The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 129th meeting at 5:00 p.m. on February 8, 2012, at the Fishers Lane Conference Center in Rockville, Maryland, in closed session for a review of grant applications, Merit Award nominations, and a Merit Award extension. The meeting recessed at 6:40 p.m.  The Council reconvened in closed session on February 9, 2012, at 8:00 a.m., when Dr. Tatiana Foroud presented the report of the Board of Scientific Counselors.  Dr. Abraham Bautista, Director, Office of Extramural Activities, NIAAA presided over the closed sessions. In accordance with the provisions of Sections 552b(C)(6), Title 5, U.S.C. and 10(d) of Public Law 92-463, the closed session on February 8, 2012, excluded the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds.  Dr. Kenneth Warren, Acting Director, NIAAA, convened the Council in open session on February 9, 2012.

Council Members Present:

Linda L. Chezem, J.D.

Fulton T. Crews, Ph.D.

Suzanne M. de la Monte, M.P.H., M.D.

Cindy L. Ehlers, Ph.D.

Marianne L. Fleury

Scott L. Friedman, M.D.

Andres G. Gil, Ph.D.

Kathleen Grant, Ph.D.

Andrew C. Heath, D.Phil.

John H. Krystal, M.D.

Craig McClain, M.D.

Edward P. Riley, Ph.D.

Linda P. Spear, Ph.D. 

Ex Officio: Daniel Kivlahan, Ph.D., Department of Veterans Affairs 

Chairperson: Kenneth R. Warren, Ph.D. 

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

Senior Staff:

Jenny Czajkowski, Vivian B. Faden, Ph.D., Michael E. Hilton, Ph.D., Robert Huebner, Ph.D., George Kunos, M.D., Ph.D., Howard B. Moss, M.D., Antonio Noronha, Ph.D., Samir Zakhari, Ph.D. 

Other Attendees at the Open Sessions

Approximately 60 additional observers attended the open session, including representatives from constituency groups, liaison organizations, NIAAA staff, and members of the general public. 

Call to Order of the Open Session, February 9, 2012

Dr. Kenneth Warren called the open session of the 129th meeting of the Council to order at 8:50 a.m. on Thursday, February 9, 2012, and welcomed participants.  He introduced Dr. Tatiana Foroud, Chair, NIAAA’s Board of Scientific Counselors, and new Council members Judge Linda Chezem, Dr. Fulton T. Crews, Dr. Craig McClain, Ms. Mimi Fleury, and Dr. Daniel Kivlahan (ex officio).Council members and NIAAA senior staff introduced themselves.

 Director’s Report

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

• Legislation, budget, and policy.  During the fiscal year ending on September 30, 2011, NIAAA obligated $458.3 million and awarded 707 research project grants, including 150 competing awards.  Significantly fewer awards were made than in past years, reflecting budget tightening and no or low growth throughout the National Institutes of Health (NIH). NIAAA’s success rate was 19%, 1% greater than NIH as a whole.  NIAAA also funded 21 research centers for a total of $28 million and supported 124 grants for “other research support” totaling $30.7 million.  NIAAA also supported 300 full-time training positions for a total of $11.9 million.

  President Obama signed FY 2012 budget legislation into law on December 23, 2011.  NIH received $30.6 million, including an 0.189% across-the-board reduction and a transfer of $8.7 million by the Secretary of Health and Human Services.  The spending bill eliminated the National Center for Research Resources and created the National Center for the Advancement of Translational Science.  NIAAA’s FY2012 appropriation amounts to $459.4 million, an increase of 0.3% over FY 2011, which compares favorably with other agencies and departments.  NIAAA estimates that this funding will support 659 research grants, including 156 new and competing awards.  NIH policy eliminates the 2% inflationary increase where applicable.  The average cost of research project grants in FY 2012 is anticipated to equal FY 2011 costs.

  Release of the President’s budget proposal for FY 2013 was expected on February 13, 2012.

• Director’s activities.  Dr. Warren highlighted NIAAA’s role in a training project held in conjunction with a World Health Organization study on the prevalence of fetal alcohol spectrum disorders (FASD) in Eastern Europe.  Representatives of Belarus, Kazakhstan, Moldova, Poland, Russia, and Ukraine—all countries with a high prevalence of alcohol exposure—met for training on FASD diagnosis in Minsk, Belarus, where Dr. Warren also spoke at the Republican Research and Practical Center of Mental Health. 

