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dustry. As I said at the outset, I think all this could be done by the industry itself. Something certainly must be done, and since it seems that there is no chance at all of it ever happening in what I consider the best as well as the most pleasant way, I view S. 1552 an essential step in reducing the present drug hazards.
Senator KEFAUVER. Dr. Modell, I want to compliment you and thank you for a very forthright and frank statement in which you give your views plainly, and, of course, we are grateful that your views have been based upon much experience, background, and knowledge of the subject that you are talking about.
In talking about generic and brand names; first, you make a distinction between the brand name and the trade name, the brand name being the name of the house that makes the drug, and then the trade name being the name that they give it which is different from the generic
An example would be Schering's prednisone; Meticorten would be the trade name.
Dr. MODELL. “Schering” would be the brand name and "Meticorten” would be the trade name.
Senator KEFAUVER. On page 16 you get to one of the problems that we are talking about.
In my view, the proposed legislation offers an important step in the rectification of the problem of nomenclature. It makes it mandatory for each new drug to have an acceptable official name when introduced on the market, which a quasi-legal organization cannot guarantee.
I take it you have reference there to the program of the AMA and the U.S. Pharmacopoeia in trying, on a voluntary basis, to get the drug manufacturers to accept a satisfactory generic name?
Dr. MODELL. That is what I had in mind.
Senator KEFAUVER. And by "cannot guarantee," you mean there is no compulsion; that if the drug company does not want to cooperate in order to accept the recommended generic name, there is nothing at present that can be done about it?
Dr. MODELL. There is nothing I know of right now that can put any pressure on to force an acceptable generic name.
Senator KEFAUVER. This bill, of course, gives the ultimate authority to the Secretary of Health, Education, and Welfare, and I would envision that this authority would be used. I think it is important to state that the Secretary of Health, Education, and Welfare would act upon recommendation of the AMA and the USP, or, alternatively, that when they were unable to bring about an agreement, the matter then be referred to the Secretary of Health, Education, and Welfare, who then would be able to insure that there was a proper generic name.
Would that be the way you would recommend?
Dr. MODELL. I had assumed all along that the Secretary of Health, Education, and Welfare could not undertake to do this, at least with his present organization.
I assume that something along the lines you mentioned would be worked out.
Senator KEFAUVER. That he would use all voluntary, existing machinery to the fullest?
Dr. MODELL. I was quite certain that was what would have to be done, should this legislation be enacted.
Senator KEFAUVER. We have had testimony that there are some drugs on the market with no generic name or with several generic names for the same drug, is that correct?
Dr. MODELL. There are some drugs that have no pronounceable, official name and maintain that status for as long as they are legally permitted.
I do recall that there is some legislation which requires some sort of a generic type of name or a trademark will be lost.
Some sort of an official name has to be given, but there is a period of time when one is not required and during that time sometimes the most impossible names that are used.
I have here, somewhere in my notes, one name that must be about 75 letters long. This is a device to make it impossible for the person using the drug to get the habit of using the generic name, when it is first introduced, and to favor the habit of using the trade name which may be five or six letters long. From then on it is quite difficult to change.
Senator KEFAUVER. Might not, also, some worthwhile progress be made in simplifying some of the present generic names that may be 75 letters long?
Dr. MODELL. There is no chance of some of them being used unless they are changed. Unpronunceable and impossible-to-remember names should be changed, so that progress along those lines could be made.
Senator KEFAUVER. Senator Hruska, you have some questions?
Senator HRUSKA. Doctor, I think you have contributed a great deal here in your testimony and it is a very fine statement. In your final paragraph you refer to the increase in the profits of the drug industry.
Are you aware that it is quite unorthodox in this committee room to try to increase the profits of the drug industry?
Dr. MODELL. I have also praised industry, sir.
Senator HRUSKA. The burden of the testimony here and the efforts of certainly the majority on this committee have been to say that profits are so horrendous, they are so God-awful, that they ought to be cut down.
Are you advocating something that will result in the increase in the profits of the drug industry?
