Department of Health and Human Services
National Institutes of Health
National Institute on Drug Abuse
Minutes of the 93rd Meeting of the National Advisory Council on Drug Abuse
May 16-17, 2006
The National Advisory Council on Drug Abuse convened its 93rd meeting at 3:00 p.m. on May 16, 2006 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland.
Dr. Nora D. Volkow, Director of NIDA, chaired the overall meeting and Dr. Timothy P. Condon, Deputy Director of NIDA, chaired the review of applications. The closed portion of the meeting on May 16, from 3:00 p.m. until 5:00 p.m. was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open session, which was open to the public, was May 17th, from 8:45 a.m. until 1:30 p.m. The Council adjourned on May 17, 2006 at 1:30 p.m.
Council Members Present:
Rodolfo Arredondo, Jr., Ed.D.
Council Members Absent:
Warren K. Bickel, Ph.D.
Steve Brasington, M.D. (Ex officio)
Jeanne Brooks-Gunn, Ph.D.
Mark T. Greenberg, Ph.D.
Bankole A. Johnson, M.D., Ph.D.
Peter W. Kalivas, Ph.D.
Herbert D. Kleber, M.D.
Barry M. Lester, Ph.D.
Thomas E. Lucking, Ed.S.
Patricia I. Ordorica, M.D.
Linda J. Porrino, Ph.D.
John P. Rice, Ph.D.
Ellie E. Schoenbaum, M.D.
Claire E. Sterk, Ph.D.
Richard R. Suchinsky, M.D.
Constance M. Weisner, Dr.P.H.
Marina E. Wolf, Ph.D.
Janet Wood, M.B.A., M.Ed.
Council Chairs Present:
Nora D. Volkow, M.D.
Timothy Condon, Ph.D.
Teresa Levitin, Ph.D.
Federal Employees Present:
National Institute on Drug Abuse, NIH, DHHS
Jane Acri, Ph.D.
Thomas Aigner, Ph.D.
Ann Anderson, Ph.D.
Nathan Appel, Ph.D.
Ruben Baler, Ph.D.
Lula Beatty, Ph.D.
Elizabeth Babecki, M.P
Jamie Biswas, Ph.D.
Nicolette Borek, Ph.D.
William Bukoski, Ph.D.
Jessica Chambers, Ph.D.
Redonna Chandler, Ph.D.
Nora Chiang, Ph.D.
Allison Chausmer, Ph.D.
Jim Colliver, Ph.D.
Christine Colvis, Ph.D.
Wilson Compton, M.D., M.P.E.
Timothy Condon, Ph.D.
Kevin Conway, Ph.D.
Aria Crump, Sc.D.
Carol Cushing, R.N.
Dorynne Czechowicz, M.D.
Richard Denisco, M.D.
Marta DeSantis, Ph.D.
Augusto Diana, Ph.D.
Gayathri Dowling, Ph.D.
Kathleen Etz, Ph.D.
Lynda Erinoff, Ph.D.
Bennett Fletcher, Ph.D.
Jerry Flanzer, Ph.D.
Jerry Frankenheim, Ph.D.
Joseph Frascella, Ph.D.
Elizabeth Ginexi, Ph.D.
Meyer Glantz, Ph.D.
Harold Gordon, Ph.D.
Steven Grant, Ph.D.
Mark Green, Ph.D.
Debra Grossman, M.A.
Steve Gust, Ph.D.
Peter Hartsock, PH.D.
Richard Hawks, Ph.D.
Mark Headings, MPA
Paul Hillery, Ph.D.
Thomas Hilton, Ph.D.
Meena Hiremath, Ph.D.
Richard Jenkins, Ph.D.
Dionne Jones, Ph.D.
Cheryl Kassed, Ph.D., M.S.P.H.
Jackie Kaftarian, Ph.D.
Jagjitsingh Khalsa, Ph.D.
Suman Rao King, Ph.D.
Raynard S. Kington, M.D., M.B.A., Ph.D.
Thomas Kresina, Ph.D.
Elizabeth Lambert, M.Sc.
Diane Lawrence, Ph.D.
Eliane Lazar-Wesley, Ph.D.
Geraldine Lin, Ph.D.
Yu (Woody) Lin, Ph.D.
Rita Liu, Ph.D.
