Minutes of the 102nd Meeting of the National Advisory Council on Drug Abuse

May 12, 2009

The National Advisory Council on Drug Abuse convened its 102nd meeting at 8:30 a.m. on May 12, 2009 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 May 12, 2009, from 8:30 a.m. until 10:30 a.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 May 12, 2009, from 11:00 a.m. until 2:00 p.m. The Council adjourned on May 12, 2009 at 2:00 p.m.

Council Members Present:

Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Debra K. DePrato, M.D.
Anita S. Everett, M.D. R.
Igor Grant, M.D.
Eric J. Nestler, Ph.D., M.D.
Daniele Piomelli, Ph.D.
Mary Jane Rotheram-Borus, Ph.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
Dale Walker, M.D.
Marina E. Wolf, Ph.D.
Janet Wood, MBA
Xiaoyan Zhang, Ph.D.

Council Members Absent:

John P. Allen, Ph.D., M.P.A.
Louis E. Baxter, M.D.
Warren K. Bickel, Ph.D.
Francisco X. Castellanos, M.D.
Ellie E. Schoenbaum, M.D.

Council Chairs Present:

Nora D. Volkow, M.D.
Timothy Condon, Ph.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:

Khursheed Ashghar, Ph.D. - Caspian Sea 
Jonathan Balcombe, Ph.D.
Anne Bowen - MasiMax Resources
Sue Camaione - MasiMax Resources
Shelley Caplan - IQ Solutions, Inc.
Helen Cesari, M.S.C. - CSR, Inc.
William Corrigall, Ph.D.
Susan David, Ph.D.
Stacia Fleisher - AACAP
Mark T. Greenberg, Ph.D. - Penn State University 
Lee Heming, Ph.D. - ASA 
William Hurwitz - ICCA 
Andrew Kessler, Ph.D. - CAADAC
Marian Kratage, M.S. - MasiMax Resources
Joan Levy Zlotnik - IASWR
Sarah Mandell, Ph.D. - Society for Research in Child Development
Meghan McGowan, Ph.D. - Federation of Behavioral Psychological and Cognitive Sciences
Vera Nordalm - IQ Solutions, Inc.
Patricia President - CSR, Inc.

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 and welcomed the Council and staff. Dr. Timothy Condon, Deputy Director, NIDA, 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; the AIDS Research Program; the Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; and the Division of Basic Neuroscience and Behavioral Research; presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc.

   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.

   For this Council, 1,095 applications, requesting $1,095,664,955 in Total Years Direct Costs, went to review. Of these, 532 were scored by the Scientific Review Groups (SRGs) representing $139,717,360 in First Year Direct Costs and $589,824,253 Total Years Direct Costs. Council concurred with the SRGs in time and amount.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members. 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: September 15-16, 2009; February 2-3, 2010; May 5-6, 2010; September 14-15, 2010.

2. Consideration of the Minutes of Council

   The Minutes of the February 2009 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. For FY 07, the actual budget provided a 0.6% increase from the previous year. The 2008 Budget Authority was that same amount, while the 2009 Conference figure was a 2.7% increase, and the 2010 Presidential budget was an increase of 1.2%.

   She then presented what was new at NIH, identifying NIH's role in the American Recovery & Reinvestment Act (ARRA), noting that NIH had received over $10 billion for two years and that NIDA had received a little over $261,000,000. This money would go to a variety of activities, including $8.2 billion for scientific research priorities, $400 million for comparative effectiveness research and $500 million for NIH buildings and facilities. She noted that this was an exciting opportunity for NIH. She then described the intent and the scientific areas that were delineated for the Challenge Grants in Health and Science Research competition, (RC1). NIDA science fits into these areas, and CSR, which will conduct the review of the Challenge applications, has received more than 20,000 applications. Dr. Volkow also described the (RC2) Research and Research Infrastructure "Grand Opportunities" (GO) award program that was intended to attract high impact ideas that would lend themselves to short-term, non-renewable funding. NIDA's priorities for GO grants included vaccines & immunotherapies, biomarkers, genetics, criminal justice, and several other areas. Dr. Volkow also described two other ARRA announcements, one for administrative supplements and one for competitive revision applications. She then noted that the NIDA ARRA signature projects would be on eradicating tobacco addiction and the genetics of brain development. Each Institute was asked to submit two signature projects, one that would be of interest across multiple Institutes and one that would be more institute specific. Approximately 440,000 annual deaths in the U.S. are attributable to cigarette smoking, so eradicating tobacco addiction is a bold proposal that, if successful, would have a major impact on public health. Dr. Volkow then showed the expected distribution of ARRA dollars at NIDA, with most of the funds going to support applications that were not earlier funded and could be completed in two years.