Dr. MODELL. I have not the slightest objection to the industry making more money, provided that the practice of medicine and the health of the Nation is improved at the same time.
Senator HRUSKA. I see. That is fine.
Senator KEFAUVER. That is one point of disagreement between the majority and Dr. Modell.
Senator HRUSKA. In this matter of names for drugs, Doctor, you have said you understood and had in mind that the Secretary of Health, Education, and Welfare would call upon such available organizations as there are now by way of voluntary organization for expert assistance or to get experts in the field.
Of course, if this law is to mean anything, he would have to be the man with the final say-so, would he not, so that if he wanted to override these voluntary organizations or these experts and so on and say, "Well, now, what you say, gentlemen, is true, very likely, and it impresses me a great deal, but my decision is thus-and-so," so that he would be the final source of authority?
Is that also in your thinking in this regard ?
Dr. MODELL. Well, sir, it is unquestionably a possibility, but I think that in many Departments of our Government the chief of a division may not be an expert in the lines on which he ultimately must pass, yet I believe, in general, the opinion of the expert is taken.
I do not see how that can be avoided in any administrative organization. This also would apply to smaller organizations or perhaps even to the American Medical Association. The people who make the final decision might not be the experts in the problem of nomenclature.
But I grant you what you say is correct. I just do not see it as an unusual circumstance.
Senator HRUSKA. Mr. Chairman, we did have some discussion earlier about the Time article and the reply of Dr. Austin Smith.
I would like to ask consent that they be set forth at this point in the record, both the article in Time and the letter to the editor by Dr. Austin Smith and the editor's notation which is added at the bottom of Dr. Austin Smith's letter.
If they are not already in the record, I would like to suggest that that be done.
Senator KEFAUVER. They are not in the record. Would you want them printed in the record at this point or made exhibits?
Senator HRUSKA. They should either be printed in the record at this point or there should be a reference at this point to the page of the record where they do appear. Either alternative would be very satisfactory as far as I am concerned.
Senator KEFAUVER. Let us make a reference to the page in the record where they appear. Exhibit 43 will be the article in the J.A.M.A. and 44 will be the Time magazine article. Let 45 be the letter of Dr. Smith to Time.
(Exhibits 43, 44, and 45 may be found beginning on p. 849.)
Senator KEFAUVER. Would it be possible for us to secure a copy of the letter from Mr. de Haen to Dr. Smith ?
Dr. MODELL. That is only a statement from Mr. de Haen to me.
Senator KEFAUVER. Dr. Modell, we again thank you very much for coming down and giving us your counsel. We know that you have given a lot of thought to the provisions of this bill; that your opinion about it will carry much weight; and we thank you very sincerely.
Dr. MODELL. Thank you very much.
(An editorial by Dr. Modell in Clinical Pharmacology and Therapeutics, “Anyone for a Symposium ?” may be found beginning on p. 976.)
Senator KEFAUVER. Our next witness is Dr. Allan M. Butler.
Dr. Butler was president of the Physicians Forum; is that right? STATEMENT OF DR. ALLAN M. BUTLER, PAST PRESIDENT, THE
PHYSICIANS FORUM, PROFESSOR OF PEDIATRICS, EMERITUS, HARVARD MEDICAL SCHOOL, AND DIRECTOR OF CLINICAL SERV. ICES, METROPOLITAN HOSPITAL OF DETROIT
Dr. BUTLER. Past president.
Senator KEFAUVER. He received his M.D. degree at Harvard in 1926, has held positions ranging from teacher to professor of pediatrics
from 1931 to the present time. He was also chief of children's medical service of Massachusetts General Hospital 1939-60.
We know you to be a very eminent physician and well qualified to discuss the subject matter here. We appreciate your presence very much, Dr. Butler. Dr. BUTLER. Thank
you. Senator HRUSKA. Doctor, before you start your statement, may I ask you: You were associated with the Harvard Medical School until recently, were you not, at the Massachusetts General Hospital ?
Dr. BUTLER. That is correct. And I am now professor of pediatrics emeritus at Harvard University.
Senator HRUSKA. At Harvard University?
