DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH

NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

139th Meeting of the
NATIONAL ADVISORY COUNCIL ON ALCOHOL ABUSE AND ALCOHOLISM

June 10, 2015

The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 139th meeting at 9:00 a.m. on Wednesday, June 10, 2015, at NIAAA headquarters in Rockville, Maryland. The Council met in closed session to review grant applications; the meeting recessed at 9:40 a.m. 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. Dr. George Koob reconvened the Council in open session at 10:18 a.m.

Council Members Present:

Carol A. Casey, Ph.D.
Linda L. Chezem, J.D.
Fulton T. Crews, Ph.D.
Carlo C. DiClemente, Ph.D.
Marianne L. Fleury
Hon. Joseph Thomas Flies-Away, J.D., M.P.A.
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.
Adolf Pfefferbaum, M.D.
Rajita Sinha, Ph.D.
Dan Kivlahan, Ph.D., ex officio (VA)

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

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

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

 Senior Staff:

 Vivian Faden, Ph.D.; Ralph Hingson, Sc.D., M.P.H.; Robert Huebner, Ph.D.; Keith Lamirande, M.B.A.; Gary Murray, Ph.D.; Antonio Noronha, Ph.D.; Patricia Powell, 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 general public.

 Call to Order and Introductions

 Dr. George Koob called the open session of the Council meeting to order at 10:18 a.m. on Wednesday, June 10, 2015. Council members and senior NIAAA staff introduced themselves. 