• NIAAA staff and organization.  Dr. Warren announced the appointment of Mr. Keith Lamirande as NIAAA Executive Officer; Ms. Jennifer Czajkowski as NIAAA Deputy Executive Officer, and Ms. Monique Hill as NIAAA Committee Management Specialist.

• NIAAA Multimedia products.  NIAAA’s newest publications include the February 2012 issue of the webzine NIAAA Spectrum, an Alcohol Alert issue on FASD published online in January 2012, and Alcohol Research & Health issues on preventing alcohol abuse and alcoholism (December 2011) and on genetics (February 2012).  As part of NIAAA’s seasonal outreach effort, a fact sheet on “New Year, Old Myths, and New Fatalities” that warned against impaired driving during the holidays, received considerable positive attention from major media outlets.

NIAAA Intramural Program: Update

Dr. George Kunos, NIAAA Scientific Director, described recent efforts—and their scientific, economic, and political rationale—by NIAAA and the National Institute on Drug Abuse (NIDA) to develop joint research ventures in advance of the anticipated creation of a new institute on addiction. Scientific advantages would accrue from looking together at commonalities and differences in the neural bases and treatment of alcohol and drug addictions.  From an economics point of view, funds available for intramural research have decreased over the past 4 years, and collaborative programs would enable each intramural program to decrease its expenses while enjoying more resources than might separate, competing programs.  Dr. Michael Gottesman, NIH Deputy Director for Intramural Research, and Dr. Bonci urged Dr. Kunos to develop a plan to be incorporated into final recommendations to the Substance Use, Abuse, and Addiction (SUAA) Task Force that is planning the reorganization.

Dr. Kunos reported that efforts have begun to create a joint clinical program, headed by Dr. Markus Heilig, under which Dr. Bonci agreed that NIDA would contribute some resources and work in NIAAA’s clinical setting, while NIAAA would reduce its funding contribution.  Dr. Kunos proposed genetics as another area of interaction, and Dr. Bonci has agreed to join NIAAA in developing a joint program of neurogenetics of alcohol and drug addiction under NIAAA’s Dr. David Goldman.  In addition, Dr. Kunos has proposed that Dr. Bonci’s optogenetics program may benefit from an NIAAA scientist placed at NIDA to work on joint projects and research initiatives.  NIDA currently has a strong medicinal chemistry program, established as a joint NIDA/NIAAA laboratory, where NIDA provides funding and NIAAA provides a fellow to work on joint projects.  Dr. Gottesman has recommended to the SUAA Task Force that the two intramural programs remain structurally separate in a prospective new addiction institute.  Dr. Kunos pointed out that NIH lacks resources in the foreseeable future to bring the two Institutes together.  Both programs are considered strong, with complementary strengths in various areas. 

Discussion.  Dr. Kunos responded to Dr. Cindy Ehlers’s question that clinical activities, including imaging, will take place at the Baltimore center. NIDA clinical investigators will be able to develop joint protocols with NIAAA scientists, and certain clinical trials can be conducted at the clinical center location.  Dr. Kunos added that he has not yet learned about impending structural changes in this new effort.  Dr. Kathleen Grant commended Dr. Kunos on initiating joint activities with NIDA’s Intramural Program and inquired about joint recruitment and other efforts to achieve synergy.  Dr. Kunos stated that joint recruitment for tenure track scientists is ongoing. Dr. Fulton Crews applauded this effort. Dr. Warren noted that this effort has potential to serve as model in the future collaboration of the intramural programs.  Dr. Kunos stated that he earlier had suggested to NIDA Director Nora Volkow that this collaborative approach could be accomplished independent of the creation of a new institute. 

Substance Use, Abuse, and Addiction Reorganization: Update

 Dr. Lorraine Gunzerath, Special Assistant, Office of the Director, NIAAA  reported that the report “Scientific Management Review Board [SMRB] Recommendations to NIH on Substance Use, Abuse, and Addiction Research” has been approved by NIH, and strategic planning and portfolio analysis to implement its recommendations are proceeding on independent tracks.  Portfolio analysts include representatives of the NIH Director and Deputy Director’s office plus representatives of NIAAA, NIDA, National Cancer Institute, National Institute of Mental Health, and National Institute of Diabetes and Digestive and Kidney Diseases, and chaired by an impartial National Institute of Neurological Disorders and Stroke representative.  Deliberations on multi-behavior or multi-addiction synergies are proceeding without regard to the specific scientific behaviors that may be identified for attention; the separation of focus has generated concern in the field.  Release to the public of the results of the scientific plan and the portfolio analysis is expected in fall 2012. 

