DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
138th Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM
February 4−5, 2015
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 138th meeting at 2:00 p.m. on Wednesday, February 4, 2015, at NIAAA headquarters in Rockville, Maryland. The Council met in closed session to hear the Board of Scientific Counselors’ Report, presented by Dr. Tatiana Foroud; the meeting recessed at 2:45p.m. The Council reconvened at 3:00 p.m. for a review of grant applications and a special Council review. 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. That meeting concluded at 5:00 p.m. Dr. George Koob reconvened the Council in open session the following day, Thursday, February 5, 2015, at 9:10 a.m.
Council Members Present:
Andrea Barthwell, M.D.
Carol A. Casey, Ph.D.
Linda L. Chezem, J.D.
Fulton T. Crews, Ph.D.
Suzanne M. de la Monte, M.P.H., M.D.
Carlo C. DiClemente, Ph.D.
James H. Eberwine, Ph.D.
Marianne L. Fleury, B.A.
Hon. Joseph Thomas Flies-Away, J.D., M.P.A.
Andres G. Gil, Ph.D.
Paul J. Gruenewald, Ph.D.
Paul J. Kenny, Ph.D.
Sarah N. Mattson Weller, Ph.D.
Craig J. McClain, M.D.
Robert O. Messing, M.D.
Patricia E. Molina, M.D., Ph.D.
Rajita Sinha, Ph.D.
Daniel R. Kivlahan, Ph.D., ex officio-VA
Charles S. Milliken, M.D., ex officio-DoD
NIAAA Director and Chair: George F. Koob, Ph.D.
NIAAA Deputy Director: Kenneth R. Warren, Ph.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Vivian Faden, Ph.D.; Ralph Hingson, Sc.D., M.P.H.; Robert Huebner, Ph.D.; Keith Lamirande; Gary Murray, Ph.D.; Antonio Noronha, Ph.D.; Patricia Powell, Ph.D.
Chair, NIAAA Board of Scientific Review: Tatiana Foroud, Ph.D.
Other Attendees at the Open Session:
Approximately 90 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 Council meeting to order at 9:10 a.m. on Thursday, February 5, 2015. He recognized the service of Andrea Barthwell, M.D., Suzanne de la Monte, M.D., and Andres Gil, Ph.D., whose terms on the Council were ending. Dr. Koob then welcomed new Council members Carlo DiClemente, Ph.D., James Eberwine, Ph.D., and Paul Kenny, Ph.D., and Council members and senior NIAAA staff introduced themselves.
Dr. Koob highlighted key recent Institute activities, referring to the written Director’s Report.
- NIAAA budget. NIAAA’s budget remains flat. Congress appropriated $446 million to NIAAA for Fiscal Year (FY) 2014, and NIAAA awarded 657 research project grants (RPGs), including 180 competing awards, for a success rate of 19%. NIAAA currently supports 17 research centers, 137 other research grants, 269 training positions, research and development contracts amounting to $36.5 million, and intramural grants amounting to $49 million. In 2015, NIH received a total of $30 billion, $ 150 million over FY 2014. NIAAA estimates it will support a total of 668 RPGs in FY 2015 including 167 competing awards. Preliminary budget planning for FY 2016 is underway.
- NIAAA staff transitions. Dr. Jennifer Hobin has joined NIAAA’s Office of Science Policy and Communications as a senior health science policy analyst. Dr. Falk Lohoff has joined the Laboratory of Clinical and Translational Studies, Division of Intramural Clinical and Biological Research, as chief of the Section on Clinical Genomics and Experimental Therapeutics. Ms. Joan Romaine has joined the Office of the Director as a health specialist in the HIV/AIDS Research Program. Ms. Erin Manor now serves as Chief, Administrative Services Branch.
- Honors and awards. Dr. Koob received the 2014 Innovator Award from the Treatment Research Institute in recognition of his scientific contributions and leadership in advancing understanding of how the brain and body respond to alcohol consumption. Dr. Koob noted that Drs. Edith Sullivan and Adolf Pfefferbaum have published The Handbook of Clinical Neurology, to which many NIAAA staff and Council members have contributed, and that Dr. Karl Johnson was awarded a Postdoctoral Research Associate Fellowship (PRAT), an award given to outstanding trainees in pharmacological sciences.
