Minutes of the 87th Meeting of the National Advisory Council on Drug Abuse

May 19-20, 2004

The National Advisory Council on Drug Abuse convened its 87th meeting at 2:00 p.m. on May 19, 2004 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora Volkow, Director, NIDA, chaired the overall meeting, and Dr. Timothy Condon, Deputy Director, NIDA, chaired the application reviews. The meeting on May 19 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 May 20 at 9:00 a.m. and was open to the public. The Council adjourned May 20 at 2:20 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.D.
Dorothy K. Hatsukami, Ph.D.
Kenneth J. Hoffman, M.D., M.P.H. (ex officio)
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
Scott A. Reines, M.D., Ph.D.
Peggy B. Sapp 
Claire E. Sterk, Ph.D.
Richard T. Suchinsky, M.D. (ex officio)
Jose Szapocznik, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, Dr.P.H.
Robert L. Woodson, Sr., M.S.W.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Jeanne Brooks-Gunn, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Robert C. Malenka, M.D., Ph.D.

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

Other Federal Employees Present:

Geoff Patton, Ph.D. - National Cancer Institute, NIH
Luci Roberts, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

Jim Bernstein - American Society for Pharmacology and Experimental Therapeutics
Jack Blaine, M.D. - Contractor
Anne Bowen - MasiMax Resources
Sue Camaione - MasiMax Resources
Emily Coakley - Substance Abuse Funding News
Judith Cornelius - Child and Adolescent Bipolar Foundation
Marie Dyak - Entertainment Industries Council
Sam Estes - Society for Women's Health Research
Christine Hartel - National Academy of Sciences
Cheryl Kassed, Ph.D., M.S.P.H. - MasiMax Resources
Mary Kratage - MasiMax Resources
David Liu, M.D. - Contractor
Lou Ann Maier - MasiMax Resources
Mary Ann McCabe, Ph.D. - Society for Research in Child Development
Geoff Mumford, Ph.D. - American Psychological Association
Bill Northey - American Association for Marriage and Family Therapy
Patricia Pettinato - MasiMax Resources
Barbara Solt - Institute for the Advancement of Social Work Research
Dan Tisch - MasiMax Resources, Inc.
Marion Torchin - MasiMax Resources, Inc.
Roy Walker - CSR, Inc.
Deidre Watkins - Contractor
Jo Weekly - MasiMax Resources, Inc.
Mary Westcott, Ph.D. - Contractor
Lori Whitten - MasiMax Resources, Inc.
Megan Zuckerman - Therapeutic Communities of America

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 Treatment Research and Development; the Division of Epidemiology, Services and Prevention Research; the Division of Neuroscience and Behavioral Research; and the Center on AIDS and Other 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. Requests for three MERIT awards and four administrative supplements were reviewed. There were no MERIT extensions.

   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. Conflict of interest statements were signed by each member. Members were not required to leave if an application in conflict with that member was acted upon en bloc.

   For this Council, 995 applications, requesting $1,053,315,433 in Total Years Direct Costs, went to review. Of these, 556 were scored by the Scientific Review Groups (SRGs), representing $130,314,866 in First Year Direct Costs and $581,795,356 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved three MERIT awards and three administrative supplements.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, 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 also called attention to future Council dates.

2. Consideration of the Minutes of Council

   The Minutes of the February 12-13, 2004 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow began her report by giving an update of the NIH Roadmap activities. She announced that Dr. Timothy Condon is serving as NIDA's representative for the Roadmap activities. Dr. Volkow added that NIDA program staff has contacted potential grantees to encourage them to apply for the Roadmap initiatives and that, to date, 44 researchers have applied. She added that a website has been created featuring the Roadmap activities most relevant to NIDA.

   Dr. Volkow reported that an NIH Blue Ribbon Panel on Conflict of Interest Policies has prepared a recently released report.

   Budget

   Dr. Volkow reported that the NIDA estimated budget for FY 2004 has an increase of 3.0% over the FY 2003 appropriation. The President's budget request for NIDA for FY 2005 has a projected 2.9% increase over the FY 2004 appropriation; this would bring NIDA's budget to slightly over one billion dollars.

   NIDA Program Reviews

   Dr. Volkow summarized NIDA's response to the four main recommendations of the Blue Ribbon Task Force on Health Services Research co-chaired by Drs. Thomas McLellan and Constance Weisner. She noted that, based on this report, NIDA's initial goals are to: 1) implement a standard definition of health services research; 2) increase research on organizational, management and economic issues; 3) develop standards for evidence-based practice; and 4) evaluate causal associations.

