This volume covers a wide range of conceptual, epistemological and methodological issues in the philosophy of science raised by reflection upon medical science and practice.

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical trials — the “community equipoise” strategy . 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 equipoise strategy involves the suggestion that our judgment that neither treatment is to be preferred 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: medical knowledge is best understood as residing in the community, the judgments of others count as evidence, and so should change one's own opinion, subjects would not be better off outside the trial, and 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. (shrink)

Recognizing that all traits are the result of an interaction between genes and environment, I offer a set of criteria for nevertheless making sense of our practice of singling out certain traits as genetic ones, in effect making a distinction between causes and mere conditions. The central criterion is that a trait is genetic if it is genetic differences that make the differences in that trait variable in a given population. A second criterion requires that genetic traits be individuated in (...) a way that matches what some genetic factors cause specifically. Clarifying our causal and classificatory language here can help us to avoid confusions of both theoretical and practical significance. (shrink)

The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to informed (...) consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating. Keywords: randomized clinical trials, ethics CiteULike Connotea Del.icio.us What's this? (shrink)

This paper critically examines a particular strategy for resolving the central ethical dilemma associated with randomized clinical 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 equipoise 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. (shrink)

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. (shrink)

It is often claimed that a clinical investigator may ethically participate (e.g., enroll patients) in a trial only if she is in equipoise (if she has no way to ground a preference for one arm of the study). But this is a serious problem, for as data accumulate, it can be expected that there will be a discernible trend favoring one of the treatments prior to the point where we achieve the trial's objective. In this paper, I critically evaluate Benjamin (...) Freedman's 'clinical equipoise' solution to this dilemma. I argue that Freedman actually puts forth at least two distinct contrasts - one in terms of community vs. individual equipoise, and another concerning clinical vs. theoretical equipoise - and that neither of them resolves the dilemma. I then make a proposal for a more adequate account of how to think about the circumstances under which entering subjects in trials would be justified - a 'sliding-scale equipoise' that arises out of a discussion of patients' values. (shrink)

The public attitude to animal use in Australia and New Zealandcan be inferred from survey results and political activity. The publicis concerned about the rights of animals as far as any uses causing painare concerned, but takes a more utilitarian view of the taking of lifewhere no suffering is involved. Many of the participants in two recentANZCCART conferences fall short in their knowledge of and attitudetoward these concerns. Animal welfare legislation and standards need tobe reformed so that painful animal use (...) is eliminated, even if economicgrowth suffers as a result. (shrink)

This paper examines some criticisms that have been made of two standard genetic methodologies: heritability and path analysis. I conclude that the criticisms should be taken seriously, concerning both the accuracy of heritability measures and their significance. In light of the fact that such studies remain prominent in the literature, I consider what possible rationale they can retain consistent with these criticisms. In particular, I consider (1) a role in the identification of high-risk individuals and (2) a heuristic role in (...) the planning of research strategy. (shrink)

This paper is a preliminary exploration concerning how the ethics of research on human subjects may differ when we move from the well-discussed context of research on therapies to the less-discussed context of research on enhancements. A number of differences are described. There are some features that make such research more morally problematic in certain ways, but some of the features may actually ameliorate some of the moral tensions that exist in human subjects research. It is hoped that this analysis (...) will aid and encourage discussion of the topic that could help guide those who intend to carry out such this research. (shrink)

With both the cost and quality of health care under scrutiny, many in the health care industry have turned to outcomes research and practice guidelines for answers. But many physicians have resisted, claiming their clinical judgment is a better guide. Both camps may be right.

: 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. (shrink)

Sober argues that the units of selection problem in evolutionary biology is to be understood and solved by applying the general analysis of what it means for C to cause E in a population. The account he utilizes is the unanimity account, according to which C causes E in a population when C raises the probability of E in each causal context. I argue that he does not succeed here, both because the unanimity account is not well grounded in the (...) general case, and because there are important differences between cases of population causation which do involve selection and those which do not. (shrink)

The units of selection problem is an issue within evolutionary theory (or the philosophy thereof) and concerns the question of what units or objects are acted upon by natural selection -- for example, whether these are genes, organisms or groups of organisms. One of the central theses of Elliot Sober’s recent book, The Nature of Selection, is that the philosophical problem of what it means for something to be a unit of selection is to be understood by applying the correct (...) account of what it is in general for a factor to be a cause in a population.The account of population-causation that Sober utilizes for this purpose comes from the recent literature on probabilistic causality. This account requires that for C to cause E in a population, a unanimity condition must be satisfied: C must raise the probability of E in each causal context. (shrink)

We are pleased to once again present to the readers of Theoretical Medicine and Bioethics papers from the Philosophy of Medicine Roundtable. Previous issues have followed the 3rd and 4th Roundtables, and the current issue presents a selection from the more than 20 papers presented at the 5th Philosophy of Medicine Roundtable, which took place in New York, at Columbia University, in November 2013. Like its predecessors, held in Birmingham, AL, Rotterdam, and San Sebastian, this Roundtable attracted speakers from around (...) the world. It also featured keynote presentations from Rita Charon of Columbia University and Ross Upshur of the University of Toronto.It may seem somewhat odd to feature a special issue on philosophy of medicine in a journal that effectively has philosophy of medicine in its title. However, a review of the contents of this journal and similar ones, such as the Journal of Medicine and Philosophy, will quickly reveal such an issue’s purpose. The dominant content of these j .. (shrink)