Minutes of the 73th Meeting of the National Advisory Council on Drug Abuse

September 14-15, 1999

The National Advisory Council on Drug Abuse convened its 73rd meeting at 1:00 p.m. on September 14, 1999 Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Alan I. Leshner, Director, NIDA, chaired the overall meeting, and Mr. Richard A. Millstein, Deputy Director, NIDA, chaired the application reviews. The meeting on September 14 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 15 at 9:00 a.m. and was open to the public. The Council adjourned September 15 at 2:05 p.m.

Council Members Present:

Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D. (September 15 only)
Joe D. Bennett, M.D.
Rand D. Conger, Ph.D.
Morton E. Goldberg, D.Sc.
Thomas A. Hedrick, Jr.
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.
Perry F. Renshaw, M.D., Ph.D.
Kathy Sanders-Phillips, Ph.D.
Lei Yu, Ph.D.
Richard T. Suchinsky, M.D. (ex officio; September 15 only)

Council Members Absent:

Andrea G. Barthwell, M.D.
Kathleen T. Brady, M.D., Ph.D.
Gerald H. Friedland, M.D.
Linda Fuller, M.D. (ex officio)
Catherine A. Stevens, J.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 Present:

Jay Cinque, Ph.D. - Center for Scientific Review, NIH
Susan Matthews - National Institute of Mental Health, NIH
Angela Pattatucci, Ph.D. - Center for Scientific Review, NIH
Anita Miller Sostek, Ph.D. - Center for Scientific Review, NIH
Jane Steinberg, Ph.D. - National Institute of Mental Health
Julian Szorlosa, PhD. - Center for Scientific Review, NIH
Thomas Tatham, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

Rupert Ambrose - IQ Solutions
Sara Brookhart - American Psychological Society
Barbara Cire - MasiMax Resources
Lipin Wang - University of Cincinnati
Lauren Fasig - Society for Research on Child Development
Geoff Mumford - American Psychological Association
David Hess - Consortium of Social Science Associations
John Lanigan - Institute for the Advancement of Social Work Research
Robert Mathias - MasiMax Resources
Al Nugent - MRI
Barbara Shine - NIDA NOTES
Haimi Sinforaw - The Blue Sheet
Ray Vainco - ROW Sciences
Patrick Zickler - NIDA NOTES

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 welcomed the Council and staff. 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 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

   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. Khursheed Asghar. 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 Dr. Susan Coyle. 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 reported back to the full Council for discussion and 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, 510 applications, requesting $803,173,677 in Total Years Direct Costs, went to review. Of these, 328 were scored by the Scientific Review Groups, representing $94,653,199 in First Year Direct Costs and $466,213,289 in Total Years Direct Costs. The full Council approved each subcouncil committee's recommendations, including four administrative supplements, one MERIT award, and three extensions of MERIT awards.

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.

2. Consideration of the Minutes of the 71st and 72nd Council

   The Minutes of the February 2-3, 1999 and the May 25, 1999 meetings were approved as written.

3. Acknowledgement of Council Service

   Dr. Leshner expressed his and NIDA's appreciation for the service of Ms. Stevens, Mr. Hedrick, Dr. Koob, and Dr. Yu. A certificate of appreciation and plaque were presented to those present.

4. Future Meeting Dates

   Future meeting dates for Council were announced as follows:

   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 reported recent changes in staff. In addition, he noted that Dr. Bill Bukoski had been recognized with the Society for Prevention Research Public Service Award and that Dr. Roy Pickens had received the J. Michael Morrison Award from the College on Problems of Drug Dependence.

   Planning for NIDA's 25th Anniversary Celebration is proceeding well. The event will be marked with presentations for scientific and general audiences, poster exhibits, and a reception on September 27, 1999.

   Budget

   Dr. Leshner announced that there is not yet a budget appropriation. Under the President's proposed budget, NIDA would receive an increase of 2.4% over FY 1999. He cautioned that the President's budget would not allow for a re-competition of the National Drug Abuse Treatment Clinical Trails Network or for any major new initiative.

