Minutes of the 89th Meeting of the National Advisory Council on Drug Abuse

February 15-16, 2005

The National Advisory Council on Drug Abuse convened its 89th meeting at 2:00 p.m. on February 15, 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 application reviews. The meeting on February 15 was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The meeting reconvened on February 16 at 9:00 a.m. and was open to the public. The Council adjourned on February 16 at 1:54 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.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.
Peggy B. Sapp
Claire E. Sterk, Ph.D.
Richard T. Suchinsky, Ph.D.
Constance M. Weisner, Dr.Ph.D.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Jeanne Brooks-Gunn, Ph.D.
Mark T. Greenberg, Ph.D.
David Vlahov, Ph.D.
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
Jim Bernstein - American Society for Pharmacology
Jack Blaine, M.D. - Contractor
Anne Bowen - MasiMax Resources, Inc.
Andrea Browning, Ph.D. - Society for Research in Child Development
Sue Camaione - MasiMax Resources, Inc.
Lauren Costantini - Titan Pharmaceutical
Bill Corrigall, Ph.D. - Contractor
Heidi Ecker, Ph.D. - American Psychological Society
Julia Equmeyer - Consortium of Social Science Associations
Cheryl Kassed, Ph.D., M.S.P.H. - MasiMax Resources
Bertha Madras, Ph.D. - Harvard Medical School
Mary Mayhew - Contractor
Pam Moore - Federal Grants Contracts Weekly
Geoff Munford, Ph.D. - American Psychological Association
Shellee Nickel - National TASC
Eileen Resnick, Ph.D. - Society for Women's Health Research
Sin Schnore - Purdue Pharmaceutical L.P.
Thelma King Thiel - Hepatitis Foundation International
Daniel Tisch, Ph.D. - MasiMax Resources, Inc.
Diedre Watkins - MasiMax Resources, Inc.
Mary Westcott, Ph.D. - Contractor
Lori Whitten, Ph.D. - MasiMax Resources, Inc.
Melanie Whitter - Abt Associates, Inc.
Evelyn Yang - Community Anti-Drug Coalition of America
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 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 Neurosciences and Behavioral Research; the Division of Clinical Neuroscience, Development and Behavioral Treatments; the Division of Epidemiology, Services and Prevention Research; and the Division of Pharmacotherapies and Medical Consequences of Drug Abuse 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, 1,882 applications, requesting $1,884,310,369 in Total Years Direct Costs, went to review. Of these, 998 were scored by the Scientific Review Groups (SRGs), representing $236,381,639 in First Year Direct Costs and $1,007,721,269 Total Years Direct Costs. Council concurred with the SRGs in time and amount. Requests for one MERIT extension and three new MERIT nominations were reviewed and approved.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, including two new members, Dr. John Rice and Dr. Barry Lester, 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. The next meeting is May 17, 2005. Subsequent meetings are September 20-21 and February 7-8, 2006.

2. Consideration of the Minutes of Council

   The Minutes of the September 20-21, 2004 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow reported on the NIDA estimated budget for FY 2006. This year's budget increased 1.2 percent and the 2006 budget will increase 0.4 percent.

   Dr. Volkow reported on the supplemental ethics regulations that affect all NIH employees. These regulations set out broad prohibitions regarding outside activities, holdings, and awards. She also mentioned the new NIH policy on enhancing public access to archived publications resulting from NIH-funded research. NIH-funded investigators are asked to release manuscripts as soon as possible and within 12 months of final publication. These peer-reviewed publications will be available in a web-based archive to be managed by the National Library of Medicine. This will provide the public with better access to research publications.

   Dr. Volkow presented the NACDA Bioethics Taskforce immunotherapy recommendations, based on a recent IOM report, summarizing both present and long-term recommendations and emphasizing the importance of immunotherapy research.

   Dr. Volkow highlighted several recently published PAs and RFAs, described their importance and noted that NIDA is participating with other NIH components and agencies in eight new PAs and eight new RFAs. Foci include co-morbidity, HIV/AIDS, behavior and brain development.

   Dr. Volkow announced that Dr. Jacques Normand will be the Director of the new NIDA Office of HIV/AIDS and she noted that four NIDA initiatives had been approved by the NIH Office of AIDS Research for FY 2006.

   Dr. Volkow highlighted the Special Population/Health Disparities program and NIDA's African American initiatives. Thus far, activities have included a preliminary portfolio analysis, a scientific meeting, and the use of administrative supplements for research on the intersection of drug use and the criminal justice system.

