Minutes of the 103rd Meeting of the National Advisory Council on Drug Abuse

September 15-16, 2009

The National Advisory Council on Drug Abuse convened its 103rd meeting at 2:00 p.m. on September 15, 2009 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director, NIDA, chaired the meeting. The closed portion of the meeting on September 15, 2009, from 2:00 pm. 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 September 16, 2009, from 8:30 a.m. to 12:00 p.m. The Council adjourned on September 16, 2009 at 12:00 p.m.

Council Members Present:

Louis E. Baxter, M.D.
Warren K. Bickel, Ph.D. 
Francisco X. Castellanos, M.D.
Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Igor Grant, M.D.
Mary Jane Rotheram-Borus, Ph.D.
Ellie E. Schoenbaum, M.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
R. Dale Walker, M.D.
Marina E. Wolf, Ph.D.
Janet Wood, MBA

Council Members Absent:

John P. Allen, Ph.D., M.P.A.
Debra K. DePrato, M.D.
Anita S. Everett, M.D.
Eric J. Nestler, Ph.D., M.D.
Daniele Piomelli, Ph.D.
Xiaoyan Zhang, 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:

Aisha Cain - CSOSA
Shelley Caplan - IQ Solutions, Inc.
Susan David, Ph.D.
Andrea de la Flor, M.A. - CADCA
Andrew Kessler, Ph.D. - CAADAC
Judy McKee, J.D. - NAAG
Julie Miller, Ph.D. - Masimax Resources
Ray Niaura, Ph.D. - Brown University
Vera Nordalm - IQ Solutions, Inc.
Denise Osborn, J.D., M.P.H. - ASTHO
Martha Paterson - American Pharmacists Association
Amy Pollick, Ph.D. - Association for Psychological Science
Patricia President - CSR, Inc.
Barbara Wanchisen, Ph.D. - The National Academies
Dianne Welsh - CSR, Inc.
L. Whitten, Ph.D. - Masimax Resources

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. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. Dr. Timothy Condon, Deputy Director, NIDA, 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 Division of Basic Neuroscience and Behavioral Research; Division of Clinical Neuroscience and Behavioral Research; Division of Epidemiology, Services and Prevention Research; Division of Pharmacotherapies and Medical Consequences of Drug Abuse; Office of Science Policy and Communications; the AIDS Research Program presented their applications for consideration by the Council. Applications submitted under the American Recovery and Reinvestment Act were also presented for consideration. 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.

   Council concurred with the recommendations for all of the applications reviewed by CSR and NIDA scientific review groups.

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: February 2-3, 2010; May 5-6, 2010; September 14-15, 2010; February 1-2, 2011; May 10-11, 2011; September 13-14, 2011.

2. Consideration of the Minutes of Council

   The Minutes of the May 2009 meeting were approved as written.

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

   Dr. Volkow began her report by announcing that A. Thomas McLellan, Ph.D. had been confirmed as Deputy Director, ONDCP on August 7. She then turned to a budget update, noting that the NIDA budget in 2009 was increased by 2.7% and that the 2010 President's Budget called for an increase of 1.22%. She also discussed how the NIDA ARRA dollars had been distributed. NIDA received $261,156,000 in ARRA support, and most of those funds went to support applications that had already been submitted. About 40% of the budget will go to support Challenge, GO and other ARRA new grants. Further, NIDA has identified three major goals to highlight for support as NIDA Signature Projects under ARRA: 1) eradicate tobacco use and addiction; 2) understand how genes influence the development and morphology of the human brain; and 3) develop immunotherapies for substance related disorders. Relevant grants will come from GO, Challenge, and other sources.

   Of major news at NIH is the appointment of Francis S. Collins, M.D., Ph.D. as the 16th Director of the National Institutes of Health. He was unanimously confirmed by the Senate on August 9, 2009 and sworn in on August 17, 2009. Dr. Collins has identified five key opportunities for the NIH: 1) applying unprecedented opportunities in genomics and other high throughput technologies to understand fundamental biology and to uncover the causes of specific diseases: 2) translating basic science discoveries into new and better treatments; 3) putting science to work for the benefit of the health care system; 4) encouraging a greater focus on global health; and 5) reinvigorating and empowering the biomedical research community.

   Dr. Volkow announced that the Scientific Review Management Board (SMRB) met on September 1, 2009, and the next public event related to the Board's work on substance abuse and addiction issues is scheduled for September 23, 2009, when the Substance Abuse and Addiction (SUAA) working group of the SMRB will hold a public forum.

