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National Advisory Council Meeting-May 26-27, 2004


National Advisory Council on Alcohol Abuse and Alcoholism

Summary of the 106th Meeting

May 26-27, 2004


The National Advisory Council on Alcohol Abuse and Alcoholism convened its 106th meeting at 5:30 p.m. on May 26, 2004, at the Pooks Hill Marriott in Bethesda, Maryland, in a closed session, and again at 9:00 a.m. on May 27 in an open session at the Natcher Conference Center, National Institutes of Health, Bethesda. Dr. Eugene Hayunga, Chief of the Extramural Project Review Branch, presided over the closed review of grant applications on May 26, and Dr. Ting-Kai Li, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) presided over the open session the following day.

In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the meeting on May 26 was closed to the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The open session for discussion of program and policy issues began at 9:05 a.m. on May 27 and adjourned at 2:05 p.m.

Council Members Present:

Sandra A. Brown, Ph.D.
Raul Caetano, M.D., Ph.D.
Howard J. Edenberg, Ph.D.
George F. Koob, Ph.D.
Steven M. Mirin, M.D.
Stephanie S. O'Malley, Ph.D.

Hon. James W. Payne
Kenneth J. Sher, Ph.D.
Alan C. Swann, M.D.
Boris T. Tabakoff, Ph.D.
Hope Taft
Robert E. Taylor, M.D., Ph.D.

Ex-Officio Council Members Present:

Colonel Kenneth J. Hoffman, M.D., M.P.H.
Richard T. Suchinsky, M.D.

Chairperson:   Ting-Kai Li, M.D.

Executive Secretary:   Karen Peterson, Ph.D.

NIAAA Staff:

Sally Anderson, Ph.D.
Faye Calhoun, D.P.A., M.S.
Mark Goldman, Ph.D.
Eugene Hayunga, Ph.D.
Ralph W. Hingson, Sc.D, M.P.H

Bob Huebner, Ph.D.
Steve Long
Antonio Noronha, Ph.D.
Kenneth R. Warren, Ph.D.
Samir Zakhari, Ph.D.

Other Attendees on May 27, 2004

Approximately 100 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order of the Closed Session

Dr. Eugene Hayunga called the closed session of the 106th meeting of the NACAAA to order at 5:35 p.m. on Wednesday, May 26, 2004, for consideration of grant applications. Dr. Hayunga reviewed procedures for critiquing grant applications and reminded Council members of regulations pertaining to conflict of interest and confidentiality. Members absented themselves from the discussion and evaluation of applications from their own institutions and in situations involving any real, apparent, or potential conflict of interest. The closed session adjourned at 6:30 p.m.

Call to Order of the Open Session and Introductions

Dr. Li called the open session to order at 9:05 a.m. on May 27, 2004. Members of the Council and of the audience introduced themselves.

Director's Report

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

  • Budget. Neither the House of Representatives nor the Senate has scheduled markup of the President's FY2005 budget. NIAAA is requesting $441,911,000, a 3.1 percent increase over the previous year, including funds for AIDS research. Appropriations committees in both houses have held hearings. In the Senate on April 1, Dr. Elias Zerhouni served as primary presenter for the National Institutes of Health (NIH); specific questions also were directed to individual Institutes. The House held two hearings that addressed issues related to NIH's various Institutes; Institute directors presented at one of the two. On April 29, Rep. Ralph Regula held a theme hearing for the National Institute for Mental Health (NIMH), National Institute on Drug Abuse (NIDA), NIAAA, Substance Abuse and Mental Health Services Administration (SAMHSA), and the Department of Education's Office of Safe and Drug-Free Schools. This successful meeting aimed to demonstrate interaction among the agencies.

  • Director's activities. Dr. Li made presentations to both NIMH's and NIDA's Councils on how alcohol research intersects with mental health and substance abuse disorders. At the National Medical Leaders Meeting hosted by the National Highway Traffic Safety Administration (NHTSA) on the harmful effects-particularly automobile crashes-of alcohol abuse, Dr. Jeff Runge, Surgeon General Richard Carmona, and Dr. Li made presentations. Dr. Li also presented at Washington University, University of Michigan, University of California-San Francisco, Kaiser Permanente's Division of Research, American Association of Anatomists, and the American Society of Addiction Medicine.

  • Staff transitions
    • With the addition of three new directors, all five NIAAA divisions now have permanent leadership. Dr. George Kunos has headed the Intramural Division and Dr. Sam Zakhari has been at the helm of the Division of Metabolism and Alcohol Effects. Ralph Hingson, Sc.D., M.P.H., now leads the Division of Epidemiology and Prevention Research; Antonio Noronha, Ph.D., directs the Division of Neuroscience and Behavior; and Mark Willenbring, M.D., will direct the Division of Treatment and Recovery Research. Dr. Li acknowledged the contributions of acting division directors Drs. Bob Huebner (Division of Treatment and Recovery Research) and Sally Anderson (Division of Neuroscience and Behavior).

    • Dr. Li announced the retirements of Jan Howard, Ph.D., Chief, Prevention Research Branch; Forrest Weight, M.D., Chief, NIAAA's Laboratory of Molecular and Cellular Neurobiology; and the departure from the Institute of Anton Bizzell, M.D., medical officer in the former Office of Collaborative Research; and Geoffrey Laredo, Director, Office of Policy and Public Liaison.

    • Chen-Hua Tian, M.D., Ph.D., a Humphrey Fellow at The Johns Hopkins University, is spending six weeks at NIAAA in a "professional affiliation" that will increase his experience with alcohol treatment research prior to returning to his native China.

  • Research priority emphasis and core support teams. NIAAA restructuring has resulted in establishment of five research emphasis and two infrastructure teams. The restructuring is hoped to lead to a strong and flexible structure that allows NIAAA to respond quickly to emerging opportunities, promote creativity, foster multidisciplinary approaches among alcohol scientists, increase their interaction, and strengthen staff's scientific development. The goals are for the teams to focus on areas identified as NIAAA priorities for expanded research and to promote a stronger interdisciplinary focus. The research emphasis teams include underage drinking, medications development, mechanisms of alcohol action and injury, behavioral and environmental interventions, and etiology of risk of alcohol abuse and alcohol-genes and environment and their interactions. The two core resource teams are technology and analysis, and centers and training.

