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National Advisory Council Meeting - June 10-11, 2009
Summary of the 121th Meeting
June 10-11, 2009
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 121st meeting at 5:30 p.m. on June 10, 2009, at the Fishers Lane Conference Center in Rockville, Maryland, in a closed session. Dr. Abraham Bautista presided over the closed review of grant applications and consideration of MERIT Award nominations. Dr. Kenneth Warren, Acting Director, NIAAA, presided over the Council’s open session on June 11, 2009. In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the session on June 10, 2009, was closed to the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds.
Council Members Present:
Michael E. Charness, M.D.
David W. Crabb, M.D.
Gen. Arthur T. Dean
Cindy L. Ehlers, Ph.D.
Scott L. Friedman, M.D.
R. Adron Harris, Ph.D.
Deborah S. Hasin, Ph.D.
Andrew C. Heath, D.Phil.
John H. Krystal, M.D.
Peter M. Monti, Ph.D.
Edward P. Riley, Ph.D.
Linda P. Spear, Ph.D.
Ex-officio: John P. Allen, Ph.D., M.P.A.
Chairperson: Kenneth R. Warren, Ph.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Vivian B. Faden, Ph.D., Ralph W. Hingson, Sc.D., M.P.H., Mark Willenbring, M.D., Robin Kawazoe
Other Attendees on June 11, 2009
Approximately 75 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, June 10, 2009
Dr. Abraham Bautista called the closed session of the 121st meeting of the Council to order at 5:30 p.m. on Wednesday, June 10, 2009, for consideration of grant applications. He 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. Council members then considered nominations for the MERIT Award. The closed session adjourned at 6:55 p.m.
Call to Order and Introductions, June 11, 2009
Dr. Kenneth Warren called the open session to order on June 11, 2009, at 9:00 a.m. and welcomed participants. He reported that Drs. Kishore, Klassen, and Professor Palmer were unable to attend the meeting. Council members and NIAAA senior staff introduced themselves.
Dr. Warren noted that all NIAAA Director’s Reports are accessible on NIAAA’s Web site, and he highlighted recent Institute activities:
American Recovery and Reinvestment Act of 2009: Impact of Economic Stimulus on NIH
Sally Rockey, Ph.D., Acting Deputy Director for Extramural Research, NIH, stated that ARRA will help NIH to advance biomedical research. NIH received $10 billion directly in ARRA funds, of which $8.2 billion was allocated for extramural scientific research; $1 billion for extramural repair, improvements, and construction; $500 million for intramural repair, improvements, and construction; and $300 million for extramural scientific equipment. NIH also received $400 million for comparative effectiveness research via the Agency for Healthcare Research and Quality.
To expand the science, NIH will fund current grantees to take existing projects in new directions and will fund NIH-wide and programs specific to NIH Institutes and Centers (IC). Most ARRA funds are to be obligated by September 2009. New NIH-wide opportunities include Challenge Grants to be awarded to about 500 grantees at $500,000 for each of 2 years. NIH has received more than 20,000 applications for a broad range of activities, with most related to enabling technologies and translational research; about 3% of the applications are expected to be funded. Dr. Rockey asserted that the extraordinary response reflects untapped capacity and potential in the scientific community to put forth creative ideas. Ideas and advances will emerge in the future, and infrastructure needs must be addressed in order to support them. NIH has received more than 2,000 applications for Grand Opportunities (GO) Grants totaling at least $200 million. GO grants will fund projects with high impact that are well defined, large in scale, and require more than $500,000 yearly. ARRA funds also support summer research jobs for students and teachers through supplementing existing grants to allow grantees, principal investigators, and NIH laboratories to hire summer students. The goal is to build a pipeline to encourage research careers. Approximately $35 million will fund about 4,000 jobs over the summers of 2009 and 2010, and NIH is considering how to continue the program into the future. Academic institutions have experienced the economic slowdown, and ARRA funding will promote hiring of 100–200 faculty members to initiate pilot programs in biomedical research, particularly bioethics.
