U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

 Minutes of the 137th Meeting of the

 NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM

 September 10–11, 2014

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 137th meeting at 5:00 p.m. on September 10, 2014, at NIAAA headquarters in Rockville, Maryland. Dr. George Koob, Director, NIAAA, called the closed session to order, and Dr.  Abraham Bautista, Director, Office of Extramural Activities, led a review of grant applications and a Merit Award extension. In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C., and 10(d) of Public Law 92-463, the public was excluded from this meeting for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The closed session recessed at 6:35 p.m. Dr. George Koob, Director, NIAAA, reconvened the Council in open session at 9:00 a.m. on September 11, 2014. 

Council Members Present:

Andrea Barthwell, M.D.
Carol A. Casey, Ph.D.
Fulton T. Crews, Ph.D.
Suzanne M. de la Monte, M.P.H., M.D.
Marianne L. Fleury
Hon. Joseph Thomas Flies-Away, J.D., M.P.A.
Andres G. Gil, Ph.D.
Paul J. Gruenewald, Ph.D.
Sarah N. Mattson-Weller, Ph.D.
Patricia E. Molina, Ph.D., M.D.
Adolf Pfefferbaum, M.D.
Rajita Sinha, Ph.D.
Daniel Kivlahan, Ph.D. (ex officio)
Charles S. Milliken, M.D. (ex officio)
James H. Eberwine, Ph.D. (ad hoc)

NIAAA Director and Chair: George F. Koob, Ph.D.

NIAAA Deputy Director: Kenneth R. Warren, Ph.D.

Executive Secretary: Abraham P. Bautista, Ph.D.

Senior Staff: 

Vivian Faden, Ph.D.; Michael Hilton, Ph.D. ; Robert Huebner, Ph.D.; Keith Lamirande; Gary Murray, Ph.D.; Mark Egli, Ph.D.; Patricia Powell, Ph.D.

Other Attendees at the Open Sessions:

Approximately 80 observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public.

Call to Order and Introductions

Dr. George Koob called the open session of the Advisory Council meeting to order at 9:05 a.m. on Thursday, September 11, 2014. He expressed appreciation to Drs. Andrea Barthwell, Suzanne de la Monte, and Andres Gil, whose terms on the NIAAA Council are expiring, and introduced ad hoc Council member Dr. James Eberwine. Council members and senior leadership introduced themselves. 

Director’s Report

Dr. Koob highlighted key recent Institute activities, referring to the written Director’s Report. 

• NIAAA budget.  Dr. Koob reported that NIAAA was taking steps to close out its FY2014 budget. National Institutes of Health (NIH) Director Francis Collins planned to announce BRAIN Initiative grants amounting to $46 million; NIAAA’s portfolio will manage one of these grants. NIH’s FY2014 budget amounts to $29.9 billion, $1 billion more than the previous year’s budget, and NIAAA is receiving $445.4 million, a 2.9% increase over FY 2013. The FY2014 appropriation is anticipated to support 677 Research Project Grants (RPGs), including 174 competing awards, compared to 671 RPGs and 166 competing awards the previous year. Dr. Koob stated his goal to increase the number of RPGs funded in the future. For FY2015 the President has requested a budget of $30.4 billion for NIH and $446 million for NIAAA, but it was anticipated that Congress would delay budget action and pass a continuing resolution. Negotiations have begun on the FY2016 budget.
   
• Honors and awards.  Dr. Koob shared the 25th annual Neuronal Plasticity Prize of the Fondation IPSEN for his work on neurobiology of addiction and alcoholism, and Drs. Pal Pacher and George Kunos have been named Thomson Reuters Highly Cited Researchers in the area of pharmacology/toxicology.
   
• NIAAA staff transitions. Dr. Koob welcomed Dr. Lori Ducharme, NIAAA’s new Program Director for Health Services Research; Workforce Resources Specialist Richard Doucette; and Rachel Quade, who serves as secretary/assistant for the Division of Neuroscience and Behavior.  Patricia Scullion has retired from NIAAA, and Jenny Czajkowski and Jennifer Norsworthy have left NIAAA for positions elsewhere. NIAAA has named Fred Donodeo as permanent Director of the Communications and Public Liaison Branch.
   