In November 2011 NIAAA initiated an informal request through the Research Society on Alcoholism for input into NIH’s scientific planning process.  In February 2012 NIH issued a formal request from public stakeholders for recommendations and rationale regarding scientific opportunities and public health needs.  NIAAA planned to invite all 2011 and 2012 grant applicants to respond to the request for information (RFI) and solicited Council members’ participation. 

 Dr. Gunzerath emphasized that NIH has invited recommendations only for synergistic ideas that may be applied to anything topic to the new addiction institute.  Behaviors of potential interest may be normal, necessary, or beneficial in moderation—but that can become overextended, habitual, addictive, or beyond the individual’s control to stop, to the extent of damaging health and safety of self or others and/or to come to dominate a person’s lifestyle and behavioral repertoire to the extent of causing legal, financial, relationship, or employment harms.  Also appropriate would be investigations into preventable disease states that primarily result from such behaviors or normal, beneficial uses of substances such as alcohol.  

NIAAA has received suggestions on potential initiatives, which Dr. Gunzerath summarized. 

Genetics, epigenetics, and gene-environment interactions.  Smoking, alcohol dependence, illicit drug use, obesity, and maladaptive habitual behaviors such as gambling, compulsive shopping, and internet gaming addiction are all multigenic, complex traits.  Studies of genetic risk factors for addiction have had difficulty identifying specific genes or gene networks that predict risk, but limited genomic evidence suggests the presence of both common sources of genetic risk for multiple addictions and addiction-specific risks.  Obesity and alcohol dependence are particularly synergistic; each condition’s strong taste component must be understood.  Gene-finding efforts also should be focused, at least in part, on understanding the commonalities in underlying the behavioral dysregulation.  For each addiction, evidence exists that environmental risk factors play an important role and that they interact with the genetic predisposing factors.  An opportunity exists to examine commonalities in the environmental risk factors that confer protection from addiction diagnosis broadly.  

Early exposure.  Investigators have demonstrated the role of early exposure to an addiction target as a risk factor for subsequent abuse for all addictive drugs.  Analogous roles also have been demonstrated of risk-taking behavior for adult gambling, childhood obesity for adult obesity, and childhood smoking for adult nicotine addiction and lung cancer.  Opportunities exist for comparative studies of genomic risk factors to allow targeted prevention of the environmental exposure level before the crucial biological conversions characteristic of addictive behavior have had time to solidify.  

Other aspects of human variability.  One can study a specific basic behavior, initial use, or excessive use, or the transition from initial to excessive use, to maladaptive use, or to dependence; aspects of habit maintenance, reinforcement, and relapse; effects of withdrawal or tolerance or sensitization on behavior or consumption; and the maturing out of hazardous behaviors due to naturally occurring factors.  An underlying question remains about some individuals’ susceptibility to one behavior and not others. 

Brain mechanisms.  The neuroscience of addictive behaviors demands a study approach that examines both similarities and differences in the neurobiology of abuse and addiction across different substances and activities.  Cross-examination of the commonalities and distinctions of the actions of different substances will provide valuable information for the design of effective treatment studies.  

Comorbidity.  Questions exist about the impact of exposure to or presence of one addictive behavior on the likelihood of a different addictive behavior, either in a co-abuse scenario or as a substitute when the first behavior is stopped.  Anecdotal evidence suggests that persons in AA programs lean on other oral or ingestive behaviors, such as smoking or caffeine.  Additionally, epidemiological survey data and genetic and family history studies often show links between addictive behaviors and psychiatric disorders.               

Systems approaches.  Implementation of a systems approach to brain networks underlying addictive behaviors by incorporating data from appropriate animal models and model organizations with human genetic and genomic information can be undertaken by consortia that could integrate basic and clinical or translational approaches to research and could implement systems analysis.  The potential benefit of the coordination across multiple addictive behaviors is the opportunity to consolidate a prevention strategy and conserve resources.  An offsetting consideration is the questionable cost-effectiveness of a universal versus a targeted strategy.              

Prevention.  Multi-behavioral prevention studies require data harmonization, a multilevel approach whereby a common set of core measures can be used by multiple investigators conducting separate independent research.  This approach permits pooling of common data elements across studies to increase statistical power, replicate and validate findings, use meta analysis and secondary analysis to generate new hypotheses, and explore novel research questions and conduct cross-study comparisons to provide economies of scale and to enhance translational research.     

Treatment.  Because the disorders under discussion are primarily behavioral in nature, relevant therapeutic interventions, including pharmacotherapy, are designed to reduce addictive behavior or promote healthy behavior.  Diverse behavioral disorders have been shown to be alleviated by a common set of behavioral mechanisms, including decreasing the efficacy of positive and negative reinforcers associated with the behavior, changing stimulus control over the behavior, increasing the probability of punishment, and strengthening alternative behaviors that are incompatible with the target behavior.  Such an approach might help identify pharmacotherapy strategies that are useful for multiple disorders.               

Policy.  The legal status of any substance or behavior contributes to its use, misuse, abuse, or dependence, and also contributes heavily to the public health burden.  Likewise, the social and cultural acceptability of any behavior influences the extent to which its excesses are viewed as an addiction.      

Epidemiology.  Prevention, treatment, and policy all must be supported by a robust surveillance system and epidemiology, which requires population-based representative studies of both the individual and the multiple combinations of addictive behaviors.               

Dr. Gunzerath stated that much may be learned from finding similarities across alcohol dependence, smoking, stimulant abuse, other drug abuse, obesity, gambling, and other addictions, as well as details that highlight their differences.  Such findings may cover areas ranging from prenatal exposure and early environmental to genetics to socialization within peer, family, and the larger cultural context.  Risks as well as recovery also may be impacted by early screening and prevention interventions, policy and economic issues, and treatment discoveries and the individual's access to them.  Various addictive behaviors may be comorbid, or, alternatively, may allow for a lesser-evil substitution, either intentionally or as a chosen coping strategy.  Given the different study approaches specific to each addiction, this convergence will not arise easily from simply comparing outcomes of ongoing studies, but will require design and execution of new protocols. 

Discussion.  Dr. Scott Friedman expressed concern about liver research and other areas of inquiry that would not fit logically into an addiction institute.  Dr. Crews suggested that familiarity with the strategic plans of other Institutes could offer clues to new areas of synergy, and Dr. Gunzerath agreed to make the strategic plans available.  Dr. Warren stated that he will consider Dr. Cindy Ehlers’s idea to enlist NIAAA’s Extramural Advisory Board (EAB) to consider possible synergistic initiatives to submit to NIH.  Dr. Crews suggested inviting NIDA Council members to participate in a joint EAB-type meeting; however, Drs. Gunzerath and Krystal pointed out that NIAAA Council members’ previous overtures to NIDA were not met with interest. 

Dr. John Krystal suggested that some topics, such as teratologic effects of maternal consumption of drugs of abuse, represent areas of opportunity but are associated with concerns expressed by members of both NIAAA and NIDA Councils about diffusion or loss of these portfolios.  Dr. Warren stated that the SMRB specifically named fetal alcohol as an example of an area appropriate to move into the new structure, but the SMRB did not mention NIDA’s counterpart programs.  Dr. Krystal suggested highlighting the desirability of keeping those areas together in a new addiction institute.  Dr. Warren asserted that considering synergies represents an important opportunity.  Several Council members observed the difficulty in developing a scientific strategic plan for an institute whose mission is not articulated.  Judge Linda Chezem stated the need to look across NIH for synergies on how to better understand substance use and misuse in addition to addiction—a focus critical to the justice system. 

Consideration of the Joint NIAAA/NIDA Council and the 128th NIAAA Council Meeting Minutes, and Future Meeting Dates  

Council members unanimously approved the minutes of the joint NIDA/NIAAA Council meeting held on September 12, 2011, and of the 128^th NIAAA Council meeting held on September 13, 2011.  Future Council meetings will take place on June 6–7 and September 19–20, 2012; February 6–7, June 12–13, and September 18–19, 2013; and February 5–6, June 4–5, and September 10–11, 2014. 

Diagnostic Issues Work Group: Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders

Dr. Sally Anderson, Coordinator and Executive Secretary, Interagency Coordinating Committee on Fetal Alcohol Spectrum Disorders’ (ICCFASD), OD/NIAAA, reported on the autumn 2011 conference on alcohol-related neurodevelopmental disorder (ARND) organized by ICCFASD’s Diagnostic Issues Work Group.  As background, Dr. Anderson explained that in 2004, a task force of the Centers for Disease Control and Prevention (CDC) issued guidelines for screening and diagnosing fetal alcohol syndrome (FAS) and established a training program for healthcare professionals.  At that time, the task force deemed the evidence on ARND to be insufficient to include in the training curriculum.  A 2009 expert workshop held by the ICCFASD Diagnostic Issues Work Group determined that evidence indeed was sufficient to proceed with recommendations on screening and diagnosis for ARND in pediatric and primary care settings.  The Work Group subsequently engaged the collaboration of the American Academy of Pediatrics (AAP) in planning and executing a conference.  The Work Group and its collaborators planned a jury trial–style conference to assess and confirm whether sufficient evidence exists.  The planners formulated critical questions to be addressed, made recommendations for panelist to hear the evidence, developed a list of potential experts to present evidence, and made recommendations on the briefing book content.  

Sponsored by ICCFASD, NIAAA (as lead), CDC, and AAP, the Recognizing Alcohol-Related Neurodevelopmental Disorder (ARND) in Primary Health Care of Children conference was held in autumn 2011.  Panelists included pediatricians, a child psychologist and psychiatrist, neuropsychologist, special education expert, practitioner of occupational/physical therapy or speech pathology, an FASD expert/resource person, and a legal/social services/policy/advocacy arena representative. Prior to the conference, panelists received comprehensive briefing books related to a set of questions.  At the conference experts presented evidence culled from the peer-reviewed literature, following which sequestered panelists consulted and wrote consensus statements on the conference questions. 

In their deliberations, panelists developed a consensus statement that recognized that prenatal alcohol exposure (PAE) can cause significant neurodevelopmental and behavioral disorders, that primary care clinicians for children should be alert to evidence of maternal alcohol use, and that early intervention may improve outcomes.  Their consensus response to each of the questions follows: 

Question 1A.  What is ARND and how can it be diagnosed? Evidence of central nervous system (CNS) developmental abnormalities

Consensus response: The brain is susceptible to the neurotoxic effects of alcohol at all stages of gestation.  Based on extensive animal and clinical research, patterns of significant structural and functional changes in the CNS appear attributable to PAE, with strong concordance between human and animal data.  Animal studies demonstrate that the timing, dose, and frequency of PAE differentially harm specific neuronal structures and brain circuits. 

Question 1B.  What is ARND and how can it be diagnosed? Evidence of a complex pattern of behavior and cognitive abnormalities

Consensus response: Compelling animal and human data show that PAE negatively affects several domains of cognition and behavior.  Research data suggest that PAE can be associated with general cognitive impairments and specific impairments in several areas (e.g., information processing, attention, executive function, social cognition, self-regulation, adaptive functioning).  These life-long problems may be primary to PAE or primary to comorbid conditions or the interaction of a number of factors.  Behavioral and cognitive phenotypes specific to PAE have been elusive; they are confounded by variability of exposure (dose, duration, and timing) and potential interactions among environmental factors, genetics, and exposure to other toxic substances.

Question 2.  Can ARND be differentiated from other disorders?

Consensus response: Differentiating ARND from other complex neurodevelopmental disorders can be challenging due to limited studies attempting to distinguish ARND phenotype(s) from other disorders; it requires prudent clinical judgment and consideration of other causes.  Investigation is recommended to refine understanding of clinical profiles attributable to PAE and developmental patterns of ARND.  Future advances in the identification of biomarkers and the development of sensitive/specific tests will assist clinicians in diagnosis.  Investigations of other complex developmental disorders need to inquire about PAE. 

Question 3.  What PAE evidence is necessary?

Consensus response: PAE is confirmed based on maternal self-report, a collateral reporter, and/or by documentation in medical or other records.  Data from animal studies confirm that, at the highest levels of alcohol exposure in the first trimester, facial and brain anomalies occur in concert.  Alterations in brain development can occur over a range of alcohol dosages throughout gestation.  Variable patterns of maternal drinking may lead to differential fetal outcomes.  Variability in both maternal and fetal characteristics affect the potential for alcohol-induced alterations in brain development.  It is not currently possible to define a safe limit of alcohol consumption during pregnancy. 

Question 4.  What signs/symptoms will be useful for screening?

