Overview/Brief History

We have used medications to treat chronic opioid addiction both in the United States and abroad for more than 40 years. Drs. Dole and Nyswander conducted the initial research in evaluating the use of methadone to treat opioid addiction at Rockefeller University between 1963 and 1964, and were joined by a number of gifted clinicians, including Dr. Mary Jeanne Kreek. Drs. Dole and Nyswander published their initial research in the Journal of the American Medical Association (JAMA) in 1965, which set the precedent for an enormous amount of evidence-based research to evaluate how methadone would be used to treat chronic opioid addiction. No other medication has been as exhaustively studied for the treatment of any other chronic disease.

The real expansion of methadone treatment came when President Nixon appointed Dr. Jerome Jaffe to be the Director of Special Action Office for Drug Abuse Prevention (SAODAP) in 1971. The Food and Drug Administration published the first federal methadone regulations in 1972 and the Narcotic Addiction Treatment Act (NATA) defined the closed panel of opioid treatment programs (OTPs) in 1974, which continues to the present time .

After three decades, another medication was introduced to treat chronic opioid addiction. The Drug Abuse Treatment Act of 2000 (DATA 2000) paved the way for buprenorphine to be widely used in the United States, primarily by waived physicians in private medical practice settings and, secondarily, in opioid treatment programs. We are anticipating changes in federal regulations, which will expand the use of buprenorphine in the OTP within the coming months.

Throughout this process, these medications have been used against the backdrop of enormous social stigma, which has limited access to treatment for opioid addiction for the past half century. The stigma is overwhelming and has limited public funding for this treatment in addition to suppressing program expansion in community-based settings. Some of the initial public policy rationale for using methadone maintenance in the treatment of opioid addiction was rooted in the practical matter of reducing costs to society. This was first reported in 1991 by the New York State Division of Substance Abuse Services when making the comparison of treating a patient with methadone for approximately $5,000.00 per patient/year, when compared to the cost of untreated heroin addiction at $45,000.00 per individual/year. The cost effectiveness of medication-assisted treatment for opioid addiction has been repeatedly demonstrated through a series of studies without any shadow of a doubt. It has also been long proven that crime is significantly reduced among opioid addicted individuals as they enter and remain in treatment, including seminal studies by Dr. David Nurco and Dr. John Ball.

What is forgotten, even at the present time, in spite of evidence-based research and NIDA’s published and well-disseminated Principles of Addiction Treatment is something that Dr. Vincent Dole alluded to in 1989.

“The problem was one of rehabilitating people with a very complicated mixture of social problems on top of a specific medical problem, and that practitioners ought to tailor their programs to the kind of problem they were dealing with. The strength of the early programs, as designed by Marie Nyswander, was in the sensitivity to individual human problems. The stupidity of thinking that just giving methadone will solve a complicated problem seems to me beyond comprehension.”

In our judgment, this also applies to the use of buprenorphine in private practice settings. Medication is only part of the treatment experience.

New Trends

We are also bearing witness to a number of critical trends, which are affecting the future of medication-assisted treatment for opioid addiction. We know that Schedule II prescription opioids such as oxycodone and hydrocodone products have been increasingly prescribed to treat chronic pain over the course of the past 10 years. This has also translated into a remarkable increase in the prescription of methadone for chronic pain in the United States as well. Illustratively, the number of prescriptions of methadone dispensed through pharmacy channels was approximately 500,000 in 1998 and went past 4 million in 2006. We have also seen a significant increase in methadone-associated mortality and federal reports have attributed such increasing deaths to the distribution of methadone through pharmacy channels and the illicit market. Numerous media reports have reported on this trend, which has had a chilling effect on public support for using methadone maintenance in treating chronic addiction.

These mortality reports have also attracted the attention of federal and state legislators, who are seeking to place greater controls on how Schedule II opioids are prescribed, including methadone. Senator Rockefeller asked the Government Accountability Office (GAO) to develop a report on methadone-associated mortality and it is anticipated that this report will be released before AATOD’s next national conference in New York (April 25-29, 2009). It is expected that this report will conclude that the majority of methadone-associated mortality in the United States is attributed to the increased prescribing of methadone for pain as opposed to the use of the medication for treating opioid addiction. This is in agreement with previously published federal agency reports.

We are also seeing a number of state legislative initiatives to declare methadone as a DUI offense, in spite of numerous studies demonstrating the safety of driving and operating machinery. It is remarkable after more than 40 years of in-depth research into the use of such medications in treating chronic opioid addition that we continue to struggle as a culture about accepting the use of such medications. We have long known that one of the most effective methods of confronting such stigma is a multiyear public education campaign, explaining what chronic opioid addiction is and how it can be effectively treated.

The urgency of implementing such a federally funded campaign is taking on more steam as a greater number of patients, who are being admitted to opioid treatment programs and physicians offices with buprenorphine, are reporting Schedule II opioids as their primary drugs of abuse when entering treatment. AATOD has been working with NDRI, a nationally respected research organization, under the auspices of the Denver Health and Hospital Authority and the RADARS® System. We have been conducting this research since January 2005 to the present time with more than 29,000 patients completing surveys as they are admitted to treatment. The results are quite stunning. Of the 75 OTPs participating in this study in more than 30 states, more than 40% of the patients indicate that prescription opioids are the primary drugs of abuse as they enter treatment. In some states, OTPs report that more than 70% of their patients are presenting with prescription opioid addiction. More than 65% of the patients are Caucasian. We also know that 33% of the individuals, who endorse the use of prescription opioids on the survey, are injecting the drugs. We have found that the patients are younger with the largest group in the 18-25 range and chronic pain is also increasingly cited as a reason for entering treatment. Remarkably, more than 50% of the patients indicate that their source of the primary prescription opioid was either a friend or a relative.

Finally, we are also confronting the challenge of providing access to medication-assisted treatment in the criminal justice system through Drug Courts and correctional institutions. At present, there are 7 million people under state and federal jurisdiction with more than 2 million people in either jails or prisons. We know that approximately 44% of men and 52% of women meet the criteria for alcohol and drug dependence as they are incarcerated. There are a number of models for the use of methadone and buprenorphine in prisons and jails throughout the United States but it is reaching a fraction of the number of people who need access to such care.

The bottom line is that we need to increase public education for the use of such medications in treating opioid addiction as we continue to work against the social stigma that limits such treatment access. Healthcare reform should be used as a method of changing this longstanding and challenging reality. One rule of thumb certainly applies. People want access to addiction treatment when family members and loved ones fall victim to such a disease. They are not interested in stigma when they are desperate to get good care in a facility that employs knowledgeable and compassionate caregivers.