Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...
Narcotics research, rehabilitation, and treatment. Hearings, Ninety ... Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...
'402How many would you say are being treated with other drugs?Dr. Gardner. At this point in time, a very small number. Theonly other drugs that are really being studied A\dth any kind of intensityare the derivative of methadone, acetyl-methadol, and some blockingagents as Dr. Edwards mentioned, cyclazocine and naloxone. Thestudies involving cyclazocine and naloxone do not include more thana few hundred patients.Chairman Pepper. So if there are 200,000 or 300,000 heroin addictsin the United States, your opinion is that probably less than 50,000are receiving treatment with some approved drug?Dr. Edwards. On some apjjroved drug, that is correct; j'^es.Chairman Pepper. Well, now. Doctor, I would like to have therecord show clearly what the function of the Food and Drug Administrationis. You are not charged with trying to solve the herohiproblem in the country, are you, in the sense of having responsibilityfor developing a drug that will block heroin addiction, heroin euphoria?Dr. Edwards. No; but we do have the responsibility of workingwith and encouraging research in this area.Chairma!! Pepper. Does your agency carry on any research ofits own in this field, to try to find a drug that would be a blockage orimmunizing drug?Dr. Edwards. No. We are not doing any immediate work ourselves.Chairman Pepper. That is what I was getthig at. You are notcharged with the responsibility by law of furnishing the funds to carryon independent research to try to find a drug that will be a blockageor an immunizing drug for heroin?Dr. Edwards. We are supplying funds to the Committee on DrugDe])endence.Chairman Pepper. You are more or less a policing agency toexamine drugs that are projiosed to you and to see whether or notafter projier inquiry is made, they are efficacious and/or safe drugs?Dr. Edwards. That is correct. Our responsibility is to evaluatethe scientific data obtained from these various programs and to evaluatethe safety and efficacy of the drugs.Chairman Pepper. And since submissions to your agency mightbe made by another Government agency, or almost anybody whowants to use a drug, private pharmaceuticals or NIMH, and tryingto carry on an inquiry, trying to develoji a particular type of dnig.Dr. Edwards. Yes, sir; that is correct.Chairman Pepper. Does NIMH in your opinion generallyhave responsibility in this field as the initiating agency to try and dosomething about the drug i)roblem?Dr. Edwards. I think it has the })rime responsibility in the FederalEstablishment for initiating and stimulating r(>search in this area;yes.Chairman Pepper. Well, now, has NIMH submitted to the Foodand Drug Administration any drug and asked for your evaluation ofthose di-ugs with res])ect to the treatment of heroin addiction?Dr. Edwards. For the specifics I would have to ask Dr. Gardnerto answer.Dr. Gardner. They submitted a|)plications for investigational newdrug status for not only methadone, but for some other drugs, particularl}^those that are being studied in the Lexington Research Center,
403and this is only for the investigational phase. Beyond that, of course,if the}' are to be marketed, that would become part of the responsibilityof the pharmaceutical industry.Chairman Pepper. Well, now, Doctor, one of the things that thiscommittee is ver}' interested in and very concerned about, is tr^nngto develop a system by which everything that can be done, shall bedone as quickly as it can be done to do something effective about theheroin addiction problem in this country.You know, of course, what it is costing the country in terms oflost lives and ruined careers and crime and loss of propert}', et cetera.I know your agency is desirous within the bounds of propriety andwithin the limitations of law to be cooperative. We heard here alittle bit ago about a drug, for example, that some doctors have beenusing in respect to the heroin addiction that they think blocks thephysical craving for heroin, and it has been used on a number ofpeople, according to one of the doctor \vitnesses who appeared, andanother doctor had sent some of his patients to receive treatment