IC-specific programs include $30 million in grants to be awarded by the National Institute of Mental Health for strategic autism research. In addition, ARRA funds permitted raising the eligibility limit for Academic Research Enhancement Awards (AREA), a provision anticipated to attract U.S. institutions to apply for these funds. Dr. Rockey described a variety of other programs to be facilitated by ARRA funds, including dissertation support and small business supports, and she noted that construction awards will be made in FY2010 due to the prior extensive review process required.
The Office of the NIH Director has allocated $509.5 million of the $800 million in ARRA funds, and $290.9 million remains unallocated in anticipation of confirmation of a new NIH Director. The Common Fund will receive $120 million, and ARRA will fund additional New Innovator Grants for young investigators.
Dr. Rockey noted that extraordinary accountability and reporting responsibilities attach to the ARRA funds. Each grant and supplement is reported as a separate grant, and recipients must report quarterly on jobs and expenditures. In addition to posting on www.usaspending.gov , reports will appear on the Web sites www.recovery.gov/?q=node/579 and www.federalreporting.gov , and NIH will provide further reporting guidance as it emerges. NIH will report on ARRA’s economic and employment effects and the scientific accomplishments the funding promotes. NIH currently is developing processes to track these successes.
Discussion: Dr. Cindy Ehlers asked how NIH will accommodate the 97% of unsuccessful Challenge Grant applications that eventually will be resubmitted. Dr. Rockey responded that NIH’s peer review process can accommodate that volume and that strategizing with the extramural community and modeling are underway to manage resubmissions. Impacts on the success rate and base funding remain uncertain. In response to a question from Dr. Scott Friedman, Dr. Rockey noted that Council members and funded scientists might thank Congress for its support and emphasize to decision makers the untapped potential demonstrated by the response to ARRA. In response to a question from Dr. Ehlers, Dr. Warren responded that NIAAA received 418 applications for Challenge Grants and that NIAAA participated in all ARRA-related RFAs. Dr. Bautista stated that 30 GO applications and 16 applications for P30 faculty-hiring awards have been received. Dr. Warren pointed out that proposed projects exceed resources for every program, which will lead inevitably to low success rates.
NIH Scientific Management and Review Board Deliberations: An Overview
Dr. Warren explained that the Scientific Management and Review Board (SMRB) has its roots in an Institute of Medicine (IOM) study requested by Congress, to make recommendations on NIH’s organization and function. In the 2003 report, the IOM suggested potential areas for restructuring including potential mergers and eliminations. Among the recommendations for consideration was the potential reincorporation of the National Human Genome Institute into the National Institute of General Medical Sciences; the potential merger of NIAAA and the National Institute on Drug Abuse (NIDA); and organizational changes related to the intramural program and the Clinical Center. In 2006, Congress incorporated a number of IOM recommendations into the NIH Reform Act, including the IOM recommendation for NIH to create and charter the SMRB. Congress required the SMRB to determine whether and to what extent organizational authorities should be used, and to issue a report not less frequently than every 7 years with recommendations regarding use of the authorities and the underlying reasons for them.
SMRB’s members were appointed during 2008-2009 and the first meeting convened in April 2009. Set by the NIH Director’s Office, the agenda included management, organization, and integration issues regarding the NIH Intramural Program and NIH Clinical Center, and the proposed merger of NIAAA and NIDA. NIH Acting Deputy Director, Dr. Lawrence Tabak, NIDA Director Dr. Nora Volkow, and Dr. Warren made presentations, and eight individuals made public comments on the merger including several NIAAA Council members. Active discussion ensued on both agenda issues, and at its conclusion, members voted to form three workgroups: Deliberating Organizational Change Workgroup to draft overarching principles of organization and criteria for contemplating change, including development of principles for an optimal design of a biomedical research enterprise; Substance Use, Abuse, and Addiction (SUAA) Workgroup, to consider whether changes within NIH could further optimize research into substance use, abuse, and addiction; and Clinical Center/Intramural Research Workgroup, to consider whether any changes can optimize opportunities available in a central research program at NIH. Dr. Warren noted that when contemplating specific changes in the organization of NIH, the SMRB must consult with IC Directors and NIH scientific leaders not on the SMRB, IC Advisory Councils, external scientific organizations, and patient organizations.
