Director’s Report to the National Advisory Council on Drug Abuse Director’s Report to the National Advisory Council on Drug Abuse September 20, 2006

Director’s Report to the National Advisory Council on Drug Abuse Director’s Report to the National Advisory Council on Drug Abuse Budget Update Recent NIDA Activities What’s NIH?

NIDA BUDGET (Thousands) IncreaseOver Prior Year IncreaseOver AIDSAIDS TOTALTOTAL NonAIDSNonAIDS $693,282 $313, Actual $1,006, % $699,956 $300, Approp. $1,000, % 2007 PB $695,563 $299,266 $994,829 $695,563 $299,266 $994, % 2007 House $994, % 2007 Senate $1,000,

What’s NIH? Adaptive Strategies in the Context of Changing Science and Public Health Elias A. Zerhouni, M.D., Director National Institutes of Health What’s NIH? Adaptive Strategies in the Context of Changing Science and Public Health Elias A. Zerhouni, M.D., Director National Institutes of Health

Challenge of Rising U.S. Health Expenditures Biomedical Research Must Deliver Challenge of Rising U.S. Health Expenditures Biomedical Research Must Deliver 8% 10% 12% 14% 16% 18% 20% National Health Expenditures as a Percent of GDP 1980 Actual Projected Source: Percent of U.S. GDP

What is NIH’s Core Strategic Vision? Transform medicine and health from a Curative to a Preemptive paradigm Accelerate fundamental research into our understanding of complex biological systems and their regulation at the earliest molecular stages of disease. Remove barriers to translation of these findings from the bench to the bedside Provide the evidence and knowledge base to enable our healthcare system to intervene before disease strikes and not after! Transform medicine and health from a Curative to a Preemptive paradigm Accelerate fundamental research into our understanding of complex biological systems and their regulation at the earliest molecular stages of disease. Remove barriers to translation of these findings from the bench to the bedside Provide the evidence and knowledge base to enable our healthcare system to intervene before disease strikes and not after!

Points of Tension Managing in Challenging Times? Large vs Small Scale science? Infrastructure vs hypothesis driven RO1s? Basic vs. translational research: What is the right balance? Peer review : what to do given demand/supply imbalance? How does NIH address public health issues How do we best communicate with constituencies How do we continue to support the best intra and extramural science by the best scientists ? What should be at the top of our agendas? Large vs Small Scale science? Infrastructure vs hypothesis driven RO1s? Basic vs. translational research: What is the right balance? Peer review : what to do given demand/supply imbalance? How does NIH address public health issues How do we best communicate with constituencies How do we continue to support the best intra and extramural science by the best scientists ? What should be at the top of our agendas?

Road Map II: Strategic Initiative Inclusion Criteria The overarching goal of all Roadmap initiatives is to accelerate the discovery and translation of scientific knowledge into public health benefits benefits. Roadmap is conceived of as a five to ten year ‘incubator space’ for NIH initiatives that meet all of the following criteria: initiative truly transforming –could it dramatically affect l Is the proposed initiative truly transforming –could it dramatically affect how biomedical and/or behavioral research is conducted over the next decade? synergistically promote and advance the individual missions l Will the outcomes from the proposed initiatives synergistically promote and advance the individual missions of the Institutes and Centers to benefit health? require participation from NIH as a whole l Does the proposed initiative require participation from NIH as a whole and/or does it address an area (s) of science that does not clearly fall within the mission of any one IC or OD program office? something that no other entity is likely or able to do l Is the proposed initiative something that no other entity is likely or able to do, and is there a public health benefit to having the results of the research in the public domain? The overarching goal of all Roadmap initiatives is to accelerate the discovery and translation of scientific knowledge into public health benefits benefits. Roadmap is conceived of as a five to ten year ‘incubator space’ for NIH initiatives that meet all of the following criteria: initiative truly transforming –could it dramatically affect l Is the proposed initiative truly transforming –could it dramatically affect how biomedical and/or behavioral research is conducted over the next decade? synergistically promote and advance the individual missions l Will the outcomes from the proposed initiatives synergistically promote and advance the individual missions of the Institutes and Centers to benefit health? require participation from NIH as a whole l Does the proposed initiative require participation from NIH as a whole and/or does it address an area (s) of science that does not clearly fall within the mission of any one IC or OD program office? something that no other entity is likely or able to do l Is the proposed initiative something that no other entity is likely or able to do, and is there a public health benefit to having the results of the research in the public domain?

