Friday, May 29, 2009

Mr. Chairman and Members of the Committee:

I am pleased to present the President’s Fiscal Year 2010 Budget request for the National Institute on Alcohol Abuse and Alcoholism (NIAAA), of the National Institutes of Health (NIH).   The FY 2010 budget includes $455,149,000, which is $4,919,000 more than the FY 2009 appropriation of $450,230,000.

NIAAA’s long-range vision for medicine with respect to alcohol-related health issues is that research on the health effects of alcohol will reduce the burden of illness attributable to excessive alcohol consumption thereby enhancing the well-being of individuals at risk, their families, and society-at-large. Through translation of NIAAA supported research findings, we have an unparalleled opportunity to significantly reduce the burden of illness due to alcohol-related problems.   We are especially appreciative of the American Recovery and Reinvestment Act Funds which will accelerate our progress.   NIAAA’s budget request and its research projects are consistent with the President’s multi-year commitment for Cancer and Autism.   

CURRENT SCOPE OF THE PROBLEM AND RESEARCH

According to the Centers for Disease Control and Prevention, alcohol is the third leading cause of preventable death in the United States (U.S.).   Even more important from a public health perspective, alcohol misuse negatively affects the quality of life for millions of Americans.   According to the World Health Organization, alcohol is one of the top ten causes of Disability Adjusted Life Years (DALYs) in the U. S. and contributes to a number of the other leading causes. Alcohol problems cost the U.S. an estimated $185 billion annually, with almost half the cost resulting from lost productivity due to alcohol-related disabilities. According to NIAAA’s National Epidemiologic Survey on Alcohol and Related Conditions, over 18 million people ages 18 and older suffer from alcohol abuse or dependence and only 7 percent of them receive any form of treatment. Furthermore, heavy drinkers, who are not dependent but nevertheless at risk for adverse health and psychosocial outcomes, are seldom identified.   The consequences of alcohol misuse can affect both drinkers and those around them at all stages of life, from damage due to alcohol exposure of the developing embryo, to injuries, to tissue and organ damage resulting from chronic, heavy alcohol use.   Therefore, to achieve its goal of reducing the heavy burden of illness from alcohol misuse, NIAAA’s research focus must be broader than simply reducing alcohol-related mortality; it must encompass reducing the risk for all adverse alcohol-related outcomes at all stages of life.  

Research supported by NIAAA has reframed our understanding of alcohol dependence in several ways by demonstrating that: 1) it is a developmental disorder that often has its roots in childhood and adolescence; 2) the highest prevalence of alcohol dependence in the U.S. general population occurs in 18-24 year olds; 3) there is substantial variation in the severity and chronicity of dependence among individuals; and 4) a large percentage of individuals with alcohol dependence are highly functional in society, and therefore go largely unnoticed by the healthcare system.  

These findings underscore the opportunity to: 1) be able to better predict which individuals are at risk for future dependence by understanding the complex interplay between genetic, environmental, and developmental factors; 2) preempt future problems through research-based prevention efforts for children and adolescents as well as screening and guidance for people of all ages about how drinking patterns, especially binge drinking, relate to adverse health outcomes; 3) conduct research to develop treatment options that are personalized to individual needs and lifestyles; and 4) engage individuals, communities, and professional groups to be actively participatory in shaping the future of healthcare as it relates to alcohol misuse.  

OUTLOOK FOR THE FUTURE

NIAAA is revolutionizing alcohol treatment by providing evidence-based options for addressing the full range of alcohol related problems. For example, research has shown the value of alcohol screening in primary care and mental health settings to help patients understand the risks associated with different drinking patterns.   NIAAA has developed tools that clinicians can use to screen and intervene in these settings.  Moving treatment of less severe forms of alcohol dependence into mainstream medical care will decrease stigma, improve availability, accessibility, and appeal of treatment options, and ultimately reduce the number of people who suffer with dependence. Alcohol-dependent patients will benefit from NIAAA’s research focusing on the development of new treatments including behavioral therapies and medications that will shorten the duration, number, and severity of episodes of dependence and prevent, for most, the development of chronic, relapsing dependence.  Studies suggest that as a result of these types of intervention, most people with mild to moderate dependence will recover.       

Patients with more severe and/or relapsing dependence, are more complex to treat and often need multi-faceted, personalized addiction services that may include medications, counseling, psychotherapy, and case management.  These patients often have other health (infectious diseases, mental illness, and liver disease) and psychosocial (family, marital, and workplace) problems, some that are the direct result of their alcohol misuse. Comprehensive treatment must take all of these into account. NIAAA-supported research will continue to develop and refine treatment options for these individuals, both for their alcohol dependence as well as the many adverse health consequences that may result.  Collectively these changes in the approach to treatment of alcohol problems will substantially reduce the public health burden of heavy drinking and alcohol use disorders .

Ensuring that appropriate research-based guidance about alcohol use for special populations, including pregnant women, is available will result in a dramatic reduction in the incidence of fetal alcohol spectrum disorders, the most severe forms of which produce lifelong disability, and may also decrease the incidence of Sudden Infant Death Syndrome (SIDS).   NIAAA research will continue to inform this guidance, including information about the risks of alcohol exposure to the developing embryo and fetus, and will make it accessible to primary health care providers and obstetricians.  For pregnant women who drink despite the best advice, research is focused on developing nutritional and/or pharmacological agents that may lessen the negative effects of alcohol exposure.  

