Mr. BLATNIK. Would that indicate, then, Mr. Irish, that you are satisfied that there is no problem and that the health and welfare of the public in the field of tranquilizers is adequately protected? Mr. IRISH. I have not studied the problem of tranquilizer advertising because, as I said before, it is advertising of ethical drugs and we have had no cases initiated by complaining physicians or anyone else in the case of tranquilizers that we would have any occasion to process. Mr. BLATNIK. Mr. Babcock, did you wish to make a comment? Mr. BABCOCK. I have in a way been placed in a position of being opposed to the opinion of the General Counsel, and I would like to clarify my thinking, for whatever use it may be to the committee. I do not say we do not have jurisdiction over advertising to doctors. Indeed I say positively we do. I think it goes to the kind of representations made to doctors in advertising published in medical journals, or perhaps anywhere. We do have jurisdiction over false claims made to doctors. For example, here is an advertisement which represents that a product has been clinically tested and is now in common use in Johns Hopkins University for the cure of, let's say, arthritis, and it is false from beginning to end. I would take that and we could and would summarily deal with it. There is no sanctuary in this section for that type of advertising. Let's take a second illustration, where the formula of a product is misrepresented as containing many ingredients which are not there, or which are claimed to be there falsely. I would attack that as quickly. But if you want me to evaluate claims made for the curative properties or the therapeutic or palliative effects, then we are way over in the area that the learned doctor here gave such a fine talk about a little while ago. I think if the section means anything, it means that in that area we are not supposed to function, and it is more or less moot, as you heard here, because we have not been asked to function. But this committee asked outright would we or could we. In my opinion, this section gave sanctuary from our jurisdiction of that type of claim made in medical journals on the condition prescribed in the statute, and I would like the committee to consider my thinking. It is that type of claim where we are not supposed to function. We are not to tell the doctor what he can and cannot do in the practice of his profession. Thank you. Mr. BLATNIK. Supposing a claim in the professional literature, Mr. Babcock, is incorrect. As a material fact, they comply with the law. They cite all of the beneficial responses or reactions to the drug, but omit any contrary indications. Mr. BABCOCK. Well, since they are still in the area of the clinical claims of beneficial effects, in my judgment, we would be excluded from taking action. Mr. PLAPINGER. Governor, and Mr. Kintner, in Dr. Dowling's statement he referred to the fear that an attempt to enforce a code of ethics among the manufacturers might be considered to be a violation of the antitrust laws. Would you comment on the antitrust implications of these codes? Mr. KINTNER. Well, we have issued guides for cigarette advertising; we have issued tentatively guides for rubber advertising. Those guides were issued by the Commission on the advice of the lawyers on the staff. The Commission had no fear of getting into an area where the antitrust laws might be affronted. Mr. PLAPINGER. I think the doctor was referring to voluntary codes among the manufacturers themselves, rather than the Government responsibility. Mr. KINTNER. The danger there is that they get together and discuss advertising and then they go into perhaps pricing and other related topics. That is the danger of industry issuing such guides. I think that there is a safeguard where the Government agencies participate in issuing the guide and consult with industry as to the meaning of the advertising, the meaning of the terms used by the industry and then determine what is lawful and what is not lawful. Mr. PLAPINGER. But a voluntary code of ethics promulgated by the industry itself, without the concert with respect to prices Mr. KINTNER. I wouldn't see any antitrust problem with respect to a voluntary code promulgated by the industry on the advertising. It is only when you get into the other areas that you have antitrust implications. So long as the industry promulgates its code of good taste with respect to advertising, I don't see any antitrust problem. Indeed I think the industry should be encouraged to study this problem and to voluntarily clean its house. Obviously, with the limited staff of both our agency and the Food and Drug Administration, much voluntary adherence to the law must be secured from industry. All violations can't be on an involuntary basis. Mr. ANDERSON. May we point out at this time that the broadcasting and telecasting association has not long since prepared a so-called code, a code of ethics. And coming back to Mr. Kintner's statement here as to the actions by the Commission, I believe that we have around 160 trade practice conference rules in effect now with