Theoretical Medicine and Bioethics

Death, unity, and the brain Abstract The dead donor rule holds that removing organs from living human beings without their consent is wrongful killing. The rule still prevails in most countries, and I assume it without argument in order to pose the question: is it possible to have a metaphysically correct, clinically relevant analysis of human death that makes organ donation ethically permissible? I argue that the two dominant criteria of death—brain death and circulatory death—are both empirically and metaphysically inadequate as definitions of human death and therefore hold no epistemic value in themselves. I first set out a neo-Aristotelian theory of death as separation of soul (understood as organising principle) and body, which is then fleshed out as loss of organismic integrity. The brain and circulatory criteria are shown to have severe weaknesses as physiological manifestations of loss of integrity. Given the mismatch between what death is, metaphysically speaking, and the dominant criteria accepted by clinicians and philosophers, it turns out that only actual bodily decomposition is a sure sign of death. In this I differ from Alan Shewmon, whose important work I discuss in detail.

Akira Akabayashi (ed): The future of bioethics: international dialogues

Joo-Young Lee: A human rights framework for intellectual property, innovation and access to medicines

Outcome-adaptive randomization in clinical trials: issues of participant welfare and autonomy Abstract Outcome-adaptive randomization (OAR) has been proposed as a corrective to certain ethical difficulties inherent in the traditional randomized clinical trial (RCT) using fixed-ratio randomization. In particular, it has been suggested that OAR redresses the balance between individual and collective ethics in favour of the former. In this paper, I examine issues of welfare and autonomy arising in relation to OAR. A central issue in discussions of welfare in OAR is equipoise, and the moral status of OAR is crucially influenced by the way in which this concept is construed. If OAR is based on a model of equipoise that demands strict indifference between competing interventions throughout the trial, such equipoise is disturbed by accruing data favouring one treatment over another; OAR seeks to redress this by weighting randomization to the seemingly superior treatment. However, this is a partial response, as patients continue to be allocated to the inferior therapy. Moreover, it rests upon considerations of aggregate harms and benefits, and does not therefore uphold individual ethics. Issues of fairness also arise, as early and late enrollees are randomized on a different basis. Fixed-ratio randomization represents a fuller and more consistent response to a loss of equipoise, as so construed. With regard to consent, the complexity of OAR poses challenges to adequate disclosure and comprehension. Additionally, OAR does not offer a remedy to the therapeutic misconception—participants' tendency to attribute treatment allocation in an RCT to individual clinical judgments, rather than to scientific considerations—and, if anything, accentuates rather than alleviates this misconception. In relation to these issues, OAR fails to offer ethical advantages over fixed-ratio randomization. More broadly, the ethical basis of OAR can be seen to lie more in collective than in individual ethics, and overall it fares worse in this territory than fixed-ratio randomization.

Paula Gerber and Katie O'Byrne (eds): Surrogacy, law and human rights

Taking patient virtue seriously Abstract Virtue theory in philosophical bioethics has influenced clinical ethics with depictions of the virtuous doctor or nurse. Comparatively little has been done with the concept of the virtuous patient, however. Bioethicists should correct the asymmetry in virtue theory between physician virtues and patient virtues in a way that provides a practical theory for the new patient-centered medicine—something clinicians and administrators can take seriously.

Evidence for personalised medicine: mechanisms, correlation, and new kinds of black box Abstract Personalised medicine (PM) has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells (iPSCs) so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system.

Is "aid in dying" suicide? Abstract The practice whereby terminally ill patients choose to end their own lives painlessly by ingesting a drug prescribed by a physician has commonly been referred to as physician-assisted suicide. There is, however, a strong trend forming that seeks to deny that this act should properly be termed suicide. The purpose of this paper is to examine and reject the view that the term suicide should be abandoned in reference to what has been called physician-assisted suicide. I argue that there are no good conceptual or philosophical reasons to avoid the suicide label. I contend that intending one's death is essential to the nature of suicide, and this intention is normally required on the part of the terminally ill patient when she knowingly takes a life-ending drug. Additionally, the analysis shows that any plausible strategy that avoids the term suicide is counteracted by the way in which advocates of the practice want to make it legal.

Henk ten Have: Global bioethics: an introduction

The harm of medical disorder as harm in the damage sense Abstract Jerome Wakefield has argued that a disorder is a harmful dysfunction. This paper develops how Wakefield should construe harmful in his harmful dysfunction analysis (HDA). Recently, Neil Feit has argued that classic puzzles involved in analyzing harm render Wakefield's HDA better off without harm as a necessary condition. Whether or not one conceives of harm as comparative or non-comparative, the concern is that the HDA forces people to classify as mere dysfunction what they know to be a disorder. For instance, one can conceive of cases where simultaneous disorders prevent each other from being, in any traditional sense, actually harmful; in such cases, according to the HDA, neither would be a disorder. I argue that the sense of harm that Wakefield should employ in the HDA is dispositional, similar to the sense of harm used when describing a vile of poison: "Be careful! That's poison. It's harmful." I call this harm in the damage sense. Using this sense of harm enables the HDA to avoid Feit's arguments, and thus it should be preferred to other senses when analyzing harmful dysfunction.