National Advisory Council on Alcohol Abuse and Alcoholism

Summary ofthe 105th Meeting

February 4-5, 2004

The National Advisory Council on Alcohol Abuse and Alcoholism (NACAAA) convened for its 105th meeting at 5:30 p.m. on February 4, 2004, at the Bethesda Suites Marriott in Bethesda, Maryland; again at 8:30 a.m. on February 5 for a closed meeting at the same location; and then for a public policy session that convened at 9:30 a.m. Dr. Ting-Kai Li, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), presided over the closed review of grant applications on February 4, the closed session to hear a report from the Board of Scientific Counselors on February 5, and the open session on February 5.

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 4 was closed to the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The open session for discussion of program and policy issues began at 9:30 a.m. on February 5 and adjourned at 3:07 p.m.

Council Members Present:

Ex-Officio Council Member Present:

Colonel Kenneth J. Hoffman, M.D., M.P.H.

Chairperson: Ting-Kai Li, M.D.

Executive Secretary: Kenneth R. Warren, Ph.D.

NIAAA Staff:

Other Attendees on February 5, 2004

Approximately 85 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

Dr. Ting-Kai Li, Director, NIAAA, called the closed session of the 105th meeting of the NACAAA to order at 5:30 p.m. on February 4, 2004, for consideration of grant applications. Dr. Kenneth R. Warren, Director, Office of Scientific Affairs, reviewed procedures for critiquing grant applications 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 recessed at 6:45 p.m. that evening and reconvened the next morning at 8:30 a.m. Dr. George Kunos led the discussion of the report of the Board of Scientific Counselors. The closed session adjourned at 9:20 a.m.

Call to Order of the Open Session and Introductions

Dr. Li called the open session to order at 9:30 a.m. Members of the Council introduced themselves, and Dr. Li welcomed four new Council members: Judge James Payne, Marion Superior Court Juvenile Division, Indianapolis, Indiana; Kenneth J. Sher, Ph.D., Professor, Department of Psychological Sciences, University of Missouri-Columbia; Alan C. Swann, M.D., Ph.D., Professor and Vice Chair for Research, Department of Psychiatry and Behavioral Sciences, University of Texas-Houston; and Boris T. Tabakoff, Ph.D., Professor and Chair, Department of Pharmacology, University of Colorado School of Medicine.

Director's Report

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

• Budget. On January 26 President Bush signed into law an appropriations bill that provides $428.4 million in FY2004 to NIAAA-a 3.1 percent increase over FY2003. Of this amount, $26.8 million is earmarked for HIV/AIDS. NIAAA had begun to use part of this budget under a continuing resolution. The President has requested $441.9 million for NIAAA for FY2005, including funds for HIV/AIDS, an increase over FY2004 of $13.5 million, or 3.1 percent. The budget reflects small but steady growth, but calls for a reduction in FTEs from 263 to 246.
  
  
• Address change. NIAAA's administrative office moved in January to its new quarters at 5635 Fishers Lane, Rockville, Maryland. New intramural laboratories will reside soon in the adjacent building, a move that will facilitate intramural and extramural programs and scientists working together.
  
  
• Reorganization. NIAAA reorganized administratively, effective on October 1, 2003. The reorganization restructured extramural programs to four divisions from three and created a system of interdisciplinary teams to look at scientific areas for new directions and priorities. Future plans call for creation of infrastructure teams.
  
  
• To inform the Federal Government's dietary guidelines to be issued in 2005, the Department of Health and Human Services (HHS) has asked NIAAA to assess the strength of the evidence relating to health risks and potential benefits of moderate alcohol consumption. Of special interest were effects on cardiovascular disease, breast cancer, obesity, birth defects, and other conditions. NIAAA scientific staff prepared a state-of-the-science report, convened an expert panel of external researchers to provide feedback, and sent the final report to the Director of the National Institutes of Health (NIH), who forwarded it to HHS Secretary Tommy Thompson. The report noted that the relationship between moderate alcohol consumption and disease outcomes is confounded by age, gender, genetic susceptibility, metabolic rates, comorbid conditions, lifestyles, patterns of consumption, and other factors, and that warning labels already exist regarding fetal alcohol syndrome and drinking and driving. The report concluded that current scientific knowledge on risks and benefits related to various levels of alcohol consumption does not suggest a need to modify existing guidelines on moderate alcohol use, which is14 drinks per week for men and 7 for women. The report also noted that since risks for some conditions and diseases increase with higher consumption levels, men should consume no more than four drinks per day and women should consume no more than three.
  
  
• NACAAA's Working Group on Binge Drinking held a workshop in November 2003 to determine factors that define heavy episodic drinking or distinguish it from other patterns of alcohol use and abuse. Diverse voices from the field were represented, including Federal staff. The task force included Council members Drs. Brown, Caetano, Koob, Hoffman, and Sher, as well as Sean O'Connor. NIAAA Associate Director Dr. Mark Goldman offered context on the definitions, concepts, and controversy associated with binge drinking. The scientific perspective has evolved, but specificity has been lacking. The Working Group crafted a recommended definition for binge drinking to serve as an advisory to NIAAA to submit to the field, which Dr. Goldman presented to the Council. Discussion was tabled until later in the meeting.
  
