Minutes of the 66th Meeting of the National Advisory Council on Drug Abuse

May 13-14, 1997

The National Advisory Council on Drug Abuse convened its 66th meeting at 9:00 a.m. on May 13, 1997 in Conference Room G, Building 31C, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. Dr. Alan I. Leshner, Director, NIDA, chaired the meeting. The meeting on May 13 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 14, 1997 at 9:00 a.m. and was open to the public. The Council adjourned at 1:50 p.m.

Council Members Present:
Susan G. Amara, Ph.D.
Lawrence S. Brown, Jr., M.D.
Marian W. Fischman, Ph.D.
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.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
Rafaela R. Robles, Ed.D.
Kathy Sanders-Phillips, Ph.D.
Linda S. Slattery
Catherine A. Stevens, J.D.
Lei Yu, Ph.D.
Col. Terry K. Schultz, M.D. (ex officio)
Richard Suchinsky, M.D. (ex officio)

Council Members Absent:
R. Lorraine Collins, Ph.D.
June E. Osborn, M.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:
Andrea Baruchin, Ph.D. - National Institute of Mental Health
William E. McGarvey, Ph.D. - Office of the Director, NIH
Susan Old, Ph.D. - National Heart, Lung and Blood Institute
Sarah Richards - Office of the Director, NIH

Members of the Public Present:
Marie Dyak - EIC
Neilsen Hobbs - The Blue Sheet
Sloan Mahone - American Academy of Child and Adolescent Psychiatry
Robert Mathias - R.O.W. Sciences/NIDA NOTES
Pam Moore - Capitol Publications
George Mumford - American Psychological Association
Chris Peterson - Stanford Research Institute (SRI)
Angela Sharpe - COSSA
Paula Skedvold - Society for the Psychological Study of Social Issues and American Psychological Society
Linda R. Wolf-Jones - Therapeutic Communities of America
June R. Wyman - ROW Sciences

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. An overview of voting policies and procedures was provided. Dr. Leshner reminded members of the NIH confidentiality and conflict of interest policies.

2. Application Reviews

   The Council was 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 and the Medications Development Division were reviewed by a subcouncil committee chaired by Khursheed Asghar, Ph.D. 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 William C. Grace, Ph.D. 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. 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, 474 applications, requesting $420,140,538 in Total Years Direct Costs, went to review. Of these, 292 were scored by the Scientific Review Groups, representing $61,621,051 in First Year Direct Costs and $262,775,626 in Total Years Direct Costs. The full Council approved each subcouncil's recommendations. One new and three extension MERIT applications were approved. Council recommended establishing a panel to ensure that there would be maximal access to and utilization of the data from a longitudinal study of importance to the nation.

Information on specific programs was presented. These programs include the Special Population Research Seminar Series, a research supplements program, the Historically Black Colleges and Universities initiative, intramural programs, MARC, MBRS, and the Hispanic initiative.

The special seminar series brings in small groups for lectures on drug abuse and grants development. Some factors which appear to be related to future grant receipt are having a Ph.D. rather than another degree, not working in a community based organization, not having an administrative position, and having senior NIDA grantees at the seminar. Research supplements to ongoing grants tend to focus on persons near the "end of the pipeline"; however, funds from the Office of Research on Minority Health have allowed a new program to attract high school and undergraduate students. NIDA continues to target development for Historically Black Colleges and Universities (HBCUs), and nine HBCUs are now collaborating on drug abuse issues. Eleven HBCUs are working with the Drug Abuse Research Technical Assistance Program program. The Hispanic Initiative will be starting in the summer to provide intensive research development experiences.

Council discussion followed and focused on the importance of mentoring and role models. Mentoring is a critical component of researchers' development. Also, in order to attract researchers, it is useful to make explicit the relationships among research, public health, and public policy. Council expressed some concern about the inability to evaluate programs because of difficulties identifying who is and is not a minority and because of limited access to relevant data. A need for involvement of training directors in minority program enhancement was noted, and NIDA's work with training directors was described.

1. Call to Order

   Dr. Alan I. Leshner called the open portion of the meeting to order, 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 67th Council

   The Minutes of the February 4 - 5, 1997 meeting were approved as written.

