Minutes of the 71st Meeting of the National Advisory Council on Drug Abuse

February 2-3, 1999

The National Advisory Council on Drug Abuse convened its 71st meeting at 2:00 p.m. on February 2, 1999 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 February 2 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 3 at 9:00 a.m. and was open to the public. The Council adjourned February 3 at 3:06 p.m.

Council Members Present:
Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D.
Andrea G. Barthwell, M.D.
Joe D. Bennett, M.D.
Linda F. Fuller, M.D. (ex officio)
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.
Thomas A. McLellan, Ph.D.
Perry F. Renshaw, M.D., Ph.D.
Kathy Sanders-Phillips, Ph.D.
Catherine A. Stevens, J.D. (February 2 only)
Lei Yu, Ph.D.
Richard T. Suchinsky, M.D. (ex officio; February 3 only)

Council Members Absent:
Kathleen T. Brady, M.D., Ph.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
Clyde B. McCoy, 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:
John Chao - Office of Science Policy, NIH
Gamil Debbas, Ph.D. - Center for Scientific Review, NIH
Diana Jaeger - Office of Policy for Extramural Research Administration, NIH
Elliot Postow, Ph.D. - Center for Scientific Review, NIH
Barbara K. Rimer, Dr.P.H. - National Cancer Institute, NIH
Lan-Hsiang Wang, Ph.D. - National Heart Lung and Blood Institute, NIH

Members of the Public Present:
Virginia Anthony - American Academy of Child and Adolescent Psychiatry
Debra Bernstein - DANYA Corporation
Jim Bernstein - American Society for Pharmaceuticals and Experimental Therapeutics
Jan Brose - Management Assistance Corporation
James Callahan - American Society of Addiction Medicine
Barbara Cire - NIDA NOTES/MasiMax Research
Jeffrey Hoffman - DANYA Corporation
John Lanigan - IASWR
Geoff Mumford - American Psychological Association
Angela Sharpe - Consortium of Social Science Associations
Haine Shiferaw - The Blue Sheet
Chuck Thomas - Marijuana Policy Project
Ray Varico - ROW Sciences
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 introduced new members, Dr. Perry Renshaw, Dr. Joe Bennett, and Dr. Linda Fuller. He then provided an overview of the agenda for the meeting. Mr. Richard A. Millstein, Deputy Director, NIDA, reminded those present that the Federal Advisory Committee Act applies to Council and that this meeting was closed to the public. Dr. Teresa Levitin, Executive Secretary, described recent changes in grants policies at NIH, 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

   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, the Medications Development Division, and the Center for AIDS and Other Medical Consequences were reviewed by a subcouncil committee chaired by Dr. Teresa Levitin. 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 Grace. Each subcouncil committee reviewed applications and made recommendations for concurrence with the initial Scientific Review Group. Requests for administrative supplements were also reviewed. The recommendations were carried back to the full Council for approval.

   Members absented themselves from subcouncil and the 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, 450 applications, requesting $392,328,951 in Total Years Direct Costs, went to review. Of these, 299 were scored by the Scientific Review Groups, representing $55,077,292 in First Year Direct Costs and $243,962,672 in Total Years Direct Costs. The full Council approved each subcouncil committee's recommendations, including seven administrative supplements.

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 thanked the new members, Dr. Joe Bennett, Dr. Perry Renshaw, and Dr. Linda Fuller, for joining the Council. He noted that Dr. Kathleen Brady had been appointed as a new member but was unable to attend. Dr. Leshner announced that Dr. Reese Jones was rotating off Council and that this would be his last meeting, and he thanked Dr. Jones for his service.

2. Consideration of the Minutes of the 70th Council

   The Minutes of the September 15-16, 1998 meeting were approved as written.

3. Delegation of Authority for Administrative Actions

   Council approved a renewal of its Delegation of Authority for Administrative Actions for the period February 1999 through January 2002. This delegation enables NIDA staff to make administrative increases to grant awards under certain circumstances in order to increase administrative efficiency.

