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

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

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404system of treatment and rehabilitation facilities all over this country,in every community in America where there was a need for it—wouldyou suggest that such treatment and rehabilitation programs should beconducted through clinics where there M'Ould be proper supervisionand the like, rather than permit these drugs to be prescribed by individualpractitioners?Dr. Edwards. I think a drug with the potential danger—and Iwill use the words "potential danger"—of methadone, if it is going tobe used on a widescale basis, it has got to be used through institutionaltypeclinical settings. I don't think they can be used through individualpractitioners.Chairman Pepper. And your regulations have been moving ratherin that direction?Dr. Edwards. Our regulations are definitely moving in thatdirection.Chairman Pepper. The clinic can require the patient or the recipientof the treatment to be there in person and receive it when the}' thinkit is desirable to do this.Dr. Edwards. That is right.Chairman Pepper. And they can give him certain therapeutic andoccupational and other assistance.Dr. Edwards. That is correct, because there isChairman Pepper. Which the doctor doesn't profess to be able toafford.Dr. Edwards. I think your point is an extremely good one, that weneed more than just methadone tlierap}-. There is a whole range ofrehabilitative services that have to go into the rehabilitation of anyaddict and it is more than just a single drug. You have to have otherforms of therapy as well.Chairman Pepper. Mr. Brasco?Mr. Brasco. Yes.Dr. Edwards, can you tell us how long you have been investigatingthe properties of methadone in terms of its safety?Dr. Edwards. If I might, I would like to have Dr. Gardner answerthat. He is better acquainted with the specifics.Dr. Gardner. Actuall}^, of course, we haven't been investigating it.Mr. Brasco. Well, you make a determination as to whether or notit is a safe drug.Dr. Gardner. Yes.Mr. Brasco. Somebody should be investigating it.Dr. Gardner. I meant we only evaluate the data submitted by thepeople who conduct the studies. Most studies have been in progressfor only the past year and insufficient data has been submitted as j^etto fully evaluate the safety and efficacy of methadone maintenance.Mr. Brasco. Well, let me ask you this, Dr. Edwards. All of j^ourstatement is replete with the fact that there are certain judgmentcriteria, and I heard a moment ago that there are approximately30,000 people in the prograni already. Now, what are you workingtoward in terms of getting to a point that you can say whether or notthis is a safe drug or not a safe drug?Dr. Gardner. Well, first of all, the 30,000 might be on the high side,but something between 20,000 and 30,000 people are probabh^ inthese programs. In terms of safety we must know about any adverse

405effects this drug will produce in long-term use. Will it interfere withnormal functioning? How many deaths may occur from the licit orillicit use of this drug, given the amounts necessary for a maintenanceprogram. We do need to know how much illicit distribution stems fromthe approved program because this, in a sense, affects the safety of thisuse of methadone.We want to know what the possible death rate is, just from theuse of this drug alone. We want to know how much illicit distributionthere is from the progi*ams, because if we were to substitute tliis typeof addiction for another type of addiction, and it would be widespread,there would be widespread abuse and illicit trade with the drug.Mr. Brasco. Would that really make a difference in terms of itssafety? I appreciate that most of the drugs that we have on the markettoday can be diverted and are diverted into illegal channels. Wehaven't stopped manufacturing them. Is that one of the considerationsthat is bogging dowm the determination?Dr. Gardner. No; it is not the only consideration. We do not havethe data submitted to us to permit an adequate evaluation of safetyand eflficacy.Dr. Edwards, In other words, we do not at this time have thescientific information available to us that will establish the long-termor even the short-term safety of this particular drug.Mr. Brasco. Well, hoAv long has it been under consideration interms of years or months?Dr. Edwards. Well, of course, the drug was considered sometimeago. Short-term studies were done when the drug was being consideredfor its analgesic and its antitussive properties, but at that time, again,no long-tei-m studies were done. These were short-term studies.Mr. Brasco. What does that short-term mean? A month, 2 weeksor a year?You see, the thing that I am concerned about, and maybe I canmake myself a little more explicit, it seems to me when we get someof these drugs, and I appreciate that everyone wants to be safe inmaking a determination with respect to a drug, but—well, take cyclamates,for instance, we found out—I don't knov\^ how long it took toinvestigate that—that it has a property that may cause cancer of thekidneys and I, along -with, other people, have been drinking all oftliis diet stuff with it.Now ^ve have got a drug and you have approximately 30,000people using it ina program. I, myself, have recommended a numberof young people in my o-wn district into the program. They have comeback to my office and people who were in trouble before with the law,marital problems, are now working, living at home in a family relationship,and I tliink really the important thing is when can your agencymake a determination so we can either say that methadone is notsafe or say it is available for general use?Dr. Jennings. Well, sii-, I think you have raised questions of bothsafety and efficacy.Mr. Brasco. I am trying to find out from you how long you need.Dr. Jennings. Yes, sh.Mr. Brasco. You might study this thing to death. That is what Iam concerned about.Dr. Jennings. The drug has a long history for relatively shorttermuse. It has been studied or used sometimes in a situation that

