Overdiagnosis and disease are related concepts. Widened conceptions of disease increase overdiagnosis and vice versa. This is partly because there is a close and complex relationship between disease and overdiagnosis. In order to address the problems with overdiagnosis, we may benefit from a closer understanding this relationship. Accordingly, the objective of this article is to elucidate the relationship between disease and overdiagnosis. To do so, the article starts with scrutinizing how overdiagnosis can explain the (...) expansion of the concept of disease. Then it investigates how definitions of disease address various challenges of overdiagnosis. The article specifically investigates recent attempts to clarify the relationship between the concepts of disease and overdiagnosis. Several shortcomings are identified and lead to a closer analysis of overdiagnosis in the diagnostic process. Contrary to recent contributions to the field, it is argued that cases of overdiagnosis are not cases of disease. They are nonverified labelling of disease. It is revealed how overdiagnosis establishes an unwarranted link between indicative phenomena, such as polyps or cell changes, and harm, and thereby generates a link to disease. One implication of this study is that we should stop attributing disease language to indicative phenomena. That is, we should stop calling it "cancer screening" when we are actually searching for polyps. Another implications is that we should strive for scientific progress in differentiating phenomena that are of negative value to us from those that are not. In overdiagnosis we diagnose something that is not disease: it is over-diagnosis. (shrink)

Overdiagnosis and disease are related concepts. Widened conceptions of disease increase overdiagnosis and vice versa. This is partly because there is a close and complex relationship between disease and overdiagnosis. In order to address the problems with overdiagnosis, we may benefit from a closer understanding this relationship. Accordingly, the objective of this article is to elucidate the relationship between disease and overdiagnosis. To do so, the article starts with scrutinizing how overdiagnosis can explain the (...) expansion of the concept of disease. Then it investigates how definitions of disease address various challenges of overdiagnosis. The article specifically investigates recent attempts to clarify the relationship between the concepts of disease and overdiagnosis. Several shortcomings are identified and lead to a closer analysis of overdiagnosis in the diagnostic process. Contrary to recent contributions to the field, it is argued that cases of overdiagnosis are not cases of disease. They are non-verified labelling of disease. It is revealed how overdiagnosis establishes an unwarranted link between indicative phenomena, such as polyps or cell changes, and harm, and thereby generates a link to disease. One implication of this study is that we should stop attributing disease language to indicative phenomena. That is, we should stop calling it “cancer screening” when we are actually searching for polyps. Another implications is that we should strive for scientific progress in differentiating phenomena that are of negative value to us from those that are not. In overdiagnosis we diagnose something that is not disease: it is over-diagnosis. (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)

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)

Medicalization is frequently defined as a process by which some non-medical aspects of human life become to be considered as medical problems. Overdiagnosis, on the other hand, is most often defined as diagnosing a biomedical condition that in the absence of testing would not cause symptoms or death in the person’s lifetime. Medicalization and overdiagnosis are related concepts as both expand the extension of the concept of disease. They are both often used normatively to critique unwarranted or contested (...) expansion of medicine and to address health services that are considered to be unnecessary, futile, or even harmful. However, there are important differences between the concepts, as not all cases of overdiagnosis are medicalizations and not all cases of medicalizations are overdiagnosis. The objective of this article is to clarify the differences between medicalization and overdiagnosis. It will demonstrate how the subject matter of medicalization traditionally has been non-medical (social or cultural everyday life) phenomena, while the subject matter of overdiagnosis has been biological or biomolecular conditions or processes acknowledged being potentially harmful. They also refer to different types of uncertainty: medicalization is concerned with indeterminacy, while overdiagnosis is concerned with lack of prognostic knowledge. Medicalization is dealing with sickness (sick role) while overdiagnosis with disease. Despite these differences, medicalization and overdiagnosis are becoming more alike. Medicalization is expanding, encompassing the more “technical” aspects of overdiagnosis, while overdiagnosis is becoming more ideologized. Moreover, with new trends in modern medicine, such as P4 (preventive, predictive, personal, and participatory) medicine, medicalization will become all-encompassing, while overdiagnosis more or less may dissolve. In the end they may converge in some total “iatrogenization.” In doing so, the concepts may lose their precision and critical sting. (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)

