PROPOSALS TO LOOSEN THE PROMOTER'S SNARE To physicians. It would not be surprising to find that some physicians react with anger at any criticism of ethical drug companies, for surely all the bountiful gestures from industry must have forged some warm friendships. Let them hold their fire and consider! There are ample grounds for kindly feelings between doctors and those who furnish them with invaluable remedies without the ardent wooing of promotion. However, as long as the prescription remains the means to a sale, short-sighted promoters will consider it "good business" to make prescribers feel something close to kinship with the purveyors of drugs. This is a shaky foundation for true and lasting friendship. A little reflection should lead physicians to beware the eroding effects on their traditional independence and on the trust they have received from the people. Doctors must adopt universal skepticism toward "educational" material emanating from sources outside their own publications and institutions, and even these will be suspect so long as there is any reluctance to apply critical standards in acceptance of advertisements, or to speak out freely on other abuses, for fear of losing the subsidy of promoters. The legitimate medical literature needs overhauling, as to both source of support and techniques of communication. In addition to looking out for himself the physician must be willing to pay his own way. He would bridle at the prospect of being considered a "sucker," or a puppet of any vested interest-a possibility he faces when he becomes beholden for entertainment or deeply entangled in the web of promotion. Never forget that the patient pays the bill. Physicians should not discount their latent power nor hesitate to assume their full stature and call a halt to invasion of their province. Prestige is a fragile flower that demands conscientious cultivation to save it from pests and weeds blown in by the winds of promotion. In the light of reason the bugaboos of censorship and socialism will be dispelled, and the indispensibility of higher criticism for maintenance of excellence and good taste will be acknowledged. Watchfulness will be required to check the increasing transfer of products from "ethical" channels into the category of "over-the-counter ethicals," a source open to patients without recourse to a doctor's prescription. Casual tolerance of this trend is a form of professional suicide, which might be a boon to promoters, but not to the people, who appear only too anxious to drug themselves at the beckoning of unscrupulous hucksters. In essence, physicians should hold themselves aloof in unhampered devotion to their calling, while exchanging a wholesome respect with others contributing to the public health but never being guilty of prescribing drugs under unconscious influence of personal favors or subtle entanglement with the affairs of drug manufacturers; nor can the profession ever shirk the task of setting its own house in order, particularly with regard to the unkempt medical literature, to inadequacies in the techniques of medical training, to easy-going ways of financing activities of medical societies, and to indulgence of wayward physicians who may be unwittingly aiding and abetting the schemes of promoters. None of these proposals should be allowed to provoke conflict between the groups making equally vital contributions to the public health; the best interests of all parties can be fostered only by suitable cooperation, which is distinct from collaboration. Conferences between responsible representatives of medical educators and the pharmaceutical industry would be desirable, e.g., the Association of American Medical Colleges and the Pharmaceutical Manufacturers Association. To the ethical drug firms.-The position of managers of drug companies dependent on doctors' good will to sell their products is not altogether enviable. It takes a reasonable profit to make the stockholders happy, and this must be gained in a fiercely competitive market. The manufacture of drugs is an exacting business, not only because of legal standards but because imperfections in the product can be disastrous and no excuses will satisfy the public. There are enough internal problems in such an industry, but a final obstacle must be overcome before the volume of sales will permit' a profit-the man who writes the prescription must be won over to favor the product. The great body of preoccupied, conservative, and proud physicians is no slight obstruction to place in the path of any enterprise; little wonder a great blast of promotion was found necessary to move them. Even allowing for all these difficulties, the ethical drug firms may have overshot their mark. Physicians and the public are beginning to feel they are pushed around too much. Unless the medical educator is completely overpowered, sooner or later there will be a wholesale opposition to pharmaceutical invasion of the field of medical education. To be sure doctors and their organizations are notorious for accepting almost any offer of subsidy or entertainment, but their feeling of gratitude will not be strong enough to check their ire when they realize their prerogative to exercise dominant influence over the habits and beliefs of physicians has been bought. Ethical drug firms should reconsider the appropriateness of attempting to influence physicians by subtle infiltration into the educational process and through a vast meddlesome subsidization that is hard to distinguish from payola. If the pharmaceutical industry can afford to subsidize medical affairs, they should d so through larger unrestricted contrib tions to organizations devoted to the interests of the profession, such as the National Fund for Medical Education rather than allowing their resources to be used as a means of undermining the control of physicians over their own af fairs or as a nefarious scheme of putt relations. Matters would improve if the ethica drug industry shook off the exuberant promoters who have drawn them int the use of techniques customary in the sale of ordinary commodities but highly questionable for application to promotion of medical remedies. This industry ba better take another look at that word "ethical" and make certain its mean. is applied to the manner of doing bus