   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 two recently released NIH-wide Requests for Applications (RFAs), "Hepatitis C Cooperative Research Centers" and "HIV Prevention Trial Units." He also noted that NIDA issued an NIH Guide Notice, "Supplements for the Study of Drug Abuse and HIV/AIDS." These initiatives reflect the importance of the activities of the Center on AIDS and Other Medical Consequences of Drug Abuse.

   A number of meetings are reported in the printed Director's Report. Dr. Leshner highlighted several of these. The Federation of American Societies for Experimental Biology and NIDA sponsored a July conference on "Pulmonary Pathophysiologic and Immune Consequences of Smoked Substance Abuse." NIDA's emphasis on genetics was highlighted in a NIDA workgroup sponsored workshop, "The Role of Behavior Genetics in NIDA's Vulnerability to Drug Addiction Initiative" in May. Opportunities for behavioral researchers addressing drug abuse were addressed in April at the meeting of the Society for Research on Child Development as part of NIDA's "Early Career Pathways" series. Finally, several meetings, including one titled "Glimpses into the Working Brain," were held as part of Brain Awareness Week. NIDA took the lead among NIH components in organizing Brain Awareness Week activities this year.

   Other initiatives to shape the research agenda are continuing, many as a result of Council's input. The National Drug Abuse TreatmentClinical Trials Network reviews were completed and the network will become a reality in the near future. The National Cancer Institute, the Robert Wood Johnson Foundation, and NIDA will be launching the Transdisciplinary Tobacco Use Research Centers once final approval for awards is given by the National Cancer Advisory Board. An announcement for Medication Development Centers was re-issued, and awards for those are forthcoming. In addition, Genetics of Drug Addiction Vulnerability was an RFA reviewed over the summer, and it will result in several awards. Another announcement meriting specific mention is one on drug courts, a growing phenomenon that needs research attention.

   NIDA is engaged in a formal strategic planning process. A Council subcommittee is assisting with the planning process and will report later.

   Dr. Leshner announced that NIDA recently reorganized its administrative structure (1) to better integrate and highlight the development of treatments for drug abuse, (2) to move to the next generation of prevention research, and (3) to integrate AIDS activities, as well as activities related to other medical consequences of drug abuse. He outlined the new structure and stressed that the reorganization is intended to further NIDA's ability to pursue its goals rather than to correct any problems in previous structures.

   Public Information

   The annual Prism Awards, a joint activity of NIDA with the Robert Wood Johnson Foundation and the Entertainment Industries Council, were held in March. These awards are presented for accurate depictions of drug abuse and addiction in the media. The K-Mart Kids Race Against Drugs was held, and about 500,000 copies of NIDA's Mind Over Matter informational materials were distributed. A successful town meeting was held in Atlanta at the Carter Center, and one is planned for Seattle.

   The Intramural Research Program has developed and inaugurated a Teen Tobacco Addiction Treatment Research Center to address adolescent nicotine addiction, and it has been very well received by the Baltimore population.

   In June, a New Drug Application, or NDA, was filed with the Food and Drug Administration (FDA) for a buprenorphine/naloxone combination, which makes two NDAs pending for anti-opiate treatment medications. This is noteworthy because anti-opiate NDAs have not been filed since the development of LAAM, approved by the FDA in 1992. Related initiatives are attempting to create a climate where buprenorphine/naloxone can be incorporated into mainstream medical practice. These initiatives involve the Drug Enforcement Agency, the Center for Substance Abuse Treatment, which has regulatory authority for the Department of Health and Human Services (DHHS) over anti-opiate medications, and other DHHS components. A multi-site, office-based practice trial is also underway for "Buprenex," and manuals for physicians have been prepared and are being tested.

