111th Meeting Minutes

May 10, 2012

The National Advisory Council on Drug Abuse convened its 111th meeting at 8:30 a.m. on May 10, 2012 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland.  Dr. David Shurtleff, Deputy Director, NIDA, opened the meeting. The closed portion of the meeting on the morning of May 10, 2012, was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees.  The open portion, which was open to the public the afternoon of May 10, 2012, was chaired by Dr. Nora D. Volkow, Director, NIDA, and began at 11:00 a.m.  The Council adjourned on May 10, 2012 at 2:35 p.m.

Council Members Present
Nabila El-Bassel, D.S.W.
Carl Hart, Ph.D.
Elizabeth Howell, M.D.
Robert Lenox, M.D.
Caryn Lerman, Ph.D.
Kelvin Lim, M.D.
Barbara Mason, Ph.D.
Linda Mayes, M.D.
Eric Nestler, Ph.D., M.D.
Marina Picciotto, Ph.D.
John Rotrosen, M.D.
James Sorensen, Ph.D.
Steven Wolinsky, M.D.

Council Members Absent
Thomas Kirk, Ph.D.,
Michael Nader, Ph.D.,
Jon-Kar Zubieta, Ph.D., M.D.

Council Chairs
Nora D. Volkow, M.D.
David Shurtleff, Ph.D.

Executive Secretary
Teresa Levitin, Ph.D.

Federal Employees Present:

Members of the Public Present
Yoshie Davison, M.S.W. - American Academy of Child and Adolescent Psychiatry (AACAP)
Julie Miller, Ph.D. - RTI International
Evelyn Yang, Ph.D. - Community Anti-Drug Coalitions of America (CADCA)

Closed Portion of the Meeting - May 10, 2012

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. David Shurtleff, Deputy Director, NIDA, called the meeting to order and welcomed the Council and staff. He 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.

2. Application Reviews

   In turn, the Director or a designee for 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. Council also approved the MERIT application and administrative supplements.

   Members must absent themselves from the Council meetings during discussion of, and voting on, individual 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.

Open Portion of the Meeting - May 10, 2012

1. Call to Order

   Dr. David Shurtleff, Acting Deputy Director, NIDA, called the open portion of the meeting to order. 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. Shurtleff called attention to the future 2012 Council meeting: September 6, 2012.

2. Consideration of the Minutes of Council

   The Minutes of the February 2012 meeting were approved as written.

3. Discussion of Special Council Review Pilot - Teresa Levitin, Ph.D., Director, Office of Extramural Affairs

   Dr. Levitin asked Council members for feedback about the closed session Special Council Review pilot study for added consideration of applications from investigators currently receiving $1.5 million or more in annual total costs for research support. A number of comments were raised. Some Council members thought it was a good idea to have additional, specific discussion at Council of this type of application as part of their stewardship responsibilities; others voiced concerns about the potential for diminishing the role of the initial peer review. However, there was consensus that the trigger for additional Council scrutiny should be the direct, not the total costs, requested. Direct costs were seen as a better measure of support for the actual research being proposed or conducted, and Council noted that it would be essential to be able to identify exactly what dollars are specifically going to each investigator when there are multi PI applications. Council also did not favor any dollar caps on investigators. If this policy were to continue, Council thought that the application might need to be modified to ask for more information about other support; could NIH provide guidelines on how much detail should be routinely provided? Council noted that it would be essential to ensure that review committees did not inappropriately consider the dollar threshold as a review criterion. There was also some concern about how this policy might affect junior investigators, if at all. For example, might more of them be named as key staff to avoid triggering this additional Council review? What effects might there be? Finally, and of great concern, was the recognition that this is an era of big science, big laboratories, big data centers, and large teams. Substantial resources are needed for much of the big science being conducted today and likely to be conducted in the future. Council was unanimous in urging caution to ensure that large laboratories and productive scientists and teams of scientists are not penalized and that implementation of the policy be carefully monitored to be sure that it did not prove to be incompatible with how the best scientists/science functions today and tomorrow.

4. Update on Data Harmonization: Substance Abuse and Addiction In the PhenX Toolkit - Kevin Conway, Ph.D., Deputy Director, Division of Epidemiology, Services, and Prevention Research (DESPR)

   Dr. Conway began his update on data harmonization for measures of substance abuse and addiction through use of the PhenX Toolkit by noting that his presentation would assess the extent of measurement commonality in the addiction sciences, present NIDA’s efforts to increase measurement commonality, and review NIDA’s policy and describe dissemination efforts. In order to assess the extent of measurement commonality, a portfolio analysis of 829 active R01s across 8 program units – NIDA and NIAAA epidemiology, prevention, services and treatment units --was conducted. A 17% random sample of 141 applications yielded 548 distinct measures. Dr. Conway identified the top 10 measures by research domain, e.g., diagnostic measures, psychopathology scales, personality measures, substance use disorder scales, substance use quantity and frequency measures and cognitive-neurologic measures, describing the density of commonality by domain. It was clear from this analysis that that there is a substantial number and variety of different measures across each of the areas of science identified.

