There is growing interest among pharmaceutical policymakers in how to “disinvest” from subsidized medicines. This is due to both the rapidly rising costs of healthcare and the increasing use of accelerated and conditional reimbursement pathways which mean that medicines are being subsidized on the basis of less robust evidence of safety and efficacy. It is crucial that disinvestment decisions are morally sound and socially legitimate, but there is currently no framework to facilitate this. We therefore reviewed the bioethics literature in (...) order to identify ethical principles and concepts that might be relevant to pharmaceutical disinvestment decisions. This revealed a number of key ethical considerations—both procedural and substantive—that need to be considered when making pharmaceutical disinvestment decisions. These principles do not, however, provide practical guidance so we present a framework outlining how they might be applied to different types of disinvestment decisions. We also argue that, in this context, even the most rigorous ethical reasoning is likely to be overridden by moral intuitions and psychological biases and that disinvestment decisions will need to strike the right balance between respecting justifiable moral intuitions and overriding unjustifiable psychological impulses. (shrink)

What clinicians, biomedical scientists, and other health care professionals know as individuals or as groups and how they come to know and use knowledge are central concerns of medical epistemology. Activities associated with knowledge production and use are called epistemic practices. Such practices are considered in biomedical and clinical literatures, social sciences of medicine, philosophy of science and philosophy of medicine, and also in other nonmedical literatures. A host of different kinds of knowledge claims have been identified, each with different (...) uses and logics of justification. A general framework is needed to situate these diverse contributions in medical epistemology, so we can see how they fit together. But developing such a framework turns out to be quite tricky. In this survey, three possible frameworks are considered along with the difficulties associated with each of them. The essay concludes with a fourth framework, which considers any epistemology as part of a practice that is oriented toward overcoming errors that emerge in antecedently given practices where knowledge is developed and used. As medicine indirectly advances health by directly mitigating disease, so epistemology indirectly advances knowledge by directly mitigating error. (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)