- Funding opportunities. New NIAAA Requests for Applications (RFAs) and Program Announcements (PAs) have been issued. For example, NIAAA is soliciting grant applications on alcohol biosensors development, research on the Neurobiology of Adolescent Drinking in Adulthood (NADIA), research on investigational new drug-enabling development of medications to treat alcohol use and alcohol-related disorders and alcohol education project grants. Funding will be available for secondary analyses of existing alcohol epidemiology data (NESARC-National Epidemiologic Survey on Alcohol and Related Conditions) and for research into unconventional roles of ethanol metabolizing enzymes, metabolites and cofactors in health and disease. NIAAA is participating in the NIH Brain Initiative, NIH Big Data to Knowledge (BD2K), Systems Science and Health in the Behavioral and Social Sciences, tobacco regulatory research, pediatric HIV and AIDS, behavioral targets to improve adolescent substance abuse interventions, and research on sex and gender.
- NIAAA research highlights and accomplishments. Dr. Koob highlighted several recent papers related to prenatal, perinatal, and adolescent alcohol exposure that open doors for future study. For example, a DTI-based tractography study of the effects on brain structure showed that higher levels of maternal alcohol consumption during pregnancy were associated with lower levels of axial diffusivity. Dr. Koob expressed his hope that NIAAA’s animal and human studies will elucidate mechanisms that will allow interventions and improve or ameliorate completely these disorders. In another study in mice, data has shown also that MicroRNA-30A-5p in the prefrontal cortex controls the transition from moderate to excessive alcohol consumption; the results have implications for novel biomarker development to identify problem drinkers and to suggest novel pharmacotherapies to treat drinking problems in humans. Other research has demonstrated that alcohol binge drinking during adolescence or dependence during adulthood reduces prefrontal myelin in male rats, findings important for understanding the mechanism of such effects in humans. Dr. Koob also highlighted research that by genetically interfering with a key synaptic plasticity molecule, PSD-95 in the prefrontal cortex led to significant weakening of fear memories in mice. Targeting PSD-95-related mechanisms may represent a novel approach to alleviating trauma-related anxiety associated with alcohol use disorder. And finally in another study, osteopontin deficiency promotes alcohol neutrophilic hepatitis in mice. This animal model is a promising tool for better understanding human alcoholic hepatitis.
- Director’s goals. Dr. Koob outlined overall NIAAA goals to achieve FDA approval for medications for treatment of alcoholism, to implement effective behavioral treatments for alcoholism, to implement effective prevention strategies for drinking during pregnancy and for adolescent drinking; to eliminate alcohol-related HIV pathology, to develop effective treatments for fetal alcohol spectrum disorder (FASD) and alcoholic liver disease, to develop appropriate treatment of comorbidities associated with alcoholism, to recruit young investigators and eliminate disparities in the alcohol field, and to provide equal pay for women and minorities in the alcohol field.
- Key initiatives and programs. NIAAA’s key initiatives and programs include early diagnosis of FASD and fetal alcohol syndrome; underage and college drinking initiatives; treatment, especially medications development; comorbidity, especially post-traumatic stress disorder (PTSD); alcoholic liver disease, alcohol and HIV/AIDS, and biosensors.
- New Funding Opportunities Announcements (FOA). Dr. Koob stated that the Adolescent Brain Cognitive Development (ABCD) Study – U24 Coordinating Center FOA (RFA DA 15-014) was just released. NIAAA also plans to seek contractors to form a network of laboratory sites to conduct multiple Human Laboratory Paradigms (HLAB). HLAB will serve as a screening model for candidate compounds to treat alcohol use disorder. Such a Human Laboratory Program will provide standardization and promote replicability and will provide a critical component of medications development in conjunction with the NIAAA’s Clinical Investigations Group (NCIG) program
Discussion. Dr. Koob responded to a question from Dr. Patricia Molina that “Rethinking Drinking” (publication and website) addresses a wide audience and that the publication is available in both English and Spanish. Dr. Rajita Sinha commended NIAAA on the information it publishes. Dr. Vivian Faden stated that NIAAA has worked with MedScape to develop a free Continuing Medical Education program on NIAAA’s “Youth Screening Guide.” In response to a question from Dr. de la Monte on addictive behavior and neurodegeneration white-matter abnormalities, Dr. Koob explained that data show that though neurons in the adult brain cannot regenerate in most brain areas, alternate pathways can be strengthened that enable recovering alcoholics to recover function.
