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National Advisory Council Meeting - June 8-9, 2011
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
Summary of the 127th Meeting
June 8-9, 2011
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 127th meeting at 5:30 p.m. on June 8, 2011, at the Fishers Lane Conference Center in Rockville, Maryland, in closed session for a review of grant applications. The meeting recessed at 7:20 p.m. The Council reconvened on June 9, 2011, at 9:00 a.m. Dr. Abraham Bautista, Director, Office of Extramural Activities, presided over the closed session. In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the closed session on June 8, 2011, excluded the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. Dr. Kenneth Warren, Acting Director, NIAAA, presided over the Council’s open session on June 9, 2011.
Council Members Present:
Andrea G. Barthwell, M.D.
Suzanne M. de la Monte, M.P.H., M.D
Cindy L. Ehlers, Ph.D.
Scott L. Friedman, M.D.
Andres G. Gil, Ph.D.
Kathleen Grant, Ph.D.
Deborah S. Hasin, Ph.D.
Vimal Kishore, Ph.D.
John H. Krystal, M.D.
Edward P. Riley, Ph.D.
Linda P. Spear, Ph.D.
Gyongyi Szabo, M.D., Ph.D.
Ex-officio Members Present:
John Allen, Ph.D., M.P.H.
Jill Carty, Psy.D.,, M.S.P.H.
Chairperson: Kenneth R. Warren, Ph.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Vivian B. Faden, Ph.D., Ralph Hingson, Sc.D., M.P.H., Robert Huebner, Ph.D., Keith Lamirande, Howard B. Moss, M.D., Antonio Noronha, Ph.D., Samir Zakhari, Ph.D.
More than 150 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, National Institute on Drug Abuse (NIDA) staff, and members of the general public.
Call to Order
Dr. Kenneth Warren called the open session of the 127th meeting of the Council to order at 9:00 a.m. on Thursday, June 9, 2011, and welcomed participants. He introduced new Council members Drs. Andrea Barthwell, Suzanne de la Monte, and Andres Gil, and welcomed returning member Dr. Cindy Ehlers. Council members and NIAAA senior staff introduced themselves.
Dr. Warren highlighted key recent Institute activities, referring to the written Director’s Report.
Legislation, budget, and policy. President Obama signed legislation extending funding for all Federal agencies through September 2011. National Institutes of Health (NIH) received $30.7 billion, down 0.8% from FY 2010. Reflecting ongoing fiscal problems this reduction will have significant impacts on NIH programs, including those of NIAAA. For FY 2011 NIAAA will receive $458.3 million, down $4.1 million, or 0.8%, from 2010. In FY 2011 NIAAA will support 683 research project grants (RPGs), a reduction from 706 in 2010, and new and competing awards will drop from 189 in 2010 to 147 in 2011. NIAAA will reduce awards for modular and nonmodular noncompeting RPGs by 1% from FY 2010 levels, a 4% reduction in grantee commitments of record for noncompeting awards; NIAAA is applying the same policy to other grants, except for SBIR/STTR and Research Career Awards, which are funded in full, and National Research Service Awards Individual Fellowships, for which stipends will increase by 2%. NIAAA will fund 287 full-time training positions.
Under the President’s FY 2012 budget request submitted in February 2011, NIH would receive $31.8 billion, $0.5 billion more than in 2010, representing a 1.5% increase. NIAAA’s appropriation would increase by $469.2 million, a 1.5% increase over 2010 levels. Although the Senate had held a hearing on the NIH budget, the House of Representatives had not scheduled hearings. NIAAA has begun work on the FY 2013 budget.
Director’s activities. In May 2011 NIAAA cosponsored a meeting in Volterra, Italy, “Alcoholism and Stress: A Framework for Future Treatment Strategies,” attended by researchers from 14 countries; NIAAA provided travel stipends to young investigators. Dr. Warren delivered the keynote address, and several NIAAA leaders and staff made presentations. A subsequent meeting in Rome on “Alcohol Across the Life Span: What Clinicians Need to Know” featured lectures by U.S. alcohol researchers, including Dr. Edward Riley, and a skill-building session on screening and brief intervention and medical management of alcohol addiction in primary care settings led by Dr. Peggy Murray and other key leaders in the alcohol field.