. Recent philosophers of science have not only revived the classical argument from inductive risk but extended it. I argue that some of the purported extensions do not fit cleanly within the schema of the original argument, and I discuss the problem of overdiagnosis of disease due to expanded disease definitions in order to show that there are some risks in the research process that are important and that very clearly fall outside of the domain of inductive risk. Finally, (...) I introduce the notion of epistemic risk in order to characterize such risks. (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 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. (shrink)

Overdiagnosis is an emerging problem in health policy and practice: we address its definition and ethical implications. We argue that the definition of overdiagnosis should be expressed at the level of populations. Consider a condition prevalent in a population, customarily labelled with diagnosis A. We propose that overdiagnosis is occurring in respect of that condition in that population when the condition is being identified and labelled with diagnosis A in that population ; this identification and labelling would (...) be accepted as correct in a relevant professional community; but the resulting label and/or intervention carries an unfavourable balance between benefits and harms. We identify challenges in determining and weighting relevant harms, then propose three central ethical considerations in overdiagnosis: the extent of harm done, whether harm is avoidable and whether the primary goal of the actor/s concerned is to benefit themselves or the patient, citizen or society. This distinguishes predatory, misdirected and tragic overdiagnosis; the degree of harm moderates the justifiability of each type. We end with four normative challenges: methods for adjudicating between professional standards and identifying relevant harms and benefits should be procedurally just; individuals, organisations and states are differently responsible for addressing overdiagnosis; overdiagnosis is a matter for distributive justice: the burdens of both overdiagnosis and its prevention could fall on the least-well-off; and communicating about overdiagnosis risks harming those unaware that they may have been overdiagnosed. These challenges will need to be addressed as the field develops. (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)

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)

There are many analogies between medical and judicial practice. This article explores one such analogy, between “medicalization” and “criminalization.” Specifically, drawing on an analogy between a judge’s speech act of delivering a verdict and a physician’s speech act of giving a diagnosis, it suggests a novel account of the phenomenon of “overdiagnosis.” Using this approach, we can make some headway in understanding debates over the early detection of cancer. The final section outlines the relationship between this approach and familiar (...) debates in philosophy of medicine on the nature of disease and in philosophy of science on the “value-free ideal.”. (shrink)

Cancer screening programmes cause harm to individuals via overdiagnosis and overtreatment, even where they confer population-level benefit. Screening thus appears to violate the principle of non-maleficence, since it entails medically unnecessary harm to individuals. Can consent to screening programmes negate the moral significance of this harm? In therapeutic medical contexts, consent is used as a means of rendering medical harm morally permissible. However, in this paper, I argue that it is unclear that the model of consent used within therapeutic (...) medicine can be applied unproblematically to preventive medicine. Invitation to screening changes the pragmatic norms and expectations of the patient–doctor encounter such that two key principles of consent may be violated. First, the pragmatics of a medical invitation are such that patients may fail to be adequately informed, since patients appear to assume medical invitations are made with their best interests in mind, even where information to the contrary is outlined. Second, screening invitations may place pressure on patients; in the context of a medical encounter, to make an invitation to screening may constitute an inducement to accept. In order to be sure that a patient’s consent to a screening invitation is valid, we must make clear to patients that their decision to accept screening may be shaped not only by how information about screening is presented, but by the pragmatic form of the invitation itself. (shrink)

Emil Kraepelin's nosology has been reinvented, for better or worse. In the United States, the rise of the neo-Kraepelinian nosology of DSM-III resuscitated Kraepelin's work but also differed from many of his ideas, especially his overtly biological ontology. This neo-Kraepelinian system has led to concerns regarding overdiagnosis of psychiatric syndromes (.

