National Advisory Council Meeting - February 6-7, 2008
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NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
Summary of the 117th Meeting
February 6-7, 2008
The National Advisory Council on Alcohol Abuse and Alcoholism convened for its 117th meeting at 5:30 p.m. on February 6, 2008, at the FishersLaneConferenceCenter in Rockville, Maryland, in a closed session, and again at 8:15 a.m. on February 7, also in closed session. The Council convened in open session at 9:00 a.m. on February 7. Dr. Tina Vanderveen presided over the closed review of grant applications on February 6. Dr. Ting-Kai Li, Director of the National Institute on Alcohol Abuse and Alcoholism, presided over the closed session on February 6; the closed session on February 7, at which the Board of Scientific Counselors’ June 2007 Report was presented; and the open session the same day.
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 February 6, 2007, 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.
Cheryl J. Stephens Cherpitel, M.P.H., Dr.P.H.
David W. Crabb, M.D.
Gen. Arthur T. Dean
Cindy L. Ehlers, Ph.D.
R. Adron Harris, Ph.D.
Deborah S. Hasin, Ph.D.
Victor M. Hesselbrock, Ph.D.
Joannes B. Hoek, Ph.D.
Lynell W. Klassen, M.D.
Mack C. Mitchell, Jr., M.D.
Peter M. Monti, Ph.D.
Ex-officio: Joyce Adkins, M.P.H, Ph.D.
Chairperson: Ting-Kai Li, M.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Senior Staff:
Ralph W. Hingson, Sc.D., M.P.H., Robin I. Kawazoe, 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 February 7, 2008
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 of the Closed Session, February 6, 2008
Dr. Tina Vanderveen called the closed session of the 117th meeting of the Council to order at 5:30 p.m. on Wednesday, February 6, 2007, for consideration of grant applications. She 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 7:00 p.m.
Review of the Scientific Director, February 6, 2008
In a session on February 6, 2008, closed to the public and to NIH/NIAAA staff, Dr. Joannes Hoek chaired the performance review of the NIAAA Scientific Director.
Board of Scientific Counselors, February 7, 2008
In a session closed to the public and NIH/NIAAA staff, Dr. George Michalopoulos chaired the review of the June 2007 meeting of the Board of Scientific Counselors.
Closed Session, February 7, 2008
The Council met in a closed session to complete consideration of a grant application.
Call to Order of the Open Session and Introductions, February 7, 2008
Dr. Ting-Kai Li called the open session to order on February 7, 2008, at 9:00 a.m. and welcomed participants. He announced the absences of Council members Dr. Hidekazu Tsukamoto and Dr. Vimal Kishore. Members of the Council, NIAAA staff, and audience introduced themselves.
NIH Peer Review
Lawrence Tabak, D.D.S., Ph.D., reported on the NIH peer review process and recommendations for change. He explained that NIH’s self-study of its peer review system, in partnership with the broad scientific community, aims to strengthen that system by addressing the challenges inherent in increasingly broad, complex, and interdisciplinary science. The charge is to fund the best science by the best scientists, with the least administrative burden.
A working group of the Advisory Committee to the Director (ACD) and a working group of the NIH Steering Committee have taken the lead in the study. The diagnostic phase, begun in July 2007 and completed in January 2008, elicited considerable direct input from a wide range of stakeholders, including individuals, professional societies, voluntary health organizations, patient advocacy groups, administrators of institutions of higher learning, members of NIH National Advisory Councils, and individuals selected to serve as scientific liaisons between the study working groups and the extramural community. A similar internal process at NIH involved an internal survey, collection of data from many internal NIH committees on previous peer review experiments, and a series of town hall meetings attended by NIH staff. The investigators synthesized the input, tabulated the data, analyzed how other domestic and international agencies deal with review and support of science, and have reported findings back to stakeholders.
Dr. Tabak articulated the core values of the peer review process: ensure preservation of the scientific competence of reviewers and the review process, and the fairness and integrity of the review process; ensure that proposed solutions address a specific challenge and must be testable in some format; and ensure funding of the best science, while recognizing that “best” depends on such factors as scientific quality, public health impact, and mission of the NIH Institute or Center. Themes include administrative burden, support for investigators at various stages of career development, review(er) quality, and strains on the system that supports research.
