February 4-5, 1997

The National Advisory Council on Drug Abuse convened its 65th meeting at 9:00 a.m. on February 4, 1997 in Conference Room 10, Building 31C, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD. Mr. Richard A. Millstein, Deputy Director of the National Institute on Drug Abuse (NIDA) chaired the meeting on February 4, 1997, from 9:00 a.m. to 3:00 p.m.. During this portion of the meeting, applications for federal grant assistance were reviewed, and this meeting was open only to Council members and federal employees. The meeting reconvened on February 5, 1997 at 9:00 a.m. and was open to the public. Dr. Alan I. Leshner, Director, NIDA, chaired. The Council adjourned at 3:45 p.m.

Council Members Present:
Susan G. Amara, Ph.D. 
Lawrence S. Brown, Jr., M.D. 
R. Lorraine Collins, Ph.D. 
Marian W. Fischman, Ph.D. 
Morton E. Goldberg, D.Sc. 
Thomas A. Hedrick, Jr. 
Reese T. Jones, M.D. 
Nancy J. Kaufman, R.N., M.S. 
George F. Koob, Ph.D. 
Clyde B. McCoy, Ph.D. 
Thomas A. McLellan, Ph.D. 
June E. Osborn, M.D. 
Rafaela R. Robles, Ed.D. 
Kathy Sanders-Phillips, Ph.D. 
Catherine A. Stevens, J.D. 
Lei Yu, Ph.D. 
Col. Terry K. Schultz, M.D. (ex officio) 
Richard Suchinsky, M.D. (ex officio)

Council Members Absent:
Linda S. Slattery

Council Chairs Present:
Alan I. Leshner, Ph.D.
Richard A. Millstein

Executive Secretary:
Teresa Levitin, Ph.D.

Federal Employees Present:
National Institute on Drug Abuse

Thomas Aigner, Ph.D. 
Khursheed Asghar, Ph.D. 
Robert J. Battjes, D.S.W. 
Ann Blanken 
Roger Brown, Ph.D. 
William Bukowski, Ph.D. 
Debra Carle 
William Cartwright, Ph.D. 
Peter Cohen, Ph.D. 
James Colliver, Ph.D. 
Raquel Crider, Ph.D. 
Kimberly Crown 
Mary Custer, Ph.D. 
Dorynne Czechowicz, M.D. 
Susan David 
James Dingell, Ph.D. 
Bennett Fletcher, Ph.D. 
Henry Francis, M.D. 
Jerry Frankenheim, Ph.D. 
Joseph Frascella, Ph.D. 
Lyle Furr
  Stephen Gane 
Meyer Glantz, Ph.D. 
William C. Grace, Ph.D. 
Diana Haikalis 
Richard Harrison 
Paul Hillery, Ph.D. 
Camilla Holland 
Arthur Horton, Ed.D. 
Syed Husain, Ph.D. 
Beverly Jackson 
Coryl Jones, Ph.D. 
Theresa Lee, Ph.D. 
Geraline Lin, Ph.D. 
Rita Liu, Ph.D. 
Robin Mackar 
Jack Manischewitz, Ph.D. 
Kesinee Nimit, M.D. 
Lisa Onken, Ph.D. 
Moira O'Brien 
Nancy Pilotte, Ph.D. 
Jonathan Pollock, Ph.D.
  Rao Rapaka, Ph.D. 
Laura Rosenthal 
Larry Seitz, Ph.D. 
David Shurtleff, Ph.D. 
Hari Singh, Ph.D. 
Vincent Smeriglio, Ph.D. 
Karen Skinner, Ph.D. 
Zili Sloboda, Sc.D. 
Pamela Stokes 
Pushpa Thadani, Ph.D. 
Jaylan Turkkan, Ph.D. 
Frank Vocci, Ph.D. 
Naimah Weinberg, M.D. 
Randolph Williams 
Steven Zukin, M.D.

