Dr. KLINE. Considering that it takes probably a month and a half to get the publication out, this was quick action. They knew what to do, which I am afraid some of my medical colleagues don't know.

So, in this case, I am pointing out that this can be done by an individual, which I think would be equally effective, and doesn't require legislation or regulation. In the testimony, I have discussed why I don't think it is practical to attempt regulation. But in order not to take up the time of the committee and since they have read the prepared statement, I have omitted that here.

Mr. MEADER. I was interested in this question of leaking, because sometimes committees of Congress are faced with that problem. Dr. KLINE. Really?

One or two other points on this score, and I'll wind up.

One is that I have used as an illustration some of our own foolishness where we rushed into print very precipitantly on what we thought were dangerous side effects. Subsequently, we felt this was largely our own fault. The drug did have side effects. It has to be used with great caution in selected patients, but we had issued a more or less blanket condemnation, which later I felt the necessity of retracting, in the same journal in which the original article had appeared, pointing out that the drug still was probably not as potent as some of the others, but we had rushed our conclusions.

Then this point of fact, there are occasionally investigators who get carried away by what they are doing and write some very glowing reports. There are 1 or 2 of our colleagues, whom I am sure both Dr. Ayd and my self and other scientists-psychiatrists-know, who routinely find results 2 or 3 times as good as anybody else does. We are fully aware who these people are.

What is interesting is the frequency with which these people are not quoted by the pharmaceutical houses, because the implication would be if they quoted these people, the pharmaceutical houses would be in agreement that the results were such and such. Since this is not in conformity with the fact, it would again lead clinicians to question the value of the product. So that even the investigators who are intemperate usually are shortly abandoned by the pharmaceutical houses when they find that the work is not substantiated, since they don't want to be caught with their quotations down. They do not go out looking for people who will give laudatory reports.

As I say again, it is strictly business. In the long run it is poor business to oversell your product, because when it doesn't stand up, your reputation suffers.

I won't go into the details of it, but I think the matter of regulating both the articles themselves and the advertising is not the responsibility of the investigator and not the responsibility of the pharmaceutical house. As Dr. Joseph Garland has pointed out in an issue of the New England Journal of Medicine, which is a very estimable, highly regarded journal, in an editorial of December 5, 1957, entitled, "Editorial Responsibility for Medical Advertisements" (see appendix, exhibit 6, p. 186), he makes what appears to be the very reasonable point that it is the editor of the medical journal who is responsible for accepting or rejecting advertising. This is also true of the articles. I think if the criteria for acceptance of articles and for promotional literature were as high in all journals as it is in most of them, at least that aspect of it would need no discussion.

There probably are a few journals who are operating marginally, and who probably even solicit advertising that will keep them going so that they can stay in existence. But even there

Mr. PLAPINGER. These are not the journals published under the auspices of the medical societies, or are they?

Dr. KLINE. No; these are usually private publications.

Mr. PLAPINGER. Are the journals other than the so-called strictly professional journals widely circulated?

Dr. KLINE. No; the circulation is relatively small. There is a prestige value connected with publication in certain journals. There are some journals however to which some of us won't send articles. Having an article appear there has almost a negative value, the attitude being, "well, you couldn't get it published anywhere else."

These are the marginally operating journals, of which there are a very few. I think Dr. Garland's point is very good, that this is an editorially responsibility, rather than any other.

Then, drawing to a close, I bring up the final point

Mr. BLATNIK. What page are you referring to there?

Dr. KLINE. Now I am on page 23, the last paragraph. The major charge leveled against the pharmaceutical houses is that some of them in some of their promotional literature have been "extravagant" to put it mildly.

I pointed out in an editorial the reasons for this. I still see no reason to think that I was not correct. The background making this situation possible is the extreme difficulty in evaluating improvement in psychiatric patients of all types. Unfortunately, there do not exist criteria equivalent to temperature, X-ray findings, or specific laboratory tests which will indicate the degree and time of improvement.

Therefore, in such a situation, judgment is dependent upon the subjective evaluation of the examining physician. At times, there is over-enthusiasm for agents which do affect behavior. I think some of us at times were overly enthusiastic, although others of us were cidcumspect from the very beginning. We indicated that we felt that these drugs had a definite effect, and that had tremendous implications, but we didn't feel they were a panacea. There were a few extravagant articles which indicated that we could now tear down the mental hospitals and go home, but these were unusual.

