Department of Health and Human Services
National Institutes of Health
National Institute on Drug Abuse
Minutes of the 68th Meeting of the National Advisory Council on Drug Abuse
February 3-4, 1998
The National Advisory Council on Drug Abuse convened its 68th meeting at 9:00
a.m. on February 4, 1998 at the Bethesda Marriott Hotel, 5151 Pooks Hill Road,
Bethesda, Maryland. Dr. Alan I. Leshner, Director, NIDA, chaired the meeting.
The meeting on February 3 was for the purpose of reviewing applications for federal
grant assistance and was open only to Council members and federal employees. The
meeting reconvened on February 4 at 9:00 a.m. and was open to the public. The
Council adjourned February 4 at 3:04 p.m.
Council Members Present:
Susan G. Amara, Ph.D.
Lawrence S. Brown, Jr., M.D.
R. Lorraine Collins, Ph.D. (February 3 only)
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.
G. Alan Marlatt, Ph.D.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
June E. Osborn, M.D. (February 3 only)
Rafaela R. Robles, Ed.D.
Kathy Sanders-Phillips, Ph.D.
Linda S. Slattery (February 3 only)
Catherine A. Stevens, J.D.
Lei Yu, Ph.D.
Col. Terry K. Schultz, M.D. (ex officio)
Richard Suchinsky, M.D. (ex officio; February 4 only)
Council Members Absent:
Marian W. Fischman, Ph.D.
Council Chairs Present:
Alan I. Leshner, Ph.D.
Richard A. Millstein
Teresa Levitin, Ph.D.
Federal Employees Present:
National Institute on Drug Abuse
| Thomas Aigner, Ph.D.
Khursheed Asghar, Ph.D.
Robert Battjes, D.S.W.
Lula Beatty, Ph.D.
Jamie Biswas, Ph.D.
Jack Blaine, M.D.
Roger Brown, Ph.D.
William Bukoski, Ph.D.
William Cartwright, Ph.D.
Robert Caudle, Ph.D.
Peter Cohen, M.D.
James Colliver, Ph.D.
Leslie Cooper, Ph.D.
Dorynne Czechowicz, M.D.
Peter Delaney, D.S.W.
Jerry Frankenheim, Ph.D.
Joseph Frascella, Ph.D.
Meyer Glantz, Ph.D.
William C. Grace, Ph.D.
Steven Gust, Ph.D.
Peter Hartsock, Dr.P.H.
Richard Hawks, Ph.D.
Barbara Herman, Ph.D.
Arthur MacNeil Horton, Ed.D.
Jagjitsing Khalsa, Ph.D.
Elizabeth Lambert, M.S.
|| Lana Le
Theresa Lee, Ph.D.
Geraline Lin, Ph.D.
Rita Liu, Ph.D.
Arnold Mills, M.S.
Cindy Miner, Ph.D.
Kesinee Nimit, M.D.
Lisa Onken, Ph.D.
Nancy Pilotte, Ph.D.
Jonathan Pollock, Ph.D.
Elizabeth Radhert, Ph.D.
Rao Rapaka, Ph.D
Catherine Sasek, Ph.D.
David Shurtleff, Ph.D.
Hari Singh, Ph.D.
Karen Skinner, Ph.D.
Zili Sloboda, Sc.D.
Betty Tai, Ph.D.
Pushpa Thadani, Ph.D.
Alan Trachtenberg, M.D.
Frank Vocci, Ph.D.
Naimah Weinberg, M.D.
Cora Lee Wetherington, Ph.D.
Stephen Zukin, M.D.
Other Federal Employees:
Laurence Stanford, Ph.D. - Center for Scientific Review, NIH
Marina Volkov, Ph.D. - Office of Behavioral and Social Sciences Research ,
Members of the Public Present:
David Hess - COSSA
Linda R. Wolf Jones, D.S.W. - Therapeutic Communities of America
Jennifer Katz - CD Publications
Walter L. Faggett, M.D. - National Medical Association
Robert Mathias - ROW Sciences
Nancy Moy - SRI International
Geoff Mumford, Ph.D. - American Psychological Association
Michaela P. Richardson - ROW Sciences
Harold Pincus, M.D. - American Psychiatric Association
Lisa Putman - The Blue Sheet
Julia Spencer - NPN
Chuck Thomas - Marijuana Policy Project
Paul Young - NOVA
Peggy Young - NOVA
Closed Portion of the Meeting - February 3, 1998
- 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 meeting to order
and provided an overview of the agenda for the meeting. Dr. Teresa Levitin, Executive
Secretary, provided a summary of voting policies and procedures, detailed instructions
on Council review procedures, and reminders about NIH confidentiality and conflict
of interest policies.