4. Future Meeting Dates

   Future meeting dates for Council were announced as follows:

   May 25 - 26, 1999
   September 14 - 15, 1999
   February 8 - 9, 2000
   May 16 - 17, 2000
   September 12 - 13, 2000
   February 14-15, 2001
   May 16-17, 2001
   September 12-13, 2001

5. NIDA Director's Report

   Dr. Leshner opened his report with a special acknowledgment of Mr. Thomas A. Hedrick, Jr. and the Partnership for a Drug Free America for their work in developing a recent publication, Growing Up Drug Free: A Parent's Guide to Prevention. This has been published by the Department of Education. Dr. Leshner reminded Council that NIDA's 25th Anniversary is being celebrated with a number of special events, and the Institute is moving into a new building, the NIH Neuroscience Center, later in February.

   Budget

   Dr. Leshner reported that the NIDA appropriation for FY 1999 is $608.171 million, an increase of 14.3% over FY 1998. He cautioned that while he is very pleased with the support from the Administration and Congress that this represents, the increase should not be interpreted as likely to allow large increases in the proportion of applications funded. NIDA expects to fund about 100 more applications in FY 1999 than in FY 1998, but its overall success rate is projected to remain below the NIH average through FY 2000. The President's Budget for FY 2000 proposes a 2.4% increase for NIDA, or $622.751 million.

   Council asked about the impact of funding increases on Research Project Grants (RPGs). Dr. Leshner provided figures on the overall increases in funding RPGs and demonstrated the impact of growing costs for non-competing applications. In response to a question about the potential impact of increases from a cigarette tax, Dr. Leshner indicated that there is currently no activity suggesting that such money is likely to be forthcoming.

   Review Issues

   After a lengthy period of activity around reorganizing review groups at the Center for Scientific Review, NIH is now implementing the new groups. Information on the new review groups is available on the Web. An area of current discussion is the degree to which, and how, public representatives should be included in initial reviews. Some NIH and Department of Defense components include public representatives in their initial reviews.

   Shaping the Research Agenda

   Dr. Leshner referred Council members to the printed Director's Report for a complete list of new program announcements. He highlighted a recently released Request for Applications (RFA), "Genetics of Drug Addiction Vulnerability." An RFA for "Centers for the Development of Medications to Treat Drug Abuse" was also noted. Drug courts, behavioral therapy, and behavioral science are the focus of other RFAs. The National Drug Abuse Treatment Clinical Trials Network RFA was released in January. Several RFAs have been released with other NIH components. Among these is one on "Transdisciplinary Tobacco Use Research Centers." As reflected in the printed Director's Report, NIDA is consolidating its Program Announcements and reducing their number.

   NIDA is continuing to work on initiatives to improve drug abuse treatment by improving existing treatments and developing new ones. More and better multi-element, multi-component interventions that focus on developing the recipients' abilities to function in a number of domains are needed. The major undertaking in this area is the National Drug Abuse Clinical Treatment Clinical Trials Network, and the applications for those awards will arrive in April.

   Public Information

   Several activities are occurring to help disseminate the findings of NIDA research. A town meeting was held in Des Moines in October, and another town meeting in May will take place at the Carter Center in Atlanta. The 5th Annual Constituent Conference was held in December, and representatives of 49 constituent groups provided their perspectives on NIDA activities and reported on their own activities. The discussions from that Conference and other meetings have helped prioritize goals for the new millennium. Research must be used to inform public policy, and, in addition to treatment initiatives, goals will focus on methamphetamine, nicotine, vulnerability to drug abuse, and prevention of drug abuse.

   Dr. Leshner reported on the "NIDA Goes to School" science education initiative, which provided a "school box" of materials for teaching about drug abuse to every public and private middle school in the nation as well as schools at American military bases overseas. In addition, there is a companion website. The materials were developed with the National Association of Biology Teachers. NIDA also has an activity with the K-Mart Family Foundation, the "K-Mart Annual Kids Race Against Drugs." The Office of National Drug Control Policy's anti-drug use media campaign is progressing, and NIDA is supporting the evaluation of that. "Treatment Solutions," a video on drug abuse treatment, was released at the Constituent Conference and will be distributed to interested groups. Finally, manuals are being developed for specific therapies, as is a Principles of Drug Addiction Treatment publication. This latter manual is designed to provide the public with straightforward, research-based information much as did the parallel prevention manual, Preventing Drug Use among Children and Adolescents: A Research Based Guide.

