Wendy A. Rogers

This paper draws attention to gendered dimensions of surgical device failure, focusing on two case studies—hernia repair mesh for pelvic organ prolapse, and metal-on-metal hip implants. We explore possible reasons for higher rates of harms to women, including systematic biases in health research and device regulation. Given that these factors are readily identifiable, we look to feminist scholarship to understand what might maintain them, including the role of cultural factors within surgery, such as gendered communication patterns and sexism. We then canvas potential measures to mitigate the increased risk of harms faced by women who use implanted devices.

Despite concerns about the relationships between health professionals and the medical device industry, the issue has received relatively little attention. Prevalence data are lacking; however, qualitative and survey research suggest device industry representatives, who are commonly present in clinical settings, play a key role in these relationships. Representatives, who are technical product specialists and not necessarily medically trained, may attend surgeries on a daily basis and be available to health professionals 24 hours a day, 7 days a week, to provide advice. However, device representatives have a dual role: functioning as commissioned sales representatives at the same time as providing advice on approaches to treatment. This duality raises the concern that clinical decision-making may be unduly influenced by commercial imperatives. In this paper, we identify three key ethical concerns raised by the relationship between device representatives and health professionals: impacts on healthcare costs, the outsourcing of expertise and issues of accountability and informed consent. These ethical concerns can be addressed in part through clarifying the boundary between the support and sales aspects of the roles of device representatives and developing clear guidelines for device representatives providing support in clinical spaces. We suggest several policy options including hospital provision of expert support, formalising clinician conduct to eschew receipt of meals and payments from industry and establishing device registries.

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

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.

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis.

Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect

Our motivation for proposing a special issue of IJFAB on vulnerability is twofold. First, there is growing interest in the concept of vulnerability within both bioethics and feminist theory. Reflecting this interest, this special issue provides a forum for exploring the relevance for bioethics of feminist perspectives on vulnerability. Second, despite growing recognition within bioethics of the moral significance of vulnerability, the concept remains under-theorized in bioethical (and wider philosophical) discourse. Questions that are central to current debates but that require further theoretical analysis include the following: What is vulnerability and what are the sources of vulnerability? What duties are owed ..

Surgical advances can provide great benefits to patients but can come at a cost. The successes are often matched by failures that cause harm to patients. The risks of surgery create a strong ethical imperative for research to establish the safety and efficacy of new treatments. Surgical research is, however, challenging for a number of reasons including the lack of a clear boundary between variations in practice, innovation and research, its irreversible nature, the difficulty of performing placebo-controlled randomised trials, confounding factors such as surgeon learning curves and conflicts of interest. In this chapter the ethical issues raised by surgical innovation are explored with the use of a case study based on the uptake of vaginal mesh to treat vaginal prolapse to highlight these issues (Sects. 12.1 and 12.2). In Sect. 12.3 the argument for the value of a structured approach to introducing innovations, such as that developed by the IDEAL Collaboration, which clarifies both ethical and methodological issues at each stage of research is proposed. This chapter recognises that ethical challenges extend beyond adequate ethical evaluation of the innovation in the care of individual patients to include broader issues such as justice in access to any new interventions.

Forms of Artificial Intelligence (AI) are already being deployed into clinical settings and research into its future healthcare uses is accelerating. Despite this trajectory, more research is needed regarding the impacts on patients of increasing AI decision making. In particular, the impersonal nature of AI means that its deployment in highly sensitive contexts-of-use, such as in healthcare, raises issues associated with patients’ perceptions of (un) dignified treatment. We explore this issue through an experimental vignette study comparing individuals’ perceptions of being treated in a dignified and respectful way in various healthcare decision contexts. Participants were subject to a 2 (human or AI decision maker) x 2 (positive or negative decision outcome) x 2 (diagnostic or resource allocation healthcare scenario) factorial design. We found evidence of a “human bias” (i.e., a preference for human over AI decision makers) and an “outcome bias” (i.e., a preference for positive over negative outcomes). However, we found that for perceptions of respectful and dignified interpersonal treatment, it matters more who makes the decisions in diagnostic cases and it matters more what the outcomes are for resource allocation cases. We also found that humans were consistently viewed as appropriate decision makers and AI was viewed as dehumanizing, and that participants perceived they were treated better when subject to diagnostic as opposed to resource allocation decisions. Thematic coding of open-ended text responses supported these results. We also outline the theoretical and practical implications of these findings.

