National Advisory Council on Alcohol Abuse and Alcoholism

Summary of the 96th Meeting

February 7-8, 2001

The National Advisory Council on Alcohol Abuse and Alcoholism convened for its ninety-sixth meeting at 7 p.m., on February 7, at the Pook's Hill Marriott Hotel, Bethesda, Maryland, and at 8:35 a.m., on Thursday, February 8, at the Natcher Conference Center, National Institutes of Health (NIH), Bethesda, Maryland. Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), presided during the first half of the open session and Dr. Mary Dufour, Deputy Director of NIAAA, presided during the closed session and the second half of the open session.

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 February 7 for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The meeting was open to the public from 8:30 a.m. - 3:00 p.m. on February 8, 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
Ms. Linda Kaplan, CAE
Dr. George Koob
Dr. Barbara Mason
Dr. Steve Mirin
Ms. Sheryl Ramstad Hvass, J.D. (February 7 only)

Council Members Absent:

Dr. Matthew McGue
Mr. Paul Samuels, J.D.

Ex-officio Council Members Present on February 8

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 February 8

In addition to Council members and outside speakers there were approximately 70 observers present during the open meeting including NIAAA staff, liaison organization representatives, and other observers.

Call to Order of the Closed Session

Dr. Mary Dufour, Deputy Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the closed session of the ninety-sixth meeting of the National Advisory Council on Alcohol Abuse and Alcoholism at 7 p.m., February 8, 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 February 7 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 Introduction of New Members

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the open session of the ninety-sixth meeting of the National Advisory Council on Alcohol Abuse and Alcoholism at 8:35 a.m. on Thursday, February 8, 2001.

Dr. Gordis introduced four new Council members including: Dr. Sandra Brown, Professor of Psychology and Psychiatry at the University of California at San Diego; Dr. Raul Caetano, Professor and Assistant Dean, School of Public Health, University of Texas at Dallas; Dr. George Koob, Director, Division of Psychopharmacology, The Scripps Research Institute, LaJolla, California; and Dr. Steve Mirin, Medical Director of the American Psychiatric Association in Washington, D.C.

Ms. Sheryl Ramsted Hvass, Commissioner of the Minnesota Department of Corrections in St. Paul, Minnesota, attended the orientation for new Council members and closed Council session on February 7, but had to return to Minnesota early because of the demands of her office.

Dr. Matthew McGue and Mr. Paul Samuels were also unable to attend the Council meeting because of other commitments.

Dr. Gordis then asked the other Council members, and all in attendance, to introduce themselves.

Director's Report to Council

Dr. Gordis highlighted parts of the written Director's Report to Council, which was prepared by Ms. Brenda Hewitt, Special Assistant to the Director.

The FY 2001 budget for NIAAA totals $340.5 million and represents a 16.2 percent increase over the FY 2000 budget.

The NIAAA Web site is being revised and an online version of the Tenth Special Report to the U.S. Congress on Alcohol and Health has been added.

The Third National Alcohol Screening Day will be held on Thursday, April 5 during Alcohol Awareness Month.

The Leadership to Keep Children Alcohol Free, also known as the Governors' Spouses Initiative, is progressing well, and a Web site has been developed for the Initiative on the NIAAA Home Page.

The Council Subcommittee on College Drinking is finalizing its report for presentation to the full Council at the June 2001 Council meeting.

Dr. Mary Dufour, Deputy Director of NIAAA, was promoted to the rank of Assistant Surgeon General in the Public Health Service Commissioned Corps.

The Office of Collaborative Research has been active in a wide range of activities including fetal alcohol syndrome activities and international research activities.

The Institute's Research to Practice Initiative is progressing well in New York State and North Carolina.

Two new issues of Alcohol Alert are now available including: From Genes to Geography: The Cutting Edge of Alcohol Research and New Advances in Alcoholism Treatment.

A major Request for Applications (RFA) for an Integrative Neuroscience Initiative on Alcoholism has been issued. The RFA is designed to promote multidisciplinary neuroscience research collaborations among a wide-range of research resources and experts.

Project COMBINE is recruiting patients for a multi-site clinical research study involving pharmacologic treatment with two drugs, acamprosate and naltrexone, singly and in combination, together with two kinds of behavioral therapy. Project COMBINE builds on the findings about behavioral therapies from Project MATCH.

The Division of Intramural Clinical and Biological Research is recruiting for positions in the Laboratory of Clinical Studies.

Dr. Gordis then reviewed some staff changes including the addition of Ms. Karen Watkins as a budget analyst in the Financial Management Branch and Ms. Judith Downey as a program analyst to work with Leadership to Keep Children Alcohol Free.

Dr. Harold Holder called Council members attention to the retirement of Mr. James Vaughan, Council Executive Secretary and Deputy Director of the Office of Scientific Affairs, as of April 1.