Proponents of the emerging field of P4 medicine argue that computational integration and analysis of patient-specific “big data” will revolutionize our health care systems, in particular primary care-based disease prevention. While many ambitions remain visionary, steps to personalize medicine are already taken via personalized genomics, mobile health technologies and pilot projects. An important aim of P4 medicine is to enable disease prevention among healthy persons through detection of risk factors. In this paper, we examine the current status of P4 medicine (...) in light of historical and current challenges to predictive and preventive medicine, including overdiagnosis and overtreatment. Moreover, we ask whether it is likely that in silico integration of patient-specific data will be able to better deal such challenges and to turn risk predictions into disease-preventive actions in a wider social context. Given the lack of evidence that P4 medicine can tip the balance between benefits and harms in preventive medicine, we raise concerns about the current promotion of P4 medicine as a solution to the current challenges in public health. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Close Enemies: The Relationship of Psychiatry and Psychology in the Assessment of Mental DisordersPhilippe Le Moigne, PhDAs Peter Zachar rightly points out in his comment, the assessment of mental disorders underwent new developments with the release of the Diagnostic and Statistical Manual of Mental Disorders-V in 2013 (American Psychiatric Association, 2013). Whereas in 1980, the manual had been thought of in a rigorously categorical way, on the basis of (...) distinct and closed syndromic entities, this new version advocated the development of a radically dimensionalist approach, with the diagnosis aiming this time to restore the whole symptomatological picture of the patient on a spectrum of ratings are supposed to cover the entirety of psychiatric semiology (American Psychiatric Association, 2013).For its part, my article aimed to show how standardized assessment, guided by the return of psychiatry’s authority and the assertion of its legitimacy in the diagnostic field, gave the ascendancy in the 1980s to the classificatory tradition and thus to the categorical model, to the detriment of personality approach and test psychology which offered a competing solution here. This perspective, historically dated, may have led the reader to think that there is an antagonism that cannot be overcome here. Rather, it should be seen as a form of structuring opposition, or even a “complementarity inscribed in rivalry,” between psychiatry and psychology, which is naturally susceptible to change over time.Indeed, the reversal operated by the Diagnostic and Statistical Manual of Mental Disorders-V is not total because it cannot be total. The defense of the dimensionalist approach, dear to the psychological testing tradition, was intended here to allow the identification of co-morbidities, present in most patients but poorly apprehended by the categorical approach, and to open up diagnosis to prevention by screening for minor manifestations of psychopathology when they suggest the [End Page 259] development of a manifest episode of the disease in the more or less long term. The risk here is that we end up with overdiagnosis and thus an over-representation of false positives (Wakefield, 2015). In other words, this type of approach does not escape the obligation to determine threshold scores, likely to indicate the lower limit of the disorder, and thus to resort to a categorical approach. There is a first affinity between the two perspectives which obeys, beyond the divergences in principle, a technical requirement.But the two approaches have even more in common when we look at their epistemological background: they share the idea that the representation and the intervention on mental disorder, to use Ian Hacking’s expression (1983), must be based on the model proposed by the physical and natural sciences. And as Greta Kaluzeviciute aptly points out in her comment, this orientation leads to the idea of measuring mental disorder in particular to conduct elaborate quantification operations to determine, for example, whether two entities are statistically distinct or whether a drug has a significant effect on the evolution of a pathology.This is in fact an old question that can be formulated as follows, to use the expression of the psychometrician Joel Michell (1999): are psychological dimensions metric? In other words, if we want to apply the language of numbers to mental disorders, they must share its properties, two of which seem essential: it must be possible to establish that each mental disorder, in the same way as qualities attributable to length for example, has a zero and can be divided by means of gradients (or degrees of intensity) whose interval is constant (Le Moigne, 2018; Michell, 1999). For lack of space, let us only address the second condition. This one has already been denied by many, starting with Bergson at the end of the nineteenth century (1889). He does not believe in the quantification of psychological expressions, starting with sensations. What is the common point, he wrote, between the feeling of a mild pain, as one feels a stiffness, and the sensation of a needle being hammered into your flesh? For him, one and the other of these intensities are incomparable, so that they do not belong to a similar register of sensations that one could stage from a 0 toward a... (shrink)

Increased knowledge of the gene–disease associations contributing to common cancer development raises the prospect of population stratification by genotype and other risk factors. Individual risk assessments could be used to target interventions such as screening, treatment and health education. Genotyping neonates, infants or young children as part of a systematic programme would improve coverage and uptake, and facilitate a screening package that maximises potential benefits and minimises harms including overdiagnosis. This paper explores the potential justifications and risks of genotyping (...) children for genetic variants associated with common cancer development within a personalised screening programme. It identifies the ethical and legal principles that might guide population genotyping where the predictive value of the testing is modest and associated risks might arise in the future, and considers the standards required by population screening programme validity measures . These are distinguished from the normative principles underpinning predictive genetic testing of children for adult-onset diseases—namely, to make best-interests judgements and to preserve autonomy. While the case for population-based genotyping of neonates or young children has not yet been made, the justifications for this approach are likely to become increasingly compelling. A modified evaluative and normative framework should be developed, capturing elements from individualistic and population-based approaches. This should emphasise proper communication and genuine parental consent or informed choice, while recognising the challenges associated with making unsolicited approaches to an asymptomatic group. Such a framework would be strengthened by complementary empirical research. (shrink)

