Minutes of the 94th Meeting of the National Advisory Council on Drug Abuse

September 19-20, 2006

The National Advisory Council on Drug Abuse convened its 94th meeting at 3:00 p.m. on September 19, 2006 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland. Dr. Nora D. Volkow, Director of NIDA, chaired the overall meeting and Dr. Timothy P. Condon, Deputy Director of NIDA, chaired the review of applications. The closed portion of the meeting on September 19th, from 3:00 p.m. until 6:00 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 20th, from 8:30 a.m. until 1:30 p.m. The Council adjourned on September 20, 2006 at 1:30 p.m.

Council Members Present:

Rodolfo Arredondo, Jr., Ed.D.
Warren K. Bickel, Ph.D.
Steve Brasington, M.D. (Ex officio)
Jeanne Brooks-Gunn, Ph.D.
Mark T. Greenberg, Ph.D.
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Ellie E. Schoenbaum, M.D.
Richard R. Suchinsky, M.D. (Ex officio)
Constance M. Weisner, Dr.P.H.
Marina E. Wolf, Ph.D.
Janet Wood, M.B.A., M.Ed.

Council Members Absent:

Bankole A. Johnson, M.D., Ph.D.
Thomas E. Lucking, Ed.S.
Claire E. Sterk, Ph.D.

Council Chairs Present:

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

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present:

Virginia Ashton - AACAP
Anne Bowen - MasiMax Resources, Inc.
Sue Camaione - MasiMax Resources, Inc.
Mark Decker - Synergy Enterprises, Inc.
Margaret Diggins - Social & Scientific Systems
Julie Egermayer - COSSA
W.E. Ford - Synergy Enterprises
Stacia Hall - AACAP
Sonia Kandathis, M.P.H. - AMFAR (The Foundation for AIDS Research)
Roxanne Kibben - Synergy Enterprises
Marian Kratage - MasiMax Resources, Inc.
Emily Lang - CADCA
Judy McCormally - IQ Solutions
Geoffrey Mumford, Ph.D. - American Psychological Association
Rick Offner - DB Consulting
Amy Pollick, Ph.D. - Association for Psychological Science
Claire Ricewasser - AC-Anon Family Groups
Tim Turner, Ph.D. - National Assoc. of Social Workers
Diedre Watkins - MasiMax Resources, Inc.
Lori Whitten - MasiMax Resources, Inc.
Andy Wright - NPAA
Joan Levy Zlotnik, Ph.D. - Institute for Advancement of Social Work Research
Patricia Zickler - NIDA Notes

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. Dr. Condon provided an overview of the agenda for the meeting and reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public. Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Division of Epidemiology, Services and Prevention Research; and the Division of Pharmacotherapies and Medical Consequences of Drug Abuse presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc.

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

   For this Council, 1,090 applications, requesting $1,050,360,062 in Total Years Direct Costs, went to review. Of these, 523 were scored by the Scientific Review Groups (SRGs) representing $115,405,135 in First Year Direct Costs and $478,975,976 Total Years Direct Costs. Council concurred with the SRGs in time and amount.

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Volkow called attention to future Council meetings.

2. The NIH Office of Portfolio Analysis and Strategic Initiatives Deputy Director, NIH - Raynard S. Kington, M.D., M.B.A., Ph.D., Deputy Director, NIH

   Dr. Raynard Kington presented a brief overview of the new NIH Office of Portfolio Analysis and Strategic Initiatives. He noted that the NIH has been particularly adept at setting priorities within its Institutes and Centers and within relatively small areas of science. That is, each of the 27 Institutes and Centers (ICs) of NIH has successfully developed its own plans, sometimes including other ICs, but NIH has not been as successful in strategic planning in areas that cut across the missions of several ICs. What is needed, therefore, is a way to resolve the current ad hoc approach to trans-NIH research, and the Office of Portfolio Analysis and Strategic Initiatives (OPASI) has been created to do exactly that.

