Mary Jean Walker

This paper examines potential ethical and legal issues arising during the research, develop- ment and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individ- ual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detri- mental to best personalizing treatment decisions in the clinic.

Artificial devices that functionally replace internal organs are likely to be more common in the future. They are becoming more and more technologically feasible, increases in chronic diseases that can compromise various organs are anticipated, and donor organs will remain necessarily limited. More people in the future may have bodies that are partly nonorganic. How might artificial organs affect how we experience and conceptualize our bodies and how we understand the relation of the body to the experiencing, acting subject, or self? Here, I focus on artificial heart devices (AHDs), including total artificial hearts (TAHs) and ventricular assist devices (VADs). While other devices, such as pacemakers and implantable cardiac defibrillators, assist the heart, I focus on devices that replace rather than assist organic function. AHDs, I argue, may have two opposing effects. On the one hand, having an AHD could alter experience, seemingly confirming that selves are shaped by the specifics of embodiment. On the other hand, AHDs are likely to encourage people to regard bodies as machines that are separable from the self. AHDs thus both confirm and undermine a body-self dualism. People with these devices may come to regard their bodies as machinelike even while having an artificial part alters their subjective experience.

Positive claims about narrative approaches to healthcare suggest they could have many benefits, including supporting person-centred healthcare (PCH). Narrative approaches have also been criticised, however, on both theoretical and practical grounds. In this paper we draw on epistemological work on narrative and knowledge to develop a conception of narrative that responds to these concerns. We make a case for understanding narratives as accounts of events in which the way each event is described as influenced by the ways other events in the narrative are described. This view of narratives recognises that they can contribute knowledge of different kinds of connections between events: not just causal, and not just of patient’s perspectives. Additionally, narratives can add further epistemic value by suggesting potentially useful lines of inquiry. We take narrative approaches to healthcare to include clinicians considering both patients’ informational offerings and their own professional understandings as narratives. On this understanding, our account is able to overcome the major theoretical and practical criticisms that have been levelled against the use of narrative approaches in healthcare, and can help to explain why and how narrative approaches are consistent with PCH.

Recently, concerns have been raised about the phenomenon of 'overdiagnosis', the diagnosis of a condition that is not causing harm, and will not come to cause harm. Along with practical, ethical, and scientific questions, overdiagnosis raises questions about our concept of disease. In this paper, we analyse overdiagnosis as an epistemic problem and show how it challenges many existing accounts of disease. In particular, it raises questions about conceptual links drawn between disease and dysfunction, harm, and risk. We argue that "disease" should be considered a vague concept with a nonclassical structure. On this view, overdiagnosed cases are 'borderline' cases of disease, falling in the zone between cases that are clearly disease, and cases that are clearly not disease. We then develop a précising definition of disease designed to provide practical help in preventing and limiting overdiagnosis. We argue that for this purpose, we can define disease as dysfunction that has a significant risk of causing severe harm to the patient.

The ethical debate about neurotechnologies—including both drugs and implanted devices—has been largely framed around the questions of whether and when these technologies could damage or promote authenticity. Patients can experience changes in mood, behavior, emotion, or preferences—seemingly, changes in character or personality. Some describe such changes by saying they feel like different people; that they have become either more or less themselves; or that they feel as though some of their moods, behaviors, emotions or preferences are not their own. These kinds of statements are used to describe both changes that a drug or device is...

Advances in prosthetic design should benefit people with limb difference. But empirical evidence demonstrates a lack of uptake of prosthetics among those with limb difference, including of advanced designs. Non-use is often framed as a problem of prosthetic design or a user’s response to prosthetics. Few studies investigate user experience and preferences, and those that do tend to address satisfaction or dissatisfaction with functional aspects of particular designs. This results in limited data to improve designs and, we argue, this is pragmatically and ethically problematic. This paper presents results of a survey we conducted in 2017 with people with upper limb difference in Australia. The survey sought to further knowledge about preferences surrounding prosthetics and understanding of how preferences relate to user experience, perspective, and context. Survey responses demonstrated variety in the uptake, use and type of prosthetic—and that use of, preferences about, and impacts of prosthetics rely not just on design factors but on various contextual factors bearing on identity and social understandings of disability and prosthetic use. From these results, we argue that non-use of prosthetics could be usefully reframed as an issue of understanding how prosthetics can best support users’ autonomy. This supports the claim that there is a need to incorporate user engagement into design processes for prosthetic limbs, though further work is needed on methods for doing so.

The literature of Twelve Step groups such as Alcoholics Anonymous contains apparently contradictory implications regarding powerlessness and personal responsibility. In this essay I examine the treatment of these concepts in Twelve Step literature and their implications for the self-conception of people in these programs. In the first section, I examine the literature to demonstrate that addicts are presented as powerless over, yet responsible for, their addictive behaviors. In the second section, I outline two potential ways people in Twelve Step programs might reconcile this contradiction within their self-conception, but I argue that neither is satisfactory. In the third section, I draw on Paul Ricoeur's theory of narrative identity to develop an account of how someone ni a Twelve Step group could coherently understand herself as both powerless and responsible.

