Strategic Planning and Priorities of the National Institute on Alcohol Abuse and Alcoholism American Recovery and Reinvestment Act of 2009 (ARRA) and Other Research Opportunities - PowerPoint PPT Presentation

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Strategic Planning and Priorities of the National Institute on Alcohol Abuse and Alcoholism American Recovery and Reinvestment Act of 2009 (ARRA) and Other Research Opportunities


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Title: Strategic Planning and Priorities of the National Institute on Alcohol Abuse and Alcoholism American Recovery and Reinvestment Act of 2009 (ARRA) and Other Research Opportunities

Strategic Planning and Priorities of the National
Institute on Alcohol Abuse and AlcoholismAmerican
Recovery and Reinvestment Act of 2009 (ARRA) and
Other Research Opportunities
Kenneth R. Warren, Ph.D. Acting Director National
Institute on Alcohol Abuse and Alcoholism
NIAAA Training Directors Meeting and Trainee
Workshop New Orleans, Louisiana March 13, 2009
  • History
  • 1970 - Created as the U.S. Governments
    principal agency for programs to understand,
    prevent, and treat alcohol abuse and alcoholism
  • 1993 - Became one of 27 science Institutes and
    Centers of the National Institutes of Health
  • Mission To support and promote the best science
    on alcohol and health for the benefit of all
  • understanding how alcohol use impacts normal and
    abnormal biological functions and behavior
  • improving the diagnosis, prevention, and
    treatment of alcohol-induced health disorders
    including alcohol dependence
  • reducing the harm caused by high-risk alcohol use
  • Thereby enhancing the quality of overall health

Why a Special Focus on Problems that Arise from
  • Alcohol is a part of the legal social context in
    many countries and cultures and is used on many
    ceremonial occasions such as marriage, birth, and
    death, and to enhance the enjoyment of social
  • And it is used by most individuals without posing
    harm to themselves or others
  • Nonetheless, alcohols misuse is a leading risk
    factor for morbidity and mortality in the United
    States and worldwide

Harmful Drinking is a Leading Risk Factor for
Disease Burden in the U.S.
  • 18 million Americans (8.5 of the population age
    18 and older) suffer from alcohol abuse or
  • Alcohol problems cost U.S. society an estimated
    185 billion annually
  • Alcohol consumption is among the top ten leading
    causes of DALYs
  • Among Actual Causes of Death Alcohol ranks 3rd
    with an estimated 85,000 annually

Disability-adjusted life years (years of
potential life lost due to death plus years of
healthy life lost to disability)
Two Distinct Patterns of Drinking Produces the
Most Harm
Binge Drinking (too much, too fast) 5/4
drinks/2 hours
Heavy Drinking (too much, too often) frequent
5/4 drinks/day
  • acute consequences including
  • unintentional death and injury
  • homicide and violence
  • suicide attempts
  • particularly prevalent among adolescents and
    young adults
  • chronic consequences including
  • liver cirrhosis
  • cardiovascular diseases
  • pancreatitis
  • dementia
  • alcohol dependence

Research Priorities from the NIAAAStrategic
NIAAA Strategic Planning
  • In 2006, NIAAA initiated a new Planning process
    to develop a Strategic Plan that would reflect
    priorities across all age categories and all
    scientific disciplines that impact upon alcohol
  • Given that science is moving at a greater pace
    than ever before a decision was made that the
    Plan would not be static but rather updated on a
    yearly basis to be always current.
  • The format was a life-course perspective
    graphically represented with the life-course

NIAAAs Alcohol Research Programs Are Addressing
Alcohol Issues Throughout The Lifespan
  • Lifespan Transcending Themes
  • Metabolism
  • Epigenetics
  • Epidemiology
  • AUD Diagnosis
  • Neurobiology
  • Health Services Research

Lifespan Transcending Theme Genes Environment
  • It is now well recognized that neither genes nor
    environment alone explains why an individual
    develops alcohol dependence or pathologies (FAS,
    ALD). Rather, it is the interplay of GxE.
  • Many genes in Alcohol Dependence already
    identified (GABRA2, GABRA6, COMT, OPMR1, etc.)
  • Opportunities include
  • Whole Genome Association Studies
  • Lymphoblastoid Cell Lines gene identification
    from the many existing genetic studies on
    alcoholism (COGA, etc.)