   Dr. Volkow then turned to recent NIDA activities, highlighting new data on use of selected illicit drugs among persons aged 12 or older from 2002-2008. While use of many drugs appears relatively stable, there has been a substantial reduction in methamphetamine use in this same population over the same time period. The Division of Pharmacotherapies & Medical Consequences of Drug Abuse (DPMCDA) is focusing on translating basic science discoveries into new and better treatments. To facilitate this process, NIDA will publish a request for applications for 2010 for the new NIDA Translational Avant-Garde Award for Medication Development for Diseases of Addiction. This announcement will encourage investigators at different points in drug discovery to move more quickly on the path of translation. Further, Dr. Peter Kalivas has been chairing the Medication Development Research Grants Workshop and will report to Council in September of 2010 their findings and recommendations to revitalize and accelerate the process of translation. Dr. Volkow emphasized the importance of developing medications that can be more quickly brought to treatment settings.

   The Division of Basic Neurosciences & Behavioral Research (DBNBR) is working with the NIDA Science of Genetics Workgroup chaired by Dr. Eric Nestler. One meeting is scheduled to take place in November, and the report of findings and recommendations will be presented to Council at the May 2010 meeting. The workgroup is looking at the current genetics portfolio and will provide recommendations as to how NIDA might best invest research dollars in this fast-changing area.

   For the Division of Clinical Neurosciences & Behavioral Research (DCNBR), Dr. Volkow presented some interesting findings concerning nicotinic acetylcholine receptors in smokers and non-smokers at different times after withdrawal. These findings are relevant to NIDA's Signature focus on eradicating tobacco use and addiction. She also noted that an RFA from that division on integrating translational neuroscience and adolescent drug abuse treatment has been issued and that applications are due in September.

   An interesting study funded by the Division of Epidemiology, Services & Prevention Research (DESPR) has shown that parenting moderates the impact of a genetic vulnerability factor on youths' substance use.

   Dr. Volkow also highlighted results from the Communities that Care prevention program showing the positive effects on children of the community intervention in terms of their subsequent lower rates of drug, alcohol and other problem behaviors. A virtual town hall meeting was held to motivate other communities based on the Communities that Care paradigm.

   Dr. Volkow began her presentation on the Center for the Clinical Trials Network (CCTN) by noting that Council member and member of the CTN Oregon-Hawaii Node, Dr. Dale Walker, had been named the 2009 Indian Physician of the Year by the Association of American Indian Physicians. Dr. Volkow and the Council congratulated Dr. Walker. Dr. Volkow stated that the CTNs will be competing for continued support. She noted another CTN success story: two CTN HIV interventions have been selected by the CDC for their list of recommended, evidence-based interventions for HIV prevention.

   For the AIDS Research Program, Dr. Volkow presented an important study published in JAMA that looked at the access to antiretroviral medication of people released from prison and the effects of their not being able to obtain refills in a timely fashion once they are released. There is also evidence that early treatment decreases infectivity, and one of NIDA's main initiatives will be to support research, through an RFA, for work in the criminal justice system to seek, test and treat HIV-positive prisoners. A meeting will be held in January 2010 to provide clinical recommendations for HIV prevention and treatment of substance abusers where there is scientific evidence and will identify priority areas for clinical research. Attendees will include representatives from ONDCP, CDC, OAR/NIH and other organizations as well as many eminent scientists. Dr. Volkow then described the success of the AIDS Avant-Garde program and noted other activities of the AIDS Research Program.

   Dr. Volkow reported that Dr. Barry Hoffer will be stepping down as the Scientific Director for the Intramural Research Program, though he will continue to remain a senior intramural investigator. NIDA has placed advertisements for the Scientific Director position in a number of journals.

   She also noted that NIDA will be releasing an announcement for research on substance use and abuse among military personnel, veterans, and their families. Friends of NIDA recently held a well-attended briefing on substance abuse and risk factors in military personnel, veterans, and their families. Dr. Volkow described the projects of the INTEL ISEF high school student participants who had won first, second and third prizes from NIDA and Friends of NIDA for their science projects. NIH has also started to award prizes at this competition. She also noted the role NIDA would have at the Society for Neuroscience annual meeting, where a satellite program will again be presented. These satellite programs have presented the most exciting work NIDA supports in the neurosciences and drug abuse and are very well attended.

