Minutes of the 75th Meeting of the National Advisory Council on Drug Abuse

May 16-17, 2000

The National Advisory Council on Drug Abuse convened its 75th meeting at 1:00 p.m. on May 16, 2000 in 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 May 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 May 17 at 9:00 a.m. and was open to the public. The Council adjourned May 17 at 11:42 a.m.

Council Members Present:

Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D.
Andrea G. Barthwell, M.D.
Joe D. Bennett, M.D.
Kathleen T. Brady, M.D., Ph.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc.
Steven C. Hayes, Ph.D.
Ruth L. Kirschstein, M.D. (ex officio)
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
Perry F. Renshaw, M.D., Ph.D.
David L. Rosenbloom, Ph.D.
Kathy Sanders-Phillips, Ph.D.
James E. Smith, Ph.D.

Council Members Absent:

Nancy J. Kaufman, R.N., M.S.
A. Thomas McLellan, Ph.D.
Kathleen R. Merikangas, Ph.D.
Linda Fuller, M.D. (ex officio)
Richard T. Suchinsky, M.D. (ex officio)

Council Chairs Present:

Alan I. Leshner, Ph.D.
Richard A. Millstein, J.D.

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 Mathews - National Institute of Mental Health
Christine Melchior, Ph.D. - Center for Scientific Review, NIH
Elliot Postow, Ph.D. - Center for Scientific Review, NIH
Linda Robbins - National Institute of Mental Health
Don Schneider, Ph.D. - Center for Scientific Review, NIH
Kate Whelan - National Institute of Mental Health

Members of the Public Present:

James Callahan - American Society of Addiction Medicine
Barbara Cire - MasiMax Resources
Cathi Coridan - National Mental Health Association
Marie Dyak - Entertainment Industries Council
Lauren Fasig, J.D., Ph.D. - Society for Research in Child Development
Alan Kraut, Ph.D. - American Psychological Society
Geoffrey Mumford, Ph.D. - American Psychological Association
Al Nugent - MRI
Barbara Sears - 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 Leshner, Director, NIDA, called the meeting to order and welcomed the Council and staff. Mr. Richard A. Millstein, Deputy Director, NIDA, provided an overview of the agenda for the meeting, and he 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 Council functions and voting policies and procedures. She also reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Division of Neuroscience and Behavioral Research; the Center on AIDS and Other Medical Consequences of Drug Abuse; the Office of Science Policy and Communications; the Division of Treatment Research and Development; and the Division of Epidemiology, Services, and Prevention Research presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Requests for MERIT application extensions were also reviewed and approved.

   Members absented themselves from the 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, 457 applications, requesting $412,907,957 in Total Years Direct Costs, went to review. Of these, 289 were scored by the Scientific Review Groups, representing $59,220,757 in First Year Direct Costs and $255,258,723 in Total Years Direct Costs. The Council approved 21 administrative supplements and two 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 74th Council

   The Minutes of the February 8-9, 2000 meeting were approved as written.

3. Dr. Ruth Kirschstein

   Dr. Leshner introduced Dr. Ruth Kirschstein, the distinguished Acting Director of NIH. Dr. Kirschstein remarked that she was delighted to be able to address Council and noted that she has been talking to different NIH advisory councils while she is Acting Director. She reported that the appropriation hearings went remarkably well and that Congress has been extremely generous to NIH over the past two years. Congress, the American public, and the academic community have grown increasingly interested in how well NIH uses its resources, and Dr. Kirchstein stressed that NIH has spent wisely and well in research whose aim is improving prevention or treatment of diseases and medical conditions. There was a discussion about health disparities among ethnic groups, and Dr. Kirschstein assured the Council members that NIH is committed to resolving these disparities. She noted that NIH will have a strategic plan that will propose to narrow the gap in disparities in health status by supporting research on diseases that disproportionately affect minority populations. Dr. Kirschstein mentioned that the draft strategic plan will be reviewed by a number of people and will be discussed at the Institute Directors' budget retreat being held June 15-16. The Office of Research on Minority Health will then review the plan and make comments. Dr. Kirschstein asked each Institute to develop its own plan, noting the overall plan will be a synthesis of the most important elements of those plans. The activities related to that strategic plan will be a part of FY 2002 budget submission.

   Dr. Kirschstein stressed the need for careful scrutiny of clinical research in light of recent events surrounding a gene therapy trial, adding that the confidence of the American public in NIH research must be maintained. There will be Congressional hearings regarding stem cell and gene therapy research and animal (particularly chimpanzee) research.

