National Advisory Council on Alcohol Abuse and Alcoholism

Summary of the 93rd Meeting

February 9-10, 2000

The National Advisory Council on Alcohol Abuse and Alcoholism convened for its ninety-third meeting at 7 p.m., on February 9 at the Pook=s Hill Marriott Hotel, Bethesda, Maryland, and 8:15 a.m., on Thursday, February 10, in Conference Room E1/E2 of the Natcher Conference Center, National Institutes of Health (NIH), 9000 Rockville Pike, Bethesda, Maryland.

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), presided during both the open and closed sessions.

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 p.m. until 9 p.m., on February 9, for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. After being closed from 8:15 a.m. to 8:45 a.m. on February 10 for the consideration of MERIT nominations, the meeting was opened to the public from 9:00 a.m. until 3:15 p.m. for the discussion of program and policy issues.

Council Members Present:

Dr. Marilyn Aguirre-Molina
Dr. Henri Begleiter
Dr. Alpha Estes Brown
Dr. Richard Deitrich
Dr. Anna Mae Diehl
Dr. Marc Galanter
Dr. Mark Goldman
Dr. Rueben Gonzales
Dr. Harold Holder
Ms. Linda Kaplan, CAE
Dr. Barbara Mason
Dr. Matthew McGue
Dr. Carrie Randall
Mr. Paul Samuels, J.D.

Council Member Absent:

Ms. Sheryl Ramstad Hvass, J.D.

Ex-officio Council Members Present on February 10

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

Special Guests

Dr. Ruth Kirschstein, Acting Director, National Institutes of Health (NIH)
Dr. H. Westley Clark, Director, Center for Substance Abuse Treatment (CSAT), SAMHSA
Mr. David Moore, Association of American Medical Colleges (AAMC)

In addition to Council members and special guests there were approximately 70 observers present during the meting including NIAAA and NIH staff, liaison organization representatives, and other observers.

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the closed session of the ninety-third meeting of the National Advisory Council on Alcohol Abuse and Alcoholism at 7 p.m., February 9 for the consideration 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 with one research training grant application recommended for High Program Priority for up to three years for funding consideration purposes. Thirty-seven of the applications with priority scores of two hundred or better, percentile scores of 20.0 or better, and no human or animal subjects or minority or gender or other concerns were approved in early January by Council under the Procedures for Expedited En Bloc Council Concurrence for Grant Applications approved at the September 16, 1999 Council meeting. Applications which were ANot 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 9 Council meeting. 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 AScored@ applications are at the IRG and Council recommended funding levels and the total years= direct costs for ANot Scored@ applications are the requested amounts.

Council members also recommended one MERIT extension for four additional years and approved seven MERIT nominations for funding consideration by NIAAA.

Dr. Enoch Gordis, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), called to order the open session of the ninety-third meeting of the National Advisory Council on Alcohol Abuse and Alcoholism at 9 a.m., on February 10.

Dr. Gordis introduced three new Council members including Dr. Alpha Estes Brown, Senior Minister of the Community United Methodist Church in Washington, D.C., and founder and chair of the ACause Children Court Coalition@ of Washington, D.C.; Dr. Richard Deitrich, Professor of Pharmacology at the University of Colorado Health Sciences Center in Denver; and Dr. Rueben Gonzales, Associate Professor, Department of Pharmacology and Toxicology in the College of Pharmacy, at the University of Texas at Austin.

Dr. Gordis said that the fourth new Council member, Ms. Sheryl Ramstad Hvass, Commissioner of the Minnesota Department of Corrections in St. Paul, was unable to attend because of State Government activities. Dr. Gordis also introduced Dr. Heather Miller of the Office of Extramural Programs in the Office of the Director at NIH. Dr. Miller was formerly a staff member in the NIAAA Prevention Research Branch.

Dr. Gordis concluded the introductions by having all of the Council members and other attendees introduce themselves.

Dr. Gordis highlighted parts of the written Director=s Report to Council which will also be posted on the NIAAA home page at http://www.niaaa.nih.gov.

The President=s FY 2001 Budget request for NIAAA represents a 5.6 percent increase over FY 2000. The final amount will not be known until after Congressional action.

Dr. Gordis said that this year=s recipient of the Senator Howard Hughes Memorial Award is

Ms. Sis Wenger, Executive Director of the National Association for Children of Alcoholics. The Hughes Award is designed for people in the field who have been leaders in translating research findings into the treatment or prevention or social policy areas.

