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National Advisory Council Meeting-May 25-26, 2005


National Advisory Council on Alcohol Abuse and Alcoholism

Summary of the 109th Meeting

May 25-26, 2005


The National Advisory Council on Alcohol Abuse and Alcoholism convened for its 109th meeting at 5:30 p.m. on May 25, 2005, at the Fishers Lane Conference Center in Rockville, Maryland, in a closed session, and again at 8:35 a.m. on May 26 in an open session. Dr. Tina Vanderveen presided over the closed review of grant applications on May 25. Dr. Ting-Kai Li, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), presided over the open session on May 26.

In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the meeting on May 25 was closed to the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds.

Council Members Present:

Howard J. Edenberg, Ph.D.
Victor M. Hesselbrock, Ph.D.
Joannes B. Hoek, Ph.D.
Gail A. Jensen, Ph.D.
Mack C. Mitchell, M.D.
Stacia A. Murphy
Stephanie S. O'Malley, Ph.D.
Alan C. Swann, M.D.
Boris T. Tabakoff, Ph.D.
Hope Taft
Robert E. Taylor, M.D., Ph.D.
Hidekazu Tsukamoto, D.V.M., Ph.D.

Ex-Officio Council Members Present:
CDR Frank A. Little, Sr.
Richard T. Suchinsky, M.D.

Chairperson: Ting-Kai Li, M.D.

Executive Secretary: Karen P. Peterson, Ph.D.

Senior Staff:
Faye Calhoun, D.P.A., M.S., Vivian B. Faden, Ph.D., Mark Goldman, Ph.D., Ralph W. Hingson, Sc.D., M.P.H., Bob Huebner, Ph.D., George Kunos, M.D., Ph.D., Stephen Long, Howard Moss, M.D., Antonio Noronha, Ph.D., Tina Vanderveen, Ph.D., Kenneth R. Warren, Ph.D., Mark Willenbring, M.D., Samir Zakhari, Ph.D.

Other Attendees on May 26, 2005

Approximately 60 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order of the Closed Session, May 25, 2005

Dr. Tina Vanderveen, Director, Office of Extramural Activities, called the closed session of the 109th meeting of the Council to order at 5:30 p.m. on Wednesday, May 25, 2005, for consideration of grant applications. Dr. Vanderveen reviewed procedures and reminded Council members of regulations pertaining to conflict of interest and confidentiality. Members absented themselves from the discussion and evaluation of applications from their own institutions and in situations involving any real, apparent, or potential conflict of interest. The closed session adjourned at 7:05 p.m.

Call to Order of the Open Session and Introductions, May 26, 2005

Dr. Li called the open session to order on May 26, 2005, at 8:35 a.m. and welcomed participants. Members of the Council introduced themselves. Dr. Li welcomed the Department of Defense's (DOD) acting representative, CDR Frank Little, Sr., to the Council and noted that Col. Kenneth Hoffman has retired from military service.

Director's Report

Referring to the published "Director's Report," Dr. Li highlighted the following Institute activities:

  • Budget. The President's FY2006 budget request for NIAAA is $440.3 million, an increase of $2.1 million, or 0.5 percent over the FY2005 budget. The budget can support 216 competing grants at a success rate of around 30 percent, a favorable rate compared to other NIH Institutes. At this level NIAAA's budget will fund 19 alcohol research centers at $32.1 million, 94 research career awards at $11.4 million, and 257 pre- and post-doctoral trainees at an additional $11.4 million. The Institute will fund research and development contracts at a slightly lower level, including the NESARC epidemiological study, research on biosensors and other high-risk activities, and the Alcohol Policy Information System. NIAAA's budget will support intramural research at 111 FTEs and research, management, and support at $24.0 million.

    In April Dr. Zerhouni was the principal presenter for the NIH budget at FY2006 Congressional hearings in the House and Senate. Dr. Calhoun gave the oral presentation for NIAAA during House Theme hearings (see www.niaaa.nih.gov/about/Statement%204.05.htm).

