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)

Information and computer technology has come to play an increasingly important role in medicine, to the extent that e-health has been described as a disruptive innovation or revolution in healthcare. The attention is very much focused on the technology itself, and advances that have been made in genetics and biology. This leads to the question: What is changing in medicine today concerning e-health? To what degree could these changes be characterized as a ‘revolution’? We will apply the work of Thomas (...) Kuhn, Larry Laudan, Michel Foucault and other philosophers—which offers an alternative understanding of progress and revolution in medicine to the classic discovery-oriented approach—to our analysis. Nowadays, the long-standing curative or reactive paradigm in medicine is facing a crisis due to an aging population, a significant increase in chronic diseases and the development of more expensive diagnostic tools and therapies. This promotes the evolution towards a new paradigm with an emphasis on preventive medicine. E-health constitutes an essential part of this new paradigm that seeks to solve the challenges presented by an aging population, skyrocketing costs and so forth. Our approach changes the focus from the technology itself toward the underlying paradigm shift in medicine. We will discuss the relevance of this approach by applying it to the surge in digital self-tracking through health apps and wearables: the recognition of the underlying paradigm shift leads to a more comprehensive understanding of self-tracking than a solely discovery-oriented or technology-focused view can provide. (shrink)

The term ‘environment’ is not uniformly defined in the public health sciences, which causes crucial inconsistencies in research, health policy, and practice. As we shall indicate, this is somewhat entangled with diverging pathogenic and salutogenic perspectives (research and policy priorities) concerning environmental health. We emphasise two distinct concepts of environment in use by the World Health Organisation. One significant way these concepts differ concerns whether the social environment is included. Divergence on this matter has profound consequences for the understanding of (...) health and disease, for measures derived from that understanding targeting health promotion and disease prevention, and consequently, for epistemic structures and concept development in scientific practice. We hope to improve the given situation in public health by uncovering these differences and by developing a fruitful way of thinking about environment. Firstly, we side with the salutogenic conception of environment as a _health resource_ (as well as a source of health risks). Secondly, we subdivide the concept of environment into four _health-oriented environmental categories_ (viz., natural, built-material, socio-cultural, and psychosocial) and we link these with other theoretical notions proposed in the health sciences literature. Thirdly, we propose that in public health ‘environment’ should be understood as consisting of all extrinsic factors that influence or are influenced by the health, well-being, and development of an individual. Consequently, none of the four categories should be excluded from the concept of environment. We point out the practical relevance and fruitfulness of the conception of environment as a health source and frame this in causal terms, representing _individual health environments_ as causal networks. Throughout, we side with the view that for the design of human health-promoting settings, increased attention and consideration of environmental resources of salutogenic potential is particularly pressing. (shrink)

The idea of personalised medicine (PM) has gathered momentum recently, attracting funding and generating hopes as well as scepticism. As PM gives rise to differing interpretations, there have been several attempts to clarify the concept. In an influential paper published in this journal, Schleidgen and colleagues have proposed a precise and narrow definition of PM on the basis of a systematic literature review. Given that their conclusion is at odds with those of other recent attempts to understand PM, we consider (...) whether their systematic review gives them an edge over competing interpretations. We have found some methodological weaknesses and questionable assumptions in Schleidgen and colleagues’ attempt to provide a more specific definition of PM. Our perplexities concern the lack of criteria for assessing the epistemic strength of the definitions that they consider, as well as the logical principles used to extract a more precise definition, the narrowness of the pool from which they have drawn their empirical data, and finally their overlooking the fact that definitions depend on the context of use. We are also worried that their ethical assumption that only patients’ interests are legitimate is too simplistic and drives all other stakeholders’ interests—including those that are justifiable—underground, thus compromising any hope of a transparent and fair negotiation among a plurality of actors and interests. As an alternative to the shortcomings of attempting a semantic disciplining of the concept we propose a pragmatic approach. Rather than considering PM to be a scientific concept in need of precise demarcation, we look at it as an open and negotiable concept used in a variety of contexts including at the level of orienting research goals and policy objectives. We believe that since PM is still more an ideal than an achieved reality, a plurality of visions is to be expected and we need to pay attention to the people, reasons and interests behind these alternative conceptions. In other words, the logic and politics of PM cannot be disentangled and disagreements need to be tackled addressing the normative and strategic conflicts behind them. (shrink)

BackgroundOver the past decade, the exponential growth of the literature devoted to personalized medicine has been paralleled by an ever louder chorus of epistemic and ethical criticisms. Their differences notwithstanding, both advocates and critics share an outdated philosophical understanding of the concept of personhood and hence tend to assume too simplistic an understanding of personalization in health care.MethodsIn this article, we question this philosophical understanding of personhood and personalization, as these concepts shape the field of personalized medicine. We establish a (...) dialogue with phenomenology and hermeneutics (especially with E. Husserl, M. Merleau-Ponty and P. Ricoeur) in order to achieve a more sophisticated understanding of the meaning of these concepts We particularly focus on the relationship between personal subjectivity and objective data.ResultsWe first explore the gap between the ideal of personalized healthcare and the reality of today’s personalized medicine. We show that the nearly exclusive focus of personalized medicine on the objective part of personhood leads to a flawed ethical debate that needs to be reframed. Second, we seek to contribute to this reframing by drawing on the phenomenological-hermeneutical movement in philosophy. Third, we show that these admittedly theoretical analyses open up new conceptual possibilities to tackle the very practical ethical challenges that personalized medicine faces.ConclusionFinally, we propose a reversal: if personalization is a continuous process by which the person reappropriates all manner of objective data, giving them meaning and thereby shaping his or her own way of being human, then personalized medicine, rather than being personalized itself, can facilitate personalization of those it serves through the data it provides. (shrink)