The Sham Surgery Debate and the Moral Complexity of Risk-Benefit Analysis

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).

I find the clinical-equipoise principle attractive for three reasons. One, it looks like a fairly clear decision rule. It presents a principled yet practicable way of setting an absolute limit on the exposure to risks and withholding of benefits that patients experience in clinical trials. Two, the decision rule addresses an important moral intuition: No matter the societal or scientific benefit and no matter how competent, robust, and well-informed the subject, there is a limit to the amount of burdens we as a society (as a matter of policy) should be willing to allow a subject to take on. Three, the equipoise doctrine incorporates another firmly held moral view about what a physician's role is—that of being guided by the best interests of the patient. Thus, the clinical-equipoise principle is a refreshingly practical rule that addresses a thorny ethical problem using values with which we are already familiar.

The trouble is, I am not convinced that the clinical-equipoise principle is sufficiently justified. The requirement of clinical equipoise for physicians recruiting their own patients into a clinical trial seems a plausible, if sometimes rebuttable, guide so as not to run roughshod over their duties to their patients. But as a requirement for all physician-researchers (or for clinical research in general), it is not clear why the rule applies. Physicians, not infrequently, serve in roles in which the duty of beneficence is subordinated to another legitimate interest, as in forensic evaluations in which the physician's first duty is to the state. Even here, though, we recognize the tricky moral situation by requiring a full disclosure to the patient to the effect that it is not an ordinary doctor-patient interaction (in fact warning him or her that it might not be in his or her interest to cooperate) and also, in general, not allowing dual agency—that is, a doctor cannot be a patient's forensic evaluator and be his or her physician at the same time. We do not, however, require that forensic evaluations must be consistent with the best interests of the patient.

Whether clinical equipoise applies to all clinical research, including research with competent adults, probably turns not...