Fool's gold: Revising the gold standard in clinical research

Though research ethics has both ethical and epistemological components, to date, the epistemological component has been largely overlooked. The following work represents an attempt to address this lacuna in the literature in the context of the contemporary controversy concerning the proper use of placebo controls in randomized controlled trials (RCTs). Typically, this controversy is framed as a conflict between the demands of ethics and science: ethics requires that, if effective treatment exists, second-generation treatments ought to be tested against said treatment; good science, however, requires the use of placebo controls. In contrast, I argue that this controversy is best understood when it is framed not as a conflict between the demands of ethics and science but as a conflict concerning science itself; a conflict over what constitutes ‘good science’.; Proponents of placebo controls typically rely on a conception of internal validity as a ‘criterion of self-containment’. A clinical trial, it is argued, is internally valid if and only if “it is capable of generating, from within, evidence that speaks unambiguously to the relative benefit of the treatments being compared”. Implicit in this conception of internal validity is the assumption that ‘self-containment’ of this sort is possible. But this assumption violates what is now taken to be a commonplace in the philosophy of science: the Duhem-Quine thesis. This thesis asserts that empirical tests are holistic; that is, empirical observations confirm or disconfirm a given statement or hypothesis only against the background of a network of theoretical assumptions. In other words, no test or trial is ‘self-contained’ in the sense demanded. For this and other reasons I conclude that resistance to the use of active controls in RCTs is based on a fundamental misconception of the scientific enterprise.