Minutes of the 148th Meeting of the NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
148th Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
May 15, 2018
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 148th meeting at 9:49 a.m. on Tuesday, May 15, 2017, at NIAAA headquarters in Rockville, Maryland. The Council met in closed session from 9:02 a.m. to 9:46 a.m. to review grant applications and cooperative agreements. Dr. Abraham Bautista, Director, Office of Extramural Activities, presided over the Council’s review session, which, in accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C., and 10(d) of Public Law 92-463, excluded the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The closed session recessed at 9:46 a.m.
Howard C. Becker, Ph.D.
Daniel J. Calac, M.D.
Carlo C. DiClemente, Ph.D.
Tom B. Donaldson
James H. Eberwine, Ph.D.
Tatiana M. Foroud, Ph.D.
Robert J. Hitzemann, Ph.D. (on telephone)
Paul J. Kenny, Ph.D.
Arun J. Sanyal, M.D.
Vijay H. Shah, M.D. (on telephone)
Frank A. Sloan, Ph.D.
Susan M. Smith, Ph.D.
Edith Vioni Sullivan, Ph.D.
Constance M. Weisner, D.R.P.H.
NIAAA Director and Chair: George F. Koob, Ph.D.
NIAAA Deputy Director: Patricia Powell, Ph.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Senior Staff: Vicky Buckley, M.B.A.; David Goldman, M.D.; Ralph Hingson, Sc.D., M.P.H.; M. Katherine Jung, Ph.D.; George Kunos, M.D., Ph.D.; Raye Litten, Ph.D.; Antonio Noronha, Ph.D.; and Bridget Williams-Simmons, Ph.D.
Other Attendees at the Open Session:
Approximately 65 observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the public.
Call to Order and Introductions
NIAAA Director George Koob, Ph.D., called the open session of the Council meeting to order at 9:49 a.m. on Tuesday, May 15, 2018. Council members and senior NIAAA staff introduced themselves
Director’s Report
Dr. Koob highlighted key recent NIAAA activities, referring to the written Director’s Report, which was distributed to Council members.
- Staff Transitions: Hemin Chin, Ph.D., joined the NIAAA Division of Neuroscience and Behavior as a Senior Program Director in April 2018. Studly Auguste joined the Office of the Clinical Director (OCD) as Clinical Operations Manager on April 2, 2018. Csaba Matyas, Ph.D., joined the NIAAA Laboratory of Cardiovascular Physiology Tissue Injury in May 2018 as a Postdoctoral Visiting Fellow. Sofia Bouhlal, Ph.D., who was a Visiting Fellow in the NIAAA Section on Clinical Psychoneuroendocrinology and Neuropsychopharmacology (CPN), has returned to France to be with her family. She remains an active collaborator with the CPN team. Bridget Williams-Simmons, Ph.D., has been appointed as the Director of the NIAAA Office of Science Policy and Communications. Jennifer A. Hobin, Ph.D., has been appointed as Chief of the NIAAA Science Policy Branch.
- Budget: NIH received $37 billion for Fiscal Year (FY) 2018, which provided a general increase to all NIH Institutes and Centers (ICs). NIAAA received $509.6 million, $27.1 million above the FY 2017 enacted level. There were specific increases for research on opioids, Alzheimer’s disease, antimicrobial resistance, and influenza, as well as continued support for the Gabriella Miller Kids First Pediatric Research Program. The President’s FY 2019 budget, released in February, requests $33 billion for NIH, a $1 billion decrease from FY 2017. This includes $469.1 million for NIAAA, a $13.4 million decrease from FY 2017.
- Collaborative Research on Addiction at NIH (CRAN): The ABCD study now has over 9,000 participants enrolled. The first curated release of ABCD study data occurred in February 2018 through the NIMH Data Archive, providing 30 terabytes of high-quality baseline data obtained from the first 4,500 participants, including basic demographics, physical and mental health, substance use, culture and environment, neurocognition, tabulated structural and functional neuroimaging data, minimally processed brain images, and biological data such as pubertal hormone analyses.
- New Notice of Funding Opportunities (NOFOS): New NOFOs include Genetics of Alcohol Sensitivity and Tolerance (R01 - Clinical Trial Not Allowed) PA-18-660; (R21/R33 – Clinical Trial Not Allowed) PAR-18-659; Supplements to Advance Research (STAR) from Projects to Programs (Administrative Supplement Clinical Trial Optional) PA-18-647 for early established investigators; and Understanding Processes of Recovery in the Treatment of Alcohol Use Disorder (R01 - Clinical Trial Optional) PA-18-619 (R21 - Clinical Trial Optional) PA-18-620, representing a new and vigorous exploration of recovery.
- NIH-wide NOFOs: NIH-wide NOFOs in which NIAAA is participating include Challenges of the Opioid Epidemic in Minority Health and Health Disparities Research; Women and Sex/Gender Differences in Drug and Alcohol Abuse/Dependence; Alzheimer’s Disease and its Related Dementias; the BRAIN Initiative; HIV Research Training Program for Low- and Middle-Income Country Institutions; Improving Patient Adherence to Treatment and Prevention Regimens; Reciprocal Basic Behavioral and Social Linkages Between Sleep and Stress; Health of Transgender and Gender Nonconforming Populations; Basic Science-Clinical Collaborations to Understand Structural Birth Defects; and Analyses of Data for the Gabriella Miller Kids First Data Resource.
- NIAAA-FDA-AASLD Alcoholic Hepatitis Workshop: In March 2018, NIAAA, the Food and Drug Administration (FDA), and the American Association for the Study of Liver Diseases (AASLD) hosted a 2-day workshop titled Clinical Trial Design and Endpoints for Alcoholic Hepatitis (AH) and other Alcohol-Associated Liver Diseases (AALD). The purpose of the workshop was to develop recommendations for standardized definitions, variable sets, screening and assessment tools, and procedures to advance clinical research and drug development in AH and AALD. The workshop included talks about alcohol use disorder (AUD) and AUD treatment, a new and emerging topic in the hepatology field. Kathy Jung, Ph.D., Director of NIAAA’s Division of Metabolism and Health Effects (DMHE), and her staff are taking the lead in addressing the challenges in undertaking clinical trials and translational research in this domain.
- Role of Alcohol in the Opioid Epidemic: On March 13, 2018, the Friends of NIAAA hosted a Congressional meet-and-greet. Dr. Koob spoke about the role of alcohol in the opioid epidemic and its relationship to pain sensitivity. This is burgeoning area of research for NIAAA.
- Community Anti-Drug Coalitions of America (CADCA): The CADCA National Leadership Forum was held at National Harbor, Maryland, on February 6, 2018. Dr. Koob gave a presentation about NIAAA research priorities, recent advances, and emerging research concerns. Lori Ducharme, Ph.D., highlighted the NIAAA Alcohol Treatment Navigator in a session about evidence-based alcohol treatment. Ralph Hingson, Sc.D., M.P.H., provided an overview of federal efforts related to underage drinking prevention.
