than 100 years ago, called the Brunonian system. As I have said. before

it held that life depended on perpetual stimulation, all disease came from too much or too little; it was sthenic or asthenic. (That is strong or weak.) Nothing simpler. Purge, vomit, and bleed one and soak the other in alcohol. No other diagnosis or therapy was required. The up-to-date physician of Brown's day was able to add to the physician's havoc, to the disease's handicap, in a dance macabre which is said to have killed more persons than the French Revolution and the Napoleonic Wars taken together.

You have already quoted this paragraph from Dr. Starr's article, so I need not continue, but it really indicates chiefly the sequence with which results are published; good ones first, then dissents, complications, side effects, and the untoward and unexpected limitations of therapy are likely to be published later by the more critical, cautious people who take longer to accumulate their evidence.

As I gather, the position of the AMA presented by Dr. Hussey is that the judgment of efficacy should be left in the hands of the practicing physician who is dealing essentially with an individual case. Unhappily, this has been the source of much, if not most, of the error in our comprehensions of disease and in our beliefs in the effectiveness of various long discarded and outmoded forms of therapy. Let me give an example:

During the late 1930's, when I first was working in the field of medicine, we used to see, particularly in the Southern States, a great many people seriously ill with pellagra. They might die of it if they were not treated.

Happily, this disease has been largely wiped out by our improved economic situation and perhaps helped out by the fortification of flour and bread which restores to it some of the vitamins and minerals removed in milling.

If a person at a certain stage of acute pellagra is put to bed and given a pellagra-producing diet, he will improve. This improvement is short lived, but it may last for several days, or even a week. Any treatment, any procedure used at such a time is followed by this nonspecific improvement. Thus, everything that was ever used by physicians, and this included almost every drug available in the pharmacopoeia, was praised as a specific cure.

Only when recognition of this nonspecific phase of improvement had been gained by clinical investigation was a proper evaluation of therapy possible.

The main criticism of Freudian psychoanalytic therapy has been that its evaluation is individual and anecdotal. It deals with events in the continuum of a person's life. The essence of judgment has to be post hoc. Something happened first and, therefore, it caused something that happened second. The difficulty or inability to use controlled and comparative experiments and the impossibility of having the opportunity to test without either therapist or patient knowing what is going on, as may be done in the "double blindfold test," has made many physicians reluctant to accept the firmly avowed beliefs of certain psychoanalysts. To some extent, and this is true of much science, it has to be taken on faith.

Physicians are desperately anxious to relieve, to succor, and to restore to health the patients who come to them in their difficulty. It is only natural that as physicians we are pleased to ascribe to our own

efforts such good changes as occur and blame on the nature of the disease, the patient's refractoriness, orneriness, or something else, failures we encounter. The observer parallax or body English, our intense hopes, make it extraordinarily difficult for anyone to observe his clinical results dispassionately. There may be the tremendous placebo effect of a strong, vigorous, and enthusiastic personality. The use of this attribute is a valuable and legitimate form of helping the patient. But without the controlled experiment, without the realization of biological variation among persons and with time, mazes in the still incompletely mapped terrain of the natural history of disease conspire to make the practicing physician's judgment of efficacy difficult and uncertain. No one for a moment denies that in the last analysis the physician has the responsibility and must determine both the choice of an effective drug and his interpretation of its effect. Nothing in S. 1552 abrogates this responsibility.

An editorial in the July 6, 1961 issue of the New England Journal of Medicine dealing with Furaltadone indicates that the claims made for its efficacy were erroneous both as an agent to prevent infection or to eradicate it when it had occurred, presumably in large degree because the effect of the drug in a test tube was very much greater than its effect in the human body.

Quoting the editorial:

The arguments that have been brought forth in support of this drug will give little comfort to those who oppose pending legislation that would extend the authority of the Food and Drug Administration to require proof of efficacy as well as lack of toxicity before authorizing the release of new drugs for sale * * * Those who are entrusted with protecting the public, including the medical profession, should require solid evidence of useful activity obtained under reasonably controlled conditions in a reasonable number of cases rather than a collection of testimonials before permitting a drug to be prescribed for the treatment of life-threatening illnesses.

The only thing I wish to say about patents is said from an entirely different view of legitimate industrial use: That it is repugnant to the medical profession to think of patenting any technique or method of therapy.

