Wednesday, April 2, 2014

Mr. Chairman and Members of the Committee:

As the new Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) of the National Institutes of Health (NIH), I am pleased to present the President’s Budget request for the Institute.  The fiscal year (FY) 2015 NIAAA budget request of $446,017,000 reflects an increase of $606,000 over the comparable FY 2014 enacted level of $445,411,000.

SCOPE OF THE PROBLEM

Excessive alcohol use has profound effects on individuals, families and communities; and the Centers for Disease Control and Prevention (CDC) estimates that excessive alcohol consumption cost the U.S. $224 billion in 2006.  In 2012, nearly one quarter of the U.S. population aged 21 and older and over 15% of young people ages 12-20 reported binge drinking (i.e. consuming five or more drinks on a single occasion) at least once in the past month, according to the Substance Abuse and Mental Health Services Administration (SAMHSA).  Binge drinking has serious acute and long term consequences – both for youth and adults.  NIAAA estimates that 18 million Americans have an alcohol use disorder (AUD) and NIAAA research has established an important connection between early alcohol use and the development and severity of AUD.  Of those who meet the criteria for an AUD, only about 15 percent ever seek treatment. 

NIAAA RESEARCH

To reduce the considerable burden of illness and the societal costs associated with alcohol misuse, NIAAA is working to advance evidence-based prevention and treatment for alcohol problems for individuals at all stages of life, including those with co-occurring disorders.  NIAAA’s research portfolio is broad, ranging from studies on the underlying biological mechanisms that drive excessive drinking and the development of medications for AUD targeting these mechanisms, to studies on policies and interventions designed to reduce harm both to drinkers and those around them. NIAAA’s portfolio also includes both research on the health benefits associated with moderate drinking and on the consequences of alcohol misuse, including fetal alcohol spectrum disorders (FASD), alcohol effects on the developing adolescent brain, and alcohol effects on tissue and organ damage.

NIAAA’s cutting edge work in the neuroscience of alcohol effects on the brain provides not only a firm foundation for development of novel treatments for AUD but also a framework for prevention. The NIAAA portfolio focuses on the neurocircuitry changes that promote the development of AUD as well as those that convey resilience.  Particularly critical are the studies of the adolescent brain and how excessive alcohol intake can delay, or permanently compromise normal development of the brain’s executive and self-regulatory functions.

A key goal of NIAAA is to work with other NIH Institutes and Centers and Federal agencies to enhance integration of research on the abuse of alcohol and other substances.  Notably, NIAAA co-leads the Collaborative Research on Addictions at NIH (CRAN) with the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI); co-chairs the Alcohol Policy and Underage Drinking Subcommittee of the HHS Behavioral Health Coordinating Council with the CDC; and collaborates with the National Institute of Mental Health (NIMH), NIDA, Department of Defense (DoD) and the Veterans Administration (VA) on the implementation of the National Research Action Plan for Improving Access to Mental Health Services for Veterans, Service Members, and Military Families.

Recognizing that medications currently available to treat AUD can be highly effective but do not work for everyone, NIAAA continues to make significant progress towards developing additional evidence based pharmacotherapies.  NIAAA’s Clinical Investigations Group (NCIG), established to rapidly test candidate compounds (within 12-18 months), is streamlining the medications development process for AUD.  NCIG recently completed a multisite clinical trial that showed the anti-smoking medication varenicline (Chantix®) significantly reduced alcohol consumption and craving in both smokers and non-smokers with AUD. Going forward, NCIG will test both repurposed and novel compounds often working in collaboration with extramural scientists and the pharmaceutical industry.  NIAAA also supports promising pharmacotherapy research outside of NCIG.  In an independent study, the widely prescribed anti-seizure medication gabapentin, used to treat pain and used off-label for migraines, reduced heavy drinking and other related symptoms in alcohol dependent patients.  A study to replicate the gabapentin finding within NCIG is anticipated.  It is important to note that currently available medications are very effective for many, and that NIAAA is working to make clinicians and the public aware of the range of available treatment options for AUD, as well as promoting research into more effective implementation of treatment.

Given that AUD often co-occurs with other substance use and/or mental health disorders, major priorities of the Institute are to understand the complex relationships between and develop effective treatments for alcohol misuse and co-occurring disorders.  For example, AUD frequently co-occurs with post-traumatic stress disorder (PTSD), thereby complicating treatment for both conditions.  PTSD is prevalent among military personnel and veterans, and also among individuals who have experienced sexual assault – a far too common occurrence on college campuses, and one often associated with excessive drinking by both perpetrators and victims.  PTSD increases risk for AUD; conversely, chronic alcohol use may increase the risk for PTSD by altering the brain’s ability to recover from a traumatic experience. Using an animal model of PTSD, NIAAA intramural researchers discovered that chronic alcohol exposure altered neurons in the medial prefrontal cortex region of the brain, making the animals slower to suppress a conditioned fear response. Differences in the ability to handle fear responses could help explain differences in vulnerability to PTSD among humans, and lead to new therapeutic approaches and diagnostic risk biomarkers.  NIAAA also supports other promising studies on co-occurring PTSD and AUD.