  • Director's activities. Dr. Li delivered keynote presentations at meetings of the American Psychopathological Association and the University of Southern California's Institute of Health Promotion and Disease Prevention Research, Pacific Rim Transdisciplinary Tobacco Use Research Center (TTURC), and Transdisciplinary Drug Prevention Research Center's conference on tobacco and alcohol use. NIAAA has joined the TTURC group, which now is studying alcohol as well as tobacco use. NIAAA funds one of the seven TTURC centers, headed by Dr. O'Malley. Dr. Li also gave presentations at George Washington University's grand rounds and represented Dr. Zerhouni in Taiwan by delivering a keynote presentation at the dedication of Taiwan's National Health Research Institute. Dr. Li also spoke at a national leadership conference of the National Association of Addiction Treatment Providers.
  • NIAAA staff update. Dr. Karen Peterson has been named Chief, Research Policy and Special Programs Branch, Office of Scientific Affairs. Dr. Li noted that special advisor to the NIAAA director Suzanne Medgyesi-Mitschang has retired and acknowledged her service to the Institute. Jeffrey Toward, Ph.D., has joined the program staff at the National Institute of Nursing Research.
  • Research Priority Emphasis and Core Support Teams. Dr. Li highlighted the Underage Drinking Initiative and studies using genomic, proteomic, and metabolic approaches to identify biomarkers and to study the mechanisms of disease.
  • NIAAA research programs. Dr. Li noted honors and other activities involving NIAAA Council members and staff. The Butler Center for Research at the Hazelden Foundation presented the Dan Anderson Award to Dr. O'Malley for her research in addiction recovery. Drs. Ellen Witt, Vivian Faden, Gayle Boyd, and Cherry Lowman were section editors for the recently published book Recent Developments in Alcoholism: Alcohol Problems in Adolescents and Young Adults. Dr. Willenbring presented talks at conferences of Spain's Sociedad Espanola de Toxicomanias, International Society of Addiction Medicine, and American Society of Addiction Medicine (ASAM). Dr. Willenbring moderated NIAAA's symposium at the ASAM meeting, at which Dr. Moss presented.

    Dr. Li reported a collaboration with the Department of Justice's Office of Juvenile Justice and Delinquency Prevention on Enforcing Underage Drinking Laws (EUDL) in Rural Communities, for which NIAAA's Centers for Evaluation will evaluate program outcomes in seven states. The new research grant program Rapid Response to College Drinking Problems will fund a minimum of 15 colleges and universities, and the evaluation centers will evaluate outcomes.

  • Research reports. Dr. Li highlighted publications with trans-Institute importance. A study on alcohol and body mass index by Drs. Breslow and Smothers looks at the relationship of quantity and frequency of drinking to obesity. Dr. Hingson and colleagues have shown in multiple communities over the course of a decade that enforcing various community interventions works to reduce alcohol-related fatal crashes. Dr. Kunos's laboratory participated in a published study that shows that endocannabinoids help to regulate energy metabolism in the synthesis of fat in the liver. The study has important potential for treatment of obesity and smoking; common mechanisms show potential for alcohol intake. A paper has shown that long-acting naltrexone injection is effective in treating alcohol dependence and use, and another paper studies the mechanisms for formation of fatty liver and the effects of alcohol.
  • Outreach. NIAAA continues to support the Leadership to Keep Children Alcohol Free, a group that publicizes the perils of underage drinking. Following the last election, six new governors' spouses have joined, for a total of 37 active members and 15 emeritus members. More than 2,000 sites nationwide participated in Alcohol Screening Day in April, including many activities on campuses and military installations, in order to identify alcohol problems early and to provide help in the form of brief intervention and other approaches. NIAAA has continued to work with the Community Anti-Drug Coalitions of America (CADCA).
  • Multi-media products from NIAAA. NIAAA produces evidence-based educational materials, including The Cool Spot website (www.thecoolspot.gov) for middle school students. The National Association of Government Communicators awarded the website a first-place Gold Screen Award, and, in an international competition, the website earned one of five nominations for a Webby in the best government website category. NIAAA staff received an honorable mention at the NIH Plain Language Award ceremony.

    Dr. Li noted that the next two issues of Alcohol Research & Health will focus on screening and brief interventions. NIAAA has translated into Spanish and published "Alcohol: A Women's Health Issue," and Dr. Li asserted the need to translate media products into various languages to accommodate changing demographics in this country.