   This office will provide a new opportunity for more trans-NIH dialogue, decision making and funding. It will also offer transparent, systematic processes for several activities, including determining how much NIH spends on research related to specific diseases and conditions; assessing scientific opportunities and public health needs and integrating them into trans-NIH-wide funding priorities and coordinating funding of research areas that cut across all, or fall between, the missions of individual Institutes and Centers. In addition, OPASI will improve evaluation of the effectiveness of programs and it will allow the NIH to be more nimble, dynamic, and responsive to emerging scientific opportunities and public health needs. Thus, the mission of OPASI is 1) to provide NIH Institutes and Centers with the methods, tools, and information necessary to improve management of their large and complex scientific portfolios; 2) to identify--in concert with multiple other inputs--important areas of emerging scientific opportunities or rising public health challenges; 3) to help accelerate investment in these areas, focusing on those involving multiple Institutes and Centers and 4) to coordinate and make more effective use of NIH-wide evaluation processes.

   Dr. Kington presented the structure of OPASI. The OPASI Director will report to the Director, NIH. The structure will include three Divisions: 1) Resource Development and Analysis for the development and use of analytic tools and information, e.g., knowledge management; 2) Strategic Coordination for the strategic coordination NIH-wide planning and the provision of an incubator space for trans-NIH initiatives, e.g., the NIH Roadmap; 3) Evaluation and Systematic Assessments for planning, conducting, coordinating, and supporting program evaluations for ICs, trans-NIH initiatives, GPRA and PART.

   Dr. Kington then described how new initiatives are chosen. He pointed out that there have been scientific consultation meetings which encourage scientists from academia and industry as well as public representatives to submit ideas. Ideas have also been obtained from NIH staff, and the ICs have nominated many potential topics for initiatives. Further, web-based public comment and input have been encouraged so that broad science and lay communities have had the opportunity to participate in ideas that have been generated. Consultation meetings have been a valuable source of ideas for new Roadmap initiatives, with ideas selected through a rigorous process of discussion, synthesis and priority setting. Dr. Kington pointed out the importance of Council members and others providing input, and he encouraged Council members to provide new ideas. He noted that, over the next six months to a year, these lists of potential initiatives will be shortened to produce a set of activities to begin in FY 08.

   Dr. Kington also described the mission and structure of a new Council of Councils. The mission of this group is to help prioritize topics that have been proposed as initiatives. It will be composed of about 30 members, including representatives from each Institute, Center, and the OD Program Office Advisory Council as well as the NIH Council of Public Representatives. The ICs and the OD program offices will nominate three candidates, two scientists and one lay member. The NIH Director will make final selections, ensuring that there is representation of a broad range of disciplines and perspectives on this Council of Councils.

   Dr. Kington noted that there will also be a common fund which will provide a formal structure to pool resources for trans-NIH priorities and will provide a more efficient and effective means of doing business. In FY 2007 the common fund will be about 1.6% of the total NIH budget. The common fund will increase to up to 5% of the total NIH budget, contingent upon growth of the NIH budget and the identification of trans-NIH scientific opportunities and public health needs. OPASI will use current NIH grant review and grant management structures with lead ICs providing scientific management, while the common fund will provide capital and researchers will provide results to advance public health. There will be a 10 year maximum for initiatives to remain in OPASI. Thus, there will be new projects brought into OPASI on a regular basis.

   Dr. Kington concluded his presentation by noting that OPASI will provide a novel approach to assure that NIH is more effective and more efficient in meeting its mission as the nation's medical research agency, and he again encouraged Council members to respond to the RFI that will soon be issued so that they could comment on ideas which have already been presented and also suggest new ideas.

   Dr. Kington then answered questions from Council members and provided additional information about the relationship between OPASI and current offices in the NIH Office of the Director, about the OPASI budget and staffing and about knowledge management for portfolio analysis.

3. Consideration of the Minutes of Council

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

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

   Dr. Volkow began her report with a budget update, noting that the 2006 NIDA appropriation of $1,000,029,000 represented a .6% decrease over the prior year and that the President and House 2007 budget figure of $994,829,000 would yield a .5% decrease over the prior year.

   She then presented information about new activities at NIH, referring to a presentation by Dr. Elias Zerhouni, Director, NIH, on adaptive strategies in the context of changing science and public health. She pointed to the challenge of rising health expenditures and reminded everyone of NIH's core strategic vision: to transform medicine and health from a curative to a preemptive paradigm; to accelerate fundamental research on complex biological systems and their regulation at the earliest molecular stages of disease; to remove barriers to translation of findings from the bench to the bedside; and to provide evidence and knowledge to enable the healthcare system before disease strikes. Several points of tension were also noted: how can NIH best balance large vs. small-scale science, basic vs. translational research, infrastructure vs. hypothesis driven R01s? Other issues include how to handle the demand/supply imbalance in peer review, how to address public health issues, how to communicate with constituencies, how to continue to support the best intra and extramural science and scientists, and how to decide what should be at the top of the agenda.

