Minutes of the 80th Meeting of the National Advisory Council on Drug Abuse

February 20, 2002

The National Advisory Council on Drug Abuse convened its 80th meeting at 9:00 a.m. on February 20, 2002 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Glen R. Hanson, Acting Director, NIDA, chaired the overall meeting and Mr. Richard A. Millstein, Deputy Director, NIDA, chaired the application reviews. The first part of the meeting was open to the public. The closed session was held in the afternoon for the purpose of reviewing applications for federal grant assistance and was open only to Council members and Federal employees. The Council adjourned February 20 at 4:45 p.m.

Council Members Present:

Hortensia D. Amaro, Ph.D.
Kathleen T. Brady, M.D., Ph.D.
Kenneth J. Hoffman, M.D., M.P.H. (ex officio)
Nancy J. Kaufman, R.N., M.S.
Robert C. Malenka, M.D., Ph.D.
G. Alan Marlatt, Ph.D.
A. Thomas McLellan, Ph.D.
Scott A. Reines, M.D., Ph.D.
Perry F. Renshaw, M.D., Ph.D.
David L. Rosenbloom, Ph.D.
Kathy Sanders-Phillips, Ph.D.
Richard T. Suchinsky, M.D. (ex-officio)
Jose Szapocznik, Ph.D.

Council Members Absent:

Joe D. Bennett, M.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
James E. Smith, Ph.D.

Council Chairs Present:

Glen R. Hanson, Ph.D., D.D.S.
Richard A. Millstein, J.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse

Other Federal Employees Present:

Della Hann, Ph.D. - NIH, OD, Office of Extramural Research
Mark Rohrbaugh, Ph.D., J.D. - NIH, OD, Office of Technology Transfer
Ted Roumel, C.R.A. - NIH, OD, Office of Technology Transfer

Members of the Public Present:

Neal Barnard, M.D. - Physicians Com. for Responsible Medicine 
Wilson Compton, M.D., M.P.E. - Univ. of Washington School of Medicine
Linda Jones, D.S.W. - Therapeutic Community of America 
Andrew Kessler - American Psychological Society
Robert Matthias - MasiMax Resources, Inc.
Geoffrey Mumford, Ph.D. - American Psychological Association
Sid Schnoll, M.D. - Purdue Pharma L.P.
Susan Weiss - National Mental Health Association
Christine Whitmore, Ph.D. - American Institutes for Research (AIR)/Prospect Center

1. Call to Order

   Dr. Glen R. Hanson 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 Council

   The September 2001 meeting was cancelled. The Minutes of the May 2001 meeting were approved by written assent.

3. NIDA Director's Report

   Dr. Hanson began his presentation by thanking the staff for their support and for continuing to move the Institute forward during the transition in leadership as a result of Dr. Alan Leshner leaving NIDA to join the American Association for the Advancement of Science (AAAS). He announced that on December 1, 2001 Dr. Kirschstein named him Acting Director of NIDA and that the search is under way for a permanent director. Dr. Hanson commented that he plans to proceed aggressively to achieve the objectives and mission of NIDA. He stated that he would emphasize translation (moving basic discoveries into practice); cooperation (working together within NIDA and with other institutes to achieve common goals); and prevention (encouraging science-based research). He noted the overlap among NIDA, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health and the National Institute on Alcohol Abuse and Alcoholism and suggested further partnering and working closely together with these Institutes.

   Dr. Hanson announced that the U.S. Senate confirmed Dr. Andrea Barthwell as Deputy Director for Demand Reduction of the White House Office of National Drug Control Policy (ONDCP). Dr. Hanson also announced that Dr. Lula Beatty will be on detail to the National Center on Minority Health and Health Disparities (NCMHD) and Dr. Don Vereen will assume her responsibilities in the Special Populations Office. Dr. Hanson welcomed new staff members and reported on other recent changes at NIDA. He introduced Dr. Wilson Compton, from the University of Washington School of Medicine, who was recently selected to become Director of the Division of Epidemiology, Services and Prevention Research. He also announced that Dr. David Shurtleff was named Acting Director for the Division of Neuroscience and Behavioral Research and Dr. Paul Schnur was named Acting Deputy Director.

