Department of Health and Human Services
National Institutes of Health
National Institute on Drug Abuse
Minutes of the 70th Meeting of the National Advisory Council on Drug Abuse
September 15-16, 1998
The National Advisory Council on Drug Abuse convened its 70th meeting at 2:00
p.m. on September 15, 1998 in Conference Rooms E1 and E2, Natcher Building, National
Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland. Dr. Alan I. Leshner,
Director, NIDA, chaired the meeting. The meeting on September 15 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 September 16 at 9:00
a.m. and was open to the public. The Council adjourned September 16 at 2:55 p.m.
Council Members Present:
Susan G. Amara, Ph.D.
Hortensia D. Amaro, Ph.D.
Rand D. Conger, Ph.D.
Gerald H. Friedland, M.D.
Morton E. Goldberg, D.Sc. (September 16 only)
Thomas A. Hedrick, Jr.
Reese T. Jones, M.D.
Nancy J. Kaufman, R.N., M.S.
Clyde B. McCoy, Ph.D.
Thomas A. McLellan, Ph.D.
June E. Osborn, M.D.
Kathy Sanders-Phillips, Ph.D. (September 16 only)
Catherine A. Stevens, J.D. (September 16 only)
Lei Yu, Ph.D.
Richard T. Suchinsky, M.D. (ex officio; September 16 only)
Council Members Absent:
Andrea G. Barthwell, M.D.
George F. Koob, Ph.D.
G. Alan Marlatt, 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
| Ana Anders, M.S.W.
Khursheed Asghar, Ph.D.
Andrea Baruchin, Ph.D.
Robert Battjes, D.S.W.
Jack Blaine, M.D.
Roger Brown, Ph.D.
William Bukoski, Ph.D.
William Cartwright, Ph.D.
Robert Caudle, Ph.D.
Nora Chiang, Ph.D.
James Colliver, Ph.D.
Jean Comolli, B.S.N., M.B.A.
James Cooper, M.D.
Susan Coyle, Ph.D.
Lee Cummings, J.D.
Dorynne Czechowicz, M.D.
Susan David, M.P.H.
Lynda Erinoff, Ph.D.
Kathy Etz, Ph.D.
Bennett Fletcher, Ph.D.
Henry Francis, M.D.
Jerry Frankenheim, Ph.D.
Joseph Frascella, Ph.D.
Meyer Glantz, Ph.D.
William C. Grace, Ph.D.
|| Steven Grant, Ph.D.
Debra Grossman, M.A.
Alejandro Gutierrez-Pons, Ph.D.
Richard Hawks, Ph.D
Paul Hillery, Ph.D.
Arthur MacNeil Horton, Ed.D.
Coryl Jones, Ph.D.
Jagjitsing Khalsa, Ph.D.
Elizabeth Lambert, M.S.
Theresa Lee, Ph.D.
Deborah Leiderman, M.D.
Geraldine Lin, Ph.D.
Rita Liu, Ph.D.
Minda Lynch, Ph.D.
Robin Mackar, M.P.H.
Arnold Mills, M.S.
Cindy Miner, Ph.D.
Richard Needle, Ph.D.
Kesinee Nimit, M.D.
Jacques Normand, Ph.D.
Moira O'Brien, M.Phil.
Lisa Onken, Ph.D.
Nancy Pilotte, Ph.D.
Jonathan Pollock, Ph.D.
Rao Rapaka, Ph.D.
Elizabeth Robertson, Ph.D.
Cathrine Sasek, Ph.D.
|| Larry Seitz, Ph.D.
Charles Sharp, Ph.D.
David Shurtleff, Ph.D.
Hari Singh, Ph.D.
Karen Skinner, Ph.D.
Zili Sloboda, Sc.D.
Vincent Smeriglio, Ph.D.
Mark Swieter, Ph.D.
Betty Tai, Ph.D.
Pushpa Thadani, Ph.D.
Jaylan Turkkan, Ph.D.
Frank Vocci, Ph.D.
Marina Volkov, Ph.D.
Susan Volman, Ph.D.
Naimah Weinberg, M.D.
Herb Weingartner, Ph.D.
Cora Lee Wetherington, Ph.D.
Stephen Zukin, M.D.