Proponents of the emerging field of P4 medicine argue that computational integration and analysis of patient-specific “big data” will revolutionize our health care systems, in particular primary care-based disease prevention. While many ambitions remain visionary, steps to personalize medicine are already taken via personalized genomics, mobile health technologies and pilot projects. An important aim of P4 medicine is to enable disease prevention among healthy persons through detection of risk factors. In this paper, we examine the current status of P4 medicine (...) in light of historical and current challenges to predictive and preventive medicine, including overdiagnosis and overtreatment. Moreover, we ask whether it is likely that in silico integration of patient-specific data will be able to better deal such challenges and to turn risk predictions into disease-preventive actions in a wider social context. Given the lack of evidence that P4 medicine can tip the balance between benefits and harms in preventive medicine, we raise concerns about the current promotion of P4 medicine as a solution to the current challenges in public health. (shrink)

This book focuses on justice and its demands in the way of providing people with medical care. Building on recent insights on the nature of moral perceptions and motivations from the neurosciences, it makes a case for the traditional medical ethic and examines its financial feasibility. The book starts out by giving an account of the concept of justice and tracing it back to the practices and tenets of Hippocrates and his followers, while taking into account findings from the neurosciences. (...) Next, it considers whether the claim that it is just to limit medical care for everyone to some basic minimum is justifiable. The book then addresses finances and expenditures of the US health care system and shows that the growth of expenditures and the percentage of the gross national product spent on health care make for an unsustainable trajectory. In light of the question what should be changed, the book suggests that overdiagnosis and medicalizing normal behavior lead to harmful, costly and unnecessary interventions and are the result of unethical behavior on the part of the pharmaceutical industry and extensive ethical failures of the FDA. The book ends with suggestions about what can be done to put the U.S. health care system on the path to sustainability, better medical care, and compliance with the demands of justice. (shrink)

Prostate cancer (PCa) is one of the the most common cancers in men. A blood test called prostate-specific antigen (PSA) has a potential to pick up this cancer very early and is used for screening of this disease. However, screening for prostate cancer is a matter of debate. Level 1 evidence from randomised controlled trials suggests a reduction in cancer-specific mortality from PCa screening. However, there could be an associated impact on quality of life due to a high proportion of (...) overdiagnosis and overtreatment as part of the screening. The US Preventive Services Task Force (USPSTF) in 2012 recommended that PSA-based PCa screening should not to be offered at any age. However, considering the current evidence, USPSTF recently revised its recommendation to offer the PSA test to men aged 55–69 years with shared decision-making, in line with earlier guidelines from the American Cancer Society and the American Urological Association. A shared decision making is necessary since the PSA test could potentially harm an individual. However, the literature suggests that clinicians often neglect a discussion on this issue before ordering the test. This narrative discusses the main controversies regarding PCa screening including the PSA threshold for biopsy, the concept of overdiagnosis and overtreatment, the practical difficulties of active surveillance, the current level 1 evidence on the mortality benefit of screening, and the associated pitfalls. It offers a detailed discussion on the ethics involved in the PSA test and highlights the barriers to shared decision-making and possible solutions. (shrink)

In modern medicine, health risks are often managed through the collection of health data and subsequent intervention. One of the goals of clinical genetics, for example, is to identify genetic predisposition to disease so that individuals can intervene to prevent potential harms. But recently, some clinicians have suggested that patients should undergo less testing and monitoring in an effort to reduce overdiagnosis and overtreatment. In this paper, I explore how clinicians navigate the tension between identifying real disease risks for (...) their patients with concerns about overdiagnosis and overtreatment. I focus on clinicians ordering genetic testing for inherited cardiovascular diseases. Of the genes determined to be “clinically actionable” by the American College of Medical Genetics and Genomics, half are related to cardiovascular diseases. But, due in part to high levels of uncertainty surrounding cardiovascular genetics, there is still disagreement within the field about how to order and interpret these tests. Based on semi-structured, in-depth interviews with 20 clinicians who order genetic testing for cardiovascular diseases, I find that there is considerable variability in the ways that clinicians determine which types of genetic tests are appropriate for their patients and how they interpret test results. Most importantly, I find that many providers do not presume that more genetic data will lead to better care. Instead, increased genetic data can lead to confusion and inappropriate treatment. This re-valuation of the utility of medical data is crucial for bioethicists to explore, especially as medical fields are sorting through increasing amounts of data. (shrink)

