Minutes of the 70th Meeting of the National Advisory Council on Drug Abuse

September 15-16, 1998

The National Advisory Council on Drug Abuse convened its 70th meeting at 2:00 p.m. on September 15, 1998 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 September 15 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 16 at 9:00 a.m. and was open to the public. The Council adjourned September 16 at 2:55 p.m.

Council Members Present:
Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc. (September 16 only)
Thomas A. Hedrick, Jr.
Reese T. Jones, M.D.
Nancy J. Kaufman, R.N., M.S.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
June E. Osborn, M.D.
Kathy Sanders-Phillips, Ph.D. (September 16 only)
Catherine A. Stevens, J.D. (September 16 only)
Lei Yu, Ph.D.
Richard T. Suchinsky, M.D. (ex officio; September 16 only)

Council Members Absent:
Andrea G. Barthwell, M.D.
George F. Koob, Ph.D.
G. Alan Marlatt, 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:
Elliot Postow, Ph.D. - Center for Scientific Review, NIH
Peggy Schnoor - Office of Science Policy and Technology
Transfer, NIH
Paula Skedsvold, Ph.D. - Office of Behavioral and Social Sciences
Research, NIH

Members of the Public Present:
Geoff Mumford, Ph.D. - American Psychological Association
Haine Shiferaw - The Blue Sheet
Jan Brose - Capital Consulting Corporation
John Lanogan - IASWR
Jeff Hoffman - DANYA Corporation
Mark Brown - Capitol Consulting Corporation
Marc Pearce - NADCP
Beatrice Edner - American Psychiatric Association
Barbara Cire - MasiMax Research
Angela Sharpe - Consortium of Social Science Associations
Henri Crosby - DANYA Corporation
Kayla Pope - American Academy of Child & Adolescent Psychiatry
John de Miranda - National Association on Alcohol Drugs & Disability - Youth Power
Chuck Thomas - Marijuana Policy Project
James F. Callahan - American Society of Addiction Medicine
Edward G. Singleton - The Mayatech Corporation

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 introduced new members, Dr. Hortensia Amaro and Dr. Rand Conger. He then provided an overview of the agenda for the meeting. Dr. Teresa Levitin, Executive Secretary, provided a summary of voting policies and procedures, detailed instructions on Council review procedures, and reminders 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 Education 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. 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. Requests for administrative supplements were also reviewed. 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, 491 applications, requesting $437,101,069 in Total Years Direct Costs, went to review. Of these, 313 were scored by the Scientific Review Groups, representing $62,296,890 in First Year Direct Costs and $262,667,710 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 introduced the new members, Dr. Hortensia Amaro and Dr. Rand Conger, and he expressed gratitude for their willingness to serve. He noted that Dr. June Osborn was completing her term of service and thanked her for her dedication and hard work.

2. Consideration of the Minutes of the 69th Council

   The Minutes of the May 19-20, 1998 meeting were approved as written.

3. Future Meeting Dates

   Future meeting dates for Council were announced as follows:
   
   February 2 - 3, 1999
   May 25 - 26, 1999
   September 14 - 15, 1999
   February 8 - 9, 2000
   May 16 - 17, 2000
   September 12 - 13, 2000

4. NIDA Director's Report

   Dr. Leshner opened his report with a special acknowledgment of Dr. Zili Sloboda, who is retiring from Federal Service. He noted her many accomplishments, most recently as Director, Division of Epidemiology and Prevention Research, and thanked her for her service. Council members were referred to the printed copy of the Director's Report for other staff changes.

   Budget

   Dr. Leshner reported that budget negotiations for FY 1999 are continuing, and NIDA is awaiting the outcome of conference discussions. The FY 1998 appropriation was $527.175 million, reflecting a 7.6% increase over FY 1997 levels. The FY 1999 President's budget request reflects an increase of 8.4% increase for NIH overall, with NIDA's allocation expected to be $576.299 million, which is a 9.3% increase. The House of Representatives is proposing $575.426 million (a 9.2% increase) for NIDA, while the Senate is proposing $603.274 million (a 14.4% increase). These proposals show strong support for biomedical research and would allow an accelerated pace of ongoing NIDA activities and the initiation of new activities.