Compliance with Inclusion Guidelines
Dr. Judith A. Arroyo, NIAAA Minority Health and Health Disparities Coordinator, presented data for incorporation in NIAAA’s 2015 Biennial Advisory Council Report Certifying Compliance with the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research. The NIH Revitalization Act of 1993 requires inclusion of women and members of minority groups and their subpopulations in all NIH-funded clinical research; NIH must support outreach efforts to recruit and retain those populations in clinical studies; exclusions may be made solely by the NIH Director or Institute/Center Director; cost is not an acceptable reason for exclusion; and Phase III trials should be designed and implemented to allow valid, meaningful analysis across gender, ethnic, and racial groups.
Dr. Arroyo described NIAAA’s procedures to ensure compliance: All FOAs include a section on the inclusion policy; program officials answer questions from potential applicants; special attention is given to identification of Phase III clinical trials; scientific review officers (SROs) inform peer reviewers about the inclusion policy; peer review groups determine whether an acceptable inclusion plan is present; SROs summarize reviewers’ comments and code summary statements to reflect review committees’ comments and concerns; program officials discuss issues of noncompliance with applicants, who may modify applications to address reviewers’ concerns; target and enrollment data are recorded and tracked electronically; upon award, program officials evaluate and approve required population target and cumulative enrollment reports of ongoing projects; and NIAAA provides staff training on the inclusion policy.
NIAAA data show that the percentages of women in clinical studies differed only slightly from FY 2013 to FY 2014 at around 44-45%. For FY 2013 total minority enrollment was 44%, and for FY 2014 it was 37%. Dr. Arroyo noted the challenges in categorizing race and ethnicity among Hispanics, and stated that numbers of Black enrollees rose slightly over the 2-year period, while white enrollment rose more substantially, at about 5%. Enrollment of Hispanics declined from 18% in FY 2013 to about 8% in FY 2014. Inclusion of minorities was assessed in both intramural and extramural research projects. Several studies with large minority enrollment ended in FY 2013 and thus contributed to the diminished numbers of minority subjects in FY 2014. Several studies initiated in FY 2015 are expected to raise the numbers of minority participants. Dr. Arroyo reported that NIAAA has contracted with two companies to collect a database of non-English-language measures currently used in alcohol-related research.
Discussion. Dr. Gil observed that minority enrollment reports that cover more than 2 years might be more meaningful. He suggested that NIAAA consider subjects to be part of a study regardless of whether data collection has been completed and that using oversampling to address power issues that arise in study sections may be a useful strategy. Dr. Arroyo responded that the way data are collected for this report has limitations. Some studies that NIAAA supports may involve secondary analyses of existing data with large numbers of minorities, but these are not reflected in the report. She also explained that oversampling was conducted on the NESARC III. There were about 7000 African Americans and 8000 Hispanics sampled in 2014 for NESARC. Once this study is no longer included in the report, overall participation rates for racial and ethnic minorities could drop in future reports. New policies for inclusion and reporting are likely to make data collection easier and perhaps more reliable.
Dr. De la Monte raised the issue of informed consent among minority individuals who do not speak English, suggesting that such participants might view a video about consent made in their language. Dr. Arroyo responded that consent strategies are under development. To Dr. DiClementi’s inquiry about the degree to which minority populations in studies represent the population, Dr. Arroyo responded that typically the distribution of the minority population is similar to the general population. Dr. Koob stated his intent to monitor minority enrollment. Dr. Messing noted the challenge of determining ethnicity of people from Central America or Mexico.
The Council unanimously approved the report.
Concept Clearance: Ultrasound Elastography in Assessment of Liver Stiffness in the U.S. Population
Dr. Gary Murray, Acting Director, Division of Metabolism and Health Effects, NIAAA, reviewed a research contract opportunity concept regarding assessment of liver stiffness in the U.S. population by means of ultrasound elastography. The ultimate goal is to determine the prevalence of alcoholic fatty liver disease in the United States, a question raised by Dr. Koob upon joining NIAAA.
Dr. Murray explained that alcoholic liver disease is a mosaic of diseases with a variety of symptomatology. He reviewed the scant early literature on the quantitative assessment of this condition, noting that 90−100% of heavy drinkers develop fatty liver disease, as previously reported by Lieber et al. 1965 (J.Clin.Invest 44:11009-1021) and Mathurin et al, 2007 (Aliment Pharmacol Ther 25:1047-1054). A 2013 paper from a national cross-sectional National Health and (Nutrition Examination Study [NHANES) revealed that ultrasound data can help determine the extent of nonalcoholic fatty liver disease and with appropriate questions to determine alcohol use could be extended to alcoholic fatty liver disease.
