Minutes of the 83rd Meeting of the National Advisory Council on Drug Abuse

February 12-13, 2003

The National Advisory Council on Drug Abuse convened its 83rd meeting at 1:00 p.m. on February 12, 2003 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Glen R. Hanson, Acting Director, NIDA, and Mr. Richard A. Millstein, Deputy Director, NIDA, chaired the overall meeting. Mr. Millstein chaired the application reviews. The meeting on February 12 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 13 at 9:00 a.m. and was open to the public. The Council adjourned February 13 at 3:25 p.m.

Council Members Present:

Rodolfo Arredondo, Ed.D.
Dorothy K. Hatsukami, Ph.D.
Steven C. Hayes, Ph.D.
Kenneth J. Hoffman, M.D., M.P.H. (ex officio)
Peter W. Kalivas, Ph.D.
Robert C. Malenka, M.D., Ph.D.
Thomas McLellan, Ph.D.
David L. Rosenbloom, Ph.D.
James E. Smith, Ph.D.
Claire E. Sterk, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, Dr.P.H.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Norman B. Anderson, Ph.D.
Scott A. Reines, M.D., Ph.D.
Peggy B. Sapp
Richard T. Suchinsky, M.D. (ex-officio)
Jose Szapocznik, Ph.D.
Robert L. Woodson, Sr., M.S.W.

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, NIH, DHHS

Other Federal Employees Present:

Bernie Arons - Office of the Director, NIMH
Cathy Deeds - DHHS/OS/ASAM
Anthony Demsey, Ph.D. - Office of Extramural Research, OD, NIH
Della Hann, Ph.D. - Office of Extramural Research, OD, NIH
Lora Kutkat - Office of Science Policy, OD, NIH
Walt Mitton - Office of the Director, NIH
Luci Roberts, Ph.D. - Center for Scientific Review, NIH

Members of the Public Present:

M.B. Hatem - MasiMax Resources
Lee Herring - American Sociological Association
Andrew Kessler, J.D. - American Psychological Society
M. Kratage - MasiMax Resources
Lou Ann Majer - MasiMax Resources
Jack Manischewitz, Ph.D. - Contractor
Eileen McGrath, J.D. - American Society of Addiction Medicine
Geoffrey Mumford, Ph.D. - American Psychological Association
Bill Northey - American Association for Marriage and Family Therapy
Richard Schmitz - National Assoc. of Addiction Professionals
Viviana Simon, Ph.D. - Society for Women's Health Research
Barbara Solt - Institute for the Advancement of Social Work Research
William Tatum - Consortium of Social Science Associations
Daniel Tisch - MasiMax Resources
Christine Whitmore, Ph.D. - American Institutes for 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).

   Mr. Richard A. Millstein, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. He provided an overview of the agenda for the meeting and reminded those present that the Federal Advisory Committee Act applies to Council meetings and that the meeting was closed to the public. Mr. Millstein introduced four new Council members: Dr. Rodolfo Arredondo, Dr. Peter Kalivas, Dr. Claire Sterk, and Dr. Constance Weisner. Other Council members introduced themselves in turn. Dr. Teresa Levitin, Executive Secretary, summarized voting policies and procedures, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Office of Science Policy and Communications; 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 a MERIT extension 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, 565 applications, requesting $516,834,097 in Total Years Direct Costs, went to review. Of these, 355 were scored by the Scientific Review Groups (SRGs), representing $80,855,000 in First Year Direct Costs and $359,731,626 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved one MERIT extension.

1. Call to Order

   Dr. Glen R. Hanson, Acting Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, NIDA staff, and visitors. Dr. Hanson introduced the new Council members, Drs. Arredondo, Kalivas, Sterk, and Weisner. He noted that five Council members were unable to attend. Dr. Hanson announced that future Council meeting dates are May 21-22 and September 17-18, 2003. 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 Minutes of the September 18-19, 2002 meeting were approved as written.

3. NIDA Director's Report

   Dr. Hanson welcomed and introduced new staff members and reported on other recent changes at NIDA. He announced that Dr. Howard Chilcoat has joined the Division of Epidemiology, Services and Prevention Research (DESPR) as Chief of the Epidemiology Research Branch. Dr. Chilcoat is a psychiatric epidemiologist with a focus on the epidemiology of drug use and problems related to use. Other new staff were introduced. Dr. Hanson also announced that Dr. Jack Stein was named Chief, Services Research Branch, DESPR, and that Dr. Cindy Miner has been named Acting Deputy Director, Office of Science Policy and Communications. Dr. Hanson reported that Dr. Nora Volkow has been appointed as the new director of NIDA. Dr. Volkow is currently Associate Director for Life Sciences at Brookhaven National Laboratory (BNL), Director of Nuclear Medicine at BNL, and Director of the NIDA-Department of Energy's Regional Neuroimaging Center at BNL. She is recognized as an expert on the brain's dopamine system and is particularly known for her work investigating the mechanisms underlying the reinforcing, addictive, and toxic properties of drugs of abuse in the human brain.

