113th Meeting Minutes

February 5-6, 2013

The National Advisory Council on Drug Abuse convened its 113th meeting at 2:00 p.m. on February 5, 2013 in Conference Room C, 6001 Executive Boulevard, Bethesda, Maryland.  Dr. Nora D. Volkow, Director, NIDA, chaired the meeting. The closed portion of the meeting on February 5, 2013, was for the purpose of reviewing applications for Federal grant assistance and was open only to Council members and Federal employees.  The open portion, which was open to the public on February 6, 2013, began at 8:30 a.m.  The Council adjourned on February 6, 2013 at 1:00 p.m.

Council Members Present
Nabila El-Bassel, D.S.W.
Carl Hart, Ph.D.
Elizabeth Howell, M.D.
Terry Jernigan, Ph.D.
Thomas Kirk, Ph.D.
Robert Lenox, M.D.
Caryn Lerman, Ph.D.
Kelvin Lim, M.D.
Barbara Mason, Ph.D.
Linda Mayes, M.D.
Michael Nader, Ph.D.
Marina Picciotto, Ph.D.
John Rotrosen, M.D.
Steven Wolinsky, M.D.
Jon-Kar Zubieta, Ph.D., M.D.

Council Chairs
Nora D. Volkow, M.D.

Executive Secretary
Teresa Levitin, Ph.D.

Federal Employees Present

Members of the Public Present
Erica Ahmed - Mental Health America
Kate Buchanan, MPH - American Academy of Child and Adolescent Psychiatry (AACAP)
Kate Cleffi, B.A. -  RTI International
Janet Conteh
Yoshie Davison, M.S.W. -  American Academy of Child and Adolescent Psychiatry (AACAP)
Michael Etka, B.A. - National TASC
Heidi Fordi - American Academy of Child and Adolescent Psychiatry (AACAP)
Robert Forman, Ph.D. - Alkermes
Ken Fox, B.A. - American Society of Addiction Medicine (ASAM)
Michael Gray, M.S. - TASC
Katia Howlett, Ph.D. - Synergy Enterprises, Inc.
Sharon Issurdatt, LCSW (MSW) - National Association of Social Workers
Penny Mills, M.B.A. - American Society of Addiction Medicine (ASAM)
Wendy Naus  - Association of Independent Research Institutes
Pat President, M.S. - CSR Incorporated
Michelle Rodrigues, M.B.A. - SRI
Vena Schexnayder, M.A. - NAADAC
F. Snyder - NOVA
Roy Walker - Synergy Enterprises, Inc.

Closed Portion of the Meeting - February 5, 2013

1. Call to Order

   This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

   Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.

   Dr. Teresa Levitin, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies.

2. Application Reviews

   In turn, the Director or a designee for the Division of Epidemiology, Services and Prevention Research; the Division of Pharmacotherapies and Medical Consequences of Drug Abuse; the Division of Basic Neuroscience and Behavioral Research; the Division of Clinical Neuroscience and Behavioral Research; the Office of Science Policy and Communications; and the Office of Translational Initiatives and Program Innovations presented their applications for consideration by the Council.  For each, Council provided concurrence with the initial scientific reviews en bloc.  Council also approved one MERIT application. Relevant applications were presented to Council for Special Council Review, and Council found them all meritorious and agreed with program assessments. All Trans-NIH Initiatives, i.e., Blueprint and Roadmap applications and NIDA Secondary applications were made available for Council’s approval.

   Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is a conflict of interest, real or apparent.  Conflicts of interest statements were signed by each member of the Council.  Members were not required to leave if an application in conflict with that member was acted upon en bloc.

Open Portion of the Meeting - February 6, 2013

1. Call to Order

   Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order.   She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment.  Dr. Volkow called attention to future Council meetings:   May 7-8, 2013 and September 4-5, 2013.

2. Consideration of the Minutes of Council

   The Minutes of the September 2012 meeting were approved as written.

3. NIDA Director's Report - Nora D. Volkow, M.D., Director, NIDA
   Dr. Volkow began her report with a budget update, noting that the 2013 President’s Budget proposed a total 0.2% increase over the prior year, while the CR for 2013 proposed a total 0.3% increase over the prior year.  Under both budgets, NIDA would remain an Institute with slightly over a billion dollar budget.  Dr. Volkow noted that a continuing resolution is now in place, and she also noted the uncertainty of the budget situation because of the uncertainty of sequestration.  Thus, a conservative funding strategy is being followed.

