Revised May 2014
February 4, 2014
The National Advisory Council on Drug Abuse convened its 116th meeting at 8:30 a.m. on February 4, 2014 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. The closed portion of the meeting on February 4, 2014, was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion, which was open to the public on February 4, 2014, began at 10:30 a.m. The Council adjourned on February 4, 2014 at 4:10 p.m.
Council Members Present
Regina Carelli, Ph.D.
Nabila El-Bassel, Ph.D., D.S.W.
Carl Hart, Ph.D.
James Hildreth, Ph.D., M.D.
Elizabeth Howell, M.D.
Terry Jernigan, Ph.D.
Thomas Kirk, Ph.D.
Robert Lenox, M.D.
Caryn Lerman, Ph.D.
Kelvin Lim, M.D.
Barbara Mason, Ph.D.
Linda Mayes, M.D.
Michael Nader, Ph.D.
Marina Picciotto, Ph.D.
John Rotrosen, M.D.
Jon-Kar Zubieta, Ph.D., M.D.
Nora Volkow, M.D.
Mark Swieter, Ph.D., Acting
Federal Employees Present
Jane Acri, Ph.D.
Members of the Public Present
Jason Ezzell - PPD Laboratory Monitoring
Lori Pellutz - SRI International
Julie Croxford - RTI International
Susan Hayashi - JBS International, Inc.
Katia Howlett - Synergy Enterprises, Inc.
Patrick Zickler - Synergy Enterprises, Inc.
Closed Portion of the Meeting – February 4, 2014
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. She 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. Mark Swieter, Acting 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.
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, 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. Council also approved two Method to Extend Research in Time (MERIT) awards.
Administrative supplements were approved. Relevant applications were presented to Council for Special Council Review, and Council agreed with program assessments. All Trans-NIH Initiatives, i.e., Blueprint and Common Fund applications and NIDA Secondary applications also received Council concurrence.
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 4, 2014
Call to Order
Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order. 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. She called attention to future Council meetings: May 6-7, 2014 and September 2-3, 2014, February 3-4, 2015.
Consideration of the Minutes of Council
The Minutes of the September 2013 meeting were approved as written.
NIDA Director’s Report - Nora Volkow, M.D., Director, NIDA
Dr. Volkow began her presentation with an introduction of newly appointed leadership within NIDA. Dr. Wilson Compton was appointed NIDA Deputy Director; he had been the Director of the Division of Epidemiology, Services and Prevention Research (DESPR). Dr. Redonna Chandler was appointed Acting Director of the Division of Epidemiology, Services and Prevention Research (DESPR); Dr. Joni Rutter, who had been Acting Director of the Division of Basic Neuroscience and Behavioral Research (DBNBR), was appointed Director of DBNBR; and Mr. Dave Daubert was appointed Deputy Executive Officer.
Dr. Volkow also introduced and welcomed new Council members, Dr. Ann Andorn, Medical Director of Safety, Evaluation and Risk Management, Office of the Chief Medical Officer, GlaxoSmithKline and Dr. Laura Beirut, Professor of Psychiatry at Washington University, St. Louis.
Dr. Volkow then provided Council with an update on the budget. She explained that the budget for fiscal year 2014 will be a 3% increase over that of fiscal year 2013, but it still remains lower than that of 2012. The increase over fiscal year 2013’s budget may be due to the cuts related to the sequester. She reminded the attendees that NIDA has a mandate to allocate approximately one third of its budget to research HIV/AIDS and drugs. And thus, most of the research directly related to neuroscience, medication development and epidemiology is covered by this mandate.
Turning to what is new at NIH; Dr. Volkow spoke about the four new initiatives presented at the NIH Leadership Forum for the Institutes’ Directors: 1. Analysis of Review Group Outputs (ARGO) study. The purpose of this study is to examine to what extent review study sections have remained the same even though the science has advanced at a faster pace; are the current study sections able to maintain the dynamic range necessary to keep up with this faster pace; and how could NIH more proactively identify emergent fields of science. 2. Approaches to Supporting Science; the use of different mechanisms, such as the Pioneer Award used via the Common Fund to ensure likelihood of successful initiatives and transformative science, and sunset less effective programs. 3. Approaches to maximize efficiencies and reduce redundancy of Core Facilities. The Core Facilities provide access to instruments, technologies, services, and expert consultation across the NIH. 4. Approach to enhance the NIH Biosketch and to better emphasize the applicant’s actual contribution instead of the applicant’s academic and research pedigree.