Regarding administrative burden, with too many applications in the system, low success rates for initial submissions “clog” the queue of applications. The percentage of R01-equivalent grants made for first submissions currently roughly equals the percentage of grants awarded for amended applications, a dramatic change since 1998 when awards were made overwhelmingly for initial applications. Study data also suggest that feedback to applicants is ambiguous, particularly for noncompetitive applications. Suggested solutions include pre-application review of first-time submissions to identify noncompetitive applications rapidly; applications limited to a single submission; administrative re-review for applications with correctable deficiencies; two-score system that indicates merit of the application as received and merit with all deficiencies corrected; and a checkbox to indicate “not recommended for resubmission.” Other administrative challenges include too many mechanisms, which leads to uncertainty and “gaming,” and too much time spent writing applications. Suggested solutions include collapsing mechanisms by scale, complexity, or points along a career pathway; shorten applications; assume greater risk by funding early-career investigators; and create a competitive Select NIH Investigator Award that recognizes extraordinary past accomplishment, features a shortened application, and requires a minimum commitment of 51 percent effort plus service on study section, if asked. Ideas to introduce new investigators into the system, as well as to provide increased stability for more established investigators, include funding a higher percentage of early-career investigators, creating NIH-wide mechanisms for shared resources for research associates/research assistant professors, and establishing a Select NIH Investigator Award.
Regarding review(er) quality, informants asserted that the current scoring system introduces false precision by the process; reviewers weight different elements of an application in an uneven manner; evaluation focuses on weaknesses; excessive emphasis is placed on methodology and preliminary data, with insufficient emphasis on impact and innovation; and emphasis is misplaced on mentoring applicants rather than reviewing scientific merit. Suggested solutions include making the scoring system scientifically defensible; employing a weighted scoring system to evaluate impact, innovation, research plan, investigator/environment, and service to science; scoring and then ranking iteratively, requiring that study section members remain until the process is complete; considering merit of the application only as written; and limiting applications to a single submission. The study also addressed the issues of lack of training and accountability for reviewers and study section chairs; whether peers make the best reviewers; too few people deciding applications’ fate; how to engage more people in the wisdom of the application; factual errors in summary statements that diminish review credibility; and review of amended applications by new reviewers, leading to new issues raised. Suggested solutions include providing meaningful reviewer training, rating reviewers’ reviews, adopting the editorial board model, linking reviewers to the full lifecycle of an application, and limiting applications to a single submission. Suggestions to counter the existence of insufficient incentives to serve on review panels include adding time to extant grants; making service more flexible; mandating service, if asked, but certainly as a condition of accepting highly meritorious awards; developing a cadre of select reviewers; and providing training to reviewers.
Strains on the system that supports research include finite resources coupled with the perception of excessive indirect costs and support redundancy, too many resources concentrated in the hands of too few investigators, and undervaluation of team science. Suggested solutions include imposing a minimum percentage effort for principal investigators and other key participants.
Dr. Tabak explained that the NIH Director will receive a set of recommendations by February 29, 2008, and implementation and analysis of the recommendations accepted by the Director to begin in March. Eventually a set of new NIH policies will emerge. The Web site http://enhancing-peer-review.nih.gov provides detailed information on the peer review process.
Discussion: Dr. Michalopoulos observed the need for firm criteria for selection of study section members that reflect the field’s complexities, the importance of the preservation of support for senior investigators, and the difficulty and cost of funding the best research. Dr. Mack Mitchell noted the excessive time spent in study section on unfundable applications in order to grant a fair hearing and suggested that an initial triage might improve efficiency and permit greater input on competitive grants. Dr. Tabak noted that many individuals focused comments on that issue, with some identifying ambiguity regarding a notice of “not recommended for resubmission.” Dr. Cindy Ehlers endorsed the editorial board approach and brought up the issue of assignment to the appropriate study section.
Dr. Li observed that editorial review involves mentorship, raising the question of how much responsibility for mentoring resides in the NIH review system and how much in grantee institutions. Dr. Tabak concurred that NIH must consider whether to continue the mentorship function at the NIH level. Dr. Michael Charness suggested that the editorial board format might help eliminate the false precision of study sections, address the issue of appropriate expertise for each grant, increase review efficiency by identifying applications with no hope of funding, and improve cost-effectiveness of the review process. Dr. Li asserted that the primary issues are securing adequate funding for research, at minimum to overcome inflation costs, and bringing some reviews back to the Institutes.
Director’s Report/Special Announcements
Referring to the published “Director’s Report,” Dr. Li highlighted the following Institute activities:
§ Legislation, budget, and policy. Since 1996, when Congress passed the Mental Health Parity Act, subsequent reauthorization bills have not incorporated provisions for parity for substance abuse, despite introduction of bills in both Houses. In December 2007 the President signed a consolidated appropriations act that increased NIAAA’s budget for FY 2008 by $0.2 million to $436.2 million. The President’s budget request for FY 2009 includes an increase in the NIAAA budget of $0.4 million, representing 0.1 percent over the FY 2008 budget, an amount considerably below the inflation rate. The current budget enables NIAAA to support research grants at a success rate of approximately 28.6 percent, an outstanding level compared to other Institutes, but this rate was accomplished with the sacrifice of established investigators who agreed to take cuts in order to fund new investigators. In FY 2009 the success rate is projected to drop to 25 percent or less.