   Turning to what is new at HHS and NIH, Dr. Volkow pointed out that there would be a functional, rather than a structural, integration of NIDA, NIAAA and relevant programs from NCI and other institutes.  Based on the activities of the past two years, including the significant strides by NIDA and NIAAA to coordinate substance use, abuse, and addiction research, NIH decided that functional integration would be the better option to support.  NIH also stated that, given the unique current budgetary challenges, NIH needed to focus its energies on the entire biomedical research enterprise.  A functional integration would look something like the Brain Blueprint, but there would only be three institutes with major involvement:  NIAAA, NIDA and, to a lesser extent, NCI because of its tobacco portfolio.  Dr. Volkow pointed out that this functional integration of substance use, abuse and addiction science would be carried out in a variety of ways, with a steering committee of NCI, NIAAA and NIDA Directors leading the functional integration, participation from the three Councils, designation of staff from NCI, NIAAA, NIDA and other ICs to support the functional integration, and use of clear metrics for ongoing evaluation to ensure the integration is proceeding successfully.  The extant strategic plan will serve as a blueprint for the functional integration steering committee, and additional program-specific metrics will be developed once specific goals are identified.  Dr. Volkow then described several next steps.  These include implementing a regular series of planning and monitoring discussions for the steering committee which will be charged with developing further initiatives in consultation with stakeholders and assessing and determining joint funding targets. It is expected that the steering committee will, on a yearly basis, identify projects that will be supported under this functional organization. For 2013, it was decided to provide supplements to grantees that have research relating HIV and drug use to expand their research to include alcohol use.  It is uncertain what the future budget will be for new projects.  Other next steps include determining additional areas of IRP integration and determining an appropriate schedule for joint Council meetings.  Progress will be reported to the Councils at their January/February meetings.  Also, the search for a permanent NIAAA Director will be open through March 4, 2013.

   Dr. Volkow then noted that a working group advising NIH had recommended in an article in Science Insider that most chimpanzee research cease and that most research chimpanzees be retired.  Any remaining chimpanzee research should ensure that the animals are kept in proper living conditions.  Turning to another topic, Dr. Volkow briefly described some NIH Pain Consortium Activities and noted the increasing focus on chronic pain.  There are now 12 Centers of Excellence in Pain Education.  These have been developed because of the realization that there was very little teaching about pain in medical school and medical students were not being sufficiently prepared to screen and treat pain, despite a recent IOM report documenting the large number of people suffering from chronic pain.  Also an increasing number of individuals are dying from overdoses from pain medication, and the medical community needs to be better able to address this growing problem.  The Consortium will support fMRI data-sharing on pain, with open access, a one-stop shop (portal) to obtain all data, data that are well annotated and harmonized across sites.  The potential for having a biomarker to monitor pain is of great interest across the NIH.  There will be a consensus workshop on opioids for chronic pain, with several potential topics/questions, such as the efficacy of opioids for treating chronic pain, risks for addiction, population differences, training needs as to what type of opioids should be used in managing chronic pain and research gaps and priorities.  Dr. Volkow emphasized the importance of research to clarify how to administer opioids for optimal efficacy and minimal adverse effects, and she raised a number of questions that need to be addressed.  Dr. Volkow also presented two new common fund FOAs: one is an enhancing genotype by tissue expression project, with molecular analyses of stored biospecimens, and the other is on determinants and consequences of personalized health care and prevention.

   Dr. Volkow next presented some of NIDA’s recent activities and events.  She described the new translational research program that will be led by Dr. Elena Koustova.  This program will proactively identify opportunities to bring basic scientific findings into products that relate to treatment, prevention, or biomarkers and will integrate research across NIDA more effectively than is currently the case.  Dr. Volkow then presented some data from the 2012 Monitoring the Future Study showing the prevalence of past year drug use among 12th graders, the percentage of U.S. 12th grade students reporting past month use of cigarettes and marijuana, and 12th graders’ past year marijuana use vs. perceived risk of occasional marijuana use.  She noted that there were not dramatic differences from the findings of last year, with the trends going in the same directions.  A very important point is that the use of marijuana continues to increase and has been significantly increasing over the past five years across all age groups.  Decreases in tobacco smoking and alcohol use are continuing, and the abuse of prescription medications has remained about the same.  She also presented data on opioid and stimulant drug use and noted that the number of adolescents who believe that marijuana is harmful is declining.  Some data on emergency department visits related to stimulant medications were also presented, and the substantial increase in emergency room admissions over the last five years is noteworthy, especially the more than tripling of emergency room visits among those ages 18-25.

   Several new and continuing announcements have been published.  These include the time-sensitive drug abuse mechanism announcement, an announcement on prescription drug abuse and an announcement on accelerating the pace of drug abuse research using existing data.  Further, there is an NIH announcement in collaboration with FDA that is requesting research relevant to the Family Smoking Prevention and Tobacco Control Act.  Topics such as smokeless tobacco initiation use, statistical modeling, consumer perception of tobacco products, cigar initiation, and nicotine dependence threshold among youth and adults are some of the topics of interest.