- NIAAA Communication and Outreach: Dr. Ducharme and Aaron White, Ph.D., participated in an hour-long discussion titled “The United States of Alcohol Abuse” on National Public Radio’s 1A program on January 9, 2018. A teleconference for stakeholders and federal partners highlighting the findings of the new, NIAAA-funded study, “Prevalence of FASD among First-Graders in US Communities,” was held in partnership with Collaboration on Fetal Alcohol Spectrum Disorders Prevalence (CoFASP) investigators and the National Organization on Fetal Alcohol Syndrome (NoFAS). As part of Alcohol Awareness Month in April, NIAAA conducted a variety of activities, including social media outreach with the National Council on Alcoholism and Drug Abuse, the American Society of Addiction Medicine, and the National Center for Complementary and Integrative Health at NIH, on topics such as how to start a conversation about AUD treatment with a loved one, resources for friends and families, and alcohol treatment resources.
- Progress in Reducing Underage and College Drinking: Underage and young adult harmful drinking is a major focus at NIAAA. The 2017 Monitoring the Future survey revealed that underage drinking has been reduced by one-third over the past ten years. In FY 2017, NIAAA funded 27 grants totaling $8 million on underage drinking prevention, and 47 grants totaling $15 million in college-age drinking prevention. NIAAA has also developed Alcohol Screening and Brief Intervention for Youth: A Practitioner’s Guide, and CollegeAIM, a resource for helping colleges address harmful and underage student drinking that has been distributed to every college campus in the United States. Two major research studies funded by NIAAA also address underage drinking: the National Consortium on Alcohol and Neurodevelopment in Adolescence (NCANDA) and the current Adolescent Brain Cognitive Development (ABCD) study.
- Alcohol Policy Research: NIAAA’s policy portfolio includes 12 active grants ($7.4 million) in FY 2014 and 18 active grants ($9.5 million) in FY 2017. Policy grants constituted 10 percent of the budget in Division of Epidemiology and Prevention Research in 2017. NIAAA continues to encourage more policy research applications via Public Policy Effects of Alcohol, Marijuana, and Other Substance Related Behaviors and Outcomes (PA-17-132, 134, & 135). Finally, NIAAA maintains the Alcohol Policy Information System (APIS), a large searchable database of alcohol-related federal and state policies. Marijuana policies have recently been added to APIS.
- NIAAA Research Highlights: Dr. Koob presented highlights of NIAAA-funded studies:
“Digoxin Suppresses Pyruvate Kinase M2 (PDM2) – Promoted HIF-1A Transactivation in Steatohepatitis” was published in Cell Metabolism (2018 Feb 6; 27(2):339-350.e3) by X Ouyang, S-N Han, J-Y Zhang, E Dioletis, BT Nemeth, P Palcher, D Feng, R Bataller, J Cabezas, P Stärkel, J Caballeria, RL Pongratz, S-Y Cai, B Schnabl, R Hoque, Y Chen, W Yang, I Garcia-Martinez, F-S Wang, B Gao, NJ Torok, RG Kibbey, and WZ Mehal. The findings of their study support the concept that the transcription factor HIF-1 alpha orchestrates a highly conserved host protective response to hypoxia, a common feature observed in animal models of alcohol-induced liver disease and, more recently, in the liver of human binge drinkers. A persistent HIF-1 alpha response to hypoxia in a host, similar to chronic inflammation, is thought to contribute to the development of many medical conditions, including alcohol-associated liver diseases (AALD). This study also demonstrates the potential of digoxin, a widely used medication for heart disease, in treatment of AALD via the HIF-1 alpha pathway.
“Apoptosis of Enterocytes and Nitration of Junctional Complex Proteins Promote Alcohol-Induced Gut Leakiness and Liver Injury” was published in the Journal of Hepatology (2018 Feb 16. (18) 30121-1) by YE Cho, L-R Yu, MA Abdelmegeed, SH You, and BJ Song. The molecular mechanisms through which binge alcohol-induced gut leakiness contributes to endotoxemia and inflammatory liver disease are poorly understood This study demonstrated the critical roles that apoptosis of enterocytes (cells of the intestinal lining) and nitration of intestinal junctional complex proteins followed by ubiquitin-dependent proteolytic degradation play in promoting binge alcohol-induced gut leakiness.
“Implications of Altered Maternal Cytokine Concentrations on Infant Outcomes in Children with Prenatal Alcohol Exposure” was published in Alcohol (2018 May; 68:49-58) by KD Sowell, JY Uriu-Adams, J Van de Water, CD Chambers, CD Coles, JA Kable, L Yevtushok, N Zymak-Zakutnya, W Wertelecki, CL Keen; and the Collaborative Initiative on Fetal Alcohol Spectrum Disorders (CIFASD). They examined the relationship between maternal alcohol consumption, maternal immune profile, and risk of FASD in the offspring using a prospective CIFASD cohort in Ukraine. While maternal alcohol use was associated with increased cytokine levels throughout pregnancy, women without a proper balance of pro-inflammatory cytokines and anti-inflammatory cytokines in the third trimester had an elevated risk of having a child with FASD.
“Prevalence of Fetal Alcohol Spectrum Disorders in 4 US Communities” was published in JAMA: Journal of American Medical Association (2018 Feb 6; 319(5):474-482) by PA May, CD Chambers, WO Kalberg, J Zellner, H Feldman, D Buckley, D Kopald, JM Hasken, R Xu, G Honerkamp-Smith, H Taras, MA Manning, LK Robinson, MP Adam, O Abdul-Rahman, K Vaux, T Jewett, AJ Elliott, JA Kable, N Akshoomoff, D Falk, JA Arroyo, D Hereld, EP Riley, ME Charness, CD Coles, KR Warren, KL Jones, and HE Hoyme. In this study, active-case ascertainment, the most reliable approach for estimating the prevalence of fetal alcohol spectrum disorders (FASD), was used to determine new prevalence estimates among four U.S. communities (8 sites) with varied demographics. Prevalence estimates ranged from 1.1 to 5 percent. Although not necessarily generalizable to all U.S. communities, these estimates are likely more accurate than previously reported estimates for the United States. Given that children with FASD often go undiagnosed or misdiagnosed, it is important for clinicians and researchers to be aware of the prevalence of FASD.
“Binge Drinking Above and Below Twice the Adolescent Thresholds and Health-Risk Behaviors” was published in Alcoholism: Clinical and Experimental Research (2018 April 10. doi: 10.1111/acer.13627) by R Hingson and W Zha. They found that drinking at or greater than twice the age-/gender-specific binge thresholds for adolescents for reaching a blood alcohol level of .08 percent was a strong predictor of increased health-risk behaviors among high-school students.
“What ‘Likes’ Have Got to Do with It: Exposure to Peers’ Alcohol-Related Posts and Perceptions of Peer Approval for Alcohol Use” was published in by SC Boyle, DJ Smith, AM Earle, and JW LaBrie (J. Am. Coll. Health 2018 Feb 6:1-7). They found that underage college students, who lack ample first-hand experience observing alcohol use among close friends, may rely on social network sites, specifically the “likes” attached to peers' alcohol-related posts, to estimate injunctive drinking norms. For first-year college students who have not yet initiated drinking, observing peers' alcohol-related posts to receive abundant "likes" may increase perceptions of peer approval for risky drinking.