  
• Congressional testimony. Idaho First Lady Patricia Kempthorne testified on September 30, 2003, before the U.S. Senate Subcommittee on Substance Abuse and Mental Health Services. A founding member of Leadership to Keep Children Alcohol Free, she recommended more hearings on youth drinking, a Surgeon General's call to action on childhood drinking, collection of national data on alcohol use and attitudes (including those of young children), and increased U.S. investment in underage drinking research.
  
  
• Mark Keller Honorary Lecture. At NIH on November 18, Dr. Adolph Pfefferbaum presented the 2003 Mark Keller Honorary Lecture, the Institute's highest award to recognize outside scientists. NIAAA has selected Council member Dr. George Koob to present the 2004 Mark Keller Honorary Lecture.
  
  
• Researcher interactions
  
  
  • In the QTL to Gene project, four alcohol research centers-Portland, Missouri, Scripps, and the University of Connecticut-sponsored a conference to discuss animal work on identification of genes involved in alcohol actions.
    
    
  • At NIAAA's trainee workshop at Indiana University-Indianapolis to promote interdisciplinary research and understanding, trainees presented their work to one another.
    
    
  • Dr. Faye Calhoun spoke at the North Carolina President's Summit on Alcohol Use and Abuse, focused on college drinking and hosted by North Carolina First Lady Mary Easley.
    
    
  • Ohio First Lady Hope Taft hosted the second Smart and Sober Celebration for middle-school students.
  
  
  
• New products. NIAAA has published an issue of Alcohol Research & Health on epidemiology and the second edition of Assessing Alcohol Problems: A Guide for Clinicians and Researchers.
  
  
• Scientific programs
  
  
  • NESARC (National Epidemiological Survey and Alcohol-Related Conditions) data are emerging that will inform the trajectory of alcohol use and disorders through the life course, and also provide data on what constitutes risky drinking. The data indicate that studies should concentrate on people age 25 or younger.
    
    
  • NIAAA's College Drinking Prevention Website had more than one million hits in September.
    
    
  • High-visibility journals, including PNAS, Science, Nature, and General Biological Chemistry, have published many alcohol-related articles; intramural scientists have contributed to many of the articles. NIAAA's intramural scientists were active in one of Science Magazine's "Breakthroughs of the Year."
    
    
• Staff transitions. NIAAA has recruited Nanwei Cao, Ph.D., to manage the SMART database; investigator (tenure-track) Andrew Holmes to lead the Section on Behavioral Science and Genetics, Laboratory for Integrative Neuroscience; and Alexei Yelisseev, Ph.D., to serve as a staff scientist in the Nuclear Magnetic Resonance Laboratory.
  
  
• NIAAA will sponsor a symposium called Advances in Alcoholism Treatment and Health Sciences Research on April 24 at ASAM's annual meeting in Washington, D.C.

Managing to Mission: Speeding Science to Services

James Stone, M.S.W., Deputy Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA), described SAMHSA's approaches to accelerate the transfer of scientific knowledge into the field for adoption. He stated that more effective tools now are available to address the gap between research and treatment for mental health and substance abuse disorders. Recovery is a reality, and people with mental illnesses have more hope. He noted that 50 years ago was a time of peak institutionalization for hundreds of thousands of people with mental illnesses and substance abuse problems. In the 1930s and 1940s institutionalization was common for people with problems that seemed strange to society. Treatment tools in those days included thorazine, an improvement over barbiturates as a tranquilizer, and insulin shock and cold wraps. No professional substance abuse treatment was available, and simple detoxification was associated with high risk of DTs and death.

Significant advances include new medications and evidence-based programs and services proven to be effective in the treatment of mental illnesses and substance abuse. But gaps remain: Many consumers do not receive services that would enable them to live safe and productive lives in the community. The Institute of Medicine (IOM) reports an average time lag of 17 years from research to practice, and many Americans are untreated or receive treatment that is not effective.

SAMHSA's most recent National Survey on Drug Use and Health found that fewer than half of Americans with severe mental illnesses obtain treatment. Factors include primarily cost, and also stigma, not knowing where to go, and fear of commitment or other coercion, among others.

Substance abuse treatment is needed by 22.8 million Americans age 12 or older, of whom only 10.3 percent receive specialized substance abuse treatment. A significant number sought treatment, but did not obtain it. Fully 9.1 percent of young Americans needed treatment for an alcohol or illicit drug problem, and only 8.2 percent received treatment; this leaves an estimated 2.1 million youth who needed treatment for a substance abuse problem, but did not receive it.

Mr. Stone described SAMHSA's mandate, structure, and approach. SAMHSA's activities promote better access to effective services. Effective services are those shown to produce positive treatment outcomes. A SAMHSA-wide focus on content areas guides SAMHSA's three centers-Center for Substance Abuse Treatment (CSAT), Center for Substance Abuse Prevention (CSAP), and Center for Mental Health Services (CMHS). A matrix delineates SAMHSA's priority issues: co-occurring disorders, substance abuse treatment capacity, seclusion and restraint, strategic prevention framework, children and families, mental health system transformation, disaster readiness and response, homelessness, aging, HIV/AIDS and hepatitis, and criminal justice. Its cross-cutting principles include science to service and evidence-based practices.

In SAMHSA's work to speed science to services, the National Registry of Effective Programs, an Internet-accessible directory of substance abuse prevention programs with proven efficacy, will expand to include mental health treatment programs. SAMHSA's new Science to Service Office will promote translation of science into service and develop opportunities for service providers to inform scientists, so that research agendas reflect services-related issues. CSAT's 14 regional Addiction Technology Transfer Centers have worked with NIDA's Clinical Trials Network to fund dissemination planning. CSAT's Practice Improvement Collaboratives fund 14 metropolitan or statewide grantees to promote access to evidence-based services.