Marsha Lopez, Ph.D.
Minda Lynch, Ph.D.
David McCann, Ph.D.
Gerald McLaughlin, Ph.D.
Cecelia McNamara-Spitznas, Ph.D.
Mary Ellen Michel, Ph.D.
Ivan Montoya, M.D.
Ro Nemeth-Coslett, Ph.D.
Kesinee Nimit, M.D.
Sami Noursi, Ph.D.
Moira O'Brien, M.Phil.
Lisa Onken, Ph.D.
Murat Oz, M.D., Ph.D.
Jen Jong Pan
Moo Park, Ph.D.
Nancy Pilotte, Ph.D.
Denise Pintello, Ph.D.
Jonathan Pollock, Ph.D.
Melissa Racioppo, Ph.D.
Rao Rapaka, Ph.D.
Eve Reider, Ph.D.
Elizabeth Robertson, Ph.D.
Carmen L. Rosa, M.S., M.T., R.A.C.
Douglas Rugh, Ph.D.
Joni Rutter, Ph.D.
Catherine Sasek, Ph.D.
John Sattlerlee, Ph.D.
Paul Schnur, Ph.D.
Charles Sharp, Ph.D.
Ming L. Shih, Ph.D.
David Shurtleff, Ph.D.
Belinda Sims, Ph.D.
Hari Singh, Ph.D.
Karen Sirocco, Ph.D.
Karen Skinner, Ph.D.
Vincent Smeriglio, Ph.D.
Laurence Stanford, Ph.D.
Anna Staton, MPA
Jack Stein, Ph.D.
Mark Swieter, Ph.D.
Betty Tai, Ph.D.
Pushpa Thadani, Ph.D.
David Thomas, Ph.D.
Yonette Thomas, Ph.D.
George Uhl, M.D. & Ph.D.
Frank Vocci, Ph.D.
Susan Volman, Ph.D.
Paul Wakim, Ph.D.
Robert Walsh, B.S.
Kay Wanke, Ph.D. & M.P.H.
Naimah Weinberg, M.D.
Susan Weiss, Ph.D.
Cora Lee Wetherington, Ph.D.
David White, Ph.D.
Da-Yu Wu, Ph.D.
Members of the Public Present:
Khursheed Asghar, Ph.D. - Contractor
Virginia Ashton - AACAP
Jack Blaine, M.D. - Contractor
Anne Bowen - MasiMax Resources, Inc.
Andrea Browing - Society for Research in Child Development
Sue Camaione - MasiMax Resources, Inc.
Bill Corrigall, Ph.D. - Contractor
William Dewey, Ph.D. - Univ. of Virginia Commonwealth
Julie Egermayer - COSSA
W.E. Ford - Synergy Enterprises
Stacia Hall - AACAP
Alyson Haywood - Madison Assoc.
Alexis Horan - American Society of Addiction Medicine
Andrew Kessler - NAADAC
Roxanne Kibben - Synergy Enterprises
Marian Kratage - MasiMax Resources, Inc.
Alan Kraut, Ph.D. - American Psychological Association
Kristin Kreager - AACAP
Joan Kub - JHU, School of Nursing
Mary Mayhew - Contractor
Geoffrey Mumford, Ph.D. - American Psychological Association
Michael Oxman, Ph.D. - Contractor
Patricia Pettinato - MasiMax Resources, Inc.
Darrel Regier, M.D. - American Psychiatric Association
Roy Walker - CSR, Inc.
Diedre Watkins - MasiMax Resources, Inc.
Jo Weekley - MasiMax Resources, Inc.
Lori Whitten - MasiMax Resources, Inc.
Joan Levy Zlotnik - Inst. for Advancement of Social Work Research
Patricia Zickler - NIDA Notes
Closed Portion of the Meeting - May 16, 2006
- Call to Order
This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Dr. Timothy Condon, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. Dr. Condon provided an overview of the agenda for the meeting and reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public. Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.
- Application Reviews
In turn, the Director or a designee for the Office of Science Policy and Communications; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Division of Epidemiology, Services and Prevention Research; and the Division of Pharmacotherapies and Medical Consequences of Drug Abuse presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc.
Members must absent themselves from the Council meetings during discussion of, and voting on, applications from their own institutions or other applications in which there is a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave if an application in conflict with that member was acted upon en bloc.