“The OPRM A118G Polymorphism: Converging Evidence Against Associations with Alcohol Sensitivity and Consumption” was published in Neuropsychopharmacology (2018, 43:1530–1538) by ME Sloan, TD Klepp, JL Gowin, JE Swan, H Sun, BL Stangl, and VA Ramchandani. Numerous studies have associated the A118G functional genetic polymorphism in the mu-opioid receptor gene (OPRM1) with alcohol consumption and sensitivity; however, larger genome-wide association studies have yet to demonstrate an association between A118G and having a diagnosis of AUD. This study examined the effect of the mu-opioid receptor variant, OPRM1-A118G, on alcohol self-administration, subjective response, and craving in a sample of social drinkers; the results indicated no significant effects. Also, analysis of a larger sample of 965 participants of European ancestry found no relationship between OPRM1 genotype and alcohol consumption in participants with or without AUD. These findings suggest that there may not be an association between the OPRM1 A118G genotype and alcohol consumption or sensitivity in individuals of European ancestry.
“Advancing Analytic Approaches to Address Key Questions in Mechanisms of Behavior Change Research” was published in the Journal of Studies on Alcohol and Drugs (2018; 79:182–189) by KA Hallgren, AD Wilson, and K Witkiewitz. Mediation analysis frameworks have been the primary approach used to evaluate mechanisms of behavior change (MOBC), but a greater understanding of how MOBC operate requires advanced analytic techniques that consider the dynamic and non-linear change processes that take place in AUD treatment. This article highlights and reviews several statistical approaches that may enhance understanding of MOBC in AUD treatment, which may be useful in studying recovery.
“Development and Initial Characterization of a Novel Ghrelin Receptor CRISPR/CAS9 Knockout Wistar Rat Model” was published in the International Journal of Obesity (Lond) (2018 Jan 30 [Epub ahead of print]) by LJ Zallar, BJ Tunstall, CT Richie, YJ Zhang, ZB You, EL Gardner, M Heilig, J Pickel, GF Koob, LF Vendruscolo, BK Harvey, and L Leggio. The hormone ghrelin is known for its role in regulating appetite and food intake, and previous studies have shown that ghrelin is also involved in the brain's reward and stress pathways. The current study describes the development of a novel transgenic rat model lacking the ghrelin receptor that will enable future research on the role of the ghrelin system in substance use disorders and other behaviors.
“Unique Treatment Potential of Cannabidiol for the Prevention of Relapse to Drug Use: Preclinical Proof of Principle” was published in Neuropsychopharmacology (2018. doi:10.1038/s41386-018-0050-8) by G Gonzalez-Cuevas, R Martin-Fardon, TM Kerr, DG Stouffer, LH Parsons, DC Hammell, SL Banks, AL Stinchcomb, and F Weiss. They found that cannabidiol (CBD) conferred beneficial effects on reversing drug-seeking behavior, anxiety, and impulsivity, as well as long-lasting effects with only brief treatment. The authors argue that targeting concurrent behaviors associated with relapse risk may be a more effective strategy than targeting a single behavior.
“The Role of Aging, Drug Dependence, and Hepatitis C Comorbidity in Alcoholism Cortical Compromise” was published in JAMA Psychiatry 2018; 75(5):474–483 by EV Sullivan, NM Zahr, SA Sassoon, WK Thompson, D Kwon, KM Pohl, A Pfefferbaum. An accompanying editorial, “Age, Alcohol Use, and Brain Function: Yoda says: With Age and Alcohol, Confused is the Force,” was also published in the same issue (75(5):422) by GF Koob. This study examined changes in regional brain volumes in alcohol-dependent individuals and age-matched controls, aged 25 to 75, who received one or more MRI scans over a 14-year period. Alcohol-dependent individuals had significantly more age-related decreases in brain volumes, most prominently in the frontal cortex. Drug dependence or hepatitis C (HCV) compounded the effects.
“Working Memory Training Improves Alcohol User’s Episodic Future Thinking: A Rate-Dependent Analysis” was published in Biological Psychiatry: Cognitive Neuroscience and Neuroimaging (2018; 3:160-167) by SE Snider, HU Deshpande, JM Lisinski, MN Koffamus, SM LaConte, and WK Bickel. A hallmark of addictive behavior is a deficit in delay discounting, i.e. an inability to postpone immediate rewards (e.g., consuming a drink) and to discount or not select larger future rewards. The current study found that working memory training in alcohol-dependent individuals significantly improved episodic future thinking in those who had the highest discounting rates at baseline.
- Emerging Issues: Dr. Koob highlighted several emerging issues of concern to NIAAA, including:
Binge Drinking: “Drinking Beyond the Binge Threshold: Predictors, Consequences, and Changes in the U.S.,” published in the American Journal of Preventive Medicine (2017 Jun; 52(6):717-727) by RW Hingson, W Zha, and AM White, found a 13 times higher risk of emergency room (ER) visits among binge drinkers (4+ drinks for women, 5+ drinks for men, on an occasion) and a 93 times higher risk among extreme binge drinkers (12+ drinks for women, 15+ drinks for men, on an occasion). NIAAA is forming a working group of external experts to better understand the social and cultural determinants of extreme binge drinking to inform the development of improved interventions.
Alcohol and Women’s Health: Gaps between women and men are narrowing for prevalence, frequency and intensity of drinking, early onset drinking, having an AUD, drunk driving, and self-reported consequences. Women are more likely to experience blackouts, liver inflammation, brain atrophy, cognitive deficits, certain cancers, and to experience negative affect during withdrawal and stress or anxiety-induced relapse. Little is known about why these health effects occur. Of 230 structural neuroimaging studies on substance use over 23 years, only 26 percent evaluated sex differences. More clinical research about sex differences and alcohol is needed.
More People Aged 65+ Are Drinking and Binge Drinking. “Trends in Alcohol Consumption Among Older Americans: National Health Interview Surveys, 1997 to 2014,” published in Alcoholism: Clinical and Experimental Research (2017 May; 41(5):976-986) by R Breslow, IP Castle, CM Chen, and BI Graubard, found that older Americans are increasingly consuming more alcohol and engaging in more binge drinking; the gap between older men and women is narrowing.
Urgent Need to Grow the Addiction Medicine Workforce. Many providers do not perform AUD screening, and are unaware of evidence-based treatments or where to refer people. The goals of NIAAA’s initiatives in response to this emerging issue are to improve physician training in substance use prevention and treatment at all levels, from undergraduate and graduate medical education through residency, fellowship, and beyond; and to integrate prevention, early intervention, and treatment into routine medical care. Information about AUD and its treatment is also needed for nurses, clinical psychologists, pharmacists, and other health professions. NIAAA has supported the Board of Addiction Medicine scholarship program that aims to place board-certified addiction physicians in every community in the United States. Next steps include: 1) Dr. Ducharme is leading a group to modify the Alcohol Treatment Navigator for treatment providers, and 2) Peggy Murray, Ph.D., is leading an effort to develop a core curriculum/information that all providers should know about alcohol.