• Funding opportunities. Dr. Koob described a new program announcement (PA) pertaining to connectomes involved in human disease, several reissued PAs involving research centers, and a reissued PA on international research collaboration on alcohol and alcoholism.                                                        
   
• Research highlights and accomplishments. Dr. Koob noted two newly published books: Drs. Antonio Noronha and Changhai Cui have edited Neurobiology of Alcohol Dependence, and Dr. Koob was first author on the updated textbook to undergraduates Drugs, Addiction, and the Brain.
   
• Research highlights. Dr. Koob discussed NIAAA’s recent research successes, including, for example, a developmental study of fetal alcohol spectrum disorder (FASD) in which functional MRIs show different cortical activation patterns compared to controls for visuo-spatial attention at similar performance levels. An integrative neurosciences study shows that knockout mice that lack the peroxisome proliferator-activated receptor alpha are more vulnerable to neuroinflammatory responses associated with chronic alcohol exposure. Neuroinflammatory research on rats reveals that alcoholics can show recovery after abstinence, but recovery follows pathways in the brain different from those used in normal individuals. Research on adolescents shows that, in rats and mice, alcohol exposure can produce elements of impulsivity associated with loss of frontal cortex functioning, and that impairments generated during adolescence can be reversed. Intramural research on adults shows that ghrelin released in the gut to activate appetite also activates alcohol craving; NIAAA has initiated a program to investigate the potential use of ghrelin antagonists to treat alcohol craving. Dr. Koob also reported that research on racial and ethnic disparities in alcohol service utilization shows lower rates among Hispanics and African-Americans compared to Whites, and women compared to men, with the strongest evidence of disparities between the minority groups and Whites occurring among women.
   
• BRAIN Initiative. NIAAA will participate in NIH’s BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative, whose Multi-Council Workgroup will provide scientific advice.
   
• Collaborative Research on Addiction at NIH (CRAN) initiative. Under the CRAN Initiative, the Adolescent Brain and Cognitive Development (ABCD) study hopes to release notice of funding opportunities in FY2015. Sponsored by the National Institute on Drug Abuse (NIDA), NIAAA, National Cancer Institute (NCI), and the National Institute of Child Health, this program aims to conduct imaging and neuropsychiatric testing of 10,000 10−12 year olds over a 10-year period. 

 

NIH BRAIN Multi-Council Working Group Report

Dr. James H. Eberwine, Professor, Department of Pharmacology, and Co-director, Penn Genome Frontiers Institute, University of Pennsylvania School of Medicine, presented highlights of the BRAIN Initiative. The initiative will analyze the central nervous system over the next decade in hopes that a more detailed understanding of the brain will inform interventions for various types of mental disorders. The first five years will emphasize technology development, following which the research focus will shift to use of technology to map the brain. The initiative’s Multi-Council Working Group has developed a series of principles for generic collaboration among basic scientists and clinicians, and individuals with expertise in a variety of areas.

 New investment in the BRAIN Initiative is expected to grow to $400 million annually by FY2018 and to $500 million by FY2021, with a total infusion of $4.5 billion by FY2025. Dr. Eberwine described grants to be awarded in September 2014 and in FY2015. The Multi-Council Working Group’s administrative committee has proposed new initiatives, some of which have earned preliminary approval, including short courses to train scientists in new technologies; Small Business Innovative Research (SBIRs) programs for start-up companies engaged in brain-related work; and micro-scale connectivity. Dr. Eberwine welcomed ideas from Council members about potential projects for NIAAA researchers. 

Discussion. In response to Council members’ questions, Dr. Eberwine stated that as technologies are developed, refined, and verified at multiple sites, research will transition quickly into human systems; the Food and Drug Administration will facilitate rapid introduction of new intervention strategies for humans; and research has emphasized noninvasive methodologies. 