Lifespan Transcending ThemeEpigenetics
  • We know that alcohol is an epigenetic effecter
    agent. Shown thus far
  • Increase DNA methylation of the promoter region
    of ?-synuclein gene associated with alcohol
    dependence and craving in humans
  • (Chronic) demethylates genes for the NMDA
    receptor subunit NR2B
  • Differentially suppress ADH1A, 1B, 1C in human
    hepatoma cell line via histone methylation.
  • More evidence accumulating

Lifespan Transcending Theme Metabolism
  • Opportunities
  • Enhance understanding of the pharmacokinetics of
    alcohol to explain individual differential
    responses to alcohol as they relate to
    biological/behavioral vulnerabilities to harm
    from alcohol use
  • Understanding role of alcohol in generation of
    ROS, and impairment of oxidative defense
    mechanism to gain a better understanding of
    alcohol pathology
  • Metabolomics To understand metabolic effects of
    alcohol and its potential use as Biomarkers

Lifespan Transcending Theme Neuroscience
  • Identify the neurocircuits, neuropharmacology,
    and neurochemistry that underlies alcohols
    physiological and behavioral actions including
    the development of compulsive alcohol use
    (alcohol seeking, reinforcement, relapse)
  • Explore alcohol effects with the CNS at many
    levels from molecular and cellular to structural
    and cognitive to understand actions including
    learning, memory, tolerance, dependence

Alcohol and the Embryo and Fetus
  • Despite our knowledge on FASD many questions
  • At the molecular level, the role of gene
    expressions and epigenetics
  • Contributions to pathology from other risk
    factors e.g., stress and nutrition
  • Role of protective agents choline, NAP, SAL
  • Improvement in diagnosis 3-D facial imaging
    coupled to self-educating (machine learning)
    computer technology
  • Determining the true prevalence of FAS in the
  • Development of Interventions for FASD children

Early to Middle Childhood The Interval of
Emerging Risk
  • In early childhood, the interplay of biological
    and environmental factors shape normal
    development, as well as risk and resilience for
    abnormal development
  • There is an opportunity to pursue an enhanced
    understanding of the contributions of
  • biology (e.g., hormonal development)
  • environment, GxE (epigenetics)

as underlying factors for risk and resilience to
harmful alcohol use and Alcohol Dependence across
the FULL lifespan
  • Critical period risk of dependence increases
    inversely with age of onset of drinking
  • A time of heightened risk-taking for many.
  • Brain continues to mature through adolescence
    into perhaps the early or mid-20s
  • Scientific opportunities include
  • Adolescent decision-making
  • Alcohols effects on brain structures and
    behavioral regulatory systems through imaging
    (dtMRI, fMRI) and neurobehavioral assessment
  • Identifying endophenotypic and intermediate
    phenotypic markers of drinking risk
  • Establishing the extend of vulnerability of the
    adolescent brain to alcohols acute and chronic

Young Adult
  • (Age 18-29) Period with the highest prevalence
    of Alcohol Abuse and Alcohol Dependence
  • Many will transition out of dependence without
    treatment Important to understand WHY and how
    i.e., what is different in biology, personality,
  • Opportunity to determine functional differences
    through imaging (electrophysiology, fMRI, etc.)
    in those who will continue to be alcohol
    dependent and those who will transition out

Midlife Organ Pathology
  • Period when most organ pathologies become
    clinically significant
  • Important potential initiatives around metabolic
    effects on organs, liver and others
  • Important co-morbidity with Hepatitis C and HIV

Midlife Behavior Treatment
  • Period when most individuals will seek treatment
  • Even for those who enter treatment, major
    contributors to change may occur before
    entering treatment
  • Uncovering mechanisms of behavior change, and
    adapting that knowledge, will improve recovery
    for all

Midlife Medications Development
  • Many promising agents under test
  • Opportunities exist to
  • Develop animal models better reflecting
    endophenotypes in alcohol dependence
  • Develop improved human laboratory paradigms with
    surrogate outcome markers
  • Identify through basic research target sites for
    lead compounds
  • Expand pharmacogenetic research (Predictive and
    Personalized medicine)
  • Develop collaborative networks with industry and

Senior Adult
  • Only 0.5 of population reported past-year
    dependence 1.4 abuse
  • Greater potential for medications interactions
  • Growing population
  • Trans-NIH longitudinal research studies can
    provide important information of alcohol problems
    in seniors in a cost efficient manner

The American Recovery and Reinvestment Act of
2009 (ARRA)
  • On February 17, 2009 President Obama signed the
    American Recovery and Reinvestment Act of 2009
  • Among its many goals, the ARRA seeks to preserve
    and create jobs, promote economic recovery, and
    increase economic efficiency by spurring
    technological advances in science and health 
  • As part of the ARRA, NIH will receive 10 billion
    for use in 2009 and 2010 including
  • 1 billion for extramural construction
  • 800 million to the Office of the NIH Director
    for extending and developing appropriate programs
    (e.g., challenge grants)
  • 400 million for Comparative Effectiveness
  • 7.4 billion will be provided to the NIH
    institutes and centers (proportional to their

The American Recovery and Reinvestment Act of
2009 (ARRA)
  • The ARRA impact is expected to extend beyond the
    immediate scientists who will receive funds, to
    allied health workers, technicians, students,
    trade workers, etc.
  • Beyond the immediate economic stimulus, the
    science funded by the Recovery Act will
    positively impact upon the health of the nation
    for years to come 
  • Information about these critical projects and
    their impact on the economy will be posted on

What Funding Mechanisms Will Be Supported Under
In general, NIH will focus scientific activities
in several areas
  • Recently peer reviewed, highly meritorious R01
    and similar mechanisms capable of making
    significant advances with a two-year grant
  • Administrative and competitive supplements to
    current grants. 
  • Shared Instrumentation Grants 100K 500K
    (from NCRR)
  • High-End Instrumentation 600K - 8M (from NCRR)
  • Other Programs to be announced once approved
  • NIH Challenge Grant program RFA OD-09-003 due
    April 27. -- A new program that will support
    research which addresses specific scientific and
    health research challenges in biomedical and
    behavioral research that will benefit from
    significant 2-year jumpstart funds.