  • NIAAA interdisciplinary research programs

    • Suicide prevention. NIAAA, NIMH, and other Institutes have developed an RFA and PA for Developing Centers on Interventions for the Prevention of Suicide (DCIPS). Proposals have been reviewed, several of which focused on alcohol and suicide.

    • Tobacco use. NIAAA will partner with NIDA and the National Cancer Institute (NCI) on the TTURC Initiative, Transdisciplinary Tobacco Use Research Centers, which is undergoing competing renewal.

    • Translational research in the emergency department. As an outcome of the National Alcohol Screening Day Initiative, NIAAA and SAMHSA will conduct a major study to investigate ways to screen, identify, and treat patients in hospital emergency departments for alcohol problems.

    • Trauma and alcohol. Approximately half of patients with trauma have alcohol-related issues. NIAAA, the Centers for Disease Control and Prevention (CDC), and SAMHSA will evaluate the impact on treatment for problems that alcohol produces of insurance laws that may preclude third-party insurers from paying for alcohol-related injuries.

    • Underage drinking. A large new initiative has been undertaken in response to an IOM report requesting formation of an interagency coordination committee on prevention of underage drinking. Chaired by SAMHSA Administrator Charles Curie, the committee also includes NIAAA, the Department of Justice's Office of Juvenile Justice and Delinquency Prevention (OJJDP), NHTSA, White House Office of National Drug Control Policy (ONDCP), CDC, Office of the Surgeon General, and others. From NIAAA, Drs. Mark Goldman, Vivian Faden, and Trish Powell are involved in developing an agenda with timelines.

    • Underage drinking

      • NIAAA and the Association of Academic Health Centers convened an invitational conference on strategies to delay onset of drinking in young children. The 22 invitees concurred on the feasibility of NIAAA partnering with academic health centers in rural and suburban settings to develop community-based programs that focus on individual, family, schools, communities, and health care professionals-and expressed interest in participating in such a program. The American Legacy Foundation supported the meeting, and representatives of the Robert Wood Johnson Foundation attended. A final report of the conference will be distributed to Council members when it is published.

      • NIAAA will collaborate in an OJJDP-funded grant program to reduce underage drinking in rural populations. Once prevention sites are selected, NIAAA will assign its grantees to improve study plans and carry out the evaluation.

    • Sudden infant death syndrome (SIDS) among Native Americans. A project in which NIAAA has worked with the National Institute of Child Health and Human Development (NICHD), Indian Health Service, Centers for Disease Control, and others has found that the neurochemical abnormalities in SIDS are similar to those seen in fetal alcohol syndrome-and the association with alcohol is higher, relating to a serotonin pathway involved in brain development in the fetal stages.

  • Project COMBINE has finished its recruitment and currently is in the analysis phase. Results are expected soon.

  • Research grant application and peer review activities. In the current round, 318 new and competing continuation research grant applications were considered for funding. At 29 review meetings NIAAA's extramural project staff evaluated 149 applications, 47 percent of the total assigned to NIAAA. Funding levels and numbers of funded applications will be known in September.

  • Research reports. Since the February Council meeting, NIAAA's extramural grantees and intramural scientists have published more than 180 peer-reviewed articles. Among those with media coverage were:

    • "Adolescent Brains Show Reduced Reward Anticipation," an MRI study conducted by Bjork and Hommer's group that appeared in The Journal of Neuroscience. The Los Angeles Times, Newsday, and other publications discussed the study's findings.
    • JAMA recently commented on the work of extramural scientist Barbara Smothers, "Alcohol Problems Often Missed in Hospital Admissions," which appeared in Archives of Internal Medicine.

    • NIAAA's National Epidemiological Survey on Alcohol and Related Conditions (NESARC) was described recently in JAMA and in Archives of General Psychiatry.

    • The COGA research group identified the GABA receptor alpha II subunit as very linked to alcoholism and also to brain EEG activity, which may be important as an endophenotype.

    • A study examines the interrelationship of one of the major alcohol action sites, the GABA receptor, and the CRF, a mechanism that underlies anxiety and depression.

  • Outreach activities

    • In partnership with SAMHSA, NIAAA helps to fund the successful National Alcohol Screening Day and looks forward to screening at non-mainstream sites, including emergency rooms, colleges, and other high-risk settings, and also workplaces.

    • In April to observe National Alcohol Awareness Month, several conferences were held: Parents' Resource Institute for Drug Education Study and, in Ohio, the Reach Out Now teach-in program that targets reduction in underage drinking. Mrs. Taft, co-chair of Leadership to Keep Children Alcohol-Free, invited Dr. Li, Rep. Regula, and SAMHSA Administrator Curie to teach sixth graders in Canton.

  • Dr. Li referred attendees to the printed Director's Report for information on additional outreach activities that have taken place at the national and local levels, and award-winning multimedia products. http://www.niaaa.nih.gov/about/roster.htm#council

  • Publications. In its update of the successful Helping Patients with Alcohol Problems: A Health Practitioner's Guide, NIAAA made the guide more useful and sensible to medical professionals. NIAAA has developed two science curricula on alcohol for middle-school students.

  • New programs. NIAAA will co-sponsor a meeting on Complexities of Co-occurring Conditions that will focus on mental health and substance abuse. The conference also will involve NIMH, SAMHSA, the Agency for Healthcare Research and Quality, and the Health Resources and Services Administration.

Extramural Advisory Board and Initiatives Update

Dr. Li stated that NIAAA plans to establish an Extramural Advisory Board (EAB) to help provide scientific guidance and establish research priorities. Dr. Lorraine Gunzerath, coordinator of this activity, explained that the new research teams will present reviews of NIAAA's grant and contract portfolios, and the state of the science, to the EAB. The teams will recommend new directions for research through concept papers. The EAB will discuss the plans; the EAB's concurrence, modification, or deferral of the proposals will serve as a major input item in determining and revising objectives of both the Institute and individual teams. The EAB can advance new ideas for research that teams will explore.