Director’s Report

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

•  NIAAA budget. The President signed the Fiscal Year (FY) 2015 budget in December 2014, under which the National Institutes for Health (NIH) received a total of $30.3 billion, $150 million more than in FY 2014. NIAAA received $447.2 million, an increase of 0.03% over the previous year. NIAAA expects to support 697 research project grants, including 167 competing awards, in FY 2015. For FY 2016 the President is requesting $31.3 billion for NIH and $459.8 million for NIAAA that includes $12.7 million, a 2.8 % increase above FY 2015 appropriation.
• Legislative initiatives. Current legislative initiatives, launched by President Barack Obama in January 2015, include the Precision Medicine Initiative to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies from which to select treatments that work best for specific patients. Dr. Koob anticipates that NIAAA will participate through many of its ongoing activities. The $215 million requested for FY 2016 for the initiative would be administered by NIH, the Food and Drug Administration, and the Office of the National Coordinator for Health Information Technology. Another important legislative initiative, the 21st Century Cures Initiative, led by Representative Fred Upton, Chairman of the House Energy and Commerce Committee, would enhance and accelerate the discovery, development, and delivery of new treatments and cures. The initiative would provide $2 billion each year from FY 2016-2020 for an NIH innovation fund and would increase loan repayment limits for young emerging scientists.
•  NIAAA staff transitions. Dr. Koob noted a number of staff changes at NIAAA. Ms. Cara Breeden has joined NIAAA’s Communications and Public Liaison Branch as a technical writer/editor. In the Office of Resource Management, Ms. Vicki Buckley now serves as NIAAA’s Deputy Executive Officer and Ms. Karen Harrington as Chief, Intramural Administrative Management Section. Ms. Jon’lethia King has joined NIAAA’s Office of the Director as a staff assistant, and Dr. Mariela Shirley has returned to NIAAA as Health Science Administrator in the Division of Epidemiology and Prevention Research. Mr. Jeff Thurston and Mr. Kelvin Zeigler have joined NIAAA as Grants Management Specialists, and Dr. Aaron White now serves as Senior Advisor to the Director for Research and Statistics. Departing NIAAA staff include Ms. Jo-Ann Kriebel and Mr. James Padgett.
• Honors and awards. Dr. Koob announced several awards bestowed on NIAAA staff members. Dr. Adeline Bertola received the 2015 NIAAA Daniel Hommer Award, and Dr. David Goldman received the Annual Distinguished Researcher Award from the Research Society on Alcoholism. Dr. Koob received the R. Brinkley Smithers Distinguished Scientist Award from the American Society of Addiction Medicine, and Dr. Raye Litten, Dr. Joanne Fertig, Ms. Megan Ryan, and Dr. Daniel Falk received NIAAA’s 2015 Scientific Achievement Group Award. In addition, the American Psychological Association honored Dr. Marcia Scott with a Meritorious Research Service Commendation.
• New funding opportunities.  NIAAA issued notice of funding opportunities on Specialized Alcohol Research Centers; Investigational New Drug (IND)-Enabling Development of Medications to Treat Alcohol Use Disorder [AUD] and Alcohol-Related Disorders; Summer Research Educational Experience Programs; Alcohol Impairment of Immune Function, Host Defense, and Tissue Homeostasis; and Human Studies to Evaluate Promising Medications to Treat Alcohol Use Disorder. NIAAA participates in NIH-wide BRAIN Initiative and Big Data to Knowledge Initiatives (BD2K) and FOA’s issued by other NIH Institutes and Centers.
• NIAAA research highlights. Dr. Koob highlighted several research projects at NIAAA:  Studies on Prevalence of Alcohol-Interactive Prescription Medication Use Among Current Drinkers showed that 42% of adult current drinkers in the United States used alcohol-interactive medications and that prevalence was higher (78%) among elderly current drinkers;  Findings from the National Epidemiologic Survey on Alcohol and Related Conditions III [NESARC-III] show that 14% of U.S. adults met DSM‑5 criteria for AUD, while 30% met the criteria sometime in their life, while only 20% of adults with lifetime AUD sought treatment.
• Dr. Koob also noted that the amount of alcohol in drinks during a bout of drinking has risen significantly over the last decade, and that DSM-4 data for abuse and dependence correspond almost identically to DSM-5 data for alcohol use disorders
• In another study on aldehyde dehydrogenase and ethanol metabolism, Dr. Koob described that pharmacologic agents could be used to alter substrate specificity of related enzymes as replacements for defective isoforms in alcohol metabolism. He also noted that aldehyde dehydrogenase-3 activator (Alda-89) may be useful not only as an alcohol detoxifying drug, but as a cancer preventing strategy. 
• Dr. Koob highlighted brain studies related to a pharmacological intervention that reverses epigenetic and behavior changes induced by alcohol exposure in adolescence, and the role of neuropeptide Y (NPY) signaling in reducing binge drinking and anxiety. 
• In a study on the heterogeneity of alcohol use disorder (AUD): understanding the mechanisms to advance personalized treatment, Dr. Koob discussed the framework for classifying AUD into major functional domains and identifying constructs and measures within those domains that could be used to better characterize and tailor treatments to individuals with AUD.AUD.
• Dr. Koob presented a study that identified a panel of common and rare variants in 30 candidate genes for nicotine dependence, frequently comorbid with alcohol dependence. This work also demonstrates a novel methodology for identifying “hidden heritability of addictive disorders.
• Rethinking Drinking. Forty percent of NIAAA website visitors to the Rethinking Drinking website visit by mobile device. As a result, NIAAA has updated its mobile app to display optimally on tablets, smart phones, and desktop monitors. Dr. Koob also emphasized the value of the website in all his encounters with media.
• NIAAA Strategic Plan FY 2015–2019. Dr. Koob presented an outline of NIAAA’s draft strategic plan and invited Council input. Areas of focus include: understand and prevent alcohol misuse and AUD; expand AUD treatment and recovery research; develop AUD medications; understand, prevent, and treat co-occurring AUD and post-traumatic stress disorder (PTSD); address the effects of alcohol on aging populations; prevent, diagnose, and treat fetal alcohol spectrum disorders; prevent, diagnose, and treat alcoholic liver disease; and reduce the spread of HIV and improve health outcomes for HIV-positive individuals by addressing alcohol misuse. Cross-cutting themes include alcohol across the lifespan, precision medicine, health disparities, genetics, and communications and education.

 NIAAA’s Proposed Reorganization 

Dr. Koob reported that NIAAA proposes to establish a new Division of Medications Development, and he solicited Council members’ input. He stated that the new division would better reflect NIAAA priorities and would increase the Institute’s emphasis on medications-development efforts focused on treating AUD.  Designed to heighten public awareness of NIAAA’s work to develop new medications, this change is anticipated to be budget neutral and to use existing Institute resources. 

Enhancing Reproducibility through Rigor and Transparency 

Dr. Koob described the new NIH-wide initiative on Enhancing Reproducibility Through Rigor and Transparency, whose principles aim to clarify NIH’s longstanding expectations regarding rigor and transparency, and how these should be addressed in grant applications. The initiative is intended to raise awareness and begin culture shifts in the scientific community, as well as to prompt applicants to consider issues that they may have downplayed or ignored in the past. In addition, NIH seeks to improve the way that applicants describe their work, provide sufficient information for reviewers, to demonstrate to its public stakeholders that NIH seriously considers their concerns, and to ensure that NIH invests in the best science and minimizes unnecessary burden. NIH plans to clarify and revise application instructions and existing review criteria. New provisions would take effect for applications with receipt dates beginning on or after January 25, 2016. Four areas of clarification include attention to scientific premise; rigorous experimental design; consideration of relevant biological variables, such as sex and gender; and authentication of key biological and/or chemical resources. 

