Minutes of the 95th Meeting of the National Advisory Council on Drug Abuse

February 6-7, 2007

The National Advisory Council on Drug Abuse convened its 95th meeting at 3:00 p.m. on February 6, 2007 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director of NIDA, chaired the overall meeting and Dr. Timothy P. Condon, Deputy Director of NIDA, chaired the review of applications. The closed portion of the meeting on February 6th, from 3:00 p.m. until 5:00 p.m. was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open session, which was open to the public, was February 7th, from 8:30 a.m. until 12:00 p.m.. The Council adjourned on February 7, 2007 at 12:00 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.D.
Warren K. Bickel, Ph.D.
Steve Brasington, M.D. (Ex officio)
Mark T. Greenberg, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Ellie E. Schoenbaum, M.D.
Claire E. Sterk, Ph.D.
Constance M. Weisner, Dr.P.H.
Marina E. Wolf, Ph.D.
Janet Wood, M.B.A., M.Ed.

Council Members Absent:

Jeanne Brooks-Gunn, Ph.D.

Council Chairs Present:

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

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:

Virginia Ashton - AACAP
Madelyn Blair - Pelerei, Inc.
Marcie Bough - American Pharmacists Association
Anne Bowen - MasiMax Resources, Inc.
Andrea Browning - Society for Research in Child Development
Sue Camaione - MasiMax Resources, Inc.
Mark Decker - Synergy Enterprises, Inc.
Margaret Diggins - Social & Scientific Systems
Stacia Hall - AACAP
Jennifer Isenberg - IQ Solutions
Roxanne Kibben - Synergy Enterprises, Inc.
Ashley Kranz - Society for Research in Child Development
Marian Kratage - MasiMax Resources, Inc.
LouAnn Maier - MasiMax Resources, Inc.
Amy Pollick, Ph.D. - Association for Psychological Science
Claire Ricewasser - Al-Anon Family Groups
Laura Rosenthal - Contractor
Jean Shin, Ph.D. - American Sociological Association
Lori Whitten - MasiMax Resources, Inc.
Ken Zith - IQ Solutions
Joan Levy Zlotnik, Ph.D. - Inst. 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. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. 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 this portion of the meeting was closed to the public.

   Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, 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 Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Division of Epidemiology, Services and Prevention Research; and the Division of Pharmacotherapies and 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.

   Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave if an application in conflict with that member was acted upon en bloc.

   For this Council, 871 applications, requesting $932,650,792 in Total Years Direct Costs, went to review. Of these, 261 were scored by the Scientific Review Groups (SRGs) representing $69,454,872 in First Year Direct Costs and $314,556,149 Total Years Direct Costs. Council concurred with the SRGs in time and amount.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the 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 called attention to future Council meetings.

2. Consideration of the Minutes of Council

   The Minutes of the September 2006 meeting were approved as written.

3. NIDA Director's Report - Nora D. Volkow, M.D., Director, NIDA

   Dr. Nora Volkow thanked Drs. Arredondo, Kalivas, Sterk and Weisner for their willingness to extend their terms on Council in order to be available for this meeting. She also noted that Ms. Laura Rosenthal, who had been the NIDA Executive Officer and Associate Director for Management, retired after 39 years of government work, the last 17 of which were in NIDA. Dr. Volkow thanked Ms. Rosenthal for all her service and also expressed her thanks to Ms. Donna Jones for agreeing to serve as the Acting Director, OPRM, and the Acting Executive Officer of NIDA.

   In the budget update section of her report, Dr. Volkow noted that the 2006 actual budget yielded a -0.8% difference from the previous year while the 2007 C.R. would provide a +0.1% increase over the prior year. She also noted that on January 15, the President signed the NIH Reform Act which authorizes a new process to facilitate trans-NIH research. Key provisions in that Bill include the establishment of a Division of Program Coordination, Planning, & Strategic Initiatives (DPCPSI) within the Office of the Director and a common fund for projects as well as a Council of Councils to advise on research proposals. Further, there will be a Scientific Management Review Board to conduct organizational reviews and make recommendations. Importantly, the Bill also authorizes (but does not appropriate) an increase in NIH funding for each of the next three years and requires a public process for reorganizing NIH programs. Dr. Volkow also noted that Dr. Alan Krensky has been appointed as the Director of OPASI.