As an example, in Britain a couple of hundred years ago a family named Chamberlen invented forceps which they kept secret. They obtained a monopoly and over four or five generations they were able to save their patents whereas others were allowed to go on to destruction.

This is, of course, of harm to physicians.

If a new method of medical treatment or a new surgical procedure comes along, those who have discovered its efficacy are anxious that it be available not only in Iowa City or at the Mayo Clinic, but in Boston, Bombay, Budapest, Birmingham, and everywhere.

Of the problem of advertising I shall say only that overenthusiastic promotion is annoying to me and has been responsible for at least one unhappy example of and I quote now from Dr. Garland, who is editor of the New England Medical Journal, in an article published in the British Medical Journal, May 20, 1961:

Conflict of interest on the part of an important Government official for the sorry situation was presented of a public servant with a financial interest in the promotion of a product on which he had to pass judgment, of "interlocking financial ties of drug houses, advertising agents, with drug accounts, journals dependent on drug ads, and laboratories which test drugs."

This melancholy example of financially incestuous relations has put a certain chill on the devout pronouncements of those who claim pristine purity for the entire pharmaceutical industry. While none deny its marvelous contributions and its essential value, it is not perfect.

Senator KEFAUVER. I assume, Dr. Bean, this editorial was referring to Dr. Welch, whose situation was brought out before this committee. Dr. BEAN. As the lawyers say, ipse res loquitur. It speaks for itself. Senator KEFAUVER. That is a new ability.

Dr. BEAN. I fight fire with fire.

Senator KEFAUVER. Ipse res loquitur.

Dr. BEAN. Now, in conclusion, may I have your indulgence in ending with a quotation which in a whimsically antique way epitomizes our common goal, all of us, as we approach it along obviously disparate paths. It is by John Bunyan, the author of "Pilgrim's Progress," and it comes from a tract he wrote called "The Jerusalem Sinner Saved; or, Good News for the Vilest of Men."

Christ Jesus, as you may perceive, has put himself under the term of a physician, a doctor for curing of diseases; and you know that applause and fame are things that physicians much desire. That is it that helps them to patients, and that also that will help their patients to commit themselves to their skill for cure with the more confidence and repose of spirit. And the best way for a doctor or physician to get themselves a name is, in the first place, to take in hand and cure some such as all others have given up for lost and dead. Physicians get neither name nor fame by pricking of wheals, or picking out thistles, or by laying of plaisters to the scratch of a pin: every old woman can do this. But if they would have a name and fame-if they will have it quickly, they must as I said, do some great and desperate cures. Let them fetch one to life that was dead; let them recover one to his wits that was mad; let them make one that was born blind to see; or let them give rip wits to a fool; these are notable cures; and he that can do thus; and if he doth thus first, he shall have the name and fame he desires; he may lie abed till noon.

Thank you.

Senator KEFAUVER. Dr. Bean, your statement has been very interesting. It is philosophical, too. It is thoughtful and it has added a little brightness and cheer to our considerations. We thank you for coming back and being with us.

As I understand your testimony, you favor in general, with perhaps some refinements, some legislative provision providing that the voluntary efforts of the AMA and the U.S. Pharmacopoeia would be made use of, but you feel there should be reposed somewhere in the Government as a neutral agency the matter of determining claims of efficacy, is that right?

Dr. BEAN. Yes, sir, that is correct.

Senator KEFAUVER. And the same would go for generic names in case other efforts do not work out?

Dr. BEAN. Yes, sir.

Senator KEFAUVER. Would you feel that some medical consideration should be given to the matter of passing upon patent applications by the big companies?

Dr. BEAN. That seems to me very reasonable. I think that is an extremely difficult problem, and I am not competent to speak on it, but I think it sounds sensible that rather than just lawyers of just businessmen or just engineers, those who pass on the patents and patentability of drugs should include representatives of the pharmacological, pharmaceutical, and medical experience.

Senator KEFAUVER. And you recite the importance, also, of making available drugs that are patented to other physicians in the interest of the general welfare and health of the public by citing the English experience.

That is one of the aims of this bill, also.

While you are not an expert on patents, the bill, as you know, does provide that if a drug is patented, the patent should extend for 17 years, which is the present time period provided that after 3 years the company agrees to provide licenses to qualified applicants on paymen of a royalty not to exceed 8 percent of the sales price.

Does that strike you as being reasonable?

Dr. BEAN. I guess it is.