She then presented on the progress of the BRAIN Initiative, which has the support of the President and Dr. Collins. Forty four million dollars will fund this initiative in fiscal year 2014. The NIH Advisory Council to the Director BRAIN Working Group identified six different focus areas of research, which were released via Funding Opportunity Announcements (FOAs) on December 17, 2014. Two of the areas are focused at the cellular level: Using existing tools to classify brain cell types; and development and validation of novel tools to analyze process in the brain. Three other areas are focused at the circuit level: New technologies and novel approaches for large scale recording and modulation in the nervous system; optimization of transformative technologies; and integrated approaches to understanding circuit function in the nervous system. Dr. Volkow encouraged experts among the Advisory Council members to participate in any applicable BRAIN related FOAs.
Dr. Volkow next spoke about a study that was published in Science in 2006 by Dr. Raynard Kington, former Deputy Director of NIH. The paper highlighted a disturbing finding that of all NIH grants funded between 2000 and 2006, only 15% were awarded to black investigators. The Common Fund will publish three Funding Opportunity Announcements to respond to this concern, under the direction of Dr. Tabak, current Deputy Director of NIH. 1. NIH National Research Mentoring Network (NRMN), encouraged organizations with experience in mentoring individuals from diverse backgrounds as they pursue careers in biomedical research to submit for a grant. 2. NIH Building Infrastructure Leading to Diversity (BUILD), encourages institutions that seek to engage undergraduate students in innovative mentored research training programs to submit applications. 3. NIH Coordination and Evaluation Center for Enhancing the Diversity of the NIH-Funded Workforce Program, encourages institutions with expertise in data coordination and evaluation of research training, career development, and mentoring programs to submit applications.
Dr. Volkow moved onto current activities at NIDA. She began by discussing the plan to reorganize and create a Division of Extramural Affairs (DEA) such as the majority of institutes are organized, as opposed to the current Office of Extramural Affairs structure. Moving to a division category would expand its visibility and include extramural program activities, which will better allow NIDA to coordinate trans-NIH programs and initiatives such as CRAN, BRAIN and the Center for Training Coordination. In addition, the DEA would be responsible for and oversee the grants management branch.
Dr. Volkow next provided Council with recently published studies highlighting NIDA’s Priority Areas. In the first area of Prevention Research, results from Monitoring the Future that were released in December 2013, the CESAR publication, among others, showed that Marijuana use among US 12th grade students is trending up, while use of both alcohol and cigarettes is trending down. This trend is also visible among 8th and 10th grade students and might be due to a decreased perception of marijuana as being dangerous as States move to legalize its use. In addition, the results indicate that adolescents are consuming others’ medical marijuana prescriptions, even in states that have not legalized medical marijuana use. The decrease in use of alcohol and cigarettes could be attributed to very successful advertising campaigns. There will be increased focus on monitoring use of new forms of tobacco administration. A complete list of the prevalence of past year drug use among 12th graders was shared with Council members and meeting attendees. One of the concerns is the continued significant use of amphetamines with 8.7% of 12th grade students having reported its use in the past year. NIDA has a funding announcement available to encourage research on the impact of changing marijuana policies and laws on public health outcomes: Public Health Impact on the Changing Policy/Legal Environment for Marijuana (R01).
Next, Dr. Volkow moved onto the Treatment Interventions Priority Area. She highlighted a new Buprenorphine Implants for Treatment of Opioid Dependence that is currently being evaluated for approval by the FDA. The implants would improve compliance rates and facilitate the care of these patients. A study by Vallee M, et al shows how pregnenolone interferes with THC effects, which offers a completely new and unexpected path towards potential medication treatments in the case of marijuana addiction.