Other Federal Employees:
Elliot Postow, Ph.D. - Center for Scientific Review, NIH
Peggy Schnoor - Office of Science Policy and Technology
Paula Skedsvold, Ph.D. - Office of Behavioral and Social Sciences
Members of the Public Present:
Geoff Mumford, Ph.D. - American Psychological Association
Haine Shiferaw - The Blue Sheet
Jan Brose - Capital Consulting Corporation
John Lanogan - IASWR
Jeff Hoffman - DANYA Corporation
Mark Brown - Capitol Consulting Corporation
Marc Pearce - NADCP
Beatrice Edner - American Psychiatric Association
Barbara Cire - MasiMax Research
Angela Sharpe - Consortium of Social Science Associations
Henri Crosby - DANYA Corporation
Kayla Pope - American Academy of Child & Adolescent Psychiatry
John de Miranda - National Association on Alcohol Drugs & Disability -
Chuck Thomas - Marijuana Policy Project
James F. Callahan - American Society of Addiction Medicine
Edward G. Singleton - The Mayatech Corporation
Closed Portion of the Meeting - September 15, 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 introduced new members, Dr. Hortensia Amaro and Dr. Rand Conger. He then 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, the Medications Development Division, and
the Center for AIDS and Other Medical Consequences 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, and
the Office of Science Policy and Education were reviewed by a subcouncil committee
chaired by Dr. Susan Coyle. Each subcouncil committee reviewed applications and
made recommendations for concurrence with the initial Scientific Review Group.
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. Requests
for administrative supplements were also reviewed. 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, 491 applications, requesting $437,101,069 in Total Years
Direct Costs, went to review. Of these, 313 were scored by the Scientific Review
Groups, representing $62,296,890 in First Year Direct Costs and $262,667,710 in
Total Years Direct Costs. The full Council approved each subcouncil committee's
recommendations, including seven administrative supplements.
Open Portion of the Meeting - September 16, 2001
- 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 introduced the new members, Dr. Hortensia Amaro and Dr. Rand Conger, and
he expressed gratitude for their willingness to serve. He noted that Dr. June
Osborn was completing her term of service and thanked her for her dedication and
- Consideration of the Minutes of the 69th Council
The Minutes of the May 19-20, 1998 meeting were approved as written.
- Future Meeting Dates
Future meeting dates for Council were announced as follows:
February 2 - 3, 1999
May 25 - 26, 1999
September 14 - 15, 1999
February 8 - 9, 2000
May 16 - 17, 2000
September 12 - 13, 2000
- NIDA Director's Report
Dr. Leshner opened his report with a special acknowledgment of Dr. Zili Sloboda,
who is retiring from Federal Service. He noted her many accomplishments, most
recently as Director, Division of Epidemiology and Prevention Research, and thanked
her for her service. Council members were referred to the printed copy of the
Director's Report for other staff changes.
Dr. Leshner reported that budget negotiations for FY 1999 are continuing, and
NIDA is awaiting the outcome of conference discussions. The FY 1998 appropriation
was $527.175 million, reflecting a 7.6% increase over FY 1997 levels. The FY 1999
President's budget request reflects an increase of 8.4% increase for NIH
overall, with NIDA's allocation expected to be $576.299 million, which
is a 9.3% increase. The House of Representatives is proposing $575.426 million
(a 9.2% increase) for NIDA, while the Senate is proposing $603.274 million (a
14.4% increase). These proposals show strong support for biomedical research and
would allow an accelerated pace of ongoing NIDA activities and the initiation
of new activities.
The integration of basic neuroscience applications into the Center for Scientific
Review has been completed, and Dr. Leshner noted details on review integration
will be provided later in the day. The integration of human development and AIDS
applications has also occurred. Planning for behavioral science integration is
continuing and has proved to be complex. Dr. Leshner informed the Council that
the proposed scientific review groups may be seen on the World Wide Web, and he
encouraged the Council to look at the proposed groups and provide feedback.
Members were reminded of relatively recent policies related to review: the
issuance of a policy on inclusion of children in NIH sponsored research and the
need for prior agreement from an Institute before the submission of any application
requesting more than $500,000 in direct costs for any year.
