109th Meeting Minutes

September 12-13, 2011

The National Advisory Council on Drug Abuse convened its 109th meeting at 3:30 p.m. on September 12, 2011 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 12, 2011, from 3:30 p.m. until 5:30 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, on September 13, 2011, was from 8:30 a.m. until 1:00 p.m. The Council adjourned on September 13, 2011 at 1:00 p.m.

Council Members Present:
Francisco Castellanos, M.D.
Steven Childers, Ph.D.
Thomas Crowley, M.D.
Nabila El-Bassel, D.S.W.
Anita Everett, M.D. R.
Elizabeth Howell, M.D.
Thomas Kirk, Ph.D.
Caryn Lerman, Ph.D.
Linda Mayes, M.D.
Eric Nestler, Ph.D., M.D.
James Sorensen, Ph.D.
Hazel Szeto, Ph.D., M.D.
Dale Walker, M.D.
Steven Wolinsky, M.D.
Jon-Kar Zubieta, Ph.D., M.D.

Council Members Absent:
Ex Officio: John P. Allen, Ph.D., M.P.A.
Marina Picciotto, Ph.D.

Council Chair:
Nora D. Volkow, M.D.

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:
William Corrigall, Ph.D. - Contractor
Yoshie Davison, M.S.W. - American Academy of Child and Adolescent Psychiatry
Julie Miller, Ph.D. - RTI International
Andrea Silva, M.A. - American Academy of Child and Adolescent Psychiatry
Lori Whitten, Ph.D. - RTI International
Robert Yates, M.S. - Social & Scientific Systems

Closed Portion of the Meeting - September 12, 2011

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. 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. 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 Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; and the Office of Science Policy and Communications 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.

Open Portion of the Meeting - September 13, 2011

1. 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. Dr. Volkow called attention to future Council meetings: February 14-15, 2012, May 10, 2012, September 5-6, 2012.

2. Consideration of the Minutes of Council

   The Minutes of the May 2011 meeting were approved as written.

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

   Dr. Volkow opened the meeting by thanking the retiring Council members for their service on Council and acknowledging the importance of their many contributions. She then presented the NIDA Discovery Award to Dr. Raphael Mechoulam for his extraordinary work in substance abuse and neurosciences. Dr. Volkow described some of Dr. Mechoulam's discoveries as she introduced him. Dr. Mechoulam thanked Dr. Volkow and briefly described his funding history at NIH and his continuing research interests.

   Dr. Volkow began her Director's Report by noting with sadness the passing of Dr. Robert Schuster, NIDA Director from 1986-1992; Dr. Joseph Brady, President, Institute for Behavior Resources and Professor Emeritus, Johns Hopkins University School of Medicine; and Dr. Tom Brady, Program Officer with the Services Research Branch of DESPR. She briefly described the important roles each had played in NIDA's mission.

   She then turned to the budget, noting that for 2011 the President's budget called for a 3.3% increase while the full year Continuing Resolution would mean a 0.9% decrease from the previous year. In her comments about what is new at NIH, Dr. Volkow showed preliminary information about how NIDA applications fare at CSR study sections. The data do not indicate any systematic bias across study sections at CSR. She discussed the recent Science article about race, ethnicity and research awards, noting the disparity between NIH research awards for Black/African American and both other minority groups and the full sample of applicants for NIH funding. She noted that NIDA's record in supporting minority investigators would be addressed later in the day.

   Dr. Volkow then reported on the NIH leadership forum she had attended where a topic on which she spoke was the economic impact of NIH-funded research. She discussed how economic impact could be conceptualized and measured and presented, as an example of ways to consider economic impact, an article on the role of public-sector research in the discovery of drugs and vaccines that concluded such research has had a more immediate effect on improving public health than was previously realized. She cited other data to demonstrate the important, far-reaching and positive consequences of NIH research on economic growth. NIH intramural laboratories have been particularly productive in developing new FDA approved drugs.

   Dr. Volkow next presented the NIH Blueprint for Neuroscience Research Grand Challenge: Developing Novel Drugs for Disorders of the Nervous System. Seven applications will be funded with this U01 mechanism, though none is in drug addiction, and an outreach campaign for NIDA investigators is needed so that they will successfully compete for these funds. Other research opportunities were described, including Common Fund opportunities and ideas from NIH Institutes and Centers, including NIDA-relevant ideas on biomarkers for chronic pain using functional brain connectivity and development of new medications to treat chronic pain.