The consequences of binge drinking for all ages range from acute, e.g. injuries and blackouts, to long term, e.g. severe AUD and organ damage.  Recent results of NIAAA-supported research have revealed that binge drinking may be harmful in more ways than previously thought.  For example, in results published this year, a single episode of binge drinking (which in the study raised the blood alcohol concentration to 0.08 g/dL, the legal limit for driving while intoxicated, within 60 minutes) increased leakage of bacterial endotoxins from the gut into the bloodstream and elicited an immune response, demonstrating that binge drinking produces acute damage in the body, even in healthy people.  Notably, women had higher blood alcohol levels and circulating endotoxin levels than men.  Often viewed as a rite of passage, binge drinking is pervasive among our nations’ youth with 1.7 million young people ages 12-20 engaging in this behavior five or more times per month according to SAMHSA.  NIAAA’s current studies on the effects of alcohol on the developing brain will inform a more extensive study under CRAN to assess the effects of drugs and alcohol, alone and in combination, on the adolescent brain.  College and University Presidents are especially concerned about the rampant heavy use of alcohol among their students resulting in an estimated 1,825 deaths, 696,000 assaults, and 97,000 sexual assaults annually.  NIAAA will soon release a decision tool to help college administrators select effective evidence-based interventions appropriate for their campuses.  NIAAA also promotes screening and brief intervention (SBI) for youth, and launched an online course with Medscape to provide continuing medical education for health care professionals to help them conduct fast, evidence-based alcohol SBI with youth. To date, over 14,000 health care providers have been Medscape certified. 

Preventing, diagnosing, and treating alcoholic liver disease (ALD) is also a major priority.  NIAAA funds four research consortia to pursue new clinical approaches to treat alcoholic hepatitis, a severe form of ALD.  NIAAA will also continue to pursue biomarkers of liver injury to facilitate earlier diagnosis. 

NIAAA has significantly advanced our understanding of the health and social impacts of alcohol use and misuse.  NIAAA will continue to pursue opportunities leading to better outcomes for alcohol-related problems, and support a diverse biomedical research workforce that is equipped to tackle these public health challenges.

George F. Koob, Ph.D.
Director, National Institute on Alcohol Abuse and Alcoholism

Dr. George Koob, an internationally-recognized expert on alcohol and stress, and the neurobiology of alcohol and drug addiction, began his tenure as Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA) on January 27, 2014.  As NIAAA Director, Dr. Koob oversees NIAAA’s $445 million budget, which funds alcohol-related research in a wide range of scientific areas including genetics, neuroscience, epidemiology, prevention, and treatment.

Even before beginning as NIAAA Director, Dr. Koob had a longstanding relationship with the Institute.  Throughout his career, he received funding from NIAAA and other NIH institutes for many significant research projects.  Importantly, he also led a 10-year, NIAAA-funded, multi-institutional consortium dedicated to identifying the molecular basis of alcoholism.

Dr. Koob received his Ph.D. in Behavioral Physiology from Johns Hopkins University in 1972. He spent most of his career at the Scripps Research Institute, where he served as the Director of the Alcohol Research Center, and as Professor and Chair of the Scripps’ Committee on the Neurobiology of Addictive Disorders.  Early in his career, he served as a researcher in the Department of Neurophysiology at the Walter Reed Army Institute of Research and in the Arthur Vining Davis Center for Behavioral Neurobiology at the Salk Institute for Biological Studies.  He was a post-doctoral fellow in the Department of Experimental Psychology at the University of Cambridge.

Dr. Koob began his career studying the neurobiology of emotion, including how the brain processes reward and stress. His contributions advanced our understanding of the anatomical connections of emotional systems and the neurochemistry of emotional function.  This background led to investigations into why certain alcohol drinkers transition to addiction while others do not, and how the brain and body respond to alcohol consumption.

Dr. Koob’s work has significantly broadened our understanding of the neurocircuitry associated with the acute reinforcing effects of alcohol and other drugs of abuse, and of the neuroadaptations of the reward and stress neurocircuits that lead to addiction.  In addition, he has validated key animal models for addiction associated with alcohol and drugs and identified the major role that brain stress systems play in the development of addiction. Dr. Koob is the author of more than 600 peer-reviewed scientific papers, and the co-author of The Neurobiology of Addiction, a comprehensive review of the most critical neurobiology of addiction research conducted over the past 50 years.

Dr. Koob is the recipient of many prestigious honors and awards, including the Daniel Efron Award for excellence in research and Axelrod Mentorship Award from the American College of Neuropsychopharmacology, the Distinguished Investigator and Marlatt Mentorship Awards from the Research Society on Alcoholism, and the Mark Keller Award from NIAAA.