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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644narcotic antagonist, and the other is the final testing of a long actingform of methadone.It is also time, I believe, for the Federal Government to bring an endto a fiction, a useful fiction, but nevertheless a fiction, nainely thatmethadone maintenance is an experimental procedure. This fiction isnecessary in order to, in effect, license m.etliadone maintenance programs.Continued close control over such programs is uncjuestionablynecessary. It should, however, be done through licensing rather thanthrough its retention as an investigational procedure.Spending lots of money will not alone assure a good result. Lots ofmoney may be necessary, but good planning must go with it.Mr. Perito. Doctor, I take it from your statement that you havesevere reservations about the present concept of the IND number aspresently structured through FDA.Dr. Kramer. I have reservations about it only in that it is a fictionand that certain disadvantages in the use of this treatment are causedby this fiction. I have tried to emphasize that control is necessary,but it should be done through a legitimate procedure rather than, asI say, through a subterfuge.Mr. Perito. In other words, you do not believe that since there are30,000 addicts being treated under a methadone maintenance approachthat the FDA is seriouslv making a determination as to whether thedrug is in fact, safe and efficacious.Dr. Kramer. I know that thev are making such statements. I readone such statement in the press. The American Medical News publisheda letter from the public information director of the FDA in which heinsisted that it was, in fact, an experimental procedure. jMost of usinvolved in the study of methadone maintenance would disagree, Ibelieve.Mr. Pertto. Do you think substantial disadvantages flow to thephysician as a result of the present system of allowing methadonemaintenance only under the investigational new drug permits?Dr. KRA]vrER. I think that it increases the difficulty in initiating andexpanding legitimate pi-ograms.Mr. Perito. Doctor, based upon your experience, would you saythat antagonists have a j^lace in civil commitment programs?Dr. Kraimer. x\ntagonists ?Mr. Perito. Eight ; do you believe that antagonist drugs, like cyclazocine,naloxone, have a place in the treatment armamentaria ofphysicians ?Dr. Kramer. I believe any useful technique to control addiction hasa place in civil commitment programs; yes, including the use of narcoticantagonists.Mr. Perito. Do you know, based upon your experience, whethernarcotic antagonists are being used in civil commitment programs inCalifornia?Dr. KRA:\rER. I am reasonably certain that they are not being soused. They may be used for detection, the so-called Nalline test is used,I believe, in Los Angeles County. But in terms of a treatment procedure,to the best of mv knowledge, they are not being used in civilcommitment programs in California.^Ir. Perito. Doctor, you have a substantial ex]:)erience Avith the civilccnnmitment piT)gram in California. Based upon your experiences, do

645you think that it is possible to structure an involuntary civil commitmentprogram which will produce results, results in the sense thatyou will increase the number of people being substantially helped?Dr. Kramer. Yes, I believe that civil commitment programs canbe structured so that the success rate will be substantially increased.I think this can be done through reasonable and extensive use of allthe modalities that we currently have available, including methadonemaintenance, potentially including narcotic antagonists, potentiallyincluding Synanon-type programs.One of the problems in the civil commitment program in Californiais that in the so-called group therapy meetings, the man's likelihood ofdepaiting from the institution depended on what he said in the groupmeeting. This encouraged a certain amount of deception on the part ofthe patients.Mr. Perito. Have the treatment approaches changed with the passageof time since the inception of civil commitment programs inCalifornia ?Dr. Kr.\mer. Yes ; there have been some changes. I think a genuineeffort is being made on the part of the people who are running theprogram. I have never denied their desire to make their programsuccessful.The changes for the most part have been procedural rather thansubstantial. The one most promising aspect of this is that the CaliforniaDepartment of Corrections, which has the authority over the civilcommitment program, has on its own initiated a methadone maintenanceprogram, both for civilly committed addicts, and for feloneouslycommitted addicts, and has in the last year or so allowed their paroleesto be admitted to methadone maintenance programs.I might point out that about a year ago, we had to go to court to askto have a patient of ours admitted to a methadone maintenance programand I must say that though we lost in the courts, the pressure ofthe publicity probably forced the change on the part of the paroleboard.Mr. Perito. The committee has heard some limited testimony onthe NARA program, Narcotic Addict Rehabilitation Act, which Iknow you are familiar with. By and large, I think it is fair to capsulizeit that the implementation of the act has not been particularly successful,has not spanned a broad range of treatment approaches, nor hasit been able to help that may people. Based upon your experiences, whydo you think that NARA has not done so well ?Dr. Kramer. I pointed out in my statement that from the informationthat I had, which is now about 6 months old—I have not gottenmore recent information—they seemed at least at the beginning tobe doing a little bit better than the California or New York programs.One reason that they have not done even better, perhaps, is becausethose running the program seem, frankly, rather antagonistic to themethadone maintenance approach. When I spoke with one worker inthe NARA program, he almost apologized for the fact that they hadseveral patients on outpatient status who were receiving methadoneand he did not in fact include them in his list of successes.Mr. Perito. Do you think the States on their own can structureprograms in the civil commitment area vrithout substantial help fromthe Federal Government ? Based upon your experiences ?