   Dr. Volkow described Roadmap II, noting that the overarching goal of all Roadmap initiatives is to accelerate the discovery and translation of scientific knowledge into public health benefits. Thus, any proposed initiative must be truly transforming, dramatically affecting how biomedical and/or behavioral research is conducted over the next decade, and the outcomes must synergistically promote and advance the individual missions of the Institutes and Centers to benefit health. Further, an initiative must require participation from NIH as a whole and/or address science that does not clearly fall within the mission of any one IC or OD program office, and be something that no other entity is likely or able to do and will benefit the public health. Dr. Volkow presented the schedule for Roadmap II.

   She then turned to NIDA-specific activities, responding to points raised by reports from two recent Council workgroups. For example, the Council workgroup on NIDA's approach to grant making had raised questions about the success of new investigators. Dr. Volkow noted that NIDA is now above the NIH average in terms of new investigators on R01 awards as a percentage of competing investigators. The Council workgroup reviewing basic science had encouraged expansion of the portfolio, and Dr. Volkow reported on three successful RFAs that did exactly that: 1) social neuroscience, 2) prescription opioid use and abuse in the treatment of pain, and 3) the epigenetics of addiction. Taken together, these announcements brought in almost 200 applications. Many of these applications were of very high quality and will be important additions to the NIDA portfolio. She also described the new Genes, Environment and Development Initiative (GEDI). This program has grown out of a portfolio review and envisions supporting grants that will combine environmental, genetic, developmental and phenotypic components in order to provide useable resources and serve as a foundation for fine mapping of GEDI components. It is responsive to the Council recommendations to develop more cross-NIDA activity and to take advantage of unique opportunities; in this case, opportunities to be found through integrating science in current grants.

   Dr. Volkow then reported on selected activities of each division. The Division of Basic Neuroscience and Behavioral Research has released a Program Announcement to capitalize on the NIH knockout mouse project, high-throughput genetic and RNAi methods and research in GEI and will use genetic models to investigate mechanisms of drug dependence and test potential therapeutics.

   The Division of Clinical Neuroscience and Behavioral Research has funded important work using imaging technologies in new ways. Dr. Volkow reported results on the use of fMRI activation signals as feedback to control specific brain regions. She noted that two independent laboratories have trained individuals to activate the anterior cingulate gyrus, raising the fascinating question of whether subjects could be taught to regulate the intensity of craving for drugs or to strengthen inhibitory control.

   The Division of Pharmacotherapies and Medical Consequences of Drug Abuse, using scientific board recommendations for the clinical evaluation of medications for further trials, has grouped a number of medications into "go," "data missing for decision," and "no go" categories. Dr. Volkow briefly described some of these medications and the decisions about them.

   The Division of Epidemiology, Services and Prevention Research has completed a number of activities as part of the criminal justice initiative, including training for judges, providing a special criminal justice and drug abuse web page with slides, fact sheets and other information and releasing a program announcement focused on "Drug Abuse as a Cause, Correlate, or Consequence of Criminal Justice Related Health Disparities among African Americans". She noted that Dr. Redonna Chandler would provide more information about an important new publication on principles of treatment as well as other aspects of this initiative later in the day.

   Under the Center for the Clinical Trials Network, Dr. Volkow noted FDA approval for an HIV rapid test that will use blood or oral fluid, cost about $12-15/kit, take only 20 minutes, and it also can be administered by counselors. This is a very important advance for screening in outpatient drug abuse treatment facilities like those in the CTN.

   Dr. Volkow then reported on recent and upcoming meetings, conferences and events, describing NIDA's role in them. These meetings included the 13th World Conference on Tobacco or Health, the College on Problems of Drug Dependence annual meeting, the American Psychological Association annual meeting and the National Hispanic Science Network on Drug Abuse annual conference. Further, a Congressional briefing on preventing drug abuse was sponsored by the Friends of NIDA. NIDA will sponsor a mini-convention at the 2006 meeting of the Society for Neuroscience and a Blending Addiction Science and Practice meeting in Seattle in October. Both types of meetings have been very successful in the past, and Dr. Volkow invited Council members to attend these upcoming meetings.

