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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400Mr. Perito. Were you getting data from the Dole-Nyswanderprogram back in 1963, 1964, when they first started experimentation?Dr. Gardner. No. At that time there was no IND procedure forthis and methadone for the maintenance treatment of heroin addictionwas not specifically precluded or guided by any regulations.Mr. Perito. Do you now have proper manpower in your agency toinvestigate the 277 methadone maintenance programs and protocolsso that your Agency is able to make an informed judgment as to thesafety and efficacy of such treatment programs?Dr. Edwards. Manpower, as far as we are concerned, is a veryscare commodity. Our inspectors in the field are involved in the food,product safety, and drug fields of activity. So the real answer to yourquestion is no, but we have given this a very high priority in theagency and are expanding special effort in this area.We consider this one of the major problems that we are confronted\\dth and have diverted a lot of our manpower into this ])rogram. Imust also say, however, that it takes a person with special training toreally get involved in these programs, in the inspect programs suchas this. Consequently, we are in the process of training some of ourpeople in the inspectional techniques necessary to inspect theseprograms and to give us the kind of information we need atheadquarters.Mr. Perito. Do you know how many people FBNDD have assignedto work with you in conjunction with this effort?Dr. Edwards. Not specifically.Dr. Jennings. No, sir; but to backtrack a little bit to explain someof the background that Dr. Gardner referred to, until recently aninvestigator of any drug was entitled to begin his investigations assoon as he had filed with us his notice that he intended to do so. As amatter of fact, he was entitled to begin the investigations as soon ashe had mailed in his application.Mr. Perito. In other words, a licensed physician could startimmediately without getting your prior approval?Dr. Jennings. That is right. About a year ago, for reasons notdh"ectly related to methadone but to other investigational drugs, wepromulgated a regulation that requu^ed a 30-day waiting periodbefore he could begin his investigations.When the methadone regulations went into effect in April, theycontained still another safeguard. That is, that there would have to beprior approval, not only by the Food and Drug Administration butby the Bureau of Narcotics and Dangerous Drugs before the studiescould be instituted.We have now been informed that the Bureau of Narcotics andDangerous Drugs is going to make an onsite investigation of eachinvestigator prior to giving their required approval to the investigationalnew drug investigation. The studies that exist now were notsubjected to this sort of scrutiny. Prior to April 2, they were approvedby the Food and Drug Administration in the manner then part of ourprocedure; that is, the investigator's qualifications were examined,his protocol was reviewed, and if there was nothing obvious thatwould prevent the application trom being approved, it was permittedto go into effect in accord with the then current procedure, that is, a30-day waiting period.

401Now, because of our attention having been brought to certainabuses tliat Dr. Gardner can speak of, we have undertaken to examinethese programs that are ah'eady set up. Some of them will be examinedbecause we have reason to beheve that they may not be measuringup. Others will be examined on the basis of getting a representativesampling of institutional and private programs, and as was indicatedby Mr. Ingersoll yesterday, we believe that there will be actionstaken against some of these in the very near future.Mr. Perito. Prior to the promulgation of the regulations on April 2,1971, how long did your Agency have under consideration the proposedregulations?Dr. Edwards. Quite some time. I think it was about 9 months,wasn't it?Dr. Jennings. Yes, sir. The efforts on the part of the Food andDrug Administration to promulgate these regulations probably goback for more than a year. I can tell you that the}^ did not initiallymeet mth the unqualified approval of the medical commmiity, thescientific communit}^, and the people who are investigating the drug,and especially the strong proponents of methadone as a treatment forheroin addiction.Mr. Perito.Thank you.Chan-man Pepper. Mr. Blommer, our associate chief counsel, do3^ou have any questions?Mr. Blommer. Yes, Mr. Chairman.Dr. Edwards, is your agency at this time granting new IND numbersto invest gate methadone maintenance?Dr. Edwards. We are not granting any additional IND's forindi\ndual investigators, single investigators, that aren't part of aninstitution.Mr. Blommer. If I understand your testimony here already, thereare 30,000 individuals being maintained on methadone, is that correct?Dr. Edwards. That is an estimate, but that is a rough estimate.Mr. Blommer. And I assume that because you are granting newnumbers, you feel that 30,000 is not a large enough figure or thatthere should be more people in methadone maintenance programs?Dr. Edwards. I don't know if that is really the criteria. We areAvilling to grant an IND number to anyone that we think is, first ofall, a responsible investigator that can provide the kind of informationwe need to fully evaluate the drug.Now, I can't say whether Vv^e need 30,000 or 60,000 people. I can'tgive you a specific answer on what the exact number should be.Mr. Blommer. Well, Doctor, if you find that methadone maintenanceis either not safe or not effective, then you will recommend thatall these methadone programs be closed down, I assume.Dr. Edwards. That is right.Mr. Blommer. 1 have no further questions.Chairman Pepper. Doctor, how many addicts does your agencyestimate there are in the United States?Dr. Gardner. I think we have the same kind of rough estimatethat anybody has, which is hi the range of a couple of hundred thousand,maybe 100,000, 200,000.Chairman Pepper. And about 30,000 are on methadonemaintenance.

