The sham surgery debate and the moral complexity or risk-benefit analysis.

Access provided by University of Michigan @ Ann Arbor [Access article in PDF] The Sham Surgery Debate and the Moral Complexity of Risk-Benefit Analysis Scott Y. H. Kim University of Rochester Sham surgery ought to be allowed, in carefully defined situations, as a control condition in randomized trials of certain unproven surgical procedures. As a statement of the mere possibility of ethical sham surgery, this seems a modest claim. To argue for or against an entire class of research studies as though it were a matter to be decided by reason—Franklin G. Miller (2003) sees the opponents of sham surgery engaging in "faulty reasoning"—is itself an interesting phenomenon deserving some commentary. (In what follows, assume that the scientific warrant is present and that, all things considered, the sham surgery condition will provide the most useful clinical information, because my goal is to focus on the risk-benefit issue as a vehicle for making a more general point.) People who receive sham surgery are exposed to more surgical and intervention-related risks and burdens than they would have been exposed to if they had been managed medically. Can this extra burden be justified? Sham surgery isn't just one thing; it is potentially a large subset of the universe of the various types of risks and burdens in clinical research, with many elements yet to be defined (imagine, for example, that in the future some surgical procedures involve no incisions in the sense we know today). To rule out sham surgery, one would essentially be saying something like: All randomized clinical trials with sham surgery controls involve unacceptable risk-benefit profiles. In order for such a statement to be true, sham surgery would need to violate a fairly robust action-guiding principle. Some think this is clinical equipoise (Clark 2002; London and Kadane 2002). ..

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