§ Director’s activities. In October 2007 Dr. Li gave the opening lecture at an international symposium on liver and pancreatic disorders in Japan to observe Asian Pacific Digestive Diseases Week. Dr. Tsukamoto served as principal organizer of the symposium, Dr. Samir Zakhari served as a co-organizer, and Dr. Bin Gao gave a keynote lecture. Dr. Li traveled to Seoul to speak on alcohol epidemiology and to sign, along with the Director of the KoreanCenter for Disease Control and Prevention, a letter of intent to increase cooperation in alcohol biomedical and behavioral research and in education. NIAAA will welcome one or two potential post-doctoral fellows and has commenced a research project to look at alcohol injury in emergency rooms in Korea, parallel to an NIAAA research project with China. Dr. Li introduced NIAAA grantee Dr, Dale Walker’s keynote speech at an NIH-sponsored symposium marking American Indian and Alaskan Native Heritage Month. Dr. Li was among the speakers at a congressional briefing hosted jointly by the newly formed Friends of NIAAA Coalition and the House Addiction, Treatment, and Recovery Caucus. Friends of NIAAA helps disseminate research information to interested groups. Dr. Li spoke at the second international conference on neuroimaging and alcoholism hosted jointly by NIAAA and the NIAAA-fundedCenter for Translational Neuroscience of Alcoholism.
§ NIAAA staff and organizational changes. Dr. Li reported that Peter Delany, Ph.D., has left NIAAA to serve as Director of the Office of Applied Studies, Substance Abuse and Mental Health Services Administration. Retirees include Laurie Foudin, Ph.D., Roger Hartman, and Norman Salem, Ph.D. Veronica Alvarez, Ph.D., joined NIAAA as Acting Chief, Section of Neuronal Structure, Laboratory for Integrative Neuroscience, and Dale Hereld, M.D., Ph.D., joined as a Program Director in the Division of Metabolism and Health Effects (DMHE). Max Guo, Ph.D., was named Deputy Director, DMHE, and Kenneth Warren, Ph.D., was selected to serve as NIAAA’s Deputy Director. The American Psychiatric Association has named Howard Moss, M.D., a Fellow of the organization. NIAAA welcomed Presidential Management Intern Rebekah Geiger and NIH Management Intern Jessica Rodriguez.
§ Research priority emphasis and core support teams. In the area of underage drinking, Pediatrics will publish a supplemental issue in April 2008 that summarizes the relevant science. Dr. Vivian Faden and Dr. Trish Powell, who have spearheaded NIAAA’s underage drinking initiative, received commendations from the Surgeon General’s Office.
§ NIAAA research programs
- INSERM. NIAAA and France’s INSERM jointly presented the third in a series of research symposia. Designed to rejuvenate alcohol research in France, the 3-year collaboration has generated meetings and personnel exchanges, including soon a new jointly staffed center at the Scripps Research Institute. NIAAA has a successful program to send post-doctoral students and junior faculty to France. Dr. Li and Peggy Murray have met with top French governmental science advisors to discuss collaboration on AIDS research and clinical diagnosis of fetal alcohol syndrome problems.
- NIAAA Review Branch Reorganization. Reorganization of NIAAA’s Review Branch has resulted in four study sections.
- RFAs: Applications. Dr. Li stated that Institutes and Centers have concerns about issuing RFAs that might attract too many applications, particularly in an environment of tightened budgets. NIAAA has issued RFAs in specific areas that include, for example, P20s—exploratory/developmental alcohol research centers—that generated 11 responses in the current year and raised the issue of funding in the out years. A potential solution involves reopening the P01 mechanism, thus accommodating more multidisciplinary research projects that could evolve into projects eligible to apply for centers. Other RFAs include competing renewals for P50s and P60s and 2 RFAs on mitochondria.
- Research reports. Extramural programs report significant research progress in the area of screening and brief intervention in the contexts of hospital emergency departments and in ranking the health impact and cost-effectiveness of screening and brief intervention in primary care settings. In response to a request by the World Health Organization, NIAAA will look at disability-adjusted life years (DALYs) related to 10 or more diseases using NESARC prevalence and incidence data at five sites in the United States and Canada. Other reports describe an investigation of the severity of alcohol use by the RTI approach that reveals which diagnostics are more specific and sensitive, and a study that shows endocannabinoids to be receptors in the brain and that cannabinoids have a role in liver hepatosteatosis and fibrosis, thus connecting the two most important organs with regard to alcohol and the common receptor mechanism.