3. Future Meeting Dates

   Future meeting dates for Council were announced as follows:
   
   September 16 - 17, 1997
   February 3 - 4, 1998
   May 19 - 20, 1998
   September 15 - 16, 1998

4. Report of the Director

   Dr. Leshner noted that the Director's report is available on the World Wide Web through NIDA's home page.

   Budget

   The support of the Administration and the Congress is evident in the budget figures. The FY 1998 Presidential Budget request is for $521.915 million for NIDA, an increase of 6.7% over the FY 1997 appropriation. This level of funding would provide NIDA a success rate of 27% for research project awards, up from 24% for FY 1997 and comparable to the NIH average of 28%. This level would allow NIDA to award 60-65 new or competing grants over the number currently awarded. The Administration has indicated that about half of the increase should be for medications development, in particular for developing an anti-cocaine medication, and the other half should be for enhancement of the research program.

   Other events of note related to the budget are that the Office of National Drug Control Policy has transferred $4.85 million to NIDA for medications development, to be used for one time expenditures, and Dr. Varmus has used his one-percent transfer authority to give NIDA an increase of about $1.2 million, which is restricted to use for medication development.

   Review Issues

   The review of grant applications at NIDA will be affected by two important activities. One is the examination of and revision of the NIH critieria for the review of applications, and the other is the integration of NIDA's peer review into the rest of the NIH peer review at the Division of Research Grants (DRG). Regarding the review criteria, Dr. Varmus has determined that five criteria will be used at NIH. These are: significance, approach, innovation, investigator, and environment. These may be weighted differently for different applications, and summary statements are to be organized around them. One goal of these new criteria is to foster more innovative research.

   Integration of peer review into DRG is well under way in the area of neuroscience. There is now information available on the web on the integration of neuroscience, and comments are being solicited. The integration of neuroscience will serve as a prototype for integration of other areas, and it is important to note that new scientific review groups are being created, rather than adapting extant groups to accommodate NIDA's applications. Basic behavioral science and AIDS applications are the next two areas for integration. Dr. Leshner asked the Council members to carry home the message that integration is being done in a thoughtful and careful manner, and input is solicited.

   Shaping the Research Agenda

   The B/START announcement is being re-issued to bring new and junior investigators into the field of drug abuse, and it involves multiple NIDA divisions. A meeting on cognitive science research is planned as a satellite to the American Psychological Society meeting, and AIDS will be a theme at the College on Problems of Drug Dependence meeting. Childhood psychopathology as a risk factor for drug abuse is another area of increasing focus, and a national meeting on heroin is planned for the end of September.

   The NIH workshop on the medical uses of marijuana on February 19th and 20th was held and had speakers on clinical research who were not marijuana experts and speakers with expertise on clinical indications. The first day was for scientific presentations, and the second day was for public comment. A report is in preparation, but the general consensus was that the database around purported medical uses of marijuana is not very extensive, although there are some indications for which THC is approved and is a potential medication. Dr. Leshner expects the panel to recommend that NIH do additional research to inform the debate, and there will likely be a process developed at NIH for setting these priorities.

   Public Information

   The Division of Epidemiology and Prevention Research has released a science-based guide to drug abuse prevention as an outgrowth of the National Conference on Prevention Research last year. The town meetings have continued, and are always established jointly with local coalitions of groups concerned with drug abuse. The Journal of Hospital Practice has put out a very well executed special issue on drug abuse which covers a broad range of topics. Time magazine has covered drug abuse issues with NIDA cooperation. Brain Awareness week was in March, and Dr. Leshner was asked to present at the NIH's "mini-med school" on Capitol Hill.

   Bill Moyers is producing a series on drug abuse for PBS, and the PBS producers have been pleased enough with the progress that it has been expanded from a four-part to a five-part series. NIDA has just completed making the first "NIDA Prism Awards" to people in the entertainment industry for accurate depictions of drug abuse and addiction in the media, and these were very well received. Another important event was that Senators Levin and Kerry, with Senator Moynihan joining them, held a forum on medication development on Capitol Hill during which members of Congress and staff listened to presentations from scientists and industry representatives. Finally, there was a hearing called by Congressman Shays on the issue of informed consent by vulnerable populations, and the CDC, NIH, FDA, and Office of the Secretary, HHS were involved. The guidelines that this Council had produced on the use of drugs of abuse in research with humans were discussed at several points and were seen as a model of how to provide advice to institutional review boards and investigators.