Discussion.  Dr. Robert Messing suggested that NIH ask applicants to allow their raw data to be reviewed and subjected to post-hoc statistical analysis. Several Council members discussed challenges and possible solutions regarding the new expectations for research on gender differences. Dr. Fulton Crews suggested strategies to accommodate the change in policy, including studying all females or all males and obtaining data on both sexes through multiple experiments, and he highlighted the need for reproducibility. Dr. Messing suggested that issuing an RFA to study sex differences might induce more researchers to study that area of the science. Dr. Mark Egli stated that NIH will not require studies to have both male and female subjects; it will require consideration of sex as a biological variable in all applications, and the policy will be integrated into the peer review process. Dr. Sarah Mattson-Weller pointed out that studies that do not include both males and females are not generalizable, especially for medications. Dr. Patricia Molina agreed with Dr. Mattson-Weller’s comment. 

Hughes Award Presentation

Dr. Koob presented the annual NIAAA Senator Harold Hughes Memorial Award to Dr. Jonathan Gibralter, President of Frostburg State University and Chair of the NIAAA College Presidents Working Group to Assess Harmful Student Drinking. Named in honor of U.S.  Senator Harold Hughes, the award recognizes the contributions of a nonresearcher with an outstanding ability to create effective prevention and treatment programs grounded in scientific research, and to connect the alcohol prevention, treatment, and policymaking communities. Dr. Koob stated that Dr. Gibralter has helped to recruit other college presidents to bring NIAAA’s research and science-based information to campuses and students across the country. Dr. Gibralter accepted the award via video call, commending the work of the Alcohol Task Force at Frostberg State University in Maryland, which has implemented NIAAA’s research findings. He stated that he looked forward to the release of the College Alcohol Intervention Matrix mobile app—a decision-making resource developed by NIAAA for college and university presidents. 

Collaborative Research on Addiction at NIH (CRAN): Update      

Dr. Peggy Murray, Director, Global Alcohol Research Program, NIAAA, highlighted two activities of Collaborative Research on Addiction at NIH (CRAN), which is the functional collaboration of NIAAA, National Institute on Drug Abuse (NIDA), National Cancer Institute (NCI) and other NIH Institutes and Centers to work together on multi-substance related research. Regarding the first activity, Dr. Murray stated that the Adolescent Brain Cognitive Development (ABCD) study, whose RFAs closed in April 2015, elicited an excellent response from applicants. The second activity was a meeting of 80 current CRAN grantees from diverse perspectives who convened in May to meet other investigator teams, develop networks, begin discussions on an agenda for the future, and identify challenges to CRAN research. A highly positive meeting evaluation revealed the need to educate reviewers about both translational and CRAN research, to have an appropriate structure in place, to generate more conversation between preclinical and clinical investigators about polysubstance abuse, and to focus more on clinical dilemmas regarding the most effective treatment regimen. Attendees observed that CRAN provides a framework for both preclinical and clinical research, and that it has elevated the status of polysubstance research. Meeting attendees observed that CRAN has removed barriers to investigate e-cigarettes, comorbid depression, and prescription drugs, along with alcohol. All called for more interdisciplinary training, and some recommended establishing a study section looking at collaboration across the field of addiction. They asserted that a CRAN mentorship program is needed to foster interest in translational research, possibly enhanced by additional funding opportunities. Some attendees identified the need for published guidelines for multi-substance research, for a systematic review of multi-substance instruments and measures, and for holding CRAN symposia at major scientific meetings. Dr. Murray noted that most  attendees would not have attended the meeting, had it not  been mandatory for grantees 

NIH Big Data to Knowledge (BD2K) Initiative: Update

Dr. Jennie Larkin, Chair, NIH Big Data to Knowledge (BD2K) Initiative, described the trans-NIH extramural program to advance data-science research and development, and training. Dr. Larkin explained that the initiative focuses on biomedical big data, where big data refers to some combination size and complexity of large data sets, such as genomics, patient partnerships, clinical data, health data, and behavioral data. Data science aims to maximize the potential of existing data, develop new collection and analytical methods, identify and enable new research directions, and strengthen and diversify the biomedical research workforce. BD2K’s mission is to use data science to foster an open digital ecosystem that will accelerate efficient, cost-effective biomedical research to enhance health, lengthen life, and reduce illness and disability. 

