Minutes of the 67th Meeting of the National Advisory Council on Drug Abuse

September 16-17, 1997

The National Advisory Council on Drug Abuse convened its 67th meeting at 9:00 a.m. on September 16, 1997 in Conference Room 10, Building 31C, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. Dr. Alan I. Leshner, Director, NIDA, chaired the meeting. The meeting on September 16 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 September 17, 1997 at 9:00 a.m. and was open to the public. The Council adjourned at 11:50 a.m.

Council Members Present:
Lawrence S. Brown, Jr., M.D.
R. Lorraine Collins, Ph.D. (September 16 only)
Marian W. Fischman, Ph.D.
Morton E. Goldberg, D.Sc.
Reese T. Jones, M.D.
Nancy J. Kaufman, R.N., M.S.
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
June E. Osborn, M.D. (September 17 only)
Rafaela R. Robles, Ed.D.
Kathy Sanders-Phillips, Ph.D.
Linda S. Slattery (September 16 only)
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:
Susan G. Amara, Ph.D.
Thomas A. Hedrick, Jr.
George F. Koob, 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:
Bobbi Bennett - Office of Communications, OD, NIH
Robert Moore - Office of Extramural Research, OD,NIH
Susan Persons - Office of Behavioral and Social Sciences Research, OD, NIH
Phillip Wiethorn - National Institute of Neurological Disorders and Stroke

Members of the Public Present:
Virginia Anthony - American Academy of Child & Adolescent Psychiatry
Sarah Brookhart - American Psychological Society
Jan Brose - Capital Consulting Corporation
Marie Dyak - EIC
S. Iyengar - The Blue Sheet
Robert Mathias - R.O.W. Sciences
Geoff Mumford - American Psychological Association
Christine Sannerud - Drug Enforcement Administration
Angela Sharpe - COSSA
Linda R. Wolf-Jones - 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. Alan I. Leshner, Director, NIDA, called the meeting to order and provided an overview of the agenda for the meeting. A summary of voting policies and procedures, detailed instructions on Council review procedures, and reminders about NIH confidentiality and conflict of interest policies were provided.

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 Khursheed Asghar, Ph.D. Applications from the Division of Clinical and Services Research, the Division of Epidemiology and Prevention Research, and the Office of Science Policy and Communications were reviewed by a subcouncil committee chaired by William C. Grace, Ph.D. 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. 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, 503 applications, requesting $440,962,000 in Total Years Direct Costs, went to review. Of these, 307 were scored by the Scientific Review Groups, representing $63,723,589 in First Year Direct Costs and $267,209,453 in Total Years Direct Costs. The full Council approved each subcouncil's recommendations. Five new MERIT applications were approved. Council approval for administrative supplements to eight grants was also sought and received.

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. He also informed those present that Council minutes are now available on NIDA's home page.

2. Consideration of the Minutes of the 67th Council

   The Minutes of the May 13 -14, 1997 meeting were approved as written.

3. Future Meeting Dates

   Future meeting dates for Council were announced as follows:
   
   February 3 - 4, 1998
   May 19 - 20, 1998
   September 15 - 16, 1998
   February 2 - 3, 1999
   May 25 - 26, 1999
   September 14 - 15, 1999

4. Report of the Director

   Dr. Leshner asked the Council to note that details regarding information dissemination activities, such as town meetings and the upcoming National Conference on Heroin Use and Addiction, were available in the members' individual folders but would not be covered in the Director's report. A number of new hires, promotions, and the upcoming retirement of Dr. James Dingell were announced. The recent retirement of Mr. Gary Palsgrove was also noted. A final general announcement was made that an NIH Bioengineering Symposium would be held at the conference center February 27 - 28, 1998.

   Budget

   Dr. Leshner reiterated NIDA's obligation to conduct outstanding science, and he noted that recognition of NIDA's commitment to science is translated into continuing support in the budget process. For FY 1997, NIDA was appropriated a 6.7% increase. The FY 1998 President's budget request would provide a 6.7% increase again, while the House and Senate versions provide for a somewhat greater increase. As the proposed average increase is 6% for NIH overall, the President's budget of $521.915 million represents more than the NIH average support. One feature in the FY 1998 proposals is a redistribution of AIDS and non-AIDS funds. NIDA is seeing an increase in both its AIDS and non-AIDS budgets. AIDS money is being redistributed to bring more NIH components more fully into the AIDS arena.

   For FY 1997, NIDA actually received a 9% budget increase due to a transfer of $2 million from the NIH Director's Discretionary Fund and a transfer of $9.5 million in asset forfeiture funds from the Office of National Drug Control Policy (ONDCP). In FY 1997, NIDA anticipates a success rate of 24%, or 296 new and competing continuation applications. Under the FY 98 proposals from the President, House and Senate, that rate would be between 26 and 27%, depending on which budget is adopted.

   A question was asked about the redistribution of AIDS dollars. Dr. Leshner clarified that the intended effect is to increase AIDS research in different institutes, and the redistribution should increase NIDA's collaborative efforts in new endeavors. A question was asked about whether or not the ONDCP money was likely to continue to be provided and NIDA's priorities for its use. Council was informed that the money was provided for one time and was earmarked for development of cocaine medications.