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling.

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was extracted from each guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources.

The question of whether activism should be overtly embraced as part of the bioethicist's role deserves serious consideration. Like others, we agree that bioethics is inescapably partisan; bioethical deliberation is based on trying to determine morally relevant features of situations and morally justifiable outcomes. Where disagreement arises is over the degree to which bioethicists should be activists. Meyers argues for a somewhat circumscribed role, limited to action on ethically concerning institutional matters, for those who are financially independent of the institutions. We take a broader view, arguing that some issues are so morally egregious that there is a duty to take a stand against them, even if the prospects of success are dim. There is a need for further debate, sharing of experiences, and analysis of case studies, to support bioethicists who take a stand.

Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special features of both surgery and innovation

We thank Goldstein and Peterson, Caplan, and Bramstedt for engaging with our paper on the ethics of publishing and using Chinese transplant research that involves organs procured from executed prisoners.1–4 In that paper, we examine consequentialist and deontological arguments for and against using data from unethical research. Goldstein and Peterson question the relationship between the social and scientific value of the research and the decision to publish the results. They argue that the failure to publish scientifically valid and socially valuable Chinese transplant research results in potential repetition of the research and subsequent exposure of new participants to research risks for data that already exists. This argument has intuitive appeal, in both its positive form (the data are already there so let’s use them) and negative form (by not using the data we subject future participants to avoidable research risks). Prima facie, failure to use the data does seem to breach a fundamental principle of research ethics, that of only exposing people to risks in research to produce novel and socially valuable knowledge. However, this point relies heavily on the assumption that data from unethical research are valid and valuable. This is a useful assumption to make in a theoretical argument as it clarifies the challenge of weighing up the potential utility of the …

Recent calls for retraction of a large body of Chinese transplant research and of Dr Jiankui He’s gene editing research has led to renewed interest in the question of publication, retraction and use of unethical biomedical research. In Part 1 of this paper, we briefly review the now well-established consequentialist and deontological arguments for and against the use of unethical research. We argue that, while there are potentially compelling justifications for use under some circumstances, these justifications fail when unethical practices are ongoing—as in the case of research involving transplantations in which organs have been procured unethically from executed prisoners. Use of such research displays a lack of respect and concern for the victims and undermines efforts to deter unethical practices. Such use also creates moral taint and renders those who use the research complicit in continuing harm. In Part 2, we distinguish three dimensions of ‘non-use’ of unethical research: non-use of published unethical research, non-publication, and retraction and argue that all three types of non-use should be upheld in the case of Chinese transplant research. Publishers have responsibilities to not publish contemporary unethical biomedical research, and where this has occurred, to retract publications. Failure to retract the papers implicitly condones the research, while uptake of the research through citations rewards researchers and ongoing circulation of the data in the literature facilitates subsequent use by researchers, policymakers and clinicians.

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.

In this article we examine the role and ethics of communications in planning for an influenza pandemic. We argue that ethical communication must not only he effective, so that pandemic plans can be successfully implemented, communications should also take specific account of the needs of the disadvantaged, so that they are not further disenfranchised. This will require particular attention to the role of the mainstream media which may disadvantage the vulnerable through misrepresentation and exclusion.

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.

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.

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.

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.

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.

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.

Breast cancer screening aims to help women by early identification and treatment of cancers that might otherwise be life-threatening. However, breast cancer screening also leads to the detection of some cancers that, if left undetected and untreated, would not have damaged the health of the women concerned. At the time of diagnosis, harmless cancers cannot be identified as non-threatening, therefore women are offered invasive breast cancer treatment. This phenomenon of identifying non-harmful cancers is called overdiagnosis. Overdiagnosis is morally problematic as it leads to overall patient harm rather than benefit. Further, breast cancer screening is offered in a context that exaggerates cancer risk and screening benefit, minimises risk of harm and impedes informed choice. These factors combine to create pathogenic vulnerability. That is, breast cancer screening exacerbates rather than reduces women’s vulnerability and undermines women’s agency. This paper provides an original way of conceptualising agency-supporting responses to the harms of breast cancer overdiagnosis through application of the concept of pathogenic vulnerability.