Dr. Murray proposed that NIAAA develop a contract with the National Center for Health Statistics to perform ultrasound on a representative sample of the non-institutionalized population in the United States. The project would seek to determine the extent of alcohol use in this cohort and to perform this additional testing in cooperation with the National Institute on Diabetes and Digestive and Kidney Diseases (NIDDK). The study would measure liver stiffness using ultrasound elastography, to link these measurements to other National Health and Nutrition Examination Study (NHANES) data to provide estimates of the prevalence of liver fibrosis and fatty liver by key socio-demographic and clinical characteristics, and to provide estimates of liver fibrosis and fatty liver by type of liver disease: viral, alcohol-related, and nonalcoholic liver disease. Issues to be addressed include the number of subjects to include, whether the target population can be clearly stated and articulated, and whether the contract can encompass analysis of the results. Dr. Murray asserted that the contract could fill the information gap on the extent of alcohol-related liver disease in the context of all other liver disease. Information on demographic variation in this non-institutionalized study population is critical to the design of better outreach to the most severely affected communities. Such a study would measure both liver fibrosis and fatty liver, and their progression to more severe cirrhosis, hepatocellular carcinoma, and mortality. Dr. Murray stated that NIDDK has shown interest in such a project and that it may also attract NIH-wide interest.
Discussion. Council members expressed interest in the endeavor. Dr. Fulton Crews suggested stratifying alcohol consumption. Dr. Sinha observed that NHANES has detailed nutrient information on what subjects eat. She suggested that changes in those NHANES questions as well as metabolic hormones maybe of interest
Consideration of Minutes of the September 2014 Council Meeting and Future Meeting Dates
Council members unanimously approved the minutes of the NIAAA Council meeting held on September 11, 2014.
NIAAA has scheduled Council meetings in 2015 for June 10 and September 16–17. In 2016 the Joint Council meeting (NIAAA, NCI, and NIDA [CRAN]) will take place on February 11, and the NIAAA Council will meet on February 11–12, June 8–9, and September 14–15. In 2017 the Joint Council (CRAN) meeting will take place on February 8, and the NIAAA Council will meet on February 8–9, June 7–8, and September 13–14.
Neurobiology of Adolescent Drinking in Adulthood (NADIA) Consortium Progress Report
Dr. Fulton Crews, Director, Bowles Center for Alcohol Studies, University of North Carolina−Chapel Hill, explained that the NADIA Consortium aims to understand the neurobiological mechanisms for the impact of underage drinking on adult brain. The NADIA Consortium has contributed to defining normal adolescent brain maturation as well as the impact on adult neurobiology of adolescent alcohol exposure in underage drinking models
All 8 NADIA research components study rats, control for prenatal and post-natal environment and use standardized adolescent alcohol procedures modeling underage drinking in humans. The NADIA defines rat adolescent age, about post-natal weeks four through seven, using characteristic behaviors that cross species including risk taking, novelty seeking, high reward motivation, low harm avoidance, low aversion, and high social interaction, as well as sexual maturation and puberty. Adolescent neurobiology is poorly understood, however, both human and rat findings suggest maturation to adulthood parallels development of the frontal cortex, key neurotransmitter systems and development of adult executive functions.
Dr. Crews stated that fetal alcohol research has established growing parts of the brain are uniquely sensitive to alcohol toxicity, and that recent studies reveal that adolescence likely is the highest risk period for initiating alcohol dependence. NADIA adolescent rat studies find high alcohol tolerance, e.g. low sedative response, an age related low response to alcohol. Human studies find a low response to alcohol is among the highest risk factors for developing alcoholism. Also the low adolescent sedative response to alcohol is consistent with studies finding Adolescents’ drink as many as 15-20 alcoholic drinks per occasion per 24 hours and have many more blackouts from drinking. The combination of maturing brains high sensitivity to alcohol neurotoxicity and the low sedative response to alcohol allowing unusually heavy binge drinking make adolescence a particularly vulnerable period for long lasting effects.