   Shaping the Research Agenda

   Dr. Hanson highlighted several recent meetings of interest. Among the most noteworthy was NIDA's first health disparities conference, Bridging Science and Culture to Improve Drug Abuse Research in Minority Communities. This well-attended meeting was held in conjunction with the Robert Wood Johnson Foundation in Philadelphia on September 24-26, 2001. NIDA staff conducted roundtables on various NIDA programs, research opportunities and areas of drug abuse research. NIDA also hosted its 7th Constituent Conference, Blending Research and Practice, in December 2001. This conference provided NIDA the opportunity to respond to concerns and research recommendations from the field. NIDA staff recently organized several symposia at the Society for Neuroscience annual meeting. These included symposia on microarray research, Ecstasy (MDMA), the role of frontal cortex in drug addiction, and molecular biology-based treatments for pain. Dr. Hanson noted that the 51st biannual meeting of the Community Epidemiology Work Group (CEWG) was held in San Diego in December 2001. The CEWG is composed of researchers from 21 metropolitan areas of the United States who meet to report on topics such as patterns and trends of drug abuse in their respective areas. Dr. Hanson noted several other meetings and mentioned that NIDA will host a conference, Blending Clinical Practice and Research: Forging Partnerships to Enhance Drug Addiction Treatment, in March 2002 in New York City. This meeting will provide clinicians and researchers an opportunity to examine the latest findings about drug abuse and addiction and their application to clinical practice. The Clinical Trials Network (CTN) has planned several meetings in 2002, including the CTN Criminal Justice System Interest Group meeting.

   Budget

   Dr. Hanson reported that the budget for FY 2001 had increased 12.2 % over the FY 2000 budget. The FY 2002 budget has an estimated 13.9 % increase and the FY 2003 has an estimated 8.6% increase. These new increases will allow NIDA to launch or expand a number of important initiatives.

   Initiative Implementation

   Dr. Hanson reported that the increased budget dollars would support new initiatives to expand efforts in all priority areas. He mentioned several new program announcements (PAs). One PA will support basic research in the role of the limbic system and brain ontogeny in drug abuse. Another will increase the capacity of minority institutions with limited sponsored research experience to conduct drug abuse research, and another will attract new investigators into the neuroimaging area of research. Dr. Hanson announced that the organizational unit of the Clinical Trials Network (CTN) has been elevated to a Center. A new Request for Applications (RFA) will expand the CTN by encouraging trials in geographical areas not currently well represented. Other initiatives will address such areas as developing new approaches in preventing HIV and other infections in drug users, making behavioral therapies more community-friendly, better understanding criminal justice-involved individuals with addictive disorders, and studying inhalant abuse.

   Dr. Hanson described the NIH Extramural Loan Repayment Program. The purpose of this program is to recruit and retain highly qualified health professionals as clinical investigators with participants contractually agreeing to engage in clinical research as extramural grantees or awardees. Dr. Hanson requested that Council help publicize this program.

   Dr. Hanson reported on recent drug use trends from the Monitoring the Future Study conducted for NIDA by the University of Michigan, noting that there were some interesting group changes. For instance, the highest age group had a slight decline in ecstasy use, while the eighth grade showed some increase. He added that education and increases in the perception of risk have stabilized the use of ecstasy. He also noted that cigarette use continues to decline in 8th through 12th graders, but steroid use is on the rise among 12th graders. Dr. Hanson reported that a public service announcement on steroids was issued last year by NIDA and that 400,000 information cards were handed out. A 30-second video about steroids that had been aired during the Olympics was shown to Council and staff.

   Dr. Hanson summarized research on the role of stress in drug abuse, noting that stress is a critical factor in both the initiation of and relapse to drug abuse. He commented that individuals with post-traumatic stress disorder have a 4-5 times greater risk of substance abuse than those who do not. Dr. Hanson added that research has shown that corticotrophin-releasing factor (CRF) plays an important role in how stress impacts reinstatement of drug use and that this could have important implications for treating addiction. He commented that articles pertaining to stress and its relationship with substance abuse can be found on the NIDA website and that plans to launch an initiative will further research in this area. NIDA will sponsor several scientific meetings related to stress and substance abuse this year.

