Minutes of the 69th Meeting of the National Advisory Council on Drug Abuse

May 19-20, 1998

The National Advisory Council on Drug Abuse convened its 69th meeting at 9:00 a.m. on May 19, 1998 in Conference Rooms E1 and E2, Natcher Building, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland. Dr. Alan I. Leshner, Director, NIDA, chaired the meeting. 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 3:04 p.m.

Council Members Present:
Susan G. Amara, Ph.D.
Andrea G. Barthwell, M.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc.
Reese T. Jones, M.D.
Nancy J. Kaufman, R.N., M.S.
George F. Koob, Ph.D.
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
June E. Osborn, M.D. (May 19 only)
Kathy Sanders-Phillips, Ph.D.
Catherine A. Stevens, J.D.
Lei Yu, Ph.D.
Col. Terry K. Schultz, M.D. (ex officio)
Richard Suchinsky, M.D. (ex officio)

Council Members Absent:
Hortensia D. Amaro, Ph.D.
Rand D. Conger, Ph.D.
Thomas A. Hedrick, Jr.
Linda S. Slattery

Council Chairs Present:
Alan I. Leshner, Ph.D.
Richard A. Millstein

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:
National Institute on Drug Abuse

Other Federal Employees:
Karol Kumpfer, Ph.D. - Center for Substance Abuse Prevention
Marina Volkov, Ph.D. - Office of Behavioral and Social Sciences Research, NIH

Members of the Public Present:
Steven Stocker - ROW Sciences
Sloan Mahone - American Academy of Child & Adolescent Psychiatry
Pamela Moore - Capitol Publications
Linda R. Wolf Jones, D.S.W. - Therapeutic Communities of America
Linda Kaplan - National Association of Alcohol and Drug Abuse Counselors
Julie Shroyer - Capitol Associates
Lisa Putman - The Blue Sheet
Pat Kobor - American Psychological Association
Chuck Thomas - Marijuana Policy Project

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).

   Mr. Richard A. Millstein, Deputy Director, NIDA, called the meeting to order and introduced new members, Dr. Andrea G. Barthwell and Dr. Gerald H. Friedland. He then provided an overview of the agenda for the meeting. Dr. Teresa Levitin, Executive Secretary, provided a summary of voting policies and procedures, detailed instructions on Council review procedures, and reminders about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   The Council divided into two subcouncil committees for the purpose of expediting application reviews and allowing for in-depth discussion as needed. Applications from the Division of Basic Research and the Medications Development Division were reviewed by a subcouncil committee chaired by Dr. Khursheed Asghar. Applications from the Division of Clinical and Services Research, and the Division of Epidemiology and Prevention Research were reviewed by a subcouncil committee chaired by Dr. William C. Grace. Each subcouncil committee reviewed applications and made recommendations for concurrence with the initial Scientific Review Group. These recommendations were carried back to the full Council for approval.

   Members absented themselves from subcouncil and full Council meetings during discussion of, and voting on, applications from their own institutions or other applications in which there was a conflict of interest, real or apparent. Requests for administrative supplements were also reviewed. 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, 528 applications, requesting $481,865,181 in Total Years Direct Costs, went to review. Of these, 347 were scored by the Scientific Review Groups, representing $69,463,800 in First Year Direct Costs and $297,519,144 in Total Years Direct Costs. The full Council approved each subcouncil committee's recommendations, including nine administrative supplements. One MERIT application was approved for continuation.

1. Call to Order

   Dr. Alan I. Leshner called the open portion of the meeting to order and welcomed the Council members, NIDA staff, and visitors. He 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. Leshner welcomed the new members and expressed gratitude for their willingness to serve. He noted that Dr. Terry Schultz is retiring from the Department of Defense and will, therefore, no longer serve on Council. Dr. Leshner acknowledged Dr. Schultz's years of service and thanked him for his work.

2. Consideration of the Minutes of the 68th Council

   The Minutes of the February 3-4, 1998 meeting were approved as written..

3. Future Meeting Dates

   Future meeting dates for Council were announced as follows:
   
   September 15 - 16, 1998
   February 2 - 3, 1999
   May 25 - 26, 1999
   September 14 - 15, 1999
   February 8 - 9, 2000
   May 16 - 17, 2000
   September 12 - 13, 2000

4. NIDA Director's Report

   Dr. Leshner prefaced his report by noting some internal changes in NIDA. In particular, the Office on AIDS and the Clinical Medicine Branch have been combined to establish a Center on AIDS and Other Medical Consequences, to be headed by Dr. Henry Francis. The establishment of this Center reflects NIDA's growing emphasis on the medical sequelae of drug abuse.