Staff and grantee honors. Dr. Pal Pacher was named Star Reviewer of the Year by the editors of the American Journal of Physiology–Cell Physiology.
Outreach. Several NIAAA staff participated in the Dana Alliance for Brain Initiative’s Brain Awareness Week at the National Museum of Health and Medicine, where they presented the Cool Spot Carnival, targeted at young people to prevent underage drinking.
Multimedia NIAAA products. A special supplement issue of the journal Alcohol to celebrate the 40th anniversary of NIAAA was published in Brain Behavior and Immunity (2011) 25, Supplement1, 1-178. Included are articles based on presentations at the NIAAA-supported Satellite Symposium at the 2010 Society for Neuroscience annual meeting. The latest issue of NIAAA Spectrum, which appears online, has been released.
- NIAAA Research Programs. The NIAAA Clinical Investigations Group, an Institute-directed Phase 2 clinical trials program supported by contract, tests promising medications to treat alcohol use disorders. The program aims to design rapid Phase 2 proof of concept trials of particularly promising compounds supported by theory and based on data; if an efficacy signal is detected, efforts are made to further advance the compound.
Mentored Career Development Award Evaluation
Dr. Laurel Haak, Chief Science Officer at Discovery Logic, and Ms. Jennifer Sutton, Program, Policy, and Evaluation Officer in NIH’s Office of Extramural Research, described a trans-NIH evaluation project to determine the effectiveness of NIH’s K Award program to foster development of new investigators. Using existing quantitative data sources and a matched comparison group design, the evaluation examined applicant and awardee characteristics, program features, and whether participation in an NIH mentored career development program affects career outcomes. The study focused on Mentored Research Scientist Development Awards (K01), Mentored Clinical Scientist Research Career Development Awards (K08s), and Mentored Patient-Oriented Research Career Development Awards (K23).
Demographic analysis revealed that the programs reach out to the appropriate groups. While K01 and K23 applicants were evenly distributed by gender, males accounted for more than two thirds of applicants to the K08 program; award rates did not differ by gender. Applicants to the K01 program were primarily PhDs, while K08 and K23 applicants were generally MDs and MD/PhDs. While the proportion of applicants from underrepresented groups was lower than in comparable PhD and medical school graduate cohorts, the award rate for Black, Hispanic, and Native American applicants was consistent with the overall K program rate. Applicant’s median age was 37; K01 applicants were typically 3–5 years past their terminal degree, while K08 and K23 applicants were generally 7–10 years past their terminal degree.
Outcomes included specific publications as a proxy for research productivity and subsequent NIH funding as a proxy for retention in career. Regression discontinuity analysis revealed significant outcomes:
- K awardees, as compared to matched unfunded applicants, were more likely to (a) have subsequent publications and applications for subsequent NIH research awards; (b) have a higher percentage of years with subsequent NIH support; (c) apply for and receive at least one competitive renewal of an R01 grant; and (d) have a higher R01 award success rate as a group than individuals with no prior career development support. Among individuals who published, K23 awardees had a significantly higher publication count per author in journals with a higher impact factor.
- The study found differences in the impact of career development support among various types of K awardees: (a) K01 awardees were more likely to apply for R01 awards later than the comparison group of unfunded applications; (b) K08 and K23 awardees had significantly higher rates of subsequent NIH research awards than comparable unfunded applicants; (c) male K01 and K23 awardees were more likely to apply for and receive subsequent R01s and RPGs than their female counterparts, but no differences were discerned between male and female K08 awardees; and (d) K awards appeared to have the greatest impact on subsequent NIH research involvement of MDs.
Ms. Sutton described policy developments over the course of the study and their implications. During the period targeted for evaluation, changes occurred in NIH’s career development programs: The transition K22 award grew in size, and NIH’s concurrent support policy was modified to allow researchers to draw a salary in the final 2 years of K awards. Since 2005 NIH has introduced additional career development opportunities for new investigators: (a) K99/R00 Pathway to Independent award, (b) CTSA program and its institutional career development awards, (c) early-stage investigator policy, and (d) modification of effort requirements to permit K awardees to temporarily hold part-time institutional appointments.