For this Council, 957 applications, requesting $854,307,265 in Total Years Direct Costs, went to review. Of these, 530 were scored by the Scientific Review Groups (SRGs) representing $116,189,143 in First Year Direct Costs and $482,788,646 Total Years Direct Costs. Council concurred with the SRGs in time and amount. A request for one new MERIT was reviewed and approved. Council approved one administrative supplement. Council concurred with the IRG's recommendation on an appeal.
Open Portion of the Meeting - May 17, 2006
- Call to Order
Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed the Council members. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. Dr. Volkow called attention to future Council meetings.
- Consideration of the Minutes of Council
The Minutes of the September 2005 meeting were approved as written.
- NIH at the Crossroads: Myths, Realities and Strategies for the Future - Elias A. Zerhouni, M.D., Director, NIH
Dr. Zerhouni pointed out that the NIH budget is facing a "perfect storm." He noted that the Federal Deficit, Defense and Homeland Security priority requirements, Hurricane Katrina, as well as the pandemic flu costs and domestic budget cuts, have all contributed to the NIH budget circumstances. Further, after the doubling of the NIH budget in five years, Congress, though strongly supportive of the NIH mission, is now interested in providing more resources for the physical sciences. In addition, there has been general inflation in the costs of doing biomedical research.
Dr. Zerhouni noted that he hoped to dispel myths about success rates and the budget, and, in order to do so, he posed three questions: 1) Is NIH placing too much emphasis on translational science at the expense of basic of research? 2) Is NIH over-investing in big projects and initiatives at the expense of investigator-initiated research? and 3) Is the success rate due to the Roadmap initiative? Dr. Zerhouni then presented data to address each of these questions.
He noted that NIH's commitment to basic research has not changed and, furthermore, will not change. About two-thirds of NIH's budget goes to basic research and about one-third goes to applied research. He reiterated that this commitment has not changed and will not change.
To answer the question of whether NIH is over-investing in big projects at the expense of investigator-initiated research, Dr. Zerhouni presented data on Program Announcements and Requests for Applications from 1995-2005, which showed that NIH has continued to support investigator-initiated awards as the primary source of research ideas and funding. He reiterated that NIH is committed to investigator-initiated research and showed that the proportion of investigator-initiated applications has remained robust over time. Unsolicited grants far outnumber solicited ones.
Dr. Zerhouni then addressed the question of the role of the Roadmap, since one prevalent myth is that the Roadmap has siphoned funds and lowered the success rate of investigator-initiated projects. Dr. Zerhouni explained the reasons for developing the Roadmap initiative and noted that it was developed with substantial extramural input. He also noted that the Roadmap was developed to increase synergy across the NIH and to respond to concerns about the perceived "balkanization" of NIH. Roadmap projects are those that are beyond the scope of a single institute or center, though they benefit all NIH and the public health. Roadmap projects address emerging areas of science and high-risk/high-impact research, and they enable the science infrastructure. Dr. Zerhouni also pointed out the important role NIDA has taken in the NIH Roadmap, including NIDA involvement in the development of clinical trial networks, NIDA support for molecular libraries and the imaging Roadmap initiative and NIDA's co-leadership on an interdisciplinary research initiative to develop innovative methodology in social and behavioral sciences research.
Dr. Zerhouni noted that in FY05, the Roadmap was only .8 percent of the total NIH budget, and for FY 06, that amount will rise to only 1.2 percent of the total NIH budget. Further, the Roadmap is not a single initiative but, rather, in FY05, included over 345 individual awards, 40 percent of which were for basic research, 40 percent of which were for translational research and 20 percent of which were high-risk research. The Roadmap creates "incubator space" to accelerate critical research efforts that address major cross-cutting NIH priorities. Furthermore, this "incubator space" is now a permanent part of the new NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI). Dr. Zerhouni presented the NIDA Director's Pioneer Award program as one example of a successful Roadmap activity. He noted that this program is designed to support individuals with high-risk, potentially ground-breaking ideas. One example of the success of this program is Dr. Sunney Xie. Dr. Sunney Xie is the first to show translation of a gene at the level of a single protein molecule in a live cell. His work has been published simultaneously in Science and Nature.
