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The pharmaceutical industry in this country must adhere strictly to the requirement for controlled studies in Phases II and III of clinical investigation. It is true that the regulations specify only adequate and well-controlled trials and that comparisons may be made with no treatment , a placebo control, an active treatment control, or a historical control . In practice, however, the so-called pivotal studies comprise randomized , double-blind, placebo- or treatment-controlled (depending upon class of drug) trials supplemented by full case records. The use of placebo controls in patients invariably raises (or should raise) ethical and legal questions. To no one's surprise, some complex, multicenter, controlled trials (even government-sponsored ones) which have mobilized considerable technical and medical resources and logistic support have gone astray or obfuscated the issue under study. The purpose of the statutory requirement is to prove that a new drug is safe and effective for its intended use. Every effective drug has inherent safety hazards. Ergo, efficacy and safety are relative terms. To insist that each new drug product be both effective and completely safe is unrealistic. To insist that drug effectiveness be determined almost exclusively by "adequate and well-controlled trials" is to ignore historical precedents, the realities of the present, serendipitous discovery, and the percipient talents ofgifted clinical investigators. Sonnenreich has put the matter into perspective when he states that "clinical judgment is overridden by regulatory fiat demanding slavish adherence to a single standard of scientific proof." From the clinical investigator's viewpoint, there are significant legal and financial encumbrances to research. These can have a profound effect on the clinical investigation of new drugs by the pharmaceutical industry. The regulatory climate imposed by centralized government has made new drug development a lengthy, expensive, and difficult exercise. Continued and expanded bureaucratic intrusion will undoubtedly compound these problems and therefore should be resisted by concerned clinical scientists. The Physician's Heritage IRVINE H. PAGE* These are two of the most persuasive speeches I have ever heard. I almost come to believe them, which makes me immediately suspicious. *Box 516, Hyannis Port, Massachusetts 02647. Perspectives in Biology and Medicine ¦ Winter 1980 ¦ Part 2 | S153 For instance, when we say that the public has lost faith in us: I have heard that now for ten years. I'm not sure who the public is that has lost faith, because the public I see seems to have great faith in me, as well they should; but the rest ofyou, I don't know about you! I begin to worry because if you keep on saying something, you know, it will become true. The public certainly has lost some faith in us, and rightly so, because we have pulled some real boo-boos, but on balance they like us pretty well and think we are doing a good job. Perhaps it is worth reminding you that we do have methods for informing the public about physicians' problems, but I don't think we have done nearly as good ajob as we should. The AMA has tried valiantly, but I am afraid the academic community has not done much to help. The Institute of Medicine of the National Academy of Sciences has not put itself in a position to be effective; a few of the basic scientists, notably the pharmacologists, have done quite well. The truth is that as we now stand we do not have access either to Congress or to the public except via the media, and the media too often have presented the worst side of research—the hoop-de-do and the so-called breakthroughs—all of which more and more people are failing to buy. The other thing I would hope that medical people will remember is that even though we may have lost some of the shine on our halo we are still physicians. We are still people who have to console and comfort and try to cure. If we lose that, we will lose something very precious, because you cannot buy pity, you cannot buy confidence and faith very easily. The physician should be a physician, not a lawyer or a government employee in the sense that being one allows hegemony...


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pp. S153-S154
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