National Advisory Council Meeting - February 16-17, 2011

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 126th meeting at 5:30 p.m. on February 16, 2011, at the Fishers Lane Conference Center in Rockville, Maryland, in closed session for a review of grant applications and a Merit Award extension.  The meeting recessed at 7:00 p.m.  The Council reconvened on February 17, 2011, at 8:00 a.m., when Dr. Tatiana Foroud presented the report of the Board of Scientific Counselors.  Dr. Abraham Bautista, Director, Office of Extramural Activities, NIAAA, presided over the closed sessions.  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 February 16, 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 February 17, 2011. 

Council Members Present:

David W. Crabb, M.D.
Gen. Arthur T. Dean
Cindy L. Ehlers, Ph.D.
Scott L. Friedman, M.D.
Kathleen Grant, Ph.D.
R. Adron Harris, Ph.D.
Deborah S. Hasin, Ph.D.
Andrew C. Heath, D.Phil.
Vimal Kishore, Ph.D.
Lynell W. Klassen, M.D.
John H. Krystal, M.D.
Larry I. Palmer, LL.B.
Edward P. Riley, Ph.D.
Linda P. Spear, Ph.D.
Gyongyi Szabo, M.D., Ph.D.

Ex-officio: John Allen, Ph.D., M.P.H.

Chairperson: Kenneth R. Warren, Ph.D.

Executive Secretary: Abraham P. Bautista, Ph.D.

Senior Staff:

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.

Other Attendees:

Approximately 50 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order

Dr. Kenneth Warren called the open session of the 126th meeting of the Council to order at 8:55 a.m. on Thursday, February 17, 2011, and welcomed participants.  Council members and NIAAA senior staff introduced themselves.

Director’s Report
 
Dr. Warren highlighted key recent Institute activities, referring to the written Director’s Report.

• Legislation, budget, and policy.  The FY2010 budget year ended on September 30, 2010.  During that year, NIAAA awarded 706 research grants (of which 189 were new and competing awards), supported 21 research centers, awarded 116 grants additional grants, and supported 289 full-time training positions.  With the remaining $52.9 million in American Recovery and Reinvestment Act funds, NIAAA supported the second year of 2-year awards, a limited number of high-priority administration supplements, and three research project grants.

In FY2011 the Federal Government has operated under a continuing resolution; NIAAA expenditures have been annualized at a FY2010 dollar level.  The FY 2011 President’s budget requests an increase for the National Institutes of Health (NIH) of 3.2%, or $1 billion, with a slightly smaller rate of increase for NIAAA.  The final budget awaits congressional action, and NIAAA spending has proceeded cautiously in light of many uncertainties.

The FY2012 President’s budget request proposed $31.8 billion for NIH, an increase of 1.9% over FY2010.  The budget proposed $469.2 million for NIAAA, representing a $7.1 million increase, or 1.5%, over FY2010 levels. 

Under the proposed FY2011 budget, the number of competing research project awards drops from 189 in FY2010 to 151 projects, but rebounds under the FY2012 proposed budget to 194.  Reductions in total awards are expected for FY2011 and FY2012.  Prior to 2011, NIAAA had succeeded for a decade in avoiding a “roller coaster” award pattern.  NIAAA has enjoyed among the highest pay lines and success rates in NIH to date.

• Director’s activities.  In November 2010 Drs. Warren, Peggy Murray, and Edward Riley participated in a World Health Organization (WHO) planning meeting in the Netherlands to develop the protocol for the first global study of the prevalence of fetal alcohol spectrum disorders (FASD) in low- and middle-income countries.  Dr. Warren served as a co-chair of the meeting.  Following that meeting, the three NIAAA representatives made presentations at the inaugural European meeting on FASD. 

Dr. Ralph Hingson reported on a WHO planning meeting at which WHO’s global strategy to reduce harm associated with alcohol misuse was unveiled.  WHO has published a country-by-country statistical status report on multiple indicators of alcohol misuse; WHO’s monitoring system, similar to the U.S. Alcohol Policy Information System, offers great potential for researchers. 