§ O utreach activities. Dr. Li explained that NIAAA conducts outreach in order to disseminate knowledge. In the area of underage drinking, the Surgeon General has issued a Call to Action, and the former and present Acting Surgeon Generals have initiated a process of taking the message to States. In addition, the Office of National Drug Control Policy (ONDCP) has decided to add the issue of addressing underage drinking to its mission statement. Efforts have begun to create financial incentives for primary care providers to conduct screening and brief interventions for alcohol use. Dr. Li emphasized pursuing the goal of risk reduction. Outreach related to the Clinician’s Guide has been effective in educating treatment professionals.
Extramural Advisory Board Report on Health Services Research
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 recommendations on progress and opportunities for health services research, the results of a September 2007 meeting at which participants reviewed the health services research portfolio plus a report prepared by the Division of Treatment and Recovery Research. A group of ad hoc experts, Council members, and Institute staff and management served as advisors.
As background, Dr. Crews explained that Congress mandated in 1992 that Institutes obligate 15 percent of their budgets to health services research. In 1997 NIAAA released its national plan, Improving Delivery of Alcohol Treatment and Prevention Services, as a blueprint. Dr. Crews defined alcohol health services research as a multidisciplinary field of applied research that seeks to improve the effectiveness and efficacy of services and access to equitable care that is designed to reduce the public health burden of alcohol use and related disorders across the life span. This research examines how social factors, financing systems, service environments, organizational structures and processes, health technologies, and personal beliefs and behaviors affect access to and utilization of services, the quality and cost of those services, and in the end health and the well-being of individuals, families, and communities. Health services research involves translation of basic into clinical research and implementation of clinical research findings in clinical practice.
From 1997 to the present, NIAAA has funded 153 health services research projects totaling $159 million, mostly outcome/effectiveness, economic and financing, and technology studies. Many efforts generated evidence to support the clinical and economic benefits of providing treatment. In addition, two major effective medications, naltrexone and acamprosate, have been approved for use as part of a treatment regimen, and several behavioral interventions have been established as effective (cognitive behavioral therapy, motivational enhancement therapy, and 12-step facilitation therapy). Moreover, NIAAA has taken a leadership role in the growing body of emerging evidence on the interaction between genes and alcohol, the lasting effects of alcohol on the brain, and the concept that alcohol use disorder may be described using a chronic disease model. Dr. Crews noted that health care systems have been slow to implement intervention tools and care models that NIAAA-funded research has shown to be effective. The EAB discussed outcomes, economics, organization, access and utilization, methodology, technology, dissemination, and the research infrastructure to recommend for health services.
Because of the heterogeneity of alcohol use disorders, the appropriate approach on the continuum of care from universal prevention to treatment depends on the severity of the disorder. In addition, in the past few years, alcohol dependence has come to peak around age 21; the most common time to enter treatment is at age 31; and the average age for NIAAA trial participants is 40, a situation that indicates the need to shift to prevention approaches to focus on an earlier age group rather than clinical trials in people two decades older than the peak incidence of alcohol dependence.
The specific recommendations for priorities are:
1. The NIAAA should set research priorities according to a range of intervention models that address the full spectrum of services for drinking and alcohol disorders (at-risk, harmful, dependent drinkers), and the methods and costs of dissemination and implementation. These should include addiction specialty services, but should emphasize areas that have received insufficient attention, such as general/mental health services and services outside the medical sector (e.g., in criminal justice, social welfare, work place, and school settings).
2. NIAAA should develop research to determine how specialty care, hospital systems, primary care providers, and other systems such as criminal justice may best be influenced to improve access to care. In these efforts, economic and other incentive programs should be considered, along with encouraging systems-level analyses of evidence-based protocols, quality of care indicators, quantitative measures of alcohol risk (biomarkers, quantity-frequency, others), or other system-change options, including process measures.
3. A research priority should be to understand attitudes and decision-making behavior in terms of views on the nature of drinking and alcohol disorders and their treatment (ranging from studies of professionals in training and in practice to other providers, purchasers, and payers). A key purpose of this research is to inform the development and implementation of evidence-based services.
4. Studies should examine how attitudes toward treatment and barriers to care shape willingness to seek and/or accept service across the full spectrum of drinking and alcohol disorders. This should lead to the formulation and testing of strategies to reduce barriers and increase acceptability of services.