   Council members praised these efforts and noted that the field greatly desires such information. Methods of enhancing the dissemination of research findings were suggested and included talk shows, book reviews, synthesis articles in widely read medical journals, press briefings, and local media coverage. Members also noted a need to target insurance companies and others who control reimbursement for treatment and prevention, not just clinicians.

6. OMB Circular A-110 and the Freedom of Information Act - Ms. Diana Jaeger

   Ms. Diana Jaeger, Acting Director of the NIH Office of Policy for Extramural Research Administration, presented information on a requirement of the Omnibus 1999 Appropriations bill. In that bill, Congress directed the Office of Management and Budget (OMB) to amend OMB Circular A-110, the Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations. The amended language extends the Freedom of Information Act (FOIA) to "require Federal awarding agencies to ensure that all data produced under an award will be made available to the public" under the FOIA. This language has many implications for the NIH and its grantees, and issues to consider relate to the definition of data, confidentiality, protection of human subjects, period of access, costs of implementation, and maintenance of the integrity of research. NIH is working to clarify the intent and potential impacts of the change. A Federal Register notice is expected to provide opportunity for comment on the planned implementation. Council members expressed concern about the impacts this legislation could have. Ms. Jaeger noted that the issues of data sharing will remain, regardless of this particular piece of legislation, and encouraged Council members to provide NIH with input on data sharing in general.

7. The Clinical Trials Network - Dr. Stephen Zukin

   Dr. Zukin, Director of NIDA's Division of Clinical and Services Research, provided an update on the current status of the National Drug Abuse Treatment Clinical Trials Network initiative. He reviewed the purpose of the network, to provide a durable infrastructure for a research partnership among NIDA, community-based providers, and researchers, as well as to conduct clinical trials of behavioral and pharmacological interventions. He described the structure of the network and the plans for its expansion over time. A Request for Applications was released in January, and applications are due in April. Funding of the first group should occur by the end of September. Council members commented that there is a great need for this initiative and that it is highly desired by the research and practitioner communities. However, some members cautioned that, due to historical factors, research is not welcomed by all the patient communities which might be involved. Another possible barrier is that some community programs do not operate independently of large managed care corporations. These concerns should be considered as the initiative moves forward.

8. NIDA and NCI Update on the Transdisciplinary Tobacco Use Research Centers Initiative -- Dr. Jaylan Turkkan

   Dr. Turkkan, Chief of the Behavioral Sciences Research Branch, Division of Basic Research, reported on the development of a Request for Applications for Transdisciplinary Tobacco Use Research Centers (TTURCs). NIDA and the National Cancer Institute (NCI) developed this RFA partially in response to a Robert Wood Johnson Foundation effort to highlight multidisciplinary activities. The TTURCs are to facilitate research in tobacco use and nicotine addiction by ensuring a synthesis across levels of analysis and disciplines and by using diverse research approaches. It is hoped that the research will translate basic science into clinical interventions. Each TTURC is to be organized around a theme and address transdisciplinary issues. Dr. Barbara Rimer from NCI presented that Institute's perspective on the TTURC initiative and noted that the collaboration between NIDA and NCI had energized tobacco and nicotine researchers. Ms. Kaufman, NIDA Council Member, was asked to comment on the Robert Wood Johnson Foundation's involvement. She noted that, pending final approval by its board, the Foundation may be able to provide each center with support for a policy research component and a component for translation of research findings to the public and practitioners. She also noted the importance of the transdisciplinary aspects of the TTURC initiative.

   Council requested clarification of the program areas addressed in the initiative and asked about the distinction between NCI's and NIDA's programs in the announcement. Dr. Leshner explained that NIDA addresses nicotine's addictive aspects while NCI addresses health aspects of smoking and smoking prevention. Dr. Rimer added that NCI is also interested in smoking cessation.

9. Implementation of the NIH Policy on Minority and Gender Representation - Mr. Richard Millstein

   Mr. Millstein, NIDA's Deputy Director, explained that the NIH Revitalization Act of 1993 requires biennial reports describing the manner in which each NIH Institute has complied with requirements for the inclusion of women and minorities in clinical research. As part of this process, Council was mailed the relevant data on inclusion and asked to certify that NIDA has successfully implemented the NIH Guidelines. The Council approved a motion certifying NIDA's successful implementation of the NIH Guidelines. Mr. Millstein also described the work of a NIDA committee he chairs that monitors the implementation of this policy.