The third Priority Area is HIV and Drugs, which constitutes one third of the NIDA budget. Dr. Volkow described promising results of one study that could lead to future medical therapies to inhibit Caspase-1 and to slow the rate of CD4 T-cell death via pyroptosis. She provided background information on the purpose and process of awarding Avant-Garde grantees. Similarly, NIDA will support Early Stage Investigators in the HIV/AIDS and Genetics fields of research via the Avenir Award Program.
Dr. Volkow also discussed the successful Drug Facts Week event that was sponsored by intramural and extramural scientists from NIDA, NIAAA and NIMH that provides evidencebased facts on drug abuse and addiction to adolescents. The Principles of Adolescent Substance Use Disorder: A Research Based Guide was developed as a result of this effort to help guide substance abuse treatment programs. In addition, she spoke about other online resources, such as the Medical School Curriculum that provides a series of videos demonstrating effective adolescent screening techniques.
Dr. Volkow spoke about two remarkable events including her meeting with the Dalai Lama in October to better understand the neuroscience of addiction in order to prevent the abuse of drugs in India and Tibet. This has led to his planned visit to NIH in March 2014. And finally, Dr. Volkow presented the recent winners of the NIDA’s Addiction Science Awards, Intel International Science and Engineering Fair (ISEF), followed by a list of FOAs that focus on both the prevention and treatment priority areas.
Council thanked Dr. Volkow for her presentation. One line of questions focused on bridging together the Avenir, Avant-Garde and the New Innovator award programs to ensure that NIDA is supporting visionaries and great science. Council members complimented NIDA as a whole for its progressive work in clinical trials, pharmaceutical research and criminal justice implementation science and provided examples including the SAETR system, the Phoenix Program and CJDATS.
Five new program concepts were presented to Council. Dr. Geetha Subramanian, Deputy Director of the Center for Clinical Trials Network presented a concept for an initiative aimed at research targeting youth and prescription stimulant abuse that provide interventions for older adolescents and college age young adults. Council agreed that more research is needed to understand the causes and effects of misuse and abuse of short and long-term stimulant drugs. Dr. Steven Sparenborg, Addiction Medicine Team Leader, Center for Clinical Trials Network presented a concept for an initiative to continue supporting and to expand the Clinical Trials Network. Council commended NIDA on its leadership in the Clinical Trials Network and supported its goal for continuing and expanding the program.
Dr. Joni Rutter, Director of the Division of Basic Neuroscience and Behavioral Research (DBNBR), presented concepts for two initiatives to employ a new type of investigator-focused award that NIDA is interested in developing. To be named Avenir Awards, these will identify early stage investigators (ESI) who propose high impact research and who show promise of being future leaders in drug abuse and addiction research. A minimum 25% effort to activities supported under the award will be required. One Avenir initiative will be targetted to ESI whose research is in the field of genetics; the second Avenir initiative will be for ESI whose research is in the area of HIV/AIDS. Council expressed enthusiasm for these initiatives and for the great potential they will provide ESI. Members recommended that the length of the award be five years to ensure sufficient time for creativity and success of the awardees.
Dr. Lisa Onken, Chief of Behavioral Treatment and Development Branch, Division of Clincal Neuroscience and Behavioral Research presented a concept for an initiative on smoking cessation in people with schizophrenia. The purpose is to develop, test and implement better and targeted treatments for this population. This will be a joint effort by NIDA along with NIMH, NCI and NIAAA, all of whom are strongly interested in supporting this program. Council agreed that this was an important topic, especially with regulations requiring hospitals to become smoke-free environments.
There were no Public Comments
The 116th meeting of the National Advisory Council on Drug Abuse was adjourned at 4:10 p.m.
I hereby certify that the foregoing minutes are accurate and complete.
Nora D. Volkow, M.D.
National Advisory Council on Drug Abuse
Mark Swieter, Ph.D.
Executive Secretary, Acting
National Advisory Council on Drug Abuse
Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.