Minutes of the 86th Meeting of the National Advisory Council on Drug Abuse

February 11-12, 2004

The National Advisory Council on Drug Abuse convened its 86th meeting at 2:00 p.m. on February 11, 2004 in Conference Room C, Neuroscience Center, National Institutes of Health, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora Volkow, Director, NIDA, chaired the overall meeting, and Dr. Timothy Condon, Deputy Director, NIDA, chaired the application reviews. The meeting on February 11 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 12 at 9:00 a.m. and was open to the public. The Council adjourned February 12 at 1:55 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.D.
Jeanne Brooks-Gunn, Ph.D.
Dorothy K. Hatsukami, Ph.D.
Kenneth J. Hoffman, M.D., M.P.H. (ex officio)
Bankole A. Johnson, M.D., Ph.D.
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Thomas E. Lucking, Ed.S.
Robert C. Malenka, M.D., Ph.D.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
Scott A. Reines, M.D., Ph.D.
Peggy B. Sapp 
Jose Szapocznik, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, Dr.P.H.
Nancy R. Zahniser, Ph.D.

Council Members Absent:

Claire E. Sterk, Ph.D.
Richard T. Suchinsky, M.D. (ex officio)
Robert L. Woodson, Sr., M.S.W.

Council Chairs Present:

Nora D. Volkow, M.D.
Timothy Condon, Ph.D.

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse, NIH, DHHS

Other Federal Employees Present:

Kendall Bryant - National Institute on Alcohol Abuse and Alcoholism
William Grace, Ph.D. - OAR, OD, NIH
Claire Gutkin, Ph.D. - Center for Scientific Review, NIH
Warren Hewitt - Office of National Drug Control Policy
Willo Pequegnat, Ph.D. - National Institute of Mental Health
Marina Volkov, Ph.D. - National Institute of Mental Health
Kenneth Warren, Ph.D. - National Institute on Alcohol Abuse and Alcoholism

Members of the Public Present:

Hortensia Amaro, Ph.D. - Northeastern University, Boston, MA
Jennifer Ayers - NAADAC, The Association for Addiction Professionals
Jack Blaine, M.D. - Contractor
Margaret Blasinksy - CSR, Incorporated
Sue Camaione - MasiMax Resources
Trish Davidson - American Academy of Child and Adolescent Psychology
Marie Dyak - Entertainment Industries Council
Jill Egeth, Ph.D. - Federation of Behavioral, Psychological And Cognitive Sciences
Glen Fischer - Management Assistance Corporation
Christopher Gregory - Biopharmaceutical Research Consultants
Ernesto Guerra - American Psychological Association
Cheryl Kanuck - Second Genesis/Therapeutic Communities of America
Cheryl Kassed, Ph.D., M.S.P.H. - MasiMax Resources
Andrew Kessler, J.D. - American Psychological Society
Mary Kratage - MasiMax Resources
David Liu, M.D. - Contractor
Geoff Mumford - American Psychological Association
William Narrow - American Psychiatric Association
Bill Northey - American Association for Marriage and Family Therapy
David L. Rosenbloom, Ph.D. - Join Together
Mercedes Rubio, Ph.D. - American Sociological Association
Barbara Solt - Institute for the Advancement of Social Work Research
Marion Torchin - MasiMax Resources, Inc.
Deidre Watkins - MaxiMax Resources, Inc.
Jo Weekly - MasiMax Resources, Inc.
Mary Westcott, Ph.D. - Contractor
Patrick Zickler - MasiMax Resources, Inc.
Kim Zink - IQ Solutions, Inc.

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. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. He also introduced six new Council members: Dr. Jeanne Brooks-Gunn, Dr. Bankole Johnson, Dr. Herbert Kleber, Mr. Thomas Lucking, Dr. Patricia Ordorica, and Dr. Linda Porrino. Other Council members introduced themselves in turn. Dr. Condon 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. 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 two MERIT awards were reviewed and approved. There were no MERIT extensions or administrative supplements.