• Staff and grantee honors.  Kimberly Nixon, Ph.D., received the highly prestigious Presidential Early Career Award for Scientists and Engineers; she is the third NIAAA researcher to be so honored in the last 3 years.  Dr. Pal Pacher was invited to serve on the editorial boards of Free Radical Biology & Medicine and American Journal of Physiology: Heart and Circulation Physiology.  Dr. Pacher also became one of the top 100 most-cited pharmacology researchers in the world, according to the Institute for Scientific Information.
• Press releases.  NIAAA issued press releases on high-quality research, for example: NIH-Supported Mice Studies Suggest Treatment Target for Alcohol Problems; NIH-Supported Study Finds Strategies to Reduce College Drinking; NIH-Led Study Identifies Genetic Variant That Can Lead to Severe Impulsivity; and Gene Variants Predict Treatment Success for Alcoholism Medication.
• Multimedia NIAAA products.  Highlights of products reflecting NIAAA’s knowledge base include the Winter 2011 issue of the NIAAA Newsletter, the online NIAAA Spectrum, and NIAAA’s fact sheet “New Year, Old Myths, New Fatalities,” a seasonal outreach effort.  
• News media interactions.  Many news media interactions have taken place with NIAAA staff and researchers, evidence of interest in NIAAA’s cutting-edge scientific research.
• NIAAA staff and organization.  Dr. Dionne Godette has joined NIAAA’s Division of Epidemiology and Prevention Research as a health scientist administrator.  Dr. Warren noted the departures of Ann Bradley and Dr. Margaret Mattson, and the retirement of Dr. Deborah Dawson. 
• College Presidents Working Group Task Force.  Many college presidents have accepted NIAAA’s invitation to join the Institute’s reconvened College Presidents Working Group Task Force.  Dr. Vivian Faden explained that an NIAAA task force first met in 1998 to address college-age drinking and reported in 2001 on ongoing research and new knowledge about epidemiology and interventions.  Although progress has been made in reducing drinking on college campuses since that time, students who drink still drink a lot and in extreme ways.  The task force is anticipated to help disseminate NIAAA’s information on interventions to greater numbers of college campuses.  Dr. Faden noted strong HHS interest in this issue.  Dartmouth University president Dr. Jim Yong Kim and Dr. Robert Carothers, University of Rhode Island’s immediate past president, co-chair the task force.

Preparatory to a presentation by NIH Principal Deputy Director Lawrence Tabak, Dr. Warren summarized the Scientific Management Review Board’s process and findings related to an anticipated NIAAA/NIDA merger and consolidation of portions of the NIH portfolio on substance use, abuse, and addiction. 

Compliance with Inclusion Guidelines 

Bridget Williams-Simmons, Ph.D., Health Scientist Administrator, Office of Science Policy and Communications, NIAAA, presented data for incorporation in NIAAA’s 2011 Biennial Advisory Council Report on Inclusion of Women and Minorities as Subjects in Clinical Research.  The congressionally mandated report is based on the ethical principle of justice and the importance of balancing research burdens and benefits.  The NIH Revitalization Act of 1993 requires that women and members of minority groups and their subpopulations be included in all NIH-funded clinical research; NIH must support outreach efforts to recruit and retain those populations in clinical studies; exclusions may be made solely by the NIH Director or Institute/Center (IC) Director based on a clear and compelling rationale; cost is not an acceptable reason to exclude these groups; and Phase III trials should be designed to allow for valid analyses of differences in intervention effects between gender groups and racial/ethnic groups.  Each NIH Institute or Center (IC) prepares a biennial report describing how the IC has complied with the policy; these reports are included in the NIH Director’s Report to Congress.   

