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NAMHC Minutes of the 243rd Meeting

September 11, 2015

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

Introduction

The National Advisory Mental Health Council (NAMHC) convened its 243rd meeting in open policy session at 9:00 a.m. on September 11, 2015, at the Marriott North Convention Center in Rockville, Maryland, and adjourned at approximately 1:00 p.m. In accordance with Public Law 92-463, the policy session was open to the public. The NAMHC reconvened for a closed session to review grant applications at 2:00 p.m. on September 11, 2015, at the Marriott North Convention Center in Rockville, Maryland, until adjournment at approximately 5:00 p.m. (See Appendix A: Review of Applications). Thomas Insel, M.D., Director, National Institute of Mental Health (NIMH) presided.

Council Members Present at the Grant Review and/or Open Sessions

(See Appendix B: Council Roster)

Chairperson

  • Thomas R. Insel, M.D.

Executive Secretary

  • Jean Noronha, Ph.D.

Council Members

  • Patricia Areán, Ph.D.
  • Deanna M. Barch, Ph.D.
  • David A. Brent, M.D. (by telephone)
  • Randall L. Carpenter, M.D.
  • B.J. Casey, Ph.D.
  • Benjamin G. Druss, M.D., M.P.H.
  • Lisa Greenman, J.D.
  • Hakon Heimer, M.S.
  • Michael F. Hogan, Ph.D.
  • Steven E. Hyman, M.D.
  • Marsha M. Linehan, Ph.D.
  • Maria A. Oquendo, M.D.
  • Gene E. Robinson, Ph.D.
  • Mary Jane Rotheram, Ph.D.
  • J. David Sweatt, Ph.D.
  • Carol A. Tamminga, M.D.

Ex Officio Members

  • John W. Davison, M.B.A., Ph.D. Department of Defense

Liaison Representative

  • Elizabeth Lopez, Ph.D., Center for Mental Health Services, Substance Abuse and Mental Health Services Administration (SAMSHA)

Others Present at the Open Policy Session

  • Sarah Brookhart, Association for Psychological Science
  • Michael Beyer, M2
  • Erin Cadwalader, University of Illinois
  • Jennifer Drew, Sign Language Interpreter
  • Heather Evans, Department of Veterans Affairs
  • DaShawn Fleming, Transcriber
  • Richard Frank, DHHS/Presenter
  • Paul Glimcher, New York University
  • Stuart Gordon, National Association of State Mental Health Program Directors
  • Richelle Gunter, Resources for Human Development, Inc.
  • Brian Hepburn, National Association of State Mental Health Program Directors
  • Alan Kraut, Association for Psychological Science
  • Andrew Lowe, Society for Women’s Health Research
  • Sean Lynch, SAMHSA
  • Sarah Mancoll, Society for Research in Child Development
  • Ryan Mutter, SAMHSA
  • Lotoyia Piper, Griffin Family Therapy
  • Sara Reardon, Nature
  • Andrew Sperling, National Alliance on Mental Illness
  • Judith Teich, SAMHSA
  • Daniel Vega, Sign Language Interpreter
  • Lori Whitten, Science Writer
  • Al Woodward, DHHS
  • TaRaena Yates, Synergy Enterprises

Open Policy Session Call to Order and Opening Remarks

NIMH Director Thomas Insel, M.D. called the open policy session to order and welcomed all in attendance.

Dr. Insel introduced Jean Noronha, Ph.D., as NIMH’s Acting Director, Division of Extramural Activities. He noted that Phil Wang, M.D., Dr. P.H., has moved to the American Psychiatric Association. While NIMH conducts a search for a replacement Deputy Director, Bruce Cuthbert, Ph.D., will serve as Acting Deputy Director in addition to leading the Research Domain Criteria (RDoC) project. Dr. Insel thanked Dr. Cuthbert for serving in both roles.

Approval of Minutes of the Previous Council Meeting

Turning to the minutes of the August and May 2015 Council meetings, Dr. Insel asked whether Council members had any comments, revisions, or questions. Receiving none, the Council unanimously passed the motion to approve both sets of minutes.

NIMH Director’s Report

Dr. Insel reviewed the agenda for the open policy session and provided an update on activities related to NIMH.

At the National Institutes of Health (NIH) level, each of the 27 Councils has been charged with reviewing and commenting on many different initiatives from President Barack Obama. As we are in the last year of his presidential administration, a focus on legacy and initiation of many projects is not surprising.

A major project of the Obama Administration is the Precision Medicine Initiative. Dr. Insel remarked that this Initiative has progressed since it was discussed at the last NAMHC meeting, and stressed the importance of Council feedback. The Precision Medicine Initiative has a near-term focus on cancers and a longer-term aim to generate knowledge applicable to the whole range of health and disease. Dr. Insel reviewed three key aspects of the Precision Medicine Initiative: the MATCH study on cancer, which is underway; the National Research Cohort (comprising more than a million volunteers); and the processes being put in place to address the Initiative. The Precision Medicine Initiative Working Group of the Advisory Committee to the Director of NIH has been formed and is charged with developing a vision for how to harness the advances in technology, scientific understanding, and participant engagement to develop a platform for precision medicine research and move precision medicine into every day clinical practice. The next steps for the Initiative include a report from the Working Group to describe ideas from stakeholders. Meetings and workshops for the Initiative will continue, and efforts will follow the trans-NIH implementation model. Initial funding opportunities will be announced soon, with the plan for funding to begin in fiscal year (FY) 2016. From the NIMH perspective, this Initiative is of great interest, and the Institute has described its current vision for precision medicine in psychiatry (see PMID: 25931539).

Public Law 113-235 (enacted December 16, 2014) requires NIH to develop an agency-wide 5-year scientific Strategic Plan by mid-December of this year. The 21st Century Cures Initiative, led by Representatives Fred Upton (R-MI) and Diana DeGette (D-CO) of the House Energy and Commerce Committee, also calls for a NIH Strategic Plan to outline how the agency sets priorities and ensures accountability.

