Mr. FLURRY. There are drugs on the market which are not patented or on which patents have expired and the manufacturers continue to manufacture them. I assume they produce them for a profit motive.

Senator KEFAUVER. Of course, somebody has to pass upon whether a patent is going to be issued or not. I am sure Mr. Wallace does not want a patent issued on any product that is presented, whether it is new or not.

The thing is, somebody is doing it now and what we are trying to do here is to get some medical consideration in passing on that question.

Very well, thank you very much, Dr. Barr.

Our next witness is Dr. Williams B. Bean.

Dr. Bean, we are glad to have you back with us. You and Dr. Lasagna and some of our other witnesses were good enough to testify earlier during our general inquiry into the drug industry, at which time you discussed generally the problems raised from the physcian's point of view. The purpose of your appearance and of the other physicians who have been here before, or who have not been here before, is to comment on a specific piece of legislation, S. 1552, that is before the committee.

Of course, it may well be that some of you who are authorities feel that the bill goes too far. Others may feel that it does not go far enough. You and others may have recommendations as to its improvement, or changes in language. We have already heard some of them. Or you may have recommendations as to provisions that might properly be included in the bill but which are not included in this rather modest measure, as I term it.

So, as you are an authority, we are glad to have you back with us to discuss this particular legislation.

Your very eminent record and biography, has been placed in the record earlier. I would only mention again the fact that you are now the professor and chairman of the Department of Internal Medicine at the University of Iowa; physician in chief of the Universty Hospitals in Iowa; vice president and chairman of the Medical Section of the World Medical Association; and chairman of the board of regrets of the National Library of Medicine. We are honored to have you with us again today.

STATEMENT OF WILLIAM B. BEAN, M.D., PROFESSOR OF INTERNAL MEDICINE, SCHOOL OF MEDICINE, IOWA STATE UNIVERSITY

Dr. BEAN.1 Senator, members of the committee, ladies and gentlemen, I have been sufficiently identified. I appear here as a physician representing no organized or unorganized group of doctors or anybody else. I speak my personal convictions based on my own experience. It might be said that I represent the patient-the great American public consuming the commodities of medical arts and medical science.

I shall deal only with such parts of S. 1552 as come within my competence. I am not prepared to discuss the validity of proposals dealing with the Sherman Act and amendments to the patent law, but will confine my attention largely to those provisions of section

1 The full text of Dr. Bean's prepared statement may be found on p. 1067.

4 amending the Federal Food, Drug and Cosmetic Act as they bear on the health of the community and the practice of medicine.

At the outset I should like to make my position clear. I do not see all of the points as absolutes, either all black or white. Despite the great faith of the public, scientific facts and interpretations change with the times and with our growing understanding, giving us new and better vantage points from which to make diagnoses and treat patients. The complexity of clinical medicine increases rather than decreases with our expanding knowledge. This is true of the diagnostic machinery which today often can give astonishingly precise answers to specific questions, paving the way for therapy which in some instances can be extraordinarily exact. In other instances it is necessarily uncertain, tenuous, and difficult.

I can state frankly that there are few people more opposed than I am to the monster of monolithic, centralized, all-encompassing governmental control with its expanding ant hives of a myriad of and here is a newly invented word which my exuberance carried me away with, I meant "ponderously," not "preponderously" or "preposterously"-growing bureaucracies. The question is, where does freedom become license and where does control become prohibitively restrictive? On the other hand, in a democracy operating in a capitalistic system of free enterprise, it is necessary for men of good will on both sides of important questions to state their ideas and to stand up for their principles in order that the common good be spread most bountifully among all men, not favoring a few against the many or one group against another. I wish my insights were clearer and my wisdom great enough to comprehend the extremely difficult problems which confront us.

Senator KEFAUVER. I want to say, Doctor, that your statement on the responsibility of the citizen in a democracy, is a very, very excellent one.

Dr. BEAN. Thank you, sir.

I state my views as an individual, with diffidence, but with conviction that someone should bend his attention and such talents as he may have to represent, not the voter nor the taxpayer, not even the physician or the pharmaceutical manufacturer, but the patient.