Next SMRB steps include (1) workgroup set-up (in progress), (2) three teleconferences during summer 2009, (3) SMRB meetings in winter and spring 2009–10, (4) NIAAA to propose subject matter experts as potential consultants to the SUAA Workgroup, and (5) NIAAA to compile briefing materials on both the state of the science of the alcohol field and the NIAAA portfolio for the SUAA Workgroup. Dr. Warren noted the SMRB’s Web page, http://smrb.od.nih.gov.
Discussion: Dr. John Krystal inquired about the choice of terminology: substance abuse versus alcohol and drug abuse. Dr. Warren indicated that this could indicate consideration of research areas broader than just alcohol and drugs, possibly to include food. In response to another question he noted that all of the public comments made at the SMRB meeting were in opposition to a merger but that written correspondence has been received from others favoring a merger. In response to another question, Dr. Warren noted that the charge emerging from the SMRB discussion for the SUAA was broader than merger only and could involve options to enhance research in these areas without a merger. In this context, he observed that both the National Cancer Institute and the National Heart Lung and Blood Institute have major tobacco related research programs and therefore also have an interest in addiction research. Dr. Deborah Hasin inquired about the focus of Dr. Volkow’s presentation. Dr. Warren noted that both he and Dr. Volkow limited their presentations to descriptions of their respective Institute’s programs. However, Dr. Michael Charness added that in his opening remarks former NIH Director Elias Zerhouni supported the idea of a merger, and in response to a question from NIH Acting Director Dr. Reynard Kington, Dr. Volkow expressed support for a merger. Dr. Warren noted that in response to a similar question asked of him by Dr. Kington following Dr. Warren’s presentation, he replied that in areas of common interest benefits could be achieved through enhanced collaboration without a merger.
Extramural Advisory Board Report: Gut-Liver-Brain Interactions in Alcohol-Induced Pathogenesis
Fulton T. Crews, Ph.D., Director, Bowles Center for Alcohol Studies, University of North Carolina–Chapel Hill, and Chair, NIAAA Extramural Advisory Board (EAB), presented the EAB’s portfolio recommendations regarding gut-liver-brain interactions in alcohol-induced pathogenesis, the results of a February 2009 meeting. Dr. Crews stated that the Board’s review covered the interactions of alcohol metabolism, energy homeostasis, endocannabinoids, lipopolysaccharides, immune system, circadian rhythms, and hepatic encephalopathy. He presented a brief overview to the Council of the science underpinning the EAB’s recommendations based on a scholarly paper developed by NIAAA’s Division of Metabolism and Health Effects. The EAB made the following recommendations:
- Legislation, budget, and policy. President Barack Obama signed the FY 2009 American Recovery and Reinvestment Act (ARRA) on February 17, 2009. Appropriations for the NIAAA conference allowance, signed on March 12 for FY 2009, amount to $450.2 million, a 2.7% increase over the previous year, in addition to an ARRA allocation of about $114 million over 2 years. The FY 2010 President’s budget request reflects support for young researchers early in their careers and for high-risk/high-return research. The President’s FY 2010 budget request for NIAAA ‘s conference allowance is $455.1 million, a slight increase over FY 2009 levels. Under the proposed budget, NIAAA expects to fund approximately 196 competing research grants and 537 noncompeting grants. NIAAA also would provide support to 19 alcohol research centers ($28.2 million) and fund 98 research career awards ($14.3 million). A 1% increase in funding over base FY 2009 levels for research training would support 301 pre- and post-doctoral researchers.
- Director’s activities. Dr. Warren noted that his presentation to the Scientific Management Review Board on April 28 is available on the NIH Web site.
