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The American Journal of Bioethics 3.4 (2003) 59-61



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An Innovative Paradigm for Clinical Research

Rosamond Rhodes
Mount Sinai School of Medicine

Franklin G. Miller (2003) provides a convincing ethical analysis, showing sham surgery to be an ethically acceptable research design when an unblinded surgical trial cannot practically provide valid scientific evidence of an intervention's efficacy. As I understand it, this will be the case primarily when the differences between the two study arms are not likely to be dramatic, and when the hypothetical physiological basis for the improvement is not well-demonstrated, and when the outcome measures are largely subjective reports of improvement in levels of pain, symptoms, or quality of life. Invoking the aura of Beecher, a crusader for high ethical standards in human-subjects research, Miller actually goes further to suggest that it might, in fact, be unethical to introduce a surgical procedure into clinical practice without subjecting it to a rigorous scientific evaluation.1

Miller's conclusion rests on the distinction between the ethics of clinical medicine and the ethics of research. Let me present Miller's distinction this way: Whereas the distinctive feature of the ethics of medicine is the physician's commitment to the primacy of the patient's good (i.e., the fiduciary responsibility of doctors), research is markedly different. The aim of research is testing hypotheses, and the human subjects who volunteer their bodies to help further the research agenda are best seen as autonomous collaborators who are owed respect for their generosity and admiration for their courage and self-sacrifice.

Miller's point about the difference between the ethics of clinical medicine and the ethics of research is significant. We need to keep it in mind when we discuss both domains. We should also make the distinction clear to patients, research participants, clinicians, and researchers. Perhaps it would help to remind everyone of their particular roles and responsibilities if clinicians were to continue wearing their white coats while researchers switched to lavender coats. Physicians who also perform clinical research would simply change coats when they change roles.

Clinical Research and Innovative Therapy

Miller's crucial distinction and my two-coat solution run aground when the physician is inescapably and simultaneously both clinician and researcher. Although wearing two hats, or two coats, or a lavender and white stripped coat might look silly, this unavoidable dilemma is a fact of clinical research and is well illustrated by a recent article in The New Yorker, "Desperate Measures" (Gawande 2003). There we read of the surgeon Oliver Cope, who abandoned the standard of care and treated 39 burn victims of the Cocoanut Grove nightclub fire by applying a thin layer of gauze coated with petroleum jelly, an unstudied procedure that he had tried just twice, once on himself. We read about Cotton Mather and Zabdiel Boylston who, during the 1721 Boston smallpox epidemic, inoculated 247 healthy people, including Boylston's sons, with pus that contained the smallpox virus based on Mather's slave's account of African practice. We also read about surgeon Francis Daniels Moore, whose experiments on patients pushed medical advances in open-heart surgery, transplantation, cancer treatment, nuclear medicine, and the management of fluid and chemical imbalances. In sum, Moore's experiments on patients in the course of their treatment made medicine "more informed, more systematic, more effective, ... [and] his findings probably saved tens of thousands of lives a year" (73). Moore chose to inflict suffering to test scientific hypotheses when people were going to die despite receiving the standard of care. As Moore saw it, "the moral position was to do something, ... however dangerous or unproved" (78).

These examples show that the seriousness, imminence, or certainty of harms associated with cleaving to the standard practice can justify a physician's radical departure from it to test a hypothesis that, at least theoretically, promises a significantly better result. But Miller's point about the necessity of testing every surgical innovation by the standards of science shows that experimental verification of efficacy is required before any intervention is to be counted as...

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