Schedule for Roadmap II July 3 consultation meetings with extramural scientists August Submission of initiative concepts from IC September 2 additional consultation meetings Pilot test ‘responsiveness determination’ process on nominations to date October Release RFI for comments idea nominations from the broad public/research community November Mini-Retreat to review and prioritize idea nominations July 3 consultation meetings with extramural scientists August Submission of initiative concepts from IC September 2 additional consultation meetings Pilot test ‘responsiveness determination’ process on nominations to date October Release RFI for comments idea nominations from the broad public/research community November Mini-Retreat to review and prioritize idea nominations

NIDA Council Workgroups

The National Advisory Council on Drug Abuse Work Group On NIDA’s Approach to Grant-Making NIDA Council Constance Weisner, Dr.P.H., M.S.W. Chair David Vlahov, Ph.D. Claire E. Sterk, Ph.D. Mark Greenberg, Ph.D. Rodolfo Arredondo, Jr., Ed.D. Linda Porrino, Ph.D. Members Scott Lucas, Ph.D. Kathleen Carroll, Ph.D. Tom Kosten, M.D.

Number of New and Established Investigators Receiving Competing R01s

New Investigators on R01 Awards as a Percentage of Competing Investigators

NIDA Council Members Linda Porrino, Ph.D, Chair Barry Lester, Ph.D. John P. Rice, Ph.D. Frank Ivy Carroll, Ph.D Yasmin Hurd, Ph.D. Guy Cabral, Ph.D. Stanley Watson, M.D., Ph.D. Marina Picciotto, Ph.D. Michael Nader, Ph.D. Kathryn Cunningham, Ph.D. The National Advisory Council on Drug Abuse Basic Science Review Work Group

Social Neuroscience (RFA-DA ) 61 Applications Areas Included: Risk Taking, Decision Making, Affect Regulation, Social Isolation, Stress 61 Applications Areas Included: Risk Taking, Decision Making, Affect Regulation, Social Isolation, Stress Prescription Opioid Use and Abuse in the Treatment of Pain (RFA-DA ) 89 Applications Areas Included: Epidemiology, Clinical Neuroscience, Basic Research, Prevention and Treatment Research 89 Applications Areas Included: Epidemiology, Clinical Neuroscience, Basic Research, Prevention and Treatment Research Epigenetics of Addiction (RFA-DA ) 43 Applications Areas Included: Addiction, Cocaine, Opiates, Chromatin Modulation, Methylation, sRNAs, Allele Specific Gene Expression 43 Applications Areas Included: Addiction, Cocaine, Opiates, Chromatin Modulation, Methylation, sRNAs, Allele Specific Gene Expression

Genes, Environment & Development Initiative (GEDI)

Portfolio Review Review of 87 studies across three portfolios: –Genetic epidemiology –Longitudinal epidemiology –Prenatal exposure Many studies seem likely to meet the minimum application criteria: –Longitudinal design –Subjects are in or through period of risk for drug use –Rich environmental data at multiple levels –Data waves span at least 2 developmental periods –Categorical and quantitative drug use phenotypes –Categorical and quantitative psychiatric phenotypes –Ability to collect and share DNA (some already have DNA) Review of 87 studies across three portfolios: –Genetic epidemiology –Longitudinal epidemiology –Prenatal exposure Many studies seem likely to meet the minimum application criteria: –Longitudinal design –Subjects are in or through period of risk for drug use –Rich environmental data at multiple levels –Data waves span at least 2 developmental periods –Categorical and quantitative drug use phenotypes –Categorical and quantitative psychiatric phenotypes –Ability to collect and share DNA (some already have DNA)