- Honors. NIAAA’s online training “Video Cases: Helping People Who Drink Too Much” won first place in the Gold Screen competition of the National Association of Government Communicators in the instructional training webinar category, two Hermes Creative Awards from the Association of Marketing and Communication Professionals, and the NIH Plain Language Gold Award. More than 16,000 physicians and nurses have earned continuing education credits by accessing the program through MedScape. Dr. Warren commended Dr. Mark Willenbring for his role in the video. He noted also that NIAAA’s Dr. John Matochik and other members of the NIH Blueprint Initiative won the Excellence.gov Best Overall Award from the American Council for Technology and Industry Advisory Council. Dr. Bridget Grant received the Archibald Award and gave the Archibald Lecture at Toronto’s Center on Addictions and Mental Health. Mark A. Schuckit, M.D., is the first recipient of NIAAA’s new honorary lecture series to highlight clinical/human research, initiated as a tribute to the late Jack Mendelson.
- NIAAA staff and organization. Dr. Warren announced that new appointments to NIAAA include Jonathan Folkers as NIAAA Chief Information Officer; Ranga Srinivas, Ph.D., as Chief, Extramural Project Review Branch; Donna Casady as Budget Officer and Chief, Financial Management Branch, Office of Resource Management; Keith Lamirande as NIAAA Deputy Executive Officer; Gary J. Murray, Ph.D., as a program director in the Division of Metabolism and Health Effects; Abbas Parsian, Ph.D., as a program director in the Division of Neuroscience and Behavior; Matthew Reilly, Ph.D., as a project officer in the same Division; Daniel E. Falk, Ph.D., as a health scientist administrator in the Division of Treatment and Recovery Research; Jo-Ann Melton Kriebel as a writer/editor in the Communications and Public Liaison Branch; and Richard Rippe, Ph.D., as a scientific review officer in the Extramural Program Review Branch. Dr. Warren announced that Ms. Alesia Wilbur, Dr. Rui Costa, and Dr. Douglas Osei-Hyiaman left NIAAA for other positions.
- Multimedia products from NIAAA. NIAAA has launched a new Rethinking Drinking Web site and booklet that present practical, evidence-based information on low-risk drinking limits, symptoms of an alcohol use disorder, and strategies for cutting back or quitting. A two-volume series of NIAAA’s Alcohol Research & Health journal focuses on alcohol and neuroscience. The latest issue of Alcohol Alert addresses how alcohol changes the brain and how those changes influence behavior.
Outreach. The Friends of NIAAA Coalition sponsored a congressional briefing in May 2009 on alcohol and pregnancy.
There is evidence that moderate alcohol consumption has health benefits, whereas high consumption is harmful. Therefore, various doses and patterns of ethanol exposure, with full attention to critical biphasic effects of ethanol, need to be studied. It is important to understand the influence of critical multivariate interactions on the beneficial and pathologic effects of alcohol on liver, gut, and brain. It is important to study the pattern of alcohol consumption, with particular emphasis on critical biphasic dose effects of ethanol. Full dose response and time courses that cover quantity and frequency of drinking ranges need to be understood. Critical variables, such as quantity x frequency x duration x temporal pattern x gender x genetics x nutrition x exercise/life style x medications (e.g., statins, antidepressants) x age x circadian rhythms, and their interaction, should be considered.
Characterize endocrine, paracrine, and other signaling molecules to study interactions of multiple organ systems—liver-gut-brain (including blood brain barrier) -adipocyte-immune systems—with an eye towards therapies. Examples include modulators of endocannabinoid systems, cytokines, and peptides involved in energy homeostasis. Study innate immune mediators that contribute to brain, liver, and other system pathology, including neuroprotection and how ethanol and its metabolites alter these systems.
Measure alcohol metabolism and metabolites, and how changes in levels of metabolites affect flux through key systems and redox states in different tissues. Investigations should include effects of alcohol dose, time, gender, and genetic variation. Understand the role of acetate production and metabolism in brain, liver, and other tissues. Investigate the pharmacology of acetate, lactate, and other ethanol-induced metabolic changes. Analyses should include effects of key metabolites (acetate, lactate, others) on different systems (brain, gut, liver, endocrine) and on behavior.
Explore the effects of alcohol on the biome, small intestine/colon/gut permeability, liver clearance, and activation of the immune system via gut-permeable factors. Conduct multilevel basic and clinical studies of the relationship of the biome to human alcoholic disease. Explore the contribution of biome alterations in acute and chronic disease development.