Other Federal Employees:
Susan Old - National Heart, Lung and Blood Institute

Members of the Public Present:
Roberta Biegel - SAWHR 
K. C. Borror - OD 
Eleanor Friedenberg 
Bridget Goodman - CSR 
Alan Kraut - American Psychological Society 
Sloan Mahone - American Academy of Child and Adolescent Psychiaty 
Robert Mathias - R.O.W. Sciences/NIDA NOTES 
Nancy Moy - SRI International 
George Mumford - American Psychological Association 
Angela Sharpe - COSSA 
Marvin Scheinholtz - American Occupational Therapy Association 
Chuck Thomas - Marijuana Policy Project 
Linda R. Wolf-Jones - Therapeutic Communities of America 
Paul Young - NOVA Research

Closed Portion of the Meeting - February 4, 1997

  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).

    Mr. Richard A. Millstein, Deputy Director, NIDA, called the closed portion of the meeting to order. An overview of voting policies and procedures was provided. He reminded Council members about the NIH confidentiality and conflict of interest policies.

  2. Application Reviews

    The Council was subdivided into two subcouncils for the purpose of expediting application reviews and allowing for in-depth discussion as needed. Applications from the Division of Basic Research and the Medications Development Division were reviewed by a subcouncil chaired by Khursheed Asghar, Ph.D. Applications from the Division of Clinical and Services Research, the Division of Epidemiology and Prevention Research, and the Office of Science Policy and Communications were reviewed by a subcouncil chaired by William C. Grace, Ph.D. Each subcouncil reviewed applications and made recommendations for concurrence with the initial Scientific Review Group, and these recommendations were carried back to the full Council for approval.

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

    NIDA received 479 applications, requesting $400,413,172 in Total Years Direct Costs. Of these, 25 were withdrawn or deferred, and 314 were scored by the Scientific Review Groups, representing $61,076,548 in First Year Direct Costs and $239,458,438 in Total Years Direct Costs. The full Council approved each subcouncils' recommendations. Four new and three extension MERIT applications were approved. Approval was also given for supplemental funds for a needle exchange study in Alaska. (See Section V below.)

Open Portion of the Meeting - February 5, 1997

The second group addresses strategic planning. It is evident that there is great variability among NIH Institutes in the degree to which their respective Councils are involved in strategic planning. Although this working group's recommendations are not complete, it will have recommendations that include suggesting that each Institute have a strategic plan and that each Council have meaningful input into the plan. Dr. Varmus' expectation is that Council members do more than attend periodic meetings. Retreats that include Council and staff have been suggested as one means for Council input, and other ideas are being developed.

The review working group is addressing the role of secondary review. Again, there is much variability among Institutes as to how secondary review is conducted. Dr. Jones noted that NIDA's Council functions relatively well in this regard. The working group is considering how to deal with discretionary areas of funding, how to select grants based on either high or low priority, and how to identify areas that should not receive high priority for funding because they are "overworked" or "overmined" areas of science.

Other activities that Dr. Jones mentioned as possible Council activities included input on the numbers of RFAs and RFPs, meetings apart from Councils where members go as Council representatives, increased access to staff, involvement in intramural activities, and planning initiatives. Dr. Leshner noted that ideas are evolving and that NIDA's Council has not been involved in some of the suggested activities because NIDA's policy is to not use certain mechanisms or to use them rarely. Finally, Dr. Leshner noted that strategic planning is very difficult, given NIDA's very diverse portfolio, and before engaging in such planning, which is very time-consuming as usually done, it should be clear that it will be worth the effort.

  1. Call to Order

    Dr. Alan I. Leshner, Chair, called the open portion of the meeting to order, welcomed the Council members, NIDA staff and visitors.

    Dr. Leshner acknowledged and welcomed three new Council members; Dr. Susan Amara, Senior Scientist and Professor at the Vollum Institute, School of Medicine, Oregon Health Sciences University, and Associate Investigator at Howard Hughes Medical Institute; Dr. Morton Goldberg, a well known consultant to the pharmaceutical and biotechnology industry, and formerly a Professor, Department of Pharmacology, University of Pennsylvania; and Dr. Clyde McCoy, Professor, Department of Epidemiology and Public Health, School of Medicine, University of Miami and director of a comprehensive drug abuse research center at the university.