The NIH Strategic Plan will be a document that aggregates the plans of its component Institutes, Offices, and Centers. The document will capture themes across Offices and Institutes and will reference fundamental science, treatments and cures, and health promotion and disease prevention (with illustrative examples). The NIH Strategic Plan will also mention the agency’s culture and describe its scientific process (e.g., reproducibility, rigor, and sharing of big data). The Strategic Plan will include a section on Mission Priority Focus Areas and efforts to enhance stewardship (e.g., reducing administrative burden, maintaining the biomedical workforce, increasing workforce diversity, improving rigor, and enhancing public/private partnerships). It will acknowledge rare and pediatric diseases as a priority and recognize the NIH Clinical Center.

Dr. Insel provided an update on the Common Rule Notice of Proposed Rulemaking (NPRM), which is a priority at the White House. The modernized Common Rule is almost finished, and its goals are to enhance safeguards and respect for research participants and to increase the efficiency of the oversight process. The Common Rule has a long history, and was last revised in 1991. Every government agency that conducts human subject research (including clinical trials) agreed on these standards, but modernization was needed because much has changed in the biomedical enterprise. After briefly reviewing the major reform issues, Dr. Insel described the next steps: Publication in the September 8, 2015 Federal Register (docket number: HHS-OPSH-2015-0008) for a 90-day comment period (to December 7, 2015); conducting stakeholder engagement; consideration of public comments; development of the Final Rule; and publication of the Final Rule.

The NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiativeis guided by Brain 2025: A Scientific Vision, the report the BRAIN Working Group released a year ago. The Initiative focuses on developing tools that measure the fluctuating activity patterns of neural circuits and networks to determine how they are connected to behavior. The FY 2016 President’s Budget requested $70 million for the BRAIN Initiative, but Congress has not yet passed the budget. Many projects under this Initiative are underway, with approximately 67 new awards expected to be funded before the end of FY 2015 on September 30, 2015. Dr. Insel remarked that these projects are trying to understand the language of the brain at the speed of thought. He thanked NIMH’s Greg Farber, Ph.D., and others working on this tremendous effort in addition to their assigned jobs. The BRAIN Initiative has undertaken new international partnerships between NIH and research organizations in Canada and Australia. The BRAIN Neuroethics Workgroup is working with Initiative leadership and researchers to recommend overall approaches to handling issues and problems involving ethics. A recent report describes the Initiative and its expected outcomes (see PMID: 26197178), and a Town Hall meeting on October 20, 2015 will also inform the public about updates. Dr. Insel shared a video of a virtual, three-dimensional reconstruction and analysis of mouse cortex on a nanometer scale. This is the work of Jeff Lichtman, Ph.D., and colleagues and was recently published (see PMID: 26232230).

The status of the budget has not changed since the May meeting. The NIMH FY 2015 appropriation is $1.4 billion, a $17 million increase over the NIMH FY 2014 appropriation. Funding for competing Research Project Grants is $228 million, and $25.2 million for NIMH BRAIN Initiative projects. The SAMHSA appropriation continues to require coordination with NIMH to incorporate coordinated specialty care after a first episode of psychosis into block grants in all 50 states.

The President’s FY 2016 budget requests $31.1 billion for NIH, which represents a $1 billion increase over FY 2015. The request for NIH includes specific increases for the Precision Medicine Initiative ($200 million) and the BRAIN Initiative ($70 million). The President’s Budget is a request to Congress, and appropriation depends on Congressional action. Sequestration, which could potentially result in a 5 percent across-the-board cut, is planned for FY 2016 unless Congress acts to exempt NIH or reaches an overall budget agreement lifting current caps.

Other NIMH updates included staff changes. Ann Huston, M.P.A., was selected to be the Director of the Office of Resource Management.

At members’ request, Council formed the Behavioral and Social Science Research Workgroup. Patricia Areán, Ph.D., and Alan Leshner, Ph.D., will co-chair the Workgroup, which will hold its first meeting soon. Dr. Insel briefly reviewed the meeting agenda.

Discussion

Regarding the NIH Strategic Plan, Maria Oquendo, Ph.D., remarked that NIH is organized according to disease categories, which mirrors the field of medicine. However, co-morbidity is the rule for most patients, and NIH needs more cross-institute collaboration. Research indicates that mental health conditions influence the progression of physical diseases, through medication adherence and other effects. Dr. Insel commented that others have made this observation previously. Although there is sometimes the perception that there is no cross-talk among the NIH Institutes, he does not agree. The Common Fund and other efforts support work across NIH Institutes. However, research on co-morbidities occurs less often than NIH would like. As each institute is focused on its own mission, mixing funds can be an issue. He agreed that the NIH Strategic Plan can build in encouragement for such collaboration through mechanisms other than the Common Fund.

Steven Hyman, M.D., commented that diseases are not always well defined, particularly in mental health. A great deal of co-morbidity research is fairly descriptive, and the field needs information on the biology underlying co-morbidities to progress. The National Research Cohort might identify shared genetic and other biological risks that would complement epidemiology data, but that is not the same as discovering the biological underpinnings that connect co-morbid conditions. Trans-NIH work is complex, but there can be more significant barriers and problems in academic collaboration. Dr. Hyman remarked that the Precision Medicine Initiative is important for the mental health field. Brain disease research will build on the precision medicine foundation, so it is critical to lay the groundwork now. The cancer precision medicine model is likely not appropriate for mental illness, as behavioral problems are more complex and ill-defined (e.g., no biomarkers). This has to be explained when discussing mental health and precision medicine.

