uniqueness as a regulated drug. First, methadone (and now LAAM), are the only opiates authorized for treating opiate-dependent persons. Thus, providing methadone to patients on a regular basis creates a potential for diversion and abuse. Second, the revision of regulations has been inhibited by inertia. Although the 1972 regulations were modified in 1980, 1989, and 1993, there does not appear to have been any major public effort to reexamine the underlying assumptions or long-term consequences of the regulations until this committee review was requested. Finally, neither public nor professional attitudes, nor those of the addict community, have supported methadone treatment strongly, and in the absence of this support the existence of federal regulations has provided local communities and society at large with assurance that their concerns about methadone were being addressed. In sum, the current regulations are predicated on a belief that the societal risks of methadone outweigh the societal benefits to such an extent that extraordinary controls are necessary above and beyond those applicable to any other therapeutic drug in the United States.

In the committee's view, this belief underlying the current regulations is not valid in today's environment and the regulations should be modified accordingly. The belief has its roots in the experience of the late 1960s and early 1970s, when knowledge of methadone was not extensive and the social risks associated with heroin use seemed largely confined to the addicts themselves. Today, however, we know much more about the risks and potential misuse of methadone. Although the drug can be abused, it is rarely a primary drug of abuse. Further, there is no apparent evidence of organized crime involvement in the street market for the drug.

At the same time, the committee finds that the current regulations produce unintended results: addicts who cannot obtain a treatment program tailored to their individual circumstances, physicians who are unable to exercise professional judgment in treating individual patients, programs that are isolated from mainstream medical care (thus depriving patients of important ancillary services), and significant economic costs in assuring compliance with regulatory requirements, costs that are shared by programs, insurers, patients, and taxpayers.

The committee has concluded that correcting these faults and, in general, raising the standard of treatment entails authorizing greater clinical discretion in medical treatment and reducing the scope of government regulation. There is no compelling medical reason, in the committee's view, for regulating methadone differently from all other medications approved by FDA, including schedule II controlled substances.

Nevertheless, the committee is not recommending abolition of the methadone regulations. Although, as stated above, there is no compelling medical reason for treating methadone differently, the committee recognizes



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