This paper examines potential ethical and legal issues arising during the research, develop- ment and clinical use of a proposed strategy in personalized medicine (PM): using human induced pluripotent stem cell (iPSC)-derived tissue cultures as predictive models of individ- ual patients to inform treatment decisions. We focus on epilepsy treatment as a likely early application of this strategy, for which early-stage stage research is underway. In relation to the research process, we examine issues associated with biological samples; data; health; vulnerable (...) populations; neural organoids; and what level of accuracy justifies using the iPSC-derived neural tissue system. In relation to clinical use, we examine potential uses in pre-natal screening, and effects on clinical decision-making. Although our focus is providing recommendations for researchers developing work in this area, we identify the novel issue of deciding on an acceptable accuracy level for the system. We also emphasize an issue thus far neglected in the ethics of PM: PM tends to represent treatment decisions as though they should be directed solely by biomedical information, but this in itself could be detri- mental to best personalizing treatment decisions in the clinic. (shrink)

In contrast to standardized guidelines, personalized medicine and person centered care are two notions that have recently developed and are aspiring for more individualized health care for each single patient. While having a similar drive toward individualized care, their sources are markedly different. While personalized medicine stems from a biomedical framework, person centered care originates from a caring perspective, and a wish for a more holistic view of patients. It is unclear to what extent these two concepts can be combined (...) or if they conflict at fundamental or pragmatic levels. This paper reviews existing literature in both medicine and related philosophy to analyze closer the meaning of the two notions, and to explore the extent to which they overlap or oppose each other, in theory or in practice, in particular regarding ethical assumptions and their respective practical implications. (shrink)

This article explores the ways in which predictive information technologies are used in the field of personalized medicine and the relations between this use and how patients and disease are perceived. This is examined in a qualitative case study of a personalized cancer clinical trial, where oncologists made clinical decisions for each patient based on drug matchings and efficacy predictions produced by bioinformatic technologies and algorithms. I focus on personalized practice itself, as a postgenomic phenomenon, rather than on epistemic, ethical (...) and institutional critiques. Personalized medicine aims to process molecular, clinical, environmental and social data into individually tailored decisions. In this case, however, the engagement of clinicians with data and digital artefacts that processed multiple information sources resulted in treatment choices that were paradoxically both immutable and uncertain. In contrast to the situatedness of the body in postgenomics, this practice subverted the personalized medical approach while decontextualizing both cancer and patients. (shrink)