   Review Issues

   Council was reminded that new review criteria go into effect with the October 1 receipt date. The expectation is that the new criteria will improve reviewers' focus on the importance and innovativeness of the proposed work. A second review activity for Council's attention is that the Division of Research Grants, which has been renamed the Center for Scientific Review (CSR), is restructuring its internal organization and its study sections. Dr. Leshner noted that he expects the combined effects of new review criteria and of structural changes at CSR to improve the quality of reviews at NIH.

   Another activity of note is the continuing integration of applications into the CSR review structure. The latest iteration of plans for neuroscience applications is available on the web, and additional institutes have asked to join the process of neuroscience integration. Three other integration activities have also begun. The basic behavioral science portfolio's integration is moving ahead, and the integration of AIDS expedited review applications has begun. The third integration is that of the NIDA human development proposals, of which there are relatively few, and these will be integrated into an appropriate CSR study section. Dr. Leshner summarized by saying that the integration is being done with great care, with much discussion with the external community, and with a large amount of staff effort to ensure that the end result is the identification of the best science.

   Council inquired about plans for review of health services research applications. In response, Dr. Leshner indicated that the "line" of what will be reviewed in each institute and what will be reviewed in CSR is not set, but health services research, prevention, epidemiology, and behavioral treatment are not actively being integrated at this time and will continue to be reviewed at NIDA, at least for a while. He also noted that NIDA has created a "human resource" study section to handle K awards, fellowships, and training grants.

   Shaping the Research Agenda

   Although it continues to be a goal of NIDA to reduce the number of Requests for Applications (RFAs), an RFA has been reissued for the Strategic Program for Innovative Research on Cocaine (and Other Psychomotor Stimulants) Addiction Pharmacotherapy (SPIRCAP). SPIRCAP's intent is to foster translational research between basic researchers and clinical researchers. The B-start (Behavioral Science Track Awards for Rapid Transition) program continues. An NIH-wide RFA on gender-related differences in pain and analgesic response has been issued, and NIDA is a participating institute. Finally, NIDA issued an RFA on the Organization and Management of Drug Abuse Treatment Services, an area where more work is needed.

   Dr. Leshner noted that all program announcements are being reviewed, and less central ones will be deleted. He will also ask Council to become more involved in assessing the existing pool of program announcements and to provide input on future program announcements and RFAs. The intent of these changes is to clarify to the field which announcements are of most importance to NIDA's mission.

   A number of meetings have been held, and they continue to be of high quality. Members were referred to the list of meetings provided in the bound copy of the Director's Report for details. Similarly, members were referred to that report for information on upcoming meetings.

   The NIDA Office on AIDS has created a supplement program that has been successful in increasing the number of investigators working in AIDS. This was done by supplementing non-AIDS grants to add an AIDS component. Other initiatives continue to be maintained.

   Treatment of drug abuse, methamphetamine abuse, and prevention continue to be areas of much activity and progress. Children and adolescents continue to be addressed in prevention activities, but greater emphasis on understanding developmental issues and their relationship with drug abuse is needed.

   Public Information

   A very successful town meeting was held in May in Chicago. It began with a meeting in a high school in Congressman Porter's district that was attended by students, parents, educators, local officials, and the Congressman. It proved to be a useful opportunity to hear from parents and youth and to inform them about science. The next day, over 400 people attended the town meeting jointly sponsored by the Lieutenant Governor, the Illinois Drug Abuse Authority, and a local coalition. A town meeting will be held October 20 in Philadelphia, and plans are made to go to Detroit and to Salt Lake City.

   The Council members have been provided with examples of publications for lay and scientific audiences, and the expanded work of the Public Information Branch in preparing and releasing these publications was noted.

   A comment from Council was made that other scientific bodies have begun to use NIDA's phraseology about the "disconnect" between scientific findings and their understanding and utilization. This was praised as an example of the impact NIDA's emphasis on scientific discovery and dissemination is having.

5. Treatment Research Initiative - Dr. G. Alan Marlatt

   Dr. Marlatt reviewed the history and purposes of the treatment initiative and reported on activities of the treatment subcommittee. He placed the activities of the subcommittee in a broad context by reviewing related activities and meetings. Developmental issues and comorbidity are receiving increased focus. NIDA's activities around Stage Three treatment development have been fostered by a meeting that united treatment researchers, providers, and managed care administrators to discuss dissemination and research approaches. There was consideration given to less emphasis on large community trials and to more emphasis on smaller treatment studies that address improving treatment, as well as training and studying providers.

   Another meeting brought together researchers in HIV risk behaviors to develop cognitive measures for both adolescents and adults. A workshop is planned to foster interactions between drug abuse clinical scientists and behavioral scientists to inform those who are not familiar with drug abuse how their work may contribute to the field. Plans are being made to foster dissertations on treatment studies, increased ties with health services researchers are being fostered, and a kick-off conference is being planned for April. This conference will be a highly visible effort to document treatment effectiveness, cost-effectiveness, and role in health care.

