Minutes of the 91st Meeting of the National Advisory Council on Drug Abuse

September 21, 2005

The National Advisory Council on Drug Abuse convened its 91st meeting at 9:00 a.m. on September 21, 2005 in Conference Room C, Neuroscience Center, National Institutes of Health, 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 21 from 9:00 a.m. until 11:30 a.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 from 1:00 p.m. until 5:00 p.m. The Council adjourned on September 21, 2005 at 5:00 p.m.

Council Members Present:

Steve Brasington, MC (Ex officio)
Jeanne Brooks-Gunn, Ph.D.
Mark T. Greenberg, Ph.D.
Dorothy K. Hatsukami, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Claire E. Sterk, Ph.D.
David Vlahov, Ph.D.
Constance M. Weisner, DRPH

Council Members Absent:

Rodolfo Arredondo, Jr., Ed.D.
Peter W. Kalivas, Ph.D.
Peggy B. Sapp
Robert L. Woodson, Sr., MSW
Nancy R. Zahniser, Ph.D.

Council Chairs Present:

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

Executive Secretary:

Teresa Levitin, Ph.D.

Federal Employees Present:

National Institute on Drug Abuse, NIH, DHHS

Members of the Public Present:

Khursheed Asghar, Ph.D. - Contractor
Virginia Ashton - AACAP
Jack Blaine, M.D. - Contractor
Andrea Browing - Society for Research in Child Development
Sue Camaione - MasiMax Resources, Inc.
Jenn Columbel - National Drug Court Association
Bill Corrigall, Ph.D. - Contractor
Kim Crilly - University of Maryland
Heidi Ecker, Ph.D. - American Psychological Society
Katherin Fornin - University of Maryland
Malik Jallott - University of Maryland
Cheryl Kassed, Ph.D., M.S.P.H. - MasiMax Resources, Inc.
Andrew Kessler - NAADAC
Jane Kim - Entertainment Industries Council
Marian Kratage - MasiMax Resources, Inc.
Alan Kraut - American Psychological Association
Kristin Kreager - AACAP
Novet Lyn - University of Maryland
Mary Mayhew - Contractor
Geoffrey Mumford, Ph.D. - American Psychological Association
Amy Pearson - University of Maryland
Lori Perault - University of Maryland
Patricia Pettinato - MasiMax Resources, Inc.
Helene Quick - CSR, Inc.
J. Quintos - IQ Solutions
Darrel Regier - American Psychiatric Association
Ceil Sinnex - Substance Abuse Funding Week (CD Pubs)
Kristie Stoic, MPH - Physicians Committee for Responsible Medicine
Diedre Watkins - MasiMax Resources, Inc.
Erin Winsted - IQ Solutions
Patricia Zickler - NIDA Notes
Kim Zink - IQ Solutions

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 voting policies and procedures, 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; 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, 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, 987 applications, requesting $969,025,537 in Total Years Direct Costs, went to review. Of these, 604 were scored by the Scientific Review Groups (SRGs) representing $138,282,151 in First Year Direct Costs and $647,007,457 Total Years Direct Costs. Council concurred with the SRGs in time and amount. A request for one new MERIT was reviewed and approved. Council approved one administrative supplement. Council concurred with the IRG's recommendation on an appeal.

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. Consideration of the Minutes of Council

   The Minutes of the May 2005 meeting were approved as written.

3. NIDA Director's Report

   Dr. Volkow presented the appropriated 2005 budget, noting that it represented a 1.2% increase over the prior year. The total budget for 2005 was $1,006,419, with the AIDS portion of the budget at $313,137. The projected 2006 budget ranges from a .4% increase (PB and House) to a 2.9% increase (Senate).

   NIH is responding to aid victims of the hurricanes through a number of initiatives. NIDA activities include deployment of NIDA personnel to the affected areas. Also the Clinical Trials Network (CTN) Texas Node is helping at designated shelters and the Florida Node is providing treatment to any relocated citizens in need. Further, NIDA also expanded an announcement for time-sensitive research opportunities to include research pertaining to Hurricane Katrina. Program, review and grants management staff at NIDA, as well as the NIDA Council, will be working together to expedite the handling of these applications so that timely research can be supported.