Predictive interventions and practices are becoming a defining feature of medicine. The author points out that according to the inner logic and external supporters of modern medicine, participating in healthcare increasingly means participating in knowing, sharing, and using of predictive information. At the same time, the author addresses the issue that predictive information may also have problematic side effects like overdiagnosis, health-related anxiety, and worry as well as impacts on personal life plans. The question is raised: Should we resort (...) to stigmatization if doing so would increase participation in predictive interventions, and thereby save healthcare costs and reduce morbidity and premature death? The paper concludes that even if such a strategy cannot be ruled out in some forms and contexts, we ought to be very cautious about the dangers of shame and stigmatization. (shrink)

How can we draw the line between health and disease? This crucial question of demarcation has immense practical implications and has troubled scholars for ages. The question will be addressed in three steps. First, I will present an important contribution by Rogers and Walker who argue forcefully that no line can be drawn between health and disease. However, a closer analysis of their argument reveals that a line-drawing problem for disease-related features does not necessarily imply a line-drawing problem for disease (...) as such. The second step analyzes some alternative approaches to drawing the line between health and disease. While these approaches do not provide full answers to the question, they indicate that the line-drawing question should not be dismissed too hastily. The third step investigates whether the line-drawing problem can find its solution in the concept of suffering. In particular, I investigate whether returning to the origin of medicine, with the primary and ultimate goal of reducing suffering, may provide sources of demarcation between health and disease. In fact, the reason why we pay attention to particular phenomena as characteristics of disease, consider certain processes to be relevant, and specific functions are classified as dys-functions, is that they are related to suffering. Accordingly, using suffering as a criterion of demarcation between health and disease may hinder a wide range of challenges with modern medicine, such as unwarranted expansion of disease, overdiagnosis, overtreatment, and medicalization. (shrink)

This article investigates five kinds of vagueness in medicine: disciplinary, ontological, conceptual, epistemic, and vagueness with respect to descriptive-prescriptive connections. First, medicine is a discipline with unclear borders, as it builds on a wide range of other disciplines and subjects. Second, medicine deals with many indistinct phenomena resulting in borderline cases. Third, medicine uses a variety of vague concepts, making it unclear which situations, conditions, and processes that fall under them. Fourth, medicine is based on and produces uncertain knowledge and (...) evidence. Fifth, vagueness emerges in medicine as a result of a wide range of fact-value-interactions. The various kinds of vagueness in medicine can explain many of the basic challenges of modern medicine, such as overdiagnosis, underdiagnosis, and medicalization. Even more, it illustrates how complex and challenging the field of medicine is, but also how important contributions from the philosophy can be for the practice of medicine. By clarifying and, where possible, reducing or limiting vagueness, philosophy can help improving care. Reducing the various types of vagueness can improve clinical decision-making, informing individuals, and health policy making. (shrink)

Screening for asymptomatic disease is a routine aspect of contemporary public health practice. However, it is also controversial, because it leads to overdiagnosis and overtreatment, with many arguing that programmes are “ineffective,” i.e., the “costs” outweigh the “benefits.” This paper explores a more fundamental objection to screening programmes: that, even if they are effective, they are ethically impermissible because they breach the principle of non-maleficence. In so doing, it suggests a new approach to the ethics of risk, justifying a (...) concern with how policies affect individuals’ absolute ex-ante prospects. Part 1 sets up the tension between screening and non-maleficence. Part 2 introduces and motivates a novel interpretation of the non-maleficence principle, “ex-ante Do No Harm,” which resolves this tension. Part 3 defends and clarifies this principle by discussing its relationship to the ex-ante Pareto principle. Part 4 discusses the worry that risk estimates are too “subjective.”. (shrink)