Members of the EAB will serve as a working group of the NIAAA Advisory Council; the group will meet twice or three times annually. Nominations will emanate from a variety of sources, including Institute staff, the Council, the scientific community, and professional organizations. The NIAAA director will name a chair of the EAB. Membership is planned to represent the Institute's current research priority areas, as well as geographical, gender, and ethnic diversity. Members will have significant scientific stature and a wide range of knowledge and interests. Current members include Drs. Bankole Johnson, Andrew Heath, Thomas Greenfield, John Crabbe, Cindy Ehlers, Peter Monte, plus Fulton Crews as chair. The first meeting will be held in August 2004.

Dr. Gunzerath updated the Council on NIH roadmap initiatives that involve NIAAA; NIAAA does not have the lead on any of them. Special emphasis panels within CSR review all Roadmap applications. Only the Councils for lead Institutes conduct the secondary level reviews, but NIAAA did recommend reviewers for some of the panels. Non-lead Institutes that may be interested in applications that do not achieve the funding cut-off score may request secondary assignment. If the applications do not secure Roadmap funds, the Council of the secondary Institute must review the applications. NIAAA has claimed secondary assignment status on a number of projects, but is not required to fund the ones it has claimed.

The Neuroscience Blueprint enables the 14 Institutes with an interest in the nervous system and its functions to work together in order to accelerate advances in understanding through coordinated acquisition and use of enabling tools and resources. Existing collaborative programs include multidisciplinary programs for pre-doctoral training, mouse mutagenesis and phenotyping program, and a pediatric brain-imaging database. The Neuroscience Blueprint is anticipated to expand and complement these sorts of programs to address future areas of interest as well. Substantive focus will be placed on development, degeneration and repair, and plasticity of the nervous system and its functions, where "functions" is meant to include behavior. Enabling tools and resources might include funding mechanisms, toolkits, technology development, infrastructure, training, outreach, or integration of translational and clinical activities.

Each participating Institute was asked to convene a group of extramural scientists to serve as consultants. These consultants will review and set priorities for the relevance and importance of current resources, identify gaps and opportunities, and then provide input for a coordination plan to fill the gaps and seize the opportunities. An NIH-wide draft is expected in July with release in September. NIAAA members include Drs. Henri Begleiter, Fulton Crews, Kathleen Grant, George Koob, John Crystal, Boris Tabakoff, Victor Hesselbrock, and Michael Charness.

Dr. Li remarked that Council members will be asked to review portfolios along with the EAB, but with an eye to avoid overburdening members.

Task Force on Recommended Alcohol Questions

Dr. Li explained that recommended alcohol questions would inform investigators about what they should be asking about quantity, frequency, and other alcohol problems. Dr. Raul Caetano identified members of the Task Force on Recommended Alcohol Questions: Tom Greenfield, Andrew Heath, Sharon Wilsnack, Richard Wilsnack, Deborah Dawson, Michael Windle, Jurgen Rehm, Lorraine Midanik, Ken Sher, Deborah Dawson, Vivian Faden, and himself. Dr. Caetano reported that the Task Force mapped a set of minimum questions for research on alcohol consumption by researchers whose main field of inquiry is not alcohol. This set of three questions focuses on frequency and quantity of drinking and binge drinking, using the new Binge Drinking Task Force's definition of five drinks for a man and four drinks for a woman over 2 hours. Additional questions cover the maximum amount of drinking by an individual in a 24-hour period, frequency of this amount of drinking over 12 months and lifetime frequency of that amount of drinking.

Discussion

In an exchange of information following the presentation:

  • Dr. Edenberg suggested that the lifetime question, despite an inherent chance of misreporting, captures people who once tried to drink a lot but who found they could not do so, and thus might capture genetics information. Dr. Caetano responded that the 12-month time frame was included to conform to the focus on 12 months of the initial set of questions and also to address the issue of reliability of recall.

  • Dr. Faden added that the task force discussed getting the best approximation of quantity consumed in order to relate overall consumption and amount of consumption to health outcomes. The main reason to include the 12-month question was its predictive value for alcohol problems.

  • Dr. Sher explained that a lifetime measure cannot be used with surveillance projects in which changes can be tracked. The task force concentrated on making generic recommendations. A particular focus was to initiate collaboration with other national epidemiology efforts.

  • Dr. Caetano stated that the group discussed the appropriateness of a 12-month timeframe. Since adolescent drinking is erratic in nature, the 12-month measure would cover that appropriately.

  • Mrs. Taft questioned whether information from the questions could be used to determine the number of people in recovery. Dr. Caetano explained that after considering additional questions covering alcohol problems, they limited their discussions to the original mandate regarding alcohol consumption coverage. Dr. Sher noted that the group developed a set of guidelines on resources that deal with generic issues and that offer information on sets of questions related to drinking, motivation, consequences, and dependent symptoms. Posting this information on the website along with sample references would be a starting place. Dr. Faden concurred that as additional issues are developed, more information can be added to the website.

  • Dr. O'Malley suggested that attention be given to make the questions work well in the self-report version. Dr. Sher explained that the task to refine the questions for self-reports would not be difficult to accomplish, and that no preference was given to the method of administration of the questionnaire, whether orally, using paper and pencil, or Web based.

  • In terms of dissemination plans, Dr. Faden stated that NIAAA plans to post the information on its website and welcomed additional suggestions. Dr. Edenberg suggested proactive distribution and marketing of the questions, for example, in professional journals.

Council members voted unanimously to approve the task force's recommendation for the minimum set of questions.

NESARC (National Epidemiological Survey on Alcohol and Related Conditions)

Dr. Bridget Grant, Chief, Laboratory of Epidemiology and Biometry, Division of Intramural Programs, NIAAA, updated the Council on major findings from the NESARC database related to prevalence, age of onset, recovery, and psychiatric comorbidity. She explained that the 1991-92 National Longitudinal Alcohol Epidemiologic Survey permits analysis of change over the past decade, using the new NESARC survey as a comparison. Dr. Grant pointed out that no other surveys have used similar methodologies and almost identical questions.

