The teratogenicity of the Zika virus was considered established in 2016, and is an interesting case because three different sets of causal criteria were used to assess teratogenicity. This paper appeals to the thesis of Russo and Williamson (2007) to devise an epistemological framework that can be used to compare and evaluate sets of causal criteria. The framework can also be used to decide when enough criteria are satisfied to establish causality. Arguably, the three sets of causal criteria considered here (...) offer only a rudimentary assessment of mechanistic studies, and some suggestions are made as to alternative ways to establish causality. (shrink)

Russo and Williamson put forward the following thesis: in order to establish a causal claim in medicine, one normally needs to establish both that the putative cause and putative effect are appropriately correlated and that there is some underlying mechanism that can account for this correlation. I argue that, although the Russo-Williamson thesis conflicts with the tenets of present-day evidence-based medicine, it offers a better causal epistemology than that provided by present-day EBM because it better explains two key aspects of (...) causal discovery. First, the thesis better explains the role of clinical studies in establishing causal claims. Second, it yields a better account of extrapolation. (shrink)

Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision-making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these (...) costs and advocate for evaluating any scheme for drug regulatory tests in terms of concrete empirical benchmarks, like the error rates of regulatory decisions. (shrink)

Evidential Pluralism maintains that in order to establish a causal claim one normally needs to establish the existence of an appropriate conditional correlation and the existence of an appropriate mechanism complex, so when assessing a causal claim one ought to consider both association studies and mechanistic studies. Hitherto, Evidential Pluralism has been applied to medicine, leading to the EBM+ programme, which recommends that evidence-based medicine should systematically evaluate mechanistic studies alongside clinical studies. This paper argues that Evidential Pluralism can also (...) be fruitfully applied to the social sciences. In particular, Evidential Pluralism provides (i) a new approach to evidence-based policy; (ii) an account of the evidential relationships in more theoretical research; and (iii) new philosophical motivation for mixed methods research. The application of Evidential Pluralism to the social sciences is also defended against two objections. (shrink)

We argue that the health sciences make causal claims on the basis of evidence both of physical mechanisms, and of probabilistic dependencies. Consequently, an analysis of causality solely in terms of physical mechanisms or solely in terms of probabilistic relationships, does not do justice to the causal claims of these sciences. Yet there seems to be a single relation of cause in these sciences - pluralism about causality will not do either. Instead, we maintain, the health sciences require a theory (...) of causality that unifies its mechanistic and probabilistic aspects. We argue that the epistemic theory of causality provides the required unification. (shrink)

Varied evidence confirms more strongly than less varied evidence, ceteris paribus. This epistemological Variety of Evidence Thesis enjoys widespread intuitive support. We put forward a novel explication of one notion of varied evidence and the Variety of Evidence Thesis within Bayesian models of scientific inference by appealing to measures of entropy. Our explication of the Variety of Evidence Thesis holds in many of our models which also pronounce on disconfirmatory and discordant evidence. We argue that our models pronounce rightly. Against (...) a backdrop of failures of the Variety of Evidence Thesis, the intuitive case for the Variety of Evidence Thesis emerges strengthened. Our models do however not support the general case for the thesis since our explication of it fails to hold in certain cases. The parameter space of this failure is explored and an explanation for the failure is offered. (shrink)

Philosophical discussions on causal inference in medicine are stuck in dyadic camps, each defending one kind of evidence or method rather than another as best support for causal hypotheses. Whereas Evidence Based Medicine advocates the use of Randomised Controlled Trials and systematic reviews of RCTs as gold standard, philosophers of science emphasise the importance of mechanisms and their distinctive informational contribution to causal inference and assessment. Some have suggested the adoption of a pluralistic approach to causal inference, and an inductive (...) rather than hypothetico-deductive inferential paradigm. However, these proposals deliver no clear guidelines about how such plurality of evidence sources should jointly justify hypotheses of causal associations. We here develop such guidelines by first giving a philosophical analysis of the underpinnings of Hill’s viewpoints on causality. We then put forward an evidence-amalgamation framework adopting a Bayesian net approach to model causal inference in pharmacology for the assessment of harms. Our framework accommodates a number of intuitions already expressed in the literature concerning the EBM vs. pluralist debate on causal inference, evidence hierarchies, causal holism, relevance, and reliability. (shrink)

There are some philosophical questions that can be answered without attention to the social context in which evidence is produced and distributed.ing away from social context is an excellent way to ignore messy details and lay bare the underlying structure of the limits of inference. Idealization is entirely appropriate when one is essentially asking: In the best of all possible worlds, what am I entitled to infer? Yet, philosophers’ concerns often go beyond this domain. As an example I examine the (...) debate on mechanistic evidence and then reevaluate a canonical case study in this debate. I show that for the assessment of actual evidence, produced in a world that is far from ideal, omission of the social aspects of medical epistemology leads philosophers to draw the wrong lessons from cases they take as paradigmatic cases for their views. I close by arguing that social epistemology provides an avenue to incorporate these complications and provides the necessary framework to understand medical evidence. (shrink)