   Council thanked Dr. Volkow for her report and raised questions and comments about ways to consider the role of environmental modulators for the drug development efforts and about the importance of studying the brain in research on HIV/AIDS. It was noted that the CNS consequences are different from other biological consequences; neurocognitive status needs to be assessed and understood in addition to other factors, because there are implications for treatment and other interventions as a function of differences in neurocognitive status. Council also stressed the importance of the criminal justice efforts, noting the need for follow up treatment and access to medication. Changes were noted in California on prisoner release and access to services. The importance of understanding how substance abuse issues might be affected by health care reform, including economic models for various interventions, was addressed.

4. Dr. Normand began his update on the NIDA AIDS research program by noting that he would provide a profile of the AIDS portfolio, describing recent initiatives and future initiatives, as well as conferences and other programmatic activities. Using the Office of AIDS research areas of emphasis to describe different scientific areas, Dr. Normand noted that epidemiology is the largest area of the current NIDA portfolio, that the prevention area had decreased a bit, and that basic biomedical research has increased by about 25%.

   FY08 initiatives have included the Avant-Garde program; A-START to stimulate new investigators to come into the field of HIV/AIDS and drug abuse; the international R21 to stimulate pilot studies; a non-injection drug use Program Announcement with a set-aside to study the contribution of illicit drug use in facilitating transmission and to better understand sexual risk, as sexual risk and injection risk are not the same thing; a CTN trial that is looking at including HIV counseling or not, when offering HIV testing; work in criminal justice; and research on long-acting sustainable therapies and different delivery modalities for drugs. Several of these initiatives have been carried into FY 09, such as A-START and Avant-Garde, and new initiatives have been added, such as a fellowship program in conjunction with the International AIDS Society. Other FY 09 initiatives were also described briefly. For FY10, several new programs are proposed, in addition to carrying forward programs such as A-START and Avant-Garde and expanding the IAS/NIDA international fellowship program. These new programs include exploring HIV among criminal justice populations, looking at epigenetic regulatory mechanisms in HIV/AIDS and drug abuse, and issuing a program announcement on vulnerable populations.

   Over the last 25 years or so, NIDA's HIV prevention portfolio has focused on IDU, preventing acquisition, and on individual risk behaviors. However, several other areas of prevention research need more attention, including non-injection risk populations and structural interventions. Dr. Normand also highlighted the importance of network research.

   Recent and upcoming AIDS Program activities include work with CDC to initiate formal relationships and include NIMH in those meetings, activities at the International AIDS Society Conference in Cape Town, where a major symposium on drug abuse and HIV was on the program and there was both an Avant-Garde satellite presentation and an award ceremony for NIDA/IAS fellowships. Drs. Julio Montaner, Jerome Groopman, and Ileana Cristea, Avant-Garde awardees, presented some of their initial work. Two fellowships awardees, Maria Rangel and Micah Oyaro presented their ideas. This was a very successful conference. A number of upcoming program activities and related activities were also identified. These include a symposium session at the upcoming AIDS International Conference in Vienna and a meeting on pain as it relates to HIV and AIDS.

   Council thanked Dr. Normand for his presentation. There were no questions.

5. Dr. Compton noted that the study of community influences on health was a theme for organizing some of the work of his division. He pointed out that drug abuse/addiction can be viewed as the result of complex interactions of intrapersonal biology and behavior with the environment. He pointed out that the environment comes in many forms, that community-level environmental influences have received scant attention, that community-level opportunities include etiology research, treatment service system research, prevention intervention as well as implementation science research and that this work has particular relevance for practice and policy. He noted that research on community influences includes attention to 1) theories - what new theoretical approaches can inform research? 2) interactions - what intrapersonal and environmental factors interact with each other and with genetic factors across development? and 3) blending - how can science and services be blended to measurably impact public health outcomes? He noted the importance of studying the interaction of genetic or biological predisposition with various environmental factors, mediated through the drug of abuse and the brain to produce drug abuse and addiction.