   Dr. Volkow reported that the Clinical Trials Network Work Group, chaired by Dr. David Rosenbloom, evaluated five different aspects of the Clinical Trials Network (CTN) and made recommendations concerning the CTN's mission, organization, operations, dissemination, and collaborations with NIAAA and NIMH. The potential of the CTN as a research platform for HIV/HCV and genetics will be explored. Further, the CTN will be used as a training platform and for priority studies. NIDA will consolidate the coordinating centers - data monitoring and management - and make other changes in operations, dissemination and collaboration that will enhance the CTN.

   Dr. Volkow summarized the recommendations of the HIV/AIDS Workgroup, chaired by Dr. David Vlahov. NIDA will implement recommendations concerning organization, portfolio and collaboration across NIDA. In order to increase HIV/AIDS expertise in the divisions and the CTN and to better integrate HIV/AIDS within NIDA, CAMCODA has been dissolved and the AIDS coordination function has been brought to the Office of the Director. A national search for a permanent director for AIDS research is underway and that new director will implement other recommendations to enhance the program.

   Dr. Volkow reported that NIDA has created a new division that will better integrate clinical neurobiology with human development and behavioral therapies and take advantage of advances in imaging to better understand the neurobiological underpinnings of drug abuse and addiction. This new Division of Clinical Neurobiology, Development and Behavioral Treatments will be directed by Dr. Joseph Frascella.

   Dr. Volkow reported that reviews of the Medication Development Program and Minority Health Disparities Program are in progress. The Medications Development Workgroup, chaired by Dr. Peter Kalivas, held their first meeting May 18-19, 2004, and the Minority Health Disparities workgroup, chaired by Dr. Jose Szapocznik, is in the process of recruiting additional members.

   Recent NIDA Activities

   Dr. Volkow highlighted several recently published RFAs in prevention research in children and adolescents, in treatment interventions, and in HIV/HCV. She reported that there has been a large response to these RFAs. She also noted that NIDA has just issued a new RFA on translational research and PAs on 1) collaborative clinical trials in drug abuse, and 2) epidemiology for drug abuse. Dr. Volkow announced that NIDA is participating with other NIH institutes in 5 new PAs and 5 new RFAs. These initiatives will focus on genetics, co-morbidity, HIV/AIDS and services (with SAMHSA). She reported that NIDA has been increasing its partnership with SAMHSA. An example of this collaboration is an initiative, Buprenorphine for Non-Physician Providers, that will create training materials to increase awareness about Buprenorphine among non-physician practitioners.

   Dr. Volkow highlighted several recent meetings and events. She reported on several recent Congressional hearings in which NIDA played a role. Dr. Volkow reported that at the American Psychiatric Association's 157th annual meeting held in May in New York, NIDA sponsored 17 major lectures, 11 symposia and 9 issues workshops. She also noted that the 8th Annual Prism Awards took place in Los Angeles and was also highlighted May 12 on Capitol Hill. This event, co-sponsored with the Robert Wood Johnson Foundation and the Entertainment Industries Council, honors creative contributions in the entertainment media that accurately portray substance abuse and addiction.

4. NIH Director's Report - Dr. Elias Zerhouni

   Dr. Zerhouni, Director of the National Institutes of Health, thanked the Advisory Council for inviting him and complemented them on their work on behalf of NIDA and NIH. He presented an update of the NIH Roadmap program and the reasons for its development. Dr. Zerhouni outlined aspects of the Roadmap and stressed the importance of stimulating innovation and discovery in concepts and methods to tackle the scale and complexity of biological systems and their behavior. He noted that research teams of the future will be different from those of today and that the Roadmap includes an initiative in this area. Dr. Zerhouni also pointed out that clinical research and translational research need to be rethought as a system, including consideration of infrastructure issues, and the Roadmap will do this also. The NIH Director's Pioneer Award was cited as an example of a pilot experiment for attracting bold ideas. Dr. Zerhouni then answered questions from Council about a wide range of issues.

5. Update on the NIDA Intramural Program - Dr. Nancy Zahniser

   Dr. Zahniser, Council Liaison to the Board of Scientific Counselors, presented an overview of the NIDA Intramural Program including changes in personnel and organization. She noted that the Board of Scientists met to review progress. Dr. Zahniser reported that the clinical program has been reorganized to enhance its effectiveness and create operational efficiencies. Dr. Zahniser added that new research initiatives would reflect targeted areas such as obesity, medications discovery, molecular genetics, neuroanatomy and comorbidity. She also reported that the Imaging Branch has added a new Micropet imaging machine. Dr. Barry Hoffer, Scientific Director of the IRP, answered questions.