BackgroundThe public and healthcare workers have a high expectation of animal research which they perceive as necessary to predict the safety and efficacy of drugs before testing in clinical trials. However, the expectation is not always realised and there is evidence that the research often fails to stand up to scientific scrutiny and its 'predictive value' is either weak or absent.DiscussionProblems with the use of animals as models of humans arise from a variety of biases and systemic failures including: 1) (...) bias and poor practice in research methodology and data analysis ; 2) lack of transparency in scientific assessment and regulation of the research; 3) long-term denial of weaknesses in cross-species translation; 4) profit-driven motives overriding patient interests; 5) lack of accountability of expenditure on animal research; 6) reductionist-materialism in science which tends to dictate scientific inquiry and control the direction of funding in biomedical research.SummaryBias in animal research needs to be addressed before medical research and healthcare decision-making can be more evidence-based. Research funding may be misdirected on studying 'disease mechanisms' in animals that cannot be replicated outside tightly controlled laboratory conditions, and without sufficient critical evaluation animal research may divert attention away from avenues of research that hold promise for human health. The potential for harm to patients and trial volunteers from reliance on biased animal data1 requires measures to improve its conduct, regulation and analysis. This article draws attention to a few of the many forms of bias in animal research that have come to light in the last decade and offers a strategy incorporating ten recommendations stated at the end of each section on bias. The proposals need development through open debate and subsequent rigorous implementation so that reviewers may determine the value of animal research to human health. The 10Rs + are protected by a Creative Commons Attribution 3.0 Unported License and therefore may be 'shared, remixed or built on, even commercially, so long as attributed by giving appropriate credit with a link to the license, and indicate if changes were made.’. (shrink)

There is currently no viable alternative to the Bayesian analysis of scientific inference, yet the available versions of Bayesianism fail to do justice to several aspects of the testing and confirmation of scientific hypotheses. Bayes or Bust? provides the first balanced treatment of the complex set of issues involved in this nagging conundrum in the philosophy of science. Both Bayesians and anti-Bayesians will find a wealth of new insights on topics ranging from Bayes’s original paper to contemporary formal learning theory.In (...) a paper published posthumously in 1763, the Reverend Thomas Bayes made a seminal contribution to the understanding of "analogical or inductive reasoning." Building on his insights, modem Bayesians have developed an account of scientific inference that has attracted numerous champions as well as numerous detractors. Earman argues that Bayesianism provides the best hope for a comprehensive and unified account of scientific inference, yet the presently available versions of Bayesianisin fail to do justice to several aspects of the testing and confirming of scientific theories and hypotheses. By focusing on the need for a resolution to this impasse, Earman sharpens the issues on which a resolution turns. John Earman is Professor of History and Philosophy of Science at the University of Pittsburgh. (shrink)

How is medical knowledge made? There have been radical changes in recent decades, through new methods such as consensus conferences, evidence-based medicine, translational medicine, and narrative medicine. Miriam Solomon explores their origins, aims, and epistemic strengths and weaknesses; and she offers a pluralistic approach for the future.

Douglas proposes a new ideal in which values serve an essential function throughout scientific inquiry, but where the role values play is constrained at key points, protecting the integrity and objectivity of science.

There is currently no viable alternative to the Bayesian analysis of scientific inference, yet the available versions of Bayesianism fail to do justice to several aspects of the testing and confirmation of scientific hypotheses. Bayes or Bust? provides the first balanced treatment of the complex set of issues involved in this nagging conundrum in the philosophy of science. Both Bayesians and anti-Bayesians will find a wealth of new insights on topics ranging from Bayes's original paper to contemporary formal learning theory. (...) In a paper published posthumously in 1763, the Reverend Thomas Bayes made a seminal contribution to the understanding of "analogical or inductive reasoning." Building on his insights, modem Bayesians have developed an account of scientific inference that has attracted numerous champions as well as numerous detractors. Earman argues that Bayesianism provides the best hope for a comprehensive and unified account of scientific inference, yet the presently available versions of Bayesianisin fail to do justice to several aspects of the testing and confirming of scientific theories and hypotheses. By focusing on the need for a resolution to this impasse, Earman sharpens the issues on which a resolution turns. John Earman is Professor of History and Philosophy of Science at the University of Pittsburgh. (shrink)

We consider Geanakoplos and Polemarchakis’s generalization of Aumman’s famous result on “agreeing to disagree", in the context of imprecise probability. The main purpose is to reveal a connection between the possibility of agreeing to disagree and the interesting and anomalous phenomenon known as dilation. We show that for two agents who share the same set of priors and update by conditioning on every prior, it is impossible to agree to disagree on the lower or upper probability of a hypothesis unless (...) a certain dilation occurs. With some common topological assumptions, the result entails that it is impossible to agree not to have the same set of posterior probabilities unless dilation is present. This result may be used to generate sufficient conditions for guaranteed full agreement in the generalized Aumman-setting for some important models of imprecise priors, and we illustrate the potential with an agreement result involving the density ratio classes. We also provide a formulation of our results in terms of “dilation-averse” agents who ignore information about the value of a dilating partition but otherwise update by full Bayesian conditioning. (shrink)