    Dr. Leshner reminded the Council members and the audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and that a time for public comment would be provided at the end of the day.

  2. Consideration of the Minutes of the 67th Council

    The Minutes of the September 17-18, 1996 meeting were approved as written.

  3. Future Meeting Dates

    Future meeting dates for Council were announced as follows:

    May 13-14, 1997 
    September 16-17, 1997 
    February 3-4, 1998 
    May 19-20, 1998 
    September 15-16, 1998

  4. Report of the Director 

    Personnel Announcements

    Ms. Eleanor Friedenberg, former Director, Office of Extramural Program Review (OEPR), retired on January 31, 1996 after a long and distinguished career in the Federal Government. Dr. Leshner expressed his appreciation to Ms. Friedenberg. Dr. Teresa Levitin is serving as Acting Director of OEPR.

    Ms. Robin Kawazoe, formerly Deputy Director of NIDA's Office of Science Policy and Communications, accepted a detail to the NIH Office of Science Policy, Office of the Director.

    Ms. Beverly Jackson has been appointed Chief of NIDA's Public Information Branch in the Office of Science Policy and Communications and has experience with public information work from positions at the Children's National Medical Center and the American Psychological Association.


    Dr. Leshner presented information on, and an analysis of, the budget. The FY 1996 level represented a 4.8 percent increase over FY 1995. The final FY 1997 budget level for the Institute was $489,118,000, which was a 6.7 percent increase over FY 1996. NIDA's estimated success rate for funding will be about 26 percent. Dr. Leshner noted that the funding for NIH has benefited from strong support for biomedical research by the Congress and the Administration, and increases for NIDA are slightly above those for the NIH as a whole. NIDA's consistent emphasis on science has been adopted by others in the administration when they speak about drug abuse.

    Review Issues

    Dr. Leshner, as a member of the Peer Review Oversight Group (PROG), reported on the issues discussed by the PROG. The PROG consists of both NIH staff and extramural scientists and is charged with the oversight of peer review activities for the NIH as a whole. A major topic for the PROG is the integration of NIDA and National Institute of Mental Health (NIMH) scientific reviews into the broader NIH review structures at the Division of Research Grants (DRG). Dr. Leshner reported that he is pleased with the level of commitment and cooperation from Drs. Baldwin and Ehrenfeld at NIH, and he indicated that the integration of basic neurosciences applications is moving ahead, although he recognized the process has moved more slowly than some might wish.

    NIDA proposals will not be placed into existing study sections; rather, new study sections are being created by evaluating the relevant areas of science, involving affected Institutes, and ensuring that new review groups are constituted to correspond to needed scientific areas.

    Rating Grant Applications

    Both NIH and the National Science Foundation have been debating the criteria by which it asks reviewers to evaluate applications, and alternative rating options have been discussed. There is agreement that at least three criteria should be used: impact, approach, and infrastructure (the ability of the investigator and the organization to do the work). There is not agreement as to whether or not a fourth criterion of creativity should be used. In a January meeting with the Chairs and other representatives of NIDA's review groups, reviewers unanimously agreed that a separate criterion for creativity should not be specified.

    Council discussion of rating applications ensued. The issue of investigators' writing conservative applications because they believe that only conservative applications will get good scores was discussed, and the idea of separate mechanisms or processes to reward creativity was raised.

    Shaping the Research Agenda

    A list of new program announcements and requests for applications was provided. Dr. Leshner highlighted several of these. One program announcement resulted from a workshop NIDA held about drug use, sexual behaviors and HIV, and men who have sex with men. NIDA has issued an RFA on neurobiological substrates, "Cognitive Neuroscience and Drug Abuse." It is noteworthy that this RFA was referenced in an editorial in Science, which recognized NIDA's attempts to broad the behavioral science portfolio and to strengthen a scientific foundation for national drug abuse policy and for prevention and treatment strategies.