   Budget

   Dr. Leshner indicated that the budget figures were unchanged since presented to the Council in February. The FY 1998 budget remains $527.175 million, reflecting a 7.6% increase over FY 1997 levels. The FY 1999 President's budget request reflects an increase of 8.4% increase for NIH overall, with NIDA's allocation expected to be $576.299 million, which is a 9.3% increase. Congress is continuing to deliberate this budget, and outcomes of deliberations on tobacco legislation may have an impact on the budget. However, both Congress and the Administration strongly support NIH's activities.

   Dr. Leshner reminded the Council that in FY 1998 NIDA benefitted from resources provided outside the normal appropriation process. The Office of National Drug Control Policy transferred $9.5 million for coordinating and overseeing the evaluation of a national media campaign ($7 million) and for developing a new program of research in media communications ($2.5 million). Also, Dr. Varmus transferred $2 million for research on methamphetamine.

   Review Issues

   The Council was reminded that review integration is proceeding in three areas: basic neuroscience, basic behavioral science, and HIV/AIDS. Neuroscience applications will be reviewed in June under the new study sections, and the behavioral science reviews under new study sections will occur in the June 1999 meetings. AIDS applications will be reviewed in the new structures in July 1998. Dr. Leshner asked the Council to help monitor the integration and to help develop a process for evaluation of integration.

   A committee dedicated to review of career development applications, such as applications for fellowships, K awards, and training grants, has been developed at NIDA. Council was also asked to help the Institute monitor that process.

   Two NIH policies related to review were noted. First, there has been an issuance around the inclusion of children in NIH sponsored research, and the inclusion or exclusion of children must be justified for research applications. Second, any application requesting more than $500,000 in direct costs for any year of the project needs agreement before submission that the Institute will accept the application.

   Shaping the Research Agenda

   Dr. Leshner reported that NIDA is consolidating its existing Program Announcements (PAs), and he reviewed the distinctions between a Program Announcement and a Request for Applications (RFA). Further, NIDA and all NIH are working to establish methods for "sunsetting" a PA after a specific period. These activities should help clarify the Institute's research priorities.

   A Program Announcement, "Role of Limbic System and Brain Ontogeny in Drug Abuse," released in February, is noteworthy for attempting to stimulate research in a developmental issue, that of limbic system functions and brain development. A list of other announcements was provided to Council.

   The Council members were referred to their information folders for a list of recent meetings. Dr. Leshner noted in particular that NIDA was the lead among NIH institutes in a recent meeting focusing on the glutamate system, "The Glutamate Cascade: Common Pathways of Central Nervous System Disease States," held May 3-5. The American Society of Addiction Medicine and NIDA recently jointly sponsored a symposium on treatment for adolescent drug abusers, and NIDA hosted a meeting on stress, the CRF system, and drugs of abuse. The NIDA Office of Special Populations organized and held two meetings in March, one for the African American Researchers and Scholars Group and one for the Hispano/Latino Researchers and Scholars Group. Council members were referred to the written Director's Report for details and for information on other meetings.

   Upcoming meetings on several topics were announced. "Addicted to Nicotine: A National Research Forum" will be held in July. This national conference is sponsored by NIDA and the Robert Wood Johnson Foundation in conjunction with the National Cancer Institute and the Centers for Disease Control and Prevention. An American Psychological Society miniconference entitled "Cognition and Emotion: Applications to Drug Abuse" has been organized by NIDA staff and will occur later in May.

   Dr. Leshner informed the Council that, for the first time, the American Psychiatric Association's annual meeting will include an organized research-based program track on drug abuse and addiction. This collaborative effort of NIDA and the APA should greatly stimulate psychiatrists' involvement in drug abuse research and awareness of research findings.

   Public Information

   Several activities are occurring to help disseminate the findings of NIDA research. Dr. Leshner praised the leadership of Dr. June Osborn and her colleagues, Drs. Lonnie Bristow and David Lewis, in organizing the Physician Leadership on National Drug Control Policy effort. This is stimulating a fresh look at addiction from a medical perspective, and there is involvement of luminaries from the field of medicine that makes this effort of great significance. Dr. Leshner noted that efforts related to nicotine have been highly visible. In addition to the upcoming nicotine conference, he testified before the Senate Committee on Labor and Human Resources to inform them about nicotine addiction. He also testified for a special hearing of the Senate Appropriations Subcommittee.

   The town meetings are continuing to occur and enjoy ever greater successes. Approximately six hundred people attended the recent meeting in Boston, and one is planned for Iowa in the fall. Simultaneously with the Iowa meeting, NIDA will place science education materials developed through the NIDA Science Education program into every middle school in the United States.