   Dr. Hanson announced that Dr. Raynard Kington was appointed as the NIH Deputy Director. Dr. Kington has been serving as NIH Associate Director for Behavioral and Social Sciences Research (OBSSR), Office of the Director, NIH, and had been Acting Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Dr. Kington was an invited speaker at NIDA Council recently where he reported on OBSSR's goals of working collaboratively with NIH institutes and centers to develop a research plan to guide NIH in supporting behavioral and social science work. He also reported on developing and nurturing collaborative work between NIAAA and NIDA. Dr. Hanson noted the recent appointment of three NIH Institute Directors: Dr. Ting-Kai Li, National Institute on Alcohol Abuse and Alcoholism; Dr. Thomas Insel, National Institute of Mental Health; and Dr. Roderic Pettigrew, National Institute of Biomedical Imaging and Bioengineering.

   Dr. Hanson reported on the NIH Roadmap activity, in which NIH Institute Directors and extramural experts met several times to identify trans-NIH initiatives unique to NIH and its mission. Some initiatives identified include new approaches and new technologies, such as regenerative medicine, molecular imaging, nanotechnology, or molecular libraries; multidisciplinary research teams of the future; and re-engineering the clinical research enterprise. He added that NIDA has invested time and effort in developing molecular libraries.

   Budget

   Dr. Hanson reported that the NIDA budget for FY 2002 increased 13.1% over the FY 2001 appropriation and the FY 2003 proposed budget has an estimated 8.4% increase over the FY 2002 appropriation. The President's budget request for NIDA for FY 2004 has a projected 3.7% increase.

   Recent NIDA Activities

   Dr. Hanson reported that each of the NIDA Divisions prepared and presented at a NIDA briefing for Dr. Zerhouni, Director, NIH, in December 2002. Dr. Zerhouni commented that he was impressed with the quality of the presentations and with NIDA's portfolio. Dr. Hanson noted that a briefing, "Marijuana: What Have We Learned Through Research?" was presented to the Director, Office of National Drug Control Policy in February 2003. He also announced that the results from the annual Monitoring the Future Survey of 8th, 10th and 12th graders in U.S. schools indicate that use of marijuana, some club drugs, cigarettes and alcohol decreased from 2001 to 2002. This survey is funded by NIDA and is one of three major surveys the DHHS uses to monitor the nation's substance abuse patterns.

   Dr. Hanson highlighted several recent meetings. NIDA, the National Cancer Institute and the National Institute on Alcohol Abuse and Alcoholism collaborated to hold a meeting entitled "Pharmacologic Approaches to Nicotine Addiction" in October 2002. Participants from the extramural research community and NIH met to address issues in the discovery, development and delivery of medications. The Behavioral Treatment Development Branch hosted a meeting entitled "Behavioral Treatment Research: Future Directions" in January 2003 that brought together leaders in the treatment research field. Dr. Hanson noted that the Clinical Trials Network National Steering Committee held meetings in October and January. The Center on AIDS and Other Medical Consequences of Drug Abuse (CAMCODA) and members of the Street Youth Interest Group organized a workshop on Future Research on Runaway, Homeless and Street Youth that was held in December. Two meetings on hepatitis C, a major health concern in the drug using population, were held: one addressed management of hepatitis C in prisons and the other dealt with hepatitis C, substance abuse and psychiatric illness. Dr. Hanson noted several other meetings, including the second national conference of the National Hispanic Science Network on Drug Abuse in September and the Society for Neuroscience meeting in November in which NIDA sponsored a series of very successful symposia and poster sessions.