ness and not just the channel of distribe tion of their products. No doubt it would be impossible curtail the plethora of brands and prepe rations of products in a laissez-fairs market. This is one of the chief causes of promotional puffery and an aggrava!ing contribution to the confusion of the doctor that makes him feel he needs more "education." The Pharmaceutical Manu facturers Association might well co sider whether its members would in the long run be better off with lower sales volume and less bigness and less aggres sive competition-the alternative appear to be an ever-increasing tempo of pro tion until the whole business is dis counted by the profession and the pub The promotional campaigns which required to compete in a market depend ing on sales direct to the public are especially costly; the last barrier to th Idrain will be gone if the physician removed from the path of drug pro tion by loss of stature or further teac ency of ethical firms to get around the doctor via the "over-the-counter ethical" line of remedies. Acquisition of proprietary subsidiaries by ethical firms and vice versa must complicate matters. Cooperative projects.—A good step in the right direction has been the adoption of a Statement of Principles of Ethical Drug Promotion by the members of the Pharmaceutical Manufacturers Association. The next step is to abide by it faithfully. Even better would be a really comprehensive statement of principles prepared and adopted jointly by representatives of industry and the profession to define and govern their proper relations and separate prerogatives. This could be coupled with the establishment of a Board of Overseers made up of representatives of the public, industry, and the profession. This Board would not function as a government regulatory agency but as a private group that would be empowered to call to account either party for any infringement of the stated principles, resorting when necessary to public comment in the mass media. The freedom of each group to pursue its endeavor could be guaranteed by this continuous and equal opportunity for confrontation of opinion and exercise of influence. The people could be reassured by periodic reports from this Board of Overseers. Here again the Association of American Medical Colleges and the Pharmaceutical Manufacturers Association could cooperate in developing such a plan. To the people.-In the final analysis, the people of a democratic society have the power to take things into their own hands. If any enterprise threatens the welfare of the public, especially in matters of health, a brisk reaction can be expected. No good will come from encouraging eager politicians to seize upon health enterprises as a ladder to power. The people should not lean too heavily on bureaucratic governmental regulation, for there is no substitute for high ideals in the development of sound practices in a free society. Should it appear that unduly large resources have drifted into the possession of industry for the purposes of promotion, the structure of taxation may well be critically examined. It is not inconceivable that a plan could be devised that would limit the sums which can be charged to promotion in the cost of marketing drug products, thereby shrinking the size of the web the promoter could fabricate for his clients and freeing the profession from the threat of entanglement or undue influence from pharmaceutical "education." The people do need some assurance of responsible behavior from those to whom they have assigned the rights and privileges of serving their health needs. This can only be obtained by insisting upon some arrangement for continuous public accountability from the profession and the drug industry, such as the Board of Overseers suggested in the preceding section of these proposals. PRESERVATION OF FREEDOM FOR ALL Censorship is justifiably condemned in a free society, and the mass media should be open to free and equal use by all responsible persons. Restraint through higher criticism is not to be confused with censorship-on the contrary, it should be liberally applied in every field of endeavor to encourage excellence and good taste. The mood of the times must be changed from a squeamish feeling that open criticism is "negative" to a more wholesome regard for pointed public comment and public accountability. There is no more effective way to discourage artful attempts to enlist physicians in the sale of drugs by disguising promotion as "education" and to prevent misuse of the mass media by selfish interests rather than for the welfare of everyone. I want again to thank you for the privileges and courtesies extended to me as a witness before your Subcommittee on July 18th. Your fair manner in the conduct of the hearings and your deep concern for the health and welfare of our citizens impressed me greatly. You gave assurance, when I raised the problem of adequate funds for the FDA, that the Congress would provide the necessary budget. Time did not permit me to raise the crucial point about the mechanism for increasing the salaries for top scientist-administrators. This requires the creation of a number of super-grade positions in the FDA. Otherwise the stringent rules of the Civil Service Commission prevail. We have been through this before, in our testimony to Congressional Committees studying N.I.H. budgetary needs, and our specific requests for super-grade positions are repeatedly ignored. No wonder that currently the N.I.H. is losing many of its leading research and administrative personnel. It is a curious fact that the Congress grants hundreds of millions of dollars to the N.I.H. and doesn't provide the paltry increases in salaries necessary to retain the dedicated people who insure the success of the program. I hope the printed record will make clear a change which does not appear in my written document. You explored with me the matter of the joint committee of the U.S.P. and the AMA Council on Drugs, in the review and assignment of public names for new drugs. I contended that this joint committee was expert and fair, and that no new legislation was needed for the FDA to work with it. But now I want it understood that the initiative for the naming of a new drug should be taken by this joint committee, and not by industry, and that the |