4. Federal Support of Research, Technology Transfer and Intellectual Property Rights - Dr. Mark Rohrbaugh and Mr. Ted Roumel

   Dr. Hanson introduced Dr. Mark Rohrbaugh, Acting Director, and Mr. Ted Roumel, Assistant Director for Management and Operations, Office of Technology Transfer, Office of the Director, NIH. Dr. Rohrbaugh noted that the Office of Technology Transfer evaluates, protects, markets, licenses and monitors intellectual property generated by intramural scientists at NIH and is the lead agency for technology transfer at DHHS. He explained that the Bayh-Dole Act of 1980 governs Government funded inventions. Recent changes allow universities to retain title to inventions, although ultimately the government has residual rights. If the university elects title, it can patent and license and retain royalties, but is required to share royalties with the inventor. If the university declines title but requests it on behalf of the inventor, the NIH grants or denies this request. If granted, the inventor can patent, license and retain royalties but the Government has residual interests in these technologies and patents. Dr. Rohrbaugh explained that research tools generally have a short lifecycle, do not require significant research and development and generally do not require intellectual property incentives to make and use them. He commented that the NIH Director convened a Working Group on Research Tools in l997 with members from academia, industry, and not-for-profit groups. This work group issued recommendations and guidelines for recipients of NIH funding. This assures appropriate implementation of the Bayh-Dole Act and the importing and dissemination of NIH-funded tools. He concluded by sharing useful websites and noting that the research guidelines are on the web and will be available shortly in book form. Council raised a number of questions about the points presented.

5. Report on MDMA Conference

   Dr. Hanson summarized points from the MDMA (Ecstasy) Conference sponsored by NIDA that was held on July 19-20, 2001. Scientists from around the world met to discuss the latest research on methylenedioxymethamphetamine (MDMA) and its effects on the brain and behavior. The conference focused on Ecstasy-induced risk behaviors, long-term behavioral consequences, cardiovascular and brain toxicology, drug interactions, patterns of abuse, perceptions of risk, and implications for prevention and treatment research. Dr. Hanson gave a brief historical overview of the drug and then spoke of the physiological and psychological effects of MDMA use. He added that use of the drug is a major public health issue, with increased emergency room reports in 13 of 20 major cities surveyed by NIDA's Community Epidemiology Work Group. Dr. Hanson noted that MDMA is erroneously perceived as a safer drug than others, such as cocaine or heroin, and this perception makes it difficult to develop prevention programs.

6. Council Operating Procedures and Delegation of Authority - Dr. Teresa Levitin

   Dr. Levitin reported that NIH requires each Institute and Advisory Council to develop a document outlining the operating procedures in matters requiring Council review and action and describing Council's delegation of authority to Institute staff. She called attention to NIDA's draft Operating Procedures for Council Approvals and Statement of Understanding, adding that the draft included materials not in the previous version, such as the expedited en bloc review. Council requested that the appeal process be expanded in the document and then unanimously accepted it. Dr. Levitin commented that the Operating Procedures and Statement of Understanding would be brought before Council on a regular basis.

7. NIDA's New Prevention Initiative - Dr. Wilson Compton

   Dr. Compton thanked Council and NIDA staff for the opportunity to speak for the first time as the incoming Director of the Division of Epidemiology, Services and Prevention Research. He gave an overview of the NIDA National Prevention Research Initiative and presented his views on the role of epidemiological studies in prevention. The present NIDA prevention portfolio includes multicomponent programs covering whole communities or whole schools with interventions from early childhood through adulthood. Some of the findings from these studies show that types of drug offers differ with gender, that programs adapted to address needs of specific ethnic audiences have greater effect than those that do not, and that media intervention targeted at high sensation seeking youth resulted in major reduction in marijuana use in this group. Dr. Compton reported that there is a need to develop more reciprocity between basic and applied sciences to determine what strategies will work and to learn how we can best organize, manage and deliver prevention programs. Prevention science needs to address both initial use and escalation of use and needs to broaden the scope of theories and models by adapting successful strategies from other areas of science. Dr. Compton added that the National Prevention Research Initiative's goals are to accelerate research on innovative approaches to prevention of the initiation and progression of drug abuse and to foster research in science-based prevention in diverse communities throughout the nation. Three RFAs have been released as part of this initiative. The Transdisciplinary Prevention Research Centers RFA will accelerate development of innovative drug abuse prevention interventions. The Basic Science in Prevention Research RFA will develop innovative prevention interventions based on findings from basic biological, psychological, and social sciences. The Community Multi-site Prevention Trials will be Stage 3 studies to examine processes involved in adaptation, adoption and sustainability in multiple Òreal worldÓ settings.