   Dr. Volkow described several recent NIDA activities and events. The minority health disparities workgroup was an important workgroup that carefully reviewed the work of NIDA and acknowledged NIDA for its considerable minority research efforts. The workgroup did, however, have several recommendations. These included creating more interdisciplinary teams for research in health disparities, making reduction in health disparities a clearer priority, enhancing organization and collaboration, increasing training for minority researchers, providing incentives to promote valid analysis on minorities, and addressing research needs and priorities. Plans will be developed to evaluate progress on the task force recommendations.

   Dr. Volkow then provided data identifying how drug abuse and addiction disproportionately affect minority populations and reiterated that research on health disparities is a priority for NIDA. She further indicated how NIDA has responded and is responding to the workgroup recommendations. For example, announcements for RFAs and PAs have been developed that identify the need for interdisciplinary teams for research in health disparities. Also, several activities to enhance organization and collaboration are in place, with a NIDA health disparities strategic plan that draws on ideas from NIDA divisions, offices and centers, from working groups, and from Council. Furthermore, the NIDA workgroup on health disparities (with representatives from each division and center) will present opportunities to the director, NIDA, prior to each Council meeting, and there will be explicit emphasis on health disparities in all relevant RFAs and PAs.

   To increase training for minority researchers, NIDA will use supplements and will identify trainees and mentors. Further, NIDA will also supplement grants, where appropriate, to enable the collection and analyses of samples in minority populations. One clear priority is the examination of drugs and the criminal system where minorities are greatly over-represented.

   Dr. Volkow noted the creation of a basic science review workgroup consisting of both NIDA Council members and other senior scientists. The group was charged with reviewing the current basic science program portfolio and recommending ways of strengthening it. Its role is also to provide input into NIDA's basic science program with an emphasis on epigenetics and the neurobiology of social behaviors. They will report to the full Council at a subsequent meeting.

   Another workgroup is reviewing NIDA's approach to grant making. Dr. Volkow described the charge of this workgroup: to see if any actions or new policies might be needed to ensure that in this time of restricted budgets new investigators are protected, to examine the balance between large vs. small science at NIDA, to consider guidelines regarding principal investigators with multiple grants or laboratories with multiple grants, and to provide recommendations regarding the length of duration of various types of grants as well as to explore other issues as deemed appropriate. This group will provide a preliminary report in February to the Council.

   Dr. Volkow presented new PAs and RFAs issued by NIDA as well as those issued by other NIH components or agencies in which NIDA is a partner. These notices are available on the NIDA home page as well as in the NIH Guide.

   Dr. Volkow then presented recent accomplishments of the offices and divisions. She noted that NIDA has updated its priorities in the area of AIDS related research so that they are more clearly consistent with the priorities of the NIH Office of AIDS Research (OAR). NIDA priorities that are in strong agreement with OAR priorities include those focusing on health disparities, the role of non-injection drug use in the acquisition and transmission of HIV, international HIV/AIDS research and other areas. She also pointed out the importance of treatment studies among HIV-unaffected individuals. Though not in agreement with the OAR review on this point, Dr. Volkow noted that drug abuse treatment has been shown to be associated with reductions in risk behavior and HIV incidence. Thus, funding HIV prevention studies using drug treatment modalities in high-risk populations is very important and NIDA will continue to support this line of research.

   Dr. Volkow noted that the medications development scientific workgroup had held its second meeting in July. At this meeting, the group reviewed the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) preclinical contracts, and provided several recommendations, including recommendations about screening clinically effective drugs, collaborating with the intramural program and making better use of molecular libraries to identify molecules that could have potential for drug abuse and addiction. They also recommended exploration of drugs involved with neuroplasticity.

   Dr. Volkow's report on the Division of Basic Neuroscience and Behavioral Research (DBNBR) included a description of the NIH Knockout Mouse Project (KOMP) and the importance of making a comprehensive collection of nulls publicly available for a better understanding of mammalian gene function and modeling human disease. She described the NIH KOMP initiatives, noting that NIDA released an RFA on the development and improvement of inbred ES cell lines for use in the generation of mouse mutants (DA-06-009). A total of 18 NIH institutes are participating in KOMP activities.