"Helping Patients Who Drink Too Much: A Clinician's Guide"

Dr. Mark Willenbring presented an overview of the revised "Helping Patients Who Drink Too Much: A Clinician's Guide," to be published in July 2005. The publication's goals are to simplify the screening process (to one question on having had a heavy drinking day within the past year) and to expand screening activity to, for example, primary care, primary mental health care, emergency rooms, and trauma centers. To support the effort NIAAA will produce two-page documents for such settings as emergency rooms and pediatric and obstetrics and gynecology practices. The publication provides a step-by-step process and tools for clinicians to adapt to their own clinical process and style. It also presents full diagnostic criteria for alcohol disorders. Suggestions are given to deal with dangerous alcohol use with or without a disorder, and guidance is offered both on what to do for patients who do not accept referral and on prescribing medication for alcohol dependence. Dr. Willenbring anticipates that with better medications, the majority of patients with alcohol problems will be treated in primary and primary mental health care settings.

NIAAA plans to translate the publication into Spanish, and possibly other languages, and to work internationally on its approach. A study is under consideration to validate the screening instrument. A set of PowerPoint slides will be made available to teach clinicians how to use the guide. Future products will include two-pagers for a variety of subpopulations and a DVD with video clips of sample interviews. These resources will be available on NIAAA's website, along with online instruction courses in continuing medical education.

Discussion. Dr. Willenbring stated that NIAAA is working with a number of professional organizations and will send the publication to all medical schools. Conversations are ongoing with academic health centers, residency training directors, medical student educators, and with SAMHSA to promote and support faculty development to become teacher/clinicians and teacher/clinician/researchers.


NIAAA Extramural Advisory Board Report on Medications Development

Raye Litten, Ph.D., Division of Treatment and Recovery Research, NIAAA, presented an overview of NIAAA's Medications Development Program. NIAAA funds clinical studies on medications to treat alcohol use disorders; one Phase 3 clinical study of naltrexone and acamprosate has been completed, and 33 Phase 2 clinical trials (single site, mostly RO1 mechanisms) and 17 Phase 1 clinical trials (human laboratory studies that will yield safety and efficacy data) are funded. Among the most interesting compounds are topiramate, rimonabant, and kudzu. Several promising targets for candidate compounds have been identified at the preclinical level.

NIAAA supports research on medications for a number of special populations, including adolescents, people with alcoholism and co-occurring mental health disorders, tobacco and cocaine dependence, and other substance abuse disorders. Safety factors are an important focus, particularly in pharmacotherapy studies. Another focus is alcoholic liver disease, an area that has achieved substantial progress over the past decade to the point that clinical trials now are being conducted at various sites on promising medications for alcoholic hepatitis and cirrhosis.

The multidisciplinary medications development team includes more than 30 individuals from extra- and intramural staff. Its goal is to facilitate and accelerate discovery, development, and delivery of medications to treat high-risk drinking, alcohol abuse, dependence, and alcohol-related medical disorders. The team aims to continue to stimulate innovative research; establish internal mechanisms and decision-making protocols for evaluating and advancing lead compounds; develop collaborative networks among government, academia, and private industries and organizations, including pharmaceutical companies; and work with the Food and Drug Administration (FDA) on evidence-based clinical-trial standards and outcome measures.

A medications development plan has been compiled to accelerate drug development from lab bench to practitioner to patient, advance interdisciplinary research, and stimulate public-private partnerships, all of which are themes of the NIH Roadmap. NIAAA's Extramural Advisory Board (EAB) has reviewed the plan and identified the most important priorities for advancing the field of medications development.

Fulton T. Crews, Ph.D., Director, Bowles Center for Alcohol Studies, University of North Carolina-Chapel Hill, and Chair, NIAAA Extramural Advisory Board, presented the EAB's recommendations on medications development. The recommendations are as follows:

1: Establish a coordinated infrastructure and network of animal model laboratory testing and provide for human laboratory model development. Several paradigms of animal and human laboratory models are needed for screening of lead compounds as no one model is likely to be predictive for all facets of alcohol use disorders. Medications with known clinical efficacy should be tested in all models. A mix of established models and new models (higher throughput, primates, early stages of drinking) is needed. Human laboratory models can be a valuable bridge between animal and human studies and should be further developed. Commonality of methods and replication across sites is essential.

2: Create a flexible and open clinical infrastructure for testing medications in various stages of alcohol use disorders. Since many compounds show promise in the treatment of other disorders, investigate possible collaborations with other NIH institutes in the conduct of clinical trials. Include young adults in testing where possible since most of the diagnosis of alcohol dependence occurs before the age of 26. As appropriate, investigate the therapeutic potential of new medications in the affected adolescent population. Core assessment and standardized endpoint measurements must be established before beginning the clinical trials network. Employ a network infrastructure like NIDA's Veterans Affairs Cooperative Studies Program for efficient use of resources and time.

