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National Advisory Council Meeting - June 9-10, 2010
Summary of the 124th Meeting
June 9-10, 2010
The National Advisory Council on Alcohol Abuse and Alcoholism (NIAAA) convened for its 124th meeting at 5:30 p.m. on June 9, 2010, at the Fishers Lane Conference Center in Rockville, Maryland, in closed session for a review of grant applications, review of Merit Award extensions, and Merit Award nominations. Dr. Abraham Bautista, Chief, Extramural Project Review Branch, presided over the closed session. 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 June 9, 2010, excluded the public for the review, discussion, and evaluation of individual applications for Federal grant-in-aid funds. The meeting recessed at 7:00 p.m. Dr. Kenneth Warren, Acting Director, NIAAA, convened the Council in open session on June 10, 2010.
Council Members Present:
David W. Crabb, M.D.
Gen. Arthur T. Dean
Kathleen Grant, Ph.D.
R. Adron Harris, Ph.D.
Deborah S. Hasin, Ph.D.
Andrew C. Heath, D.Phil.
Vimal Kishore, Ph.D.
Lynell W. Klassen, M.D.
John H. Krystal, M.D.
Larry I. Palmer, LL.B.
Edward P. Riley, Ph.D.
Linda P. Spear, Ph.D.
Gyongyi Szabo, M.D., Ph.D.
Ex-officio: Jill Carty, Psy.D., M.S.P.H.
Chairperson: Kenneth R. Warren, Ph.D.
Executive Secretary: Abraham P. Bautista, Ph.D.
Michael Hilton, Ph.D., Keith Lamirande, Raye Litten, Ph.D., Howard B. Moss, M.D., Ellen D. Witt, Ph.D., Samir Zakhari, Ph.D.
Other Attendees at the Open Sessions
Approximately 40 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, June 10, 2010
Dr. Kenneth Warren called the open session of the 124th meeting of the Council to order at 9:00 a.m. on Thursday, June 10, 2010, and welcomed participants. He introduced new Council members Kathleen Grant, Ph.D., and Gyongyi Szabo, M.D., Ph.D. Council members and NIAAA senior staff introduced themselves.
Dr. Warren noted that NIAAA will celebrate its 40th anniversary with observances throughout the year. He highlighted key recent Institute activities, referring to the written Director’s Report:
- NIAAA staff and organization. Dr. Warren memorialized Brenda G. Hewitt, a valued member of NIAAA staff since 1972, and reported NIAAA staff honors and awards. The Hungarian Cardiology Society recently awarded the Gabor Gyorgy Medal to Dr. George Kunos, who also was named to the Advisory Board of the Hungarian Academy of Science. Dr. Abe Bautista received the Outstanding Service and Support Award from the Society on Neuroimmune Pharmacology. The International Behavioral Neurogenetics Society has elected Dr. Mary-Anne Enoch as its new president. Dr. David Goldman was elected a Fellow of the American College of Neuropsychopharmacology and gave the Sansone Honorary Lecture at the Washington University School of Medicine. Dr. Hua Wang received the best poster award at the 2010 joint meeting of the American Society for Clinical Investigation and the Association of American Physicians. Dr. Peggy Murray has earned her Ph.D. degree in social psychology. New NIAAA appointments include Drs. Lawrence Baizer and Soundar Regunathan, program directors in the NIAAA Division of Neuroscience and Behavior. Dr. Christina Barr was selected as a tenure track scientist to head the Section on Comparative Behavioral Genomics, Laboratory of Neurogenetics. Dr. Vijay Ramchandani became a tenure track investigator and Acting Chief of the Section on Human Psychopharmacology, Laboratory of Clinical and Translational Research. Dr. Marc Rigas joined the Science Policy Branch, Office of Science Policy and Communication. Dr. Vivian Faden organized the Fourth Meeting of the Expert Panel: NIAAA Underage Screening Project in April 2010. Dr. Warren highlighted the NIAAA Clinical Investigations Group, a program to foster the pipeline of treatment drugs. The new Mechanism of Behavioral Change Interdisciplinary Research Consortium is to build high-risk/high-payoff, interdisciplinary approaches to alcohol-related problems using mechanism-based methodologies. The NIAAA Extramural Advisory Board held a meeting on alcohol-attributed cancers.
- Multimedia products from NIAAA. Recent projects include the online NIAAA Research Gallery (http://www.niaaa.nih.gov/news-events/research-highlights), a series of capsule descriptions presented to increase public visibility of research conducted or supported by NIAAA, as well as the new online Webzine, “NIAAA Spectrum.” A special 40th anniversary edition of NIAAA’s Alcohol, Research & Health is to be issued in June 2010, and the National Institutes of Health (NIH) has established a new NIAAA exhibit in Building 31 entitled “40 Years of Alcohol Research.”
- Scientific Management and Review Board. Dr. Warren reported that the Scientific Management and Review Board (SMRB) held two meetings since the Council’s February 2010 meeting. In March 2010 the Substance Use, Abuse and Addiction (SUAA) Work Group reported progress on their discussions with the majority view favoring a functional reorganization of relevant scientific activities across the NIH , and not physically merging the NIAAA with the National Institute on Drug Abuse (NIDA). A minority of the SUAA favored structural reorganization with a merger. In May 2010, panels of outside experts were invited to comment upon the SUAA’s proposed organization options; in addition, both NIAAA and NIDA directors offered comments and responded to SMRB members’ questions. A number of comments were made by members of the public all of whom favored maintaining separate Institutes. At the conclusion of the discussion, the SMRB chair charged the SUAA Work Group with “fleshing out” the functional and structural option before the next SMRB meeting.Two additional reports were presented and accepted: The Deliberating Organizational Change for Research Excellence Working Group (DOCE) produced criteria to determine when a structural change should be considered, and a new funding model was proposed for the Clinical Center by the Working Group that had been established to review issues pertaining to that Center.
- Legislation, budget, and policy. Despite additional funding under the American Recovery and Reinvestment Act (ARRA), Dr. Warren anticipated tight budgeting into the future. The President’s proposed budget would increase NIH appropriations by $1 billion, but even with appropriation of the full amount, NIAAA likely will make 15% fewer research project grant awards than the previous year.
OppNet: The NIH Opportunity Network for Basic Behavioral and Social Sciences
Dr. Howard Moss, NIAAA Associate Director for Clinical and Translational Research, described the NIH Opportunity Network for Basic Behavioral and Social Sciences (OppNet), a congressionally mandated program inaugurated in 2009. The program aims to advance basic behavioral and social science research by building a body of knowledge about the nature of behavioral and social systems. OppNet emphasizes activities and initiatives that focus on basic mechanisms of behavior and social processes relevant to multiple NIH Institutes’ and Centers’ (IC) missions. Basic behavioral and social science research is defined operationally as “research that furthers our understanding of fundamental mechanisms and patterns of behavioral and social functioning, relevant to the Nation’s health and well-being, and as they interact with each other, with biology, and the environment.” Three research categories include behavioral and social processes (for example, sensation and perception, and emotion and motivation), biopsychosocial (for example, interactions of biological factors with behavioral or social variables), and methodology and measurement (for example, research design, measurement, data collection, data analysis, and modeling of data).
Dr. Moss stated that OppNet is guided by an advisory group, with working groups making decisions. As a trans-NIH activity, OppNet has a shared funding plan under which 24 ICs and five program offices can participate. In FY2010, NIAAA has expended $2 million in ARRA monies to fund OppNet supplements to existing grants, and the Office of AIDS Research has contributed $2 million in ARRA monies. In FY2011, OppNet will spend $20 million, and in FY2012–2014, $30 million.
Dr. Moss identified OppNet funding announcement opportunities, which included a K-18 mid-career award to facilitate a working sabbatical for a scientist in the laboratory of a basic behavioral scientist, with the anticipation to apply new learning in the original work; $2 million in ARRA funds are to be awarded. In addition, competitive revisions for a number of ARRA-funded grants dealing with basic behavioral and social science research were funded. Dr. Moss noted the committees’ difficulty in determining how well an application fit the operational definition; approximately one third of applications were not scored. Another program involved HIV/AIDS research. A strategic planning process is in place, and announcements for OppNet for FY2011 are to be released in the summer. The new OppNet Web site is http://oppnet.nih.gov.
