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, and renovations to mental hospital facilities, as reported by State authorities, as of November 1955 (15). (e) Expenditures of public institutions for mental defectives and epileptics (1953 latest year for which information is available) (36). (f) Cost of public assistance to mentally ill and defective persons (47)-- (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.) tween aberrant Rorschach, TAT and Wechsler-Bellevue responses and poor adjustment." Such a line of reasoning would please the writer greatly, since the arguer would then be applying external criteria for judging improvement. By this, it is meant that one determines how well a particular test measures "improvement" by using some external standard such as "clinical improvement." In other words, high score or low score, or no score or slow score, on some test instrument has no meaning in evaluating improvement unless it can be correlated with the patient's ability to get along in the community with a modicum of enjoyment, a minimum of danger to himself and others, and a maximum of usefulness. This consideration should eliminate with finality the idea that anyone can devise a test instrument that measures the improvement of patients without relationship to the patient's overall behavior. One may turn now to that neglected man of present-day "scientific" research, the clinical psychiatrist, and examine the way in which he continues to evaluate the improvement of patients, even though this has been proved to be scientifically impossible. The reason a patient seeks, or is forced into receiving, psychiatric help is not because he has some specific pathology but rather because he cannot get along with other people or, perhaps, with himself. Certainly, therefore, it would be reasonable to say that one criterion for improvement is that the individual has an increased ability to get along with himself and with others. Although there may be alternate means of classifying information adequately in this respect, one usable system would be to evaluate such improvement in three different areas: (1) the social, (2) the psychological, and (3) the somatic. Constructing a scale to evaluate improvement in the area of social behavior is not primarily the function of the psyschiatrist and the thoughts which will be presented here are suggested guideposts rather than final markers. Let it first be stressed very strongly that a scale of improvement in this area should concern how the patient behaves and not how he feels about how he behaves. There are many patients who believe they are performing very adequately in the social area who are complete nuisances to their families and their communities. Contrariwise, there are individuals who feel that they are hopelessly inadequate in a social sense, yet by "objective" criteria and the judgment of others are performing extremely well. Care should be taken to see that judgments of performance in these areas do not overlap. One should not allow the patient's estimate of his performance to influence judgment as to his actual behavior. Inside a psychiatric hospital there is already a scale of such social behavior: At the bottom of the scale is the patient who is in restraint or camisole on a disturbed ward. An improvement in social behavior will move the patient to a locked ward but without restraint, seclusion or camisole. Another step up the scale is the ability of the patient to function on an open ward, moving in the direction of serving some useful function about the hospital such as messenger or gardener or what-have-you. The ultimate intramural step is the judgment of the hospital staff that the patient is dischargeable. (At times, dischargeable patients may not be able to return home because of family circumstances, so that the decision should be in terms of dischargeability rather than of whether actual discharge occurs.) The process continues in a rather unbroken line, measuring whether the patient can remain out of the hospital and for how long (the time factor should be taken into consideration at all levels). Beyond that is the question as to whether he is able to stay out of entanglement with the law, the police department, or other such agencies of society. A judgment is formed on the basis of how well he gets along with his family and others with whom he comes into contact (including the social worker). Ability to return to work provides a further index of his improvement and can be even more finely graded in terms of whether the level of employment is the same or below or above that existing before illness or treatment. In other words, the more nearly an individual is able to function at his maximum capacity, the greater is the improvement. At the highest end of the scale is evaluation of how useful a person is in terms, not only of his productivity in his job, but of his contributions to community life, whether through membership in social, political, or religious organizations or in some other manner. Such a progression of improvement could undoubtedly be very methodically worked out at a conference of psychiatrists, psychologists, social scientists, and social workers. There are 2 semi-independent variables which may influence ratings on such a scale, 1 methodological, the other substantive, which should have appropriate consideration. The methodological consideration is that patients should be evaluated, not only in "closed" situations such as interviews with social workers or at hospital staff conferences, but also in an "unrestricted" situation where performance can be judged when not under the pressure which the "closed" situation often brings about. Every psychiatrist has seen patients who make excellent adjustments in the hospital but put up a very poor show at a staff conference and are, therefore, rejected (perhaps unnecessarily) for consideration of trial visit outside the hospital. Reaction to the pressure of such a "closed" situation should not be the exclusive factor in determining social improvement. Conversely, there are patients who perform extremely well at staff conferences but who are unable to make good adjustments unless they are under pressure. Analogs of this type of "closed" versus "unrestricted" observation exist at the various points at which judgments of social improvement are made. The substantive factor to be considered is that one must take into account the pressures of the environment under which progress is made. Obviously, the patient who is able to reach a certain level of social adjustment despite difficult behavior on the part of relatives, employers, and others may be more improved than the patient who is able to reach such a level only with the understanding and loving guidance of his family and the encouragement of other people in his world. Before proposing how psychological improvement can be measured, the writer would like to agree with those who have already formulated an objection, which is that social behavior is at least partly dependent on the psychological state. The author by no means suggests that the two elements are entirely independent of one another; and certainly we will ultimately have to understand the relationship between them to improve our techniques of rating improvement. The writer's contention is that at the present time, until the nature of this relationship is better understood, independent rating of the social and the psychological factors is necessary to prevent the confusion which would arise if attempts were made to interrelate incompletely articulated concepts and unverified hypotheses. One may start consideration of psychological improvement by again emphasizing a point which may easily lead to confusion since there is an apparent overlap, which in reality does not exist. The patient has certain feelings and reactions to his social behavior. These are properly only a part of the psychological area and, as previously stressed, should not be considered in making the social judgment. To illustrate, the writer will refer to a patient who is head of an important Government agency and has been repeatedly commended for the excellence with which he carries out his functions-commended equally by Republicans and Democrats. He personally believes that he is doing an inadequate job and is likely to be discharged at any time for incompetence. His feeling about his work should not enter into a judgment of his social functioning; and, even though the feeling is about social behavior, it is entirely in the psychological area. Conversely, everybody has known individuals who are incompetent and irritating to others and yet feel that they are doing extremely competent jobs and that everyone loves and admires them. The rating of their social behavior must be separated from the self-evaluation which is, again in the psychological area. The proposal which the writer wishes to make for evaluation of psychological improvement may at first sight seem extremely radical, since it ignores most of the customary techniques of evaluating this factor and ignores certain areas of information which are probably quite valid. The intent is to show that in the present state of knowledge the most adequate way of evaluating psychological improvement is by determining how satisfied and happy the patient is with himself. We do not truly know what constitutes psychological health, either in respect to mental content or emotional reaction, and until we do and also know how to measure it accurately-it is better not to attempt to apply our ignorance. This does not mean that eventually we will not be able to replace an index based on how the patient feels about himself with a more comprehensive one; of which this attitude of the patient toward himself is only one element. But until this has been worked out, it seems best to use this single index. One might immediately object that, even if a patient is perfectly happy with himself, he cannot be psychologically healthy as long as he has auditory hallucinations; and even though he is able to make a good social adjustment and is |