3: Creation of scientific advisory board that provides guidance and coordination of medications development and promotes translational research. Include basic and clinical researchers on advisory board and representatives from industry.

4: Predictive biological and developmental markers (including DNA) for identifying patients and characterizing disease progression and treatment response to candidate medications. Partner with high-tech companies. Use biomarkers for screening lead compounds. Discover and develop new biomarkers using high-throughput technologies in genomics, proteomics, and metabolomics.

5: Identification and validation of molecular targets for medications development at various stages of the disease. Identify molecular targets and circuits in the brain that may overlap in alcohol, substance abuse, and psychiatric pathophysiology. Continue to support research in identifying neurocircuits and molecular and cellular mechanisms underlying alcohol-seeking behavior and drinking that may lead to new molecular targets of drug discovery.

Discussion. Dr. Edenberg urged NIAAA to encourage all trials and preclinical laboratory experiments to collect and annotate genetic, genomic, and proteomic material, and to make that data available for analysis.

Concurrence. Council members voted unanimously to accept the EAB's recommendations, including Dr. Edenberg's comment, regarding medications development.

NIAAA Extramural Advisory Board Final Report on Gene by Environment

The charge to the EAB was to review the GxE portfolio; look for interactions, opportunities, and perspectives; and provide a five-year vision of research. The committee reached consensus that the field is not ready for large-scale studies in GxE interactions in humans at this time. The committee made the following recommendations regarding issues that need attention prior to the development of clinical studies in this area:

1. Identify specific genes related to alcohol dependence versus drug dependence versus general susceptibility to psychiatric disorders. Continue to identify genes in human and animal studies, as well as identify pleiotrophic and epistatic effects. Determine whether QTLs and genes found in animals are similar to those identified in human studies. Determine if gene expression studies in animals parallel any findings in humans.

2. Better characterize relevant phenotypes of alcohol use disorders in humans and animals using well-thought-out strategies. Identify phenotypes that translate between humans and animals.

3. Identify the most important environmental factors in humans and animals. Identify or develop instruments that can survey environmental factors in humans. Explore the effects of early life experiences and rearing environments in animals or phenotypic and gene expression.

4. Add environmental measures to existing genetic studies where genotyping already has been accomplished. Add genotyping to particularly informative studies where there are also efforts to characterize the environment. Determine how GxE can be indexed in treatment studies and normal "aging out" of drinking. Determine what interactions are optimal for recovery from alcohol use disorders.

5. Determine how development interacts with GxE in humans and animals. Assess GxE interactions during specific developmental periods, such as prenatal, early post-natal, and up to early adulthood. "Environment" may include early exposure to alcohol, nicotine, and other drugs.

6. Develop a roadmap for studies in GxE that would address issues such as design and development of relevant mathematical methods to detect effects, so GxE interactions can be correctly identified and assessed.

Discussion. Dr. Edenberg suggested adding (in item 4) environmental measures to genetic studies and equally emphasizing genetics and environment. He also noted the need to adjust the consensus statement to reflect the field's readiness to develop cross-references in ongoing studies. Proposed studies should be encouraged to consider both components.

Concurrence. The Council voted unanimously to accept the EAB report on GxE interactions.

Addressing Underage Drinking as a Developmental Disorder

Vivian Faden, Ph.D., Deputy Director, Division of Epidemiology and Prevention Research, NIAAA, described the developmental approach of NIAAA's underage drinking initiative and of the team, which acknowledged multiple developmental streams-physical, biological, cognitive, psychosocial, emotional-involved in this complicated, persistent problem among adolescents. The team's goal is to interdigitate the developmental streams in a comprehensive, developmental, multidisciplinary way to look at risk and protective factors.

Dr. Faden discussed the phenomenon of underage drinking, noting that multiple surveys find that alcohol is by far the drug of choice among adolescents and that the opportunistic way they drink is important. Adults over age 25 drink more often than youth, but youth ages 12-17 drink more (at binge levels) per occasion. Monitoring the Future data for 1975-2002 show diminished use with a higher legal drinking age, but in the early 1990s, a plateau was reached. This has motivated a new approach to underage drinking that relates to the consequences of drinking.