644narcotic antagonist, <strong>and</strong> the other is the final testing of a long actingform of methadone.It is also time, I believe, for the Federal Government to bring an endto a fiction, a useful fiction, but nevertheless a fiction, nainely thatmethadone maintenance is an experimental procedure. This fiction isnecessary in order to, in effect, license m.etliadone maintenance programs.Continued close control over such programs is uncjuestionablynecessary. It should, however, be done through licensing rather thanthrough its retention as an investigational procedure.Spending lots of money will not alone assure a good result. Lots ofmoney may be necessary, but good planning must go with it.Mr. Perito. Doctor, I take it from your statement that you havesevere reservations about the present concept of the IND number aspresently structured through FDA.Dr. Kramer. I have reservations about it only in that it is a fiction<strong>and</strong> that certain disadvantages in the use of this <strong>treatment</strong> are causedby this fiction. I have tried to emphasize that control is necessary,but it should be done through a legitimate procedure rather than, asI say, through a subterfuge.Mr. Perito. In other words, you do not believe that since there are30,000 addicts being treated under a methadone maintenance approachthat the FDA is seriouslv making a determination as to whether thedrug is in fact, safe <strong>and</strong> efficacious.Dr. Kramer. I know that thev are making such statements. I readone such statement in the press. The American Medical News publisheda letter from the public information director of the FDA in which heinsisted that it was, in fact, an experimental procedure. jMost of usinvolved in the study of methadone maintenance would disagree, Ibelieve.Mr. Pertto. Do you think substantial disadvantages flow to thephysician as a result of the present system of allowing methadonemaintenance only under the investigational new drug permits?Dr. KRA]vrER. I think that it increases the difficulty in initiating <strong>and</strong>exp<strong>and</strong>ing legitimate pi-ograms.Mr. Perito. Doctor, based upon your experience, would you saythat antagonists have a j^lace in civil commitment programs?Dr. Kraimer. x\ntagonists ?Mr. Perito. Eight ; do you believe that antagonist drugs, like cyclazocine,naloxone, have a place in the <strong>treatment</strong> armamentaria ofphysicians ?Dr. Kramer. I believe any useful technique to control addiction hasa place in civil commitment programs; yes, including the use of narcoticantagonists.Mr. Perito. Do you know, based upon your experience, whethernarcotic antagonists are being used in civil commitment programs inCalifornia?Dr. KRA:\rER. I am reasonably certain that they are not being soused. They may be used for detection, the so-called Nalline test is used,I believe, in Los Angeles County. But in terms of a <strong>treatment</strong> procedure,to the best of mv knowledge, they are not being used in civilcommitment programs in California.^Ir. Perito. Doctor, you have a substantial ex]:)erience Avith the civilccnnmitment piT)gram in California. Based upon your experiences, do

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