Regulating diagnosis-Molecular and regulatory sub-stratifications of lung cancer treatment.

The sociology of diagnosis has shown that diagnosis not only serves to label the underlying cause of disease but also to provide access to services and resources. Elaborating on this double-affordance of diagnosis, this article examines how precision medicine reconfigures diagnosis as a label and as a process in regulatory and clinical settings. Reporting from an ethnographic case study of the introduction of immunotherapy for lung cancer, the paper unfolds the uncertainties involved in dissecting diagnosis into layers and examines the efforts and negotiations it takes to enable these layers to work both as clinical entities and regulative entities with the purpose of delineating access to treatment. I suggest that the work of subdividing diseases into molecularly defined categories for the purpose of delineating treatment-eligible populations can be labelled 'diagnostic sub-stratification' and argue that it is pertinent to understand the political capacity of this strategy. Diagnostic sub-stratification involves a push of diagnosis from the clinic 'up' into the regulatory system and 'out' into the laboratories, obscuring who is accountable for the diagnostic categories employed to define patients' treatment access.

Good conduct in a context of rationing: A case study of how frontline professionals deal with distributive dilemmas of novel gene therapies.

Classical dilemmas of how to distribute limited resources have been rekindled by the rise of advanced, high-cost therapies. Building on a case study of a novel gene therapy in neuropaediatric care, this article explores the dilemmas that explicit priority setting can create for frontline professionals and develops a typology of professionals' responses to these dilemmas. Despite political attempts to centralise priority setting and spare health professionals from having to consider treatment costs at the 'bedside', this study shows that concern for economic efficiency and budget control nonetheless need to be handled and balanced against other accountabilities in the daily work of frontline professionals. Contributing to the sociological debate on priority setting and rationing, this study develops an analytical perspective attuned to the relational aspects of frontline work and the challenges related to the balancing of diverging ideas of good conduct. Further, focussing on an empirical field at the forefront of genomic medicine, this study brings the sociological debate on priority setting and rationing up to date with current developments in precision medicine.

Strategies of stratification: Regulating market access in the era of personalized medicine.

Personalized medicine raises the stakes of pharmaceutical market regulation. Drawing on pragmatist valuation studies and science and technology studies literature on personalized medicine and pharmaceutical markets, this article demonstrates how complex negotiations about the value of a pharmaceutical can constitute a market in various ways, while also shaping the concerned patient populations. Tracing the path of a pharmacogenetic treatment, Spinraza, from its approval by the European Medicines Agency to its adoption in the publicly funded Danish healthcare system, we show how the market was formatted through particular stratifications of the patient population. We conceptualize these seemingly technical moves as strategies of stratification, that is, the application of techniques to assemble and divide data - and what data are meant to represent - into groups delineated by certain characteristics. We argue that stakeholders' use of strategies of stratification has important implications not only for market access, but also for the delineation of diseases and patient populations. Hence, it is crucial to make intelligible the mutual constitution of pharmaceutical markets and patient populations and the political efforts of delineating and connecting the two.

[Rehabilitation and palliative care in cardiovascular diseases in Denmark].

An increasing number of Danes are living, and dying, with cardiovascular disease. There is good evidence for the impact of cardiac rehabilitation on coronary heart disease, heart failure and symptomatic peripheral arterial disease. However, more high-quality research is needed into a wider range of cardiac diseases including rehabilitation following cardiac arrest, and palliative care for patients with advanced heart disease. In this review it is discussed how to improve the quality of care and identify the direction of future research and development.