In any given year this encompasses a sizable part of the population. I regret that with the great press of my continuing duties as a professor, teaching medical students of all ages, a consultant, seeing patients nearly every day, an editor, and a clinical investigator of sorts trying to expose the secrets of health and disease, I have not had time to prepare a polished or an impeccably consistent statement.

Before this group on July 5, my good friend and colleague, Dr. Hugh Hussey, dean of the School of Medicine at Georgetown University, presented a brilliant and coldy logical statement of the position of the American Medical Association, vis-a-vis the proposed legislation included in S. 1552.

He properly emphasized the splendid work of the AMA and its historical relationship to various matters of legal control of food and drug purity. I agree wholeheartedly with his statement of our aims as physicians on page 4 of the mimeographed press release of his statement. Perhaps because as an administrator he does not see patients every day or în consultation see difficulties which inevitably arise, his

view of the excellence of American physicians may be a little higher than mine. I agree that they are a fine, hard-working lot. Dr. Hussey discussed various medical societies with their postgraduate educational program which

together with the expanded drug information program should insure the dissemination to the practicing physician of complete, objective, and authoritative information on new drugs when they are first introduced and up-to-date information on all significant developments in drug therapeutics.

This is an end devoutly to be wished, but with the admitted imperfectability of man, it seems a little starry-eyed to believe that a state of perfection can be achieved or will be achieved under such auspices. There is no historic precedent for it.

The matter of naming drugs, trademarking them, using proprietary or generic names and the problem of explicit definition are extraordinarily vexed.

I might note in passing that the just-released 10th edition of the Merck Manual, which is an extremely important guide and reference book for physicians, used very widely by students, nurses, and so on, includes only generic names, does not include any proprietary or brand names. This is put out by one of the leading manufacturers of drugs, as you well know.

Senator KEFAUVER. Let us take this occasion to compliment Merck on this contribution to medical information.

Dr. BEAN. They stated in the introduction that this was done to conserve space, and since this manual can fit in a large pocket, being printed, as the Bible, on India paper, it has become an extremely useful and frequently consulted volume.

The fact that they saw the wisdom of this compression of names indicates at least that this is one factor that is important in this very complex problem.

I sense something wrong when, in the same drugstore, material much advertised with a proprietary name may cost many times what the same drug with a generic name costs. In actual fact the two may be identical in all respects. If purity were guaranteed, the prescription with the generic name would save the patient with a chronic illness requiring maintenance therapy a large amount of money. The arbitrary complexity by which certain chemicals are known frustrates the physician who wishes to employ generic names. There are examples of compounds for which no generic name has been designated. If licensing a manufacturer of drugs was under Federal control, the manufacture of inferior, impure, and inert materials could be checked. I believe it is true that ethical drug manufacturers would have no difficulty in meeting such standards; others without the experience or the established good name could be kept in line. Under such a rule the practicing physician and the patient would have assurance that any drug sold legally, manufactured by the pharmaceutical industry in this country or abroad, sold by druggists here, marketed under a brand name or generic name, made by a large industrial corporation or a small one, would be of tested quality, strength, purity, safety and efficacy. Whereas the American Medical Association and the U.S. Pharmacopoeia have made real advances in this direction, the extraordinarily difficult problem of terms, word inventions, and definitions probably would be solved better if it were in the hands of an interested but neutral authority.

Let me consider now the matter of whether or not a new drug is "efficacious" and how this point should be approached, established, and monitored; and whether it is best to let the determination of the therapeutic virtue of a remedy, the scientific evaluation, and its approval or disapproval, rest in the hands of the anonymous body of "practicing physicians" or whether this should be determined under the auspices of established clinical investigators and institutions where controlled clinical investigation can arrive at a reasonable scientific interpretation of facts.

Very few people, be they laymen or practicing physicians, have any groundedly learned comprehension of the extraordinary complexity and the great difficulty of establishing even the smallest scientific fact. Because of its very real and serious apprehensions of the centralization of Federal authority, the American Medical Association in its fear has euchred itself into the astonishing posture of supporting the position that it is better to have nonefficacious drugs or those whose efficacy is as yet unestablished released freely to the American physician and the American public, rather than have those made available only when their usefulness in therapy has been determined or its probability is of so high an order that no one could object.