Collect and accumulate biosamples as part of ongoing or new studies, including DNA, RNA, protein, and gut biome, to allow biobanking and eventual analyses. Utilize metabolomics, genomics, and proteomics to study the interactions of organ systems leading to alcoholic liver and brain disease across the course of illness and the lifespan.
Explore bidirectional interactions among obesity/metabolic syndrome and alcoholism, alcohol metabolism, and alcoholic toxicity to brain and liver. Studies should include both moderate (possibly beneficial) and heavy alcohol consumption.
Investigate the course and progression of alcoholic brain and liver disease to better inform the development of experimental models, including a focus on minimal hepatic encephalopathy. Explore collaborative mechanisms to bring together researchers in the areas of liver, brain, gut, immune, endocrine, and other relevant systems.
- Investigate how alcohol acts on physiological barriers and their role in mediating interactions among various organs. The barriers include the blood-brain barrier, blood-CSF barrier, and gut barrier. Are there common elements to dysregulation or disruption of these protective barriers?
- There is evidence that moderate alcohol consumption has health benefits, whereas high consumption is harmful. Therefore, various doses and patterns of ethanol exposure, with full attention to critical biphasic effects of ethanol, need to be studied. It is important to understand the influence of critical multivariate interactions on the beneficial and pathologic effects of alcohol on liver, gut, and brain. It is important to study the pattern of alcohol consumption, with particular emphasis on critical biphasic dose effects of ethanol. Full dose response and time courses that cover quantity and frequency of drinking ranges need to be understood. Critical variables, such as quantity x frequency x duration x temporal pattern x gender x genetics x nutrition x exercise/life style x medications (e.g., statins, antidepressants) x age x circadian rhythms, and their interaction, should be considered.
Discussion: In response to a question from Dr. Hasin, Dr. Warren stated that the next EAB meeting is likely to be scheduled for February 2010.
Concurrence: The National Advisory Council concurred unanimously with the EAB recommendations.
Presentation of Council Operating Procedures
Dr. Warren described NIAAA’s “Operating Procedures for Institute Staff Actions for Administrative Supplements and Time Extensions,” which identifies procedures that would apply to projects following approval by the Council and award of funds. The parameters involve, among other topics, reasons for which adjustments may be made to awards and circumstances that require reporting to the Council. The document presented for concurrence by Council members reintroduced expedited review, a process whereby NIAAA designates a specific individual to speak for the Council regarding applications that fit specific pre-designated criteria, in this case necessitated by the increased volume of applications for ARRA funding. Dr. Bautista summarized the proposed operating procedures.
Discussion: Dr. Warren explained that no GO grant of more than $1 million in total direct cost will be awarded without Council discussion. Legal counsel has advised that more than one designated individual constitutes a subcommittee, which the Council is not authorized to form for the purpose of making a grant. Dr. Warren will send a memo to Council members on the designation of both an individual and an alternate. Concurrence for the expedited review provision would apply solely to the current round of grants.
Concurrence: The National Advisory Council unanimously concurred with the “Council Operating Procedures.” (Attached in appendix A).
Consideration of the February 2009 Minutes and Future Meeting Dates
Council members voted unanimously to approve the minutes of the Council meeting of February 4–5, 2009. Upcoming Council meetings will take place on September 16–17, 2009; February 3–4, 2010, June 9–10, 2010, September 22–23, 2010; February 16–17, 2011; June 8–9, 2011; and September 15–16, 2011.
Fetal Alcohol Spectrum Disorders and the L1 Neural Cell Adhesion Molecule
Dr. Michael E. Charness, Professor and Faculty Associate Dean, Harvard Medical School, explained that fetal alcohol syndrome (FAS), recognized in Biblical descriptions, was described initially by Lemoine in 1968 in France and 5 years later in the United States. FAS—defined as the constellation of confirmed maternal alcohol exposure, minor facial abnormalities, prenatal and/or postnatal growth retardation, and deficient brain or dysmorphogenesis—has low prevalence in the United States, although it is higher elsewhere. Only about 1 in 1,000 live births has the full FAS, but elements of severe brain abnormalities with neurological and behavioral problems appear in as many as 1 per 100 live births, a constellation now referred to as fetal alcohol spectrum disorders (FASD), the most common non-genetic cause of mental retardation.