Dr. Larkin explained that BD2K’s data-science strategy incorporates such critical issues, as sustainability, workforce development and diversity, discovery and innovation, policy and process, and leadership, and she enumerated a number of current and future activities related to each area. The initiative currently focuses on strategic thinking and planning to capitalize on the massive growth of biomedical data, to accelerate discovery, and to promote a culture of science as analytical enterprise. By 2022 NIH hopes to enable major scientific discovery through the initiative; establish and provide evidence of a more sustainable, efficient, and productive data science ecosystem; establish and provide evidence of a well-trained and diverse workforce; and build upon NIH’s leadership and reputation in data science. 

Dr. Larkin explained the concept of The Commons, a shared virtual space where scientists can find, deposit, manage, share, and reuse data, software, metadata, and workflows. Components include a computing environment, methods for varying levels of interoperability, and a digital objects compliance model. The cloud currently is useful as a computing environment where one can share, store, and compute on digital research objects, especially for large datasets. Next steps for The Commons include reviews of pilot projects and a presentation to BD2K Executive Committee (EC), regular updates to the BD2K EC, Commons Pilot Workgroup, and coordination with NIH’s Institutes and Centers (ICs). 

NIH Multi-Council Working Group on BD2K: Update

 Dr. Paul Gruenewald reported consensus among members of NIH’s Multi-Council Working Group on BD2K on the necessity and timeliness of pursuing the initiative’s aims, especially given the explosion in the quantity of data generated over the past decade. He encouraged NIAAA to determine projects of interest to put forward into the BD2K process. He also stated that genomic, proteomic and neural imaging databases were prime candidates to take up first and that these activities should be viewed as long-term developmental processes, which should be taken up one-at-a-time. Dr. Gruenewald emphasized the need to discover databases and to define ontologies. Definitions of interest to NIAAA would be developed jointly among all ICs with which NIAAA interacts, with the goal to generate well-defined indexes that enable alcohol researchers worldwide to access data efficiently. 

Discussion. Dr. Koob stated that NIAAA’s clinical and pharmacogenomics data are prime candidates for inclusion in BD2K. Dr. Larkin stated that the initiative aims to support data sharing for all biomedical data, including basic science data; first steps involve determining best strategies for data sharing and sustainability activities. Dr. Gary Murray noted that NIAAA has considered supporting systems biology approaches. Dr. Larkin observed that NIH’s Common Data Elements activities promote reproducibility and interoperability. Dr. Adolf Pfefferbaum noted the need to standardize phenotypic data and to standardize information about alcohol use and abuse across all Institutes. Dr. Carlo DiClemente raised the issue of how data will be used in the future, and Dr. Craig McClain raised a question about enforcement of standardization. Dr. Larkin responded that multiple platforms may be used that ensure interoperability and that standardization works best when it comes from the community and is facilitated by NIH. Dr. Koob added that NIAAA will increase its activities in this arena. Dr. Gruenewald pointed out that the 12 Centers of Excellence are test beds for bioinformatics work in the quest to identify a variety of problems in ecologies of data. These Centers take a bioinformatics approach to integrate the ecologies into a searchable database. Providing feedback to BD2K will help integrate the databases efficiently. 

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

 Council members unanimously approved NIAAA’s Standard Operating Procedures (Appendix 1), the minutes of the Joint Council (NIAAA, NIDA, and National Cancer Institute [CRAN]) meeting held on February 4, 2015, and the minutes of the NIAAA Council meeting held February 4–5, 2015. 

NIAAA has scheduled its next Council meeting for September 17, 2015. In 2016 the CRAN Council meeting will take place on February 11, and the NIAAA Council will meet on February 11–12, June 9, and September 15. In 2017 the NIAAA Council will meet on February 9, May 2, and September 14. The CRAN Council meeting will take place on May 3, 2017.                                                               

CSR Peer Review Update

Dr. Richard Nakamura, Director, Center for Scientific Review (CSR), NIH, updated Council members on issues related to the CSR peer review process and to the evaluation of NIAAA applications in particular. CSR reviews 70% of applications for NIH and 40% of applications for NIAAA, for a total of about 86,000 applications annually. NIH’s grant success rate, in decline since 2003, has hit historically low levels; though the NIH budget has been largely flat, its value in current dollars has declined steadily. 