Surgery is an important part of contemporary health care, but currently much of surgery lacks a strong evidence base. Uptake of evidence-based medicine (EBM) methods within surgical research and among practitioners has been slow compared with other areas of medicine. Although this is often viewed as arising from practical and cultural barriers, it also reflects a lack of epistemic fit between EBM research methods and surgical practice. In this paper we discuss some epistemic challenges in surgery relating to this lack of fit, and investigate how resources from feminist epistemology can help to characterize them. We point to ways in which these epistemic challenges may be addressed by gathering and disseminating evidence about what works in surgery using methods that are contextual, pluralistic, and sensitive to hierarchies

Recently, concerns have been raised about the phenomenon of ‘overdiagnosis’, the diagnosis of a condition that is not causing harm, and will not come to cause harm. Along with practical, ethical, and scientific questions, overdiagnosis raises questions about our concept of disease. In this paper, we analyse overdiagnosis as an epistemic problem and show how it challenges many existing accounts of disease. In particular, it raises ques- tions about conceptual links drawn between disease and dysfunction, harm, and risk. We argue that ‘disease’ should be considered a vague concept with a non-classical structure. On this view, overdiagnosed cases are ‘borderline’ cases of disease, falling in the zone between cases that are clearly disease, and cases that are clearly not disease. We then develop a pre ́cising definition of disease designed to provide practical help in preventing and limiting overdiagnosis. We argue that for this purpose, we can define disease as dysfunction that has a significant risk of causing severe harm to the patient.

Personalised medicine 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 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.

Technological advances are making devices that functionally replace body parts—artificial organs and limbs—more widely used, and more capable of providing patients with lives that are close to “normal.” Some of the ethical issues this is likely to raise relate to how such prostheses are conceptualized. Prostheses are ambiguous between being inanimate objects and sharing in the status of human bodies—which already have an ambiguous status, as both objects and subjects. At the same time, the possibility of replacing body parts with artificial objects puts pressure on the normative status typically accorded to human bodies, seemingly confirming that body parts are replaceable objects. The paper argues that bodies’ normative status relies on the relation of a body to a person and shows that persons could have similar relations to prostheses. This suggests that in approaching ethical issues surrounding prostheses, it is appropriate to regard them as more like body parts than like objects.

Programs of drug testing welfare recipients are increasingly common in US states and have been considered elsewhere. Though often intensely debated, such programs are complicated to evaluate because their aims are ambiguous – aims like saving money may be in tension with aims like referring people to treatment. We assess such programs using a proportionality approach, which requires that for ethical acceptability a practice must be: reasonably likely to meet its aims, sufficiently important in purpose as to outweigh harms incurred, and lower in costs than feasible alternatives. In the light of empirical findings, we argue that the programs fail the three requirements. Pursuing recreational drug users is not important in the light of costs incurred, while dependent users who may require referral are usually identifiable without testing and typically need a broader approach than one focussing on drugs. Drug testing of welfare recipients is therefore not ethically acceptable policy.

In this paper, we examine recent critiques of the debate about defining disease, which claim that its use of conceptual analysis embeds the problematic assumption that the concept is classically structured. These critiques suggest, instead, developing plural stipulative definitions. Although we substantially agree with these critiques, we resist their implication that no general definition of “disease” is possible. We offer an alternative, inductive argument that disease cannot be classically defined and that the best explanation for this is that the concept is structured as a cluster. We further argue that we do not need to reject the possibility of defining the general concept “disease” to legitimate developing stipulative definitions of disease that are relative to particular purposes. A cluster definition of disease is compatible with contextually motivated definitions, which may be considered précisifications of the more general cluster concept.

‘Contract cheating’ has recently emerged as a form of academic dishonesty. It involves students contracting out their coursework to writers in order to submit the purchased assignments as their own work, usually via the internet. This form of cheating involves epistemic and ethical problems that are continuous with older forms of cheating, but which it also casts in a new form. It is a concern to educators because it is very difficult to detect, because it is arguably more fraudulent than some other forms of plagiarism, and because it appears to be connected to a range of systemic problems within modern higher education. This paper provides an overview of the information and literature thus far available on the topic, including its definition, the problems it involves, its causal factors, and the ways in which educators might respond. We argue that while contract cheating is a concern, some of the suggested responses are themselves problematic, and that best practice responses to the issue should avoid moral panic and remain focussed on supporting honest students and good academic practice