   Dr. Volkow presented the membership of the Scientific Review Management Board (SMRB). She reminded the Council at the last Council meeting it was noted that the Board was going to decide whether to address the benefits and disadvantages of a merger between NIAAA and NIDA. The SMRB met April 27-28, and both Dr. Volkow and Dr. Kenneth Warren, the Acting Director of NIAAA, described their Institutes' programs and priorities. There was also an opportunity for public comment. The Board decided to discuss this matter at subsequent meetings.

   Recent NIDA activities have included creating an Office of Computational Biology and Bioinformatics headed by Dr. Ron Edgar. Dr. Edgar was introduced. The NIDA Prevention Research Review Workgroup chaired by Dr. Mark Greenberg has concluded its work and will present its final report later today.

   Dr. Volkow noted the urgent need to address the increased abuse of opiate medication, and she showed data on the use by adolescents of opiates and analgesics for non-medical purposes. The Division of Epidemiology, Services and Prevention Research (DESPR) organized a workshop on opioid prescribing to adolescents in dental settings, bringing in researchers/clinicians from the fields of dentistry, analgesia and drug abuse. Dentists are the major prescribers of opiate medications to adolescents. The workshop identified areas needing additional research and suggested that better education is needed for dentists in this arena as are improved guidelines for prescribing opioids in dentistry. She then described some funding opportunities that the Division has developed.

   Dr. Volkow highlighted several trials from the Center for the Clinical Trials Network (CTN), including protocols that are under development. Current CTN trials include the ADHD adolescent trial; the Rx opioid addiction trial-POATS; and an HIV rapid testing trial. Protocols under development include protocols on exercise, web-based therapy, and smoking cessation in substance abuse treatment.

   A search is underway for a new Director for the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCD), given the retirement of Dr. Frank Vocci. An update on medication trials in this Division was presented, and Dr. Volkow noted that a multi-site study of modafinil including alcohol-dependent patients yielded no significant treatment effect for cocaine. However, pilot results for Bupropion have been positive in non-daily meth abusers in a multi-site study with 12 weeks of treatment. She then described other clinical trials with other medications as well as several funding announcements from this division.

   In the Division of Basic Neurosciences and Behavior Research (DBNBR) there have been several new announcements for applications. Dr. Volkow briefly described several of these and pointed out why they were significant. Further, there has been important progress on the NIH Blueprint Computational Neuroscience Training Program and related training programs that NIDA manages. Several grand challenge initiatives were presented, including initiatives 1) harnessing understanding of neural plasticity to elucidate the transition from acute to chronic pain, 2) seeing connections and molecules through human neuroimaging and 3) in neurotherapeutics, developing new therapies for diseases of the nervous system.

   The Division of Clinical Neuroscience and Behavioral Research (DCNBR) has also developed a number of announcements using various mechanisms, including an RFA on brain imaging studies of negative reinforcement in humans, an RFA on neuroimaging in obesity research (with NIDDK and NIBIB) and an RFA for exploratory centers for translational research on the clinical neurobiology of drug addiction. Dr. Volkow also reported on an intriguing study showing that denicotinized cigarettes occupy nicotine receptors and that there were no significant correlations of receptor occupancy with reduction in withdrawal symptoms following smoking.

   Dr. Volkow briefly described the Avant Garde Award Program for HIV/AIDS research. She then announced staff changes in the intramural research program: Dr. Barry Hoffer will go on an IPA to Case Western Reserve University but will retain his role as tenured, Senior Investigator and NIDA consultant; Dr. Roy Wise will leave the position of Deputy but will remain in the intramural program; and Dr. Amy Newman will serve as the new Acting Deputy Scientific Director.

   Dr. Volkow then introduced NIDAMED, NIDA's new initiative to provide the medical community with drug abuse resources to enhance patient care. She noted that NIDAMED uses research-based drug use screening tools and resources in a way that is designed to be sensitive to the demands of modern clinical practice. These products will help clinicians efficiently screen at-risk patients and conduct the follow-up steps necessary to provide the best in medical care. Also of great importance is the training and certification in addiction treatment that will now be available to all physicians, regardless of specialty, not just psychiatrists. Materials from the Centers of Excellence for Physician Information were also presented. Other NIDA activities will include a research track at the American Psychiatric Association annual meeting. Dr. Volkow concluded by noting the new Secretary of HHS and the Director and Deputy Director Designates of ONDCP.