Human underage, e.g. adolescent, drinking typically involves weekend heavy binge drinking, but not daily drinking. NADIA created the adolescent intermittent ethanol (AIE) rat model that uses vapor or oral binge-like acute alcohol exposure, followed by a period of no alcohol and then another ethanol exposure across adolescence that is followed by maturation to adulthood without alcohol exposure. NADIA research components assess multiple neurobiological and psychological endpoints in adulthood. The NADIA consortium has established standardized procedures for data collection, treatment, numbering, age, and other end points, and researchers are beginning to compile multi-site datasets establishing the most robust findings of AIE induced changes in adults.
One of NADIA’s key discoveries is that adolescent alcohol exposure causes persistence of adolescent-like phenotypes in adulthood, perhaps as a key symptom of a potential adolescent alcohol syndrome. An adult adolescent-like high alcohol tolerance, e.g. low sedative response is sustained; high alcohol drinking and preference continue and high sensitivity to alcohol cognitive disruption is sustained. NADIA findings suggest adults following adolescent intermittent ethanol (AIE) continue to have adolescent-like high reward sensitivity, low aversion, adolescent-like EEG and ion channel responses to alcohol. Neurobiology studies have also found persistence of immature spines and LTP sensitivity in adult hippocampus following AIE. The NADIA consortium will continue to explore the persistence of these adolescent-like characteristics following AIE, but also have found AIE causes a decrease in adult behavioral flexibility; i.e. the AIE–treated adult animal has difficulty adjusting to changes in environment requiring relearning to succeed. NADIA studies also find high adult anxiety and negative affect following AIE. The NADIA consortium is now focused upon mechanistic studies that address these AIE induced persistent changes in adulthood to better define them as well as understand resilience and susceptibility to long lasting effects of underage drinking.
One critical mechanism involves neuroimmune activation, which increasingly appears to be linked to alcohol dependence. AIE treatment finds key neuroimmune-activating signaling molecules are persistently increased in adult brain. Increases in these neuroimmune molecules in human alcoholic brain correlate with age of drinking onset and the likelihood of becoming alcohol dependent in one’s also lifetime correlates with age of drinking onset.
NADIA scientists also discovered decreased acetylcholine neurons in various brain regions, a finding replicated across multiple NADIA components. Other multiple component findings include increased risky decision making and persistent decreases in adult hippocampal neurogenesis. NADIA has recently begun prevention/reversal experiments and found that exercise on the running wheel reverse and/or prevent the AIE induced adult neurogenesis deficit and cholinergic neuron loss. NADIA epigenetic studies link AIE induced adult anxiety, alcohol preference and hippocampal neurogenesis to chromatin changes regulating transcription that persists into adulthood, and such effects are reversible through drugs targeting key epigenetic enzymes to persistent behavioral changes. Other studies using magnetic resonance imaging (MRI) find NADIA’s rat AIE treatment alters adult brain regional volumes consistent with the changes found in the brains of individuals with alcohol use disorder. Recent studies find that cerebral cortical thickness is altered in AIE-treated adults; that will be extended to studies directly investigating connectivity of cortical neurocircuits. The NADIA consortium will integrate the findings described above, established translational endpoints to further understand the mechanisms of the persistent adulthood.
In summary, NADIA Consortium discoveries has laid the foundation for mechanistic studies by finding that adolescent alcohol exposure leads to persistence of adolescent-like responses in adulthood including high alcohol tolerance, impulsivity, risky-decision making and adolescent-like alcohol anxiolytic social responses. Multiple changes in adult neurobiology include increased neuroimmune gene expression, decreased cholinergic neurons, decreased hippocampal neurogenesis, and epigenetic changes in gene expression. The NADIA through standardized methods directed at understanding how persistent changes in neurobiology relate to altered adult alcohol responses and other cognitive and emotional changes. NADIA studies have found exercise creates resilience against AIE pathology. Proposed prevention/reversal experiments are being expanded to include anti-inflammatory, epigenetic, cholinergic and other mechanistic and potentially therapeutics that would protect or reverse neuropathology. Also the NADIA plans to expand its studies to females, reflecting the fact that human adolescent females drink more commonly now than in the past and to distinguish early and late adolescence induced changes in adulthood to better understand the impact of underage drinking on adults. The NADIA will work closely with N-CANDA human studies to translate and integrate findings.
