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Sham Surgery and Reasonable Risk

O of the most fundamental tensions within clinical research arises from the need to balance the goal of advancing the frontiers of science in order to improve the standard of care available to future persons with the goal of responding with diligence and compassion to the important interests and health needs of the research participants who make such progress possible (Jonas 1969; see also London 2003). Although this tension pervades clinical research, it is particularly salient in the debate over the use of placebo controls in clinical trials.1 Recently however, the already contentious debate about the conditions under which it is permissible to include a placebo arm in a clinical trial has been further complicated by several clinical trials in which participants have been randomized to a sham-surgery control. To many critics, sham-surgery controls differ in morally significant ways from traditional placebo controls (Macklin 1999; see also London and Kadane 2002). Generally speaking, traditional placebo controls are inert substances that are chosen precisely because of their causal inefficacy. The primary worry associated with the use of such substances are the opportunity costs that participants may incur from being randomized to them. These opportunity costs are cause for ethical concern, for example, when randomizing participants with a particular medical condition to a placebo deprives them of the opportunity to access an alternative treatment modality that is otherwise available for their condition. While opportunity costs remain a concern in the case of sham-surgery controls, the latter also raise additional concerns because the so-called placebo or sham surgeries often involve actual surgical interventions that carry their own special risks and burdens. Unlike the relatively benign profile of the traditional, inert placebo, sham-surgery controls may require recipients to undergo invasive and 13