   There are several new initiatives in the Division of Epidemiology, Services and Prevention Research (DESPR). These include efforts to standardize instruments across epidemiological studies funded by NIDA, NIAAA and NIMH, so that important questions can be answered in a more consistent fashion. The possibility of using the CJ-DATS for clinical trials in prison populations is being explored; the use of depot naltrexone for the treatment of opiate addicts in prison could lead to a very important breakthrough in treating addicted prisoners. Dr. Volkow noted that NIDA is also discussing with NIMH evaluating prisoners with co-morbid conditions. DESPR also is collaborating with DBNBR to genotype methamphetamine abusers to ensure adequate sampling in minority populations and helping to develop a scientific infrastructure to enable other countries to analyze epidemiological data on patterns of drug abuse and their impact on HIV. DESPR staff and other NIDA staff also developed a community-based treatment and prevention RFA to engage community treatment providers in needed research on drug abuse and thereby better translate research findings into community treatment.

   Dr. Volkow highlighted one project from the Division of Clinical Neuroscience and Behavioral Research (DCNBR): an RFA on the neurobiology of behavioral treatment: recovery of brain structure and function (RFA DA-05-006.) This RFA yielded 22 applications and was brought to Council yesterday for their review. She noted some of the research on children who have problems reading and on stroke victims to illustrate the plasticity of the brain and, again, noted the potential in this area for research and practice.

   The Center for the Clinical Trials Network (CCTN) has added two new nodes, awarded in September 2005. These are the Texas Node and the Appalachian Tri-State Node. Further, the Oregon Node is now named the Oregon-Hawaii Node and the South Carolina Node is now the Southern Consortium. Several new CTN protocols were presented, including one on prescription opioid treatment with approximately 12 sites to begin in the spring of 2006. Another protocol will compare the effect of buprenorphine/naloxone and methadone on liver function (starting treatment with agonist replacement therapies) and will take place in 10 sites, also in spring of 2006. A 6-site study of methylphenidate in maintaining abstinence in smokers with ADHD was also described, as was a randomized controlled trial of methylphenidate in adolescents with ADHD and substance use disorders. Further, the CTN will be developing a protocol to assess the utility of 12-step program participation in improving drug abuse treatment outcomes in cocaine and methamphetamine abusers.

   Dr. Volkow summarized a number of NIH Roadmap activities, including the results from the first round of the NIH Director's Pioneer Award. She noted that 9 awards were made in 2004 and that these investigators will present their ideas at the NIH Director's Pioneer Award symposium later this month. The 2005 awardees will also be announced at that time. In October 2005, NIDA will hold a meeting with drug abuse and addiction researchers to provide more information about the NIH Roadmap and to encourage them to participate actively in various Roadmap initiatives. Dr. Volkow noted that substance abuse researchers have historically been sensitive to translational issues and are well positioned to conduct translational research.

   Also in October there will be a molecular libraries meeting to explore the opportunities offered by the NIH Molecular Libraries Screening Centers Roadmap Initiative, and there will be presentations by NIDA-supported investigators on cellular signaling, receptor trafficking and molecular structure important in addiction. Presentations by experts in basic assay development and presentations of assays and screening targets of interest to NIDA are also among the agenda items for this meeting.

   Dr. Volkow noted a number of recent and upcoming meetings, conferences and events. She briefly described several of these, including recent Congressional briefings, hearings and events such as the PRISM premiere on Capitol Hill. A mentored K awardees meeting that addressed making the transition to independent scientist took place in August. Further, NIDA staff and grantees were active participants in a number of scientific meetings, including a very successful research tract at the American Psychiatric Association annual meeting and another at the American Psychological Association annual meeting. A mini-convention on frontiers in addiction research in conjunction with the annual neurosciences meeting in November will bring hundreds of scientists to poster sessions as well as presentations on several areas of neuroscience and addiction research. Dr. Volkow closed her presentation by noting that Council was provided a copy of the American Journal of Psychiatry in which more than half of the volume was directed to drug addition. This is unprecedented and of substantial importance to the field of drug addiction and abuse.