   Council raised questions regarding health care disparities among minorities, and in particular Native Americans, citing major problems with diabetes, alcohol, and health care facilities. Dr. Kirschstein informed Council that NIH had increased collaboration with the Indian Health Service, including a conference related to bringing research into the tribal schools. The Phoenix Pima Indian Study, doing research on diabetes, is another example of NIH working with the Indian Health Service.

   Dr. Kirschstein then answered other questions. Council asked about NIH's plan to develop researchers from ethnic communities to deal with issues of access to health care. Dr. Kirschstein stated that NIH has supported the Minority Access to Research Careers Program (MARC), the Minority Biomedical Research Support Program (MBRS), and individual research fellowships for minority students. Council made a comment that understanding how community structures and how communities organize themselves would help in understanding how to deliver better health care and how to create better health conditions for people. Dr. Leshner commented that Dr. Kirschstein is the architect of many major programs designed to try to recruit more minority scientists into biomedical research.

   Council raised a question of how behavioral health issues will be integrated into NIH. Dr. Kirschstein stressed that behavioral science is an integral part of biomedical science, noting that the National Institute of Child Health and Human Development and the National Heart, Lung, and Blood Institute, as well as other Institutes, have behavioral components as part of their biomedical sciences research.

4. NIDA Director's Report

   Dr. Leshner reported that Dr. Andrea Baruchin, Chief of the Science Policy Branch has left NIDA and moved to Tennessee and that Dr. Cindy Miner is serving as Acting Branch Chief. He also mentioned there were several new people on the NIDA staff, including Dr. Glen Hanson from the University of Utah, who will be the new Director for the Division of Neuroscience and Behavioral Research on September 1. He noted that Dr. Karen Skinner has done an outstanding job serving as Acting Director. Dr. Leshner announced that NIDA's Buprenorphine Development Team received the DHHS Secretary's Award for Distinguished Service.

   Budget

   Dr. Leshner spoke about the Senate Committee proposed appropriation for FY 2001, in which NIDA would receive an additional $100 million. The House action, and the President's 2001 budget request, would give NIDA $725,467,000, an increase of 5.5% over FY 2000. NIDA's anticipated success rate for FY 2000 will be 31%. Dr. Leshner pointed out that the average grant is $300,000 and 3.7 years long. He noted that research is expensive; for example, it costs $3.7 million per year to run a PET Center, $5.7 million to conduct a Phase III Medication Trial, $3.9 million to establish an fMRI Center, and $2.2 million per year to establish a new CTN Node.

   Policy and Planning Activities

   Dr. Leshner noted that NIDA's overall strategic plan is finished and is on the web. He thanked Council for its significant role in critiquing the early drafts.

   Dr. Leshner pointed out that the African American Researchers and Scholars Group, the National Hispanic Science Network, and the Asian and Pacific Islanders Workgroup continue to meet. A fourth group, the Native American-Alaskan Native Workgroup, met for the first time, and a senior representative from the Indian Health Service attended and offered collaboration. These workgroups help NIDA shape the research agenda, develop strategies to recruit minority investigators, and participate in the mentoring process.

   Shaping the Research Agenda

   Dr. Leshner noted several new Program Announcements, calling attention to ones in which NIDA collaborated with other NIH Institutes and ones which had recently been released, in particular "Neurobiological and Behavioral Research on Nicotine and Tobacco Components."

   Dr. Leshner reported that NIDA had sponsored a series of meetings. He mentioned the symposium entitled "Office-Based Treatment with Buprenorphine" held at the American Methadone Treatment Association Conference in San Francisco. This meeting was very important in dispelling concerns about buprenorphine. He also mentioned four Clinical Trials Network meetings that Dr. Betty Tai and her staff have organized. Dr. Leshner has initiated branch reviews in which the Branch Chiefs or members of their staff present how they shape and develop their portfolios. These have been very impressive not only in identifying staff accomplishments, but also showing the diversity of techniques and approaches staff use to interact with the extramural community.

   Initiative Implementation

   Council had urged NIDA to mount efforts addressing the transition to addiction, and Dr. Leshner mentioned that the Transitions to Addiction Workgroup had a meeting with people from truly diverse fields brainstorming about the nature of the transition to addiction. They are examining ideas for addressing both behavioral and neurobiological components of the transition.

   Dr. Leshner reported that the Clinical Trials Network group is working tremendously hard both internally and within the network itself. The first six nodes are now working together to move from research to practice. The CTN has developed the first three protocols for testing. NIDA intends to expand the network across the country and has received many applications for the second round of review.