   Initiative Implementation

   Dr. Hanson called attention to several newly released Program Announcements (PAs). These new program announcements will foster the NIDA small grant program, exploratory/developmental grant applications, cutting-edge basic research, and international research collaboration on drug addiction. The Imaging-Science Track Award for Research Transition (I/START) program announcement, designed to attract new investigators in the neuroimaging area of research, led to funding of five applications to research a variety of topics. Dr. Hanson also highlighted several recently released Requests for Applications (RFAs). One will study improving behavioral health services and treatment for adolescent drug abuse, another will foster research designed to translate tobacco addiction research to treatment, and yet another will solicit applications for research on chronic stress and drug abuse. He added that other RFAs will address areas such as using immunotherapy for addiction treatment, enhancing HIV vaccine efficacy in high-risk drug users, research to better understand the sexual risk behaviors of drug users, and the diffusion of HIV infection from drug users to non-drug using populations. NIDA's National Prevention Research Initiative (NNPRI) had released three different RFAs. Dr. Hanson also called attention to several RFAs and PAs in which NIDA has collaborated with other Institutes in areas such as nicotine, alcohol-related problems, co-morbidity, phenotypic brain mapping, behavioral therapies, neuroinformatics, hepatitis C, HIV/AIDS and aging, and complications of antiretroviral therapy.

   Dr. Hanson reported that the National Drug Abuse Treatment Clinical Trials Network added three new nodes last year in northern New England, California/Arizona and New Mexico, bringing the total to 17 nodes covering a broad geographic area and most major population groups within the U.S. He added that NIDA hopes to implement a number of new CTN protocols focusing on pregnant drug-abusing women, adolescent drug abusers, HIV risk reduction interventions, cigarette smoking cessation interventions for in-treatment drug addicts, Spanish speaking drug abusers, and women drug abusers having post-traumatic stress disorders.

   Dr. Hanson announced that the NIDA Research Report on Marijuana Abuse was recently published. This report targets marijuana abuse in this country and discusses consequences of use. He also announced that NIDA's 2003 Calendar was available. This science-based resource on drug information features Asian Americans/Native Hawaiians and other Pacific Islanders.

   He also noted that NIDA entered into an agreement with the Substance Abuse and Mental Health Services Administration (SAMHSA) to expedite the application of findings from treatment research into clinical practice. This $1.5 million agreement will provide support for SAMHSA's Center for Substance Abuse Treatment (CSAT) Addiction Technology Transfer Centers (ATTC).

   Dr. Hanson announced the U.S. Food and Drug Administration (FDA) approved buprenorphine on October 9, 2002.

4. The HIPAA Privacy Rule - Dr. Della Hann and Ms. Lora Kutkat

   Dr. Hanson introduced Dr. Della Hann, Senior Policy Advisor, Office of Extramural Research, Office of the Director, NIH, who in turn introduced Lora Kutkat from the Office of Science Policy, NIH. Ms. Kutkat gave an overview of how the HIPAA Privacy Rule may affect NIH processes involving the review, funding and progress monitoring of grants, cooperative agreements and research contracts. She noted that the Department of Health and Human Services issued final modifications to the Standards for Privacy of Individually Identifiable Health Information, the "Privacy Rule," on August 14, 2002. The Privacy Rule is a Federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information. Ms. Kutkat added that the Privacy Rule was enacted to increase the privacy protection of health information identifying individuals who are living or deceased, and to regulate known and unanticipated risks to privacy that may accompany the use and disclosure of personal heath information. She noted that NIH does not exercise enforcement oversight; rather, NIH will assume compliance from grantees and contractors. Administration and enforcement will be the task of the DHHS Office of Civil Rights (OCR). She added that researchers whose work is covered by the Rule must comply by April 14, 2003.

   Dr. Hann discussed how the Privacy Rule could impact the NIH grant and research contract processes. She noted that implementing the Privacy Rule could affect the feasibility, design, and cost of the research, and that researchers should continue to follow the PHS 398 instructions and discuss such issues, as needed, in the research plan and budget sections of the application. Dr. Hann commented that the Privacy Rule does not replace existing regulations for the protection of human subjects. She also added that peer review would continue to evaluate scientific merit and not compliance with the Privacy Rule. Dr. Hann concluded by saying that a Notice in the NIH Guide regarding the impact of the Privacy Rule on NIH processes was released on February 5, and that other educational materials will be available soon on the OCR and HIPAA websites.

5. Council Subcommittees: Structure and Function - Dr. A. Thomas McLellan

   Dr. McLellan, Chair of the recently formed Council Steering Committee, reported that one recommendation from the committee's first meeting was to consider what subcommittees are needed to help advance NIDA's mission and to develop a process by which subcommittees are formed and concluded. He added that proposed subcommittees should have a product of work and be time-limited. Suggestions for a subcommittee could come from NIDA staff or Council members. Dr. Levitin agreed to develop a subcommittee request form that would be used by Council members or NIDA staff interested in creating a subcommittee. This request would be submitted to the Steering Committee. The Steering Committee would obtain any needed additional information and then bring the request to the full Council for discussion and a recommendation. Four subcommittees were approved: trans-unit program analyses, proteomics, bioethics, and evidence-based treatment. The mechanism for forming these subcommittees was also approved by the Council.

