104th Meeting Minutes

February 2-3, 2010

The National Advisory Council on Drug Abuse convened its 104th meeting at 2:00 p.m. on February 2, 2010 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 February 2, 2010, from 2:00 p.m. until 4:30 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 3, 2010, from 8:30 a.m. until 1:00 p.m. The Council adjourned on February 4, 2010 at 1:00 p.m.

Council Members Present:
Louis E. Baxter, M.D.
Francisco X. Castellanos, M.D.
Steven R. Childers, Ph.D.
Thomas J. Crowley, M.D.
Debra K. DePrato, M.D.
Anita S. Everett, M.D.
Igor Grant, M.D.
Caryn E. Lerman, Ph.D.
Daniele Piomelli, Ph.D.
Mary Jane Rotheram-Borus, Ph.D.
James L. Sorensen, Ph.D.
Hazel H. Szeto, Ph.D., M.D.
R. Dale Walker, M.D.
Steven M. Wolinsky, M.D.
Xiaoyan Zhang, Ph.D.
Jon-Kar Zubieta, Ph.D., M.D.

Ex Officio: John P. Allen, Ph.D., M.P.A.

Council Members Absent:
Eric J. Nestler, Ph.D., M.D.

Council Chairs Present:
Nora D. Volkow, M.D.
Timothy P. Condon, Ph.D.

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:
William Corrigall, Ph.D.
Susan David, Ph.D.
Stacia Hall Fleisher, M.P.P. - American Academy of Child and Adolescent Psychiatry
Rick Hansen, M.S. - Digicon Corp.
Andrew Kessler, Ph.D. - CAADAC
Roxanne Kibben, M.A. - Synergy Enterprises, Inc.
Ann Mahony, M.P.H. - American Public Health Association
Kimberly McGraw - IQ Solutions
Julie Miller, Ph.D. - RTI
Geoff Mumford, Ph.D. - American Psychological Association
Amy Pollick, Ph.D. - Association for Psychological Science
Branka Sekis - SSS, Inc.
Blair Feldman, B.A. - Association of Independent Research Institutes
Jean Shin, Ph.D. - American Sociological Association
Susan Storti, Ph.D., R.N., C.A.R.N.-A.P. - Synergy Enterprises, Inc.
Bruce Wheeler - SRNT
Evelyn Yang, Ph.D. - CADCA

Closed Portion of the Meeting - February 2, 2010

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 Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; the Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; and the AIDS Research Program presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved all administrative supplement requests presented.

   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.

Open Portion of the Meeting - February 3, 2010

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and introduced 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 called attention to future Council meetings: May 5-6, 2010 (Wednesday and Thursday), 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 September 2009 meeting were approved as written.

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

   Dr. Volkow began her report by noting that Dr. Francis Collins, NIH Director, and Dr. Joanna S. Fowler, a NIDA grantee, had been awarded the National Medal of Science, which was presented to each of them by President Obama. She also noted that NIDA had two winners of the Presidential Award for Early Career Scientists and Engineers (PECASE) and the honorees for this prestigious award also met with President Obama.

   In terms of the budget, Dr. Volkow noted that the 2010 budget provided a 2.6% increase over the previous year and that the President's Budget called for a 3.3% increase in 2011, which would bring NIDA's total budget to $1,094,078.

   Further, NIDA grantees have received over 312M through ARRA for the two-year period, and this includes over $31M for comparative effectiveness research and over $20M from the NIH OD. With all sources of ARRA funds taken into account, NIDA has been able to support 260 grants that were beyond the pay line, 42 Challenge grants, 25 GO grants, 6 P30 faculty recruitment grants, 21 revision applications, 41 summer student and educator supplements and 14 administrative supplements. Also, a $10M GO grant was awarded to Nabi Biopharmaceuticals. Following NIDA's investment, GlaxoSmithKline Biologicals SA (GSK) and Nabi Biopharmaceuticals announced an exclusive worldwide option and licensing agreement for a nicotine-conjugate candidate vaccine (NicVAX¨).

   NIH has also published several funding opportunities, including the NIH Director's Opportunity for Research in Five Thematic Areas (RC4), the NIH Basic Behavioral & Social Science Opportunity Network (OppNet) Short-term Mentored Career Development Awards in the Basic Behavioral Social Sciences for Mid-career Senior Investigators as well as three new CER funding opportunities.

