106th Meeting Minutes

September 14, 2010

The National Advisory Council on Drug Abuse convened its 106th meeting at 2:00 p.m. on September 14, 2010 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director, NIDA, chaired the meeting. The closed portion of the meeting on September 14, 2010, from 2:00 p.m. until 5:00 p.m., was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open session, which was open to the public, was on September 15, 2010 from 8:30 a.m. until 12:00 p.m. The Council adjourned on September 15, 2010 at 12:00 p.m.

Council Members Present:
Louis E. Baxter, M.D.
Francisco X. Castellanos, M.D.
Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Debra K. DePrato, M.D.
Anita S. Everett, M.D.
Igor Grant, M.D.
Caryn E. Lerman, Ph.D.
Eric Nestler, Ph.D., M.D.
Daniele Piomelli, Ph.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
R. Dale Walker, M.D.
Steven M. Wolinsky, M.D.
Xiaoyan Zhang, Ph.D.
Jon-Kar Zubieta, M.D.

Council Members Absent:
John P. Allen, Ph.D., MPA
Mary Jane Rotheram-Borus, Ph.D.

Council Chair:
Nora D. Volkow, M.D.

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:
Andrea Baruchin, Ph.D. - Foundation for the National Institutes of Health
Shelley Caplan, B.S. - I.Q. Solutions
William Corrigall, Ph.D.
Susan David, Ph.D.
Yoshie Davison, M.S.W. - American Academy of Child & Adolescent Psychiatry
Robert Hauser, Ph.D. - National Research Council
Deborah Ismond
Meena Karithanom, M.P.H.
Julie Miller, Ph.D. - RTI
Patricia President, MLS - CSR, Inc.
Michelle Rodrigues, M.B.A. - SRI
Swee Teo
Evelyn Yang, Ph.D. - CADCA

Closed Portion of the Meeting - September 14, 2010

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Nora Volkow, Director, NIDA, called the meeting to order, welcomed the Council and staff, and reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.

   Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Division of Clinical Neuroscience and Behavioral Research (DCNBR); the Division of Epidemiology, Services and Prevention Research (DESPR); the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA); the Division of Basic Neuroscience and Behavioral Research (DBNBR); and the Office of Science Policy and Communications (OSPC) presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved all administrative supplement requests presented.

   Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave if an application in conflict with that member was acted upon en bloc.

Open Portion of the Meeting - September 15, 2010

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Volkow called attention to future Council meetings: February 2, 2011, May 10-11, 2011, September 13-14, 2011.

2. Consideration of the Minutes of Council

   The Minutes of the May 2010 meeting were approved as written.

3. NIDA Director's Report - Nora D. Volkow, M.D., Director, NIDA

   Dr Volkow began her report by providing a budget update. She noted that the 2011 President's Budget proposed a 3.3% increase for NIDA over the previous year. She then reported that she would be attending the NIH Scientific Management Review Board (SMRB) meeting that was being held September 14-15 (which was why Council would adjourn early). The Board would be presenting its recommendations about types of mergers of NIAAA with NIDA. Dr. Volkow then described changes to the NIH governance structure, which will include continuing the Steering Committee but making it smaller in membership to facilitate dialogue. However, some of the working groups will be modified, the intramural working group will be disbanded, and a diversity working group has been created. She also noted that Dr. Lawrence Tabak was appointed Principal Deputy Director of NIH, that Dr. Sally Rockey was appointed Deputy Director for Extramural Research in August (she had been serving as the Acting Deputy Director for Extramural Research) and that Dr. Robert Kaplan was appointed Director of the Office of Behavioral and Social Sciences Research and NIH Associate Director for Behavioral and Social Sciences Research in July. He will join NIH in early 2011.

   An update on ARRA was also provided, including presentation of a RFA on opportunities for research in the five thematic areas that reflect the priorities of Dr. Collins, and a number of basic behavioral and social science opportunity network (OppNet) announcements were also noted. The NIH Roadmap RFA on developing technologies for improved in vivo epigenetic imaging or analysis was also described, as was the Roadmap RFA for the epigenomics of human health and disease. NIDA has taken a leadership role in the epigenetic roadmap activities.

   Dr. Volkow then turned to recent NIDA activities and events. She reported that Dr. Timothy Condon, who had been the Deputy Director of NIDA as well as Director of the Office of Science Policy and Communications, was now a Science Policy Advisor in the Office of the Director, ONDCP. She also announced that Dr. Antonello Bonci has now arrived as Director of the Intramural Research Program. Dr. Bonci was previously Professor of Neurology, Howard J Weinberger Chair in Addiction Research at the Ernest Gallo Clinic and Research Center at the University of California, San Francisco.

