Everett pointed out the need to build an evidence base for techniques that enhance the widespread implementation of known best practices.

Dr. Vinogradov referenced Dr. Krystal’s earlier comment and agreed that the criminal justice system is an important stakeholder to consider. Dr. Jaycox said that schools are an important partner, too.

Dr. Gregory Miller pointed out some inconsistencies in the SP2020. He felt that the document too strongly emphasized a singular biological understanding of mental illness, and pointed out that content about genes makes little reference to gene expression. He suggested that the SP2020 should include more discussion of the complex interplay of the biological and psychological. Dr. Miller also added that the plan could include more information NIMH’s “global footprint” and the Institute’s overall benefit to the United States.

Dr. Neil Risch commented on the importance of studying the role of genetics and mental disorders in families.

Dr. Robinson Beale talked about the importance of global mental health studies. She said that processes can be translated and applied to rural communities in the United States.

Dr. Gordon asked the Council to review and submit their electronic comments to ensure inclusion in the document before it is submitted to the public. He encouraged the members to disseminate the SP2020 to their constituencies and solicit feedback.

Concept Clearances

Fine Mapping Genome-wide Associated Loci to Identify Causal Variants,

Alexander Arguello, Ph.D.
Division of Neuroscience and Basic Behavioral Science

Dr. Alexander Arguello talked about the complexity of psychiatric disorders and the importance of mapping of regions of the genome to specifically pinpoint variants and causal mechanisms. This effort will reduce noise within existing genome-wide association studies (GWAS) and provide the results as a resource for fine-mapping causal genetic mechanisms that drive certain neuropsychiatric phenotypes, such as schizophrenia. NIMH encourages a number of mapping approaches including statistics, functional genomics, and diverse ancestry studies.

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Discussion

Dr. Risch talked about the advantage of coding genetic variants. He pointed out that most of the variation exists outside of the coding region of a gene, presenting a challenge for GWAS. He suggested adding nuance to the concept by investigating multiple variants at once rather than focusing on one locus at a time. Dr. Almsay agreed, adding that this effort could significantly enhance the value of existing resources. She asked if the project is deliberately omitting brain and behavior traits in favor of investigating disease status and molecular features, and Dr. Arguello confirmed that they are currently focusing on diagnosis and molecular data sets. He said that adding phenotypes to the study would be premature given the limited sample size so far.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Post-Acute Interventions for the Treatment of Anorexia Nervosa

Matthew Rudorfer, M.D. andMary Rooney, Ph.D.
Division of Services and Intervention Research

Dr. Matthew Rudorfer reviewed the impact of and current treatment options in anorexia nervosa. Although no medication has been indicated for treatment of anorexia nervosa, some specialty clinics use short-term evidence-based interventions such as family-based psychotherapy and medical and behavioral approaches to restore healthy body weight. However, even the most promising of these interventions show only a 50 percent success rate by 6 to 12 months after treatment, illustrating the need for enhanced and sustained clinical response. This study supports development of treatments to promote and sustain weight restoration, emphasize relapse prevention, and target persistent, residual co-morbidities. This effort enhances existing research to improve longer term management of this serious, potentially life-threatening mental disorder.

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Discussion

Dr. Benton expressed support for the concept and mentioned Zyprexa, an effective medication for treating anorexia nervosa. Dr. King also expressed her support and asked if there are plans to support this research beyond a pilot study. Dr. Rudorfer responded that there are no resources at this time, and that NIMH will utilize the R34 grant. Dr. Vinogradov suggested that variations of cognitive behavioral therapy (CBT) may be an effective treatment to consider. Dr. Benton said that many patients with anorexia are lost in the health care system as they transition from weight restoration towards intervention, or as they transition from adolescence into adulthood. Given the prevalence of relapse and remission in anorexia, she suggested studies and psychosocial treatments that promote long-term successful outcomes of these patients.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Practice-Based Research for Implementing Scalable Evidence-Based Prevention Interventions in Primary Care Settings