GEDI Vision Funded U01 grant(s) will include – Genetic material – Environmental influences – Developmental level/status at period of exposure – Diverse phenotypes (quantitative & categorical) And assess interactions Funded U01 grant(s) will include – Genetic material – Environmental influences – Developmental level/status at period of exposure – Diverse phenotypes (quantitative & categorical) And assess interactions GEDI Study Genetic component Environmental component Developmental component Phenotypic component Provide Usable Resources Contributions to Field Foundation for Fine Mapping of GEDI Components Results Main effects G x E G x D E x D G x E x D

National Institute on Drug Abuse Special Populations Office Division of Basic Neurosciences & Behavior Research Division of Basic Neurosciences & Behavior Research Office of Extramural Affairs Office of Extramural Affairs Office of Planning & Resource Management Office of Planning & Resource Management Office of Science Policy & Communications Office of Science Policy & Communications Intramural Research Program Intramural Research Program Division of Epidemiology, Services & Prevention Research Division of Epidemiology, Services & Prevention Research Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Pharmacotherapies & Medical Consequences of Drug Abuse Center for the Clinical Trials Network Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Associate Director for Management Division of Clinical Neuroscience & Behavioral Research Division of Clinical Neuroscience & Behavioral Research Joseph Frascella, PhD Director, AIDS Research DBNBR

Genome-wide association scans Gene variants What is the functional significance? What is the functional significance? Need: Functional validation of gene variant Capitalize on: – NIH Knockout Mouse Project – High-throughput genetic and RNAi methods – Research in GEI (FY11&12) Use genetic models to: – Investigate mechanisms of drug dependence – Test potential therapeutics Need: Functional validation of gene variant Capitalize on: – NIH Knockout Mouse Project – High-throughput genetic and RNAi methods – Research in GEI (FY11&12) Use genetic models to: – Investigate mechanisms of drug dependence – Test potential therapeutics Functional Genomics (PA)

National Institute on Drug Abuse Special Populations Office Division of Basic Neurosciences & Behavior Research Division of Basic Neurosciences & Behavior Research Office of Extramural Affairs Office of Extramural Affairs Office of Planning & Resource Management Office of Planning & Resource Management Office of Science Policy & Communications Office of Science Policy & Communications Intramural Research Program Intramural Research Program Division of Epidemiology, Services & Prevention Research Division of Epidemiology, Services & Prevention Research Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Pharmacotherapies & Medical Consequences of Drug Abuse Center for the Clinical Trials Network Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Associate Director for Management Division of Clinical Neuroscience & Behavioral Research Division of Clinical Neuroscience & Behavioral Research Joseph Frascella, PhD Director, AIDS Research DCNBR

deCharms, R. Christopher et al. (2005) Proc. Natl. Acad. Sci. USA 102, Use of fMRI Activation Signals as Feedback to Control Specific Brain Regions Learned Control Over Activation and Pain Modulation Learned Control Over Activation and Pain Modulation

National Institute on Drug Abuse Special Populations Office Division of Basic Neurosciences & Behavior Research Division of Basic Neurosciences & Behavior Research Office of Extramural Affairs Office of Extramural Affairs Office of Planning & Resource Management Office of Planning & Resource Management Office of Science Policy & Communications Office of Science Policy & Communications Intramural Research Program Intramural Research Program Division of Epidemiology, Services & Prevention Research Division of Epidemiology, Services & Prevention Research Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Pharmacotherapies & Medical Consequences of Drug Abuse Center for the Clinical Trials Network Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Associate Director for Management Division of Clinical Neuroscience & Behavioral Research Division of Clinical Neuroscience & Behavioral Research Joseph Frascella, PhD Director, AIDS Research DPMCDA