NESARC surveyed more than 43,000 people, a nationally representative sample of the U.S. with a response rate of 81 percent, oversampled on Blacks, Hispanics, Latinos, and young adults. NESARC has the largest proportion of Blacks and Hispanics of any other federal survey, important because the Census Bureau predicts that Hispanics will constitute more than 25 percent of the U.S. population in 2050.

NESARC found that alcohol abuse has risen from 3 percent to 4.7 percent of the general population, an increase from 5.6 million to 9.7 million adult Americas. Alcohol dependence has declined from 4.4 percent to 3.8 percent, from 8.2 million to 7.9 million Americans. Overall using the DSM-IV definition, alcohol abuse and dependence increased from 7.4 percent to 8.5 percent, from 13.8 million to 17.6 million adult Americans.

A pattern of age of first use of alcohol peaks at ages 16 and 21, similar to the onset curve for alcohol abuse and the curve for alcohol dependence, all consistent by gender and race/ethnicity. The curve heights reflect differences in prevalence among groups. Similar curves are found for first use of tobacco, first use of cannabis, cannabis abuse, and cannabis dependence.

Among mental disorders, early onsets are found for major depression and generalized anxiety disorder, for example. The increases correspond also to the points at which increases in alcohol abuse and dependence occur, but these curves--nstead of declining rapidly over the life course--tend to plateau and remain stable until the fourth or fifth decade of life, when they begin to decline. Other mental disorders--such as phobias, panic disorders, or specific phobias--begin slightly earlier but show the same onset curve as for alcohol and drug use disorders.

Dr. Grant pointed to a critical window of opportunity for prevention of alcohol use and dependence, highlighting the need to gain an understanding of the biological and environmental factors that influence adolescent vulnerability to a variety of alcohol and other drug use disorders with early onset and that often co-occur with alcohol use disorders.

Dr. Deborah Dawson's work on recovery with NESARC used the UDATUS4, an NIAAA psychiatric assessment interview that assesses alcohol use and other disorders in the past year and also prior to the past year. NESARC found that 25 percent of the population in the past year who had alcohol dependence prior to the past year are still dependent; 27.3 percent are in partial remission; 29.5 percent remained asymptomatic drinkers; and 18.2 percent abstained. The number of people still dependent decreases over time from the onset of alcohol dependence. An initial rise is seen in partial remission, and then a steady decline over 20 years from time of onset. For both abstainers and asymptomatic drinkers, the routes to recovery increase over time.

Preliminary analysis reveals several predictors of these types of recovery. Individuals who are married have higher odds of becoming abstainers. People who are lifetime tobacco users, including many former smokers, also take the abstinence path to recovery, but people who were lifetime illicit drug users are likely to take the asymptomatic drinker route to recovery. Individuals with any DSM-IV personality disorder were less likely to abstain or drink asymptomatically. Dependent personality in males and antisocial personality in females are suspected to have a negative effect on recovery, but the analysis has not been completed.

Major findings on co-occurrence of 12-month alcohol dependence reveal that people who are alcohol dependent are 6.4 times more likely to have nicotine dependence than people who do not have alcohol dependence. Co-occurrence of alcohol dependence with mood and anxiety disorders has lower-but still significant-odds ratios. The associations between alcohol dependence and manic disorder and hypomania, and for mood disorders in general, are higher than for anxiety disorders, a finding common over many years of clinical research. NESARC was the first comorbidity study conducted anywhere to measure DSM-IV personality disorders in a community sample.

Dr. Grant presented a preview of Wave 2 of the NESARC, which will be in the field in 6 weeks. To Wave 1 measures, Wave 2 measures will add lifetime measures of obesity, sexual orientation, sexual preference, and sexual behavior. For the first time in a national survey, NESARC will measure discrimination related to race/ethnicity, religion, gender, obesity, sexual orientation, and physical disability. The survey also will measure DSM-IV post-traumatic stress disorder, both related to 9/11 and not related to 9/11. Additional measures include DSM-IV childhood and adult attention deficit hyperactivity disorder, physical exercise, acculturation scales, race/ethnic orientation, intimate partner violence, social networks, and social supports. The survey also will measure DSM-IV schizotypical, narcissistic, and borderline personality disorders, and also stressful life events.

Wave 1 NESARC data will be added to the NIAAA website on June 10, 2004. Persons can download the data, convert it to an SAS data set with an NIAAA-provided input statement, and do cross-tabs in 1.5 minutes. The data cleaning process took 18 months and analysis took 6 months, resulting in a data set released faster than any comorbidity study conducted in the United States.

Discussion

In response to Council members' questions, Dr. Grant responded that:

  • The change in the ratio of abuse to dependence between the 1991-92 survey and NESARC has not been analyzed, but it probably is important.

  • A Wave 2 kickoff meeting will take place in July, and the questionnaire will be posted on the website.

  • The average time to conduct the survey is about an hour; drug-specific dependence and personality disorders tend to extend the interview. Typically the U.S. government cannot pay survey participants, but the Office of Management and Budget will allow NESARC Wave 2 to offer $80 to each participant, an unprecedented experiment with incentives. Half the amount is contingent upon completion of the interview.

  • Discrimination due to having a substance abuse disorder will be measured indirectly using a scale developed by Bruce Link and Columbia University.

  • Two publications issued to date derive from the NESARC data set, and considerable comorbidity data is in the publication pipeline.

Dr. Caetano suggested publishing a special issue of Alcohol Research and Health. Dr. Li remarked that that was one of a number of options under consideration to make the data analysis available to the scientific community and the public at large. Dr. Grant pointed out that the website lists 18 papers related to the data set.

Bringing Research Closer to Home: The Importance of Public Outreach

Mary Woolley, President, Research! America, described her organization's advocacy work to make medical and health research a higher national policy. A nonprofit alliance with more than 450 members representing many NIH and NIAAA grant recipients and other stakeholder groups, Research! America aims to ensure that the public hears about research and its benefits, and that increased funding is achieved for medical and health research. Research! America helps its member organizations to do their own public outreach and public engagement activities. The organization makes the case for research by means of "one-pagers" that make key points using simple public opinion poll data that target media and public decision makers in state and federal government.