   Increasing measurement commonality is obtained through the PhenX Toolkit. This Toolkit provides standardized measures that have been vetted and approved by the field to help researchers compare and combine data from multiple studies. The Toolkit is a collaboration among NHGRI, NIDA, RTI International, and the OBSSR. It contains 300 measures across 21 research domains, and the Toolkit’s web site provides a brief description of each measure, the rationale for its inclusion, the standard protocols for collecting the data, and related references. Recently NIDA supplemented the Toolkit by adding the Substance Abuse and Addiction (SAA) collection.

   Dr. Conway then described the project organization and process as well as the project timeline for adding measures relevant to substance abuse and addiction, noting that a scientific panel of experts was assembled to provide overall direction, leadership and vision and pointing out that each specialty area was charged with identifying up to eight measures for inclusion. Further, the project was on time and within budget. He then provided more detail about the substance abuse and addiction core and specialty areas, noting the number of measures associated with each specialty area such as community factors, psychosocial risk factors, neurocognition and comorbidity and outcomes. He explained the tier system of the cores and provided examples of Core-Tier 1 and Core-Tier 2 measures so that Council could appreciate the range and depth of the PhenX resource. He then provided illustrative examples within specialty areas and demonstrated how to use the Toolkit.

   Dr. Conway then turned to NIDA’s data harmonization policy which was described in an NIH Guide Notice published in February of 2012. The purpose of this Notice was to announce that NIDA strongly encourages investigators to incorporate the measures from the Substance Abuse and Addiction Collection and that NIDA grantees and applicants conducting human subjects studies are strongly encouraged to incorporate, at a minimum, the Core-Tier 1 measures. Further, NIDA encourages grantees/applicants to incorporate measures from the Core-Tier 2 and Specialty areas whenever possible and appropriate. Through the use of these measures, NIDA funded researchers will be able to share, compare and integrate data across studies; thus, using common measures will enhance knowledge about substance abuse and addiction while advancing a culture of scientific collaboration. Dr. Conway presented the language on data-harmonization to be placed in NGAs and described a range of dissemination efforts for both staff and investigators. An article in the NIH Record and presentations at several professional meetings are included in the dissemination efforts. Dr. Conway concluded his presentation by acknowledging the many people who have been involved in this effort.

   Council members thanked Dr. Conway and praised this project. There was discussion about dissemination plans, about the community level measures and the neurocognitive measures and about the complexity of identifying key constructs and measures. Dr. Conway noted that the Toolkit presented recommendations for measures for specific constructs relevant to substance abuse and addiction but that the ultimate decisions are made by investigators. The question was also raised about the use of these measures with children and adolescents, and Dr. Conway responded that a wide age range was covered. The importance of measuring developmental change was noted, and the question of how the demographic categories in the Toolkit would map onto the NIH demographic inclusion categories was raised as was a question about the identification of substances used. It was noted several times that this is an evolving process and that the Toolkit will be updated to be responsive to changes in science.

5. Update on the K99/R00 and Loan Loan Repayment Programs - Susan Weiss, Ph.D., Acting Director, Office of Science Policy and Communication (OSPC)

   Dr. Susan Weiss presented an overview of the accomplishments of the NIDA K99/R00 award program. She began her presentation by noting that the NIH is committed to providing mechanisms for research independence for new investigators. Specifically, the NIH Pathway to Independence Award Program (K99/R00) that was announced in 2006 provides an opportunity for the most promising postdoctoral scientists to receive both mentored and independent research support through the same award. Dr. Weiss then described the program, noting that it provides up to five years of support, in both a mentored and an independent phase.

   She then compared NIH and NIDA funding success rates for a variety of mechanisms, including mentored fellowships, mentored K awards, research project grants and NIDA early career research grants. NIDA has been successful in supporting the next generation of scientists through these mechanisms. Dr. Weiss next focused specifically on the K99/R00 program, noting how many applications there were over the past five years as well as the number of awards and the success rate. Although the program has not been in existence long, it is possible to see how some of the earliest awardees are doing, and Dr. Weiss described the K99/R00 transition success rate and the career outcomes, thus far, of K99s who transitioned to the R00 phase. She also noted their funding history, thus far. She provided specific information on the career trajectories of the K99 FY 2007 awardees, noting how many had gone on to university positions and R-Type awards. Overall, these awardees have been successful in obtaining positions and research support.