Dr. Holder praised Mr. Vaughan's service as Executive Secretary for the Council for over 20 years and recommended that the minutes include a special commendation for Mr. Vaughan for his hard work with the Council.

Dr. Tony Beck has joined the Office of Scientific Affairs as a Scientific Review Administrator for the Biomedical Research Review Committee.

Dr. Lorraine Gunzerath has joined the Office of Scientific Affairs as part of the planning and evaluation staff.

Dr. Mark Green, Chief of the Extramural Project Review Branch left in December to assume a review position with the National Institute on Drug Abuse. Dr. Green spent many years at NIAAA and is missed.

Mr. Hal Zawacki is working with the Office of Collaborative Research as a Presidential Management Intern focusing on the College Drinking Initiative and other outreach activities.

Dr. Dennis Twombly has joined the Division of Basic Research as a Program Officer for electrophysiology and pharmacology.

Dr. Diane Lucas has joined the Division of Basic Research as a Health Scientist Administrator. Dr. Lucas has a long involvement with science and science administration at NIH having previously been at the National Heart, Lung and Blood Institute.

Dr. Mark Egli is a new Health Scientist Administrator in the Neuroscience and Behavior Research Branch of the Division of Basic Research.

Ms. Carol Vandriak is the new Secretary for the Division of Basic Research having previously been with the Marine Mammal Commission and the Division of Bioengineering and Physical Sciences at NIH.

Dr. Fred Stinson, a research psychologist with over 20 years of alcohol research experience has joined the Division of Biometry and Epidemiology.

Mr. Ward Kay is also a new staff member with the Division of Biometry and Epidemiology with expertise in survey design, planning, and longitudinal studies.

Mr. Raye Litten has been appointed Chief of the Treatment Research Branch in the Division of Clinical and Prevention Research. Dr. Litten had been a Health Scientist Administrator in the Treatment Research Branch for the past 10 years.

Dr. Suzanne Heurtin-Roberts has left the Prevention Research Branch to move to the Division of Cancer Control and Population Sciences at the National Cancer Institute.

A number of very able people have also joined the Division of Intramural Clinical and Biological Research as specified in the Director's Report.

Dr. Gordis then announced that Ms. Migs Woodside was the recipient of the Senator Harold Hughes Memorial Award for 2001. The Hughes Award is given to people who help to translate research findings into practice in terms of treatment, prevention, or public policy. Ms. Woodside was chosen from a number of outstanding nominees based on her long history of being active in alcoholism and other addictions on many fronts in New York State and on the National Advisory Council on Alcohol Abuse and Alcoholism. Ms. Woodside founded and was the President and Chief Executive Officer of the Children of Alcoholics Foundation for many years. Ms. Woodside also played a key role in bringing leading scientists together from all over the country to form the Collaborative Study on the Genetics of Alcoholism.

Remarks on the Government Performance and Review Act Meeting

Dr. Barbara Mason reported on a meeting she attended at NIH on the Government Performance and Review Act. The Act is intended to increase the accountability and efficiency of Federal agencies by requiring them to develop strategic plans, measure performance, and report on the degree to which the goals are met each year.

The NIH meeting included representatives of each Council of the 25 Institutes and Centers at NIH and featured presentations by NIH staff on science advances and stories of discovery.

It was the consensus of the working group that NIAAA made an outstanding contribution to the NIH portfolio and work from NIAAA was chosen for presentation to Congress.

Status of Leadership to Keep Children Alcohol Free

Dr. Marilyn Aguirre-Molina said that the Leadership Initiative was designed to prevent the early use of alcohol among children ages 9-15. Research has shown that the longer the age of initiation of alcohol use can be delayed, the fewer alcohol-related problems will occur at older ages.

The Leadership Initiative is sponsored by NIAAA and The Robert Wood Johnson Foundation with additional funding from the NIH Office of Research on Women's Health and other Federal agencies. The Initiative is designed to work with Governors' spouses, mainly wives, to improve the well being of children.

The Initiative has held regional meetings in San Francisco, California and Columbus, Ohio to work with the Governors' spouses and develop media outreach educational materials in both English and Spanish.

There will be a Governors' spouses emeritus group to allow for continuing participation by spouses of Governors who have left the Governor's office, such as Ms. Sue Ann Thompson of Wisconsin.

Examples of activities by Governors' spouses include developing public service announcements in their States, holding press conferences, and writing op-ed pieces.

The Executive working group for the Initiative includes participation by several ethnic and minority organizations as well as the National Conference of State legislators.

The four co-chairs of the Initiative will brief The National Governors' Association at the end of February. Several Governors' spouses will also address other national meetings, and two additional regional meetings will be held this year.

There will be a meeting of the entire Initiative in October in Washington, D.C. Information on Leadership to Keep Children Alcohol Free is now on the NIAAA Web site as is information on the College Drinking Initiative. Thirty Governors' spouses are currently participating in the Initiative and more are anticipated.