Carol Tamminga, M.D., commented on the importance of innovative approaches to brain research. Investigators are complaining about changing funding priorities and diagnostic structures, and they need information to explain the rationale. Dr. Insel noted that NIMH needs the Council’s help to educate people in the field. He just returned from India, where there is great interest in RDoC and a demand for tools. Dr. Tamminga remarked that a toolkit, slides, and notes on RDoC would be very helpful in educating people about this important project.

Marsha Linehan, Ph.D., remarked that it is great to hear about brain research initiatives, but it is important to remember the significant role of environmental factors (e.g., child raising style) on mental health. In her work, Dr. Linehan treats patients with multiple diagnoses, and she commented on the need to determine common etiological factors. The brain is critical, but so are environmental factors (e.g., early life).

Developing Evidence-Based Standards for Psychological Interventions for Mental Disorders

Patricia A. Areán, Ph.D.
Washington University

Dr. Areán described the work of The National Academies of Sciences, Engineering, and Medicine (the Academies), which has assumed the membership and honorific functions previously held by the Institute of Medicine (IOM), to develop a framework for establishing evidence-based standards for psychosocial interventions for mental and substance use disorders. A committee was charged with developing a framework from which to establish efficacy standards for psychosocial interventions used to treat individuals with mental disorders (including addictive disorders). The committee characterized the types of scientific evidence and processes needed to establish the effectiveness of psychosocial interventions. It also identified the elements of psychosocial treatments that are most likely to improve a patient’s mental health and can be tracked using performance measures. In addition, the committee identified features of health care delivery systems involving psychosocial therapies that are most indicative of high quality care and can be tracked practically.

Dr. Areán highlighted the outcomes of the committee’s report,Psychosocial Interventions for Mental and Substance Use Disorders, which was partially sponsored by NIMH. She noted that committee members included experts from different disciplines, as well as the participant perspective. The report was based on the following definition: Psychosocial interventions for mental health and substance use disorders are interpersonal or informational activities, techniques, or strategies that target biological, behavioral, cognitive, emotional, interpersonal, social or environmental factors with the aim of improving health functioning and well-being. Dr. Areán noted that psychosocial interventions are not limited to psychotherapy and include case management and suicide prevention activities. A number of psychosocial interventions have an evidence base, but there is no good system for implementing them in health care settings. A key issue is how to improve quality, and it is critical to include consumers’ voices in the determination of quality and evidence. The evidence base requires strengthening, with a broader range of populations and settings. It is important to implement interventions to improve outcomes and develop quality measures.

Overall findings include that mental and substance use disorders are a serious public health problem and that a wide variety of psychosocial interventions play a major role in the treatment of mental health and substance use conditions. Psychosocial interventions that have been demonstrated to be effective in research settings are not used routinely in clinical practice, and no standard system is in place to ensure that the psychosocial interventions delivered to patients/consumers are effective. The report includes a framework to improve the quality of psychosocial interventions and presents conclusions and recommendations in several areas: elements of therapeutic change; standards for reviewing evidence; quality measurement; and quality improvement.

Dr. Insel introduced Richard Frank, Ph.D., Assistant Secretary for Planning and Evaluation, DHHS. Dr. Frank is a leading general and health economist. In his role at DHHS, he is developing new policies and processes for assessing and reimbursing psychosocial interventions.

Dr. Frank remarked that this report originated after conversations with NIMH staff members, so it is good to see the document come to fruition. DHHS has made establishing evidence-based standards for psychosocial interventions for mental and substance use disorders a priority. From a policy perspective, it is necessary to develop appropriate accountability systems, capture the attention of stakeholders, and determine a process for dealing with complexities. This is a time of transformation in health care, particularly affecting mental health and addiction treatment. The Mental Health Parity Act, and its implementation and extension via the Affordable Care Act, provides a foundation for establishing evidence-based standards for psychosocial interventions for mental and substance use disorders. Payment systems are bringing in new resources to identify and treat mental health disorders in a way that equalizes medication and psychotherapy. At the same time, health care transformation emphasizes paying for value rather than volume. More resources are allocated to budgeted services in clinical settings that care for diverse populations, and providers must show a capacity to perform this work. Budgeted systems reward providers for performing fewer services or performing services differently. History shows that mental health disorders tend to be disadvantaged without monitoring, so there is a need to establish a system of accountability and measurement that ensures appropriate treatment (i.e., that people are getting what they pay for).

Dr. Frank noted that the Psychosocial Interventions for Mental and Substance Use Disorders report outlines important next steps for advancing measurement and accountability. He remarked that a problem with “doing what works” is not knowing what works, thus, it is critical for the field to have a user-friendly compilation of evidence-based psychosocial interventions. The United Kingdom’s National Institute for Health and Care Excellence (NICE) provides a good model based on their advanced efforts in this area. Regarding quality measurement, members of the field will need to get out of their comfort zones. The report sets out work that will not achieve its goals without attending to the accountability payment incentives found in Accountable Care Organizations (ACOs), which are essential to bringing evidence into practice. The efficacy research required to establish a set of quality measures appropriate for ACOs will necessitate a different process. All involved in the mental health field should contribute to the design of accountability mechanisms and determine what will work in real-world practice.

Dr. Frank remarked that a more developmental approach is needed for behavioral health quality measures in ACOs. Some measures used currently are perhaps not the best. The report does a good job of arguing this point. He acknowledged that there is a need to improve mental health care immediately, as vulnerable people are at risk. Therefore, the field should identify the best measures currently available and implement them in the mental health care system. Although they will not be perfect, research will improve these measures. With psychosocial interventions, what happens in treatment stays in treatment. This is why consumers must be involved in quality measurement. Many are uncomfortable with the idea of consumer involvement in this process and may believe that consumer reports are biased. However, Dr. Frank remarked that consumers are no more biased than anyone else, and their views matter. Quality measurement should incorporate consumer views.

