must spare time from everything else to do it and who are not usually well acquainted with these channels of communication. This is all the more reason why, in the field of the regulation of drugs, physicians and organizations of physicians, such as the American Medical Association, should make it their business to advise the Food and Drug Administration. The excess pressure is applied next to advertising. The description of the drug on the label and the circular accompanying the package must be accurate and well documented and must be approved by the Food and Drug Administration. Advertising pertaining to a drug, on the other hand, is under the jurisdiction of the Federal Trade Commission, who can stop a company from making a particular statement only if the statement constitutes an unfair or deceptive act. This opens the way for abuses. Within recent years the drug industry has discovered that the techniques that had been used so successfully in the advertising of soaps and toothpastes and of cigarettes, automobiles, and whisky could be used as successfully to advertise drugs to doctors. Advertising to doctors has become flamboyant, as shown by two-page gaily colored spreads in nearly every medical journal. Advertising has become incessant; nearly identical advertisements for a new drug appear in each day's mail for weeks on end. Advertising is without question confusing. The multiplicity of trade names makes it difficult to remember the actions and uses of any. Richardson Evans, writing in the English National Review in 1890, said: "Suppose a dozen people are in a small room. Two begin to talk to each other at the top of their voices. The others must either give up conversation or shout also. The result is that no one hears as well as before and that comfort is at an end. So it is with advertising ***"7 Advertising to doctors has now reached this peak, and we are deafened by the din. This leads us to the next step in the process: the use of drugs by the practicing physician. The doctor's sources of information include textbooks, journals, and speeches, written or delivered by those who have studied the drugs in laboratories and in patients. Most practicing physicians do not see a sufficient number of patients with any one disease to make a critical trial of a new drug themselves. When the drug becomes available the most they can do is to acquire skill in its use. If this information is beamed clear and true to the doctor, he is willing to listen to the commercials and patronize those who have, through their investments and their foresight, brought the drugs to him. But today the commercials are so loud, incessant, and brash that they jam the channels of communication. The bewildered physician prescribes by suggestion and not from information. At this point the reader will say: "Well, even if this makes the physician a shifting weathervane and the patient an unwitting guinea pig, the writer must be an ingenuous idealist to expect the pharmaceutical manufacturers to change their methods so long as they are putting money in their pockets." This last phrase is the key to the answer. You will recall that the twin sources of energy for the system are profits and benefit to the patient. It is already evident to most doctors, and it will soon become evident to the public, that energy has been diverted from the pathway that leads to the greatest benefit to patients. With the inevitable disillusionment that comes with the failure of each useless modification to make any advance, the pharmaceutical industry will lose its prestige and with this will lose its financial backing. It will fall, and the medical profession will be dragged down with it. Since such a catastrophe would involve doctor, industry, and patient alike, we may well look to see what each can do about it. 7 Turner, E. S.: The Shocking History of Advertising. New York, E. P. Dutton & Co., Inc., 1953, p. 169. To physicans I would say first: Keep informed. Learn the mechanisms by which drugs work, rather than the results somebody says they produce. Look for and remember the generic name, for this tells something about the drug, while the trade name tells nothing. Avoid substituting drugs for diagnoses. Furthermore, since advertisements for new drugs appear so quickly, some mechanism must be set up to bring authoritative information rapidly from investigator to practicing physician. The challenge is thrown to medical societies, medical schools, and specialty groups; keep the profession informed. My second suggestion to physicians is, inform the public. As Vannevar Bush has said: 8"*** public opinion is not formed by the radio and the press or even by those who control these mediums. It is formed by that minute fraction of the population which thinks and speaks, by that small but powerful minority, disagreeing on every issue, arguing and ridiculing, which looks beyond the diversion of the moment and influences because it labors to understand." With regard to drugs we are that "small but powerful minority," and we must use every means to make our opinion known. When a doctor prescribes a drug for no reason except that the patients want that drug, the doctor is allowing the lay press to take over the job of health educator to his patients. The good physician explains instead of prescribing. My third suggestion to doctors is to reject misleading information and repudiate those who purvey it. Doctors should read advertisements critically. They should write to editors of journals and to drug manufacturers when they question the truth of an advertisement. They should not listen again to someone who has misled them once. They should prescribe as far as possible only those drugs made by companies with high standards of advertising and read only the journals that accept that kind of advertising. In the past the council on pharmacy and chemistry of the American Medical Association (now the council on drugs) has led the fight against false advertising by quacks and vendors of patent medicines. The battle front of today has shifted, and false advertising to the public is no longer the major issue. For the future the council needs to aline its forces against false advertising to the doctor. To pharmaceutical manufacturers, I would make three suggestions: (1) That they emphasize basic research and the discovery of new drugs and avoid minor variations of existing drugs; (2) that they weigh the proposals of their sales 8 Bush, V.: Professional Collaboration, Science, 125: 49-54 (January 11) 1957. departments in the light of advice from their scientific staffs and from competent impartial clinical investigators, and (3). that they revise their advertising methods. Advertising should not be premature; advertisements for a new drug should not appear before a single clinical article is published in a reputable medical journal. Advertisements should be in keeping with the dignity of the industry from which they come and the good sense of the profession to which they go. The time is already past due for reputable manufacturers to establish a code of ethics for advertising and abide by it. When this has been done the words "ethical manufacturer" will mean a manufacturer who works for the good of the public rather than meaning, as at present, one who advertises only to the medical profession, no matter how he advertises. The regulatory