Minutes of the 90th Meeting of the National Advisory Council on Drug Abuse

May 17, 2005

The National Advisory Council on Drug Abuse convened its 90th meeting at 8:30 a.m. on May 17, 2005 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director of NIDA, chaired the overall meeting and Dr. Timothy P. Condon, Deputy Director of NIDA, chaired the review of applications. The closed portion of the meeting on May 17 from 8:30 a.m.-11:00 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 from 12:00 p.m. until 4:15 p.m. The Council adjourned on May 17 at 4:15 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.D.
Jeanne Brooks-Gunn, Ph.D.
Mark T. Greenberg, Ph.D.
Dorothy K. Hatsukami, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Claire E. Sterk, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, Dr.Ph.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Peggy Sapp
Robert L. Woodson, Sr., MSW

Council Chairs Present:

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

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse, NIH, DHHS

Members of the Public Present:

Candice Abati - Hepatitis Foundation Institute
Khursheed Asghar, Ph.D. - Contractor
Jim Bernstein - American Society for Pharmacology
Jack Blaine, M.D. - Contractor
Anne Bowen - MasiMax Resources, Inc.
Sue Camaione - MasiMax Resources, Inc.
Jenn Columbel - National Drug Court Association
Lauren Costantini - Titan Pharmaceutical
Bill Corrigall, Ph.D. - Contractor
Heidi Ecker, Ph.D. - American Psychological Society
Julia Equmeyer - Consortium of Social Science Associations
Steve Evangeliste - SRI International
Rose Howe - Lubbock Independent School District, Lubbock, TX
A. Imrie - SAIC
Cheryl Kassed, Ph.D., M.S.P.H. - MasiMax Resources, Inc.
Marian Kratage - MasiMax Resources, Inc.
Bertha Madras, Ph.D. - Harvard Medical School
Lou Ann Maier - MasiMax Resources, Inc.
Mary Mayhew - Contractor
Mary Ann McCabe, Ph.D. - Society for Research in Child Development
Pam Moore - Federal Grants Contracts Weekly
Geoff Munford, Ph.D. - American Psychological Association
Shellee Nickel - National TASC
William Nonthey - Amer. Assoc. for Marriage & Family Therapy
Eileen Resnick, Ph.D. - Society for Women's Health Research
Sin Schnore - Purdue Pharmaceutical L.P.
Ceil Sinnex - Substance Abuse Funding Week (CD Pubs)
Thelma King Thiel - Hepatitis Foundation International
Daniel Tisch, Ph.D. - MasiMax Resources, Inc.
Tim Turner - NASW
Eugene Wang, Ph.D. - Lubbock Independent School District, Lubbock, TX
Diedre Watkins - MasiMax Resources, Inc.
Joann Weekley - MasiMax Resources, Inc.
Mary Westcott, Ph.D. - Contractor
Lori Whitten, Ph.D. - MasiMax Resources, Inc.
Melanie Whitter - Abt Associates, Inc.
Sara Wilson, M.Ed. - Lubbock Independent School District, Lubbock, TX
Patricia Zickler - NIDA Notes
Kim Zink - IQ Solutions

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. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. Dr. Condon provided an overview of the agenda for the meeting 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 voting policies and procedures, 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 Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience, Development and Behavioral Treatments; the Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; and the Center for the Clinical Trials Network 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, 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, 877 applications, requesting $1,181,961,228 in Total Years Direct Costs, went to review. Of these, 428 were scored by the Scientific Review Groups (SRGs) representing $132,203,526 in First Year Direct Costs and $617,556,895 Total Years Direct Costs. Council concurred with the SRGs in time and amount. A request for one new MERIT was reviewed and approved. Council approved one administrative supplement. Council concurred with the IRG's recommendation on an appeal.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, including one new member, Dr. Mark Greenberg, NIDA staff, and visitors. 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.

2. Consideration of the Minutes of Council

   The Minutes of the February 2005 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow reported on the NIDA estimated budget for FY 2006. The 2005 appropriation provides a 1.2% increase.

   Dr. Volkow provided an update on the proposed ethics regulations that affect all NIH employees. She noted that Dr. Zerhouni has asked employees to give him feedback on this matter.

   Dr. Volkow identified PAs and RFAs that were recently issued or reissued: (1) Collaborative Multisite Research in Addiction (COMRAD) PA-05-067; (2) Minority Institutions' Drug Abuse Research Development Program (MIDARP) PAR-05-069; (3) Drug Abuse Dissertation Research: Epidemiology, Prevention, Treatment, Services and Women and Sex/Gender Differences PAR-05-083; (4) Inhalant Abuse: Supporting Broad-Based Research Approaches PA-05-099; and (5) Strategic Program for Innovative Research on Drug Addiction Pharmacotherapy (SPIRDAP) RFA-DA-05-009. NIDA is also participating in 13 new PAs and 4 new RFAs with other NIH components/agencies.

