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Statement of William B. Bean, M.D.

Re: S. 1552, 87th Congress, Drug Industry Antitrust Act
Before the Subcommittee on Antitrust and Monopoly

The Committee on the Judiciary

United States Senate

To be presented July 19, 1961

Mr. Chairman, Members of the Committee:

I am William B. Bean, M.D., of Iowa City. I appear here as a physician representing no organized or unorganized group of doctors or other group. 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 cammodities 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 Four amending the Federal Food, Drug and Cosmetic Act as they bear on the health of the community and the practice of medicine. At the cut set 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 cur 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 preponderously growing bureaucracies. The question is where does freedom become license and where does

On the other hand, in a democracy

control become prohibitively restrictive. 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 pesition and to stand up for their principles in order that the common gord be spread most bountifully among all men, not favoring a few against the many er one group against another. I wish my insights were clearer and my wisdom great enough to comprehend the extremely difficult problems which confront

us.

.

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 tax payer, 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 trying to expose the secrets of health and disease, I have not had time to prepare a polished or an impeccably consistent statement.

On 5 July my good friend and colleague, Dr. Hugh Hussey, dean of the School of Medicine at Georgetown University, presented a brilliand and coldly 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 A.M.A. and its hostorical relationship to various matters of legal control of food and drug purity. I agree whole-heartedly with his statement of our aims as physicians on page four of the mimeographed press release of his statement. Perhaps because as an administrator he does

not see patients every day or in 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 therepeutics." 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 generis names and the problem of explicit definition are extraordinarily vexed. I sense something wrong when in the same drug store, 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, frustrate 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 druggist here, marketed under a trand 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. Pharmacopeia 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 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 non-efficacious 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

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