   Dr. Volkow then reported on the NIH Global Health Research Meeting held in January of 2010 that focused on fundamental science, epidemiology/population-based approaches, diagnostics and therapeutics (drugs and vaccines) that has led to two RFAs to enhance NIH global health research efforts. Turning to a different topic, Dr. Volkow noted the status of NIH epigenomics roadmap projects, pointing to three activities of interest, including an announcement for developing technologies for improved in vivo epigenetic imaging or analysis that will be supported by NIH Common fund resources.

   Dr. Volkow reported on the status of the potential merger of NIDA and NIAAA, noting what public events had taken place and reminding Council that Dr. William Roper, Chair of the Substance Use, Abuse and Addiction Workgroup of the Scientific Management Review Board would be speaking to Council that afternoon. She listed the non-federal and federal members of that Workgroup.

   Recent NIDA activities include the appointment of Dr. Phil Skolnick as the new Director of the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA). Further, the Medications Development Research Grants Work Group, composed of both Council members and other scientists and chaired by Dr. Peter Kalivas will have a final report for Council at the fall meeting. Dr. Volkow described three medications development RFAs.

   The Division of Basic Neurobiology and Behavioral Research (DBNBR) has been working with the NIDA Science of Genetics Workgroup composed of both Council members and senior scientists whose charge is to evaluate the NIDA genetics program. This group is chaired by Dr. Eric Nestler and will report its findings at the May Council. Dr. Volkow also announced the creation of the NIDA Translational Avant-Garde Award, specifically looking at medication development for diseases of addiction and using the DP1 mechanism. She also identified two other RFAs of interest, one on deep sequencing and analysis of pharmacogenomic regions for the discovery and analysis of genetic variants contributing to drug abuse and addiction and another on epigenomic processes and non-coding RNAs in HIV/AIDS. She further noted work on establishing a public-private partnership to develop highly effective medications to treat tobacco dependence. This will be a collaborative, potentially global, effort in drug development partnership to develop, test, and facilitate access to effective medications for tobacco dependence through collaboration between public, private and civic groups.

   The Division of Clinical Neurosciences and Behavioral Research (DCNBR) has issued an RFA on cognitive remediation approaches to improve drug abuse treatment outcomes. For the Division of Epidemiology, Services and Prevention Research (DESPR), Dr. Volkow highlighted some important new results from the University of Michigan 2009 Monitoring the Future Study. She also described an RFA with OBSSR and NCI that will accelerate the pace of drug abuse research using existing epidemiology, prevention and treatment research data.

   The projects of the 2009 recipients of Avant-Garde Awards for Innovative HIV/AIDS research were described. There were four awardees in 2009, and the 2010 announcement for this program was published in December. Dr. Volkow reported on the NIDA/IAS consultation meeting on a global perspective for the prevention and treatment of HIV/AIDS among drug using populations. She noted that the distinguished panel for this meeting represented a full range of federal agencies and others concerned with HIV/AIDS and that specific recommendations will be forthcoming for each of the breakout sessions at the meeting, e.g., drug abuse treatment as HIV prevention, optimizing HIV prevention modalities, co-morbidity adherence, and criminal justice: HIV prevention and treatment, etc. She also presented a preliminary summary of the recommendations, e.g., seeking and testing in addition to healthcare should include drug treatment programs in the criminal justice system, treatment of the SUD should follow a chronic model of disease, etc. She then pointed to an RFA with NIMH and NIAID that would address HIV in the criminal justice system.

   Dr. Volkow noted that the Center for the Clinical Trials Network (CCTN) will present an update later today. She also described the rapid testing study to evaluate effective HIV testing strategies, noting differences in readiness for testing among participants.

   Recruitment efforts are continuing for the Director of the Intramural Research Program (IRP), and there are two stellar candidates being considered. Dr. Barry Hoffer will continue to serve as the Scientific Director of the IRP until a new one is appointed.

   Dr. Volkow then described several meetings NIDA had conducted or will conduct, including the 2010 Blending Conference in Albuquerque and a research track at the American Psychiatric Association. She also described the NIH Blueprint Grand Challenge project seeing to combine the strengths of academia and industry and develop licensing opportunities for new drugs for nervous system disorders. She also mentioned the SOAR program for new investigators (with NIAAA) and a joint RFA with NIMH, NIA, NIAAA and NIBIB on the development and application of PET and SPECT imaging ligands as biomarkers for drug discovery and for pathophysiological studies of CNS disorders.