As I understand Dr. Hussey's statement, he believes that the practicing physician, dealing with individual patients, should be the one who determines the efficacy, the reliability, and potency as well as the particular effect of a drug, realizing that the effect varies from patient to patient and in a given patient from time to time, depending on circumstances, as influenced by the biological and biochemical individuality of each person. It takes great experience and clinical wisdom to be able to dissect out the features of existence which are natural and those related to disease. It is a wise physician who can evaluate the alterations, if any, and their direction and degree, as they are induced by a specific therapeutic regimen or the employment of a particular drug or combination of drugs in a single patient, and generalize his results. Granting with him that we frequently imply ‘on the average" when we speak in general terms, when we deal with a patient we are considering only one person. Let me emphasize a few difficulties of allowing the good old American do-it-yourself approach of using the wonderful yeomanry of practicing physicians and the mass of patients in the United States as a willing army of guinea pigs to determine the efficacy of new drugs or to specify the degree and nature of the efficacy of established ones. Every physician his own Pasteur.

Mr. CHUMBRIS. Dr. Bean, when you mentioned awhile ago Dr. Hussey, you said "he believes." When he was expressing his view, he was expressing it on behalf of the American Medical Association and not his own individual view, is that not true?

Dr. BEAN. I cannot say from my recollection. I think he was speaking as a spokesman for the AMA.

Mr. CHUMBRIS. His entire statement was approved by the house of delegates of the American Medical Association.

Dr. BEAN. So I understand.

Senator KEFAUVER. I am not sure it was approved by the council on drugs.

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Dr. BEAN. I understand the house of delegates did not get their expert body to help them out.

Senator KEFAUVER. This is the expert body that is supposed to have jurisdiction of these matters, is it not, Dr. Bean?

Dr. BEAN. I did not mean to imply that these were personal views, but the views he expressed as a representative of the AMA.

Senator KEFAUVER. I continue to think that it is strange, indeed, that the specialized committee set up to pass upon matters of efficacy and generic names and so forth-that is, the council on drugs-seemed to have been purposely by-passed and left out in its formal deliberations on these very important questions.

It is very strange.

Mr. CHUMBRIS. The point I was making, Mr. Chairman, is that the house of delegates is the governing body of the American Medical Association, just like the Congress of the United States is the governing body of the people of the United States.

Now, when Senators and Congressmen vote on the bill, they may not have the exact approval of that particular measure by everybody in their respective States, but once the Congress has passed the bill, it becomes the law of the land.

The Congress at times may disregard an opinion of one of its committees or subcommittees, but once the Congress speaks, then it becomes final.

The point I want to bring out is that it was not Hussey as an individual. It was Dr. Hussey speaking on behalf of the house of delegates of the American Medical Association.

Dr. BEAN. I stand corrected.

Mr. CHUMBRIS. That is my only point.

Senator KEFAUVER. All right, sir. Proceed.

Dr. BEAN. As was referred to earlier by the chairman-and I believe it was added to the information to go on record-in the July 8, 1961, issue of the Journal of the American Medical Association, Prof. Isaac Starr, of Philadelphia, in a wise and perceptive paper on "The Testing of New Drugs and Other Therapeutic Agents," had strong statements to make on the subjective error physicians often get into when they attack the problem of evaluating treatment.

As a historical example of this in the past, the heroic orgies of bloodletting used by one of the most distinguished physicians this country has had, a signer of the Declaration of Independence, Dr. Benjamin Rush, he added therapeutic error to the disaster of a serious disease, yellow fever, illustrate the dangers which even the best physician in the past has gotten into, and few think that we are truly wiser than our forebears.

Senator KEFAUVER. Is that when they used leeches?

Dr. BEAN. No, sir.

I will continue and then go into the bloodletting in more detail, if you want to. A leech is a very meager way to get blood out of a person, even if you have buckets full of them to apply.

This was done by opening a hole in the vein and letting blood flow freely as one does when he donates for a transfusion except it usually went on until the patient fainted.

Another example we should never forget is the therapeutic mayhem done under the auspices of a system invented by Dr. Brown more