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NIMH Alliance for Research Progress Meeting


Location: Bethesda, MD


2015 Alliance meetingThe National Institute of Mental Health (NIMH) convened the twenty-second meeting of the Alliance for Research Progress (Alliance) on Wednesday, September 16, 2015, in Rockville, Maryland.  The purpose of Alliance meetings is dialogue, so that participants can directly hear about NIMH activities, including science advances, exciting new and ongoing research projects, and a variety of ongoing and new initiatives of the institute. Alliance meetings also provide opportunities for attendees to network with their colleagues in the advocacy community in person and to interact directly with the NIMH Director, Thomas Insel, M.D., and other senior NIMH staff.  Invitees include leaders from national mental health-related organizations representing and advocating for patients and their families. The September meeting included a discussion on depression and resiliency; an update on the RAISE Early Treatment Program; an update on the Precision Medicine Initiative; and some thoughts on barriers to getting certain mental health treatments. For more information on the speakers, please see the attached agenda and participant list.

Major Themes

Welcome and State of the NIMH
Thomas R. Insel, M.D., Director, NIMH
NIMH Director, Thomas InselDr. Insel began by remarking that this would be his last Alliance meeting as NIMH Director, before his departure to begin work with Google Life Sciences (GLS) in November. He said that after 13 years as Director, and after having had the opportunity to launch the National Center for Advancing Translational Sciences and the BRAIN Initiative, he believed it was the right time to make a change. He also commented that over the last year or so, “there has been this increasing recognition that the technology sector, which has already revolutionized communication, entertainment, information, so much of what we do, finally was getting around to look at healthcare.” Regarding mental healthcare, he said that GLS is moving forward with the belief that mental health can be significantly improved through the use of technology and data analytics that will enable behavior measurement and thus better management and individual’s own healthcare. Alliance members praised Dr. Insel for the many accomplishments and research advances made in the field under his directorship. Participants noted that during Dr. Insel’s tenure at NIMH, lessons were learned on how to continue investing in new research during a time of flat budgets and eroding purchasing power. Tremendous accomplishments include NIMH’s involvement in helping reduce the high rates of service member suicide through the Army Study to Assess Risk and Resilience in Servicemembers (Army STARRS), acting early in schizophrenia to prevent disability through RAISE, and a wealth of information learned through several other research initiatives and trials. Alliance members wished Dr. Insel well in his new role. Deputy Director, Bruce Cuthbert, Ph.D., addressing the AllianceHe introduced the newly appointed NIMH Deputy Director, Dr. Bruce Cuthbert, who will serve as the acting NIMH director beginning in November, pending   a national search for Dr. Insel’s replacement. In response to a discussion of some barriers to research, Dr. Insel noted that the Notice of Proposed Rulemaking was issued on September 8, 2015 to revise and modernize the Common Rule to improve the conduct of clinical research. Examples of the proposed changes include centralizing institutional review boards and streamlining consent forms.

Depression, Too, Is a Thing with Feathers
Andrew Solomon, Ph.D., Professor of Clinical Psychology, Columbia University Medical Center
Andrew Solomon, Ph.D., Professor of Clinical Psychology, Columbia University Medical CenterDr. Solomon shared with Alliance members the stories of several individuals with depression and related the insights he has gained through his own experience with the illness and his recovery. One story he told was that of an expectant mother with depression who decided to discontinue her antidepressants while pregnant and ultimately died by suicide during her sixth month. Dr. Solomon said that she might have survived had she continued her medication, while others who take antidepressants through pregnancy may look back and think they should not have. He emphasized that balancing the risks of the illness and treatment is a constant struggle and spoke of the continuing stigma surrounding mental health disorders and their treatments, noting that “...narrow views about how to treat these illnesses can be very problematical and very dangerous. Understanding the brain should never preclude understanding thought, and neither should things go the other way around.” Dr. Solomon also expressed the hope that treatment side effects, including the feeling of personality/character distortion, could be addressed through research. He remarked that although the seriousness of depression is evident to those attending the Alliance meeting, it is “...still not evident to so many people in the larger population of the United States and, indeed, of the world.”