Discussion

Dr. Linehan remarked that the report is great news. Although effective treatments are available, it is a terrible situation when providers think they are delivering these therapies properly but are not. In her opinion, relying on guilds to ensure appropriate delivery of these treatments is a mistake, as these groups focus on maintaining jobs and pay levels. Currently, particular knowledge about effective treatments is not required for licensure. She commented that the federal government needs to intervene on licensure requirements. Medicine requires testing of pharmacotherapies and specific qualifications to prescribe them. Federal rules should establish equivalent legal parameters for behavioral interventions (e.g., certification). Currently, there is no way to ensure that providers are implementing them properly or maintaining treatment fidelity over time, but this must happen to serve the mentally ill better.

Dr. Insel noted that medications were unregulated until the establishment of the U.S. Food and Drug Administration (FDA) in 1906. It was possible to regulate only after scientists had evidence of medication effectiveness. In the era of physical and mental health parity, consumers need to know exactly what they are receiving as psychosocial treatment, but there is not always equivalent evidence.

Dr. Frank agreed that the evidence base for psychosocial interventions is part of the problem. What is best way to solve it? Accountability is essential, and the way the system holds providers accountable must change. There is a tendency to tie payment to measurement, but applying the FDA framework to psychosocial interventions may not be appropriate, as the effectiveness of different treatments can vary for individuals. Another issue is the precision of determining the effectiveness of psychosocial treatments. Cherry picking of particular patients could occur if the system is not set up properly. Dr. Frank commented on the importance of research to identify the elements of well-executed cognitive-behavioral therapy (CBT), for example, from patient reports. Determining the appropriate questions to ask patients to determine those elements would be a good first step.

Dr. Areán commented that the committee responsible for the report discussed quality. Two models are currently in place – ensuring that clinicians are trained to provide evidence-based practices and measuring the impact of training on outcomes. The United Kingdom has a great process; NICE is non-governmental body, although it is funded by the U.K. National Health Service. NICE examines problems, evidence, and effective interventions, and Professor David M. Clark has been leading efforts to increase access to evidence-based psychotherapies. NICE’s work in this area would be very informative, as would that of the U.S. Department of Veterans Affairs. Technology can be used to facilitate patient reports about what happens during a therapeutic interaction, and patient privacy issues can be addressed.

Dr. Linehan added that in Europe, therapists earn degrees in particular treatments, whereas training is more general in the United States. Dr. Tamminga recommended that the field consider the target of regulation in the area of psychosocial interventions. The FDA addresses the scientific evidence of medication development; it does not regulate doctors, medical students, or treatment providers.

Michael F. Hogan, Ph.D., asked about the expectations for the Council’s Behavioral and Social Science Research Workgroup. Will it examine research to facilitate better measurement? Currently, measurements are inadequate, although care is now mainstream. Dr. Insel responded that the Workgroup will focus on how new developments in technology will change what is considered and measured (e.g., sensors for diagnosis, treatments that can be embedded in phones, and new apps). Providers might apply such technologies for quality control. Treatment apps can include feedback for providers. For example, feedback might let therapists know that CBT requires assignment of patient homework, and this could be tied to payment. Such feedback is not difficult to implement and is common in other areas of medicine. Technology can easily measure some aspects of fidelity and quality of psychosocial interventions. Therefore, the Workgroup might identify aspects of treatment that can be easily measured and monitored for the purposes of accountability. Dr. Insel referred Council members to the Concept presented at the May 2015 meeting by Joel Sherrill, Ph.D., entitled Pragmatic Strategies for Assessing Psychotherapy Quality in Practice.

Dr. Areán commented on the importance of engaging ACOs, which have the tools for quality assessment but cannot get health plans to adopt them. There is a great need to engage health plans. J. David Sweatt, Ph.D. remarked that in a budgeted system, a provider receives a certain amount of money to care for a particular number of people. If the cost of that care exceeds the amount allocated, then providers take a loss. Thus, providers are under pressure to use affordable treatments, and psychosocial interventions get lost because they are relatively expensive. These are the types of issues that must be addressed.

David Brent, M.D., asked Dr. Frank about patient treatment adherence (e.g., doing CBT homework) and the possibility of providing financial incentives for full participation. Dr. Frank remarked that a larger question relates to the types of arrangements underlying quality improvement efforts. These mostly focus on encouraging providers to change clinical activities and rewarding those behaviors. An open question of interest is how to incorporate rewards for consumers when they get better sooner or for less cost.

The HUMAN Project

Paul Glimcher, Ph.D.
New York University

Dr. Insel welcomed and introduced Paul Glimcher, Ph.D., who coined the phrase “neuroeconomics.” Dr. Glimcher’s training is very diverse, covering the fields of neuroscience, economics, and psychology. Although Dr. Glimcher is known for his research on the neural basis of decision making, today he will discuss the HUMAN Project.

Dr. Glimcher remarked that he has been working on the Kavli HUMAN Project for 3 years. The idea underlying the HUMAN Project is to advance behavioral science in the same way that the Human Genome Project and the Sloan Digital Sky Survey accelerated biochemistry and astronomy, respectively. The Project will provide researchers with a wealth of data to analyze for the purposes of better understanding the complex and intertwined roots of human behavior and health.

Miyoung Chun, Ph.D., Executive Vice President of Science Programs at the Kavli Foundation, asked Dr. Glimcher and Steven E. Koonin, Ph.D., Director of New York University’s Center for Urban Science and Progress, to collaborate on determining the feasibility of the Project. After a series of expert workshops, the idea emerged to conduct a large-scale study of human biology and behavior using an automated system to gather data on a large number of people. They examined the feasibility of such a research project and developed a “study need” document. The HUMAN Project has adopted the Department of Energy’s Stage-Gate model, and Dr. Glimcher reviewed the Project’s stages and advisory council structure (with focus areas of measurement, survey design, privacy and security, and scientific agenda). Chairs of the HUMAN Project’s Advisory Council submitted a document describing possibilities for the study in 2014. Dr. Glimcher remarked that a document on the Project’s conceptual design will be made public in a few weeks.

