Healthy Skepticism Library item: 5347

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Publication type: Journal Article

Lichtenberg P, Heresco-Levy U, Nitzan U.
The ethics of the placebo in clinical practice.
J Med Ethics 2004 Dec 01; 30:(6):551-4
http://jmp.oxfordjournals.org/content/31/1/65.abstract

Abstract:

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.

Keywords:
Data Interpretation, Statistical Drug Evaluation/ethics Drug Evaluation/methods Ethics, Clinical* Ethics, Research* Humans Placebos* Practice Guidelines Randomized Controlled Trials/ethics* Randomized Controlled Trials/methods Reproducibility of Results Treatment Outcome