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

420[Exhibit No.17(a)]Statement of John Jennings, M.D., Associate Commissioner for MedicalAffairs, Food and Drug Administration, Department of Health, Education,AND WelfareMr. Chairman and members of the committee, I am Dr. John Jennings, AssociateCommissioner for Medical Affairs. The committee has been supphed with acopy of my education and professional background. Commissioner Edwards hasasked me to extend his regrets that a previous commitment prevents his being hereto discuss with j-ou current research in the treatment of narcotic addiction.We are all aware of the extent of the drug abuse problem and the increasingpublic concern about heroin addiction, in particular. A variety of therapeuticapproaches, many with some partial success, have been utilized over the pastseveral yesirs—ranging from chronic hospitalization through residential programssuch as Synanon, to outpatient psychotherapeutic efforts. The time, manpower,and money required in all of these approaches have resulted in only limited success,making a successful chemical therapeutic agent an attractive alternative.This has resulted in a search for a medication that would block the euphoriceffect of herion for addicts, prevent withdrawal symptoms, be eJBfective orally, longacting, free from toxic effects, and compatible with normal performance andreasonable behavior. The addict would have to be freed of his craving or hungerfor heroin.Methadone is currently under study for the maintenance treatment of narcoticaddiction. It has been an effective analgesic since it was synthesized at the end ofWorld War II. Although for more than a decade it has been known that low oraldoses of methadone would allay withdrawal symptoms, not until 1963 was itfirst observed that large oral doses could block the euphoric effects of even highdoses of other opiates or synthetic narcotics. Thus, the current widespread interestin methadone for the maintenance treatment of heroin addicts.Methadone is a marketed drug that has been approved through the newdrug procedures for three specific uses: As an analgesic, an antitussive, and fortreatment of withdrawal symptoms in heroin addiction. The last refers to theshort-term treatment of the acute symptoms resulting from the withdrawal ofheroin from those who have become physiologicalh^ dependent.Maintenance treatment of heroin addiction with methadone is investigationalbecause substantial evidence of its safety and effectiveness for this use is not yetavailable. Although there are studies which suggest that methadone maintenancemay be effective for some heroin addicts over a period of at least months, andperhaps a few years, we are only now beginning to obtain the kind of informationwhich may eventuall}' permit us to define the place of this drug in the treatmentof heroin addiction.Because it was available on prescription, the use of methadone for maintenancetherap.y became quite widespread following the early reports of success by Doleand Nyswander.In order to collect the type of scientific data needed to support approval of anew use of a drug, it was necessary that the maintenance programs follow protocols,including recordkeeping, that could yield such data. Investigational studies ofmethadone present problems not encountered in studies with other types of drugsbecause it is an addicting narcotic with a proven capacity for abuse.Therefore, to protect the community from the hazards of diversion and abuse,and to assure the development of valid data, guidelines for methadone maintenancestudies were developed tlirough the cooperation of the National Instituteof Mental Health, the Bureau of Narcotics and Dangerous Drugs, and the Foodand Drug Administration. These guidelines were published in the Federal Registeron April 2, 1971. Prior approval of both the Food and Drug Administration andthe Bureau of Narcotics and Dangerous Drugs, Department of Justice, is requiredbefore such studies may be initiated.Heroin addicts do not constitute a homogeneous population and proper treatmentrequires that we have some knowledge about which addicts may benefitfrom this treatment approach in contrast to other tht^rapy.Some investigators have reported that 70 to 80 percent of treated addicts arerehabilitated as judged bj^ reduction in criminal activity, improvement in employmentstatus, or schooling. Most of these reports, however, have not given adequateconsideration to the bias produced by patient selection. Some idea of the difficultyof interpreting such studies can be gained from a most recent evaluation of one