Direct consequences of drinking for youth include 5,000 deaths per year among youth under age 21; physical and sexual assaults, unwanted/unintended sexual activities, and sexual risk taking; altered academic and vocational trajectories; and possible adverse effects on the developing brain. Second-hand consequences include traffic fatalities involving drivers under age 21, with half of the victims someone other than the driver; among college students under age 21, 50,000 experience alcohol-related date rape and 430,000 are injured by a drinking student. Information on second-hand effects has not been collected systematically from younger drinkers. People who report starting to drink before age 15 are four times more likely to report symptoms of alcohol dependence during their lives, regardless of family history. Prevalence of alcohol dependence is highest among young people. Age 15 to 25 is the peak time for alcohol dependence.

Dr. Mark Goldman, Associate Director, NIAAA, described the challenge of merging the notion of development with the problems of adolescent drinking. Many studies have focused on frequency and quantity without attention to the function of adolescence, which is the period to make the difficult transition from childhood, when all decisions are made for children, to adult status, when individuals must make their own life decisions. Crossing this bridge involves interwoven transitions in multiple domains, including school, social, and biological; development of self-regulation of emotions and behavior; body systems restructure; and changes in number, types, and connectivity of brain cells.

Dr. Goldman described activities of the team on underage drinking, which first consisted of NIAAA staff, who compiled a briefing on existing knowledge in relevant areas; convened a small meeting with advisory experts on adolescence; created a steering committee of major scientists in the field, plus other experts; and then added more experts. The team created a briefing book on the relevant issues, held a conference in March 2005 of the steering committee and extended experts, and established three working groups to address specific age groups and discuss cross-cutting development processes. In November 2005, the groups will meet and report with recommendations for a paradigm shift.

Projects underway include RFAs aimed at engaging large-scale academic health centers to deal with adolescents and alcohol use. The Rapid Response to College Drinking Problems also is underway, as are a collaboration with NIDA on the consequences of drug abuse and alcohol exposure on brain and behavior, several other initiatives, and an update to the briefing book.

Research priorities based on emerging themes include understanding the interplay between biological and psychosocial developmental pathways and drinking onset and trajectories, determining alcohol's effects on the developing brain, determining the architecture of adolescent drinking problems, refining the DSM-IV diagnosis of alcohol dependence for youth, and fostering developmentally tailored interventions. Dr. Goldman emphasized that particularly in adolescents, the line blurs between prevention and treatment, related to the lifetime trajectory, and asserted that more thought is needed about the dynamism of adolescence.

Discussion. Dr. Mitchell requested clarification of normative risk-taking and nonnormative use of alcohol by adolescents. Dr. Goldman described the complex interplay between high-risk developmental processes and the chance encounters and momentary circumstances that lead to adverse outcomes. He noted that developmentalists discuss the notion of "scaffolding," or creating social and other structures that protect against adverse outcomes but do not remove risk-taking. Dr. Faden suggested the need to create a shift in the normative early onset of drinking. Dr. Li added that the question relates to the issue of quantity and frequency, and whether risk-taking behavioral leads to binge drinking. Dr. Mitchell noted the need to define the goal of dealing with underage drinking-to eliminate it or to reduce harm and adverse outcomes-and to avoid sending the mixed message that risk-taking is normative adolescent behavior but that adolescent drinking should be deterred. Dr. Faden acknowledged the difficulty of the contradictory message and asserted the importance of protective measures to avoid adverse consequences. Dr. Edenberg pointed out that children and adolescents are not skilled at recognizing when they are approaching harm and suggested developing a self-questionnaire to help educate young people to recognize impending problems. Dr. Goldman acknowledged the usefulness of such a tool.


Revised Guidelines for Alcohol Administration

Judge Linda Chezem, Assistant to the Director, NIAAA, and Chair, Council Working Group on Guidelines for Alcohol Administration, submitted a draft recommendation to Council for revised guidelines on alcohol administration in experimental settings. The proposed changes in guidelines reflect great growth in evidence-based knowledge about alcohol. The group considered the science in tandem with ethical standards. The working group added a glossary, addressed changes in Federal confidentiality requirements by referral to online NIH publications, and adopted a uniform approach to issues that may involve legal determinations by placing the responsibility of ensuring compliance with local jurisdictions and states with the investigator and the IRB. The working group revised the organization of the guidelines for ease of use and strengthened the section on treatment by encouraging direct referral. Dr. Chezem stated that the working group created what is hoped to be a living document that encourages and supports, rather than limits, research.