   Council thanked Dr. Volkow for her presentation. Council noted that the creation of the new Office on Computational Biology and Bioinformatics was an excellent idea and this led to a discussion of open source vs. close source platforms. There was also discussion about the role of Council and other organizations such as CPDD in the possible merger of NIAAA and NIDA and the scientific and other advantages of such a merger. The importance of involving the various scientific communities was pointed out, and it was also noted that a shared website for community input might be useful. A comment was raised about the impact of nutrition on addiction and the possible importance of omega-3 fatty acids and other factors. There was also discussion on early diagnosis and treatment as well as the likely consequences of parity and the importance of creating partnerships with treatment programs and physicians. NIDA's collaborations with other Institutes in areas such as HIV/AIDS were mentioned, as was the importance of these collaborations.

4. Update on the American Recovery and Reinvestment Act - Christine Colvis, Ph.D., Director of Program Integration, OD, NIDA

   Dr. Christine Colvis began her presentation by noting that the American Recovery and Reinvestment act of 2009 (Recovery Act) was signed into law by President Obama on February 17, 2009. It provided an unprecedented opportunity for NIH research. She showed how DHHS is distributing the dollars it received, with $ 10 billion going directly to NIH. The impact of this funding will be to stimulate the economy, create and preserve jobs and advance biomedical research.

   Dr. Colvis then identified NIH plans for ARRA resources, including 1) selecting and funding recently peer reviewed and highly meritorious research grant applications that could be accomplished in two or fewer years; 2) funding new research applications; 3) accelerating the tempo of ongoing science through targeted supplements to current grants; 4) supporting new types of activities, such as the NIH Challenge Grant Program, that meet the goals of the ARRA and 5) using other funding mechanisms as appropriate. She then described open funding opportunities through NCRR, including the Core Facility Renovation, Repair and Improvement (G20) Program and the Extramural Research Facilities Improvement Program (C06), among others.

   She then turned to NIDA, noting that NIDA had received $ 261 million and would be participating in several of the NIH Funding Opportunity Announcements (FOAs), including the Challenge Grants in Health and Science (RC1), the Grand Opportunity (GO) grants (RC2), Supporting New Faculty Recruitment to Enhance Biomedical Research Core Centers (P30), ARRA AREA awards (R15), ARRA competitive revisions and ARRA administrative supplements. Dr. Colvis described each of these programs, noting the purpose of the announcement, submission deadlines, budget requirements, review procedures, and other matters. She listed the eleven NIDA GO scientific priority areas, which ranged from vaccines and immunotherapies, biomarkers and genetics to criminal justice and prevention infrastructure. NIDA also has identified two major goals to highlight for support as Signature Projects: eradicating tobacco abuse and addiction and understanding how genes influence the development and morphology of the human brain. Grants for NIDA's Signature Projects will come from Challenge, GO and other sources.

   Dr. Colvis then noted the distribution of NIDA ARRA resources, identifying the ARRA awards to date by state and by research field as well as by drugs of abuse, with stimulants being the area in which the largest number of grants were supported. She provided a projection of the success rates for NIDA applications under both conservative and more aggressive assumptions, looking at the likely impact of ARRA on NIDA under both sets of conditions.

   Accountability and transparency are essential parts of the Recovery Act; every taxpayer dollar spent on the economic recovery will be subject to unprecedented levels of transparency and accountability. At the President's direction, Federal agencies are taking critical steps to carry out the Act effectively. All Federal agencies and departments receiving Recovery Act funds must establish rigorous internal controls, oversight mechanisms and other approaches to meet accountability objectives. Grantees will need to fulfill detailed quarterly budget reporting requirements, and their reports will summarize the total amount of ARRA funds received that quarter and the ways those funds were expended, including a detailed list of all projects and activities and an estimate of the number of jobs created or retained. Further these reports will be publicly available.

   Council thanked Dr. Colvis. Discussion included questions about the review process, success rates, and the possible influence of the reduction in number of times an application can be submitted on the number submitted and success rates.