   Instead of reporting on activities within each of the Divisions or Offices of NIDA as she had done at previous Council meetings, Dr. Volkow presented activities in terms of priority areas for NIDA, noting that prevention research, treatment interventions and medical consequences, including HIV/AIDS, were the three major headings into which priority projects fell. This change was made because overall priorities and many activities are not limited to a single Division or Office. She briefly described the importance of the NIDA Science of Genetics Workgroup, noting that Dr. Nestler, Chair of the workgroup, had reported on their recommendations at the last Council meeting. She presented a chart showing the distribution of funds for different areas of genetics studies and noted a recent FOA in deep sequencing that is intended to support studies proposing to use next generation sequencing technologies to identify the structural and SNP variants with rare to moderate frequencies that affect risk for addiction. Dr. Volkow then discussed genetic and environmental effects on human brain development, pointing to the Gilmore et al 2010 study on the heritability of brain morphology in neonates. She also noted that the National Children Study presented an opportunity for imaging work that could provide important genetics/environment/development information.

   Turning to the priority area of treatment interventions, Dr. Volkow stressed the importance of translating basic science discoveries into new and better treatments, and she presented the grantees who will be supported under the new Translational Avant-Garde Award for Medication Development for Diseases of Addiction Program. She also noted that Dr. Elena Koustova will lead NIDA's SBIR/STTR program, directing it toward medication development and that Dr. Koustova's background in science and business, including experience in a small drug development company, have ideally prepared her for this new responsibility. Dr. Volkow then listed several potential targets for medications development and presented interesting findings from recent work on naltrexone and buprenorphine for the treatment of cocaine and cocaine use reduction with buprenorphine. She noted a study on the role of aerobic exercise in decreasing cocaine reinstatement in rodents as well as a CTN study comparing percent days of cocaine abstinence between exercise and health education groups. For NIDA's third priority area, Dr. Volkow introduced the work of NIDA Avant-Garde Program for HIV/AIDS awardee, Dr. Eric Verdin. Dr. Verdin hopes to develop new single cell technology to examine the transcriptional status of HIV in single primary lymphoid cells over time after an infection in vitro. Dr. Volkow described other HIV/AIDS activities, including the Seek, Test, Treat and Retain initiative in the criminal justice system, noting the importance of retaining individuals in treatment.

   Dr. Volkow presented the work of the three high school students who had won awards from NIDA for their INTEL ISEF projects. Further, she noted, that a NIDA grantee, Dr. Mauricio Delgado had been awarded a PECASE Award for his research on using cognitive training to modulate craving in cigarette smokers. Other activities have included expansion of the Drug Facts Chat Day into a one week activity because of the volume of calls previously experienced. A booklet, Shatter the Myths, has been written to explain the science underlying conclusions about the effects drug abuse and addiction and a national drug IQ challenge has been generated. Another very exciting opportunity has been the partnering with the MusiCares/Grammy Foundation to create a competition for high school students to create music videos about drug abuse that will be performed for the public. Work with physicians, poster development, and the satellite symposia to be held at the Society for Neuroscience meeting this fall were also described. Dr. Volkow closed by presenting preliminary data on how reviewers are using the new grant application scoring criteria, noting that assessment of the approach is the factor that has the greatest impact on outcome score.

   Council thanked Dr. Volkow for her presentation. Council comments and discussion included the question of how academic scientists can engage in the pipeline of drug discovery and development, the difficulties of developing medications for drug abuse, the lack of uniform response in clinical samples, the need to develop drugs that focus not on a specific disease but on other processes that may underlie several diseases, such as motivational or attentional processes, some of the issues surrounding disclosure, confidentiality of medical records and privacy. Also raised was the importance of outreach to minority populations and minority investigators. Dr. Volkow noted that it would be important to assess the extent to which the recommendations of the 2005 Council report on minority issues had been implemented and three Council members agreed to be on a workgroup to explore this topic. There was also discussion of the importance of studying externalizing disorders and substance abuse disorders together and of collaboration across NIH institutes, the utility of behavioral interventions, and the integration of specific behavioral and medical treatments. Also noted was the burden on investigators, both extramural and intramural, of some aspects of conflict of interest policies at NIH, academic and research institutions, journals and other venues, and the utility of a registry that could describe relevant relationships was suggested.