   Dr. Volkow summarized the NIH fiscal policy for grant awards, noting that inflationary adjustments for existing non-competing renewal awards will not be made and that each IC will manage its portfolio by using savings from not funding inflationary increases to maintain the stability of the NIH investigator pool of 9600 new and competing RPGs. Guidelines have been provided to give special consideration (in order of priority) to new investigators, first time grantees applying for their first renewal and grantees with insufficient other support.

   Dr. Volkow reported on the IC Directors' Retreat in January that was held for the purpose of considering Roadmap II activities. She reminded Council that this process had involved the participation of many in the scientific community, and she noted that the Roadmap initiatives provide important opportunities for drug abuse researchers. The top five topics selected concern the micro biome; protein capture/proteome tools; phenotyping services/tools; inflammation; and epigenetics. Concept development groups for these top five topics will be created. Further, strategic planning groups will be looking at training/careers, health disparities, the science of science, and pharmacogenomics. She also noted that NIDA is the lead for a roadmap RFA on facilitating interdisciplinary research via methodological and technological innovation in the behavioral and social sciences; the review of applications submitted in response to this RFA will take place this summer.

   Dr. Volkow turned to recommendations that had been made by Council workgroups, noting how these recommendations have been implemented. Through both RFAs and PAs, NIDA has increased its efforts in the area of development, social neuroscience and epigenetics as well as pain and HIV. As also recommended by the basic science review workgroup, NIDA is increasing support for new investigators and strengthening the dissemination of information about DBNBR services. Strategies to encourage translational research within DBNBR and across divisions were also described, including DBNBR's development of programs in social neuroscience and addiction to prescription medications and the focus of RFAs on themes that will engage the participation of more than one division.

   Dr. Volkow presented some interesting work supported by DBNBR on genes with overlapping function and identified two RFAs, one on extinction and pharmacotherapies for drug addiction and one on the mechanisms of drug abuse interactions with HIV neuropathogenesis. She noted some unexpected results from the Perlegen/Washington University nicotine dependence work and the NIDA intramural work in the targets identified through these genome association scans.

   For her report on DCNBR activities, Dr. Volkow highlighted a recent research finding that damage to the right insula disrupts addiction to cigarette smoking. She noted the importance of this finding because it identifies the insula as a key area in the process of drug addiction. Dr. Volkow also pointed to an RFA developed jointly by DCNBR and DESPR on brain imaging drug use prevention messages.

   She also noted the DPMCDA-supported finding that a combination of lofexidine and THC was most effective at decreasing marijuana withdrawal symptoms, craving and relapse. This has important treatment implications. Two RFAs from this division were also noted, one on the development of immunotherapeutic products for the treatment of methamphetamine addiction and another on the design, synthesis and preclinical testing of potential treatment agents for drug addiction.

   Dr. Volkow described recent DESPR activities and presented data from the Monitoring the Future Study which, among other results, showed that the percent of students reporting past month use of any illicit drug has decreased, though past year nonmedical use of oxycontin and vicodin remains high among high school students. However, reported daily smoking is at historically low levels.

   For her report on the CTN, Dr. Volkow noted a new protocol to evaluate reduction in percent days of stimulant use that will be a trial of combined group and individual 12-step facilitative intervention with stimulant abusers. Enrollment is expected to begin in September of 2007.

   Dr. Volkow then summarized a number of new initiatives and activities, including awards to four schools of medicine (designated "Centers of Excellence") to better train doctors to recognize substance abuse and properly refer patients and their families for treatment. She invited Council to attend an upcoming meeting on pain, opioids and addiction which will bring basic and clinical scientists as well as practicing doctors together. She also mentioned an HBO special on addiction that well be shown in March. NIDA has worked very closely with the developers of this program. Several other recent and upcoming meetings, conferences and events were also described, including a very successful blending meeting in October in Seattle and activities that will take place at the American Psychiatric Association meeting in May.

   Council thanked Dr. Volkow for her report and discussion about various points raised in her report ensued, including discussion of the findings on the role of insula, the impact of the budget on new investigators, and the kinds of information NIDA might track and report to Council. Dr. Volkow noted that NIDA would provide a summary of applications funded and other information in closed session and that Council would be asked for ideas about what items might be regularly tracked and reported to them (a "dashboard") in open session, such as how junior investigators are faring.