   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, 927 applications, requesting $988,400,187 in Total Years Direct Costs, went to review. Of these, 443 were scored by the Scientific Review Groups (SRGs), representing $115,361,401 in First Year Direct Costs and $512,023,226 in Total Years Direct Costs. Council concurred with the SRGs in time and amount. The Council approved two MERIT awards.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members, NIDA staff, and visitors. Dr. Volkow introduced the six new Council members. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Volkow announced that Mr. Richard Millstein is on detail to the Fogarty International Center for Advanced Study in the Health Sciences as Acting Deputy Director. Dr. Timothy Condon is now serving as Deputy Director, NIDA, as well as Director of the Office of Science Policy and Communications. Dr. Volkow called attention to future Council dates. The updated Council Operating Procedures and Delegation of Authority was voted on and approved by Council.

2. Consideration of the Minutes of Council

   The Minutes of the September 17, 2003 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow began her report by announcing that she is serving as a rotating member on the NIH Central Steering Committee. She noted that this committee has seven rotating members and three permanent members from the National Cancer Institute, the National Heart, Lung and Blood Institute, and the National Institute of Allergy and Infectious Diseases. She also highlighted recommendations from the report of the Institute of Medicine and the National Research Council on ways to enhance the vitality of the NIH.

   Dr. Volkow reported on the NIH Roadmap. Some of the Roadmap initiatives of particular interest include molecular libraries and imaging; research teams of the future; high-risk research; private-public partnerships, particularly in the area of medication development; and re-engineering the clinical research enterprise. She announced that Dr. Timothy Condon was named NIDA's representative for the Roadmap activities. NIDA is encouraging its grantees to submit applications for the Roadmap RFAs. The NIDA website contains a page highlighting Roadmap opportunities.

   Dr. Volkow reported that there are new initiatives to strengthen the NIH Ethics Program. For example, Dr. Raynard Kington has been appointed as Deputy Ethics Counselor for NIH. She also gave a brief update on the consolidation and centralization of services activities throughout the NIH.

   Budget

   Dr. Volkow reported that the NIDA budget for FY 2003 increased 8.2% over the FY 2002 appropriation and the FY 2004 proposed budget has an estimated 3.0% increase over the FY 2003 appropriation. The President's budget request for NIDA for FY 2005 has a projected 2.9% increase.

   Recent NIDA Activities

   Dr. Volkow highlighted several recently published RFAs in prevention research in children and adolescents. These RFAs included novel approaches to phenotyping drug abuse; behavioral and cognitive processes; animal models of adolescent drug abuse; prevention for the transition to adulthood; and the consequences of marijuana use on the developing brain. One RFA in treatment interventions will support medications development for cannabis-related disorders. Other RFAs were released soliciting research in HIV/AIDS and other infections among drug users including drug users in the criminal justice system and HIV/AIDS in pregnant drug users. Dr. Volkow announced that NIDA is participating with other NIH institutes in 8 new PAs and 4 new RFAs, totaling $9.8 million. The initiatives will focus on co-morbidity, mental illness, alcoholism and HIV. She reported that NIDA has been increasing its partnership with SAMHSA in important areas such as the Addiction Technology Transfer Center Blending Initiative.

   Dr. Volkow highlighted several recent meetings and events. At the Society for Neuroscience annual meeting held in New Orleans in November, Dr. Volkow presented the opening plenary lecture entitled "The Addicted Human Brain." She noted that this was the most successful year for highlighting NIDA research: there were 576 presentations on substance abuse. Further, the NIDA-sponsored mini-convention was very well attended and quite successful in presenting exciting new research.

   Dr. Volkow reported that the NIDA Goes Back to School materials have been very well received. These materials provide students and teachers with informative and accurate information about addiction and drug abuse. She announced that NIDA has also launched an interactive website for teens. This website is also useful for parents and teachers.

   Dr. Volkow reported that an Educational Seminar for Primary Health Care Providers co-sponsored by NIDA and the Sheppard Pratt Health System was held in Baltimore on December 17, 2003. NIDA also hosted a tent at Baltimore's New Year's Eve Spectacular, a free and widely attended alcohol-, drug- and smoke-free community event.

   Science Highlights

   Dr. Volkow reported that the Monitoring the Future Study showed an 11 percent decline of students reporting past-month illicit drug use from 2001 to 2003, and a reduction in smoking over the past 5 years. Of concern is the percentage of students reporting abuse of the painkillers Oxycontin and Vicodin. Dr. Volkow also noted that 1.2 million Americans were addicted to stimulants, 2.2 million to sedatives and 4.4 million to pain relievers. The epidemic of pain killer abuse has grown very fast and these drugs have serious medical consequences. The elderly are especially sensitive to adverse medical reactions with misuse, and these drugs also may have long-term effects in adolescent brain development. NIDA will continue research on prescription drugs and treatment and prevention.