Add to this the tremendous interest of the general public because of the frequency of mental disease, and the situation was ripe for what occurred. The sales and promotion divisions of some of the pharmaceutical houses, operating in a business frame of reference, came into conflict with the medical research divisions of the same company. The ethics and practices of the business world differ significantly in certain aspects from those of the medical profession, and it was at this juncture that some of us in the profession felt there were abuses of promotional advertising.

Mr. BLATNIK. You say they were abuses?

Dr. KLINE. Yes, sir.

Mr. BLATNIK. Do any of those abuses still exist, to your knowledge? Dr. KLINE. It is a matter of definition. I think that the promotional literature at the present time with psychopharmaceutical drugs is no better or no worse than it has been in the past with all kinds of drugs.

Mr. PLAPINGER. May I interrupt at this time?

Dr. KLINE. Yes, sir.

Mr. PLAPINGER. In your editorial, some five pages in the American Medical Association Archives of Neurology and Psychiatry, you enumerated as some of the evils: suppression of an article containing unfavorable reports, a canned article to which an investigator fixed his name, a tendency on the part of drug houses "to accentuate the positive and eliminate the negative"-that is your own languageyou referred to the conflict of research and sales, premature unwarranted claims, overeagerness of the drug houses to exploit their product, a physician tendering his talents to the drug houses. And you have made reference to the quotation out of context.

In June of 1957, your article appeared.

Dr. KLINE. That wasn't when it was written, though. It was written probably 3 or 4 months earlier.

Mr. PLAPINGER. There was a resurgence of feeling against this kind of thing.

That feeling was expressed in the journals, the bulletin of the Academy of Medicine in a report by the Council on Public Health, in the Drug Trade News, which is the trade journal of the pharmaceutical trade

Dr. KLINE. Yes.

Mr. PLAPINGER. In your article you stated

that all of the above incidents have occured within the past year. The ones I have itemized were deliberately selected because they-there have been different equally undesirable occurrences against which I and others have had to take a firm stand in protest.

Dr. KLINE. That is correct.

Mr. PLAPINGER. I am wondering, following the chairman's question about the situation as it exists today, because if I can anticipate what is in your statement on page 25, you say

in respect to regulation of advertising, it would appear that it is not a matter of "locking the barn door after the horse has escaped," but of sending out a posse after the horse has returned of its own accord.

This is in respect to the regulation of advertising, which is really, if not the primary concern of the subcommittee, my principal if parochial interest in these hearings. This indicates to me, or rather, I get the impression from this paragraph (see above quotation) that everything is all right.

But I gather that that is not so from what you have just said.

Dr. KLINE. No, I would say that the excesses which were indulged in, unquestionably, by some of the pharmaceutical houses have virtually disappeared. The one company which I make reference to, which was one of the worst offenders, as a result of the unfavorable reaction which their promotion provoked, completely reorganized their company. They literally threw out practically everyone who had anything to do with this promotional technique, including the physicians who went along with it. There may have been other reasons, but it was made fairly clear that this was a major reason, that they had brought upon themselves the animosity of virtually everyone by resorting to promotional devices which were misleading and cheap and flimflam.

The medical profession reacted so negatively against this that they reorganized the company.

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At the present time, I think the promotional literature is quite circumspect. It may happen still occasionally that someone is quoted out of context, but I suspect at this point that it is by accident, rather than what one might consider design. I have a number of other documents showing the awareness of the industry itself on this point. They have set up a number of medical ethics committees to attempt to promote some self-regulation.

Mr. PLAPINGER. May I interrupt?

Dr. KLINE. Please, sir.

Mr. PLAPINGER. In that connection, our information is that in February 1955 a guide for guidance in ethical-drug promotion was formulated by the medical section of the American Drug Manufacturers Association apparently embracing many of the evils which you have just talked about. (See appendix, exhibit 7, p. 191.) Dr. KLINE. Yes, sir.

Mr. PLAPINGER. But notwithstanding those tenets, your article in 1957 reflects incidents that took place since the promulgation of that document?

