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

396study an adequate number of patients to yield meaningful dataregarding the safety and efficacy of methadone.We have requested 6-month status reports from these programsinstead of the customary annual reports, in order to obtain adequatedata as soon as we possibly can.We expect our recently published regulations to serve as a valuabletool in insuring compliance with existing requirements. In this regard,we have recentl}^ undertaken a program for the inspection of allmethadone maintenance studies. By mid-July, we will have completedinspection of an initial 40 to 50 programs throughout the country,selected on the basis of various criteria.In addition to achieving correction of any deficiencies, we hope tostimulate improved practices and better data collecting procedures.In these inspections, whenever possible, medical officers from ourBureau of Drugs of the Food and Drug Administration will accompau}^district field inspectors. All of this will be done in closecooperation with the Bureau of Narcotics and Dangerous Drugs,which, in addition, has its own program for surveillance of themethadone studies.Preliminary results of these inspections have demonstrated that atleast some programs must be terminated. Action to do so has alreadybeen initiated in some instances.When necessary, a sponsor will be given a time limit to correctdeficiencies or face loss of his investigational status. However, beforea program is terminated, we will contact local health departments,medical societies, and other approved methadone maintenance programsin an effort to insure that continuing treatment for the addictsis available. A letter has also been sent to all State and local drugprogram officials notifying them of our inspection program; I amsubmitting a copy of this letter to you for the record.In addition to review by our own personnel, we have appomted acommittee of outside experts to assist in evaluating data as it accumulates,as well as other aspects of the ongoing programs. The committeewill also be called on to assist in reviewing any new drug applicationsfor methadone maintenance.The members of our advisory committee, some of whom have alreadyappeared before your committee, are Dr. Henry Brill, Dr.Robert Milliman, Dr. William Bloom, Jr., Dr. Max Fink, and Dr.Sidne}^ Cohen. In addition, we have contracted with Daniel X.Freedman, M.D., Dr. E. Leong Way, Ph. D., and Dr. MauriceSeevers to serve as consultants to this particular committee.The concept of narcotic blockade has stimulated a search for otherdrugs, drugs with no addicting potential, with greater safet}^ and oflonger duration than methadone. Acetyl-methadol promises some hopein that its duration of action is 72 hours in contrast to the 24 hoursin which methadone remains effective. Thus, an addict could take hismedication even under supervision, on a twice-weekly basis. However, the possible toxicity of acetyl-methadol needs further stud}'.Cyclazocine is another narcotic antagonist that has been studiedfor the treatment of heroin addiction. Its use has been limited, however,because it has some narcotic actions of its own, it can producerespiratory depression and it may be addicting.