 

R35 Activity Code:  An Award to Support an Investigator’s Research Program

Dr. Abe Bautista introduced the R35, a new, innovative award to provide sustained, flexible support to individual investigators with outstanding records of research productivity and who propose to conduct exceptional research that represents a new scientific approach or program within the investigator’s expertise. The R35 is also designed to support the investigator’s overall research program. The R35 provides a longer sustainable base of grant support for mid-career individuals for up to 8 years. NIH hopes that each IC will develop its own program and rules pertaining to, for example, salary funding levels, selection mechanisms, and research types. Reviewers will judge applications largely on the  applicants’ qualifications, expertise, and promise to translate past achievements into groundbreaking research. Specific criteria may be added to the standard review criteria.

Discussion. A number of Council members endorsed the concept of the mechanism. In response to Dr. Sarah Mattson-Weller’s query, Dr. Bautista confirmed that the R35’s objective is to promote research on new ideas by individuals with documented expertise, without the need to present an abundance of details in the application. A special emphasis panel will review applications. Dr. Koob added that the mechanism would aim to retain talented mid-career investigators. Drs. Andres Gil and Patricia Molina observed the need for care in determining the requisite level of expertise, the research areas on which to focus, and funding available through researchers’ institutions. Dr. Molina suggested that NIAAA program staff nominate candidates and urged emphasis on funding highly qualified women or underrepresented minority researchers. Members discussed requiring institutions to provide matching funds for this award. Dr. Koob stated that NIAAA will develop plans for R35 awards, and he solicited additional Council input. 

 

Alcohol Biosensors            

Dr. Kathy Jung, Program Director, Division of Metabolism and Health Effects, NIAAA, and SBIR/STTR Coordinator, described the plans of NIAAA to develop wearable alcohol biosensors that accurately determine individuals’ alcohol consumption levels, preferably in real time. Some biosensors now in use in criminal justice settings (e.g., Secure Continuous Remote Alcohol Monitor or SCRAM) are too bulky for other uses.  Dr. Jung enumerated many applications for wearable alcohol biosensors, including monitoring sobriety among pilots and impaired physicians or police; treating certain medical conditions complicated by alcohol, such as HIV/AIDS and pregnancy; and monitoring relapse. 

Dr. Jung stated that to be useful in alcohol detection, wearable devices must be comfortable, discrete, inexpensive, and removable. They must identify subjects; interpret, transmit, and record data; verify standardization and functionality; have a dependable and rechargeable power source; and have microelectronic miniaturization. A number of companies have developed effective methods for detecting and quantifying blood alcohol, while others have ongoing developmental efforts. A bottleneck that can impede developmental progress of a wearable device is the difficulty in miniaturizing electronics. Issues to consider in developing alcohol biosensors include establishing detection limits, validation, regulatory requirements, standardization of devices, and reliability assurance in the field. Uses include monitoring by criminal justice systems, alcohol research, public safety, medical conditions, and relapse monitoring. 

NIAAA proposes to advance the development of alcohol biosensors by multiple funding mechanisms. 

Discussion. Dr. Michael Hilton pointed out that security, encryption, and confidentiality are additional functional considerations. Council members expressed approval for pursuing development of alcohol biosensors. Judge Joseph Flies-Away noted that SCRAM does not always work well in cold weather. He urged interagency collaboration in studying populations, such as persons involved with criminal justice systems, of mutual interest; Dr. Koob replied that NIAAA aims to collaborate in this area. Dr. Fulton cautioned NIAAA to look into the blood alcohol level at which SCRAM technology detects usage. Dr. Molina noted the importance of determining the effect of pH or metabolic state on measurement. Dr. Gyongyi Szabo noted the usefulness of such a tool in studying alcoholic liver disease and  the effect of alcohol on other organs. Dr. Gil suggested contacting the NSF [National Science Foundation], which has funded development of wearable medical devices. Dr. Suzanne de la Monte noted the need to monitor impairment due to marijuana plus alcohol use. Dr. Koob observed that a short neuropsychological test might be useful as a mobile phone app. Col. Charles Milliken suggested bundling such an app with a sleep actograph to show how alcohol use affects sleep, a strategy that might prompt military service members either to self-refer for services. 