   Review Issues

   The integration of basic neuroscience applications into the Center for Scientific Review has been completed, and Dr. Leshner noted details on review integration will be provided later in the day. The integration of human development and AIDS applications has also occurred. Planning for behavioral science integration is continuing and has proved to be complex. Dr. Leshner informed the Council that the proposed scientific review groups may be seen on the World Wide Web, and he encouraged the Council to look at the proposed groups and provide feedback.

   Members were reminded of relatively recent policies related to review: the issuance of a policy on inclusion of children in NIH sponsored research and the need for prior agreement from an Institute before the submission of any application requesting more than $500,000 in direct costs for any year.

   Shaping the Research Agenda

   A Program Announcement "Genetic Architecture of Complex Phenotypes" was released in June in conjunction with nine other NIH components. A Request for Applications titled "Basic Behavioral and Cognitive Science Research: Approaches to the Study of HIV/AIDS and Drug Abuse" was also released in June.

   A number of meetings have been held to inform the research community of recent findings and NIDA's interest in further pursuit of those findings. NIDA's Special Populations Office hosted a meeting in Chicago,"Cannabinoid and Opiate Vascular Neuroimmunology," as part of its Research Development Seminar Series. "Buprenorphine/Naloxone Treatment of Opiate Dependence" was sponsored by the Medications Development Division in August. A meeting titled "Cognition and Emotion: Applications to Drug Abuse" was held as a miniconference within the American Psychological Society meeting in May. "Drug Addiction: A Treatable Disease," formed part of the program track at the American Psychiatric Association's summer meeting in Toronto. In July, the Robert Wood Johnson Foundation, NIDA, and the Centers for Disease Control and Prevention jointly sponsored a national conference, "Addicted to Nicotine: A National Research Forum." This meeting was highly successful in drawing attention to research on nicotine. It featured Vice President Gore as the keynote speaker.

   Also, NIDA has supported the Hispano/Latino Researchers and Scholars Work Group to recommend a program of research to determine the extent and nature of drug abuse disparities between Hispanics and other populations and the reasons therefor. A workshop on violence was held in conjunction with the College on Problems of Drug Dependence annual meeting in Scottsdale, Arizona.

   In November NIH will conduct a consensus development conference on the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder.

   Public Information

   Several activities are occurring to help disseminate the findings of NIDA research. The Town Meetings continue, and three are soon to occur in Buffalo, Saratoga Springs, and Des Moines. The one in Des Moines will focus on the growing abuse of methamphetamine across the country and ways local resources can utilize scientific findings.

   NIDA has enjoyed a great deal of favorable media exposure that helps disseminate its research. These events include, among others, an interview by BBC Radio, a Wall Street Journal article, coverage of the Addicted to Nicotine: A National Research Forum conference, and network news segments. The Council was referred to the printed Director's Report for more details. Finally, the Science Education program has released the seventh of its "Mind Over Matter" series of materials for middle schools. The latest release focuses on nicotine.

5. Physician Leadership on National Drug Policy - Dr. June Osborn

   Dr. June Osborn described the activities of the Physician Leadership on National Drug Policy (PLNDP), a group of 37 distinguished physicians that was organized by Dr. Osborn and her colleagues, Drs. Lonnie Bristow and David Lewis. The group is stimulating a fresh look at addiction from the perspective of luminary physicians who are identified with the field of substance abuse. The group quickly reached consensus that addiction is a chronic, treatable medical illness. Further, they agreed that medical schools need to do more to teach about addiction and drug abuse. The PLNDP is focused on the need for treatment of drug abuse. The PLNDP has gathered data, issued reports, educated Congress and prepared a videotape for lay audiences. The videotape was shown to Council, and it focused on prevention, treatment, and the need to avoid attaching a stigma to drug abuse. Dr. Osborn ended her presentation by noting that the PLNDP is designed to fill the gap of physician involvement in drug abuse issues and does not wish to imply any minimization of non-physicians' contributions.

   Dr. Leshner praised Dr. Osborn and the PLNDP for their efforts, noting the importance of addressing the stigma issue. Other Council members contributed ideas for support of, or directions for, the PLNDP, such as foundation support, working with the pharmaceutical industry, addressing reimbursement, and developing curricula.