   Dr. Volkow noted that the National Drug Abuse Treatment Clinical Trials Network applications were recompeted with four new applications and 11 competing continuation applications submitted for review. Further, a contract mechanism will be used for a CTN Clinical Coordinating Center and a Data and Statistics Center. There are also four new CTN protocols, including a study comparing the effect of buprenorphine/naloxone and methadone on liver function, since FDA has asked that the extent to which buprenorphine is a hepatotoxic be determined. Two protocols pertain to co-morbidity: one that is a trial of methylphenidate in adolescents with ADHD and substance use disorder and a second that is looking at methylphenidate in maintaining abstinence in smokers with ADHD. The fourth new protocol will look at treatment for the abuse of prescription opiate analgesics.

   Dr. Volkow provided a summary of the report for the Medications Development Program Workgroup. The report provided recommendations about internal organization, interactions with other NIDA Divisions, interactions with pharmaceutical companies and the role of genetics in medication development. Dr. Volkow noted that the recommendation concerning internal organization was that a scientific advisory workgroup be created that could examine the entire portfolio and provided suggestions about priorities. That workgroup has already met and Dr. Peter Kalivas reported on that first meeting later in the day.

   Dr. Volkow also reported on the recent activities of each of the divisions, noting the role of the DNBR in both NIH Roadmap and Neuroscience Blueprint activities. Dr. Volkow pointed to the lead role NIDA is taking in neuroscience blueprint activities, and she described the multi-Institute commitment to the training of neuroscientists. NIDA has taken the lead in working with other ICs to develop three announcements for interdisciplinary training in neuroscience imaging, computational neuroscience and the neurobiology of disease. Thus, for example, the neurobiology of disease announcement will provide training in translational research in neuroscience by training M.D.s, Ph.D.s, and other scientists in the multiple theories, techniques, analytic strategies and objectives of research on the neurobiology of disease. Dr. Volkow noted that DCNDBT has also been very proactive in blueprint activities. She also noted that this Division has developed a number of RFAs demonstrating the breadth and depth of their interests, including an RFA on the neurobiology of behavioral treatment, another on the consequences of drug abuse and alcohol exposure on brain and behavioral development and a third on HIV and drug abuse interventions among pregnant women in drug abuse treatment. DESPR is the Division that has developed the CJ-DATS network that focuses on drug abuse and the criminal justice system. Dr. Volkow highlighted several of the studies that are part of this network, including six studies currently in the field that are concerned with reducing HIV risk behavior as well as work on screening for mental illness and transitioning people from the prison to the community. Further, two juvenile justice studies and two HIV studies are being developed. DESOR also held a successful meeting on substance abuse and primary care and issued an RFA with SAMHSA, HRSA and AHCPR to expand the role of primary care in addressing drug use, especially marijuana, among youth in the pre-dependence phrase of drug abuse.

   Dr. Volkow also presented a summary of relevant Congressional hearings and described a number of NIDA activities including the PRISM Award ceremony. She listed NIDA- sponsored events at several professional meetings, including a substantial number of events that will be presented at the College on Problems of Drug Dependence annual meeting. There will also be a Blending Treatment and Research Conference in June. NIDA's role in an NIH initiative on the neurobiology of obesity was also noted, as was a forthcoming American Journal of Psychiatry issue on substance abuse research and addiction.

4. Update on NIDA's AIDS Research Program

   Dr. Jacques Normand, Director of the NIDA AIDS Research Program, provided an update on the new AIDS program. He first presented background information on the former CAMCODA program. He then summarized the findings and recommendations made by Council in its February 2004 report on ways to improve the structure and functioning of the AIDS program. These recommendations included creating the new position of Director, AIDS Research program (reporting to the NIDA Director), updating the policy/procedures for determining which projects qualify for AIDS funding; improving the articulation of the HIV/AIDS mission and planning process within and across the Divisions and Centers as well as increasing interaction across NIH and with the external community. Dr. Normand described how these recommendations are being implemented, noting in particular ways to plan, develop, coordinate and integrate research priorities within NIDA and externally. He also provided information on AIDS funding in each NIDA Division and on NIDA's FY04 funding of the Office of AIDS Research areas of emphasis. In addition to presenting areas of interest and new initiatives, as well as delineating goals for the AIDS research program, Dr. Normand gave a brief update on NIDA/NIH collaborative projects and partners.