 

Small Business Opportunity: Concept Clearance

Dr. Jung proposed that NIAAA publish targeted initiatives to small businesses in order to increase the number of applications submitted and to improve the quality of applications in NIAAA’s small business portfolio.  She suggested that encouraging and providing adequate funding for IND- (investigational new drug/device) enabling research would have the greatest direct impact in advancing the science. 

Discussion. Dr. Fulton Crews observed that the cost of health services research typically exceed the caps placed on government funding. Dr. Jung responded that NIH acknowledges the dilemma and is pursuing several strategies, including encouraging businesses to find other funding partners and will seek waivers of funding caps on applicable solicitation topics.  Dr. Koob stated that NIAAA anticipates working together with the NIDA on IND development. 

 

Consideration of Minutes of the June 2014 Council Meeting and Future Meeting Dates 

Council members unanimously approved the minutes of the NIAAA Council meeting held on June 4–5, 2014. 

Dr. Bautista announced that the Joint Council (NIAAA, NIDA, and NCI) will convene on the morning of February 4, 2015. The NIAAA Council will meet that afternoon in closed session, followed the next morning, February 5, by the NIAAA Council’s open session. The NIAAA Council will meet next on June 10 and September 16–17, 2015. In 2016 the Joint Council will meet on the morning of February 11, followed that afternoon by the NIAAA closed session. The NIAAA Council’s open session will be held on the morning of February 12. The NIAAA Council will meet next on June 8–9 and September 14–15, 2016. In 2017 the Joint Council will meet on the morning of February 8, followed that afternoon by the NIAAA Council’s closed session. The NIAAA Council will meet in open session on the morning of February 9. The NIAAA Council will next convene on June 7−8 and September 13−14, 2017. 

 

Alcoholic Hepatitis Consortia: Overview

Dr. Gary Murray, Acting Director, Division of Metabolism and Health Effects, NIAAA, described alcoholic hepatitis as a mosaic of disorders of varying severity that overlap as they progress from alcoholic steatosis through other diseases. NIAAA has identified alcohol hepatitis as desperately in need of research in terms of treatment. Institute-supported research has led to seminal discoveries in liver diseases not limited solely to alcoholic hepatitis. In 2012 NIAAA convened an Extramural Advisory Board (EAB) on the causes of alcoholic hepatitis, informed by a comprehensive briefing book that set forth the progression, diagnosis, definitions, and potential treatments of alcoholic hepatitis. 

The EAB recommended conducting multicenter collaborative trials using common protocols or biomarkers that address the spectrum of alcoholic hepatitis, collect and bank the biological samples, and investigate mechanisms through studies on the systems biology of multi-organ involvement. To achieve these aims, NIAAA has undertaken an initiative to expedite translation of emerging findings that could advance development into novel therapies. The initiative calls for close collaboration between basic scientists and clinicians. NIAAA funded four separate consortia in 2012 and 2013, headed by Drs. David Crabb, Gyongyi Szabo, Timothy Morgan, and Ramon Bataller, to focus respectively on translational research on the etiology of alcoholic hepatitis, proof-of-concept studies for novel therapies, novel therapies that address inflammatory storm, and a clinical observational study that examines key drivers of the disease process, classification of molecular profiles, and identification of druggable targets. 

 

DASH Study: Novel Therapies in Alcoholic Hepatitis 

Dr. Gyongyi Szabo, Associate Dean for Clinical and Translational Research, University of Massachusetts Medical School, described the work of her DASH (Defeat Alcoholic SteatoHepatitis) Consortium. Established with U01 funding from NIAAA, the consortium studies the clinical and translational components of alcoholic liver disease. Alcoholic hepatitis is a disease with high mortality for which little research progress has been made since the introduction of corticosteroid therapy in the 1970s. 