Study findings raised the following policy questions: (a) What is the best model for career development of PhDs who have had substantial research training and career development in the course of earning their degrees? (b) Is NIH doing all it can to ensure the short-term success of women investigators through its career awards? (c) What are the best ways to attract underrepresented minority researchers to biomedical research careers? and (d) Should NIH be more receptive to mid-career investigators turning to patient-oriented research after developing clinical expertise?
Discussion. Dr. John Krystal suggested that the study’s design omitted the possibility that the more talented candidates would be attracted to this program and would have even received better scores than other candidates who were considered in the analysis. Regarding Dr. Krystal’s alternative interpretation of data related to age at first R01 award, Dr. Haak acknowledged that awardees may have conducted research soon after earning their degree rather than submit grant applications, and that applicants who lacked research positions needed to write their grant applications earlier.
In response to a question from Dr. Judith Arroyo, Dr. Haak confirmed that while minority applicants for K awards are as successful as the general applicant pool, NIH acknowledges issues with recruiting representative numbers of Hispanic, Black, and Native American researchers. She noted that the small numbers of minority applicants impeded analysis by race/ethnicity. Ms. Sutton added that data from Institutes that use the K award for diversity recruitment were not considered.
To Dr. Krystal’s question regarding underrepresented minorities, Ms. Sutton responded that there is no definitive evidence to indicate financial deterrents to research careers due to disproportionate graduate education debt or greater expectations, needs, or hopes related to salary. Dr. Haak added that twice as many under¬represented minorities pursue medical careers than research careers. Dr. Gil observed that recruitment of minorities must begin in graduate school. Ms. Sutton stated that NIH will post the final report on its website.
Substance Use, Abuse, and Addiction Task Force: Update
Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, updated the Council on activities related to NIH’s Substance Use, Abuse, and Addiction (SUAA) Task Force. In November 2010 the Scientific Management Review Board recommended creating a new Institute focusing on SUAA research and related public health initiatives, and to integrate relevant research portfolios from NIAAA, NIDA, and other Institutes and Centers (ICs). Between January and March 2011, relevant NIH scientific staff in the ICs engaged in internal discussions.
In April 2011, informed by those discussions, the SUAA Task Force developed a set of draft guiding principles: (1) Science: The nature of the science being conducted is the primary factor driving recommendations; (2) Populations with co-morbid addictive behaviors: Addictive behavior frequently coexists with other medical disorders, including mental disorders (e.g., post-traumatic stress disorder, borderline personality disorder, and schizophrenia disorder). When the pathophysiology of the underlying disorder is distinct from the addictive behavior, the primary disorder requires separate consideration; and (3) Special expertise: The expertise of staff needed to manage and foster a research area is critical in recommending placement of programs.
Dr. Tabak acknowledged the complexity of the NIH portfolio encompassed by SUAA research as well as of the administrative needs to effect establishment of the new Institute. Programs and staff from as many as five ICs will be involved. He stated that, as a result of a great deal of thoughtful and helpful feedback, stakeholders external to NIH have effectively argued their need to participate in scientific planning.
Dr. Tabak presented a timeline to inaugurate the new Institute in October 2013—the start of FY 2014—whose working (but not necessarily final) title is the National Institute of Substance Use and Addiction Disorders. Between June 2011 and October 2012 two groups will address the reorganization: the SUAA Task Force and the NIDA/NIAAA Intramural Integration Working Group. The Task Force will complete the portfolio analysis of all relevant grants, cooperative agreements, contracts, and intramural research projects, and develop a final portfolio integration plan. Simultaneously, the leadership of the relevant Institutes––NIAAA, NIDA, components of the National Cancer Institute, and perhaps components of the National Institute of Mental Health and other Institutes––will develop a scientific strategic plan that includes outreach and discussion with stakeholders to devise a unified approach to the research. Dr. Tabak targeted release of the scientific strategic plan and the portfolio integration plan for October or November 2012, followed by a period of public comment. In December 2012 final recommendations are planned to be delivered to the NIH Director and to be included in the President’s FY 2014 budget proposal. NIH then will begin to implement portions of the plans independent of formal reorganization. Dr. Tabak noted the utility of convening joint Council meetings, such as the meeting scheduled for fall 2012, to promote working together. He welcomed input on NIH’s website, feedback.nih.gov.
