James Cooper, M.D.
Associate Director for Medical Affairs
Division of Clinical and Services Research
National Institute on Drug Abuse
National Institutes of Health
Department of Health and Human Services
December 11, 1998
Statement for the Record
Mr. Chairman and Members of the Committee:
I am Dr. James Cooper, Associate Director for Medical Affairs, Division of Clinical and Services Research at the National Institute on Drug Abuse (NIDA), one of the research institutes at the National Institutes of Health. I am pleased to have been invited here today with my colleagues to testify at this important hearing.
The National Institute on Drug Abuse supports over 85% of the world's research on the health aspects of drug abuse and addiction. It does this through a comprehensive research portfolio which incorporates many diverse fields of scientific inquiry and addresses the most fundamental and essential questions about drug abuse, ranging from its causes and consequences to its prevention and treatment. The scientific knowledge that is generated through NIDA research is providing us with new insight into addiction, especially on effective treatments.
I am pleased to appear here today to summarize the research findings on the neurobiology of heroin addiction and the effectiveness of methadone treatment. These findings may also be useful in responding to some of the specific questions posed by your Committees.
In the United States, approximately 600,000 people are addicted to heroin. In recent years, data from several sources suggest that there is an increase in new heroin users as well as an emerging pattern of drug use among the young. Heroin addiction is often associated with increased criminal activity and human suffering. In the past 10 years, there has been a dramatic increase in the prevalence of human immunodeficiency virus (HIV), hepatitis C virus (HCV), and tuberculosis among intravenous heroin users. From 1991 to 1995 in major metropolitan areas, the annual number of heroin-related emergency room visits has increased from 36,000 to 76,000, and the annual number of heroin-related deaths has increased from 2,300 to 4,000. The associated morbidity and mortality further underscore the enormous human, economic, and societal costs of heroin addiction.
Over the last 25 years, a significant body of evidence has accumulated on the etiology of heroin addiction and the safety and effectiveness of one of the treatments most often used for heroin addiction-- methadone. Methadone treatment has been evaluated more rigorously than any other drug abuse treatment modality, resulting in voluminous data, much of which has been published either by NIDA or its grantees.
Although other medications, such as levo-alpha acetyl-methadol [LAAM]) have subsequently been determined to be safe and effective for heroin addiction by the Food and Drug Administration (FDA), I will limit my comments today to just the treatment effectiveness of methadone.
Addiction is a Chronic Relapsing Disease
Twenty-five years of research on addiction, has provided the scientific evidence to define addiction as a chronic relapsing disease of the brain. In the case of heroin, addiction results from the prolonged effects of heroin on the brain. Reward pathways located in the mesolimbic area of the brain are activated by opiates such as heroin, as well as by other addictive drugs. These pathways appear to be a common element in what keeps drug users taking heroin and other drugs of abuse. All addictive drugs, including heroin, nicotine, cocaine or amphetamines appear to affect this circuit. Prolonged opiate use causes pervasive changes in brain function that persist long after the individual stops taking the drug. Brain imaging and other modern technologies show that the addicted brain is distinctly different from the non-addictive brain, manifested by changes in brain metabolic activity, receptor availability, gene expression, and responsiveness to environmental cues. Understanding that addiction is, at its core, a consequence of fundamental changes in brain function means that a goal of treatment must be either to reverse or compensate for those brain changes. This can be accomplished with medications or behavioral treatments, or by a combination of the two. This is basically what is accomplished through the use of medications such as methadone and LAAM B when they are used alone or combined with behavioral and social treatments -- they can help to reverse or compensate for the brain changes that occurred during the addiction process.
It is this thorough understanding of the neurobiological basis of addiction that led a recent NIH Consensus Development Panel to conclude that addiction is in fact a medical disorder. That conclusion was reached after a November 1997, Consensus Development Conference on the Effective Medical Treatment of Heroin Addiction. This forum provided NIH with an independent review and analysis by non-government scientists of the current research knowledge base on heroin addiction and its treatment and its relationship to the current status of the delivery of treatment services. The panel of experts was specifically asked to review the scientific evidence to support conceptualization of opiate dependence as a medical disorder. They unanimously concluded that careful study of the natural history and thorough research at the genetic, molecular, neuronal, and epidemiological levels has proven that opiate addiction is a medical disorder. The panel's analysis and conclusions have just been published in this week's (December 9, 1998) issue of the Journal of the American Medical Association. The Panel's Statement, along with the data which supports their conclusions, can be found in its entirety on the NIH Consensus Development Program Website at http:\\consensus.nih.gov.
Understanding the biological basis of addiction helps in understanding the efficacy of methadone treatment. It also helps to understand why medications cannot be terminated prematurely, especially when one considers how easy it is for many people to relapse to drug use. Just like diabetes and many other medical disorders, addiction is chronic and relapsing. It is imperative that treatments be administered properly to reduce the chances that the addicted individual will relapse.
We have learned much from the many large NIDA funded methadone treatment evaluation studies over the last 25 years. Methadone has been found to be a highly effective treatment for heroin addiction. There are however, still many misconceptions about what methadone is and what it is not. This medication occupies the same opioid (endorphin) receptors as heroin, but pharmacologically it is quite different. For example, each time heroin is used, there is an almost immediate "rush" or brief period of euphoria, which wears off relatively quickly, resulting in a Acrash@ and craving to use more heroin. In contrast, methadone and LAAM have a more gradual onset of action when administered orally; there is no rush. Research has demonstrated that, when methadone is given in regular doses by a physician, it has the ability to block the euphoria caused by heroin, if the individual does try to take heroin.