Research! America's accomplishments include leadership in doubling the NIH budget for the five years through 2003. Describing research in terms of health care dollars, Ms. Woolley stated that in the U.S. less than six cents of every health care dollar is spent on medical and health research, more than half of which is spent in the private sector. This fact has proven to be an effective conversation starter, and people typically are surprised that the expenditure is so low. Moreover, less than one cent of every health-care dollar is spent on prevention research, an investment in the future. Prevention research is key to prevent alcohol abuse among underage youth, for example, but because alcohol abuse must be understood before it can be prevented, research is called for.

Research! America develops "easy messages" by using current news stories and breaking down large numbers into manageable numbers. For example, Web shoppers' expenditures of $52 billion in 2002 would fund NIH for more than 18 months, and golf industry revenues of $2 billion for clubs and golf balls alone would fund NIAAA for 4.5 years. If it is the public's will, more resources can be allocated to medical and health research.

Ms. Woolley described Research! America standard polling methodology, the same methodology that the media and political candidates use; the results become a starting place for conversations. Research! America's recent findings include:

  • The U.S. should maintain its role as the world leader in medical and health research, and strong support (80 percent) exists for basic research using "my tax dollars."

  • Clinical research is considered of great or some value, but the percentage drops off when people are asked whether they would sign up for clinical trials. Only about 4 percent of people with a cancer diagnosis are enrolled in clinical trials, but more than 50 percent say they would enroll. The gap represents a lack of knowledge about clinical trials and eligibility. The research community needs to interest more people in participating in clinical research.

  • People see preventable diseases and injuries as a problem and are willing to spend money on related research. Research has helped persuade people to wear seatbelts, quit smoking, practice safe sex, and avoid excessive drinking, for example.

  • Screening for mental disorders is not associated strongly by the public with prevention. Using research, the possibility exists for prevention of many conditions.

  • People believe insufficient funds are spent on research and that it is time to address the problem of health disparities among certain groups.

  • Nurses, pharmacists, and physicians are highly trusted for information on medical and health research (no significant differences exist between these groups). Pharmaceutical companies and the Internet are trusted sources as well, even though some not-so-good information is posted on the Web.

  • Most people do not recognize the name of the government agency that funds most of the medical research paid for by taxpayers (NIH). Ms. Woolley suggested "reminding" others about this fact.

  • Half or more people in any given state cannot name a single place where medical research is conducted in their area. Remedying this situation is as simple as NIH staff or grantees self-identifying in one's community, perhaps beginning with dinner-table conversation about what they do.

  • People are overwhelmingly unable to name an institution, company, or organization in the U.S. that conducts medical research. Recognition of several brand names, including Pfizer, Hopkins, Merck, and Mayo Clinic, is positive by very low percentages of people.

  • Regarding the public's view of who should have the most influence on how funds for government medical research are spent, patients ranked first, followed closely by scientists, and then Congress, a distant third. Congress in fact makes the decisions, but patient groups and scientists, as a team, should have the most influence on how government medical research funds are spent.

  • Americans believe controlling the cost and access to health care to be the top two health priorities. Medical research can help improve the status of both priorities, and it is important to spread that message. People want to see more information about medical research in the news media. Ms. Woolley remarked that researchers can be perceived as accessible and accountable to the public, saying, "I work for you," and responding to the public's questions.

  • Researchers can develop alliances with voluntary health organizations, stakeholders that often have important influence.

  • Researchers also can value public outreach more strongly to help the public gain a sense of where research is conducted and how important it is to them. This may require a substantial cultural change.

The cover story of the March 21, 2004, issue of PARADE Magazine featured six NIH-funded researchers and stressed the importance for the public to find out more about researchers who may one day save their lives--and to support their work. Research! America is working with PARADE on a series of such stories. The point is to put a public face on research, to help the public identify more researchers in order to help researchers succeed. Research! America's chair-elect urges the research community to speak out on what they are doing to serve the public's interest.

Discussion

Dr. Koob suggested adding to Research! America's agenda a focus on the hidden costs of research that result from pressure from activists on animal issues. He noted that costs of conducting surgery on rats has risen; despite NIH's budget increase, costs are greater. Ms. Woolley responded that conversations have taken place regarding a study of the impact on morale and cost to the science community of regulatory burdens. Ms. Taft urged NIAAA to spend increased funds in the primary prevention area.

Setting Priorities at the National Institute of Mental Health

Thomas R. Insel, M.D., Director of NIMH, shared with Council members the process NIMH has engaged in to set priorities. Dr. Zerhouni and several NIH officials planned to testify at an authorizing subcommittee hearing on Capital Hill the following week. The last reauthorization took place a decade ago. In his presentation, Dr. Insel set the context for NIMH's priority-setting process:

  • NIMH's mission is to reduce the burden of mental illnesses and behavioral disorders through research on mind, brain, and behavior. The World Health Organization's (WHO) World Health Report 1996 on the global burden of disease (revised in 2002) found that in the U.S. and Canada, mental illnesses as a group represent the greatest source of disability, more than 25 percent of years lost to disability. Mental illnesses typically start early in life and are chronic, while other diseases, such as cancer or heart disease, occur later in the life cycle. Alcohol and drug use account for 11.5 percent of years lost to disability, and for some mental illnesses, such as bipolar disorder, a heavily comorbid situation exists. For the age group 18-44, mental illnesses account for half of disability, with depression more than 25 percent of disability in that age range.

  • About 30,000 suicides take place in the U.S. annually, with 90 percent related to mental illnesses. Suicides are almost twice as common as homicides in the U.S., and the WHO reports that half of all violent deaths worldwide are self-inflicted. Suicide is the third leading cause of death in adolescence, contributed to importantly by substance abuse, particularly alcohol.