Discussion: James Eberwine, Ph.D., inquired about metrics on use of the Alcohol Treatment Navigator. Dr. Ducharme responded that metrics are being tracked. There was a huge spike following the NPR 1A interview; NIAAA welcomes suggestions for other, more reliable ways to reach out to communities. Dr. Koob interjected that the American Psychiatric Association’s Council on Addiction Psychiatry is interested in the Navigator. Constance Weisner, D.R.P.H., encouraged more implementation research to support broader use of the tool. Frank Sloan, Ph.D., reiterated the importance of implementation research. Dr. Koob noted that NIAAA has met with the American Association for the Study of Liver Disease (AALSD) about the Navigator; one idea that emerged from that meeting was to encourage people who come in for liver disease treatment to pursue treatment. Cathy Jung, Ph.D., interjected that NIAAA will conduct a satellite session on Saturday for the Research Society on Alcoholism (RSA) regarding what hepatologists can do, noting that NIAAA is pursuing this avenue very actively. Susan Smith, Ph.D., recommended adding registered dietitians to the list of healthcare professionals to be trained about AUD because they record alcohol consumption in their client assessments. She also noted that addressing alcohol and women is very challenging; for example, women don’t understand the relationship between alcohol and breast cancer. Dr. Koob asked Trish Powell, Ph.D., to note this. Dr. Weisner provided updates on follow-up activities to the 2017 National Conference on Alcohol and Opioid Use in Women, including a white paper, journal submissions, a webinar on treatment for Hispanic women, and an upcoming one on FASD. Dr. Koob reported that NIAAA is evaluating its research portfolio to identify gaps in alcohol and women’s health. Tatiana Foroud, Ph.D. confirmed that this evaluation will address both younger and older women.
Alcohol Measures–An Online Database of Non-English Measures for Alcohol Research
Judith Arroyo, Ph.D., Minority Health and Health Disparities Coordinator at NIAAA, introduced DerShung Yang, Ph.D., of BrightOutcome, Inc. She explained that a decrease in minority enrollment in clinical alcohol studies, possibly due to a lack of research measures in languages other than English, prompted NIAAA to issue a call for proposals in 2013 under the Small Business Innovation Research (SBIR) program to develop a database of non-English research measures. BrightOutcome was selected to develop a data base of non-English measures employed in alcohol research including concepts related to but not specific to alcohol such as depression, anxiety, quality of life and so forth.
Dr. Yang explained that database development began with identification of measures based on reviews of language-specific abstracts using both alcohol-specific and alcohol-related measures, followed by extraction of measure psychometrics based upon reviews of measure-specific articles. Other sources, including subject matter experts, other measure databases, and NIAAA-sponsored projects, were also consulted. Development of the database software reflected responsive design principles to support all devices, compliance with Section 508 requirements, and the results of evaluations for usability and usefulness. The development process resulted in 200 searchable terms; the identification of 275 articles for psychometrics; eight searchable languages; and 19 searchable research topics, of which 8 are alcohol-specific and 12 are alcohol-related. English-language measures total 116; Spanish, 69; Chinese, 37; Japanese, 19; Korean, 14; Thai 6; Vietnamese, 3; and Tagalog, 1. Alcohol-specific search terms include alcohol consumption; alcohol use disorder; alcohol screeners; social harms; health harms; harms to others; health service utilization; and treatment process and outcome. Alcohol-related terms include drinking-related cognition; social norm/support; psychological resources/functioning; trauma and stressors; personality factors; psychiatric disorders; family risk/protective factors; cultural factors; neighborhood/environment; general health; alcohol policy opinions; and other drug use.
Dr. Yang demonstrated how the database (https://alcoholmeasures.com/) may be searched, illustrating specific features such as curated psychometric information; questionnaire downloads; measure recommendations; personal reference library; PubMed and EndNote integration; community Q&As, and mobile support. Both guided and keyword search (e.g., by country, region, or ethnic group) can be accomplished. Dr. Yang concluded his remarks by describing future activities to support use of the database, such as promoting it at alcohol research conferences, improving site features, and adding a searchable survey database.
Discussion: Dr. Weisner recommended that BrightOutcome attend health systems conferences and those of the National Association of State Alcohol and Drug Abuse Directors (NASADAD). Carlo DiClemente, Ph.D., asked if the articles reviewed are all in English or in other languages. Dr. Yang replied that currently they are all in English.
Concept Clearance: Data Science Tools for Alcohol Research
Dr. Koob introduced Elizabeth Powell, Ph.D., Division of Neuroscience and Behavior (DNB), to present a concept clearance for data science tools that is NIAAA-wide. Dr. Powell began by illustrating the enormous growth in data complexity, visualization, and presentation. Data science has expanded beyond informatics to include the storage, handling, analysis, and algorithms of data. Yet NIH is still somewhere between the big data landscape and the personal computer. Today, there are almost 200 million gene bank sequences in the National Center for Biotechnology Information (NCBI) at the National Library of Medicine. But NIH currently lacks the upload rates to manage this data and the infrastructure to make the data usable. Other data science initiatives at NIH include Big Data to Knowledge (BD2K); Phase I from 2014 to 2017 included $200 million in grants to address major data science challenges in biomedical research. The BRAIN Initiative has a data science component that is still in its infancy.
The new NIH Strategic Plan for Data Science is expected to be released in June 2018. Its overarching goals are to 1) support a highly efficient and effective biomedical research data infrastructure; 2) promote modernization of the data-resources ecosystem; 3) support the development and dissemination of advanced data management, analytics, and visualization tools; 4) enhance workforce development for biomedical data science; and 5) enact appropriate policies to promote stewardship and sustainability. There is currently an opening for a Director of Data Science in the Office of the Director (OD). Data science fellowships will be available in each IC and the OD. There is also work in progress for the T32 training programs to include training young investigators in data science, along with their scientific interests. NIAAA is considering other initiatives to support the Plan within the Institute.
Dr. Powell shared an example of data science applied to a human disorder. “Predictive Big Data Analytics: A Study of Parkinson’s Disease Using Large, Complex, Heterogeneous, Incongruent, Multi-Source and Incomplete Observations,” published in PLOS One (2016, August 5; doi.org/10.1371/journal.pone.0157077) by ID Dinov, B Heavner, M Tang, G Glusman, K Chard, M Darcy, R Madduri, J Pa, C Spino, C Kesselman, I Foster, EW Deitsch, ND Price, JD Van Horn, J Ames, K Clark, L Hood, BM Hampstead, W Daur, and AW Toga, utilized translational techniques to harmonize, aggregate, process, and analyze complex multisource imaging, genetics, clinical, and demographic data from the Parkinson’s Progression Markers Initiative (PPMI). The study resulted in the identification of four new significant predictors of the disease.
Data in the alcohol community that may be addressed under this concept clearance include Collaborative Studies on the Genetics of Alcoholism (COGA) data; NIAAA Surveillance reports; data from national surveys, including the National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), National Survey on Drug Use and Health (NSDUH) run by the Substance Abuse and Mental Health Services Administration (SAMHSA), and the Youth Risk Behavior Surveillance System (YRBSS) operated by the Centers for Disease Prevention and Control (CDC); data from NCANDA and the Integrative Neuroscience Initiative on Alcoholism (INIA); ABCD study data; investigator-maintained databases and datasets; and public databases. Human subjects’ data may be deposited in the NIMH Data Archive. Animal data has not yet been addressed. One of the challenges of this endeavor is that the field does not yet have the tools to help investigators pull specific data from a database and then compare it to data in other datasets. One focus of this concept clearance is how to design such new tools and resources.
Future directions include enabling multiscale analysis of clinical and basic science datasets through the employment of modern data science techniques of artificial intelligence, machine learning and deep learning; promoting interdisciplinary collaborations and training between alcohol researchers and data scientists; and adapting NIH data science tools and tactics for use in alcohol research.