Dr. KLINE. Yes, the industry itself, so I have been informed by a number of their people, are critical of the code perpetuated at that time, on the basis that it was without teeth, that it did not cover certain circumstances, and I know of and have seen an off-the-record draft of a new code which would appear to be much more effective. This is presently in preparation, so that the pharmaceutical industry itself was not satisfied that they had accomplished what they had intended to accomplish.

Mr. PLAPINGER. Incidentally, this code was sent to us

as an authoritative opinion of the medical directors representing their member firms of the American Drug Manufacturers Association medical section.

I am wondering, in view of your reference to the conflict-the traditional conflict between research and sales-whether this has any significance?

Dr. KLINE. It has great significance. Let me put it this way.

If the promotion and advertising were regulated entirely by the medical directors, the drug companies would probably go out of business, in the sense that they lean over so far backward in not wanting to be caught in a situation of this kind. There are times when they fail to recognize that they are working for a free-enterprise system where the firm has to make money.

Then, again, if it were run by sales and promotion, it would be practically meaningless gibberish. So the problem is to find a way in between.

The code which is presently in preparation is not from the medical directors, but from the top administration, which is an entirely different matter, because these are the men who really have to arbitrate between sales and promotion and medical research divisions.

The code with which they are coming up, as far as I can judge, and I am certainly not an expert in this area, would certainly seem to be an effective one.

Mr. PLAPINGER. May I read some of these statements in the 1955 code to you?

Dr. KLINE. Please, sir.

Mr. PLAPINGER (reading):

We believe that

1. Any statement in promotional literature should be supportable by acceptable scientific evidence.

2. Quotations from the medical literature or from the personal communications of investigators or the paraphrasing of such quotations should not change or distort the true meaning of the author.

3. If it is necessary to include comparisons of drugs in promotional literature, such comparisons should be constructive and made on a sound professional basis. 4. The release to the lay public of information relative to the clinical use of a new drug or to a new use for an established drug prior to adequate clinical acceptance and public presentation to the medical profession of such a drug or use is considered not to be in the best interests of the American public or of the medical profession.

5. The use of trade names of prescription drugs in lay advertising is considered not to be in the best interests of the American public.

6. The appearance of physicians or of actors purporting to be physicians in television or radio advertising or in promotional literature intended for lay attention is considered not to be in the best interests of the American public.

7. The use of statements by a physician or of statements which purport to have been made by a physician in advertising intended for lay attention is considered not to be in the best interests of the American public.

8. Since the development of a new drug is recognized to be the result of the efforts of a scientific team rather than of any one individual, the use of individual names in releases for lay attention should occur rarely.

9. A trademark is private property and can be used legally in promotional literature only with the consent of the owner of the mark.

10. The medical department or the medical consultants of a pharmaceutical firm should review all medical claims and assertions contained in promotional literature prior to their release.

Dr. KLINE. Let me reemphasize the point you made, that this was not adopted by the pharmaceutical directors but by the medical directors. The overall code which is now being considered by the top administration contains most of the points you have made.

Once top administration has agreed on it, then it becomes policy. This is a recommendation by the medical directors. Some of the points would, I suspect, be modified, and some of them strengthened. Mr. PLAPINGER. Which are those, Doctor? That is what concerns This seems to at least conform to much of your criticism, and seems to be perfectly reasonable. I don't know about the use of individual names in releases for lay attention, but other than that, this seems to conform to the very criticisms you have made.

me.

Dr. KLINE. Yes, my feeling would be that from what I have heard of the draft, and I am not at liberty to discuss it, is that it is not so much the contents but the matter of wording. As far as I can gather, they want to try to make it more effective by having some kind of teeth in it.

Mr. PLAPINGER. You mean that this was not tight enough and the proposed draft will be?

Dr. KLINE. That is my impression, from what I have seen of it. It is more a matter of timing, I think.

Another thing which you probably know of is that the investigation carried out jointly by the American Medical Association and the drug industry to obtain an analysis of physician's attitudes to promotional literature. They are attempting to work out with the American Medical Association an effective means of mediating differences of opinion in this respect. Their sales are dependent on the good will of the physician, and obviously these are things at which the physician takes umbrage, and therefore, they are doing their best to rectify it.