sideration must be made. In certain instances, however, it will be clearly apparent to the physician providing the treatment that an individual who has been chronically addicted might be most appropriately placed on methadone maintenance, and we felt that it was inappropriate to specifically preclude this in the regulations. Such decisions, we believe, should most appropriately be left to the clinical judgment of the physician.

10. When you testified before another Senate Subcommittee on May 23, 1972, you stated that:

"We believe that confidentiality provision in Section 408 of P.L. 92-255 deals with this problem (confidentiality of patient records) rationally and effectively.” Have your views on this issue changed?

a. Please explain the need and the impact of the regulation on confidentiality that your office promulgated in the Federal Register on November 17, 1972.

b. Please explain and discuss tre recent New York case in whach a Monhattan criminal court judge sentenced Dr. Robert Newman, director of New York City's methadone treatment program, to 30 days in jail for refusing to give to police photographs of all black patients between the ages of 21 and 35. How does this case bear on the adequacy of section 408?

Answer: My view has not changed that section 408 of Public Law 92-255 deals rationally and effectively with the problem of confidentiality of patient records. This is not to say, however, that there may not be instances where authority such as that provided by section 3 or 503 (c) of Public Law 91-513 can also be appropriately utilized.

The regulation on confidentiality promulgated on November 17, 1972, was needed in order to furnish an authoritative interpretation of section 408 of Public Law 92–255. A variety of problems had arisen, but two areas were of major concern. One was that of vocational rehabilitation and employment assistance for persons currently or formerly in treatment. The other was the relationship between section 408 of Public Law 92-255 and the confidentiality provisions of the 1970 Act (Public Law 91-513).

b. The case of People v. Newman now pending in the Court of Appeals of the state of New York involves the latter issue. In that case, a patient in a methadone treatment program claims to have witnessed a murder by a person whom she believes to have been a fellow patient. Dr. Newman refused the request of the police to allow her to view the treatment program's file or photographs of patients, and the litigation ensued.

Using the balancing test—the desirability of confidentiality of patient records in general as against the public interest in disclosure in a particular instance provided in section 408, the courts of New York, including in all probability the Court of Appeals, would hold that disclosure should be compelled in this instance. The trial court and the intermediate appellate court which heard this case have held.

Owing to the fact, however, that for certain purposes, methadone is still regarded as an investigational or research drug in the treatment of narcotic addiction, the methadone regulations published December 15, 1973 by the Food and Drug Administration contain a provision in implementation of the authority conferred on the Secretary of Health, Education and Welfare by section 3 of the 1970 Act to grant absolute confidentiality. In the Newman case, the prosecution claims that the enactment of section 408 repealed by impli caion the 1970 authority. The Federal Government filed a brief amicus curiae contending that the legal authority conferred by the 1970 Act is still in defect. The decision of the Court of Appeals is expected some time in May or June. 11. While maintained on methadone-to what extent, if any, does a patient experience any euphoria?

Answer: While maintained on methadone in a clinically effective dose and if taken orally. a patient should not experience any euphoria. If the methadone is injected as is done in treatment programs in England, then the patient will experience euphoria. In certain instances even when given by mouth, if the dose is higher than the patient can generally tolerate he will feel some lethargy. However, for the patient on an appropriate dose level, there is no scientific evidence to suggest that he will feel any kind of euphoria in any way comparable to the injected use of the drug or of heroin.

12. If a heroin addict required 50mgs. of heroin daily to prevent withdrawal, how much methadone would this same individual need to prevent withdrawal!

Table 15-3.-A COMPARISON OF NARCOTIC ANALGESICS WITH RESPECT TO DOSAGE, DURATION OF ACTION WITHDRAWAL SYMPTOMS, AND DISTINGUISHING FEATURES

The doses and durations shown in this table are based on papers reviewed by Eddy and coworkers, 1957; Reynolds and Randall, 1957; Murphree, 1962; and Lasagna, 1964.

Dose shown is the amount given subcutaneously that produces approximately the same analgesic effects as 10 mg of morphine administered subcutaneously. The figures in parentheses are the doses and the duration of action for oral, antitussive doses; they are not necessarily equieffective doses. Duration of action shown is for subcutaneous administration after intravenous administration, peak effects are somewhat more pronounced but overall effects are of shorter duration. Source: "Narcotic Analgesics," by Jerome H. Jaffe, M.D., in Goodman and Gilman.

13. What impact will the new FDA Regulations have on private practitioners who dispense methadone to individuals incarcerated in prisons, jails, or other detention centers?