Shaping the Research Agenda
A Program Announcement "Genetic Architecture of Complex Phenotypes"
was released in June in conjunction with nine other NIH components. A Request
for Applications titled "Basic Behavioral and Cognitive Science Research:
Approaches to the Study of HIV/AIDS and Drug Abuse" was also released in
A number of meetings have been held to inform the research community of recent
findings and NIDA's interest in further pursuit of those findings. NIDA's
Special Populations Office hosted a meeting in Chicago,"Cannabinoid and Opiate
Vascular Neuroimmunology," as part of its Research Development Seminar Series.
"Buprenorphine/Naloxone Treatment of Opiate Dependence" was sponsored
by the Medications Development Division in August. A meeting titled "Cognition
and Emotion: Applications to Drug Abuse" was held as a miniconference within
the American Psychological Society meeting in May. "Drug Addiction: A Treatable
Disease," formed part of the program track at the American Psychiatric Association's
summer meeting in Toronto. In July, the Robert Wood Johnson Foundation, NIDA,
and the Centers for Disease Control and Prevention jointly sponsored a national
conference, "Addicted to Nicotine: A National Research Forum." This
meeting was highly successful in drawing attention to research on nicotine. It
featured Vice President Gore as the keynote speaker.
Also, NIDA has supported the Hispano/Latino Researchers and Scholars Work Group
to recommend a program of research to determine the extent and nature of drug
abuse disparities between Hispanics and other populations and the reasons therefor.
A workshop on violence was held in conjunction with the College on Problems of
Drug Dependence annual meeting in Scottsdale, Arizona.
In November NIH will conduct a consensus development conference on the Diagnosis
and Treatment of Attention Deficit Hyperactivity Disorder.
Several activities are occurring to help disseminate the findings of NIDA research.
The Town Meetings continue, and three are soon to occur in Buffalo, Saratoga Springs,
and Des Moines. The one in Des Moines will focus on the growing abuse of methamphetamine
across the country and ways local resources can utilize scientific findings.
NIDA has enjoyed a great deal of favorable media exposure that helps disseminate
its research. These events include, among others, an interview by BBC Radio, a
Wall Street Journal article, coverage of the Addicted to Nicotine: A National
Research Forum conference, and network news segments. The Council was referred
to the printed Director's Report for more details. Finally, the Science
Education program has released the seventh of its "Mind Over Matter"
series of materials for middle schools. The latest release focuses on nicotine.
- Physician Leadership on National Drug Policy - Dr. June Osborn
Dr. June Osborn described the activities of the Physician Leadership on National
Drug Policy (PLNDP), a group of 37 distinguished physicians that was organized
by Dr. Osborn and her colleagues, Drs. Lonnie Bristow and David Lewis. The group
is stimulating a fresh look at addiction from the perspective of luminary physicians
who are identified with the field of substance abuse. The group quickly reached
consensus that addiction is a chronic, treatable medical illness. Further, they
agreed that medical schools need to do more to teach about addiction and drug
abuse. The PLNDP is focused on the need for treatment of drug abuse. The PLNDP
has gathered data, issued reports, educated Congress and prepared a videotape
for lay audiences. The videotape was shown to Council, and it focused on prevention,
treatment, and the need to avoid attaching a stigma to drug abuse. Dr. Osborn
ended her presentation by noting that the PLNDP is designed to fill the gap of
physician involvement in drug abuse issues and does not wish to imply any minimization
of non-physicians' contributions.
Dr. Leshner praised Dr. Osborn and the PLNDP for their efforts, noting the
importance of addressing the stigma issue. Other Council members contributed ideas
for support of, or directions for, the PLNDP, such as foundation support, working
with the pharmaceutical industry, addressing reimbursement, and developing curricula.