In a discussion of the NIH review process, Dr. Nakamura highlighted trends related to the frequency of amended applications in recent years, noting that the number of first submissions or A0s increased in 2014 over the previous year by 14%, a rate likely to remain steady before declining slowly in coming years. He stated that the queue system has been reestablished, and CSR is endeavoring to analyze the significance of the trajectory of the newly reinstituted A0. 

CSR seeks continuous improvement in quality, fairness, and efficiency of review, and in engagement of staff and reviewers. CSR works to recruit high-quality reviewers, study section chairs, and scientific review officers (SROs). SROs recruit reviewers who are senior scientists, NIH-funded and with strong publication record. These reviewers have earned honors from their peers, enjoy positive review experiences as ranked by NIH as well as respect from other reviewers, and have diversity of experience. 

Recent studies of the value of applicants’ citations, publications, and patents in selecting high-impact applications revealed a clear, though noisy, relationship between peer review scores and outcomes. Nevertheless, though percentile score has a major effect on the outcome of successful applications, applications are funded far beyond normal ranges, indicating that program officers (POs) are highly selective in terms of proportion of applications selected and of the requested budget. It is evident that multiple factors influence award decisions. 

Many investigators share concerns about reviewer bias; for example, Black and African American scientists receive just 55% of the expected proportion of awards compared to White scientists. Dr. Nakamura stated that the review score accounts entirely for the differential and hypothesizes that adverse bias in review and cumulative disadvantage resulting from the U.S. educational system and historical differences between Black and White populations are major sources of potential award disparity. CSR has addressed this disparity with efforts to diversify study sections; understand the causes of award disparities; advise review panels to look for sources of bias; and, for underrepresented minority scientists, enrich an existing early career reviewer program to increase familiarity with the CSR process. CSR plans to conduct an anonymization study with greater concealment of identity and institutional identity of scientists, and to encourage SROs to use surveys of reviewers and program officers as feedback to address concerns. 

CSR’s surveys of reviewers and NIH program officers (POs) about their CSR study section meeting experience found, for example, that a large majority (90%) of reviewers reported positive attitudes about overall review quality. Dr. Nakamura stated that survey feedback will enable CSR to address issues raised by the relatively small proportion of individuals who identified problems. The surveys also assessed attitudes towards alternative meeting formats: Internet-assisted meetings drew more negative responses than video-assisted and traditional formats. Dr. Nakamura stated that POs expressed relatively lower satisfaction with video-assisted meetings, and even lower satisfaction with Internet-assisted meetings, than with in-person meetings. If program staff continue to feel that the Internet format does not produce strong results for the Institutes, CSR plans to adjust the format. Dr. Nakamura stated that NIH will watch Canada’s review experience with interest; Canada has chosen to use an Internet-assisted format exclusively. 

In comparing of attitudes of POs from NIAAA and from NIH, NIAAA staff generally expressed a greater level of concern about the review process than did NIH staff, particularly on the question of adequate collective scientific expertise. NIAAA POs suggested increasing the number of reviewers with alcohol experience or forming an alcohol-focused study section to provide a more balanced review of end organ diseases, and recruiting more than two reviewers with alcohol expertise to enable a balanced discussion. Dr. Nakamura stated that CSR can develop higher concentration in study groups of reviewers with alcohol expertise, and he expressed a desire to work with NIAAA to create committees with critical masses of NIAAA applications. 

In his concluding remarks, Dr. Nakamura expressed concern over the ebb of the United States’ world stature in science and technology as the U.S. budget for scientific research declines and China’s rises. 

Discussion. Dr. Koob stated NIAAA’s willingness to work with CSR to increase the critical mass of alcohol researchers on study sections. Council members raised the issue of low scores accorded applications that stress innovation and significance, which Dr. Nakamura attributed to extremely austere budgets and consequent low tolerance for risk. In response to questions from Dr. DiClemente, Dr. Nakamura stated that CSR presents orientation sessions for new study section chairs, who are among the most prominent scientists. Important review issues include reproducibility, bias in peer review, and funding of both basic and applied scientific studies. Dr. Adolf Pfefferbaum suggested that the orientation address dismissive attitudes held by some reviewers toward alcohol research. Dr. Nakamura stated his view that applicants should be able to suggest the committee they wish to review their applications. He responded to Dr. Vivian Faden’s question that available data suggests that the number of applications has remained steady at 1.5 per principal investigator, though data for last year may be shown to differ. 

