Since the advent of drug regulation in 1962, regulatory agencies have been in the practice of using strict standards to test the safety and efficacy of medical treatments and products. Regulatory agencies, such as the FDA, demand two full-fledged Randomized Clinical Trials demonstrating the safety and effectiveness of drugs to grant its marketing authorization. On the contrary, surgical treatments are left completely unregulated. There are several reasons explaining this difference, and all of them point to the difficulty of conducting well-designed (...) RCTs in surgery. However, we argue that none of these arguments is decisive and that, under certain conditions, surgical RCTs can be morally justified and methodologically sound. Although ethical constraints restrict the number of testable surgical procedures, and surgical trials might not be as dependable as pharmaceutical RCTs, our analysis suggests that, in certain cases, it is possible to obtain high-quality evidence about the safety and efficacy of surgical procedures. Untested surgical treatments may prove to be ineffective and harm patients. Therefore, regulation of surgical procedures seems not only morally acceptable and able to provide reliable scientific evidence, but also desirable and justified from an ethical-political standpoint. (shrink)

Fact-checking agencies assess and score the truthfulness of politicians’ claims to foster their electoral accountability. Fact-checking is sometimes presented as a quasi-scientific activity, based on reproducible verification protocols that would guarantee an unbiased assessment. We will study these verification protocols and discuss under which conditions fact-checking could achieve effective reproducibility. Through an analysis of the methodological norms in verification protocols, we will argue that achieving reproducible fact-checking may not help much in rendering politicians accountable. Political fact-checkers do not deliver either (...) reproducibility or accountability today, and there are reasons to think that traditional quality journalism may serve liberal democracies better. (shrink)

In the science and values literature, scholars have shown how science is influenced and shaped by values, often in opposition to the ‘value free’ ideal of science. In this paper, we aim to contribute to the science and values literature by showing that the relation between science and values flows not only from values into scientific practice, but also from (allegedly neutral) science to values themselves. The extant literature in the ‘science and values’ field focuses by and large on reconstructing, (...) post hoc, how values have influenced science; our reconstruction of the case studies, instead, aims to show that scientific concepts and methods _too, because of specific identifiable characteristics,_ can promote some values rather than (or at the expense of) others. We explain this bidirectional relation in analogy to debates on the normativity of technical artifacts and on feminist approaches in science, and we illustrate our claims with cases from the health sciences and machine learning. While our arguments in this paper also draw on post hoc reconstructions, we intend to show where, in the science in the making, we should engage not only with the question whether a practice is value-laden, but also how specific conceptual and methodological choices can influence values down the road. All in all, these considerations expand the ways in which philosophers can contribute to more value-aware scientific practices. (shrink)

The increasing success of the evidence-based policy movement is raising the demand of empirically informed decision making. As arguably any policy decision happens under conditions of uncertainty, following our best available evidence to reduce the uncertainty seems a requirement of good decision making. However, not all the uncertainty faced by decision makers can be resolved by evidence. In this paper, we build on a philosophical analysis of uncertainty to identify the boundaries of scientific advice in policy decision making. We start (...) by introducing a distinction between empirical and non-empirical types of uncertainty, and we explore the role of two non-empirical uncertainties in the context of policy making. We argue that the authority of scientific advisors is limited to empirical uncertainty and cannot extend beyond it. While the appeal of evidence-based policy rests on a view of scientific advice as limited to empirical uncertainty, in practice there is a risk of over reliance on experts beyond the legitimate scope of their authority. We conclude by applying our framework to a real-world case of evidence-based policy, where experts have overstepped their boundaries by ignoring non-empirical types of uncertainty. (shrink)

In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology and health claim regulation. We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: a) one that argues (...) for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes. (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)