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)

Since the turn of the twenty-first century, biomedical psychiatry around the globe has embraced the so-called precision medicine paradigm, a model for medical research that uses innovative techniques for data collection and analysis to reevaluate traditional theories of disease. The goal of precision medicine is to improve diagnostics by restratifying the patient population on the basis of a deeper understanding of disease processes. This paper argues that precision is ill-fitting for psychiatry for two reasons. First, in psychiatry, unlike in fields (...) like oncology, precision medicine has been understood as an attempt to improve medicine by casting out, rather than merely revising, traditional taxonomic tools. Second, in psychiatry the term “biomarker” is often used in reference to signs or symptoms that allow patients to be classified and then matched with treatments; however, in oncology “biomarker” usually refers to a disease mechanism that is useful not only for diagnostics, but also for discovering causal pathways that drug therapies can target. Given these differences between how the precision medicine paradigm operates in psychiatry and in other medical fields like oncology, while precision psychiatry may offer successful rhetoric, it is not a promising paradigm. (shrink)

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)

What should be the content of a package of health care services that we would want to guarantee to all Americans? This question cannot be answered adequately apart from also addressing the issue of fair health care rationing. Consequently, as I argue in this essay, appeal to the language of "basic," "essential," "adequate," "minimally decent," or "medically necessary" for purposes of answering our question is unhelpful. All these notions are too vague to be useful. Cost matters. Effectiveness matters. The clinical (...) circumstances of a patient matters. But what we must ultimately determine is what we mutually agree are the just claims to needed health care of each American in a relatively complex range of clinical circumstances. Answering this question will require a public moral conversation, a fair process of rational democratic deliberation aimed at defining both just claims to needed health care and just limits. (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)

Over the last decade, personalized medicine has become a buzz word, which covers a broad spectrum of meanings and generates many different opinions. The purpose of this article is to achieve a better understanding of the reasons why personalized medicine gives rise to such conflicting opinions. We show that a major issue of personalized medicine is the gap existing between its claims and its reality. We then present and analyze different possible reasons for this gap. We propose an hypothesis inspired (...) by the Windelband’s distinction between nomothetic and idiographic methodology. We argue that the fuzzy situation of personalized medicine results from a mix between idiographic claims and nomothetic methodological procedures. Hence we suggest that the current quandary about personalized medicine cannot be solved without getting involved in a discussion about the complex epistemological and methodological status of medicine. To conclude, we show that the Gadamer’s view of medicine as a dialogical process can be fruitfully used and reveals that personalization is not a theoretical task, but a practical one, which takes place within the clinical encounter. (shrink)