   Dr. Volkow then responded to questions and comments from Council, including a question about NIDA's suggestions for Roadmap II activities and the GEDI project.

5. The Pervasiveness of Sex Differences In Drug Abuse - Cora Lee Wetherington, Ph.D., Coordinator, Women and Gender Research Program, NIDA

   Dr. Cora Lee Wetherington reported that for the last several years NIDA has been engaging in a variety of efforts to increase research in the area of sex/gender differences and that she would present a sample of the research findings that have emerged. She presented some prevalence data with respect to drug use and drug dependence, identifying male/female differences in both, raising the question of whether females are less vulnerable to drug abuse than males. Comparing population prevalence vs. conditional prevalence across different types of drugs and looking at all age groups vs. adolescents lead to the conclusions that 1) if given the opportunity, females are as likely as males to use drugs and to become dependent and 2) adolescent females, compared to males, in 8th and 10th grades are more likely to use any illicit drugs other than marijuana and are more likely to become dependent on cocaine, using more of it and using it more frequently as well as to develop nicotine dependency symptoms faster.

   Turning next to the animal models literature, Dr. Wetherington noted that the behavioral data from drug self-administration studies suggest that females are more vulnerable; to support this conclusion, she presented the findings of drug self-administration studies, looking at the amount of drug self-administered, reinforcing effectiveness, speed of acquisition of self-administration, prevalence of self-administration and escalation of cocaine self-administration, asking if a biological basis is to be found in female/male differences that may be attributable to differences in circulating gonadal hormones as well as non-hormonal factors, including emerging research suggesting the importance of sexual dimorphism in brain organization and gene expression.

   Dr. Wetherington then presented data on hormonal changes during the menstrual cycle. The menstrual cycle data raise the important question of whether the findings can be used in treatment settings to provide more effective care, given, for example, preliminary data showing that quitting smoking during the luteal phase produces poorer short-term abstinence.

   There are many studies on gender differences as predictors of drug use, and Dr. Wetherington summarized some that had studied aggressiveness, conduct disorder, cigarette use, smoking of the mother during pregnancy on boy/girl child smoking, family characteristics, peer difficulties, and parental stress. She noted that predictors are often gender-sensitive and gender-specific.

   In the prevention area, Dr. Wetherington reviewed the work of Flay et al (2004) on two prevention interventions in which boys but not girls showed significant improvement in all the target behaviors, again raising the question of whether addressing gender-based predictors in treatment and prevention efforts will improve outcomes for both males and females.

   She then turned to the brain imaging literature, describing studies on gender differences in cue-induced craving and brain deficits, showing, among other outcomes, that female smokers are much more sensitive to cigarette cues than male smokers and that, while there are many common areas of activation in male and female cocaine cue-induced craving, as shown in PET imaging, there are also many male/female differences in activation in areas such as the insula and amygdala. Differences are also found in frontal cortical deficits of cocaine-dependent male and female subjects, raising, again, the question of whether differences in outcome have implications for treatment strategies for males and females.

   There has also been substantial research on prenatal drug exposure, meaning maternal drug use during pregnancy. Dr. Wetherington suggested that "prenatal drug exposure" is no longer a feminine term by suggesting new questions: what are other effects of paternal drug use and what are the combined effects of maternal and paternal use? She also asked if that combination was playing a role in NIDA's cohort studies and what the impact might be on male versus female offspring.

   Dr. Wetherington then turned to the important area of treatment, presenting data showing that disulfiram as a treatment for cocaine-dependence was efficacious only in males and that nicotine is metabolized differently in men and women, an outcome of importance for treatment because faster nicotine metabolizers have poorer smoking cessation outcomes from transdermal NRT.

   Dr. Wetherington concluded her presentation by acknowledging researchers who conduct a sex/gender analysis of their data and noted that a sex/gender-based research approach in all areas of drug abuse research will lead to better prevention and treatment outcomes for both males and females and that gender differences are pervasive in drug abuse, that gender matters in drug abuse, and that conducting a sex/gender analysis of data is a matter of doing good science.

