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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. Kenneth R. Warren, Ph.D. Acting Director National Institute on Alcohol Abuse and Alcoholism. - PowerPoint PPT Presentation
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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 Director’s Meeting andTrainee Workshop
New Orleans, LouisianaMarch 13, 2009
DRAFT 3 - 2NIAAA Training Meeting – 03/13/2009
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History
1970 - Created as the U.S. Government’s 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 (NIH)
Mission: To support and promote the best science on alcohol and health for the benefit of all including:
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 care
DRAFT 3 - 3NIAAA Training Meeting – 03/13/2009
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Why a Special Focus on Problems that Arise from Alcohol?
Why a Special Focus on Problems that Arise from Alcohol?
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 gatherings
And it is used by most individuals without posing harm to themselves or others
Nonetheless, alcohol’s misuse is a leading risk factor for morbidity and mortality in the United States and worldwide
DRAFT 3 - 4NIAAA Training Meeting – 03/13/2009
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18 million Americans (8.5% of the population age 18 and older) suffer from alcohol abuse or dependence
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
Harmful Drinking is a Leading Risk Factor for Disease Burden in the U.S.
Harmful Drinking is a Leading Risk Factor for Disease Burden in the U.S.
*Disability-adjusted life years (years of potential life lost due to death plus years of healthy life lost to disability)
DRAFT 3 - 5NIAAA Training Meeting – 03/13/2009
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Two Distinct Patterns of Drinking Produces the Most Harm
Two Distinct Patterns of Drinking Produces the Most Harm
acute consequences including:
unintentional death and injury
homicide and violence
suicide attempts
particularly prevalent among adolescents and young adults
chronic consequences including:liver cirrhosiscardiovascular diseasespancreatitisdementiaalcohol dependence
Binge Drinking(too much, too
fast)5+/4+ drinks/2
hours
Binge Drinking(too much, too
fast)5+/4+ drinks/2
hours
Heavy Drinking(too much, too
often)frequent 5+/4+
drinks/day
Heavy Drinking(too much, too
often)frequent 5+/4+
drinks/day
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from the NIAAA
Strategic Plan
DRAFT 3 - 7NIAAA Training Meeting – 03/13/2009
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NIAAA Strategic PlanningNIAAA 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 science.
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 rainbow:
DRAFT 3 - 8NIAAA Training Meeting – 03/13/2009
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NIAAA’s Alcohol Research Programs Are Addressing Alcohol Issues Throughout The Lifespan
NIAAA’s Alcohol Research Programs Are Addressing Alcohol Issues Throughout The Lifespan
PrenatalAlcohol
Exposure
Binge Drinking
Alcoholic Family
Environment
Alcohol Dependence Medication
Interactions
Organ Damage
Lifespan Transcending
Themes
Metabolism
Epigenetics
Epidemiology
AUD Diagnosis
Neurobiology
Health Services Research
DRAFT 3 - 9NIAAA Training Meeting – 03/13/2009
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Lifespan Transcending Theme: Genes & Environment
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.)
DRAFT 3 - 10NIAAA Training Meeting – 03/13/2009
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Lifespan Transcending Theme:Epigenetics
Lifespan Transcending Theme:Epigenetics
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
DRAFT 3 - 11NIAAA Training Meeting – 03/13/2009
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Lifespan Transcending Theme: Metabolism
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
DRAFT 3 - 12NIAAA Training Meeting – 03/13/2009
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Lifespan Transcending Theme: NeuroscienceLifespan Transcending Theme: Neuroscience
Identify the neurocircuits, neuropharmacology, and neurochemistry that underlies alcohol’s 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
DRAFT 3 - 13NIAAA Training Meeting – 03/13/2009
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Alcohol and the Embryo and FetusAlcohol and the Embryo and Fetus
Despite our knowledge on FASD many questions remain:
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 U.S.
Development of Interventions for FASD children
DRAFT 3 - 14NIAAA Training Meeting – 03/13/2009
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Early to Middle Childhood: The Interval of Emerging Risk
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
DRAFT 3 - 15NIAAA Training Meeting – 03/13/2009
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Youth/AdolescenceYouth/Adolescence
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-20’s
Scientific opportunities include:
Adolescent decision-making
Alcohol’s 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 alcohol’s acute and chronic effects
DRAFT 3 - 16NIAAA Training Meeting – 03/13/2009
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Young AdultYoung 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, environment
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
DRAFT 3 - 17NIAAA Training Meeting – 03/13/2009
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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
DRAFT 3 - 18NIAAA Training Meeting – 03/13/2009
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Midlife: Behavior & TreatmentMidlife: Behavior & Treatment
Period when most individuals will seek treatment
Even for those who enter treatment, major contributors to “change” may occur before entering treatment
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p o p u latio n
1 8 + yr s . - N IA A A N ES A R C ( Gr an t, e t al ., (2 0 0 4 ) D r u g an d A lc oh ol D e pe n de n c e , 7 4 :2 2 3 -2 3 4 )1 2 -1 7 yr s - U.S . S u bs tan c e A bu s e an d M e n tal He al th S e r vic e s A dm in i s tr ation 2 0 0 3 N ation al S u r ve y on D r u g Us e an d He al th (N S D UH)
(s oc ial / in te r pe r s on al ) (ph ar m ac olog ic al /be h avior al )
Uncovering mechanisms of behavior change, and adapting that knowledge, will improve recovery for all
DRAFT 3 - 19NIAAA Training Meeting – 03/13/2009
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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 academia
DRAFT 3 - 20NIAAA Training Meeting – 03/13/2009
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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
DRAFT 3 - 21NIAAA Training Meeting – 03/13/2009
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mThe American Recovery and Reinvestment Act
of 2009 (ARRA) The American Recovery and Reinvestment Act
of 2009 (ARRA)
On February 17, 2009 President Obama signed the American Recovery and Reinvestment Act of 2009 (ARRA)
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 Research
$7.4 billion will be provided to the NIH institutes and centers (proportional to their appropriations)
DRAFT 3 - 22NIAAA Training Meeting – 03/13/2009
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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 HHS/RECOVERY.gov
The American Recovery and Reinvestment Act of 2009 (ARRA)
The American Recovery and Reinvestment Act of 2009 (ARRA)
DRAFT 3 - 23NIAAA Training Meeting – 03/13/2009
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What Funding Mechanisms Will Be Supported Under The ARRA?