   The priority areas of NIDA remain prevention, treatment, HIV and drugs, and Dr. Volkow presented some new research as well as new announcements in these areas.  For example, she showed results from a study of the effects of chronic buspiorone treatment on cocaine self-administration, and she noted that the CTN will begin a clinical trial to evaluate the extent to which buspirone could be useful in the treatment of cocaine addiction.  Dr. Volkow also introduced three new treatment announcements:  one seeking applications on translating basic science findings into the conceptualization, discovery, and preclinical evaluation of innovative therapeutics for nervous system disorders, another seeking applications to create multidisciplinary research groups for the discovery of pharmacological agents to treat and to study mental illness or SUD (with NIMH and NIAAA) and a third seeing applications on behavioral interventions development research to test efficacy, examine mechanisms of behavior change, determine dose-response, optimize combinations, and/or ascertain best sequencing of behavioral, combined, sequential or integrated behavioral and pharmacological treatments.  Dr. Volkow then presented data from a study of mortality in China of people injecting opioids and infected with HIV who received anti-retroviral therapy with or without methadone maintenance treatment.  She noted that China has implemented the largest methadone program in the world and that it has been shown there that the use of methadone can profoundly benefit the outcomes in individuals who are HIV positive and substance abusers.  Two ongoing HIV/AIDS program announcements were presented as a reminder to Council of NIDA's continuing support of AIDS/HIV research:  the AIDS-science track award for research and the drug abuse aspects of HIV/AIDS announcements.

   Dr. Volkow presented some of the findings from an IOM report on health in the United States as compared with 16 other high-income democracies in western Europe as well as Canada, Australia and Japan.  The United States is among the wealthiest nations in the world, but it is far from the healthiest.  For many years, Americans have been dying at younger ages than people in almost all other high-income countries, and this disadvantage has been getting worse for three decades, especially among women.  Also, when compared with the peer countries, Americans, as a group, fare worse in at least nine health areas: infant mortality and low birth weight; injuries and homicides; adolescent pregnancy and sexually transmitted infections; HIV and AIDS; drug related deaths; obesity and diabetes; heart disease; chronic lung disease; and disability.  Dr. Volkow noted the role of drug use in contributing to these results in each of the health areas.  Dr. Volkow then concluded her report by describing the National Drug Facts week that took place from January 28 to February 3.  All 50 states registered and there was substantial interest and participation across the country; the chat day with NIDA staff was particularly successful.

   Council thanked Dr. Volkow for a thoughtful presentation.  Questions and discussion centered around clinical trials of buspirone and cocaine and data from preclinical work, themes that emerged from the questions asked at the National Drug Facts chat day, possible reasons for changes in attitudes of adolescents about the riskiness of marijuana use, possible analyses and uses of information from chat day, use of the web to obtain information, and possible increases in the use of Provigil in the future.

4. SAMHSA’s Strategic Initiatives and Partnership Opportunities - Pamela S. Hyde, J.D., Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA)

   Ms. Hyde began her presentation by pointing out that behavioral health is essential to overall health, that prevention works, that treatment is effective and that people recover.  She then introduced the four topics she intended to address within the context of challenges and opportunities in behavioral health:  SAMHSA’s focus, the Affordable Care Act (ACA), evidence-based practices (EBPs), and partnership with NIDA.

   SAMHSA’s vision is that of a nation/community free of substance abuse and mental illness and fully capable of addressing behavioral health issues that arise from events or physical conditions.  Ms. Hyde noted that one cannot have individual or community health without behavioral health.  SAMHSA’s strategic initiatives aim to improve the nation’s behavioral health, transform health care in America and achieve excellence in operations.  Ms. Hyde listed eight strategic initiatives, and she noted she would only have time to highlight a couple.  She then presented an overview of a national behavioral health quality framework (NBHQF) being developed by SAMHSA.  This framework encompasses three aims concordant with a national quality strategy and includes ways to improve health by supporting interventions with individuals, families and communities.  Ms. Hyde then listed the six specific goals of the NBHQF.  These include providing evidence-based/effective prevention, treatment and recovery, promoting healthy living, and having accessible/affordable services.  The impact of each of the NBHQF goals can be tracked across three domains with measures for each cell.  The domains are 1) payer – public and private; 2) provider and practitioner; and 3) population – individual, family, and community.  Ms. Hyde then addressed the criteria for measures, noting that measures should have a number of characteristics, including endorsement by objective entities or expert consensus; address “high impact” health conditions; promote alignment with program attributes and across programs, including health and social programs; and reflect a mix of measurement types, e.g., outcome, process, cost/appropriateness and structure.  She then gave specific examples of measures tied to specific health goals, taking into account the payer, provider/practitioner and population.

   Ms. Hyde then noted that over 65 million people will have access to mental health and substance abuse benefits due to the ACA and the Mental Health Parity and Addiction Equity Act (MHPAEA).  She provided information about the prevalence of behavioral health conditions among uninsured adults at various income levels and the types of services they are likely to need.  There will be both an expansion of services under Medicare and the use of exchanges to provide services to those currently uninsured. Ms. Hyde stated that about 11 million of those 65 million currently uninsured people are likely to have either a mental or substance use disorder.  Seven percent of those eligible for the Medicaid expansion group might have a serious mental illness and about 14% might have a substance use disorder.  The numbers for those eligible for health exchange assistance are about the same as for the Medicaid expansion group.  SAMHSA is doing a substantial amount of work with providers, many of whom may not be used to being in an insurance environment, so there is much to do in the areas of provider development and provider capacity building.

   SAMHSA has a new evaluation policy and is trying to be more strategic in its approach to evaluation.  SAMHSA’s approaches to evidence based practices 1) ensure that existing evaluations are assessed so that program objectives guide data collection and analysis; 2) help identify programs that are meeting well defined objectives; 3) pinpoint programs appropriate for broader dissemination based on evidence of success.  Further, SAMHSA has an analytic and research agenda aimed at understanding the ACA’s impact.  This agenda will include issues around access to behavioral health care, cost of service delivery and the identification of system-level issues.  Trauma is of interest, particularly as it relates to women.  Ms. Hyde described block grants and discretionary grants, including information about questions it asks states and about the RFA process.  SAMHSA asks states several questions, including whether they have specific staff to track/disseminate information about EBPs and how they have used information regarding EBPs.  There is now a uniform block grant application so that a state can apply for both substance abuse and mental health dollars at the same time.  For the RFA process, applicants are asked to provide information on a number of issues, including training needs for implementation and which EBPs they are proposing to implement and why they have made that selection.  Ms. Hyde then presented some of the information, rating and classification systems, protocols, publications, and other tools that SAMHSA provides.  She noted that SAMHSA is starting to look at service definitions in the context of insurance payment and described services definitions and assessments of evidence, noting that SAMHSA’s “Good and Modern Addictions and Mental Health Service System Brief” provides a service definitions taxonomy and integrates the behavioral health system with a continuum of effective treatment and support services across health care, employment, housing and educational sectors.  She also noted that the field, payers, insurers, and states will all benefit from these analyses.  The service definitions include information about the target population, expected outcomes, service definition and requirements, staffing and location requirements, recommended duration and documentation requirements.  Ms. Hyde then noted the added value of this work and the importance of knowing which services work best and for whom.

   Turning to a consideration of partnerships with NIDA, Ms. Hyde first described several ongoing activities, including jointly sponsoring five Innovations in Prevention symposia and working together on Recovery Month activities.  Other activities have included working together on improved implementation/sustainment of EBPs through development of measures and tools to predict/support sustainability, awarding of SAMHSA ATTC grants in partnership with NIDA, and holding a consensus panel on the adoption of new pharmacotherapies for opioid use disorders.

   Ms. Hyde concluded her presentation by noting some of the challenges and opportunities ahead; these include changes in attitudes and laws about marijuana, misuse of prescription drugs, the needs of veterans, immigration and gun safety, among others.

   Council thanked Ms. Hyde for her presentation.  Discussion included possible reasons behind the change in marijuana laws, changes in reimbursement for treatment providers, issues in enrollment and access under the ACA, electronic health records and the impact of 42CFR Part 2 and the consent needed for medical information access as well as the possible changes to current practices because of electronic health records.  There was also discussion about partnering with NIDA in funding announcements, the importance of focusing on women and trauma, ways to influence states and providers to employ more evidence-based practices and SAMHSA's role in that process through block grant funding and other activities, implications of more shifting to an insurance model of services, and the broad role of SAMHSA in providing leadership, practice improvement, public awareness and education, as well as engaging in a variety of other activities in the service of public health.

5. Update on the Small Business Innovative Research (SBIR) Program at NIDA - Elena Koustova, Ph.D., M.B.A., Director, Office of Translational Initiatives and Program Innovations, Office of the Director, NIDA

   Dr. Elena Koustova began her presentation on the Small Business Innovation Research (SBIR) Program at NIDA by providing an overview of the federal government SBIR and Small Business Technology (STTR) programs.  She noted the budgets for each of the 11 federal agencies participating in these two set-aside programs intended to engage small businesses in federal research and development (SBIR) and to facilitate the cooperation between small businesses and academic researchers (STTR).  Dr. Koustova emphasized that in both the SBIR and STTR grant and contract programs at NIH, potential for commercialization of the research is a requirement.

   She then turned to the SBIR program at NIDA, stating that she would like to present both victories and disappointments in the NIDA $ 25 million total dollar program.  She noted the limited market opportunities and the general lack of commercial interest by big pharma.  She also described the stigma associated with drug abuse research as well as the difficulty of conducting clinical trials and the resultant limited number of quality applications from small businesses.  NIDA uses of both grants and contracts, with an emphasis on contracts when compared with other ICs, as a way to enhance the program, but contracts are very time-consuming and have other limitations.  Furthermore, the NIDA SBIR program operates in the absence of dedicated FTEs, given the policy of having SBIR/STTR grants managed by many NIDA program officers.  Dr. Koustova has created a NIDA SBIR team to address these issues and improve the program.  Team members were identified; their dedication and passion were noted.

   Many of the team’s activities have focused on implementing the recommendations of the National Research Council, which released a report in 2009 recommending ways to improve the operations of the SBIR program at NIH.  Specifically, to address the problem of modest management/senior leadership engagement, the NIDA team has created an SBIR website; allocated time for regular presentations at the NIDA senior staff meetings; created “tea with the NIDA Director”, a celebratory ceremony for the winners of the best SBIR contract topics contest; implemented separate SBIR funding meetings; established a NIDA SBIR Idea Board; and generally raised the visibility of the program.  In order to improve the relative scores and number of applications received, the team has promoted the program through attendance at many relevant meetings, wearing bright yellow T-shirts advertising NIDA’s interest in obtaining more applications, and engaging in other public information and related activities.  Scouting and outreach activities have included identifying many new databases through the Library of Congress, targeting outreach to relevant SBIRs, creating outreach lists, and distributing RFPs more widely.

   Dr. Koustova pointed out that this proactive targeting and matching small businesses to NIDA's needs is resulting in a significant increase in the number and quality of applications:  in one year, the average number of SBIR contract proposals increased from 1.5 to 4.4 per topic, and, in two years, to 11 per topic.  One RFP this year attracted 26 offers, the largest number in NIDA's history.  Further, efforts are being made to decrease the burden of managing contracts and grants on staff at the same time efforts are also being made to educate staff on commercialization issues.  Multiple templates, manuals and materials designed to assist NIDA program officers have been created and used.  Staff interest and awareness of the SBIR program has been enhanced by the creation of the NIDA SBIR Market Fair.  This fair, held in January of 2012, attracted 60 NIDA staff and gave them the opportunity to select the best of the concepts presented to them.  They used Monopoly game money and were asked to evaluate proposals on the basis of whether they would invest their own money in them.  Twelve contract concepts developed by staff were presented, and the selected topics will be rewritten as RFPs, submitted for external review and presented to the NIDA Director (Tea with Nora).  Then the RFPs will be published in the SBIR Phase I Contract Solicitation, PHS 2014.

   Dr. Koustova raised the concern that the majority of NIDA SBIR grant applications are not discussed in the study section meetings.  She provided some background information on this, noting, for example, that NIDA SBIR grant applications are spread across approximately 14 study sections and that applicants complain about the lack of appropriate expertise in some of the study sections.  Actions to remedy these concerns were noted, including discussions with CSR leadership.

   Several NIDA SBIR/STTR administrative accomplishments were presented:  the program is firmly "on NIH’s map", as exemplified by members of the NIDA SBIR team being invited to participate in NIH SBIR activities and other ICs requesting NIDA documents and templates.  Further, NIDA staff and senior leadership engagement is increasing.  Nonetheless, Dr. Koustova cautioned that many challenges remain:  building an SBIR/STTR program without FTEs and an administrative budget for an “unsympathetic” market is very difficult; having program directors who do not have commercialization or industry experience is problematic, particularly when, as is the case with NIDA, substantial interaction with --and assistance for -- potential and actual SBIR/STTR applicants are expected and needed.  Working closely with small business applicants to help them develop their ideas is essential, but it is both time consuming and challenging.  Further, the limited number of high quality grant applications and concerns about the peer review of them must still be resolved.

   Dr. Koustova concluded by presenting topics which received the largest investments and a plan for evaluating internal ideas for SBIR RFPs and RFAs, a plan that provides a rating scale of 10 criteria including urgency, market size, uniqueness, speed to market, pricing potential, cost of customer acquisition, and other factors relevant to this unique and important program.

   Council members thanked Dr. Koustova.  Discussion included questions about CSR study section composition, the numbers of NIDA grant applications assigned to various study sections, the specific challenges of reviewing drug discovery and development applications for the small NIDA niche market, and the problem of many applications not being discussed or given an overall rating.  The challenge of finding review committee members with appropriate expertise was also noted by a staff member with CSR experience.

    

6. 2013 Biennial Advisory Council Report Certifying Compliance with Inclusion Guidelines - David Shurtleff, Ph.D., Acting Deputy Director, NIDA

   Dr. David Shurtleff presented the 2013 Biennial Advisory Council Report Certifying Compliance with the NIH Policy on the Inclusion of Women and Minorities as Subjects in Clinical Research.   He noted that every two years Council is asked to certify that NIDA has complied with this policy, and he presented data to demonstrate that NIDA had done so.  Prior to the meeting, Council had received the full report of enrollment data from relevant NIDA intramural and extramural research projects.  The report included data about minority representation, ethnicity and gender representation.  Dr. Shurtleff noted that NIDA has continued to increase its representation of minority subjects in the research it supports, and there is now also gender parity.  Further, NIDA compares favorably with other NIH Institutes in terms of inclusion rates.

