Clearly the expertise of each agency will be reflected at each level of evaluation. Should differences arise between the approach of any one agency from that of another, the issue will be settled at the higher level. Ultimately the Cabinet Committee itself will be the final arbiter in determining the final formulation of the plan for a given area. Sincerely yours, NELSON GROSS, Senior Adviser and Coordinator for Mr. ROGERS. Do you feel that it would be helpful in the White House along with rehabilitation and treatment, to maybe have a deputy there that would oversee enforcement activities and at least try to coordinate them? Mr. GROSS. I cannot comment on the domestic side of it because that is a matter for Mr. Ingersoll and Mr. Rossides. I am inclined to go along with what Secretary Rossides said. On the international side, I would most strongly echo what he said. I do not believe that the Action office would be oriented to do it. It think that if the State Department is geared up properly, and I think that it is now, that it is the job of our own Department through our Ambassadors and through our country teams to develop these programs. It has to be done through the Ambassador. If you have—and I notice in your report, if I can allude to it—a suggestion for BNDD people not being connected with the Embassy, I think you are going to create great difficulty. I don't think the BNDD would get the same kind of reception they get when they talk to local foreign government officials. When they go in, if they are not sent by the Embassy, they are not going to be received in the same way and they would be scattered all over the place. Mr. ROGERS. Yes; I understand unless it was with the blessing of the Embassy. We got some feedback that it is very difficult for BNDD to go in and try to have a tough line when some of the Embassy people are saying, "Well, you know, we have to keep things going pretty well along." Mr. GROSS. You will always have that kind of debate within an embassy. Mr. Masters, by the way, is going to be the DCM in Bangkok shortly. He is very familiar with this. Mr. ROGERS. Thank you. We appreciate your being here. I am delighted to see this offensive, in effect, that you have mounted. I think it is going to be effective. We certainly hope so. Thank you, Mr. Gross. The committee stands adjourned. (Whereupon, at 12:30 p.m., the subcommittee adjourned, subject to the call of the Chair.) SPECIAL ACTION OFFICE FOR DRUG ABUSE PREVENTION MONDAY, NOVEMBER 8, 1971 HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON PUBLIC HEALTH AND ENVIRONMENT, Washington, D.C. The subcommittee met at 10 a.m., pursuant to notice, in room 2123, Rayburn House Office Building, Hon. Paul G. Rogers (chairman) presiding. Mr. ROGERS. The subcommittee will come to order, please. Our hearings today concern themselves with reports that the Food and Drug Administration is planning to change the drug methadone from its existing status of an experimental drug to an approved drug. Since the obvious outlet for methadone would be in the area of drug addiction centers and the President's proposed legislation would establish Dr. Jaffe as the man responsible for the Nation's efforts in detoxification and rehabilitation of these addicts, that office would most probably be the most directly in contact with the use of methadone. For that reason, we have invited, in addition to Dr. Edwards from FDA, Dr. Jaffe. As we all know, the drug subculture and the world of crime are almost indistinguishable and we feel that comments from the Justice Department would also be more relevant. John Ingersoll, representing the Justice Department, has also been invited. When this committee began hearings there was a general assumption that methadone was the wonder weapon which society could use to transform drug addicts into useful, productive citizens. In our desire to find some solution we, as most interested citizens, were all too ready to accept any promising solution, and surely methadone was one. But there has developed a growing concern as we traveled to centers in cities all over the Nation that methadone, far from being the magic bullet, posed a potential problem almost equal to heroin itself. In the general order of things, if a drug is classified as an investigational one, there are relatively few men licensed to experiment with that drug. In the case of methadone, however, there are more than 300 licenses. The actual number of people handling this may be double or even triple that figure. And in the case of methadone, we have seen that the majority, if not the entire number of licensed investigators, are not really investigating this drug, but are simply dispersing it. This, of course, is contrary to the protocol for IND's and I think a matter which FDA would immediately halt if another drug or substance were at issue. But I have been told that FDA has not even let a single contract to investigate methadone, and that the scanty reports forwarded so far are totally inconclusive as to its effects. I think that the fact that the long term effects of methadone use have never been studied, nor have the side effects or the effects on expectant mothers and their offspring, would be basis enough to reject approval of any drug. The fact that methadone has the potential and the history of being lethal is an added factor and one which should also weigh heavily. I do not accept the fact that methadone is a very useful drug for detoxification, and in some instances may be used for maintaining a hard addict. But for the Federal Government to give its official sanction to this drug as being safe and effective for curing addiction via and approved drug status, would cause great concern. And I have grave reservations about the Federal Government maintaining a portion of the population in a state of addiction. Our concern over reported FDA approval of methadone for wider distribution does not rest only with the question of whether the drug is effective as a cure to heroin addiction. We know that, while methadone is safe if taken as prescribed, the overall question of safety is a shadowy area. Indeed, a few would contest this committee's findings during road hearings that the present means of controlling the distribution of methadone are wholly inadequate. Under present controls, methadone's potential for death is alarming. In New York State alone, between January 1970 and August 1971, 126 methadone related deaths were reported. Twenty were due to overdoses, six involved accidental poisonings of children. It is not our intention to seek a total ban on the distribution of methadone, but to encourage only bona fide, well controlled methadone programs. It is our hope that the hearings today can serve as a vehicle to achieve this goal. I know that the problem of distribution of methadone is of particular