4. Blueprint Research Training Initiatives: Progress and Next Steps - Susan Weiss, Ph.D., Chief, Science Policy Branch, NIDA
   Blueprint research training

   Dr. Weiss began her presentation with an explanation that the Blueprint (BP) was a consortium of 16 NIH Institutes that support neuroscience research and have pooled resources to support the development of tools, training and research in areas of common interest, e.g., pain, neurotherapeutics, the human connectome. In 2005, the BP identified three priority areas for research training: computational neuroscience, neuroscience imaging and the neurobiology of disease. Dr. Weiss (OSPC) and Dr. Larry Stanford (DCNBR) chaired the committee that developed initiatives to target those areas. Dr. Weiss then briefly described the programs supported in these three research areas:

   "Computational neuroscience: from biology to model and back again" (T90), for which Dr. Susan Volman (DBNBR) is the Project Officer. The goal of this program is to provide training in both experimental neurobiology and the application of mathematical, physical, or computer science principles to develop models, test them experimentally, and use experimental data to refine the models as well as to attract students from quantitative and physical sciences to the neurosciences and to train undergraduates in biology/psychology in quantitative sciences. Four institutions were funded, and Dr. Weiss reviewed the backgrounds of the trainees and also provided information about their careers, awards, and publications.

   "Neuroscience imaging: integrating first principles and applications"(T90) for which Dr. Steve Grant (DCNBR) is the Project Officer. The goal is to support novel, interdisciplinary training programs that integrate imaging technologies, neuroscience applications and neurobiological principles, to improve neuroscientists' basic understanding of multiple technologies and to attract scientists from other disciplines such as physics, chemistry and engineering, including foreign scientists. Three institutions were funded. Dr. Weiss described the backgrounds of the trainees and provided information about their careers and publications.

   "Translational training in the neurobiology of disease" (T32) for which Ms. Beth Babecki (DBNBR) is the Project Officer. The goal is to train scientists to identify and conduct research on clinically relevant neurobiological questions and to have them learn how to translate results from basic research into clinical and disease-oriented research, as well as to appreciate how findings in clinical research can serve to inform and refine basic research. Three institutions were funded; each one developed broad curricula covering topics that span multiple diseases. Dr Weiss again described the trainees and their accomplishments to date.

   Dr. Weiss concluded by noting that, overall, for a little over $3.5 million a year, in 3% years, training has been provided to 78 undergraduates, 125 doctoral students, 33 postdoctoral fellows, and 374 summer program participants. New courses have been developed and some have been made available through websites. New majors have been developed and new faculty has been recruited, with faculty and students coming from very diverse scientific and technical backgrounds. Funding for these programs ends in 2011; however, the Blueprint IC Directors approved reissuance of RFAs for two of the programs: computational neuroscience and neuroscience imaging, with funding remaining at FY11 levels. Finally, Dr. Weiss highlighted the work of two successful grantees, and listed the names of the new blueprint committee that developed the new RFAs.

   Council thanked Dr. Weiss for her presentation and noted that this was a very successful, exciting activity. The question was raised if high school students might be included, but there are no plans to do so at this time. It was also noted that statistical genetics and other computational areas related to genetics might also be considered under computational neuroscience. There was also some discussion of large databases and new analytical tools and techniques, with the understanding that they were beyond the scope of the planned RFAs.

5. NIH Director's Report - Francis S. Collins, M.D., Ph.D., Director, NIH
   Blueprint research training

   Dr. Collins opened his remarks by noting that the Scientific Management Review Board meeting would take place later that day and that the agenda would include a report and discussion about whether there might be some reorganization carried out for substance use, abuse and addiction science. He then pointed out that this seems to be a time where the scientific opportunities have never been better, budget constraints notwithstanding. He then described his five priority opportunities for NIH, opportunities which are cross-cutting and touch on all diseases: developing high-throughput technologies to understand fundamental biology, translating basic science into new and better treatment, providing information for health care reform, e.g., comparative effectiveness research, encouraging a greater focus on global health and invigorating and empowering the scientific research community.

   Dr. Collins then provided a brief update on the status of human embryonic stem cell (hESC) research, noting that, although the temporary injunction blocking federal funding of human embryonic stem cell research had been stayed, thus lifting the suspension of all pending grants and contracts, applications and proposals, the final outcome of these challenges is not yet known. The injunction was set to halt the continuation of funds for 24 extramural grants after September 30, eight intramural research grants and funding for 20 promising new hESC applications.