The Project will longitudinally collect information on a wide variety of behaviors in an attempt to characterize the major factors that shape the human condition. An informative existing large-scale longitudinal study is the U.S. Health and Retirement Survey (HRS). HRS surveys people within the living conditions of their city, collects a great deal of economic information, and now includes health information. Although scientists have conducted many studies on human behavior with different groups of people, researchers do not know how their results relate in deep way. Researchers have not considered tying information from these studies together, so the HUMAN Project aims to connect the research to obtain deep understanding for 10,000 subjects. The Project aims to use valid, low-cost tools and to develop new, useful instruments. He reviewed examples of candidate biological and psychological measures.

The HUMAN Project coordinators plan to recruit 10,000 participants who live in 2,500 households using well-developed processes for major surveys. Dr. Glimcher briefly reviewed the Project’s extensive recruitment procedures, process for obtaining informed consent, and basic information provided by all participants. All households will be provided with a base station for automatically collecting information and each participant will receive an app that asks questions (answering never takes more than 3 minutes). This “smart” app learns the optimal time to collect data from individuals. The Project will use Global Positioning System tracking and existing commercial systems for observing financial transactions (e.g., to determine whether healthy or unhealthy food is bought). Low-cost devices can track where participants are within the house and whether family members are in close proximity. Other data collected by the Project will include information on: demographics, home environment, utility records (i.e., energy consumption), neighborhood characteristics, diet and health (e.g., family food choices), psychological characteristics, biomedical samples (including full genome sequences), occupation, family interactions, physical activity, finances, geo-location, and interaction with law enforcement.

The expected sample will be drawn from New York City, because this site has the best data infrastructure in country. Work in New York City will serve as a demonstration, and in 10 years, the Project should be able to collect this data anywhere. The HUMAN Project will oversample critical groups (e.g., young children aged 1 to 3, pre-teens, and post-retirement elders). Dr. Glimcher briefly reviewed the Project’s sample design and statistical power. The household survey technique will provide interesting health and mental health information. He mentioned various use-case examples, including real-time assessment of wellness and disease in daily life and family decision processes in secondary school education.

To ensure the privacy and security of participants, the Project will use a dual- firewall system, fully secure data warehouses, and data marts for trusted individuals inside the firewall (marts destroyed after use). The estimated costs are approximately $9 million for years 1 to 3, with $5 million for all subsequent years. Currently, the HUMAN Project’s funder is unclear beyond the initial 2 years, which will be funded by the Kavli Foundation. Dr. Glimcher remarked that Project coordinators are looking for approximately $4 to 5 million from Federal funders for years 1 to 3. New York State will contribute funding if the Project has federal support; New York City will contribute funding if the Project has New York State support.

Discussion

Dr. Insel remarked that the HUMAN Project is an ambitious and interesting effort. Dr. Hyman echoed Dr. Linehan’s earlier comment about the importance of environmental factors in mental health. The biomedical and social sciences need each other and collaboration is essential. It is not clear which individuals are affected by environmental risk factors for schizophrenia, for example. Biomarkers and genetic information should advance our understanding. Wisely used, the data collected by the Project should provide a platform for making optimal use of both social and biological approaches.

Benjamin G. Druss, M.D., M.P.H., added that this project is trying to understand the human condition and encouraged those involved to consider including important sub-cohorts (e.g., people with mental disorders). Dr. Glimcher responded that organizers of the Project have been discussing this issue. As this longitudinal study includes children, it will be able to observe the development of mental illnesses and other conditions. Statistical power is an issue, but 10,000 people should be sufficient. The goal is to demonstrate that this approach is feasible in one city and then gradually extend it to more cities and eventually, rural areas. New York City is ideal as an initial site because of its technology resources and infrastructure. Dr. Insel added that New York City has data on environmental toxicity on a block-by-block level.

Dr. Sweatt recommended that the Project include metabolomics, which reveals the impact of environment and experience on the genome. Dr. Glimcher responded that the Project has the capability to include metabolomics measures. Dr. Linehan asked whether the project would include key information about the family environment (e.g., voice tone and content of parent-child interaction). Dr. Glimcher noted that B.J. Casey, Ph.D., raised this issue previously. The Project can collect this type of data through the base station and microphones. Project organizers plan to conduct focus groups to discuss the possibility of participants opting in for this component. He added that a great advantage of this approach is that it will generate cohorts that are committed to helping with the study. Deanna M. Barch, Ph.D., remarked that the Project provides both health and mental health data, which offers enormous scientific opportunities to understanding their interaction.

Gene Robinson, Ph.D., asked how the Project will address the phenomenon of study participants behaving differently because they are aware of being observed. Dr. Glimcher responded that to some extent, researchers cannot do anything about this. However, the design includes testing the effect of different kinds of feedback to study participants, which should help address this phenomenon.

Mary Jane Rotheram, Ph.D., commented that the Project has a great deal of positive potential. However, she noted that many people in the United States are concerned about privacy. Many other places in the world implement large-scale surveillance, and although that is not the case in the United States, it could emerge as a political issue. Dr. Glimcher replied that Project organizers have considered this issue and involved experts in security who are familiar with the major sensitivities and issues. The majority of data collected by the project is pre-existing but not in one place (e.g., telephones already track people and credit cards provide very detailed information on purchasing). Additionally, the Project will have an extensive process for participants to provide informed consent. The first step in this process will be a 1- to 2-hour video for each family, for example. Finally, the Project’s database will have a high security standard. The Project has recruited hacking experts who are working on this issue.