   Council thanked Dr. Volkow for her report. Comments and questions included a discussion of the potential application of home-based HIV testing, the need for HIV testing and standards for testing in the criminal justice system, and the need for more training in how to treat drug problems, especially in adolescents, for psychiatry residents. It was noted that an integrated approach for assessment and treatment of youth by psychologists and psychiatrists is needed so that both drug and mental health problems are appropriately addressed, that the CDC recommendations on CD4 count are conservative, especially for drug abusers, that woman of color are a fast growing group of the HIV positive population and are in need of appropriate services, both prevention and treatment. The importance of intra-agency cooperation and global efforts as well as the need for integrated models of education, prevention, care and treatment across diseases using a chronic illness model were noted. Changes in Colorado after the referendum on medical marijuana was passed were noted as were questions that might be asked about the effects of this referendum. New Jersey has also just approved the use of medical marijuana. Issues about funding from tobacco companies were also noted, and Dr. Volkow reminded Council that a workgroup is looking into this complex issue. Concerns about the use of Lavamisole and the lack of research about its effects were noted. Also mentioned was the need to make data from various agencies more useful so that practitioners and other people can make better use of the data that are available while protecting the confidentiality of the respondents.

4. Operational Procedures and Statement of Understanding - Teresa Levitin, Ph.D., Director, Office of Extramural Affairs, NIDA

   Dr. Levitin began her presentation by noting that the NIH requires that each Institute and its Advisory Council develop a document outlining operating procedures to be used by the Council in fulfilling grant application review responsibilities. These procedures are to be reviewed annually with the Council members, and they are also subject to the review of the Deputy Director for Extramural Research to ensure compliance with NIH policies, applicable laws, and regulations.

   She noted that each February she presents this document to the Council for discussion and approval. The document delineates the procedures by which the National Advisory Council on Drug Abuse will operate to perform its second level of grant review, and it also gives information on related matters. It is not intended to describe all of the Council's activities, and usually there are very few changes from year to year. However, this time several changes have been incorporated in the draft document, some of which needed to be made because of changes from the enhancing peer review activities, i.e., the old scoring system was used in the document, some of which reflect changes in the way Council has been operating, i.e., Council is now providing early concurrence for RFAs and other types of applications.

   Dr. Levitin noted that the draft operating procedures and statement of understanding had been sent to the Council prior to this meeting and that several Council members had already indicated their support for the new document. She asked if there were any questions or any discussion. She then asked for a vote of approval, and Council unanimously approved the document. Dr. Levitin thanked the Council and noted that the new procedures would immediately be put in operation.

5. Update from the Center for Clinical Trials Network - Betty Tai, Ph.D., Director, Center for Clinical Trials Network, NIDA

   Dr. Betty Tai briefly described the reasons the CTN had been created by NIDA, noting that it is built and operated on the premises that addiction treatment services will be improved as evidence-based treatments are broadly implemented in community-based treatment programs, that randomized, controlled clinical trials are the gold standard for generating evidence-based treatments and that engaging the providers in the research process will improve the acceptability and adoption of research results.

   Her report to Council considered the infrastructure, research findings, research utilization and the next decade of CTN activity of the CTN program. In terms of infrastructure, there are now 16 Regional Research and Training Centers (RRTCs) and 240 Community Treatment Programs (CTPs) across 37 states and Puerto Rico. The participating CTPs include rehabilitation centers, such as the Betty Ford Center, hospitals, such as the Mayo Clinic, methadone clinics and "drug free programs" such as Odyssey House, thereby representing social, behavioral and medical models. Dr. Tai also described the CTN coordinating centers which include the Data and Statistics Centers at the Duke Clinical Research Institute and the EMMES Corporation and the Clinical Coordinating Center at EMMES.

   Turning to the CTN research portfolio, Dr. Tai presented the trials that are 1) in development and review, 2) in the data collection phase, 3) in the data analysis phase, and 4) in the publication and dissemination phase. She noted that 12 pharmacotherapy trials, 14 behavioral intervention trials, 4 HIV/HCV intervention trials, and 3 other trials have been implemented between 1999 and now. Dr. Tai then provided information about the decade of growth of the CTN, including number of completed trials and number of peer-reviewed articles. She highlighted several CTN pharmacological therapy trials, including one on extended vs. short term buprenorphine-naloxone for treatment of opioid-addicted youth whose findings were recently published in JAMA. Dr. Tai also highlighted several behavioral therapy trials, including a motivational enhancement therapy trial for Spanish speaking substance users; the trial's findings were recently published in the Journal of Consulting and Clinical Psychology. She also described challenges and opportunities for some trials, several ancillary studies, and some secondary analysis studies, including one investigating whether treatment improvements in PTSD severity affect substance use outcomes, a study that was published recently in the American Journal of Psychiatry.