Vaccine refusal occurs for a variety of reasons. In this article we examine vaccine refusals that are made on conscientious grounds; that is, for religious, moral, or philosophical reasons. We focus on two questions: first, whether people should be entitled to conscientiously object to vaccination against contagious diseases ; second, if so, to what constraints or requirements should conscientious objection to vaccination be subject. To address these questions, we consider an analogy between CO to vaccination and CO to military service. We argue that conscientious objectors to vaccination should make an appropriate contribution to society in lieu of being vaccinated. The contribution to be made will depend on the severity of the relevant disease, its morbidity, and also the likelihood that vaccine refusal will lead to harm. In particular, the contribution required will depend on whether the rate of CO in a given population threatens herd immunity to the disease in question: for severe or highly contagious diseases, if the population rate of CO becomes high enough to threaten herd immunity, the requirements for CO could become so onerous that CO, though in principle permissible, would be de facto impermissible.

In this paper I seek to clarify the role of narrative in personal unity. Examining the narrative self-constitution view developed by Marya Schechtman, I use a case of radical personal change to identify a tension in the account. The tension arises because a narrative can be regarded either to capture a continuing agent with a loosely coherent, consistent self-conception – or to unify over change and inconsistency. Two possible ways of responding, by distinguishing senses of identity or distinguishing identity and autonomy, are examined, but I argue that neither precisely maps this tension. I then develop a distinction between two ways in which narrative can unify: through “bottom-up” processes related to the connection between agency and self-conception; and “top-down” processes related to self-interpretative activity. The account provides ways to resolve some criticisms of narrative theories of identity, in particular in better accounting for the role of repudiated characteristics in narrative identity.

Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial, requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an intervention for RCT evaluation. I argue that, despite initial appearances, it is theoretically possible to use RCTs to evaluate some patient-specific medical devices. However, the argument reveals significant difficulties for ensuring the validity of such trials, with implications for how we should think about methods of evidence gathering and regulatory approaches for these technologies.

Evidence in medicine can come from more or less trustworthy sources and be produced by more or less reliable methods, and its interpretation can be disputed. As such, it can be unclear when disagreements in medicine result from different, but reasonable, interpretations of the available evidence and when they result from unreasonable refusals to consider legitimate evidence. In this article, we seek to show how assessments of the relevance and implications of evidence are typically affected by factors beyond that evidence itself, such as our beliefs about the credibility of the speaker or source of the evidence. In evaluating evidence, there is thus a need for reflective awareness about why we accept or dismiss particular claims

An increasing number of patients receive diagnoses of disease without having any symptoms. These include diseases detected through screening programs, as incidental findings from unrelated investigations, or via routine checks of various biological variables like blood pressure or cholesterol. In this article, we draw on narrative identity theory to examine how the process of making sense of being diagnosed with asymptomatic disease can trigger certain overlooked forms of harm for patients. We show that the experience of asymptomatic disease can involve ‘mismatches’ between one’s beliefs about one’s health status on the one hand, and bodily sensations or past experience on the other. Patients’ attempts to integrate these diagnoses into their self-narratives often involve either forming inaccurate beliefs about bodily sensations and/or past experience, or coming to believe that feelings and experience do not necessarily track or predict health status, leading to an ongoing sense of vulnerability to ill health. These resulting alterations in self-understanding can sometimes be considered harmful, in view of their implications for ascriptions of responsibility and ongoing anxiety.

Boorse’s biostatistical theory states that diseases should be defined in ways that reflect disturbances of biological function and that are objective and value free. We use three examples from contemporary medicine that demonstrate the complex issues that arise when defining the boundaries of disease: polycystic ovary syndrome, chronic kidney disease, and myocardial infarction. We argue that the biostatistical theory fails to provide sufficient guidance on where the boundaries of disease should be drawn, contains ambiguities relating to choice of reference class, and is out of step with medical processes for identifying disease boundaries. Although proponents of the biostatistical theory might regard these practical issues as irrelevant to the aim of providing a theoretical account of disease, we take them to indicate the need for a theoretical account that is adequate for current needs—including limiting new forms of medicalization that are driven by the identification of disease based on dysfunction. Our processes for determining the boundaries for disease need to recognize that there is no value-free method for making these decisions.

Biological dysfunction is regarded, in many accounts, as necessary and perhaps sufficient for disease. But although disease is conceptualized as all-or-nothing, biological functions often differ by degree. A tension is created by attempting to use a continuous variable as the basis for a categorical definition, raising questions about how we are to pinpoint the boundary between health and disease. This is the line-drawing problem. In this paper, we show how the line-drawing problem arises within “dysfunction-requiring” accounts of disease, such as those of Christopher Boorse and Jerome Wakefield. We then provide several detailed examples to establish that biological dysfunction cannot provide a boundary. We examine potential ways of resolving the line-drawing problem, either by dropping one of the claims that generates it, or by appealing to additional criteria. We argue that two of these options are plausible, and that each of these can be applied with regard to different diseases.