404system of <strong>treatment</strong> <strong>and</strong> <strong>rehabilitation</strong> facilities all over this country,in every community in America where there was a need for it—wouldyou suggest that such <strong>treatment</strong> <strong>and</strong> <strong>rehabilitation</strong> programs should beconducted through clinics where there M'Ould be proper supervision<strong>and</strong> the like, rather than permit these drugs to be prescribed by individualpractitioners?Dr. Edwards. I think a drug with the potential danger—<strong>and</strong> Iwill use the words "potential danger"—of methadone, if it is going tobe used on a widescale basis, it has got to be used through institutionaltypeclinical settings. I don't think they can be used through individualpractitioners.Chairman Pepper. And your regulations have been moving ratherin that direction?Dr. Edwards. Our regulations are definitely moving in thatdirection.Chairman Pepper. The clinic can require the patient or the recipientof the <strong>treatment</strong> to be there in person <strong>and</strong> receive it when the}' thinkit is desirable to do this.Dr. Edwards. That is right.Chairman Pepper. And they can give him certain therapeutic <strong>and</strong>occupational <strong>and</strong> other assistance.Dr. Edwards. That is correct, because there isChairman Pepper. Which the doctor doesn't profess to be able toafford.Dr. Edwards. I think your point is an extremely good one, that weneed more than just methadone tlierap}-. There is a whole range ofrehabilitative services that have to go into the <strong>rehabilitation</strong> of anyaddict <strong>and</strong> it is more than just a single drug. You have to have otherforms of therapy as well.Chairman Pepper. Mr. Brasco?Mr. Brasco. Yes.Dr. Edwards, can you tell us how long you have been investigatingthe properties of methadone in terms of its safety?Dr. Edwards. If I might, I would like to have Dr. Gardner answerthat. He is better acquainted with the specifics.Dr. Gardner. Actuall}^, of course, we haven't been investigating it.Mr. Brasco. Well, you make a determination as to whether or notit is a safe drug.Dr. Gardner. Yes.Mr. Brasco. Somebody should be investigating it.Dr. Gardner. I meant we only evaluate the data submitted by thepeople who conduct the studies. Most studies have been in progressfor only the past year <strong>and</strong> insufficient data has been submitted as j^etto fully evaluate the safety <strong>and</strong> efficacy of methadone maintenance.Mr. Brasco. Well, let me ask you this, Dr. Edwards. All of j^ourstatement is replete with the fact that there are certain judgmentcriteria, <strong>and</strong> I heard a moment ago that there are approximately30,000 people in the prograni already. Now, what are you workingtoward in terms of getting to a point that you can say whether or notthis is a safe drug or not a safe drug?Dr. Gardner. Well, first of all, the 30,000 might be on the high side,but something between 20,000 <strong>and</strong> 30,000 people are probabh^ inthese programs. In terms of safety we must know about any adverse

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