   Dr. Volkow reported on the activities of each division and the CTN, highlighting both NIDA initiatives and trans-NIH, ones such as the trans-NIH brain Blueprint, and the NIH MRI study of normal brain development. She noted that the Medications Development Workgroup Report has been completed. The NIDA response to recommendations will be discussed at the May 2005 Council meeting. She reported that the National Drug Abuse Treatment Clinical Trials Network RFA-DA-05-001 was issued July 7, 2004. The application receipt date was October 14, 2004. Findings from the CTN include learning that short-term Bup/Nx detoxification has high acceptability and many drug free clinics have already adopted it. Also, motivational interviewing has improved retention for stimulant abusers entering treatment.

   Dr. Volkow provided an update on the Blue Ribbon Task Force Report concerning services research. NIDA has addressed all six goals and 24 recommendations of the Blue Ribbon Task Force, including defining drug abuse services research and developing standards for evidence-based practice. Several activities to enhance the adoption of evidenced-based practices were presented.

   Dr. Volkow described several NIDA-Sponsored/Chaired symposia at the Annual Meeting of the American College of Neuropsychopharmacology. These included substance abuse in the 21st century, the neurobiology of obesity, glia and astrocytes as modulators of synaptic function, molecular genetics of addiction vulnerability and treatment, and predictors of treatment response and relapse. She also noted NIDA participation at other professional meetings.

   Dr. Volkow also summarized the prohibited and permitted outside activities for NIH employees.

4. Medications Development Workgroup Update - Dr. Peter Kalivas

   Dr. Kalivas summarized the work of the Medications Development Workgroup. The committee was charged with providing recommendations to strengthen the medications development program of research and developing a 5-year plan for the program. This plan would include identifying new pharmacotherapeutic targets to treat drug abuse and identifying the strengths as well as any problems with the organization and management of the program, including its interactions with other NIDA programs. Dr. Kalivas thanked Dr. Vocci and his staff for their assistance to the workgroup. Dr. Kalivas provided a brief history of the many achievements of the program, including establishment of a network of contracts to screen compounds in molecular and behavioral assays and establishment of working relationships with biotech and pharma groups. This program has taken the lead in evaluating compounds for addiction-related applications. Dr. Kalivas noted that as new neurobiological knowledge accrues, the role of the program will grow and that it must position itself to take full advantage of the explosion in new knowledge. It is the primary administrative tool that NIDA has for translating neurobiology into pharmacotherapies for addiction. Several concerns and recommended solutions were presented. For example, the workgroup noted that the program did not have consistent algorithms for Ògo - no goÓ decisions and recommended establishing a scientific advisory board to review and advise the program. Recommendations on evaluating novel pharmacotherapeutic targets emerging from basic research, on ways to establish optimal relationships with pharmaceutical companies, and on strengthening interactions with other divisions in NIDA were also provided. It was noted that NIDA's intramural research program is a potential collaborator for a number of activities ranging from the testing of compounds to small scale synthesis.

5. Presentation of the NIDA Public Service Award

   Dr. Volkow presented Dr. Bertha Madras with NIDA's Public Service Award. This award recognizes her scientific contributions to the understanding of drugs of abuse and her commitment to educating the public about addiction. Dr. Madras thanked Dr. Volkow, Dr. Condon, and everyone at NIDA for this award and spoke briefly about some of her scientific findings and public education activities.

6. Bioethics Task Force - Dr. Dorothy Hatsukami

   Dr. Hatsukami spoke about the guidelines for substance abuse research involving children and adolescents and described the process by which these guidelines were developed. Draft guidelines were reviewed by the Bioethics Taskforce, the Director and Deputy Director of NIDA, and the NACDA. Once endorsed, the guidelines will be posted on the NIDA website. There was Council discussion of the proposed guidelines. Council recognized that these are very complex issues, made some suggestions, and recommended that they be discussed again at the next meeting. Task Force Report

7. Public Comments

   Dr. Volkow opened the floor to comments from the public. Ms. Thelma King Thiel, Chairman and CEO of the Hepatitis Foundation International, spoke about the work the American Liver Foundation to provide the public with more information about the liver. The Hepatitis Foundation International has developed a program in collaboration with CDC on liver wellness, Hepatitis B and C and substance abuse prevention. Ms. Thiel provided some educational materials to the Council.

8. Adjournment

   The 89th meeting of the National Advisory Council on Drug Abuse was adjourned at 1:54 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.