Director’s Report to the National Advisory Council on Drug Abuse

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

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

3. NIDA BUDGET (Thousands) 2007PB 2007House 2007Senate 2005Actual 2006Approp. $693,282 $699,956 $695,563 $299,266 $994,829 $994,829 $1,000,342 NonAIDS $313,137 $300,073 AIDS $1,006,419 $1,000,029 TOTAL Increase Over Prior Year --- +1.2% -0.6% -0.5% -0.5%

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

5. Challenge of Rising U.S. Health Expenditures Biomedical Research Must Deliver 20% National Health Expenditures as a Percent of GDP Actual Projected 18% 16% 14% Percent of U.S. GDP 12% 10% 8% 1988 1994 2003 2009 1980 1982 1985 1991 1997 2000 2006 2012 2015 Source: http://new.cms.hhs.gov/NationalHealthExpendData/downloads/nheprojections2004-2014.pdf

6. What is NIH’s Core Strategic Vision? • Transform medicine and health from a Curativeto 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 systemto intervene before disease strikes and not after!

7. Points of TensionManaging in Challenging Times? • Largevs 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?

8. 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. Roadmap is conceived of as a five to ten year ‘incubator space’ for NIH initiatives that meet all of the following criteria: • Is the proposed initiative truly transforming –could it dramatically affect how biomedical and/or behavioral research is conducted over the next decade? • Will the outcomes from the proposed initiatives synergistically promote and advance the individual missions of the Institutes and Centers to benefit health? • 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? • 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?

9. 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

10. NIDA Council Workgroups

11. 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.

12. 8,000 40% 7,000 35% 6,000 30% 5,000 25% Number of Grants Percent of Grants to New Investigators 4,000 20% 3,000 15% 2,000 10% 1,000 5% 0 0% 1972 1970 1962 1964 1966 1968 1974 1976 1978 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 Fiscal Year New Investigators Established Investigators Percent New Investigators Number of New and Established Investigators Receiving Competing R01s

13. FY 2004 FY 2005 FY 2006 New - T1 New - T1 New - T1 IC IC IC 75.0% 66.7% 70.0% 1 FIC 1 FIC 1 FIC 26.1% 35.3% 50.0% 2 NINR 2 NINR 2 NCCAM 24.4% 30.0% 42.9% 3 NIDCD 3 NLM 3 NLM 23.9% 23.4% 33.3% 4 NICHD 4 NIDCD 4 NINR 22.0% 23.1% 28.1% 5 NHGRI 5 NCI 5 NIBIB 21.8% 22.7% 22.1% 6 NIA 6 NIBIB 6 NIAAA 21.4% 21.1% 20.8% 7 NCCAM 7 NIAMS 7 NINDS 21.0% 19.5% 20.7% 8 NIEHS 8 NICHD 8 NHLBI 20.7% 19.5% 20.4% 9 NCI 9 NIMH 9 NCI 20.1% 19.4% 20.0% 10 NIMH 10 NHGRI 10 NCRR 20.0% 18.0% 19.7% 11 NCRR 11 NIH 11 NIDA 18.7% 17.3% 19.0% 12 NIAID 12 NHLBI 12 NIGMS 18.6% 16.9% 18.6% 13 NIH 13 NIGMS 13 NIDCD 18.2% 16.4% 18.5% 14 NIDCR 14 NINDS 14 NIH 18.1% 16.1% 17.9% 15 NHLBI 15 NEI 15 NICHD 17.9% 15.9% 17.9% 16 NINDS 16 NIEHS 16 NIAID 17.5% 15.8% 16.7% 17 NIGMS 17 NIAID 17 NHGRI 16.9% 15.7% 15.8% 18 NIDDK 18 NIDCR 18 NIMH 16.4% 15.3% 14.9% 19 NIAAA 19 NIDA 19 NEI 16.2% 14.9% 13.7% 20 NIAMS 20 NIDDK 20 NIDDK 14.9% 14.5% 13.7% 21 NIBIB 21 NIA 21 NIAMS 14.3% 11.2% 13.3% 22 NLM 22 NIAAA 22 NIA 12.5% 8.3% 13.3% 23 NEI 23 NCRR 23 NIDCR 11.6% 7.7% 10.5% 24 NIDA 24 NCCAM 24 NIEHS New Investigators on R01 Awards as a Percentage of Competing Investigators

14. The National Advisory Council on Drug Abuse Basic Science Review Work Group NIDA Council Linda Porrino, Ph.D, Chair Barry Lester, Ph.D. John P. Rice, Ph.D. Members 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.

15. Social Neuroscience (RFA-DA-06-004) 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-06-005) 89 Applications Areas Included: Epidemiology, Clinical Neuroscience, Basic Research, Prevention and Treatment Research Epigenetics of Addiction (RFA-DA-06-007) 43 Applications Areas Included: Addiction, Cocaine, Opiates, Chromatin Modulation, Methylation, sRNAs, Allele Specific Gene Expression

16. Genes, Environment & Development Initiative (GEDI)

17. 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)

18. Provide Usable Resources Genetic component Environmental component GEDI Study Results Contributions to Field • Main effects • G x E • G x D • E x D • G x E x D Developmental component Phenotypic component Foundation for Fine Mapping of GEDI Components 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

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

20. 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) Genome-wide association scans Gene variants What is the functional significance?

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

22. Use of fMRI Activation Signals as Feedback to Control Specific Brain Regions Learned Control Over Activation and Pain Modulation deCharms, R. Christopher et al. (2005) Proc. Natl. Acad. Sci. USA 102, 18626-18631

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

24. Scientific Board Recommendations Clinical Evaluation of Medications 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 12909 Mirtazapine Quetiapine Selegiline Ondasetron

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

26. Drug Abuse Treatment for Criminal Justice Populations What Do We Know?

27. One in 4 People With HIV Will Go Through the Criminal Justice System 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) HIV/AIDS Prevention is of Paramount Importance Here

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

29. Integrating HIV Rapid Testing and Counseling into Drug Treatment HIV Rapid Test • 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 • FDA approved • blood from a finger stick or oral fluid • 20 minutes • $12-15/kit • can be done by counselors

30. Recent and Upcoming Meetings, Conferences and Events

31. 13th World Conference on Tobacco OR Health building capacity for a tobacco-free world July 12-15, 2006 Washington, D.C. www.13thwctoh.org

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

33. 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)

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

36. 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.

37. 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