- Application Reviews
The Council divided into two subcouncil committees 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 committee chaired by Dr. Khursheed Asghar. Applications
from the Division of Clinical and Services Research, the Division of Epidemiology
and Prevention Research, the Office on AIDS, and the Office of Science Policy
and Communications were reviewed by a subcouncil committee chaired by Dr. William
C. Grace. Each subcouncil committee reviewed applications and made recommendations
for concurrence with the initial Scientific Review Group, except for one application
where a re-review was recommended. 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 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.
For this Council, 480 applications, requesting $369,998,240 in Total Years
Direct Costs, went to review. Of these, 308 were scored by the Scientific Review
Groups, representing $58,689,957 in First Year Direct Costs and $242,083,240 in
Total Years Direct Costs. The full Council approved each subcouncil committee's
recommendations, including the recommendation for re-review of one application.
Two new and one continuation MERIT applications were approved.
Open Portion of the Meeting - February 4, 1998
- Call to Order
Dr. Alan I. Leshner called the open portion of the meeting to order and welcomed
the Council members, NIDA staff, and visitors. He 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.
Leshner expressed his and the Institute's gratitude for the service of five members
who are ending their terms, and certificates of appreciation were presented.
- Consideration of the Minutes of the 67th Council
The Minutes of the September 16 - 17, 1997 meeting were approved as written.
- Future Meeting Dates
Future meeting dates for Council were announced as follows:
May 19 - 20, 1998
September 15 - 16, 1998
February 2 - 3, 1999
May 25 - 26, 1999
September 14 - 15, 1999
(Executive Secretary note: Since the Council meeting, dates for 2000 have been
established as follows:
February 8 - 9, 2000
May 16 - 17, 2000
September 12 - 13, 2000)
- Report of the Director
Dr. Leshner presented revised budget figures for FY 1997 that show funds received
through transfer from the NIH Director's office and the Office of National Drug
Control Policy. The transfers resulted in a total FY 1997 budget of $499.653 million.
The FY 1998 estimated budget is $527.175 million, reflecting a 7.6% increase from
Congress. The FY 1999 President's budget proposal includes the largest increase
ever proposed for NIH, an increase of 8.4%. NIDA's allocation is expected to be
$576.299 million, which is a 9.3% increase. NIDA expects its success rate to be
around 28-30%, which is slightly below the 32% success rate of FY 1997 because
of the additional funds transferred in that year. The overall NIH success rate
is about 35%.
In response to a question from Council about the impact of accumulating non-competing
application costs as a result of the higher success rate, Dr. Leshner indicated
that the distribution of non-competing and competing awards will remain stable,
with about 1/3 of the funds going to competing applications. This is because careful
monitoring of the size and type of awards allows NIDA to maintain that success
rate. The impact of the budget on AIDS versus non-AIDS applications was raised,
and Dr. Leshner indicated that the success rates are about the same for both types
The council was informed that Dr. Levitin would cover separately the issues
related to integration with the Center for Scientific Review. They were reminded
that new review criteria are now in effect and that Council plays a valuable role
in helping determine the impact of the new criteria in identifying innovative
and creative studies. Council's help in monitoring the impact of integration was
also requested. New NIDA review committees for conference applications, applications
for medications development, and career-related applications were described.
Shaping the Research Agenda
No new Request for Applications has been issued, and one on neurobiological
effects of drug addiction therapies has been re-issued. Two new Program Announcements,
"Exploratory/Developmental Grant Applications" and "Minority Institutions
Drug Abuse Research Program (MIDARP)," were released.
Dr. Leshner noted NIDA has sponsored several recent meetings, four of which
were in conjunction with the Society for Neuroscience. A meeting was held recently
to examine new animal models of drug abuse, and one was held on naltrexone.
Dr. Leshner presented information on activities to educate the public about
drug abuse and addiction. Successful activities have been developed with the Entertainment
Industries Council. The "Prism Awards," given annually to recognize
television or movie productions that depict drug abuse accurately, are being planned
for this May. Another activity is that the Entertainment Industries Council, with
NIDA collaboration and support, has recently released a notebook to help the industry
depict drug abuse and addiction on the basis of accurate scientific information.
Town meetings are on-going. A very successful meeting was held in Philadelphia
in September, and one was held last week in Salt Lake City. There is now a waiting
list of cities which have requested town meetings. These meetings not only help
distribute information, but also help shape the research agenda as NIDA hears
the insightful comments and questions of people in different communities.