Having addressed three myths about success rates and the budget, Dr. Zerhouni then posed the question of what is actually happening. He noted that there are three fundamental drivers of today's situation. First, there has been large capacity building and a corresponding dramatic increase in the number of tenure track faculty. Second, there has been a large increase in applicants and applications since 2003. Third, appropriations were below inflation after 2003, while BRDPI in 2004 was about 5.5 percent. Dr. Zerhouni explained the four-year budget cycling phenomenon. He noted that dislocation is the disjuncture between supply and demand, but that this is a manageable situation.
Dr. Zerhouni presented data about the number of new applications that had come to NIH during the period of doubling and currently, and he posed the question of what funds are really available in any one year. He explained the difference between committed funds, uncommitted funds, and increases in funds. He showed how funds became available with the ending of grants that started four or five years ago. He also provided information about Congressional appropriations and explained the budget cycle and the difference in funds available over the time that included the doubling period and the current funding period. Dr. Zerhouni summarized this part of his presentation by noting that 1) the demand for grants "took off" (2002-2006) just as the NIH budget was "landing" (1999-2003); 2) there has been more increase in demand for grants in last two years than in the full five years of the doubling; 3) NIH budget increases have been below inflation; 4) there are budget cycle effects: the uncommitted pool in 2006 comes from 2001-2002 when doubling did not yet occur; and 5) 2003 commitments will become available in 2007, allowing for a 3 percent increase in competing grants (even with a flat budget).
Dr. Zerhouni raised the question of what lies ahead. He emphasized the importance of knowing the facts and dispelling myths, of developing adaptive strategies and of conveying a unified message of NIH's many successes and its vision for the future. He then addressed each of these points. He noted the importance of senior scientists not discouraging new scientists from entering science out of fear that they will not be funded. He emphasized that the funding situation now is part of a larger cycling phenomenon, that NIH did have a doubling of its budget that has not eroded, and that the supply/demand disjuncture will soon be brought into synchronization.
In discussing adaptive strategies, Dr. Zerhouni noted the importance of protecting knowledge and discovery. He reiterated his commitment to bringing in new talent and new investigators. He pointed out that one way to ensure that more new investigators become independent scientists is through the new "Pathway to Independence Award." This award is a transition grant to support the most promising of new investigators for two years of their post-doctoral work and three years of R01 equivalent work for those in a tenure track position. This new concept will help new investigators become independent scientists earlier in their careers.
Dr. Zerhouni also stressed the importance of conveying a unified message and increasing communication about the positive impact of NIH on science and health. He appealed to the Council to help NIH send this message at the local level and at the regional level, and emphasized that NIH will continue to do so at the national level. He noted that investment in NIH is an investment in the future and that sustained investment in science is needed.
He also shared with Council his vision of the future. He noted that in his testimony to Congress he described the return on investment in coronary heart disease, where there has been a 63 percent decrease in mortality, thereby averting early death of about one million people a year. The new and effective treatments that have been developed have represented a total investment per American over the past 30 years of only about $110.00, with the average annual investment per American of only about $3.70. Another success of NIH research is found in the area of cancer. For the first time, annual cancer deaths in the United States have fallen. Early detection and screening are more effective, minimally invasive treatments have multiplied, and new discoveries make it possible for the first time to personalize cancer treatment. The total investment per American over the past 30 years has only been about $260.00, while the average annual investment per American has only been about $8.60.
Dr. Zerhouni then spoke about the need to transfer medical research into the twenty-first century. Twenty-first century medical practice will intervene before symptoms appear and preserve normal function for as long as possible. There is now a greater understanding of pre-clinical molecular events and greater ability to detect patients at risk. Further, the paradigm of the future will be to transform medicine from curative to preemptive. Medicine will become more predictive, more personalized, and more preemptive. Patients will also be more participatory in their own care. Dr. Zerhouni noted the importance of research on how to transform the medical system from the way it is now to the way it needs to be for the twenty-first century and beyond. He concluded his presentation by reiterating the importance of the scientific community remaining calm, cool and collected through difficult times, and he noted that everyone must communicate more effectively the vision of NIH, the nature of NIH research, and the successes of that research.
- Consideration of the Minutes of Council
The Minutes of the February 2006 meeting were approved as written.