Fetal Alcohol Spectrum Disorders: Advances Toward Diagnostic Clarity

Dr. Sarah N. Mattson-Weller, Professor of Psychology, San Diego State University, described her work in investigating neurobehavioral functioning of children with fetal alcohol disorder (FAS) or heavy prenatal alcohol exposure, and in children exposed prenatally to teratogens, and in neuroimaging studies of children with fetal alcohol spectrum disorders (FASD). Since alcohol was confirmed as a human teratogen in the late 1960s in France and in the United States in 1973, the disorder designated as fetal alcohol syndrome (FAS) has been recognized as a specific pattern of facial features accompanied by intellectual and cognitive-behavioral impairment. Imaging studies have investigated brain changes due to prenatal alcohol exposure through the years, and in 2013 the DSM-5 included a diagnosis related to prenatal alcohol exposure. This area of research has focused recently not on solely detailing deficits, but importantly on learning about ability to function and possible interventions and treatment. 

Though a diagnosis of fetal alcohol syndrome has been based on a specific constellation of facial features, 60–90% of alcohol-exposed children do not share the facial features. Moreover, a recent study revealed that as many as 80% of high-risk children in foster care were not identified clinically as having been exposed prenatally to alcohol.

 Dr. Mattson-Weller’s recent research has focused on developing a sufficiently sensitive and specific test for prenatal alcohol exposure that would indicate factors that make fetal alcohol syndrome unique, as distinguished from ADHD and low intelligence. Many factors may contribute to a child’s ability to function, including prenatal alcohol exposure, IQ, socioeconomic status, ADHD, foster care experience, genetics, and others. Dr. Mattson-Weller’s neurobehavioral work confirms that the neuropsychological effects of FASD are independent of facial features; children both with and without the characteristic facial features share the same neuropsychological profile, with both groups at risk for cognitive and behavioral problems. Studies show also that behavior problems are far greater among children with prenatal alcohol exposure than among children with low IQs. 

The Collaborative Initiative on FASD (CIFASD), an NIAAA consortium in its 11th year, aims to improve the identification of prenatal alcohol–affected children. The large-scale CIFASD tests children at multiple sites using standardized neuropsychological test batteries, dysmorphological exams, and imaging. Using latent profile analysis of data from the neuropsychological test battery, Phase 1 studies generated high accuracy rates in distinguishing a heterogeneous alcohol-exposed group of children from controls (92%), even when the alcohol-exposed group excluded individuals with even a single feature of FAS (85%). With a far more diverse sample, Phase 2 studies looking at executive functioning found an overall accuracy rate of 70–76% in an FAS and non-FAS comparison. Another study compared children with ADHD but not alcohol exposure and children with alcohol exposure for executive function. The study generated an overall accuracy rate of 74%, but the test missed 40% of the alcohol-exposed children.

 Dr. Mattson-Weller’s most recent study aims to develop a cost-effective set of diagnostic tools for prenatal alcohol exposure that is easily administered by a professional in a clinical setting. In Phase 3, using two parent questionnaires (for problem behavior and for adaptive functioning), IQ score, and dysmorphology score, investigators identified children with alcohol exposure, children without exposure, and children with other clinically concerning behaviors but with no alcohol exposure. Two clinical routes for identification of affected children were tested: starting with mental health professionals and starting with dysmorphology or pediatric specialists. The accuracy rates were 85% for the mental health route and 80% for the dysmorphologist/pediatrician route. The findings represented two age groups included in the study, ages 5–7 and 10–16. 

In summary, Dr. Mattson-Weller pointed out that prenatal exposure causes wide-ranging behavioral and cognitive effects, and that 80% of alcohol-affected children are not identified through general clinical practice. Standard neuropsychological and behavioral measures now can identify 70­–90% of alcohol-affected children. Future research directions include verification of the models in additional independent samples and in other age groups, particularly adults. Improved identification can help in development of targeted interventions, including educational programs. Having a diagnosis leads to better outcomes overall, especially in the ability to provide additional supports for foster and adoptive parents who seek services for their affected children, and to prevent complex psychopathology and later criminal behavior by means of early intervention. 

Discussion. Council members discussed the reliability of study subjects’ self-reports of previous substance use, best advice regarding drinking and pregnancy, and the contribution of alcoholic fathers to the prenatal alcohol exposure of their offspring. In response to a question by Dr. DiClemente, Dr. Mattson stated that externalizing behaviors, more than internalizing behaviors, are indicators of alcohol exposure. In order to shorten the assessment process, Dr. Vivian Faden suggested the potential usefulness of an IQ test subset. 