5. Report from the NIDA Prevention Research Review Workgroup - Mark T. Greenberg, Ph.D., Chair of Workgroup

   Dr. Mark Greenberg presented a summary of the report of the NIDA Prevention Research Review Work Group. Dr. Greenberg chaired this group, which was composed of NIDA Council members and other experts in prevention research. The charge to the workgroup was to review the prevention research program portfolio, identifying strengths and gaps in the program, and to develop a five year plan for the program through 1) recommending innovative and transformative approaches, 2) providing a strategic overview to maximize the translation of prevention research findings and ensure their application into practice, 3) reviewing the prevention research infrastructure and exploring the development of new NIDA prevention research linkages and also 4) examining the organization and management of the prevention research program, including its interactions with other parts of NIDA.

   Dr. Greenberg described the phases of the prevention research continuum in order to provide a framework for the report. He then identified the notable accomplishments of the program. These include the range of types of research supported, the substantial progress that has been made in demonstrating efficacy to prevention of early substance use, the strong use of developmental theory to understand risk and protective factors for substance use and HIV across developmental periods, and the excellence of the branch staff and leadership, including their strong support for minority research training and their proactive role in building prevention science.

   Dr. Greenberg noted that there are two types of translational research. Type 1 applies basic science discoveries to intervention development for the prevention of substance abuse and HIV/AIDS. Research topics in this area address the interface between basic science and prevention intervention. The typical endpoint for Type 1 research is testing of promising new models of prevention to reduce risk for substance abuse or HIV/AIDS and to improve health and well being. Type 2 investigates factors, models and processes associated with the adoption, implementation, and sustainability of tested and effective prevention programs, policies and practices in communities, service settings and populations.

   Dr. Greenberg then listed and discussed the major findings of the work group: 1) greater support is needed in the portfolio for Type 2 research; 2) Type 1 translational research should focus on understanding how, for whom and when preventive interventions have the greatest impact; 3) a center for the advancement of prevention trials research is needed; 4) NIDA's leadership in prevention research should be expanded across NIH; 5) innovative prevention research tools and methodologies should be promoted; 6) the investment in prevention research training should be enhanced; 7) recommendations of the IOM report should be pursued. He also noted that infrastructure coordination should be strengthened and expanded both to facilitate cross-unit collaboration within NIDA and to pursue cross-Institute and cross-Agency partnering to support innovations in prevention.

   A number of supporting recommendations were also presented. Recommendation 1 was to expand Type 2 translational research to emphasize research on effectiveness of systems and services, to focus on pre-adoption issues of communication and decision-making and to support innovative and cross-disciplinary training. The second recommendation was to focus on Type 1 research through supporting research on biological and genetic factors relevant to prevention, supporting research on how and for whom prevention programs have their effects, pursuing development of novel interventions, supporting research on comprehensive models of prevention, supporting development and widespread use of data monitoring systems, and supporting replication of interventions across development and with different populations. Another recommendation was to expand support for methodological and statistical innovations, including supporting research into the utility and analysis of near-continuous time assessments, developing novel assessments of risk for substance use and dependence, and developing methods for the analysis of studies of the efficacy of Type 2 translational research and its adoption.

   Dr. Greenberg concluded by noting that the Prevention Research Branch has established strong research programs central to NIDA's mission and that it has an exceptional portfolio and outstanding leadership. Further, the opportunities to enhance prevention science should be coordinated under this branch, and there should be a greater shift towards Type 2 research and innovations in Type 1 research. He noted the need for large scale public health research on community level process and comprehensive programs and further support of early career scientists.

   Council thanked Dr. Greenberg for his presentation. Discussion centered around coordination with mental health research, the importance of a developmental approach, the organization and financing of prevention research, the need to better integrate prevention and treatment research and programs, and the importance of ethnic and cultural diversity.

6. Public Comments

   Dr. Jonathan Balcombe, an ethologist and senior research scientist with the Physicians' Committee for Responsible Medicine, commented on the use of animals in prevention research. He noted that NIDA funds research that involves adult, young and pregnant monkeys, rats and mice and that some research subjects these animals to harmful drugs and to stressful and/or painful procedures. He noted that these animals experience prolonged stress and pain, and he pointed out that, to the degree that sentience is the foundation of our ethical systems, we may find the use of animals morally repugnant. He closed by asking that NIDA promptly cease its support of animal studies.

7. Adjournment

   The 102nd meeting of the National Advisory Council on Drug Abuse was adjourned at 2:00 p.m.

Certification

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

Council Roster

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