   Dr. Leshner thanked Dr. Marlatt for his report and praised the high level of involvement of Council members in these activities.

6. Status Report on Drug Supply - Dr. Reese Jones

   Dr. Jones reported on Council activities surrounding procedures and guidelines for the provision of marijuana for scientific and other purposes. NIDA has a contract to grow marijuana for scientific and medical use, and there is a second contract to prepare cigarettes from this marijuana. Given recent increases in interest in marijuana as a potential therapeutic agent, Council was interested in evaluating NIDA's role in these activities, and a Council subcommittee prepared a draft report that was provided to all members. The first issue addressed in the report was whether or not NIDA should continue to play a role in the growing of and access to marijuana, and the subcommittee recommended that NIDA continue to be the primary agency for this role. The second issue was how review of requests for marijuana should be handled. The subcommittee recommended that NIDA not be the primary agency for reviewing requests. Rather, requests for marijuana should be reviewed by a cross-institute, NIH body with extramural representation. Council noted that procedures may need to differ for requests that have undergone NIH peer-review and for those that have undergone other types of review. Regardless of the source of the request, scientific merit was seen as the primary consideration that should guide a decision about access to marijuana. A third major issue was who should pay for the marijuana and costs associated with its provision. The subcommittee recommended that investigators who receive the marijuana be charged for it. Finally, the subcommittee report addressed "peripheral considerations" such as the Drug Enforcement Agency's use of the marijuana supply and compounds related to marijuana.

   Council asked if there are other compounds apart from marijuana and cannabinoids that NIDA controls in a similar manner. Dr. Leshner indicated that there are many such compounds, and that most requests for them are for "core drug abuse research." The issue with marijuana, and it would apply to other compounds, is NIDA's use of funds appropriated for drug abuse research to supply material for other uses. Dr. Jones added that, indeed, the subcommittee's intent was that its recommendations apply to other compounds that might be requested in addition to marijuana and marijuana related materials. Members made additional comments on the need for good information on the pharmacologic properties of marijuana and cannabinoids and on a need to work out details on payment for compounds. Dr. Leshner asked that written comments be provided to Dr. Reese for incorporation into the subcommittee's final report.

7. Report of the Blue Ribbon Panel to Review the NIDA Division of Intramural Research - Dr. Lei Yu

   Dr. Yu introduced the purpose of the NIDA Intramural Research Program Advisory Committee, or "Blue Ribbon Panel," as being to review the overall structure and functioning of the NIDA intramural research program and to identify its strengths and weaknesses. The panel focused on structural issues. Three meetings were held, and a consensus developed early in the panel's deliberations that improvements could be effected. The report of this panel was provided to Council members.

   Some of the changes recommended result from factors common to all NIH intramural research programs, and some result from factors unique to NIDA. The report addressed five areas: communications, scientific leadership, the structure of branches and sections, the development of young investigators, and peer review. An additional two areas meriting special consideration were also highlighted: (1) training and mentoring of young scientists and (2) clinical issues. A final section dealt with administrative issues. Dr. Yu briefly reviewed the panel's conclusions in each of these areas, noted that some recommendations had already been addressed by staff and administrative changes, and that, overall, the panel thought that the intramural program had tremendous potential despite a need to address some problems.

   Council members praised the panel's work and noted that explicit benchmarks for carrying out and evaluating progress toward completing the panel's recommendations would be useful. Also, reports back to Council on progress toward these benchmarks would be useful. Council asked for more clarification on the role of the intramural program in NIDA's overall activities, and the unique contributions of the intramural program were delineated. Council noted that the panel's perspective is an academic one and that there are other, private sector, approaches to some of the issues raised. For example, pharmaceutical companies have procedures for mentoring and making decisions about support, and such perspectives might be considered. The latter part of Council's discussion focused primarily on the problems associated with insularity of a research program, the need to enhance communication both within the program and among other research sites, and methods of enhancing both the clinical and basic research activities. Dr. Leshner noted that the issues raised in the panel's report and in the Council's discussion would require follow-up over time and should be a continuing focus of the Council. He also noted that a trip to the intramural program was available to members at the close of the meeting.

8. Public Comments

   Ms. Sarah Brookhart of the American Psychological Society (APS) spoke to congratulate NIDA and Dr. Leshner on their support for behavioral research. She noted that the APS is hosting a meeting in May to address the future of scientific psychology. She also spoke on behalf of the Society for Research in Child Development to emphasize the role of developmental issues in drug abuse and to thank NIDA for continuing to stress the importance of developmental perspectives.

   Mr. Chuck Thomas from the Marijuana Policy Project questioned NIDA's interpretations and presentations of data on THC's effects and the impacts of marijuana on health. He addressed his perceptions of a bias of representation of perspectives and organizations on the Council, and he presented recommendations to NIDA to maintain scientific balance and objectivity. Dr. Leshner thanked Mr. Thomas for his comments and clarified that no Council member sits as a representative of any organization; rather, each member represents himself or herself.

Dr. Leshner adjourned the 67th meeting of the National Advisory Council on Drug Abuse at 11:50 a.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.