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

423Medical Association, American Psychiatric Association, National Acadeni^^ ofSciences-National Research Council, known authorities in the treatment of drugaddiction, and from individuals and municipalities currently operating methadonemaintenance programs.The majority of the comments are in the form of objections to provisions ofthe protocol and the regulation, as follows:1. The criteria in the protocol for the exclusion of subjects from the studies:Pregnancy, psychosis, serious physical diseases, and persons less than 18 years ofage.2. The requirement in the protocol that no more than a .3-day supply be givento a subject at one time.3. The necessity for making records available to the Food and Drug Administrationand to the Bureau of Narcotics and Dangerous Drugs and the lack of aguarantee of confidentiality of patient records.4. The requirement that one of the objectives of the studies be a return to thedrug-free state.5. The requirement that the dosage level be limited to 160 milligrams per day.6. The necessity of obtaining prior approval from the Bureau of Nacrotics andDangerous Drugs.7. The requirements for weeklj" urine analysis and other laboratory tests andexaminations.8. The classification of the use of methadone in the maintenance treatment ofnarcotic addicts as an investigational use.9. The regulation being overly restrictive and not in the best interest of thepublic.The Commissioner of Food and Drugs, having considered the comments andhaving met with representatives of interested groups, associations, and individualsfor further discussion, finds that:1. The majority of the comments are a result of interested persons interpretingthe proposal as restricting investigators to the suggested protocol. This is amisinterpretation since the protocol is intended only as a guide to assist theprofession, municipalites, organizations, and other groups who are interested insponsoring programs for the investigation of methadone in the maintenancetreatment of narcotic addicts. It is not intended that every methadone programbe confined to the limits of this protocol. Modification of the protocol and completelydifferent protocols will be accepted, provided they can be justified by thesponsor. Modifications and completely different protocols consistent with publicwelfare and safetj' will be approved.2. Since the suggested protocol is intended as an aid to those who wish to sponsorprograms for the investigation of methadone in the maintenance treatment ofnarcotic addicts, it is recognized that it would be to the benefit of the Food andDrug Administration, the Bureau of Narcotics and Dangerous Drugs, and thesponsors of the investigations to have a suggested protocol that would be acceptableto the majority of sponsors while satisfying the requirements of the twoaforementioned agencies. Accordingly, the following revisions have been made inthe regulation as adopted below:a. The provision of the protocol "Criteria for exclusion from the program" hasbeen changed to "Patients requiring special consideration." Pregnancy, psychosis,serious physical disease, and being less than 18 years of age are not reasons forautomatic elimination from a program but are conditions that merit special considerationswhich are detailed.b. A provison has been added to the protocol to permit the investigator to exceedthe dosage of 160 milligrams per day when the investigator finds it essential to doso and describes the considerations leading to such dosage levels in his protocol.c. The requirement for laboratory examinations at 6-month intervals has beenchanged to 1-year intervals.d. The objectives of the study have been clarified.3. The remaining comments concerning the protocol and not m.entioned abovedeal primarily with problems that can be met by submission of a modified protocolto be judged on individual merit.4. Regarding the objection that the recordkeeping requirements and the necessityfor making records available to the Food and Drug Administration and theBureau of Narcotics and Dangerous Drugs could violate the confidential relationshipbetween the patient and the phj^sician: The Federal Food, Drug, and CosmeticAct provides for promulgating regulations that require the sponsor of the druginvestigations to maintain adequate records and that these records be made