- NIDA Director's Report - Nora D. Volkow, M.D., Director, NIDA
Dr. Volkow described the NIDA budget, noting that in 2005 the actual budget of over 1 billion dollars represented a 1.2 percent increase over the previous year. The appropriation for 2006, however, shows a minus .6 percent decrease over the prior year.
Dr. Volkow summarized some of the contributions NIDA research has made to the public health, noting, for example, that one reason for the decrease in people dying of cancer has been the success of the campaign against smoking. She noted the importance of determining the extent to which the investment in substance abuse research has impacted other medical diseases. Following up on Dr. Zerhouni's comments about the importance of communicating the work that NIH does, Dr. Volkow pointed out how NIDA has been very proactive in communicating with the public. She noted that Ms. Sharon Jayne is working at NIDA and has organized a number of interviews on radio, television, and in print so that the value of NIDA's research to the public health can be better disseminated.
Dr. Volkow summarized recent NIDA activities. She noted that two Council workgroup reports would be presented later in the day. She also described Requests for Applications (RFAs) that had been released since the last Council meeting. These included the social neurosciences RFA, the RFA on prescription opiate abuse, and abuse in the treatment of pain and the epigenetics of addiction RFA. She briefly presented a number of other program announcements and RFAs that cover a range of scientific areas and questions within the NIDA mission, including HIV/AIDS, epidemiology, and prevention. Furthermore, Dr. Volkow noted that NIDA is participating in a number of program announcements and RFAs issued by other NIH components and other agencies. Dr. Volkow then turned to some of the most important current projects and findings in the portfolio. In terms of HIV/AIDS, Dr. Volkow pointed to the importance of early screening. She noted that, as a result of NIDA research in this area, the Centers for Disease Control is changing its policy, now recommending screening to a much wider range of populations, and early screening can mean earlier intervention and treatment. Thus, NIDA research in this area has been very influential and important. She added that the challenge to the field is to obtain community acceptance of widespread screening for HIV/AIDS.
There are important new directions in each division. For example, the Division of Pharmacotherapies and Medical Consequences on Drug Abuse (DPMCDA) is interested in the potential of the use of naltrexone, which was recently approved for the treatment of alcoholism, for its potential for the treatment of heroin abuse. Dr. Volkow listed the advantages of depot naltrexone, including the fact that it can be administered once a month, and it can be used in the prison system and the criminal justice system, increasing adherence to treatment. Another advantage of depot naltrexone is it can be exported to countries that have opiate abuse problems, but do not allow agonist therapy. Further, it may help reduce HIV/AIDS resulting from IV drug abuse.
In the Division of Epidemiology Services and Prevention Research (DESPR), the Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) program has focused on improving the outcomes for offenders with substance use disorders through effective integration of drug abuse treatment, public health and public safety systems. Dr. Volkow emphasized the importance of providing treatment for people in jails or prisons. It is estimated that 80 or 85 percent require some type of treatment. Although several NIDA studies show that treatment in prison is effective, access to treatment and medication is limited.
The Division of Basic Neuroscience and Behavioral Research (DBNBR) has been very active in supporting work to understand the genes that make a person vulnerable to experimenting with drugs. A whole genome-wide association study targeting nicotine dependence is underway to identify differences between cases and controls in nicotine dependence. NIDA researchers have been working with Perlegen Sciences, Inc. to find the genes that play a role in nicotine addiction. These types of analyses will identify genes and proteins relevant for nicotine addiction.
Dr. Volkow noted that the Division of Clinical Neuroscience and Behavioral Research (DCNBR) is developing a new initiative to disseminate messages to adolescents to persuade them of the deleterious effects of drugs. Dr. Volkow said brain-imaging technology will be used for this initiative, and she pointed to some interesting studies that have identified how imaging might be used to provide new insights on ways to tailor more effective communication.
Dr. Volkow also summarized some of the recent work of the Clinical Trials Network (CTN). She pointed out that the network has been very successful in completing several protocols. She described the importance of the cultural change taking place in community treatment programs in their willingness to use buprenorphine. This is extremely important, because almost half of the programs that refused to use medication in the past are now willing to do so as a result of participating in the CTN. She also noted dramatic changes in the adoption of motivation incentive strategies, which are inexpensive and effective. Thus, the CTN is able to bring about important cultural changes.
