Despite its vagueness Personalized, Precision, P4, P5, individualized, stratified medicine—or p-medicine in short—has become an increasingly popular term in biomedical literature. Philosophers have attempted to analyze what these various terms involve and have discussed consequences for medical practices. In this article, I argue that an important question remains unaddressed: what has made this project of p-medicine convincing to so many? My argument is that without real achievements, it would never have been. I also make the case that these achievements stem (...) from the domain of monoclonal antibodies, a new type of drug that justifies talks of personalized, precise, stratified, etc., medicine. In conclusion, while it may be possible to label any projection in the future of medicine as ‘p-medicine’, it is impossible to overlook mab-medicine as the spearhead. (shrink)

Personalised medicine has been discussed as a medical paradigm shift that will improve health while reducing inefficiency and waste. At the same time, it raises new practical, regulatory, and ethical challenges. In this paper, we examine PM strategies epistemologically in order to develop capacities to address these challenges, focusing on a recently proposed strategy for developing patient-specific models from induced pluripotent stem cells so as to make individualised treatment predictions. We compare this strategy to two main PM strategies—stratified medicine and (...) computational models. Drawing on epistemological work in the philosophy of medicine, we explain why these two methods, while powerful, are neither truly personalised nor, epistemologically speaking, novel strategies. Both are forms of correlational black box. We then argue that the iPSC models would count as a new kind of black box. They would not rely entirely on mechanistic knowledge, and they would utilise correlational evidence in a different way from other strategies—a way that would enable personalised predictions. In arguing that the iPSC models would present a novel method of gaining evidence for clinical practice, we provide an epistemic analysis that can help to inform the practical, regulatory, and ethical challenges of developing an iPSC system. (shrink)

Personalized Medicine (PM) is an evolving and often missinterpreted concept and no agreement of personalization exist. We examined the PM discourse towards foucauldian archeological and genealogical analysis to understand the meaning of “personalization” in medicine. In the archaeological analysis, the historical evolution is characterized by the coexistence of two epistemologies: the holistic vision and the omic sciences. The genealogical analysis shows how these epistemologies may affect the meaning of “person” and, consequently, the ontology of patients. Additionally, substitutions/confusions of the term (...) PM are related to continuously evolving medical knowledge and new technologies; different etymological roots of “personalization” and “person”; and cultural differences. In conclusion, if the definition of “personalization” in medicine is not clear, patients might get wrong expectations about what is achievable for their health. Therefore, epistemological trends should not be separated as they drive same goals: providing accurate diagnosis and treatments based on large data to predict disease progression. (shrink)