5. Studies should seek to develop and evaluate cost-effective disease management approaches and algorithms that are adaptive in nature, individualize care for complex patients, and in particular address adherence and retention. Such studies should cross-cut the perspectives of a range of stakeholders, including payers, purchasers, providers and consumers of care. Collaborations across other Agencies and Institutes is encouraged.
6. NIAAA should encourage longer-term outcome measurements in clinical and effectiveness trials. Research should focus on how best to measure outcomes and potential surrogate measures, as well as measures of treatment quality and process, from a multidimensional perspective. The use of archival, policy, and other secondary data sources and simulation strategies is encouraged. A priority is health economics research focused on cost and cost-effectiveness of different approaches to reducing adverse consequences such as disability and premature morbidity and mortality.
7. NIAAA should sponsor workshop(s) to further develop specific areas of health services research and to promote new collaborations.
Discussion: Dr. Mitchell emphasized the need to bring alcohol research into general medical practices and to evaluate that effort. Dr. Willenbring explained that the EAB plan departs from traditional health services research, which has focused on financing and organization of services and assumed that time-limited treatment takes place only in specialty treatment programs. It has become clear that few people seek or receive specialty services and that the vast majority of people get well over time, but little is known about the process. In order to decrease the population prevalence of alcohol dependence, more people must access treatment early in the illness. The focus cannot remain solely on older people with severe relapsing disorders, but, recognizing rapid changes in the conceptualization of diagnosis and the range of disorders, must shift to the existing infrastructure for primary care and mental health care.
In response to Dr. Charness’ suggestion to partner with the Department of Veterans Affairs (VA), Dr. Willenbring stated that NIAAA will collaborate with the VA on health services research, in particular to look at the infusion of behavioral health practitioners into VA health care facilities. Nevertheless, half the primary care providers in the U.S. practice in groups of three or fewer, and many are sole providers, posing a challenge to generalization. Dr. Willenbring stated that NIAAA also is interested with collaborating with the Department of Defense (DoD) in areas with little knowledge on successful treatment, including co-occurring alcohol dependence and post-traumatic stress disorder (PTSD) and with traumatic brain injury (TBI).
Vote of Concurrence: Council members voted unanimously to approve the EAB’s recommendations on health services research.
Update on College Drinking Research
Jason Kilmer, Ph.D., University of Washington and The Evergreen State College, spoke on individually focused interventions to reduce college student drinking and its consequences. Ninety percent of college students report that they drank over the course of the past year. Approximately 25-50 percent are heavy episodic drinkers who would warrant brief interventions as part of a broader continuum of approaches.
Dr. Kilmer observed that college students receive a range of messages that drinking and drugs are acceptable behaviors. Nevertheless, the NIAAA Task Force on College Drinking’s 2002 publication, A Call to Action: Changing the Culture of Drinking at U.S. Colleges, and presentations in the States to highlight the findings, have brought the issue to the attention of college administrators. The report describes a framework of interventions that target individuals, including at-risk or alcohol-dependent drinkers; the student body as a whole; and the college and surrounding community.
The report describes four tiers of interventions and gives examples: (1) evidence of effectiveness among college students; (2) evidence of success with general populations that could be applied to college environments; (3) evidence of logical and theoretical promise, but require more comprehensive evaluation; and (4) evidence of ineffectiveness. Effective interventions include, for example, combining cognitive-behavioral skills with norms clarification and motivational enhancement interventions, offering brief motivational enhancement interventions, and challenging alcohol expectancies. Larimer and Cronce (2007) have asserted that the 2002 recommendations for Tier 1 remain unchanged. The research shows strong support for multicomponent skills training, consistently efficacious motivational feedback, and mixed findings on expectancy challenge. Mixed findings emerged on generic norms-challenging interventions; personalized normative feedback interventions, including computer-delivered approaches, reliably change drinking behavior and consequences; more research has been conducted on mandated students, athletes, and freshman; and research is emerging on mediators of outcome. Larimer and Cronce identified significant methodological limitations that future research might address.
Under the NIAAA Rapid Response initiative, investigators at many colleges have evaluated individually focused interventions. Some interventions were either extensions of existing Tier 1 strategies with varied implementation approaches or target populations, or evaluations of novel interventions. The effort prompted collaboration both within and across sites and between researchers and clinicians, and helped colleges both address drinking on campus and advance the field. On-campus studies focused on targets of brief interventions (in health centers with first-year students, Greeks, mandated students, women, and students turning age 21) and on interventions delivered in person through a University Assistance Program, in person by peers or primary care providers, or using multiple delivery methods.