   Council thanked Dr. Weiss for her report and asked about K99/R00 support for social and behavioral scientists, whether M.D.s have also participated, how this program compares with other K awards, where it is currently being reviewed, and the number of foreign applicants for the award (noting that this is the only K award that allows foreign applicants).

6. Progress and Changes at the IRP - Antonello Bonci, M.D., Scientific Director, Intramural Research Program, NIDA

   Dr. Bonci began his presentation by noting that his vision for the IRP is the same as it was the last time he spoke to Council: to take full advantage of the unique funding system of the IRP and develop an environment where cutting edge science, human studies and drug abuse related-initiatives (not easily or quickly fundable elsewhere) could be done and to be of service to the community. He envisions covering some areas of neuroscience that may not be of great interest to many scientists but will, nonetheless, move the field forward in significant ways, such as designer drugs. He then presented the new administrative structure of the IRP, noting how well staff have responded to these changes and have become more proactive, interactive, and productive. He also identified the members of the BSC and noted that there have been many changes to the BSC, including having a smaller board with fewer ad hoc members, holding one rather than two meetings a year, using an R01-type scoring system for proposals and placing more emphasis on the potential impact and high risk/large impact on the field of research and greater relevance to the NIDA mission. The BSC has been very active and productive, particularly helping with budget issues to free up more money for new programs, which has been especially important because it has not been possible to create a blue-ribbon panel because of the possible creation of a new institute and the resultant uncertainties.

   Dr. Bonci then noted several new initiatives at the IRP, and he stressed the focus on collaboration. These include a medication development program led by Dr. Amy Newman, a joint fellowship in substance use disorder with NIA and Hopkins, since geriatric drug abuse is a major problem that has not received sufficient attention, and a thriving diversity and outreach program with fellowships that is being led by Dr. Jean Lud Cadet. Also, there are now faculty meetings, weekly data presentations, and several new committees to deal with space, performance and other matters. An intramural-extramural innovative partnership program has been created and a drug designer initiative is in progress. Dr. Bonci next noted staff changes at the IRP including hiring two outstanding scientists, Dr. Geoff Schoenbaum as Branch Chief of cellular neurobiology and Dr. Markus Heilig as Clinical Director, in collaboration with NIAAA. Also, the IRP has hired Dr. Yeka Aponte, a recipient of the NIH Stadtman Early Investigator Award, and Dr. Brandon Harvey, who will direct the Optogenetic and Transgenic Core, which is a resource for NIH. Other staff changes also were noted.

   There have been several new programs/initiatives recently created with NIAAA, and these include the new NIDA/NIAAA joint clinical program directed by Dr. Markus Heilig. This new program takes full advantage of the unique strengths of the NIAAA clinical program (e.g. beds, inpatients) located at the CRC and of the NIDA outpatient clinic program located in Baltimore. This joint program will be very effective in promoting scientific synergy and cost saving. It is advised by a board that includes Dr. Eric Strain as the chair. Dr. Bonci noted that the advisory board is reviewing the entire clinical portfolio. The joint NIDA/NIAAA clinical program has successfully completed its search for a junior faculty member and hired Dr. Lorenzo Leggio from Brown University. Dr. Bonci then noted another program recently created with NIAAA: the pilot NIDA/NIAAA early development human genetic program directed by Dr. David Goldman of NIAAA. This program will focus solely on collaborative projects with PIs for the NIDA intramural program and, if successful, there will be a joint faculty search and larger commitment of resources and personnel. There is a trans-NIH advisory board for this program chaired by Dr. Leslie Biesecker of NHGRI, and Dr. Bonci voiced optimism that a stellar human genetics program will be crafted.

   Dr. Bonci then described how he and his colleagues are building partnerships with universities, institutes and governments, including partnerships with Italy, Chile, and Taiwan. His future plans for the IRP include continuing to promote the new mission and culture, one day at a time, hiring more junior investigators, expanding and solidifying extramural partnerships and increasing the value of the IRP through a comprehensive approach to substance use disorders.

   Council members thanked Dr. Bonci for an excellent and informative update and noted the energy and excitement and innovation he has brought to the IRP. They also commented on the outstanding people he has brought to the IRP.

