Alliance for Research Progress - February 8, 2008 Meeting
• Meeting Summary (Outreach)
This document provides an overview of the eighth meeting of the National Institute of Mental Health (NIMH) Alliance for Research Progress (Alliance). The meeting served as an opportunity for participants to hear about new research and advances in the field, to network with colleagues, and to interact directly with the NIMH director, Dr. Thomas Insel, and senior NIMH staff. The meeting focused on five major themes – science of note; the National Advisory Mental Health Council (NAMHC) neurodevelopment workgroup report; new treatments; the NIMH strategic plan; and the Research, Condition, and Disease Categorization (RCDC) Project. Invitees included representatives from national voluntary organizations representing patients and their families. Please see the attached agenda for information on speakers and roster of participants.
State of the NIMH
Dr. Insel said that 2007 was the “Year of Genetic Variation” as termed by Science magazine. He briefly discussed the progress made by the Human Genome Project and how research has identified approximately 3 million common points of variation in the human genome. He noted that specific points of variation have been associated with type II diabetes, macular degeneration, and inflammatory bowel disease. The ability to zero-in on specific variations in genetic clusters is forcing researchers to reevaluate what was thought to be known about these disorders. Dr. Insel went on to note that these studies have not identified genes as the cause of disorders, but rather identify the genetic variation associated with risk for developing a disorder.
Dr. Insel also mentioned promising research on genes and the environment. He discussed a study that shows that Attention Deficit Hyperactivity Disorder (ADHD) may be related to delayed cortical maturation, which could help to explain why many youth eventually seem to improve with age. Dr. Insel also highlighted a study that found that certain variations in a gene that helps regulate response to stress tend to protect adults who were abused in childhood from developing depression. The study found that adults who had been abused and then subjected to stressors, but did not have the variations in the gene, had twice the symptoms of moderate to severe depression, compared to those with the protective gene variations. Dr. Insel also discussed clinical research as it relates to the NIH 4P’s (predictive, pre-emptive, personalized, and participatory). He said that the research and findings may be helpful in assessing individual patterns of risk to develop personalized treatments. Dr. Insel also told Alliance members about the development of a new Strategic Plan for the Institute.
NAMHC Neurodevelopment Workgroup
Daniel Pine, M.D., Chief of the NIMH Section on Development and Affective Neuroscience and Chief of the NIMH Child and Adolescent Research in the Mood and Anxiety Disorders Program, presented information on the Neurodevelopment Workgroup. The purpose of the workgroup was to advise the NAMHC on how insights about the developmental nature of mental disorders should inform research and knowledge over the next 10-20 years.
Dr. Pine said that the workgroup members reflected a broad expertise in the area of mental illness and advocated collaborative work across all disciplines. He discussed the workgroup’s charge, using anxiety disorders research as a model, and noted their conclusions and findings, which included increased collaborations with the advocacy community at every stage. The workgroup’s charge and corresponding conclusions are noted below.
- How can NIMH best integrate developmental neuroscience, behavioral science, and psychopathology to forge a deeper understanding of pathways leading to mental illnesses?
NIMH should note that scientists cluster where the research opportunities are intriguing, the resources are available, and their skill sets apply. Clinical Developmental Neuroscience can serve as a novel discipline.
- How can NIMH best stimulate the discovery of the molecular, genetic, experiential, and developmental underpinnings of mental illness development?
NIMH should work with NIH in developing the many potential molecular genetic tools to be applied in basic and clinical research; and develop robust partnerships to enhance the collection and analysis of large, ethnically diverse biomaterials and patient cohorts.
- How can NIMH best foster translational science to improve indicators of risk, to specify causal mechanisms, and to develop effective pre-emptive interventions?
NIMH should create more tools that can be used across research groups at multiple points; increase the “culture of sharing;” and establish a basic developmental branch in the Intramural Research Program (IRP).
- How can NIMH best use training, research resources, and infrastructure support to speed scientific discovery and produce a diverse workforce of translational researchers?
