Minutes of the 68th Meeting of the National Advisory Council on Drug Abuse

February 3-4, 1998

The National Advisory Council on Drug Abuse convened its 68th meeting at 9:00 a.m. on February 4, 1998 at the Bethesda Marriott Hotel, 5151 Pooks Hill Road, Bethesda, Maryland. Dr. Alan I. Leshner, Director, NIDA, chaired the meeting. The meeting on February 3 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 4 at 9:00 a.m. and was open to the public. The Council adjourned February 4 at 3:04 p.m.

Council Members Present:
Susan G. Amara, Ph.D.
Lawrence S. Brown, Jr., M.D.
R. Lorraine Collins, Ph.D. (February 3 only)
Morton E. Goldberg, D.Sc.
Thomas A. Hedrick, Jr.
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. (February 3 only)
Rafaela R. Robles, Ed.D.
Kathy Sanders-Phillips, Ph.D.
Linda S. Slattery (February 3 only)
Catherine A. Stevens, J.D.
Lei Yu, Ph.D.
Col. Terry K. Schultz, M.D. (ex officio)
Richard Suchinsky, M.D. (ex officio; February 4 only)

Council Members Absent:
Marian W. Fischman, Ph.D.

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:
Laurence Stanford, Ph.D. - Center for Scientific Review, NIH
Marina Volkov, Ph.D. - Office of Behavioral and Social Sciences Research , NIH

Members of the Public Present:
David Hess - COSSA
Linda R. Wolf Jones, D.S.W. - Therapeutic Communities of America
Jennifer Katz - CD Publications
Walter L. Faggett, M.D. - National Medical Association
Robert Mathias - ROW Sciences
Nancy Moy - SRI International
Geoff Mumford, Ph.D. - American Psychological Association
Michaela P. Richardson - ROW Sciences
Harold Pincus, M.D. - American Psychiatric Association
Lisa Putman - The Blue Sheet
Julia Spencer - NPN
Chuck Thomas - Marijuana Policy Project
Paul Young - NOVA
Peggy Young - NOVA

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 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, the Division of Epidemiology and Prevention Research, the Office on AIDS, and the Office of Science Policy and Communications 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, except for one application where a re-review was recommended. 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. 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, 480 applications, requesting $369,998,240 in Total Years Direct Costs, went to review. Of these, 308 were scored by the Scientific Review Groups, representing $58,689,957 in First Year Direct Costs and $242,083,240 in Total Years Direct Costs. The full Council approved each subcouncil committee's recommendations, including the recommendation for re-review of one application. Two new and one continuation MERIT applications were approved.

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 expressed his and the Institute's gratitude for the service of five members who are ending their terms, and certificates of appreciation were presented.

2. Consideration of the Minutes of the 67th Council

   The Minutes of the September 16 - 17, 1997 meeting were approved as written.

3. Future Meeting Dates

   Future meeting dates for Council were announced as follows:
   
   May 19 - 20, 1998
   September 15 - 16, 1998
   February 2 - 3, 1999
   May 25 - 26, 1999
   September 14 - 15, 1999

   (Executive Secretary note: Since the Council meeting, dates for 2000 have been established as follows:
   February 8 - 9, 2000
   May 16 - 17, 2000
   September 12 - 13, 2000)

4. Report of the Director

   Budget

   Dr. Leshner presented revised budget figures for FY 1997 that show funds received through transfer from the NIH Director's office and the Office of National Drug Control Policy. The transfers resulted in a total FY 1997 budget of $499.653 million. The FY 1998 estimated budget is $527.175 million, reflecting a 7.6% increase from Congress. The FY 1999 President's budget proposal includes the largest increase ever proposed for NIH, an increase of 8.4%. NIDA's allocation is expected to be $576.299 million, which is a 9.3% increase. NIDA expects its success rate to be around 28-30%, which is slightly below the 32% success rate of FY 1997 because of the additional funds transferred in that year. The overall NIH success rate is about 35%.

   In response to a question from Council about the impact of accumulating non-competing application costs as a result of the higher success rate, Dr. Leshner indicated that the distribution of non-competing and competing awards will remain stable, with about 1/3 of the funds going to competing applications. This is because careful monitoring of the size and type of awards allows NIDA to maintain that success rate. The impact of the budget on AIDS versus non-AIDS applications was raised, and Dr. Leshner indicated that the success rates are about the same for both types of applications.

   Review Issues

   The council was informed that Dr. Levitin would cover separately the issues related to integration with the Center for Scientific Review. They were reminded that new review criteria are now in effect and that Council plays a valuable role in helping determine the impact of the new criteria in identifying innovative and creative studies. Council's help in monitoring the impact of integration was also requested. New NIDA review committees for conference applications, applications for medications development, and career-related applications were described.

   Shaping the Research Agenda

   No new Request for Applications has been issued, and one on neurobiological effects of drug addiction therapies has been re-issued. Two new Program Announcements, "Exploratory/Developmental Grant Applications" and "Minority Institutions Drug Abuse Research Program (MIDARP)," were released.