concern to our colleague on the committee, James Hastings, who has devoted considerable study to the problem nationally and to its impact on his home State of New York. I might say that we have received a telegram, as I understand it, and I will be glad to yield at this time. Mr. HASTINGS. Thank you, Mr. Chairman. I would like for the record to indicate that as of October the New York Public Health Council sent a telegram to Dr. Edwards expressing their concern. I would like to read that for the record: "New York State Public Health Council at monthly meeting today expressed serious concern over rumored removal of IND status of methadone. This would result in lack of control that would be possible for any one State to regulate and jeopardize successful programs.” I have received word that Governor Rockefeller has sent a telegram to you, Mr. Chairman, and I believe to Dr. Edwards and to Secretary Richardson, and the text of the telegram is: "This is to support the action of New York State Public Health Council which recently expressed serious concern over present IND status of methadone. Changing status will result in a lack of control, would make regulation by any one State impossible, and jeopardize the present successful program." So my State, the State of New York, expresses serious concern over the possible approval of the FDA on methadone. I personally feel there is a definite therapeutic need for methadone in the maintenance program. My concern is one of control. I am sure that is a concern that is shared by all of us. I would hope that would be the purpose of this hearing. Thank you, Mr. Chairman. Mr. ROGERS. Without objection the telegrams from the Governor and the New York Public Health Council will be made a part of the record. (The telegrams follow:) Hon. ELLIOT RICHARDSON, [Telegram] ALBANY, N. Y., November 8, 1971. Secretary, Health, Education, and Welfare, Washington, D.C.: This is to support the action of the New York State Public Health Council which recently expressed its serious concern over removal of the present IND (investigational new drug) status of methadone. This change in status would result in a lack of control that would make regulation by any one State impossible and would jeopardize present successful programs. (Cc: Mr. Paul G. Rogers, U.S. Representative.) NELSON A. ROCKEFELLER. Dr. CHARLES C. EDWARDS, [Telegram] ALBANY, N.Y., October 22, 1971. Commissioner, Food and Drug Administration, Department of Health, Education and Welfare, Rockville, Md.: New York State Public Health Council at its monthly meeting today expressed its serious concern over rumored removal of present IND status of methadone. This would result in lack of control that would be impossible for any one State to regulate and would jeopardize present successful programs. NORMAN MOORE, M.D. Chairman, Public Health Council, New York State Department of Health. (Cc: President Nixon.) Mr. ROGERS. I should like to read from a letter from Dr. Neil Solomon, secretary of health and mental hygiene of the State of Maryland. DEAR MR. ROGERS: It is my opinion that methadone should only be administered under most rigidly controlled conditions. I believe there should be nationwide regulation similar to the ones proposed by the State of Maryland, which will make it unlawful for any physician to prescribe methadone except as part of controlled methadone maintenance programs or legitimate medical need. If this is not done, I predict a nationwide problem will develop with methadone that will be of the same magnitude as the one we now have with heroin. There were four deaths this year in the State of Maryland due to overdoses of methadone. These deaths could have all been avoided if we had stricter control over ths drug. Our first witness this morning is Hon. Charles Edwards, Commissioner of the Food and Drug Administration. We welcome you to the committee, and will be pleased to receive your testimony. 66-841 72 pt. 4-10 STATEMENT OF DR. CHARLES C. EDWARDS, COMMISSIONER, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE; ACCOMPANIED BY DR. ELMER H. GARDNER, DIVISION OF NEUROPHARMACOLOGICAL DRUGS; PETER HUTT, GENERAL COUNSEL; AND DR. JOHN S. ZAPP, DEPUTY ASSISTANT SECRETARY FOR LEGISLATION (HEALTH), HEW Dr. EDWARDS. Thank you, Mr. Chairman. I would like to introduce on my left, Dr. Elmer Gardner, head of the Division of Neuropharmological Drugs. On my right, Mr. Peter Hutt, General Counsel, and next to Mr. Hutt is Dr. John S. Zapp, Deputy Assistant Secretary for Legislation (Health). Mr. ROGERS. We welcome you gentlemen to the committee. Dr. EDWARDS. We appreciate this opportunity, Mr. Chairman, to discuss with you the background information leading to our current consideration of a new drug application submitted on June 28, 1971. by Eli Lilly & Co. for a Disket formulation of methadone hydrochloride to be used in the long-term treatment of heroin addiction. Until the submission of this data in this NDA, we could not take any position on the safety and efficacy of methadone in treating drug addiction. I wish to emphasize that this NDA is still under consideration. It has not yet been approved or disapproved. My remarks today, therefore, do not represent any final FDA or Department position. I also want to emphasize that methadone is an addictive narcotic drug. It is certainly not a cure-all or panacea for the treatment of heroin addiction. We at FDA also are fully aware that its use must be very closely monitored and very closely controlled. The extent of the drug abuse problem and heroin addiction, in particular, has been a cause of increasing public concern. A variety of non-drug-treatment approaches has been utilized over the past several years. They range from long-term hospitalization, to residential programs such as Synanon, to outpatient psychotherapeutic efforts. The time, manpower, and money required in all of these have resulted in only limited success. Accordingly, a chemical therapeutic agent has become an attractive alternative. This has resulted in a search for an effective medication for addicts. Through such an agent, the addict might be freed of his craving for heroin. The drug that has been most widely investigated and used for this purpose is methadone, a synthetic narcotic. Methadone has been approved and widely used as an effective analgesic since it was synthesized at the end of World War II. It has also been approved and widely used for more than a decade, in low oral doses, to allay opiate withdrawal symptoms. But not until 1963 was it first observed that this drug could possibly be of value in the treatment of heroin addiction. Maintenance treatment of heroin addiction with methadone has. since 1963, been in an investigational status. Thus, the drug is not yet approved for general use for maintenance therapy. The investigational |