    NIDA has issued HIV-oriented program announcements in further efforts to bring additional researchers into the study of the relationship between HIV, AIDS and drug use by providing supplements to ongoing grants by including an AIDS component and by participating as part of the Centers for AIDS Research NIH initiative. Also, at the College on Problems of Drug Dependence meeting this year, HIV will be a thematic topic. This is another vehicle NIDA is using to encourage more researchers to focus on the issues of HIV and AIDS.

    There was a major meeting, organized by General McCaffrey and held in San Francisco, focusing on methamphetamine. Also, Congresswoman Pelosi participated in a NIDA town meeting held immediately before General McCaffrey's meeting, and methamphetamine was a focus there. As a result of NIDA's growing recognition of methamphetamine abuse on the west coast, a methamphetamine focus has been added to the treatment initiative and NIDA's work on children and adolescents. Other town meetings are also being carried out.

    NIDA has begun working on three major initiatives: treatment, children and adolescents, and amphetamine use. These initiatives will be reflected in the President's fiscal year 1998 budget. Also, as part of the process of creating work groups to foster collaborations across divisions, NIDA has created two new work groups, one in the area of pain and analgesia and one in the area of genetics. A conference on the genetics of drug abuse is planned.

    Dr. Varmus has asked each Institute to review its intramural activities. As a result, NIDA has created a group that is reviewing the Intramural Research Program (IRP), its overall structure, the processes by which it operates, the location, and the facilities. The distinction between this group and the Board of Scientific Counselors (which reviews specific intramural research projects) was made.

    NIDA focuses both on information development and the dissemination of that information. A National Research Conference on Prevention Research was held, and Secretary Shalala and General McCaffrey attended. One outcome of the conference has been the development of a guide called "Preventing Drug Use among Children and Adolescents: A Research-Based Guide." This guide has been widely disseminated. The Center for Substance Abuse Prevention is using this guide with its grantees, heightening its impact.

    In November, the Third Annual Constituents' Conference was held with the drug abuse practice, scientific and policy communities. This conference is a continuing activity, and its purpose is to foster the use of science to change policy and practice.

    NIDA has continue to work with Scholastic magazine. The Institute recently sent science-based activities materials to 4,500,000 elementary school students.

    With the aid of the Office of National Drug Control Policy, NIDA has established a brain imaging center in the intramural program, and resources there include a PET scanner and cyclotron. This equipment gives NIDA's intramural research program the potential to evolve into a regional brain imaging research center.

    On February 19 and 20, NIH will hold a scientific workshop to examine potential medical uses of marijuana for a variety of indications and the role NIH should have in examining potential medical uses. Dr. Leshner noted that he will be organizing that workshop but stressed that it is an NIH-sponsored activity rather than a NIDA-based activity. High level representatives of several NIH components, including NCI, NEI, NIAID, the Office of AIDS Research, NIMH, NIDR, NINDS, and the NIDDK are collaborating on this meeting. He stressed that the meeting will focus on scientific questions.

    Brief Council discussion on collaboration with the Institute of Medicine occurred, as the IOM is also looking at some marijuana issues. Dr. Leshner clarified that the IOM is looking not only at medical issues but also at abusability and non-medical concerns. The NIH meeting will focus on medical applications.

    Public Information

    The Division of Epidemiology and Prevention Research has released a science-based guide to drug abuse prevention as an outgrowth of the National Conference on Prevention Research last year. The town meetings have continued, and are always established jointly with local coalitions of groups concerned with drug abuse. The Journal of Hospital Practice has put out a very well executed special issue on drug abuse which covers a broad range of topics. Time magazine has covered drug abuse issues with NIDA cooperation. Brain Awareness week was in March, and Dr. Leshner was asked to present at the NIH's "mini-med school" on Capitol Hill.

    Bill Moyers is producing a series on drug abuse for PBS, and the PBS producers have been pleased enough with the progress that it has been expanded from a four-part to a five-part series. NIDA has just completed making the first "NIDA Prism Awards" to people in the entertainment industry for accurate depictions of drug abuse and addiction in the media, and these were very well received. Another important event was that Senators Levin and Kerry, with Senator Moynihan joining them, held a forum on medication development on Capitol Hill during which members of Congress and staff listened to presentations from scientists and industry representatives. Finally, there was a hearing called by Congressman Shays on the issue of informed consent by vulnerable populations, and the CDC, NIH, FDA, and Office of the Secretary, HHS were involved. The guidelines that this Council had produced on the use of drugs of abuse in research with humans were discussed at several points and were seen as a model of how to provide advice to institutional review boards and investigators.