Eve Reider, Ph.D.
Division of Services and Intervention Research

Dr. Eve Reider said that the goal of this concept is to encourage scalable, sustainable implementation of research for prevention interventions in pediatric primary care settings. The project aims to leverage testing health service resources as a platform for delivering these interventions. She explained that sustainable approaches to prevention will require systematic identification of young people in need, followed by high-fidelity delivery of tailored, service-ready interventions. The research conducted by this project would contribute to an evidence base of effective, scalable interventions that can be implemented and sustained in pediatric primary care settings, including underserved populations who can be endorsed by the US Prevention Services Task Force and covered by insurance. Dr. Reider concluded that the scope of this research would include developing and testing algorithms and strategies for identifying and matching at-risk youth to appropriate prevention interventions, as well as strategies to train and support providers in delivering these interventions with fidelity.

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Discussion

Dr. Robinson Beale said that this concept is important and will enable study of risk identification in primary care settings. She suggested partnering with schools to ensure that parents know that their teenage children need annual check-ups. Dr. Robinson Beale also recommended considering the funding and flexibility of the primary practice, and added that fee-for-service modalities may limit their capacity to intervene. Dr. Benton mentioned a Medicare guideline that requires certain early identification screenings for children older than 11 years, including the PHQ-9. She also noted the importance of decreasing stigma to encourage care-seeking behaviors among families. Dr. Benton added that pediatric primary care providers have limited office time, and clinicians benefit from assistance in understanding available payment supports. Dr. Everett suggested clarifying the word “youth” to include children and adolescents, as well as clarifying that the interventions include procedures other than screening.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Laboratories to Optimize Digital Health

Adam Haim, Ph.D.
Division of Services and Intervention Research

Dr. Adam Haim explained that digital health tools can help clinicians track and understand the course of illness across the lifespan and can provide evidence-based interventions to those unable to access in-person treatments. To this end, this effort will encourage collaborations between academic research and digital health technology developers to establish digital mental laboratories, which will launch trials, identify and enroll participants, refine intervention content, and enhance service delivery. NIMH continues to support the development and testing of digital health technology, but NIMH-funded research in digital health has not kept pace with the rapid development of commercial technologies. Research indicates that a significant proportion of consumers use commercial digital health strategies to access mental health treatment, presenting an opportunity for academic researchers to provide their expertise. Together, researchers and large digital mental health platforms can collaborate to improve the quality, delivery, and sustainability of health care services.

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Discussion

Dr. Vinogradov commented that this concept is timely and pragmatic. She pointed out the need for additional evidence about who would benefit most from these approaches. Mr. Staglin agreed and added that these technologies would benefit from scientific rigor. He also said that sustained engagement is a primary challenge to the effectiveness of digital health interventions. He suggested that the concept could be expanded to include concepts such as neuroplasticity-based intervention. Mr. Staglin also recommended incentivizing companies to participate by facilitating insurance coverage for companies whose apps receive FDA approval. Dr. Haim replied that several technology companies have approached NIMH enthusiastically, but that NIMH is looking for companies that are willing to form meaningful partnerships with academia.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Mental Health Consultation via Telehealth to Optimize Care for Emergency Department Patients with Suicide Risk

Mike Freed, PhD, EMT-B and Jane Pearson, Ph.D.
Division of Services and Intervention Research

Dr. Michael Freed explained that the goal of this concept is to identify feasible tele-mental health consultation approaches for suicide prevention services in emergency departments (EDs), and to examine if and how these services are associated with reduced suicide-related outcomes. An increasing evidence base suggests that the ED is a valuable setting in which to provide suicide prevention practices, including universal screening, brief interventions, and follow-ups. However, there is limited research on the effectiveness of telehealth in suicide prevention. This concept aims to investigate issues related to telehealth interventions, including risk reduction, inpatient/outpatient triage patterns, duration of ED visits, suicide rates, and financing.