1.GO Talampanel (Antiepileptic; AMPA antagonist) GVG (Antiepileptic; inbibitor GABA transaminase) Topiramate (Antiepileptic; multiple mechanisms) Modafinil (multiple mechanisms) 2. Data missing for decision Disulfiram Aripiprazole 3. NO GO GBR Mirtazapine Quetiapine Selegiline Ondasetron 1.GO Talampanel (Antiepileptic; AMPA antagonist) GVG (Antiepileptic; inbibitor GABA transaminase) Topiramate (Antiepileptic; multiple mechanisms) Modafinil (multiple mechanisms) 2. Data missing for decision Disulfiram Aripiprazole 3. NO GO GBR Mirtazapine Quetiapine Selegiline Ondasetron Scientific Board Recommendations Clinical Evaluation of Medications

National Institute on Drug Abuse Special Populations Office Division of Basic Neurosciences & Behavior Research Division of Basic Neurosciences & Behavior Research Office of Extramural Affairs Office of Extramural Affairs Office of Planning & Resource Management Office of Planning & Resource Management Office of Science Policy & Communications Office of Science Policy & Communications Intramural Research Program Intramural Research Program Division of Epidemiology, Services & Prevention Research Division of Epidemiology, Services & Prevention Research Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Pharmacotherapies & Medical Consequences of Drug Abuse Center for the Clinical Trials Network Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Associate Director for Management Division of Clinical Neuroscience & Behavioral Research Division of Clinical Neuroscience & Behavioral Research Joseph Frascella, PhD Director, AIDS Research DESPR

What Do We Know? Drug Abuse Treatment for

NIDA’s Criminal Justice Initiative Published “Principles of Drug Addiction Treatment for Criminal Justice Populations” Press Conference -- July 24, 2006 Special Criminal Justice & Drug Abuse Web Page Featuring Slide Presentations, Fact Sheets and other info Training for Judges in collaboration with Illinois TASC “Drug Abuse as a Cause, Correlate, or Consequence of Criminal Justice Related Health Disparities Among African Americans (R01)” PA Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) Published “Principles of Drug Addiction Treatment for Criminal Justice Populations” Press Conference -- July 24, 2006 Special Criminal Justice & Drug Abuse Web Page Featuring Slide Presentations, Fact Sheets and other info Training for Judges in collaboration with Illinois TASC “Drug Abuse as a Cause, Correlate, or Consequence of Criminal Justice Related Health Disparities Among African Americans (R01)” PA Criminal Justice Drug Abuse Treatment Studies (CJ-DATS) One in 4 People With HIV Will Go Through the Criminal Justice System One in 4 People With HIV Will Go Through the Criminal Justice System HIV/AIDS Prevention is of Paramount Importance Here HIV/AIDS Prevention is of Paramount Importance Here

National Institute on Drug Abuse Special Populations Office Division of Basic Neurosciences & Behavior Research Division of Basic Neurosciences & Behavior Research Office of Extramural Affairs Office of Extramural Affairs Office of Planning & Resource Management Office of Planning & Resource Management Office of Science Policy & Communications Office of Science Policy & Communications Intramural Research Program Intramural Research Program Division of Epidemiology, Services & Prevention Research Division of Epidemiology, Services & Prevention Research Division of Pharmacotherapies & Medical Consequences of Drug Abuse Division of Pharmacotherapies & Medical Consequences of Drug Abuse Center for the Clinical Trials Network Center for the Clinical Trials Network Teresa Levitin, PhD Laura Rosenthal Timothy Condon, PhD Betty Tai, PhD David Shurtleff, PhD Frank Vocci, PhD Wilson Compton, MD, MPE Barry Hoffer, MD, PhD Office of the Director Nora D. Volkow, MD Director Timothy P. Condon, Ph.D. Deputy Director Laura S. Rosenthal Associate Director for Management Associate Director for Management Division of Clinical Neuroscience & Behavioral Research Division of Clinical Neuroscience & Behavioral Research Joseph Frascella, PhD Director, AIDS Research CCTN

