Evidence-Based Medicine is a relatively new movement that seeks to put clinical medicine on a firmer scientific footing. I take it as uncontroversial that medical practice should be based on best evidence—the interesting questions concern the details. This paper tries to move towards a coherent and unified account of best evidence in medicine, by exploring in particular the EBM position on RCTs.

The problem of collecting, analyzing and evaluating evidence on adverse drug reactions (ADRs) is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of the health-care practice. Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a special (...) attention to the privileged role assigned to randomized controlled trials in Evidence Based Medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended effects, in that the unknowns at stake are heterogonous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their main focus is methodological, and regards the fact that bias and confounding do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints which we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood to be different in the case of evidence for risk vs. benefit assessment. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. (shrink)

Semmelweis’s investigations of puerperal fever are some of the most interesting in the history of medicine. This paper considers Hempel’s analysis of the Semmelweis case. It argues that this analysis is inadequate and needs to be supplemented by some Kuhnian ideas. Kuhn’s notion of paradigm needs to be modified to apply to medicine in order to take account of the classification schemes involved in medical theorising. However with a suitable modification it provides an explanation of Semmelweis’s failure which is argued (...) to be superior to some of the external reasons often given. Despite this success in applying Kuhn’s ideas to medicine, it is argued that these ideas must be further modified to take account of the fact that medicine is not a natural science but primarily a practice designed to prevent and cure diseases. (shrink)

Semmelweis’s investigations of puerperal fever are some of the most interesting in the history of medicine. This paper considers Hempel’s analysis of the Semmelweis case. It argues that this analysis is inadequate and needs to be supplemented by some Kuhnian ideas. Kuhn’s notion of paradigm needs to be modified to apply to medicine in order to take account of the classification schemes involved in medical theorising. However with a suitable modification it provides an explanation of Semmelweis’s failure which is argued (...) to be superior to some of the external reasons often given. Despite this success in applying Kuhn’s ideas to medicine, it is argued that these ideas must be further modified to take account of the fact that medicine is not a natural science but primarily a practice designed to prevent and cure diseases. (shrink)

Evidence based medicine (EBM) is under critical debate, and person centered healthcare (PCH) has been proposed as an improvement. But is PCH offered as a supplement or as a replacement of EBM? Prima facie PCH only concerns the practice of medicine, while the contended features of EBM also include methods and medical model. I here argue that there are good philosophical reasons to see PCH as a radical alternative to the existing medical paradigm of EBM, since the two seem committed (...) to conflicting ontologies. This paper aims to make explicit some of the most fundamental assumptions that motivate EBM and PCH, respectively, in order to show that the choice between them ultimately comes down to ontological preference. While EBM has a solid foundation in positivism, or what I here call Humeanism, PCH is more consistent with causal dispositionalism. I conclude that if there is a paradigmatic revolution on the way in medicine, it is first of all one of ontology. (shrink)