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Discussion

Dr. King, Dr. Benton, and Dr. Jaycox expressed support for the concept. Dr. King noted the significant barriers to implementation in EDs. She suggested encouraging investigators to consider stakeholder input and working across multiple EDs to capture differences across health care systems, with an emphasis on rural or underserved populations.

Dr. Amy Kilbourne asked Dr. Freed to define “telehealth” versus “virtual care” and wondered about clinical liability across state lines. Dr. Freed answered that “telehealth” is defined as “the remote delivery of healthcare services and clinical information using telecommunications technology.” One goal of this research is to answer questions about legal policies and liability. Capt. Colston suggested that other health services research, such as opioid use disorder, should be included in the concept.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Effectiveness of Implementing Sustainable Evidence-Based Mental Health Practices in Low-Resource Settings to Achieve Equity in Outcomes for Traditionally Underserved Populations

Denise Juliano-Bult
MSW, Division of Services and Intervention Research

Ms. Denise Juliano-Bult explained that this concept was developed in collaboration with the Office of Disparities Research and Workforce Diversity and also the NIMH Disparities team. The purpose of this initiative is to encourage studies that develop and test the effectiveness of strategies for implementation and sustainable delivery of evidence-based mental health practices in settings where limited resources create barriers to care. In recognition that patients from underserved populations tend to experience disproportionately worse mental health outcomes, this project aims to address delivery barriers at provider, clinic, organizational, and systems levels, not only to assess capacity for implementation but also the potential of these interventions to improve health equity.

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Discussion

Dr. Kilbourne suggested that the project include concepts related to user-centered design and technology to improve the consumer’s ability to overcome implementation barriers. She also noted the importance of differentiating front-line implementation and organizational implementation, suggesting that the concept should include an economic evaluation of the cost effectiveness and added value associated with implementing these evidence-based practices across diverse sites. Dr. Benton commented that this concept is an exemplar of NIMH-supported evidence-based practices that can be translated into community settings.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Social Drivers of Mental Illness in Low & Middle- Income Countries; Mechanisms and Pathways of Intervention for Youth

Beverly Pringle, Ph.D.
Center for Global Mental Health Research

Dr. Beverly Pringle said that this concept will stimulate research on the mechanisms and pathways of interventions that target modifiable social drivers of mental illness in youth living in low- and middle-income populations. These drivers include domestic violence, abuse, environmental hazards, armed conflict, parent loss, and other extreme adversities that put youth at risk for developing emotional and behavioral problems. Over time, these conditions predict poor outcomes including low educational attainment, substance use, and chronic mental illness. As a result, there is a need for targeted interventions, including trauma-focused care and socio-cultural approaches, in areas experiencing severe shortages of mental health professionals. Data collected from this project would be relevant for youth in the United States who face chronic adversity in low-income settings. 

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Discussion

Dr. King supported the broad focus range of this concept. Dr. Jaycox agreed, and wondered if the project could be broken down into smaller, more direct initiatives. Dr. Gordon replied they could consider creating multiple RFAs. Cpt. Colston added that school systems are a valuable setting in which to translate and implement community-based interventions for substance abuse, suicide risk, and other mental health problems among youth. Dr. Pringle said that the global community has asked for more options, including multi-family interventions in school settings. However, researchers have not addressed the bi-directional effects of these interventions.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Advancing Differentiated Care Approaches for Adolescents Living with HIV-1

Susannah Allison, Ph.D.
Division of AIDS Research

Dr. Susannah Allison reviewed the data related to HIV-related deaths in the United States, where youth HIV outcomes are among the poorest in the world. Given these health disparities, health care providers have identified an urgent need to develop innovative approaches to differentiated HIV care delivery, which responsively allocates services and resources to those with the highest level of need. The goal of this concept is to expand the number of differentiated care approaches for adolescents in order to meet their unique needs and disparities. The goal is to rapidly engage young people in care, harness the support of family and peers, encourage novel trial designs, and address HIV in a youth-centered context.