   Dr. Tai then discussed research utilization of CTN findings. She noted that research utilization is the process through which research findings are put in use in the form of practices and policies. This is a process that is difficult and slow, and it is not an action that begins when research is completed but, rather, should be seen as a two way, concurrent process. A number of CTN research utilization activities were described, including the CTN dissemination library, on-line data sharing data sets, and major regional research utilization workshops. Several NIDA-SAMHSA blending products were also described. Furthermore, CTN serves as a training platform, through NIDA's INVEST program, for international scientists and health administrators.

   Dr. Tai then turned to proposed activities over the next decade, noting that the CTN RFA had been reviewed in February and would go to May Council. She delineated the mission and goals of the CTN for the future: to bring drug abuse treatment into mainstream medical practice, to maintain a flexible research strategy/portfolio, to maintain a training platform for the clinical workforce and to facilitate research utilization. She noted how the infrastructure might expand and change, and she mentioned some of the challenges and opportunities, including those in information technology, approaches to accommodate physiologic and genetic information, new statistical tools and techniques, innovative trial/study designs, and a management model for the chronic disease of drug abuse. She noted that, in order to conduct research to impact practice, different questions must be asked and a different approach is needed to address these questions. Dr. Tai closed her presention by reviewing the CTN premises she had presented at the beginning of her talk and added another: research questions that impact practice must be addressed.

   Council thanked Dr. Tai for her presentation. There was discussion about the co-occurrence of PTSD and substance abuse and the need to treat them concurrently, the importance of working with the VA, the costs and cost-benefits evaluation of the CTN, the importance of having multiple sites addressing the same problem, and the importance of a partnership between treatment providers and researchers. Changes in providers' views of the value of contingency management treatment and the role of the CTN in those changes were noted. The question of how CTN can be used as a platform for genetics studies was raised; Dr. Tai noted the close working relationship between the CTN and the NIDA genetics consortium, and Dr. Joni Rutter provided additional information about NIDA's DNA repository. Dr. Tai closed by inviting the Council to the CTN steering committee meeting.

6. Update on Meetings of the Substance Use, Abuse & Addiction (SUAA), Working Group of the SMRB - William Roper, M.D., Chairman, SUAA Working Group, Scientific Management Review Board (SMRB), NIH

   Dr. Roper began his presentation by stating that he would provide a brief introduction to the Scientific Management Review Board (SMRB), a context for their deliberations, clarification of the charge of the Substance Use, Abuse and Addiction (SUAA) Working Group, a summary of their briefings to date and a description of the deliberation process.

   He noted that the NIH Reform Act of 2006 established the Scientific Management Review Board to provide "advice to the appropriate officials...regarding the use of the authorities...to reorganize the National Institutes of Health (P.L. 109-482). One of the SMRB working groups is the SUAA, and it is charged with evaluating whether organizational change can optimize research into substance use, abuse, and addiction. Other working groups will be focusing on other topics. Dr. Roper listed the non-federal and federal members of the SUAA Working Group.

   He then raised the question of why consider this particular organizational change at this particular time; he pointed out that neuroscience research has revealed that addictive substances, including drugs and alcohol, differentially affect brain receptors and can result in unique neuropathologies and similarly activate certain physiological pathways, including the brain's reward circuit, which can result in compulsive substance use. Dr. Roper posed a key question for deliberation: considering both biological differences and similarities, "Does the current organization separating research institutes on drug and alcohol use, abuse, and addiction provide an optimal infrastructure for supporting these areas of scientific research?" The socio-political context for this question needs to be recognized: the NIH Reform Act established the SMRB to advise NIH on the use of organizational authorities; in 2003 the National Academies recommended considering merging NIAAA and NIDA (the option of a combined institute of addiction was also identified by the Lewin Group in 1988); the Drug Abuse Education, Prevention, and Treatment Act of 2001 (S.304) required the DHHS Secretary to request an IOM study to determine whether combining NIDA and NIAAA would strengthen scientific research efforts and increase economic efficiency, but the study has yet to be conducted. Thus, the specific charge of the SUAA working group is "...to recommend whether organizational change within NIH could further optimize research into substance use, abuse, and addiction and maximize human health and/or patient well being." The working group will consider scientific opportunities, public health needs, and new research technologies; research in these areas under existing NIH structure; criteria for contemplating changes in the organization and management of NIH today; strategies for implementing changes in the organization and management of NIH today; and metrics and methodologies that could be used for evaluating the impact of changes in the organization and management of NIH.