Dr. Williams-Simmons enumerated NIAAA’s procedures to ensure compliance: All notice of funding opportunities that involve human subjects include a section on the NIH inclusion policy; program officials answer questions from potential applicants; special attention is given to identification of Phase III clinical trials; scientific review officers (SRO) inform peer reviewers about the inclusion policy before and during reviews; review groups determine whether women and minorities have adequate representation in relevant projects; SROs summarize reviewer comments and code summary statements to reflect review groups’ comments and concerns; applications with unacceptable inclusion plans are barred from funding; program officials discuss issues of noncompliance with applicants, who may modify plans and/or provide additional information to address reviewers’ concerns; program officials evaluate and approve required population target and cumulative enrollment reports of ongoing projects; program officials monitor target and enrollment data; and NIAAA provides staff training on the inclusion policy. 

Data for FY 2009 and 2010 reveal that women constituted considerably more than half the enrollment population in clinical studies, and minorities constituted nearly half the total enrollment.  In NIAAA’s few Phase III clinical trials, females and minorities accounted for more than half the total enrollment.  The racial and ethnic populations with greatest representation in 2009 and 2010 for both extramural clinical studies and Phase III trials were White, Black/African American, Asian, more than one race¬, and unknown.  The Hispanic enrollment doubled from 2009 to 2010.  

Discussion.  Dr. David Crabb observed NIAAA’s outstanding recruitment record.  Dr. Cindy Ehlers noted that few Hispanics were counted among the target populations.  Dr. Williams-Simmons responded that NIAAA has no explanation for the significant drop in Hispanic enrollment since the last report. 

Certification.  Members of the NIAAA National Advisory Council voted unanimously to accept the report.  

Consideration of the September 22–23, 2010, Meeting Minutes and Future Meeting Dates

Council members unanimously approved the minutes of the Council meeting of June 9–10, 2010.  Future Council meetings will take place on June 8–9, 2011; September 14–15, 2011; February 8–9, 2012; June 6–7, 2012; and September 19–20, 2012. 

Achieving Successful Translation of Science to Practice Through Community-Based Participatory Research

Gen. (Ret.) Arthur T. Dean, Chairman and Chief Executive Officer, Community Anti-Drug Coalitions of America (CADCA), asserted that adding a community voice strengthens alcohol research work.  NIAAA has provided more than 5,800 CADCA coalitions—which have critical interests in such alcohol issues as underage drinking, binge drinking, alcoholism, and impaired driving—with evidence that is useful in their community-based work.  Since NIAAA and CADCA began working together, CADCA has published The Practical Theorist 6: Using Science to Combat Underage Drinking (2006).

In observing the need for a bridge between researchers and community activists in solving community problems, Gen. Dean described community-based participatory research, a collaborative research/evaluation endeavor between researchers and community members.  All partners participate in the research process, and the unique strengths that all partners bring to the table are recognized.  Incorporating community residents in the research makes the research more applicable, contributes to more effective use of findings, and ultimately helps solve serious problems in the community.  Researchers’ definition of problems may differ from that of community residents.  In community-based participatory research, stakeholders seek to recognize community strengths and assets, in addition to problems, and bridge their perspectives to work in harmony.

Gen. Dean pointed out the benefits of researchers working with CADCA community coalitions, because coalitions understand their own communities. They have connections to key community leaders, can facilitate researchers’ understanding of, and integration into, the community; and provide access to local data.  Many coalition members have been trained as “everyday scientists” to use evidence-based, data-driven programs, policies, and strategies, and to create good local datasets.  CADCA has facilitated community research partnership projects in such areas as underage drinking and impaired driving, has facilitated development of fundable research proposals, disseminates relevant research to the field, and has collaborated on the STOP Act.  CADCA’s Annual Survey of Coalitions, which offers the best data on community-based organizations available, is based on an annual survey of 1,000 coalitions on such topics as outcomes, how they are achieved, community focus, community size, and community budget.  CADCA’s Community-Researcher Partnership Meetings incorporate presentations by prevention and alcohol policy scientists, as well as experts on Screening, Brief Intervention, and Referral to Treatment (SBIRT); family/school interventions; and environmental interventions.  CADCA considers its coalitions to be a strategy, not a program, designed to affect the entire community at the population level. 

