PERSPECTIVES IN BIOLOGY AND MEDICINE Volume 26 · Number 3 · Spring 1983 THE PUBUC CHARACTER OF SCIENTIFIC MEDICINE WILUAM A. SILVERMAN* Use of the scientific method in clinical medicine—especially the experimental format of the randomized control trial in the evaluation of new treatments—has come under increasing fire in recent years. Some critics hold that too many human experiments are poorly designed [I]. For example, most clinical trials are simply too small to test posed questions rigorously [2]; problems concerning subtle sources of bias and sampling error are often neglected [S]; and restrictions imposed by trials frequently defeat the requirement of realism [4]. In sharp contrast to these constructive criticisms that urge physicians to strengthen a valuable tool, other voices have called for a halt to experimentation in clinical medicine [5]. The community at large (and specifically lawyers, ministers, bioethicists , and legislators) has been poorly informed about the logical basis of the experimental approach and the inherent safety in this orderly , cautious methodology. Misconceptions abound, and strong feelings have stood in the way ofimprovement in understanding. In another context, John Kenneth Galbraith observed, "Where the reality does not accord with wish, our practice is to devise a myth which then serves as a bridge between evidence that cannot be escaped and the belief which is sought." The cost of maintaining the myths which have been devised concerning the subject of clinical experimentation has become substantial , and the common good can no longer afford ignorance of this matFrom William A. Silverman, Human Experimentation: A Guided Step into the Unknown (Scientific American Books, in preparation). This paper was presented in somewhat different form as the Sixth Annual Daniel Y. E. Perey Lecture, McMaster University, Hamilton , Canada, May 26, 1982. ?Address: Ninety La Cuesta Drive, Greenbrae, California 94904.© 1983 by The University of Chicago. All rights reserved. 003 1-5982/83/2603-0350$01 .00 Perspectives in Biology and Medicine, 26, 3 · Spring 1983 \ 343 Like weapons in the modern arsenals of war, therapies have become exceedingly powerful, and the potential for harm on a very wide scale has escalated accordingly. Spectacular treatment disasters have made it clear that informal let's-try-it-and-see methods of testing new proposals are more risky now than ever before in history. What must be faced is that there are no certainties in medicine—every clinical test of a new treatment is, by definition, a step into the unknown. And the question of how physicians set out to narrow the area of uncertainty about an innovation cannot be avoided: it is a public issue. In randomized control trials (RCTs), human subjects are enrolled in formal experiments which have been planned to put specific questions concerning health and well-being to critical tests. The powerful approach attempts to harness the uniformity-of-nature principle in order to make reasonable predictions about the future. The risk-limiting humanized instrument is the sharpest tool which has been devised for evaluating the limits of applicability of new proposals. Donald Frederickson , former director ofthe National Institutes of Health, pointed out that RCTs have become indispensable ordeals on the modern medical scene [6]. But for a number of reasons the view of the man on the street remains unshaken—the phrase "human experimentation" conjures up an image of demented doctors working in a chamber of horrors (fig. 1). We need to try and understand the origin of this destructive myth. Since the time of Hippocrates, Western physicians have taken an oath in which they swear to protect their patients "from whatever is deleteriFig . 1.—The "mad-doctors'-laboratory" image [7] 344 I William A. Silverman · The Public Character ofScientific Medicine ous and mischievous." As it turned out in much of the past, common treatments were neither specifically nor intentionally injurious—most were harmless palliatives. Even when doctors used highly lethal agents like mercury and arsenic as supposed remedies, injury and death occurred on a relatively small scale, if for no other reason than the fact that few could afford professional services. Nonetheless, the long list of barbarous practices is quite incredible. The following account [8] of treatment administered in the seventeenth century gives some idea of the excesses that were possible...