Discussion: Howard Becker, Ph.D., inquired about the quality of data entered into the system, e.g., unpublished or only published? He also noted that people may gain access to the data, but not understand its context, e.g., whether and how it has been adapted or accommodated, so they can use it properly. Dr. Powell responded that the decision about when to release data is determined by policy that NIH will establish. The type of data (e.g., descriptors of what has been done to the data) will be part of the metadata. Dr. Foroud contrasted how major studies she has worked on prepare and release data. She asked what could be done to get people to read the material that is posted about what’s been done to the data, e.g., how the measure was collected or the sample ascertained. Many researchers want to skip that step. Edith Sullivan, Ph.D. reiterated Dr. Foroud’s point. She noted that the integrity of the NCANDA data is remarkable, but also requires a remarkable amount of time and resources to clean the data. Dr. Powell commented that that’s why sustainability and stewardship of data is important. Dr. Koob asked if the ABCD data is clean. There was assent from Council members. Dr. Sloan stated that his research staff spend an incredible amount of time trying to get permissions from public agencies to combine data. He also noted that different people use different assumptions to clean data; these assumptions may be in conflict. Dr. Powell responded that data ontologies can help address this problem. Statistical procedures to clean data are evolving. Dr. Eberwine interjected that data analysis programs also be collected because they change. David Goldman, M.D., suggested adding intramural alcohol research to the list of alcohol-related data to be addressed. He offered support for Drs. Foroud’s and Sullivan’s comments, noting that unclean data will be incorporated into future analyses based on previous analyses that were conducted with unclean data, thus compounding the problem. He argued that it is insufficient to have human or genome data sharing policies because they ensure that investigators upload unclean data. Arun Sanyal, M.D., emphasized the importance of this discussion, noting that combining data elements (CDEs) may or may not work. Dr. Powell responded that there are common data sets that all ICs will use and others that will be IC-specific. Because this is a new area, she anticipated that adaptation will occur. Dr. Koob noted that the ABCD data being posted is raw data. Dr. Sullivan agreed, saying a priority is to get the data out quickly. John Matochik, Ph.D., DNB, interjected that there is a big paradigm shift occurring: People are demanding quicker access to raw data such as brain images. Raw data does not mean unclean, unprocessed data. The important point is that the data science field is changing and NIH should get on board. He asserted that data problems are understood, but what’s important is how well they are handled.
BRAIN Initiative Update
Dr. Eberwine updated Council members of the status of the BRAIN Initiative, which is now five years old. Since 2014, 345 awards totaling $548.3 million have been granted under the program. In FY 2017, 110 awards totaling $169.6 million have been made. The projected total funding of the BRAIN Initiative, drawn from base funding and additional funds from the 21st Century Cures Act, is expected to total $5.9 billion. Thus, almost 90 percent of total expenditures are anticipated in the coming five years. BRAIN representatives are trying to recruit researchers from diverse fields to study the brain, and NIAAA investigators are encouraged to submit applications. In FY 2018, there will be 20 NOFOs announced; some are currently open.
The Brain Initiative Cell Census Network, launched in FY 2017, is an example of a major initiative within the larger BRAIN Initiative. It seeks to understand how cells develop biology through a gated analysis of datasets, and will provide a comprehensive reference for all different cell types in human, monkey, and mouse brains. Currently, there are nine funded projects to support four parts of the Network: a Brain Cell Data Center; a Mouse Brain Cell Census Center; a Mouse Brain Cell Census Collaboratory; and a Human and Nonhuman Primate Brain Cell Census Collaboratory. Following 3-year pilot grants to identify cell types, the next steps of the Cell Census Network are to focus on the mouse cell census in FY 2017-2021 and then ramp up for the human census from FY 2021-2025. Over $250 million will be invested in the Network over the next five years.
A Neuroethics Division of the BRAIN Multi Council Working Group addresses ethical issues that emerge from the Initiative. It has held topical workshops on key issues and is developing Neuroethics Guiding Principles for the NIH BRAIN Initiative. These Principles will serve as an overarching neuroethics framework, and will include suggestions on how to integrate neuroethics into BRAIN-funded research.
The 4th Annual BRAIN Meeting was held on April 9-11, 2018. There were over 1200 registrants, with 950 people attending in person. NIH Videocasts helped bring the lay public, including high school classes, into the meeting.
BRAIN 2025: Creating Scientific Vision was the genesis of the BRAIN Initiative. Created in 2013 by a Working Group of the NIH Advisory Committee to the Director, it established the scientific priorities and overarching principles of the Initiative. At the 4th BRAIN Meeting, NIH Director Francis Collins, M.D., Ph.D., announced a new Working Group to update the scientific vision laid out in BRAIN 2025 to guide the second half of Initiative, identify valuable areas of new and continued technology development, and consider the Initiative’s unique contributions.
A search committee to identify a Director for the Brain Initiative has made a recommendation so the position may be filled soon.
Discussion: Dr. Smith inquired about how the mouse studies have been harmonized. Dr. Eberwine explained that the transcriptome datasets are uploaded to a public database every three to four months. There are data coordination groups that are trying to harmonize that data and make sure the formats are appropriate. Dr. Smith asked about the handling of animals. Dr. Eberwine responded that such information was included in the metadata. Dr. Smith encouraged the inclusion of detailed handling practices in the metadata. Dr. Sanyal commented that most vivariums are hypothermic for mice. If they’re shivering and their sympathetic systems are turned on, that might affect their brain readouts. Dr. Eberwine replied that the transcriptome is always a snapshot in time and that having animals with the same genetic background is the most important factor.
Consideration of Minutes of the February 2018 Council Meeting and Future Meeting Dates
Council members unanimously approved the minutes of the NIAAA Advisory Council meeting held February 8, 2018.
In 2018, the Council will meet on September 13. Council meetings in 2019 will be held on February 7, May 14, and September 12; the CRAN Council will meet in 2019 on May 15. In 2020, the Council will meet on February 6, May 12, and September 10; the CRAN Council will meet in 2020 on May 13.
Council broke for lunch at 12:02 p.m. and reconvened at 12:58 p.m. for the afternoon session.
NIAA Advisory Council Subcommittee/Working Group on Diversity and Health Disparities Biomedical Workforce
Dr. Koob seeks to establish a National Advisory Council Working Group on Diversity and Health Disparities in the Biomedical Workforce in order to expand the pool of diverse alcohol researchers, as well as the number of investigators studying how to reduce alcohol-related health disparities. The proposed Working Group will be charged with exploring and making recommendations to the NIAAA Director on how to better identify, recruit, train, mentor, and retain diverse health disparities researchers in the alcohol field. Dr. Koob has asked Daniel Calac, M.D., to chair the Working Group. Drs. Arroyo and Powell, and Lynn Morin, M.A., will participate from NIAAA. Historically, results of efforts to improve diversity in the workforce have been uneven. For example, there has been a steady increase in women engaged in science and some scientific organizations have adopted a practice of alternating between men and women as president and on councils. Opportunities for women are improving at NIH, but pay discrepancies remain. Women are underrepresented in the NIAAA intramural research program. Efforts to increase the number of minority investigators/applicants has worked to a lesser extent. There is a need to focus on mentoring of diverse researchers from start to finish. Existing mentoring programs, such as the one for Native Americans that Dr. Calac runs and one at the University of Maryland Baltimore County, have been successful. NIAAA also has a U54 grant in North Carolina where there is an exchange of mentors (from the University of North Carolina) and mentees (from North Carolina Central University), which will be evaluated. Thus, the Working Group should include external members with experience in this area, as well as Council members.