Answer: The specific question of methadone distribution to inmates in penal institutions is currently under consideration by the policy Review Board. At the present time, private practitioners can dispense methadone to individuals who are incarcerated by submitting to FDA form FD 2632 "Application for Approval of Use of Methadone in a Treatment Program." If approved, the physician would be permitted to conduct a methadone treatment program within the confines of the correctional facility in the same manner and with the same responsibilities as a sponsor of a community-baser program. As a general rule, however, most private practitioners who dispense methadone in penal facilities are also providing such treatment to the general population, and they must provide supportive services.

14. I understand your office is sponsoring research on other maintenance-type drugs for heroin addicts.

a. What progress is being made in this regard?

b. Would the use of drugs such as LAAM help to solve the diversion problem? c.During the Subcommittee hearings in Indianapolis on February 14, 1973, Dr. Hanus J. Grosz, brought to our attention his proposal to employ propranolol (inderal) in the treatment of Heroin Addiction. I have included copies of his correspondence with the Subcommittee and your office and would appreciate

an assessment of his proposal as well as a report on the status of his NIMH grant application #DA 00643 entitled "Adrenergic Blockers in the Treatment of Heroin Addiction."

Answer: a. Among the drugs being developed at this stage are narcotics antagonists. These are compounds which, when administered to a human, will totally block the effects of heroin. Researchers in the drug abuse field believe that narcotic antagonists might have potential value in at least three clinical situations:

(1) for the treatment of people following withdrawal from methadone maintenance;

(2) for the treatment of those who are not interested in treatment with methadone; and

(3) for the treatment of young users or early users who are inappropriate subjects for methadone maintenance.

Over the past 18 months, the Special Action Office has initiated a major effort to uncover useful antagonists and to make them available for large-scale clinical studies. The first antagonists had many side effects and were short acting, making them useless for maintenance purposes. Recently, however, a few series of new compounds have been shown to have strong antagonist properties with few, if any, side effects. A few of these appear in initial studies to have a duration of action of at least 24 hours.

The antagonists undergoing the most active testing at present are the following:

(1) EN-1639A.-This is the most promising new narcotic antagonist. In early clinical studies, it seems to last for 24 hours and to be side-effect free. Further clinical studies are now in progress in New York City and New Haven, Connecticut, financed by the federal government.

(2) BC-2605.-This is another promising new antagonist. The early studies indicate that this compound may also be very useful clinically. Further evaluation of this compound is underway in Lexington, Kentucky, financed by the federal government.

(3) M-5050.-This antagonist has only been tested in animals, but it has shown considerable promise. It will undergo the first tests in humans this spring in a government-funded facility.

(4) Cyclazocine.-This antagonist has been tested since 1968. Its major drawback is that some researchers have noted side effects. It is, however, being tested now in over 100 patients throughout the country. Such testing will give researchers experience using antagonists; and newer antagonists will replace cyclazocine in these programs if further tests show them to be preferable.

(5) Naloxone. This compound is a pure narcotic antagonist which is too short acting to be very useful clinically. It is being used in about 50 patients now; it is anticipated that the newer compounds will be placed in these programs as they become available.

b. The Special Action Office is also working directly with a number of investigators to accelerate the investigation of the value of L-acetly methadol. or LAAM, a long acting form of methadone.

This drug has effects that last 72 hours and can be given three times a week. The increased use of this drug in place of methadone would result in increased convenience to patients, involving fewer trips per week to the treatment center. In addition, a marked decrease in the amount of medication available for illicit redistribution would result from the accompanying reduc tion in the need for large take-home supplies.

c. Dr. Grosz's NIMH grant application, entitled "Adrenergic Blockers in the Treatment of Heroin Addiction," was reviewed by the Intramural Research Group of NIMH and has not been approved for funding at this time. This office does not, as a general rule, engage in independent reviews of NIMH grant applications and, consequently, has not reviewed the proposal.

However, the concept of utilizing propranolol in the treatment of heroin addiction will be researched through funds provided by the Federal Government. The NIMH, under the coordination of the Special Action Office, has recently released a request for proposal for the study of propranolol in the treatment of heroin addiction. This RFP has been sent to Dr. Grosz and others. It is anticipated that at least two contracts will be let by the Government for

the study of propranolol. The funding for these contracts will be made available from funds provided by Section 224 of Public Law 92-255.

Senator BAYH. Dr. Gardner, Sherwin Gardner, Acting Commissioner of the FDA of the Department of HEW, is our last witness. STATEMENT OF DR. JOHN JENNINGS, ASSOCIATE COMMISSIONER FOR MEDICAL AFFAIRS, REPRESENTING THE FOOD AND DRUG ADMINISTRATION, ACCOMPANIED BY PETER BARTON HUTT, GENERAL COUNSEL, FDA; MERVIN H. SHUMATE, METHADONE PROJECT MANAGER; GERALD F. MEYER, DIRECTOR, OFFICE OF LEGISLATIVE SERVICES; AND DR. ELMER GARDNER, ASSISTANT COMMISSIONER FOR PLANNING AND EVALUATION

Senator BAYH. Dr. Jennings, I see you are present, but I don't see Gardner. Am I in error?

Dr. JENNINGS. Yes, sir. I am here representing the agency today. Senator BAYH. It is well represented. It is not the first time you assumed that role, please proceed.

I won't ask the same question I asked before-who is running the FDA today?

Dr. JENNINGS. We have sufficient fact, I think, the agency is in good hands at the moment.

If you wish, in view of the limited time available, we will submit the statement for the record and then answer whatever questions you might have, either now or in writing. I would, however, like to comment very briefly on the issues discussed at our last meeting on March 29th.

As you and your staff are now aware, FDA's report on methaqualone and the Secretary's recommendation that methaqualone be placed on schedule II were transmitted to the Department of Justice last night.

You also expressed concern about the time it has taken to reconsider the scheduling of the so-called short-acting barbiturates. We promised to accelerate the completion of our report on these drugs. Mr. Chairman, this report will be completed and given to Mr. Gardner by the end of this week. Assuming it is satisfactory, it will be signed and forwarded to the Secretary early next week. Senator BAYH. Is this on methaqualone?

Dr. JENNINGS. No, short-acting barbiturates. The methaqualone statement went to the Department of Justice last night.

[Information subsequently supplied for the record was marked "Exhibit No. 26 and 27," and is as follows:]

EXHIBIT No. 26

Hon. CASPAR WEINBERGER,

APRIL 26, 1973.

Secretary, Department of Health, Education, and Welfare, Washington, D.C. DEAR MR. SECRETARY: As you know, Dr. John Jennings, Associate Commissioner for Medical Affairs of the Food and Drug Administration, accompanied by Mr. Peter Hutt, Mr. Marvin H. Shumate, Mr. Gerald F. Meyer, and Dr. Sherwin Gardner appeared before the Subcommittee on Juvenile Delinquency on April 5, 1973 to testify regarding the nature and scope of methadone abuse

and diversion in the United States. During the course of their testimony, the question of the proposed transfer of the shorter acting barbiturates from Schedule III to Schedule II of the Controlled Substances Act was raised. As I am sure you are aware, the Bureau of Narcotics and Dangerous Drugs recommended this rescheduling on November 17, 1972; even though five months have elapsed, the Department of Health, Education, and Welfare has not yet acted on this recommendation. As the April 5 hearing, the representatives of the Food and Drug Administration assured me that their recommendation would be made to you within the next few days, and that a formal recommendation from the Department of Health, Education, and Welfare would be forthcoming within a week, or by April 12, 1973. To date, three weeks later, I have not been informed that any such recommendation has been made.

I would appreciate your prompt explanation of the delay, since the transfer of the shorter acting barbiturates is a matter of great concern to me and many of my colleagues.

Sincerely,

BIRCH BAYH, Chairman.

Hon. BIRCH BAYH,

EXHIBIT No. 27

THE SECRETARY OF HEALTH, EDUCATION, AND WELFARE,
Washington, D.C., May 17, 1973.

Chairman, Subcommittee To Investigate Juvenile Delinquency, Committee on the Judiciary, U.S. Senate, Washington, D.C.

DEAR SENATOR BAYH: Thank you for your letter of April 26 inquiring about the status of the Department's recommendation to the Bureau of Narcotics and Dangerous Drugs (BNDD) relative to the transfer of certain barbiturates from Schedule III to Schedule II of the Controlled Substances Act.

As you no doubt are aware by now, the Food and Drug Administration (FDA) sent its recommendation to the Department about a week after the April 5 hearing and a formal letter of recommendation was forwarded to BNDD on April 27. I understand FDA personnel notified Mr. John Rector, Deputy Counsel of the Subcommittee, by telephone when the recommendation was made. However, a copy of our letter to the Justice Department is enclosed for your information.

Director, Bureau of Narcotics and Dangerous Drugs, Department of Justice, Washington, D.C.

DEAR MR. INGERSOLL: The Food and Drug Administration has evaluated your recommendation of November 16, 1972 to transfer nine barbiturate sedativehypnotic drugs from Schedule III to Schedule II of the Controlled Substances Act. We find there is a substantial risk to the public health due to the potential for abuse of these drugs as they are currently controlled. We recommend the following nine drugs be transferred from Schedule III to Schedule II of the Controlled Substances Act:

Amobarbital, butabarbital, cyclobarbital, heptabarbital, pentobarbital, probarbital, secobarbital, talbutal, and vinbarbital.

Since these drugs have important medical uses, we anticipate working closely with the Bureau of Narcotics and Dangerous Drugs to insure adequate supplies are maintained to satisfy medical and scientific requirements.

It is possible that strict control of these drugs may lead to an increased demand for illicit use of other central nervous system depressant substances. We are pre