- Report on Review of NIDA Neuroscience and AIDS Science at the Center for
Scientific Review - Dr. Elliot Postow
Dr. Postow reported on results from the recent review cycle, which was the
first to include NIDA's neuroscience and AIDS applications in the newly
constituted Center for Scientific Review (CSR) review groups. CSR has committed
itself to on-going evaluation of the integration activities and has applied for
and received "1% evaluation funds" to monitor the integration. Cautioning
that interpretation is limited by the small numbers of applications involved,
he presented data on the outcomes of reviews of neuroscience applications. His
general conclusions were that there was much variability over different scientific
review groups, that NIDA applications were about as likely to be scored at the
25th percentile or better as others, and that usually the number of unscored NIDA
applications was comparable to the number of unscored applications from other
NIH Institutes. However, some review groups seemed more likely to give NIDA poorer
scores. The NIDA scores in the Integrated Functional and Cognitive Neurosciences
IRG were comparable to other scores. For the Molecular, Developmental, and Cellular
Neuroscience IRG, both NIDA and NIMH tended to have more unscored applications
than other NIH components.
Dr. Leshner asked about the impact of recalibrating the median from 2.5 to
3.0. Dr. Postow presented data to suggest the percent of unscored applications
was not affected, and the overall CSR median score moved from 240 to 265. Further,
the distribution of scores was flattened. Dr. Postow concluded that the review
groups are scoring, overall, as requested and implementing the score changes fairly.
Council asked about the basis of calibration for "unscoring". Dr. Postow replied
that the traditional adjectives were no longer being used, so the frame of reference
is the grants one is "used to seeing" recently. Council raised the issue of round-to-round
variability in the quality of applications, and Dr. Postow noted CSR has examined
variability in scores, which is not an equivalent concept. Council sought and
received assurance that applicants are being informed about the scoring changes.
Council discussed the importance of keeping in mind that the purpose of the scores
is to help make funding decisions and that this is especially difficult around
the "payline margins." Finally, a member noted that reviewers need adequate orientation
to the changes.
After Dr. Postow's presentation, Council decided to form a subcommittee to
monitor the impact of integration and the reviews of NIDA applications. Related
concerns surfaced, such as whether or not all areas of NIDA's science could be
monitored and would receive fair treatment, whether or not the procedure of not
discussing unscored applications was working as well as intended, the level of
encouragement provided in summary statements, and the need to focus reviews on
the contribution the work could make.
- Plans for the Center for AIDS and Other Medical Consequences of Drug Abuse
- Dr. Henry Francis
Dr. Francis presented information on NIDA's plans for the Center for
AIDS and Other Medical Consequences of Drug Abuse (CAMCODA). He addressed his
personal understanding of the nature of the AIDS epidemic and the need to prevent
not only infection, but also ignorance. He described the history of the development
of CAMCODA and then gave an overview of current research support and other activities.
Finally, he expressed NIDA's ideas about how CAMCODA can operate with other
NIDA and NIH components to support and facilitate research, the development of
new ideas, and needed discussion. Council members asked about the relationship
of CAMCODA to the NIH Office of AIDS Research, and it was explained that CAMCODA
will be the "final common pathway" with NIH OAR for programmatic and
budget discussions, but this does not preclude informal interactions with OAR
by staff outside CAMCODA. Discussion also addressed the need for comprehensive
activities that address a variety of medical conditions associated with HIV as
well as prevention and behavioral issues.
- Update on Methadone Regulations and Accreditation - Mr. Robert Lubran
Mr. Lubran spoke to the Council about Center for Substance Abuse Treatment
(CSAT) activities related to methadone accreditation. In response to a 1995 Institute
of Medicine report and an NIH Consensus Panel on Effective Treatment for Heroin
Addiction, the current Food and Drug Administration procedures for regulation
of methadone treatment are being replaced by an accreditation model that the Substance
Abuse and Mental Health Services Administration (SAMHSA) will oversee. Mr. Lubran
described three sets of activities related to this: regulatory reform, a demonstration
program, and technical assistance. The exact details of regulatory reform for
how the functions will be altered and transferred to SAMHSA are being finalized
with the Office of Management and Budget (OMB). Therefore, the exact plans may
not be distributed to the public at this time. However, the general approach is
for a "mixed" regulatory/accreditation approach that is similar to accreditation
programs that have existed in other areas for years. The demonstration project
has already been approved by the OMB and is being developed with the Commission
on Accreditation of Rehabilitation Facilities (CARF) and Research Triangle Institute
(RTI). CARF is involved in setting standards, as they already accredit methadone
programs, and will provide training. The RTI will evaluate the demonstration program.