Lisa Greenman, J.D., wondered whether the government would have access to the Project’s data. Dr. Glimcher remarked that a bigger concern is ensuring that insurance companies and other entities do not have access to Project information. Dr. Casey commented that the Project is a wonderful opportunity to use existing data in a prosocial way. The enthusiasm expressed by Council members reflects the significance of New York as a model for the involvement of other cities and states moving forward. Dr. Glimcher added that the Project will help improve our understanding of New York City and State, which are socially atypical but selected for their technological advantages.

Big Data to Knowledge (BD2K) Multi-Council Working Group Update

Gene Robinson, Ph.D.
University of Illinois at Urbana-Champaign

Dr. Robinson represents NAMHC on the Multi-Council Working Group on Big Data to Knowledge (BD2K). He reviewed the Working Group’s mission to use data science to foster an open digital ecosystem that will accelerate efficient, cost-effective biomedical research to enhance health, lengthen life, and reduce illness and disability. The Working Group’s strategic thinking is driven by the need to be prepared – that is, responding to take advantage of the opportunities offered by a major disruption in the biomedical research enterprise arising through digitization and exponential growth. Accelerating discovery during this time of disruptive development and catalyzing a cultural shift towards a more analytical enterprise while managing expectations are also drivers of the Working Group’s strategic thinking. Dr. Robinson reviewed the strategic areas (leadership, sustainability, workforce development and diversity, discovery and innovation, and policy and process) and resource distribution.

By 2020, BD2K would like to achieve the following goals: enable major scientific discovery; establish and provide evidence of a more sustainable, efficient and productive data science ecosystem (both internal and external to NIH); establish and provide evidence of a well-trained and diverse workforce able to use and develop biomedical data science tools and methods; and build upon NIH’s leadership and reputation in data science. Dr. Robinson highlighted cross-cutting successes for BD2K, including research objects in the NIH Commons, more than 100 public lectures, voxel-wide genome scanning, a genomic data-sharing policy, and involvement of 185 institutions. Dr. Robinson noted new BD2K workshops on a variety of topics and pointed out several new activities, particularly the recent Executive Order, Creating a National Strategic Computing Initiative.

Discussion

Dr. Sweatt remarked that this is a great project. Locally, trying to implement big data can be challenging, particularly involving individual investigators. Investigators often need incentives to get them started. He asked whether the Working Group has discussed this barrier and ways to get individual investigators involved in big data. Dr. Robinson replied that all Centers of Excellence have a strong outreach component, which makes tools and training available. Dr. Sweatt noted that most investigators need to be interested in analyzing a particular data set to get involved.

Dr. Insel thanked Dr. Robinson for his report and involvement in the Working Group.

Noting that discussions were running behind schedule, Dr. Insel suggested that Council postpone the Global Mental Health Update from Pamela Collins, M.D., M.P.H., until the next meeting. The presentation deserves its full time allowance, as there are many exciting initiatives in global mental health. He thanked Dr. Collins for her fantastic work in the area, which has seen new programs and interesting results.

Concept Clearances

Dr. Insel remarked that the Concepts put forth today connect with the NIMH Strategic Plan for Research, in that they are part of developing initiatives to implement its Strategic Objectives. He thanked all who worked to develop the Concepts and noted that these ideas are at an early stage. Council members’ feedback will help shape the Concepts so staff can finalize them. Presentations will be brief to leave time for Council discussion. NIMH will post approved Concepts on the Website for further feedback.

Role of Myeloid Cells in Persistence and Eradication of HIV Reservoirs from the Brain

Jeymohan Joseph, Ph.D.
Division of AIDS Research

The eradication and cure of HIV is a major priority of the NIH Office of AIDS Research. The identification and targeting of HIV central nervous system (CNS) reservoirs is a key priority area for the NIMH Division of AIDS Research. This initiative will stimulate research on the mechanisms of HIV persistence in myeloid cells and strategies to target this reservoir in the CNS. The goals of the research are to determine mechanisms of HIV persistence, functional changes in persistently infected cells, and strategies for identifying and targeting persisting/latent HIV in myeloid cells in the CNS. The work will also develop strategies for silencing HIV, in vivo and in vitro models to study HIV persistence in the CNS, and a new class of delivery agents that can increase the bioavailability of drugs inside the CNS.

Discussion

Dr. Insel remarked that this is a major issue in the era of working toward a cure for HIV and an AIDS-free generation. Dr. Tamminga noted that this Concept could serve as a model for research on many immune related illnesses. Researchers should consider ways that microglia-mediated proteins might affect other brain diseases. Dr. Insel commented that this is a great point and that NIMH might invite the National Institute of Allergy and Infectious Diseases to participate in this initiative. NIMH will contribute brain and behavior expertise.

Applied Research towards Zero Suicide Healthcare Systems

Jane Pearson, Ph.D.
Division of Services and Intervention Research

A significant proportion of suicide decedents in the United States – approximately 30 percent (state data) to 80 percent (health maintenance organization data) – have accessed health care within the year of their deaths. The goal of this initiative is to reduce the burden of suicide events in health care systems through intervention effectiveness and implementation research. Specifically, this initiative aims to expand the evidence base for the Zero Suicide project’s practice-to-research efforts, creating a stronger basis for dissemination and large-scale implementation of effective risk detection, intervention and service delivery strategies for suicide prevention. As knowledge about optimal suicide risk detection and treatment continue to advance, this initiative aims to expand the number of learning health care systems in the United States that focus on reducing suicide events as part of their business model.

Studies conducted in the United Kingdom, by the U.S. Veteran’s Health Administration, and by the Henry Ford Behavioral Health System have reported that suicide deaths decrease when suicide safety measures are implemented. For example, when health systems in the United Kingdom implemented at least 7 of 10 recommended practices, suicide deaths decreased as much as 35 percent. Safer health care practices would have an impact on the U.S. suicide rate. There are potential opportunities for incentives to reduce suicides in the health care system, particularly in the context of health care reform.

