vigorously resisted by law enforcement agencies, resulting in the closure of these clinics. The FBN upheld this antimaintenance position for the next 40 years. The use of methadone to treat opiate addiction thus violated the FBN's long-standing policy against maintenance treatment of addiction.

The experimental work of Drs. Vincent Dole and Marie Nyswander on methadone maintenance at the Rockefeller Institute in New York City in the early 1960s led to an initial report on methadone treatment in the Journal of the American Medical Association (Dole and Nyswander, 1965). Following the success of the studies on methadone by Dole and his colleagues, the number of methadone treatment programs began to increase in all major U.S. cities. In 1968, fewer than 400 patients were enrolled in methadone maintenance programs nationwide. By January 1973, the number of patients enrolled in federal and nonfederal maintenance programs had increased to 73,000 (U.S. Congress, 1973c, p. 4). Administration of some of these programs was lax, resulting in the diversion of methadone to the street market by various means. In addition, in the early 1970s, a number of cities, particularly those on the East Coast, experienced a decline in heroin supplies, owing to a combination of enforcement efforts and dock strikes; the relative scarcity of heroin stimulated the market demand for illicit methadone as a substitute for heroin. The Bureau of Narcotics and Dangerous Drugs (BNDD, successor to the FBN, FDA, and the Special Action Office for Drug Abuse Prevention developed regulations for the operation of methadone programs primarily in order to control the problem of diversion.1

The concerns over methadone diversion of the early 1970s shaped many of the provisions of FDA methadone regulations issued in December 1972. Although it is not always clear whether a specific provision was designed to prevent diversion or to serve some other purpose or both, the following provisions are among the main ones that seem to have been included primarily to limit the likelihood that methadone would reach the street:

  • Requiring that methadone in the treatment of opiate addiction be dispensed only by programs licensed by the federal government;
  • Placing limits on the dispensing of methadone for treatment of narcotic addiction in hospitals;

1  

A number of newspaper articles published at the time contributed to the view that methadone diversion was a problem. The tone of the articles is suggested by some of their titles: "Study finds black market developing in methadone" (New York Times, January 2, 1972, by J.W. Markham); "Curse or cure? Controversy balloons over use of methadone as a heroin substitute" (Wall Street Journal, July 27, 1972, by I. Walters); "Methadone: Will it spread addiction?" (National Observer, May 29, 1972, by A. Gribbon).



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