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Discussion

Dr. Robinson Beale expressed support for the concept but was concerned about transferring psychosocial interventions among diverse settings. She suggested maximizing impact by addressing issues related to fidelity and reproducibility. Dr. Jaycox asked about differences across international settings (e.g., United States versus Africa) and suggested that outcome variance across populations may be significant. Dr. Allison replied that this is a valid concern and needs to be addressed it in the project.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Mood disorders in people living with HIV: Mechanisms and Pathways

Vasu Rao, M.B.B.S., M.S.
Division of AIDS Research

Dr. Vasu Rao presented an overview of mood disorders as a co-morbidity in people living with HIV. Research suggests that lifetime prevalence of mood disorders among people with HIV is close to 60 percent, but less than half of this population seeks care. Unfortunately, only a small proportion of those who do seek care achieve remission, suggesting that people with HIV and mood disorders may experience unique biological, psychological, and social factors. The purpose of this initiative is to support studies that investigate the interplay of biological, behavioral, emotional, cognitive, and social mechanisms underlying mood disorders in people living with HIV.

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Discussion

Dr. Gotlib expressed support for the concept and wondered if similar studies could be conducted to investigate the pathways related to depression as a co-morbidity for other disorders. Dr. Blakely pointed out that this topic overlaps with circuit neuroscience, and he suggested noting glial biology in any post-mortem analyses. Dr. Benton said that this study is innovative because it describes pathways related trauma and stress as they relate to the impact of depression and other mood disorders on HIV, bringing the field closer to understanding how the mechanisms of mood-related symptoms impact brain development and neural circuitry.

Dr. Gordon called for a motion to approve the concept. A motion to approve was passed.

Abbreviated Concept Clearance

Dr. Gordon explained the process for reviewing the abbreviated proposed concepts. The Council will briefly review the titles of these concepts and submit their written comments separately. They do not plan to discuss these concepts at this time. Dr. Gordon publicly announced the intent to fund the following three initiatives, which are renewals of existing R25 grant programs:

• JNIMH Mentoring Networks for Mental Health Research Education (abbreviated)
  James Churchill, Ph.D. and Mark Chavez, Ph.D.
  NIMH Training Team
• NIMH Research Education Programs for Psychiatry Residents (abbreviated)
  James Churchill, Ph.D. and Mark Chavez, Ph.D.
  NIMH Training Team
• NIMH Short Courses for Mental Health-Related Research Education (abbreviated)
  James Churchill, Ph.D. and Mark Chavez, Ph.D.
  NIMH Training Team

Dr. Gordon reviewed the next two concepts, illustrating NIMH interest in the areas of brain circuitry and neuroscience:

• Behavioral Tasks Targeting Brain Subsystems Relevant to Anhedonia (abbreviated)
  Andrew F. Rossi, Ph.D.
  Division of Neuroscience and Basic Behavioral Science
• Engineering Next-Generation Human Nervous System Microphysiological Systems (abbreviated)
  David Panchision, Ph.D.
  Division of Neuroscience and Basic Behavioral Science

Dr. Gordon review the last two abbreviated concept proposals, which will be supported on a funds-available basis:

• Eradication of HIV from Central Nervous System Reservoirs (abbreviated)
  Jeymohan Joseph, Ph.D.
  Division of AIDS Research
• HIV Infection of the Central Nervous System (abbreviated)
  Jeymohan Joseph
  Ph.D., Division of AIDS Research

Dr. Gordon called for a motion to approve these concepts. A motion to approve was passed.