Gen. Dean suggested three areas on which community-based participatory research would offer added value: efficacy studies on promising practices in the field, improving existing evidence-based policy research by refining existing interventions and exploring issues of dosage, and conducting translational research on factors that make coalitions effective in implementing their work.  CADCA suggests the need for participatory research projects on alcohol outlet density, compliance checks, price and tax, SBIRT, social host ordinances, social networking, and comprehensive community interventions. 

Current CADCA projects to disseminate community-based participatory research findings include webinars for STOP Act grantees on evidence-based environmental strategies targeting underage drinking and brokering community-researcher relationships to foster community-based participatory research.  Challenges include the urgent need to establish partnerships, which take time to develop; inconsistency among funders in defining community-based participatory research; need to develop statistical methodologies in community-based research to account for “messiness” in this type of research; and grant reviewers insufficiently knowledgeable about the process.  Gen. Dean noted also that insufficient funding mechanisms exist to support community-based participatory research projects in this area.
 
Discussion.  Dr. Deborah Hasin asserted the need for young researchers in social epidemiology who are engaged in multilevel modeling of alcohol and other substance outcomes to become aware of CADCA and the research opportunities the organization offers.  Gen. Dean stated that such efforts are underway, including a project with Wake Forest University.

Dr. Crabb inquired about efforts to control for the “messiness” in community research.  Gen. Dean acknowledged the challenge of implementing community-based research in environments that do not lend themselves to randomized controlled trials (RCT).  He stated that CADCA’s National Community Anti-drug Coalition Institute has trained 10,000 people in 150 settings to enable coalitions to improve their communities.  CADCA communicates regularly with its 5,800 coalitions in the United States and nine other countries, and has an active evaluation and research department.  Gen. Dean expressed his desire to partner with NIAAA to develop evidence-based strategies.  He solicited input from Council members and introduced CADCA’s website, www.cadca.org.

Health Policy Implications of Fetal Alcohol Spectrum Disorder Research

Prof. Larry Palmer, of the Virginia Commonwealth University and College of William and Mary Law School, discussed the relationship between scientific research and health policy in the context of fetal alcohol spectrum research.  Research has linked certain developmental disorders with alcohol in pregnancy, which has led to regulations requiring public health warnings on alcohol containers—despite questions about whether a biomarker can be developed to determine a woman’s level of alcohol consumption in order to prevent birth defects.  Prof. Palmer described several additional elements at play in perceptions of scientific research and health policy: the role of “fetal politics” in setting the health agenda; lack of justice in the “justice system,” just courts; vulnerable populations, related to Tuskegee scientific experiments; and emergence of “regulatory science,” a new concept of Federal public health.

Prof. Palmer asserted that health policy development to date has not placed sufficient emphasis on ethics in alcohol research.  He explained that the Federal requirement for alcohol warning labels was influenced by Michael Dorris’s 1989 book The Broken Chord about raising a child with fetal alcohol syndrome (FAS).  Not often remembered is that the book’s foreword called for jailing pregnant women who consistently drink during pregnancy—an example of “fetal politics” in the policy arena.  Based on recent constitutional cases in South Carolina related to abortion, the principle of “fetal interest” has been cited to separate the fetus from the pregnant woman, leading to the notion that a pregnant woman who takes drugs inflicts environmental harm on a developing embryo—and thus is guilty of child abuse.  These concepts are likely to create problems in implementation of alcohol policy.

Prof. Palmer pointed out that “justice system” in common parlance typically refers to courts, and not necessarily justice, but that law is embodied in a series of legal institutions.  As an analogy, he noted that a health system involves fresh water, policy considerations, and healthcare delivery.  NIH enables background science to influence the healthcare delivery system, while the public health system promotes prevention—alcohol warning labels, for example, to help prevent downstream injuries to the fetus.  The U.S. healthcare delivery system has subsumed many prevention functions from the public health system.