I have no idea of the business aspects of it or what the level should be. It seems reasonable to me that the manufacturer of any drug and its availability should not be a monopoly which could be restrained under either the whim of someone who did not want to release it for any reason, or if it was in restraint of trade by virtue of its being owned or controlled by one person to the disadvantage of the public. On the other hand, I recognize that this is an area in which incentive is very important, and I do not know at what level industrial incentive disappears and at what level industrial incentive must be monitored. I simply am not competent to speak to that.

Senator KEFAUVER. Of course, the obvious purpose of that provision is that after 3 years during which the company has control of a very important drug for the health of the people they should agree to license it so that other companies can manufacture it, and more people will have an opportunity of getting it. There could be some competition between the holder of the patent and those to whom that company grants a license which might bring down the price of the drug.

The testimony shows that in many cases that has brought down the price of the drug.

Are there any other questions?

Mr. CHUMBRIS. On that point, Mr. Chairman, could I make one comment?

Senator KEFAUVER. If you want to ask a question, Mr. Chumbris. Mr. CHUMBRIS. It is in relation to this point that you have just raised.

I am glad, Dr. Bean, that you said that it is a question of incentive when we talk about patents, because I think it fits in exactly with your last paragraph:

Let them fetch one to life that was dead; let them recover one to his wits that was mad.

Dr. BEAN. I want to see those patented very promptly.

Mr. CHUMBRIS. Yes, sir.

Now, the reason why I bring up incentive is that more and more, every day, we have had drugs that I think almost everyone agrees have cut the death rate of pneumonia from 60 to 80 percent and the death rate of childbirth to 62 percent.

I mean it is all in the charts, as Dr. Smith brought out. And if there seems to be a difference between the minority view and the majority view, it is that the minority view on this point is that we feel that there should not be any possible restriction to those who do the invent

ing, those who do the manufacturing, to bring about these lifesaving drugs that you have referred to in your last paragraph.

You talk about the medical aspects and I am referring to the drugs.

Senator KEFAUVER. Mr. Chumbris, is that a question?

Mr. CHUMBRIS. That is the only comment I am going to make on Dr. Bean's testimony, Mr. Chairman.

The record is replete with the States now saving millions of dollars in taxes because the people, instead of staying in mental institutions, go back home because of certain drugs, as has been brought out. That is my only comment.

Senator KEFAUVER. Mr. Flurry, do you have any questions?
Mr. FLURRY. No questions.

Senator KEFAUVER. Mr. Wallace?

Mr. Kittrie, do you have any questions?

Mr. KITTRIE. I would like to ask one or two of the witness.

Dr. Bean, are you a member of the American Medical Association. Dr. BEAN. I was up until this morning. I guess I am. I edit one of its journals or at least I am book review editor of the Archives of Internal Medicine, which is one of the 10 specialty journals under the aegis of the J.A.M.A. editorial group.

Mr. KITTRIE. Since you engaged in an analysis of the AMA position, I would like to get your comments on this following question. I did not ask this question of the representatives of the AMA, when they were here. It occurred to me later, and I was wondering if there is an explanation.

When the AMA testified here, as you well know, they indicated they believed that the responsibility as to efficacy should be left to the individual doctor; they did not feel it should be determined on a governmental level.

They left us with the impression that as long as a new drug is approved as not being overly toxic, that this is sufficient. They felt that the individual doctor can take it from that point and make a decision for himself.

Yet, in examining some of the literature that the AMA presented here, I noticed, for example, in a little brochure in which they describe their advertising policy they said that in deciding whether or not a drug advertisement should be accepted, they would reserve to themselves the right to discuss and analyze efficacy. That is, for purposes of advertising in their own magazine, they did not feel that the decision made by the Food and Drug Administration was sufficient. They did not feel that just because a drug was approved, they would go ahead and advertise it. Apparently, they felt that they needed to impose some internal censorship. Apparently they felt that the individual member was not properly trained to decide for himself. If they feel this way about accepting advertisements, should not the same apply to the whole area of efficacy in general? That is, for purposes of advertising they are not willing to accept any drug just because it was approved by the Food and Drug Administration, so is not that an indication, almost a proof, that they do not consider the decision of the Food and Drug Administration sufficient?

Dr. BEAN. I imagine there are plenty of inconsistencies in any position that they take, but it does seem to me that you have put your finger on a paradox in these two points: