Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...
Narcotics research, rehabilitation, and treatment. Hearings, Ninety ... Narcotics research, rehabilitation, and treatment. Hearings, Ninety ...
346tons in 1962 and to 155 tons in 1969. The United States consumesabout 16 percent of world production. May I add parenthetically, Mr.Chairman, that it requires about 10 units of opium to produce one unitof codeine.It seems that there are safe and effective substitutes and syntheticequivalents for morphine, which is a severe painkiller. Indeed, someare reported to be superior for use in man. But it is equally apparentthat worldwide, the medical preference for drugs derived from opiumremains strong; that is, the annual increases in production and consumptionare indicative. Proposals to ban opium production, worldwide,have not met with support and there is no evidence that eventhe American medical community would accept such a move withoutextensive consultations.Nonetheless, we feel that advocacy of such a ban is a proper position.We shall also continue to work for increased international controls,particularly to control production, until complete abolition becomesa reality.Mr. Chairman, you asked also for my views regarding methadonemaintenance procedures and whether there is a black market inmethadone.In recognition of the acceptance of methadone on an investigationalbasis in the treatment of heroin addiction the Food and Drug Administrationand the Bureau of Narcotics and Dangerous Drugsjointly issued methadone maintenance regulations effective April 2,1971.The regulations provide for advance approval of such programsby the two agencies with a maximum amount of flexibility. The standardswere agreed upon after an intensive study of many existing programsand after consultation with leading scientific authorities aroundthe country. The regulations, if faithfully followed, insure that patientsreceive adequate treatment and protection, that scientificallyuseful data can be generated and that possibilities of di^-ersion of thedrug into illicit channels are minimized.Each methadone program is also required to register with BNDDin order to conduct research with a schedule II substance. Our inspectionalprogram will cover all methadone clinics on a periodic basis toinsure that proper safeguards are maintained to prevent diversion.Safeguard requriments will be that methadone supplies be securelylocked up with limited access ; that a complete and accurate record bemaintained of all methadone receipts and dispositions ; and that patientsbe regularly monitored through urinalysis and observation toinsure that they are taking the methadone dispensed to them.I am confident that with diligent regulatory efforts by both FDAand BNDD we can effectively curtail the existing diversion problems.Where flagrant violators are uncovered, we intend to vigorously pressfor corrective measures.Failure to conduct such programs within a framework of propercontrols involves hazards to the individual and to society. Great cautionneeds to be exercised in the selection of patients for treatment becauseparticipation entails a high IcacI of narcotic dependence whichmany young persons, who are only peripherally involved in the abuseof narcotic di'iigs, could avoid by less radical forms of treatment. Wemust be sure that programs of treatment are not causing more cases
347of methadone addiction than they are preventino; continued cases ofheroin addiction. We hope that longer acting substances will soon bemade available. This would I'educe the risks of diversion and make thewhole program more attractive to the patient.Complete cure of addicts from narcotic use has not been accomplishedin any statistically significant numbers. On the other hand,once an addict is stabilized on methadone, he apparently is more receptiveto reintegration into a normal, acceptable way of life in thecommunity.Methadone is available illicitly in many areas of the country, primarilyin retail level quantities.Our regions report an increasing trend of methadone availabilityand a corresponding price decrease. During the 7-month period fromDecember 1969 through June 1970, BNDD purchases and seizures ofmethadone totaled 8.202 dosage units. In the succeeding 7-month periodfrom July 1970 through Januarv 1971, BNDD purchases andseizures totaled 33,981 dosage units. This fourfold increase reflects adisturbing trend.The methadone we presently encounter on the street is primarily oflegitimate manufacture. During the last 10 months, from July 1970through April 1971, our laboratories have examined 217 exhilDits ofmethadone submitted by our agents and State and local enforcementofficials. This repi-esents roughly 1 percent of all drug exhibits submittedfor analysis.Two dosage levels of commercially manufactured tablets have beenencountered—the 5 and 10 milligram sizes. Some exhibits have been inan orange juice preparation, in capsules, foil-wrapped powder and inliquid form ready for injection.The synthesis of methadone is a fairly complicated process and onlytwo clandestine laboratory operations have been uncovered in thiscountry in the past 20 years. One laboratory, capable of producinglarge quantities of methadone, was seized in Tupelo, Miss., about 2years ago, and the other laboratory was found in New York during1952. And we presently have one investigation involving the possibilityof a clandestine methadone laboratory.Methadone sells illicitly on average for about 60 cents per tablet. Itappears to be coming from patients in maintenance programs who areselling the methadone dispensed to them, or in some instances, tradingit for heroin ; loose prescribing practices by some physicians accountin part for the drug available on the street; there are security problemsin many clinics which result in the pilferage of methadone ; andthere are also some instances where patients are simultaneously enrolledin more than one program and they sell the excess methadonedispensed to them.We believe that the new regulations, while closely guarding againstdiversions_ of methadone, will at the same time allow the medicaland scientific communities to continue studies to determine the extentto which methadone maintenance techniques may be used in the managementof morphine-type dependence ; but I emphasize again that theprogram depends upon the willingness of practitioners to follow reasonableguidelines and prevent diversion, and some have done a commendablejob.
- Page 316 and 317: 304to result from the insuflScient
- Page 318 and 319: 306It is this role of the intervent
- Page 320 and 321: 308EESULTSStudies concerning tlie p
- Page 322 and 323: 310The method derives from a specia
- Page 324 and 325: 312Why is this happening? What need
- Page 326 and 327: m)effective with uncured alcoholics
- Page 328 and 329: I316Casriel, who is medical-psychia
- Page 330 and 331: 318resort to heroin. One must not f
- Page 332 and 333: .320in Permanent Cure of Narcotic A
- Page 334 and 335: 322!(4) '-Modification of Adaptatio
- Page 336 and 337: 324sections of the country, all sor
- Page 338 and 339: ;Mr.Pertto.niuch,I?,Mr. Peritq. Tha
- Page 340 and 341: 328Chairman Pepper. Mr. Steiger.Mr.
- Page 342 and 343: , Mr., In''wMr, WiNx.nltiiink tlie
- Page 344 and 345: :332"Stomach cramps" were found to
- Page 346 and 347: 'i.We334'""^li'anTOanl^ETPPEiL That
- Page 348 and 349: :))))336would be deprived of any cl
- Page 350 and 351: 338less abuse liability than agents
- Page 353 and 354: NARCOTICS RESEARCH, REHABILITATION,
- Page 355 and 356: CONTENTSApril 26 1April 27 77April
- Page 357 and 358: :•vEXHIBIT NO. 4 (a) AND (b)Eddy,
- Page 359: :lovernor,vnEXHIBIT NO. 21 (a) and
- Page 362 and 363: 342have no desire to preempt the au
- Page 364 and 365: 344We hope these hearings will prov
- Page 368 and 369: 348SOUTHEAST ASIAAs you know also,
- Page 370 and 371: 350I would also point out as I did
- 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
347of methadone addiction than they are preventino; continued cases ofheroin addiction. We hope that longer acting substances will soon bemade available. This would I'educe the risks of diversion <strong>and</strong> make thewhole program more attractive to the patient.Complete cure of addicts from narcotic use has not been accomplishedin any statistically significant numbers. On the other h<strong>and</strong>,once an addict is stabilized on methadone, he apparently is more receptiveto reintegration into a normal, acceptable way of life in thecommunity.Methadone is available illicitly in many areas of the country, primarilyin retail level quantities.Our regions report an increasing trend of methadone availability<strong>and</strong> a corresponding price decrease. During the 7-month period fromDecember 1969 through June 1970, BNDD purchases <strong>and</strong> seizures ofmethadone totaled 8.202 dosage units. In the succeeding 7-month periodfrom July 1970 through Januarv 1971, BNDD purchases <strong>and</strong>seizures totaled 33,981 dosage units. This fourfold increase reflects adisturbing trend.The methadone we presently encounter on the street is primarily oflegitimate manufacture. During the last 10 months, from July 1970through April 1971, our laboratories have examined 217 exhilDits ofmethadone submitted by our agents <strong>and</strong> State <strong>and</strong> local enforcementofficials. This repi-esents roughly 1 percent of all drug exhibits submittedfor analysis.Two dosage levels of commercially manufactured tablets have beenencountered—the 5 <strong>and</strong> 10 milligram sizes. Some exhibits have been inan orange juice preparation, in capsules, foil-wrapped powder <strong>and</strong> inliquid form ready for injection.The synthesis of methadone is a fairly complicated process <strong>and</strong> onlytwo cl<strong>and</strong>estine laboratory operations have been uncovered in thiscountry in the past 20 years. One laboratory, capable of producinglarge quantities of methadone, was seized in Tupelo, Miss., about 2years ago, <strong>and</strong> the other laboratory was found in New York during1952. And we presently have one investigation involving the possibilityof a cl<strong>and</strong>estine methadone laboratory.Methadone sells illicitly on average for about 60 cents per tablet. Itappears to be coming from patients in maintenance programs who areselling the methadone dispensed to them, or in some instances, tradingit for heroin ; loose prescribing practices by some physicians accountin part for the drug available on the street; there are security problemsin many clinics which result in the pilferage of methadone ; <strong>and</strong>there are also some instances where patients are simultaneously enrolledin more than one program <strong>and</strong> they sell the excess methadonedispensed to them.We believe that the new regulations, while closely guarding againstdiversions_ of methadone, will at the same time allow the medical<strong>and</strong> scientific communities to continue studies to determine the extentto which methadone maintenance techniques may be used in the managementof morphine-type dependence ; but I emphasize again that theprogram depends upon the willingness of practitioners to follow reasonableguidelines <strong>and</strong> prevent diversion, <strong>and</strong> some have done a commendablejob.
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