Discussion. In response to a question by Dr. Friedman, Dr. Tabak stated that he will provide information to the Council on NIH’s obligation to notify Congress about creation of the new Institute. He responded to Dr. Linda Spear that the reorganization will be budget neutral; the scientific portfolio will drive budget changes related to grants, contracts, associated personnel, and the proportionate fraction of administrative support required. He replied to Dr. Gyongyi Szabo and NIDA Council member Dr. James Sorensen’s questions that the scientific strategic planning process will be driven by leaders of the affected ICs. As part of the Executive Branch, NIH consults with the Secretary of Health and Human Services (HHS) and the Office of Management and Budget prior to communicating with Congress. In response to Dr. Kathleen Grant’s question, Dr. Tabak stated that no predetermined conditions have been imposed on the size or movement of any Institute’s portfolio. He predicted minimal cost of the reorganization by making best use of existing space and structures; no current plans exist for a physical merger of intramural programs. Dr. Tabak responded to Dr. Mark Goldman, Research Society on Alcoholism, and to Dr. Deborah Hasin that the organizational infrastructure for the scientific strategic plan—including the nature of stakeholder involvement—has not been established formally. He expressed confidence that NIAAA will ensure appropriate representation from the stakeholders represented on its Council. The scientific strategic planning process will proceed simultaneously with the internal analysis of the best fit for aspects of the scientific portfolio and will proceed based on SUAA Task Force recommendations with due attention to public comment once a preliminary model is published.
Dr. Ehlers inquired how NIH will reconcile NIAAA’s ability to look at both the health benefits and adverse effects of alcohol with NIDA’s prohibition against investigating the benefits of drugs of abuse. Noting that tobacco addiction issues contribute additional complexity, Dr. Tabak responded that all dimensions will be addressed in the reorganization. He replied to Dr. Howard Moss that conversations are anticipated at the Departmental level on the Office of National Drug Control Policy’s relationship to the new Institute.
Dr. Tabak explained, in response to Dr. Goldman’s question, that upon release of the scientific strategic plan, the public can offer input on decisions related to liver disease, fetal alcohol spectrum disorders, and other scientific areas. Dr. Boris Tabakoff, National Foundation for Chemical Dependency Disease, inquired about the fate of other ICs’ intramural research components. Dr. Tabak responded that an assessment is underway of relevant intramural programs for engagement and integration into the new Institute. NIDA and NIAAA’s intramural programs have sought opportunities for synergy independent of the reorganization. Dr. Tabak endorsed Dr. Goldman’s observation that reallocation of the portfolio to reflect the size of the problems to be solved might be considered in the planning process, although much will depend on available funds as research projects terminate.
Given the multiple complex factors, Dr. Ehlers observed, insufficient time may be allocated to develop the scientific strategic plan. Dr. Tabak responded to Dr. Krystal that a joint meeting of the NIAAA and NIDA Councils during the period of public comment will be possible. Responding to Dr. Spear’s query about simultaneous development of the portfolio integration plan and scientific strategic plan, Dr. Tabak stated that a mission statement might be developed early in the process.
Presentation of Council Operating Procedures
Council members unanimously approved NIAAA’s Operating Procedures for Institute Staff Actions for Administrative Supplements and Time Extensions (Appendix 1), and Procedures for Expedited En Bloc Concurrence by Council (Appendix 2).
Consideration of the Minutes of the Meeting of February 16–17, 2011, and Future Meeting Dates
Council members unanimously approved the minutes of the Council meeting of February 16–17, 2011. Future Council meetings will take place on September 12–13, 2011; February 8–9, 2012; June 6–7, 2012; September 19–20, 2012; February 6–7, 2013; June 12–13, 2013; and September 18–19, 2013. The open meeting to be held on September 12, 2011, will include members of the NIDA and NIAAA Councils.
