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)

Human uterus transplantation is currently under investigation as a treatment for uterine infertility. Without a uterus transplant, the options available to women with uterine infertility are adoption or surrogacy; only the latter has the potential for a genetically related child. UTx will offer recipients the chance of having their own pregnancy. This procedure occurs at the intersection of two ethically contentious areas: assisted reproductive technologies and organ transplantation. In relation to organ transplantation, UTx lies with composite tissue transplants such as (...) face and limb grafts, and shares some of the ethical concerns raised by these non-life saving procedures. In relation to ART, UTx represents one more avenue by which a woman may seek to meet her reproductive goals, and as with other ART procedures, raises questions about the limits of reproductive autonomy. This paper explores the ethical issues raised by UTx with a focus on the potential gap between women's desires and aspirations about pregnancy and the likely functional outcomes of successful UTx. (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)

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)

Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only (...) identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. (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)

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)

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. (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)

Patient visits are an important opportunity for general practitioners to discuss the risks of smoking and cessation strategies. In Australia, the guidelines on cessation published by the Royal Australian College of General Practitioners represent a key resource for GPs in this regard. The predominant message of the Guidelines is that pharmacotherapy should be recommended as first-line therapy for smokers expressing an interest in quitting. This, however, ignores established evidence about the success of unassisted quitting. Our analysis of the Guidelines identifies (...) a number of potential conflicts of interest which may have affected the advice provided. These include extensive funding by the pharmaceutical industry of sources cited to support the recommendations, and relations between members of the Guidelines Content Advisory Group and the pharmaceutical industry. Recommendations issued by professional bodies have enormous potential impact upon public health and there is a need for the highest levels of scrutiny and transparency in their development. Information about research cited in guidelines should include funding sources, and developers should be free of obvious conflicts of interest. Smoking remains the leading preventable cause of global mortality. Concerns related to pharmaceutical industry funding of research, scientific integrity and recommendations on smoking cessation by medical advisory groups clearly have implications beyond Australia. (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)

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)

Clinicians and policy makers the world over are embracing evidence-based medicine. The promise of EBM is to use summaries of research evidence to determine which healthcare interventions are effective and which are not, so that patients may benefit from effective interventions and be protected from useless or harmful ones. EBM provides an ostensibly rational and objective means of deciding whether or not an intervention should be provided on the basis of its effectiveness, in theory leading to fair and effective healthcare (...) for all. In this paper I closely examine these claims from the perspective of healthcare for women, using relevant examples. I argue that the current processes of evidence-based medicine contain a number of biases against women. These biases occur in the production of the research that informs evidence-based medicine, in the methods used to analyse and synthesise the evidence, and in the application of EBM through the use of guidelines. Finally, the biomedical model of health that underpins most of the medical research used by EBM ignores the social and political context which contributes so much to the ill-health of women. (shrink)

Trust is taken to be one of the foundational values in the doctor-patient relationship, facilitating access to the benefits of health care and providing a guarantee against possible harms. Despite this foundational role, some doctors betray the trust of their patients. Trusting involves granting discretionary powers and makes the truster vulnerable to the trustee. Patients trust medical practitioners to act with goodwill and to act competently. Some patients carry pre-existing vulnerabilities, for reasons such as gender, poverty, age, ethnicity, or disability, (...) and these vulnerabilities can be exacerbated when such patients extend their trust to a doctor. Gender stereotypes reduce women's ability to challenge and thereby assess their doctor's competency. In addition, women are more likely to be distrusted by their doctors and have their experiences of medical symptoms discounted. In this paper, we analyze two extreme examples of breaches of medical trust that exploited the vulnerability of women in the health care system: the "unfortunate experiment" at the National Women's Hospital in New Zealand and the Harold Shipman murders of elderly patients in the United Kingdom, examining the potential role of gender in the outcomes with regard to trust. Major breaches of medical trust such as these typically lead to government inquiries, revisions of ethical guidelines, and substantive policy change in an effort to re-establish public and patient trust. We argue that the medical profession has an ethical obligation to put mechanisms in place to protect vulnerable patients from abuses of trust, to monitor colleagues' competence, and to be prepared to blow the whistle to protect patients who are not in a position to recognize misplaced trust. Such mechanisms will act disprosportionately to reduce harm to women as patients. (shrink)