Alliance members commenting on presentationsDr. Solomon said that during his own experience with depression he found his vitality seeping away and then came to feel that it was simply painful to be alive. After beginning treatment, he spent a great deal of time thinking about medications and their effects; after several rounds of improving, and then discontinuing medications and relapsing, he finally came to understand that depression is a lifetime project. “The opposite of depression is not happiness, but vitality,” he said, and he explained that when he is not depressed he appreciates the various ways in which the illness had stretched him and has given him “a reason to find and to cling to joy.” He concluded, “...each day that I wake up and I'm not depressed feels to me like a small miracle...each of those days I gamely side with the reasons for living over those reasons for dying that once seemed so incredibly clear to me.  And I think that is a deeply privileged rapture.” He commented that even though treatment can be inadequate, more treatments are available now than ever before, many of which have been the result of extraordinary advancements in science and psychiatry, and in particular, exploration of the structure of the brain.

The RAISE Early Treatment Program: What We Did and What We Learned
Nina R. Schooler, Ph.D.; Professor of Psychiatry & Behavioral Sciences; SUNY Downstate Medical CenterNina R. Schooler, Ph.D., Professor of Psychiatry & Behavioral Sciences, SUNY Downstate Medical Center
Dr. Schooler opened her remarks by saying that the Recovery After an Initial Schizophrenia Episode (RAISE)-ETP focuses on developing and testing a specialty care program that provides comprehensive early treatment in community clinics for the first episode of psychosis (FEP). The goal of the program is to maximize recovery and change the trajectory of the illness over time. RAISE-ETP was compared with prevailing treatment practices across the United States. Using the embedded team model, the program was implemented in 34 sites in 21 states: 17 sites received community care and 17 sites received NAVIGATE, a recovery-focused and team-based program that emphasizes shared client and family decision-making. Dr. Schooler spoke about client characteristics and perceptions of treatment and how they were measured and said that it was found that clients who received NAVIGATE were more likely to remain in treatment and experience more improvement in quality of life than clients in community care; were more likely to be working or in school; and experienced a greater degree of symptom improvement during the first six months, which was maintained over time.

Alliance members listening to presentationsThrough RAISE, it was found that patients experiencing FEP have a better response to antipsychotics than do multi-episode patients and that effective medication doses are lower for the first episode. The results also show that a coordinated specialty care model can be implemented in a diverse range of community clinics using resources already available to most communities, and that the quality of life of clients with FEP can be improved. Dr. Schooler remarked that the primary outcomes of RAISE-ETP will be published soon, and a rigorous RCT will be conducted to evaluate the program. Alliance members discussed how in the absence of a full community care center some elements of the program could eventually be delivered in the home and through virtual teams. Members also mentioned the possibility of implementing RAISE on college campuses and asked about translation and cultural adaptation, which Dr. Schooler said would be a focus of the next generation effort.

Dr. Insel provided an overview of the broader context of RAISE, including the RAISE Connection Program, a feasibility effort that created coordinated specialty care programs in New York City and Baltimore, and which led to national adoption. He said that NIMH, encouraged by the feasibility study and the early NAVIGATE/ETP results, is planning the Early Psychosis Intervention Network (EPINET), which will be broader culturally and involve scaling up early intervention for psychosis through a learning healthcare system. Dr. Insel said that this effort is an acknowledgment that bundled coordinated specialty care works, especially for people who have not been sick for more than 74 weeks (the typical duration of untreated psychosis in the United States). He pointed out that it also is an acknowledgment that we already have some of the tools needed to identify early phases that lead to psychosis. Going forward, these efforts will be brought together to create a healthcare system/network that will collect standardized data to inform care.

Eric Green, M.D., Ph.D., Director, National Human Genome Research Institute, NIHU.S. Precision Medicine Initiative
Eric Green, M.D., Ph.D., Director, National Human Genome Research Institute, NIH
Dr. Green reviewed the course of events associated with the proposed Precision Medicine Initiative (PMI), from President Obama’s expression of his strong interest in genomics and precision medicine (an approach to treating and preventing disease that takes into account an individual’s genes, environment, and lifestyle) as a high Administration priority, to NIH Director Francis S. Collins’ acceptance of an advisory panel’s recommendations for implementing a key component of the initiative: the creation of a U.S. National Research Cohort. This cohort would be made up of one million or more Americans who will be willing to share genomic data, lifestyle information, and biological samples, all linked to their electronic health records (EHRs). The National Research Cohort will forge a new model for doing science that emphasizes engaged participants; open and responsible data sharing; strong privacy protections; and the conversion of the healthcare system into a learning system. Participants will be centrally involved in the design and implementation of the cohort, which will provide scientists with a ready platform for observational studies of drugs and devices, tests of wearable sensors for monitoring health, and more rigorous interventional studies.