Studies have consistently shown that methadone is highly effective in retaining in treatment a large proportion of patients, reducing their intravenous drug use and criminal activity and enhancing their social productivity. In addition, research has shown that methadone is not only effective in treating heroin addiction, but it is cost-effective as well, especially when one compares it to the cost of incarceration.
From a public health perspective, methadone treatment is better than other treatment modalities in retaining patients who enter treatment for heroin addiction. Retention rates are dose dependent and are further enhanced when psychosocial interventions are made available by qualified professional therapists. Enhanced retention rates are critical when one considers the abundance of research which demonstrates that the longer a patient stays in treatment, the more likely he/she will stop or at least significantly reduce drug use during and after treatment. These findings alone are important during these times of increasing heroin availability and HIV and hepatitis infection among drug users and their sexual partners. Numerous studies have shown that drug abuse treatment, especially methadone programs, are highly effective in preventing the spread of HIV. Individuals who enter drug treatment programs reduce their drug use, which in turn leads to fewer instances of drug-related HIV risk behaviors such as needle sharing and unsafe sex practices.
Similar conclusions about the efficacy of methadone treatment have been reached by prestigious organizations such as the American Medical Association, the National Academy of Sciences Institute of Medicine, the World Health Organization, and as I mentioned earlier, the NIH Consensus Panel.
My remarks about what the science has taught us to date about methadone treatment effectiveness, do however need some qualification. Methadone treatment is effective when methadone is part of what I would consider a quality treatment program. In this type of program, a well-trained treatment physician will provide patients with adequate methadone doses to reduce not only the individual's opiate use, but their craving as well. Ensuring the patient gets an appropriate dose of methadone will increase the likelihood of both the patient's retention and treatment outcome. Furthermore, outcomes are improved when programs allow patients to stay in treatment long enough to ensure that rehabilitation has been complete and that the risk of relapse is minimal. Simply put, good programs will individualize treatment to meet the needs of a particular patient. Just as a physician treating any other illness would do, patients need to be evaluated on a patient-by-patient basis. Some may only need to be treated for a short time, while others may require a longer treatment regimen.
Equally important, treatment programs must address the whole person. Meaning, they make available when necessary, a variety of psychosocial and vocational rehabilitation opportunities to help the patient become a functional member of society. A quality program will also address all aspects of the patient's addiction, including any co-morbid mental or medical disorders that the patient may have. They do this by providing appropriate pharmacological, psychological or behavioral interventions to treat disorders in addition to the patient's addiction and insure that patients receive AIDS risk reduction counseling and medical care as needed.
Availability of Treatment
There is increasing concern among the field about the availability of treatment to those in need. The majority of my following comments on this aspect of treatment are based on findings from the statement issued by the NIH Consensus Development Panel.
The Panel raised concern about the current limited availability of methadone and LAAM treatment for the approximate 600,000 people known to be addicted to heroin. "Most do not receive treatment, and the financial cost of untreated heroin addiction to the individual, the family, and to society are estimated to be approximately $20 billion per year." The Panel stressed the importance of providing more comprehensive services, such as substance abuse counseling, psychosocial therapy and other supportive services to enhance retention and to achieve even more successful outcomes. Equally important, they identified a number of barriers to the effective use of methadone treatment related to misperception and stigma attached to heroin addiction, the people who are addicted, those who treat them, and the settings in which services are provided. Thus, the Panel urged that methadone and LAAM be made more widely available and that the current barriers be removed.
To meet these objectives, the Panel made a number of specific recommendations. For example, they strongly recommended that legislators and regulators recognize that methadone maintenance treatment is both cost-effective and compassionate and that benefits for treatment be part of public and private insurance programs.
The panel also helped set the stage for expanding access to treatment, by recommending that the current federal and state regulations limiting treatment availability and the ability of physicians to provide methadone for their patients be eliminated and that alternative means, such as physician certification or program accreditation, be instituted. This would help improve the quality of methadone maintenance treatment programs.
Another identified impediment to quality medical care of methadone maintenance programs is the shortage of qualified physicians and other healthcare providers who can competently treat heroin addiction. Hence, the Panel recommended that all primary care medical specialists, psychiatrists, nurses, social workers, psychologists, and physician's assistants be taught principles of diagnosing and treating patients with heroin addiction.
In conclusion, I would like to reiterate that 25 years of research has shown that drug addiction treatment, especially methadone, is quite effective in reducing not only drug use but also in reducing the spread of infections like HIV/AIDS and in decreasing criminal behavior. Thus, drug treatment benefits not only the individual patient but also both public health and public safety.
We have come a great distance in our approaches to understanding and treating drug addiction, but we still have quite a distance ahead of us. We can improve the quality and availability of treatment in the country if we put treating addiction on equal footing with other chronic diseases. The science in this field is strong and the success rates for treating addiction are comparable to or better than those for many other illnesses. Expanding access to treatments will benefit us all.
Thank you once again for inviting me to participate on this panel. I will be happy to answer any questions you may have regarding the scientific findings I just presented.