simplification of psychiatric treatment. Careful studies show with increasing clarity that these drugs alleviate symptoms, but do not by themselves cure mental illness. Yet we rarely find this limitation emphasized in the pamphlets distributed by the manufacturers. When manufacturers, physicians and patients come to believe that presently available drugs of this group alone can cure mental illness, other necessary treatments such as psychotherapy may be delayed or omitted altogether. Unfortunately, just this happens rather often. We frequently observe patients who have received "tranquilizers" for weeks and months without any effort having been made to modify the patient's fundamental disorder. As I said earlier, drug manufacturers are not alone to blame for this sort of medical practice. Yet one cannot avoid the impression that some of them have encouraged it through their advertising practices.

This brings me to discuss some of the advertising practices to which critical physicians in general, and myself in particular, take exception. Many of the abuses which we criticize are exceedingly subtle. They consist not of untruths, but of half or quarter or eighth truths presented in such a way that you can mistake them for the whole truths. And yet the manufacturer when questioned may righteously deny that he wrote anything but the truth and deny that he intended to distort the evidence. The more important offenses of advertising which occur to me are the following:

(1) The presentation of data in advertising brochures which is given an appearance of high scientific quality without in fact possessing this. For example, drug manufacturers frequently include in these brochures bibliographic references to ostensibly scientific publications to which the reader can turn for fuller details of the benefits claimed for the drugs. However, such bibliographies are frequently partially or completely spurious. They are heavily loaded with what we call "personal communications" (which means not published at all), with articles in foreign medical journals, and impressionistic, uncontrolled articles often of second-rate American journals. Moreover, from more substantial articles, sentences may be taken out of context and made headings for an advertising brochure. Such headings catch the eye and impress the mind. If the reader does not consult the original article from which the sentence was extracted, he may never know that the physician thus quoted had also a great many qualifying reservations about the drug in question. Finally, I may mention the complete failure of such drug brochures to mention trials of the drugs which showed them to be less valuable or of no value whatever. It may be argued that to ask this is to require too much of a man of commerce. Perhaps so, but then he should not disguise his material if he were a man of science. For to use the language and manner of science surely carries with it the responsibility of practicing the total behavior of scientists which is to examine all kinds of results dispassionately.

Many of the advertisements for these drugs offer a strange mixture of the quasi-scientific presentation of data with a dramatic, frequently pictorial message. The words or pictures unfold a story of miserable mental suffering transformed into radiant happiness through, so they imply, the beneficent effects of the drug advertised. Much of the advertising is pitched at a very low level of intelligence. It appeals

directly to emotional symbols, frequently unconscious, and bypasses the higher thought processes which should come into play in judging the effectiveness of a drug. Presumably this kind of material would not be used if there were not grounds for believing in its effectiveness which fact is a disappointing reflection on the critical faculties of physicians to whom nearly all of it is addressed.

(2) The advertising of the drug manufacturers frequently fails to give proper emphasis to complications and side effects of the drugs. Drugs which can in fact have quite serious complications may be presented as possessing only minor hazards when careful studies have shown this not to be so. In the heat of competition many companies brought out new drugs containing comparatively minor modifications of compounds previously tested. They then claimed, frequently quite prematurely, that these drugs brought fewer side effects and complications than their predecessors. This kind of advertising can produce a temporary rush to a new drug on the part of uncritical physicians. (3) The advertising of the drugs can include a serious oversimplification of mental illness and its cure leading the unwary physician and patient to believe that the answer has already been found.

Each of the various offenses I have listed has been committed and it is not difficult to find examples, some of which I have brought with me. I will repeat, however, that although the offenses are serious and considering the human suffering involved, heartless and cynical, the number of offenders is small.