   Treatment providers, policy makers, and researchers benefitted from their interactions and attendance at the NIDA treatment conference held in April. Approximately 900 people attended. Another accomplishment, one that grew from Council discussions about two years ago, was the development of a manual for assisting communities evaluate the local context and local environment so that those communities can successfully implement prevention programs, modifying them as needed to the local needs. This manual, Assessing Drug Abuse within and across Communities, has been very well received.

   A methamphetamine research report has been released as part of the ongoing research report series. A Practical Theorist report on drugs in the brain has been released by the Community Anti-Drug Coalition of America (CADCA).

   A depiction guide has been developed with the Entertainment Industries Council in order to help those in the entertainment industry accurately depict drug abuse and addiction in their products. Relatedly, NIDA, along with the Entertainment Industries Council and the Robert Wood Johnson Foundation, held the second annual Prism Awards. The Prism Award is given for accurate depictions of drug abuse and addiction in the media. Over 350 people, more than expected, attended the award ceremony, which attests to the impact NIDA can have by recognizing others' efforts to reduce drug abuse. Finally, the Bill Moyers' series, "Close to Home: Moyers on Addiction," was noted as a major accomplishment in disseminating information about addiction, its consequences, and its presence across ethnic and cultural groups. It was seen by approximately 12 million people.

5. Report from the Director, Center for Substance Abuse Prevention - Dr. Karol L. Kumpfer

   Dr. Leshner introduced Dr. Karol Kumpfer, who was recently appointed the Director of the Center for Substance Abuse Prevention at the Substance Abuse and Mental Health Services Administration. Dr. Kumpfer began her remarks by noting epidemiologic and societal trends of concern to the drug abuse field. These include increases in alcohol, tobacco, and drug use in youth; changes in demographics; reductions in the "safety net" of Medicaid and Medicare; lack of support for substance abuse treatment under managed care systems; corrections-based rather than medical solutions to drug use; and cuts to CSAP discretionary grant programs. Citing her experience as a state deputy director involved in substance abuse planning in 1982, Dr. Kumpfer outlined the challenges that local communities face in such times of reduced budgets, especially if they do not have guidance and management accountability. However, she noted that there were reasons for optimism despite the current concerns. These reasons include a much better (than in 1982) understanding of how to develop and implement effective prevention programs and increased collaboration among federal agencies. Collaboration has also been strengthened at the state and private sector level. Further, science is providing hope to parents by clarifying that, while peer influence is important under some circumstances, parents also have influence. A major remaining challenge is to help researchers disseminate their results to those who need them.

   Dr. Kumpfer presented her model of CSAP's role as a bridge from research to practice. CSAP/SAMHSA can serve as a bridge by 1) field testing promising models; 2) facilitating adoption of best practices; 3) supporting infrastructure development; and 4) promoting service availability. She also noted that CSAP has a budget line apart from its block grants, the Knowledge Development and Application (KD&A) activity. To illustrate, she gave three examples of CSAP programs to develop knowledge, disseminate information, and develop the capacity to use information. She then presented information on upcoming "KD&A" announcements and activities for CSAP.

   Council members expressed support for Dr. Kumpfer's vision of CSAP's role and expressed a desire for close collaboration between NIDA and CSAP as prevention programs are implemented, evaluated, and "marketed" for dissemination. The potential for using schools of public health to assist in CSAP's activities was also noted, and Dr. Kumpfer informed Council of a faculty development program that would be relevant for those in schools of public health.

6. New and Proposed NIDA Initiatives and Council Suggestions - Dr. Alan I. Leshner

   Dr. Leshner opened and led a discussion of scientific opportunities and priorities for the Institute and noted that five areas in particular had been identified and developed in consultation with Council and other sources. These priorities are: (1) The Treatment Initiative, which includes medications and behavioral components; (2) Children and Adolescents, with particular focus on the domains of prevention and issues surrounding prenatal and developmental factors; (3) Vulnerability to Addiction, which goes beyond examining determinants of use to examine genetic and other determinants of addiction; (4) Methamphetamine Research, in order to avert the growing crisis of methamphetamine use as it spreads eastward across the nation; and (5) Combating Nicotine Addiction, which examines the nature of addiction to nicotine and interventions for nicotine addiction.

   Council commented that attention to marijuana was absent in the foregoing discussion, and Dr. Leshner replied that NIDA already has a substantial investment in marijuana research and solicited Council's further input on the issue. Dr. Leshner further noted that the legislative authority for NIDA includes studies of the abusability of marijuana but not studies of marijuana's indications for specific medical conditions. These are within the purview of other institutes of the National Institutes of Health.