  5. Report on the meeting of the Advisory Committee to the Director, NIH - Reese T. Jones, M.D.

    Dr. Jones reported on the meeting of the Advisory Committee to the Director, NIH (ACD), which was held December 13. He clarified that he attended this ACD meeting but is not a member of the ACD itself. Rather, he is a member of a 23 person committee of representatives from all NIH Councils.

    The first topic Dr. Jones addressed was the report of the ad hoc "Review Panel for the Study of `Interventions to Reduce HBV, HCV, and HIV in IDUs'" to the ACD. This panel was created by Dr. Varmus to advise him on issues related to the funding of a NIDA project dealing with needle exchange in Alaska, with Dr. Dennis Fisher as the principal investigator. The project examines interventions to reduce HBV, HCV, HIV in 500 former and 600 current intravenous drug users, and it involves comparisons of a street based needle exchange with the use of pharmacies for exchanges. Random assignment to a source of needles (street exchange or pharmacy), extensive data collection, 6 month follow up, and a data safety monitoring board were elements of the project. Although the application had undergone local IRB approval, NIDA peer review, Council approval, and OPRR review before funding, allegations were made by Dr. Sidney Wolfe and Dr. Peter Lurie that the project violated human subjects' protections.

    Dr. Varmus constituted a panel of qualified ethicists and scientists to examine this project. The panel was chaired by Dr. Robert Levine and engaged in a thorough review of both the application itself and the process by which it was reviewed and funded. The panel members met with the principal investigator, the Chair of the IRB that approved the project, and others.

    Dr. Jones summarized the findings of the panel's report to the ACD. The panel concluded that the design was appropriate for the scientific questions being asked, that the interventions were adequate, and that the combination of IRB, IRG, Council, and OPRR approval was more than adequate for protecting human subjects. The study was seen as significant in that it addresses "second generation" needle exchange questions about the best ways to deliver needles, and no group was exposed to excessive risk. Dr. Jones also noted that the original allegations of human subjects violations were not well founded and did not reflect the content of the application.

    Council noted that the process that the ACD pursued in examing this project was impressive in its scholarliness and thoroughness. Dr. Jones reiterated that, ideally, ethical issues would be resolved by a local IRB, which is much more familiar with local circumstances than other groups might be.

  6. Report on Ongoing Activities of the Committee of Council Members - Reese T. Jones, M.D.

    Turning from the needle exchange issue, Dr. Jones reported on the ongoing activities of the 23 member Committee of Council Members. The Committee has had its third meeting, which took place in December. There are three three subcommittees of this group: the advocacy subcommittee, the strategic planning group, and the grant review group.

    The advocacy group is focused on public awareness, interaction with the public and the role of Council in promoting and educating the public about NIDA and NIH. One of the concerns of this group is that NIH has relatively little name recognition. NIDA's Council was presented with documents from this group which provided information about NIH and suggestions for increasing name recognition.

  7. Update on Integration of Peer Review - Teresa Levitin, Ph.D.

    At the May 1996 meeting, Council adopted principles to guide the process of integration of NIDA science into the Division of Research Grants (DRG) review structures. Among the elements in that document was a statement that science, not mechanism, should guide referrals and reviews of applications. Also, the document stressed the importance of merging the generic (non-mission specific) areas of NIDA's research with other Institutes' research in a true integration and not simply "shoehorning" NIDA's science into extant review structures.