   Dr. Shurtleff provided some background information on the NIH Revitalization Act of 1993 that mandated the inclusion of women and minorities in human subjects research.  He noted the section in the Act that reinforced the existing NIH inclusion policy by stating that women and minorities must be included in all clinical research studies and must be included in Phase III clinical trials with a trial designed to permit valid analyses.  The policy also states that cost is not allowed as an acceptable reason for exclusion and that NIH needs to support outreach efforts to recruit and retain women, minorities and their subpopulations in clinical studies.  Dr. Shurtleff then described the critical role of staff in ensuring compliance, and he stated that applications are not awarded if they do not provide an adequate recruitment plan and a target enrollment.  Furthermore, non-competing renewal funds are not awarded unless staff has determined that inclusion criteria have been met.  Dr. Shurtleff noted that in 2011, there was mandatory training for relevant NIDA staff to ensure staff understood this policy and its implementation.

   The role of an NIH advisory council is to review the data on compliance for its institute or center and certify that institute or center is in compliance.  Therefore, Dr. Shurtleff asked for a Council motion to certify NIDA compliance.  NIDA would then transmit its portion of the report to the NIH Director for inclusion in the final NIH report.  Council unanimously voted to approve the NIDA section of the report, thereby indicating their agreement that NIDA was in compliance with the NIH policy on inclusion of women and minority subjects in clinical research.

7. Operating Procedures and Delegation of Authority - Teresa Levitin, Ph.D., Office of Extramural Affairs, NIDA, and Executive Secretary, NACDA

   Dr. Levitin reminded Council that every year Council members must review and approve the NIDA Council operating procedures and delegation of authority.  She noted that NIDA Council does so at each February Council meeting.  This document describes many of the Council’s activities, and, after Council approval, it is forwarded to the NIH Office of the Director to ensure compliance with NIH extramural policy.  The draft document had been provided to Council prior to the meeting, and Dr. Levitin noted that the document was essentially the same as the one Council had approved in 2012.  Although some points had been clarified, no substantive changes were being recommended.  Dr. Levitin then briefly reviewed the document, highlighting the matters that require Council review and action and the matters that are delegated to staff for review and action.  She pointed out other aspects of the operating procedures.  Dr. Levitin assured Council that any unusual issue or activity would be brought to their attention, even if it were a matter that had been delegated by Council to staff for action.  There were no questions or suggested changes.  Council unanimously voted to approve the 2013 draft operating procedures and delegation of authority document.  Council unanimously voted to approve the document.

8. AIDS Research Program Update - Jacques Normand, Ph.D. Director, AIDS Research Program, Office of the Director, NIDA

   Dr. Normand began his presentation on NIDA’s AIDS Research Program by stating the five objectives around which his presentation was organized:  1) a description of NIDA’s current HIV/AIDS portfolio, 2) review of the current epidemiology of HIV, 3) review of what HIV prevention strategies are effective, 4) a brief overview of recent initiatives and activities of the AIDS Research program, and 5) research priorities.

   The NIDA portfolio of approximately $320 million funds projects in several research areas, with the behavioral and social science area the largest, followed by natural history/epidemiology and etiology/pathogenesis.  Funding is also provided for therapeutics and vaccine research as well as for training, infrastructure and capacity building and information dissemination.  A pie chart that summarized the program allocation of funds to these different areas was presented.  Dr. Normand noted that research in the areas of pathogenesis and natural history have increased substantially in the last few years, mainly as a result of issuing various announcements in the biomedical areas such as system biology and proteomics.

   Turning to the domestic epidemiology of HIV/AIDS, Dr. Normand described HIV incidence in the United States from 2006-2009, noted the estimated number of new infections by transmission category, and indicated the HIV incidence by race/ethnicity as well as the estimated rate of new HIV infections by gender and race/ethnicity.  The data demonstrate the disproportionate burden of this disease on Black/African American men.  Although the overall rate of incidence has been fairly stable at about 50,000 cases a year, the rates of incidence within various transmission categories have changed dramatically over the past 25 years or so.  Dr. Normand provided additional data on the HIV incidence by transmission category, noting that male to male sexual contact was the major transmission category and that the national epidemic has always been driven by men who have sex with men (MSM), with that category being the number one category for incidence and prevalence.  Data on the HIV incidence by age at infection were also presented.  Dr. Normand then presented the HIV incidence among MSM by race/ethnicity and age and the estimated number of new HIV infections among MSM in the ages of 13-29 by race/ethnicity from 2006-2009 as well as the percent of undiagnosed HIV cases by age.  He noted that 60% of HIV+ youth do not know their serostatus, up from 48% in 2006.  Dr. Normand concluded this section of his presentation by showing the HIV care engagement cascade, from HIV infected to adherent/undetectable, as a way of trying to identify the most efficient way for tackling the incident cases.