Dr. Charness stated that he recognized similarities in the pathology of FAS and a pediatric genetic disorder involving the cell adhesion molecule L1, which prompted the question of whether ethanol modifies the biological actions of L1 and whether that would explain the similar abnormalities. Dr. Charness stated that the L1 cell adhesion molecule is critical for development, is expressed throughout the life cycle, and is important in adult learning and memory. The molecule has a critical role in helping neurons migrate to the right destination in the developing nervous system, allows neural pathways to form by bringing cells together to form nuclei, allows axons to form discrete fascicles and maintain their path in the nervous system, and allows neurons to survive throughout the lifecycle.
Research has shown the following: (1) Ethanol potently and selectively inhibits cell adhesion mediated by the L1 cell adhesion molecule (as shown in L1-transfected mouse fibroblasts and rat neural cells). The dose response curve was similar in a number of different biological systems. (2) Alcohol effects on L1 are consistent with a specific ligand-receptor interaction, an unanticipated and relatively unique finding. The properties of alcohol molecular size, shape, and flexibility at key regions, and the absence of steric hindrance at the OH region, are important features in producing all-or-none effects. (3) The presence of a ligand-receptor interaction between alcohols and L1 predicts the discovery of ethanol antagonists. Many molecules that look like molecules active in blocking adhesion, but that have no action of their own, could block the effect of active molecules. Active molecules, called agonists, have a molecular structure similar to antagonists. (4) Molecules that antagonize ethanol inhibition of L1 adhesion also prevent ethanol-induced cell death and teratogenesis (birth defects) in mice. At day 8, a mouse embryo exposed to ethanol has statistically fewer paired segments, while an embryo cultured in the presence of octanol and ethanol reverses the effect of ethanol to stunt the embryo’s growth as well as reduces certain malformations of the embryo. (5) The peptides NAPVSIPQ (NAP) and SALLRSIPA (SAL), which prevent ethanol teratogenesis, also potently antagonize ethanol inhibition of L1 adhesion. Experiments demonstrated that the ability of NAP to block ethanol’s effect in birth defects depended on its ability to block ethanol effects on L1. NAP prevents ethanol-induced neural tube defects by promoting normal closure. (6) Alcohol agonists and antagonists directly photolabel critical regions of the L1 lg1-lg-4 domain. Photoligands act as agonists and antagonists in their ability to inhibit adhesion or to block the effects of ethanol on L1. Mass spectroscopy and homology modeling led to the hypothesis that alcohol inhibits cell adhesion by disrupting a molecular conformation (shepherd’s crook) that is favorable for one L1 molecule to bind to another. (7) The alcohol photolabel binding site is critical for L1 adhesion.
In the future, Dr. Charness hopes to develop a detailed model of the binding site that would permit computerized design and screening, on a much larger scale, of FDA-approved drugs, and perhaps novel drugs, that might be ethanol antagonists that could be helpful in preventing a number of toxic effects of ethanol both during development and in the adult nervous system.