the various industries in the United States that in the main have come to us and said we have problems in our industry and they are bad; and, before they get too bad and things go to pieces, let's sit down and talk them over and maybe we can get a set of rules; and we have around 160 of those in effect now. So I don't think that they are looking at that as having insuperable qualities. Mr. PLAPINGER. The fact that it has been under discussion indicates that there is some concern in the industry concerning the quality of the advertising, and this is also reflected in articles that have appeared in the various medical journals that will be in the committee's records, and there are references in the committee's records. Mr. KINTNER. I see no reason why the industry could not promulgate a code of good taste with respect to advertising. If they get into areas involving restraint of trade, that is a different thing altogether. Mr. PLAPINGER. But your offices or the Commission would be available to promulgate a code of fair trade practices? Mr. KINTNER. We definitely would assist in that respect. Mr. ANDERSON. We are doing it every day in the Bureau of Consultation. Mr. MEADER. Mr. Chairman, I think that distinction that you just mentioned is a very important one. The establishment of a code of ethics for an industry, some trade association of the industry, is one thing, but where the industry has power to enforce that code, that is where you run into your difficulty with the antitrust laws and that is what Dr. Dowling suggested in his statement. I don't know whether you were here to hear it. He suggested it might require an exemption from the antitrust laws to give some authority to the trade association to police its members and prevent them from Mr. KINTNER. I would agree that if you put enforcement teeth into it, you might well run afoul of the antitrust laws, but if you place it only on a voluntary basis, a matter of good advertising taste and what is best to the industry with respect to making of categories of representations, that is another matter. But if you get into such areas as limiting production, limiting the price of drugs, you have really gotten into antitrust law violation. Mr. MEADER. I gather what he had in mind was that before any advertising could be sent to the medical profession, this cartel would have to pass upon its accuracy and whether or not it was false and misleading, and if that were the case, it would be very possible anyhow for leaders in the industry to prevent a competitor from putting a drug on the market by saying we won't approve your advertising. Mr. KINTNER. That is correct. It has elements, very serious elements of danger, both to the competitive situation in the industry and to the public generally. I would say that the industry is better served through the Food and Drug Administration passing upon the representations to be made with respect to new ethical drugs. Mr. PLAPINGER. Mr. Chairman, before we adjourn, will the subcommittee please grant permission to the staff to insert at appropriate places in the record copies of exhibits, articles, and other similar material? (See appendix, exhibits 14A and 14B, pp. 227 and 259.) Mr. BLATNIK. Without objection, it will be so ordered, and the hearings are adjourned. (Whereupon, at 1:05 p. m., the hearing was adjourned.) APPENDIX EXHIBIT 1 WHAT IS THE OVERALL DIRECT COST OF MENTAL ILLNESS IN THE UNITED STATES TODAY? (Prepared by National Committee Against Mental Illness) 1. It is estimated that mental illness costs annually approximately $4,172,124,955. This includes: (a) Total maintenance expenditures of public mental hospitals for fiscal 1956 (42) – (b) Estimated cost of care and maintenance of 60,293 neuropsychiatric patients in Veterans' Administration hospitals (1956) (25)- (c) Veterans' Administration compensation and pension payments to veterans whose only or major disability was classified as a mental illness or psychoneurotic disorder in 1956 totaled (46)--. Estimated cost of construction of new Veterans' Administration hospitals for psychiatric and neurologic patients 1947-55 totals $121,184,229 (16). (d) Total amounts appropriated for new construction, additions, (f) Cost of public assistance to mentally ill and defective persons (g) 1955 loss in earnings of patients admitted to mental hospitals in 1954 (8) The loss to the Federal Government in Federal income tax revenue on those lost earnings totaled $271,000,000 in 1955 (8) $662, 146, 372 238, 000, 000 284, 240, 844 750, 000, 000 157, 908, 029 18, 303, 360 2,061, 526, 350 Total___ EXHIBIT 2 4, 172, 124, 955 CRITERIA FOR PSYCHIATRIC IMPROVEMENT By Nathan S. Kline, M. D., Orangeburg, N. Y.1 [Reprinted from the Psychiatric Quarterly, vol. 31, pp. 31-40, January 1957] The psychiatrist has sometimes been accused of not knowing what he is doing and to this is added the further charge that he may not even know what he is supposed to be doing. In point of fact, the psychiatrist does know what he is doing and why he is doing it, but he has never been able to formulate this with sufficient clarity to prevent enthusiasts