In addition to courts, the legal system incorporates legislatures.  Legislatures’ complicated reconciliation processes to pass laws are important elements of health policy, as are the range of theories and standards judges impose when they interpret statutes.  Administrative and regulatory agencies, including NIH, also play roles in health policy, as do market-based institutions such as healthcare providers, healthcare facilities, and public and private health financing schemes.  Prof. Palmer suggested that the public health infrastructure maybe considered as both legal and market-based institutions.  In terms of bioethics, medical ethics, and legal institutions, additional market-based institutions include science and its support and financing, biotechnology, “families” and fetal-political concepts of when one becomes a person, and religion.  Prof. Palmer asserted that it is not necessarily a legal institution’s job to frame and resolve a particular issue; market forces also help to resolve large societal issues.

Prof. Palmer stated that the Tuskegee experiments led to legislation that currently regulates human research.  Vulnerable populations have continued to be victims of medical misuse, and in November 2010 President Obama appointed a bioethics commission to conduct a thorough review of human subjects’ protection to determine if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.  The Institute of Medicine (IOM) has reported that safeguards are inadequate to protect individuals in terms of ethical questions, and that the safeguards protect institutions instead.  In the context of community-based participatory research in prison populations, for example, a question arises about the role of prisoners and re-entry advocacy groups in decisions.  Prof. Palmer anticipates the commission to recommend a systems view of human protection. 
 
Congress has given the Food and Drug Administration (FDA) new powers to require studies after drug approval for marketing, thus endowing the FDA with health promotion responsibility.  Following accelerated implementation of new drugs, the knowledge base changes and unanticipated collateral risks emerge.  NIH’s Advancing Regulatory Science initiative, which investigates the safety of post-marketing drugs, appears to question the traditional model of regulation following problem identification.  Under consideration is a continuous process of gathering information, planning a drug, planning studies for that drug that incorporate post-marketing and ethical considerations.  Prof. Palmer’s study group, “Ethical Issues in Studying the Safety of Approved Drugs,” is considering whether randomized control trial (RCT) represents the best model to study people already using a drug. 

In its review of Avandia, the FDA permitted the drug to remain on the market but required physicians to elicit consent from patients who continue to use it; for some patients, no other drug works to control diabetes.  For the first time FDA allowed the public to see disagreement within the agency about strategy for a drug—evidence that the notion of risk-taking has changed.  FDA Director Margaret Hamburg acknowledges that the science is not always clear and that she must make scientific judgments that may involve disagreements.  Under the notion of regulatory science, certain agencies must study how to incorporate scientific knowledge in regulation, including strategies for involving patients in research plans.

In conclusion, Prof. Palmer stated that although Thomas, Warren, and Hewitt (2010) implied that the discovery of biomarkers might improve care of the resulting children, their work has been cited to justify legislation (in Wisconsin and South Dakota, for example) to allow civil commitment of pregnant women who drink. Given his perspective as a “citizen/scholar,” Prof. Palmer suggested the need for a “comparative effectiveness” study of these statutes versus states that have done nothing.  He anticipated that the law may be used in the future in an aggressive fashion that results in coercion against women.

Discussion.  Dr. Warren stated that he is unaware of any state that has prosecuted a pregnant woman for alcohol use, despite laws on the books, and noted that the South Carolina law prosecuted women using illicit drugs and not alcohol.  He explained that NIAAA’s Prenatal Alcohol, SIDS, and Stillbirth study, designed to address alcohol as a risk factor in an area with high SIDS prevalence, involves one state with civil commitment legislation and another that does not have such a law on its books.  NIAAA was able to negotiate with the attorney general of the first state to conduct the research.  Prof. Palmer suggested that the negotiation may not bind future attorneys general of that state.

Dr. Howard Moss inquired about the likelihood of pharmaceutical companies revealing to the public their proprietary information on the long-term effectiveness of products on the market.  Prof. Palmer responded that while accountability and transparency are important public health values, companies would prefer to retain as much proprietary information as possible.  He asserted that legal sanctions against individuals who violate regulations may overcome reluctance to disclose, noting that the question remains open about the characteristics of a future regulatory system.  He stated that FDA Director Hamburg appears to be changing the culture at FDA Hamburg to reduce the fear of transparency. 