   Council members thanked Dr. Wetherington for her presentation, and raised a number of issues, including questions about the possible role of paternal drug use on offspring, treatment effectiveness, the importance of gender analyses, and gender differences in prevention intervention outcomes.

6. Treatment is the Key: Addressing Drug Abuse Problems in the Criminal Justice System - Redonna Chandler, Ph.D., Director, Services Research Program, Division of Epidemiology, Services & Prevention Research, NIDA

   Dr. Redonna Chandler provided a report on aspects of NIDA's program on drug abuse in criminal justice settings. She noted that the criminal justice system is made up of many different organizations and entities. She presented key events, players and intervention opportunities that need to be taken into account, ranging from entry into the criminal justice system at the time of arrest to community reentry in the form of probation, parole or release. At each point, different key players and intervention opportunities present themselves. Dr. Chandler noted the close link between drug abuse and crime, with, for example, 52% of women and 44% of men in jail meeting alcohol/drug dependence criteria and with drug use involved in more than 50% of violent crimes. Further, she noted that regular drug use is reported for 70% of individuals in state prisons and local jails and that addiction is common in the juvenile justice system as well. The estimated cost of drug abuse is about 181 billion dollars and 107 billion dollars is associated with drug related crime.

   There are two main approaches to the drugs/crime interface: 1) the public health approach with its focus on addiction as a disease needing treatment and the associated problem of getting people to participate in treatment for a long enough period of time for the treatment to be successful and 2) the public safety approach with its focus on the illegal behavior aspect of drug use and its punishment and with the associated problem of recidivism. Dr. Chandler presented an integrated public health-public safety strategy, bringing together the strengths of each approach and blending the functions of the criminal justice and treatment systems to optimize outcomes. Thus, one feature of this strategy includes community-based treatment and close supervision with consequences for non-compliance that are immediate and certain.

   Dr. Chandler devoted the remainder of her presentation to one of several ways NIDA is engaging the criminal justice system: the publication of Principles of Drug Abuse Treatment for Criminal Justice Populations. This research-based guide lists several principles of drug abuse treatment and provides evidence to support each principle. It is based on about 15 years of research in both the drug abuse and criminology literatures and it distills essential material down to 15 principles, with the intent of providing professionals in the criminal justice system guidelines as they consider ways in which they deliver treatment and services to those who have drug abuse problems.

   Although there was not sufficient time to discuss each principle, Dr. Chandler highlighted several of them and presented one of several possible pieces of science supporting each of them. For example, she illustrated the principle that drug addiction is a brain disease that affects behavior with a slide showing how brain changes in addiction help explain continued drug use and relapse. Another principle is that treatment must last long enough to produce stable behavioral changes. Data were provided showing that treatment of 90 days or more was substantially more effective than treatment lasting for a shorter period of time. Still another principle, that treatment should target factors that are associated with criminal behavior, was supported with data showing that targeting multiple behaviors reduces recidivism. Offender treatment targets include antisocial feelings, attitudes, orientations, values; anger/hostility; and alcohol/drug problems, among others. Other important principles, e.g. that a balance of rewards and sanctions encourages prosocial behavior and treatment participation, that continuity of care is essential, that medications are an important part of treatment for many drug abusing offenders, were also presented with supporting data.

   Dr. Chandler concluded by noting that NIDA science is being used to change the criminal justice system in important ways and that treatment is the key to change, because neither punishment alone nor forced abstinence during incarceration teaches people what they need to know in order to be able to deal with their drug addiction and change their problematic behaviors. She also noted that on-going collaboration and research with the criminal justice system is essential.

   Council thanked Dr. Chandler for her presentation, and she responded to questions and comments about treatment opportunities in different types of prisons, about medication for addiction and barriers to providing medication within the prison system, and about the need to consider issues of comorbidity.

7. Public Comments

   Dr. Joan Levy Zlotnik, Executive Director of the Institute for the Advancement of Social Work Research (ISWR) noted the importance of looking at differential treatment and service options for men and for women in the criminal justice system. She also presented some recent activities of ISWR and commended NIDA for its involvement in social work research infrastructure programs and related activities.

8. Adjournment

   The 94th meeting of the National Advisory Council on Drug Abuse was adjourned at l:30 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.