NIMH should attract clinical-scientists; integrate research initiatives with training initiatives; and provide exposure to translational opportunities and new technology through summer initiatives and mini-sabbaticals and technical application institutes.
Developing New and Better Treatments: Challenges and Opportunities
Wayne Goodman, M.D., Director of the NIMH Division of Adult Translational Research and Treatment Development, talked to Alliance members about developing new and better treatments for mental disorders. He briefly discussed the history of psychotropic drugs as a story of serendipity and the development of novel drugs aimed at new targets in the brain. Dr. Goodman noted that NIMH and other research organizations will need to capitalize on the development of specific drugs through the use of molecular biology to create personalized and pre-emptive treatments.
Dr. Goodman discussed the importance of a team approach to move scientific research from the bench to the bedside to practice. He told Alliance members about exciting translational research involving ketamine for the rapid treatment of depression; D-cycloserine to enhance extinction learning during behavioral therapy; and deep brain stimulation as a last resort treatment for individuals with Obsessive Compulsive Disorder. He also mentioned the potential benefits and risks associated with each of the treatments discussed. Dr. Goodman concluded that there are several necessary steps required to develop new and better treatments, including facilitating early phase clinical trials to explore potential new treatments; assessing changes in a clinical domain or targeting symptoms within the larger syndrome; evaluating changes in intermediate phenotypes that may be more closely tied to underlying biology; seeking to identify and characterize subgroups of patients who are responders or non-responders to treatment; and using biomarkers to help identify patients who are better candidates for certain treatments.
Following the presentation, Alliance members commented on the innovative treatments and the need for more scientific education for the public and advocacy groups. Members also suggested that the clinical community pay special attention to the research conducted at NIH, in order to respond to consumers who have questions about new treatments that may involve risk.
NIH Research, Condition, and Disease Categorization (RCDC)
Timothy Hays, Ph.D., Chief of the Portfolio Analysis and Scientific Opportunities Branch in the NIH Office of the Director, told Alliance members about a transformative project that will provide stakeholders with more information on NIH spending. He discussed the current reporting system and noted that the 2006 NIH Reauthorization requires that NIH establish an electronic system to uniformly code research grants and activities. Dr. Hays explained that RCDC is an electronic system that will report NIH spending to Congress and the public each fiscal year and that the system will list research projects for approximately 360 research and disease areas from 27 NIH institutes, centers, and offices. Dr. Hays outlined the benefits of the new system, which will offer consistency in the definition of projects; transparency in reporting funding for projects and categories; efficiency by establishing a process to more quickly define categories and funding levels; and opportunities for further portfolio analysis. He noted that reported funding levels might go down or up as a function on the methodology of RCDC. To address this issue, the summary categorization data reported for 2007 will have a side-by-side summary of FY07 data derived from RCDC for comparison purposes. The RCDC system will launch in 2009 with full project listings beginning with FY08 research funding.
Alliance members expressed concern about the consistency of the data from previous years and the accuracy of the data in RCDC. Alliance members also questioned how they would present RCDC data to Congress and their constituency groups and asked if they could offer additional feedback on the system once it is launched. Dr. Hays reemphasized the benefits of the system as it relates to consistency, transparency, and efficiency. He also discussed the reasons why Congress requested the new system and mentioned that his office is in the process of educating Congressional staff on the systems capabilities and reporting.
Dr. Insel summarized the key points discussed during the meeting and thanked Alliance members for providing helpful feedback and expertise. Alliance members thanked Dr. Insel for his continued leadership and the opportunity to hear about exciting new mental health research that may yield positive outcomes; discuss important information on changes in the field and topics of public interest; and network with colleagues.
|NIMH Alliance for Research Progress - February 8, 2008|
Alliance Speakers (L to R) Dr. Nakamura, Dr. Pine, Dr. Insel, and Dr. Goodman
Dr. Tim Hays (Speaker)