Discussion and Vote: Dr. Arroyo encouraged Council members who are interested in women’s participation in the biomedical workforce to also participate. Dr. DiClemente commented that the key is to get people passionate about science early in their careers. He suggested pre-mentoring initiatives such as summer internships in neuroscience. Dr. Koob responded that he considers such efforts to be part of mentoring. Dr. Calac observed that Native American high school students interested in pursuing medical careers need better career guidance. He also emphasized the importance of identifying and helping those who take a break in their educations. Dr. Koob agreed. He said that what stands out in analyses of NIH grant patterns is that minority applicants tend to give up because they don’t understand the process of revising and resubmitting applications. That issue can be remedied with guidance. Dr. Calac also suggested that there are legislative solutions to some issues, for example, whether or not taxes need to be paid on funds received from loan repayment programs. Council unanimously approved a motion to establish the proposed Working Group.
Council Member Presentation: Civil and Criminal Sanctions for Drinking and Driving--Are They Effective?
Dr. Koob introduced Dr. Sloan to report on what works to reduce drinking and driving. The case for government intervention or policy on this issue depends in part on the assumptions one makes about rational decision-making. A rational decision maker weighs the benefits and costs of decisions, e.g., whether to consume alcohol, and how much to consume before driving. A rational decision maker may also employ self-control devices, e.g., choosing a designated driver. In contrast, an irrational decision maker is impulsive, i.e., s/he does not weigh benefits and costs or use self-control devices. Therefore, external controls, such as a server who limits a person’s excessive drinking at the bar, may be needed. Much, but not all, of public alcohol policy is based on an assumption of irrational behavior. Driving while intoxicated (DWI) is an exception. Civil and criminal sanctions for drinking and driving and reckless driving implicitly assume rationality.
Empirical evidence about the effectiveness of administrative law in reducing DWI suggests that reductions in days and hours of sales has some effect, as does reducing the density of alcohol outlets, which are associated with increased drinking and driving and an increased number of alcohol-related fatalities. Empirical evidence about the effectiveness of criminal law policies is mixed. Evidence about enforcement (policing) is not robust, as it is often hard to measure empirically. There is some support for laws affecting the scope of DWI and the disposition of charges process. Less is known about probation/parole.
Evaluating the effectiveness of criminal law policies relies on the use observational data with regression analysis; randomized clinical trials are not feasible in this context. The dependent variables are typically motor vehicle fatalities; binge drinking; self-reported drinking/driving; self-reported binge drinking; and/or other measures of alcohol consumption. There are numerous statistical problems in these studies. The better-designed ones’ account for endogeneity of policies, area, and time fixed effects. Findings may be supplemented with data from surveys of alcohol servers and drinkers to look inside the ”black box” of their mindsets. Such evaluations have shown that what works in criminal law policies are raising the minimum drinking age; reducing the minimum blood alcohol concentration (BAC) for DWI violations; and active prosecution and conviction of those whose BAC is above the minimum level.
What doesn’t work is mandating minimum fines and jail terms. Evidence for why changing minimum sanction levels does not work came from an NIAAA-supported Survey of Alcohol and Driving undertaken by Dr. Sloan and his colleagues. The Survey was conducted in eight U.S. cities in three waves. Almost one in five (17.7 percent) of respondents reported driving during the past year after having drunk too much. Based on data from the study, the probability of arrest for DWI was calculated at 0.0078. If the minimum DWI fine was increased by $200, the expected value of the charge per episode of driving after drinking too much was calculated at $1.15—about the price of a can of domestic beer at a grocery store. Increasing minimum time in jail by 48 hours for a first DWI offense had an expected value of 17 minutes. Secondary prevention, however, may work because penalties increase markedly with subsequent arrests.
A very promising area with substantial evidence is drug courts. There are now some alcohol courts and some drug courts address alcohol. DWI courts remain in the minority, and only a small fraction (slightly >1%) of persons arrested for DWI are referred for court treatment. In a North Carolina study, persons convicted of DWI who completed a treatment program were less likely to be re-arrested and convicted of DWI, based on a 4-year follow-up. DWI courts were more effective in reducing re-arrests for DWI than hybrid (drug and alcohol) courts were. Parent participation in drug treatment courts did not reduce the probability that their children were arrested on a substance-related charge.
Within civil (tort) law, motor vehicle tort is the most common. Its deterrent effect is blunted by the existence of casualty insurance, even though casualty insurance premiums are experience-rated. Where it is in effect, no-fault auto insurance has blunted the deterrent effect that motor vehicle tort would otherwise potentially have. One study showed that laws specifying premium increases following DWI conviction (presumably increases above those increases in premiums that insurers would impose for DWI voluntarily) is a deterrent to drunk driving. Thus, premium increases are more effective than fines.
Tort law covering dram shop liability addresses server responsibility for serving obviously intoxicated adults. A review of 11 studies reported a median reduction of 6.4 percent in alcohol-related motor vehicle fatalities with dram shop liability in jurisdictions where premises are licensed. Unfortunately, dram shop laws have been weakened over time due to political opposition from dram shops, so this effect may not be found today. The evidence for social host liability, which imposes responsibility on social hosts serving alcohol to adults or minors after an injury occurs, is not as strong as for dram shop liability. There is some empirical evidence on social host liability as applied to minors; one study showed that social host liability for minors reduced the drunk-driving fatality rate by 9 percent.
The Survey of Alcohol and Driving cited above reveals that drinker-drivers are generally knowledgeable about DWI laws; have higher rates of time preference and time inconsistency; lack self-control on measures other than those directly related to drinking; have cognitive status about the same as others; are less prone to plan events involving drinking, such as selecting a designated driver in advance of drinking; and are more impulsive based on non-alcohol-related measures. Thus, there is room for establishing more empirical evidence about drinking and driving, beyond examining the impact of statutes.
The implications of these findings are 1) There is a case for implementing public policies based on the premise that drinker-driver behavior is somewhat irrational; such policies include incapacitation via jail, mandated use of SCRAM® devices to measure BAC or ignition interlock devices, increasing the excise tax on alcohol, raising the minimum drinking age, and treatment for AUD; 2) There is a role for tort liability in decreasing drinking and driving based on empirical evidence, most clearly for dram shop liability; 3) Specialized treatment courts show promise in reducing drunk driving; the current scale of such court referrals, however, is insufficient to affect drunk driving at the population level.