The second National Alcohol Screening Day is scheduled for April 6, 2000. The National Alcohol Screening Day is cosponsored by the Center for Substance Abuse Treatment and is especially popular on college campuses.

The National Leadership Initiative to Keep Children Alcohol Free, which is cofunded by The Robert Wood Johnson Foundation, is going well and a major organizational meeting is planned for March.

The NIAAA is also working with the Center for Substance Abuse Treatment in the creation of a Researcher in Residence Program. The program is designed to help translate research findings into daily treatment practice by placing recognized scientists for brief periods of residence at participating clinical treatment sites. The program is being piloted in New York State and is also planned for North Carolina and other States. Some of the new therapies to be introduced include new pharmacotherapies such as Naltrexone and manual directed verbal therapies developed by Project MATCH.

Dr. Gordis stated that the Dietary Guidelines Advisory Committee composed of people appointed by both the Department of Health and Human Services (HHS) and Department of Agriculture, was developing recommendations for consideration by the Secretaries of the two Departments and for release in a few months.

The Institute is working with the NIH Office of Research on Minority Health (ORMH) on a Fetal Alcohol Syndrome Clinicians Guide Project. The project includes development of several publications to help prevent fetal alcohol syndrome.

Another collaborative activity involves development of a Request for Application (RFA) on Studying Alcohol and Sprituality in conjuction with the Fetzer Institute of Kalamazoo, Michigan. This collaboration represents the first time that NIAAA has worked with a private foundation for the cofunding of a research initiative.

The NIAAA has a listing of about 260 liaison organizations some of which attend the Council meeting and participate in the informal liaison representatives meeting after each Council meeting.

The Tenth Special Report to the United States Congress on Alcohol and Health is in the final stages of approval within HHS.

The Institute is also working with Mothers Against Drunk Driving (MADD) staff and editors of childrens= magazines to promote the use of research findings by MADD and to promote awareness of the impact of alcohol on children.

The Institute has appointed Dr. George Kunos as the new Director of its intramural research program beginning in May. Dr. Kunos is currently Professor and Chief of Pharmacology at the Medical College of Virginia.

Dr. Gordis thanked Dr. Norman Salem for serving as Acting Director of the Institute=s intramural research program for the last two years.

Dr. Gordis announced that Dr. Antonio Noronha has been appointed Chief of the Institute=s Neuroscience and Behavior Research Branch in the Division of Basic Research. Dr. Noronha received his Ph.D. from Loyola University in Chicago and worked as a neuroscientist at the Neurology Institute before joining NIAAA as a Scientific Review Administrator in 1990.

Dr. Jules Seldon is a new Scientific Review Administrator in the Office of Scientific Affairs.

Dr. Seldon has both a VMD and a Ph.D. in Genetics from the University of Pennsylvania. Before coming to NIAAA, Dr. Seldon was a research fellow in genetic and cellular toxicology at MERCK.

Dr. Robert Huebner has been appointed Deputy Director of the Division of Clinical and Prevention Research at NIAAA. Dr. Huebner previously headed the Health Services Research Program at NIAAA.

Captain Darryl Bertolucci, Chief of the Epidemiology Research Branch, in the Division of Biometry and Epidemiology, is retiring after 30 years in the U.S. Public Health Service Commissioned Corps.

Dr. Mark Goldman, co-chair of the Council Subcommittee on College Drinking, reviewed the history and status of the Subcommittee which began a year and a half ago. The Subcommittee includes college presidents and 12 researchers and the co-chair is Father Edward Malloy, President of the University of Notre Dame.

The Subcommittee has two panels. The first panel on Contexts and Consequences is designed to look at the college drinking environment and the nature of the problems related to college drinking. The second panel on Prevention and Treatment is designed to look at which programs are effective and which are not effective in preventing and treating alcohol-related problems including violence and sexual assault.

Both panels are developing reports which will be used to develop an overall Subcommittee report for presentation to Council at its February 2001 meeting. There are also plans to widely disseminate the report which will have a receptive audience among college presidents and administrators, fraternities, and other student organizations.

Mr. Stephen Long, Acting Executive Oficer for NIAAA, said that the report should also help to bring researchers and college presidents together to design and evaluate new programs to reduce alcohol-related problems among college students.

Dr. Alpha Estes Brown asked if the College Drinking Subcommittee had explored the theory of culture creation through marketing efforts by the alcohol industry to deal with captive audiences such as college students and the military.

Dr. Goldman said that the Subcommittee was addressing the issue of advertising and that it was a very complicated issue involving the broader university community and societal attitude toward alcohol use.