Dr. Volkow then turned to the NIH Roadmap and pointed out how actively NIDA grantees have participated in Roadmap activities, receiving grants, both in 2004 and 2005. Specifically, in FY 2004, seven grants from the Roadmap were awarded to NIDA researchers. Fifteen grants related to NIDA's research were awarded. In FY 2005, eight grants were awarded to NIDA researchers and sixteen grants related to NIDA's research were awarded. Thus, NIDA's investment in the Roadmap has more than paid for itself. Dr. Volkow noted that it was also important to recognize that participation in these NIH-wide initiatives will allow the field of drug abuse research to advance faster and will also create a dialog with other institutes and areas and fields of research.
Dr. Volkow provided an overview of recent upcoming meetings, conferences and events, demonstrating that NIDA has been extremely active in a number of meetings, including a symposium on "Geography and Drug Addiction" as well as a conference sponsored by the New York Academy of Sciences with Brown Medical School on "Resilience in Children." The Tenth Annual Prism Awards took place in April and was very well attended. NIDA prepared a research track for the American Psychiatric Association annual meeting in May of this year, as well as one for the American Psychological Association annual meeting. At the College of Problems of Drug Dependence meeting, there were many scientific presentations as well as a grant-writing workshop and international activities. Finally, Dr. Volkow noted that on June 12th there will be a Congressional briefing sponsored by the Friends of NIDA on "Prevention of Drug Abuse and the Importance of Brain Development" and in October of 2006 there will be a "Blending Addiction Science and Practice" meeting in Seattle, Washington that will bring together scientists and community treatment providers to focus on translation.
- Report of Workgroup on NIDA's Approach to Grant-Making - Linda Porrino, Ph.D., Member of Workgroup
Dr. Porrino summarized the report of the workgroup on NIDA's Approach to Grant Making. She noted that the charge of the group was to determine if any actions or new policies might be needed on the following: 1) protecting new investigators; 2) providing a balance between large and small science; 3) identifying guidelines regarding principal investigators with multiple grants; 4) providing recommendations on the duration of grants; and 5) considering other issues, as deemed appropriate. Dr. Porrino pointed out that each of these areas is very complex and that recommendations could have unintended consequences. The workgroup members organized their recommendations as follows: 1) protecting new investigators; 2) enhancing the science mission of NIDA; and 3) increasing research innovation.
Dr. Porrino noted that each of the divisions had provided information to the workgroup on how new investigators are identified and supported. The workgroup quickly realized that there is no uniform definition and tracking of data on new investigators across NIDA. Therefore, the workgroup recommended that NIDA-wide data on new investigators be collected. More specifically, the workgroup recommended that the success of new investigators be carefully tracked and that an annual report be presented to Council on the funding of new investigators for various types of awards, e.g. K and R mechanisms. It was further recommended that funds be set aside for promising new investigators. Dr. Porrino noted that the data provided to the workgroup suggested that NIDA has been doing a very good job in supporting new investigators and in developing new investigators in every division. Nevertheless, she reiterated the need for gathering consistent NIDA-wide information on the success of new investigators to be reported to Council on an annual basis.
The workgroup also voiced its support for a CSR pilot currently underway to provide rapid feedback for new investigators which would allow them to reapply earlier than is currently the case. The workgroup also recommended tracking and expanding mechanisms that are successful in funding early career investigators, such as the New Pathway to Independence Award (K99/ R00). Another recommendation was to expand the use of mentored K mechanisms. The workgroup also noted the importance of taking into account the extent to which training and mentoring were provided in ongoing large grants. Thus, for example, are centers providing mentoring for junior investigators? Have some principal investigators on NIDA grants been more successful than others in developing new investigators? The workgroup recommended that the extent to which investigators provided mentoring and training be taken into account as part of funding decisions in addition to other criteria such as the quality of the science and the needs of the Institute. The workgroup also recommended examining opportunities for training and mentoring by programs such as the NIDA CTN and the CJDATS. The workgroup also recommended that the centers program go from unsolicited to solicited applications in order to maximize programmatic flexibility and budgetary control, that applications be solicited by a once-a-year announcement, and that funding decisions about centers should include not only the quality of the science and the innovation proposed by the center but also evidence of collaboration and support for new investigators.
