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May 16, 2001
Presented by Alan I. Leshner, Ph.D., Director, National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services
Presented to House and Senate Appropriations Subcommittees

Mr. Chairman, and Members of the Committee:

Statement for the Record

I am pleased to present the President's budget request for the National Institute on Drug Abuse, a sum of $907,369,000, which reflects an increase of $126,394,000 over the comparable Fiscal Year 2001 appropriation.

NIDA's Comprehensive Portfolio

New scientific discoveries are fundamentally changing how this Nation approaches drug abuse and addiction. As we speak, more and more diverse patient populations are receiving the best treatments that science has to offer as a result of the work of our National Drug Abuse Treatment Clinical Trials Network. Promising new medications for treating addiction to nicotine, methamphetamine, cocaine, heroin, and other drugs are being tested and developed further. And, our increasing knowledge about the health and developmental consequences of drugs of abuse, particularly emerging drugs like Ecstasy (MDMA), is allowing us to rapidly provide communities with the science-based tools to prevent and treat drug problems at the local level. It is the tremendous advances from science, fueled in part by the very generous increases in the past several budget cycles, that have allowed the National Institute on Drug Abuse (NIDA) to accomplish these momentous achievements and are providing us with renewed hope for a safe and healthy drug-free citizenry.

NIDA supports more than 85% of the world's research on the health aspects of drug abuse and addiction, including the impact that drugs have on other diseases such as AIDS, hepatitis C, and tuberculosis. Because NIDA is so central to the entire research enterprise, the Institute maintains a very comprehensive research portfolio. We focus on all drugs abuse, both legal and illegal, including nicotine, with the exception of a primary focus on alcohol. NIDA also rapidly translates all of its new findings into formats that will be useful and used by a variety of audiences. I will highlight some recent accomplishments and mention a few promising directions.

National Drug Abuse Treatment Clinical Trials Network

One of the best examples of the impact that science can have on local communities is in the treatment arena. Thanks to recent treatment advances, NIDA was able in FY 1999 to jump-start and then in FY 2000 to greatly expand what has quickly become a national clinical research infrastructure for testing science-based drug addiction treatments in real-life community-based treatment settings. The result is that science-based treatments are now more accessible to diverse groups of patients suffering from various addictions. Patients from across the country can now participate in the 7 research protocols that are already being run through the National Drug Abuse Treatment Clinical Trials Network (CTN) with another set of trials nearing the implementation stage. Until the establishment of the CTN, researchers and treatment providers had to rely on treatment results from studies conducted in specialized settings with much restricted subject populations. Through this present network of 14 research centers and over 80 community treatment programs on the front lines of clinical practice across the country, the CTN is engaging much of the drug abuse community in a national effort against addiction and its consequences.

Additionally, the CTN provides a much needed infrastructure to more efficiently and rapidly disseminate other kinds of research findings to practitioners and patients across the country. The CTN is a major step toward achieving NIDA's millennial goal of improving the quality of drug addiction treatment in this country using science as the vehicle. The network is still not complete, however. Many areas of the country are yet to be brought into its auspices. Future plans call for the CTN to spread out geographically which will better serve the more than 5 million individuals that the Office of National Drug Control Policy reports are currently in need of treatment. The CTN will also serve as a natural vehicle to reach segments of the population that have traditionally been the least likely to access medical help, such as minority populations, disadvantaged populations, urban and rural communities, and others whose health care needs are unmet.

Responding to Ever-Emerging New Drug Problems

Unfortunately, the overall picture of drug abuse in the United States is constantly changing. As soon as we get a clear understanding of drug use patterns and gain some control over existing drug problems, new dangerous substances seem to emerge. Similar to the way a virus mutates, both regional and national drug abuse patterns are constantly reshaping and rarely remain static. Tried and true prevention and treatment approaches may not work with many of the new drugs that are emerging on the scene today. For example, newly emergent drugs like methylenedioxymethamphetamine (MDMA or "Ecstasy"), which acts as both a hallucinogen and a stimulant, require new prevention and treatment approaches, as does the unique stimulant methamphetamine. By having our pulse on these constantly changing drug trends, NIDA is poised to use the power of scientific research and its application to avert emerging drug problems before they become national epidemics. Nowhere is this proactive approach better exemplified than with the role that science continues to play as our Nation discusses and responds to menacing drugs like MDMA and methamphetamine. Because these club drugs were identified early on by NIDA as potential health problems, we were able to launch our Club Drug Research Initiative, and dissemination effort to rapidly inform communities about these drugs. The fact that over 700,000 people have visited our dedicated website on this topic since we launched it in late 1999 demonstrates the interest that people have in receiving science based information. Not only have we come a great distance in educating the public about these drugs, but our science has revealed some ground-breaking findings.

Research shows that "club drugs" such as MDMA are far from benign substances. MDMA has been found in animals and most recently in humans to be neurotoxic, resulting in long-lasting or possibly permanent damage to the neurons that release serotonin. MDMA has also been found to impair an individual's learning and memory abilities. Accumulating evidence shows that chronic heavy use of MDMA is associated with sleep disorders, depressed mood, anxiety, impulsiveness and hostility, and memory loss. These cognitive effects have been found to last even up to six to 12 months after abstinence from the drug. Because of the abundance of research findings that continue to emerge on this topic, NIDA will bring leading researchers from across the globe to the NIH campus this summer to discuss the myriad of findings and determine the best future research directions to answer important remaining questions about the causes and consequences of MDMA use and how best to deal with them.