   Several recent NIDA activities and events were noted for each of NIDA's priority areas: prevention, treatment, and medical consequences. Under prevention research, Dr. Volkow cited a recent study looking at the role of childhood self-control in predicting health, wealth, and public safety. Recent SBIRT developments were also presented. These include work on options for adolescent drug abuse screening for medical settings, revision of the NIDAMed screening to improve efficiency and work with ONDCP and HHS on proposals for including drug abuse screening as a standard part of electronic medical records systems. Some new PAs and RFAs were also identified, including an RFA to integrate drug abuse prevention and treatment in primary care settings and a PA on the epidemiology of drug abuse.

   Under the priority area of treatment interventions, Dr. Volkow presented data from an interesting study on CB2 receptors modulating cocaine's actions in mice and described a CTN study on cocaine use reduction with buprenorphine that will be enrolling subjects to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence in a sample of individuals meeting diagnostic criteria for both cocaine and opioid dependence or opioid abuse. Dr. Volkow also presented two new RFAs in this priority area: the translational Avant-Garde Award for Medication Development for the Treatment of Substance Use Disorders (RFA-DA-12-010) and the Remote Monitoring System for Detecting Cocaine Ingestion/Intoxication (RFA-DA-12-007). She noted the importance of being able to decrease drug usage, even when abstinence is the ultimate goal. Because it is often difficult to achieve abstinence, it is important to identify interventions and medications that will reduce use, a concept approved by the FDA for alcohol, though not for illicit drug use.

   In the HIV and Drugs area, Dr. Volkow noted that an AIDS Avant-Garde Award had been awarded to Dr. David Ho to develop a novel HIV therapy that could be administered monthly. She noted that Dr. Ho had won the TIME magazine 1996 Man of the Year award for pioneering the early use of the antiretroviral cocktails that have reduced the death rate from AIDS. Dr. Volkow then identified all of the current AIDS Avant-Garde awardees and their ongoing pioneering research. She also described briefly the 6th IAS conference on HIV pathogenesis, treatment and prevention, noted some relevant research findings and presented new PAs and RFAs in this area, including an RFA that NIDA has joined on promoting engagement in care and timely antiretroviral initiation following HIV diagnosis and the NIDA FY12 Avant-Garde Award Program HIV/AIDS research RFA.

   In other news, Dr. Redonna Chandler was presented the 2011 NIDA Director's Innovator Award for harmonizing and standardizing the instruments used by awardees of the RFA "HIV Seek, Test and Treat in Criminal Justice Settings" to increase comparability across the studies. There were three addiction science awardees from the INTEL high school science and engineering competition. There was a dramatic reading by Debra Winger and Arliss Howard of Act III of Long Day's Journey into Night, a free CME event that was very well attended and positively evaluated. The Second Annual National Drug Facts Week will take place from October 31 to November 6. Also, NIDA has again organized a mini convention, Frontiers in Addiction Research, at the Society for Neuroscience Research meeting, which will take place in November.

   Council members thanked Dr. Volkow for her presentation. There was discussion about the economic impact of NIH research on society and the importance of this type of analysis in presenting the value of NIH to the public. The importance of identifying effective treatments, tracking their use in the community, and making the public aware of them was also noted. Dr. Volkow proposed that a Council work group be established to identify which successful treatments have been widely adopted and what barriers there have been to adoption. The importance of preventive interventions was also noted, and Council members found the data on early self-control and subsequent outcomes interesting and provocative in this regard. Several Council members noted the implications of the findings for drug abuse and other research questions, including the role of parents in teaching self-control to their children and strategies for teaching self-control/delay discounting to adults. The complexity of implementing evidence-based treatments was noted, and the difficulty of knowing what parts of a complicated intervention might be more or less effective was also discussed, as was the need for a stronger science of implementation and sustainability of programs. Finally, the importance of Council participating in the creation of a new Institute focusing on alcohol and drug use and addiction was again mentioned.

4. Points to Consider Regarding NIDA Grantees and Tobacco Industry Funding - James Sorensen, Ph.D., Council Workgroup Member

   Dr. James Sorensen began his report by stating the issue of concern: tobacco companies fund scientific research in academic and other settings, and recent court rulings have found self-serving biases in tobacco industry supported research, thus leading to the perception of compromised research results.

   A Council work group was established by Dr. Volkow in 2009 to explore key issues regarding tobacco industry funding of NIDA grantees and applicants. In 2010, a meeting, Funding 7 Scientists/Organizations that Accept Support from Tobacco Companies Research, was held to provide input/recommendations to the Council work group regarding development of policy on acceptance of tobacco industry funding. Participants included members of the NIDA Council, NIDA, NCI, and other NIH staff and members of the research community. A Points to Consider document, Regarding Tobacco Industry Funding of NIDA Applicants, was drafted and revised, and this document was presented to the Council.