   Public Information

   NIDA has mounted a number of initiatives to disseminate information about science to serve the public health. Particularly noteworthy is the club drugs initiative. The club drugs website is very popular, having 217,000 "hits" in the last 2 months. NIDA has circulated a large number of materials about club drugs. NIDA has also mounted a major initiative on anabolic steroid abuse because there is an increase in use among 8th and 10th graders. Dr. Leshner mentioned an anabolic steroid prevention program developed by a NIDA grantee, the Atlas Program, and a counterpart program for young women, the Athena Program. NIDA has published a research report on anabolic steroid abuse to make the public aware that the Institute is a resource for information about this problem.

   Dr. Leshner noted that NIDA co-hosted a seminar entitled "Gender Differences in Addiction and Recovery" with the Society for Women's Health Research held at the Smithsonian Institution in Washington, D.C. It was very well received. He also noted the Fourth Annual PRISM Awards at the Beverly Hills Hotel. This event was co-sponsored with the Robert Wood Johnson Foundation and the Entertainment Industries Council. NIDA had a successful meeting held jointly with the CDC and Center for Substance Abuse Treatment in Baltimore on HIV and Hepatitis C in substance abusers. This was a timely meeting, given the fact that 80% of intravenous drug users have Hepatitis C.

   Council members suggested that NIDA support research on whether illicit drugs and alcohol impact adolescent brains differently and also suggested further study of gender issues in drug addiction. Council commended NIDA for looking at the transition from drug abuse to addiction, and also suggested NIDA look at the transition from addiction back to recovery. Dr. Leshner thanked Council for these important suggestions.

5. Expedited Council Procedures - Dr. Teresa Levitin

   Dr. Levitin discussed the expedited en bloc process. She informed Council that it was a procedure for obtaining Council concurrence with the recommendations of the initial review group prior to the actual Council meeting. Designated Council members act on behalf of the full Council on the straightforward, noncomplex applications, allowing an applicant to be funded sooner. This process also allows Council more time to focus on the applications that need discussion. Only those applications that fall within certain parameters would be eligible for expedited en bloc concurrence. Expedited en bloc procedures cannot be used with foreign applications or those with any bars to funding. Council unanimously agreed that all R, K and T mechanisms having a 15th percentile or better or a 150 priority score or lower should be included in the expedited pool if their budgets were $300,000 or less (direct costs) in any one year.

6. Council Subcommittee on Strategic Planning for Medication Development - Dr. Morton Goldberg

   Dr. Goldberg reported that the subcommittee, consisting of five Council members and three outside consultants, had met for two days in early April. He noted that the subcommittee was impressed with the accomplishments of the medications development program during its ten-year period, particularly the successes of LAAM, buprenorphine, and buprenorphine/naloxone combination treatments for opiate addiction. The subcommittee was asked to address three issues: 1) what are the overarching strategies NIDA should pursue to maximize the successful development of new medications for the treatment of addiction, 2) what changes in the programmatic balance would improve the odds of success, and 3) what changes are needed in the way that the medications development program is organized and the way it interacts with the pharmaceutical industry and academia? The subcommittee recommended having more meetings with pharmaceutical companies to promote better relationships. A major advantage of these interactions would be to provide enriched samples of compounds for high throughput screening for potential anti-addictive activity. They also recommended that more emphasis be placed on contract research to optimize the development of agents and that NIDA meet with FDA to delineate specific requirements for bringing forward new therapeutic agents, particularly in the field of cocaine addiction. Finally, the subcommittee thought that the Clinical Trials Network would provide new understanding of how new therapies could be introduced into practice and also educate practitioners with respect to new treatments for medications development. It was pointed out that since the medications development program is centered within NIDA, it has the potential to tap some unique strengths within the basic science portfolio, the clinical neuroscience portfolio, and the Intramural Research Program.

7. Subcommittee to Review and Revise the Guidelines for the Administration of Drugs in Human Subjects - Dr. Perry Renshaw

   Dr. Renshaw reported that substantial progress has been made in revising the guidelines that were developed and published a few years ago. The subcommittee thought the guidelines should more clearly address the special vulnerabilities of mentally ill drug using subjects. It would also be advantageous to develop guidelines for when it is appropriate to administer drugs of abuse to individuals who have completed detoxification but are not enrolled in a treatment program. The subcommittee anticipates that a draft report of the revised guidelines will be ready for the September Council meeting.

   Council suggested several items for future agendas, including discussion of gender differences in addiction and recovery, health services research, and a synthesis of health disparities research findings.

8. Public Comments

   Dr. Leshner opened the floor to any comments from members of the public. Marie Dyak from the Entertainment Industries Council stated she hoped the NIDA research agenda would include study of how individuals and families cope with any brain damage that might be the result of drug abuse.

Dr. Leshner adjourned the 75th meeting of the National Advisory Council on Drug Abuse at 11:42 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.