7. Director’s Report - Nora Volkow, M.D., Director, NIDA

   Dr. Volkow began her report by providing a budget update, noting that 2012 had brought an increase of .3% over the prior year and that the 2013 President’s Budget would provide a .2% increase, although there is still much uncertainty. She then described the process for development of a scientific strategic plan for the new SUD Institute, noting that it has-- and will -- include plans to 1) identify new scientific and public health needs not addressed by NIH through soliciting input from NIH scientific staff and from external stakeholders (e.g., researchers, patient advocates and the general public); 2) assess suggested new scientific opportunities and public health needs, taking into account the current missions of NIDA, NIAAA, NCI and other ICs; and 3) develop a draft scientific strategic plan to integrate new scientific opportunities identified by NIH staff and the public with existing priorities in SUD research and solicit public input on the draft plan. Dr. Volkow then presented the scientific strategic plan development action timeline, noting that in fall of 2012 the draft scientific strategic plan will be released and there will be a public comment period, with the final recommendations being presented to the NIH Director in December 2012 and included in the President’s FY 2014 Budget, with October 2013 as the date for standing up the new Institute. She thanked Council members who had already sent in comments on the proposed new institute and encouraged those who had not yet commented to take the time to do so.

   Turning to recent NIDA activities and events, Dr. Volkow reiterated the priority areas of NIDA as prevention research, treatment interventions and HIV/drugs. She presented data on the increases in deaths from drug overdoses/ drug poisoning. She then noted the increase in opioid prescriptions and the need for education to ensure there is neither over- nor under-prescription of pain medication. She described the NIH Pain Consortium Centers for Excellence in Pain Education, an activity initiated by NIDA and involving 11 Centers throughout the country supported by eight institutes as well as OBSSR and ORWH. In April, Dr. Volkow was one of the keynote speakers at the first national prescription drug abuse summit. This was an excellent opportunity to bring together leaders from CDC, ONDCP, DEA, CADCA and other organizations; there were over 700 participants including scientists, health care providers and policy makers. Dr. Volkow then presented new NIH FOAs issued in collaboration with the FDA Center for Tobacco Products, one of which focuses on research relevant to the Family Smoking Prevention and Tobacco Control Act and the other of which provides administrative supplements.

   In the priority area of treatment interventions, data were presented on nicotine and cocaine vaccines. It was noted that NicVAX failed to meet its primary endpoint in two phase III studies, though higher abstinence was observed in subjects with higher immunity to nicotine. Data from several recent studies on issues relevant for a cocaine vaccine were presented; results and strategies were discussed. A new PAS has been issued to create strategic alliances for medications development. It will leverage the strengths of multiple entities, e.g., academic and nonprofit institutions as well as pharma and biotech companies, to facilitate drug development, and each partner will contribute expertise. Dr. Volkow described opportunities with health care reform to expand the involvement of the health care system in the treatment of SUD and to reach people who are not receiving treatment, and she noted the effects of screening and brief intervention in primary health care settings across several countries on decrease in illicit substance involvement. She then presented new announcements relevant to services and economic research as well as services research studies of prevention, addiction, treatment and HIV.

   In the area of HIV and drugs, Dr. Volkow noted the work of Dr. Montaner (an Avant Garde awardee) and others on HAART as HIV prevention, cited data on major gaps in the implementation cascade from infected to adherent/undetectable and noted that, despite increases in ART, incidence of HIV in the United States has remained stable, likely reflecting, in part, failure to treat those with SUD. She then discussed the implementation of STTR in substance abusers, suggesting opportunities with health care reform and the criminal justice system as well as noting the need to educate physicians about the importance of providing antiretroviral therapy at lower cell counts than is typically done by infectious disease physicians. She presented data on implementing rapid HIV testing with or without counseling in drug treatment centers and efforts to seek, test, and treat HIV in the criminal justice system. She noted the evidence of the need to treat substance abusers who are HIV positive in order to contain the HIV epidemic. The new AIDS Avant Garde FOAs were also noted.

   Several other activities were cited: NIDA’s Easy-o-Read Drug Facts won a ClearMark Award of Distinction from the Center for Plain Language, and there will be an NIH screening of Addiction Incorporated, a major motion picture about Dr. Victor DeNoble, a former research scientist for “big tobacco” who testified before Congress in 1994 about his research showing the addictive nature of nicotine.

   Council thanked Dr. Volkow for her presentation. There was discussion about the areas of science that might go into the new institute, including the question of where research on pain might be located. Dr. Volkow again noted the importance of Council members providing their opinions to NIH. There is no current plan for NIAAA and NIDA councils to meet again.