Discussion

Dr. Hogan, co-lead of the Zero Suicide Advisory Group, remarked that he has been involved in this area and followed the issue for many years. There is a package of approaches and interventions that no one is using in practice. In his view, elaborate public health approaches have not improved this problem, but they also have not been systematic. Although the burden is clear, suicide deaths are not yet seen as a priority for the health care system. A survey indicated that approximately 45 percent of those who provide mental health care felt inadequately trained to work with patients who are suicidal. It is important to ask patients in care if they are suicidal, assess the severity of suicidal thoughts, develop a safety plan, and restrict means of self-harm. Typically, the treatment for suicidal patients is to provide therapy for their mental illness and hope that suicidal thoughts resolve. Mental health treatment is a good first step but inadequate as an intervention for patients who are suicidal. There is a need to stay in close contact while patients are vulnerable and to validate this approach. The field needs well-structured evaluations of interventions for suicide in health care settings. He thanked Dr. Pearson for her work on this initiative.

Dr. Insel commented that this is a signature effort for NIMH. The Zero Suicide project sets a high bar, but it is good to have a numerical metric. Council members should provide specific feedback on how to focus this initiative, as it involves research, policy, and practice. NIMH will focus on the research component.

Dr. Tamminga noted that her organization recently conducted a suicide survey with approximately 100,000 patients entering a hospital. The results were surprising: of all those entering the hospital, the incidence of active suicide was 1.9 percent and the incidence of recent past suicidal thoughts was about 6 percent. The field needs guidance on how to address suicides during hospital care.

Dr. Linehan commented that a study that found “caring letters” reduced suicides has been replicated once, although most people do not use this practice. Other treatments that have been shown to reduce suicide attempts are not used. Efforts are needed to increase the use of such practices. Most facilities do not provide adequate training to address suicide. The field needs to address therapists and clinicians’ concerns that they will be sued if they do not hospitalize patients who express thoughts of suicide.

Dr. Hogan noted that the Zero Suicide Toolkit provides information on better care and describes the team-care model. He described this information as common sense aligned with evidence, although it requires evaluation. This Website provides enough information for providers to start addressing suicide in a better way. Dr. Insel remarked that the proposed NIMH initiative lays the groundwork for reducing rates of suicide while in care. The mental health field does not usually focus on mortality.

Dr. Insel called on Council members to vote, and all members were in favor of moving the Concepts forward.

Comments from Retiring Council Members

Dr. Insel thanked retiring Council members for their work over their 4-year team and welcomed the remarks and observations of those who are attending their final meeting as Council members today.

Randall L. Carpenter, M.D., commented that four years on the Council goes by quickly and that he will miss serving. Dr. Carpenter’s perspective is one of academic medicine, the pharmaceutical industry, and biotechnology. He appreciated the talent of NAMHC and NIMH colleagues and remarked that it had been an honor to work with them. Dr. Carpenter remarked that he was most impressed with NIMH’s courage to lead. A tremendous challenge will be dealing with the accelerating pace of technology and information, including evaluating the limits of new technologies and big data. However, he noted that the biggest challenge occurs when new insights and technologies make established knowledge outdated and irrelevant. This is a human problem, as scientists and clinicians spend years developing expertise and must adjust when their work is no longer on the cutting edge. For NIMH, the challenge is to create a culture that embraces innovation and does not fund outdated approaches. It will require courage to lead and implement this change.

Ms. Greenman remarked that it has been a great honor and privilege to work with NIMH and the Council. Although serving can be intimidating for a non-scientist, she always felt welcome and valued at meetings. During her term, she tried to represent the concerns of those with family members with mental disorders. She related her experience as a parent with a young child at the NIH Clinical Center and remarked that everyone in the family learned a great deal. Treatment at the NIH Clinical Center was a cornerstone of support for her son, now 20 years old, and others in community. The experience taught her about mental health care and the needs of people who participate in care. Ms. Greenman commented that she brought that experience to her work on the Council and stressed that families need help now rather than scientific breakthroughs in the future. She thanked NIMH and Council members for valuing this perspective.

Ms. Greenman explained that as a lawyer and public defender, she also represented the needs and concerns of people involved with the criminal justice system to the Council. She has served as a bridge between lawyers, clients, and mental health professionals to understand what has gone wrong in lives. Ms. Greenman commented that there is a low level of treatment access for people who are incarcerated. She suggested that Council members consider the person as well as neural circuits. Ms. Greenman emphasized the importance of acknowledging the impact of poverty and racism on people’s lives. Disadvantaged people often do not get the services they need, and Council should discuss the impact of race, culture, and ethnicity on mental health. She encouraged Council members to continue to ensure that research participation benefits those involved and noted her concerns about research that labels young children as psychopaths and uses damaging terms (e.g., callous and unemotional). In conclusion, Ms. Greenman thanked NIMH for the opportunity to serve on the NAMHC. Dr. Insel thanked Ms. Greenman for her tremendous and insightful contributions to the Council. He commented on the importance of having a public member’s perspective and asked that Ms. Greenman stay engaged with Council.

Dr. Hyman remarked that he was moved by Ms. Greenman’s comments. He stated that it had been an amazing and positive experience to serve as a Council member. As a person with a basic neuroscience background, he has been moved by the experiences of people with mental health conditions and turned his attention to practice. Although there have been breakthrough discoveries in psychotherapies and devices that can change people’s lives, medication development has not made such advances. New technologies—including genomics, cognitive neuroscience, and behavioral science—have incredible potential to generate major scientific advances. However, we are decades away from implementing these breakthrough technologies. The RDoC initiative is an example of NIMH leadership that will ultimately help people, and such courage is important because the science of mental health is much more difficult than other areas of biomedicine. Dr. Hyman commented that NIMH is moving in the right direction and thanked the Institute for the opportunity to serve. Dr. Insel thanked Dr. Hyman for serving on the Council. He added that the field looks to Dr. Hyman for leadership, which has been inspiring for NIMH. He remarked that the Institute would continue its relationship with Dr. Hyman.