   Turning to the question of which prevention strategies are effective, Dr. Normand noted that the components of a comprehensive HIV prevention strategy include:  drug treatment as HIV prevention, ART as HIV prevention, community-based outreach, syringe access, supervised injection rooms, sexual risk reduction (condom use), PrEP/microbicides and PEP, male circumcision, and prevention/treatment of STI.

   Several recent initiatives and activities of the program were described.  FY13 priorities include the Avant-Garde (DP1) program, A-START, the International AIDS Society (IAS)/NIDA fellowship, several announcements in basic biomedical and behavioral areas and international collaborations.  Dr. Normand highlighted a recent initiative on treatment as prevention, an initiative with the seek/test/ treat/retain perspective, in the criminal justice system and among vulnerable populations.  International collaborations are also part of this initiative, and the CTN has recently initiated two large projects.

   Future activities will employ a combination of known strategies approach, because scientific evidence clearly shows that a variety of interventions can prevent HIV transmission, and a combination of prevention strategies adapted for specific contexts is the best hope for eliminating HIV transmission among drug users.  A potential collaboration with a French agency, ANRS, was also described, and for IAS/NIDA fellowships, adding international mentors to the “mentor bank” and adding new fellows as well as expanding the program to include other international fellows and web based networking are proposed activities.  More international research collaborations are planned, and several new topics and activities are under consideration, including work with NIAAA for new research and reinitiating work with NIAID to increase research on young, minority MSM, since reducing the incidence of HIV/AIDS requires reducing the incidence among this group.  Other possible areas include HepC research and research on integration of care in order to better coordinate infectious disease and addiction medicine.  Dr. Normand also listed several planned international meetings for 2013, including the 7th International AIDS Society Meeting in Malaysia.

   Dr. Normand closed his presentation by listing several achievements of the AIDS Research Program.  These include NIDA being the leading research institution with regard to investing in treatment as prevention, substantially enhancing NIDA’s basic biomedical portfolio, increasing the HIV protocol in the CTN, and leading funding for HIV research in the criminal justice system Council thanked Dr. Normand and noted the importance of the seek/test/treat/retain perspective, the need for better coordination among federal agencies, the difficulty of engaging “street kids” in services, and issues around access to care.  Council also discussed the issues surrounding care for underage children and early intervention in this country and abroad for injection drug users, the importance of understanding local issues in initiating effective programs, differences in the African American and Hispanic communities that need to be considered in developing interventions, and the consistent finding that treatment is one of the most efficient prevention interventions at the population level.  A question was raised about the association between incarceration and new infections, and Dr. Normand stated that there are a few studies of this issue and it appears that infection rates in prison are very low.  However, the overlap between HIV infected and drug using populations in jail and prison is high and the link to health care once someone is released is poor.  NIDA was congratulated for developing the seek/test/treat program, the Avant-Garde program and other successful initiatives.

9. Update on the NIDA Intramural Research Program - Antonello Bonci, M.D., Scientific Director, Intramural Research Program

   Dr. Bonci began his brief update of the NIDA intramural research program (IRP) by sharing his vision for the IRP: to take full advantage of the unique funding system of the IRP and develop a world class scientific environment where cutting edge science, human studies and substance abuse-related initiatives can be developed.

   He then described both the challenges of realizing this vision and some of the changes he has implemented in order to do so, given the limitations on resources.  He has “taxed” most of the 40 investigators at the IRP at a 10% rate in order to raise additional funds for new programs and new staff.

   Dr. Bonci then noted the increase of publications with impact factors above 8 as a partial way of measuring successful performance and pointed out that the impact factor has almost doubled in the last three years.  Both productivity and quality are increasing.

   A slide showing the 30 laboratories at the IRP provided evidence that there are no longer big laboratories, and Dr. Bonci noted that having smaller laboratories has enhanced collaboration, which was his goal.

   Dr. Bonci identified the status of IRP personnel, noting the number of junior staff, both pre- and post-doctoral, visiting fellows and others in order to illustrate the point that he is trying to attract as many new people as possible.

   Another change is the development of cost effective cores as resources for the intramural and extramural scientific communities.  The recently hired Optogenetic and Transgenic Core Director is Dr. Brandon Harvey, and Dr. Da-Ting Lin has just been hired as the Imaging Core Director so that the IRP can be at the cutting edge of imaging technology.  Resources are also being directed toward creating an electron microscopy core and a histology core.  A behavioral core is also planned.  These cores enhance collaboration and efficiencies.

   Several new initiatives were listed, and these include development of a medication development program, a joint fellowship with NIA and Johns Hopkins in substance abuse disorders, an enhanced diversity and outreach program and special funding to hire diversity/minority students and post-docs and to track their success after they leave the IRP, an intramural-extramural innovative partnership program for new ideas that would not otherwise receive funding, a designer drug initiative, and, as noted earlier, an optogenetic transgenic rat core facility.