Dr. Szabo observed that understanding the disease has potential to inform many other aspects of alcohol research. Chronic inflammation is common to various organ-damage pathologies discovered as part of the alcohol effect, and her lab has studied the roles and effects of acute and chronic alcohol on modulating immune responses and inflammation.  Dr. Szabo explained that various receptor signals and receptor systems recognize inflammation and induce a response; most often inflammation resolves itself, but chronic alcohol use disturbs the homeostasis, and chronic inflammation can lead to fibrosis and cirrhosis. NIAAA studies have revealed the multifactorial nature of the pathogenesis of alcoholic liver disease. Dr. Szabo described a number of adverse direct effects, including effects on human and mouse hepatocytes that result in fat deposition, even after a single dose of binge drinking alcohol, and changes in gut permeability and in the microbiome. Dr. Szabo’s lab has found that the Toll-like receptor 4 (TLR4) downstream signaling molecule, Interferon Regulatory Factor 3 (IFR3), plays a major role in protection against alcoholic liver disease. 

Dr. Szabo traced the multiple patterns of pathology in alcoholic hepatitis. .She noted the dual role of certain innate immune signaling pathways and IRF3, and described interactions among cell death, TLRs, and inflammasomes—all leading to the sense that multiple signals come from a variety of sources that can amplify the inflammation process. She described the progression of the disease from normal to fatty liver among those who excessively drink alcohol (but reversible with abstinence), and then to acute alcohol hepatitis, and then cirrhosis. Dr. Szabo enumerated gaps in knowledge about alcoholic liver disease, including predisposing factors in alcoholic patients, triggers of severe acute alcohol hepatitis, classification of clinical stages, effective therapies, and biomarkers that predict clinical outcome and response to therapy.

To identify key pathways of pathology that can be translated to treatment, Dr. Szabo established a consortium with an interventional arm that performs multicenter clinical trials with data collection/statistics and also provides interaction between the sciences and translational phases of research at several centers. Participants in the consortium include Cleveland Clinic, University of Texas Southwestern, University of Massachusetts, Louisville University, and Mt. Sinai Hospital. The research aims for scientific integration,  to achieve focus on key elements of the pathogenesis of alcoholic hepatitis, such as,  the inflammatory cascade and innate immune activation, gut integrity, and cell survival and death pathways. The hypotheses to be tested are that: (1) the syndrome of acute alcohol hepatitis (AAH) results from severe inflammation and dysregulation of cytokine release; (2) gut-derived endotoxins and other bacterial products that trigger inflammation are a consequence of increased permeability and altered gut barrier function; and (3) compounds that improve the gut barrier function (in both moderate and severe disease), reduce the associated inflammation (severe disease), and prevent the development of hepatorenal syndrome and other organ failure (severe disease) in the treatment of severe AAH.

 In order to offer novel therapies to patients with moderate and severe alcoholic hepatitis, investigators designed separate pilot studies and clinical trials hoped to inform the design of subsequent clinical trials. Severe alcoholic hepatitis patients will receive either corticosteroids (standard of care) or a combination of interleukin-1 (IL-1) receptor antagonist plus pentoxifylline and zinc supplements; each agent targets various components of the disease pathology. The study is based on preclinical evidence in mice that the IL-1 receptor antagonist attenuates ASH and progression of liver damage. In a study of patients with moderate alcoholic hepatitis who have continued gut permeability and abnormalities, investigators are evaluating the effect of probiotic supplements versus standard of care on improvement in Model For End-Stage Liver Disease (MELD) scores and gut mucosal integrity. 

