Department of Health and Human Services
National Institutes of Health
National Institute on Drug Abuse
Minutes of the 65th Meeting of the National Advisory Council on Drug Abuse
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
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.
Roger Brown, Ph.D.
William Bukowski, Ph.D.
William Cartwright, Ph.D.
Peter Cohen, Ph.D.
James Colliver, Ph.D.
Raquel Crider, Ph.D.
Mary Custer, Ph.D.
Dorynne Czechowicz, M.D.
James Dingell, Ph.D.
Bennett Fletcher, Ph.D.
Henry Francis, M.D.
Jerry Frankenheim, Ph.D.
Joseph Frascella, Ph.D.
|| Stephen Gane
Meyer Glantz, Ph.D.
William C. Grace, Ph.D.
Paul Hillery, Ph.D.
Arthur Horton, Ed.D.
Syed Husain, Ph.D.
Coryl Jones, Ph.D.
Theresa Lee, Ph.D.
Geraline Lin, Ph.D.
Rita Liu, Ph.D.
Jack Manischewitz, Ph.D.
Kesinee Nimit, M.D.
Lisa Onken, Ph.D.
Nancy Pilotte, Ph.D.
Jonathan Pollock, Ph.D.
||Rao Rapaka, Ph.D.
Larry Seitz, Ph.D.
David Shurtleff, Ph.D.
Hari Singh, Ph.D.
Vincent Smeriglio, Ph.D.
Karen Skinner, Ph.D.
Zili Sloboda, Sc.D.
Pushpa Thadani, Ph.D.
Jaylan Turkkan, Ph.D.
Frank Vocci, Ph.D.
Naimah Weinberg, M.D.
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
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
- 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
- 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
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
Open Portion of the Meeting - February 5, 1997
- 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.
- Consideration of the Minutes of the 67th Council
The Minutes of the September 17-18, 1996 meeting were approved as written.
- 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
- Report of the Director
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
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
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
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.
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.
- 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
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.
- 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
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.
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.
- 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.
- 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
"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."
- 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.
- 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.
- 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.
- 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.
- 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.
- 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,
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.
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.