   Dr. Leshner noted NIDA has sponsored several recent meetings, four of which were in conjunction with the Society for Neuroscience. A meeting was held recently to examine new animal models of drug abuse, and one was held on naltrexone.

   Public Information

   Dr. Leshner presented information on activities to educate the public about drug abuse and addiction. Successful activities have been developed with the Entertainment Industries Council. The "Prism Awards," given annually to recognize television or movie productions that depict drug abuse accurately, are being planned for this May. Another activity is that the Entertainment Industries Council, with NIDA collaboration and support, has recently released a notebook to help the industry depict drug abuse and addiction on the basis of accurate scientific information.

   Town meetings are on-going. A very successful meeting was held in Philadelphia in September, and one was held last week in Salt Lake City. There is now a waiting list of cities which have requested town meetings. These meetings not only help distribute information, but also help shape the research agenda as NIDA hears the insightful comments and questions of people in different communities.

   NIDA has organized or participated in a number of other meetings. Dr. Leshner noted the National Conference on Heroin Use and Addiction, held September 29th and 30th in Washington, and the NIH Consensus Development Conference on Effective Medical Treatment of Heroin Addiction, held in November. A "National conference on Drug Addiction Treatment: From Research to Practice" will be held in April.

   The science education activities at NIDA continue to have a significant impact. Examples of posters developed for middle schools were provided to Council, and NIDA has received very positive feedback on these from the National Association of Biology Teachers. The NIDA Infofax is operational, and about 2,500 requests for information have been received, all in the first month of operation. The NIDA home page continues to be widely utilized.

   The 4th Annual NIDA Constituents' conference was held, and 43 constituent groups were represented.

   Council praised NIDA's activities and noted that there is a need for more attention to the health care system and health professionals. The example that drug abuse treatment is better integrated into the criminal justice system than the health care system was given to stress this point.

   Dr. Leshner agreed with this observation and noted that Dr. June Osborn is chairing a group of physicians to address that concern. He further noted that the American Medical Association's president has declared substance abuse as the core issue for his presidency. Also, NIDA has successfully built collaborations with the medical community to address drug abuse, and NIDA's status at NIH has helped give credibility to NIDA's work.

   An audience member, Dr. Walter Faggett, asked to be recognized and, upon recognition, spoke to say that the National Medical Association supports NIDA's efforts related to health care systems and training. Council then further discussed the need for attention to issues of managed care, service provision, and professional training.

5. Subcommittee Report on the Treatment Research Initiative - Dr. G. Alan Marlatt

   Dr. Marlatt summarized treatment subcommittee activities. A major upcoming event is the April conference on drug treatment and its effectiveness, and the committee has been addressing the theme of the conference. One need is for a delineation of basic principles of treatment, in much the same way that NIDA has recently been able to provide basic principles for prevention. Also, there needs to be more attention to criteria for measuring treatment outcomes, especially in the context of other events in a person's life (e.g., health, economic, and marital problems). Other themes to address include barriers to implementation of treatment programs and the settings in which treatment is best provided.

   A preliminary program has been prepared for the conference, which will occur April 8 - 9. The themes mentioned, as well as some others, such as comorbidity, will be addressed. The development of drug abuse interventions by substance abusers themselves rather than by professional health care providers is also an important area. Dr. Marlatt recommended recent articles in the American Psychologist (December 1997) and Psychology of Addictive Behaviors as good resources.

   Dr. Leshner thanked Dr. Marlatt for his report.

6. Subcommittee Report on Craving Research - Dr. George Koob

   Dr. Koob noted that research on craving has been hampered because there is not consensus on the definition of craving. Clinicians have difficulty describing the phenomenon, and animal models with good predictive value exist but are not clearly connected to clinical events. The subcommittee on craving is recommending three steps to help address the need for more craving research. First, a small meeting of approximately eight people, the majority of whom should be clinicians, could be convened to develop a very brief definition of craving and a description of its domain. The definition and description could be published in a non-NIDA outlet. Second, specific initiatives for craving, such as a program announcement or a request for applications could be used to generate more research. Third, because of the cross-disciplinary nature of craving research, a special review panel is needed, and it could be reconvened as needed to review groups of applications on craving.

   Council members commented that the group that works on the definition of craving should include representatives of organizations that provide clinical care to substance abusers. Also, there was discussion of including animal researchers to ensure that the disconnect between clinical and animal models is addressed. Using the meeting as a "case-definition" forum was suggested. Other discussion focused on the advantages and disadvantages of having a definition published in a government or non-government outlet. Dr. Leshner noted that the definition and description document should be reviewed by the Council before publication.