6. NIH Policy on Minority/Gender Representation - Mr. Richard Millstein

   Mr. Millstein announced that Council was being called upon to examine NIDA's implementation of the "Women and Minorities as Subjects in Clinical Research" section of the NIH Revitalization Act of 1993. This Act states that institute advisory councils prepare biennial reports describing the manner in which the institute complies with this NIH policy on minority/gender representation. This report will be part of a document prepared by the Office for Research on Women's Health (ORWH) and will be reviewed by the NIH Director and then forwarded to Congress. Mr. Millstein noted that, as the Chair of the NIDA committee, he is the official that ensures implementation and compliance. He also noted that NIH has a Tracking and Inclusion Committee on which Dr. Jack Manischewitz was the NIDA representative. The draft report of the 2003 Biennial Advisory Council Report Certifying Compliance with Inclusion Guidelines was presented to Council and Council concluded that NIDA is successfully implementing the NIH guidelines on minority and gender representation. Council voted to approve the report and its findings.

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

   Dr. Levitin gave an overview of NIDA's Operating Procedures for Council Approvals and Statement of Understanding. She noted 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. Dr. Levitin noted that this document was identical to last year's version except for a minor clarification in the administrative supplements section. Council voted unanimously to accept the proposed document.

8. The Genetics Program at NIDA - Dr. Jonathan Pollock

   Dr. Pollock gave an update of recent progress in understanding genetics and addiction. He noted that with genomes being rapidly sequenced, mutations can be identified for simple genetic disorders. NIDA's genetics extramural program consists of twin and adoption studies, and ongoing molecular genetic studies of drug addiction vulnerability. There are studies analyzing the actions of drugs using model genetic organisms such as mice, C. elegans, zebra fish and drosophila. These studies provide ways of analyzing the actions of drugs of abuse as well as provide ways of developing potential animal models. NIDA's intramural genetics research program has a large component led by Dr. George Uhl. Evidence from twin, adoption, and inbred rodent strain studies shows that addiction is a heritable disorder as well as a brain disorder. Genes are implicated in addiction vulnerability and some specific genes have been implicated in addiction, i.e., dopamine beta-hydroxylase (DBH) is associated with cocaine-induced paranoia, a 5HT1B receptor variant is associated with conduct disorder and alcoholism, and a FAAH missense mutation is associated with drug dependence. Dr. Pollock noted that individuals with a defect in certain metabolism pathways have a 5-10-fold reduction in risk for alcoholism or appear to smoke fewer cigarettes. Genome wide scans are beginning to find convergent results. He noted that in 1999 the NIDA Genetics Consortium (NGC) was established. This group of 17 researchers from 11 different institutions focuses on studies of addiction to opiates, cocaine, nicotine and poly drug abuse. He added that these investigators contribute data to the NIDA Center for Genetic Studies, a repository of biosamples and associated data. This repository uses blood samples to generate immortalized cell lines as a permanent source of DNA. Anonymized data are stored in a central database and this provides the opportunity to pool data to increase the power of the studies and facilitate sharing. He noted that genetic research is uncovering mechanisms of action of drugs of abuse; for example, we can separate the mechanism of tolerance from withdrawal. Dr. Pollock concluded that genetic research can help with better understanding of environmental factors in addiction, in improving treatment interventions, and in facilitating understanding the neurobiology of addiction and drug abuse.

9. Council Subcommittees Reports

   Reports from the four extant Council subcommittees were presented. Dr. S. Jackie Kaftarian presented the report from the Prevention Subcommittee. She noted that this subcommittee was formed a year and a half ago when the National Prevention Research Initiative was being planned. The Subcommittee looked at the potential of the Initiative in accelerating substance abuse prevention research, expanding knowledge about science-based prevention programs and services, and translating prevention research to practice. Dr. Kaftarian commented that the Subcommittee was helpful in disseminating the Initiative's three RFAs. Council accepted the final report and voted to disband the subcommittee since it had completed its task.

   Dr. Jack Stein presented the report from the Criminal Justice Subcommittee. He noted that the Subcommittee met for the first time at the May 2001 Council and had completed its two tasks: 1) provided feedback on the development of the Criminal Justice Research Initiative and 2) helped develop a plan to address criminal justice-related issues. Dr. Stein reported that the most significant product was the release of the RFA to establish the Criminal Justice Drug Abuse Treatment Research System (CJ-DATS). Seven research sites have been funded, including one coordinating center based at the University of Maryland. With the Subcommittee's tasks accomplished, Council approved the motion to disband.