4. NIH Director's Pioneer Award - Jeremy Berg Ph.D, Director, NIGMS

   Dr. Berg gave a brief overview of the NIH Roadmap for Medical Research, noting the three major theme areas of Roadmap activities: identifying new pathways to discovery, re-engineering the clinical research enterprise and developing research teams of the future. He described the nine implementation areas that flowed from the three major themes, one of which has focused on high-risk research. The NIH Director's Pioneer Award is one of the high-risk research projects and is intended to support creative individuals, not specific research projects. Through a significantly simplified nomination (application) process and the use of a flexible spending authority, NIH intended to develop a program that would attract investigators with the most innovative and exciting ideas. Dr. Berg described the multi-tiered review process, which was intended to be different from the standard NIH receipt and review process. He noted that more than 1300 nominations were received and that about a third of those were invited to apply. Of those, about 20 finalists were interviewed and a selection of nine awardees was made for FY2004. Each award provides $500,000 in direct costs yearly for up to five years and requires the awardee to spend at least half time on Pioneer work. The program was continued in FY2005 with some minor modifications: self-nomination only; encouragement of applications from women, underrepresented minorities and individuals in early to mid-career, and the requirement that the applicant address why this award would be appropriate for him/her. More than 800 nominations were received for the FY 2005 competition. The 2005 awards will be announced at a Pioneer Symposium on September 29, at which time there will also be short presentations from all nine FY 2004 awardees as well as a roundtable discussion with awardees about high-risk/ high-impact research.

5. Minority Health Disparities Report - Lula Beatty, Ph.D., Director, Special Populations Office, NIDA

   Dr. Beatty described the need for minority and health disparity programs in drug abuse research, discussed NIDA's approach to addressing racial/ethnic minority and health disparities needs in drug abuse research, presented NIDA's minority and health disparity programs and activities, and identified challenges in developing and implementing minority health disparity programs. More specifically, the need for these programs can be divided into a public health/science need, a science workforce need and an adherence/cooperation with policy need. Dr. Beatty provided additional information on each of these needs, e.g., there is limited information on drug abuse in racial/ethnic minority populations and not enough specific knowledge to inform prevention and treatment. As part of her discussion of the science workforce need, Dr. Beatty noted that there are not enough racial/ethnic minority researchers in drug abuse/addiction research and not enough conducting research in racial/ethnic minority populations. Dr. Beatty noted that NIDA is the chief architect and supporter of research on the health aspects of drug abuse and addiction and must stimulate and increase the scientific knowledge base on drug abuse and addiction needed for all population groups.

   Dr. Beatty then described the goals of the Special Populations Office at NIDA. It was created to encourage and enable minority scientist participation in drug abuse research and encourage increased research on drug abuse in minority populations. Dr. Beatty described the many ways her Office accomplishes these goals, e.g. diversity supplements, the Minority Institutions' Drug Abuse Research Program, (MIDARP), summer research opportunities, development of the Health Disparities Strategic Plan, the African American Initiative, and the Southern Africa Initiative. She provided detailed information about each of these programs, including the number of awards for the Minority Supplement Program and details about the Summer Research with NIDA Program to provide research experiences for high school and undergraduate students. She also noted the success of the MIDARP capacity development program through improvements in the announcement and review process. The Historically Black Colleges and Universities (HBCU) initiative has also been successful in providing technical assistance and capacity development. Dr. Beatty provided data demonstrating health disparities in the health and criminal justice arenas. Dr. Beatty also focused on the NIDA African American initiative and described its efforts to develop a set of recommendations addressing research needs and priorities, research training, collaborations, and outreach/dissemination activities. A number of activities are currently in place and new activities are planned.

   Dr. Beatty also addressed the activities of the racial/ethnic minority work groups (groups of primarily researchers and others in drug abuse programs representing the four major racial/ethnic minority populations) whose purpose is to provide advice and/or support to NIDA's efforts at increasing racial/ethnic participation in research and improving research on racial/ethnic minority issues. After presenting selected accomplishments of each group, Dr. Beatty described the health disparities plan, noting that NIH requires such a plan and that the NIH plan includes the specific plan of each Institute. NIDA's health disparities plan includes research, infrastructure development, public information and outreach. Dr. Beatty expanded on each of these areas. She also described a health disparities conference that will take place in October.

   Dr. Beatty presented a variety of other activities and programs that her Office has developed, sponsored or joined with other NIDA and NIH units to develop, including meetings, announcements, publications and other activities. She also identified some difficulties, including inadequate trainee tracking data. Dr. Beatty concluded that underrepresented minorities are entering the biomedical workforce as a direct result of the NIH minority research training programs; and she addressed the importance of improving mentoring. Dr. Beatty concluded her presentation with a number of recommendations and a summary of lessons learned at NIDA. She pointed to the supportive leadership and colleagues at NIDA and to the importance of NIDA's long-term commitment and active outreach to minority scientists and minority populations.