1,000,000 people in USA are infected with HIV – 40,000 new cases each year – 250,000 – 300,000 of persons with HIV are unaware they are infected – ¼ of persons who test HIV+ fail to return to receive results CDC now recommends offering routine HIV testing to persons at risk for HIV 1,000,000 people in USA are infected with HIV – 40,000 new cases each year – 250,000 – 300,000 of persons with HIV are unaware they are infected – ¼ of persons who test HIV+ fail to return to receive results CDC now recommends offering routine HIV testing to persons at risk for HIV Integrating HIV Rapid Testing and Counseling into Drug Treatment FDA approved blood from a finger stick or oral fluid 20 minutes $12-15/kit can be done by counselors FDA approved blood from a finger stick or oral fluid 20 minutes $12-15/kit can be done by counselors HIV Rapid Test

Recent and Upcoming Meetings, Conferences and Events Recent and Upcoming Meetings, Conferences and Events

13 th World Conference on Tobacco OR Health building capacity for a tobacco-free world July 12-15, 2006 Washington, D.C.

Sixth Annual Conference Drug Abuse and HIV/AIDS: Implications for the Hispanic Population September 13-16, 2006 Scottsdale, Arizona

Preventing Drug Abuse: Putting Science to Practice for Real World Solutions Preventing Drug Abuse: Putting Science to Practice for Real World Solutions A Congressional Briefing Sponsored by The FRIENDS OF NIDA Monday, June 12, 2006 Noon - 2:00 pm Rayburn House Office Building Room 2168 (Gold Room) Monday, June 12, 2006 Noon - 2:00 pm Rayburn House Office Building Room 2168 (Gold Room)

NIDA-Sponsored Mini-Convention at the 2006 Meeting of the Society for Neuroscience NIDA-Sponsored Mini-Convention at the 2006 Meeting of the Society for Neuroscience

Conclusions Fundamentally, as an Institute, NIDA is doing well in protecting early career investigators in this era of shrinking funding opportunities. NIDA is currently promoting innovative research via a number of standard mechanisms. Improvements on all of these fronts can be made by NIDA continuing activities such as: – collecting accurate data on new investigators – increasing use of mechanisms that stress innovation and nurture early investigators (e.g., B/START) – educating PIs that training/mentorship must be present in all multi-grant or large grant environments – increasing the funding and scope of Mentored K Awards – establishing an Innovation Committee – increasing awareness of the various trans-NIH initiatives, such and the Roadmap and Blueprint. Fundamentally, as an Institute, NIDA is doing well in protecting early career investigators in this era of shrinking funding opportunities. NIDA is currently promoting innovative research via a number of standard mechanisms. Improvements on all of these fronts can be made by NIDA continuing activities such as: – collecting accurate data on new investigators – increasing use of mechanisms that stress innovation and nurture early investigators (e.g., B/START) – educating PIs that training/mentorship must be present in all multi-grant or large grant environments – increasing the funding and scope of Mentored K Awards – establishing an Innovation Committee – increasing awareness of the various trans-NIH initiatives, such and the Roadmap and Blueprint.

Conclusions/Summary DBNBR has established strong research programs central to the mission of NIDA: to bring the power of science to bear on problems of drug abuse. DBNBR plays a critical role in translation of basic science conducted in their division to studies of human patients conducted in other NIDA divisions Opportunities to enhance basic science include: – Investment in emerging areas of social neuroscience and epigenetics – Strengthened dissemination of services – Continued fostering of the careers of new investigators – Continued emphasis on the “revolution” in the ways science will be conducted in the future DBNBR has established strong research programs central to the mission of NIDA: to bring the power of science to bear on problems of drug abuse. DBNBR plays a critical role in translation of basic science conducted in their division to studies of human patients conducted in other NIDA divisions Opportunities to enhance basic science include: – Investment in emerging areas of social neuroscience and epigenetics – Strengthened dissemination of services – Continued fostering of the careers of new investigators – Continued emphasis on the “revolution” in the ways science will be conducted in the future