Discussion. Dr. Sinha pointed to the need to investigate variation in frequency of ethanol administration as well as in quantity, factors that Dr. Crews confirmed are addressed the NADIA studies. As with fetal alcohol syndrome, it is not possible to identify a safe amount for adolescents to drink. In response to a question from Dr. Eberwine, Dr. Crews stated that NADIA believes that adolescent alcohol alters glial neuronal signaling that changes adult neurobiology. Dr. de la Monte raised the issue of exercise, about which Dr. Crews noted the need to investigate resilience and risk factors to protect individuals and may provide therapeutics. To Dr. Kenny’s question about co-abuse of nicotine and tobacco, Dr. Crews confirmed that nicotine is anti-inflammatory. He indicated that how co-abuse of nicotine and alcohol impact neuroimmune signaling is not known. He added that he believes loss of cholinergic neuronal ChAT is epigenetic, although hypotheses on epigenetic mechanisms need further experimentation.
Ms. Mimi Fleury observed that the work supported by NIAAA, including the NADIA Consortium, has changed the dialogue on underage and college drinking. She asserted that the science related to adolescent brain development is critical to creating the guardrails for young people as they navigate a toxic adolescent culture and to emphasizing the necessity to delay first use of alcohol.
Dr. Koob observed that a critical part of NIAAA’s mission is to provide the science for changing policy
Council of Councils Report
Dr. Craig J. McClain, Professor of Medicine, Division of Gastroenterology, Hepatology and Nutrition, School of Medicine, University of Louisville, explained that the National Institute of Health’s Council of Councils, whose members are nominated by individual Institutes, advises the NIH Director. Typical meetings include updates by the Council of Councils’ chair, the NIH Director, and representatives of individual Institutes; a review of applications; and discussions regarding the Common Fund. The Council recently discussed dietary supplements, a topic of interest for NIAAA because of their marked influence on epigenetics; Big Data awards; Workshop Report: Enhancing Efficiency of Research Core Facilities, and the importance to grant applicants of conforming to the new biographical sketch format.
At the last meeting, NIH Principal Deputy Director Lawrence Tabak discussed the limited availability of public and private, domestic and international support for biomedical research; the need for increased diversity in the biomedical research workforce; and exceptional opportunities. These exceptional opportunities include the BRAIN Initiative; SPARC (Stimulating Peripheral [nervous system] Activity to Relieve Conditions), a new initiative from the Common Fund; ebola and other vaccine development; and the Precision Medicine Initiative.
Dr. McClain described a number of activities under the Common Fund, whose programs are transformative, unique, catalytic, synergistic, and cross cutting throughout NIH. Among these programs are an evaluation of mechanisms to learn how neurostimulation can cause reprogramming and a Knockout Mouse Production and Phenotyping (KOMP2) initiative. He reported that NIH has increasing interest in funding the best scientists, particularly new investigators. NIH is also considering an emeritus award for scientists approaching the end of their careers.
Council Member Round Table Discussion on Social Media
Judge Linda L. Chezem, Professor, Department of Youth Development and Agriculture Education, Purdue University, led the Council’s discussion of Internal Review Boards’ (IRB) ability to protect human subjects while at the same time help researchers accomplish the task at hand, especially when that task involves social media. Major issues include privacy protection, stigma, and sensitive information, as well as the value of the information acquired using social media. The federal government has made a large investment in social media, but questions arise about whether the data acquired actually answers research queries.
Judge Chezem reported a number of issues discussed at a recent Indiana IRB retreat, particularly confidentiality, integrity, availability of data in the media, and consent. She called the Council’s attention to a Justice Department recommendation to its agencies to support policy development regarding the use of social media sites. She also cautioned that researchers with data on servers outside the United States have no legal control over that data. Control over data and study subjects’ privacy depend on servers’ physical location. A study whose servers reside beyond the borders of this country cannot reasonably assure subjects’ privacy.
Discussion. In response to Dr. Koob’s question about the extent to which NIAAA funds projects that involve social media, Dr. Robert Freeman stated that under the recent Collaborative Research on Addiction in NIH (CRAN) FOA, NIAAA has funded two domestic grants. Prior to CRAN, and during the recent round of grant awards, the number of projects involving social media has increased.
Dr. Kenneth Warren explained that most NIAAA-funded projects to date relate to the impact of social media, its use as an adjunct to treatment, direct provision of treatment, or direct provision of some aspect of prevention. Other projects look at the impact of various types of communications and their meaning in terms of alcohol problems in youth and older people. He pointed out that because of social media, some data generated from research on treatment, prevention or in increasing the risk of alcohol problems are being stored in a social media network.