   Dr. Collins pointed out that NIH is the steward of medical and behavioral research for the nation, and when he has spoken at various NIH Councils, he has asked the leaders of each Institute what examples they would like to share of the science they are supporting. He stated that one of the examples from NIDA is work on discovering variations in the genome that have an effect on nicotine dependence. He also pointed to the stories that have come from individuals who have been utilizing the nicotine vaccine in clinical trials as a means of trying to stop smoking, and he shared the story of Leslie, a woman who had tried to stop smoking many times and was only able to do so as a result of participating in the phase II NicVAX clinical trial. Dr. Collins told this story to Senator Harkin at the Senate Appropriations Hearing. NicVax is now in phase III, with 1,000 smokers at 20 centers around the United States. NIH Recovery Act funds are helping to support this first-ever phase III trial of a smoking cessation vaccine.

   One of Dr. Collins' highest priorities is translation, making sure we are capitalizing on basic science discoveries and moving them into clinical applications. He spoke briefly about therapeutics and the lengthy time it takes to go from a new target for therapeutics to an FDA- approved drug, highlighting the particular challenges of going from basic to preclinical phases. Programs supported by the common fund are providing some of the resources to make it possible for promising compounds to move more quickly through these phases. Further, he identified stages in the process where new NIH/FDA partnerships are being forged. There will be an NIH/FDA joint leadership council meeting in October. Also, NIH has joined with FDA in funding a regulatory science initiative. Four projects will be funded from this joint regulatory science initiative in diverse areas of research, and FDA is contributing additional funds to the initiative.

   Dr. Collins then turned to Health Care Reform and described a bold new paradigm relevant to such reform: the cures acceleration network (CAN), the goal of which is to dramatically advance development of new treatments and cures for debilitating and life threatening diseases by reducing barriers between laboratory discoveries and clinical trials. Up to $50 million has been designated in the House and Senate appropriation for FY 11 and flexible funding mechanisms will be included, but funds have not yet been appropriated. These efforts would be synergistic with biotech and pharma companies. He noted that one of his goals, as well as that of the Scientific Management Review Board, is to look at how NIH is organized to see whether the optimal structures are in place to smoothly transition through the pipeline of basic discovery to clinical application and to make therapeutic development efforts as efficient as possible.

   Information on the budget was next addressed. Dr. Collins expressed gratitude that Congress and the Administration see medical research as such a good investment, and the President's budget for 2011 is a billion dollars over the 2010 base. However, because the Recovery Act dollars are limited to two years, there is a four billion dollar drop-off between 2010 and 2011, assuming Congress's number is close to that of the President. Further, inflation is a factor reducing buying power, making NIH effectively have less than was the case in 2002 in terms of what can be purchased with the dollars appropriated. This leaves NIH with much more great science than can be supported, and success rates have been going down. Dr. Collins pointed out that hunkering down and making conservative decisions and avoiding doing anything novel because of concerns about the budget would be a serious mistake and that strong leadership will be needed to make difficult decisions.

   Dr. Collins closed by noting that this may be the best of times in terms of exciting science and the worst of times in terms of stress related to financial limitations, at least as measured by success rates for grant applications. He emphasized the importance of continuing to make the case for the value of medical research for human health, for the economy, for all the benefits it creates and concluded by stating that we are not limited by ideas, by great scientists or by great science; we are limited by resources, and, although this will be stressful, Dr. Collins stated his belief that we would get through stressful times, as we always have.

   Council thanked Dr. Collins for his presentation. Comments were raised about the role of CSR in identifying the best science, the consequences of the decline in success rates, and the importance of scientific leadership both for human health and for a robust economy. In response to a question, Dr. Collins noted that it was too soon to know how health care reform might impact efforts to translate personal medicine into practice but that he hoped that using the best science of personalized medicine would be embraced by health care reform. Council mentioned, and there was agreement about, the importance of data sharing, electronic health records and reducing the time from basic research to wide-spread dissemination and application. Council also commented on the need to form collaborations with the education, legal and other systems for health care reform to be most effective. Finally, Council again thanked Dr. Collins, as did Dr. Volkow, for addressing them and responding to their questions and comments.

6. Public Comments

   There were no public comments.

7. Adjournment

   The 106th meeting of the National Advisory Council on Drug Abuse was adjourned at 12:00 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.