   Dr. Sorensen summarized the Council work group position as follows: NIDA is one of the leading Federal agencies supporting research to prevent and control tobacco use and addiction; as a steward of Federal funds intended to promote the public health, NIDA must ensure the integrity of the science it supports. Given that the tobacco industry manufactures, markets, and distributes products that are both addictive and lethal, the work group believes that the interests of the tobacco industry are fundamentally incompatible with the scientific goals and public health mission of NIDA.

   Dr. Sorensen then presented recommendations for the approval of Council: 1) NIDA applicants and grantees who accept tobacco industry funding should consider that it could: compromise the perceived objectivity of their research results and affect the overall credibility of their research findings; be viewed as contributing to tobacco industry interests; and negatively impact NIDA's credibility and the public trust in NIDA-funded research; and 2) NIDA, when making funding decisions, should consider whether a grantee's funding relationship with tobacco companies may impact the credibility of the research results as well as public confidence in NIDA's stewardship of its funds and its research-based recommendations; and whether the impact of such a relationship on public trust and confidence is outweighed by the potential public good from funding the application.

   Council thanked Dr. Sorensen for his report and recognized that the issues he had raised were extremely complex. For example, it was noted that even defining the tobacco industry itself was complicated because there are pharmaceutical firms that were created by the tobacco industry that produce nicotinic compounds of great value to the scientific community. Dr. Sorensen noted that the work group had provided an initial definition of the tobacco industry. Also, the work group distinguished companies that manufacture or distribute products such as cigarettes from those that develop products to help people stop smoking. The role of IRBs was mentioned, and it was noted that legal advice had been obtained in developing this report. Discussion included how these recommendations could actually be implemented, how scientific independence is maintained, and what responsibility and limitations Council has in these matters and the audience(s) for whom the document was intended. The importance of full disclosure of funding sources was noted. The question was raised as to whether Council could, as part of its second level of review responsibility, consider applications from grantees receiving tobacco industry funding separately, rather than as part of en bloc consideration; doing so is within Council's purview. After additional discussion, Council unanimously voted to accept this document as a working document, with the understanding that it would undergo further discussion and refinement as needed.

5. Report of the Diversity and Health Disparity Workgroup: Taking Stock and Moving Forward - Anita Everett, M.D., Council Workgroup Chair

   Dr. Everett, Chair of the Diversity and Health Disparities Work Group, presented the charge given to the work group by Dr. Volkow: 1) examine NIDA's efforts at supporting minority investigators and at recruiting minority subjects into NIDA-funded research studies and clinical trials and 2) explore the extent to which each of the recommendations of the 2005 Racial/Ethnic Minority Healthy Disparities Council Work Group was implemented. She identified the six work group members, noting that Drs. Sorensen and Walker from the Council were also on the work group.

   Dr. Everett described the data gathering activities of the work group and acknowledged all of the presenters of the materials. The work group held two face to face meetings and several teleconferences in order to complete its mission.

   In response to the first part of the charge, the work group identified a number of programs that support minority investigators, e.g., the African American, Hispanic, Asian/Pacific Islander and Native American Researchers and Scholars Expert Minority (REM) Work Groups, the Diversity-Promoting Institutions Drug Abuse Research Program (DIDARP), and the NIDA Summer Research Program, as well as several others. She then presented data from 2005-2010 on NIDA's efforts at supporting minority investigators, noting funding success rates. This was followed by assessing the percentages of minority awardees receiving fellowship, research career award, and research project grant support in fiscal years 2005-2010. She summarized these data by noting that there has not been much change in funding success rates among Hispanic and Asian/Pacific Islander investigators over the five-year period investigated, and that the rates of funding success of those minority groups are similar to White and overall success rates. However, there does seem to have been an increase in success rates among African American investigators during that same period. She noted that the numbers are quite small in some cases, and that great caution must be taken in drawing conclusions. She also pointed out that, while it is not clear which diversity-promoting programs might be contributing to success in obtaining funding, it is the case that NIDA efforts toward increasing the number of applications are likely successful for some groups.

   The work group concluded that NIDA has been quite successful in recruiting minority subjects into research studies and clinical trials. This conclusion was based on comparisons of NIDA's enrollment of minority subjects in its clinical studies and trials compared to that of NIH as a whole and the 2010 census data. In the past five fiscal years, the portion of NIDA's portfolio focused on health disparities and minority health has progressively increased.