Following on President Bush's New Freedom Commission on Mental Health, CMHS is transforming the nation's mental health system. The Commission's report acknowledges the disorganization of mental health services in America, which results in poor quality or no services for many Americans. CMHS is developing an action plan for a change process that will promote greater access to evidence-based services for people with mental illnesses. As this transformation is promoted and discussed, SAMHSA will emphasize closing the gap from science to service.

CMHS soon will publish six toolkits for advocates, consumers, administrators, and clinicians on assertive community treatment, integrated treatment of co-occurring substance abuse and mental illness, supported employment, illness management, medication management, and family education, training, and support.

Discussion

In an exchange of information following the presentation:

• Mrs. Taft expressed enthusiasm that SAMHSA aims to reduce the time research takes to get to the field and her hope that the field will inform researchers of other areas that need to be examined. Mr. Stone confirmed that communication goes in both directions.
  
  
• Mrs. Taft described Scholastic/SAMHSA's Reach Out Now program that targets every fifth- and sixth-grade teacher in the U.S. for an April teach-in designed to raise the age of first use of alcohol. She urged everyone to contact an elementary school teacher and teach a lesson, drawing on their own expertise. She noted that in 2003, Ohio's public treatment program treated 234 kids age 6 through 12 for addiction. More attention is necessary to younger children to build the resiliency necessary to keep them alcohol free.
  
  
• Dr. Hoffman suggested using an electronic health record to disseminate science to the practitioner and to improve continuity of care. This approach would incorporate outcomes management and a measure to identify money is spent, rather than what physicians bill for.
  
  
• Dr. Li noted the importance of the NIH Institutes working jointly with SAMHSA, as the Institutes evaluate programs and SAMHSA evaluates cost-effectiveness and efficacy of such interventions.

Consideration of Recommendation on Definition of Binge Drinking

After a lengthy discussion led by Dr. Goldman on refining the Working Group's draft on binge drinking, the Council unanimously approved the following recommendation:

A "binge" is a pattern of drinking alcohol that brings blood alcohol concentration (BAC) to .08 grams percent or above. For the typical adult this pattern corresponds to consuming 5 or more drinks (male) or 4 or more drinks (female) in about 2 hours. Binge drinking is clearly dangerous for the drinker and for society.

• A drink is defined as half an ounce of alcohol (e.g., one 12 oz. beer, one 5 oz. glass of wine, one 1½ oz. shot of distilled spirits).
  
  
• Binge drinking is distinct from "risky" drinking (peak BAC between .05 and .08 grams percent) and "benders" (2 or more days of sustained drinking to intoxication).
  
  
• For some individuals (e.g., older people; those taking other drugs or certain medications), the number of drinks needed to reach a binge-level BAC is lower than for the "typical adult." People with risk factors for the development of alcoholism have increased risk with any level of alcohol consumption, even that below a "risky" level.
  
  
• For pregnant women, any drinking presents risk to the fetus.
  
  
• Any drinking by persons under the age of 21 is illegal.

Consideration of Council Minutes

The Council unanimously approved the minutes for the closed session of the September 2003 meeting. The Council unanimously approved, as amended, the minutes of the June 2003 meeting (Dr. Mirin was present only at the closed session).

Drug Abuse and Addiction Research at NIDA: Recent Progress . . . Future Plans

Nora Volkow, M.D., Director, National Institute on Drug Abuse (NIDA), described the state of NIDA's research, which is guided by the Institute's mission to use science in order to make an impact on the problems of drug abuse and addiction. She reviewed NIDA's organizational structure: its science divisions-Neuroscience and Behavioral Research, Treatment Research and Development, Epidemiology, Services and Prevention Research, as well as the intramural program, the Center on AIDS and Other Medical Consequences of Drug Abuse and the Center for the Clinical Trials Network (CTN).

Although the obvious culprit in addiction is drugs, the biological, behavioral and environmental issues involved are numerous and complex. Drugs themselves are not sufficient to cause addiction; other processes and variables are also involved. Epidemiological studies have identified environmental risk and protective factors, but the mechanisms underlying the effects are not yet well understood. Risk factors include biological predisposition to addiction, previous history, and developmental modifications to neurobiology. Dr. Volkow favors a systems approach to enhance an understanding of addiction that can promote better treatments.

NIDA's priorities include prevention research, treatment interventions, and research training. To make a major impact, prevention must be emphasized, while concurrently focusing on treatment. Prevention should target particularly those who are most vulnerable, adolescents and children, because addiction often starts at these stages of development and interferes with development later in life.

Prevention research is not straightforward, and sufficient knowledge of what is relevant has not yet been developed. Dr. Volkow noted that relevant areas of study include genetics (determining which genes affect vulnerability to or protection from abusing drugs); brain development and its effect on vulnerability, a wide variety of environmental factors, comorbidity (particularly substance abuse with psychiatric diseases); and treatment.

The complexity of drug abuse and addiction makes generating genetic explanations difficult. Nevertheless, data from association studies have indicated more reproducibility in loci identified than for most other complex disorders. Research that identifies the relevant genes and the proteins they encode can lead to development of improved prevention interventions for addiction.