4. Mapping the Social Environment - Yonette Thomas, Ph.D., Chief, Epidemiology Branch, DESPR

   Dr. Yonette Thomas noted the importance of integrating social and genetic epidemiology and described several activities initiated to do this. In particular, she described a November 2006 workshop on mapping the social environment that focused on developing a definition of the social environment; identifying best measures or different elements of the social environment; and specifying methodological challenges and leading constructs for drug abuse research.

   Dr. Thomas used information from that workshop to divide her presentation into three major sections: 1) ways to think about the social environment; 2) ways to develop social environment metrics for drug abuse research; and 3) conclusions. She noted that there are many definitions of the social environment and that the definition of a person's social environment needs to include human relationships, living and working conditions, income level, educational background and communities. All these factors have a powerful effect on health. She then presented a framework for viewing individual/population health over time and across levels of analysis, noting also the epidemiological triad of host/social environment/agent-vector.

   Several examples of the ways in which the social environment influences health were identified. For example, the coexistence of neighborhood disadvantage, drug use, and stress increases the number of stressors individuals are exposed to, may undermine individual psychosocial resources and decreases social resources available to individuals. A conceptual model of neighborhood disadvantage, life stress and drug use was presented. This model identifies both psychological and social resources as well as stressors and psychological distress, and Dr. Thomas provided key examples of how one might think about the social environment. Data on neighborhood environment influences on the opportunity to use drugs in late childhood/early adolescence were also presented. Multiple levels of the environment influence the etiology of drug problems, and Dr. Thomas provided information about some of these influences and then presented data on gene and environment interactions.

   She then turned to the important topic of developing social environment metrics for drug abuse research, noting the common elements and measures and the methodological challenges and solutions that need to be taken into account. The domains that need to be considered include the family, peers, school, neighborhood, and community/culture, with cross-cutting themes of social supports, norms, the quality of relations and prosocial vs. antisocial factors. The challenges to this complex way of thinking are both conceptual and methodological and include the challenge of identifying key associations among multiple levels of the social environment and determining causes as well as providing specific construct and group definition and calculating statistical power for multilevel interactions. The several solutions to these challenges include sensitive collection of social environment data from surveys and direct observation, including obtaining independent samples of community observers and using video surveys of neighborhoods. Administrative/archival data are also important sources of information, with police department, real estate data and school data as examples of sources.

   Dr. Thomas concluded by noting 1) the social environment needs to be considered as a fundamental cause of drug-related behaviors; 2) characteristics of the social environment can make communities particularly vulnerable to elevated rates of substance abuse; 3) built environment changes need to be evaluated and statistical models must allow for changes over time; 4) each of these factors directly contributes to rates of drug use and can also exacerbate propensities to use or abuse drugs among certain individuals; 5) for use in gene-environmental studies, the social environment must be measured just as thoroughly and rigorously as the human genome.

   Council thanked Dr. Thomas for her presentation and there was then discussion about rates of marijuana and tobacco use in African-American and Hispanic groups, about the role of religiosity as an important factor in delaying early marijuana and tobacco use among African-American youth, about differences in drug abuse in mixed and residential use neighborhoods, and about the role of executive functioning, with social neuroscience and genetic epidemiology informing each other.

5. Updates on HIV Testing and Counseling African-American Consultation - Jacques Normand, Ph.D., Director, AIDS Research, NIDA

   Dr. Jacques Normand 1) reported on the recent African-American Consultation meeting and 2) presented NIDA's revised HIV testing and counseling policy for Council's discussion and approval. He noted that on December 11, 2006, a meeting took place to discuss how increased HIV testing and counseling could best serve the African-American community and that he would highlight research challenges and recommendations raised in that meeting. Dr. Normand then presented data on the nature and magnitude of the problem. Dr. Normand then presented data demonstrating that African Americans bear a disproportionate burden of HIV/AIDS in the United States, with, for example, non-Hispanic blacks' annual rate of death due to HIV disease being far higher than the rate for any other racial/ethnic group. Dr. Normand noted that the implementation of scaled-up HIV testing and counseling activity will identify a disproportionate number of African Americans as being HIV positive and that we must ensure that research minimizes potential harmful effects, such as stigmatization, while optimizing potential benefits, such as early diagnosis and linkage to care.