   With reference to the second part of the charge of the work group, Dr. Everett summarized the 2005 recommendations and NIDA's efforts to implement them. The work group was satisfied with NIDA's efforts toward using the NIH Roadmap (Common Fund) to encourage interdisciplinary teams and approaches. However, the work group did not find adequate efforts toward an alignment between the NIDA Strategic Plan and the NIDA Strategic Plan on Reducing Health Disparities that had been recommended in 2005. The workgroup noted that there was a recommendation to enhance NIDA organization and collaboration around minority issues and that, although there is much work throughout NIDA on health disparities, with more attention and resources this could be strengthened. Also, although there are several programs to increase training opportunities for minority investigators, as was recommended in 2005, it is difficult to track the career progression of minority investigators, and thus evaluate the success of these programs. There was a recommendation to create incentives to promote valid analyses on minorities, and NIDA has funded several studies that use small group methodologies, and the CTNs have had some focus on small group methods. In order to implement the recommendation 9 to address the research needs and priorities of populations with the greatest health disparities, NIDA has moved forward with several activities, with a special focus on those at risk for HIV/AIDS and American Indian populations.

   Dr. Everett concluded her presentation with recommendations of the 2011 work group to NIDA: 1) develop a comprehensive implementation plan for coordinating and leading NIDA's diversity and health disparities efforts; 2) explore options for organizational restructuring of the activities related to enhancing diversity in the extramural research community; 3) provide applicants from diverse communities with opportunities to engage with the entire grant application review process; 4) maximize the utility of the REM work groups through improved coordination and collaboration among them and with NIDA; 5) develop a tracking system for monitoring and evaluating the submission and funding metrics of applicants supported through NIDA's diversity efforts; 6) develop a focused strategy to enhance the dissemination of research findings on minority health disparities; and 7) enhance support for translational studies on substance use problems in minority populations to support the adaptation of evidence-based interventions for those populations.

   Council members thanked Dr. Everett for her report. Council unanimously approved the report. Dr. Volkow noted that NIDA would respond to the recommendations and also thanked the work group for its efforts.

6. Presentation of Concept Clearances - NIDA Program Staff

   Five new program concepts were presented to Council. First, Dr. Joni Rutter, Acting Director, DBNBR, spoke about the role of glia in drug abuse and HIV. She noted the importance of examining the complex nature of glia cell function and activation in response to drugs of abuse and HIV, including the role of glia in neurotoxicity in drug abuse and HIV, glia as mediators of addiction (mechanism and targets), glia as mediators of HIV effects and glial modulation of neural circuit development and neuroplasticity. Council agreed that this was a timely and important topic and also pointed to the need for understanding developmental issues.

   Second, Dr. Wilson Compton, Director, DESPR, presented a concept on the service delivery system and the Affordable Care Act. He commented on the importance of studying the impact of the ACA on drug abuse prevention and treatment services and raised several questions that might be addressed, noting that the ACA heralds unprecedented transformation of health care delivery including drug abuse prevention and treatment and he stated that the proposed research program has the potential to inform policy, clinical practice and future research needs in a time of rapid and fundamental change. Council praised this concept, agreeing that it is timely and very important. Council noted that paying attention to already implemented aspects of the ACA will be relevant and that the gathering of baseline data will be essential to answering questions of interest. They appreciated that Dr. Compton had considered what other NIH institutes and other agencies might be interested in joining with NIDA on this program.

   Third, Dr. Redonna Chandler, Chief of the Services Review Branch, DESPR, presented an initiative called CJDATS-A, or Criminal Justice for Drug Abuse Treatment Studies for Adolescents. This concept builds on work that has been funded at NIDA for the past eight years, the CJDATS multi-site collaborative network working with criminal justice systems to look at drug abuse prevention and treatment research. The new concept is to intervene for HIV and drug 10 abuse by having researchers partner with juvenile justice agencies, such as truancy, teen and family courts. Dr. Chandler identified several research topics, noting that supporting research to integrate evidence-based drug abuse and HIV prevention and treatment for adolescents into the juvenile justice system has the potential to rescue young lives, help families and communities and save money. Council was enthusiastic about this concept.

   Fourth, Dr. Jamie Biswas, Chief, Medications Research Grants Branch, DPMCDA, presented a concept for an announcement that should help accelerate medications development for substance use disorders. She noted the importance of accelerating the pace of medications development, particularly in areas of unmet clinical need such as cocaine and methamphetamine dependence and the disorders that accompany them. Under this announcement, applicants would partner with a private or public entity that would provide significant resources for accomplishing the proposed work. The ability to leverage funds/resources should result in reaching goals in a shorter time frame than is the case with a traditional grant. Council thought this was an innovative program and raised the issue of intellectual property and the importance of clarifying this complex issue.

   Finally, Dr. Ming Shih, a program officer in DPMCDA, presented a concept on the synthesis and early stage evaluation of medications to treat SUDs. The goals of this proposed program are to generate candidates for pre-IND studies; to encourage innovative ideas and approaches for faster and cost-efficient medication development; and to promote a "fail fast/fail cheap" ethos among grantees. The impact of this program would be to accelerate the pace of bringing viable drug candidates to the next stage of development. Council also supported this concept.

7. There were no public comments.
8. Adjournment

   The 109th 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.