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

418maybe the rest of their lives, or whether it should be used only forwithdrawal.Dr. Edwards. Yes. Part of what we approve the drug on are theindications for the use of the drug and this all goes, of course, in thelabeling for the use of the drug. In other words, what are the specificindications.Mr. Keating. I guess what concerns me is that we constantlycenter these discussions that we have on maintenance programs andwe don't seem to be talking enough about withdrawal, the withdrawaland rehabilitation process.I am not accusing you of this by any matter of means, becauseyours is a limited area, I think, as far as this is concerned, but constantlythrough these hearings I am concerned that one doctor whois handling the dispensing of methadone says we don't tread intothat area for fear that we will discourage them from participating inthe program at all, and I am a little bit concerned that we may justbe moving in one direction which may be injurious to the nationalhealth of our 3^oung people.Dr. Edwards. Again, I would say your point is extremely welltaken. I share your concern, and this again is exactly the point weare trying to make. There are an awful lot of answers we don't haveon this drug, and until we have them, I think it is the responsibilityof the FDA, the National Institute of Mental Health, the Bureauof Narcotics and Dangerous drugs, to proceed cautiously in allowingthe use of this drug.Mr. Keating. Well, I know that it is not easy to arrive at a jierfectsolution and I am sure that no amount of investigation will give youa perfect solution, but I believe that we should be cautious andshould arrive at a goal that protects the country as a whole.That is all, Mr. Chairman.Chairman Pepper. Doctor, just two questions. If methadone isfound not to be safe, what happens to the 30,000 methadone addictsM'ho are now being maintained on it?Dr. Jennings. I think there has been considerable misunderstandingof what our goals are here. I think if it hasn't alread}^ been donewe might submit for the record a co])y of our regulations governingthe investigation of methadone for mahitenance treatment of heroinaddiction.These set forth, among other things, a protocol or a plan for theinvestigation of methadone which requires that prior to entry intothe program, the subject or i^atient must undergo certain examinations,i>hysical examination and certain laboratory studies, whichmust be repeated at intervals. It is, I think, already obvious that weare not concerned with relatively short-tei-m use of the th'ug but,rather with extended use such as is envisioned by Dr. Dole and thosewho follow his way of thinking. vSo, if it became apparent to us thatsome of these routine examinations and hiboratory studies wereshowing the development of abnormalities, these wou.ld have to beweighed against whatever evidence we had for the eflicacy of thedrug.This is always the case with a potent drug offered for seriousindications, and if the benefits to be derived outweigh the risks, thenwith |jro[)er precautions the use could continue.