401Now, because of our attention having been brought to certainabuses tliat Dr. Gardner can speak of, we have undertaken to examinethese programs that are ah'eady set up. Some of them will be examinedbecause we have reason to beheve that they may not be measuringup. Others will be examined on the basis of getting a representativesampling of institutional <strong>and</strong> private programs, <strong>and</strong> as was indicatedby Mr. Ingersoll yesterday, we believe that there will be actionstaken against some of these in the very near future.Mr. Perito. Prior to the promulgation of the regulations on April 2,1971, how long did your Agency have under consideration the proposedregulations?Dr. Edwards. Quite some time. I think it was about 9 months,wasn't it?Dr. Jennings. Yes, sir. The efforts on the part of the Food <strong>and</strong>Drug Administration to promulgate these regulations probably goback for more than a year. I can tell you that the}^ did not initiallymeet mth the unqualified approval of the medical commmiity, thescientific communit}^, <strong>and</strong> the people who are investigating the drug,<strong>and</strong> especially the strong proponents of methadone as a <strong>treatment</strong> forheroin addiction.Mr. Perito.Thank you.Chan-man Pepper. Mr. Blommer, our associate chief counsel, do3^ou have any questions?Mr. Blommer. Yes, Mr. Chairman.Dr. Edwards, is your agency at this time granting new IND numbersto invest gate methadone maintenance?Dr. Edwards. We are not granting any additional IND's forindi\ndual investigators, single investigators, that aren't part of aninstitution.Mr. Blommer. If I underst<strong>and</strong> your testimony here already, thereare 30,000 individuals being maintained on methadone, is that correct?Dr. Edwards. That is an estimate, but that is a rough estimate.Mr. Blommer. And I assume that because you are granting newnumbers, you feel that 30,000 is not a large enough figure or thatthere should be more people in methadone maintenance programs?Dr. Edwards. I don't know if that is really the criteria. We areAvilling to grant an IND number to anyone that we think is, first ofall, a responsible investigator that can provide the kind of informationwe need to fully evaluate the drug.Now, I can't say whether Vv^e need 30,000 or 60,000 people. I can'tgive you a specific answer on what the exact number should be.Mr. Blommer. Well, Doctor, if you find that methadone maintenanceis either not safe or not effective, then you will recommend thatall these methadone programs be closed down, I assume.Dr. Edwards. That is right.Mr. Blommer. 1 have no further questions.Chairman Pepper. Doctor, how many addicts does your agencyestimate there are in the United States?Dr. Gardner. I think we have the same kind of rough estimatethat anybody has, which is hi the range of a couple of hundred thous<strong>and</strong>,maybe 100,000, 200,000.Chairman Pepper. And about 30,000 are on methadonemaintenance.

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