Challenge Grants
  • Each NIH Institute, Center, and Office has
    selected specific Challenge Topics within the
    broad Challenge Areas related to its mission that
    have been accorded the highest priority by the
  • Institute specific information available on each
    Institutes Web-Site.

Broad Challenge Areas
  • Behavior, Behavioral Change, and Prevention
  • Bioethics
  • Biomarker Discovery and Validation
  • Clinical Research
  • Comparative Effectiveness Research (CER)
  • Enabling Technologies
  • Enhancing Clinical Trials
  • Genomics
  • Health Disparities
  • Information Technology for Processing Health Care
  • Regenerative Medicine
  • Science, Technology, Engineering and Mathematics
    Education (STEM)
  • Smart Biomaterials Theranostics
  • Stem Cells
  • Translational Science

Challenge Areas with NIAAA Topics
Challenge Areas and Challenge Topics
  • Examples of high priority topics for NIAAA
  • Identifying Phenotypic Markers for Positive
    Behavior Change
  • Capturing Social Network Information for Groups
    at High Risk for Negative Health Behaviors
  • Ethical Issues in the Translation of Genetic
    Knowledge to Clinical Practice
  • Developing high-throughput biomarker assays from
    finger-stick dried blood spots
  • Medication Development for Hepatic Fibrosis
  • Innovative Analyses of Existing Clinical Datasets

Detailed information on NIH Challenge Areas,
Topics and Grants can be found on the NIH Website
Comparative Effectiveness Research (CER)
  • Recovery Act funds allocated to NIH specifically
    for comparative effectiveness research (CER) will
    be available to support additional grants
  • Projects receiving these funds will need to meet
    the definition of CER a rigorous evaluation of
    the impact of different options that are
    available for treating a given medical condition
    for a particular set of patients.
  • Such a study may for example compare similar
    treatments, analyze very different approaches,
    such as surgery and drug therapy, or include the
    development and use of clinical registries,
    clinical data networks, and other forms of
    electronic health data that can be used to
    generate or obtain outcome data as they apply to

Thank you
Kenneth R. Warren, Ph.D. Acting Director National
Institute on Alcohol Abuse and Alcoholism
Animal Rights ¹ Animal Welfare
1980s - a movement to defend the rights of
animals begins.
Tenet 1Animals should not be used for
clothing, food, entertainment, or experiments.
Tenet 2 Animals should have legal rights and
the status of personhood.
NIHs Proactive Animals in Research Agenda
  • To meet Immediate challenges
  • Give our staff tools to assist their grantees.
  • Provide better support to our investigators.
  • Work with funded institutions.
  • To address long-term challenges
  • Improve communications.
  • Document health impact.
  • Mobilize the stakeholders.

The use of animal models in biomedical research
is facing major challenges
I. Immediate challenge Guard the publics
investment in biomedical research from
threats violence
  • against institutions
  • against investigators and their families
  • against others who support research institutions
  • II. Long term challenges
  • Improve publics understanding of the role of
  • research to advance medicine and health
  • Change in societal views of relationship
  • humans and other animals
  • Change in the legal status of animals

Who should respond to this challenge?
  • Government
  • Funding Agencies
  • Research Institutions
  • Grantees
  • Biomedical and Pharmaceutical Industries
  • Professional Organizations
  • Advocates for Biomedical Research
  • The Public

What we advise you to do.
  • Learn about the laws to protect research
  • Be diligent about careful preparation of the
    sections of the grant application about animals.
  • Know where to get advise about animal research
    protocols your institutions Animal Care and Use
    Committee, the NIH Office of Laboratory Animal
    Welfare (OLAW), and your NIAAA project officer.
  • Understand how results of your research may
    contribute to the advancement of medicine and
    improvements in human health.

What we advise you to do, continued.
  • Understand when you must have changes in your
    research approved by your Animal Care and Use
    Committee, your NIAAA Project Officer, and/or
    NIAAA Grants Management.
  • Assess your vulnerabilities. Goggle yourself.
  • Know the preparedness plan and phone numbers to
    call for emergencies at your lab, office, and
  • Develop good relationships with you neighbors
    and the larger community where you live.

Some Web sites with useful information and
resources about the use of animals in
research A National Institutes of Health (NIH)
Web site http//
/index.htm Federation of American Societies for
Experimental Biology (FASEB) www.animalrightsextr Society for Neuroscience
inResearch see Animals in Research Resources
Universal Message for Alcohol Use Across The
Col. Evan Hoapili USAF (ret.), Francis E. Warren
Air Force Base, Cheyenne, Wyoming
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