Discussion. To a question from Dr. Deborah Hasin, Dr. Moss responded that CSR probably will convene special panels to review OppNet applications.
Consideration of the February 4–5, 2010, Meeting Minutes and Future Meeting Dates
Council members unanimously approved the minutes of the Council meeting of February 4–5, 2010. Future Council meetings will take place on September 22–23, 2010; February 16–17, 2011, June 8–9, 2011, and September 14–15, 2011; February 8–9, 2012, June 6–7, 2012, and September 19–20, 2012.
Presentation of Council Operating Procedures
Council members unanimously approved NIAAA’s Operating Procedures for Institute Staff Actions for Administrative Supplements and Time Extensions. (See Appendix I)
Imaging-Based Advances in Basic Fetal Alcohol Spectrum Disorders Research
Kathleen K. Sulik, Ph.D., a professor in the Department of Cell and Developmental Biology & Bowles Center for Alcohol Studies, University of North Carolina–Chapel Hill, described imaging-based studies in a mouse model for fetal alcohol spectrum disorders (FASD). Dr. Sulik explained that maternal alcohol abuse is the leading known cause of congenital mental disability in the United States, with an incidence of 1 in 750 live births of full-blown fetal alcohol syndrome (FAS) and 1% in FASD, at an estimated cost of $6 billion annually.
Alcohol’s effects in humans involve both cognitive-behavioral characteristics and structural abnormalities in the brain. Dr. Sulik noted that studies show frontal aspects of the brain to be particularly affected in children with FASD. Using animal models, investigators can identify critical developmental periods for alcohol exposure and dose/response relationships, examine the brain in great detail at the histological and cellular levels, study correlations between structural and functional changes, and verify and expand diagnostic criteria for FASD.
Dr. Sulik’s group concentrates on events early in embryonic mouse development—gestational days 7–11, corresponding to a time in humans when women do not yet recognize they are pregnant. When mice are exposed to alcohol at day 7, they develop the same facial characteristics as humans in full-blown FAS in addition to a wide spectrum of severity in birth defects. One in 250 pregnancies results in defects on the holoprosencephaly spectrum, but only 1 in 20,000 is born with this defect due to other severe defects that interfere with live birth. Dr. Sulik described morphological abnormalities that affect the mouse brain’s midline tissue, characteristic facial features, ganglionic eminences, and septal region.
Funded by the collaborative initiative on FASD, Dr. Sulik’s work engages magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI) to conduct comprehensive studies of animal brains following prenatal acute early alcohol insult, to define facial dysmorphology resulting from prenatal ethanol exposure, and to study regions other than the brain and face that might provide diagnostic indicators of FASD. In addition, an ARRA-supported RC1 award enables her group to develop faster DTI methodologies; to develop a software framework for a new, automated mouse brain data analysis; and to apply methodologies advanced in the previous aims to examine alcohol’s effect on the pre- and postnatal mouse brain. In in-vivo MRI and DTI studies, linear measures are readily made from high-resolution images in individual brain slices, and fetal brains are manually segmented, colored in several views, and then reconstructed accurately in 3D to allow volume measurements of specific regions of the fetal brain. The group has created an atlas of normal mouse-brain development stages, and can follow changes over time in various structures.
New findings include identification of tiny bumps on the mouse brain surface that correlate highly with seizure activity and the absence of a pituitary gland in some alcohol-exposed mice. Dr. Sulik’s consortium is reconstructing mouse faces and brains accurately using MRI, comparing faces of alcohol-exposed animals to those of normal animals using sophisticated software, and correlating facial and brain changes. In comparing images of normal and abnormal mice, in addition to the expected defects, a variety of facial defects is evident, many of which can occur within the same litter.
DTI reveals that prenatal ethanol exposure diminishes the corpus callosum, even in mice with apparently normal facial and brain gross morphology. DTI’s color coding illustrates that where the corpus should be, i.e., fibers run from front to back. Some mice with abnormal faces have normal brains, while others have no corpus callosum. DTI has enabled looking at a variety of fiber tracts with confirmation of expected results.
The RC1 grant allowed the group to translate findings on fetal animals into postnatal animals; DTI analyses of postnatal 45-day mice illustrate corpus callosum abnormalities. Using tractology, investigators can reconstruct the corpus callosum fiber tract. In new studies in postnatal mice using a Rotarod, Dr. Sulik’s group’s initial and surprising findings show that alcohol-exposed animals perform better than control animals; and they do not get intoxicated as easily.
Dr. Sulik asserted that applying advanced imaging techniques provides unprecedented opportunities to understand both the genesis and consequences of prenatal alcohol exposure. She noted that these problems develop as a result of an insult that occurs at a stage before a woman would know if she were pregnant.
Discussion. To Dr. Linda Spear’s query, Dr. Sulik responded that variation within a litter appears related to slight differences in developmental stage. Dr. Hasin observed that the gender gap in drinking is converging at younger ages and inquired how Dr. Sulik’s work might inform a prevention effort. Dr. Sulik responded that it is unlikely that anyone will know how much alcohol is too much; the public health message is “better safe than sorry.”
Turning Discoveries into Treatments: Strategies for Catalyzing Translational Research
Barbara Alving, M.D., MACP, Director, National Center for Research Resources (NCRR), NIH, described the Clinical and Translational Science Award (CTSA) Program (www.CTSAweb.org), which provides infrastructure support for all NIH’s ICs. NCRR, a $1.2 billion center (excluding ARRA funds), provides tools to translate research from basic discovery to improve patient care. CTSA aims to improve the way biomedical research is conducted in the United States, speed translation of laboratory discoveries into treatment, engage communities in clinical research, and train a new generation of clinical and translational researchers. Institutions that have received CTSA awards work as a consortium with NIH. Targeting advanced degree-granting programs, the awards focus on community engagement, improved biostatistics, clinical resources, clinical research ethics, and collaboration with other NIH ICs. NCRR has built 46 CTSA sites—or Homes for Clinical and Translational Science—in 26 states, with a goal to reach 60 sites by 2011. NCRR also funds Institutional Development Awards (IDEA) in less populous states, to which CTSA sites are expected to reach out with leveraged funding.
Dr. Alving identified the processes in translating basic research to clinical and community practice: improve clinical research management process; promote comparative effectiveness research; promote collaborations, provide tools, and address informatics needs; and train the workforce. She cited several examples by which CTSAs have accomplished these aims, including advancing T1 research by encouraging public-private partnerships: CTSA served as catalyst to link Scripps Health, Qualcomm, other technology firms, and other CTSAs to participate in a large trial to evaluate a small vital-function-monitoring device to reduce re-hospitalization and sudden death after discharge. Columbia University’s CTSA-funded collaborative research has developed and patented a novel rehabilitation device for people with severe physical disability. A Northwestern University course addresses innovations in medical devices. CTSA’s Pharmaceutical Assets Portal matches investigators with “shelved” pharmaceutical compounds that may be repurposed for other uses; University of California–Davis has established relationships with pharmaceutical companies to develop the portal and list compounds.
In order to improve efficiencies in clinical research at CTSA sites, the program focuses on institutional review board (IRB) and regional reciprocity, tracking the IRB process beyond initiation of the protocol, negotiation of IRB agreements and material transfer agreements, and recruitment, retention, and outreach for underrepresented populations. As an example, a CTSA consortium at Vanderbilt University developed a clinical statin trial for H1N1 patients that required only 37 days for seven CTSAs to obtain IRB approval to join the study. Dr. Alving explained that Vanderbilt’s open-source informatics work includes ResearchMatch, a successful national online recruitment registry in which 50 CTSA institutions participate, and REDCap, a Web-based tool used in multiple institutions that supports data capture and dissemination for clinical and translational research.
With support from ARRA funds, CTSA activities to enhance community health include both collaborative community engagement and capacity building in comparative effectiveness research. Examples include an HPV immunization project in Chicago schools that utilized CTSA Ethics and Community Engagement Clusters to engage with the underserved community, teenagers, and parents to promote adolescent health. Also, the Washington University CTSA, HealthStreet, linked 1,500+ residents to relevant studies and enrolled 378 individuals in research studies, of whom 80% were members of minority groups. This study provided social services and online job search capability, as well as health services.