Council Member Round Table

 Dr. Koob asked Council members for their input on the proposed NIAAA Strategic Plan and on development of the BD2K enterprise. Under BD2K, NIAAA likely will convene a group to work on possibilities for phenotype standardization in all the domains in which NIAAA has an interest, including genetics. Ms. Mimi Fleury described a collaborative research project between Community of Concern and NIAAA that was highlighted recently by a special printing of a booklet that showcases NIAAA resources and information related to Rethinking Drinking, and that are distributed to treatment centers, clinicians, and patients. In addition, a recent middle school outreach in Alexandria, Virginia, schools demonstrated how NIAAA’s science translates into everyday life.

 In response to a question from Dr. DiClemente, Dr. Kenneth Warren described NIAAA’s participation in a large developmental study on the effects of alcohol that represents a major resource for further study. Dr. Koob added that Dutch investigators with a large data set have contacted NIAAA about working together on the ABCD study. On the issue of how much to drink, Dr. Warren stated that he recommends that the “wisest course during pregnancy is to refrain from use.” Council members discussed the issue of guilt experienced by mothers who drank alcohol prior to knowing about their pregnancy; Dr. Mattson-Weller pointed out that 50% of pregnancies are unplanned and recommended “contracept or don’t drink.” Ms. Fleury noted a congruent issue with regard to underage drinking. Because scientists do not know what harm may come from young people drinking a little, it is recommended to delay drinking.

 Ex-officio Members’ Reports               

Dr. Daniel Kivlahan, National Program Director for Addictive Disorders, Mental Health Services, Department of Veterans Affairs (VA), reported that despite discontinuation of funding for some implementation science projects, the VA continues to promote research on alcohol use disorders (AUD). Veterans Administration (VA) budget constraints severely limit travel (unless supported by research funds), and training for evidence-based practices. Future research funding is anticipated to be maintained at least at the FY 2015 level.  High-profile research efforts include the Million Veterans Project to conduct genomic testing on veterans, and projects to evaluate appropriate implementation of addiction-focused pharmacotherapy. Fewer than 10% of the population seen in VA and diagnosed with AUD receive initial exposure to FDA-approved medications though rates are higher in specialized care, and approximately 1/3 of veterans with AUD cross that threshold. The Clinical Practice Guideline for Substance Use Disorders developed with the Department of Defense is under revision. 

Discussion. Dr. Craig McClain stated that VA study sections lack sufficient expertise on alcohol research. 

Public Comment

 Ms. Pamela Walters, Al-Anon Family Groups, illustrated the effects of alcohol on family members of alcoholic individuals and reported findings of the organization’s recent membership survey that indicate the need for further education of doctors on alcoholism. Doctors, nurses and other health care workers saw 11% of U.S. Al-Anon members and 27% of Canadian members, while counselors or therapists referred 79% of U.S. members and 62% of Canadian members for services.

 Adjournment

The meeting adjourned at 4:03 p.m.

 CERTIFICATION

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

/s/

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

/s/

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

 

APPENDIX 1

Operating Procedures for Institute Staff Actions
for Administrative Supplements and Time Extensions
 
Approved by NCAA on june 10, 2015

 The Institute staff may take the following actions without Council review.  All staff actions shall be documented and those over $50,000 for direct costs shall be presented to the Council for its information at the first appropriate opportunity. 

1. Institute staff may take administrative action without prior Council approval to award funds in excess of the amount recommended by Council for research and research training grants and cooperative agreements (1) to cover increased direct and associated operational costs not anticipated at the time the Council concurred with the project, or (2) to finance an additional period of not more than 1 year.
 

2. Administrative increases and extensions should be provided only when necessary to the successful conduct of the project and must not represent changes in the basic goals or intent of the project.  These increases may be made to cover unanticipated costs of a project and can include, but are not limited to:

- Loss of equipment originally available to the project from other sources; 

- Increased cost of equipment and related services, e.g., data analysis, animal purchase and care   costs; 

- Making modifications for the purpose of taking advantage of serendipitous and other unanticipated opportunities to increase the value of the project consistent with the originally approved objectives and purposes of the project; 

- Preparing and disseminating materials concerning the project and for the purpose of ensuring that important findings from the project are made widely available in a timely and effective manner; 

- Correction of errors, oversights or omissions in applications, review group recommendations, or awards;

- Orderly termination of a project;

-  Awards for an interim period due to a deferral;

-  Award of funds to research project grants based on the receipt of a supplemental application to provide support for re-entry into research, disabled, or underrepresented minority investigators, underrepresented minority undergraduate or graduate students who work on research aims previously reviewed during competitive evaluation of the parent grant. 

