Today\'s surge of big data coming from multiple sources is raising the stakes that pharmacovigilance has to win, making evidence synthesis a more and more robust approach in the field. In this scenario, many scholars believe that new computational methods derived from data mining will effectively enhance the detection of early warning signals for adverse drug reactions, solving the gauntlets that post-marketing surveillance requires. This article highlights the need for a philosophical approach in order to fully realize a pharmacovigilance 2.0 revolution. A state of the art on evidence synthesis is presented, followed by the illustration of E-Synthesis, a Bayesian framework for causal assessment. Computational results regarding dose-response evidence are shown at the end of this article.

This paper develops a probabilistic reconstruction of the No Miracles Argument (NMA) in the debate between scientific realists and anti-realists. The goal of the paper is to clarify and to sharpen the NMA by means of a probabilistic formalization. In particular, I demonstrate that the persuasive force of the NMA depends on the particular disciplinary context where it is applied, and the stability of theories in that discipline. Assessments and critiques of \"the\" NMA, without reference to a particular context, are misleading and should be relinquished. This result has repercussions for recent anti-realist arguments, such as the claim that the NMA commits the base rate fallacy (Howson (2000), Magnus and Callender (Philosophy of Science, 71:320-338, 2004)). It also helps to explain the persistent disagreement between realists and anti-realists.

In their comparative analysis of Randomised Clinical Trials and observational studies, Papanikoloau et al. (2006) assert that \"it may be unfair to invoke bias and confounding to discredit observational studies as a source of evidence on harms\". There are two kinds of answers to the question why this is so. One is based on metaphysical assumptions, such as the problem of causal sufficiency, modularity and other statistical assumptions. The other is epistemological and relates to foundational issues and how they determine the constraints we put on evidence. I will address here the latter dimension and present recent proposals to amend evidence hierarchies for the purpose of safety assessment of pharmaceuticals; I then relate these suggestions to a case study: the recent debate on the causal association between paracetamol and asthma. The upshot of this analysis is that different epistemologies impose different constraints on the methods we adopt to collect and evaluate evidence; thus they grant \"lower level\" evidence on distinct grounds and at different conditions. Appreciating this state of affairs illuminates the debate on the epistemic asymmetry concerning benefits and harms and sets the basis for a foundational, as opposed to heuristic, justification of safety assessment based on heterogeneous evidence.