5. Report on the Division of Research Grants and the Integration of NIDA Science - Dr. Ehrenfeld

   The Director, DRG, Dr. Elvera Ehrenfeld, presented a brief history of her own career and made the point that just as her own research became more inter-disciplinary over time, so too has science in general. The multi-disciplinary nature of science challenges the review process, and the DRG must not work in isolation from the scientific community or the Institutes and Centers to meet this challenge. A brief discussion of the DRG structure and functions was provided. Dr. Ehrenfeld has identified several issues that need attention. The length of time, about a year, between submission and decision to award is too great. Procedures for amended or resubmitted applications need to be improved. In addressing these two major concerns, DRG is cognizant that it must not simply take existing processes and make them faster; rather, it must find more efficient methods. This might require re-engineering, changing, eliminating, and automating some current procedures.

   Dr. Ehrenfeld noted that scientific review groups need to be examined to make sure that the proportion of applications that each receives is appropriate for the activity in the field of science. If the most competitive applications all go to the same group while less competitive ones go to another group, this could represent a type of "entitlement" for less active or competitive areas. Another concern is that review groups not sacrifice breadth of perspective for all the different technologies inherent in multi-disciplinary research. This is the distinction between asking "Does anybody care if this science gets done?" versus "Can it be done well?"

   Recruitment of members and the need for flexibility in allowing them to serve is being addressed, as is the need to evaluate new procedures.

   Regarding the integration, Dr. Ehrenfeld believes that the procedure that was developed for neuroscience worked well. The experience has taught DRG a great deal about how to accomplish integration and should be very useful for moving ahead with the next two areas for integration, behavioral science and AIDS.

   Council had several comments and questions. A need for creative mechanisms for identifying innovative, "trans-disciplinary" studies was noted, and Dr. Ehrenfeld indicated that no simple answer was possible, but consideration needs to be given to the types of study sections, their membership, the "self-fulfilling prophecy" of the research community that prevents its members for trying daring ideas, and training of reviewers. Flexibility in reviewers' terms and in their roles may help. A pre-review for technical issues may also help. The idea of a "three page proposal" similar to those used in Europe was suggested. It was stated that mature investigators would recognize and correct technical difficulties as they occur in the research and that long applications encourage focus on insubstantial technical details which ought not be a focus of review. Dr. Ehrenfeld agreed that a shortened application was a good idea, but she indicated that three pages would not allow for a demonstration of genuine scholarship. She also noted that there were differences in the types of review groups which serve a single institute and those of the DRG, which serve multiple institutes, so it is difficult to generalize about whether or not technical details are over-emphasized. In response to a comment about Council's role in the review process, Dr. Ehrenfeld encouraged Council members to be active in determining programmatic relevance of applications and balancing that with scientific merit. Finally, the need for evaluation of changes and the importance of a clear vision of what review should accomplish and how were noted.

6. Programs to Enhance Minority Participation - Dr. Beatty

   Dr. Lula Beatty, Director, NIDA's Special Populations Office, presented an overview of NIDA's initiatives to increase the number of minority researchers. She noted that one must take a long term perspective on this issue, given the length of time it takes to train researchers and establish them. Many barriers to establishing an adequate "pipeline" for minority researchers have been identified. Many potential investigators are not in research universities that help them develop. Others have concerns about the peer review system and whether or not it takes into account biases in the research community (e.g., bias in awarding tenure may have an effect on peer review of an investigator's credentials or eligibility for service on a review committee).

   There is a need to define "measures of success" for NIDA's attempts to increase minority researchers' involvement, e.g., tenured professor with an R01 from NIDA is not the only measure of success. Furthermore, identifying minority researchers is difficult, and the methods of doing so are imperfect. This complicates efforts to evaluate changes due to NIDA's efforts.

7. Video - Dr. Leshner

   A videotape that runs continuously through the traveling NIDA exhibit was shown to the Council and briefly discussed.

8. Interim Report on the Blue Ribbon Panel to Review the Division of Intramural Research - Dr. Leshner

   Because Dr. Lei Yu was ill and not able to present his report on the review of the intramural research program, Dr. Leshner summarized that activity instead. NIDA's review is being chaired by Dr. Stanley J. Watson, University of Michigan, and other members are Dr. Steven R. Childers, Wake Forest University; Dr. Ellen Frank, University of Pittsburgh; Dr. Avram Goldstein, Stanford University; Dr. Eric Kandell, Columbia University; Dr. Nora Volkow, Brookhaven National Laboratory; and Dr. Lei Yu, Indiana University. The committee has interviewed a number of people, including Dr. Leshner, Mr. Millstein, the Scientific Director, Intramural Branch Chiefs, post doctoral fellows, and other intramural staff. The final report is nearly complete and will include recommendations for change.

   Council discussion followed and focused on the need for more interaction between the intramural program and the Council. Council asked how much input they should have into broad intramural objectives and suggested that more Council knowledge of intramural activities might help them make better decisions about extramural priorities in order to avoid unnecessary redundancy.

9. Treatment Research Initiative - Dr. Marlatt

   Dr. Marlatt summarized progress on NIDA's treatment research initiative since the last Council meeting. He reminded the Council that the treatment initiative is an attempt at "bridging one of the disconnects" between public understanding of drug treatment and research findings. Some of the areas being addressed in the treatment initiative are 12 step programs, pharmacotherapies, cognitive-behavioral therapies, the role of spiritual treatments, and matching treatment to specific patient characteristics. Special populations are being addressed in the initiative, as is comorbidity with mental health disorders. HIV prevention needs to be further integrated with drug treatment, and that represents another exciting area for the initiative.

   One example of successful attempts to initiate and support proposals has been the behavioral therapy initiative from Drs. Zukin and Onken. This has brought leading behavioral therapists and other psychosocial treatment people into the drug abuse field. From that experience, it is possible to endorse three major steps. First, there is a need for "stage one" research to develop new and novel treatments and prevention activities. Second, efficacy trials need to be conducted, and "stage three" would consist of treatment transportability or effectiveness research.

   The treatment initiative has planned a number of meetings. A "kick off" conference was discussed, and it was viewed as parallel to the recent prevention conference that sought consensus on basic principles. Although the treatment field may not be ready, it would be useful to have a conference to develop basic principles about treatment that people could agree upon as essential. Treatment personnel and policy makers could attend the conference. In addition to principles of treatment, the conference might address the implementation of treatment in managed care settings or under insurance coverage. A one-and-a-half or two day meeting in early 1998 is being considered, and potential speakers would be Secretary Shalala, General McCaffrey, and Dr. Leshner. Topics could include overviews of treatment approaches and specific drug targeted ones on opiates, nicotine, and cocaine. Treatment delivery issues could be covered, as could special populations, criminal justice concerns, adolescents, women, HIV, and other topics.

   Council discussion on the Treatment Research Initiative was held until after the report on the Craving Research Initiative.

10. Craving Research Initiative - Dr. Koob

    Dr. Koob reported on a meeting of a subcommittee of Council that had discussed research issues in craving. The subcommittee reached a consensus that NIDA needs to take steps to define the problem. Research has been impeded because each investigator approaches craving from his or her own unique perspective, and NIDA could play a role in defining the issue. A number of suggestions were also offered to utilize innovative methods to fund applications.

    Council discussion endorsed the need for definition of craving as an essential next step. Discussion then turned to the Treatment Research Initiative, and a need for a companion component, or treatment research information initiative, to "bridge the disconnect" was noted.

11. Council Future Agendas - Mr. Millstein

    Mr. Millstein noted that items currently planned for future meeting include secondary data analysis and issues around children and adolescents. A suggested future topic was Council's role in monitoring the impact of integration of peer review into DRG.

12. Public Comments

    There were no comments from the public.

Mr. Millstein adjourned the 66th meeting of the National Advisory Council on Drug Abuse at 1:50 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.