Dr. Gordis introduced Dr. Nancy Day, Program Director in Epidemiology and Associate Professor of Psychiatry, Epidemiology, and Pediatrics, at Western Psychiatric Institute and Clinic in Pittsburgh. Dr. Day chaired the Council Subcommittee, which included Dr. Mark Goldman and a number of other leading research experts as noted in the Subcommittee Report.

Dr. Michael Eckardt, Senior Scientific Advisor in the Office of Scientific Affairs, provided staff support for the Subcommittee and coordinated preparation of the Report.

Dr. Eckardt reviewed the history and purpose of the Council extramural portfolio review process, which encourages field input into the Institute=s research priority setting process.

Dr. Nancy Day then reviewed the Subcommittee=s membership and the purpose of epidemiolgical research on alcohol use, abuse, dependence, and consequences. The field of alcohol epidemiology is very broad because the effects of alcohol are numerous in terms of medical, psychological, social, legal, and economic consequences.

The Subcommittee divided the epidemiology research portfolio into several categories including alcohol morbidity and mortality; alcohol and injuries, including violence and accidents; special populations such as youth, women, the elderly and various racial and ethnic groups; and measurement and methodology.

Dr. Day reviewed the Subcommittee=s recommendations for each of the categories of epidemiological research and emphasized the need to develop comparable research measures to ensure accuracy and promote the use of standard research measures by the broader field of alcohol researchers. The Subcommitte recommended that there be a joint workshop between epidemiologists and geneticists to ensure that uniform data are collected and shared on genetically informative samples.

One overarching recommendation was that NIAAA move beyond purely descriptive studies to use of more analytical and theoretical models with explanatory variables.

Dr. Matthew McGue said the report was great and that he agreed with the recommendation for a workshop to bring together epidemiologists and geneticists. He also recommended that the Institute look at the issues of if and how to collect DNA from large surveys as some other Institutes are currently doing.

Dr. Gordis added that survey research also needed to add economic as well as genetic information, since economic factors also impact on alcohol, e.g., price.

Following the discission, Council members unnamiously approved the Council Subcommittee Report on the Review of the Extramural Research Portfolio for Epidemiology.

Dr. Ernestine Vanderveen, Director of the Alcohol Research Centers Program and Deputy Director of the Division of Basic Research at NIAAA, briefed Council members on plans for a review of the Centers Program by the Council Subcommittee on Alcohol Research Centers. The members of the Council Subcommittee include Dr. Henri Begleiter, Dr. Richard Dietrich,

Dr. Mark Goldman, Dr. Rueben Gonzales, Dr. Harold Holder, and Dr. Carrie Randall with staff support by Dr. Michael Eckardt, Senior Scientific Advisor to the Office of Scientific Affairs at NIAAA.

The Subcommittee met for the second time on February 9 and has identified long term issues such as developing and implementing an evaluation process and short term issues such as whether to utilize other Center mechanisms in addition to the current P50 specialized centers mechanism. This could include the use of the comprehensive center (P60) mechanism, the developmental center (P20) mechanism, and the core center (P30) mechanism.

Dr. Vanderveen concluded her report by saying that Council would be considering the next group of Center applications at the September Council meeting including both new and competing renewal applications. She also gave Council members descriptions of 14 of the 15 active Alcohol Research Centers. The description for the newest Center on genetic epidemiology is not yet available.

Mr. James Vaughan presented the minutes of the September 15-16, 1999 Council meeting. The minutes were approved as written.

Mr. Vaughan then reviewed the proposed meeting dates for the June and September 2000 meeting and proposed dates for the 2001 Council meetings. The future Council meeting dates will be June 7-8; September 13-14; and February 7-8, 2001, June 6-7, 2001, and September 19-20, 2001.

Dr. Ruth Kirschstein, Acting Director and Deputy Director of the National Institutes of Health, briefed Council members on the President=s budget request for FY2001 which includes funds for over 31,000 research grants. Given the size of the overall NIH budget and recent budget increases, it is important for NIH to inform Congress and the American public of what has to be done with the funds, especially in the area of clinical research.

As part of the emphasis on clinical research, the NIH will also have a priority to help reduce or eliminate health disparities between minority groups and the majority population. Each Institute, therefore, is being asked to integrate the health disparities reduction priority into their strategic plans and future budgets. The Office of Research on Minority Health at NIH will play an important role in developing an overall plan for NIH to reduce health disparities among various ethnic groups.

Dr. Kirschstein then answered questions from Dr. Mark Goldman about why the NIAAA budget remained so small relative to the other Institutes and the magnitude of the alcohol problem; and from Dr. Richard Dietrich about what NIH was doing in the area of stem cell research.