Biomarkers, stemming from NIAAA-supported genetic and epigenetic research, will be available that: 1) predict individual risk for future alcohol dependence; 2) assess progression of at risk drinking through dependence; and 3) track damage to tissue and organs.  These tools will enhance the ability of health care providers to offer guidance to patients about their drinking patterns and determine appropriate health care based on individual risk factors.  A repertoire of medications will facilitate treatment tailored to the needs of the patient.   Personalized treatment including medications and behavioral therapies will be based on individual genetic make-up, desired drinking outcomes, attention to co-occuring disorders, ease of compliance, and other factors.

MOVING FORWARD

NIAAA supported biomedical and behavioral research is supporting the research that will contribute to realizing the vision outlined above.   Ongoing studies, as well as new initiatives, will provide the scientific knowledge and tools, to improve our ability to predict which individuals are at increased risk for alcohol-related problems including dependence, preempt the harm from alcohol misuse, and provide personalized treatment.

The integration of routine alcohol screening, and where appropriate, brief intervention and/or referral to specialty treatment into primary health care for all ages is central to reducing consequences of alcohol misuse.   NIAAA will continue to develop teaching and training tools to increase the usage of A Clinician’s Guide: Helping Patients Who Drink Too Much.   NIAAA has also recently launched Rethinking Drinking, a new Web site and booklet that provide information and tools to help individuals change harmful drinking patterns, either on their own or by helping them reach the decision to seek help.  NIAAA is also developing guidance on screening and brief intervention for children and adolescents, recognizing that criteria developed for adults may not fit the needs or behaviors of youth.  

Medications development remains a central focus of the Institute.   Emerging data are changing the way we look at alcohol dependence, guiding us to be more strategic about the medications we test, the way we test and design them, and how we determine the subpopulations of patients most likely to benefit from them.   For example, new understanding of the relationship between withdrawal induced anxiety and relapse has provided additional targets for drug development to minimize relapse. Broadening the desired treatment outcome, from targeting only abstinence to including reduction in heavy drinking, is also influencing the medications that are being tested as well as how they are tested.   Other compounds that may mitigate tissue and organ damage are under study.

Most individuals with alcohol dependence do not access treatment yet many of them recover without the benefit of professional care or facilitated self-help.   NIAAA continues to investigate the process leading to a decision to stop drinking or to seek help.   In concert with a broader NIH Roadmap Initiative, NIAAA is currently supporting studies to understand mechanisms of change away from harmful health behaviors.

Given our current state of knowledge and what we are learning from ongoing studies, we are optimistic that we can substantially reduce the burden of illness for alcohol-related problems and the suffering it brings to individuals, their families and society at large.

Kenneth R. Warren, Ph.D. , Acting Director, National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health, Department of Health and Human Services

Dr. Kenneth R. Warren, Deputy Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), was named Acting Director of the Institute on November 1, 2008.  The NIAAA is a component of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services.

Dr. Warren is a nationally-recognized expert on alcohol and pregnancy, and a long-time senior administrator at NIAAA. He joined the Institute in 1976 as a staff member of the then Division of Research. He later became Chief of the Biomedical Research Branch, and then Deputy Director of the Division of Extramural Research.  From 1984 to 2005 he directed the Office of Scientific Affairs, which had responsibility for peer review, grants management, committee management, scientific communications, and the activities of the NIAAA National Advisory Council and Extramural Advisory Board.  From 2002 to 2007, Dr. Warren served as Associate Director for Basic Research, and, until late 2008 as Acting Director of the Institute’s Office of Science Policy and Communications.

A graduate of the City College of New York, Dr. Warren earned his doctorate degree in Biochemistry from MichiganStateUniversity in 1970.  He subsequently held postdoctoral positions at the University of California, Los Angeles and at University of Michigan Mental Health Research Institute before joining the Federal government in a research position at the Walter Reed Army Institute of Research in 1974

Dr. Warren has maintained an active interest in all areas relating to alcohol and health, and often served as the editor of the triennial Reports to Congress on Alcohol and Health.  He has been particularly active in research on the effects of alcohol use during pregnancy, including fetal alcohol syndrome (FAS) and fetal alcohol spectrum disorders (FASD).  Dr. Warren initiated NIAAA’s research program on FAS over 30 years ago. He currently chairs the government-wide Interagency Coordinating Committee on FAS. 

Dr. Warren has received numerous honors, including a superior service award from the Public Health Service in 1982 for his work in development of the first Surgeon General’s Advisory on FAS.  In 1994, Dr. Warren received the Seixas Award from the Research Society on Alcoholism (RSA).  In 2002, he received the Henry Rosett Award from the Fetal Alcohol Syndrome Study Group of RSA.  In 2007, the National Organization on Fetal Alcohol Syndrome (NOFAS) honored Dr. Warren by placing his name into their Tom and Linda Daschle FASD Hall of Fame, followed by the receipt of the NOFAS Excellence Award in 2008.