Discussion: Dr. Koob asked if there were differences in state laws regarding penalties for drunk driving; he had heard, for example, that Wisconsin’s penalties were quite low. Dr. Sloan responded affirmatively. Dr. DiClemente noted that many states mandate a 20-hour training after a first or second DWI. He asked if there is any data about such mandatory education. Dr. Sloan stated that he was unfamiliar with research on this topic, but questioned if 20 hours of training is sufficient. Dr. Koob inquired if ignition interlock devices work. Dr. Sloan said yes, but noted they represent an issue of freedom. Ralph Hingson, Sc.D., commented that ignition interlocks work very well; Mothers Against Drunk Driving (MADD) is promoting a proposal that they be used by all DWI offenders, not just repeat offenders. One study showed they reduce traffic fatalities by 8 percent. Dr. Koob asked if drunk driving rates are plateauing or if there are ways to push them lower. Dr. Sloan responded that there has been some decline in drunk driving, but it’s not precipitous. Dr. Becker inquired about the impact of ride-hailing services on young adults’ plans to drink outside the home. Dr. Sullivan reported on a newspaper article that stated DWIs have dropped precipitously in the San Francisco Bay Area due to ride-hailing services. Dr. Sloan responded that he was unaware of anyone who had studied this topic. Dr. Smith commented that Wisconsin has a high number of DWI violations; the state’s argument about why penalties aren’t stiffer are economic, i.e., as a rural state, residents need their cars to drive to work so if the state takes away their licenses, residents can’t work and support their families. Dr. Sloan responded that that argument is similar to the one that states dram shop liability is bad because it puts small businesses out of business. Dr. Koob concluded the discussion by noting that more work about DWI is needed.
Council Member Presentation: Stigma Matters--Addressing Providers’ Stigma Towards Persons Who Use Drugs
Dr. Koob introduced Carmen Albizu-Garcia, M.D., who is currently completing a study about how stigma among healthcare providers affects health outcomes. Her research is primarily focused on illegal drugs.
According to the 2017 World Drug Report, five percent of the global adult population used drugs at least once in 2015; 2.9 million of those drug users, or 0.6 percent of the global adult population, suffer from drug use disorders. Globally, less than 10 percent receive opioid agonist treatment, the standard of care. In the United States, the 2016 National Survey on Drug Use and Health reported about 19.9 million adults needed substance use treatment in the past year, representing 8.1 percent of adults. Of this group, only 3.6 million received any treatment, with 2.1 million receiving specialty treatment.
If people with HIV are given opioid agonist treatment, they become functional and can participate actively in retroviral treatment for HIV. But health care providers in North America often put off anti-retroviral therapy (ART) for people living with HIV who inject drugs due to stigma towards people who use illicit drugs (PWID). The rejection of drug users is higher than that of criminals, and results in poor health among PWID in the United States. Not only drug users, but also the drugs themselves are stigmatized, e.g., there is a belief that prescribing methadone or buprenorphine is substituting one drug for another. Within the drug court system, there is little use of opioid agonist therapy.
Stigma functions by stereotyping drug users as under-serving persons with attributes that place them at risk of social exclusion, loss of status, health inequities, and premature death. Stigma is typically exercised in relationships characterized by power differentials, such as the relationship between provider and patient. Intersectionality complicates the problems. Illegal drug use is symbolically linked to other stigmatized conditions, including HIV/AIDs, mental illness, HCV, incarceration, and crime. Yet HIV, HCV, and overdoses are not inevitable consequences of injecting drug use and can be prevented.
Influences from different levels of the eco-system--from the macro policy level to intrapersonal beliefs-- set the normative expectations that play out in the process of stigmatization. At the macro level, drug prohibition has not been very successful. At the meso level of the eco-system, the media play an integral role in shaping public opinion and policy making; one study of media messages from 1950-2010 found that 47 percent portrayed drug users as dangerous. Such widespread stereotyping by the media has sustained public policy and social rules, including those governing addiction treatment, that have placed greater emphasis on managing risk and public safety over recovery.
Health professionals are subject to social influences that devalue drug users, yet exploration of stigma by health professionals is scarce. One study found that mental health care professionals presented with a case labeled as a “drug abuser” were more likely to indicate that punitive measures were necessary to curtail the individual’s drug use problems. In another, providers who attributed their patients’ opioid consumption to recreational use or to manage withdrawal symptoms from opioid dependence viewed patients less sympathetically and as less deserving of help than those who overused prescribed drugs.
When Dr. Albizu-Garcia and her colleagues began their research on health provider stigma, they found no theoretical definition of the concept. Therefore, they translated, adapted, and validated the existing Community Attitudes toward Substance Abuse Scale with Puerto Rican health professionals in training and practice. Using a convenience sample and a self-administered questionnaire, their research showed that stigma scores varied by discipline with physicians and nurses scoring significantly higher than psychologists and social workers. Within disciplines, scores were not significantly different between students and those health and social service providers of the same discipline.
Examining responses to specific items, the researchers found that although 76 percent of participants agreed that addiction is a chronic illness, 50 percent believed that one of its main causes is lack of self-discipline and will power. Forty percent agreed or were uncertain that addicts are a burden on society. Seventy percent agreed that as soon as a person shows signs of a drug addiction that person should be required to get treatment. Half (50 percent) agreed there is something about individuals with drug addictions that makes it easy to tell them apart from people who don’t use drugs. Almost one-third (30 percent) agreed that anyone with a drug abuse history should be excluded from public office.
Among 132 entering graduate students in a health profession, 89 percent associated “drugs” with illegal substances, and there was a perception that drugs inevitably lead to personal (36 percent) and social (56 percent) deterioration. About one in six (16 percent) believed that any drug use leads inevitably to addiction. Narratives included the perception that “drugs are like a cancer that second by second eats up our youth and society.”
In an exploratory qualitative study of the perceptions of 16 clients currently receiving medication-assisted treatment towards providers and treatment in abstinence based programs in which they previously participated, these prior treatments were associated with punishments, disciplining, and highlighting of participant’s flaws. This kind of “help” was not what clients expected when entering treatment. Feelings of anger and frustration resulted, and negatively affected treatment retention.
A 2004 clinical trial led by Stephen C. Hayes from the University of Nevada, Reno, compared three intervention modalities to assess their effect on stigma reduction pre and post intervention and at 3-month follow up. Educational training that emphasized the role of biological factors in addiction and its treatment resulted in no significant changes. Multicultural training that emphasized the role of race, ethnicity, family structure, language, and spiritual beliefs did not sustain change at the 3-month follow-up mark. Acceptance and Commitment Treatment (ACT) that emphasized the role of psychological barriers to client engagement resulted in no significant change post-intervention, but significant improvement at the 3-month follow up.
To address the issue of stigma, Dr. Albizu-Garcia recommended that interdisciplinary research teams from diverse academic institutions work together and partner with service agencies, community organizations, advocacy groups, and, if possible, with policy makers. This approach allows rigorous multi-level eco-system and cross-cultural research evidence to enhance awareness of the problem and to influence the political will to address it through public health advocacy.
Discussion: Dr. Koob stated that Dr. Albizu-Garcia’s presentation was as applicable to alcohol as it was to drugs. He commented that stigma is not only present in providers, but also in the individual who is using. People self-medicate to address their sense of despair because they feel they are not well received by others. Dr. Albizu-Garcia responded that shame is one of the major internalized emotions and is due to the external message received from others. Her colleagues are conducting research to support interventions that can empower drug users when they enter a relationship with a provider, given the likelihood that provider stigma will continue. They are hoping to also develop an intervention for providers to reduce their sense of stigma as a provider of substance use disorder treatment services. Dr. Koob asked Dr. DiClemente if he agreed that the issue of stigma also applied to AUD; Dr. DiClemente responded affirmatively, citing attitudes and policies toward pregnant women who drink alcohol. Dr. Koob affirmed that more cross-disciplinary research on stigma is needed.