Not enough is known about drug interactions in adolescents; the vast majority of animal studies on drug effects have used adult subjects, although drug abuse generally starts in adolescence, during a period of significant brain development. Dr. Volkow described a brain morphology study that compared the size of areas of the brain in adolescents and adults. Differences were greatest in the two target areas of drugs of abuse, the subcortical region-important in drugs' reinforcing effects-and the frontal lobe-one function of which is to mediate judgment, or inhibitory control. The frontal lobe is one area of the brain where changes occur in individuals addicted to drugs; activity here is attenuated when intoxicated with alcohol. Understanding these factors can help in developing strategies to educate young people about difficulties they may have in making judgments and developing activities to accelerate development.

Although the alcohol literature acknowledges that brain development starts in the womb, little in the drug literature has addressed this factor. For example, although it is known that nicotine crosses the placenta, 17 to 30 percent of women in the United States who smoke continue to smoke when they become pregnant. Nicotine receptors appear early in development, and research has shown that smoking during pregnancy may produce more deleterious effects than taking cocaine-for example, low birth weight, conduct disorder in childhood and adolescence, early experimentation with tobacco, ADHD, and lower IQs. The public is largely unaware of this information, and experiments have not yet been conducted to understand the reasons for these effects.

Many epidemiological studies have helped to identify environmental protective and risk factors. Risk factors include poor family support, drug availability, poverty associated with poor family support and lack of alternative behaviors, and crime. In addressing the neurobiological factors that mediate social stressors as a risk factor for drug abuse, Communities That Care's methodology to quantify relative risk by neighborhood permits researchers to identify areas where an intervention is more likely to have an effect, to assess objectively whether interventions are useful or not, and to use a powerful tool in genetics research. If a gene makes an individual more vulnerable to addiction, the interaction of that gene with factors in the environment that also increase vulnerability may greatly increase the risk for addiction.

Dr. Volkow noted that researchers understand that the environment is relevant, but they don't yet know why. A series of studies that measured dopamine D2 receptors in different types of addiction show that the brains of persons who abuse alcohol, cocaine, heroin, and methamphetamine all have lower numbers of receptors in comparison to controls, which may make people more susceptible to taking drugs. The consequences of chronic drug use include a reduction in dopamine D2 receptors, which makes individuals more vulnerable to taking drugs. Recent work by Michael Nader and colleagues showed that social interactions can produce significant changes in neurobiology-here on a protein related to vulnerability to addiction-dopamine D2 receptors. When housed together, dominant monkeys had higher numbers of dopamine D2 (DA D2) receptors than their subordinate counterparts although it was not possible to predict which animals would become dominant, based on the level of receptors the monkeys displayed when they were housed separately. After being housed together, the monkeys were exposed to a procedure through which they could self-administer cocaine. In this environment, animals with high levels of receptors did not administer cocaine to any significant extent, unlike the subordinate animals, with low levels of receptors, who did self-administer the drug. This finding shows that, in treating addictions, it may be relevant to find interventions that can compensate for the changes that environmental factors can induce. Dr. Volkow then presented a study by Thanos and colleagues which showed that increasing receptor levels reduced alcohol consumption dramatically. These studies suggest that increased levels of receptors seem to serve as a protective factor, but that environmental factors can modulate the degree to which an individual is vulnerable or protected.

Dr. Volkow asserted that an important step in preventing drug use should be to focus on persons with mental disorders such as conduct disorder, learning disabilities, and attention deficit disorder, who are more likely to account for a large percentage of persons who will become addicted. In terms of prevention, it will be important to learn why young people with mental illnesses are more vulnerable to taking drugs.

In terms of treatment, many behavioral interventions have been devised, and interest exists to develop methodologies to test and standardize them. Some medications have shown success, and more progress is appearing in the animal-study research pipeline. Studies have shown that cannabinoid antagonists can interfere with multiple drugs of abuse and alcohol intake. Although a major challenge to advancing NIDA's medications development agenda has historically been inadequate pharmaceutical industry incentive to develop drugs for treating addiction, cannabinoid antagonists appear to have useful applications, not only in the treatment of addiction but for models of obesity as well.

One path might be to entice pharmaceutical companies to permit studies on human subjects, perhaps related to nicotine addiction. Dr. Volkow noted that some targets are different from the usual way of thinking, and different strategies are under consideration. A protective factor for avoiding the development of alcohol abuse is the inability to metabolize alcohol, which makes the experience of alcohol aversive. Because this appears to also be true for nicotine, pharmaceutical companies are developing inhibitors of enzymes that metabolize nicotine; preliminary data are interesting. Another strategy is the use of CRF antagonists. The animal literature shows that an important variable in triggering relapse in various addictions is stress. Stress generates autonomic and central nervous system responses, which, if interfered with, can lead to relapse.

In the context of behavioral interventions, neuroscience research has shown that the adult human brain is susceptible to changes in response to environmental stimulation. Dr. Volkow described a study involving London taxi drivers that showed that their posterior hippocampi were larger than non-taxi drivers after many years of constant use in navigating the city. The implication is to develop interventions that could improve brain circuits that may have been negatively impacted by chronic drug abuse, and may not be optimally functional. When an area in the brain is dysfunctional, glucose consumption declines. Drug-addicted individuals show decreases in activity in the orbito frontal cortex. It makes sense, then, to try to develop interventions-similar to exercises for reading disabilities or attention deficit disorder-that strengthen the processes carried out by that area of the brain that involves inhibitory control, regardless of whether the dysfunction is due to genetics or the chronic administration of drugs or other environmental factors.