6. Report on Review of NIDA Neuroscience and AIDS Science at the Center for Scientific Review - Dr. Elliot Postow

   Dr. Postow reported on results from the recent review cycle, which was the first to include NIDA's neuroscience and AIDS applications in the newly constituted Center for Scientific Review (CSR) review groups. CSR has committed itself to on-going evaluation of the integration activities and has applied for and received "1% evaluation funds" to monitor the integration. Cautioning that interpretation is limited by the small numbers of applications involved, he presented data on the outcomes of reviews of neuroscience applications. His general conclusions were that there was much variability over different scientific review groups, that NIDA applications were about as likely to be scored at the 25th percentile or better as others, and that usually the number of unscored NIDA applications was comparable to the number of unscored applications from other NIH Institutes. However, some review groups seemed more likely to give NIDA poorer scores. The NIDA scores in the Integrated Functional and Cognitive Neurosciences IRG were comparable to other scores. For the Molecular, Developmental, and Cellular Neuroscience IRG, both NIDA and NIMH tended to have more unscored applications than other NIH components.

   Dr. Leshner asked about the impact of recalibrating the median from 2.5 to 3.0. Dr. Postow presented data to suggest the percent of unscored applications was not affected, and the overall CSR median score moved from 240 to 265. Further, the distribution of scores was flattened. Dr. Postow concluded that the review groups are scoring, overall, as requested and implementing the score changes fairly. Council asked about the basis of calibration for "unscoring". Dr. Postow replied that the traditional adjectives were no longer being used, so the frame of reference is the grants one is "used to seeing" recently. Council raised the issue of round-to-round variability in the quality of applications, and Dr. Postow noted CSR has examined variability in scores, which is not an equivalent concept. Council sought and received assurance that applicants are being informed about the scoring changes. Council discussed the importance of keeping in mind that the purpose of the scores is to help make funding decisions and that this is especially difficult around the "payline margins." Finally, a member noted that reviewers need adequate orientation to the changes.

   After Dr. Postow's presentation, Council decided to form a subcommittee to monitor the impact of integration and the reviews of NIDA applications. Related concerns surfaced, such as whether or not all areas of NIDA's science could be monitored and would receive fair treatment, whether or not the procedure of not discussing unscored applications was working as well as intended, the level of encouragement provided in summary statements, and the need to focus reviews on the contribution the work could make.

7. Plans for the Center for AIDS and Other Medical Consequences of Drug Abuse - Dr. Henry Francis

   Dr. Francis presented information on NIDA's plans for the Center for AIDS and Other Medical Consequences of Drug Abuse (CAMCODA). He addressed his personal understanding of the nature of the AIDS epidemic and the need to prevent not only infection, but also ignorance. He described the history of the development of CAMCODA and then gave an overview of current research support and other activities. Finally, he expressed NIDA's ideas about how CAMCODA can operate with other NIDA and NIH components to support and facilitate research, the development of new ideas, and needed discussion. Council members asked about the relationship of CAMCODA to the NIH Office of AIDS Research, and it was explained that CAMCODA will be the "final common pathway" with NIH OAR for programmatic and budget discussions, but this does not preclude informal interactions with OAR by staff outside CAMCODA. Discussion also addressed the need for comprehensive activities that address a variety of medical conditions associated with HIV as well as prevention and behavioral issues.

8. Update on Methadone Regulations and Accreditation - Mr. Robert Lubran

   Mr. Lubran spoke to the Council about Center for Substance Abuse Treatment (CSAT) activities related to methadone accreditation. In response to a 1995 Institute of Medicine report and an NIH Consensus Panel on Effective Treatment for Heroin Addiction, the current Food and Drug Administration procedures for regulation of methadone treatment are being replaced by an accreditation model that the Substance Abuse and Mental Health Services Administration (SAMHSA) will oversee. Mr. Lubran described three sets of activities related to this: regulatory reform, a demonstration program, and technical assistance. The exact details of regulatory reform for how the functions will be altered and transferred to SAMHSA are being finalized with the Office of Management and Budget (OMB). Therefore, the exact plans may not be distributed to the public at this time. However, the general approach is for a "mixed" regulatory/accreditation approach that is similar to accreditation programs that have existed in other areas for years. The demonstration project has already been approved by the OMB and is being developed with the Commission on Accreditation of Rehabilitation Facilities (CARF) and Research Triangle Institute (RTI). CARF is involved in setting standards, as they already accredit methadone programs, and will provide training. The RTI will evaluate the demonstration program. Finally, CSAT has a contract to provide preaccreditation and postaccreditation technical assistance to programs. Mr. Lubran concluded his talk with a brief description of other CSAT initiatives related to methadone and drug treatment.