Dr. Alpha Estes Brown asked how the results of the Initiative would be evaluated in terms of policies and per capita consumption of alcohol and other indices.

Dr. Aguirre-Molina said it was her understanding that NIH was developing an evaluation plan.

Dr. Gordis said that evaluation would be complex because of the many intermediate steps between the Governors spouses' interest and efforts and what is translated into a policy with legislative and/or regulatory support.

Update on Council Subcommittee on College Drinking

Dr. Harold Holder briefed Council members on the history and purpose of the Council Subcommittee on College Drinking, which was established in 1998 to look at college drinking problems from two perspectives: one on epidemiology and the other on interventions and strategies. The Subcommittee includes a number of college presidents as well as alcohol research experts. The Subcommittee report will be titled Crisis on Campus: Changing the Culture of Drinking on U.S. Campuses and will be presented at the June Council meeting.

The Subcommittee report will contain recommendations to college presidents about what could be done in both the short and long term to reduce college drinking related problems and to NIAAA on the research opportunities and gaps in scientific knowledge.

Dr. Holder then showed a video developed by the faculty of the Communications Department of Louisiana State University for college freshman orientation purposes.

Dr. Estes Brown asked about some of the terminology used in the video such as drink responsibly and drink moderately with no definition of what they meant.

Dr. Holder said that college presidents faced a difficult challenge since many students are already drinking at high levels.

Ms. Linda Kaplan said it was confusing to wait until the end of the video to say that students had to be 21 to drink since the preceding and following frames say drink in moderation. College freshmen are especially likely to be under the legal drinking age.

Review of Council Operating Procedures

Mr. James Vaughan, Executive Secretary for the National Advisory Council, reviewed the provisions of the Council Operating Procedures for Institute Staff Actions for Administrative Supplements, Time Extensions, and Expedited En Block Concurrence for Grant Applications. The Council Operating Procedures were last reviewed at the February 2000 Council meeting.

Following Mr. Vaughan's presentation, Council approved an increase in the direct cost limit for Expedited En Block Council Concurrence from $350,000 to $500,000. All other provisions of the Council Operating Procedures remain the same. (See revised Council Operating Procedures /Expedited En Block Concurrences for Grant Applications.)

Consideration of the Minutes of the September 13-14, 2000 Council Meeting and Future Meeting Dates

The minutes of the September 13-14, 2000 Council were approved as presented by Mr. James Vaughan, Council Executive Secretary.

The Council meeting dates for 2001 are June 6 and 7 and September 19 and 20. The proposed meeting dates for 2002 are February 6 and 7, June 5 and 6, and September 18 and 19.

The USA Multicenter Trial of Acomprosate for Alcohol Dependence

Dr. Barbara Mason began her remarks by referring to an article on the use of acamprosate to help treat alcohol dependence in the February 12 issue of Newsweek magazine. The article quotes both Dr. Gordis and Dr. Mason and refers to the clinical trial of acamprosate that Dr. Mason is leading.

Dr. Mason first presented some background information about the high relapse rates for current treatments for alcohol dependence. Two independent studies both found that about half of patients studied had returned to drinking within three months from the date of admission to treatment.

For 50 years, Antabuse was the only medication available to act as a relapse prevention agent after treatment for alcohol dependence.

The shift from inpatient to outpatient treatment of alcohol dependence makes the development of new and more effective treatments for use on an outpatient basis especially important.

The Treatment Research Branch of NIAAA has been very involved in the development of medications to treat alcohol dependence, including the use of naltrexone.

The study on acamprosate is an industry sponsored project with assistance from NIAAA staff in identifying investigators and appropriate research sites. The study is funded by Lipha Pharmaceuticals, which is a division of Merck of Darmstadt, Germany.

Dr. Mason then described the characteristics of acamprosate. Acamprosate seems to be specific to symptoms of alcohol dependence and has no hypnotic or anxiolytic effects. It does not have antidepressant or neuroleptic or dopaminergic or any other effects other than that specific to alcohol. There is also no evidence of a rebound effect or an abuse potential. It is not metabolized by the liver and is excreted by the kidneys and can, therefore, be used by patients with hepatic impairment.

Acamprosate takes about five days to reach a steady state and has no known drug interactions. It was developed in France and first became commercially available in France in 1989. It is now available throughout most of Europe, South America, and parts of Asia and Africa.

Dr. Mason then presented information on studies of acamprosate to date. Most studies have been of males in their early forties and over 4,500 patients have been studied in double-blind, placebo-controlled trials in eleven countries in Europe. With two exceptions, these studies have shown a higher rate of total abstinence with acamprosate than with a placebo.

Naltrexone, seems to be best at preventing relapse to heavy drinking in patients who sample alcohol, whereas, acamprosate seems to be best at helping patients maintain sobriety. Acamprosate also increased the abstinent period prior to the first drink among patients who did return to drinking and the cumulative abstinence duration for the entire treatment period for all patients. This is true among a broad range of patients, and countries, and cultures. Its effects were also observed within the various traditional therapies given at the individual sites.