Dr. Porrino then turned to the complex problem of how to increase research innovation. Establishment of a NIDA innovation committee was recommended. This committee would identify highly innovative applications that received scores that would place them outside the funding range, but would be worth funding because of their innovative and potentially important contributions to the portfolio. Such applications could be provided full or partial support. The workgroup also recommended developing a NIDA-wide definition of innovation that could be used in funding decisions. The workgroup also recommended evaluating the Cutting Edge Basic Research Awards (CEBRA) program to determine if it is supporting innovation at both the initial R-21 and subsequent R-01 stages. Another recommendation was to designate HIV/AIDS as one of the areas for encouraging new investigators and new ideas in order to provide more innovation for this important area. It was also recommended that administrative supplements be reviewed to see if they could be better used to support opportunities that might otherwise be missed, to enhance new investigators and to increase innovation within the scope of the originally funded application. Dr. Porrino noted that maintaining innovative science is absolutely critical, although it is difficult to identify innovation.
Dr. Porrino noted that NIDA is doing extremely well in protecting and developing new investigators, and, particularly in this time of shrinking opportunities, NIDA continues to focus on and enhance new investigators' careers. The workgroup also believed that NIDA was doing a very good job of promoting innovative research using both NIH and NIDA-specific mechanisms. She reiterated the importance of encouraging principal investigators to train and mentor junior people on their grant applications. The workgroup also recommended increasing the funding and scope of mentored-K awards.
Finally, she summarized some of the major recommendations of the workgroup: 1) collect accurate data on new investigators across NIDA using a standard definition; 2) increase the use of mechanisms that stress innovation and nurture early investigators; 3) educate principal investigators on the importance of training and mentorship in all multi-grant or large grant environments; 4) increase the funding and scope of mentored-K awards; 5) establish an innovation committee; and 6) increase awareness of the various trans-NIH initiatives such as Roadmap and Blueprint so that NIDA can participate even more actively in these initiatives.
- Report of Basic Science Review Workgroup - Linda Porrino, Ph.D., Chair of Workgroup
Dr. Porrino presented a summary of the report from the NIDA Basic Science Review Workgroup. She noted that the charge of that workgroup was to produce a report that included 1) review of the basic science program portfolio; 2) recommendations to strengthen the current program; 3) input into the five-year plan for NIDA's basic science program; and 4) examination of the organization and management of the Division of Basic Neuroscience and Behavioral Research (DBNBR) and its interactions with other NIDA divisions and units. The Basic Science Review Workgroup met twice and corresponded via e-mail in order to produce this report. The report includes cross-cutting findings and recommendations as well as theme-specific findings and recommendations.
Dr. Porrino noted that there are a number of outstanding accomplishments in DBNBR. These include an exceptionally strong portfolio; recruitment of excellent scientists in and outside the field of substance abuse; strong leadership and staff; success in identifying new areas of importance to NIDA and recruiting a critical mass of scientists to those areas; the training of new investigators; efforts to increase gender and minority diversity; and a thematic approach to program development that cuts across the branches. Dr. Porrino elaborated on these points, and noted, in particular, that the record for the training and supporting of new investigators has been especially successful. The division also has made exceptional efforts to increase gender and minority diversity.
Dr. Porrino pointed out that there were a number of opportunities to enhance the work of the divisions. The workgroup noted the importance of encouraging translation of findings from this division into questions to be addressed by other NIDA divisions. In order to facilitate DBNBR moving basic sciences work into issues relevant to other divisions, the workgroup recommended the formation of a task force on translational research. Dr. Porrino also raised the possibility of assigning grants to program staff in more than one division. Another idea was forming an innovation committee that might identify and recommend support for applications that were particularly innovative but had scores placing them outside the range of what was likely to be funded.
Another opportunity would be to focus on the development of improved animal models, ones that would have greater predictive value. Dr. Porrino noted that DBNBR has done an outstanding job of developing animal models, such as models for relapse and chronic drug use, but that animal models for many other questions, such as questions in social neuroscience, would be of great value. The workgroup also recommended improving the dissemination of information about NIDA services. One of the strengths of DBNBR is the services provided to investigators, such as drug repository and genetic material. In particular, the workgroup recommended that dissemination of these resources be improved for new investigators in order for them to take better advantage of the opportunities that are available. Another recommendation was to continue efforts to encourage grantees to use NIH Roadmap and Blueprint funding opportunities.
