This paper argues that there exists a collective epistemic state of ‘Broad Medical Uncertainty’ regarding the effectiveness of many medical interventions. We outline the features of BMU, and describe some of the main contributing factors. These include flaws in medical research methodologies, bias in publication practices, financial and other conflicts of interest, and features of how evidence is translated into practice. These result in a significant degree of uncertainty regarding the effectiveness of many medical treatments and unduly optimistic beliefs about (...) the benefit/harm profiles of such treatments. We argue for an ethical presumption in favour of openness regarding BMU as part of a ‘Corrective Response’. We then consider some objections to this position, including concerns that public honesty about flaws in medical research could undermine trust in healthcare institutions. We suggest that, as it stands, the Anti-Corrective Response is unconvincing. (shrink)

The explanatory/pragmatic-trial distinction enjoys a burgeoning philosophical and medical literature and a significant contingent of support among philosophers and healthcare stakeholders as an important way to assess the design and results of randomized controlled trials. A major motivation has been the need to provide relevant, generalizable data to drive healthcare decisions. While talk of pragmatic and explanatory trials could be seen as convenient shorthand, the distinction can also be seen as harboring deeper issues related to inferential strategies used to evaluate (...) causal claims regarding medical treatments. A comprehensive, critical analysis of the distinction and underlying epistemological framework upon which the distinction is based, particularly with respect to treatment effectiveness, has yet to be forthcoming. I provide this, analyzing the distinction’s relationship to generalizability and cognate distinctions between ideal conditions and real-world practice, internal and external validity, and efficacy and effectiveness. I also analyze recent philosophical work that relies on the explanatory/pragmatic-trial distinction and that advocates for more pragmatic trials. I conclude that as an organizing principle for trial-design decisions and trial evaluation, the explanatory/pragmatic-trial distinction is conceptually problematic and not as useful as its proponents seem to think. Since some pragmatic-trial features can be inimical to establishing treatment effectiveness, pragmatic-trial features should not be conflated with pragmatic trials’ avowed goals. If the distinction is to be useful, it and some associated concepts, including generalizability, should be reformulated, lest they continue to underlie a medical epistemology that could contribute to methodologically flawed and potentially unethical advice for the design and interpretation of trials. (shrink)

Medical necessity (claiming that a medical intervention or care is – at minimum – reasonable, appropriate and acceptable) depends on empirical evidence and on the interpretation of that evidence. Evidence and its interpretation define the standard of care. This commentary argues that both the evidence base and its interpretation are currently weak gatekeepers. Empirical meta-research suggests that very few medical interventions have high quality evidence in support of their effectiveness and very few of them also have relatively thorough assessments of (...) their potential harms. Therefore, evidence on the risk-benefit ratios carries almost always very large uncertainty. Arbitration about medical necessity is thus left to the interpretation process. Professional guidelines are notoriously unreliable and biased in this regard. Regulatory approval ends up being the key arbitrator, but over the years the regulatory process has been subverted. Regulatory approval currently does not mean that an intervention has a favourable risk-benefit ratio, but simply that it can be marketed, sold and made profit from. The process leads to a tragedy of commons where the final victim is society at large: medical necessity is invoked as an alibi for medicine to absorb societal resources. (shrink)

The EBM+ programme is an attempt to improve the way in which present-day evidence-based medicine (EBM) assesses causal claims: according to EBM+, mechanistic studies should be scrutinised alongside association studies. This paper addresses two worries about EBM+: (i) that it is not feasible in practice, and (ii) that it is too malleable, i.e., its results depend on subjective choices that need to be made in order to implement the procedure. Several responses to these two worries are considered and evaluated. The (...) paper also discusses the question of whether we should have confidence in medical interventions, in the light of Stegenga's arguments for medical nihilism. (shrink)