National Advisory Council on Alcohol Abuse and Alcoholism

Summary of the 97th Meeting

June 6-7, 2001

In accordance with the provisions of Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S.C. and Section 10(d) of Public Law 92-463, the meeting was closed to the public from 7- 8 p.m., on June 6 for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The meeting was open to the public from 9 a.m. - 3 p.m. on June 7, for the discussion of program and policy issues.

Council Members Present:

Dr. Marilyn Aguirre-Molina
Dr. Alpha Estes Brown
Dr. Sandra Brown
Dr. Raul Caetano
Dr. Richard Deitrich
Dr. Anna Mae Diehl
Dr. Rueben Gonzales
Dr. Harold Holder
Dr. George Koob (open session only)
Dr. Barbara Mason
Dr. Matthew McGue
Dr. Steve Mirin (open session only)
Ms. Sheryl Ramstad Hvass, J.D.

Council Members Absent:

Ms. Linda Kaplan, CAE
Mr. Paul Samuels, J.D.

Ex-officio Council Members Present on June 7

Mr. Roger Hartman, ex-officio member from the Department of Defense (DOD)
Dr. Richard Suchinsky, ex-officio member from the Department of Veterans Affairs (VA)

Other Attendees on June 7

In addition to Council members and outside speakers there were approximately 90 observers present during the open meeting including NIAAA staff, liaison organization representatives, and other observers.

Call to Order of the Closed Session

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the closed session of the ninety-seventh meeting of the National Advisory Council on Alcohol Abuse and Alcoholism at 7 p.m., June 6, for the consideration of grant applications.

Review of Grant Applications

Dr. Kenneth Warren, Director, Office of Scientific Affairs, reviewed the procedures for the conduct of grant application review, and reminded the Council members of the regulations pertaining to conflict of interest and confidentiality.

Members absented themselves from the discussion and evaluation of applications from their own institutions, or in situations in which a potential conflict of interest, real or apparent, might occur. Members also signed a statement to this effect.

Council members concurred with all initial review committee recommendations for all grant applications available to them as summarized below. Applications which were "Not Scored" or with a percentile score of 40 or worse were not reviewed by Council.

The following table is a summary of applications assigned to NIAAA for the June 6 Council meeting and includes applications approved before the Council meeting by mail ballot or expedited Council concurrence. The table excludes applications for Small Grants (R03s), Fellowships (Fs), conference grants (R13s) for $50,000 or less in annual direct costs, and foreign applications with a percentile score greater than 50 percent. Small Grants and Fellowships and most conference grant applications do not require Council approval since they are for $50,000 or less in annual direct costs. The total years’ direct costs for "Scored" applications are at the IRG and Council recommended funding levels and the total years’ direct costs for "Not Scored" applications are the requested amounts.

Call to Order and Opening Remarks

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the open session of the ninety-seventh meeting of the National Advisory Council on Alcohol Abuse and Alcoholism, at 9 a.m., June 7, 2001.

Dr. Gordis noted that two Council members, Ms. Linda Kaplan and Mr. Paul Samuels, were unable to attend the Council meeting.

Dr. Gordis then asked all of the Council members and other attendees to introduce themselves.

Director’s Report

Dr. Gordis reported that the budget was sound for the present year. However, he impressed upon his colleagues that although Congress is in the third year of the proposed doubling of the NIH budget it remains important to focus on what NIH will do when the doubling comes to an end. He added that close attention to the issue now might preclude problems for new and competing grants in future years.

Dr. Gordis next reviewed Brain Awareness Week in which he was a speaker, and which was co-sponsored by NIH and the DANA Alliance for Brain Initiatives. Dr. Gordis praised Dr. Dennis Twombly’s presentation as the star of the event. Dr. Twombly presentation included an excellent model of the brain. More than 400 6^th and 8^th grade students and their teachers from Washington, D.C., participated in scientific activities that introduced them to the principles of neuroscience. Equipped with special glasses, students participated in a simulation of the effects of alcohol on the brain. They learned what the impact of alcohol might be when individuals believe they are in control but are not.

Dr. Gordis reviewed the activities of the February 20, 2001, NIAAA-sponsored workshop titled "Exploiting Clinical Trials to Study the Biological Basis for Recovery." The main issue was the extent to which investigators can exploit the populations of large clinical trials for studies outside the original goal of the clinical trial.

On the subject of problem drinking among college students, Dr. Gordis noted NIAAA’s National Advisory Council Working Group on College Drinking. He highlighted that the Working Group was comprised of college presidents and alcohol researchers who provided their expertise and guidance to NIAAA. This Group is chaired by Dr. Mark Goldman, Professor of Psychiatrist in Florida and Father Edward Malloy, president of Notre Dame.

Highlighting the Governors Spouses’ Initiative, which now includes 30 Governor’s spouses, Dr. Gordis commended their work in education, the media, video productions, and other activities.

Dr. Gordis briefly mentioned Alcohol Screening Day in which approximately 50,000 people across the country were screened at college and community sites.

Dr. Gordis then commented on the topic of impaired professionals which was discussed during in a meeting in which he participated. The meeting had been organized by the New York City Bar Association’s Commission on Alcohol & Substance Abuse in the Profession. Dr. Gordis was a speaker at this meeting. Issues underscored included, but were not limited to:

• Intervention—who is intervening?

• What are the payoffs as far as recovery of the impaired person?

• Draconian punishment—is it a deterrent?

• Salvaging the careers of physicians and other professionals

• Determining how long a physician has been impaired

• Egregious examples of physicians practicing with alcohol problems

• Problems related to the lack of a single database

• Protecting the public, protecting the patient

• Physicians reporting their alcohol problem

Dr. Gordis briefed the Council on the meeting of the NIAAA senior staff and the Directors of Alcohol Research Center in Durham, N.C, on May 7, 2001.

Dr. Gordis noted that NIAAA publications such as Make a Difference, Talk to Your Children, and the Project Northland are widely used in Russia, and the Project Northland was translated into Russian and is being used in Russian schools.

Referring to constituency activities, Dr. Gordis reminded the group that NIAAA maintains a program of formal collaborations with outside groups. Also, more than 400 outside groups comprise OPLPL’s contact list.

Continuing, Dr. Gordis commented on the Researcher in Residence Program and its obstacles and potential for success.

Turning to another topic, Dr. Gordis apprised the Council of a change in format for the Report to Congress on Alcohol and Health. He cited reasons for the change: the report is no longer required by law; the report is expensive and time-consuming to produce; and the "State of the Science" report in the Special Report replicates those in the NIAAA journal Alcohol Research & Health.

Dr. Gordis noted the excellence of RSA satellite symposiums. He informed the group that the COMBINE study’s clinical recruitment had begun and was progressing successfully.

Dr. Barbara Mason shared that the European Case Reports had been assembled. She commented on the Alcohol and Violence Workshop and noted that half of children appearing in emergency rooms have alcohol-related problems.

Dr. Gordis commended the accomplishments of several colleagues including Dr. Richard Veech’s and Dr. Kunos. He also announced Dr. David Lovinger’s acceptance of the position of Chief of the Laboratory of Integrative Neuroscience; and Dr. Stephen Ikeda’s acceptance of Chief of the Laboratory of Molecular Physiology. Dr. Gordis referenced the DICBR-Sponsored Seminars—listed on page 28 of Report of Institute Activities. He recognized new NIAAA members who included Dr. Denise Russo, Ann Malner, Dr. Eugene Hayunga, and Dr. Dorita Sewell.