Dr. Porrino listed a number of specific accomplishments of DBNBR. She noted that one of the most outstanding accomplishments has been the establishment of the NIDA Genetics Consortium and the success of studies using this resource. Another area of accomplishment is the expansion of studies across the life span. The addition of studies in adolescence to the development portfolio was seen as particularly noteworthy and critical to NIDA's portfolio. The development of programs in the area of lipidomics was also praised, as was the program for the distribution of drugs and other materials, although, as noted, it was also recommended that this program be expanded and improved. The workgroup also praised the basic science studies of virology and immunology and emphasized the importance of the continued development of animal models that better mimic various aspects of the human drug experience.
Dr. Porrino pointed out that the report provided a detailed review of each of the thematic areas that unite the division and go across its various branches. Although she did not have time to go into the specifics of each of these theme areas, she did highlight some of the most important ones. For example, the workgroup thought that the addition of the neurobiology of social behavior as a thematic area going across DBNBR is a very important one, and this area, particularly with emphasis on genetics and epigenetic studies, will be of tremendous value to NIDA and the scientific community as well as the public health.
The workgroup also suggested emphasizing developmental studies, perhaps through the establishment of a developmental research program that might be lodged in the office of the Director of NIDA. The workgroup also recommended expanding the genetic consortium, continuing the emphasis on HIV/AIDS, particularly on animal models, and continuing emphasis on the development of safe and effective pain medications, as well as providing more focus on methamphetamine and ecstasy.
Dr. Porrino concluded by pointing out that the division has established a strong research program central to the mission of NIDA. Further, she noted that the division plays a critical role in the translation of basic science conducted in that division to studies of human patients conducted in other NIDA divisions. She emphasized that there are opportunities to enhance the work of the division and that these opportunities include, but are not limited to: 1) investing in emerging areas of social neuroscience and epigenetics; 2) strengthening the dissemination of services and materials available to the field; 3) continuing to foster the careers of new investigators; and 4) continuing to look to the way science will be conducted in the future. She pointed out that the division functions exceedingly well and that its portfolio is, overall, outstanding.
- Update on the Intramural Program - Peter Kalivas, Ph.D., Liaison to the Intramural Program
Dr. Peter Kalivas presented highlights of the activities of the NIDA Intramural Research Program (IRP). He reported that Dr. Kenner Rice will join the Intramural Research Program this summer. Dr. Rice is a medicinal chemist who will oversee a number of important projects.
The IRP entered into a contractual arrangement with the Maryland Psychiatric Research Center that will lower residential clinical expenses and promote clinical collaborations. Also, by late winter of 2006, most of the IRP will have moved to a new facility which is located on The Johns Hopkins campus. Dr. Kalivas noted that IRP staff are looking forward to this move and to the new resources that will be available at this location. Dr. Kalivas also noted that Dr. Yun Wang has been awarded tenure and will lead the Neural Protection and Regeneration Research Section of the IRP. Further, Dr. Marilyn Huestis has also been awarded tenure, and she will lead the Chemistry and Drug Metabolism Research Section. Also, Dr. Kenzie Preston was appointed as the Chief, Clinical Pharmacology and Therapeutics Research Branch. Dr. Kalivas noted that there had been an extramural review in November of 2005 of several sections of the IRP and that a more detailed report will be provided at a later time.
He reminded Council of the NIH policy concerning shared resources. That is, specialized reagents or animal models (vectors, transgenic animals, etc.) should be publicly available within 24 months of publication. Dr. Kalivas noted that the IRP, with few exceptions, already conforms to the NIH policy. He suggested, however, that instead of keeping this an informal way of doing business, Council might wish to formalize the policy for all IRP investigators. Therefore, it was proposed that all specialized animals and reagents be made available according to NIH guidelines to investigators individually and/or via repositories. This motion was unanimously approved by the Council. Thus, there is now a formal policy in place for the sharing of resources generated at the IRP.
The 93rd meeting of the National Advisory Council on Drug Abuse was adjourned at l:30 p.m.
I hereby certify that the foregoing minutes are accurate and complete.
|Nora D. Volkow, M.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.