Dr. Szabo highlighted research features at the DASH Consortium’s component centers. The clinical translational component at the University of Massachusetts involves evaluating various biomarkers, particularly microRNAs that could be used as biomarkers of alcoholic liver disease in various stages or in response to therapy, and evaluating TLR4 tolerance and several unique biomarkers. This component will also conduct interventional studies in mice to evaluate potential new targets. The group at Louisville University is investigating the role of probiotics in modulating mucosal integrity, evaluating new inhibitors that would affect cell death, and investigating corticosteroid resistance. Cleveland Clinic investigators are evaluating biomarkers for alcoholic hepatitis severity and sensitivity to treatment, conducting pharmacogenetic analysis, and conducting preclinical studies in mouse models to identify and validate new drug targets. Cleveland Clinic data have shown that activating factor metabolites appear to correlate with alcoholic liver disease, a finding that warrants further evaluation for biomarker analysis. At Mt. Sinai, investigators have found that osteopontin (from milk) represents a protective factor in the gut and reduces the translocation of lipopolysaccharide (LPS); this represents a potential target for intervention.  The consortium has established a data and tissue biorepository center that collects comprehensive data for all patients in every part of the clinical trial, patient demographic clinical information, prospective data in observational studies, and biological samples. 

Dr. Szabo plans synergy among the U01 components: clinical trial, human cell models, animal models, and molecular studies from the perspective of novel therapies, biomarkers, and pharmacogenomics. The consortium has established a large clinical network, established a data coordination center and biorepository, started two novel clinical trials, and integrated translational science components. Though no specific therapy for alcoholic hepatitis has been identified yet, opportunities exist to improve the definition of alcoholic liver disease and its clinical stages, design new treatment paradigms, centralize data collection, expand the clinical network, capture additional clinical data/liver ‌samples, and educate patients and the public about alcoholic liver disease and participating in clinical trials. The ultimate goal is to cure alcoholic liver disease.

Discussion. Dr. Koob noted that Dr. Szabo serves as president of the American Association for the Study of Liver Diseases, and that NIAAA has selected Dr. Craig McClain, a key investigator of the DASH Consortium,  to deliver the Keller Lecture. Dr. Koob stated that a surge in high-intensity binge drinking among young people is emerging, highlighting the importance of research on alcoholic liver disease. Dr. Szabo responded yes to a question from Dr. Rajita Sinha as to whether  the Consortium provides counseling and monitoring of patients’ drinking behavior. Dr. Szabo added that the Consortium also collects data on alcohol drinking history. In response to Dr. Crews’ question regarding anti-inflammatory medications, Dr. Szabo stated that the IL-1 receptor antagonist has been found to attenuate inflammation in the brain, and another investigator has found that the IL-1 receptor can change alcohol-addictive behavior.

 

New Horizons in Alcohol Research: Using Electronic Health Records
                                       
Dr. Constance Weisner, Research Scientist, Division of Research, Kaiser Permanente, and Professor, University of California−San Francisco, described significant opportunities offered by health reform to study alcohol problems in health care. With impetus from the Affordable Care Act (ACA), and with health plans’ data and the ability to attract strong researchers, health care plans have become valuable research sites. Dr. Weisner stated that the Centers of Medicaid and Medicare (CMS) as an outgrowth of the ACA requires health plans to use electronic health records and that patient portals, important in providing patient-centered care, will be useful also to researchers.  She pointed out that there are now over 9 NIH, AHRQ, or PCORI-funded networks through the HMO Research Network (HMORN), with NIH the main sponsor.
 
Kaiser-Permanente (KP) is a member of the HMORN.  Using it as an example, it accords a central place for alcohol in its total health approach under ACA due in part to parity and health reform, but also to NIAAA-funded health services work in establishing the business case. KP considers primary care as a health home that treats a whole continuum of problems; KP screens for and treats moderate alcohol problems, and refers individuals with more severe problems to specialty care. Once patients are stabilized, they return to primary care for monitoring and, if necessary, further care. KP has merged all its data into one in-house virtual data warehouse (VDS) and has harmonized its longitudinal data across 18 other health plans; a single platform provides greater efficiency, lower costs, and enhanced security. KP’s membership in the HMORN enables collaborative research on large populations with other public-domain research centers based in health plans and universities. NIH and other organizations have provided support to harmonize the datasets and to minimize impediments to bioresearch.
 