   Council supported the concept of a national clinical trial network for drug abuse treatment interventions and suggested that a similar network for studying prevention might be useful. Members also suggested topics that could be included under the areas mentioned, such as prices and access as affecting vulnerability to addiction or epidemiologic issues in methamphetamine research. Treatment in children and adolescents was mentioned as a need, as was the treatment delivery system and its need to be responsive to both drug abuse and HIV disease. Developing therapeutics for HIV and ensuring their applicability to drug users was another topic of interest to Council. International studies, continued work in basic neuroscience, and collaboration around training issues (e.g., to support research training and to ensure clinical training is based on scientific findings) were other needs noted.

7. New Center Program and Review Guidelines - Dr. Teresa Levitin

   Dr. Levitin reported that the current guidelines for NIDA centers were established in 1995 with the understanding that they would be re-examined after NIDA had some experience in implementing them. An internal NIDA steering committee has met and proposed some changes, but the basic parameters have not changed. NIDA centers still represent the entire breadth of NIDA-supported science, and they are expected to demonstrate superb centerness and stellar science. The new document clarifies the meaning of "centerness" and makes clear the distinctions among types of centers. The guidelines now incorporate the new review criteria, and procedural and administrative changes have been included. The centers review committee will meet three times annually, and a preliminary assessment of science will occur at the first step of the two stage review.

   Council asked about the number of NIDA centers and how that compares to other NIH components. Dr. Leshner explained that NIDA has a smaller percent of its budget dedicated to centers than the average NIH Institute. A discussion of several issues related to centers ensued. These issues included renewability of centers, supplements, and operationalization of "centerness." Council expressed a desire for data on renewal rates for NIH and NIDA centers.

8. Ethnic/Cultural Issues in Drug Addiction Treatment - Dr. Kathy Sanders-Phillips

   Dr. Sanders-Phillips noted that she presented a workshop on ethnic and cultural issues in drug treatment at NIDA's recent drug treatment conference, and this workshop formed the basis for her comments. She presented an overview of the literature on health interventions and drug treatment with minority populations, and she presented data from her own research. Previous research has often ignored minority populations and been limited by a failure to address the heterogeneity of minority groups. Other methodological concerns (e.g., failure to establish service equality among groups, failure to distinguish between cultural background and cultural identity) were noted. Research has often been based in a deficit model, and sociocultural factors have been addressed poorly - or not at all. Confounding issues, such as poverty and attitude towards treatment, also are often not addressed. Factors related to successful interventions with minorities were outlined, and suggestions for future research directions were made.

   Dr. Leshner and Council thanked Dr. Sanders-Phillips for her overview and discussed the implications her comments would have for several NIDA initiatives, such as the treatment network and research training, as well as for the way research applications are reviewed.

9. Treatment Research Subcommittee Report - Dr. Alan Marlatt

   Dr. Marlatt summarized the highlights of the recent NIDA treatment conference (National Conference on Drug Addiction Treatment: From Research to Practice, April 8-9, 1998). He related that General McCaffrey's keynote address emphasizing that research should inform public policy was well delivered and well received. Theory and data were consistently integrated throughout the conference, and there was evidence of integration of types of treatment so that different modalities were combined to heighten treatment effectiveness over what would be expected from a single modality intervention. Dr. Marlatt summarized several presentations. He reported that a publication on principles of effective drug treatment is in early stages of development as a result of the conference. Dr. Leshner thanked Dr. Marlatt for his report and indicated interest in the treatment publication mentioned.

10. Children and Adolescents Subcommittee Report - Dr. Kathy Sanders-Phillips

    Dr. Sanders-Phillips reported that the Children and Adolescents Subcommittee members at their first meeting spent time in getting acquainted with each other and learning about NIDA's activities around children and adolescents. Particular items of discussion were the policy on inclusion of children in research, follow-up of children prenatally exposed to drugs into their school ages, neuroimaging, risk behaviors, and criminal justice concerns. They also discussed a need for training minority researchers in child and adolescent research. Dr. Leshner thanked Dr. Sanders-Phillips for her report.

11. Council Comments

    Future topics for Council meetings were raised. Topics of interest included the proposed transfer of methadone from an FDA regulatory program to a CSAT certification program. Council indicated that an update on that issue from CSAT would be useful. An update on the development of new study sections was requested, and the point was made that data on review groups' functioning would be helpful. A discussion of the mission of the new NIDA Center on AIDS and Other Medical Consequences was requested. A final area of interest was treatment in correctional settings.

12. Public Comments

    Mr. Chuck Thomas of the Marijuana Policy Project provided his perspective on recent legislation before Congress and urged NIDA to increase marijuana's availability for medical research.

Dr. Leshner adjourned the 69th meeting of the National Advisory Council on Drug Abuse at 3:04 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.