As to remedies for unreasonable advertising of these drugs, I think we must expect these to come from several sources in order to remove the several contributing factors to the success of such advertising. The medical profession has begun to concern itself with improving the quality of its evaluation of drugs. Editors of medical journals are becoming more critical of shoddy research. They are preventing more physicians from making fools of themselves by insisting on higher standards in the conduct of research and the evaluation of its results. Moreover, the National Institute of Mental Health has established a Psychopharmacology Center whose business will include careful study of all reports on these drugs and their successors. In addition, we always work for and expect continuing education and discrimination on the part of the public in their use of these drugs. Regarding what can be done to modify distortions in the advertising of drugs, I think even the most severe critics of the manufacturers would hope that they could police themselves. Physicians would certainly prefer to invite the drug manufacturers to exert an inner discipline rather than propose external controls. Most drug manufacturers sensitively accept the fact that the merchandising of medicines to relieve human ills carries the responsibility of sacrificing profit for the welfare of patients where these conflict. Accordingly most of them, as I have already emphasized, conduct their advertising with great propriety. This sensible majority may be able in some manner to persuade other companies who offend that the interests of the industry require all and not just some of them to exercise self-control.

If the drug manufacturers cannot moderate their own advertising, a question will arise as to the advisability of external controls. Legal restrictions I would think undesirable, although they may prove necessary. Laws which would adequately curb the subtle offenses of the

few offenders would require great ingenuity in their devisers. Laws which were too lax would have little or no value, and those too severe could injure the innocent manufacturers.

If a measure of control beyond self-discipline on the part of the manufacturers becomes necessary I might mention one which would still fall short of regulatory laws. This would be the establishment of a commission, perhaps fashioned after the Civil Rights Commission. Such a commission could be composed of representatives of the drug manufacturers, of the medical profession (perhaps represented by members of the Council on Pharmacy and Chemistry of the American Medical Association), and by representatives of the United States Food and Drug Administration. This commission could scrutinize advertising and other sales practices and could receive complaints about abuses.

I hope very much that all external controls of this kind will prove unnecessary and that these hearings by their thoughtful examination of the serious issues involved will evoke in the minds of the few offending drug manufacturers a necessary sense of their responsibility to the public.

Mr. BLATNIK. Thank you very much, Dr. Stevenson.

Mr. Plapinger.

Mr. PLAPINGER. Doctor, we haven't mentioned the names, as you have gathered from the testimony.

Dr. STEVENSON. I think under the heading of "examples of failure to emphasize adequate harmful side effects of drugs" I might mention drug A, which was marketed across the country after only two clinical studies had been published containing negligible mention of side effects. Subsequently harmful side effects of this drug were published and-I know four references—and yet subsequent advertising of this drug-have continued to neglect and minimize side effects.

In other words, there has been no real picking up as to the rare, to be sure, but nevertheless important side effects.

Mr. PLÁPINGER. When you mentioned subsequent advertising, how current are these examples you are referring to?

Dr. STEVENSON. They were all published in 1956, only about a year or 6 to 12 months after the drug was first marketed.

Mr. PLAPINGER. I see. And what about examples of current advertising on the same drug?

Dr. STEVENSON. Current advertising on the same drug frequently refers back to these original two papers, as if nothing much had been done since then, and it gives an impression that this covers everything. Another drug, the advertising of which I thought of since, was drug B, in which the advertising represents the drug as having negligible side effects, and complications. And yet a report-two reports by reliable investigators have described important and potentially dangerous side effects. Again, the current advertising in my opinion doesn't sufficiently emphasize the side effects.

Mr. PLAPINGER. Doctor, you were sitting next to Dr. Ayd as he was examining the samples of advertising.

Dr. STEVENSON. One of them is the same.

Mr. PLAPINGER. One of them is the same?

Dr. STEVENSON. In fact, Dr. Ayd is one of the authors who has drawn attention to the harmful side effects of this drug, and his com

ments have not to my mind been sufficiently emphasized in the subsequent advertising. In addition to Dr. Ayd, another physician has recently published an article on the same drug pointing out the potentially harmful and serious side effects.

And then under the heading of "Use in Advertising of Uncontrolled Investigations With Neglect of Negative Studies and Controlled Experiment," this, I would say, is one of the most widespread evils, because though we understand the importance of careful quotation by the advertisers of papers which have been published on a drug, that to me doesn't seem sufficient. I think there is such a wide disparity between the best and the worst in research work that a drug manufacturer may quote work which is second rate and uncontrolled, and omit work which has been carefully controlled and which reflects the ineffectiveness or lesser effectiveness of the drug. The upshot of it is that the advertising may report quite accurately work which has been done, but the impression may be communicated that this drug is more effective than it is.