In the context of study methodologies, Dr. Warren cited a recent journal article that observed that no RCTs have ever been conducted of the effectiveness of the parachute.  New approaches and other lines of evidence are needed to complement RCTs in the alcohol field.

Neurobiology of Alcohol Addiction

Dr. R. Adron Harris, Director, Waggoner Center for Alcohol and Addiction Research, University of Texas–Austin, began his presentation on the mechanism by which alcohol reprograms the chemical hardware and software of the brain; however, he was interrupted and will return to Council at a later date to present this topic in its entirety.

National Institutes of Health Director’s Report

Dr. Lawrence A. Tabak, Principal Deputy Director, NIH, summarized Scientific Management Review Board (SMRB) actions.  In November 2010 the SMRB recommended that NIH establish a new Institute on substance use, abuse, and addiction, which would integrate relevant portfolios from NIAAA, NIDA, NCI, and other appropriate ICs, and transfer nonsubstance use, abuse, and addiction research currently housed in NIAAA and NIDA to other relevant ICs.  NIAAA and NIDA would be dissolved; funding levels would be maintained; and a new director would be recruited to lead the new Institute.  NIH would try to protect and respect people and the research for which NIAAA and NIDA have provided stewardship.  Although employment would continue, not everyone would retain his or her precise current position.

NIH’s Substance Use, Abuse, and Addiction Task Force, co-chaired by Drs. Tabak and Stephen Katz, is meeting with subject matter experts selected by all affected ICs to discuss the nuances and breadth of the science, and how the science interfaces and synergizes.  The Website Feedback NIH has yielded comments related to this activity.  Dr. Tabak noted that NIDA’s National Advisory Council sent a letter requesting input to the Task Force from the extramural community, but as a way to structure discussion and comment, the task force will continue in its current course to have internal discussions and then create a straw model to circulate back to all stakeholders.

By spring 2011 NIH will ask the HHS Secretary to make a determination on a merger and to send notification to Congress.  Her determination will be informed by the findings of the task force responsible for gathering information and activities.  An administrative review and reorganization package will be drafted and submitted to the Secretary in summer or fall 2011.  The reorganization is projected for 2013.  Dr. Tabak acknowledged the angst created by this change for NIH colleagues and scientists.

Discussion.  Dr. Scott Friedman expressed disappointment that the NIAAA National Advisory Council had not been asked to advise on this matter.  He inquired how the reorganization would advance the science.  Dr. Tabak responded that strong potential synergies would arise from placing programs related to the addiction portfolio in NIDA and NCI (tobacco) in juxtaposition with NIAAA programs.  Neuroscientists argue that the pathways that underlie addiction behavior response are similar across substances that can be used or abused; that the reward system invoked by the use of these substances is common; and, where it is not common, scientists could learn by comparing and contrasting.  Because NIAAA’s portfolio extends beyond solely addiction, substance use and abuse are included in the charge.  Dr. Friedman stated that liver scientists express deep concern about the orphan status of end-organ damage, particularly liver damage, as a major public health problem.

Gen. Dean cautioned that people become overly attached to a straw model proposed for comment.  Dr. Tabak responded that the SMRB process incorporated scores of hours of presentations by science, judicial, and public policy experts.  He explained that a straw model developed in a similar NIH consolidation process underwent considerable transformation prior to the final recommendation.  In addition to listening to experts, NIH conducted hours of telephone conferences with stakeholders, received 1,200 comments via NIH’s portal or email, and held scores of telephone conversations with key stakeholder groups and individual investigators. 

Dr. Edward Riley inquired about time lines for next steps.  Dr. Tabak explained that completion of the straw model is expected by late March 2011.  The task force expects to rely on affected Institutes to provide it with key stakeholder groups to which to reach out for input.  The goal is for the Secretary to make a decision and forward her recommendation in the spring, to create a reorganization package in summer or early fall, and to forward the plan for incorporation into the President’s FY2013 budget proposal.  Dr. Warren stated that the two most important stakeholders are the National Advisory Councils of NIAAA and NIDA, and suggested holding a joint Council meeting to discuss the straw model.  Dr. Tabak acknowledged the feasibility of such a meeting.