   Future Directions

   Dr. Volkow reported that FY 2005 initiatives will include prevention research in children and adolescents, treatment interventions, and training. She noted that NIDA is promoting a better understanding of brain, behavior and health interactions. This initiative will foster research to better understand brain diseases, including addiction, and to develop strategies to promote optimal health. Dr. Volkow stated that the first milestone was to create a matrix that would catalog ongoing projects and would identify pertinent scientific questions, as well as identify areas of redundancy and areas that need to be developed. It would also identify technology or infrastructure that needs to be developed and would optimize the chances for integrating efforts across research centers, institutes and agencies. The matrix is based on systems and translational research approaches.

4. . NIAAA - New Directions for Research - Dr. Ting-Kai Li

   Dr. Volkow introduced Dr. Ting-Kai Li, Director of the National Institute on Alcohol Abuse and Alcoholism. Dr. Li reported on developmental issues in alcohol research at NIAAA. The mission of the NIAAA is to create a knowledge base that will increase the understanding of normal and abnormal biological functions and behavior relating to alcohol use. This knowledge base will also improve the diagnosis, prevention, and treatment of alcohol-related problems and alcoholism as well as enhance access to quality health care. Dr. Li provided an overview of the complex effects of alcohol. He noted that alcohol is the third leading risk factor in burden of disease in developed countries. He also noted that environmental influence is the most important factor contributing to initiation of drinking, but with continued drinking, the pharmacological effects of alcohol and personality begin to dominate. He added that there is a large variation in individual responses to alcohol and provided information on the metabolism of ethanol.

   Dr. Li reported that researchers are using different animal models in alcohol research and medication development. He provided information on co-occurring disorders and noted the importance of studying genes that predispose individuals to alcoholism and genes that protect against it. Dr. Li pointed out that the current research priorities of NIAAA will include rural and small urban area underage drinking, medications development, the neurobiology of adolescent drinking, and alcohol metabolism and markers.

5. Clinical Trials Network - Dr. David Rosenbloom

   Dr. Rosenbloom, Chair of the Council Task Force on the Clinical Trials Network, summarized the Task Force's recommendations. The Task Force recommended that the CTN program be continued, and that it expand studies of evidence-based practice in diverse populations and test modifications of evidence-based practices to promote wide adoption. He noted that the CTN could play an important role in collaborations with NIAAA, NIMH, and the NIH Roadmap. The Task Force also made several recommendations for CTN research priorities. They recommended more attention to practical clinical trials, the inclusion of more cost benefit and effectiveness measures in all protocols, and more attention to ensuring diversity. Dr. Rosenbloom reported that the Task Force recommended further simplifying the internal protocol review process. Another recommendation was for a single independent data coordinating center to improve quality and lower cost. The Task Force also made specific recommendations with respect to dissemination, including expanding links to State Directors.

   Dr. Rosenbloom reported other recommendations concerning governance and size, and concluded that the size of the network allowed it to provide access to a large and diverse population of drug abusing individuals throughout the country. Council voted to accept this report.

6. National Hispanic Strategic Plan on Drug Abuse - Dr. Jose Szapocznik

   Dr. Szapocznik gave an update of the National Hispanic Science Network on Drug Abuse. He noted that the mission of this NIDA-funded network is to increase the amount and quality of research on Hispanic drug abuse and to foster the development of Hispanic scientists in drug abuse research. The Network's major activities include establishing a network of Hispanic scientists, students, and NIH federal advisors; holding an annual National Scientific Conference; sponsoring an annual Summer Research Training Institute for graduate students and post-doctoral fellows; and having an on-line measures archive translated into Spanish. Dr. Szapocznik noted that a website has been designed to coordinate the activities (www.HispanicScience.org). He pointed out that few prevention and treatment interventions have been tested with Hispanics and few validated instruments have been translated into Spanish. Dr. Szapocznik presented the National Strategic Plan for Drug Abuse Research, which was summarized in a document prepared by over 60 scientists and has as its goal the identification of gaps in research and scientific opportunities that can enhance the rate of discovery with regard to Hispanic drug abuse. Dr. Szapocznik noted, among other points, that familism is especially important in the Latino culture and is seen as protective against drug use. He added that future research could evaluate how cultural change influences drug use, and familism should be studied as a protective factor. Dr. Szapocznik concluded by noting that Hispanics will become a larger part of the U.S. population in the future, and that there is a need for much more work on the role of culture, cultural adaptation, and acculturation in understanding drug use and abuse.

