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. (shrink)

Overdiagnosis refers to diagnosis that does not benefit patients because the diagnosed condition is not a harmful disease in those individuals. Overdiagnosis has been identified as a problem in cancer screening, diseases such as chronic kidney disease and diabetes, and a range of mental illnesses including depression and attention deficit hyperactivity disorder. In this paper, we describe overdiagnosis, investigate reasons why it occurs, and propose two different types. Misclassification overdiagnosis arises because the diagnostic threshold for the disease in question has (...) been set at a level where many people without harmful disease are nonetheless diagnosed. We illustrate misclassification overdiagnosis using the example of chronic kidney disease. Misclassification occurs in diseases diagnosed using biomarkers or based on patient reported phenomena. Maldetection overdiagnosis arises because, at the time the diagnosis is made and despite the presence of a 'gold standard' diagnostic test, it is not possible to discriminate between harmful and non-harmful cases of the index disease. We illustrate maldetection overdiagnosis using the example of thyroid cancer. While there is some overlap between misclassification and maldetection overdiagnosis, this conceptual analysis helps to clarify the phenomenon of overdiagnosis and is a necessary first step in developing strategies to address the problem. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

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. (shrink)

Throughout March and April 2020, debate raged about how best to allocate limited intensive care unit resources in the face of a growing COVID-19 pandemic. The debate was dominated by utility-based arguments for saving the most lives or life-years. These arguments were tempered by equity-based concerns that triage based solely on prognosis would exacerbate existing health inequities, leaving disadvantaged patients worse off. Central to this debate was the assumption that ICU admission is a valuable but scarce resource in the pandemic (...) context.In this paper, we argue that the concern about achieving equity in ICU triage is problematic for two reasons. First, ICU can be futile and prolong or exacerbate suffering rather than ameliorate it. This may be especially true in patients with COVID-19 with emerging data showing that most who receive access to a ventilator will still die. There is no value in admitting patients with poor prognostic indicators to ICU to meet an equity target when intensive critical care is contrary to their best interests. Second, the focus on ICU admission shifts focus away from important aspects of COVID-19 care where there is greater opportunity for mitigating suffering and enhancing equitable care.We propose that the focus on equity concerns during the pandemic should broaden to include providing all people who need it with access to the highest possible standard of end-of-life care. This requires attention to culturally safe care in the following interlinked areas: palliative care, communication and decision support and advanced care planning. (shrink)

Current practices of identifying and treating small indolent thyroid cancers constitute an important but in some ways unusual form of overdiagnosis. Overdiagnosis refers to diagnoses that generally harm rather than benefit patients, primarily because the diagnosed condition is not a harmful form of disease. Patients who are overdiagnosed with thyroid cancer are harmed by the psycho-social impact of a cancer diagnosis, as well as treatment interventions such partial or total thyroidectomy, lifelong thyroid replacement hormone, monitoring, surgical complications and other side (...) effects. These harms seem to outweigh any putative benefit of knowing about a cancer that would not have caused problems if left undiscovered. In addition to harms to patients, thyroid cancer overdiagnosis leads to significant opportunity costs at a societal level, due to costs of diagnosis and treatment. Unlike many other overdiagnosed cancers, accurate risk stratification is possible with thyroid cancer. At the individual patient level, use of this risk information might support informed choice and/or shared decision-making, as mandated by clinical ethics frameworks. And this approach might, to some extent, help to reduce rates of diagnosis and intervention. In practice, however, it is unlikely to stem the rising incidence and associated harms and costs of overdiagnosed thyroid cancer, especially in situations where health professionals have conflicts of interest. We argue in this article that thyroid cancer overdiagnosis may be usefully understood as a public health problem, and that some public health approaches will be readily justifiable and are more likely to be effective in minimising its harms. (shrink)

This paper raises questions about the epistemological foundations of evidence-based medicine . We argue that EBM is based upon reliabilist epistemological assumptions, and that this is appropriate - we should focus on identifying the most reliable processes for generating and collecting medical knowledge. However, we note that this should not be reduced to narrow questions about which research methodologies are the best for gathering evidence. Reliable processes for generating medical evidence might lie outside of formal research methods. We also question (...) the notion of the knower that is assumed by EBM. We argue that EBM assumes an enlightenment conception of knowers as autonomous, substitutable individuals. This conception is troubled by the way that clinicians learn the role of anecdote in health care and the role of patient choice, all of which bring into play features of clinicians and patients as situated individuals with particular backgrounds and experiences. EBM's enlightenment conception of the knower is also troubled by aspects of the way evidence is produced. Given these limitations, we argue that EBM should retain its reliabilist bent, but should look beyond formal research methodologies in identifying processes that yield reliable evidence for clinical practice. We suggest looking to feminist epistemology, with its focus on the standpoints of individual situated knowers, and the role of social context in determining what counts as knowledge. (shrink)

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. (shrink)

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope individuals have to (...) influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

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. (shrink)

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. (shrink)

Many countries are experiencing increasing levels of demand for access to assisted reproductive technologies. Policies regarding who can access ART and with what support from a collective purse are highly contested, raising questions about what state responses are justified. Whilst much of this debate has focused on the status of infertility as a disease, we argue that this is something of a distraction, since disease framing does not provide the far-reaching, robust justification for state support that proponents of ART seem (...) to suppose. Instead, we propose that debates about appropriate state responses should consider the various implications for health and broader well-being that may be associated with difficulties starting a family. We argue that the harms and disruption to valued life projects of subfertility-related suffering may provide a stronger basis for justifying state support in this context. Further, we suggest that, whilst ART may alleviate some of the harm resulting from subfertility, population-level considerations can indicate a broader range of interventions aimed at tackling different sources of subfertility-related harm, consistent with broader public health aims. (shrink)