Status of Leadership to Keep Children Alcohol Free

Dr. Marilyn Aguirre-Molina reported on the continuing activities of the 30 Governors’ spouses participating in the Leadership to Keep Children Alcohol Free initiative and other highlights of the program. Several spouses have spoken at national meetings, produced PSA’s, and written op-ed pieces. She noted that in April, USA Today published a letter to the editor on the problem of underage drinking from First Ladies Vicky Cayetano of Hawaii, Hope Taft of Ohio, Sharon Kitzhaber of Oregon, and Michele Ridge of Pennsylvania, the four national Co-Chairs of the Leadership initiative. Dr. Aguirre-Molina further noted that First Ladies Sharon Davis of California and Frances Owens of Colorado recently joined the initiative. In addition, the Governors’ spouses of Georgia and North Carolina sponsored policy briefings for State Legislators and other policy makers. As a result of those briefings, both legislatures created study groups to examine further the underage drinking issue in their respective States. In Wyoming, Governor and Mrs. Geringer hosted a statewide meeting on alcohol education for policy makers and practitioners in the field. In addition to these activities, the initiative produced two publications in recent months. The first, Keeping Kids Alcohol Free, Strategies for Action, is a new guide for community leaders and others undertaking local prevention efforts. The second, How Does Alcohol Affect the World of a Child, is the updated edition of a booklet already widely distributed by the initiative. Both publications are also being made available in Spanish. In conclusion, Dr. Aguirre-Molina announced that the second national conference for the initiative will be held in Washington next January.

Summary of Questions, Answers, and Comments

Dr. Alpha Brown asked whether "Keeping Alcohol Free" is on the Web.

Dr. Aguirre-Molina responded that it is, and is linked from the NIAAA Web site.

New Underage Drinking Public Service Announcements (PSAs)

Before showing the Public Service Announcements (PSAs), Diane Miller gave a brief presentation on the process involved in developing the PSAs. This project was a collaborative effort with the Substance Abuse and Mental Health Services Administration (SAMHSA). Many people were involved in the project; Ms. Miller recognized and thanked Dr. Gayle Boyd, NIAAA; Dr. Anita Eichler and Mr. Stephen Wing, SAMHSA; Ms. Dianne Welsh and Linda Pemberton, CSR; Initio, Inc., Dr. Kim Worden; and the many children who shared their thoughts and ideas with us.

The project’s goal was to prevent or reduce the early onset of alcohol use. To meet this goal, two 30-second television and two 60-second radio PSAs were developed. Early on we selected the target audience, 11-13 year olds, commonly referred to as "tweens." Three rounds of focus groups were held with the target audience. The first round of focus groups was designed to gather information about "tweens" lifestyles and attitudes. Based on the information gathered from this round of focus groups, a number of messages were developed and four were selected to be tested in the second round of focus groups. Each of the participants reviewed and graded the four messages. Based on the feedback from this round of focus groups, two messages were selected. Actual productions began and the PSAs were developed. Paid children actors were used in the PSAs. A third, and final, round of focus groups was held as a final communication check.

Each PSA conveys one message and the messages are consistent with the Office of National Drug Control Policy’s (ONDCP) National Media Campaign. The messages are based on development of positive norms -- "cool kids don’t drink" - and resistance/refusal skills -- "it’s okay to refuse a drink." Messages do not depict negative behavior.

The PSAs will be disseminated through various channels. One of the main vehicles for disseminating the PSAs is through ONDCP’s Media Campaign’s Pro Bono Match Programs. The PSAs were submitted for review to an ONDCP committee, approved, and sent to 102 of the largest TV and radio outlets. The earliest the PSAs may be aired will be June 25.

Other dissemination activities include engaging the Governors spouses’ support in sending the PSAs to local media outlets in their respective States. NIAAA and SAMHSA also will be enlisting the support of organizations and associations in airing the PSAs.

In addition to developing the PSAs, a website targeting "tweens" was developed, based on information obtained from the focus groups. The 11-13 year olds said that they were more likely to access information on a website than to call a toll-free number. As a result, we developed an interactive web site that features a TV/Radio Spots web page, an interactive Scenario/Options web page, a "Stuff to Know" web page, and links to other kids websites.

Summary of Questions, Answers, and Comments

Dr. Alpha Brown commented that he appreciated the hard work that went into the PSAs, and raised two questions. The first was to inquire of the rationale for using paid actors. He commented that using non-actors might encourage the kids to become activists in prevention, and to serve as a subsequent information base. He wondered whether there was a scientific reason for the use of paid actors. The second question addressed whether consideration would be given in the future to adding information on tobacco and marijuana to the website, given that alcohol, tobacco and marijuana are the three drugs most used by kids.

On the question of paid actors, Ms. Miller noted that there were several reasons for using paid actors. The first was the time factor--it took three days to film the television PSAs; without actors it would have taken much longer and we were under a time constraint to submit the PSAs for the ONDCP’s Pro Bono Match Program. In addition, the use of paid actors was highly recommended by the firm that produced the PSAs. This firm has produced many PSAs using kids. Lastly, there was the legal issue regarding permission and releases. However, Ms. Miller noted that in the future, the Institute would explore the use of non-actors.

Regarding the second question, Ms. Miller noted that alcohol is the number one drug of abuse among kids and the desire was to have a website that focused exclusively on that topic. Also, there are other websites, such as Freevibe, which focus exclusively on marijuana and other illicit drugs.

Dr. Aguirre-Molina asked what was meant by the phrase "stayed within the concept of ONDCP PSAs?"

Ms. Miller answered that the ONDCP has a very large contract for their media campaign but the contract is limited to illicit drugs. Funds from the contract cannot be used to either develop or pay for the airing of underage drinking spots. However, ONDCP does have a pro bono match. The media outlets are required to give pro bono air-time equal to the value of the purchased air time. ONDCP can distribute underage drinking PSAs for the pro bono match, and these can be shown, potentially, in prime time.

Ms. Miller went on to note that for the alcohol PSAs to be included in the pro bono match they must be approved by the ONDCP review committee. All PSAs, whether paid or pro bono, must be approved by this committee. If the spots are not consistent with the ONDCP philosophy, they are rejected. NIAAA wanted to be sure that the messages in its PSAs were consistent with the ONDCP messages so they would be included on the pro bono reel.

Dr. Barbara Mason noted that as the mother of a tween that she thought the spots were absolutely terrific. Knowing how well received the NIAAA pamphlet was on talking to teens about alcohol in the school systems, she wondered if there’s a way to get the schools involved in this activity because she believed that they would be most receptive. She noted that she received the NIAAA pamphlet in the mail from the school system, in addition to the copy she received from NIAAA. She noted that she could see the pamphlet and video spots working hand-in-hand.

Ms. Miller responded positively. She noted that when she said organizations and associations, that NIAAA is getting ready right now to produce about 800 copies of the PSAs, and schools are target organizations. The Institute is preparing a letter to go out under the signature of Dr. Gordis, as well as the Acting Administrator of SAMHSA.

Dr. Alpha Brown asked whether the Institute is planning to put the radio ads, the 60-second ads, on simultaneously. Are they going to run concurrently or simultaneously to the TV ads?

Ms. Miller responded that we will send the radio and TV PSAs at the same time to the respective outlets.

Award Announcement

Dr. Gordis announced that Ms. Diane Miller and Dr. Gayle Boyd shared an NIH Plain Language Award.

Break

Report of the Council Working Group on Research Priorities

Drs. Caetano, Eckardt, and McGue discussed research priorities.

Dr. Michael Eckardt, Office of Scientific Affairs, defined the Working Group’s major goal as providing NIAAA with field and Council input on research priorities, in this instance, for FY 2003. The Working Group is also asked to comment on NIAAA-related accomplishments in the past year, including scientific advances and stories of discovery. He explained that the Working Group’s suggestions are considered along with suggestions from Council Subcommittees that have reviewed various portions of NIAAA’s extramural research portfolio, suggestions from NIAAA senior staff, congressional directives, and NIH and DHHS initiatives.

Dr. Raul Caetano summarized research priorities for epidemiology and psychosocial areas.