Dr. Alving identified the core competencies involved in training multidisciplinary clinical and translational scientists ( http://www.ctsaweb.org/corecompetencies ). In some CTSAs, scholars work with pharmaceutical companies to learn about the industry, and NCRR plans to work with the Food and Drug Administration (FDA) in developing regulatory science.
Discussion. Responding to Professor Larry Palmer, Dr. Alving stated that NIH has worked with FDA on an ongoing basis. She asserted that scientists, FDA, and the public health field would benefit from an established program whereby scientists work at FDA. Dr. Andrew Heath observed that few statisticians appear to be involved in the CTSA program. Dr. Alving stated that NCRR funds training of biostatisticians in academic institutions, acknowledging that NIH must work on the issue as well. Vanderbilt University provides free statistical support for scientists to enable them to develop robust protocols that stand up well to IRB review. Dr. Alving explained to the Council that the Science Education Partnership Award (SEPA) programs forge links with museums, fund mobile science vans on a variety of topics, engage teachers in projects to develop better tools to teach science, and fund teacher education seminars.
NIH Council of Councils Report
Dr. David Crabb, NIAAA’s representative to the NIH Council of Councils, presented a report of the group’s November 2009 meeting. He described the authorities under the NIH Reform Act of 2006, including establishment of the Division of Program Coordination Planning and Strategic Initiatives (DPCPSI) to identify trans-NIH research for support by the Common Fund. The Council of Councils advises the NIH Director on matters related to DPCPSI and makes recommendations on conduct and support of trans-NIH research proposals.
NIH’s major opportunities include applying high throughput technologies to understand fundamental biology and to uncover the causes of specific diseases, translating basic science discoveries into new and better treatments, putting science to work for the benefit of healthcare reform, encouraging a greater focus on global health, and reinvigorating and empowering the biomedical research community. New programs in 2010 include establishing the feasibility of a Library of Integrated Network-based Cellular Signatures (LINCS) and creating the first installment of a reference collection, creating a community resource for protein capture reagents, fostering global health research, translational applications of stem cells, knockout mouse phenotyping program, understanding motivation as part of the science of behavior change, and collaboration with FDA in developing regulatory science. The 2011 agenda likely will include health economics, an HMO collaboratory on healthcare and effectiveness research, and new models for large prospective studies. Dr. Crabb elicited input from NIAAA Council members.
Discussion. Dr. Harris suggested the value of including ethanol in the small molecule initiative and in mouse phenotyping.
SBIR Contract Proposals Concept Clearance
The Council discussed contract proposals under consideration for a Small Business Innovative Research (SBIR) solicitation. No conflict of interest among Council members was identified.
Factorial Assessment of Psychiatric Comorbidity in Alcohol Abuse and Dependence. Dr. Hasin acknowledged the need for neuroscientists to consider dimensional assessment of psychiatric disorders, but expressed concerns related to duplication of effort and commercialization potential in the proposed contract. She explained that measures of depression have been used widely, though not specifically in individuals with alcohol problems; distinguishing alcohol effects from depressive symptoms has been long debated; scales are available at no cost; and the instrument to be developed would be expected to measure things outside the scope of a single symptom scale. Project Officer Dr. John Matochik explained the background behind the proposal, noting that investigators may be unaware of existing instrumentation, that sub-diagnostic individuals need to be incorporated into the research, and that the study of comorbidity must be encouraged. Gen. Arthur Dean pointed out the need for NIAAA to focus its SBIR program on translational, community-based activity. SBIR/STTR Coordinator Max Guo noted that a small amount of funds would be allocated to this contract. Dr. Vimal Kishore questioned whether the proposal as written would translate knowledge into practice. Dr. Matochik stated that the goal of the contract would be to develop a commercial product for use by other alcohol researchers to capture the full range of psychiatric co-morbidity in their subjects. Dr. Kishore encouraged NIAAAA to broaden its investigation into state-of-the-art research prior to issuing a solicitation. Dr. Heath identified the need for a simple Web-based self-assessment to capture information on alcohol-exposure and drinking history. There was not much enthusiasm for this concept from the Council Members. Therefore, no motion was offered for clearance of this concept.