    Those statements describe the process is now underway. The first scientific area being integrated is the basic neurosciences; this involves five Institutes with substantial basic neuroscience portfolios: the National Institute on Drug Abuse, the National Institute of Mental Health, the National Institute on Aging, the National Institute of Neurological Disorders and Stroke, and the National Institute of Child Health and Human Development. Each of these Institutes has participated in joint examination of its portfolios and participated in the development of five cluster areas. These cluster areas overlap and are: (1) molecular and cellular neurosciences, (2) developmental neurosciences, (3) integrative, regulatory and behavioral neurosciences, (4) cognitive neurosciences, and (5) brain disorders and clinical neurosciences. Within each there are specific subareas or topics that will guide what science from each Institute goes into a given cluster area.

    The areas are operationalized in great detail, and information on them has been presented at neurosciences meetings and elsewhere. Information is available through NIDA's Web homepage, and NIH is working to keep the neurosciences community informed about this process.

    A group of scientists will meet in March to work with staff from the five Institutes to sort neuroscience application abstracts into reasonable, scientifically bounded groups which can form the boundaries of study sections under each cluster. This will be the first step in an iterative process between the NIH and the outside community to ensure that the new study sections meet the needs of both the NIH and the constituent scientific community. The goal is to have the new study sections in place by the February 1998 submission date for the basic neurosciences applications. Dr. Levitin noted that this is a long and labor intensive process but that it is working well.

    Dr. Collins asked if NIDA had identified areas seen as specific to drug abuse that will be kept in house for review. Dr. Leshner replied that the areas are not yet defined.

    The Council stressed the need to evaluate how applications fare under the new system. Dr. Leshner reminded the Council that the changes in review were legislatively mandated. Dr. Levitin added that members of NIDA's current review committees will be asked to serve as reviewers on the new DRG neuroscience study sections.

    Dr. Leshner underscored the importance of Council identifying applications that should be given special consideration for funding. He reiterated that it is a responsibility of the Council to help NIDA identify applications that should be paid but may not be paid because they are on the funding margin. Such projects may be very innovative or have major public health importance.

  8. Council Review of Implementation of the NIH Policy on Minority and Gender Representation - R. Lorraine Collins, Ph.D.

    Council received a memo outlining the NIDA review of the implementation of the NIH policy on inclusion of minorities and women in clinical research. The Office of Research on Women's Health is coordinating and preparing a report for NIH which will be submitted to Congress.

    Council raised issues about the data they reviewed, noting that NIDA's data addressed only extramural research and were not broken down by Division. Issues about numbers of minority investigators also were raised. Council endorsed the following statement:

    "The National Advisory Council on Drug Abuse at its February 4-5, 1997 meeting, reviewed the procedures for the implementation of the revised NIH guidelines for inclusion of women and minorities in clinical research. The Council has also reviewed pertinent extramural data for both NIH as a whole and NIDA in particular. The Council has determined that NIDA has successfully implemented the NIH guidelines."

  9. Policy on Administration of Drugs to Human Subjects - Reese T. Jones, M.D.

    Dr. Jones reported on a subcommittee of Council that has been working on the development of guidelines for the administration of drugs to human subjects. Earlier drafts of the document have been circulated to Council, and the subcommittee presented a final document for Council's approval. Council commented that this is an excellent document that provides guidance without instituting too many limitations. Council unanimously approved the new guidelines for the administration of drugs to human subjects. They will now move through NIH for clearance and release to the extramural field. Dr. Leshner thanked the Council for its help with the guidelines.

  10. Peer Review Issues - Subcouncil Reports

    Dr. Kaufman reported back to the Council that several issues arose during the review of grant applications the previous day. Medications development and craving were noted as areas that need more attention through either announcements or specific review committees. Percentiles and critiques were seen as sometimes incongruent. A final issue was a need for Council to be more familiar with the full range of science reviewed by NIDA. Dr. Collins noted concerns in her Subcouncil about longitudinal research, questions about ownership of data, and the need for more secondary data analysis. There was a suggestion that NIDA encourage wide availability of data for secondary analyses from projects it supports.

    The Council encouraged NIDA to continue efforts to keep reviewers informed about review policy.