Dr. Mark Goldman presented several priorities:

• A continued focus on college drinking

• Enlarge NIAAA’s constituency in terms of community support

• Craving and tolerance, which are indicative of alcohol dependence that can be looked at from a personality perspective as well as a perspective of the several biomedical mechanisms

• Developmental psychology is a potential vehicle for the integration of the biomedical and psychosocial areas. Given that developmental psychology focuses on areas of an individual’s life and because of the interaction that exists between personality, environment, and gene action, developmental psychology would provide the framework for examining the interaction in biomedical and psychosocial areas as the individual progresses during different stages of life.

Dr. Harold Holder’s priorities:

• Test individual and mixed (reinforcement) strategies to delay the onset of alcohol drinking—evidence suggests that the earlier the onset of drinking, the more severe the complications later in life, including increased probability of alcohol dependence

• Five-year national prevention trials to reduce high-risk drinking and related problems among college students

• Develop and field-test an alcohol sensor for testing of immediate BAC and exposure over the past 24 to 48 hours—most data are self-reported data and are valid, but need data that are not self-reported

• Test strategies to increase adoption of science-based prevention/intervention by practitioners

• Test early interventions for multi-problem youths, binge drinkers, smokers, high-risk sex, and violent behaviors

Dr. Stephanie O’Malley proffered priorities that include:

• Implementing research into practice

• Focusing on translating results from randomized clinical trials into programs in the community

• Developing a greater understanding regarding motivation to seek treatment—goal is to bring more drinkers into treatment

• Improving treatment retention—keeping patients in treatment so that they benefit from new medications

• Studying the interaction between alcohol and tobacco—co-morbidity between the two areas, such as partial cross-tolerance, shared genetic vulnerability, and attenuated sensitivity

Dr. Samuels’ list of priorities spanned the following:

• Focusing on the effectiveness of treatment and prevention—cost offsets are critical elements of treatment; research dependent on funds and the outside world’s and policy makers’ appreciation of NIAAA’s work

• Uncovering the causes and nature of addiction to alcohol

• Discovering alcohol’s link to social and health problems—50% of interpersonal and social problems reside with alcohol-dependent drinkers, but not all drinkers who have alcohol-related problems in the community are alcohol dependent, they may be only alcohol abusers

• Outreach to providers in the recovery community

Dr. Caetano’s priorities include:

• Pursuing national studies in epidemiology, including DUI, domestic violence, and FAS

• Developing consensus conferences

• Resolving health disparities

• Measurement of alcohol consumption; examining alcohol problems and alcohol dependence

• Spatial epidemiology involving geographical localization associated with interacting events of interest requires the development of new methodology. Identifying clusters, occurrence of events, and trying to predict why those clusters are occurring based on social demographic data, geographical data of small areas, and small communities

• Treatment research focused on ethnic groups

• Translating research into practice

Summary of Questions, Answers, and Comments

Dr. Alpha Brown asked to what degree do these recommendations help overcome the disparities in treatment and research, prevention, and intervention vis-à-vis minorities?

Dr. Caetano responded that this is difficult to answer. One must examine the recommendations to see specifically what is going to be accomplished. There are many health disparities. DUI, FAS, and violence were mentioned. These are the three areas in which health disparities are very evident but are not the only ones. So it is likely that the answer would be that they would be covered to some extent but not fully.

Dr. Warren also noted that there is a separate Health Disparities Strategic Plan, which NIAAA has already placed on its web site.

Dr. Mirin noted that there is much consensus about the needs for research dealing with the identification and early intervention in youth. Such research is important from a prevention standpoint. Dr. Mirin asked about the other end of the spectrum, the elderly. He noted that there are a number of organizations that advocate in the field having concerns about the under appreciation of alcohol problems in this population; its impact on issues such as compliance with medical treatment, accidents, domestic violence; and a whole host of other complicating factors. He expressed a concern that this population is under-sampled in some studies.

Dr. Caetano responded that the 2000 Census is showing us that there are two big trends. One is an increase in the elderly population. The other is an increase in the ethnic population—the minorities. He expressed, therefore, that this is where our focus should be. He noted that we need to understand more about these populations if we want to be prepared for what’s going to happen 30, 40, or 50 years from now.

From an epidemiological perspective, what happens is that investigators sample a number of individuals, but if they do not over-sample a specific group, such as the 65-year-olds and older, they will obtain only a very small number of people from this age group for analysis. They are then very limited as to what you can do with the data.

Dr. Caetano indicated that he is aware that providers are very concerned over late-onset alcoholism. He suggested that the field needs a good study that would, as suggested by Dr. Mirin, over-sample the elderly population and look at the extent of the problems there. He also noted that he does not think that one sees this population in treatment.

Dr. Mason noted that one problem in epidemiological sampling of the elderly for alcoholism is the fact that the elderly population will be missed because some of the diagnostic criteria, such as impaired vocational functioning, do not apply. So the field also needs some modification of the diagnostic criteria these groups.

Dr. Caetano agreed with Dr. Mason. There are other criteria which are problematic. For instance, one of the criteria for alcohol dependence in the Diagnostic and Statistical Manual of the American Psychiatric Association (DSM) is spending a lot of time drinking and involved in activities that lead to drinking. If you’re retired, you have lots of time on your hands, and since you’re measuring time relative to other responsibilities that you have, there may be problems in applying that criterion of alcohol dependence among the elderly.

Dr. Aguirre-Molina again raised the issue of the changing demographics of the United States, where 30 percent of the population is Latino, African American, or Asian, and it’s expected, over the next 20 years, to continue to grow to 40 percent or more. She noted that it is important to get a handle on this issue. She commented, as well, that is incredibly important for the Institute and field to assure that studies have adequate representation of these emerging population groups now. The numbers are so great and our information base is so limited. She noted that suddenly, America has a bimodal distribution of young ethnics and more elderly whites. She further commented that we do need some very focused studies with the general population having adequate representation or distribution that matches the overall population.

Dr. Eckardt noted that NIH reports on gender, ethnicity, and racial composition of its human studies on a yearly basis.

Dr. Aguirre-Molina asked what NIH does with this information, and what kind of accountability is built into those requirements.

Dr. Eckardt responded that if NIH research is not approximating the national proportions, then a plan has to be implemented to correct the situation.

Dr. Sandra Brown further commented on the tracking issue. She noted that in many studies, we do not have samples large enough to analyze the findings for specific populations. She went on to suggest a consensus meeting to develop core measures that are considered important from an intervention perspective or a measurement or diagnostic perspective. If the field had such core measures that would be one way to get better scientific yield across sub-populations. Even if in individual studies there were insufficient data to analyze, issues could be analyzed more broadly across multiple studies.

Dr. Eckardt noted that NIAAA considers health disparities or minority research to include only those studies in which there were planned comparisons between minority or ethnic groups or there was over-sampling.

Dr. McGue noted that the fundamental issue is the limits of generalizability. To what extent are processes ethnic-specific versus generalized. To address this question, one probably needs targeted over-sampling and projects really targeted to address those questions. He saw a priority of really addressing issues of generalizability across ethnic groups rather than just getting whatever the appropriate proportions are in the various projects.

Dr. Alpha Brown noted that excellent points were presented in terms of priorities. However, when he thinks of the African American community, he thinks of the social problems that affect the community. For example, the Nation’s capital has the highest arrest rate in the country—four times the national average for adults, three times for kids, and it’s mostly from the Black community. Looking at prison populations, alcohol is associated with 40 to 80 percent of the problem. He noted that he was concerned about epidemiological studies addressing the true specific needs of communities of color. Prisons and jails and teenage pregnancies and a whole host of other kinds of issues need to be looked at and examined not just for African American communities, but he suspects for other communities as well. He would like to assure that prioritizations address real social ills.

