Minutes of the 74th Meeting of the National Advisory Council on Drug Abuse

February 8-9, 2000

The National Advisory Council on Drug Abuse convened its 74th meeting at 1:00 p.m. on February 8, 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 February 8 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 9 at 9:00 a.m. and was open to the public. The Council adjourned February 9 at 2:54 p.m.

Council Members Present:

Susan G. Amara, Ph.D.
Andrea G. Barthwell, M.D.
Kathleen T. Brady, M.D., Ph.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc.
Steven C. Hayes, Ph.D.
Nancy J. Kaufman, R.N., M.S.
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
A. Thomas McLellan, Ph.D.
Kathleen R. Merikangas, Ph.D.
Perry F. Renshaw, M.D., Ph.D.
David L. Rosenbloom, Ph.D.
James E. Smith, Ph.D.
Richard T. Suchinsky, M.D. (ex officio, February 9 only)

Council Members Absent:

Hortensia D. Amaro, Ph.D.
Joe D. Bennett, M.D.
Rand D. Conger, Ph.D.
Kathy Sanders-Phillips, Ph.D
Linda Fuller, 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
Chris Melchior, Ph.D. - Center for Scientific Review, NIH
Heather Miller, Ph.D. - Office of Extramural Research, OD, NIH
Paula Skedsvold, Ph.D. - Office of Behavioral and Social Sciences Research, OD, NIH

Members of the Public Present:

Barbara Cire - MasiMax Resources
Brunie Emmanuel - National Council on Alcoholism and Drug Dependence
Glen Fischer - Management Assistance Corporation 
Sheila Harley, J.D. - Birch & Davis, Inc.
Jeffrey Hoffman, Ph.D. - DANYA, Inc.
Luciana Lopez - FDC
Sloan Mahone - Center for the Advancement of Health
Kayla Pope - American Academy of Child and Adolescent Psychiatry
Barbara Shine - NIDA NOTES
Connie Tomber - Society for Women's Health Research
Raymond Varisco - ROW Sciences
Linda R. Wolf-Jones, D.S.W. - Therapeutic Communities of America
Paul Young - NOVA
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).

   Mr. Richard A. Millstein, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. He then 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. Mr. Millstein introduced new Council members, Drs. Steven C. Hayes, Kathleen R. Merikangas, David L. Rosenbloom, and James E. Smith, and other Council members introduced themselves in turn. 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

   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 a brief description of the unit's portfolio and the applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews, either en bloc or after discussion of specific applications. Requests for administrative supplements and a MERIT application were also reviewed.

   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, 385 applications, requesting $351,608,488 in Total Years Direct Costs, went to review. Of these, 266 were scored by the Scientific Review Groups, representing $56,235,329 in First Year Direct Costs and $241,967,144 in Total Years Direct Costs. The Council approved one administrative supplement, one MERIT award, and one extension of a MERIT award.

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 73rd Council

   The Minutes of the September 14-15, 1999 meeting were approved as written.

3. Welcome to New Members

   Dr. Leshner welcomed the following new members: Drs. Steven C. Hayes, Kathleen R. Merikangas, David L. Rosenbloom, and James E. Smith.

4. Future Meeting Dates

   Future meeting dates for Council were announced as follows:

   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 that the Office of Extramural Research had been renamed the Office of Extramural Affairs.

   Budget

   Dr. Leshner announced that the appropriation for FY 2000 was $687,376,000. The President's 2001 budget request gives NIDA $725,467,000. This represents an increase of 5.5% over FY 1999. The average NIH institute increase is 5.2-5.3%. NIDA's anticipated success rate for FY 2000 will be 31%.

   Policy and Planning Activities

   Dr. Leshner noted NIDA's overall strategic plan had been developed and would be presented to the Council later in the meeting. A strategic plan for medication development will be produced with Council input. The President has declared the elimination of disparities among racial and ethnic groups as an administration priority, and NIDA has a series of strategic activities related to health disparities but now will develop a unified plan. Council volunteers are needed for the Medication Development Strategic Plan and the Health Disparities Strategic Plan.

   Council asked about funding for the health disparities activities and coordinating them with the Office of AIDS Research, and Dr. Leshner provided details on how funding and coordination would be accomplished.

   Shaping the Research Agenda

   Dr. Leshner noted that a number of meetings have been held since the last Council meeting, including meetings on the role of stress in drug abuse (one on early environmental stress and one on adult stress) and a NIDA-sponsored symposium entitled "Early Environmental Stress and Biological Vulnerability to Drug Abuse." The African American Researchers and Scholars Group has continued to meet, and the Asian and Pacific Islander Workgroup held their first meeting. Dr. Leshner announced that the Hispanic-Latino workgroup has decided to rename their group the National Hispanic Science Network. The functions of these three groups are to provide advice on research related to health disparities and to recruit and mentor young scientists. Dr. Leshner reported that NIDA is in the process of establishing a Native American and Alaskan Native workgroup as well. Mention was made of the NIDA presence at the Society for Neuroscience meeting and the spectacular booth and array of NIDA-sponsored workshops and symposia.