Preliminary analysis in several studies has found that participants were less likely to transition to drinker status and experienced less growth in drinking across the first year of college after a parent intervention, experienced a reduction in overall alcohol-related harms and drinking variables in a primary care setting, delayed increases in the quantity and frequency of drinking after an orientation program, reported less alcohol consumption at 6-month follow-up, reduced drinking quantity and frequency when they received personalized normative follow-up, and experienced a less risky drinking trajectory and reductions in drinking and related consequences.
The Rapid Response experience highlighted the importance of collaboration across and within campuses, with recognition that they share concerns, issues, and problems; emphasized evaluation and further examining “what works”; highlighted a continuum of strategies; and raised additional research questions. Future issues to be addressed include reducing barriers to implementation, including dissemination, fidelity, and bringing programs to scale; screening and outreach to students who may not participate in interventions; advancing assessment and measurement; examining the role of parents and faculty in curriculum infusion and making conversations about referrals; emerging technology in interventions; studying context of use (other substances and behaviors, dual diagnosis, and increasing psychopathology on campuses); studying the impact of receiving counseling services on retention from a sustainability standpoint; and recognizing the importance of patience.
Robert Saltz, Ph.D., Associate Director, Prevention Research Center, Pacific Institute for Research & Evaluation, Berkeley, California, discussed environmental prevention strategies to reduce college student drinking problems. He observed the range and intensity of attention to college-age drinking that was inspired by the Task Force’s A Call to Action. Dr. Saltz noted that many college administrators have expressed skepticism about the transference to campus of interventions shown to be effective in general populations (the Task Force’s Tier 2 recommendations), including alcohol control measures, enforcing underage laws, restricting outlet densities, and enforcing DUI laws. But Toomey and colleagues (2007) demonstrate otherwise in their update of environmental approaches to prevention.
Correlational studies using national samples of college campuses on student drinking and associations with environmental influences or policies show that campuses surrounded with greater density of alcohol retail outlets report higher levels of student drinking and associated problems; price, promotion, and taxes relate expectedly to rates of consumption; and reduced access to alcohol on campus typically results in lower consumption, except on campuses surrounded by many retail outlets. Alcohol- and substance-free dorms have lower incidence of drinking, but not just alcohol-free dorms. The existence of local and State alcohol policies relate to lower high-risk drinking. Dr. Saltz suggested that the NIAAA Alcohol Policy Information System might facilitate study of policy changes over time.
Opportunistic studies have looked at the effects of controlled access, such as keg bans, alcohol-free residences, and alcohol bans in sports stadiums. Several studies of social norms campaigns showed reduced consumption, but effects are not universal. Multicomponent interventions that involve campus and community often indicate lower levels of incidence of drinking. Many studies are pre/post studies on single campuses and most lack comparison, with results suggestive of further research.
The Rapid Response Initiative looks at a variety of environmental influences. The University of Michigan’s residential learning communities program has been shown to increase academic performance and has a self-selection bias for lower alcohol consumption, but some evidence shows that learning communities could be protective. Early results of FordhamUniversity’s program of improved enforcement against drinking in dorms, plus extensive activity programming, show comparatively fewer incidents. Early results of a student-designed social norms campaign at OhioStateUniversity show lower 30-day prevalence of alcohol problems. The University of Rhode Island’s campus-community intervention engaged students in activities to reduce drunk driving, including enforcement, party patrols, and sales to minors, framed in the DUI prevention network. The campaign showed increased awareness and perception of the intervention, but no change in drinking behavior; however, a steady decline related to students in targeted communities, and further research is indicated. At WesternWashingtonUniversity investigators combined enforcement operations, community coalitions, and programming to bring students housed off campus closer to their neighbors as part of the community. A large, statistically significant effect, reduction of drinking 5 or more drinks in the preceding 2 weeks, was achieved in 1 year.
In a more rigorous, controlled intervention, San DiegoStateUniversity’s two-campus study of a DUI intervention with increased enforcement and a publicity campaign substantially reduced self-reported DUI. The Matter of Degree program implemented at campuses from the top third of a national sample of campuses as measured on their drinking levels, including 10 intervention and 32 comparison sites, combined policy, enforcement, and marketing of the policies. An initial comparison showed no differences, but the five campuses that implemented the intervention with greatest fidelity showed a reduction over time in alcohol consumption levels and problems. An NIAAA-funded randomized, controlled trial (RTC) looking at social norms showed that alcohol outlet density affects consumption levels, suggesting the need to consider combinations of interventions to determine effectiveness. Dr. Saltz’s RTC project to evaluate the efficacy of a risk management approach to alcohol problem prevention involved 14 California campuses. The integrated intervention, targeted at off-campus parties, involved compliance checks, DUI check points, party patrols, a social host “response cost” ordinance, and a social host safe party campaign. The likelihood of getting drunk at an off-campus party decreased significantly at intervention sites, where likelihood of intoxication in bars and restaurants also decreased. Sites with highest-fidelity/dosage showed greatest reductions in likelihood of intoxication.