Now, in the case of drug A, there have been two reports in the literature which have been controlled with, as we call them, administration of placeboes. I don't know whether you are familiar with the methods of control and the attempts to eliminate the influence of suggestion. Would you like me to explain it?

Mr. PLAPINGER. Yes; I think so for the record.

Dr. STEVENSON. As I said in my statement, any time you give a drug to the patient you arouse in the patient an expectation of its effectiveness. And this expectation can produce important physiological effects. These are not just imaginary effects, but actually a physiological effect.

Mr. BLATNIK. They can be measured, real effects, short term, but real effects?

Dr. STEVENSON. That is right, for example, changes in the blood pressure, and gastric function. And, of course, some of them cannot be measured objectively, because they are effects in the mind and in the attitude and behavior, but nevertheless they can be observed. And the frequency and extent of such effects, the effects of suggestion vary greatly, they vary with different patients, because we know that certain patients are more suggestible than others. In addition we know that certain persons during certain conditions, most especially anxiety, are most suggestible; that is, all of us are more suggestible when we are anxious than when we are relaxed. This has a bearing because it means that with mentally ill patients, who of course are anxious almost invariably, most of them are, we have a situation which is loaded with suggestibility. The studies which have been done as to the incidence of these effects of suggestion show that they range from about 25 to 75 percent; in some series you can get an effective response, an apparent response from the effects of suggestion only, giving blank pills in 25 percent of the population to whom the drug is administered.

In other studies where presumably the patients were more anxious or more suggestible for other reasons, the incidence of effects from suggestion has run as high as 75 percent. Many students of this subject will quote incidences of 40 to 50 percent. What this means is that in order to have a really accurate understanding of the effects of the

drug you must allow for this effect, because otherwise if you are in the area of 40 to 50 percent effectiveness, your ostensible benefits may be coming entirely from the influence of the patient's expectation of the drug. And these factors of suggestion can be strongly influenced by the attitude and behavior of the physicians and the nurses.

For example, in one study which I might mention, with apparently comparable patients, to one group of patients with an illness the physicians giving out the drugs said, "We have a new drug which is the latest thing for your trouble, and it is going to help you." And they told that directly to the patients. To another group of comparable patients they didn't say anything directly, but they allowed word to filter down to the patients through the nurses to the effect that a new drug is coming out and the doctors want to see if it is any good or not. Otherwise the patients were handled the same, and they were both given a completely blank drug, a blank pill, what we call a placebo. In the group to whom the doctors had given a positive suggestion 75 percent of the patients responded. In the group which had been led to think the drug might be of value, 25 percent responded. So, in that you can see an extraordinarily powerful influence just from the manner in which the drug is administered.

I might mention also that the toxic effect of the drug can be frequently communicated through suggestion, so that when one patient hears about toxic effects of the drug in a ward, other patients may pick this up through suggestion and imitation. And this again naturally gives a fictitious impression of the drugs having more side effects than they actually have.

Well, coming back to drug A, I was going to mention the two reports which have been carefully controlled, that is that the use of placebo tablets, blank tablets on drug A have shown in one case one was a comparison with the barbiturate and the other was a comparison with a blank tablet-and in both cases drug A did not prove any more efficacious than the blank tablets or the barbiturate. When you consider that the barbiturate is one twenty-fourth the cost of drug A, it gives rise to concern as to what is going on.

Mr. BLATNIK. It is like taking aspirin instead of some new supposedly wonder antibiotic drug?

Dr. STEVENSON. Yes.

Mr. BLATNIK. Doctor, I have been looking over quite a bit of this material we have been receiving, and I notice on page 5 you made reference to quasi-scientific presentation of data with dramatic, frequently pictorial messages. And we have one sample, which we are not identifying, on the right and the left. You see the gray picture of feet, actual photography, a nice angle, and on the right you have the color. Now, medically speaking, is this type of pictorial presentation necessary to indicate to a physician that this patient in the gray shot is most likely a patient in a hospital or in some institution, and the one on the right in color with a wall-to-wall rug on the floor is most likely at home?

Now, this is an elaborate picture. I wish I could afford to use work like this in my campaign back home instead of one-color jobs. Here we have a whole booklet, an elaborate picture on the left in gray, and the one on the right smiling in color. This constitutes a very well established and respectable and reliable pharmaceutical firm. Is there any