   Briefings to date have included an introduction to SUAA research at the NIH from Dr. Kenneth Warren, Acting Director, NIAAA, and Dr. Nora Volkow, Director, NIDA. Perspectives from prevention specialists, treatment providers, patient advocates and policy specialist have also been provided, and Dr. Roper listed the names and affiliations of those who have provided information to the working group. Perspectives on the science of SUAA research have also been presented, and Dr. Roper provided the names and affiliations of those who had presented their scientific perspectives to the working group. Further, these briefings have included attention to alternative models for organizing SUAA research, with perspectives from the judicial system, academia and industry, and, again, Dr. Roper presented the names and affiliations of those who had provided information.

   Dr. Roper summarized the findings from the briefings to date by noting that the advocates for reorganization believe that the science would benefit from synergy of commonalities (emerging scientific research indicates similar reward pathways underlie compulsive behavior and both alcohol and drug abuse often begins in adolescence with similar early risk factors) The high prevalence of drug users who also use alcohol suggests both scientific and policy justification for reorganization, and the segregation of disciplines creates public health gaps. Those favoring merger also note that reorganization, particularly merging, would create synergy for advancing the science of substance use, abuse and addiction and increase flexibility in cross-training. On the other hand, advocates against reorganization note that it would create research gaps in understanding, given the multiple organ targets of alcohol and the unique factors underlying abuse and addiction. They also note that contextual and socio-cultural differences warrant separate, focused research efforts and that there is a lack of compelling evidence to suggest reorganization would improve treatment, prevention, research and/or training. Further, they note that the current organization mirrors the separation of professional and scientific associations. These advocates also suggest that reorganization, particularly merging, would decrease emphasis on the effects of alcohol on multiple organ targets, jeopardize priority/budget of alcohol-related research and create organizational/administrative obstacles and reversals.

   Dr. Roper noted that the initial dialogue focused on either the status quo or merging institutes. He then stated that it is important to consider that mergers can take multiple forms and have multiple options. He presented diagrams of several different options, noting that each option needs to be carefully considered to maximize functional integration. Thus, the data analyses will include in-depth analysis of several key questions: 1) How is the science being (or not being) served by the current organization? Are any areas of science neglected? Are there gaps in public health? 2) What research is (or is not) already conducted by NIH and in the field of addiction? What is the scientific and funding portfolio of addiction related research? Are there existing collaborations across ICs? 3) How do other countries/organizations optimize the organization of SUAA research?

   Dr. Roper then outlined the process for considering change by presenting three steps: 1) assessing the need for change; 2) evaluating options for change and 3) implementing and evaluating the change. He closed his presentation by listing several discussion topics: are there any additional data or perspectives that the working group should consider during its deliberations? Is there a need to reorganize SUAA research at the NIH? What are the pros and cons of maintaining the status quo? Does the spectrum of potential models accurately capture feasible options? Dr. Roper stressed that no decisions have been made and that input from Council will be of value.

   Council thanked Dr. Roper for his presentation. Questions and comments were raised about the timeline for action, the stakeholders who have provided input, the importance of sufficient funding for both Institutes, the significance of change to various stakeholders, the process that is in place, the possible broadening of the Institutes' portfolios, co-morbidity and the importance of recognizing the prevalence of co-morbidity, and ways to enhance interagency coordination, and anticipate future needs and opportunities. Dr. Roper reiterated that he would welcome more ideas and feedback from Council and Council then discussed ways to provide information to the SUAA. It was decided that a draft resolution would be developed and that Council would have a conference call to develop, discuss and vote on the resolution.

7. Public Comments

   There were no public comments.

8. Adjournment

   The 104th meeting of the National Advisory Council on Drug Abuse was adjourned at 1:00 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.