7. National Advisory Council on Drug Abuse Workgroup on HIV/AIDS Findings and Recommendations - Dr. David Vlahov

   Dr. Vlahov chaired the Task Force on HIV/AIDS. The Director of NIDA charged this group with reviewing the HIV/AIDS portfolio to ensure responsiveness to emerging trends, to review interactions with NIDA and with other NIH institutes and agencies, to examine CAMCODA's organization and management, and to help define a 5-year vision of the NIDA HIV/AIDS research portfolio. Dr. Vlahov noted that in response to emerging trends, it is important to have better utilization of epidemiologic data. Also of importance is international research. NIDA has a leadership role in this area. Dr. Vlahov added that NIDA's current and future international role needs further articulation and commitment. Models and expertise are needed for integrating drug abuse treatment and HIV/AIDS issues. The Task Force noted the importance of considering medical consequences of drug abuse; using the CTN to test HIV treatment and prevention; studying the impact of emerging drugs on immune and nervous systems; more cutting edge HIV intramural research; and initiating more translation of work. Also recommended was placing the coordination of HIV/AIDS outside Divisions and Centers by establishing an HIV/AIDS Coordinator in NIDA OD; creating an entity to further develop focus on the medical consequences of drug abuse; improving articulation of the HIV/AIDS mission and planning process for each Division, Center, and the Intramural Program; and developing more staff expertise on HIV consistent with the mission of each program. Council voted to accept this report.

8. Blue Ribbon Task Force on Health Services Research - Dr. Constance Weisner

   Dr. Weisner co-chaired the NIDA Health Services Research Task Force. The Health Services Research Blue Ribbon Task Force was established at the request of Dr. Elias Zerhouni, Director, NIH. The Task Force was composed of members from the National Advisory Council on Drug Abuse and prominent leaders from the field of drug abuse and services.

   The purpose of the HSR Task Force was to identify strengths and gaps in NIDA's health services research program and to develop a set of recommendations to best position NIDA, particularly through its Division of Epidemiology, Services and Prevention Research, to address the future needs of the field.

   The Task Force unanimously agreed that health services research at NIDA has accomplished a great deal in understanding access, utilization, and outcomes, as well as the organizational and financial factors that influence them. This work has taken place at a critical and opportune time of increased NIH emphasis on developing evidence-based practices.

   The Task Force recommended that NIDA provide a clearer understanding of drug abuse services research and ways it can serve NIDA's broader mission of contributing to the health of the public. They also recommended an increase in the research portfolio on prevention and treatment systems as well as on organizational, management, financing practices, policies and costs. NIDA was encouraged to lead and collaborate in the development of standards for evidence-based practice and to work more with NIAAA, NIMH, SAMHSA and other NIH Institutes on these and other issues. Given the complexity of the issues affecting drug abuse prevention, treatment, and services research, NIDA is also encouraged to collaborate more across its own Divisions, Centers, and Branches. The Task Force recommended that DESPR be the central location for coordination and collaboration of these activities. Council voted to accept this report. (Note: The full report is available at 3 http:/ww2.drugabuse.gov/about/organization/nacda/HSRReport.pdf.)

9. Public Comments

   Dr. Volkow opened the floor to comments from members of the public. Mr. Andrew Kessler from the American Psychological Society informed the NIDA staff and Council of recent activities in which NIDA had participated with the APS. Most noteworthy were the article written by Dr. Volkow and published in the January issue of "The Observer," and the NIDA symposium at the APS annual meeting.

   Ms. Barbara Solt from the Institute for the Advancement of Social Work Research thanked NIDA staff for the symposium presented at the Society for Social Work Research meeting and for NIDA's help in career development and training of social work doctoral students.

10. Adjournment

    The 86th meeting of the National Advisory Council on Drug Abuse was adjourned at 1:55 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.