Pharmacist-Mediated Brief Alcohol Interventions: Possibilities and Challenges
Dr. Vimal Kishore, Alcohol Research Center of Louisiana State University Health Sciences Center and College of Pharmacy of Xavier University, described a potential role for community pharmacists in alcohol prevention and brief intervention. As an aside, he noted that his current work involves developing a protective agent that enables tripling the time of individuals’ safe exposure to radiation.
Dr. Kishore stated that while research studies have demonstrated the effectiveness of screening and brief interventions in reducing alcohol use and alcohol-related problems, its implementation in medical practice has lagged. He asserted that screening and brief intervention protocols can be adopted by pharmacists in community healthcare centers; the randomized, pharmacist-delivered, brief alcohol intervention study he initiated in 2001 was the first such U.S. study. Dr. Kishore stated that pharmacists’ education and training—underpinned by accreditation standards that incorporate promotion of health improvement, wellness, and disease prevention—prepare them well for public health roles beyond medication management. Community pharmacists based in healthcare centers have extensive experience in screening and counseling interventions for blood pressure, cholesterol, diabetes, smoking cessation, and other conditions. Nevertheless, pharmacists remain underutilized in health promotion and disease prevention, including alcohol and substance use prevention. Public opinion polls consistently demonstrate pharmacists’ trustworthiness.
Many pharmacy websites urge visitors to seek help from pharmacists in managing their diabetes, high blood pressure, and other ailments, and in managing wellness through such lifestyle changes as smoking cessation and improving diet and exercise. Alcohol use is barely mentioned. Dr. Kishore suggested that NIAAA enlists pharmacists as alcohol interveners. Despite a lack of alcohol prevention–specific training, emerging joint CME programs may offer new opportunities.
According to the World Health Organization, decision makers often accord prevention and reduction of the harmful use of alcohol a low priority, despite evidence of its serious public health effects. The agency supports initiatives for screening and brief interventions for hazardous and harmful drinking at primary healthcare and other settings. Dr. Kishore urged NIAAA to continue to place emphasis on programs and projects focused on preventing and reducing the harmful use of alcohol, support research on healthcare provider–delivered brief alcohol interventions, and actively seek means to promote involvement of pharmacists, particularly in community healthcare settings.
Discussion. Dr. Ehlers suggested that pharmacists’ conversations with patients about drug interactions with herbal products and vitamins offer opportunities to discuss alcohol interactions without delivering an intervention, a role with particular significance for individuals at high risk for alcohol dependence. Dr. Ralph Hingson stated that NIAAA’s Division of Prevention Epidemiology has issued a program announcement for new models of screening and brief intervention with adolescents and young adults. He added that pharmacists have an opportunity to intervene in the rising percentage of overdose poisoning deaths involving alcohol and other drugs by learning how to intervene effectively and then address translation and implementation issues. Dr. Murray stated that NIAAA funded faculty-development programs in pharmacy schools in the 1980s to develop an interest in screening and brief intervention for alcohol. She asserted that retail pharmacists have a role to play as they fill prescriptions for individuals who may lack easy access to their physicians. Moreover, pharmacists know more than physicians about alcohol interactions. Core competencies should include information about alcohol and drug interactions, and schools should stress work in this area. Dr. Kishore urged first developing a program in healthcare centers and then focusing on retail pharmacists, who currently are not reimbursed for counseling. Dr. Arroyo noted that community pharmacy offers opportunities to help address health disparities issues. Developing nations have integrated pharmacists more than the United States.
SBIR Concept Proposal Review
Members unanimously approved the SBIR concept proposal presented by Drs. Gary Murray and Raye Litten. In a peer-reviewed program NIAAA will entertain proposals from small businesses for discovery and preclinical development of compounds to treat alcohol-use disorders and tissue damage.