   Dr. Bonci then noted staff changes including hiring Dr. Geoff Schoenbaum as Branch Chief for cellular neurobiology, Dr. Markus Helig as Clinical Director for the joint NIAAA/NIDA clinical program (who has brought needed structure to the clinical program and has created a scientific advisory board to review all clinical protocols), Dr. Yeka Aponte, hired through the NIH Stadtman search, and Dr. Donna Calu, hired as an Early Independent Scientist.

   Several programs/initiatives have been recently created with NIAAA.  A joint NIAAA/NIDA search for a clinical junior faculty position was successfully completed, and Dr. Lorenzo Leggio from Brown University has been hired.  A pilot early development human genetics program was also described.  This program will be directed by Dr. David Goldman, and it will focus solely on collaborative projects with intramural investigators.

   The next major IRP event will be a review of all of its activities and leadership by an independent NIH Blue Ribbon Panel.

   Council thanked Dr. Bonci, commented on the outstanding quality of the diversity program, discussed what the IRP is best situated to do, given its structure and resources, (e.g., take risks, develop long term projects such as tool building or make more transgenic rats), asked about basic research, such as biomarkers and the interface of the basic and clinical programs, and congratulated Dr. Bonci on his efforts to enhance collaboration and on his other changes to the IRP.

10. Presentation of Concept Clearances - Redonna Chandler, Ph.D. Chief, Services Research Branch, Division of Epidemiology Services, and Prevention Research (DESPR), NIDA; John Satterlee, Ph.D., Program Director, Epigenetics Genetics, and Molecular Neurobiology Research Branch, Division of Basic Neuroscience and Behavioral Research (DBNBR), NIDA; Jamie Biswas, Ph.D., Chief, Medications Research Grants, Branch, Division of Pharmacotherapies and Medical Consequences of Drug Abuse, (DPCMDA), NIDA

    Three concepts for FOAs were presented to Council for their consideration and comment.  First, Dr. Redonna Chandler presented an initiative focusing on enhancing data harmonization across seek/test/treat/retain (STTR) research projects.  She noted that it has been demonstrated that if HIV positive people are identified early, immediately started on antiretrovirals, and retained in care and on their medications, then transmission of HIV will be drastically reduced and their health will improve.  She also noted that data harmonization is a strategy intended to increase the comparability of data collected across a set of independent projects.  In this case, it will be used prospectively to develop common measures to collect data in key domains in a near identical fashion and thereby increase statistical power and address new research questions.  She noted that NIDA has funded a number of studies looking at the STTR cascade with different populations and brought them together to work on data harmonization, but more support and continuity are needed.  This proposed initiative would stabilize support for data harmonization and expand the data that would be a part of an integrated data set.  Specifically, a single coordinating center would be established to provide technical, logistical and statistical support.  The center would work with NIDA staff to identify and coordinate access to the integration of data from other HIV databases.  Council was supportive of this concept, noting that the rewards of this initiative would be reaped for many years.

    Second, Dr. John Satterlee presented a concept on brain activity.  He noted that about 25% of the body’s glucose is consumed by brain functions, even though the brain only makes up about 2% of body weight.  In order for this glucose consumption to occur, orchestrated glial-neuronal interactions are necessary to produce, deliver, and use this energy.  Dr. Satterlee also pointed out that there are several papers showing that there are multiple abuse substances that impact brain energy utilization in several ways.  A portfolio analysis across NIH revealed that there are only about 20 grants investigating this important area, and only one NIDA grant in this area was identified.  At the NIDA mini-convention at the last SfN, meeting, a session was held entitled “Brain Energetics and Neurotransmission:  Fueling Neurons and Glia”.  Several brain energetic researchers talked about their work and provided links to substance abuse.  Based on this background work, Dr. Satterlee proposed a concept focusing on substance use disorders and energy utilization in neurons and glia.  The purpose would be to investigate molecular regulation of brain energy and metabolism and its interaction with chronic substance use.  This initiative is intended to encourage researchers in substance abuse to explore brain energy utilization as well as to encourage researchers in brain energetic to add substance abuse exposure to some of their studies.  The concept would encourage both exploratory and hypothesis driven applications.  Council congratulated Dr. Satterlee for addressing this complex area of research and indicated support for this new activity.

    Third, Dr. Jamie Biswas presented a concept for medications development centers of excellence.  She noted the need for focusing efforts on medications development and pointed out the importance of staff involvement in this effort.  She emphasized that substantial programmatic involvement in a centers program is advantageous to all parties.  Council noted that a targeted approach would be of use and supported this concept.

11. There were no Public Comments

12. Adjourn

    The 113^th meeting of the National Advisory Council on Drug Abuse was adjourned at 1:00 p.m.

Certification

I hereby certify that the foregoing minutes are accurate and complete.

Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.