Dr. Green said that in near term, the initiative will focus on cancer, focusing support into programs to identify new cancer subtypes and therapeutic targets; test precision therapies (with private sector partners); and expand understanding of therapeutic response. Longer term, the goal is to generate the knowledge base needed to apply precision medicine across the whole range of health and disease by supporting creative approaches for detecting, measuring, and analyzing a wide range of biomedical data; testing these innovations in small pilot studies; and evaluating the most promising approaches in greater numbers of people over longer periods. In addition, with its emphasis on participant engagement and transparency, PMI will change the research culture to one that is more participant-and partnership-focused and to address diversity and health disparities issues.

Thoughts on Moving Forward in Mental Health Treatments
Henry T. Greely, J.D., Professor of Law and Director of the Stanford Program in Neuroscience and Society, Stanford University
Henry T. Greely, J.D. , Professor of Law and Director of the Stanford Program in Neuroscience and Society, Stanford UniversityMr. Greely described how his interest in mental illness and the law intensified earlier this year when an older relative’s relentless depression eventually led to suicidal ideation and commitment to an inpatient facility. Despite treatment, the patient continued to deteriorate, and electroconvulsive therapy (ECT) was sought, which resulted in a vast improvement in the patient’s condition. Mr. Greely outlined some of the barriers to getting ECT in California, which include laws that continue to be unduly restrictive and based on old fears. Regarding the stigma still surrounding ECT, he said that past abuses tend to get the most attention even when circumstances have changed, adding that “dystopias always sell better than utopias.” He also wondered why there is a tendency to believe that it is acceptable to use indirect ways to change the brain but not direct methods, even if proven safe and effective. ECT, for example, is still subject to debate despite its documented 80 percent response rate. He argued that nondrug or device treatments, such as ECT, noninvasive neuromodulation, deep brain stimulation, and focused ultrasound, deserve more attention, particularly with the pharmaceutical industry backing out of mental health and central nervous system research, and a dried up drug delivery pipeline. Mr. Greely also emphasized that a scientific approach is needed to help us understand how these methods work and to persuade insurers to pay for them.

Mr. Greely emphasized that progress will require unrelenting hard work and continuing the focus on mental illness as a physical illness—“a disease of a physical organ”—and he remarked that there is strength in solidarity and in the willingness to talk openly about mental illness. He also said that regarding ongoing discussion about these issues in mental health and the law, most of the mental health law academics he knows are looking at the insanity defense and mental health parity, although there is huge interest among judges in neuroscience and the law. Dr. Insel added that the past few years seen greater focus on device developmental than on pharmaceutical development. Mr. Greely agreed and said that consumers read about such devices and can get many of them directly, but he is concerned that inexpensive yet unproven devices are taking the spotlight, with little attention given to ensuring medical safety and effectiveness.


Alliance members sharing their viewsIn closing the meeting, Dr. Insel said that a much broader conversation is needed about ways to improve attitudes about mental health and that Alliance members can help move this conversation forward. He also remarked that the day’s discussions have helped illuminate both the suffering and amazing resilience of people with depression and other mental illnesses. Dr. Insel pointed out some of the ways NIMH is trying to change the culture, such as through RAISE, which is demonstrating that “bundled interventions, providing choice to consumers and clients and families so they can get what they want out of a toolkit,” seem to work especially well earlier in the course of schizophrenia. Although the future of PMI is unclear, mainly because of budget issues, planning continues, he said, and it will be critical that the individuals Alliance members represent are included. Finally, the Alliance heard an inspiring presentation about how evidence for efficacy does not necessarily ensure access to treatment and how treatments are often as stigmatized as illnesses. Dr. Insel said that a broad range of negative attitudes must be grappled with and that we need to “think about ways of improving our attitudes, our approaches, public understanding, and really, at the end of the day, public policy as well.” Dr. Insel concluded his remarks by expressing confidence that he is leaving the Institute in excellent hands, with Dr. Bruce Cuthbert as Acting Director, and with the spectacular group of people who make up the leadership team. He said that it has been a great honor to work with the members of the Alliance all of these many years and that there is much to be excited about going forward.

Alliance members commenting on presentationsAlliance members thanked Dr. Insel for his service, wished him the best in his new position, and applauded him for his accomplishments and progress while Director of NIMH.

View additional images from the 2015 Alliance for Research Progress Meeting on the NIMH Flickr photo stream at