  • The overall economic cost of mental illnesses is difficult to determine. The President's New Freedom Commission on Mental Health reported in 2003 that the direct cost of treatment of mental illnesses is about $71 billion. Scarce current data for indirect costs reveal that social services related to mental illnesses cost approximately $79 billion. People with severe mental illness are cared for through Medicaid. Data for 2004 show that new atypical antipsychotic pharmaceuticals will cost about $10 billion, the third largest class of drugs in terms of cost. More than half of this cost is absorbed through Medicaid or the Department of Veterans Affairs (VA), and the burden is breaking the bank in many states.

  • NIMH currently spends more than $1.3 billion for research and development (R&D), and debate in Congress centers on the appropriate percentage increase.

  • NIH and its Institutes' budgets are in "budget whiplash," from 12-15 percent increases down to a 7-8 percent increase in 2003, 3 percent in the current year, and likely well below 3 percent for 2005. Budget discussions no longer focus on keeping up with inflation, but rather on survival and how to do innovative science and protect investment in new grants when the budget declines.

  • NIMH's success rate--the chances a grant applicant will be funded within three tries--has fallen to about 23 percent, compared with NIH's 30 percent success rate. Although NIMH funding is 80 percent higher than five years ago, 40 to 50 percent more applications are being submitted; research costs have risen about 40 percent, with clinical research costs rising even faster than research on animals; and stipends for trainees have risen 6 percent. At NIMH, the average cost of a grant is $340,000 annually. About 70-75 percent of expenditures represents outyear grant funding, which leaves little monies for new grants. The pay line is plummeting to the 15th percentile.

Given harsh budgetary realities and difficult impending decisions, NIMH has undertaken the useful exercise of considering its status, values, and priorities. NIMH identified the need to measure (1) relevance to the mission of reducing the burden of mental disorders through research: what discoveries would make a difference; (2) traction: where current scientific opportunities now allow moving quickly to make new discoveries; and (3) innovation: adapting the peer review process to permit identification of proposals that do not fit the typical, conservative mold.

Dr. Insel described gaps and future directions with potential to make a difference:

  • Better understanding of physiology may have a great impact on burden, for example, a biomarker for bipolar disorder or the equivalent of cholesterol for schizophrenia, to enable understanding of who is at risk and development of preventive strategies.

  • Despite the potential of genomics, beyond certain drugs no new treatments have developed over last few decades.

  • New strategies for prevention are needed based either on genetics or understanding biomarkers to inform about the risk architecture for each disease.

  • New strategies for dissemination are needed, particularly of effective treatments that are not used by the people who most need them.

  • In terms of traction, opportunities are emerging to begin to apply basic neuroscience to clinical questions. It is important to understand each disorder at multiple levels-genes, cells, behavioral/ cognitive aspects, animal models, and new treatments. Although mental disorders lag behind alcohol and substance abuse, for which better animal models exist, in behavioral neuroscience and the study of fear or extinction behavior, knowledge now exists across the various levels. Research permits understanding of biological rhythms and reveals the presence of unique dedicated circuits for social information processing for which there are now interesting models.

  • Innovation relates to having a new set of tools. Toolkits now exist for neuroscience and some clinical research, for example, for developing a platform for clinical trials and approaches to individualized treatment. Discussion has focused on where next investments would go and how to protect some funding to do the most innovative work and to seed work through mechanisms such as greenhouse grants or pioneer awards.

  • The Neuroscience Blueprint is an opportunity to partner with other Institutes, using innovative tools and platforms.

  • NIMH has identified the need to do translational science. Pathophysiology, diagnostic tests, and biomarkers relate to the bench-to-bedside process. From a bedside-to-practice perspective, dissemination is critical to move the existing knowledge base on mental disorders from the research community into the general community.

  • NIMH Council workgroups found that the Institute's organizational structure permits translational projects to fall through the cracks. NIMH will initiate a series of new divisions at the interface between bench and practice on translational research. The divisions will cover child, adult, and health and behavioral issues such as AIDS, adherence, risk taking, and decision making, among others. NIMH will measure success not just by the quality of its portfolio, but by how ideas flow between divisions. Examples include an fMRI protocol that would study a clinical group, not just healthy undergraduates, and brain research that might inform on what science is needed.

  • NIMH will borrow from NIAAA a strategy to develop transitions for ideas by creating cross-divisional program teams with resources to address major needs.

Dr. Insel observed that much of NIMH's portfolio in basic neuroscience overlaps with the work of other Institutes. NIMH undertakes research on normal development, social science research, basic behavioral science, and basic neuroscience. The challenge is to set priorities and adhere to NIMH's core values and mission. NIMH must do some research on its own--and some in partnership with others.

NIMH currently is grappling to devise strategies to accomplish a change in priorities. Possibilities include using grant and other mechanisms to reflect new priorities, but it is more difficult to lower pay lines in certain areas. NIMH Council workgroups are considering areas that are ready for redirection, finding it difficult to recommend areas for cuts. Over the next few months, NIMH will create statements for its website and professional journals that identify its updated priority areas, inviting researchers to submit applications for those priority areas. Discussions are ongoing to reflect the changes in peer reviews.

Discussion

In an exchange of information following Dr. Insel's presentation:

  • Dr. Li commented that Institutes can collaborate among themselves to work around the problem. For example, NIAAA currently collaborates with the Centers on Suicide. The roadmap and Neuroscience Blueprint offer additional opportunities to work for the common good.

  • Dr. Tabakoff suggested convening cross-Institute workgroups, perhaps to set common priorities. Dr. Insel remarked that the 14 Institutes involved in the Neuroscience Blueprint might collaborate in joint clinical trials or epidemiological studies that span common interests, for example, on persons with Parkinson's, of whom 40 percent present with depression that has never been measured, or on surveys of mental disorders that also include questions on alcohol and substance abuse.

  • Dr. Edenberg observed that NIMH and NIAAA represent 37 percent of the burden of diseases and urged that both areas be heavily included in the new half-million person NIH trial. Dr. Li stated that NIAAA is active in this respect and that the Institute has been a part of the planning. He raised the issue of the burden of lengthy interviews.