Knowledge about treatments must be developed, and targets exist for development of medications. But problems exist with bringing research from the bench to bedside, and then from bedside to the community. In a 2003 editorial in Science, Steve Hyman, former Director of the National Institute of Mental Health, noted that knowledge on cognition and schizophrenia has increased six-fold in six years, as measured by new papers published-but virtually no papers have been translated into clinical trials. Although scientific knowledge is growing quickly, the infrastructure to move it into practice has not kept pace.

The New England Journal of Medicine published a study in June on the percentage of patients in the best U.S. medical centers who received standard medical care. Examination of charts revealed considerable variability across diseases, ranging from 80 percent receiving standard medical care for cataracts and breast cancer, down to 10 percent for alcohol dependence. Drug abuse is not identified. These results raise the question of how to translate proven effective research into care in the community.

Since 1998 NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN) has worked to identify problems and facilitate translation from bench to bedside and bedside to community. Each of 17 nodes in U.S. medical centers with a strong basis in substance abuse research is associated with a number of community treatment providers. The centers conduct trials at multiple sites simultaneously, recognizing the need for expediting research and addressing differences in a wide variety of patient populations. An evaluation is underway that may lead to a NIDA/NIAAA collaboration to engage the CTN infrastructure to investigate issues related to alcoholism. Dr. Volkow noted that comorbidities are a challenge in research on alcoholism, which must address the consequences of comorbid use and how comorbidities affect treatment, prognosis, and preventive interventions.

Collaboration is key, particularly with SAMHSA, the providers of substance abuse treatment and prevention services. NIDA and SAMHSA are building strong collaborations on multiple initiatives and are blending funding. Comorbidities drive the need for collaboration with NIAAA and other Institutes, because substance abuse and alcoholism affect many medical illnesses, including mental illnesses, AIDS, and cancer, and also child development. The overlap in research interest areas makes it important to incorporate and optimize resources to target the reality of addiction and to help that knowledge to benefit the community.

Discussion

In response to questions from Council members, Dr. Volkow explained that:

• Translational research using a systems approach is an important item on NIH's Roadmap. Nevertheless, reviewers have scored translational applications so low that they have not been funded. NIDA has studied the review process and is devising remedial strategies. One strategy is to create study sections to review translational grants, but sometimes such study sections have graded applications as poorly as other reviewers. NIDA plans to put forth a program announcement that includes translational development as a priority. Dr. Volkow stated that if NIDA does not change its review process, ideas will stop there due to lack of funding priority.
  
  
• Creating public/private partnerships in drug development is indispensable, but it has been difficult. NIDA and other substance abuse agencies have suggested this strategy as an NIH priority. ONDCP is creating a committee to develop a systematic way to develop incentives, but this is a political issue, and although NIDA cannot make policy, it can identify roadblocks, including access to pharmaceutical companies to develop medications and also lack of parity in reimbursement for physicians to ask if kids are taking drugs or not.
  
  
• NIDA will partner with NIAAA in developing cannabinoid antagonists as promising therapeutics. Dr. Volkow acknowledged the value of the scientists network, but stated that more needs to be done in parallel to speed research.
  
  
• A NIDA/NIAAA collaboration on pharmaceutical development using the CTN is under discussion. Although the CTN may serve as an incentive to pharmaceutical companies for testing compounds to treat substance abuse, because of the CTN's in-place infrastructure and the possibility to test at lower cost, the industry currently has no target appropriate to test. Use of buprenorphine has experienced a roadblock because of regulatory issues.
  
  
• Although illegal use of prescription drugs is an important problem, particularly opiates used in the treatment of pain, no strategies exist to identify it. Dr. Volkow noted the necessity of using creativity to address this issue with the pharmaceuticals in a way that is important to the companies, such as a medication resistant to addiction for pain or an antipsychotic that also addresses smoking cessation, and she welcomed suggestions.
  
  
• NIDA has met with CTN director Betty Tai to identify good candidates for collaboration on seeking ways to shape stakeholder interest. A substantial Request for Proposals has been issued to facilitate integration of networks. Dr. Volkow stated that she will contact CDC's Prevention Research Centers and has already suggested collaborating with NIMH.

Dr. Li discussed ongoing collaborations, including joining NIDA and the Cancer Institute in TTURC, to add attention to alcohol as well as smoking; NIAAA has contributed $1.2 million to this effort. NIDA has joined NIAAA in funding NESARC. Researchers connected to NIDA's CTN have formed an alcohol interest group. It is necessary to program money into the effort to be full partners, and it is important to determine the best mechanism, both fiscally and administratively, to do so. It has been a challenge to identify and access NIH's existing resources.

In the area of science, because of commonalities in mechanisms and the existence of many drugs, Dr. Li asserted that the issues of which receptors, what is drug specific, and what is comorbid all are important. It is critical to take advantage of common research populations to increase the knowledge base. Both NIDA and NIAAA are striving to do this, as are other Institutes. Dr. Li noted that Dr. Volkow is working to put the word "behavior" into NIH's lexicon.

