So-called "clinical equipoise" and the argument from design.

In this article, I review and expand upon arguments showing that Freedman's so-called "clinical equipoise" criterion cannot serve as an appropriate guide and justification for the moral legitimacy of carrying out randomized clinical trials. At the same time, I try to explain why this approach has been given so much credence despite compelling arguments against it, including the fact that Freedman's original discussion framed the issues in a misleading way, making certain things invisible: Clinical equipoise is conflated with community equipoise, and several versions of each are also conflated. But a misleading impression is given that, rather than distinct criteria being arbitrarily conflated, a puzzle is solved and a number of features unified. Various issues are pushed under the rug, hiding flaws of the "clinical equipoise" approach and thus deceiving us into thinking that we have a solution when we do not. Particularly significant is the ignoring of the crucial distinction between the individual patient decision and the policy decision.

Pulling the plug on clinical equipoise: a critique of Miller and Weijer.

As clinicians, researchers, bioethicists, and members of society, we face a number of moral dilemmas concerning randomized clinical trials. How we manage the starting and stopping of such trials--how we conceptualize what evidence is sufficient for these decisions--has implications for both our obligations to trial participants and for the nature and security of the resultant medical knowledge. One view of how this is to be done, "clinical equipoise," recently has been given an extended defense by Paul Miller and Charles Weijer in their article "Rehabilitating Equipoise." The present paper critiques this position and Miller and Weijer's defense of it. I argue that their attempted rehabilitation fails. Their analysis suffers from a number of confusions, as well as a failure to make crucial distinctions, adequately to clarify key concepts, or to think through exactly what needs to be established to justify their claim. We are left with little reason to uphold the clinical equipoise criterion.

Community-equipoise and the ethics of randomized clinical trials.

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clincial trials (RCTs) -- the "community equipoise" strategy (CE). The dilemma is that RCTs appear to violate a physician's duty to choose that therapy which there is most reason to believe is in the patient's best interest, randomizing patients even once evidence begins to favor one treatment. The community equipose strategy involves the suggestion that our judgment that neither treatment is to be preferred (that there obtains a state of "equipoise") is to be assessed according to a community rather than an individual standard. Thus, though a physician may personally believe that there is some reason to prefer one treatment, patients can legitimately be randomized if there remains disagreement in the community of medical professionals. Rationales in favor of this conception include the following: (i) medical knowledge is best understood as residing in the community, (ii) the judgments of others count as evidence, and so should change one's own opinion, (iii) subjects would not be better off outside the trial, and (iv) the point of any trial is the resolution of dispute in the medical community. I critically examine these rationales and argue that they are insufficient. Amongst the problems are tensions between various of these underlying rationales, and important ambiguities in just what the CE criterion is to amount to. Finally, I argue that even if use of CE was justified, it would not justify carrying out RCTs anywhere near long enough to discharge our duty to gain reliable knowledge on which to base safe and effective medical practice. Hence, we need some different justification for carrying out RCTs.