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Tuesday, December 6, 2011

NIH Institutes ACNP Update

WAIKOLOA, HI – The 2011 NIH Institutes Update for the American College of Neuropsychopharmacology (ACNP) was held Sunday afternoon, December 4. The session was introduced by ACNP President Dr. Eric Nestler, who noted that ACNP was fortunate to have a larger panel of presenters than usual, including representatives from 5 National Institutes of Health (NIH) Institutes.

Panel members were Dr. Neil Buckholtz, Chief of Dementias of Aging Branch, National Institute on Aging (NIA), Dr. Thomas Insel, Director, National Institute of Mental Health (NIMH), Dr. Story Landis, Director of the National Institute of Neurological Disorders and Stroke (NINDS), Dr. Kenneth Warren, Acting Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and Dr. Susan Weiss, Acting Director, Office of Science Policy and Communications, National Institute on Drug Abuse (NIDA).

Dr. Buckholtz began the session by speaking about NIH funding in general, noting that while NIH currently is working with a continuing resolution budget from Congress, there is hope that a budget appropriation will occur this calendar year. He also noted that the lack of an agreement by the Congressional Supercommittee could trigger an 8% budget cut for all of NIH in fiscal year (FY)2013, if nothing is done to avert that cut. He indicated that while the news appears grim, that NIH Institutes have funding to support research projects and he encouraged researchers to continue to submit grant applications, a comment echoed by subsequent panelists.

Key initiatives for NIA include developing and implementing new diagnostic guidelines for Alzheimer’s Disease including guidelines for preclinical research studies, focusing on biomarker studies, supporting translational research, and working with other NIH Institutes to add aging-relevant research initiatives to existing studies.

Next, NIMH Director Dr. Thomas Insel spoke about budget challenges facing NIMH, which in FY2011 awarded the lowest number of research grants (465 new and competing continuation applications) since 1998. This amounts to a 16% success rate, an all time low. He noted that NIMH anticipates increasing the number of FY2012 research grant awards to about 500 (7.5% increase). Dr. Insel spoke about the downward trend in research grant success rates since 2002, due primarily to increased numbers of submissions in the face of stable and declining budget appropriations. He noted that the NIMH funding strategy is designed to protect early stage investigators, fund innovative ideas, fund research project grants, and will reach to fund ideas that peer review committees did not quite get right.

Key NIMH initiatives include the STARRS study assessing suicide in the military, with over 25,000 people currently enrolled, a project assessing recovery after a first break in schizophrenia (RAISE), and a biomarkers project (EMBARC) assessing biomarkers of major depression and treatment response. NIMH also is interested in medications development research, particularly now that big pharma is withdrawing from this research area. It is revamping its intramural research program with new facilities and with a translational focus. NIMH is inviting extramural scientists to help build this program by doing an intramural sabbatical. NIMH also is working to develop the next generation of leaders by fostering development of MD/PhD young investigators.

NINDS Director Dr. Story Landis reported that research project grant (RPG) success rates at her Institute were about 20%, with an increase in the number of RPGs awarded in FY2011 (749) versus FY2010 (699). Early stage investigators were funded up to the 25th percentile. She indicated that NINDS is working to find a better balance between basic, clinical, and translational science and is focused on retaining medical resident researchers.

Dr. Landis discussed an important point in therapeutics development research: many studies cannot be independently replicated, as reported recently. This is resulting in a higher proportion of failed clinical trials than in past. Accordingly, NINDS is focusing on improved experimental design including structured data analysis protocols, as well as on replication studies, to reduce the likelihood of late stage drug development failures. Related to this issue, NINDS is supporting NeuroNEXT, a program that standardizes clinical trial conduct and management.

Dr. Warren, NIAAA Acting Director, spoke next and noted that FY2011 was a very tight year budgetwise, with a total appropriation budget of $458 million. NIAAA funded 150 new and competing continuation awards, with total funding of 685 projects in FY2011.

Dr. Warren reported on a number of goals for NIAAA including development of additional treatment medications and medication combinations, development of better phenotypic animal models, and improvement of human laboratory paradigms. Dr. Warren also indicated that NIAAA is very interested in identifying additional cellular targets for alcohol (e.g., proteins/receptors/intracellular sites).


Other key initiatives include development of an adolescent alcohol use disorder screening guide with questions tailored for different age groups, and support of longitudinal studies in children and adolescents aged 12-21 to determine effects of adolescent alcohol abuse on brain development. Existing cross-sectional studies in this area have linked adolescent alcohol use to brain structural abnormalities, but longitudinal studies are needed definitively establish a link between alcohol exposure and brain changes.

Dr. Warren ended his presentation by summarizing the status of the structural reorganization of NIAAA and NIDA, which he noted actually is more than a merger of the two Institutes, since up to 8 Institutes may be involved in the process. He noted that the initial time table for the reorganization had to be abandoned to accommodate the complexity of the process, which includes developing a strategic plan for substance use and addition research and conducting a research portfolio analysis. The current time table proposes that the strategic plan and portfolio analysis drafts will be released in the fall of 2012 for a public comment period. Then, final recommendations will be made such that reorganization plan funding can be included in the President’s FY2014 budget.

Dr. Susan Weiss, Acting Director, NIDA Office of Science Policy and Communications, was the final panel presenter. She noted that nonmedical use of prescription pain medications now is second only to marijuana abuse in terms of prevalence, and highlighted a recent Centers for Disease Control alert on opioids documenting that hospital treatment admissions and opioid related deaths had more than quadrupled over the past decade. She indicated that NIDA is taking a lead on supporting a planned “Call to Action” by the United States Surgeon General to reduce opioid pain medication abuse.

In terms of funding issues, Dr. Weiss noted that as with other Institutes, NIDA grant application success rates have been lower due to increased numbers of grant applications and reduced funding levels. NIDA is seeking to protect young investigators and has been funding K awards with higher priority scores, and is reaching beyond pay lines to fund promising investigators and ideas. Dr. Weiss made a special note of the NIDA budget allocation to pharmacotherapeutic development, which was 12% of the total budget this past year. She indicated that NIDA’s funding in this area has been stable for a number of years and pharmacotherapeutic development is not occurring to the exclusion of other research areas.


She mentioned a number of priority areas for NIDA including prevention research, clinical trials for a nicotine vaccine and for a new opioid addiction treatment, studies of the medical consequences of addiction, and neuroimaging biomarker studies. She also noted that NIDA is supporting efforts to increase access to large datasets such as the functional connectomes project, which includes more than 2000 resting state functional MRI datasets. Increasing access to these and other datasets could help principal investigators by enabling them to work with data generated by others, resulting in substantial cost savings since subjects would not have to be recruited.

The session ended with a short Open Discussion including 2 questions.

The first question focused on the apparent bias of NIH peer review committees identified in the Ginther report (published in Science in August)—showing that African American applicants have a statistically significant disadvantage in receiving NIH awards.

Dr. Richard Nakamura, who became Acting Director of the Center for Scientific Review in September, commented that NIH is concerned about this issue and is investigating it.


The second question focused on whether there is active management for “distributing the wealth” away from Principal Investigators with multiple research project grants to others, particularly young investigators making the transition from K award to independent funding support. Dr. Landis commented that former NIH Director Zerhouni identified this as a vulnerable transition time. The only Institute with an explicit policy on this issue is NIGMS, which requires its Council to specially review and approve funding of PIs with award that would total more than $750,000 per year. There has been discussion of this issue by Sally Rockey in her blog Extramural Nexus, which can be found here.


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