Dr. Alpha Estes Brown said that many of the health disparities and problems in the District of Columbia were related to high alcohol consumption.

On response to a question from Dr. Harold Holder, Dr. Kirschstein said that NIH plans to emphasize disease prevention research, including behavioral changes and social science interventions.

Dr. H. Westley Clark, Director of the Center for Substance Abuse Treatment (CSAT) of the Substance Abuse and Mental Health Services Administration (SAMHSA), described the programs of the Center for Substance Abuse Treatment which includes a block grant to States of $1.6 billion for FY2000. This block grant funds an estimated 47 percent of all publicity funded substance abuse treatment slots excluding the Veterans Administration substance abuse treatment programs. The combined block grant and State resources provide treatment to about 900,000 people annually.

Dr. Clark said that alcohol was almost always used by substance abusers and that many had co-occurring mental disorders.

The Center for Substance Abuse Treatment also works with NIAAA and NIDA to develop and implement improved treatment methods. He stated that the cost of substance treatment is offset by a reduction in crime-related costs and victims.

Dr. Brown asked if there were any studies about the influence of the use of tobacco and alcohol on illegal smoking and use of illegal drugs?

Dr. Clark said that was more of a question for NIAAA and the Center for Substance Abuse Prevention, but that there was a tie among the use of alcohol, other drugs, and smoking. Polysubstance abusers are the norm with very few monosubstance abusers.

Mr. Paul Samuels asked how the research and service communities could work better together?

Dr. Clark said that this issue was being addressed as part of a national treatment plan effort.

Dr. Gordis asked about the problem of tracking individuals in substance abuse treatment programs since many rotated among several programs both public and private?

Dr. Clark said that CSAT was working with State and local governments to resolve the issue of achieving unduplicated counts given the need for privacy and other issues.

Dr. Anna Mae Diehl, Professor of Medicine, Gastroenterology Division, Johns Hopkins School of Medicine in Baltimore, Maryland, then presented some of her research findings on the relation of fat and alcohol to liver disease.

Dr. Diehl stated that about a quarter of the adult population in the United States has fatty liver, and that 10 percent of the people who have a fatty liver will die from it. Nonalcoholic fatty liver disease passes through the same stage as alcoholic liver disease including inflammation and cirrhosis.

Dr. Diehl then described some of the effects of obesity on the immune system and liver disease in a naturally occurring mouse strain that is fat and more subject to nonalcoholic liver disease than lean mice. Alcohol may stress normal liver cells similar to the way fat does thus making the cells more vulnerable to disease.

Dr. Diehl said that the obese mice also naturally produced alcohol in their intestinal tract from the carbohydrates in their diet with the level being highest in the morning after nocturnal feeding.

After Dr. Diehl concluded her remarks, she answered a number of scientific questions regarding her presentation.

Mr. David Moore, Associate Vice President for Government Relations at the Association of American Medical Colleges (AAMC), said that the 5.6 percent or $1 billion budget increase requested for NIH, by the President, was a substantial amount, especially when compared to the increases requested for other health agencies in HHS.

Mr. Moore stated that the fact that Federal budget is projecting a surplus should help to ease the spending caps on discretionary spending that were passed in 1997.

The AAMC supports the overall NIH budget priorities, especially with regard to strengthening the clinical research infrastructures and training of scientists in clinical research.

The AAMC is concerned, however, about the proposed decrease of 1,300 new and competing awards in FY 2001 compared to FY 2000.

Since the NIH budget has increased by $5 billion over the last three years and may be doubled at the end of this five-year period, the question arises as to how much longer can 15 percent increases continue and what will happen when the large increases end? While the AAMC is supporting a 15 percent or $2.7 billion increase for NIH in FY2001, it believes that it should not grow at the expense of other public health agencies such as the Centers for Disease Control and Prevention, Food and Drug Administration, Health Resources and Services Administration, and other public health programs. The AAMC, therefore, supports budget increases for the other parts of the public health service continuum and increases for other science agencies such as the National Science Foundation as well.

Mr. Moore said there was strong bipartisan support in Congress for another 15 percent increase for NIH in FY 2001.

There are, however, four factors which could affect the large budget increase. The first is the possibility of a decrease in economic growth and prosperity that have produced the recent budget surplus.

A second concern is the departure at the end of 2000 of a number of leading Congressional champions for medical research including Representative John Porter and Senator Connie Mack.