Discussion. Dr. Hesselbrock questioned whether the working group considered various routes of administration. Judge Chezem responded that the discussion and broad guidelines were not limited just to oral administration. Dr. Taylor stated that the intent was to present starting requirements for any alcohol administration study, with the understanding that as risks rose, investigators would add additional measures to protect subjects and not encumber everyone with a restrictive set of guidelines.

Dr. Mitchell asked for clarification of the provision on administering alcohol to underage subjects. Dr. Chezem noted that several states allow the administration of alcohol to research subjects below age 21. Dr. Taylor suggested adding a footnote to the guidelines document regarding legal drinking age. Dr. Willenbring raised the issue of potential for coercion into treatment. Dr. Warren noted that the language on that subject has not changed since 1989; efforts are made to facilitate recovery for subjects; and all individuals have the right to decline.

Adoption. Members of the council voted unanimously to adopt the revised guidelines on alcohol administration with the recommended modifications.

NIDDK Research Agenda: Shared Interests with NIAAA

Dr. Allen Spiegel, Director, National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK), described his Institute's research agenda as it intersects with NIAAA's interests. He noted that NIDDK's current $1.7 billion budget comes with a congressional mandate to conduct and support research, training, health information dissemination, and other programs with respect to diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematological diseases. He noted that NIDDK has responsibility for chronic, debilitating illnesses, many of which are rising in incidence, and described the Institute's organizational structure. Its Division of Nutritional Research coordinates nutritional activities across Institutes and Departments and is an area of interface with NIAAA. NIDDK is involved across the spectrum of health problems and disease with fundamental, basic research, epidemiologic research, genetics, molecular biology, identification of risk factors, clinical trials, mechanisms and influences, determining effectiveness in community and clinical settings, and then dissemination to national education programs. The Institute's programs attempt to put into practice the outcomes of NIH-sponsored research.

Dr. Spiegel noted a tremendous increase in information about biochemistry and intermediary metabolism at all levels, including the physiology-integrated level. The adipose (fat) cell synthesizes fatty acids and stores and breaks down fat. Fat cells secrete hormones, one of which, leptin, is involved at the hypothalamic level in reproduction. Obesity is now understood as an inflammatory state that involves substances secreted by fat cells as well as white blood cells brought into fat in conditions of fat abundance; this mechanism may underlie cardiovascular involvement, atherosclerosis, and insulin resistance.

Regarding the adverse consequences of obesity, a meeting of the obesity task force is scheduled to explore differences in mortality associated with obesity between two recent CDC studies reported in JAMA. Drs. Breslow and Smothers have found that small alcohol amounts are not incriminated with increasing body mass index, although heavy drinking with less frequency is correlated. The epidemic of obesity has increased, according to the body mass index of height and weight, an admittedly imperfect, population-based measure. NHANES data show substantial increases in obesity in population groups in both genders; while the difference for non-Hispanic white children is not significant, non-Hispanic black and Mexican American children show significant differences between 1988-1994 and 1999-2000. Dr. Spiegel discussed the implications of promoting the themes of health literacy and personal responsibility, noting that fresh foods are more expensive and difficult to obtain than high-calorie, less nutritive foods.

Dr. Spiegel stated that extraordinary health consequences relate to obesity, which led the obesity task force to create a strategic plan for NIH obesity research (www.obesityresearch.nih.gov). In a discussion of medical complications of obesity, he noted that visceral fat is particularly dangerous and that waist circumference is important. He noted that cannabinoid receptors have become good medication targets with importance for appetite and tobacco smoking control, and that they also have peripheral effects in the liver. Dr. Spiegel noted that alcohol is one cause of pancreatitis and that increased obesity has been accompanied by increased incidence of nonalcoholic fatty liver disease. There appear to be final common pathways that blend alcoholic as well as nonalcoholic fatty liver disease, and NIDDK is studying people who are obese and who drink, an important shared interest with NIAAA.

NIDDK's Liver Disease Branch has spearheaded an action plan for liver disease research that involved input from the community at large. Liver disease as a cause of death ranks twelfth nationally overall, which may be an underestimate, and considerably higher for ages 35-64 and among Native Americans. In FY2003 NIDDK supported 39 percent of total NIH liver research; NIAAA supported 9 percent. Benchmark goals in the action plan will be monitored for effectiveness. Goals with greatest relevance to NIAAA include therapy for nonalcoholic and alcoholic liver disease, noninvasive markers for hepatic fibrosis, tests to screen for early detection of primary liver cancer, improved living donor liver transplantation, standardized nomenclature and grading systems, and reduced overall mortality from chronic liver disease.

