Minutes of the 77th Meeting of the National Advisory Council on Drug Abuse

February 13-14, 2001

The National Advisory Council on Drug Abuse convened its 77th meeting at 11:00 a.m. on February 13, 2001 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 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 February 14 at 9:00 a.m. and was open to the public. The Council adjourned February 14 at 3:10 p.m.

Council Members Present:

Hortensia D. Amaro, Ph.D.
Andrea G. Barthwell, M.D.
Kathleen T. Brady, M.D., Ph.D.
Gerald H. Friedland, M.D.
Steven C. Hayes, 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.
Kathleen R. Merikangas, 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.
James E. Smith, Ph.D.
Richard T. Suchinsky, M.D. (ex officio)
Jose Szapocznik, Ph.D.

Council Members Absent:

Joe Bennett, M.D.
Rand D. Conger, Ph.D.

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:

Mary Custer, Ph.D. - Center for Scientific Review, NIH
Doreen S. Koretz, Ph.D. - National Institute of Mental Health, NIH
Karen Sirocco, Ph.D. - Center for Scientific Review, NIH
Paula Skedsvold, Ph.D. - Office of Behavioral and Social Sciences Research, OD, NIH
Arlene Stanton, Ph.D. - Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment
Brent Stanfield, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

Candace Baker - National Association of Alcoholism and Drug Abuse Counselors
Meredith Bosler - Society for Research in Child Development
Barbara Cire - MasiMax Resources
Cathi Coridan - National Mental Health Association
Marie Dyak - Entertainment Industries Council
Lauren G. Fasig, Ph.D., J.D. - Society for Research in Child Development
Irene Gainer, R.N., J.D. - National TASC
John Lanigan - Research Forum on Children, Families and New Federalism
Sarah Knab, M.P.H. - Society for Women's Health Research
Rachel Loock - TRI
Robert Mathias - MasiMax Resources
Farida Mohamenshan - Distilled Spirits Council of the United States
Nancy Moy - Stanford Research Institute
Geoffrey Mumford, Ph.D. - American Psychological Association
Al Nugent - Midwest Research Institute
Michael Pollack - American Psychological Association
Frank Tims, Ph.D. - Univ. of South Florida and Operation PAR
Susan Weiss - National Mental Health Association
Lori Whitten - ROW Sciences
Patrick Zickler - MasiMax Resources
Joan Zlotnik, Ph.D. - Institute for the Advancement of Social Work Research

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 Treatment Research and Development; the Division of Epidemiology, Services, and Prevention Research; the Division of Neuroscience and Behavioral Research; and the Center on AIDS and Other Medical Consequences of Drug Abuse presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Requests for MERIT applications 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, 521 applications, requesting $447,268,947 in Total Years Direct Costs, went to review. Of these, 344 were scored by the Scientific Review Groups, representing $73,060,565 in First Year Direct Costs and $313,563,563 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved two administrative supplements, one new MERIT award and one extension of a MERIT award. One appeal was brought before Council, and Council concurred with the IRG recommendation.

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 76th Council

   The Minutes of the September 12-13, 2000 meeting were approved as written.

3. Welcome to New Members

   Dr. Leshner welcomed the following new members: Drs. Robert C. Malenka, Scott A. Reines, and Jose Szapocznik and one new ex-officio member, Dr. Kenneth J. Hoffman.

4. NIDA Director's Report

   Dr. Leshner called attention to the Director's Report summarizing research at NIDA and in the field. He welcomed new staff members and announced that Dr. Rita Liu was appointed Associate Director for Grant Activities, Office of Extramural Affairs, and that Dr. Pat Needle has assumed a temporary position as Director, Executive Secretariat for the 2002 World AIDS Congress in Barcelona, Spain. Dr. Steven Gust will serve as Acting Director for the NIDA International Program in her absence. Dr. Leshner also called attention to program activities highlighted in the Director's Report, as well as many staff accomplishments, honors and awards.