from allied or "enemy" disciplines from misunderstanding and misappropriating what they misunderstand. This 1 Director, research facility, Rockland State Hospital, Orangeburg, N. Y., and research associate, department of psychiatry, College of Physicians and Surgeons, Columbia University. is certainly not due to an unwillingness on the part of the psychiatrist to verbalize (an understatement). The difficulty arises from the fact that a good clinical psychiatrist must have the moral fiber of a fanatic, the tolerance of a rake, and the logic of a poet. As with any other artist, it is easier to create than to explain: Shelley's inadequate description of what constitutes poetic activity is an example; painters and musicians have written largely nonsense when they tried to describe what they were doing. The physiologist, the biochemist, the statistician, and even occasionally, the psychologist will argue that the psychiatrist does not have the criteria whereby to evaluate improvement "scientifically." This, the writer believes to be false but since the accusation is so persistent, he feels it would be appropriate to consider first what "the scientist" thinks he means by criteria for improvement. The essence of science, we are constantly told, is measurement; and, ergo, to evaluate or measure improvement, one must have a nice scale, preferably metric and linear. The relative merits of various types of scaling techniques, questions as to the number of cases needed for validation of the instrument, the problems of analysis of skew distributions and the joys of selecting a matrix for a factorial study provide a Barmecide feast. One can go through all the motions of doing a nutritious evaluation without any relationship to the food of thought. When one speaks of improving "making better," judgment can be made either by internal standards or external ones. "By internal standards" means either that the author of the standards decides in advance what he will call a satisfactory performance and then proceeds to judge improvement in terms of how closely these standards are achieved, or else he abrogates his own decisionmaking capacity and elevates the mean, the average, the mode or the norm into the seat of honor. In the latter case, the more a person behaves like the mass of one's fellow mortals the more "improved" he is. As an example of the first kind of internal standard: A psychiatrist makes an a priori decision that "expression of aggression" is somehow or other pathological (or perhaps that suppression of aggression is pathological-both points have been argued) and then proceeds to consider that patients are improved as their expressions of overt aggression (or their lack) are reduced or increased. Another example would be afforded if someone decided on a priori grounds that masturbation, or regular bowel movements or practical jokes were either good or bad, and then rated improvement in terms of movement toward or away from the center of gravity in these respects. The internal scale apotheosizing the commonplace is too well known to need more than brief exemplification. The Rorschach, the Wechsler-Bellevue, the TAT, the electroencephalogram, and legion upon legion of other tests have defied the standard deviation and assumed the mean to be sacrosanct. From the common-sense point of view (a heretical position to assume in some circles), the fact that a drug may "improve" the electroencephalographic pattern until it is "normal" has no meaning if the patient continues to have symptoms of brain tumor or epilepsy. An average Rorschach response does not rule out the possibility that the subject may be completely mad, nor does a superior score on the Wechsler-Bellevue mean that the possessor has enough sense to earn a living. In a recent paper Whittier showed that, after reserpine treatment, the Funkenstein test on schizophrenics "improved" (was more like the nonpsychotic response) but that this was not correlated in any way with therapeutic response. Thus the test improved-but the patient did not. Conversely, deviant ratings from preestablished criteria or from norms are equally unimpressive. Of the general population, 15 percent show abnormalities on the electroencephalogram but remain completely symptom-free. The possessors of some very odd-looking Rorschach and TAT responses are most creative and useful citizens and some with mighty low Wechsler-Bellevues make mighty good money and have some mighty good times. Conformity to, or deviation from, "internal" test criteria are useless, per se, as a means of measuring improvement. The writer hopes that this line of reasoning has aggravated a sufficient number of listeners. This will probably provoke them to thinking "the poor benighted fool (to put it kindly) seems to forget that there is high correlation between certain EEG patterns and brain tumor or epilepsy, and a similar correlation be 2 Barmecide feast-An illusion or pretense of plenty. (From the Arabian Nights story of the Barmecide noble who invited a guest for dinner, served on damask tablecloth, golden dishes, and crystal, but without any food.) |