10. The Office of National Drug Control Policy Media Campaign and the NIDA Evaluation - Ms. Susan David

    Ms. David, Research Coordinator, Division of Epidemiology and Prevention Research, reviewed the history and purpose of the Office of National Drug Control Policy's current Youth Anti-Drug Media Campaign. Mr. Thomas Hedrick, Council Member, contributed to this background by describing the involvement of the Partnership for a Drug Free America. Ms. David then described the progress in the media campaign, its phases of implementation, and the plans for the evaluation. The evaluation is being conducted by WESTAT under support by a contract from NIDA. The primary purpose of the evaluation is to examine the outcomes and impacts of the campaign on children and parents, and a variety of variables are being assessed. The measurement activities include a repeated cross-sectional survey, a longitudinal cohort survey, media tracking and monitoring, and examinations of beliefs, attitudes, and behaviors, among other variables. Council discussed the need to address both the negative consequences of drug use and the positive consequences of non-use. Clarification of the selection of the age range for the youth target audience was requested, and a need to involve youth in the development of the messages was suggested.

11. Report of the Council Subcommittee on Craving - Dr. Reese Jones

    Dr. Jones reminded Council that the Subcommittee on Craving was developed because within the research community there are differing conceptualizations of craving and of ways to measure it. A draft document addressing the issue has been developed by subcommittee members and associates in the extramural community. A discussion of how to refine and use the document followed. Possibilities included publication in a professional journal, incorporation of sections into program announcements, discussion in a web-based forum, or a combination of approaches. Other issues mentioned were related to authorship and to whether or not the document would be viewed as representing an official position of NIDA or the Council. The consensus was that NIDA staff should develop and disseminate the document.

12. Report of the Council Subcommittee on Monitoring Review Integration -- Dr. Susan Amara

    Dr. Amara reported that the Subcommittee on Monitoring Review Integration met and discussed data from the two most recent review cycles. The data are difficult to interpret because of the variability within review committees, and consistent patterns have not emerged. The subcommittee made suggestions for improving the format and content of the data presentation, and the members stressed the need to monitor the content and tone of the reviews themselves.

13. Update on NIDA's Research Dissemination Activities - Dr. Timothy Condon

    Dr. Condon, Director of the Office of Science Policy and Communications, presented an overview of activities to disseminate the results of NIDA-sponsored research to the public, practitioners, researchers, and constituents. Demonstrations and examples of some materials were provided. In particular, Dr. Condon noted the popularity of the NIDA Town Meetings and the manner in which they involve several levels of the community in their planning and implementation. The NIDA Exhibit Program has expanded from providing a NIDA presence at 20 conferences in 1994 to 46 conferences in 1998. The circulation of NIDA NOTES has increased substantially over the years. It is now published 6 times annually. NIDA's "Go Cards" are a recent innovation to publicize the Info Fax Line and Web-site, and over 600,000 have been distributed. Other materials shown or mentioned include the NIDA Research Reports, the Community Drug Alert Bulletins, booklets on specific drugs or issues (e.g., prevention), treatment manuals, and pamphlets. The "NIDA Goes to School" activities have targeted science education in middle schools, and NIDA is collaborating with the K-Mart Family Foundation to reach youth audiences. In addition, the number and quality of press releases has increased, as has their utilization by the media. The Prism Awards have attracted the attention of the entertainment industry and rewarded accurate depictions of drug abuse by the entertainment media. Finally, NIDA has organized activities around its 25th Anniversary. Council endorsed NIDA's proactive approach to dissemination and provided suggestions for enhancing activities.

14. Council Comments

    Council members noted some issues for NIDA's continuing attention. Dr. Sanders-Phillips addressed a need for research on factors other than individual level ones, such as social, ecological, and societal factors. Dr. Barthwell discussed a need for enhanced dissemination of research to the drug courts community, and Dr. Koob stressed greater dissemination of intervention-related findings to the general public.

15. Public Comments

    Mr. Chuck Thomas of the Marijuana Policy Project urged NIDA to make marijuana available for research studies without requiring those studies to go through NIH peer review and approval.

Dr. Leshner adjourned the 71st meeting of the National Advisory Council on Drug Abuse at 3:06 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.