  • Dr. Mirin acknowledged the difficulty of the managerial and political task that NIMH has set out for itself. To his suggestion of engaging in public/private partnerships, Dr. Insel responded that NIH has encouraged fostering more such partnerships and has discussed opportunities with neuroscience directors of pharmaceutical companies. Conflict of interest is a concern, and although the private sector largely focuses on clinical trials, pharmacology research suffers from a lack of credibility. Partnerships in which pharmacology provides funds and NIH offers credibility may be a good match, particularly in areas significant to public health in which pharmacology is not interested. A series of meeting has been held to achieve common ground. Recent adverse publicity regarding SSRIs may encourage the pharmacology community to cooperate.

  • Dr. Koob urged engaging the Council to help focus on innovation and reduce redundancy. Dr. Insel concurred with the need to balance the number of applications funded in various areas. He pointed out also that innovation relates to novel conceptual frameworks and focusing on something not yet funded. That piece, which currently does not fare well, must be approached proactively by instituting a new program. Dr. Li commented that all NIH shares this major concern.

ETOH Database

Dr. Li presented a capsule history of the ETOH Database of alcohol-related literature. NIAAA recently contracted out an evaluation of this program. Since the program began in 1971, information technology processes have changed and the challenge has become how to improve its cost-efficiency resources now available. At the previous Council meeting, SALIS Executive Director Andrea Mitchell urged NIAAA to continue to maintain the ETOH Database. Also at that meeting Diane Miller and Dr. Faye Calhoun presented the evaluation contractor's findings. Following discussion at that meeting, the Council constituted a working group to evaluate the final findings. The working group included Drs. Sher, Koob, Caetano and Judge Payne.

Dr. Koob reported for the working group that the ETOH Database overlaps significantly with other government databases and no longer is cost-effective. Maintaining the database currently costs $400,000-$500,000 annually. In light of tightening NIH budgets, the working group recommended that NIAAA:

  • Discontinue updates to ETOH and instead maintain it as an archival, searchable database supplemented by links to other relevant resource and databases. Additional resources would be necessary to expand ETOH to fulfill its original charge, which would involve looking beyond the alcohol literature and into the non-journal area.

  • Organize and maintain a compilation of searchable databases on NIAAA's website, modernizing it to become a relevant resource.

  • Make available an ETOH webpage link on the NIAAA webpage.

  • Encourage input from SALIS and other relevant organizations to the new ETOH webpage. The approach would be to represent a variety of disciplines, prevent duplication, and make the resource more comprehensive-all with a minimum number of clicks.

  • Encourage PubMed to abstract the 4 "high impact" journals not represented in other databases.

Dr. Koob explained that his research assistant had not known about ETOH, although he appreciated it when he first accessed it. The percentage of the ETOH database that indexes chapters, announcements, reports, monographs, conference newsletters, symposium magazine articles, legislation materials, hearings, and other sources has declined from 33 percent to 16 percent currently. Many up-to-date resources can be picked up by NCADI.

Discussion

Dr. Sher clarified that publications are rated on "impact factors" as reported by the Institute for Scientific Information (ISI) in annual journal citations reports. Judge Payne observed that legal research is forced to confront the same kind of crisis that the medical field is experiencing. He expressed support for the recommendations. Dr. Caetano reflected that austerity budgets require difficult decisions and stated his support for the recommendation. Dr. Hoffman observed that different target audiences have different needs for information and suggested that the VA National Centers for PTSD's database may offer an interesting model. Dr. Tabakoff added that the information needs of the research community and clinicians in the substance abuse area have changed. Informatics, co-citations, and pathway mapping are now used, for example. He suggested attention to evolution and novel uses of resources and technology in the future. Dr. Li stated that the Society for Neuroscience has put together a master database of more than 100 databases, but the issue remains of the cost of maintaining each database as well as the master, and who will pay for it. Dr. Tabakoff remarked that a small Institute such as NIAAA should not be the primary funding source; nevertheless, it can be innovative in how it focuses on databases with addictions information and helps researchers hit the right spot. Dr. Koob stated that that is the plan envisioned for the ETOH webpage, a compilation of databases maintained by other sources, not NIAAA. The working group welcomes input from Council members and groups outside NIAAA to provide constructive input to NIAAA to make ETOH and its website better without additional burden to the Institute. Dr. Edenberg expressed support for the innovative idea of using pre-tested, pre-programmed search strategies to help people use the information.

SALIS Executive Director Andrea Mitchell told the Council that a cost-value analysis of ETOH shows that it costs 0.1 percent of NIAAA's total annual budget to keep ETOH and the thesaurus alive each year. Ms. Mitchell requested time for SALIS to review the "additional materials" document. Ms. Mitchell presented SALIS's position on ETOH:

  • No database is comparable to ETOH for its breadth and depth of coverage.

  • NIAAA has not fully considered the value of ETOH, which is an asset to the Institute. At a cost of less than 0.1 percent of NIAAA's total budget, SALIS believes the cost of ETOH to be minimal relative to its total value.

  • NIAAA has not thoroughly explored the implications of defunding, given investments over time, ETOH's contribution as an information resource for the public good, and the numbers of persons and organizations that will suffer time and financial losses from the decision.

Ms. Mitchell termed the defunding of ETOH as a loss to the alcohol field, and stated that SALIS will distribute its position paper on the issue and advocate retaining and maintaining the database. Dr. Tabakoff suggested that if SALIS attempts to rationalize the continued existence of the database, it would be valuable to present plans for its evolution and to inform the Council how ETOH could be better and how SALIS will help with the evolution. He stated that he agrees with the Council's position, but if SALIS challenges that position, the Council needs to hear more about the future.

Dr. Sher explained that, lacking a librarian to conduct his searches, he repeats the same search across multiple databases. He called attention to the marginal benefit of information and the fact that individuals' needs differ. Although the working group was sympathetic to continuing ETOH, because many people benefit from that tool, it has become difficult to justify economically. Ms. Mitchell explained that with the state-of-the-art software used by CSR for ETOH, Inmagic, it is possible to link to the document when it resides online. This could be done for ETOH. Dr. Li stated that the goal is to discuss mechanisms to address the issues raised and invited Ms. Mitchell to provide further input at the close of the meeting.