NRC/IOM Report on Underage Drinking

Mary Ellen O'Connell, MMHS, Senior Program Officer, National Research Council of the National Academy of Sciences, described a report on "Reducing Underage Drinking: A Collective Responsibility," released in September in a pre-publication format under the aegis of the Board on Children, Youth, and Families. The National Academy appoints committees that represent diverse views in terms of age, ethnicity, gender, and geography. Members serve on a pro bono basis, and committees' consensus views are based on literature reviews and input from other sources. Ms. O'Connell, who served as study director, acknowledged the contributions of Drs. Hingson and Brown, who presented some of the many papers the committee commissioned. Input also was elicited from a range of stakeholders at hearings and materials submitted.

Congress's mandate for the study was to review the evidence on a range of programs aimed at underage drinking, including media-based programs and interventions directed to youth and to the environment, and to propose cost-effective strategies. The committee endorsed the current legal framework, under which alcohol use is illegal for youth under 21.

The committee's analysis of drinking trends among youth versus adults found that underage kids drink on fewer days per month (six) than adults (eight), but they drink a lot more (five drinks) when they drink than adults (three drinks). The committee found this cause for concern in view of the consequences. Driving accidents due to drinking have diminished, but they remain a serious issue. Sixty-nine percent of kids who die in alcohol-related traffic fatalities die at the hands of a drinking driver. Licensed drivers under age 21 who are drinking are involved in fatal crashes twice as often as adults. Underage drinking is associated also with violence, suicide, academic failure, and other serious problems. Research shows that heavy alcohol use impedes adolescent brain development, and early alcohol use correlates highly with future adult dependence. A PIRE study shows the estimated cost of underage drinking at $53 billion (in 1996 dollars).

The principles that guided the study's work included the following: (1) The problem of underage drinking is endemic and will not change without intervention, and (2) resources are not commensurate with the prevalence of the problem. The goal of the strategy is to sustain a strong societal commitment among all stakeholders, including governments, but also industry, colleges, entertainment, and particularly adults.

Ms. O'Connell discussed the components of the strategy:

• Adult-oriented media campaign. A media campaign would animate and sustain broad national commitment to reducing drinking among youth. Youth typically obtain alcohol from adults, and adults underestimate the problem. A recent ONDCP study showed that a third of parents whose child had had five or more drinks on a single occasion within the previous month reported that their child does not drink. Adults should be the primary targets of the campaign, and more work is to be done on the campaign's messages.

  Ms. O'Connell pointed out that ONDCP's television and print ads that coincided with Super Bowl week in January included alcohol for the first time. In addition, the conference committee report for the upcoming HHS budget includes funds for development of a parent-oriented ad campaign.
  

• National partnership. Although underage drinking represents a significant source of profits for the alcohol industry, its members direct significant resources toward tackling the problem. Anheuser Busch reports an investment of more than $375 million toward education campaigns, and the Century Council, an umbrella organization, reports an investment of more than $120 million over 10 years. But the evidence of the effects of these investments is unclear. The committee recommends that the industry use its resources to help fund a national foundation devoted to reducing underage drinking.
  
  
• Advertising restraint by alcoholic beverage manufacturers. Although companies say they do not target youth, the ads reach young people anyway. The committee recommends that companies exercise restraint and restrict ads that reach a significant underage audience, minimize marketing practices with substantial underage appeal, and establish an independent review board. In addition, HHS should monitor exposure of youth to alcohol advertising and report to Congress and the public. Data on alcohol brands should be collected in Monitoring the Future and the National Survey of Drug Use and Health to increase accountability.
  
  
• Entertainment industry. The prevalence of alcohol-related images and messages is pervasive in the media. Forty percent of rock music, 38 percent of television programs rated TV-G, and 93 percent of the most popular movies in 1996-97 include references to alcohol use. The committee recommends that the entertainment industry create a rating system specific to alcohol and, for accountability, that HHS periodically monitor a representative sample of media and report to Congress.
  
  
• Access. The committee recommends that states strengthen their drinking laws. Similar to the Synar Amendment regarding commercial availability of tobacco, states should achieve designated rates of retail compliance regarding sales of alcoholic beverages. In terms of social availability, parents should stop giving alcohol to minors. In addition, initiatives should be examined that target youth, such as facilitating or enforcing zero tolerance laws that prohibit youth from driving with any alcohol in their systems.
  
  
• Youth interventions. Educational approaches should be evidence based, and programs shown not to work should be discontinued. For example, DARE should not be continued, and the resources should be refocused on programs demonstrated to work. Availability of services to accommodate clinical needs should be expanded.
  
  
• College interventions. NIAAA's "A Call to Action" was a seminal report. The committee recommends refining it and similar documents to allow colleges to tailor their approaches to the circumstances of their particular institutions.
  
  
• Community interventions. The committee views community mobilization as an opportunity to mirror activities at the Federal level. At the local level, the response should be tailored to the local problem, and the Federal government should fund specific community-level activities that target alcohol, similar to activities for drugs.
  
  
• Government assistance and coordination. The committee recommends that Federal interagency coordination be established and that a single HHS resource center be created. In addition, states should establish coordinating bodies to organize the work of multiple agencies involved with alcohol issues. Federal and state governments should increase alcohol taxes and adjust them by the Consumer Price Index. This recommendation is based on evidence that taxes have a disproportional impact on use and that taxes have decreased over the past several decades in inflation-adjusted terms.
  
  
• Research and evaluation. The committee recommends evaluation of all activities related to refining the strategy as it proceeds.