Discussion. Dr. Tabakoff suggested that NIDDK and NIAAA form partnerships related to, for example, coordinated tissue collection. Dr. Spiegel described an approach of ancillary studies to clinical trials by the general investigative community in selected cohorts, recognizing the tension of principal investigators and clinical trials groups with a sense of ownership, and balancing that with the need to enlarge opportunities to the general investigative community, which NIDDK has undertaken with diabetes and obesity cohorts. He stated that he will review for possible opportunities three ongoing networks related to treatment with interferon for hepatitis C, which co-exists with alcohol problems; a study of African Americans with viral hepatitis C; and a network for nonalcoholic steatohepatitis. He cited the need to collect data on alcohol.

NIAAA Strategic Plan: The Next Five Years

Dr. Kenneth Warren reported that NIAAA is developing its FY2006-2010 strategic plan, which defines opportunities that relate to specific achievable priorities. The new plan will be dynamic, to reflect new knowledge and new technologies, and will be used as a foundation for develop annual plans that contribute to congressional justification. Input comes from the EAB, the external scientific community (for example, the Research Priorities Committee of the Research Society of Alcoholism), an assessment of the outcomes and achievements of the previous plan, GRPA goals, and trans-NIH opportunities (for example, Roadmap and Neuroscience Blueprint). NIAAA staff have documented progress made on the 2001-2005 plan. Many overarching goals in the 2001-2005 strategic plan have remained priority research issues for NIAAA and have become the focus of NIAAA's current transdisciplinary research teams. Each team has been assessing scientific opportunities and NIAAA's research portfolio; three reports to date have been presented to the EAB; and two reports have been presented to the Council. Two infrastructure teams, Training and Centers and Technology and Analysis, will contribute to the strategic plan. Research divisions also have been actively engaged in planning activities. NIAAA will seek input from broader constituencies and hopes to develop a website to allow review of the input.

Discussion. Dr. Warren stated that the target date for the draft plan is September 2005. All EAB reviews will not have been completed by that time, so the plan will reflect best judgments and will be modified as the EAB reports are issued. Dr. Hoek suggested that distributing the outcome analysis of the 2001-2005 plan would be helpful to Council and the research community.

Presentation of Council Operating Procedures

Dr. Karen P. Peterson, Executive Secretary, National Advisory Council on Alcohol Abuse and Alcoholism, presented draft recommendations for changes to operating procedures related to compliance with NIH provisions on cost commitment procedures and to an adjustment in percentile and priority scores for expedited en block concurrence for grant applications to reflect an adjustment in the payline.

Concurrence. The Council voted unanimously to accept the changes to the Council Operating Procedures.

Consideration of the February 2005 Minutes and Future Meeting Dates

The Council unanimously accepted the minutes, as submitted, of the Council meeting held on February 2-3, 2005. Dr. Peterson advised that the next Council meeting will take place on September 14-15, 2005, in Rockville, Maryland.

Ex-officio Member and Liaison Representative Reports

CDR Little noted that DOD has provided input to the Interagency Coordinating Committee on Underage Drinking about the armed services' prevention activities and resources allocated in order to support the committee's interim report to Congress, engaged in dialogue with NIAAA staff on the Department of Justice's Enforcing Underage Drinking Laws (EUDL) initiative to assess possibilities for collaboration, engaged aggressively in three demonstration projects to support healthy behavior initiatives on tobacco cessation, weight management, and Web-based alcohol prevention education. In the near future a permanent ex officio Council member will be assigned. Dr. Li noted that the new clinician's guide should be of interest to DOD.

Public Comment

Time was set aside for public comment, but no members of the public made presentations.

Adjournment

Dr. Li adjourned the meeting at 2:25 p.m.

CERTIFICATION

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


/s/

Ting-Kai Li, M.D.
Director
National Institute on Alcohol Abuse and Alcoholism
and
Chairperson
National Advisory Council on Alcohol Abuse and Alcoholism

/s/

Karen P. Peterson, Ph.D.
Chief, Research Policy and Special Programs Branch
Office of Scientific Affairs
and
Executive Secretary
National Advisory Council on Alcohol Abuse and Alcoholism


Updated: August 2005

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