Dr. Mirin noted that with the changing demographics of the population, we are actually aware of the need to look at ethnic and cultural differences and developmental issues for illnesses across the life cycle, including in the elderly. To that end, the DSM-V process has begun and APA has established six working groups. Two of the groups address exactly these issues. He noted that Dr. Gordis is a member of the advisory committee for DSM-V.

Dr. Aguirre-Molina asked whether it be possible to have the Health Disparities Plan as an agenda item at the next meeting. This was agreed to.

Dr. Eckardt noted that when we talk about 5-year plans, what’s presented here today is a 1-year slice of that plan, for fiscal year 2003. He emphasized that there is a long term 5-year plan, and then there are more operational components each year. One issue which he believed Council members were alluding to was just how the 1-year plan relates and makes progress toward the overall health disparities 5-year plan.

Dr. Matthew McGue went on to summarized biomedical priorities, which he referred to as an ongoing discussion rather than a final list of priorities. He cited several themes, among them, the following:

• NIAAA should be more involved in Bioinformatics. A vast amount of biological data is being generated—gene sequencing data, gene expression, microarray data, imaging, and up to 128-channel EEG and ERP recordings. There’s a clear need to have systems in place to process, integrate, and make biological data accessible to the research community.

• Genetics was seen as a high priority at NIAAA, including animal models—particularly with mouse and the continuing support for the use and development of transgenic knockouts and more recently, random mutagenesis screens. Gene- chip technology is of importance to the alcohol field. Important also is the modulation of alcohol toxicity, drug efficacy and response, the extent to which individual genotypes differ in the way they react to pharmacological interventions, the way they react to alcohol and to the effect of alcohol on tissue systems.

• Medication development and therapeutics: should focus on combinatorial chemistry to manipulate existing pharmacological interventions. Medications needed to treat specific and end-stage diseases such as liver disease and cardiomyopathy.

• Neurobiological approaches are: needed to understand the neuroadaptive changes that accompany long-term exposure to alcohol, in particular, how those long term changes convey risk for alcohol dependence. The relationship between satiety and alcohol reward mechanisms was given as a specific area where there’s some interesting work now on neuropeptide Y and this should be a priority, along with leptin. Dr. Caetano already mentioned the interesting interactions between nicotine and alcohol.

• Pathogenesis: identifying alcohol’s toxic effect as well as the toxic effects of its metabolites, particularly acetaldehyde. We need better endophenotypes, phenotypes that mediate the genetic effect but are more proximal to the primary gene product. Those endophenotypes need to be developed in a longitudinal research setting.

• Understanding heterogeneity essentially between alcohol abuse and alcohol dependence. Understanding resilience as well as dependence. Understanding individuals who succeed in spite of all obstacles to succeed and the mechanisms that underlie that and individuals that not only succeed developmentally but also succeed in treatment. Better integration across a wide range of areas.

Summary of Questions, Answers, and Comments

Dr. Koob asked how the Institute would find funds for such programs as combinatorial chemistry and development of new medications.

Dr. Eckardt responded that the Institute has a formal planning process underway to look at medication development. With limited resources, the issue is how to best utilize those resources.

Dr. Aguirre-Molina asked whether NIAAA would be interested in looking at the research network on tobacco that Robert Johnson has funded. She suggested examining the network to get the entire range of biomedical and social science projects for the purpose of undertaking integrated research. She suggested this would be a place to begin and an ambitious attempt to get people who don’t talk or work together to figure out how they might do joint studies, or at least exchange ideas.

Dr. McGue noted that the specific recommendation that came out of the working group was for NIAAA to consider specific targeted topics that would bring together small groups of researchers. He further noted that craving is one example of an issue where you have people working from the behavioral to the neurobiological and the molecular level. The benefit there is not only to inform each other of what’s going on, but also to actually challenge how what one is doing is relevant to what the other is exploring. He believes this is something that is more effective in small groups where you must confront one another.

Dr. Eckardt responded that this is an ongoing process and encouraged Council members to make suggestions known to the Institute for consideration.

Dr. Caetano noted that he wanted to emphasize the issue of bringing people together. He remarked how he learned tremendously in a meeting on tolerance. For the first time he realized that the people who are dealing with human subjects were talking about one type of tolerance, which was basically chronic tolerance, tolerance that arises in humans after years and years and years of alcohol use. And the investigators using animal models to study tolerance were basically talking about acute tolerance, that is, tolerance that developed in animals in one hour. There was obviously a big difference in the two processes that were being identified by the same name but were totally different phenomena. He noted that there is a lot to learn from each other if we have the opportunity to be in the same room and examine the same issue together.

Chemical Approaches to Understanding Alcohol Drinking Behavior

Dr. Reuben Gonzales presented to the National Advisory Council on the research programs of his laboratory. He emphasized that the basic question that guides the laboratory is: How does alcohol drinking occur, and what controls it? His presentation emphasized the following points:

• Alcohol drinking is a very complex behavior, but it ultimately is controlled by the brain. To gain a complete understanding of even a simple behavior, it is necessary to look at various levels of analysis. It is known that various brain systems coordinate and work together to produce an ultimate behavior. Neural systems are made up of individual circuits, which are made up of individual cells, and we have gained significant knowledge on how cells communicate with each other. Ultimately, the cell’s function is controlled and regulated through molecular interactions. There is much elegant work in progress on this type of integrative approach.

• In Dr. Gonzales’ laboratory, they have concentrated on examining the cellular and molecular events in a functional manner, combined with behavior. This is a multidisciplinary, multilevel analysis focusing at the chemical and behavioral level. To undertake such research they are employing methods that permit them to monitor the chemical changes that are occurring in the brain while the experimental animal, is engaging in the particular behavior— in this case, alcohol drinking.

• Microdialysis is the technique used. Microdialysis is essentially a chemical sampling technique. It allows the investigators to introduce a chemical window into the brain.

• The animals used in the self-administration studies are mice and rats. Most of the work to date has been done in rats with the mouse a more recent development. Because of the ease of genetic manipulation, the use of mice will allow the investigators to use new genetic models, and they hope it will allow them to gain insights not available with rats. The overall technique for alcohol self-administration was developed many years ago and it does not model alcoholism per se. In their approach, they are assuming that the information they obtain from this type of "normal" alcohol self-administration will eventually give them critical information in terms of alcoholism. However, Dr. Gonzales noted the approach does not address such issues as loss of control or really compulsive drinking, although, new animal models are being developed along those lines.

• Dr. Gonzales showed a computer animation to illustrate the technique that they are using.

• The microdialysis probe is placed in the brain
  
  
  • An inlet tube introduces the fluids, and this is connected through another tube to an outlet. They pump fluids into the inlet, and what the animation shows is that the fluids then reach the working part of the microdialysis probe.
    
    
  • The chemical diffusion takes place and allows the investigators to sample the chemicals that were being released from the brain.
    
    
  • Looking closely at the dialysis membrane, it is a molecular filter that allows small molecules to pass through it and excludes large molecules.
  
  
  • The molecules that they are interested in are the ones that are released by neurons that allow communication between neurons. These molecules readily pass through this membrane.

Dr. Gonzales explained that the technique is called microdialysis because the dimensions of the probe are in the micron range. The diameter is approximately twice the width of a human hair, and the length ranges depending on the region of the brain and the experimental subject that you’re using. From another animation, he demonstrated where the probe is placed in the rat brain. His demonstration included a view of one of the pathways that they believe to be involved in motivated behavior and implicated to a large degree in the actions of various drugs. He emphasized that there are various pathways in the brain. The advantage of the microdialysis probe is that the small nature of the probe does not cause a major amount of tissue damage. With the probe in place, the rat can undergo its normal repertoire of behaviors, including eating and alcohol drinking, as the case may be.

Another major advantage is that they can continue to sample over a period of time, and under various behavioral conditions.