A third possible obstacle to continued NIH growth is that Congress will begin to ask what did we get for the $105 billion investment over a five-year period and why does NIH need another $2.7 increase? This will require more sophisticated answers and strategic plans to document how the funds will be spent and what they will produce.

The last potential obstacle is a decrease in the public support for medical research as a result of problems with the protection of human subjects or stewardship of Federal funds.

Dr. Goldman asked how NIAAA could overcome the problem of having a relatively small budget compared to other NIH Institutes and the magnitude of the alcohol problem?

Mr. Moore replied that individual constituencies could certainly make a special case for additional funding for NIAAA based on the $160 billion annual economic costs to society of alcohol related problems.

Mr. Samuels agreed with Dr. Goldman in that NIAAA could never get beyond its relative small funding base if it only receives the same portional increase as other NIH Institutes. He also agreed with Mr. Moore about the need to increase funding for alcohol and drug abuse treatment and prevention services as well as for research.

Dr. Begleiter said that it was important for advocates not to over promise what can be done by research and overestimate how fast research findings can be translated into clinical practice. He also said that research technology has gotten much more expensive and that biomedical research is contributing to the economic growth and prosperity of the Nation in terms of the biotechnology and pharmaceutical industries.

Dr. Richard Suchinsky asked about the possibility of NIH requesting the merger of some of the Institutes along scientific lines as a way of increasing efficiency?

Mr. Moore said that the organizational issue will become more pressing as the number of Institutes and Centers increases. He also said that some Institutes were actually merging some administrative functions such as personnel.

Dr. Michael Eckardt provided Council members with background information on the Council Subcommittee on Research Priorities. The Subcommittee was established in 1998 and met for the first time in January 1999. Results of the first meeting were reported to Council by Dr. Matthew McGue. The next Subcommittee meeting is scheduled for March 21, and will be reported to the June Council meeting by Dr. Henri Begleiter. The other members of the Subcommittee are Dr. Mark Goldman, Dr. Harold Holder, Dr. Ting Kai Li who is a member of the Advisory Committee to the Director of NIH, Dr. Matthew McGue, Dr. Carrie Randall, Mr. Paul Samuels, and former Council member, Ms. Migs Woodside of the Children of Alcoholics Foundation.

The Council Subcommittee on Research Priorities is intended to provide a broad overview of the various research recommendations included in the extramural portfolio reviews. The Subcommittee will also provide input on Institute research priorities for the Congressional budget justification and Institute proposals in response to NIH areas of research emphasis. In summary, the Subcommitee will meet on an annual basis to provide advice to the Institute on research priorities across portfolio reviews, to identify research advances and projects that may be useful in areas of emphasis and for stories of discovery for budget justification purposes. The Subcommittee will then report to the full Council on what has taken place and what is being proposed.

Mr. Roger Hartman, ex-officio Council member representing the Department of Defense (DOD), said that DOD had received $14.5 million in FY 1999 and $25 million in FY 2000 for 15 different areas, one of which is alcohol research. Afunding decision on the first awards will be made in March.

The DOD and VA have a joint effort to establish clinical practice guidelines for alcoholism.

Dr. Richard Suchinsky, ex-officio Council member representing the Department of Veterans Affairs (VA), said that the VA had developed some comprehensive substance abuse treatment guidelines which will serve as the basis for developing common guidelines with DOD. The major area requiring development is treatment for adolescents.

There is a Veterans= Millennium Health Bill which will have an impact on the research infrastructure in the VA. The bill includes an additional $15 million for treatment of patients with post traumatic stress disorder and substance abuse problems.

Ms. Sis Wenger, Executive Director for the National Association for Children of Alcoholics, said that in reference to the joint VA and DOD treatment guidelines, a recent issue of Alcohol Research and Health reported better treatment outcomes when something is included for the family and children. She also said that the VA and DOD should consider consulting with some of the physicians on the expert panel for the primary care initiative that produced the pediatric supplement that she gave to Council members a few months before.

Ms. Mary Beth Johnson, of the Addiction Technology Transfer Center National Network, informed Council that the Network had been instrumental in North Carolina in November in a very successful Research to Practice Symposium. There are two more symposia scheduled for New York in April and Colorado in June in conjunction with the National Association of Alcohol and Drug Abuse Counselors= conference.

Ms. Johnson said that the Addiction Technology Transfer Center was funded by the Center for Substance Abuse Treatment and was available to assist NIAAA and other organizations in the field.

There were no public comments.

The Council adjourned at 3:15 p.m.

CERTIFICATION

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

Posted: April 19, 2000