   Dr. Compton then presented some key findings to illustrate ideas about blending science and services at the community level, and ideas about population influences on health. In discussing community level services research, Dr. Compton noted that macro-level treatment services research tends to focus at the program, organization, system or state levels. Yet, community-level factors influence service availability, access, and utilization. Studies attending to community influences hold great potential for identifying barriers to service delivery. After a discussion of state-level services research and the presentation of some interesting findings from this perspective, as well as some interesting findings from community-level services research, Dr. Compton focused on some recent community-level prevention research findings. He spoke first about the results of the virtual town hall meeting and then described the Community Youth Development Study, an operating system or way to implement evidence-based programs, and the PROSPER program, which is driven by community organizers and the communities themselves. He also presented the findings from an HIV prevention study conducted by Dr. Ted Hammett and noted the challenges to motivating communities to implement evidence-based prevention programs and assess their effectiveness. He also identified the challenge of finding ways communities could retain the core elements of proven programs while adapting them for their unique conditions as well as implementing and sustaining effective programs.

   Dr. Compton closed by noting that he had tried to illustrate the way that the Division links programs across epidemiology, services, and prevention research though understanding a society-behavior-biology nexus. In addition to continuing this type of work, Dr. Compton noted that the Division has been working with the Clinical Trials Network, the CTSAs, SAMHSA and other groups to use their infrastructures to understand community influences on health and he emphasized the importance of looking for ways to link genetic studies and neurobiology studies with macro-level factors.

   Council thanked Dr. Compton for his presentation and asked a number of questions about the data he had presented, noted the importance of outreach to minority communities, including American Indian communities, asked how children with significant biological vulnerabilities might be identified, and addressed the important differences between universal and selective prevention programs. Dr. Compton noted that higher-than-average risk groups might be the place to consider more focus on gene-environment interactions and concluded by mentioning a workshop to be held in January on social network influences on health behaviors.

6. Update on the American Recovery and Reinvestment Act - Christine Colvis, Ph.D., Director of Program Integration, OD, NIDA

   Dr. Colvis provided some background on the American Recovery and Reinvestment Act of 2009 (Recovery Act), noting that NIH received $10.4 billion and describing the allocation of those funds and NIDA's participation in the various FOAs of NIH. She also described two new ARRA funding announcements, 1) the BRDG-SPAN (RC3) which is intended to address the funding gap between promising research and development and transitioning to the market and 2) the Small Business Catalyst Awards for Accelerating Innovative Research (R43) which is intended to support entrepreneurs who propose pioneering and transformative approaches to address major biomedical or behavioral challenges with the potential for downstream commercial development. Dr. Colvis noted that the R15 Academic Research Enhancement Award to stimulate research in educational institutions that have not been major recipients of NIH support was another FOA of interest; this announcement supports small scale health-related research projects such as pilot research projects and feasibility studies and secondary analysis of available data sets.

   Dr. Colvis presented the 15 broad research areas of the Challenge Grant, noting the number of grants per Challenge area that NIDA received. There were 877 Challenge grant topics distributed over the 15 areas, and NIDA had listed 105 of those topics as being of interest. After presenting the distribution of grants by Challenge area for NIDA, she identified the five most popular topics of NIDA applicants: 1) a new look at longitudinal data; 2) behavioral and medication interventions to treat drug-abuse disorders in a non-specialty-care settings; 3) integrated vs. separate treatment of substance abuse and comorbid conditions; 4) biomarkers for pain; 5) identification, validation and exploitation of new molecular targets for the treatment of drug addiction.

   She then provided similar information for the GO grant applications. NIDA had 11 different priority areas. Of particular interest are small molecule development and vaccine immunotherapies, thereby strongly emphasizing treatment. Dr. Colvis also described the results of the P30 Faculty Recruitment ARRA effort, noting that the purpose of this announcement was to expand the pool of multidisciplinary researchers on biomedical topics relevant to NIH by providing funds to hire and provide appropriate startup packages and develop pilot research projects for newly independent investigators. She then showed the distribution of total number of ARRA grantees to date by state and the distribution by dollars of the NIDA ARRA grantees to date. NIDA has ARRA grantees in nearly every state in the union.

   Next Dr. Colvis described the ARRA reporting requirements, noting both that quarterly reports must be filed and there are many resources available to assist grantees. She further described some NIH resources available for information and assistance and noted that business offices will have a great deal of NIH Web information available to guide them through the reporting process, including continuously updated FAQs and a hyperlink to the NIH Reporter, the replacement for the CRISP system.

   Council thanked Dr. Colvis for her presentation but raised no questions.

7. Public Comments

   There were no public comments.

8. Adjournment

   The 103rd meeting of the National Advisory Council on Drug Abuse was adjourned at 12:00 p.m.

Certification

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

Council Roster

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