   Dr. Leshner gave Council members his perspective on issues that he thinks will be very important to address in the year 2000 and beyond. These include garnering knowledge at behavioral, biological, and molecular levels about factors influencing the transition from drug use to drug addiction. Another issue is moving prevention research to address what works for whom under which circumstances. New ways to disseminate prevention programs effectively, given local circumstances, also need to be explored. Addressing the life course of an addictive disorder is another under-studied area that will merit attention in the future. Council agreed that these are important issues.

6. NIDA's Draft Strategic Plan - Dr. George Koob

   Dr. Koob reported on the results of a Council subcommittee's review of NIDA's Draft Strategic Plan. While the subcommittee appreciated the document's comprehensiveness, they recommended that it be made more concise and focused to increase its effectiveness. Their second recommendation was that the document be revised to convey greater enthusiasm about NIDA's initiatives, and their final major recommendation was that specific strategies to accomplish the goals be set forth, especially in regards to prevention and treatment areas. Dr. Koob indicated that the subcommittee is willing and able to provide specific details on how to implement these suggestions and ensure a better balance among basic, prevention, and treatment research areas.

   Council discussion reiterated the possibility of using the strategic plan for a variety of purposes, such as publicizing NIDA's work to relevant consumers, in addition to its being a scientific document that guides NIDA initiatives. They also encouraged highlighting the "new millennium" issues Dr. Leshner noted earlier, and they suggested amplifications of those issues that could be incorporated.

7. Public Members on Peer Review Committees: The NIMH Experience - Dr. Jane Steinberg

   Dr. Jane Steinberg, Acting Director, Division of Extramural Activities, National Institute of Mental Health, reported on the factors that led NIMH to incorporate public members, such as members of patients' families or persons with a community provider or payor perspective, into peer review groups. She discussed the process of recruiting, selecting, and training these members, and she noted issues that had to be addressed with the scientific members of the review groups. A key element was training both the public and the scientific members about the role of the public members. Another key element was involvement of relevant constituency groups in the selection process. She outlined the training provided and the issues that arose in implementation. Preliminary outcomes were reported and indicate that the experience was generally, but not uniformly, perceived as positive. Most reviewers thought that review functioned well before the incorporation of public members and that it functioned well afterwards. Specific feedback for changes often included mutually exclusive suggestions, e.g., public members needed to be encouraged to be less vocal or to be more vocal. Overall, reviewers supported continuation of inclusion of public members but with in-depth orientation before every review.

   Council members related their own experiences with use of public members in various review settings. They stressed the need for training and clarity on each reviewer's role. The term "public member" was questioned and a comment was made that these are really "non-researcher reviewers." Thinking about them in that light opens new possibilities for understanding their roles. Dr. Leshner added that a critical issue is when and under what circumstances these reviewers should be used. He requested that Dr. Levitin work with a subcommittee of Council members to provide recommendations about this topic. Drs. McCoy and Sanders-Phillips agreed to serve on this subcommittee.

8. Review Integration Subcommittee Report - Dr. Clyde McCoy

   Dr. McCoy reported on the activities of the Council subcommittee examining the integration of NIDA's science into the review structures at the Center for Scientific Review (CSR). They have examined data from recent review rounds and there is some suggestion of unevenness in the reviews across study sections. They reported that, not surprisingly, a recent NIH survey of satisfaction with peer review revealed a strong association between satisfaction and the receipt of funds, and they reported that CSR has will assess satisfaction with the neurosciences merger. NIDA's Council has been asked to comment on potential areas of inquiry for this study, and Dr. Rand Conger, a subcommitte member, reported on the feedback they would like to give CSR. Primarily, they suggest types of data to collect and a broader sampling frame that would include reviewers themselves.