The Rapid Response Initiative is building increasing evidence in support of Tier 2 interventions for college populations, better capability for achieving population-level change, and capability for use of group RCTs to evaluate environmental interventions. Future research will involve building comprehensive, full-spectrum interventions. Replications are needed, as are effectiveness studies that emphasize mediators and moderators, diffusion research, and basic research on organizational and community change.
Discussion: In response to a question from Dr. Monti, Dr. Kilmer responded that investigators have begun to discuss investigating on-campus marijuana and nicotine usage using interventions shown to be effective in the general adult population. Monitoring the Future data show that marijuana use rates are similar to tobacco. Motivational interviewing around marijuana use is associated with reductions in use, consequences, or both, and some work with an online personalized feedback intervention with marijuana has prompted consideration of an in-person brief intervention. Since drinking does not occur in a vacuum, Dr. Kilmer acknowledged the value of investigating the impact of other substances. Dr. Saltz added that with measures of drug and alcohol use present in most surveys, mediational or moderator analysis might determine whether people using other substances may be less affected by population-level interventions.
Dr. Saltz responded to Dr. Li that the studies define and educate participants on a standard drink size. The studies focus on the level of consumption on a continuum, rather than a threshold of risk, and no standardized term for risky drinking exists. Dr. Li asserted that lack of a standardized term for at-risk drinking represents a liability in terms of credibility. Dr. Saltz suggested the need to educate college administrators that they must reduce risk associated with drinking along a continuum, not just among a small group of high-risk drinkers. Dr. Mitchell stated that he is unaware of evidence that lower levels of alcohol consumption increase risk of any adverse outcomes, which sometimes occur randomly. He inquired about where to draw the line in terms of a pharmacologic effect of alcohol at different blood levels. Dr. Kilmer acknowledged the daunting task of distinguishing between high-risk episodes for people whose typical use appears less at risk, versus individuals who seem to be more at risk, and trying to emphasize not necessarily quantity and frequency, but looking at the impact on the individual. Dr. Li noted that the definition in the Clinician’s Guide, 4-plus drinks for women and 5-plus drinks for men, not to exceed 14 drinks a week, needs to be tested in a controlled trial.
Gen. Dean questioned the appropriateness of applying the adult guidelines in the Clinician’s Guide to a population of primarily underage drinkers. He also applauded the investigators’ work on prevention and early intervention in the broader population. Dr. Li concurred that all messages and interventions must be age specific. He noted that minimum drinking age laws vary, although Federal guidelines exist, and APIS may help in crafting State-specific guidelines. Dr. Hingson pointed out that considerable variability exists in State laws; although it is illegal to purchase or furnish alcohol to minors, under some circumstances parents can furnish alcohol to their children, and some States permit people under age 21 to sell or serve alcohol. Zero tolerance laws make driving illegal after any drinking for persons under age 21. He asserted that the Rapid Response program has produced stronger evidence that individually oriented interventions and comprehensive community intervention can make a difference. Challenges include bringing interventions to scale and integrating environmental and individual interventions, but tools are emerging to address this public health problem. Dr. Li clarified that the primary issue is to give clear messages on college-age drinking. Gen. Dean clarified that no States allow parents to serve alcohol to anyone’s children but their own.
Dr. Crews inquired about the advisability of intervening earlier, during high school years. Dr. Saltz stated that some components of the college-based interventions are not appropriate, because high schools are not residential. Campus interventions would tailoring for a different target population and a different setting. Dr. Kilmer added that some dissertations report good preliminary results from brief interventions with high school students and noted that the Botvin Life Skills program targets the entire population.
Consideration of the September 2007 Minutes and Future Meeting Dates
Council members voted unanimously to approve the minutes of the Council meeting of September 19-20, 2007. Dr. Abraham Bautista announced that upcoming Council meetings will take place on June 4-5, 2008; September 17-18, 2008; February 4-5, 2009, June 10-11, 2009, September 16-17, 2009; and February 3-4, 2010, June 9-10, 2010, September 15-16, 2010.