Dr. Gyongyi Szabo inquired about addiction portfolios that may be drawn into the new Institute from other Institutes.  Dr. Tabak stated that NCI’s tobacco addiction portfolio will be incorporated, and possibly NIMH’s portfolio related to compulsion disorders.  Other portfolios may be suggested later.

Dr. John Krystal observed that restructuring comes at a cost, including fragmentation of stable Institutes’ ongoing missions as well as personal costs.  He inquired about the extent to which Institutes might retain elements of their current addiction portfolios, which might compromise optimal synthesis, and how NIH will evaluate the success of the proposed synthesis and weigh synthesis’ cost/benefit.  Dr. Tabak stated that the initial evaluation of success involves evidence of a synergy in the work supported over a period of time.  Intramural programs, which also will merge, can lead to more synergies more rapidly and may serve as a bellwether.  In any case, evaluation must involve a longer-term view.

Dr. Hasin suggested that Congress might tend to reduce funding for merged Institutes in expectation of economies resulting from eliminating redundancy.  Dr. Tabak stated that NIH has continually made the case that they do not expect reductions—the body of work must be supported.  NIH must continue to make the case that research is chronically insufficient to meet public health needs.  Advocacy from all stakeholders is necessary to influence Congress about challenges, opportunities, and lost opportunities.  Dr. Hasin suggested the need for a communications plan to such lay audiences as Congress.

Dr. Andrew Heath noted that the greatest potential for synergy occurs in the alcohol and tobacco arena regarding, for example, prevention and policy research.  He inquired about the logistics of allocating space following a merger.  Dr. Tabak responded that once science-based decisions are made, personnel and then space decisions will be made, based on short- and long-term planning, to achieve geographical approximation.  To the extent possible, personnel will be kept with their programs; however, many people multitask on multiple programs, and best matches will be made.  The respective scientific directors have begun these discussions.

Dr. Harris observed that testimony to the SMRB to shape plans for reorganization revealed a majority opposed to a merged Institute, particularly alcohol researchers.  Dr. Tabak responded that based on that testimony and other discussions, the SMRB recommended establishing a new Institute.  Engaging all stakeholders to comment on the straw model for the new Institute offers all relevant parties new opportunities to comment and, through an iterative process, to influence creation of an Institute with which all parties would be comfortable.

Dr. Linda Spear inquired about the characteristics of the Institute’s new director.  Dr. Tabak stated that, apart from general characteristics, until the science to be covered is determined, determination of a director’s qualifications would be premature.  In any event, the new director must lead a far larger organization than currently exists.  The director must possess scientific vision, capacity to bring fields together in new and innovative ways, ability to speak to the lay person, and administrative sophistication.

Dr. Tabak complimented Dr. Warren on his leadership in this matter and on the professionalism of his NIAAA colleagues.

Council Member Round Table

Dr. Bautista stated that he will arrange for a joint Council meeting to discuss the expected NIH reorganization involving NIAAA, NIDA, and portfolios of several other Institutes.

Dr. Spear suggested inviting Dr. Harris to return to a Council meeting in the future to present his entire presentation.

Ex-officio Member Report

John Allen, Department of Veterans Affairs, registered his disapproval of an NIAAA/NIDA merger.

Adjournment

Dr. Warren adjourned the meeting at 12:45 p.m.

CERTIFICATION

I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.

/s/

Kenneth R. Warren, Ph.D. 
Acting Director, National Institute on Alcohol Abuse and Alcoholism 
and 
Chairperson, National Advisory Council on Alcohol Abuse and Alcoholism

/s/

Abraham P. Bautista, Ph.D. 
Director, Office of Extramural Activities
and 
Executive Secretary, National Advisory Council on Alcohol Abuse and Alcoholism