Fiscal Year 2012 Budget Request

Introduction

Mr. Chairman and Members of the Committee:

I am pleased to present the President's Fiscal year 2012 Budget Request for the National Institute on Drug Abuse (NIDA). The FY 2012 budget of $1,080,000,000 includes an increase of $20,752,000 over the FY 10 actual. The following statement updates NIDA's scientific progress in addressing drug abuse and addiction. These public health problems cost our society more than $600 billion annually in health- and crime-related costs and losses in productivity, not to mention incalculable personal and social devastation (ONDCP 2004; Rehm et al. 2009; CDC 2007). NIDA has crossed a threshold into a new research era, unprecedented in its scope, and transformative in its prevention, treatment, and policy implications for substance use disorders (SUDs).

Return on Investment: Technologies to Speed Discovery

New technologies and scientific breakthroughs continue to generate actionable information about the genetics, chemistry, and circuitry of the human brain. This knowledge has dramatically enhanced our understanding of the underlying vulnerabilities and the long-term effects of addiction on neurophysiology and behavior. Continuing advances in DNA sequencing and analytical tools have transformed the landscape of genomic exploration. For example, we can now engage in high resolution and accurate sequencing of vast genomic tracts, from many different individuals, to systematically search for and identify addiction risk variants, which may open up new targets for medications. Also, we are dissecting the epigenetic processes that can affect gene expression through persistent but reversible changes. Epigenetics research has started to help explain the deleterious impact of known environmental risk factors, like poverty or chronic stress, on vulnerability for SUDs. The burgeoning availability of genetic, epigenetic, and environmental data heralds new opportunities for translational applications. NIDA is committed to optimizing this potential through harmonization efforts that help ensure the comparability of pooled data.

Harmonized databases are crucial for individualized medicine. This is clear in the genomics field, but also in the emerging field of globally connected biomarkers, or the "human connectome," and for brain imaging. NIDA is supporting research to develop biomarkers to screen for drug exposure and addiction vulnerability that would be more accurate, reliable, and sensitive than current tests (i.e. bodily fluids, hair, questionnaires) and would help transform the way SUDs are identified and treated.

Other innovations, such as wireless remote sensing and virtual technologies, offer opportunities for transforming how prevention messages, real-time monitoring, and even some treatment modalities are delivered to the public. Having real-time, objective measures of drug use could have a huge impact on SUD treatments. One example is remote physiological monitoring (RPM), a rapidly evolving form of telemedicine that can track patients' health status (e.g., heart rate, blood pressure, skin temperature, and glucose levels) remotely, using devices that can store and transmit the results in real-time. NIDA is supplementing studies on the use of RPM for monitoring drug use to evaluate the effects of treatment interventions and their relationship to clinical outcomes. Such data could support the establishment of non-abstinence endpoints, which in turn could inform the FDA addiction medications approval process.

Emerging Psychoactive Threats to Public Health

The past few years have witnessed several alarming trends, particularly prescription drug abuse. Although opioid analgesics are among the most effective medications for pain management, they are also associated with serious and growing public health problems, including drug abuse, addiction, and overdose deaths. The Substance Abuse and Mental Health Services Administration reports a 6-fold increase in treatment admissions for opioid analgesics, from nearly 20,000 in 1998 to about 120,000 in 2008, while the Centers for Disease Control and Prevention acknowledge that unintentional poisonings involving opioid analgesics have more than tripled from 1999 through 2007, exceeding the total number of deaths involving heroin and cocaine. These trends illustrate the challenge of balancing access to critical medications for those who need them and preventing their abuse, particularly when the public does not perceive their dangers and has much greater access to them from a decade-long surge in availability. In 2009, 202 million opioid prescriptions were dispensed in the U.S., making opioids the most prescribed class of medications. NIDA is committed to helping reverse this trend by providing information on the patterns and motivations behind their abuse, sponsoring research on developing pain medications with less abuse potential, and creating curricula to minimize diversion through better prescribing practices.

Lingering public misperceptions, particularly among youth, continue to hinder our marijuana prevention efforts. The latest Monitoring the Future survey of 8th, 10th, and 12th graders reveals that daily marijuana use is up for all grades. These teens are not only at higher risk of becoming addicted, but they are functioning below optimal level at a time when their future depends on peak cognitive performance. Why is this happening now? We do not know for sure, but it is reasonable to infer that the public debates surrounding medical marijuana have increased confusion and lowered the perception of risk, an important factor in curtailing use.