bythis drug.Now, vre wouldn't, of course, in any sense of the word suggest orcondone your giving approval when it should not properly be given,but I think we do have a right to inquire whether or not good leadsthat might be developed would have all possible expedition andconsideration by your agency, because this is a matter of great publicinterest. I mean, you wouldn't put too much emphasis on the formand too little upon the substance so as to just take as a matter ofcasual day-to-day routine submissions by responsible people ofpossible antagonistic or blockage or immunizing drugs for heroinaddiction; would you?Dr. Edwards. No; we certainly wouldn't. We share your concernfor this problem and, as I mentioned earlier, we do not vrant toimpede progress in trying to develop a meaningful drug in this area.On the other hand, we do have a responsibiiitj^, first, to assure thatdangerous drugs are not allowed on the market. Second, that thedrugs are not diverted into illicit channels.Chairman Pepper. And if the National Institute of MentalHealth, which seems to have the primary responsibility by law, toldyou they had some leads, and asked your cooperation and inquiringinto the safety and efficacy of those potential drugs, you wouldcooperate with them, of course, in every way possible.Dr. Edwards. Absolutely, and we are doing this right now. Allwe w^ant to be sure of is that these studies and these drugs are beingused by people who should be using them. The National Institute ofMental Health is really the focal point in the United States for testing.Chairman Pepper. Just one other question. Doctor. Now, is it yourgeneral opinion that methadone is about the best drug that is on themarket so far for dealing with heroin addiction? I mean, even if itdoes have its defects and its faults, it has certain advantages m thetreatment of heroin addiction if properly used.Dr. Edwards. It certainly shows some promise, more so than anythingwe have currently available.Chairman Pepper. Well, now, if it were to be used—suppose wewere to recommend to the House of Representatives, and the Congressshould adopt a law and adequate funds should be provided to set up a
- Page 372 and 373: 352their farmers who have been grow
- Page 374 and 375: 354told that much of the insurgency
- Page 376 and 377: 356Mr. IxGERSOLL. Well, again, Mr.
- Page 378 and 379: 358jority of the heroin problem in
- Page 380 and 381: 360years, but I have been frustrate
- Page 382 and 383: 362Mr, Steiger. If you were goin^ t
- Page 384 and 385: 364report marihuana among junior gr
- Page 386 and 387: 366And it seems to me tliat we Avou
- Page 388 and 389: ?368effectively, then maybe we will
- Page 390 and 391: 370improvement as far as the abilit
- Page 392 and 393: 372was there. Your visits probably
- Page 394 and 395: 374the purchase of Avitnesses—I s
- Page 396 and 397: :376administrations to publicly say
- Page 398 and 399: 378Chairman Pepper. We will take a
- Page 400 and 401: 380Mr. Ingersoll. No. I don't recal
- Page 402 and 403: :382can fulfill the vow made by the
- Page 404 and 405: 384have to give you the same answer
- Page 406 and 407: 386Mr. Brasco. But that is another
- Page 408 and 409: 388Mr. Ingeksoll. Well, that is the
- Page 411 and 412: NARCOTICS RESEARCH, REHABILITATION,
- Page 413 and 414: -39,3,Dr. Edwards held a surgical f
- Page 415 and 416: 395of Narcotics and Dangerous Drugs
- Page 417 and 418: 397Naloxone, recently approved for
- Page 419 and 420: 399for example, who might be abusin
- Page 421: 401Now, because of our attention ha
- Page 425 and 426: 405effects this drug will produce i
- Page 427 and 428: 407Now, if it is not used intravene
- Page 429 and 430: 409Mr. Wiggins. Dr. Jennings, does
- Page 431 and 432: 411Penicillin is good for pneumonia
- Page 433 and 434: 413Mr. R ANGEL. But from the studie
- Page 435 and 436: 415Dr. Gardner. Again, we don't hav
- Page 437 and 438: 417Dr. Edwards. I suspect it at lea
- Page 439 and 440: 419On the other hand, if serious si
- Page 441 and 442: 421of the best known programs. Alth
- Page 443 and 444: 423Medical Association, American Ps
- Page 445 and 446: 425of the United States Pharmacopei
- Page 447 and 448: 4275. Repeated examinations. Physic
- Page 449 and 450: 429agement and rehabilitation of se