Continuing, Dr. Gonzales imparted that it has been 15 years since the first microdialysis study was done specifically regarding alcohol’s effects on the nucleus accumbens. Therefore, they know that this brain region is activated that the major neurotransmitter that is released in the nucleus accumbens, due to activation of this pathway is dopamine A large amount of data suggests that dopamine plays an important role in alcohol drinking behavior. To date, however, it is not clear exactly what that role is.

If alcohol stimulates the release from the dopamine pathway then how is it occurring? If one can understand this, and if it does play a major role either in the development or maintenance of drinking, one may be able to devise pharmacological interventions. Dr. Gonzales added that there is another potential mechanism. If the dopamine transporter is blocked, this would cause an increase in dopamine in the extracellular fluid that would be detected through microdialysis.

Dr. Gonzales explained that quantitative dialysis is a way of manipulating the conditions to get more detailed information about the dynamics of the system. He mentioned that with this type of quantitative approach, it is possible to get two major parameters: total recovery of dopamine (metabolites) and the extracellular concentration of dopamine.

Dr. Gonzales presented the findings that the increased dopamine release is due to the increased firing rate of the neuron rather than a decrease in re-uptake. He asserted that this is consistent with other electrophysiological evidence. But for the first time, they have shown that this occurs in a non-restrained, conscious animal in an intact system.

Concluding, Dr. Gonzales reiterated that one of the advantages of microdialysis is the ability to look at chemical changes while the animal is drinking, and he credited Dr Bert Weiss for many of the significant findings.

Summary of Questions, Answers, and Comments

Dr. Diehl asked what happens if you keep the dopamine levels high? Does this modify the animal’s behavior? If you use an uptake inhibitor and you keep the dopamine levels high, does that modify the animal’s behavior?

Dr. Gonzales noted that these types of studies should be done, that is studies in which the dopamine system is manipulated. He also noted that, at present, any conclusions that can be made are based on correlations. Dr. Gonzales went on to note that all of the data were not presented, but in studies with Dr. Bert Weiss some animals had been given naltrexone. Naltrexone decreased the dopamine levels and also decreased drinking behavior. Again, this finding is correlative, but it is consistent with the idea that if one manipulates the dopamine system, it may have an effect on behavior. He further commented that the genetic models are going to be very important in answering this question.

Dr. Mirin asked, with respect to the rise in dopamine levels, whether experienced rats were used in the study? He also asked whether the anticipatory rise is seen with placebo administration?

Dr. Gonzales noted that those exact studies have not been done but Dr. Bert Weiss has followed up on some other relevant work, and he has shown that not only with alcohol, but also with saccharine self-administration, that dopamine levels do increase in anticipation of the reinforcer.

Dr. Mirin asked then if there was a complete blockade of ethanol effects, might one see over time in these rats a fall-off of the anticipatory increase in dopamine? In other words, would there be desensitization?

Dr. Gonzales replied that this is possible.

CLOSED SESSION

Dr. George Kunos, Scientific Director of the NIAAA Intramural Program, presented a Report from the Board of Scientific Counselors in closed session.

Lunch Break

OPEN TO THE PUBLIC

The session begins as Dr. Gonzales concludes his discussion with a computer animation. He noted that this work for this animation was done in rats; but, presumably, similar mechanisms occur in the human brain.

Consideration of the Minutes of the February 7-8 Council Meeting and Future Meeting Dates

Presentation by Associate Director for Behavioral and Social Science Research

Dr. Raynard Kington focused on the future direction for NIH research in the Behavioral and Social Sciences. He gave marked attention to future directions that have been identified as those most likely to have significant impacts on the health of the public with sufficient support at NIH. He reminded the audience that NIAA has a well-deserved reputation for being a leader at NIH in integrating behavioral and social perspectives as a core part of its mission. The Office of Behavioral and Social Science Research (OBSSR) has defined its mission that includes three broad components, they follow:

• Enhancing behavioral and social sciences research and training at NIH

• Expanding what was described as a biobehavioral interdisciplinary perspective across institutes
  
  
• Improving communication with the health scientists and the broader public about important advances in behavioral and social science research. Those goals can be achieved by:
  
  
  • Working collaboratively with all institutes and centers in developing research agendas
    
    
  • Supporting relevant RFAs & PAs
  
  
  • Providing consultation to institutes and centers as they develop programs in the behavioral and social sciences

Dr. Kington divulged that 15 leading scholars were appointed to a committee to develop a research plan to guide NIH in more behavioral and social sciences research, focusing on areas of common interest across institutes and centers; areas with the likelihood of the greatest scientific payoff; and areas of greatest importance to the health of the public.

The committee identified 10 areas that it determined to be most important for future research in the behavioral and social sciences at NIH. The 10 focus areas follow:

• Predisease pathways

• Environment and gene expression

• Personal ties

• Healthy communities

• Population health

• Positive health or health promotion

• Inequalities

• Interventions

• Methodology and training

• Research infrastructure

Dr. Kington reviewed each area. He related that increasing evidence supports that the processes that result in poor health in adult life have their beginnings as early as prenatal care. In addition, the Committee recommended that NIH expand its support of research on key indicators of biologic influences but also the related behavioral, psychological, and social influences that precede morbidity and mortality. The idea is to develop an early warning system to identify precursors of poor health outcomes.

Regarding environment and gene expression, he remarked that the tremendous advances in our understanding of the human genome have raised a number of new questions about the pathways by which behavioral, psychological, and social factors interact with genetic factors. He continued saying that now is the time to lay the foundation for the next platform of research that will tease out the pathways that connect genetic factors with social factors and psychological and behavioral factors.

Focusing on the area of personal ties, Dr. Kington referred to the large body of literature that has demonstrated the important role that various forms of personal ties have as risk factors for a wide range of health outcomes. Also, he revealed, scientific data suggest that characteristics of communities seem to have a relationship with health outcomes of individuals which are independent of the individual characteristics of people. Community characteristics are being explored as risk factors as well. Concerning population health, Dr. Kington expressed that scientists need to have a better understanding of determinants of large and important trends in population health and in health care over time. Throughout all of these areas, the Committee agreed that it was essential to have better data that link biologic processes with behavioral and social processes.

Dr. Kington relayed the Committee’s pronounced concern that too little attention has been focused on the study of positive health outcomes, which includes not simply the absence of disease, but the presence of some forms of wellness. Some of the most interesting work is particularly looking at personal and social resources that seem to have a buffering effect when an individual is placed in that context who has personal characteristics that otherwise would not place him or her at risk for poor health outcomes.

Inequalities in health were a major focus for the Committee. Dr. Kington pointed out that there is increasing evidence illustrating that individuals’ places within hierarchies of various forms seem to correlate well with a wide range of health outcomes.

Dr. Kington directed the group’s attention to a report recently released by the Institute of Medicine that deals with intervention. The report titled Promoting Health: Intervention Strategies from Social and Behavioral Research, which details the challenges of translating what is understood about behavioral and social factors and interventions. He also recognized NIAAA’s large portfolio of intervention studies.

Addressing the broad area of methodology, training, and research infrastructure, Dr. Kington informed the group that the committee identified major methodologic problems in moving the research ahead to the next level. They also agreed that they need new measurement techniques and study designs, particularly study designs that integrate data from multiple levels of analysis from individuals to families to communities. He acknowledged that NIAAA has supported research on the measurement of alcohol consumption. But we need to have a better measure of a wide range of factors, in particular, the characteristics of social organizations from families to communities that have an impact on health. Dr. Kington related that the committee supports more longitudinal study populations, particularly those that integrate both biologic and genetic data that will help tease out how those groups of factors interact.

Dr. Kington articulated necessities that included the following:

• New type of researcher—researcher who can cut across disciplinary lines as new programs are developed

• Continual vigilance to ensure that NIH retains a diverse population of researchers who can address a wide range of outcomes and problems across a wide range of communities

• Significant partnerships with all of the institutes and centers on campus

Summary of Questions, Answers, and Comments

Dr. Caetano inquired about the Office and its collaborations. How does the collaboration happen?