5. Minority Health Disparities Workgroup

   Dr. Jose Szapocznik presented the report of the Minority Health Disparities Work Group. This group was charged with reviewing the current Minority Health Disparities Program portfolio, providing recommendations to strengthen the research mission and providing recommendations for a 5-year plan to: 1) ensure that minority issues in drug abuse research are adequately represented in NIDA-supported activities; 2) promote research training and career development; and 3) examine the organization and management of the Minority Health Disparities Program and NIDA Divisions/Centers interactions. Dr. Szapocznik noted that the workgroup based its recommendations on an extensive review of relevant NIDA grants and strategic plans, research training of minorities, supplements addressing minority health, staff interviews, and information from the four NIDA racial/ethnic minority workgroups. Dr. Szapocznik noted that there is a considerable breadth and depth of minority-relevant research throughout NIDA, including both basic and applied research. The workgroup recommended using the NIH Roadmap approach to address minority health disparities. Thus, the report presented recommendations in terms of research teams of the future, new pathways to discovery, and re-engineering the clinical research enterprise. Another recommendation was to ensure alignment of the NIDA Strategic Plan with the NIDA Strategic Plan on Reducing Health Disparities. It was noted that both strategic plans should be carefully harmonized and widely disseminated and that NIDA's Strategic Plan on Reducing Health Disparities should foster integrative/ interdisciplinary research and create opportunities for collaboration and synergy across Divisions and Centers, as well as identify translational opportunities to quicken the speed of discovery of ways to reduce minority health disparities. Other recommendations included: 1) enhancing NIDA organization and collaboration around minority health disparities; 2) increasing training opportunities for future minority researchers (for example, establishing a national mentorship program and continuing support for minority research supplements and the Minority Institutions' Drug Abuse Research Programs announcement, since it was noted that training opportunities are needed at every stage of the career development pipeline; 3) creating incentives to promote valid analyses on minorities; and 4) addressing research needs and priorities of specific minority groups, for example treatment, prevention and health services.

6. Update on Intramural Research Program

   Dr. Zahniser presented a brief update on the Intramural Research Program (IRP). She noted that Council had visited the IRP in September of 2004 and that reviews by the Board of Scientific Counselors had taken place in February 2005 and would take place in September of 2005. Dr. Zahniser described the new translational obesity/food addiction initiative that would go from pre-clinical studies through medications development, with a special emphasis on teen obesity research. She noted that the IRP is now working in collaboration with the Maryland Psychiatric Research Center, and this will lead to important studies, including studies of co-morbidity. Further, there will be sharing of resources for recruitment and training of fellows. Other research activities also are planned. These include new programs in imaging and Parkinson's disease. The imaging studies have been enhanced by the use of a 9.4 Tesla animal magnet. Dr. Zahniser reported progress on the new building on the IRP campus, which will house both NIDA and National Institute on Aging staff, thereby increasing opportunities for collaboration. Dr. Zahniser said that she had enjoyed the opportunity to serve as the Council liaison to the intramural research program.

7. Update on Bioethics Task Force

   Dr. Hatsukami noted that when the proposed guidelines for substance abuse research involving children and adolescents, which were developed by this task force, had been presented previously to Council, there had been general support for the document. However, two areas needed additional consideration: 1) examples of imminent danger that would permit disclosure of confidential information and 2) guidelines for radiation exposure. Dr. Hatsukami described the complex issues involved in describing "imminent danger" and noted that there are insufficient data to write specific guidelines, although many examples are available. Therefore, the guidelines emphasize the importance for the investigator to consult with the IRB to determine what would be considered "imminent danger". The investigators are asked to consider a number of factors, such as the presence of co-morbid disorder and the age of the minor, in assessing imminent danger. The guidelines also recommend that the consent form include information on situations that would and would not lead to disclosure of information. After consultation with experts, the task force clarified the risk involved in exposure to radiation through neuroimaging e.g., if there is repeated PET neuroimaging, consideration must be given to cumulative radiation exposure. It was noted that exposure to radiation through PET neuroimaging is more than a minor increment over minimal risk. After some discussion, Council unanimously voted to endorse these guidelines. Dr. Hatsukami then turned to the topic of the genetics of drug addiction. She noted that NIDA requested that the National Academy of Sciences examine the ethical, behavioral, and social consequences of genetics research on drug abuse, and a summary of the proceedings from a workshop convened by them was made available to Council prior to this meeting. Dr. Hatsukami summarized the papers and noted that the task force recommended that these important issues continue to be considered and that, perhaps, the NIDA Genetics Consortium could be used as a platform for further consideration of these issues. The bioethics task force also recommended that NIDA consider supporting research in the area of communication science on genetics issues in partnership with other NIH ICs and that NIDA continue to educate stakeholders on the complexity of genetic issues in order to minimize stigmatization or discrimination as a result of misuse of genetic data or its interpretation.

8. Update on the Medications Development Workgroup

   Dr. Kalivas reminded Council that the formation of a scientific advisory group to consider medications development and to identify priorities for the program was a primary recommendation of the Medications Development Program Workgroup. Thus, the charges to the advisory group included reviewing the clinical contracts to be funded in FY05 and making recommendations on the relative scientific merit of each contract and its potential for clinical success. Dr. Kalivas presented a summary of recommendations for each compound under consideration, noting the rationale for deciding whether or not to support it. The preliminary agenda for the next meeting is to 1) review preclinical contracts and use of animal models, 2) review the dopamine transporter antagonist program, and 3) revisit the ondansetron clinical contract.

9. Public Comments

   No public comments.

10. Adjournment

    The 90th meeting of the National Advisory Council on Drug Abuse was adjourned at 3:52 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.