The United States study is being conducted in support of a New Drug Application (NDA) for approval by the Food and Drug Administration (FDA). The study is double-blind and placebo-controlled with random assignment to parallel groups in 21 sites across the United States. It involves 601 male and female outpatients with the primary variable being cumulative abstinence time duration. Alcohol dependent patients with or without collateral illicit drug use were also included since a significant number of U.S. alcoholics tend to use illicit drugs in addition to alcohol. One standardized behavioral therapy was used to minimize different influences. The typical age in the U.S. study is 40 with a slightly better representation of women than in Europe.

About 40 percent of the sample had one or both parents with a history of alcoholism. Most subjects were in the moderate to moderately severe range of alcohol dependence with some in the severe range of lifetime dependency.

Placebo-treated patients were more likely to drop out of the study than with either of the acamprosate groups. Fifty percent of the U.S. study-sample was not abstinent at randomization. Only 10 percent had received any medical assistance for detoxification and only one patient received treatment on an inpatient basis out of 601 patients.

The study found a 17 percent advantage in terms of length of abstinence over placebo at the 2 gram dose level and a nearly 23 percent advantage over placebo at the 3 gram dose level. There was also a dose linear effect of acamprosate in producing a successful treatment outcome for the patients.

The only side effect of acamprosate noted was loose stools or diarrhea with little difference between the 2 and 3-gram doses. There were no deaths, no serious drug-related adverse events, or pathological changes for liver tests during the study.

In sum, results of the trial supported the safety and efficacy of acamprosate, especially in those patients with the baseline goal of abstinence. The generalizability of the findings and external validity of the study are important strengths of the study.

While acamprosate will not induce abstinence in unmotivated drinkers, it is a useful adjunct to behavioral therapy for patients with a desire to change their behavior.

Dr. Mason said that the behavioral therapy manual used in the study, which contains medication compliance enhancing techniques, was being made available to treatment providers.

Dr. Mary Dufour, Deputy Director of NIAAA, asked how much a daily dosage of acamprosate would cost. Dr. Mason said that the cost per day would probably be less than the cost of a single naltrexone tablet.

In response to a question from the audience, Dr. Mason stated that there were no reports of teratogenic potential in the literature, but that she didn't know if actual studies of fetal effects had been done.

In response to another question from the audience, Dr. Mason stated that NIAAA was studying the efficacy of acamprosate and naltrexone in combination, each one individually, and relative to placebo. Acamprosate and naltrexone act on quite different body systems. Naltrexone affects heavy drinking, but not rates of abstinance while acamprosate has an affect on rates of abstinence. They may, therefore, be best when used in combination during the early risk period of treatment.

Dr. Richard Suchinsky, ex-officio Council member representing the Department of Veterans Affairs, said that it was important to show that behavioral therapy was necessary to use with any medication to achieve the best results. If this is not done, the temptation will be for primary care physicians to prescribe the medication alone without behavioral therapy.

Dr. Mason agreed and said that patients also had to be told that they have a responsibility beyond just taking the medication.

Council Review of Institute Implementation of NIH Policy on Inclusion of Women and Minorities in Research Involving Human Subjects

Dr. Mary Dufour presented a Report on NIAAA Efforts to Implement the NIH Policy on Inclusion of Women and Minorities in Clinical Research. Dr. Dufour said that all NIH Advisory Councils have been required to review their Institute's efforts to implement the NIH Policy every two years since the Policy was first adopted as part of the NIH Revitalization Act of 1993. The NIH Office of Research on Women's Health prepares an overall NIH report to Congress that refers to the Council reviews of the Policy's implementation.

Dr. Dufour then reviewed the Institute's efforts to implement the NIH Policy. The efforts include: referring to the Policy in all program announcements and Requests for Applications; applying the Policy to the peer review of grant applications to determine whether they meet the policy requirements; and working with applicants, as necessary, to assure compliance before a grant is awarded.

Once a grant is awarded, the NIAAA program official monitors the recruitment and enrollment of women and minorities in projects. Summary information on involvement of women and minorities is then presented to the Council for review and comment.

A recent General Accounting Office (GAO) study of NIH implementation of the Policy on Recruitment of Women and Minorities in Clinical Research, recommended that NIH improve the accuracy of reporting of the tracking data and develop a more consistent and reliable coding system. The GAO also recommended that NIH do a better job of communicating the requirements for NIH defined Phase III clinical trails so that valid statistical analyses can be done for both men and women.

The NIAAA only has one Phase III clinical trial in active recruitment: Project COMBINE. The Institute has a staff collaborator to assure that Project COMBINE is appropriately designed and carried out so that valid statistical analyses can be done on women and minorities.