Redesign of the NIAAA Website
Mr. Mark Siegal, Web Manager, Communications and Public Liaison Branch, NIAAA, described the ongoing redesign of NIAAA’s website. Under a FY 2010 small-business contract, developers solicited input from internal and external stakeholders, reviewed other NIH websites, devised new branding, and created logical organization for the website’s content. For a target launch in summer or fall 2011, the contractors have updated content, introduced intuitive navigation and way-finding by adding links to relevant additional content and highlighting key content, and improved the graphic design.
A preview of the website revealed new and enhanced content on alcohol and health, and grant funding opportunities; Press Room: Twitter feed; and home page slideshow. The update emphasizes freshness, relevance, and an appropriate level of complexity to address NIAAA’s multiple audiences. Next steps involve completing site development and content migration, user acceptance testing, post-launch usability testing, and ongoing site enhancements.
Discussion. In response to Council inquiries, Mr. Siegal stated that the website will host downloadable slides for community providers and others. A more sophisticated search engine is under exploration. No blog is part of the website’s current plan, although possible in the future. Some Spanish-language publications will be posted and highlighted. A glossary function has not yet been explored.
Ex-officio Member Report
Dr. Jill Carty, Psychological Health Strategic Operations Directorate Executive Officer, Department of Defense, stated that a draft report to Congress on the comprehensive risk and prevention, diagnosis, and treatment of substance abuse disorders is navigating final coordination. The Defense Department sponsored an independent Institute of Medicine study on the prevention, diagnosis, treatment, and management of substance use disorders in the Armed Forces. The Undersecretary of Defense has signed the Alcohol/Substance Misuse Advisory Committee charter and a first meeting was held.
Dr. John Allen, Associate Chief Consultant for Addictive Disorders, Office of Mental Health Services, Department of Veterans Affairs (VA), reported that the VA is training clinicians in contingency management therapy for inpatients. In 2012 training will begin on behavioral couples’ therapy and motivation enhancement therapy. Reflecting concern with co-occurring substance problems, particularly PTSD, an expert panel will review current research and the functioning of the VA’s 150 PhD-level psychologists who specialize in substance use disorders. Following the meeting, the VA will revise its clinical recommendations for managing co-occurring disorders.
Council Member Round Table
Dr. Ehlers raised the issues of (1) granting no-cost extensions to complete research aims and (2) limiting grant applications to two reviews. Dr. Warren stated that one 1-year no-cost extension is automatic, but a request for a second extension must be strongly justified. Third submissions have been discontinued, with the aim to fund more research on the first application. Dr. Bautista suggested sending objections to NIH’s Deputy Director for Extramural Research. Dr. Ehlers observed that funding of first submissions did not seem evident in the recent grant review. Dr. Bautista noted that continuity of review may not be assured for special emphasis panels. He responded to Dr. de la Monte that while NIAAA can ensure continuity of review for such panels, the Center for Scientific Review makes its own decisions. Dr. Gil stated that budget cuts have prompted university administrators to take a conservative approach to no-cost extensions. Dr. Bautista stated that “unspent funds” does not constitute adequate justification for an extension.
Dr. Grant observed that NIAAA staff has expended considerable time and effort on the reorganization, a hidden cost in a budget-neutral lexicon; Dr. Warren noted that some staff have worked nearly full-time on the process. Dr. Krystal proposed that the Council meet during the public comment period. Dr. Warren reassured the Council that they and other key stakeholders will be able to offer feedback to NIH on the reorganization at the appropriate time in the process. Dr. Gil expressed concern regarding the development of the scientific strategic plan contemporaneously with portfolio allocation. Dr. Riley observed the advantage of providing comment on portfolio management on a regular basis. Dr. Warren stated that NIAAA leadership has presented a strong rationale for keeping its portfolio together in the new Institute, and adoption of a new planning model offers new opportunities for input. He stated that NIDA’s director takes the same attitude toward NIDA’s programs.
Dr. Goldman made a comment that there is a serious flaw in the plan, and agreed with Dr. Spear’s observation that the creators of the mission statement will determine the future.
Although time was set aside for public comment, no one chose to speak.
Dr. Warren adjourned the meeting at 1:05 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Kenneth R. Warren, Ph.D.
Abraham P. Bautista, Ph.D.