What Funding Mechanisms Will Be Supported Under The ARRA?
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.
In general, NIH will focus scientific activities in several areas:
DRAFT 3 - 24NIAAA Training Meeting – 03/13/2009
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Challenge GrantsChallenge 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 NIH
Institute specific information available on each Institutes Web-Site.
DRAFT 3 - 25NIAAA Training Meeting – 03/13/2009
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Broad Challenge AreasBroad 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 Data
Regenerative Medicine *
Science, Technology, Engineering and Mathematics Education (STEM)
Smart Biomaterials – Theranostics
Stem Cells *
Translational Science *
*Challenge Areas with NIAAA Topics
DRAFT 3 - 26NIAAA Training Meeting – 03/13/2009
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Challenge Areas and Challenge TopicsChallenge Areas and Challenge Topics
Examples of high priority topics for NIAAA include:
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 DatasetsDetailed information on NIH Challenge Areas, Topics and Grants can
be found on the NIH Website (http://grants.nih.gov/grants/funding/challenge_award/)
DRAFT 3 - 27NIAAA Training Meeting – 03/13/2009
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(CER)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 CER
DRAFT 3 - 28NIAAA Training Meeting – 03/13/2009
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Kenneth R. Warren, Ph.D.Acting Director
National Institute on Alcohol Abuse and Alcoholism
Thank you
http://www.niaaa.nih.gov
DRAFT 3 - 29NIAAA Training Meeting – 03/13/2009
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1980’s - a movement to defend the “rights” of animals begins.
Tenet 1:“Animals should not be used for clothing, food, entertainment, or experiments.”
Animal Rights Animal Welfare
Tenet 2: “Animals should have legal rights and the status of personhood.”
DRAFT 3 - 30NIAAA Training Meeting – 03/13/2009
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NIH’s Proactive Animals in Research Agenda
To address long-term challenges:
• Improve communications. • Document health impact.• Mobilize the stakeholders.
To meet Immediate challenges:
• Give our staff tools to assist their grantees.• Provide better support to our investigators.• Work with funded institutions.
DRAFT 3 - 31NIAAA Training Meeting – 03/13/2009
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The use of animal models in biomedical research is facing The use of animal models in biomedical research is facing major challenges …major challenges …
II. Long term challenges:
• Improve public’s understanding of the role of animal research to advance medicine and health • Change in societal views of relationship between humans and other animals• Change in the legal status of animals
– against institutions– against investigators and their families– against others who support research institutions
I. Immediate challenge:
Guard the public’s investment in biomedical research from threats & violence
DRAFT 3 - 32NIAAA Training Meeting – 03/13/2009
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Who should respond to this challenge?
• Government
• Funding Agencies
• Research Institutions
• Grantees
• Biomedical and Pharmaceutical Industries
• Professional Organizations
• Advocates for Biomedical Research
• The Public
DRAFT 3 - 33NIAAA Training Meeting – 03/13/2009
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What we advise you to do.
• Learn about the laws to protect research animals.
• Be diligent about careful preparation of the sections of the grant application about animals.
• Know where to get advise about animal research protocols: your institution’s 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.
DRAFT 3 - 34NIAAA Training Meeting – 03/13/2009
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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 home.
• Develop good relationships with you neighbors and the larger community where you live.
DRAFT 3 - 35NIAAA Training Meeting – 03/13/2009
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Some Web sites with useful information and resources about the use of animals in research:
A National Institutes of Health (NIH) Web site: http://grants.nih.gov/grants/policy/air/index.htm
Federation of American Societies for Experimental Biology (FASEB): www.animalrightsextremism.org
Society for Neuroscience: http://www.sfn.org/index.aspx?pagename=gpa_AnimalsinResearch see Animals in Research Resources
DRAFT 3 - 36NIAAA Training Meeting – 03/13/2009
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Universal Message for Alcohol Use Across The Lifespan
Universal Message for Alcohol Use Across The Lifespan
Col. Evan Hoapili USAF (ret.), Francis E. Warren Air Force Base, Cheyenne, Wyoming