Comment from Retiring Member

Rhonda Robinson Beale, M.D.
Chief Medical Affairs Officer
Blue Cross of Idaho Foundation for Health

Dr. Gordon thanked Dr. Robinson Beale for her contributions to this Council. Dr. Robinson Beale thanked Dr. Gordon and expressed gratitude to the Council for the opportunity to serve in this capacity, which she described as rewarding and informative, while also being daunting. She expressed her feelings that funding and attention towards mental health must also remain a priority. She hopes that NIMH will continue to focus and prioritize activities that impact the real-world settings, and she concluded by highlighting the need for strong, strategic partnerships.

Public Comment Period

Dr. Gordon invited the two registered public commenters to speak.

The first was Mr. Chase Bannister, the President of the Board of Directors for the Eating Disorders Coalition for Research Policy and Action. Mr. Bannister explained that over the last decade, NIMH research funding for eating disorders has remained level, despite the passage of appropriations report language encouraging investment in applied research for eating disorder prevention, early identification, and innovative treatment. He encouraged NIMH to foster meaningful evidence-based progress in this area by increasing research funding for eating disorders.

The second commenter was Ms. Elissa Myers, the Executive Director of the Academy for Eating Disorders. She explained that only one in three people with an eating disorder will receive treatment. She noted that NIMH funding for eating disorders is disproportionately small compared to other issues like schizophrenia, autism, and Alzheimer’s. In addition to increased funds, Ms. Myers pointed out a need for outcomes-based research in the field of eating disorders. She thanked the Council for their work and urged them to increase funding for eating disorder research and treatment development.

Dr. Gordon clarified that NIMH does not establish dollar amounts in funding a specific disorder. Rather, when they identify an underrepresented area in scientific research, they call for RFAs and allocate funding as needed to address gaps and opportunities. He concluded by thanking the Council for their efforts.

Adjournment

The open session of the NIMHAC meeting adjourned at 1:37 P.M.

Closed Session

The grant application review portion of the meeting was closed to the public in accordance with provisions as set forth in Section 552b(c)(4) and 552b(c)6. Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended. The closed session was set to resume at 2:30 pm.

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council
Summary of 257^th Meeting, September 19, 2019

Others present:

• Chase Bannister, Eating Disorders Coalition for Research, Policy and Action
• Juliane Baron, FABBS
• Sarah Brookhart, Association for Psychological Science
• Erin Cadwalader – Lewis-Burke Associates
• Andy DeSoto, Association for Psychological Science
• Jonelle Duke, Bizzell Group
• Yari Jamali, Transcriber
• Patricia Kobar, American Psychological Association
• Elissa Myers, Academy for Eating Disorders
• Marie Rowland, Science Writer
• David Sitcovsky, Autism Speaks
• Aaron Walker – National Assoc. of State Mental Health Program Directors
• TaRaena Yates, Bizzell Group

NIMH Staff

Rajini Agarwal Alexander Arguello Susannah Allison Ishmael Amarreh Phyllis Ampofo Kathy Anderson Paige Anderson Victoria Arango Jules Asher Shelli Avenevoli Susan Azrin Shaunna Bach Crystal Barksdale Andrea Beckel Mitchener Yvonne Bennett Susan Borja Beth Bowers Linda Brady Bettina Buhring Holly Campbell-Rosen Monica Carter Zieta Charles Mark Chavez Jay Churchill Rebecca Claycamp Debra Dabney Alex Denker Jamie Driscoll Tara Dutka Jovier Evans Greg Farber Michele Ferrante Michael Freed Nick Gaiano Marjorie Garvey

Karen Gavin-Evans Lisa Gilotty Nitin Gogtay Chris Gordon Margaret Grabb Erin Gray Adam Haim Wanda Harris-Lewis Samantha Helfert Robert Heinssen Lauren Hill Mi Hillefors Meena Hiremath Andrea Horvath Cathleen Hsu Shuang-Bao Hu Ann Huston Terri Jarosik Jeymohan Joseph Denise Juliano-Bult Setareh Kamali Tamara Kees Ashley Kennedy Megan Kinnane Thomas Lehner Sarah Lisanby Bo Yeon Lee Thomas Lehner David McMillen Julie Mason Doug Meinecke Sarah Morris Laurie Nadler Liz Necka Heather Ovelmen