New innovations enable patients to access patient portals by computer and smart phones, for example, to graph their blood pressure and lab tests, communicate with doctors, and receive online education. KP is researching the use of patient portals, particularly for patients  with difficulty in seeing a doctor. Innovative video visit is an alternative to be used in consultations with addiction medication specialists to help physicians prescribe recovery medications.
 
To illustrate integration of helping physicians prescribe medications and treatment referrals, Dr. Weisner described two studies that use electronic health records. A large study compared two evidence-based methods of Screening, Brief Intervention, and Referral to Treatment (SBIRT). This study screened more than 600,000 adults in 54 primary care clinics via health care visits and generated outcomes on implementation, rates of hazardous drinking over time, health plan utilization and cost, and subgroups of patient characteristics, among other factors. Following the study, with a Best Practices alert (in the Vitals Research Database section), KP now screens 86% of patients having primary care visits annually, or whenever they have a visit once they have had a positive screen. A similar study with 8000 patients in one large clinic screened adolescents via a questionnaire in tablet form. The  responses went into the electronic health record; responses related to alcohol use generated a follow-up assessment tool. The studies resulted in the development of innovative programs in  OB/GYN and FASD screening and outcomes, availability of longitudinal data,  rapid and early identification of candidates for clinical trials.
 
Dr. Weisner described ongoing biomedical research related to alcohol, including a large program on genes, environment, and health, and a genetics study with NIAAA. Survey data and tissue samples are used as well as individual health plan data and geocoding at the neighborhood level. This work has potential to merge health services work which has rich phenotype data with genetics and EHR health utilization data. The NIAAA family identification study has made the case for SBIRT by matching families with and without alcohol and drug problems; family members of alcohol treatment clients had higher rates of medical care and emergency room visits than the control group, and medical costs for family members were lowered compared to controls with successful treatment of the member with alcohol and drug problems.

With integration of health care in the ACA, new opportunities exist for all types of health systems research, which is endorsed by the Department of Health and Human Services, Federal Health IT Policy Committee, NIH, and others. Challenges at NIAAA, however, include a steep learning curve for study sections, whose members may have misconceptions about using patient data without recruitment; other Institutes have found mechanisms to do so. Dr. Weisner stated that public system and other research networks are growing, and many opportunities exist in patient-centered care to conduct research and provide patient care simultaneously. This is consistent with integrating research with “Learning HealthCare Systems”, which the Institute of Medicine and other institutions have championed.  Dr. Weisner added that another opportunity for NIAAA is funding research on alcohol and hepatitis C, considered an epidemic by the health plan, and considerable energy is focused on HIV as well.
 
Discussion. In response to a question from Dr. Hilton, Dr. Weisner pointed out that some alcohol researchers receive NIH and NIAAA grants in several sites, and although virtual data warehouses have generated reduced research costs, projects that include multiple health system research sites may not naturally fit into standardized funding opportunities such as R01s. It would be helpful to have a special program announcement using  another mechanism to solicit such research; some Institutes use the Clinical Research Cooperative Agreement (UG1). Dr. Weisner replied to Dr. Paul Gruenewald’s questions that coverage of underserved populations is expected to improve greatly in both private and public health systems, with the ACA’s Medicaid expansion and covering the newly insured (with alcohol problems being overrepresented in these individuals) and that study section misconceptions pertain largely to informed consent procedures, though HHS recommends using data collected in the course of medical care under Internal Review Board (IRB) provisions. 

 

Ex-officio Council Member Reports

Department of Veterans Affairs (VA). Dr. Daniel Kivlahan observed that as veterans’ access increases to non-VA care, tracking both services quality and effectiveness will require VA to collaborate with non-VA partners. The Veterans Choice Act places greater emphasis on more direct patient-reported outcomes for VA patients, but integrating that data into electronic health records efficiently has proven difficult, and quality concerns exist about relying on clinicians for data collection and entry versus collecting data directly from VA patients on a tablet in the waiting room, for example.