   Council noted that methadone programs are currently subject to multiple inspections by many levels of government and for both law enforcement and public health purposes. Mr. Lubran expressed optimism that consolidation of local and state inspections could be achieved as governments agree to accept accreditation, but there has not been progress on having consolidated reviews on the law enforcement side, with the DEA for example. Council also sought some clarification on anticipated time frames for securing accreditation for various types of programs and various settings (e.g., programs not currently providing methadone, physicians' private practices). Council agreed that the treatment subcommittee should look at the draft regulations when they become available. They also noted that the PLNDP would be interested in the CSAT activities.

9. Update on the Intramural Research Program - Dr. Barry Hoffer

   Dr. Hoffer provided an update on the Intramural Program's continued responses to the Blue Ribbon Panel Report. These responses include participating in NIDA-wide genetics initiatives, expanding programs on mechanisms of neurodegeneration, augmenting the clinical research activities, and securing new instrumentation. Additionally, collaborations with the Medications Development Division, NIDA and with other intramural programs have increased. A number of new personnel have been recruited, and Dr. Hoffer has instituted incentives for inter-branch collaborations at the intramural program.

   Council expressed their approval of these changes and asked if there were plans to increase activities in social and behavioral research. Dr. Hoffer replied that he is now able to direct his attention to those areas and that there is a need for infrastructure development to support such research.

10. Update on the NIDA Science Education Program - Dr. Andrea Baruchin and Dr. Cathrine Sasek

    Drs. Baruchin and Sasek described NIDA's science education program and provided examples of materials developed for science education. The program began in 1991 and attempts to improve students' knowledge of and interest in science, to increase scientific literacy among the general public, to interest more women and minorities in scientific careers, to increase understanding of the role of animals in research, and to disseminate information about the biological basis of drug abuse. NIDA's science education activities span all grade levels. A variety of mechanisms are used and include the Science Education Drug Abuse Partnership Awards (a grant program) and the Small Business Innovative Research (SBIR) program. Support is given to projects that are likely to have broad impact. Examples were presented to the Council and included an interactive, multimedia CD-ROM that emulates television shows, another interactive CD-ROM museum exhibit, and a radio program. Other examples of science education activities presented were Project DART, a team development approach; training videos developed through the SBIR; the "If You Change Your Mind" video and associated materials; "Mind Over Matter" posters on drugs of abuse; and slide packets on neuroscience. Other activities were mentioned, and plans for the future were described.

    Council asked about the particular outcome measures being used to evaluate these materials. Dr. Sasek replied that the particular measures depend on the program, but they generally involve increases in knowledge, changes in attitudes, development of interest in science, and utilization of materials. Council suggested new populations to target for science education, such as judges in drug courts and employee assistance program staff, and praised the activities of NIDA in this area.

11. Council Subcommittee Report on Treatment Research - Dr. A. Thomas McLellan

    Dr. McLellan reported on the subcommittee's meeting. Most of the discussion revolved around the clinical trials network to develop a "national laboratory" for examining treatments in "real world" settings. The plans for this network and possible activities and organizational structures were given. Dr. Leshner reminded the Council that this initiative had been described in May and that they were hearing an elaboration of the plans.

12. Council Comments

    There were no additional items for discussion.

13. Public Comments

    Mr. James Callahan spoke on behalf of the American Society of Addiction Medicine to thank Dr. Leshner, NIDA staff, and the research community for assistance in developing the second edition of Principles of Addiction Medicine. Dr. Terry Schultz, co-editor with Dr. Alan Graham, presented NIDA with a copy of their textbook, and he thanked Dr. Leshner and Dr. Dorynne Czechowicz for their leadership which had contributed to the development of the book.

    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 review and approval.

Dr. Leshner adjourned the 70th meeting of the National Advisory Council on Drug Abuse at 2:55 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.