Meanwhile, new drugs routinely emerge and gain rapid notoriety thanks to the Internet. Recent examples include "bath salts" and "spice," which are synthetic stimulants and cannabinoids, respectively.

Improving Public Healthcare - Delivery and Performance

NIDA will continue to leverage our knowledge base into better strategies for battling addiction. To further this goal, NIDA takes advantage of collaborative research infrastructures designed to deploy proven strategies rapidly and effectively. For example, NIDA's Drug Abuse Treatment Clinical Trials Network (CTN) tests evidence-based treatments in community settings with diverse patient populations, optimizing the utility and cost-effectiveness of treatments and fostering their adoption. Similarly, NIDA's Criminal Justice-Drug Abuse Treatment Studies (CJ-DATS) network promotes multilevel collaborations to bring proven treatment models into the criminal justice system, disproportionately affected by both drug abuse and HIV. These infrastructures allow for the broad testing of promising new strategies. One example, called "Seek, Test, and Treat," has great potential to improve the public health by expanding access to HIV testing and treatment, and ultimately reducing HIV spread.

Another cornerstone of our strategy is to engage physicians as "frontline" responders to patient substance abuse, providing the science-based tools they need to identify potential substance abuse in their patients and offering better options for treatment. Recent research shows, for example, that compared with methadone, buprenorphine results in fewer neonatal abstinence symptoms among babies born to opioid-addicted mothers, and is associated with decreased hospital stays and thus, costs. To bolster education in the treatment of pain, NIDA is leading a multi-Institute effort to create Centers of Excellence (CoEs) to develop curricula for medical students, nurses, resident physicians, and others. Part of our NIDAMED physician outreach initiative, CoEs have also developed and are helping to disseminate substance abuse training curricula, woefully neglected in most medical training. NIDA continues to encourage physician screening of drug abuse with the help of a Web-based interactive screening tool that generates clinical recommendations. The broad availability of these resources is an important step toward integrating substance abuse screening, brief intervention, and referral to treatment (SBIRT) into medical care, which will enable better healthcare decisions and outcomes.

Translation - Therapeutics Development

To help those affected by the disease of addiction, we need to expand the pharmacological and behavioral tools available to treat SUDs. Thus, medications development is one of the main areas that benefits from new discoveries. For example, the century-old practice of vaccination has recently been found to be a viable approach for treating addiction. In this case, the body itself is coaxed to produce antibodies that bind a drug while still in the bloodstream, blocking its psychoactive effects in the brain. Already, a nicotine vaccine that reduces craving and withdrawal symptoms is in advanced stages of development and will be market ready following approval by the FDA. Another strategy has been the development of long-acting, or depot, formulations of medications that serve to overcome poor compliance. One example is Vivitrol, an extended-release opioid antagonist (naltrexone), recently FDA-approved for treating opioid addiction. NIDA is now testing the use of depot medications in high-risk groups, such as criminal justice offenders, and in regions of the world that have high rates of HIV infection and are resistant to treatment with opioid agonist medications.

In parallel NIDA is supporting research on drug combinations, an effective strategy for treating many diseases (e.g., HIV, cancer) and one starting to show success with addiction. For example, the combination of lofexidine (a hypertension medication) and marinol (a synthetic form of marijuana's THC) shows promise in treating withdrawal symptoms among marijuana-addicted individuals. Early results also suggest that a buprenorphine-naltrexone combination could be effective in treating cocaine addiction.

New Investigators, New Ideas

To help sustain our commitment to the next generation of biomedical research scientists, NIDA supports multiple training initiatives at various career levels and areas of need (e.g., physician scientists, computational neuroscience, and medicinal chemists). Examples include efforts aimed at mentoring minority investigators and international HIV researchers, as well as multi-Institute training programs. To identify and encourage the next generation of addiction scientists, NIDA also awards special prizes at the annual Intel International Science and Engineering Fair to high school students whose projects exemplify excellent achievement in addiction science.

In closing, NIDA pledges to continue to tackle the emerging and significant public health needs related to drug abuse and addiction, taking advantage of unprecedented scientific opportunities to close the gaps in our knowledge base and develop and disseminate more effective strategies to prevent and treat drug abuse and addiction.