3. Unsolicited administrative supplements (increases in a budget funded in a prior fiscal year than that of the current award), revisions (increases in a budget in the same fiscal year as the current award), shall be documented and approved by th Division Director with the concurrence of the Grants Management Officer and Director, Office of Extramural Activities. Increases in budgets, whether supplements or revisions after or at the time of award, will be documented in the form of an Administrative Action Report.

4. The Administrative Action Report will be prepared by program staff and placed in the grant file following final action.  The Administrative Action Report should include sufficient detail and justification for the record to substantiate the necessity for the administrative action.  A summary of all administrative supplements or time extensions which exceed $50,000 for direct costs will be provided to Council members at each Council meeting.

5. Unsolicited Administrative supplements that exceed $100,000 or 25% of the parent grant’s active year’s award (whichever is higher) shall be submitted to the Council for approval. Council may also recommend reduction in budget. This action shall be discussed for approval at council meetings (closed session) or by email ballot/ECB or teleconference. The IC Director signs off on the award.

6.   Administrative supplements made for the purpose of extending the period of support may be made to assure orderly termination of a project or to support a project for a limited time pending a decision or action to continue or discontinue support (for example, when there is an IRG or Council deferral and support would terminate before completion of review).  Extensions of projects made for this purpose should be for periods as brief as possible, but in no case should they exceed 1 year.  The dollar amount of administrative supplements for such purposes should not exceed the most recent, or current, yearly direct costs budget of the project.

7.   For Solicited Administrative Supplements in response to FOAs with specific research goals and budget caps, all of the above will be applicable. However, review and approval by council will not be required. If the requested budget exceeds the NIAAA cap, the IC Director’s sign off will be required.

 APPENDIX 2

PROCEDURES FOR EXPEDITED EN BLOC CONCURRENCE FOR
GRANT APPLICATIONS

 A.  Council members will be selected by the Chair or Executive Secretary of the Council to provide en bloc concurrence on behalf of the Council.  One Council member may be assigned this concurrence responsibility for a group of applications limited by an individual Program Class Code (PCC, e.g., AN).  A Council member may be assigned more than one PCC.  An alternate Council member will be assigned this responsibility for applications within a PCC for which the primary assignee has a conflict of interest. 

B.  Applications eligible for expedited concurrence include the following mechanisms: 

1)  Mechanism:  R01, R03, R21, R13, R15, R24, R25, R34, R41, R42, R43, R44, U01, U10, U13, U19, U24, U34, U44, U54, U56, UM1, K (all), T32, T35.

2)  Percentile Score:   25 

3)  Priority Score for non-percentiled applications: 35 or better for all applications.

4)  Foreign Applications:  exclude

5)  Applications with a Human Subjects Concern, Animal Welfare Concern, Unacceptable codes for minorities, gender, or children are excluded.

 C. The Council Executive Secretary will alert the Council member(s) with delegated responsibility for expedited concurrence when summary statements for eligible applications are available on the Electronic Council Book (ECB).  Concurrently, all other members are alerted of this communication.  The Delegated Council member is requested to respond with a recommendation to concur or not on the applications for which the member has responsibility.  This should be communicated via e-mail, phone, or fax.  All Council members are reminded that they may request that any application be brought to the Council for full discussion.  To comply with the latter, all Council members are afforded a minimal period of two weeks to request full discussion on any application in any bloc. 

D.  When notifying Council of available summary statements, the Council Executive Secretary will provide the following information to the members:  Application Number, Name of Principal Investigator, Project Title, and Percentile/Priority Score. 

E.  A report of the en bloc recommendations will be presented at each Council meeting. 

F.  Council may consider the parameters for expedited eligibility at any time, but no less than once a year. 

 

APPENDIX 3

SPECIAL COUNCIL REVIEW

1. The Executive Secretary will inform the Council Members three weeks before the council meeting about eligible applications from PI/PD’s, who are identified as recipients of awards that exceed the $1.0 M threshold in active grants and pending awards (current council only). These applications will be reviewed by all Council Members for funding or non-funding consideration based on the criteria listed below. After discussion by the full council, a simple majority vote to fund or not to fund the application is required to carry out the motion. 

• Focus on innovation and unique opportunities to advance research (not incremental research).
• Competing renewal may be considered for funding because of the value of continuing a project, and the role this project plays in the PI/PD’s research program and ongoing collaborations.
• Field of research of the PI/PD’s (e.g., clinical trials, population studies.)
• Consider IC’s recommendation (funding or not funding)