Dr. Kington responded that one mechanism is the behavioral and social science coordinating committee. Representatives from each of the Institutes and Centers are assigned who meet on this committee at least once a month. That serves as a two-way flow of information—both from areas that the Institute and Centers are interested in exploring and from his Office and to the Institute and Centers.

Dr. Kington noted that there are also more informal relationships. Each of the Institutes and Centers is assigned a specific staff person in the Office who makes a point of being informed about what is happening in Institutes and Centers and will often attend the Council meetings and participate in other activities within the Institute.

Dr. Diehl noted that one of the points Dr. Kington emphasized was training scientists who could bridge the diverse disciplines. She expressed her view that NIH already has people who have been trained in that way-- physician scientists. Although NIH has well-developed mechanisms to introduce people into that career path, Dr. Diehl expressed that right now there is a risk of losing the more senior people. She commented that it takes a couple of decades to train people to have sufficient expertise to truly bridge the social and scientific dimensions. She further commented that with the current whimsies in medical practice, some of the most senior and experienced people who should be stepping up to the plate now to form this bridge are being dissuaded and leaving academics because of the pressures on their career. Dr. Diehl wondered if there’s an opportunity here for NIH to develop a system to retain these people so that they can now give back some of the investment that was made in their careers up to that point.

Dr. Kington responded that one mechanism, among others, is the loan forgiveness program, which will allow institutes to pay off educational debts of researchers who ultimately go on to clinical research. He further noted that there are very few physicians/M.D.s, Ph.D.s in social sciences, likely less than 30. Most of these individuals are very active in research and policy. Dr. Kington went on to note that there is a new generation of M.D.s/Ph.D.s who are coming out with strong foundations in clinical medicine and strong foundations in a second discipline, and usually that Ph.D. is in social sciences.

Acceptance of Minutes by Dr. Kenneth Warren

Unanimous.

Future Council Dates

Dr. Warren referred to the agenda for the future meeting dates. He noted that the meeting dates were confirmed through September 2002. Dr. Warren recommended that Council members looked at the 2003 dates because rooms must be reserved 2-3 years in advance.

Update from the National Association of Social Workers (NASW)

Ms. Nancy Bateman introduced NASW to members of the Council. She noted that NASW is the largest professional association of social workers comprising 57 chapters and 155,000 members. Their mission is to advance social work and advocate for clients—the individuals, the families, and communities. She added that NASW is concerned with consumer protection and is involved with issues around practice standards. They also do professional social work credentials and certifications. She concluded her introductions by mentioning that NASW has rolled out a new specialty certification in addictions.

Ms. Bateman summarized information gathered from their Practice Research Network. NASW conducted a random sampling of their regular members. They were particularly interested in understanding more about the population that NASW was serving that presented with alcohol and drug abuse issues. In addition, they were also able to gather general information about their membership. Excluded from the sampling were students, retirees, and those who did not have a domestic address.

Ms. Bateman shared that the response rate was 81 percent. The data revealed that NASW members are mainly women, middle-aged, and white. Ninety-one percent possess a master’s degree in Social Work, and have an average of 15 years of service. NASW members work primarily in organizations (about one quarter), 20 percent in private practice, and some in both organizations and private practice. Their concentrations span mental health 39 percent, social work 6 percent, and addiction as a specialty 2 percent, with almost 60 percent of respondents involved in direct services.

For NASW respondents in organizations who treat clients who abuse substances, half of all their clients are treated for alcohol and drug use issues; and about 30 percent are treated for alcohol use only. In private practice 45 percent are treated for alcohol use only, and slightly fewer than 40 percent presented with a dual alcohol and drug use diagnosis. More time is spent with these clients in screening and assessment than the general population of clients being seen by practitioners.

Ms. Bateman acknowledged a gap in current and ongoing training for the social work profession. That is, percent of members reported having had at least one or more hours of professional development or training in the past year. However, 53 percent of those indicated that none of these hours were focused on substance abuse. Ms. Bateman revealed that NASW wants to gear their training in the direction of alcohol and drug use. They hope that current and future survey data will prompt actions to get cutting-edge information into the hands of their practitioners. She continued stating that one of the issues on the horizon is stigmatized identity that can lead to an increase in risky behaviors such as alcohol and drug use.

Ms. Francesca O’Reilly, also from NASW, clarified the purpose of NASW’s legislative advocacy. She shared that NASW is promoting Federal policies and legislation that supports social work practice, enhances the lives of the people they serve, and advances social and economic justice. NASW has five main areas of interest:

• Health and mental health

• Economic equity

• Civil rights

• Child welfare

• Education

In the area of health and mental health, NASW is most concerned about the integrity and stability of Medicare, Medicaid, and Social Security; parity for mental and behavioral health treatment and prevention; access to coverage of appropriate and high quality health care services; and the privacy of medical records and patient information. NASW is also focused on educating policymakers about the importance of making qualified providers available and the need for a National Center for Social Work Research.

Summary of Questions, Answers, and Comments

Dr. Caetano endorsed Ms. O’Reilly’s statements regarding the fact that there is more support for mental health issues than alcohol. He attributed this to the different stigmatization of the two areas. Ms. O’Reilly agreed that many people who deal with substance abuse disorders don’t feel very comfortable discussing them, and are not willing to make it public. As a result, legislators don’t know that these kinds of programs are important to the public, and therefore won’t vote for them. She concluded that it is difficult to justify the expenditure of public dollars on programs for which legislators can’t demonstrate public support.

Dr. Gordis noted the importance of privacy but raised an issue about the tradeoff. He offered an example whereby notes were sequestered just for substance abuse conditions, but not for other domains of medicine. He continued that this would mean that people with access today would no longer have access, thereby setting up an artificial wall between people who have a substance abuse disorder and those who have other types of medical conditions such as a neurological or a liver disorder. He questioned how the system would work if under its optimum functioning an individual who was seeing somebody for hypertension, and where alcohol may be a contributing factor, whether the clinician would have access to the fact that there’s a treatment record on alcoholism in the hospital? Dr. Gordis shared that his experiences many years ago were very different, and wanted to know what the impact of the privacy regulations would be in this situation since a clinician treating an individual needs to know everything about him if he wants to give proper medical care.

Ms. Bateman replied that she is not an expert on the privacy regulations as they exist now, but that NASW’s is conducting a review of the privacy regulation comments so that they can figure out the implications of these new regulations. She shared that there is already Federal law about the privacy and confidentiality of substance abuse records, and from her point of view there are a lot of complications associated with these laws. She reminded the audience that most of NASW’s members are not practicing in substance abuse settings, but they are still seeing clients who may present with these problems. She pondered which regulations should apply in a different setting, and noted that she did not have an answer.

Ms. Bateman then shared that her members have a two-year period to comply with the privacy regulations that the Bush administration just passed as it relates to psychotherapy notes. She believed that there was recognition of the special and discreet nature of mental health records, but was not completely clear where substance abuse fell into this category. She explained that there was a very clear definition of what was defined as psychotherapy notes and what information is not defined as psychotherapy notes, but would continue to be in the record such as a summary of treatment, diagnosis and similar things. She clarified that the designation of psychotherapy notes is intended to address the more detailed information that therapists and counselors tend to keep about clients that may or may not have a lot of relevance for the record or be necessary to include in the record. Ms. O’Reilly added that given the patient’s prior consent, medical records could be shared among practitioners. Therefore, the primary care physician should be able to gain access to the necessary medical records as well as the mental health practitioner. Ms. O’Reilly concluded that the regulations would not preclude sharing information, it simply depended upon consent.