   Dr. Steven Gust presented the report from the International Subcommittee, a group that was formed in 2001 to identify areas of opportunity in international research and to provide recommendations for initiatives on how to address those opportunities. The Subcommittee presented four recommendations. The first recommendation was to expand NIDA's fellowship programs; this was accomplished through the Invest Research Fellowship, the Hubert H. Humphrey Drug Abuse Research Fellowship, and the Distinguished International Scientist Collaboration Program Award. The second recommendation was to develop a "reverse" fellowship that would support a U.S.-based NIDA grantee to work abroad with a non-U.S.-based researcher. NIDA plans to expand and redefine its Distinguished Scientist Fellowship Program to include U.S.-based investigators conducting collaborative work in another country. The third recommendation was to expand NIDA's role in international tobacco research. Dr. Gust reported that NIDA has participated in the recent NIH-wide international tobacco research program under the lead of the Fogarty International Center and has partnered with the Society for Research on Nicotine and Tobacco to support a conference on global tobacco research issues. The fourth recommendation was to stimulate the creation of research networks within foreign countries to help create the necessary infrastructure for a self-sustaining research enterprise. He added that to accomplish this a satellite meeting on fellowships and international research opportunities was held at the College on Problems of Drug Dependence (CPDD) meeting, and that a new program started by the Fogarty Center entitled "Global Health Research Initiative Program" (GRIP) will provide start-up funding opportunities for returning fellows. Dr. Gust noted the importance of Council's feedback on international program activities as well as guidance on new initiatives. Council decided to continue with the existing subcommittee and to expand its membership.

   Dr. Vince Smeriglio presented the report from the Child and Adolescent Subcommittee. He noted that this subcommittee was formed to provide input in conceptualizing child and adolescent issues, suggesting directions and approaches for activities, and planning scientific meetings. The Subcommittee interfaces with NIDA's Child and Adolescent Workgroup. He reported that recommendations from the May 2001 meeting included expanding the mentoring program on bridging child development and drug abuse research, considering a new initiative addressing youth inhalant abuse, continuing exploring youth drug use and the internet, examining the definition of drug addiction as applied to adolescents and presenting an overview of NIDA's child and adolescent research to Council. Dr. Smeriglio noted that the FY 2002 Report to Congress, "Pediatric Research Initiative," highlighted the diverse aspects of child and adolescent research and reflected the recommendations of the previous subcommittee to the Institute. Council voted to accept the final report and to disband the Subcommittee, though Council will continue to provide input to Dr. Smeriglio and the Child and Adolescent Workgroup.

10. Clinical Trials Network Update - Dr. Betty Tai

    Dr. Tai gave an update on the National Drug Abuse Treatment Clinical Trials Network (CTN). She noted that the CTN's mission is to improve drug abuse treatment throughout the nation using science as the vehicle. The CTN is unique in that it blends research and practice, is a bi-directional collaboration, and supports multi-node, multi-site randomized clinical trials. The CTN also maintains rigorous scientific standards, uses a real world approach, and targets dissemination end products. Dr. Tai commented that CTN priorities are transferability, acceptability, and sustainability. She added that the CTN started with five nodes in 1999 and now has17 Regional Research and Training Centers working in partnership with 115 community-based treatment programs across 27 states. New nodes were recently added in California-Arizona, northern New England and New Mexico. Dr. Tai gave an administrative overview of the CTN, noting that bylaws and a node performance index have been developed. A CTN Operations Guidebook containing standard operation procedures for implementing protocols is in preparation. The CTN study integrity monitoring standards for medication and behavioral trials and the study safety monitoring system to ensure patient safety and research ethics have been set. Dr. Tai reported that the current projected enrollment in the protocols by intervention type is: 4900 in non-HIV behavioral, 1500 in HIV behavioral, and 2400 in medication protocols. She noted that three of the protocols will address women's issues, two will consist of adolescents, and one will be for Spanish speakers. The CTN special interest groups address research and treatment interests in areas such as HIV/AIDS, women and gender issues, adolescent treatment, co-morbidity, buprenorphine, smoking, homelessness, and spirituality therapy treatment. These special interest groups identify and develop special research tools, develop long-range research plans and serve as expert resources. She reported that by-products of the CTN include increased appreciation of research in the CTPs, change of practice (e.g., adoption of buprenorphine detoxification for patients in drug-free clinics), ongoing training, and NIDA's presence in the community treatment programs.

11. Public Comments

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

12. Adjournment

    The 83rd meeting of the National Advisory Council on Drug Abuse was adjourned at 3:25 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.