There is a profound paradox in modern medical knowledge production: The more we know, the more we know that we (still) do not know. Nowhere is this more visible than in diagnostics and early detection of disease. As we identify ever more markers, predictors, precursors, and risk factors of disease ever earlier, we realize that we need knowledge about whether they develop into something experienced by the person and threatening to the person’s health. This study investigates how advancements in science (...) and technology alter one type of uncertainty, i.e., temporal uncertainty of disease diagnosis. As diagnosis is related to anamnesis and prognosis it identifies how uncertainties in all these fields are interconnected. In particular, the study finds that uncertainty in disease diagnosis has become more subject to prognostic uncertainty because diagnosis is more connected to technologically detected indicators and less closely connected to manifest and experienced disease. These temporal uncertainties pose basic epistemological and ethical challenges as they can result in overdiagnosis, overtreatment, unnecessary anxiety and fear, useless and even harmful diagnostic odysseys, as well as vast opportunity costs. The point is not to stop our quest for knowledge about disease but to encourage real diagnostic improvements that help more people in ever better manner as early as possible. To do so, we need to pay careful attention to specific types of temporal uncertainty in modern diagnostics. (shrink)

Science and technology have vastly expanded the realm of medicine. The numbers of and knowledge about diseases has greatly increased, and we can help more people in many more ways than ever before. At the same time, the extensive expansion has also augmented harms, professional responsibility, and ethical concerns. While these challenges have been studied from a wide range of perspectives, the problems prevail. This article adds value to previous analyses by identifying how the moral imperative of medicine has expanded (...) in three ways: (1) from targeting experienced phenomena, such as pain and suffering, to non-experienced phenomena (paraclinical signs and indicators); (2) from addressing present pain to potential future suffering; and (3) from reducing negative wellbeing (pain and suffering) to promoting positive wellbeing. These expansions create and aggravate problems in medicine: medicalization, overdiagnosis, overtreatment, risk aversion, stigmatization, and healthism. Moreover, they threaten to infringe ethical principles, to distract attention and responsibility from other competent agents and institutions, to enhance the power and responsibility of professionals, and to change the professional-beneficiary relationship. In order to find ways to manage the moral expansion of medicine, four traditional ways of setting limits are analyzed and dismissed. However, basic asymmetries in ethics suggest that it is more justified to address people’s negative wellbeing (pain and suffering) than their positive wellbeing. Moreover, differences in epistemology, indicate that it is less uncertain to address present pain and suffering than future wellbeing and happiness. Based on these insights the article concludes that the moral imperative of medicine has a gradient from pain and suffering to wellbeing and happiness, and from the present to the future. Hence, in general present pain and suffering have normative priority over future positive wellbeing. (shrink)

This issue of the Hastings Center Report includes a special report that comes out of a three-year Hastings Center research project on controversies surrounding the diagnosis and treatment of mental disorders in children. Over the last couple of decades, the number of children diagnosed with mental disorders has risen significantly, and so, too, has the number of children prescribed medications. Some critics have accused psychiatry of overdiagnosis—of sometimes diagnosing children with psychiatric disorders when their behavior is actually within the (...) range of normal. This controversy led Erik Parens and Josie Johnston, authors of the report and the Hastings Center investigators in this project, to ask what a .. (shrink)

Fake news and alternative facts have become commonplace in these so-called “post-factual times.” What about medical research - are scientific facts fake as well? Many recent disclosures have fueled the claim that scientific facts are suspect and that science is in crisis. Scientists appear to engage in facting interests instead of revealing interesting facts. This can be observed in terms of what has been called polarised research, where some researchers continuously publish positive results while others publish negative results on the (...) same issue – even when based on the same data. In order to identify and address this challenge, the objective of this study is to investigate how polarised research produce “polarised facts.” Mammography screening for breast cancer is applied as an example. The main benefit with mammography screening is the reduced breast cancer mortality, while the main harm is overdiagnosis and subsequent overtreatment. Accordingly, the Overdiagnosis to Mortality Reduction Ratio is an estimate of the risk-benefit-ratio for mammography screening. As there are intense interests involved as well as strong opinions in debates on mammography screening, one could expect polarisation in published results on OMRR. A literature search identifies 8 studies publishing results for OMRR and reveals that OMRR varies 25-fold, from 0.4 to 10. Two experts in polarised research were asked to rank the attitudes of the corresponding authors to mammography screening of the identified publications. The results show a strong correlation between the OMRR and the authors’ attitudes to screening. Mammography screening for breast cancer appears as an exemplary field of strongly polarised research. This is but one example of how scientists’ strong professional interests can polarise research. Instead of revealing interesting facts researchers may come to fact interests. In order to avoid this and sustain trust in science, researchers should disclose professional and not only financial interests when submitting and publishing research. (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)