   Budget

   Dr. Leshner announced that NIDA received a $100 million budget increase this fiscal year, a 13.7% increase over the prior year. NIDA had a 38% success rate in FY 2000, the highest in NIDA history. He noted that the quality of proposals has greatly increased and that the number of new investigators studying drug abuse has gone up 40% in the last three years.

   Dr. Leshner announced that NIH is to establish a new Institute called the National Institute of Biomedical Imaging and Bioengineering. He noted that a committee of Institute Directors is working to define the new Institute's mission and goals. He added that imaging is a useful tool in understanding drug abuse and addiction, so NIDA will work closely with the new Institute.

   Shaping the Research Agenda

   Dr. Leshner reported that NIDA had sponsored four well-attended symposia at the Society for Neuroscience meeting in New Orleans. He mentioned an international meeting cosponsored with the Thai Ministry of Public Health held in Bangkok in November. This meeting, "Pacific Regional Research Conference on Methamphetamine and Other Amphetamine-Type Stimulants," included seven Southeast Asian countries. Dr. Leshner noted that because drug abuse and addiction are problems of global proportions, a subcommittee of Council will be created to develop a plan for international research.

   Dr. Leshner noted that the NIDA National Drug Abuse Treatment Clinical Trials Network Steering Committee met in September and October. All eleven nodes participated, and the meeting included attendees from other organizations interested in joining the CTN. NIDA co-organized a trans-NIH meeting, "The Science of the Placebo: Toward an Interdisciplinary Research Agenda," that was held in Bethesda in November.

   Initiative Implementation

   Dr. Leshner reported that increased dollars are allowing NIDA to expand efforts in all priority areas. He mentioned many new RFAs and, in particular, a cross-NIH RFA, "Tools for Insertional Mutagenesis in the Mouse," shared with eleven other Institutes.

   Dr. Leshner mentioned that NIDA has been trying to determine how to better respond rapidly to emerging drug issues. He noted that it is very challenging to take what is known about one set of drugs or epidemiological patterns and quickly apply that knowledge when a new set of drugs emerges.

   Dr. Leshner reported that the "Preventing Drug Use Among Children and Adolescents" booklet is currently being updated. He noted that NIDA is to sponsor a National Prevention Research Conference in Washington, D.C. in August that will enable scientists to share research findings from the past five years. Emerging trends in drug abuse prevention will be highlighted.

   Dr. Leshner noted that the four health disparities working groups, the African American Researchers and Scholars Group, the National Hispanic Science Network Group, the Asian American/Pacific Islander Work Group, and the Native American-Alaskan Native Work Group, met together for the first time in November. This was a very successful meeting. He also noted that the National Hispanic Science Network on Drug Abuse had their first steering committee meeting in January.

   Dr. Leshner talked about the different components of comprehensive drug abuse treatment, noting that the core components are given in NIDA's treatment booklet, "The Principles of Effective Drug Treatment." This booklet has been mailed to 250,000 requestors and downloaded 167,000 times off NIDA's website.

   Dr. Leshner introduced a new phrase to Council, "blending research and practice," to identify one of NIDA's most important goals. He mentioned that a successful meeting, "Blending Clinical Practice and Research: Forging Partnerships to Enhance Drug Addiction Treatment," was held November 1-2 in Los Angeles. This meeting, part of the Clinical Trials Network (CTN) planning process, enabled researchers and practitioners to examine ways to enhance ongoing efforts to ensure research is incorporated into practice settings. Dr. Leshner announced the CTN has nearly tripled in size, and is very close to achieving the needed geographic distribution. Dr. Leshner also noted the Summit on Managed Behavioral Healthcare meeting held in December in Washington, D.C. that focused on simplified provider reporting and roadblocks to supporting clinical trials.

   Dr. Leshner reminded Council of the correlation between drug abuse and crime, noting that 60-70 percent of male arrestees test positive to drugs. The criminal justice community is advocating treatment while people are under criminal justice control. According to a 1997 survey, approximately 40 percent of correctional facilities were providing substance abuse treatment. The quality of these programs and the number of slots provided is unknown. Dr. Leshner noted that if access and quality were inadequate, treatment would not be successful. A Council subcommittee will be formed to further define the research agenda related to drugs and crime, and Council volunteers were solicited.

   Dr. Leshner reported that NIDA had sponsored a meeting, "Turning Scientific Breakthroughs into Science News," on January 11 with press officers that addressed topics such as the dissemination of research results and the challenges of promoting research. He also mentioned a special report in Newsweek magazine on addiction

   Dr. Leshner announced that the 5th annual Prism Awards would be held April 4. This event, co-sponsored with the Robert Wood Johnson Foundation and the Entertainment Industries Council, is growing in its visibility and importance. He reported that the third edition of "Spotlight on Depiction of Health and Social Issues," a resource encyclopedia for the entertainment community, covering alcohol, tobacco and other drugs of abuse, has been issued.

   Dr. Leshner reported that the next in a series of public education and research initiatives would be launched April 10 on prescription drugs, noting the new prescription drugs art card. He also reported the NIDA website was redesigned and features NIDA's new theme "keep your brain healthy, don't use drugs". The website currently has approximately 50,000 users per day. He noted the club drugs website is one of the most heavily used websites with 600,000 hits, and that the steroid abuse website is showing increased use in the last few months with over 100,000 hits.

5. Update of the Review of NIDA Science at the Center for Scientific Review - Dr. Brent Stanfield

   Dr. Stanfield reminded Council that CSR is the focal point for initial review at NIH and the central receipt point for applications. CSR also refers applications to various Institutes and review groups. CSR handles over 45,000 grant applications each year and reviews half of these using standing review committees and 130 scientific review administrators. Dr. Stanfield reported that CSR is reorganizing their study sections for better alignment with current trends in science.

   Dr. Stanfield reported that, of the number of R01 applications reviewed by the neuroscience study sections, 6.9% of them were NIDA's. Approximately 12% scored in the 15th percentile or better and 20% scored in the 25th percentile or better. Of the NIDA applications reviewed in the Behavioral and Social Sciences study sections, 13% scored in the 15th percentile or better and 22% scored in the 25th percentile or better.

   Dr. Stanfield noted that CSR is interested in evaluating each IRG every five years on a rotating basis. To do this, CSR will bring in people from outside NIH to attend the study section meetings and write a working group report. Also, the chairs of three current working groups will look at trans-IRG issues to see if there are any trends. CSR is developing a survey to send to applicants to determine how they felt their applications were treated in the newly reorganized study sections. They will develop a report that will eventually go to Council. Dr. Stanfield pointed out that he is the liaison between CSR and the Institutes and has met with all the individual Institutes.

   Council raised a question regarding study section expertise. Dr. Stanfield explained that CSR routinely requests outside opinions or brings in temporary members when expertise is lacking in an area. He also added that investigators are able to check the rosters of a meeting on the CSR website, so they can alert CSR if they think expertise is lacking.

6. New Directions for the Division of Neuroscience and Behavioral Research - Dr. Glen Hanson

   Dr. Hanson gave an overview of the recent reorganization of the Division of Neuroscience and Behavioral Research. He explained the reason for reorganization was that technology, strategies, and perspectives in science change rapidly, and the new structure should enable more rapid response to these changes. The Division's overall goal is to more efficiently identify the causes and consequences of drug abuse in order to improve treatment. The Division's major objectives include developing an understanding of factors contributing to the transition to addiction, neural development and its role in vulnerability to addiction, the genetics of vulnerability, and basic cognitive and behavioral processes related to drug abuse. The Division will stress emerging technologies to study addiction, proteomics to appreciate the role of proteins in the addiction process, and translation. The Division has been organized into five branches to reflect contemporary strategies and technologies: the Behavioral and Cognitive Science Research Branch, the Chemistry and Physiological Systems Research Branch, the Pharmacology, Integrative and Cellular Neurobiology Research Branch, the Genetics and Molecular Neurobiology Research Branch, and the Translational Research Branch.

   Dr. Hanson also gave an overview of the Division's ongoing and future RFA initiatives and program announcements. He called attention to the Insertional Mutagenesis RFA, the Cutting Edge Basic Research Awards PAR, the Research on GHB and its Precursors initiative, Computational supplements, and the Transition to Addiction RFA. He also mentioned that anticipated initiatives will address cognition and frontal lobe functions, protein trafficking, and nicotine as a model for drug abuse.

7. Childhood Disorders and Risk for Drug Abuse - Dr. Meyer Glantz

   Dr. Glantz reported on effects of childhood disorders and risk for drug abuse. He noted a meeting that was co-sponsored with NIMH, "Assessing the Impact of Childhood Interventions on Subsequent Drug Abuse," held in May 2000 in Washington, D.C. This conference was a step in developing NIDA's research program on assessing the impact of mental health treatments for childhood psychopathologies on subsequent risk for drug abuse. Special analyses on risk factors of low-level adolescent drug use versus high-level have found that risk factors for initiation and lower levels of drug involvement do not necessarily predict the transition to abuse/addiction. Research has found that influences related to escalation exist prior to involvement with drugs. No single factor or combination of factors causes drug abuse, but it develops from the interaction of multiple influences. The importance of protective factors was noted. Low-level involvement appears to be a function of social and peer factors while abuse/addiction appears to be more a function of biological and psychological processes. Dr. Glantz noted that a multi-agency advisory group looked at the relevance of resiliency and found it was not so important as protective factors. These studies helped to refocus attention on protection and prevention. Researchers also found that several psychopathologic conditions of childhood are associated with later development of drug abuse and addiction. This led to the research question "If the pathway is identified early on, can you change the trajectory?" Dr. Glantz pointed out that the intention of the May meeting was to help researchers involved in prevention or treatment programs do later assessments to see if their intervention changed the trajectory. He noted that 15% of the meeting attendees were junior investigators and minority scholars and a special training session was held for them. Dr. Glantz reported that if a risk factor can be identified early on, there could probably be a point of effective intervention.

   Council commented that NIDA could bring science and practice closer together by collaborating even more with other agencies.

8. Next Directions in Prevention Research at NIDA - Dr. Elizabeth Robertson

   Dr. Robertson introduced the staff of the Prevention Research Branch. She noted that the Branch's research objectives are preventing initiation and progression of drug use and drug-related HIV infection. To accomplish these objectives, the Branch supports randomized efficacy studies of prevention interventions for universal, selective, and indicated populations; effectiveness trials based on proven interventions; prevention services research; and methodology studies specific to prevention research design. Dr. Robertson showed scientific areas in which the Branch has grown and identified the percent increase in applications in several areas. Dr. Robertson reported that over the past 20 years NIDA has identified many modifiable risk and protective factors for targeting through prevention interventions. She noted that NIDA has identified developmental and social transitions that constitute points of vulnerability. Dr. Robertson also noted that some basic principles of prevention have been developed through the research NIDA supports. Dr. Robertson reported that the Branch has been concentrating on developing research that examines the underlying process and mechanisms that account for the success or failure of specific interventions with populations defined by gender, race/ethnicity and geographic location. She noted that the Small Business Innovative Research grant program is being used to build the prevention infrastructure by encouraging researchers to team with small businesses to produce and test research-based materials and training modules. She pointed out that making these materials available is one avenue to developing sustainable prevention programs. The SBIR program has tripled in number since 1996.

   Dr. Robertson highlighted other findings and indicated NIDA's plans to continue building the portfolio of selective and indicated interventions, and developing an HIV prevention program.

9. Robert Wood Johnson Foundation Survey on Drug Abuse - Nancy Kaufman, R.N.

   Ms. Kaufman reported on findings from a telephone poll on public attitudes toward illegal drug use and drug treatment. This nationwide survey was done last year and sampled over a thousand adults. The survey examined five different areas related to illegal drug use, treatment and prevention. She noted that when Americans were asked to name the two or three most important problems facing the nation, illegal drugs ranked sixth and was named by 13% of the American public. When asked what were the most important problems facing teenagers today, 67% said illegal drug use. She reported the survey next examined Americans' views of health and substance abuse problems, and in 2000, 22% reported that drug abuse had been a cause of trouble in their family. Ms. Kaufman noted that when asked about the seriousness of 36 health problems, illegal drugs and drug abuse ranked at the top of the list, with 57% believing it is more of a serious problem than it was five years ago. She noted that the Foundation also looked at what Americans thought about treatment of illegal drug abuse. About 74% thought people using drugs such as crack, cocaine and heroin could stop, but they needed professional help outside of their families to do so, and 13% thought they could stop on their own. She added when asked what people meant by treatment, six out of ten were referring to treatment by health care professionals. Ms. Kaufman commented that it was clear from the data that the public believes that treatment works and that it is far more readily available than is actually the case. She pointed out that 47% of Americans personally knew someone who had been in drug abuse treatment. Of the 46% of Americans who favored more government spending on treatment, only 19% were strongly in favor of a tax increase to pay for it. Ms. Kaufman reported that prevention programs are typically more popular with the public than are treatment programs. She noted that the Foundation will be focusing on helping the public understand how difficult it is to find high quality affordable treatment.

   Dr. Leshner added that the data are tremendously important and the momentum they reflect needs to be sustained.

10. Update on the National Drug Abuse Clinical Trials Network - Dr. Betty Tai

    Dr. Tai gave an update on the National Drug Abuse Treatment Clinical Trials Network (CTN). She reported the CTN had six existing nodes last year and has expanded by adding an additional eight nodes with 87 CTPs in 18 states and the District of Columbia. She noted that protocol CTN #1 will start its first enrollment shortly at the Betty Ford Center, and that protocol CTN #2 was the first to start enrollment with short-term outpatient Buprenorphine/ Naloxone detoxification. CTN #3 will have a long-term tapering protocol, starting enrollment in early summer with 14 sites participating. Dr. Tai added that CTN #4 and #5 are pilots for behavior therapy studies and that CTN #6 and #7 are pilots for the Motivational Interviewing (MI) protocol. She noted that they are not only expanding the infrastructure, but expanding the research agenda as well. She added that the next protocols are to focus on special population studies such as court-diverted patients, adolescents, patients with AIDS/HIV and HCV, and family therapy for adolescents. Dr. Tai noted that the CTN disseminates information among CTN sites by skills training sessions, plain language translated protocols, and annual meetings. Dissemination outside the CTN relies on publications of research results; workshops; collaboration with national, state, and regional groups; and promotion of adoption of tested therapies.

    Dr. Tai announced that the Clinical Trials Network web page had been updated and is accessible through the NIDA homepage. She noted that this website contains detailed information about CTN activities, as well as most of the publications.

    Dr. Leshner commented that Dr. Tai and her staff, as well as a large number of NIDA staff, have done an amazing feat in getting this number of trials up and going. He also noted that the treatment providers have taught NIDA an incredible amount about how to do research and collaboration.

11. Council Comments

    Dr. Leshner asked Council if there were any additional subjects they would like to raise. A Council member expressed a concern regarding the FDA's reduction or elimination of their Drug Abuse Advisory Committee (DAAC). It was noted that this committee was used as a sounding board for research protocols. It also reviewed the efficacy of treatments in substance abuse. Several Council members will develop a note to express Council's concern.

    Council suggested that training activities and the different mechanisms NIDA uses to attract researchers to the drug treatment field would be a useful agenda item. There is also interest in finding out more about how primary care physicians provide information and referrals for drug abuse problems.

12. Public Comments

    Dr. Leshner opened the floor to any comments from members of the public. There were no comments from the public.

Dr. Leshner adjourned the 76th meeting of the National Advisory Council on Drug Abuse at 3:10 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.