agencies of the Government function as impartial judges for the benefit of the consumer. Laws always lag behind actuality, and budgets are always deficient; but in spite of these limitations the regulatory agencies deserve great credit for keeping the present system from getting out of hand altogether. How can they do the job better? Certainly they should insist upon honest and thorough investigations by clinical investigators. They should inquire how the cases were obtained for trial; were they selected out of a larger number of cases and, if so, by what criteria? Funds should be available to them for financing tests of drugs when the evidence submitted is equivocal or unconvincing. They should also be able to employ consultants to advise them in difficult cases. These agencies need the strong backing of the medical profession; the patient's welfare must be kept continually before them so as to counteract the obvious pressures from the pharmaceutical industry. Many people believe that the laws should be amended so that the Food and Drug Administration can pass on the efficacy of a drug. At present, except in the case of the drugs that are certified, which include insulin and certain antibiotics, the Food and Drug Administration cannot prohibit the sale of an ineffective drug; its only recourse is to seize the drug as misbranded if a therapeutic effect is claimed in the circular that accompanies the package. This seems a roundabout way to protect the public. In Furthermore, the present laws leave all advertising, except that which accompanies the package, to a separate agency, the Federal Trade Commission. spite of the excellent cooperation that exists between the two agencies, this is a cumbersome method which has not succeeded in giving adequate protection to the patient. Many people believe that the law could be enforced more efficiently and more completely if advertising as well as labeling were regulated by the Food and Drug Administration. My suggestions can be summarized in two words: "information" and "regulation"; prompt and exact information for the practicing physician from the investigator, the professional societies, the medical journals and the specialty groups; willingness on the part of capable investigators, teachers, and other leaders in medicine to spend time in spreading the truth about drugs; probity and sanity on the part of the manufacturers in keeping advertising factual rather than suggestive, direct rather than irrelevant, truthful rather than misleading; recognition on the part of the practicing physician that his is the final responsibility for the use of a drug and that he cannot give this decision over to anyone else. Regulation there must be for those who will not work from higher motives; regulation by industry to the extent that it can be done; regulation by organizations of physicians where they can help, and regulation by Government where the others fail to do the work. Let those who object to the third alternative strengthen the first two. These things should be done; these things can be done; shall we here agree that these things will be done? In the words of George Washington, "Let us raise a standard to which the wise and just can repair." NOTE. Research and Educational Hospitals, University of Illinois, 840 South Wood St. (12). This paper is being published simultaneously in the AMA Archives of Internal Medicine. EXHIBIT 13 DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE, Hon. JOHN A. BLATNIK, Chairman, Subcommittee on Legal and Monetary Affairs of the Committee on Government Operations, George Washington Inn, Washington, D. C. DEAR MR. BLATNIK: In an effort to present all of the pertinent facts to you and the other members of the committee, I welcome this privilege of submitting additional information by letter for your consideration. I In my testimony which ends at the middle of page 338 of the transcript, my final sentence is as follows: "So out of our 8 budgeted positions for New Drug Division, we have but 5 filled and 2 of those represent 4 half-time men." should like, with your permission, the record to show an additional statement as follows: Mr. Chairman, we have 5 physicians in our New Drug Branch whereas, in my judgment, ideally in terms of responsibility and current workload, I believe we should have perhaps as many as 12 or 15. While this may appear as an excessive increase, careful analysis of the situation does not support such a conclusion. For example, a considerable amount of literature research is necessary on the part of these individuals if they are to maintain an intimate and up-to-date medical knowledge of their respective fields and specialties. These individuals need more time for firsthand discussion with clinical investigators and attendance at research and medical meetings, so that they are aware of all of the latest work and current thinking of informed experts in medicine. Ideally, our new drug physicians should not have to work continuously under the pressure of the statutory time limit. While I appreciate the value of pressure and urgency in getting a job done, I nevertheless feel that continuous pressure without time for reflection or introspection inevitably leads to decreased awareness, if not frank dulling of the wits. Under such circumstances I think you will agree with me that inadvertent, but nevertheless, serious errors are apt to become more likely. Also, in my testimony at the bottom of page 338 and at the top of page 339, I have indicated that there are at least two factors which hamper our recruitment of physicans for our New Drug Branch. They are the unusual degree of scientific competence required of these people and the salary limitations which exist for these positions as currently allocated. Having given serious consideration to this problem during the past 4 years, I firmly believe that the interest of the public can best be served by seeking excepted appointments for our new drug medical personnel, so that men of recognized scientific achievement can be attracted and retained in this work. You are aware, I am sure, that many other governmental agencies have successfully resolved this problem by obtaining excepted appointments which pay up to $19,000 per annum for their senior scientific personnel. The Public Health Service, Atomic Energy Commission, Department of Defense, Department of Commerce, the Veterans' Administration, the National Science Foundation, and several other agencies as well, all are able to recruit and compensate their scientific leadership because of this advantage. I believe that the operations of the New Drug Branch are so critical in terms of human health that we can well justify an effort to place this entire group in excepted appointment positions. Further support for this point of view is contained in the Citizens Advisory Committee Report of 1955 which recommended "The stature, prestige, and salaries of the professional personnel who must bear the burden of passing on new drugs should be increased" (p. 42). I am enclosing a copy of this report for your information and perusal. In addition, there are several other key scientific jobs in the Food and Drug Administration, particularly in our Bureau of Biological and Physical Sciences which, in my judgment, deserve the same consideration. Sincerely yours, ALBERT H. HOLLAND, Jr., M. D., Medical Director. |