Consensus response: Regular alcohol screening should be conducted by primary health care clinicians and obstetric caregivers.  Pediatricians should obtain medical records from the birth mother’s primary or obstetrical caregiver, and clinicians should query families in a nonjudgmental way about all risks to a child’s development.  If PAE is confirmed, clinicians should be alert for signs and symptoms that can occur during the child’s development.  Pediatric clinicians should complete a comprehensive history including developmental milestones for any child at risk for ARND.  A concern identified in any area warrants a referral for a complete evaluation and follow-up.  

Question 5.  What are the treatment needs for those with ARND?

Consensus response: Treatment plans need to be individualized to specific areas of impairment.  Treatments should draw on evidence-based practices.  Treatment may need to be modified, based upon strengths and weaknesses of the individual, and it begins with support of the affected individual and family, and enlisting support of educators, mental health professions, and school staff to enhance effectiveness.  Children with PAE have a special health care need and need ongoing surveillance in a medical home throughout their childhood and adolescence to assess ongoing treatment needs.  

Discussion.  Dr. Ed Riley clarified that FASD represents an umbrella term.  Children with FAS have specific physical, growth, and behavioral characteristics consistent with a history of alcohol exposure in utero, and children with ARND typically fall through the cracks because they lack the physical features that help in diagnosis.  Many more children have ARND than FAS and thus represent a major public health problem.  In response to a question from Dr. Friedman regarding outcomes measurement, Dr. Riley stated his hope that the AAP develops a diagnostic toolkit for pediatric healthcare providers.  Dr. Riley added that the most contentious discussion at the conference centered on differential diagnosis of ARND from ADHD or oppositional defiant disorder, but with substantial agreement that diagnosis warranted good clinical judgment in concert with knowledge of alcohol exposure.  Dr. Riley responded to Dr. Suzanne de la Monte’s inquiry that because current biomarkers measure exposure only in the second and third trimesters of pregnancy, better biomarkers are needed.  Dr. Riley replied to Dr. Deidra Roach that studies show that children with PAE have a higher incidence of abnormal EEGs and asserted the need for studies of children with FAS and ADHD.  Dr. Anderson stated that AAP has a comprehensive plan to disseminate these findings, including CDC training programs, NIAAA assistance in toolkit development, and CDC efforts to incorporate the information into medical school curricula. 

Continuous Review of Peer Review: Update on Surveys

Dr. Luci Roberts, Director, Planning and Evaluation, Office of Extramural Research, OD/NIH, described survey results regarding changes to NIH’s peer review process.  Dr. Roberts explained that applicants and extramural staff began to observe in 2006 that the peer review process reflected neither the collaborative nor competitive nature of the science at a time when pay lines were shrinking and evidence emerged that new investigators were disadvantaged by the peer review process.  NIH initiated a nationwide information-gathering effort from stakeholders and developed a set of recommendations.  In implementing those recommendations, NIH instituted programs to engage the best reviewers, improve the quality and transparency of review, ensure balanced and fair reviews across scientific fields and career stages, and conduct continuous review of peer review.  The continuous review of peer review has been achieved by a systematic, structured format for data collection from stakeholders about the peer review system in order to avoid future problems, detect stakeholder sentiment early, and implement corrections and changes.  

Initial changes to the process made in January 2009 included the phase-out of A2 applications and identification of early stage investigators, but no surveys were conducted until later.  Specific changes to peer review began in May 2009, including clustering new and early stage investigators together in the peer review order, criterion scoring, a 1–9 scoring scale, enhanced review criteria, and structured review critiques (bulleted templates).  In January 2012 NIH introduced shortened research applications and aligned review criteria with the new application format.  Dr. Roberts noted that $10.4 billion in Recovery Act funding enabled NIH to submit requests for applications for the Challenge and Grand Opportunities Programs, which attracted many thousands of grant applications and for which the streamlined new format was introduced earlier than anticipated.  Consequently, many applicants and reviewers were exposed to enhancements before they were surveyed about them, making it difficult to gauge stakeholder sentiment.  In addition, NIH also updated the data system, modified guidance for clarity, and revised the overall impact statement to a narrative format.

