The ethics and science of placebo-controlled trials: Assay sensitivity and the Duhem-Quine thesis

Journal of Medicine and Philosophy 31 (1):65 – 81 (2006)
The principle of clinical equipoise requires that, aside from certain exceptional cases, second generation treatments ought to be tested against standard therapy. In violation of this principle, placebo-controlled trials (PCTs) continue to be used extensively in the development and licensure of second-generation treatments. This practice is typically justified by appeal to methodological arguments that purport to demonstrate that active-controlled trials (ACTs) are methodologically flawed. Foremost among these arguments is the so called assay sensitivity argument. In this paper, I take a closer look at this argument. Following Duhem, I argue that all trials, placebo-controlled or not, rely on external information for their meaningful interpretation. Pending non-circular empirical evidence that we can trust the findings of PCTs to a greater degree than the findings of ACTs, I conclude that the assay sensitivity argument fails to demonstrate that placebo-controlled trials are preferable, methodologically or otherwise, to active-controlled trials. Contrary to the intentions of its authors, the fundamental lesson taught by the assay sensitivity argument is Duhemian: the validity of all clinical trials depends on external information.
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DOI 10.1080/03605310500499203
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Philosophical Explanations.Robert Nozick - 1981 - Harvard University Press.
Two Dogmas of Empiricism.Willard V. O. Quine - 1951 - Philosophical Review 60 (1):20–43.
Essays in the Philosophy of Science.Charles S. Peirce - 1957 - New York: Liberal Arts Press.

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Getting Back to the Fundamentals of Clinical Ethics.Laurence B. Mccullough - 2006 - Journal of Medicine and Philosophy 31 (1):1 – 6.
Who's in Control of the Choice of Control?James Anderson - 2009 - American Journal of Bioethics 9 (9):60-62.

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