In this paper we argue that surgeons face a particular kind of within-role conflict of interests, related to innovation. Within-role conflicts occur when the conflicting interests are both legitimate goals of professional activity. Innovation is an integral part of surgical practice but can create within-role conflicts of interest when innovation compromises patient care in various ways, such as by extending indications for innovative procedures or by failures of informed consent. The standard remedies for conflicts of interest are transparency and recusal, (...) which are unlikely to address this conflict, in part because of unconscious bias. Alternative systemic measures may be more effective, but these require changes in the culture of surgery and accurate identification of surgical innovation. (shrink)

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. (shrink)

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. (shrink)

The aim of this book is to provide an accessible account of ethics in general practice, addressing concerns identified by practitioners. It contains many examples and allows the reader to gain practical insights into how to identify and analyze the ethical issues they encounter in everyday general practice.

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. (shrink)

The interaction between evidence-based medicineand doctors' duty of care to patients iscomplex. One the one hand, there is surely anobligation to take account of the bestavailable evidence when offering health care topatients. On the other hand, it is equallyimportant to be aware of important shortcomingsin the processes and practices ofevidence-based medicine. There are tensionsbetween the population focus of evidence-basedmedicine and the duties that doctors have toindividual patients. Implementingevidence-based medicine may have unpredictableconsequences upon the overall quality of healthcare. Patients may have (...) a range of reasons forpreferring one form of treatment over another,not all of which are captured by currentformulations of evidence. This paper examinesthese issues, using relevant examples fromevidence-based medicine. (shrink)

Department of Medical Education, Flinders University of South Australia, GPO Box 2100, Adelaide SA 5001. Tel. : +61-8-7225-1111; Fax: +61-8-8204-5675; Email: lee0359{at}flinders.edu.au ' + u + '@ ' + d + ' '/ /- ->.This paper analyses the role of communication strategies in pandemic influenza planning. Our central concern is with the extent to which nations are using communication to address issues of social justice. Issues associated with disadvantage and vulnerability to infection in the event of an influenza pandemic raise (...) distinct questions about how well less well off groups will be protected. The potential for a public health emergency of this type to exacerbate existing inequalities, making those in less well off positions worse off, makes social justice an important consideration for pandemic planners. National PI plans offer insights into the ways that nations may use communication to address issues of disadvantage, thereby providing a way of examining how communication strategies are presented and their potential to mitigate inequities. Our research reviewed 12 national PI plans and assessed the extent to which nations are using communication to assist and limit possible harms to less well off groups. We outline in this paper some important issues and considerations associated with social justice and flu planning, in particular if and how plans are addressing inequalities. CiteULike Connotea Del.icio.us What's this? (shrink)

Public health plays an important, albeit often unnoticed, role in protecting and promoting the health of populations. The activities of public health are complex, performed by multiple professionals, and range from the innocuous to the intrusive. Ethical analyses in public health reflect some of this complexity and fragmentation, with no one approach able to capture the full range of ethical considerations raised by public health activities. There are however, good reasons why we should pursue such analyses. Providing a robust ethical (...) framework for public health may promote the identity and function of public health, address some of the shortcomings of utilitarianism, and help to combat the threat that public health faces through lack of political will in many parts of the world.In this paper I argue that Alasdair MacIntyre’s account of practices and virtues can make a valuable contribution to public health ethics. The first part of the paper argues that public health may properly be described as the type of practice that provides an arena for the exercise of virtues. This is followed by an analysis of the three virtues of honesty, courage and justice in public health practice. Using virtue theory captures morally important elements of public health and helps to maintain awareness of significant moral values in the practice of public health. Such awareness is crucial in maintaining and defending the integrity of public health. (shrink)

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.

Since the 1990s, glycated haemoglobin (HbA1C) has been the gold standard for monitoring glycaemic control in people diagnosed as having either type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM). Discussions are underway about diagnosing diabetes mellitus on the basis of HbA1C titres and using HbA1C tests to screen for T2DM. These discussions have focused on the relative benefits for individual patients, with some attention directed towards reduced costs to healthcare systems and benefits to society. We argue that (...) there are strong ethical reasons for adopting HbA1C-based diagnosis and T2DM screening that have not yet been articulated. The rationale includes the differential impact of HbA1C-based diabetic testing on disadvantaged groups, and what we are beginning to learn about HbA1C vis-à-vis population health. Although it is arguable that screening must primarily benefit the individual, using HbA1C to diagnose and screen for T2DM may promote a more just distribution of health resources and lead to advances in investigating, monitoring and tackling the social determinants of health. (shrink)

Volume 19, Issue 6, June 2019, Page 28-29.

We agree with Faunce’s proposal that academic legitimacy is important in ensuring that whistle-blowing is included in medical curricula. We disagree, however, with the assertion that this is best achieved by means of an over-arching theoretical foundation for health care whistle-blowing of the kind suggested by Faunce. We propose that systematic theoretical justification is neither the sole nor the main determinant of academic legitimacy when it comes to matters for inclusion in medical school curricula, and outline an alternative view, together (...) with a practical example of a healthcare whistle-blowing topic. (shrink)

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 and negative form. 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 …. (shrink)

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. (shrink)