NIDA has organized or participated in a number of other meetings. Dr. Leshner
noted the National Conference on Heroin Use and Addiction, held September 29th
and 30th in Washington, and the NIH Consensus Development Conference on Effective
Medical Treatment of Heroin Addiction, held in November. A "National conference
on Drug Addiction Treatment: From Research to Practice" will be held in April.
The science education activities at NIDA continue to have a significant impact.
Examples of posters developed for middle schools were provided to Council, and
NIDA has received very positive feedback on these from the National Association
of Biology Teachers. The NIDA Infofax is operational, and about 2,500 requests
for information have been received, all in the first month of operation. The NIDA
home page continues to be widely utilized.
The 4th Annual NIDA Constituents' conference was held, and 43 constituent groups
Council praised NIDA's activities and noted that there is a need for more attention
to the health care system and health professionals. The example that drug abuse
treatment is better integrated into the criminal justice system than the health
care system was given to stress this point.
Dr. Leshner agreed with this observation and noted that Dr. June Osborn is
chairing a group of physicians to address that concern. He further noted that
the American Medical Association's president has declared substance abuse as the
core issue for his presidency. Also, NIDA has successfully built collaborations
with the medical community to address drug abuse, and NIDA's status at NIH has
helped give credibility to NIDA's work.
An audience member, Dr. Walter Faggett, asked to be recognized and, upon recognition,
spoke to say that the National Medical Association supports NIDA's efforts related
to health care systems and training. Council then further discussed the need for
attention to issues of managed care, service provision, and professional training.
- Subcommittee Report on the Treatment Research Initiative - Dr. G. Alan
Dr. Marlatt summarized treatment subcommittee activities. A major upcoming
event is the April conference on drug treatment and its effectiveness, and the
committee has been addressing the theme of the conference. One need is for a delineation
of basic principles of treatment, in much the same way that NIDA has recently
been able to provide basic principles for prevention. Also, there needs to be
more attention to criteria for measuring treatment outcomes, especially in the
context of other events in a person's life (e.g., health, economic, and marital
problems). Other themes to address include barriers to implementation of treatment
programs and the settings in which treatment is best provided.
A preliminary program has been prepared for the conference, which will occur
April 8 - 9. The themes mentioned, as well as some others, such as comorbidity,
will be addressed. The development of drug abuse interventions by substance abusers
themselves rather than by professional health care providers is also an important
area. Dr. Marlatt recommended recent articles in the American Psychologist (December
1997) and Psychology of Addictive Behaviors as good resources.
Dr. Leshner thanked Dr. Marlatt for his report.
- Subcommittee Report on Craving Research - Dr. George Koob
Dr. Koob noted that research on craving has been hampered because there is
not consensus on the definition of craving. Clinicians have difficulty describing
the phenomenon, and animal models with good predictive value exist but are not
clearly connected to clinical events. The subcommittee on craving is recommending
three steps to help address the need for more craving research. First, a small
meeting of approximately eight people, the majority of whom should be clinicians,
could be convened to develop a very brief definition of craving and a description
of its domain. The definition and description could be published in a non-NIDA
outlet. Second, specific initiatives for craving, such as a program announcement
or a request for applications could be used to generate more research. Third,
because of the cross-disciplinary nature of craving research, a special review
panel is needed, and it could be reconvened as needed to review groups of applications
Council members commented that the group that works on the definition of craving
should include representatives of organizations that provide clinical care to
substance abusers. Also, there was discussion of including animal researchers
to ensure that the disconnect between clinical and animal models is addressed.
Using the meeting as a "case-definition" forum was suggested. Other
discussion focused on the advantages and disadvantages of having a definition
published in a government or non-government outlet. Dr. Leshner noted that the
definition and description document should be reviewed by the Council before publication.
- Implementation Plan in Response to the Blue Ribbon Panel to Review the
NIDA Division of Intramural Research - Dr. Barry Hoffer
Dr. Leshner introduced Dr. Hoffer and reminded Council of the history of the
Blue Ribbon Panel. Dr. Hoffer presented the overall concerns of the Blue Ribbon
Panel, expressed his appreciation for the support of him shown in their report,
and then systematically presented each of the Panel's recommendations and his
response to the recommendation. Dr. Hoffer has hired additional, scientifically
qualified staff, and a new mission statement to stress the integrative and translational
nature of intramural research has been developed. The hierarchical structure of
the Division has been modified to increase communication and accountability of
individuals for their own ideas and work. Steps have been taken to enhance the
independence of young investigators and mentor them, and a peer review system
is being used with input from the Board of Scientific Counselors to ensure quality
of work. Steps have been taken to improve the clinical research program, to give
it stability, and to streamline administrative processes. Increased collaboration
with other NIH and non-NIH resources has been sought and, in many cases, achieved.
The Council praised Dr. Hoffer for his rapid progress and response to the Panel's
report. They discussed and gave a number of suggestions related to frequency of
the Board of Scientific Counselors' reviews, methods to encourage junior investigators,
and mechanisms to help investigators demonstrate competitiveness in the job market
when they leave NIDA.
- Update on Integration of NIDA Application Review at NIH - Dr. Teresa Levitin
Dr. Levitin reminded the Council that two years ago they developed a statement
of principles for review integration. Review of neurosciences, AIDS, and behavioral/social
sciences is being integrated, using the principles the Council articulated. The
three merger processes have also been guided by general principles articulated
by the Directors of the affected Institutes. The mergers are at different stages
of completion, but for all of the mergers the processes of clustering applications
and creating study sections have been open to, and interactive with, the relevant
extramural communities. Twenty-one new neurosciences study sections have been
created, and they have responsibility for the entire range of basic and clinical
neuroscience applications. Review administrators are assigned, including three
from NIDA (Drs. Mary Custer, Syed Husain, and Gamil Debbas), and the committees
are being filled presently with reviewers from the current study sections. Additional
reviewers will be added as needed. In the AIDS arena, new study sections have
been suggested, and Council's input on the proposed composition is needed. The
behavioral integration is in early stages, and experts nominated by professional
associations are coming in late February to examine proposed clusters of science.
Dr. Levitin ended by stressing a continuing need for Council involvement and oversight
of integration events, and Dr. Leshner reiterated this call.
Council discussion centered on the difficulties to be expected in sorting out
the feedback that is likely to come back to NIDA from people who get reviewed
under new structures. Another Council theme was the NIDA research community's
concern that its science will not be appreciated at CSR. Dr. Leshner noted that
the concern is important and that it is critical that senior investigators be
willing to serve on committees.
- Update on the Medications Development Program - Dr. Frank Vocci
Dr. Vocci explained that the mission of the Medications Development Program
is "transforming research into treatments." The program takes basic
science findings, converts them into clinical studies, and then determines if
a medication merits further development. The Division is patterned after pharmaceutical
companies in the breadth of drug development activities supported. The Division
has had success with opiate projects, and LAAM was approved in 1993. Buprenorphine,
a buprenorphine/naloxone combination product, and depot naltrexone are also under
investigation. Dr. Vocci then reviewed scientific studies on the association of
the dopamine system with cocaine abuse and explained how the Division's activities
follow systematically from the scientific evidence and address different points
of intervention (e.g., presynaptic modulation and postsynaptic modulation). Also,
strategies not based directly on dopaminergic system events, such as modification
of conditioned cues, modulation of the stress response, and alteration of mood
states, were addressed. The progress and design of a multi-center trial on selegiline
were described, and Dr. Vocci and the Council engaged in a discussion of appropriate
end points for such a trial. Council also noted scientific findings and information
that might be useful in considering future research.
- NIH Consensus Development Conference on Effective Medical Treatment of
Heroin Addiction - Dr. Stephen Zukin
Dr. Zukin reported the results of a consensus conference jointly sponsored
by the NIH Office of Medical Applications of Research (OMAR) and NIDA. Through
presentations by various scientists, persons familiar with regulatory control
of methadone, and treatment specialists, the conference examined the evidence
on treatment of heroin addiction and made recommendations on improving treatment
and access to treatment. The results of the conference are available on the internet
at http://consensus.nih.gov. Recommendations included steps to increase public
understanding of addiction, to improve access to treatment, to improve health
professional training regarding addiction, to ease regulatory controls, and to
focus on specific populations. Council asked for clarification of the recommendation
regarding pregnant women. A concern was expressed that the recommendation did
not fully take into account evidence on methadone's effects on the fetus and the
need for more research on that issue. Other discussion focused on the roles various
federal agencies might play in implementing the recommendations.
- Other Council Comments
The activities of the subcommittee on secondary analysis of data were briefly
reported. The committee has met and is defining issues for it to address. A second
comment was that a Child and Adolescent Subcommittee could be helpful in addressing
many issues. Finally, a concern about maintaining diversity on the Council was
expressed in view of the number of persons rotating off the Council.
- Public Comments
Mr. Chuck Thomas of the Marijuana Policy Project provided data on arrests for
marijuana use and distribution and advocated NIDA and Federal support of use of
marijuana for medical conditions.
Dr. Leshner adjourned the 68th meeting of the National Advisory Council on
Drug Abuse at 3:05: p.m.
I hereby certify that the foregoing minutes are accurate and complete.
|Alan L. Leshner, Ph.D.
National Advisory Council on Drug Abuse
|Teresa Levitin, Ph.D.
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.