Dr. Dufour then presented some slides showing the numbers and percent of men, women, and minorities in all NIAAA extramural research studies for FY 1998. The FY 1999 numbers are awaiting approval by the NIH Office of Research on Women's Health.

The percentages were 1.4 percent for American Indians/Alaska Natives, 5.4 percent for Asians/Pacific Islanders, 18.6 percent for Blacks who are not Hispanic, 7.5 percent for Hispanics with the remaining 67.1 percent being for Whites who are not Hispanic and for persons of unknown race. The NIAAA percentages are roughly the same as for the rest of NIH with the exception of Asians/Pacific Islanders where NIH as a whole has a 15.5 percent level of participation.

In answer to several questions, Dr. Dufour said that efforts were being made at NIH to develop more Hispanic publications, hire more Hispanic employees and fund more research aimed at Hispanics.

In answer to another question, Dr. Dufour said that the Institute had employed special outreach efforts to enhance participation of women and minorities in Project MATCH, the Institute's previous trial. These strategies were successful and similar strategies will be used for Project COMBINE.

Following the discussion, Council members unanimously approved the following resolution:

"We, the National Advisory Council on Alcohol Abuse and Alcoholism, have reviewed the NIAAA procedures for implementation of revised NIH guidelines for the inclusion of women and minorities in clinical research. The Council has also examined the results of the Institute's efforts to enhance participation of women and minorities in all Institute studies that include human subjects. The Advisory Council finds that the NIAAA is in compliance with NIH policy to ensure that women and minorities are included as subjects in clinical research."

Recognition of 2001 Senator Harold Hughes Memorial Award Recipient

Dr. Mary Dufour introduced Mr. Geoff Laredo, Director of the Office of Policy, Legislation, and Public Liaison at NIAAA. Mr. Laredo asked Mr. Chris Williams of Phoenix House in Phoenix, Arizona, to come forward to accept the 2001 Hughes Award in behalf of Ms. Migs Woodside. Mr. Williams is the Executive Vice-President for Prevention Services at Phoenix House and Director of the Children of Alcoholics Foundation, which Ms. Woodside founded over 20 years ago.

Mr. Williams said that Ms. Woodside has been a leader in the field of advocacy, prevention, and research for a number of years and has made significant contributions in bridging the gap between research and science. Ms. Woodside's energy, breadth of knowledge and commitment to the issues related to alcohol abuse and alcoholism and how alcoholism affects children, families, and society as a whole are an inspiration to him. Ms. Woodside's continuing efforts on behalf of the Children of Alcoholics Foundation are very important and worthwhile.

Mr. Williams concluded his remarks by saying he was very proud and honored to accept the 2001 Hughes Award on behalf of Ms. Woodside.

Budget and Legislative Issues

Mr. Ray Merenstein, Vice-President for Programs at Research!America, and Mr. Kevin Mathis, Executive Director of the Campaign for Medical Research, then briefed Council members on current budget and legislative issues related to NIH and the alcohol research field.

Mr. Merenstein began by saying that Research!America is committed to the full continuum of medical and health research including all of NIH and the Agency for Health Research and Quality, the research supported by pharmaceutical companies, and research supported by philanthrophic organizations such as the Lasker Trust and McDonald Foundation.

He then described Research!America which was founded in 1989 as a nonprofit advocacy organization. The Board of Directors includes former Congressmen and health and medical research leaders. Members of Research!America include advocacy organizations like the American Heart Foundation and American Cancer Society; medical schools; public health schools; nursing schools; and some major philanthropic organizations.

Project 435 is designed to deliver a message about the need for medical and health research in all 435 congressional districts. Only 3 percent of the American public are knowledgeable about NIH and over sixty percent cannot name a research institution in their area even if they live near a university. That is not good enough when the NIH budget is over twenty billion dollars annually.

Since Research!America is an advocacy organization that cannot lobby Congress, the Campaign for Medical Research has been established to conduct actual lobbying of Congress. Research!America concentrates instead on visiting editorial boardrooms with members of the scientific community and the patient population, writing letters and op-ed pieces, doing presentations at academic health centers, sponsoring media-science round tables, and conducting advocacy and outreach workshops.

Advocacy efforts are also directed at State governments to ensure that tobacco settlement dollars are going to health related programs.

Mr. Merenstein then elaborated on the four "P's" that influence budget and legislative priorities. They are political issues such as stem cell and fetal tissue research; privacy and protection of patients' rights; parity of alcohol, drug abuse, and mental health issues with other health issues; and payment for research and related treatment and prevention programs.

Mr. Merenstein said that a recent poll of Congress, 65 Congressional staff members, public health professionals, academic leaders, media representatives, and the general public revealed different usage of the terms health promotion, disease prevention, and public health. Some tend to prefer to use the term "health promotion and disease prevention" whereas others generally prefer to use the term, "public health."