Developing Centers on Interventions for Prevention of Suicide

Charlene E. Le Fauve, Ph.D., explained that suicide prevention is an NIAAA priority at a time when NIH Institutes are encouraged to collaborate with each other. In America in 2001, more than 30,000 Americans died by suicide, mostly males in a ratio of 3-5:1. Suicide is the third leading cause of death for 15 to 24 year olds, following unintentional injuries and homicide. Comorbidities connected with suicide include mainly mental illnesses, substance abuse and alcohol use disorders, affecting up to 90 percent of all people who die by suicide. Having three conditions potentiates the risk for suicide more than having one of the conditions alone.

Dr. LeFauve stated that NIAAA's involvement in DCIPS began in March 2002 with an NIH workshop on alcohol and suicide behavior cosponsored by NIAAA and NIMH. In October 2002 the IOM published "Reducing Suicide: A National Imperative," a report cosponsored by NIAAA, NIMH, NIDA, CDC, SAMHSA, and the VA. The DCIPS emanated as a response to this report. NIMH, NIDA, and NIAAA recognized that insufficient research infrastructure exists to reduce adequately the burden of suicidality. The developing centers' primary goal is to support an infrastructure mechanism to build capacity at qualified institutions to enable them to pursue a research agenda that contributes to effective suicide treatment and prevention. The RFA, cosponsored by NIDA, NIMH, and NIAAA, committed $2.3 million in FY2004 to NIH Exploratory Center grants (P20s) to fund three new grants. A special emphasis panel reviewed 14 proposals to build networks, foster interdisciplinary collaboration, develop new research methods, develop and pilot test novel treatments, and cultivate training. Areas of research needed include state, community, and college-based prevention; attempting to examine definitions and registries across service settings of what is suicide; adverse event measurement; testing novel pharmacologic combination treatments for comorbid patients; endophenotyping and genotyping; and looking for surrogate imaging biomarkers.

NIAAA expects to support one developing center and will explore opportunities for co-funding other promising applications. Five applications had very good scores and a few focused primarily on alcohol use disorders, co-occurring suicidality, or depression. The initiative has experienced substantial progress. Collaborations with NIH and other Institute centers will take place as this program evolves. Medications development initiatives are a priority in this area, and combination behavioral and pharmacotherapies, familial transmission, neurobiology, biomarkers, prospective studies, and candidate gene approaches are ripe areas for exploration. The Alcohol and Suicidal Behavior Supplement has been published. Dr. Sher noted an upcoming special issue of Drug and Alcohol Dependence.

Alcohol Administration to Human Subjects

Dr. Li reported that NIAAA is forming a new Council working group to update NIAAA guidelines on alcohol administration to human subjects. The guidelines, published in 1988 and revised in 1989, are used by investigators around the world. The group will determine what is out of date in terms of current practices, ethical practices regarding privacy, science, and best practices in clinical review. Drs. Linda Chezem, Ken Warren, and Karen Peterson will begin the process of updating the guidelines, and Council members were invited to work with staff.

Council Operating Procedures

Dr. Hayunga explained recommended updates to the en bloc expedited concurrence procedure in the Council's operating procedures. The operating procedures define actions that staff can take without Council review or prior approval related to administrative changes, additional spending, increased direct costs, operational costs not anticipated, and the possibility of financing an additional year of a grant. Examples of changes include increases in salary or fringe benefits, loss of equipment, modifications to take advantage of serendipitous and other unanticipated opportunities to increase the value of project, minor errors, supplemental applications to provide support for reentry into research by persons who are disabled, underrepresented minority investigators, and administrative supplements for various purposes.

The purpose of expediting en bloc concurrence is to permit more rapid funding for the most highly meritorious applications. Under continuing procedures, one Council member would be assigned to applications within a particular program class code, although any member can request discussion by the full Council. The types of grant applications include RO1, R13, R21, R15, R24, R25, the entire K series, T32, SBIR, and STTR. The expedited en bloc concurrence excludes proposals with $500,000 or more in direct costs, foreign applications, applications with human subjects concerns, inclusion of women and minorities, inclusion of children, or use of laboratory animals.

The proposed change relates to redefining the standard for priority scores and percentiles in this group. Approval was requested for using expedited en bloc concurrence for only those applications with a percentile of 12 or better and only those applications with a priority score of 150 or better.
In discussion of a motion to approve the changes, Dr. Koob expressed concern about the potential negative effect of lowering the percentile and priority score on scores in general. Dr. Hayunga explained that this provision, which is not a funding cutoff, is designed to enable Council members to discuss borderline applications more fully. The change will enable Council to expedite the very best applications, but at the same time discuss those at the margins. The motion was carried unanimously.

Consideration of the February 2004 Minutes and Future Meeting Dates

Ms. Mitchell of SALIS stated that she takes issue with certain aspects of the representation of the discussion on the ETOH Database in the minutes of the February 2004 Council meeting. However, she offered no specific changes to be made. The Council unanimously accepted the minutes as submitted. Dr. Peterson noted that the next Council meeting will convene on September 8, 2004, at the Pooks Hill Marriott in Bethesda, Maryland, and on September 9 at the Natcher Building on the NIH Campus. Dr. Li stated that the proposed dates for 2005 meetings are informational only (February 2-3, May 25-26, and September 14-15).

Ex-Officio Member Report and Public Comment

Dr. Hoffman reported that an alcohol abuse reduction committee reviewing Health-Related Behavior from DOD 2002 reported increases in binge drinking since 1998 as well as adverse consequences. The committee will develop an action plan before the next survey is published.

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

Adjournment

Dr. Li adjourned the meeting at 2:05 p.m.

CERTIFICATION

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

/s/

Ting-Kai Li, M.D.
Director
National Institute on Alcohol Abuse and Alcoholism
and
Chairperson
National Advisory Council on Alcohol Abuse and Alcoholism

/s/

Karen Peterson, Ph.D.
Office of Scientific Affairs
Executive Secretary
National Advisory Council on Alcohol Abuse and Alcoholism


Prepared: June 2004

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