   Dr. Leshner noted the important role of Council in planning, including the development of a variety of initiatives. NIDA is not simply "doing more of the same," but is addressing new areas and expanding work in others. The areas mentioned were: vulnerability to addiction, transition to addiction, neurobiology of addiction, the next generation of prevention research, AIDS and other medical consequences, methamphetamine and club drugs, and national treatment improvement. Dr. Leshner gave, as examples, a recent Request for Applications, "Neurobiological and Behavioral Research on Nicotine and Tobacco Components" and a Program Announcement, "Social Work Research Development Program." Dr. Leshner also called attention to two program announcements in the area of imaging of drug abuse, "Bioengineering Research Partnerships" and "Bioengineering Nanotechnology Initiative."

   Several activities related to informing the public have occurred. Dr. Leshner spoke with legislative leaders from foreign countries about bridging the disconnect between scientific knowledge about drug addiction and application of that knowledge. The booklet on the principles of drug addiction treatment was released and is widely utilized.

   Dr. Leshner reported that another successful town meeting was held in Seattle and that the sixth annual Constituency Conference held in Virginia was one of the best NIDA has had. It allowed important discussion on the research agenda and ways to ensure its utility.

   NIDA is working on a guide to HIV prevention, and it was noted that principles of outreach to the drug abuse community are being developed. Further, there is a national public service campaign to make available neuroscience information relevant to youth.

6. NIDA's Draft Strategic Plan - Dr. Andrea Baruchin

   Dr. Baruchin discussed the development of NIDA's strategic plan. An Institute of Medicine report had recommended that all NIH institutes develop a strategic plan, and in January 1999, the Director, NIH, provided instructions to initiate the plans. NIDA's plan was developed with input from a Council subcommittee, NIDA staff, the full Council, extramural researchers, and constituents, and it evolved over several iterations. The final plan's overarching goal is to reduce the health and social consequences of drug abuse and addiction by increasing the understanding of the nature of addiction through basic and clinical research. Three strategies were developed to reach that goal: 1) to give the community science-based tools to prevent drug abuse and addiction; 2) to develop and distribute tools to improve the quality of drug abuse treatment nationwide; and 3) to disseminate research discoveries to educate the public about the disease of addiction and reduce stigma. It was delivered to NIH in December 1999.

7. Clinical Trials Network - Dr. Betty Tai

   Dr. Tai gave an update on The National Drug Abuse Treatment Clinical Trials Network (CTN), talking about the goals, accomplishments and mission of the CTN. Progress since the last Council includes establishing a NIDA CTN office; a steering committee consisting of the P.I.s, one community representative from each node, and one NIDA representative; several subcommittees and three independent boards consisting of an Oversight Ad Hoc Review Board, a NIDA Protocol Review Board, and a Data Safety Monitoring Board. The Steering Committee developed guidelines for evaluating research concepts and selected three as initial areas: 1) buprenophine/naloxone for opiate detoxification, 2) contingency management for treatment continuation and decreased drug use, and 3) motivational enhancement for treatment compliance. An RFA to expand the network in FY 2000 has been released, and it is attracting much attention.

   Council noted the importance of the CTN activities and concepts selected. The opportunity to incorporate a neuroscience perspective was noted, as were a number of national startup activities.

8. Report on the Intramural Research Program - Dr. Barry Hoffer

   Dr. Hoffer updated the Council on the Intramural Research Program and its continued response to the NIH Blue Ribbon Panel that reviewed the IRP three years ago. In response to the Panel's concerns about career development, Dr. Hoffer gave several examples of staff who have progressed to tenure positions, including a formal tenure track recruitment from Toronto. He addressed another issue cited in the report concerning computer support and general information resource management and informed the Council that Dr. Vahabzadeh was recruited to develop and manage information resources. He reported on other new recruitments and promotions and mentioned senior fellows who develop research programs, some staying and some returning to academia. In response to a Panel concern about collaboration in the IRP, Dr. Hoffer reported on steps he has taken to encourage multidisciplinary, multi-branch, investigator-initiated research programs. IRP staff have put together a teen tobacco treatment research center and a THC initiative, and are developing a core chemistry laboratory that involves the Clinical Pharmacology and Therapeutics Research Branch as well as the Behavioral Neuroscience Research Branch. Dr. Hoffer reported that the Board of Scientific Counselors is now at its full 12 member complement and has reviews twice a year. By the fall of 2001 they will have a regular four-year review cycle in place. Also in response to Report recommendation, Dr. Hoffer announced that the IRP has a permanent clinical director, Dr. Jean Cadet, who is very effective in dealing with the clinical research program.

   Another area where major strides have been made is in mentoring and training fellows. The K22 mechanism is being initiated to allow fellows to transition to extramural research. In closing Dr. Hoffer noted that he has developed an infrastructure to encourage intramural staff to work in a collaborative way with extramural colleagues, including collaborating with the CTN network.

   Dr. Leshner thanked Dr. Hoffer for his presentation and noted NIDA's intramural program is now a model for NIH.