David Panchision Michele Pearson Beverly Pringle Dianne Rausch Andrew Rossi Geetha Senthil Matthew Rudorfer Judy Rumsey Agnes Rupp Chris Sarampote Rachel Scheinert Michael Schoenbaum Aileen Schulte Teri Senn Pamela Shell Joel Sherrill Janine Simmons Dawn Smith Michael Stirratt Leandra Stubbs Abhi Subedi Brooke Sydnor Alexander Talkovsky Jeena Thomas Ashlee Van't Veer Aleksandra Vicentic Becky Wagenaar-Miller Ann Wagner Susan Wetherby Makeda Williams Abera Wouhib Andrea Wijtenburg Yong Yao Natalie Zeigler

Appendix A

Summary of Primary MH Applications Reviewed
Council: September 2019

IRG Recommendation
Category	Scored #	Scored Direct Cost $	Not Scored (NRFC) #	Not Scored (NRFC) Direct Cost $	Other #	Other Direct Cost $	Total #	Total Direct Cost $
Research	573	$851,705,356	444	$516,976,452	0	0	1017	$1,368,681,808
Research Training	0		0		0	0	0
Career	65	$49,946,475	37	$30,401,146	0	0	102	$80,347,621
Other	0	0	0	0	0	0	0	0
Totals	638	$901,651,831	481	$547,377,598	0	$0	1119	$1,449,029,429

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

Laura A. Almasy, Ph.D. (22) Professor Department of Genetics Perelman School of Medicine University of Pennsylvania Philadelphia, PA	Cheryl A. King, Ph.D. (21) Director Mary A. Rackham Institute Professor, Department of Psychiatry and Psychology University of Michigan Rachel Upjohn Building Ann Arbor, MI
Marjorie L. Baldwin, Ph.D. (22) Professor Department of Economics W. P. Carey School of Business Arizona State University Tempe, AZ	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
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	Gregory A. Miller, Ph.D. (20) Professor and Chair Department of Psychology University of California, Los Angeles Los Angeles, CA
Randy D. Blakely, Ph.D. (20) Professor Department of Biomedical Sciences Charles E. Schmidt College of Medicine Florida Atlantic University Jupiter, FL	Yael Niv, Ph.D. (21) Professor Princeton Neuroscience Institute, Room 143 Department of Psychology Princeton University Princeton, NJ
Ian H. Gotlib, Ph.D. (20) David Starr Jordan Professor and Chair Department of Psychology Stanford University Stanford, CA	Neil J. Risch, Ph.D. (21) Director Institute of Human Genetics Lamond Family Foundation Distinguished Professor In Human Genetics University of California, San Francisco 513 Parnassus Avenue San Francisco, 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	Rhonda Robinson Beale, M.D. (19) Senior Vice President and Chief Medical Officer Blue Cross of Idaho Meridian, ID
David C. Henderson, M.D. (20) Chair Department of Psychiatry Boston University School of Medicine Boston, MA	Elyn R. Saks, J.D., Ph.D. (20) Orrin B. Evans Professor of Law Gould School of Law University of Southern California Los Angeles, CA
Lisa H. Jaycox, Ph.D. (20) Senior Behavioral Scientist Health Program Rand Corporation Arlington, VA	Sophia Vinogradov, M.D. (22) Donald W. Hastings Endowed Chair University of Minnesota Medical School Professor and Department Head Department of Psychiatry Minneapolis, MN
Brandon Staglin, M.S. (21) Director Marketing and Communications One Mind Institute Rutherford, CA	Christopher A. Walsh, M.D., Ph.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

Liaison Representative

• Anita Everett, M.D., DFAPA
  Acting Director, Center for Mental Health Services
  Substance Abuse and Mental Services Administration
  Rockville, MD