Dr. Gordis asked Dr. Mirin to comment on his experience with the patient’s interest in privacy for very personal reasons, versus the need of the practitioner in a medical setting or at a hospital to know everything about the patient he’s seeing. Dr. Mirin began by sharing that during the two-year interim before actual implementation, there would be some opportunities to comment, and that his organization had in fact been asked to provide comments. He agreed that there is a need to segregate certain kinds of information that doesn’t have direct relevance to a medical practitioner treating liver disease, for example, but reasoned that there can be a means to learn that someone has a diagnosis of alcoholism, is in a treatment program, is getting x, y, and z kinds of treatment, without necessarily divulging personal information. Dr. Gordis asked would the fact that a person is being treated for alcoholism be shielded under the present regulations, or would people in the institution know it? Dr. Mirin confirmed that the treatment for alcoholism would not be shielded. However, he wondered what level of consent would be needed to obtain aggregated data on patient populations for epidemiologic research studies. Dr. Gordis concluded that this question would open up a hornet’s nest that couldn’t be addressed right now, and thanked Ms. Bateman and Ms. O’Reilly for their presentations.

Discussion of Policy Issues

Dr. Aguirre-Molina noted that Dr. Harold Holder had asked her to follow up on questions raised at the previous night’s Grant Review section of the Council meeting. This has to do with the number of applications received by NIAAA in both the treatment and prevention areas. She asked what the thinking is on why prevention research applications are declining, and how have NIAAA prevention research applications done in the NIH review process? She also asked what can be done to increase the number of applications coming through for prevention research?

Dr. Gordis responded that he would first ask Dr. Warren to comment on how prevention grants have done in the NIH review process. Then he would call upon Dr. Fuller and any one of his colleagues who would like to join him to comment.

Dr. Warren addressed both treatment as well as prevention applications, and he noted that there are technical differences between how those two areas are handled in the context of review.

Dr. Warren explained that virtually all research applications in the treatment area are reviewed, not within the Center for Scientific Review (CSR), but rather by a chartered review committee within NIAAA. With respect to treatment research applications Dr. Warren provided his impression that the number of treatment applications appears to be decreasing over the last few rounds. He did not know the full reason for this, and he expressed that there could be multiple factors involved. Dr. Warren noted that while others will provide their own perspectives, all these views will be based on perceptions rather than data, which will need to be retrieved from the historical files to assess the question more completely.

With respect to prevention research, Dr. Warren noted that the regular research (R01) prevention applications are reviewed within Scientific Review Groups in the Center for Scientific Review. Most of the alcohol prevention research applications are assigned to committees that carry the acronyms of SNEM-1, and SNEM-2. These CSR committees serve the entire NIH, but since their focus is on particular areas of behavioral research found in only a select number of Institutes, they likely review applications for somewhere between six and eight Institutes.

Dr. Warren did not have the perception that the number of prevention applications has been decreasing, but he noted that the number of prevention applications with outstanding percentile scores may change from round-to-round. With CSR committees reviewing applications from more than Institute, and with percentile scores calculated on the basis of all applications before the Committee, rather than on an Institute by Institute basis, the percentile ranking for NIAAA’s prevention applications can change significantly between rounds. This phenomenon is less of an issue for treatment applications since the Scientific Review Group responsible for their review sees only NIAAA applications. Dr. Warren commented that in 1996, NIAAA integrated the review of prevention research applications into CSR. When the integration first took place, the Institute monitored quite closely the performance of NIAAA applications in the new CSR committees. At that point in time NIAAA applications fared very well. Dr. Warren noted that based on his own casual observations, looking at the scores of the applications coming from SNEM-1 and SNEM-2, and the predecessor to these committees (Community Prevention and Control) he has observed that occasionally alcohol applications have had the best scores coming from the committees. But given the size of the pool of applications, in any given round the percentile scores for NIAAA applications will differ based upon both the quality of the alcohol applications before the Review Committee, as well as the relative quality of the applications from other Institutes.

Dr. Warren invited Dr. Caetano to share his perspective as an individual who has served on more than one CSR review committee having responsibility for the review of prevention applications.

Dr. Caetano noted that he had been a member of the old NIAAA Epidemiology and Prevention Review Committee that was integrated into CSR forming Community Prevention and Control (CPC). This committee later split into SNEM-1 and SNEM-2. When this split took place, Dr. Caetano moved to SNEM-2. Dr. Caetano noted that throughout his period of service on these committees—and this is more than five years of grant review—he was always very happy with the way alcohol research was treated. In the Community Prevention and Control study section, the grants that were reviewed came from a wider set of Institutes, and there were large prevention applications from NCI and other big institutes at the NIH. When the Community Control section then became SNEM-1 and SNEM-2, then the applications’ review became much more focused on mental health, drug abuse, and alcohol. In all of his experiences with CSR committees, Dr. Caetano noted the he never observed any bias against alcohol application, and he thought that all the applications received what is a fair and competent review at all times.

Dr. Fuller agreed that in the early experience, the prevention grants fared very well. He noted that there had been a reorganization more recently, and there had also been a change in the review group’s membership. Dr. Fuller noted that he thought the prevention grants have fared slightly less well. Since this was a relatively new change, Dr. Fuller noted it was difficult to pinpoint the cause.

Dr. Gordis asked if Dr. Fuller wanted to comment also on the question raised by Dr. Aguirre-Molina about the apparent diminishing frequency of applications in these domains.

Dr. Fuller indicated that NIAAA would have to generate the numbers. If there was a decline in prevention, he thought that had only been recent in contrast to treatment in which there had been a decline.

Dr. Aguirre-Molina suggested that the Institute try to obtain any data it can on this issue.

Dr. Warren noted that NIAAA could pull data. He also commented that because the review process is a qualitative process, it will be difficult to quantify certain aspects of the discussion. Dr. Gordis noted that this would be useful.

Dr. Caetano commented that he had also been concerned with the very small number of epidemiology applications. He then asked to what extent the decline in treatment applications could be a negative consequence of the large clinical trials that NIAAA is conducting. He noted that one might think that it would be the other way around because these trials would stimulate more research, but Dr. Caetano wondered if the large clinical trials could be a cause of the decline.

Dr. Mason expressed her concern about the small number of treatment applications and noted that it seemed as though treatment researchers respond to RFAs, and that is where the bolus of treatment projects have historically come in. Related to Dr. Caetano’s comment on the large trials, she noted that the current trial, Project COMBINE, is looking at naltrexone and acamprosate, and she then raised the question of what will come after acamprosate?

Dr. Mason noted that earlier Dr. Koob brought up the issue of the bottleneck in his work where his animal models identified promising compounds, but they are not yet to a stage of obtaining an IND. She noted this is one type of problem limited future clinical studies. Dr. Mason also mentioned her interest in enhancing communication between basic science program staff who may be aware of projects using pharmacological probes to identify mechanisms of action that may have implications for treatment. Finally, Dr. Mason indicated that she would also be interested in having program staff track SBIRs that have the potential to move work that’s at a basic science level to the human testing phase. She suggested some form of tracking in these three areas. Dr. Mason thinks they need RFAs to stimulate the treatment researchers.

Dr. Gordis brought the discussion to a close, noting that this issue could be returned to in the future.

Dr. Gonzales noted that he wanted to second the comments that were made earlier about tracking the health disparity plan, and it would be great to have updates yearly or every so often.

Dr. Gordis agreed and noted that NIAAA has the five-year plan now.

Dr. Gordis then called on the ex officio members to present.

Mr. Hartman noted that the DOD is about to embark on a study of the effectiveness of having DOD personnel in recovery from addiction live in Oxford Houses. This had been mandated by Congress who two years ago directed DOD to do a study to assess the long-term treatment outcome effectiveness of DOD personnel who would go to live in Oxford House recovery homes following their more intensive term of treatment. The DOD is at the very beginning stages of talking with the Oxford House leadership. This is not just for the active duty population but potentially any retirees or dependents can participate in this study. He expressed that retirees may be more likely to use Oxford House than the active duty population. He noted that this project will necessarily be a long study, at least a couple of years, because the average length of time someone chooses to live in an Oxford House is on the order of 16 months. Mr. Hartman acknowledged that the VA has a lot more experience with the Oxford House connection than DOD, but they are starting.