9. Council Review Integration Subcommittee Report - Dr. Clyde McCoy

   Dr. McCoy reminded Council that it had reviewed a document related to review integration and that it had approved requesting data from CSR to assist Council in its discussion of review issues. Council endorsed continued communication with CSR, including follow-up requests for data and meetings with CSR to discuss a "Council of Councils."

10. Research on Drugs and Crime - Mr. Jeremy Travis

    Dr. Leshner introduced Mr. Jeremy Travis, Director of the National Institute of Justice (NIJ) in the Department of Justice. Mr. Travis noted that NIJ and NIDA have many shared interests and have collaborated closely to increase the rigor, relevance and interdisciplinary nature of research addressing the relationship between drugs and crime. Mr. Travis described the ADAM (Arrestee Drug Abuse Monitoring) program, which is conducted in 35 cities around the country with plans for expansion in every city with a population over 200,000. The importance of this program is in making possible the tracking of long-term changes in drug use patterns and the localization of discussions regarding drug policy. There is also an international ADAM program. He noted that NIJ relies on the work NIDA does, particularly on treatment effectiveness, and this work has facilitated some merging of public health and public safety perspectives and some blending of criminal justice and health approaches to the problem of drug abuse. Dr. Leshner added that the focus on drug problems as local in nature is a useful insight from NIJ. "Public health" and "public safety" were noted as more useful terms than the traditional demand/supply dichotomy. Council posed the question of whether local legislation could be influenced from the national level with model legislation. Mr. Travis responded that NIJ's role as a research institute is to develop knowledge about different ways of approaching problems. Also, NIJ has been particularly effective at helping practitioners learn from each other.

11. Health Disparities Research - Dr. Lula Beatty

    Dr. Beatty updated the Council on NIDA's health disparities research activities. She described the Special Populations Office and the progress it has made. The Special Populations Office has two major goals: 1) to improve research on minority populations and 2) to increase the number of minority researchers. Dr. Beatty noted a need for better understanding of prevention and treatment of drug abuse and addiction in minority communities. Dr. Beatty reported that one accomplishment of NIDA's past activities has been an increased interest in NIDA and drug abuse research within minority communities. There is a research supplement program that allows administrative supplements for existing grants to encourage minority individuals to pursue a research career. Dr. Beatty described the African-American Researchers and Scholars Group that was started in 1994 and the support they provide for minority investigators. The National Hispanic Science Network is reorganizing and a current focus is to identify relevant research methods and measures. The Asian-Pacific Islander workgroup met for the first time in December. The Native American and Alaskan Native workgroup is scheduled to meet in May of this year. Also mentioned were an HBCU initiative, a Hispanic initiative, workgroups, a summer research program, the Minority Recruitment and Training Program (MRTP) within the intramural program, and the Minority Institutions Drug Abuse Research Program (MIDARP). Support for minority supplement awards has increased dramatically over the last six years, going from a little under $0.5 million dollars in 1999 to about $2 million last year. Dr. Beatty noted that the summer research program with NIDA was becoming very popular and doing well, with 39 students being placed last summer.

12. Council Subcommittee on Expanding Membership on Scientific Review Groups - Dr. Steven C. Hayes

    Dr. Hayes reported the subcommittee met to consider issues around adding public members to review committees. The committee decided that public members could increase the quality of reviews by providing a different perspective in the areas of subject recruitment, informed consent, and other human subject issues. More generally consumer members could help foster the fit between science, practice, and consumer needs, thereby building bridges between the generators and consumers of science. The committee recommended that NIDA move forward to add public members to its treatment and services study sections no earlier than the February 2001 review committee meetings to ensure sufficient time for recruitment and training. A focused recruitment process as well as uniformly applied training procedures for public members was recommended. Dr. Leshner asked the committee to continue to help monitor this activity and also to help in identifying people who might be appropriate to serve.

13. Council Subcommittee on Expanding Membership on Scientific Review Groups - Dr. Steven C. Hayes

    Dr. Hayes reported the subcommittee met to consider issues around adding public members to review committees. The committee decided that public members could increase the quality of reviews by providing a different perspective in the areas of subject recruitment, informed consent, and other human subject issues. More generally consumer members could help foster the fit between science, practice, and consumer needs, thereby building bridges between the generators and consumers of science. The committee recommended that NIDA move forward to add public members to its treatment and services study sections no earlier than the February 2001 review committee meetings to ensure sufficient time for recruitment and training. A focused recruitment process as well as uniformly applied training procedures for public members was recommended. Dr. Leshner asked the committee to continue to help monitor this activity and also to help in identifying people who might be appropriate to serve.

14. Council 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 subject issues. He noted that the National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects are intended to help identify issues to be considered in the development or review of research protocols involving the administration of drugs. The document is organized around four general issues (risk benefit, informed consent, subject selection and confidentiality) and 13 specific issues, and the subcommittee provided recommendations on areas needing additional Council input. These include the impact of age, pregnancy, and prior treatment experience. A draft will be developed with NIDA staff and returned to Council for comment. Dr. Leshner noted the need to build in a process to get input from the field.

15. Public Comments

    There were no comments from the public.

Dr. Leshner adjourned the 74th meeting of the National Advisory Council on Drug Abuse at 2:54 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.