Brief Historical Background

The original concept of methadone maintenance to treat opioid use disorder developed from the early research work of Drs. Vincent Dole, Marie Nyswander and Mary Jeanne Kreek at Rockefeller University in the mid-1960s.


“An effective pharmacologic intervention had to meet stringent conditions to successfully treat narcotic addiction. It must eliminate the euphoric appeal of heroin and the abstinent symptoms that draw addicts back to drug use; it must be sufficiently free from toxic dysphoric effects that patients will continue with treatment; it must be orally effective, long-acting, medically safe and compatible with normal performance at work and at school with responsible behavior in society.” [3]


Methadone treatment expanded quickly in the late 1960s based on the success of their research efforts. In the book, Addicts Who Survive: An Oral History of Narcotic Use in America, 1923-1965, Dr. Dole wrote,


“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 problems they were dealing with. The strength of the early programs as designed by Marie Nyswander was in their sensitivity to individual human problems. The stupidity of thinking that just giving methadone to solve a complicated problem seems to me beyond comprehension” [4]


In our judgment, Dr. Dole’s comment is especially relevant given current policy considerations in treating opioid use disorder with medications. Dr. Dole’s comment reflects the importance of the assisted part of treatment.


In 1972, the Food and Drug Administration (FDA) published regulations for methadone treatment programs. No formal clinical guidelines were available to operate OTPs until SAMHSA published the above referenced treatment improvement protocol, State Methadone Treatment Guidelines, in 1993.[5]


It is important to point out that a damaging and influential series of articles “Methadone, The Deadly Cure” was published by the Sun Sentinel in Florida during June of 1983.[6] A quote from the editor follows:

“the public doesn’t care very much about methadone patients. They don’t enjoy a very good reputation, nor do they get much sympathy.  Indeed, the nationwide program to treat heroin addicts with methadone was not set up with the idea that it was being done to help addicts. It was being touted as a way of protecting society and keeping addicts from committing crimes.”


An objective observer could reasonably argue that such stigma, as represented in this quotation, is just as pervasive at present, which is why one of our Association’s recommendations is to develop a long-term national education campaign about the value of medications in the treatment of patients with opioid use disorder.

The importance of this reference from the Sun Sentinel is that it would lay the groundwork among federal legislators to request that the General Accounting Office (GAO) develop a report on this topic. In response, the GAO did publish a report in March 1990 – “Methadone Maintenance – Some Treatment Programs Are Not Effective; Greater Federal Oversight Needed”.[7] This report was sent to Chairman Congressman Charles B. Rangel of the House Select Committee on Narcotics Abuse and Control/House of Representatives and underscored the great disparity of quality care being offered to patients through OTPs, including subtherapeutic dosing and insufficient program services. It also highlighted that the FDA was not fulfilling its responsibilities in regulating the system. The GAO reviewed the practices of twenty-four OTPs operating in eight states. As a result, the House Select Committee on Narcotics Abuse and Control/House of Representatives immediately convened a hearing and was sharply critical of the FDA.


Following the release of this report, the FDA commissioned the Institute of Medicine (IOM) to conduct a comprehensive review of federal regulations for methadone treatment programs. The IOM published its report in 1995[8] and recommended that the federal oversight of methadone treatment programs should change from process-oriented regulations to a more patient-centered outcome driven approach. The IOM also concluded “the need exists to maintain certain enforceable requirements in order to prevent substandard or unethical practices that have socially undesirable consequences.”


Following the release of the IOM report, the Department of Health and Human Services (DHHS) implemented a strategy to transition federal oversight from the FDA to SAMHSA. After years of interagency federal discussions, SAMHSA would assume the responsibilities of providing oversight to OTPs in 2001[9] through approved accreditation bodies, which continues to the present.




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