Interventions to Prevent and Treat Substance Abuse Among Children, Adolescents, and Adults with FASD. Dr. Edward Riley explained that the proposal aims to develop programs that engage, inform, teach, and reinforce skills to avoid substance use prenatally or in individuals with FASD across the life span. He suggested that a solicitation reflect the need to accommodate individuals on a spectrum of intellectual capacity and incorporate high-risk persons in juvenile and criminal justice settings. He pointed out that underlying causes of brain damage may be unknown, as is a way to determine the cause. Dr. Heath commented on the absence of the term evidence base in the proposal. Dr. Raye Litten concurred with Council members’ comments. Council members approved clearance of this concept proposal.
Medications Development for the Treatment of Alcohol Use Disorders and Alcohol-Induced Tissue Damage. Dr. John Krystal explained that this proposal fosters unique partnerships among academia and biotechnology and pharmaceutical companies to make advances in medications development for alcoholism and has potential to accelerate introduction of novel and interesting targets and biomarkers into industry. Dr. Adron Harris stated that while promising lead compounds abound, most pharmaceutical companies are closing down their CNS research, making partnering with biotechnology companies critical to maintain momentum. Dr. Kishore questioned the relevance of several aspects of this proposal to SBIR, noting that they pertain to basic drug discovery and testing, and he suggested paring down the proposal. Dr. Krystal commended the breadth of the proposal as a strategy to generate widespread interest. Dr. Litten stated that FDA has approved four new medications and described success stories under SBIR contracts. Gen. Dean expressed concern that this proposal does not align with the SBIR process as intended. Dr. Heath cautioned that the language in the proposal may indicate smoking as a target without targeting alcohol issues. Dr. Litten asserted that process described in the proposal has generated products in a slow, iterative way and is designed to involve small companies. Mr. Palmer suggested that in addition to research, the field needs new patient registries or technologies to promote post-marketing safety, and to incorporate biotechnology companies in the global drug development process. Dr. Kishore suggested that SBIR’s focus should be on applied science conducted by small companies. A majority of Council members voted in favor of clearance of the concept.
K Mechanisms and Concern with Caps and Number of K Awards
Council members resumed a previously tabled discussion on funding caps on NIAAA’s K02 and K05 awards. Dr. Krystal noted that a dollar limit may generate a gap between the award and typically expectable salary levels, which may discourage seasoned, well-paid investigators from applying. He recommended amending K02 awards to allow supplementation by other Federal grant sources to enable flexibility similar to that associated with the K05 award. Another option would be to raise the cap, while recognizing that NIAAA would make fewer awards. Dr. Riley encouraged continuing to offer K awards. Dr. Moss endorsed the K05 award, but asserted the need to consider the realities inherent in funding university faculty. Dr. Krystal suggested constituting a Council subcommittee to consider the issue further and report back to the Council at a later date. Dr. Warren stated that he would appoint a Grants Management staff member to advise the subcommittee.
Ex-officio Member and Liaison Representative Reports
Dr. Jill Carty stated that the Department of Defense’s promotional campaign that targeted 17 to 24 year olds found binge drinking levels at 38% at all institutions engaged in the campaign, compared to 49% in the control group. She reported that Congress has charged the Defense Department to conduct a comprehensive assessment of all preventive, treatment, and administrative actions related to substance abuse problems. A working group was established that will report on progress.
Ms. Sis Winger, President, National Association for Children of Alcoholics (NACoA), reported that former NIAAA Deputy Director Faye Calhoun will chair NACoA’s board of directors. Ms. Winger and Dr. Warren sit on the FASD Expert Panel of the Substance Abuse and Mental Health Services Administration’s (SAMHSA) Fetal Alcohol Spectrum Disorders Center for Excellence. She urged NIAAA to translate the science for people who read Parent Magazine and Seventeen, as well as to develop curricula.
Dr. Warren adjourned the meeting at 1:00 p.m.
I hereby certify that, to the best of my knowledge, the foregoing minutes are accurate and complete.
Kenneth R. Warren, Ph.D.
Abraham P. Bautista, Ph.D.