Scientists and health professionals need to reach out beyond their typical areas to talk to the Chambers of Commerce and business leaders in their communities to inform them about the benefits of health research. Business and other leaders should be invited to laboratories to see the potential importance of research studies.

Mr. Kevin Mathis, Executive Director for the Campaign for Medical Research, described the Campaign which was begun in 1998. The Campaign for Medical Research works with former top Congressional leaders to educate members of Congress on the importance and advances from medical research, and, it works with the health community to develop a consensus on health research.

Ms. Sara Burkhardt, of the American Psychological Society, said that it was also important for NIH to receive increases for management and administrative support in order to assure that research funds are effectively programmed and monitored.

Mr. Mathis agreed.

Non-human Primate Model of Excessive Alcohol Intake: Biomedical and Temperamental Variables

Dr. Dee Higley, Research Psychologist in the Laboratory of Clinical Studies in the Division of Intramural Clinical and Biological Research at NIAAA, began his presentation by describing the characteristics of the feral rhesus monkeys which are subjects for Dr. Higley's research. Rhesus monkeys have many similarities to humans on the genetic level with a highly developed central nervous system and similar neurological structures and developmental stages. They also live in a very complex social structure with strong maternal and peer influences during their socialization process.

Young female rhesus monkeys stay with their troop in order to maintain family bonds and status. Young male rhesus monkeys leave their troop at puberty and venture out to join a new troop. About one in four of them are killed in the process and social skills play a large role in success or failure.

Dr. Higley said that Cloninger's Type I and Type II alcoholism models are useful in studying the developing monkey. Type II behavior includes impulsivity, aggressiveness, anti-social behavior, risk taking behavior, and difficulties in maintaining social relationships.

A principal neurobiological or brain feature of Type II alcoholism is a serotonin deficit. The rhesus monkey's serotonin system is more similar to humans than is a rodent's. Serotonin levels in rhesus monkeys tend to remain stable at high or low levels over time just like temperament and personality. Differences in levels start as early as day 14 and are still present ten years later. The serotonin system therefore has wide implications in terms of behavioral traits over time.

Research in a rhesus monkey colony in South Carolina has confirmed that monkeys exhibiting more risk-taking behavior have low serotonin levels. To the extent that alcoholism and alcohol abuse are a problem of impaired impulse control, one might hypothesize that individuals with low serotonin levels would be more likely to consume alcohol to excess.

Rhesus monkeys will voluntarily consume alcohol levels if it is part of a wine-like solution of about 8.5 percent alcohol sweetened with aspartame. Some monkeys consume alcohol to excess while others don't drink much alcohol. Most are somewhere in between. Monkeys with low serotonin levels consume much more alcohol than monkeys with high serotonin levels.

The personality style associated with high alcohol consumption is impulsive with a high degree of aggression. Rhesus monkeys have a high capacity for aggression and a certain amount of aggression is important to maintain social status. The rhesus monkeys that exhibited a high level of violent, impulsive aggression had low serotonin levels, whereas, rhesus monkeys that used controlled aggression to maintain social status had higher levels of serotonin. Rhesus monkeys with poor impulse control and violent tendencies were the most likely to die or be killed than those with high serotonin levels and good impulse control.

Monkeys with low serotonin levels tend to spend a lot of time by themselves, and have few social interactions. They also tend to be low in social skills. They have a dysregulated sleep activity pattern and are intrinsically tolerant to the effects of alcohol. Higher levels of tolerance to alcohol's effect often leads to higher levels of consumption.

Dr. Higley said that genetic differences interact with environmental influences to produce behavioral patterns. A recent study by Dr. Higley indicates that about 38 percent of the variance in alcohol consumption among rhesus monkeys is a result of genetic influences.

The best evidence of the environmental influences on serotonin levels and alcohol consumption came from studies where baby monkeys were taken from their mothers shortly after birth and reared in peer groups without maternal and adult care. These monkeys tend to be excessively clinging and tend to get into fights with other monkeys. They also tend to consume more alcohol in a binge-like pattern, whereas, the mother reared monkeys tend to be more like social drinkers. This pattern continues into adulthood.

Dr. Higley stated that mother-reared monkeys had lower cortisol levels than peer-reared monkeys. Monkeys with high plasma cortisol levels drink more alcohol as a young adult than those with low plasma cortisol.

A recent study by Dr. Allison Bennett, of Dr. Higley's laboratory, indicates there are several variations in genes that govern the serotonin system for humans and in monkeys, but not in rodents or prosimians. Humans with the short allele variation of this gene have shown a number of psychiatric disorders and lower whole blood glucose and serotonin levels than those with the long allele variation. This difference in behavior related to allele lengths is lessened if the monkey is mother-raised and exaggerated if the monkey is peer-raised.

This illustrates the importance of gene and environmental interaction in determining behavior.

