Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...

395of Narcotics and Dangerous Drugs, and the Food and Drug Administration.These guidehnes were pubhshed in the Federal Registeron April 2, 1971. Prior approval of both the Food and Drug Administrationand the Bureau of Nai'cotics and Dangerous Drugs is requiredbefore such studies may be initiated.Heroin addicts do not constitute, as you know, a homogeneouspopulation and proper treatment requires that we have some knowledgeabout which addicts may benefit from this treatment approachin contract to other types of therapy.Some investigators have reported that 70 to 80 percent of treatedaddicts are rehabilitated as judged by reduction in criminal activit}*,improvement in employment status, or schooling. But most of thesereports have not given adequate consideration to the bias producedby patient selection. Some idea of the difficulty of interpreting suchstudies can be gained from a most recent evaluation of one of thebest known programs. Although the program had a very broad criteriafor admission, more applicants were not admitted, and I emphasizenot, to the study than were admitted.In general, those patients admitted to the study and remainingin treatment, when compared to the overall heroin addict population,tended to be older, more often white, and in better health. Thisgroup, which had an improved employment status and reducedcriminality, was not representative of the total heroin addict population.Therefore, this study, as well as others reported to date, cannotbe used to generahze the results for the entire addict population.^Vliether those not accepted for treatment would have fared as wellas those accepted of course is as yet unanswered. Reports have notprovided the kind of data that enables better patient selection.Also, data are needed to distinguish the role played by the drugitself from the role played by the psychological, the social, and theoccupational rehabilitative efforts in such programs; and markedproliferation of programs may produce many in which only the drugis used and no rehabilitation is pro^^.ded.Methadone maintenance treatment may be a valuable therapy inreducing heroin addiction, but we believe it is wise to proceed cautiouslyin moving toward its general prescription use for this purpose.We need better evidence to determine the safety of this treatment.It is well to bear in mind that methadone maintenance treatmentrepresents substituting methadone addiction for heroin addiction anddoes not represent the absence of drug addiction. One of the hazardsof methadone treatment is that j^oung drug users who are not physiologicallydependent on heroin might become addicted to methadoneas a result of treatment. Another hazard stems from the possibilityof death if a nonaddict takes the usual maintenance dose of methadoneintravenously or because of the addictive eft'ect, if an addict ''shoots"methadone while still taking heroin. We do not wish to have a potentiallyvaluable therapy discredited because of its misuse by somepractitioners while its efficacy is being evaluated.We now have some 257 investigational new drug exemption (IND)numbers assigned to sponsors representing 277 methadone treatmentprograms. Of these, 185 programs are institutional programs. Theremainder are being carried on by private practitioners. However, atpresent, no appfication is being approved unless the program can