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)

Proponents of the emerging field of P4 medicine argue that computational integration and analysis of patient-specific “big data” will revolutionize our health care systems, in particular primary care-based disease prevention. While many ambitions remain visionary, steps to personalize medicine are already taken via personalized genomics, mobile health technologies and pilot projects. An important aim of P4 medicine is to enable disease prevention among healthy persons through detection of risk factors. In this paper, we examine the current status of P4 medicine (...) in light of historical and current challenges to predictive and preventive medicine, including overdiagnosis and overtreatment. Moreover, we ask whether it is likely that in silico integration of patient-specific data will be able to better deal such challenges and to turn risk predictions into disease-preventive actions in a wider social context. Given the lack of evidence that P4 medicine can tip the balance between benefits and harms in preventive medicine, we raise concerns about the current promotion of P4 medicine as a solution to the current challenges in public health. (shrink)

Although it is now generally acknowledged that new biomedical technologies often produce new definitions and sometimes even new concepts of disease, this observation is rarely used in research that anticipates potential ethical issues in emerging technologies. This article argues that it is useful to start with an analysis of implied concepts of disease when anticipating ethical issues of biomedical technologies. It shows, moreover, that it is possible to do so at an early stage, i.e., when a technology is only just (...) emerging. The specific case analysed here is that of 'molecular medicine'. This group of emerging technologies combines a 'cascade model' of disease processes with a 'personal pattern' model of bodily functioning. Whereas the ethical implications of the first are partly familiar from earlier -- albeit controversial -- forms of preventive and predictive medicine, those of the second are quite novel and potentially far-reaching. (shrink)

_Philosophy of Molecular Medicine: Foundational Issues in Theory and Practice_ aims at a systematic investigation of a number of foundational issues in the field of molecular medicine. The volume is organized around four broad modules focusing, respectively, on the following key aspects: What are the nature, scope, and limits of molecular medicine? How does it provide explanations? How does it represent and model phenomena of interest? How does it infer new knowledge from data and experiments? The essays collected here, authored (...) by prominent scientists and philosophers of science, focus on a handful of mainstream topics in the philosophical literature, such as _causation_, _explanation_, _modeling_, and _scientific inference_. These previously unpublished contributions shed new light on these traditional topics by integrating them with problems, methods, and results from three prominent areas of contemporary biomedical science: _basic research_, _translational_ and _clinical research_, and _clinical practice_. (shrink)

The phrase "personalized medicine" has a built-in positive spin. Simple genetic tests can sometimes predict whether a particular individual will have a positive response to a particular drug or, alternatively, suffer costly and debilitating side effects. But little attention has been given to some challenging issues of justice raised by personalized medicine. How should we determine who would have a just claim to access particular treatments, especially very expensive ones? How effective do those treatments need to be?If there were a (...) thick, bright line separating minimal responders from maximal responders, then we could allocate these treatments in a fair and cost-effective way. But there is no bright line. The .. (shrink)

Recently, individualized or personalized medicine (PM) has become a buzz word in the academic as well as public debate surrounding health care. However, PM lacks a clear definition and is open to interpretation. This conceptual vagueness complicates public discourse on chances, risks and limits of PM. Furthermore, stakeholders might use it to further their respective interests and preferences. For these reasons it is important to have a shared understanding of PM. In this paper, we present a sufficiently precise as well (...) as adequate definition of PM with the potential of wide acceptance. (shrink)

Although it is now generally acknowledged that new biomedical technologies often produce new definitions and sometimes even new concepts of disease, this observation is rarely used in research that anticipates potential ethical issues in emerging technologies. This article argues that it is useful to start with an analysis of implied concepts of disease when anticipating ethical issues of biomedical technologies. It shows, moreover, that it is possible to do so at an early stage, i.e. when a technology is only just (...) emerging. The specific case analysed here is that of ‘molecular medicine’. This group of emerging technologies combines a ‘cascade model’ of disease processes with a ‘personal pattern’ model of bodily functioning. Whereas the ethical implications of the first are partly familiar from earlier—albeit controversial—forms of preventive and predictive medicine, those of the second are quite novel and potentially far-reaching. (shrink)

The Diagnostic and Statistical Manual of Mental Disorders (DSM) is universally acknowledged as the prominent reference textbook for the diagnosis and assessment of psychiatric diseases. However, since the publication of its first version in 1952, controversies have been raised concerning its reliability and validity and the need for other novel clinical tools has emerged. Currently the DSM is in its fourth edition and a new fifth edition is expected for release in 2013, in an intense intellectual debate and in a (...) call for new proposals. (shrink)