8. Update on Peer Review - Richard Nakamura, Ph.D., Acting Director, for Scientific Review (CSR)

   Dr. Nakamura presented the NIH mission and noted that NIH achieves its mission largely through awarding research grants based on review of applications from extramural scientists and that CSR is the portal for NIH grant applications. The CSR mission is to see that NIH grant applications receive fair, independent, expert and timely reviews—free from inappropriate influences – so NIH can fund the most promising research. He stated that in 2011, CSR reviewed 77% of NIDA grant applications and then showed a chart of grant success rates from FY78 to the present, pointing out the decline in success rates. He described the NIH peer review process and noted that in FY11, CSR received 85,000 applications, of which 58,000 were reviewed in CSR by 16,000 reviewers in 1,465 review meetings managed by 230 Scientific Review Officers.

   Dr. Nakamura then reviewed the “enhancing peer review” process which had led to a number of recent changes in review policy and practice. First, there has been the improvement of study section alignment through input from the community, internal IRG reviews, open houses and the CSR advisory council. CSR is also using maps of science and publication clouds of review committee members to better conceptualize and align study sections. A second issue concerns addressing review and funding for new investigators, and Dr. Nakamura noted the age distribution for new investigators in 1980 and the projection of age distribution of NIH RPG investigators for 2020. He described NIH efforts to address review and funding for new investigators, with NIH deciding to control the process at the level of funding rather than during review. The only difference in review is that all the applications from new investigators are clustered for discussion. Institutes establish different pay lines for new investigators and early stage investigators, and funding for them has increased.

   A third enhancement comes through advancing additional review platforms. These new platforms help recruit reviewers, and electronic review models reduce travel. Electronic review includes telephone assisted meetings, video assisted discussions, internet-assisted meetings and telepresence meetings. Dr. Nakamura described telepresence study sections, noting positive and negative features. A forth enhancement has been to fund the most promising research earlier, and this has been done by reducing the number of amendments from two to one, with the A0 application going from 30% to over 50% of total awards. Dr. Nakamura provided data on how this change has reduced average time to award. Recruiting the best reviewers is a fifth enhancement, and several successful strategies were noted. These include moving a meeting a year to the west coast, using additional review platforms, developing a national registry of volunteer reviewers, providing tangible rewards for reviewers, such as no submission deadlines, and allowing more flexible time commitments in terms of years of service/number of meetings. Another enhancement has been having reviewers focus more on the impact and significance, and less on the approach, of an application. This has been accomplished in several ways, including by shortening the applications, making sure significance is scored, and providing more training to reviewers and chairs.

   Dr. Nakamura then described the attempts to save reviewers’ time. He noted, however, that although the applications have been shortened, reviewers are being asked to review more applications. He also suggested that the bulleted critiques were initially too cryptic in many cases, and CSR is working with reviewers and chairs to remedy this. Dr. Nakamura then discussed the scoring system, noting some concerns, and he described plans to review and evaluate these enhancements on a continuing basis, pointing out that applicant and reviewer surveys and advisory council surveys have already taken place and that a survey on the shorter applications is planned.

   Turing to the topic of new investigators, Dr. Nakamura described how career stage is considered and how new investigators differ from early stage investigators. He also described the early career reviewer program which is intended to train qualified scientists without significant prior review experience so that they become effective reviewers, to help emerging researchers advance their careers by exposing them to review experience and to enrich the existing pool of NIH reviewers by including scientists from less research-intensive institutions as well as those from research-intensive institutions. He described the requirements for becoming an early career reviewer, including not having R01 NIH or equivalent funding, showed how to apply to the program, and noted that the program has been very well received.

   Dr. Nakamura then described future plans, which include better distribution of applications across study sections, predictive evolution of study sections, better applicant tools for requesting study sections, better SRO tools for finding reviewers, increased diversity and reduced award disparities and development of a science of peer review. He concluded his remarks by inviting feedback from the Council and showing a picture of CSR staff.

   Council members thanked Dr. Nakamura for an excellent, comprehensive report. There was discussion about the composition of study sections, the quality of applications in different study sections, the importance of scientists being willing to serve on study sections when invited to do so, the workload for reviewers, the use of bibliometric measures, ways to bring more senior scientists into review committees, the absence of a second revision opportunity, the overall success rate, the definition of a new application, and the challenge to scientists applying for renewal or second R01. The Council members praised Dr. Nakamura for his openness and candor.

9. There were no Public Comments
10. Adjourn

    The 111th meeting of the National Advisory Council on Drug Abuse was adjourned at 2:35 p.m.

Certification

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

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.