   The consultation meeting had two major objectives: 1) to ensure that NIDA identifies all potential harmful and beneficial effects associated with conducting research on HIV testing and counseling and 2) to solicit suggestions on how to enhance the beneficial effects while mitigating the harmful effects of HIV testing. Meeting participants included representatives from AIDS advocacy groups, drug policy organizations, federal agencies, faith communities and researchers. Many challenges and recommendations were identified. Specifically, there is an health disparities challenge, because African Americans are more segregated than any other racial/ethnic group, and this segregation determines SES by affecting quality of education and employment opportunities, income and health. The impact of segregation on health disparities is not disease-specific and can adversely impact access to quality care. Recommendations included developing, implementing and evaluating interventions that address the social context to improve access and use of health care services, including HIV testing and counseling; training health care professionals to be more culturally sensitive; and developing strategies to better use social institutions within the community to deliver interventions.

   Dr. Normand then described HIV/AIDS conspiracy beliefs and the challenge of those beliefs. He indicated ways they might be addressed. He also pointed to the challenge of stigma, noting that prevention messages do not adequetely address stigma and that new strategies are needed to do so. One recommendation was to develop culturally sensitive educational programs to address stigma across African American subgroups. Dr. Normand noted several HIV testing challenges, including the linkage to treatment, giving existing funding limitations, and the fact that African Americans are late testers. Testing recommendations include identifying the factors that deter people from assessing HIV screening and identifying ways to implement and evaluate the integration of HIV/AIDS services as part of drug abuse treatment. Dr. Normand then turned to challenges in the criminal justice system, noting the high prevalence of HIV infection in criminal justice populations and stating that denial, fear of illness and concern about confidentiality are major deterrents for inmates. Recommendations included developing and evaluating health discharge planning strategies and developing HIV transmission prevention interventions for re-entry into the community.

   Dr. Normand then turned to the report of the AIDS ethics workgroup which had been established by Council a year ago. The workgroup was asked to accomplish two major tasks: 1) review and update NIDA's 2001 policy on counseling and testing for HIV/AIDS and other infectious diseases and 2) develop guidelines for NIDA-supported investigators engaged in domestic and international HIV prevention trails to ensure that proper ethical principles for protecting human participants were being followed and that adequate provision of care was being addressed after the trials were completed. Dr. Normand provided an historical perspective on the NIDA counseling and testing policy, noting the rationale for the initial policy in 1995 and its proposed revision. The revised policy points to the importance of HIV risk reduction education and recommends taking note of significant advancement in rapid testing and effective treatment. Further, the revised policy applies to both domestic and international research and has expanded to include providing materials on the prevention, testing and treatment for other infectious diseases that are common among drug abusers. Dr. Normand reminded Council that NIDA funds may not be used to support testing, counseling and treatment services for HIV that are outside the scope of the NIDA-sponsored research design. However, investigators are strongly encouraged to seek and identify alternative sources of funding for the provision of appropriate services for their research subjects and to provide information in their progress reports on this matter. There was some discussion of issues surrounding mandatory vs voluntary testing in the criminal justice system and some of the ramifications of rapid test kits being available without an associated means of education and referral. Council unanimously approved the revised policy and the National Institute on Drug Abuse Policy on HIV/AIDS Education, Counseling, Testing and Treatment (2007-revised policy) will be available on the NIDA web.

6. Public Comments

   Ms. Madelyn Blair expressed her appreciation that NIDA appreciated the importance of environmental factors in the HIV/AIDS epidemic.

   Dr. Joan Zlotnik, Executive Director, Institute for the Advancement of Social Work Research, also commented on the importance of recognizing the links among social/environmental factors, health disparities and HIV/AIDS. She thanked NIDA for its investment in social work research, noted the importance of working with physicians through the new centers for excellence, and commented on the utility of having representatives of other disciplines involved in these centers.

   Ms. Claire Ricewasser from Al-Anon Family Groups commented on the importance of having information available to the public that is clear and easily understood. She also reported some results from a membership survey and commented on the importance of public education, treatment access and health improvement.

7. Adjournment

   The 95th meeting of the National Advisory Council on Drug Abuse was adjourned at l2:00 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.