Discussion: Dr. Friedman inquired how ethanol affects the critical components of this complex system. Dr. Charness responded that phosphorylation of L1 cytoplasmic domains is needed to make them sensitive to ethanol. The ability to turn on and off ethanol sensitivity under this condition offers clues to explain why, in population studies, some subjects are found to be genetically sensitive to ethanol while others are not. It is likely that there are genetic factors that determine whether women are more or less at risk to have babies with fetal alcohol spectrum disorders. Dr. Harris noted that the binding site (L1) must be precise and small changes in this site would affect alcohol binding. However, despite a change in the L1 binding site, ethanol still binds with a small change in potency. Dr. Charness indicated that they were pleased that the site was functional and were disappointed that the effect on ethanol binding to L1 was not greater. His team has started super-computer docking experiments to see if all of the molecules they had looked at before would dock in this region and the results were positive. Dr. Harris cautioned that the azido photoaffinity labeling can be misleading because it reacts with whatever is nearest to it at the time and it can react with other amino acid residues as well. Dr. Charness responded that the experiments employed titration assays with high concentrations of octanol and azibutanol. The binding achieved by both labels were the same as that which produced the biological effects. The two sites labeled were close to each other and functionally significant. Dr. Friedman asked if his group has characterized L1 in fetal alcohol syndrome. Dr Charness mentioned that they had not. In response to Dr. Willenbring’s question on the effects of butanol as an antagonist in the intact animal, Dr. Charness explained that his group has tested octanol and ethanol, but not butanol. The concentration of octanol that is effective in these assay systems is quite a bit lower than the concentrations that produce intoxication in other systems. Dr. Willenbring also asked about future clinical trials. Dr Charness replied that in terms of clinical trials the interesting agents are the peptides SAL and NAP which are also being tested now by industry for their potential utility in the treatment of Alzheimer’s disease. Dr. Charness also noted that it is risky to undertake clinical trials when pregnant women are involved. On the other hand, pregnant women sometimes arrive in emergency rooms severely intoxicated, and the risk of the drug might be less dangerous than the risk due to on-board alcohol. Finally, Dr. Charness confirmed for Dr. Krystal that in rodents, systemic administration of the SAL and NAP peptides to the mother is protective of the fetus and that the peptide does cross the placenta.
Rethinking Drinking Booklet and Web Site
Ms. Maureen Gardner, technical writer and editor, NIAAA, introduced Rethinking Drinking, the new NIAAA booklet designed originally as a handout to accompany the Clinician’s Guide and the highly interactive Web site (RethinkingDrinking.niaaa.nih.gov).The project’s major goals are to educate people as to how much alcohol is too much and to encourage and support people who drink too much in making a change. The products were a major team effort involving some 40 staff members, grantees, and contractors, as well as field tests with 80 at-risk drinkers. Ms. Gardner reported positive early reviews, particularly on the materials’ nonjudgmental quality, and solicited feedback from Council members.
NIAAA targeted the materials toward the 60 million U.S. adults who exceed low-risk drinking limits. According to NIAAA research, one in four has an alcohol use disorder and the rest are at increased risk. Many do not know that their drinking pattern puts them at risk. They tend to underestimate how much they drink and overestimate how much others drink. Many think the ability to “hold their liquor” is a good thing, whereas it puts them at risk. Careful recruiting and intensive audience research helped developers understand the views of people who need the information and thus to refine the materials’ messages, format, and graphics. The at-risk drinkers were at different readiness levels for change, and their disparate viewpoints, expressed in focus groups and in-depth interviews, were invaluable in accommodating the range of perspectives. One person noted, for example, that “daily” drinking patterns did not apply to him because he didn’t drink daily; the wording was changed to “on any single day.”
Ms. Gardner explained selected features of the Web site, which is divided into two sections: “How much is too much?” and “Thinking about a change?” A major objective is for visitors to check their drinking pattern, so they can receive feedback about the risk associated with their pattern and where their pattern fits compared with other U.S. adults. “What’s your pattern?” is the most popular Web page on the site, followed by the page with the signs of problem drinking. Other features include an interactive pros and cons worksheet for making a change; tips on cutting down on drinking; drinking tracker cards; and a unique cocktail content calculator. Ms. Gardner stated that the Boeing Industries Employee Assistance Program (EAP) has established a link from its Web site to the calculator, which serves as a backdoor into the NIAAA site. NIAAA plans to develop a widget to enable others to link Web pages to the calculator.
Both formats of Rethinking Drinking have been well received. Media represents both a key audience and an intermediary to the main audience, and press coverage has helped to generate 230,000 visitors to the Web site and 78,000 booklets ordered since March 2009. Bulk orders for the booklet have been placed by HMOs, clinics and hospitals, mental health and substance abuse services, community prevention programs, EAPs, high schools, colleges, medical schools, military organizations, faith-based organizations, justice system components, drug courts, and DUI rehabilitation courses. Although it is difficult to measure changes in drinking behavior as a result of the Rethinking Drinking Web site, grantees at the University of Missouri are developing a secure version of the Web site that will enable doctors to communicate with patients about their drinking, and the project will yield hard data. Moreover, focus testing revealed that both formats increased awareness of risks of heavy drinking, which is a precursor to behavior change. Ms. Gardner welcomed ideas for other partnerships.