Dr. Roberts described the methodology of the Phase 1 surveys conducted in 2011, noting that Phase 2 surveys were currently underway.  She distinguished between reviewers, applicants, and others who rated the peer review system before the changes and those who rated it after the changes.  Phase 1 surveys showed that reviewers found the 9-point scoring range to be adequate; Advisory Council members found the scoring range easy to understand; program officers rated criterion scores as one of the changes most helpful for advising applicants; and applicants, reviewers, and NIH staff (including scientific review officers [SROs] and project officers [POs]) rated clustering as helpful in the review process.  Reviewers rated structured critique templates as more efficient than the narrative format, but they considered the templates not to be helpful in explaining factors that affect review outcomes.  POs and SROs strongly disagreed more often than they strongly agreed that enhanced review criteria resulted in greater clarity regarding applications’ strengths and weaknesses.  Dr. Roberts stated that it has been difficult to operationalize the review criteria in the context of each application.  While reviewers preferred the new system, applicants and NIH staff were split between the old and new systems.  Advisory council members preferred the new system slightly, and program staff preferred the old system. 

Reviewers rated the new system as significantly less fair than the old system; applicants, too, preferred the fairness of the old system but not to a significant extent.  Significantly fewer reviewers reported that they were very satisfied with the system than applicants.  While SROs and POs reported that the peer review system was very fair or somewhat fair, and were split about their satisfaction with the system, Dr. Roberts acknowledged that it is unfair to ask staff to rate a system of which they are a part.  

Dr. Roberts stated that Phase 2 surveys will focus on the shortened research strategy, alignment of applications with review criteria, and NIH’s post-submission materials policy.  

Discussion.  Dr. Roberts stated that data show that elimination of A2s has had its intended effect.  Dr. Crews inquired about evaluation of review panels’ skill in rating scientific quality.  Dr. Roberts responded that NIH is considering evaluating criterion scores to determine the study sections that acknowledge innovation and identify significance more often, and to determine which factors might influence scores.  Dr. Crews stated his institution’s view that submitting a competitive renewal can be disadvantageous because the short format may inhibit a full description of progress; he advises his faculty to submit new applications and incorporate past work as preliminary data.  Dr. Roberts stated that reviewers of high-risk, high-reward programs follow NIH instructions to recognize the science using the specified review criteria, and expressed hope that this trend will expand to other study sections.  She observed the need to permit reviewers to recognize the science and to weight the criteria as they see fit.  Dr. Roberts responded to a question from Dr. Grant that appeals under the new review system had increased, but with attention to improving uniformity of the appeals process across ICs and upon issuance of guidance to that effect, numbers of appeals have declined.  She added that NIH continues to address problems associated with bulleted critiques. 

Dr. Craig McClain noted that investigators’ sole concern is whether or not they receive awards, not the content of the critique.  Dr. Roberts concurred, noting that the factor that accounted for the vast majority of variance among applicants was whether or not they received funding; otherwise virtually no differences were discerned.  Dr. McClain added his view that eliminating A2 awards contributes to a fairer system.  

Alcohol Screening for Youth: Introduction to NIAAA’s New Guide for Health Care Practitioners

Dr. Vivian Faden, Director, Office of Science Policy and Communications, NIAAA, introduced the new Alcohol Screening and Brief Intervention for Youth: A Practitioner’s Guide.  Dr. Faden explained that alcohol screening is important because so many children and adolescents drink, generating such negative consequences as poor school performance, unwanted and unintended sex, injuries, and alcohol poisonings among others.  Three-quarters of adolescents report experience with alcohol prior to high school graduation, and especially youth ages 18–20 engage in high-risk binge drinking.  

Dr. Faden stated that screening sends a message of concern and offers opportunities for young people to speak with a knowledgeable person and for providers to intervene both before and after drinking starts or problems develop.  The screening’s two questions inquire about frequency of drinking and whether a patient’s friends drink.  In collaboration with the AAP, NIAAA enlisted clinicians’ help in developing the materials.  The guide offers tools to begin the conversation with children before they begin drinking, and children can learn to expect these questions from health professionals.  The guide helps clinicians to identify youth at high-risk for using alcohol, to find those who have just begun to drink, and to identify hazardous use and dependence.  Initially tested for use by pediatricians, family practitioners, nurse practitioners, and physician assistants, NIAAA hopes it also will be used in other settings. 

The empirically based questions vary in presentation by age group: Clinicians ask children under 11 first about their friends’ drinking and ask the 11–14 year olds first about their own drinking.  The guide presents a step-by-step process for practitioners and includes a pocket guide.  After asking the two screening questions, practitioners can give advice to patients who do not drink.  For patients who drink, clinicians can gauge risk level, suggest appropriate interventions, and provide follow-up.  