Patient or public involvement in health research is increasingly expected as a matter of policy. In theory, PPI can contribute both to the epistemic aims intrinsic to research, and to extrinsically valued features of research such as social inclusion and transparency. In practice, the aims of PPI have not always been clear, although there has been a tendency to encourage the involvement of so-called ordinary people who are regarded as representative of an assumed patient perspective. In this paper we focus (...) on the epistemic potential of PPI, using theoretical work in epistemology to develop a nuanced account of patients’ experiential knowledge and how this might contribute directly to conceptual development, hypothesis generation and data interpretation. We also consider how some features of health research pose barriers to this kind of epistemic contribution. Drawing on Miranda Fricker’s idea of testimonial injustice, we explore how disciplinary indicators of credibility in clinical and academic health research contexts might be wrongly applied to those involved in PPI, undermining their potential to contribute. Finally we argue for a range of strategies to maximize opportunities for patients to engage with research teams and make epistemologically significant contributions to research. (shrink)

Medical issues affecting health care have become everyday media events. In response to mounting public concern, growing numbers of bioethicists are being appointed to medical school faculties and public policy panels. However the ideas voiced in these forums are seldom informed by feminist perspectives. In this important book, a distinguished group of feminist scholars and activists discuss crucial bioethics topics in a feminist light. Among the subjects explored are the care/justice debates, transforming bioethics, practice, and reproduction. The book also covers (...) less commonly discussed issues, such as culturally appropriate responses to reproductive health problems in developing countries. (shrink)

This volume breaks new ground by investigating the ethics of vulnerability. Drawing on various ethical traditions, the contributors explore the nature of vulnerability, the responsibilities owed to the vulnerable, and by whom.

Financial and nonfinancial conflicts of interest in medicine and surgery are troubling because they have the capacity to skew decision making in ways that might be detrimental to patient care and well-being. The recent case of the Articular Surface Replacement (ASR) hip provides a vivid illustration of the harmful effects of conflicts of interest in surgery.

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.

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)

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)

Inclusion in research is a question of both scientific validity of research results and just distribution of the benefits of medical research within a community. Therefore, inappropriate exclusions from research can be regulated as a matter of science or a matter of ethics. In this paper we examine the definitions of appropriate/fair inclusion in the Australian and U.S. regulatory systems and discuss the processes for interpreting and implementing these normative standards. In the second part of the paper, we present original (...) results from the first study of sex-specific research in Australia. One hundred and thirteen published papers were examined: 35 percent were classified as inappropriate sex-specific research, where exclusion was not biologically necessary, and/or there was no justification for the exclusion of one sex. Our results indicate that a scientific approach to inclusion, rather than one grounded in ethical review, is likely to be more effective in achieving appropriate sex-specific research. In the absence of effective regulation, we will continue to see research that discriminates unfairly and perpetuates gender stereotyping. (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)

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)

108 COWLEY RD, OXFORD, ENGLAND, OXON, OX4 1JF.

When implanted devices fail, the harms are significant. In addition to the patient’s original problem, the failure of the device can cause its own considerable damage, requiring removal of the implant and, in some cases, precipitating ongoing health problems. One recent high profile case of device failure is that of the metal-on-metal De Puy ASR hip replacement system, which left tens of thousands of people with cobalt-chromium toxicity and the need for a joint revision. Another concerns tissue repair mesh products (...) marketed for repair of pelvic organ prolapse, which have the unfortunate complication of grating on adjacent organs.1 These kinds of outcomes are... (shrink)

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. (shrink)

OBJECTIVES: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. BACKGROUND: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. METHODS: Using conceptual analysis, this article synthesizes findings from relevant literature, and (...) from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. RESULTS: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation, is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something "new". CONCLUSIONS: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations. (shrink)

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)

Surgery is an increasingly common and expensive mode of medical intervention. The ethical dimensions of the surgeon-patient relationship, including respect for personal autonomy and informed consent, are much discussed; but broader equity issues have not received the same attention. This paper extends the understanding of surgical ethics by considering the nature of evidence in surgery and its relationship to a just provision of healthcare for individuals and their populations.

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)

The American Journal of Bioethics, Volume 11, Issue 9, Page 18-20, September 2011.