7. Implementation Plan in Response to the Blue Ribbon Panel to Review the NIDA Division of Intramural Research - Dr. Barry Hoffer

   Dr. Leshner introduced Dr. Hoffer and reminded Council of the history of the Blue Ribbon Panel. Dr. Hoffer presented the overall concerns of the Blue Ribbon Panel, expressed his appreciation for the support of him shown in their report, and then systematically presented each of the Panel's recommendations and his response to the recommendation. Dr. Hoffer has hired additional, scientifically qualified staff, and a new mission statement to stress the integrative and translational nature of intramural research has been developed. The hierarchical structure of the Division has been modified to increase communication and accountability of individuals for their own ideas and work. Steps have been taken to enhance the independence of young investigators and mentor them, and a peer review system is being used with input from the Board of Scientific Counselors to ensure quality of work. Steps have been taken to improve the clinical research program, to give it stability, and to streamline administrative processes. Increased collaboration with other NIH and non-NIH resources has been sought and, in many cases, achieved.

   The Council praised Dr. Hoffer for his rapid progress and response to the Panel's report. They discussed and gave a number of suggestions related to frequency of the Board of Scientific Counselors' reviews, methods to encourage junior investigators, and mechanisms to help investigators demonstrate competitiveness in the job market when they leave NIDA.

8. Update on Integration of NIDA Application Review at NIH - Dr. Teresa Levitin

   Dr. Levitin reminded the Council that two years ago they developed a statement of principles for review integration. Review of neurosciences, AIDS, and behavioral/social sciences is being integrated, using the principles the Council articulated. The three merger processes have also been guided by general principles articulated by the Directors of the affected Institutes. The mergers are at different stages of completion, but for all of the mergers the processes of clustering applications and creating study sections have been open to, and interactive with, the relevant extramural communities. Twenty-one new neurosciences study sections have been created, and they have responsibility for the entire range of basic and clinical neuroscience applications. Review administrators are assigned, including three from NIDA (Drs. Mary Custer, Syed Husain, and Gamil Debbas), and the committees are being filled presently with reviewers from the current study sections. Additional reviewers will be added as needed. In the AIDS arena, new study sections have been suggested, and Council's input on the proposed composition is needed. The behavioral integration is in early stages, and experts nominated by professional associations are coming in late February to examine proposed clusters of science. Dr. Levitin ended by stressing a continuing need for Council involvement and oversight of integration events, and Dr. Leshner reiterated this call.

   Council discussion centered on the difficulties to be expected in sorting out the feedback that is likely to come back to NIDA from people who get reviewed under new structures. Another Council theme was the NIDA research community's concern that its science will not be appreciated at CSR. Dr. Leshner noted that the concern is important and that it is critical that senior investigators be willing to serve on committees.

9. Update on the Medications Development Program - Dr. Frank Vocci

   Dr. Vocci explained that the mission of the Medications Development Program is "transforming research into treatments." The program takes basic science findings, converts them into clinical studies, and then determines if a medication merits further development. The Division is patterned after pharmaceutical companies in the breadth of drug development activities supported. The Division has had success with opiate projects, and LAAM was approved in 1993. Buprenorphine, a buprenorphine/naloxone combination product, and depot naltrexone are also under investigation. Dr. Vocci then reviewed scientific studies on the association of the dopamine system with cocaine abuse and explained how the Division's activities follow systematically from the scientific evidence and address different points of intervention (e.g., presynaptic modulation and postsynaptic modulation). Also, strategies not based directly on dopaminergic system events, such as modification of conditioned cues, modulation of the stress response, and alteration of mood states, were addressed. The progress and design of a multi-center trial on selegiline were described, and Dr. Vocci and the Council engaged in a discussion of appropriate end points for such a trial. Council also noted scientific findings and information that might be useful in considering future research.

10. NIH Consensus Development Conference on Effective Medical Treatment of Heroin Addiction - Dr. Stephen Zukin

    Dr. Zukin reported the results of a consensus conference jointly sponsored by the NIH Office of Medical Applications of Research (OMAR) and NIDA. Through presentations by various scientists, persons familiar with regulatory control of methadone, and treatment specialists, the conference examined the evidence on treatment of heroin addiction and made recommendations on improving treatment and access to treatment. The results of the conference are available on the internet at http://consensus.nih.gov. Recommendations included steps to increase public understanding of addiction, to improve access to treatment, to improve health professional training regarding addiction, to ease regulatory controls, and to focus on specific populations. Council asked for clarification of the recommendation regarding pregnant women. A concern was expressed that the recommendation did not fully take into account evidence on methadone's effects on the fetus and the need for more research on that issue. Other discussion focused on the roles various federal agencies might play in implementing the recommendations.

11. Other Council Comments

    The activities of the subcommittee on secondary analysis of data were briefly reported. The committee has met and is defining issues for it to address. A second comment was that a Child and Adolescent Subcommittee could be helpful in addressing many issues. Finally, a concern about maintaining diversity on the Council was expressed in view of the number of persons rotating off the Council.

12. Public Comments

    Mr. Chuck Thomas of the Marijuana Policy Project provided data on arrests for marijuana use and distribution and advocated NIDA and Federal support of use of marijuana for medical conditions.

Dr. Leshner adjourned the 68th meeting of the National Advisory Council on Drug Abuse at 3:05: 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.