Dr. Kivlahan stated that VA provides a full continuum of care for alcohol use disorders. More than half a million veterans annually have a diagnosis of substance use disorder, of whom 80% have a diagnosis of alcohol use disorder; only a third of these individuals have contact with addiction specialty care. A VA multisite trial has led to an implementation study that will seek to surmount barriers to providing alcohol care management within primary care clinics. Ultimately, VA seeks to provide integrated behavioral health services wherever the veteran presents. Collaborative care is a major theme in the VA system, including focusing on pain management and use of opioids and alcohol, often together. VA is refining its data operations for ease of use, to promote effective panel management, and to capitalize on opportunities to improve care.

 VA has added extended-release naltrexone to its formulary. The VA funds seven sites of interprofessional advanced fellowships in treatment for alcohol and other drug addiction; the agency hopes to involve addiction psychiatrists and addiction medicine providers as well as associated health professionals such as social workers, psychologists, pharmacists, and others. Dr. Koob observed the need to increase the focus on integration vis-à-vis recovery and treatment. He requested that the VA look into use of gabapentin in clinical trials, and Dr. Kivlahan agreed to review existing clinical data.

Department of Defense (DoD).  Col. Charles Milliken, M.D. reported that the Department of Defense (DoD) has published an instruction on substance use in response to the Institute of Medicine’s 2013 report. The instruction supports help for active duty service members with substance use problems to engage with the VA system upon exit from the military. The instruction, which also enables family members to receive better care, emphasizes the DoD’s patient-centered medical home (PCMH), in which SBIRT is promoted. The Army is pilot testing its Behavioral Health Data Platform in behavioral health clinics, where individuals answer standardized questions and data is to be stored in a data warehouse (under construction). Following successful PCMH pilot programs that used the same platform for screening for depression, PTSD, anxiety, and alcohol on each patient who presented, plans are underway to implement the program across systems in the coming year. The Army is evaluating new findings on AUDIT-C, a survey diagnostic tool, based on new research by Dr. Kivlahan. Col. Milliken stated that the military faces the challenge of convincing career-oriented members to endorse alcohol treatment proactively.

 

Public Comment and Public Liaisons

Dr. Sarah Cavanaugh, Physicians Committee for Responsible Medicine, urged NIAAA to broaden its prevention and education efforts for excessive alcohol use. She questioned the strategy to study fetal alcohol spectrum disorders (FASD) using animal models and instead urged NIAAA to invest in research aimed at discovering and testing methods to educate women on the effects of fetal alcohol exposure, enhancing family support networks, and investigating novel methods for widespread implementation of these measures. Ms. Pamela Walters, Al-Anon Family Groups, thanked Dr. Koob for his interview with Al-Anon, which appears on Al-Anon’s website. Al-Anon is a nationwide 12-step program for anyone affected by others’ drinking. She noted publication of the new issue of the organization’s public outreach magazine, Al-Anon Faces Alcoholism. Dr. Susan Rich, a child and adolescent psychiatrist whose Seventh Generation Foundation promotes prevention and treatment of neurodevelopmental disorder associated with prenatal alcohol exposure (NDPAE), asserted the need to shift government research dollars from basic animal models to population-based primary prevention and treatment efforts. She described a new prevention program that promotes the use of contraception for reproductive-age alcohol consumers. She asserted that agencies both engage in insufficient research on treatment of individuals with FASD and provide inadequate support for long-term housing and vocational supports for this population. She noted the urgent need for standards of care for NDPAE and for increased understanding by the psychiatrists who treat them.

 

Adjournment

The meeting adjourned at 1:05 p.m. 

CERTIFICATION

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

/s/

George F. Koob, Ph.D.
Director
National Institute on Alcohol Abuse and Alcoholism
and
Chairperson
National Advisory Council on Alcohol Abuse and Alcoholism 

/s/

Abraham P. Bautista, Ph.D.
Director
Office of Extramural Activities
and
Executive Secretary
National Advisory Council on Alcohol Abuse and Alcoholism