Although health and disease occupy opposite ends of a spectrum, distinguishing between them can be difficult. This is the “line-drawing” problem. The papers in this special issue engage with this challenge of delineating the boundaries of disease. The authors explore different views as to where the boundary between disease and nondisease lies, and related questions, such as how we can identify, or decide, what counts as a disease and what does not; the nature of the boundary between the two categories; and what sorts of considerations could justify the location of that boundary. In exploring these questions, the papers draw on detailed clinical examples, provide theoretical critiques of existing approaches to disease definition, and offer new ways to conceptualize key features in debates about disease, including harm and biological dysfunction.

Medicine seeks to overcome one of the most fundamental fragilities of being human, the fragility of good health. No matter how robust our current state of health, we are inevitably susceptible to future illness and disease, while current disease serves to remind us of various frailties inherent in the human condition. This article examines the relationship between fragility and uncertainty with regard to health, and argues that there are reasons to accept rather than deny at least some forms of uncertainty. In situations of current ill health, both patients and doctors seek to manage this fragility through diagnoses that explain suffering and provide some certainty about prognosis as well as treatment. However, both diagnosis and prognosis are inevitably uncertain to some degree, leading to questions about how much uncertainty health professionals should disclose, and how to manage when diagnosis is elusive, leaving patients in uncertainty. We argue that patients can benefit when they are able to acknowledge, and appropriately accept, some uncertainty. Healthy people may seek to protect the fragility of their good health by undertaking preventative measures including various tests and screenings. However, these attempts to secure oneself against the onset of biological fragility can cause harm by creating rather than eliminating uncertainty. Finally, we argue that there are good reasons for accepting the fragility of health, along with the associated uncertainties.

Neil Levy argues that while addicts who believe they are not addicts are self-deceived, addicts who believe they are addicts are just as self-deceived. Such persons accept a false belief that their addictive behaviour involves a loss of control. This paper examines two implications of Levy's discussion: that accurate self-knowledge may be particularly difficult for addicts; and that an addict's self-deceived belief that they cannot control themselves may aid their attempts at self-control. I argue that the self-deceived beliefs of addicts in denial and of self-described addicts differ in kind. Unlike the self-deception of an addict in denial, that of the self-described addict allows them to acknowledge their behaviour. As such, it may aid an addict to develop more self-control. A paradoxical implication is that this self-deception may allow an addict more self-knowledge

Many health care systems include programs that allow patients in exceptional circumstances to access medical interventions of as yet unproven benefit. In this article we consider the ethical justifications for—and demands on—these special access programs (SAPs). SAPs have a compassionate basis: They give patients with limited options the opportunity to try interventions that are not yet approved by standard regulatory processes. But while they signal that health care systems can and will respond to individual suffering, SAPs have several disadvantages, including the potential to undermine regulatory and knowledge-generation structures that constitute significant public goods. The “balance” between these considerations depends in part on how broadly SAPs are used, but also on whether SAPs can be made to contribute to the generation of knowledge about the effects of health interventions. We argue that patients should usually be required to contribute outcome data while using SAPs.

In the recent neuroethics literature, there has been vigorous debate concerning the ethical implications of the use of neurotechnologies that may alter a person’s identity. Much of this debate has been framed around the concept of authenticity. The argument of this chapter is that the ethics of authenticity, as applied to neurotechnological treatment or enhancement, is conceptually misleading. The notion of authenticity is ambiguous between two distinct and conflicting conceptions: self-discovery and self-creation. The self-discovery conception of authenticity is based on a problematic conception of a static, real inner self. The notion of self-creation, although more plausible, blurs the distinction between identity and autonomy. Moreover, both conceptions are overly individualistic and fail sufficiently to account for the relational constitution of personal identity. The authors propose that a relational, narrative understanding of identity and autonomy can incorporate the more plausible aspects of both interpretations of authenticity, while providing a normatively more illuminating theoretical framework for approaching the question of whether and how neurotechnologies threaten identity.

Recent evidence from the neurosciences and cognitive sciences provides some support for a narrative theory of self-understanding. However, it also suggests that narrative self-understanding is unlikely to be accurate, and challenges its claims to truth. This article examines a range of this empirical evidence, explaining how it supports a narrative theory of self-understanding while raising questions of these narrative's accuracy and veridicality. I argue that this evidence does not provide sufficient reason to dismiss the possibility of truth in narrative self-understanding. Challenges to the possibility of attaining true, accurate self-knowledge through a self-narrative have previously been made on the basis of the epistemological features of narrative. I show how the empirical evidence is consistent with the epistemological concerns, and provide three ways to defend the notion of narrative truth. I also aim to show that neuroethical discussions of self-understanding would benefit from further engagement with the philosophical literature on narrative truth.