Council Member Presentation: Health Services Research—Opportunities Using the Electronic Health Record
Dr. Koob introduced Dr. Weisner who conducts research at the Division of Research at Kaiser Permanente Northern California. She began by highlighting the role of health services research, which increasingly focuses on health systems data, especially electronic health records (EHRs). Health services research uses methods based on new statistical innovations that facilitate causal relationships using observational data, provides access to a population base that includes rare diseases and understudied population groups, and generally provides information that is broader and longitudinal in nature, in contrast to traditional medical research.
Between 2008 to 2015, the adoption of EHRs in non-Federal acute care hospitals increased from less than 10 percent to over 80 percent; by 2018, over 90 percent have adopted EHRs. Patients use EHRs to make medical appointments, communicate with physicians, order prescriptions, view lab test data and history, plan for health care and obtain health condition information, choose physicians, complete health questionnaires, engage in online interventions (e.g., weight, sleep); and participate in treatment interventions. Clinicians use them for screening, checking clinical guidelines, decision and intervention support, checking for co-occurring problems/medication indications, checking for treatment history, accessing and adding progress notes, seeing information from other departments, and communicating with patients (encrypted email or video visits). Researchers use EHRs for epidemiology, prevention, pragmatic and clinical trials, comparative effectiveness research, implementation research, and genetics and neuroscience.
EHRs include all patient contacts with the health system, as well as extensive information about the providers and patient panels. In the example used for the presentation, these disparate data have been pulled together into a virtual data warehouse (VDW) being used by over twenty health systems. The VDW can be queried to identify people with specific characteristics (e.g., demographics, medical condition) to enroll them in clinical trials or other research studies. There is a substantial effort to clean the data and to make sure that it relies on standardized measures entered in standardized fashion. The EHR also facilitates registries, such as ones on HIV, HCV, and opioids. Family members can be linked to patients in these registries. This allows research such as a 2010 study supported by NIAAA that matched patients diagnosed with an alcohol or drug disorder and their family members to families in which an alcohol or drug use disorder was not present. The research demonstrated that spouses and children of those with an alcohol or drug use disorder had higher medical utilization and costs prior to the alcohol/drug disorder information being entered into the EHR. After treatment, medical costs of these family members were reduced to those of the families without an alcohol or drug disorder. This finding helped promote alcohol and drug screening within the health system.
The Health Care Systems Research Network consists of over 20 health care systems across the United States, whose EHR data are harmonized in a VDW, permitting a variety of studies across these health systems. Kaiser Permanente’s Northern California Division, representing 4.1 million ethnically and socioeconomically diverse members, is an example of one of these health systems. Over 300 active clinical trials are currently underway within the Division. One example of an alcohol-related study was the NIAAA-sponsored ADVISE (Alcohol Drinking as a Vital Sign) that examined adult screening, brief intervention, and referral to treatment (SBIRT) in 54 clinics involving over 500 physicians and 650,000 patients. The clinics were randomly assigned to a physician arm, in which the physician was trained to conduct SBIRT; a non-physician arm, in which medical assistants were trained to screen and nurses, health educators, or behavioral health specialists conducted the brief intervention and referral; or a control, Usual Care, arm. The outcome measure was amount of drinking. Results indicated high marks for medical assistant screening, but lower marks for non-physician interventions. As a result, the Northern California Division adopted a hybrid model in which all adult primary care patients are screened annually by medical assistants with an NIAAA evidence-based screener, and physicians provide brief advice, medications, or referral to Addiction Medicine treatment as appropriate. Between June 2013-February 2018, 89 percent of primary care visits were screened, and 67 percent of those eligible for a brief intervention received one. Physicians are willing to engage in these interventions because alcohol affects the health outcomes that they care about, as well as medication adherence and healthcare utilization and cost.
EHRs can facilitate research on health disparities because they can use innovative approaches to address language, race/ethnicity, sexual orientation, immigration status, neighborhood characteristics, and travel/logistical issues (e.g., for elderly, disabled, mothers with small children). Kaiser Permanente has multiple mobile apps on issues such as anger management and sleep in various languages; their use can be tracked through the EHR.
Dr. Weisner encouraged Council members to conduct research with multidisciplinary staffs and to contact and work with health systems that use EHRs.
Discussion: Dr. Koob opened the discussion by noting that this is an area of research where NIAAA could benefit, but he is not yet sure what needs to be done. He encouraged Dr. Weisner to meet with Dr. Ducharme and Dr. Joanne Fertig, to talk about how NIAAA could take advantage of Kaiser’s access to large numbers of patients. He asked if Kaiser data could be harmonized with that from other health systems. Dr. Weisner noted that only eight of the over 20 health systems in the Health Care Systems Research Network are Kaiser Permanente health systems; the Network is currently developing work on HEDIS performance measures with the OCHIN Practice-Based Research Network that includes Federally Qualified and Community Health Centers and uses a different EHR. Because of the International Statistical Classification of Diseases and Related Health Problems (currently ICD-10) classification system, the same measures and codes are used by the different EHRs, but significant infrastructure work is required to harmonize the data. Dr. Sanyal stated that providers’ coding on EHRs is so bad that in one study examining opioid overdoses, one-third of the cases were missing any reference to opioids on the chart. He asked what Kaiser has done to train providers to consistently input information. Dr. Weisner responded that it depends on the health system; Kaiser Permanente Northern California began using EHRs in 1984, and there is a high premium and oversight on how clinicians input information. Paul Kenny, Ph.D., inquired if Dr. Weisner anticipated a time when samples from patients could be sequenced and stored in a repository. Dr. Weisner responded that Kaiser Permanente has well over half a million samples and many have questionnaires that go with them. It has also started a birth cohort which will be very large. There is a process for external researchers getting access to the data. There’s been only one alcohol study to date; Kaiser would like to have more. Dr. DiClemente observed that if a physician enters tobacco information into the EHR, tobacco pops up every time the physician opens the record, noting that this process improves the quality of the data. Dr. Weisner reiterated that Kaiser Permanente is not the only player in the field; others are as well. However, it has been easier to conduct alcohol-related research in an integrated health care system that includes all health departments, including specialized alcohol treatment. Dr. Albizu-Garcia inquired if having salaried physicians made a difference because their income is not dependent on the billing codes that they're using. Dr. Weisner responded that she thought auditing and physician bonuses were stronger factors. Dr. Albizu-Garcia asked if Kaiser’s data could be linked to external data sources to study patient transitions, e.g., between the health system and the prison system. Dr. Weiser replied that some states like Oregon and Oklahoma are doing some linking, but that health systems are not due to privacy concerns.
Public Comments
Andy DeSoto, Ph.D., Assistant Director for Policy at the Association of Psychological Science (APS), announced that APS recently released the first issue of a new journal, Advance of Methods and Practices in Psychological Science. APS opposes NIH’s expanded definition of clinical trials because it increases the burden on behavioral researchers who work with human subjects, and encourages NIH to consult with the behavioral and social science research community to ensure helpful changes in definition.
Jeff, Alcoholics Anonymous (AA), reported that AA has approved new pamphlets for potential members, including lesbian, gay, bi-sexual, and transgender (LGBT) individuals, women, Hispanic women; and those with a mental illness. It has also a published a book on AA and the military, and translated AA’s basic text into an oral version in Navaho.
Adjournment
The meeting adjourned at 3:22 p.m.
CERTIFICATION
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
/s/