Methamphetamine, another popular club drug, has also been found to cause neuronal damage to an individual's brain cells, similar to some of the damage that occurs from stroke or Alzheimer's. Again, the abnormal brain function persists well after drug use has stopped. For example, methamphetamine abusers who were drug-free for up to eleven months still had significant memory and coordination deficiencies that were directly linked to brain changes produced by their prior drug use. (see figure 1 below). These alarming results have led NIDA to expand its portfolio in all areas, with a special emphasis to look more closely at the potential health and developmental consequences that methamphetamine use by women of child-bearing years might have on the developing child.

PET Scans showing normal brain and METH Abuser brain - METH abuser brain shows less activity in normal regions and slightly increased activity in areas that are less active in the normal brainFigure 1 Source: Volkow, N.D. et al, Am. J. Psychiatry, 158(3), pp. 377-382, 2001.

Neuroscience Portfolio Sets Stage For New Treatments

The convergence and application of powerful new tools and emerging technologies are accelerating the pace of neurobiological advances and allowing researchers to ask and answer questions that were not even imaginable five years ago. NIDA has nearly doubled the breadth and depth of its basic and clinical neuroscience portfolios. It has also allowed us to use basic research as the foundation for the entire NIDA portfolio, from prevention efforts to medications development.

One of the major new areas that NIDA will exploit in the neuroscience arena is to build on our knowledge about how specific brain circuits are affected by drugs of abuse, so that we can more precisely determine how these brain pathways are impacted by chronic exposure of drugs and how this can ultimately result in addiction. We have learned much, but still do not completely understand what causes an individual to make the critical transition from being able to voluntarily use and then abstain from drugs to the uncontrollable compulsive drug-seeking state that has become the hallmark of addiction. An array of new technologies, such as microarrays, which can simultaneously analyze the activity of thousands of genes, is allowing us to better elucidate the molecular and cellular mechanisms by which voluntary drug use can evolve over time into addiction. We will be better able to determine what genes are being turned on and off by drug exposure and to identify patterns of gene expression that make some individuals more vulnerable to addiction than others. For example, researchers found that individuals with a genetic deficiency in an enzyme that metabolizes nicotine (CYP2A6) are less likely to start smoking, and smoke less if they do start, than individuals with normal CYP2A6 activity. Building on this knowledge, researchers tested more than 200 compounds to decrease CYP2A6 activity and found that one compound (methoxsalen) commonly used to treat skin disorders may be helpful to people who want to quit smoking. This is just one example of the role that genetic research can play in helping us to develop even more novel therapeutic approaches to prevention and treatment of tobacco smoking.

Developing new approaches for treating addiction to nicotine is an important research endeavor for NIDA. NIDA will work both independently and collaboratively to bring more pharmacological and behavioral therapies for nicotine addiction to fruition. NIDA is especially interested in developing treatments that are specifically tailored to adolescent populations. At our Teen Tobacco Treatment Research Center in Baltimore, for example, over 60 adolescent patients are participating in a 3-month outpatient study that is helping to determine the most effective methods for treating tobacco dependence in this population. These findings will be used to improve treatment for teens across the country.

Science-Based Principles For Drug Abuse Prevention

Just as NIDA has declared as our millennial goal to improve the quality of drug abuse treatment nationwide using science as the vehicle, we are working to do the same in the prevention arena. To ensure that science-based prevention principles and protocols can be effectively used by a wide variety of populations across the country NIDA plans to launch a National Drug Abuse Prevention Trials System in FY 02. Leading prevention researchers will be brought together at NIDA's 2nd National Conference on Drug Abuse to discuss the latest prevention findings and to help NIDA prioritize the most promising prevention programs that should be initially tested in the new System.

Blending Public Health and Public Safety Approaches

In the same way that we have developed and sent to the field general principles that define effective prevention and treatment strategies, we are working to lay out standardized principles about duration, setting, and detailed protocols that should be used to more effectively treat individuals while they are under criminal justice control. Given the fact that untreated addicted criminal offenders have extremely high rates of post-release recidivism both to drug use and to criminality, NIDA's research can play a pivotal role in helping to address this public health and public safety issue. As we continue to learn about how to improve treatment outcomes and how to reduce the risk of relapse for patients undergoing treatment, NIDA will use this knowledge to work with the Department of Justice and others to improve the treatment of addicted criminals, particularly those with co-occurring mental disorders.

Science Leads Our National Discourse

Scientific advances continue to come at a tremendous pace and are not only improving the health and quality of life for our citizens, but are changing how we as a Nation view and approach addiction. Understanding initial drug use as a voluntary, and thus preventable, behavior; and understanding addiction to be a treatable, often chronic and relapsing disease of the brain, forces us as a Nation to adopt an even more sophisticated approach to dealing with this nation's drug problems. Having science set the stage for our course of action, including furthering the blending of public health and public safety approaches, is clearly the best way to reduce the enormous financial and social burden of drugs on our society. There are indicators at all levels, federal, state and local, that this is in fact occurring. NIDA will continue to provide the latest science-based information to ensure the national discourse on this topic proceeds. We will also continue to ensure that new findings rapidly reach local communities. Science brings us all renewed hope and confidence for a healthy and prosperous future. It is NIDA's role to ensure that this hope for the future is fully realized.

Government Performance and Results Act (GPRA)

NIH Budget request includes the performance information required by the Government Performance and Results Act (GPRA) of 1993. Prominent in the performance data is NIH's second annual performance report which compares our FY 2000 results to the goals in our FY 2000 performance plan. As performance trends on research outcomes emerge, the GPRA data will help NIH to identify strategies and objectives to continuously improve its programs.