Discussion: Dr. Hasin suggested the utility of using the materials as an intervention and testing their efficacy. She also noted that a YouTube presence might generate visits to the Web site. Dr. Friedman stated that Rethinking Drinking represents a good referral source for physicians. He suggested enlisting the alcoholic beverage industry to disseminate this information through their products and at bars and sporting events where people drink to excess. He also suggested adding a link for patients with liver disease and noted the need to inform drinkers that chronic alcohol use sensitizes them to Tylenol toxicity. Dr. Warren noted that issues related to pregnancy and medications appear on the Web site. Ms. Gardner responded to a question from Dr. Heath that while a link for underage drinkers offers good messages, adults are the target audience. She responded to Dr. Crabb that additional products might include materials to accommodate a lower-literacy audience and Spanish-language materials. Dr. Charness suggested adding supplemental data to the Web site to which primary care providers could refer patients with medical challenges and thus enhance and augment brief interventions. Dr. Krystal suggested adding an online drinking diary that might also yield anonymous data useful to NIAAA. Ms. Gardner noted that several countries have such programs, and Dr. Willenbring stated that www.stickk.com is based on contingency management of behavioral change. Dr. Harris suggested that the drink calculator and diary seem like natural iPhone apps. Dr. Judith Arroyo suggested convening investigators in NIAAA’s portfolio who do Web-based prevention and interventions on an expert panel. Dr. John Allen stated that he will consider how to incorporate the materials into veterans’ primary care services.
Time was allocated for public comment, but no one came forward to speak.
Dr. Warren adjourned the meeting at 1:06 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Kenneth R. Warren, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
National Advisory Council on Alcohol Abuse and Alcoholism
Abraham P. Bautista, Ph.D.
Office of Extramural Activities
National Advisory Council on Alcohol Abuse and Alcoholism
PROCEDURES FOR EXPEDITED EN BLOC CONCURRENCE FOR
The National Advisory Council on Alcohol Abuse and Alcoholism approved the following procedures and criteria for Expedited En Bloc Concurrence of grant applications assigned to the National Institute on Alcohol Abuse and Alcoholism (NIAAA).
A. Council members will be selected by the Chair of the Council to provide en bloc concurrence on behalf of the Council. One Council member will be assigned this concurrence responsibility for a group of applications limited by an individual Program Class Code (PCC, e.g., AN). A Council member may be assigned more than one PCC. An alternate Council member will be assigned this responsibility for applications within a PCC for which the primary assignee has a conflict of interest.
B. Applications eligible for expedited concurrence include the following mechanisms:
1) Mechanism: P30, R01, R21, R13, R15, R24,, R25, K (all), T32, R41, R42, R43, R44, RC1, RC2.
2) Percentile Score: 20.0 or better on old system; 30.0 or better on new system
3) Priority Score for non-percentiled applications: 150 or better on old system; 35 or better on new system for all applications, including RC1 or RC2
4) Maximum Direct Cost in any year: $500,000 ($1,000,000 on RC2)
5) Foreign Applications: exclude
6) Applications with a Human Subjects Concern, Animal Welfare Concern,
Unacceptable code for minorities, gender, or children are excluded.
C. The Council Executive Secretary will alert the Council member(s) with delegated responsibility for expedited concurrence when summary statements for eligible applications are available on the Electronic Council Book (ECB). Concurrently, all other members are alerted of this communication. The Delegated Council member is requested to respond with a recommendation to concur or not on the applications for which the member has responsibility. This should be communicated via e-mail, phone, or fax. All Council members are reminded that they may request that any application be brought to the Council for full discussion. To comply with the latter, all Council members are afforded a minimal period of two weeks to request full discussion on any application in any bloc.
D. When notifying Council of available summary statements, the Council Executive Secretary will provide the following information to the members: Application Number, Name of Principal Investigator, Project Title, and Percentile/Priority Score.
E. A report of the en bloc recommendations will be presented at each Council meeting.
F. Council may consider the parameters for expedited eligibility at any time, but no less than once a year.