Council Member Round Table
Dr. Hoek described the several open house workshops held in 2007 by NIH’s Center for Scientific Review (CSR) to elicit input from stakeholders on improvements to the peer review process, operation of CSR, and current study section organization. Specific workshop topics included molecular and cellular biology and liver diseases (attended by Dr. Hoek) and immunology (attended by Dr. Klassen), and attracted audiences with diverse interests. The workshops were structured like EAB meetings, with smaller discussion subgroups that later integrated and generated the blended recommendations that are posted on the CSR Web site http://cms.csr.nih.gov/AboutCSR/Openhouses.htm .
All workshops addressed two basic questions: (1) What are the most important scientific questions or enabling technologies that you expect in the next 10 years in your discipline? (2) Is the science of your discipline adequately evaluated within the current study section alignment? The alcohol research community in general feels that, except for a few specific areas, much alcohol research falls by the wayside because study sections do not do a good job of enlisting persons with expertise or interest in alcohol-related problems. Important developments in the biological and clinical sciences are difficult to address in CSR’s current review process. Much of the science tends to be highly integrative, with direct relevance for clinical applications and translational research. Dr. Hoek observed that you cannot learn what you want to know by looking at a little bit of the system; the problem with reviewing science from this integrative perspective is that a grant application must go to particular study section, which might not have all the necessary expertise, and thus this kind of research is generally not funded. In addition, this research usually involves a team approach, which is difficult to handle in the structure that stresses primary investigators, and this type of research also generally is not funded. Dr. Hoek stated that integrative science is supported more effectively in the European context, unhampered by the CSR-type review structure, which then results in more advanced science in Europe.
Dr. Hoek pointed out that with study sections organized by disease, disease-related issues that are broader than a particular organ, except for the liver, are inadequately addressed. Ad hoc reviewers who may have the appropriate expertise nevertheless have less impact in an established study section. Similar issues exist for toxicology research, which addresses problems of broad organ systems and diseases and which also receives inadequate review.
Dr. Klassen stated that the session he attended on immunology confirmed many of Dr. Hoek’s comments. Participants generally agreed that the future must emphasize integrative research. A majority concurred that in the current review system, investigators in alcohol and toxicology are inadequately represented, which led to a recommendation for more specific study section review. Significant debate, with no consensus, involved whether new investigators fare worse in review than established researchers; CSR data do not support that position. Equal numbers of participants spoke for and against shortening grant applications.
Gen. Dean congratulated NIAAA on its work in community-based research and its focus on alcohol problems across the spectrum of involvement. Dr. Li noted the problem of documentation of the burden of illness. An upcoming NIAAA initiative will focus on data related to overall impact due to morbidity, working with Chris Murray in the context of the global burden of disease, and working with good statistics on prevalence and incidence for alcohol-related disorders.
Ex-Officio Member Report and Comment
Col. Joyce Adkins stated that psychological health and TBI recently have become important issues at DoD. Congress appropriated $9 billion to spend in FY 2008 limited to the areas of PTSD and TBI, with $300 million for research divided equally between the conditions. DoD is working to establish two multidisciplinary, multiagency consortia—one clinical and one research—that integrate PTSD and TBI.
Based on recommendations from both internal and external review groups, DoD established a Senior Oversight Council in collaboration with the VA that meets weekly to determine progress in combat-related psychological health disorders and TBI. With its new funds DoD also is establishing, at the new WalterReedNationalMedicalCenter in Bethesda, the DefenseCenter for Excellence for Psychological Health and TBI to develop and monitor the research program. The Center will involve its Federal partners, and Col. Adkins invited NIAAA to participate. DoD also is forming partnerships in the clinical arena and is working with the Public Health Service to incorporate 200 uniformed mental health providers into military treatment facilities around the country, an effort to integrate behavioral health into primary care facilities that include family practice, women’s, and pediatric clinics.
DoD has an aggressive screening program during and following the deployment cycle, plus an annual health assessment. The AUDIT has been added to the post-deployment health reassessment. Through its Center for Excellence, DoD’s telehealth system is expanding to reach out to National Guard and Reserve members in remote areas to provide screening, brief intervention, and treatment modalities. DoD also is providing training on substance abuse disorders to primary care providers. Col. Adkins echoed Dr. Li’s prediction that funding will continue. She noted that alcohol abuse is much more prevalent than PTSD and much less likely to be referred or treated. Dr. Li expressed NIAAA’s interest in joining the consortium.
Public Comment
Time was set aside for public comment, but no one came forward to speak.
Adjournment
Dr. Li adjourned the meeting at 2:05 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/
Abraham P. Bautista, Ph.D.
Chief
Extramural Project Review Branch
and
Executive Secretary
National Advisory Council on Alcohol Abuse and Alcoholism