Dr. BUTLER. Yes. And my present position I will describe a little later when I read my statement.
Senator HRUSKA. The Metropolitan Hospital of Detroit has been mentioned. Is that where the Community Health Organization of Detroit has its center of operations!
Dr. BUTLER. No. The Metropolitan Hospital and clinics at Detroit is a private hospital which is providing medical care not only to any person in Detroit that comes to the hospital for medical care, but, also, is providing health and medical care to those people of Detroit who join the Community Health Association.
Senator HRUSKA. As a matter of fact, this is the only hospital to which members of that Community Health Association do go for their hospitalization?
Dr. BUTLER. At the present time it is the only hospital which is providing health and medical care to members of that Community Health Association.
Senator HRUSKA. Who are the sponsors of that Community Health Association ?
Dr. BUTLER. I wish I had a list of the board of directors of the Community Health Association.
Senator HRUSKA. What organization is the sponsor? Where do the members come from, from the Community Health Organization ?
Dr. BUTLER. The board of trustees or the directors of the Community Health Association, if I remember correctly, are about 15 people representing industry, law, education, ministry, and labor unions of the city of Detroit.
Senator HRUSKA. Are you associated in any way with the Community Health Association?
Ďr. BUTLER. I am not associated with the Community Health Association.
I am the director of clinical services of the Metropolitan Hospital and clinics and chief of the pediatric service of the Metropolitan Hospital and clinics.
Senator HRUSKA. What part in the Community Health Association does the United Auto Workers have?
Dr. BUTLER. It has two parts. I think of the 12 to 15 directors, 3 are individuals who hold administrative positions in the UAW.
Also, I think about half of the funds that were borrowed by the Metropolitan Hospital and clinics for the development of the hospital and clinical facilities and the staff to take care initially of people subscribing to the Community Health Association has come from the United Automobile Workers.
The other half has come from one or more of the banks of Detroit I think.
Senator KEFAUVER. All right, sir.
Dr. BUTLER. I am Dr. Allan M. Butler and I am appearing here in behalf of the Physicians Forum, a national organization of physicians established 22 years as a forum for the consideration of proposals to improve the efficiency, availability, and equality of medical care. Major improvements in the Nation's medical care system have been necessitated by the rapid increase in medical science and technology that has so expanded the potentialities for effective medical therapy and for the prevention of illness and complications of illness.
As professor at the Harvard Medical School for 30 years, past associate editor of the New England Journal of Medicine and of the Journal of Clinical Investigation, chairman for several years of the pharmacy committee of the Massachusetts General Hospital, as a member of the OSRD Committee on Clinical Testing of Anti-Malarial Drugs during World War II, as past president of the American Pediatric Society and of the Physicians Council for Information on Child Health (now the Physicians Council), and as present director of clinic services of the Metropolitan Hospital and Clinics of Detroit, I have had ample personal experience to justify a deep concern for the impact of the promotional and other questionable practices of the pharmaceutical industry on doctors and layment. That this concern is widespread throughout the medical profession is indicated b yeditorials, committee reports, and comments by individuals in such professional journals as the New England Journal of Medicine, Pediatrics, the Journal of Medical Education, and the Medical Letter.
We, therefore, welcome your committee's inquiry into excessive drug prices, pernicious drug promotion, chaos in drug names, monopolistic controls of drug patents and markets, and the adverse effect of all these factors on the prescribing habits of physicians.
We also wish to congratulate the committee on its comprehensive and revealing collection of data, its fair and conservative appraisal of the situation and its thoughtful conclusions as summarized in the statement by Senator Estes Kefauver in the opening hearings on July 5, 1961.
After careful review of the committee's data, appraisal, and conclusions and of its own experience, the board of directors of the Physicians Forum unanimously and enthusiastically endorsed S. 1552.
I would like to submit the statement of the board with the statement that I am now making.
Senator KEFAUVER. Is that attached?
Senator KEFAUVER. Suppose we have this printed at this point in the record.
(The document referred to follows:)
1 The full text of Dr. Butler's prepared statement may be found on p. 1108.