Finally, CSAT has a contract to provide preaccreditation and postaccreditation
technical assistance to programs. Mr. Lubran concluded his talk with a brief description
of other CSAT initiatives related to methadone and drug treatment.
Council noted that methadone programs are currently subject to multiple inspections
by many levels of government and for both law enforcement and public health purposes.
Mr. Lubran expressed optimism that consolidation of local and state inspections
could be achieved as governments agree to accept accreditation, but there has
not been progress on having consolidated reviews on the law enforcement side,
with the DEA for example. Council also sought some clarification on anticipated
time frames for securing accreditation for various types of programs and various
settings (e.g., programs not currently providing methadone, physicians' private
practices). Council agreed that the treatment subcommittee should look at the
draft regulations when they become available. They also noted that the PLNDP would
be interested in the CSAT activities.
- Update on the Intramural Research Program - Dr. Barry Hoffer
Dr. Hoffer provided an update on the Intramural Program's continued
responses to the Blue Ribbon Panel Report. These responses include participating
in NIDA-wide genetics initiatives, expanding programs on mechanisms of neurodegeneration,
augmenting the clinical research activities, and securing new instrumentation.
Additionally, collaborations with the Medications Development Division, NIDA and
with other intramural programs have increased. A number of new personnel have
been recruited, and Dr. Hoffer has instituted incentives for inter-branch collaborations
at the intramural program.
Council expressed their approval of these changes and asked if there were plans
to increase activities in social and behavioral research. Dr. Hoffer replied that
he is now able to direct his attention to those areas and that there is a need
for infrastructure development to support such research.
- Update on the NIDA Science Education Program - Dr. Andrea Baruchin and
Dr. Cathrine Sasek
Drs. Baruchin and Sasek described NIDA's science education program and
provided examples of materials developed for science education. The program began
in 1991 and attempts to improve students' knowledge of and interest in
science, to increase scientific literacy among the general public, to interest
more women and minorities in scientific careers, to increase understanding of
the role of animals in research, and to disseminate information about the biological
basis of drug abuse. NIDA's science education activities span all grade
levels. A variety of mechanisms are used and include the Science Education Drug
Abuse Partnership Awards (a grant program) and the Small Business Innovative Research
(SBIR) program. Support is given to projects that are likely to have broad impact.
Examples were presented to the Council and included an interactive, multimedia
CD-ROM that emulates television shows, another interactive CD-ROM museum exhibit,
and a radio program. Other examples of science education activities presented
were Project DART, a team development approach; training videos developed through
the SBIR; the "If You Change Your Mind" video and associated materials;
"Mind Over Matter" posters on drugs of abuse; and slide packets on neuroscience.
Other activities were mentioned, and plans for the future were described.
Council asked about the particular outcome measures being used to evaluate
these materials. Dr. Sasek replied that the particular measures depend on the
program, but they generally involve increases in knowledge, changes in attitudes,
development of interest in science, and utilization of materials. Council suggested
new populations to target for science education, such as judges in drug courts
and employee assistance program staff, and praised the activities of NIDA in this
- Council Subcommittee Report on Treatment Research - Dr. A. Thomas McLellan
Dr. McLellan reported on the subcommittee's meeting. Most of the discussion
revolved around the clinical trials network to develop a "national laboratory"
for examining treatments in "real world" settings. The plans for this
network and possible activities and organizational structures were given. Dr.
Leshner reminded the Council that this initiative had been described in May and
that they were hearing an elaboration of the plans.
- Council Comments
There were no additional items for discussion.
- Public Comments
Mr. James Callahan spoke on behalf of the American Society of Addiction Medicine
to thank Dr. Leshner, NIDA staff, and the research community for assistance in
developing the second edition of Principles of Addiction Medicine. Dr. Terry Schultz,
co-editor with Dr. Alan Graham, presented NIDA with a copy of their textbook,
and he thanked Dr. Leshner and Dr. Dorynne Czechowicz for their leadership which
had contributed to the development of the book.
Mr. Chuck Thomas of the Marijuana Policy Project urged NIDA to make marijuana
available for research studies without requiring those studies to go through NIH
review and approval.
Dr. Leshner adjourned the 70th meeting of the National Advisory Council on
Drug Abuse at 2:55 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.