- Page 451 and 452: —431As the agenc.v within HEW whi
- Page 453 and 454: 433and complex acts such as driving
- Page 455 and 456: 435(Inig induces physical and psych
- Page 457 and 458: 437Chiiirmtin Pepper. Doctor, I thi
- Page 459 and 460: 439A large proportion of youngsters
- Page 461 and 462: 441Dr. Brown, what would you say is
- Page 463 and 464: 443Chairmiui Pepper. Wliat is tlie
- Page 465 and 466: 446The state of the art is promisin
- Page 467 and 468: 447Lot nie ask you first, is tlic d
- Page 469 and 470: 449Chairman Pepper. Do you happen t
- Page 471 and 472: 451want you to take a look at. We w
403<strong>and</strong> this is only for the investigational phase. Beyond that, of course,if the}' are to be marketed, that would become part of the responsibilityof the pharmaceutical industry.Chairman Pepper. Well, now, Doctor, one of the things that thiscommittee is ver}' interested in <strong>and</strong> very concerned about, is tr^nngto develop a system by which everything that can be done, shall bedone as quickly as it can be done to do something effective about theheroin addiction problem in this country.You know, of course, what it is costing the country in terms oflost lives <strong>and</strong> ruined careers <strong>and</strong> crime <strong>and</strong> loss of propert}', et cetera.I know your agency is desirous within the bounds of propriety <strong>and</strong>within the limitations of law to be cooperative. We heard here alittle bit ago about a drug, for example, that some doctors have beenusing in respect to the heroin addiction that they think blocks thephysical craving for heroin, <strong>and</strong> it has been used on a number ofpeople, according to one of the doctor \vitnesses who appeared, <strong>and</strong>another doctor had sent some of his patients to receive <strong>treatment</strong> bythis drug.Now, vre wouldn't, of course, in any sense of the word suggest orcondone your giving approval when it should not properly be given,but I think we do have a right to inquire whether or not good leadsthat might be developed would have all possible expedition <strong>and</strong>consideration by your agency, because this is a matter of great publicinterest. I mean, you wouldn't put too much emphasis on the form<strong>and</strong> too little upon the substance so as to just take as a matter ofcasual day-to-day routine submissions by responsible people ofpossible antagonistic or blockage or immunizing drugs for heroinaddiction; would you?Dr. Edwards. No; we certainly wouldn't. We share your concernfor this problem <strong>and</strong>, as I mentioned earlier, we do not vrant toimpede progress in trying to develop a meaningful drug in this area.On the other h<strong>and</strong>, we do have a responsibiiitj^, first, to assure thatdangerous drugs are not allowed on the market. Second, that thedrugs are not diverted into illicit channels.Chairman Pepper. And if the National Institute of MentalHealth, which seems to have the primary responsibility by law, toldyou they had some leads, <strong>and</strong> asked your cooperation <strong>and</strong> inquiringinto the safety <strong>and</strong> efficacy of those potential drugs, you wouldcooperate with them, of course, in every way possible.Dr. Edwards. Absolutely, <strong>and</strong> we are doing this right now. Allwe w^ant to be sure of is that these studies <strong>and</strong> these drugs are beingused by people who should be using them. The National Institute ofMental Health is really the focal point in the United States for testing.Chairman Pepper. Just one other question. Doctor. Now, is it yourgeneral opinion that methadone is about the best drug that is on themarket so far for dealing with heroin addiction? I mean, even if itdoes have its defects <strong>and</strong> its faults, it has certain advantages m the<strong>treatment</strong> of heroin addiction if properly used.Dr. Edwards. It certainly shows some promise, more so than anythingwe have currently available.Chairman Pepper. Well, now, if it were to be used—suppose wewere to recommend to the House of Representatives, <strong>and</strong> the Congressshould adopt a law <strong>and</strong> adequate funds should be provided to set up a
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