Ex-Officio Member and Liaison Representative Reports and Public Comments

Mr. Roger Hartman, ex-officio Council member representing the Department of Defense (DOD), said that Dr. Jarrett Clinton was still acting Assistant Secretary of Health in DOD. He also asked for comment on the impact of the faith-based initiative on the alcoholism treatment field.

Dr. Mary Dufour said the Institute had issued an RFA on spirituality and alcohol and was reaching out to the faith-based community to include them in the Institute's research agenda.

Ms. Linda Kaplan stated that it was important for the Institute to get research information out to the alcoholism-field, and to the public and to policymakers in a brief format.

Dr. Timothy Roehrs, of the Sleep Research Society, said that the Institute's RFA on Alcohol and Sleep research had been useful, but that there was still a problem with sleep researchers being reluctant to do alcohol research and vise versa.

To overcome this gap, Dr. Roehrs said that cross training on the informal or workshop level would be helpful. He stated that there was a lot of technology and trained people who are working in clinical centers that are open to others on weekends where alcohol researchers could be doing research. The Sleep Research Society would be more than pleased to train alcohol researchers on the intricacies of sleep research and how to cross the barriers between the two fields.

Dr. Dufour said that sleep research is a fascinating field with a wide range of research opportunities related to alcoholism. Further interdisciplinary research between the two fields is highly desirable.

Ms. Kathleen Sheehan, Director of Public Policy for the National Association of State Alcohol and Drug Abuse Directors, said that she was concerned that substance abuse services were slipping into the arena of social services and loosing their footing with regard to being a public health service. This is especially true with the faith-based service providers who are social as opposed to health service providers.

Ms. Sheehan said it was also important for NIAAA to be concerned about how current medications are being utilized and financed in addition to focusing on developing new medications. There is now direct funding of HIV medications costing 600 or 700 million dollars annually. Similar funding would greatly improve the use of medications developed for substance abuse treatment.

Ms. Sheehan concluded her remarks by saying that the topic of co-occurring mental health and substance abuse illness continues to be extremely important. Additional research is needed on the relation of mental illness and co-occurring substance abuse disorders and on other illnesses that also co-occur with substance abuse. The issue of co-occurring disorders is important for health insurance parity purposes.

Mr. Lanny Parsons, Project Director for the Northeastern States Addiction Technology Transfer Center, said that there were 13 Addiction Technology Transfer Centers in the country covering 39 States. He referred Council members to a number of technology transfer publications he had brought to the meeting and said the Centers were available to provide up to date training for substance abuse professionals and other professionals in medicine, nursing, social work, and other fields.

Mr. Chris Williams, Vice President for Prevention Services at Phoenix House and Director of the Children of Alcoholics Foundation, encouraged further efforts to translate research into practice, especially in the prevention field. Mr. Williams described several innovative programs sponsored by the Children of Alcoholics Foundation in San Francisco, California and Brooklyn, New York, and other locations.

Ms. Sis Wenger, of the National Association for Children of Alcoholics, announced that they had developed a fact sheet for children of addicted parents and volume 2 of Children of Alcoholics selected readings.

Ms. Valerie Haymaker, Research Scientist with the Research Center of the Hazelton Foundation in Center City, Minnesota, informed Council that the Butler Research Center was disseminating research updates eight or more times a year.

Ms. Claire Ricewasser, Associate Director of Public Outreach for Alanon Family Groups, reported that Alanon had developed a series of short pamphlets for Employee Assistance Programs, alcoholics, families of alcoholics, and the judicial system. Alanon is also preparing for its 2001 membership survey and updating several publications.

Mr. Rob Fleming, publisher of a newsletter for the recovery community in the Washington, D.C. area, said that the Center on Addiction and Substance Abuse (CASA) at Columbia University, had just published a study on the burden of addiction on State governments. This information is useful in educating State and local government officials and members of Congress about the cost of addiction and that less than five percent of State funds are being spent for research or for the prevention and treatment of addiction.

The Council adjourned at 03:08 p.m.

CERTIFICATION

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

Posted: April 20, 2001

Approved February 8, 2001

Operating Procedures for Institute Staff Actions
for Administrative Supplements and Time Extensions
National Advisory Council on Alcohol Abuse and Alcoholism

The Institute staff may take the following actions without Council review. All staff actions shall be documented and those over $50,000 for direct costs shall be presented to the Council for its information at the first appropriate opportunity.

1. Institute staff may take administrative action without prior Council approval to award funds in excess of the amount recommended by Council for research and research training grants and cooperative agreements (1) to cover increased direct and indirect operational costs not anticipated at the time the Council concurred with the project, or (2) to finance an additional period of not more than 1 year.
   