6. Bioethics Task Force Update- Dr. Dorothy Hatsukami

   Dr. Hatsukami gave an update of the Bioethics Taskforce. She commented that the Taskforce was asked to examine bioethical, social and legal issues regarding 1) the use of immunotherapies and sustained release formulas for treating drug addiction, 2) the genetics of drug addiction, and 3) child and adolescent research.

   To address the first issue the National Institute on Drug Abuse commissioned a report from the National Research Council (NRC) and the Institute of Medicine (IOM) to investigate the behavioral, legal and social questions likely to arise from the unique characteristics of immunotherapies and sustained release formulations for the treatment of drug addiction, if and when these medications become available. These issues include concerns regarding who should be given these medications and under what circumstances. The pre-publication copy of the report, New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions, has been completed. The taskforce was asked to review the report, determine whether they would recommend endorsement of the NRC/IOM Committee's recommendations, and come to a consensus on the recommendations that should receive high priority by NIDA.

   NIDA commissioned another report from the NRC/IOM to examine bioethical issues related to genetics of drug addiction. A conference was held in November of 2002. Several papers were presented. This report is pending review by the Bioethics Taskforce.

   NIDA also commissioned the American Academy of Child and Adolescent Psychiatry to develop guidelines for conducting research with children and adolescents that are specific to the area of substance use and abuse. While the report was thorough in describing guidelines for conducting research in children and adolescents in general, it did not fully address issues specifically associated with drug use or abuse; more work is now being done to do so.

7. NRC/IOM Report on New Treatments for Addiction: Behavioral, Ethical, Legal, and Social Questions - Mr. Henrick Harwood and Dr. S. Michael Owens

   Mr. Harwood, Chair of the Committee on Immunotherapies and Sustained-Release Formulations for Treating Drug Addiction, gave a report on the recommendations of the Committee. Mr. Harward noted that the Committee was commissioned at the request of NIDA and the Institute of Medicine to advise NIDA on the behavioral, ethical, legal, and social issues concerning potential uses of immunotherapies and sustained-release formulations. The Committee considered major themes and issues and proposed 10 primary recommendations.

   Dr. Owens reported on active immunization and passive immunization (monoclonal antibodies) and depot formulations. He noted the potential uses of immunotherapies and depot medications for relapse prevention. Dr. Owens summarized the 10 primary recommendations that included clinical trials recommendations, treatment and financing issues, behavioral response recommendations, and consent and coerced treatment recommendations. The Council voted to accept this report.

8. New Directions for the Center for Substance Abuse Prevention - Ms. Beverly Watts-Davis

   Dr. Volkow introduced Ms. Watts-Davis, Director of the Center for Substance Abuse Prevention (CSAP), Substance Abuse and Mental Health Services Administration (SAMHSA). Ms. Watts-Davis gave an overview of SAMHSA's strategic plan, noting that the mission of SAMHSA is to build resilience and facilitate recovery. She noted that this could be accomplished by measuring and reporting program performance, increasing service availability, and improving service quality. Ms. Watts gave an overview of SAMHSA's Strategic Prevention Framework (SPF). She noted that the SPF works to bring together multiple funding sources to create a community-based approach to substance abuse prevention. She added that an estimated $45 million would be available to fund up to 20 SPF SIG grants in fiscal year 2004. These grants will enable states, territories and the District of Columbia to implement the SFP to deliver effective substance abuse prevention and mental health promotion programs in their communities.

   Ms. Watts-Davis noted that the Department of Health and Human Services, through SAMHSA/CSAP, is committed to bringing down the rates of underage drinking and has committed $30 million in funding in FY 2004 for communities to address this problem. She added that additional information can be found on SAMHSA's website (http://www.samhsa.gov).

9. Public Comments

   Dr. Volkow opened the floor to comments from members of the public. Ms. Judith Cornelius, a member of the Board of Directors of the Child and Adolescent Bipolar Foundation, spoke about problems of bipolar adolescents and drug abuse and stressed the need for more research on treatment of addiction in children and adolescents.

10. Adjournment

    The 87th meeting of the National Advisory Council on Drug Abuse was adjourned at 2:20 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.