9. Report from the Director, Center for Substance Abuse Treatment - Dr. H. Westley Clark

   Dr. Westley Clark spoke about the complementary roles that NIDA and the Center for Substance Abuse Treatment (CSAT) play in addressing substance abuse treatment needs. He spoke candidly about the need to juggle personnel, policy, and politics to achieve important public health goals, and he outlined some of those goals: reducing the health and social costs of drug and alcohol abuse, reducing the transmission of infectious diseases, preventing the violence and neglect that stem from substance abuse, and addressing racial disparities in health care. Dr. Clark described the Targeted Capacity Expansion Program and block grant programs that help meet the goals. He described his work with NIDA to ensure that CSAT sponsored treatments are scientifically sound and effective, as well as acceptable to providers and patients. He focused on five specific initiatives: (1) a national plan to improve substance abuse treatment, (2) a practice research collaborative project, (3) the transfer of oversight of methadone and LAAM from the Federal Drug Administration to the Substance Abuse and Mental Health Services Administration, (4) an office-based opiate treatment initiative, and (5) a buprenorphine initiative.

   Council members inquired about the process behind the Notice of Proposed Rule Making related to oversight of methadone and LAAM. Dr. Clark explained the federal process and the background of the proposed changes. Other Council comments praised Dr. Clark's vision and addressed perceived policy and public attitude changes that need to occur, including changes in insurance coverage and reimbursement.

10. Human Subjects Research Issues Subcommittee Report- Dr. Thomas McLellan

    Dr. McLellan summarized the discussions of the Council subcommittee that was recently formed to consider human subjects issues. He noted that NIDA has been proactive in regard to humans subjects issues through the development of the National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects. The subcommittee has discussed inclusion of children as subjects, administration of drugs to occasional users, and administration of drugs other than the one the volunteer subject customarily abuses. Competence for informed consent has been discussed, as has informing volunteers about the drugs administered in protocols. The subcommittee will prepare comments on areas where the existing Guidelines need improvement and provide these to NIDA staff. Dr. McLellan noted that the Guidelines will need continuous updating as science changes and new issues emerge.

11. NIDA's Behavioral Treatment Development Program - Dr. Lisa Onken

    Dr. Onken outlined the history of the Behavioral Treatment Program. A behavioral treatment development initiative was launched in 1992 to support pilot and initial development of treatments. This "Phase I" work has led to Phase II efficacy trials. The next step, exporting the efficacious treatments to implementation in the community, is being launched in conjunction with the Clinical Trials Network. Dr. Onken gave examples of studies and their results that are part of the Behavioral Treatment Development Program. She noted plans for a similar program to develop applications from cognitive neuroscience findings, and she stressed the need for incorporating research on training therapists as part of the larger research agenda. Finally, she cautioned that these stages do not progress in the linear fashion in which they appeared for purposes of an orderly presentation, but they include feedback loops and interrelationships that NIDA is striving to better utilize.

    Council inquired about the criteria used in invoking feedback loop mechanisms and stressed the importance of considering training and reimbursement issues. Another comment noted the possibility of using constituent groups to assist in developing and disseminating the program. Finally, Council noted a need to study behavioral treatments in the context of medication provision and understand the interactions between the two modalities.

12. Council Comments

    Dr. Koob suggested that NIDA's Council take up the issue of supplements to better understand how they are used and to help, if possible, with their effective use. Dr. Leshner noted that this is a topic that is gaining attention within the Institute and that Council involvement could be helpful.

    Dr. Goldberg suggested that an update on the intramural program would be a welcome topic.

    Dr. Amaro stressed the importance of systematically investigating issues related to gender and ethnicity in the Clinical Trials Network and of fully integrating that research into the network.

13. Public Comments

    Dr. John Lanigan, Executive Director of the Institute for the Advancement of Social Work Research, acknowledged the work of NIDA and encouraged support of infrastructure development for Schools of Social Work as a means of helping NIDA achieve the goals outlined in the Council session.

    Ms. Sara Brookhart from the American Psychological Society and the Society for Research on Child Development (SRCD) echoed her appreciation for NIDA's work and introduced Lauren Fasig, who will represent the SRCD in Washington.

Dr. Leshner adjourned the 73rd meeting of the National Advisory Council on Drug Abuse at 2:05 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.