Throughout, this book questions our accepted definitions and biases, showing the self-reflective nature of scientific activity within society.

In a recent paper in this journal, John Worrall (2008) used the example of a series of trials involving extracorporeal membrane oxygenation (ECMO), a technology for the treatment of respiratory failure in newborns, to illustrate the relationship between ethics and epistemology in medical research. One of the issues considered was whether or not it was ethical to perform a particular clinical trial at all, and he showed clearly that the answer was intimately related to epistemological judgments about the weight to (...) be given existing evidence concerning treatment effectiveness. In the case of ECMO, a trial was initiated at the University of Michigan (Bartlett et al. 1985), despite the fact that the researchers had .. (shrink)

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

David Sackett and Jack Wennberg have each introduced and developed ideas and methods that have had major impacts on how we think about and perform clinical research. Sackett is best known for his work in Evidence-Based Medicine (Sackett et al. 1997); Wennberg, upon noting wide geographic (and other) variations in best practices for the same conditions, stressed the importance of comparative effectiveness in clinical decision-making (Wennberg et al. 1993). When these two collaborated in an editorial about the current state of (...) the art and science of clinical research, it comes as no great surprise that they produced some truly memorable guidance. And, as is so often the case for inspired—and inspiring—advice, their .. (shrink)

Survival of the fittest in evolutionary biology has a counterpart in the evolution of research paradigms. It’s called survival of the funded, and there is a sense in which paradigms are even more adaptable than species. Whereas species may become extinct if their fitness declines below a critical threshold, paradigms can rise again, perhaps with a new name, following fiscal collapse, provided only that funding is once again made available.A current example is the born-again concept of comparative effectiveness research , (...) which achieved resurrection status with the passage of the Affordable Care Act of 2010. The ACA established a private, nonprofit entity to oversee publicly financed CER. According to .. (shrink)

Because “evidence” is at issue in evidence-based medicine (EBM), the critical responses to the movement have taken up themes from post-positivist philosophy of science to demonstrate the untenability of the objectivist account of evidence. While these post-positivist critiques seem largely correct, I propose that when they focus their analyses on what counts as evidence, the critics miss important and desirable pragmatic features of the evidence-based approach. This article redirects critical attention toward EBM’s rigid hierarchy of evidence as the culprit of (...) its objectionable epistemic practices. It reframes the EBM discourse in light of a distinction between objectivist and pragmatic epistemology, which allows for a more nuanced analysis of EBM than previously offered: one that is not either/or in its evaluation of the decision-making technology as either iconoclastic or creedal. -/- . (shrink)

In his Art and Illusion, art historian Ernst Gombrich argues that the emergence and development of styles of pictorial representation depend on the availability of certain schemata, which can be documented. He himself documents the schemata responsible for the emergence and development of several styles. Nothing of this kind has been done as far as the growth of scientific knowledge is concerned. In this article we discuss whether is it possible to document something analogous to Gombrich's schemata that can be (...) of crucial relevance for the development of clinical research. (shrink)

Ethics and epistemology in medicine are more closely and more interestingly intertwined than is usually recognized. To explore this relationship, I present a case study, clinical trials of extracorporeal membrane oxygenation (ECMO; an intervention for persistent pulmonary hypertension of the newborn).Three separate ethical issues that arise from this case study-whether or not it is ethical to perform a certain trial at all, whether stopping rules for trials are ethically mandated, and the issue of informed consent-are all shown to be intimately (...) related to epistemological judgments about the weight of evidence. Although ethical issues cannot, of course, be resolved by consideration of epistemological findings, I argue that no informed view of the ethical issues that are raised can be adopted without first taking an informed view of the evidential-epistemological ones. (shrink)

Obviously medicine should be evidence-based. The issues lie in the details: what exactly counts as evidence? Do certain kinds of evidence carry more weight than others? (And if so why?) And how exactly should medicine be based on evidence? When it comes to these details, the evidence-based medicine (EBM) movement has got itself into a mess – or so it will be argued. In order to start to resolve this mess, we need to go 'back to basics'; and that means (...) turning to the philosophy of science. The theory of evidence, or rather the logic of the interrelations between theory and evidence, has always been central to the philosophy of science – sometimes under the alias of the 'theory of confirmation'. When taken together with a little philosophical commonsense, this logic can help us move towards a position on evidence in medicine that is more sophisticated and defensible than anything that EBM has been able so far to supply. (shrink)

Even in the increasingly individualized American medical system, advocates of 'personalized medicine' claim that healthcare isn't individualized enough. With the additional glamour of new biotechnologies such as genetic testing and pharmacogenetics behind it, 'Me Medicine'-- personalized or stratified medicine-- appears to its advocates as the inevitable and desirable way of the future. Drawing on an extensive evidence base, this book examines whether these claims are justified. It goes on to examine an alternative tradition rooted in communitarian ideals, that of the (...) common good as a goal in medicine. (shrink)

The evidence-based medicine (EBM) movement is touted as a new paradigm in medical education and practice, a description that carries with it an enthusiasm for science that has not been seen since logical positivism flourished (circa 1920–1950). At the same time, the term ‘‘evidence-based medicine’’ has a ring of obviousness to it, as few physicians, one suspects, would claim that they do not attempt to base their clinical decision-making on available evidence. However, the apparent obviousness of EBM can and should (...) be challenged on the grounds of how ‘evidence’ has been problematised in the philosophy of science. EBM enthusiasm, it follows, ought to be tempered. The post-positivist, feminist, and phenomenological philosophies of science that are examined in this paper contest the seemingly unproblematic nature of evidence that underlies EBM by emphasizing different features of the social nature of science. The appeal to the authority of evidence that characterizes evidence-based practices does not increase objectivity but rather obscures the subjective elements that inescapably enter all forms of human inquiry. The seeming common sense of EBM only occurs because of its assumed removal from the social context of medical practice. In the current age where the institutional power of medicine is suspect, a model that represents biomedicine as politically disinterested or merely scientific should give pause. (shrink)

Neo-positivism is dead. Let that imperfect designation stand for the project that dominated and defined the philosophy of science, especially in its Anglophone form, during the fifty or so years following the end of the Second World War. While its critics were many,1 its death was slow, and some think still to find a pulse.2 But die it did in the cul-de-sac into which it was led by its own faulty compass.

This paper describes a Bayesian approach to the design and analysis of clinical trials, and compares it with the frequentist approach. Both approaches address learning under uncertainty. But they are different in a variety of ways. The Bayesian approach is more flexible. For example, accumulating data from a clinical trial can be used to update Bayesian measures, independent of the design of the trial. Frequentist measures are tied to the design, and interim analyses must be planned for frequentist measures to (...) have meaning. Its flexibility makes the Bayesian approach ideal for analysing data from clinical trials. In carrying out a Bayesian analysis for inferring treatment effect, information from the clinical trial and other sources can be combined and used explicitly in drawing conclusions. Bayesians and frequentists address making decisions very differently. For example, when choosing or modifying the design of a clinical trial, Bayesians use all available information, including that which comes from the trial itself. The ability to calculate predictive probabilities for future observations is a distinct advantage of the Bayesian approach to designing clinical trials and other decisions. An important difference between Bayesian and frequentist thinking is the role of randomization. (shrink)

This volume thus clears the ground for the productive and fruitful integration of these new developments into philosophy of science.