Sham Surgery and Genuine Standards of Care: Can the Two be Reconciled?

Important ethical issues are raised by the use of sham surgery controls in clinical trials, and we agree with Franklin G. Miller (2003) that care must be taken not to obscure significant and morally relevant differences between different uses of sham surgery controls. Because the ethical issues that arise in this context are so fundamental, however, great care must also be taken to understand the diversity that exists among the arguments that have been used to evaluate previous uses of sham surgery controls. In particular, there are at least two views about foundational issues in the ethics of human-subjects research that differ precisely in their standards for determining which differences between sham surgery controls are the morally relevant ones (London and Kadane 2002). To be clear, Miller adopts and articulates one of these standards, and the novel aspect of its analysis lies in the fact that it applies this standard to three different sham surgery-controlled clinical trials. However, Miller's claims about leading arguments against the use of sham surgery controls lump together views that, though they might argue for similar conclusions, do so from very different premises. This creates unnecessary confusion about the state of the debate. The confusion is exacerbated by an apparent conflation of the claim that there are "strong prima facie reasons for rejecting the use of sham surgical controls" (London and Kadane 2002, 414) with the much stronger claim that there should be an absolute prohibition on the use of such controls. In what follows, therefore, we briefly examine the moral presuppositions of Miller's favored standard, the moral presuppositions of an important alternative, and what it takes to override one set of prima facie reasons for rejecting the use of sham surgery controls in clinical research.

Miller's View: Weighing Harms to Individuals against Benefits to Science

Miller correctly notes that in the context of standard medical practice, patients and their care providers must decide whether the risks to the patient from a proposed treatment plan are reasonable in light of the corresponding benefits to the same patient. In the therapeutic context the various burdens associated with an invasive surgical procedure, for example, are justified only to the extent that they are offset or outweighed by the various potential benefits they promise to the same individual. Presumably the same must be true of the various tools or modalities that are used for diagnostic and monitoring purposes.

Here, and elsewhere (Miller 2002), however, Miller argues that "it is erroneous to hold that clinical research should be governed by the same ethical standards as apply to the practice of medicine" (Miller 2003). Two claims in particular are used to support this conclusion. First, Miller argues that in clinical research a variety of invasive and painful procedures is routinely employed in clinical trials and that

these studies, which pose risks to participants without compensating benefits, are generally considered ethically acceptable, provided that the risks have been minimized, are not excessive, and are justified by the value of the knowledge to be gained from the research.

Second, Miller claims that clinical research would be "impossible if it were held to the ethical standard of promoting the medical best interests of patients that governs therapeutic medicine."

Miller thus thinks that recent critics of the use of sham surgery controls make the fundamental error of not recognizing that medical research and clinical medicine are governed by different moral norms. This leads them to err in treating sham surgery controls as exceptional or as qualitatively different from other aspects of clinical research that "expose patients to risks that are not compensated by medical benefits."

On Miller's view, what these critics have failed to see is that within medical research the risks to an individual, whether associated with the use of...