To promote use of the guide, a series of FAQs addresses anticipated practitioners’ questions and provides support on confidentiality, motivational interviewing, and resources to more information.  It offers suggestions for additional assessment and guidance in developing local community referral resources.  

Dr. Faden emphasized that the AAP endorsed the guide, and enabled NIAAA to disseminate it to AAP’s 60,000 members.  Released in October 2011, NIAAA has distributed an additional 100,000 copies.  The guide has enjoyed high demand from HMOs, medical schools, and practitioners.  With collaborators from Harvard Medical School, NIAAA is developing a continuing medical education course for use of the guide in clinical settings and to assess the tool’s usefulness in triaging for other behavioral risk factors. 

Discussion.  Ms. Mimi Fleury suggested that the information will be useful to school counselors and parents.  Dr. Faden responded that such groups as school counselors and nurses will be asked to advise NIAAA, and Dr. Faden invited Ms. Fleury to participate in a developing a version of the guide intended for parents and schools.  In response to Dr. Heath’s observation that inquiries about parental alcohol problems are needed, Dr. Faden stated that the guide incorporates an FAQ item on this issue.  Dr. Riley added that the ARND recommendations incorporate questioning about family alcohol patterns.  Drs. Riley and Krystal noted the potential value of Dr. Faden’s slide presentation as a web-based resource and also suggested incorporating the presentation on a CD that accompanies the guide. 

Ex Officio Member Report 

Dr. Daniel Kivlahan, Acting National Mental Health Program Director, Office of Mental Health Services, Department of Veterans Affairs (VA), reported that the VA and dozens of its stakeholders have developed a strategic plan to implement the full continuum of services for substance use disorders into clinical practice and to harness implementation science to evaluate effectiveness.  Dr. Kivlahan noted that in FY 2011, 480,000 veterans had substance use disorders diagnoses (75% for alcohol use), but only a third had contact with specialty care, underscoring the need to make services available in settings outside the VA.  The VA is working to promote both basic recognition of the disorders and effective pharmacotherapy in primary care settings.  Ninety-seven percent of eligible patients are screened for alcohol misuse, and follow-up takes place for 75% of that group.  

The VA recognizes that most individuals identified as needing treatment have received treatment earlier or are unwilling to go.  The VA works with NIAAA to evaluate collaborative care models in primary care settings.  Special populations of concern include veterans with co-occurring PTSD and substance use disorders, the VA has begun to make treatment resources available in PTSD clinics.  Veterans with hepatitis C represent another high-profile group, and the VA currently is evaluating how to integrate services most effectively and efficiently.  Co-occurring pain and substance use has led the VA to focus on alcohol use, a strategy that veterans commonly use to self-manage pain.  

Dr. Kivlahan noted that the VA and the Department of Defense have an active cross-departmental strategy to facilitate the transition from active, Guard, or Reserve duty into the VA, and to promote efforts at resilience and recognition.  The “Make the Connection” media campaign and website encourage treatment for mental and substance use disorders.  The VA has great interest in providing web-based care and to improve access for rural veterans.  The Department devotes considerable resources to outreach to veterans who are homeless and to engage service providers in a harm-reduction model.  The VA has established medical homes, called patient-aligned care teams, designated for veterans who are homeless and who need management of many services in ways consistent with harm reduction.  Dr. Kivlahan stated that the VA is eager to partner with NIAAA. 

Council Members Round Table

Dr. Krystal noted that while the SMRB suggested that consolidation of NIDA and NIAAA made sense only in the context of the incorporation of the tobacco addiction portfolio within the addiction institute, substantial doubts exist about whether the majority of that portfolio in fact would be incorporated.  Dr. Warren responded that because the portfolio analysis will not be finalized or publicized until fall, discussion should be postponed.  In response to Dr. Grant’s observation about the difficulty of commenting on a scientific strategic plan without knowledge of the portfolio, Dr. Warren suggested that Council members comment on all opportunities for scientific inquiry that cross boundaries that occur to them—including those related to programs that might move from NIAAA, for the benefit of a successor Institute.  Dr. Warren considered Dr. Ehlers’s suggestion that the head of each NIAAA division engage grantees in an information-gathering exercise and then formally submit their compiled guidance. 

Adjournment

Dr. Warren adjourned the meeting at 12:35 p.m. 

CERTIFICATION 

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

/s/

Kenneth R. Warren, Ph.D.

Acting 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