8. Update on NIDA's Intramural Program - Dr. A. Thomas McLellan

   Dr. McLellan reported that he represented Council at the meeting of the NIDA Intramural Research Program's Board of Scientific Directors. He commended the Director of the Intramural Research Program for reviewing, over time, every member of the staff to assure accountability in terms of project development. At the latest meeting seven scientists, including the Director, and the behavioral neuroscience and clinical programs were reviewed. Dr. McLellan explained that these reviews were similar to those conducted by an IRG with frank discussions of strengths and weaknesses and subsequent recommendations for improvement. He added that recruitment is under way for four positions and that a new building is planned for 2007.

9. Update: Child and Adolescent Portfolio and Plans - Dr. Vincent Smeriglio

   Dr. Smeriglio gave an overview of NIDA's child and adolescent research program. He identified members of the Council Subcommittee on Children and Adolescents. Some of the recommendations from that subcommittee included considering a new initiative addressing youth inhalant abuse, exploring youth drug use and the Internet, and expanding the mentoring program on bridging child development and drug abuse research. Dr. Smeriglio highlighted recent activities of the Child and Adolescent Workgroup and called attention to the NIDA website for further information on work groups, research topics and abstracts of funded studies. He talked about ongoing research on the consequences of prenatal drug exposure and the importance of studies with longitudinal cohorts of children at various ages. He mentioned that through the Health and Developmental Consequences of Prenatal Exposure to Methamphetamine RFA a large-scale multi-site study and a MDMA study with U.S. and British collaborators were funded. Dr. Smeriglio noted multi-institute collaborations on studies involving HIV, AIDS and drug abuse in adolescents. He also mentioned a recently published RFA with joint sponsorship among NIDA, the National Institute on Deafness and Communication Disorders, and the National Institute of Biomedical Imaging and Bioengineering on pediatric neuroimaging and a program announcement with set-aside funds seeking young investigators to do short-term pilot studies on pediatric neuroimaging. He highlighted other RFAs and PAs and called attention to the inhalant abuse RFA issued in November 2001. Dr. Smeriglio showed several new materials for dissemination, including a NIH curriculum supplement series on CD-ROM geared toward high school students. He concluded with an update on career development activities.

10. Other Council Comments

    Dr. Hanson invited comments from Council. There was some discussion on how to use Council more effectively to develop new areas of research.

11. Public Comments

    Dr. Hanson opened the floor to comments from members of the public. Dr. Neal Barnard, President of the Physicians Committee for Responsible Medicine, asked Council to consider the review procedures by which grantee institutions mandate the search for alternatives to animal use, giving an example of animal use in proposed HIV and drug use research experiments.

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, provided an overview of the agenda for the closed portion of the meeting, and 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 Treatment Research and Development; the Division of Epidemiology, Services and Prevention Research; the Division of Neuroscience and Behavioral Research; the Center on AIDS and Other Medical Consequences of Drug Abuse; and the Office of Science Policy and Communications presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Requests for a new MERIT application, merit extensions, and administrative supplements were also reviewed and approved.

   Members must absent themselves from the Council meetings during discussion of, and voting on, applications from their own institutions or other applications in which there is 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, 445 applications, requesting $436,880,434 in Total Years Direct Costs, went to review. Of these, 248 were scored by the Scientific Review Groups, representing $59,480,034 in First Year Direct Costs and $266,704,357 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved two administrative supplements and one new MERIT award and two MERIT extensions. An appeal was brought before Council, and Council concurred with the IRG recommendation.

Mr. Millstein adjourned the 80th meeting of the National Advisory Council on Drug Abuse at 4:45 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.