   
2. Administrative increases and extensions should be provided only when necessary to the successful conduct of the project and must not represent changes in the basic goals or intent of the project. These increases may be made to cover unanticipated costs of a project and can include, but are not limited to:
   
   
   • Cost increases due to State, university, or labor union stipulated salary increases and fringe benefits;
     
     
   • Increased staff salaries not anticipated at the time of application;
     
     
   • Loss of equipment originally available to the project from other sources;
     
     
   • Increased cost of equipment and related services, e.g., data analysis, animal purchase and care costs;
     
     
   • Making modifications for the purpose of taking advantage of serendipitous and other unanticipated opportunities to increase the value of the project consistent with the originally approved objectives and purposes of the project;
     
     
   • Preparing and disseminating materials concerning the project and for the purpose of insuring that important findings from the project are made widely available in a timely and effective manner;
     
     
   • Correction of errors, oversights or omissions in applications, review group recommendations, or awards;
     
     
   • Orderly termination of a project;
     
     
   • Awards for an interim period due to a deferral;
     
     
   • Award of funds to research project grants based on the receipt of a supplemental application to provide support for re-entry into research, disabled, or underrepresented minority investigators, underrepresented minority undergraduate or graduate students who work on research aims previously reviewed during competitive evaluation of the parent grant.
     
     
3. Administrative supplements (increases in a budget funded in a prior fiscal year that that of the current award), revisions (increases in a budget in the same fiscal year as the current award), and increases in the budget at the time of award are limited to $50,000, for direct costs for an individual project. Such supplements shall be documented and approved by the Division Director with the concurrence of the Grants Management Officer, and, if the proposed supplement exceeds 15 percent of direct costs, the Office of Scientific Affairs. Under exceptional circumstances and with the approval of the Institute Director, larger supplements/revisions not to exceed $100,000 for direct costs may be awarded.
   
   
4. Administrative supplements made for the purpose of extending the period of support may be made to assure orderly termination of a project or to support a project for a limited time pending a decision or action to continue or discontinue support (for example, when there is an IRG or Council deferral and support would terminate before completion of review). Extensions of projects made for this purpose should be for periods as brief as possible, but in no case should they exceed 1 year. The dollar amount of administrative supplements for such purposes should not exceed the most recent, or current, yearly direct costs budget of the project.

Increases in budgets, whether supplements or revisions after or at the time of award, will be documented in the form of an Administrative Action Report. The Administrative Action Report will be prepared by program staff and placed in the grant file following final action. the Administrative Action Report should include sufficient detail and justification for the record to substantiate the necessity for the administrative action. A summary of all administrative supplements or time extensions which exceed $50,000 for direct costs will be provided to Council members at each Council meeting.

Concurred with the National Advisory Council on Alcohol Abuse and Alcoholism at its February 8, 2001 meeting for a period of 1 year.

Appendix A: Procedures for Expedited En Bloc Council Concurrence for Grant applications.

/S/
____________________

James F. Vaughan
Executive Secretary
National Advisory Council on
Alcohol Abuse and Alcoholism

Appendix A
Approved February 8, 2001

PROCEDURES FOR EXPEDITED EN BLOC CONCURRENCE FOR
GRANT APPLICATIONS

The National Advisory Council on Alcohol Abuse and Alcoholism approved the following procedures and criteria for Expedited En Bloc Concurrence of grant applications assigned to the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

1. Council members will be selected by the Chair of the Council to provide en bloc concurrence on behalf of the Council. One Council member will be assigned this concurrence responsibility for a group of applications limited by an individual Program Class Code (PCC, e.g., AN). A Council member may be assigned more than one PCC. An alternate Council member will be assigned this responsibility for applications within a PCC for which the primary assignee has a conflict of interest.
   
   
2. The Council has agreed upon the parameters for applications eligible for expedited concurrence:

   1) Mechanism: R01, R21, R13, R15, R24,, R25, K (all), T32, R41, R42, R43, R44

   2) Percentile Score: 20.0 or better

   3) Priority Score for non-percentiled applications: 200 or better

   4) Maximum Direct Cost in any year: $500,000

   5) Foreign Applications: exclude

   6) Applications with a Human Subjects Concern, Animal Welfare Concern,
   Unacceptable code for minorities, gender, or children are excluded.

3. The Council Executive Secretary will alert the Council member(s) with delegated responsibility for expedited concurrence when summary statements for eligible applications are available on the Electronic Council Book (ECB). Concurrently, all other members are alerted of this communication. The Delegated Council member is requested to respond with a recommendation to concur or not on the applications for which the member has responsibility. This should be communicated via e-mail, phone, or fax. All Council members are reminded that they may request that any application be brought to the Council for full discussion. To comply with the latter, all Council members are afforded a minimal period of two weeks to request full discussion on any application in any block.
   
   
4. When notifying Council of available summary statements, the Council Executive Secretary will provide the following information to the members: Application Number, Name of Principal Investigator, Project Title, and Percentile/Priority Score.
   
   
5. A report of the en bloc recommendations will be presented at each Council meeting.
   
   
6. Council may consider the parameters for expedited eligibility at any time, but no less than once a year.

Posted: April 20, 2001