  11. Treatment Research Initiative - G. Alan Marlatt, Ph.D.

    A subcommittee of Council is working with NIDA staff on an initiative to improve the quality and availability of treatment for people with addiction problems. Two main goals are to "bridge the disconnect" between research findings and treatment applications and to strengthen the research base. Activities for both goals are being undertaken. These activities are comprehensive and include conferences for disseminating information and exchanging ideas between researchers and treatment professionals, workshops on interventions, workshops to develop research both in behavioral and medications areas, health services related meetings, and attempts to integrate behavioral and medications therapies. Dr. Marlatt provided examples of successful therapies developed through research. Potential focus areas identified were motivating people for treatment, addressing managed care and the provision of services, defining which drugs would be part of an initiative, integrating drug treatment into broader psychosocial therapies so that it is not separated from other care, and harm reduction, among others. Council discussed these ideas and provided information on current research and service provision initiatives from their own experiences.

  12. Research on Infants, Children and Adolescents - Vincent Smeriglio, Ph.D.

    Dr. Smeriglio presented an overview of NIDA's portfolio on child and adolescent research, and he then presented a more focused look at NIDA's research on the consequences of prenatal drug exposure. Pediatric research encompasses ages zero (birth) to twenty-one years. Areas of study include etiology and epidemiology of drug use; prevention at individual, family, and community levels; treatment; diagnosis and screening; HIV; and violence, as well as other areas. In FY 1995/1996, there were about 20-25 human studies that NIDA supported on prenatal effects. Most of these are prospective studies whereby a cohort of mothers and infants is recruited either during pregnancy or at birth and then followed. Detailed information on the ages studied was presented, and Dr. Smeriglio addressed the complex confounding factors that challenge studies on prenatal effects. Issues that need to be considered are many and include dose and timing of exposure, methods of assessing effects, methods of assessing use (e.g., self-report, meconium and hair analysis) confounding social factors, nutrition, and diseases.

    A noteworthy initiative in this area is a collaborative study supported by NIDA, the National Institute of Child Health and Human Development, the Center for Substance Abuse Treatment, and the Administration for Children, Youth, and Families. The study involved screening of 19,000 charts and meconium specimens for almost 12,000 infants, giving information on prenatal exposure. Then, 1400 children started follow-up at 1 month of age. Part of this effort resulted in the development of an extensive neurodevelopmental assessment battery, and the study promises to reveal very important results on prenatal exposure effects.

    An overview of interesting research results from NIDA-supported and other studies was provided, and plans for future work in the area were outlined.

  13. Council Future Agenda Items - George Koob, Ph.D.

    Dr. Leshner began this discussion by acknowledging that craving and longitudinal data concerns had already been noted as topics for future discussion. Dr. Koob then presented issues that arose in a subcommittee meeting to develop future agenda items and communicate Council concerns. Topics that arose included a desire for more clarification of the role of Council; the role of Council in public comments and an opportunity for Council to respond to public concerns in a meaningful way; methods for Council members to share their scientific expertise with one another and staff; interaction with the intramural program; increased communication among members (e.g., through e-mail); feedback on funding decisions - especially when Council made a specific recommendation; and methods for keeping Council familiar with the overall portfolio of the Institute. Discussion of many of these points ensued. Dr. Leshner noted the importance of Council and NIDA working together to identify ways to enhance the functioning of the Council.

  14. Public Comments

    Mr. Chuck Thomas, Marijuana Policy Project, criticized the methods by which the Institute makes marijuana available to researchers and advocated that NIDA automatically provide marijuana to any study that the FDA has approved. He also expressed concern that NIDA organized a conference on medicinal uses of marijuana without consulting him, and he provided a list of potential speakers.

    Dr. Leshner clarified for Mr. Thomas that the conference was organized by NIH, not NIDA.

    Ms. Linda Wolf Jones, Executive Director of Therapeutic Communities of America, expressed appreciation for the activities of NIDA and the Council.

    Dr. Leshner thanked the speakers for their comments.


The 65th meeting of the National Advisory Council on Drug Abuse was adjourned at 3:45 p.m. on February 5, 1997.


I hereby certify that the foregoing minutes are accurate and complete.

Alan L. Leshner, Ph.D.
Director, NIDA
National Advisory Council on Drug Abuse
Teresa Levitin, Ph.D.
Executive Secretary
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.