Discussion

In discussion following her presentation, Ms. O'Connell clarified the following points:

• The review of the science needs more work related to what leads to underage use and to effective intervention approaches, for example, in the workplace, in elementary schools, and in high schools, where half the students already drink. Further research is needed to tailor the strategy for specific developmental stages; currently all drinkers under age 21 are treated the same.
  
  
• The committee envisioned an industry-funded nonprofit organization to reduce drinking to include many stakeholders, both public and private. Since industry's interventions are not evaluated, this approach might help them gain credibility in their approach to the issue. As an accountability measure, industry could not have majority control.
  
  
• The recommendations focused solely on a media campaign.

Future Collaborative Opportunities: Reducing Underage Drinking Through Coalitions

Richard Yoast, M.D., Director, Office of Alcohol and Other Drug Abuse, American Medical Association (AMA), explained that his office's primary focus is the reduction of harms related to underage drinking and collegiate high-risk drinking in the communities around those universities. Two AMA programs funded by the Robert Wood Johnson Foundation (RWJF) undertake this work: Reducing Underage Drinking Through Coalitions, a series of coalitions in 10 states, Puerto Rico, and the District of Columbia, and A Matter of Degree (AMOD), 10 university-community partnerships that focus on changing the community environment surrounding the students and focusing primarily on changing alcohol policies. Harvard University is evaluating the collegiate program under the supervision of Henry Wechsler.

Dr. Yoast stated that the AMOD sites use multiple interventions: policy, social norms activities, enforcement, municipal and university policy, and messaging by recruiters, campus tour guides, and school administrators to incoming and continuing students. Harvard will soon publish a report on outcomes. Findings of the AMOD program sites are demonstrating declines in second-hand effects and harms, multiple changes in campus and community policy, and changes in campus/community relations in a wide range of areas, not just alcohol. The interactions have become a model by which cities and universities can work in a different kind of relationship. Communities themselves have begun to embark on their own long-term alcohol policy agendas.

A related advocacy initiative was undertaken on both the national level, to highlight local projects, and in four local sites, which aimed to change local community policy. The sites received intensive training on how to do community advocacy, community organizing, and media advocacy. Successes included changes in numerous policies, including bar-server training and a ban on drink specials. Nebraska formed a state coalition to change drivers licenses, and Newark, Delaware, passed an enforcement tax to pay for additional police in that community, BAC limits for the city lower than the state's, and nuisance ordinances. Iowa has adopted this model to replicate in communities across the state. Beyond its traditional academic role, the university can act as a prime mover in changing alcohol behavior.

Challenges include sustainability of the state coalition projects, funding for all of which terminates at year-end. Half the sites have not yet secured resources to continue. Neither the Federal nor state governments are providing funds in this area; foundation and government support is declining or nonexistent for alcohol policy research and intervention, while alcohol industry policy and media activities are expanding, and the industry is establishing its own coalitions at state and local levels.

The AMA has established an Action Team on Alcohol and Health composed of representatives of federation member societies, the AMA Alliance (physicians' spouses), and medical students. The medical student section is helping to develop strategies to educate medical students more about alcohol issues, particularly childhood and underage adolescent drinking, and is also working in communities. Einstein Medical College, for example, is conducting environmental scans with groups in its neighborhood to discern the level of alcohol advertising targeted at young people.

AMA has collaborated in the past with NIAAA to disseminate information in "A Call to Action," which has been well received by universities. AMA has crafted and distributed a letter to accompany the "Helping Patients with Alcohol Problems" guide sent to primary care physicians, helped to plan Alcohol Screening Day, and collaborated with Leadership to Keep Children Alcohol Free. AMA has conducted research on developing strategies for screening and intervening with adolescents, especially through school-based health clinics. AMA, which developed the GAPS guidelines for adolescent preventive services, is considering adding alcohol and other drug abuse interventions into their algorithms.

AMA and NIAAA have discussed using AMA as a vehicle to train and involve physicians in screening and intervention. AMA is considering best mechanisms, and obstacles, to transfer knowledge. AMA will use online training services, and also will determine whether the Continuing Medical Education (CME) model is appropriate or a barrier. AMA's Quality Section is examining how to translate science faster into practice and how to help medical students retain their knowledge and awareness of alcohol and dependency issues following internship and residency.

The Action Team set highest priority on drinking by young people, including underage drinking, high-risk drinking by young adults, and childhood drinking. Public awareness and consumer demand for screening services are lacking on this issue. The Action Team also focuses on the lack of attention to provision of services to adolescents in chemical dependency; services are less available than two decades ago due to changes in insurance, a decline of specialty hospitals, and a decline in student assistance programming and other services. A related problem is lack of parity for substance abuse services and coverage, and particularly a lack of language to address adolescents' needs. In addition, the Action Team is interested in the impact of adding a comprehensive screening and intervention component to the college programs encompassing prevention and policy change; the interest focuses on what the change in setting does to increase the potential effectiveness of clinical services, and what provision of clinical services does to add to the community and environmental change the program achieves.

With NIAAA, as it has done with other organizations, AMA hopes to increase its independent, visible, credible, and activist voice on alcohol issues. AMA enjoys easy access to the media and plans to speak more to the public and the media about the health impacts of underage and childhood drinking.

NIAAA has started to fill research gaps, but resources are declining for research and implementation of alcohol-abuse policy interventions in communities. RWJF has cut back funding for Bridging the Gap, which focuses on policy outcomes compared to behavioral surveys.