6. Research Training and Career Development - Susan Weiss, Ph.D., Branch Chief, Office of Science Policy, NIDA

   Dr. Weiss provided an update on NIDA's research training program, noting the types of fellowships, career development awards and institutional training grants NIDA sponsors, the role of the NIDA Research Training Committee and its membership, and the success NIDA has had in invigorating its research training program, beginning in the mid 1990s under the leadership of Dr. Timothy Condon.

   She showed the growth of both individual and institutional Ruth L. Kirschstein National Research Service Awards (NRSA) from FY 86 to FY 04, and she pointed out the substantial growth in mentored K development awards beginning in the late 1990's. NIDA has also been successful in training clinical researchers, as shown by the substantial increase in the KO8, K12 and K23 awards, with PhD, MD and MD/PhD awardees. Dr. Weiss pointed out the importance of the mentored K award as a way to transition a scientist into an independent researcher, and she described the different kinds of mentored K awards used by NIDA. She also showed how the 2005 career development mentored K awards (total 133) varied by program area, with the largest number in the treatment area. The largest number of 2005 NRSA Fellowship awards is in the basic neurobiology area and the total number across all areas is 158. For 2005 there were 52 NRSA institutional training (T32 awards), with the highest number being in the behavioral neurosciences area. Also she noted that NIDA is currently at the NIH average in terms of the percent of the IC's awards budget as measured in FY 2004 training and career (Fs, Ts, and Ks) support.

   Dr. Weiss then outlined some of the challenges and goals for a tightening economic future: continuing the NRSA program at current levels despite increasing costs; encouraging clinical and patient-oriented research training; ensuring a balanced training portfolio; enhancing the training of minority researchers; supporting interdisciplinary training; creatively using other mechanisms to support new scientists and optimizing investment through program evaluation.

7. Loan Repayment Program - Susan Weiss, Ph.D., Branch Chief, Office of Science Policy, NIDA

   Dr. Weiss described the NIH Loan Repayment Program (LRP), noting that it is a vital component of our nation's efforts to attract health professionals to careers in research. The LRP repays up to $35,000 per year of qualifying educational debt and the resulting taxes to awardees who agree to perform certain types of research for two years. The areas of research may be clinical, pediatric, contraception and infertility, or health disparities research, and there is also a clinical research LRP for individuals from disadvantaged backgrounds.

   Dr. Weiss described the eligibility requirements for the LRP, provided information about the kinds of research included under the different LRPs, noting, for example, the requirement that pediatric research must be directly related to diseases, disorders and other conditions in children. Dr. Weiss also provided information about the LRP benefits, application receipt and referral, peer review and review criteria, and IC funding considerations. She then described NIDA's support of the LRP, noting the growth since FY2002 in both numbers of applications and numbers of awards in both clinical and pediatric areas, the two LRP programs that NIDA supports. She pointed out that NIDA has about $ 3.6 million committed to the LRPs. The overall success rate this year was 45% for new and 69% for renewal applications, with support going primarily to PhD researchers, though MD and MD/PhD awardees are also in the LRP. Dr. Weiss concluded by encouraging Council to inform colleagues about the LRP programs.

8. Public Comments

   Andrew Kessler, representing the Association for Addiction Professionals (NAADAC reminded Council that September is Addiction Recovery Month and that September 20th, 2005 was Addiction Counselor's Day. He thanked NIDA for its support and read excerpts of the comments presented to the U.S. House of Representatives last week in honor of National Addiction Recovery Month. He also noted other sources of Congressional support and again thanked NIDA for its continued commitment to addiction counselors.

   Dr. Darrel Regier from the American Psychiatric Association commended Dr. Volkow and NIDA research tracts and presentations given at the American Psychiatric Association annual meetings. He noted that these outstanding scientific presentations have been enthusiastically received by meeting participants. He also commented on the importance of research training for minority investigators in psychiatry and described an academic consortium that is committed to increasing funding of NIDA, NIAAA and NIMH.

   Ms. Kristie Stoick from the Physicians Committee For Responsible Medicine distributed a statement from that organization.

9. Adjournment

   The 91st meeting of the National Advisory Council on Drug Abuse was adjourned at 5:00 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.