Dr. Tamminga remarked that she appreciated the opportunity to serve on the Council, as it was exciting to hear about national- and NIMH-level initiatives. It is difficult to know the direction of the mental health field, yet NIMH has led in this dynamic environment. It is best to move with the data to make new discoveries. Dr. Tamminga noted that she has taken the concepts discussed at Council meetings back to her own organization, and she encouraged Council members to act as ambassadors to the field. She commented that the variety of expertise represented on the Council was impressive and that NIMH does a great job of bringing a diverse group to the table. A diverse Council recognizes the complex picture of mental illness and what its treatment will be like in the future. Dr. Tamminga thanked NIMH.

Dr. Insel expressed gratitude to all the retiring Council members. He added that NIMH asked a great deal of Council members. The Institute appreciates the wisdom and commitment of all Council members. NIMH will ask them to serve in other ways (e.g., on study sections and workgroups).

Public Comment

Dr. Insel invited members of the audience to make any comments to the Council.

Lotoyia Piper, a social worker in private practice, thanked NIMH and the Council for the opportunity to attend and comment. She remarked that practitioners and service providers should be involved in the discussion on evidence-based standards for psychosocial interventions. Dr. Areán agreed about the importance of service providers’ perspectives on evidenced-based interventions. The development of the Psychosocial Interventions for Mental and Substance Use Disorders report included input from clinicians, and these participants brought their significant experience to the process. Dr. Insel thanked Ms. Piper for her comments and noted that the initiative on evidence-based psychosocial interventions continues to evolve. The report describes the problem, but there is much to be done to advance this issue. Some of that work can be done by practitioner groups, particularly helping to address the issues of accountability and regulation during a time of change in the health care system.

Hearing no further comments from the public, Dr. Insel adjourned the meeting at approximately 1:00 p.m.

Appendix A

Summary of Primary MH Applications Reviewed

September 2015

Category

IRG Recommendation

Scored
#

Scored
Direct Cost $

Not Scored
(NRFC)
#

Not Scored
(NRFC)
Direct Cost $

Other
#

Other
Direct Cost $

Total
#

Total
Direct Cost $

Research

571

$698,449,366.00

425

$429,848,914.00

34

$5,635,730.00

1030

$1,133,934,010.00

Research Training

1

$2,078,820.00

0

$0.00

0

$0.00

1

$2,078,820.00

Career

50

$34,467,340.00

20

$14,466,075.00

1

$100,000.00

71

$49,013,415.00

Other

0

$0.00

0

$0.00

0

$0.00

0

$0.00

Totals

622

$734,995,526.00

445

$444,314,989.00

35

$5,735,730.00

1102

$1,185,026,245.00

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institute of Mental Health
National Advisory Mental Health Council

(Terms end 9/30 of designated year)

Chairperson

  • Thomas R. Insel, M.D.
    Director
    National Institute of Mental Health
    Bethesda, MD

Executive Secretary

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

Members

  • Patricia A. Areán, Ph.D. (16)
    Professor
    Director of Targeted Treatment Development
    University of Washington
    Department of Psychiatry and Behavioral Sciences
    Seattle, WA
  • Deanna M. Barch, Ph.D. (16)
    Gregory B. Couch Professor of Psychiatry
    Department of Psychology, Psychiatry and Radiology
    Washington University
    St. Louis, MO
  • 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
  • BJ Casey, Ph.D. (16)
    Sackler Professor
    Department of Psychiatry and Neuroscience
    Sackler Institute for Developmental Psychobiology
    Weill Medical College of Cornell University
    New York, NY
  • 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
  • Hakon Heimer, M.S. (16)
    Founding Editor
    Schizophrenia Research Forum
    Brain and Behavior Research Foundation
    Providence, RI
  • 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
  • Marsha M. Linehan, Ph.D. (17)
    Professor and Director
    Behavioral Research and Therapy Clinics
    Department of Psychology
    University of Washington
    Seattle, WA
  • Maria A. Oquendo, M.D. (17)
    Vice Chair for Education
    Professor of Psychiatry
    Department of Psychiatry
    Columbia University
    New York State Psychiatric Institute
    New York, NY
  • Gene E. Robinson, Ph.D. (16)
    Director, Institute for Genomic Biology
    Swanlund Chair
    Center for Advanced Study Professor in Entomology And Neuroscience
    University of Illinois at Urbana-Champaign
    Urbana, IL
  • Mary Jane Rotheram, Ph.D. (16)
    Bat-Yaacov Professor of Child Psychiatry And Behavioral Sciences
    Director, Global Center for Children and Families
    Director, Center for HIV Identification Prevention And Treatment Services (CHIPTS)
    Semel Institute and the Department of Psychiatry, University of California, Los Angeles
    Los Angeles, CA
  • J. David Sweatt, Ph.D. (16)
    Professor
    Evelyn F. McKnight Endowed Chair
    Department of Neurobiology
    Director, McKnight Brain Institute
    University of Alabama at Birmingham
    Birmingham, AL
  • Hyong Un, M.D. (17)
    Head of EAP & Chief Psychiatric Officer
    AETNA
    Blue Bell, PA

Ex Officio Members

Office of the Secretary, DHHS

  • Sylvia M. Burwell
    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

  • Theresa Gleason, Ph.D.
    Deputy, Chief Research & Development Officer
    Office of Research & Development
    Department of Veterans Affairs
    Washington DC

Department of Defense

  • John W. Davison, M.B.A., Ph.D.
    Chief, Conditioned-Based Specialty Care Section
    Clinical Support Division
    Defense Health Agency
    Department of Defense
    Office of the Chief Medical Officer (OCMO)
    TRICARE Management Activity, OASD (HA)
    Falls Church, VA

Liaison Representative

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