Dr. Yoast urged viewing alcohol policies, including at the state level, as comprehensive rather than piecemeal in terms of prevention, treatment, and service policies. He asserted that much greater service delivery capacity is necessary for adolescents, as is a clear agenda to continue and improve community policy interventions as they achieve improved effectiveness.

AMA's general website address is www.ama-assn.org/go/alcohol. Its Alcohol Policy Solutions website address is www.alcoholpolicysolutions.net; it describes advocacy activities such as liquor-free television, examples of coalitions, and resources for other activists.

Discussion

Ms. Taft complimented AMA on its work to further the spread of environmental approaches among communities and among prevention people. She encouraged AMA to continue nurturing relationships with community leaders. In response to a question, Dr. Yoast stated that he was unaware of recent surveys of medical training in the addiction area, but physician behavior surveys have shown that large percentages of physicians do not recognize signs of chemical dependency when presented with them, and a low rate of intervention results. Current training is inadequate, and what is presented often is lost during the years after medical school.

Ex-Officio Members Reports

Ex-Officio Member Dr. Hoffman stated that the Department of Defense is rejuvenating its efforts with an Alcohol and Tobacco Use Reduction Committee. Managers for these programs have examined together treatment policies and research related to tobacco and alcohol treatment that might be needed within Defense.

Liaison Representative Comments and Public Comments

Andrea Mitchell, representing the Substance Abuse Librarians and Information Specialists (SALIS), spoke about the status of the ETOH database. She noted that ETOH is a comprehensive and multidisciplinary alcohol-specific science database on research from the late 1960s forward that includes document types beyond journals, including books, book chapters, think-tank reports, practice manuals, and other resources. Because of its specificity to alcohol and its use of the NIAAA-funded Alcohol and Other Drug Thesaurus, she noted that records are indexed to alcohol science and the alcohol field.

Ms. Mitchell presented SALIS's request that NIAAA not cancel future development and support of the ETOH database and Alcohol and Drug Thesaurus, and continue to index and abstract the alcohol literature, and to consider the costs of passing the burden of searching across multiple databases on to NIAAA grantees and others.

Discussion

Dr. Li responded that NIAAA is still considering options with respect to ETOH. NIAAA is evaluating ETOH's database, in terms of function and cost. Dr. Li noted the existence of the unique resources of the National Library of Medicine (NLM) and that duplication of effort exists. NIAAA is considering whether cost savings would accrue if the Institute were to work with NIDA, the NLM, and other Federal agencies.

Dr. Faye Calhoun introduced Diane Miller, Chief of the Communications and Public Liaison Branch, Office of Research Translation and Communication, and Jeffrey Toward, a health science administrator with the Office of Scientific Affairs. Both are involved in collecting data and leading the ETOH database transition project. Dr. Calhoun noted that when ETOH was established 30 years ago, alcohol research was developing and personal computer capability was limited. At the creation of OSAP/CSAP in 1987, ETOH was modified to focus more on capturing research literature, with the NCADI database responsible for non-research materials.

Dr. Calhoun further noted that in 2004, increased access exists to databases supported by the NLM, including Medline, PubMed, Locator Plus, and others. PubMed administrators count 600 million annual searches from worldwide. NIH resources are available to alcohol researchers and investigators. The CRISP database and many other resources are available now that were not previously available on-line. NIAAA's homepage also lists resources unavailable in the past. ETOH is being evaluated in part because of the increasing number of alcohol research and publication resources, the current breadth and depth of alcohol research, and the difficulty and significant cost involved in increasing the number of monthly entries and making the database sufficiently comprehensive to support the alcohol research centers. In addition, no other NIH Institute supports a separate database.

So far, the review has found that in 2003, 73 percent of ETOH's references were journal articles, 11 percent abstracts, and 7 percent chapters. NIAAA compiled an updated list of 112 core journals to which the ETOH database subscribes; these journals accounted for 82,287 of the citations within ETOH, of which only one third were found to be unique to ETOH. The unique journals accounted for 3,591 citations (4 percent of the total number of journal citations), and four journals unique to ETOH accounted for more than half of those citations.

NIAAA currently is discussing with NLM the possibility of transitioning some of ETOH's functions to NLM, including adding the four journals unique to ETOH to NLM's subscription list.

Dr. Koob suggested additional polling from the centers. He suggested that Council learn how much the ETOH database costs, noting that the funding and energy required to maintain and expand it may make it impossible to maintain, and noted that if the level of NIAAA research is threatened by spending funds on the database, that would not be good. Dr. Sher suggested thinking about ways to move alternative literature, such as government reports, into traditional databases that have excluded it. But, he noted, it is difficult to evaluate the issue without knowing of possible solutions that would meet the need and not be redundant. Dr. Caetano pointed out that researchers in some alcohol subfields may feel more impact by the loss of ETOH, such as fields related to social sciences.

To a Council member's question Dr. Li responded that NIAAA is exploring various options. Issues of cost and usability are under consideration, as is identifying who uses ETOH extensively. Databases can be maintained in several ways, public or proprietary, as is done by two alcohol research centers. Dr. Li noted that room exists for improvement and cost-efficiency, based on progress in science and dissemination of knowledge.

Although time was set aside for public comment, no speakers chose to offer input to Council members.

Adjournment

Dr. Li adjourned the meeting at 3:07 p.m.

CERTIFICATION

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

Prepared: April 2004