Director

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Directors Report to the National Advisory
Council on Drug Abuse
September 20, 2006
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(No Transcript)
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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
---
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Whats New _at_ NIH? Adaptive Strategies in the
Context of Changing Science and Public Health
Elias A. Zerhouni, M.D., Director National
Institutes of Health
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Challenge of Rising U.S. Health
Expenditures Biomedical Research Must Deliver
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National Health Expenditures as a Percent of GDP
Actual Projected
18
16
14
Percent of U.S. GDP
12
10
8
2012
2009
2006
2003
2000
1997
1994
1991
1988
1985
1982
1980
2015
Source http//new.cms.hhs.gov/NationalHealthExpen
dData/downloads/nheprojections2004-2014.pdf
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What is NIHs 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!

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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?

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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?

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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

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NIDA Council Workgroups
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The National Advisory Council on Drug Abuse Work
Group On NIDAs 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.
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Number of New and Established Investigators
Receiving Competing R01s
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New Investigators on R01 Awards as a Percentage
of Competing Investigators
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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.
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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
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Genes, Environment Development Initiative
(GEDI)
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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)

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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

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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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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Functional Genomics (PA)

• Need Functional validation of gene variant
• Capitalize on
• NIH Knockout Mouse Project
• High-throughput genetic and RNAi methods
• Research in GEI (FY1112)
• Use genetic models to
• Investigate mechanisms of drug dependence
• Test potential therapeutics

Genome-wide association scans
Gene variants
What is the functional significance?
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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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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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
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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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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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

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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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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(No Transcript)
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One in 4 People With HIV Will Go Through the
Criminal Justice System
NIDAs 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
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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
Barry Hoffer, MD, PhD
Joseph Frascella, PhD
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HIV Rapid Test
Integrating HIV Rapid Testing and Counseling
into Drug Treatment

• 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

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Recent and Upcoming Meetings, Conferences and
Events
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13th World Conference on Tobacco OR Health
building capacity for a tobacco-free world
July 12-15, 2006 Washington, D.C.
www.13thwctoh.org
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Sixth Annual Conference
Drug Abuse and HIV/AIDS Implications for the
Hispanic Population
September 13-16, 2006 Scottsdale, Arizona
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(No Transcript)
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NIDA-Sponsored Mini-Convention at the 2006
Meeting of the Society for Neuroscience
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(No Transcript)
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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.

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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