Dr. Sarah Mattson-Weller observed that many future projects are likely to use social media for recruitment or retention of subjects. Dr. Gil suggested that social media and the location of servers are two separate issues, noting that the federal government aims to make its data available broadly. Dr. Barthwell inquired whether NIAAA funds projects in which social media are used to understand communications among adolescents about ways they use alcohol. Dr. DiClemente added that alcohol and drug use data will be added to the mix as integrative care and electronic medical records become more prevalent, presenting a major challenge for IRBs. Dr. Barthwell pointed out that confidentiality is breached every day when email is used to confirm appointments. Dr. Peggy Murray suggested the need to train IRBs about questions to ask. Judge Chezem suggested convening IRB retreats where experts would speak to the critical issues. Dr. Gil added that his IRB has added new members with expertise in information technology.
Ex-officio Members’ Reports
Dr. Daniel Kivlahan, National Program Director, Addictive Disorders-Mental Health Services, Department of Veterans Affairs (VA), presented updates regarding the Veterans Health Administration. The VA Clinical Practice Guideline on Management of Substance Disorders is under revision in collaboration with the Department of Defense using systematic reviews that include evidence developed by NIAAA-funded investigators, a number of whom are members of the panel. VA also is exploring adaptation of a mobile phone app developed with NIAAA funding and is collaborating with the developer to bring the code inside the VA firewall. The mobile phone app extends access for relapse prevention services to individuals who cannot access continuing care in person. Dr. Kivlahan mentioned Dr. Dave Gustafson’s Addiction-Comprehensive Health Enhancement Support System (A-CHESS) smart phone app that extends access for relapse prevention services. Due to technical and intellectual property issues, a decision was made to cancel a VA software development contract that had begun to bring the A-CHESS app inside the VA information security firewall. Dr. Gustafson has expressed interest in finding a way to make the app available to Veterans, but they would need a mechanism independent of VA information technology that could maintain key A-CHESS functionality (e.g., social media features). He also stated that Congress has mandated VA to implement the Veterans Choice Act that includes a section that requires a comprehensive external evaluation of VA services that will involve specific focus on mental health and substance use disorder treatment. The VA received approval to adjust some internally monitored metrics on pharmacotherapy implementation to give credit for prescription of topiramate when alcohol use disorder is part of the presenting problem. Congress funded expansion of a broader PTSD consultation program that will soon allow VA to consult with community providers to try to promote better attention to PTSD and co-occurring alcohol use disorders. Dr. Koob advised Dr. Kivlahan that in the future NIAAA may have medications with fewer side effects than topiramate but equally effective. Dr. Koob stated that NIAAA intends to reach out to the VA, Department of Defense, and the National Institute on Drug Abuse (NIDA) on consolidating the focus on PTSD and alcoholism research.
Dr. Charles S. Milliken, Principal Investigator, Department of Psychiatry, Division of Neuroscience, Walter Reed Army Institute of Research, Department of Defense, highlighted new published data from the Department’s Survey of Health-Related Behaviors, which found heavy alcohol use to be significantly correlated with higher rates of suicidal ideation and a history of suicide attempts. In a survey conducted 3 months post-deployment to a combat theater, members of the regular Army combat brigade have an association of more alcohol misuse with higher levels of combat exposure. In that study, researchers isolated the threat of injury and death, and also exposure to atrocities. Exposure to atrocities also was associated with higher alcohol-related misbehaviors. A longitudinal study of a National Guard combat brigade found twice the rate of alcohol misuse upon return; nevertheless, combat exposure in that group was negatively associated with alcohol misuse, and individuals who experienced active killing had lower levels of alcohol misuse. Another National Guard combat brigade study looked at post-deployment experiences and civilian stressors during the post-deployment phase; the first 3 to 6 months back were associated with higher rates of alcohol abuse.
Dr. Mei-Chun Lei, Physicians Committee for Responsible Medicine, urged NIAAA to set new priorities for its grant portfolio in order to fund larger implementation studies that benefit humans, while at the same time eliminating some of the most ethically questionable animal research least likely to translate to a benefit for human health. Ms. Pamela Walters, Al-Anon Family Groups, highlighted the devastating effects of alcohol on people other than just the alcoholic individual.
The meeting adjourned at 12:55 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
George F. Koob, Ph.D.
National Institute on Alcohol Abuse and Alcoholism
National Advisory Council on Alcohol Abuse and Alcoholism
Abraham P. Bautista, Ph.D.
Office of Extramural Activities
National Advisory Council on Alcohol Abuse and Alcoholism