Dr. Gordis asked whether residence in an Oxford House is a disciplinary action.

Mr. Hartman responded no; that this must be voluntary. It’s a totally residential situation. He noted as well that there is no counseling at Oxford House. It is simply a living arrangement.

Dr. Gordis asked if the residents are still on active duty, if they go to work and in uniform.

Mr. Hartman answered yes.

Dr. Suchinsky noted that the Veterans Health Administration is about to undergo a rather major change in leadership. The current Under Secretary of Health has tendered his resignation and a search is underway for his successor. That successor will have an impact on the structure of the VA health care system and what happens with the VA addictions programs and the VA drug and alcohol programs. Dr. Suchinsky next mentioned the VA’s Mental Illness Research and Education Centers, MIREC. The VA now has more than a dozen MIRECs funded throughout the country. He remarked that at least a third of the MIRECs have chosen as their major focus the issue of substance abuse co-morbidities, with a lot of emphasis on the co-morbidity of other psychiatric disorders and alcohol disorders. Dr. Suchinsky considered this as a very positive development.

Dr. Gordis opened the Council meeting for presentations from liaison representatives.

Ms. Sarah Brookhart noted that her organization, the American Psychological Society, feels as though NIAAA is home for them at NIH. Ms. Brookhart noted that approximately a third of NIAAA’s PIs and a third of NIAAA’s budget goes to psychology researchers. APS works very closely with NIAAA year-round, and an exciting thing is coming up: Sandra Brown will be chairing an all-day symposium, a pre-conference meeting at the APS convention in Toronto. She also commented on the issue of adolescents and alcohol abuse, noting that they have been receiving many phone calls, and that a session will held on this topic at their annual meeting.

Dr. Sara Jo Nixon, representing the Government Affairs and Advocacy Committee for the Research Society on Alcoholism, commended NIAAA for their aggressive research agenda. She remarked that RSA and NIAAA share a number of primary agenda and objective items, and that RSA is pleased with most of the legislative actions this past year regarding those issues. Dr. Nixon opined about the decrease in certain types of applications in recent years and their funding—whether it’s submission or whether it’s a funding of those. She added that RSA would like to see a balanced research agenda, including both biomedical and psychosocial foci.

Ms. Joanne Gampel from the Center for Substance Abuse remarked that it was her first NIAAA Advisory Council meeting and that she was immensely pleased to participate. Ms. Gampel noted that she didn’t realize that SAMHSA was working with NIAAA on the youth campaign, ages 11 to 13. She wondered if NIAAA was going to have another campaign for high schoolers. She was surprised to hear that NIAAA has a decrease in applications for prevention and treatment. Ms. Gampel remarked that SAMHSA was having an large increase in applications.

Dr. Sandra Brown remarked that she liked the idea of extending that focus from the 11- to 13-year-old group to the high school group. She noted that if we look at the Institute of Medicine’s report, we have more services in prevention and more services at the upper end of treatment for those with severe dependence, and fewer for those who are just beginning problems. That is a stage in high school where many kids are beginning to have problems with alcohol, and Dr. Brown would like to support that idea.

Ms. Andrea Mitchell, representing Substance Abuse Librarians and Information Specialists and the Alcohol Research Group, pointed out that from the beginning, the Substance Abuse Librarians were the group that advocated for the ETOH database to be made available to the public. They also advocated for a thesaurus, so that at least the level of the librarians in this country and the information specialists who needed access to databases, had a common language. She thanked Dr. Gordis for being the first NIAAA Director to listen to them and to follow through.

Ms. Mitchell disclosed that ETOH is the number one alcohol science database in the world and that the librarians are keenly aware of that. She stated that they would like for more people to be aware of ETOH through more marketing and promotion of the database, not just ads in some of the journals, which they have been doing, but more specific training to learn how to use it and to use it well.

For the benefit of those of us who are not professional librarians, Dr. Gordis asked if Ms. Mitchell would give a definition of a thesaurus, and how ETOH differs from Medline or PubMed.

Dr. Koob asked if they could have that written down and given as a handout.

Dr. Gordis responded that we have printed material on the ETOH and we’d be happy to send you what we have.

Ms. Mitchell noted that the librarians would like to see more funding to educate and train people to use the database.

Dr. Gordis remarked that this was a good start and that NIAAA would put together some information on this for anyone who wants it.

NIAAA will prepare a flyer that will be available at conferences and will also demonstrate and provide training at conferences and workshops.

Ms. Stephanie Mennen, Assistant Director of Public Policy with Mothers Against Drunk Driving (MADD) noted that MADD has a wonderful working relationship with NIAAA, and that they are very proud of that relationship. Ms. Mennen said she was also pleased to learn about some of the research areas that NIAAA is heading in. Particularly areas of interest to MADD are research on brain development and the effects of alcohol on the developing brain. MADD used this research over the past couple of years to help in a lot of different areas, particularly, most recently on the issue of underage drinking. MADD has received many telephone calls on this issue, specifically on the 21 minimum drinking age.

Ms. Mennen noted that college drinking is an issue that MADD is continuing to work on with NIAAA and others. Some more research on college drinking, what’s happening on college campuses, and how we solve the problem is very helpful. One of the action items that MADD has been pushing for this year, one of their top priorities, is the enactment of a national media campaign to prevent underage drinking.

Ms. Barbara Foley, an emergency nurse who runs the Emergency Nurses Association Injury Prevention Institute, noted that their main program is underage alcohol use, drinking and driving, and noncompliance of safety belts to young children. Ms. Foley said that they show their program in a graphic slide presentation on the consequence of what they see in the emergency room on a daily basis. Their program is shown to approximately 300,000 youth annually. They talk about what happens to the brain with alcohol. They also have an older American program that is shown to about 150,000 older Americans annually. Ms. Foley noted that Emergency Nurses Association Injury Prevention Institute has been in existence for 15 years. They have a 23,000-member association and are very much interested in all the research NIAAA is doing.

Ms. Martha Leyshon, a longtime resident of Montgomery County noted she had been interested in alcoholism programs since they were a part of NIMH. Ms. Leyshon shared pictures of Harold Hughes and of Bill Wilson at the hearings establishing NIAAA. She noted that Marty Mann also spoke at these Hearings. She also showed some earlier pictures of Mercedes McCambridge, Marty Mann, Harold Hughes, Ruth Fox, and Reverend Kellerman.

Dr. Gordis remarked that many of the names are familiar to many at NIAAA. He noted that NIAAA has an award named after Senator Hughes, which is given every year, and it’s a distinguished lecturer who speaks at NIH main auditorium every year. Dr. Gordis noted that he had the pleasure of working with Ruth Fox in her office for a couple of years during his last days in his research career in the 1960s in New York. Dr. Gordis thanked Ms. Leyshon for sharing her story with NIAAA

Dr. Warren added that he had seen the photo album, and that it is a very valuable resource. He noted that these were the only pictures that he had seen of the hearings that established this Institute.

Dr. Koob asked if there was any written history of NIAAA. He noted that the American College of Neuropsychopharmacology initiated a few years ago documentation of the origins of that group, which could include some of NIAAA’s your premier members.

Dr. Gordis responded that the 25^th anniversary issue of the Alcohol and Health World did give a great deal of the history of the creation of the NIAAA. In addition it had some of the seminal papers in the field, their front pages copied and then commented on by contemporary researchers.

Ms. Brenda Hewitt noted that she wrote the history for the 25^th anniversary issue.

Adjournment

The Council adjourned at approximately 3 p.m.

CERTIFICATION

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

Prepared August 2001