The first clash occurred after World War I, when so-called "morphine clinics" existed and physicians prescribed or dispensed morphine to addicts. Some addicts were veterans of the American Civil War, the Spanish-American War, and WWI, who had become addicted during treatment for war wounds, but most of them came from the growing population of nonmedical addicts (Courtwright, 1982). The Narcotics Division of the Prohibition Unit of the Department of the Treasury, which was then responsible for enforcing the Harrison Narcotic Act, concluded that this activity was not the legitimate practice of medicine but simple drug trafficking. The Treasury Department swiftly closed the clinics and made it personally and professionally risky for physicians to "maintain" a narcotic addict for any reason. In did so, however, only after the American Medical Association had adopted a resolution, in 1920, opposing "ambulatory clinics'' (Musto, 1987, p. 148)

This story, as summarized above, became part of the "lore" that affected medical practice and research for almost 50 years and had a profound influence on government officials when the issue of narcotic maintenance again emerged in relation to methadone. In 1972, the public health establishment, including the Secretary of Health, Education, and Welfare, the Food and Drug Administration, the National Institute of Mental Health, and the Special Action Office for Drug Abuse Prevention, was unprepared to allow the Bureau of Narcotics and Dangerous Drugs, DEA's predecessor agency, to unilaterally define the parameters of medical practice for the use of methadone in the treatment of heroin addiction. As a consequence, a new set of rules—the third, on top of the FDA and DEA schemes—was added, one that inserted FDA deeply into the practice of medicine, notwithstanding its protestations to the contrary. Congress ratified this joint responsibility of law enforcement and public health officials for methadone through this third set of rules in 1974 with the passage of the Narcotic Addict Treatment Act (NATA). To examine in detail the evolution of this third set of rules—commonly referred to as the FDA or DHHS methadone regulations—we turn, first, to the period of the mid-1960s.

The 1960s

Increased use of heroin in the post World War II period first became apparent in the early to mid 1950s. By the end of that decade, New York City had established a special program for young people. The U.S. Public Health Service hospital at Lexington, Kentucky, admitted a number of unemancipated minors from major eastern U.S. metropolitan areas. And during the Eisenhower Administration, a minimum mandatory narcotics law was enacted in 1956, effective July 1957.



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