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)

In current philosophical discussions on evidence in the medical sciences, epidemiology has been used to exemplify a specific version of evidential pluralism. According to this view, known as the Russo–Williamson Thesis, evidence of both difference-making and mechanisms is produced to make causal claims in the health sciences. In this paper, I present an analysis of data and evidence in epidemiological practice, with a special focus on research on the exposome, and I cast doubt on the extent to which evidential pluralism (...) holds in this case. I start by focusing on the claim that molecular data allows for the production of mechanistic evidence. On the basis of a close look at the ways in which molecular data is used in exposome research, I caution against interpretations in terms of mechanistic evidence. Secondly, I expand my critical remarks on the thesis by addressing the conditions under which data is categorised as evidence in exposome research. I argue that these show that the classification of a dataset as a type of evidence is dependent on the ways in which the data is used. This is in contrast with the approach of evidential pluralism, where evidence is classified in different types on the basis of its intrinsic properties. Finally, I come back to what I consider the core of the thesis and suggest that the epidemiological research analysed in the paper indicates different interpretations of evidential pluralism and its applicability in the health sciences. (shrink)

The setting of evidential standards is a core practice of scientific assessment for policy. Persuaded by considerations of inductive risk, philosophers generally agree that the justification of evidential standards must appeal to non-epistemic values but debate whether the balance of non-epistemic reasons favours varying evidential standards versus maintaining fixed high evidential standards in assessment, as both sets of standards promote different and important political virtues of advisory institutions. In this paper, I adjudicate the evidential standards debate by developing a novel (...) argument from justice, drawing on the IPCC’s assessment of climate impacts as a case study. I argue that in assessments marked by background evidential inequality, maintaining fixed high evidential standards results in an unequal distribution of ‘epistemic power’ among stakeholders, producing a ‘powerful assessment’ for the data-rich (a high rate of findings) and a ‘weak assessment’ for the data-poor (a low rate of findings). Where such inequalities of epistemic power disadvantage those in data-poor regions with respect to fundamental interests, such as basic human rights, we have decisive reasons of justice to vary evidential standards. (shrink)

It has recently been argued that successful evidence-based policy should rely on two kinds of evidence: statistical and mechanistic. The former is held to be evidence that a policy brings about the desired outcome, and the latter concerns how it does so. Although agreeing with the spirit of this proposal, we argue that the underlying conception of mechanistic evidence as evidence that is different in kind from correlational, difference-making or statistical evidence, does not correctly capture the role that information about (...) mechanisms should play in evidence-based policy. We offer an alternative account of mechanistic evidence as information concerning the causal pathway connecting the policy intervention to its outcome. Not only can this be analyzed as evidence of difference-making, it is also to be found at any level and is obtainable by a broad range of methods, both experimental and observational. Using behavioral policy as an illustration, we draw the implications of this revised understanding of mechanistic evidence for debates concerning policy extrapolation, evidence hierarchies, and evidence integration. (shrink)

To be effective, a medical intervention must improve one's health by targeting a disease. The concept of disease, though, is controversial. Among the leading accounts of disease-naturalism, normativism, hybridism, and eliminativism-I defend a version of hybridism. A hybrid account of disease holds that for a state to be a disease that state must both (i) have a constitutive causal basis and (ii) cause harm. The dual requirement of hybridism entails that a medical intervention, to be deemed effective, must target either (...) the constitutive causal basis of a disease or the harms caused by the disease (or ideally both). This provides a theoretical underpinning to the two principle aims of medical treatment: care and cure. (shrink)

In this commentary, I propose a framework for thinking about data quality in the context of scientific research. I start by analyzing conceptualizations of quality as a property of information, evidence and data and reviewing research in the philosophy of information, the philosophy of science and the philosophy of biomedicine. I identify a push for purpose dependency as one of the main results of this review. On this basis, I present a contextual approach to data quality in scientific research, whereby (...) the quality of a dataset is dependent on the context of use of the dataset as much as the dataset itself. I exemplify the approach by discussing current critiques and debates of scientific quality, thus showcasing how data quality can be approached contextually. (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 purpose of this chapter is to describe what we see as several important new directions for philosophy of medicine. This recent work (i) takes existing discussions in important and promising new directions, (ii) identifies areas that have not received sufficient and deserved attention to date, and/or (iii) brings together philosophy of medicine with other areas of philosophy (including bioethics, philosophy of psychiatry, and social epistemology). To this end, the next part focuses on what we call the “epistemological turn” in (...) recent work in the philosophy of medicine; the third part addresses new developments in medical research that raise interesting questions for philosophy of medicine; the fourth part is a discussion of philosophical issues within the practice of diagnosis; the fifth part focuses on the recent developments in psychiatric classification and scientific and ethical issues therein, and the final part focuses on the objectivity of medical research. (shrink)

Evidence-based medicine (EBM) has long deemphasized mechanistic reasoning and pathophysiological rationale in assessing the effectiveness of interventions. The EBM+ movement has challenged this stance, arguing that evidence of mechanisms and comparative studies should both be seen as necessary and complementary. Advocates of EBM+ provide a combination of theoretical arguments and examples of mechanistic reasoning in medical research. However, EBM+ proponents have not provided recent examples of how downplaying mechanistic reasoning resulted in worse medical results than would have occurred otherwise. Such (...) examples are necessary to make the case that EBM+ responds to a problem in clinical practice that urgently demands a solution. In light of this, we examine the failed rollout of efavirenz as a first-line HIV treatment in Zimbabwe as evidence of the importance of mechanistic reasoning in improving clinical practice and public health policy decisions. We suggest that this case is analogous to examples commonly given to support EBM. (shrink)

The standardised randomised clinical trial (RCT) has been exceedingly popular in medical research, economics, and practical policy making. Recently, RCTs have faced criticism. First, it has been argued by John Worrall that we cannot be certain that our sample is not atypical with regard to possible confounding factors. I will argue that at least in the case of medical research, we know enough about the relevant causal mechanisms to be justified to ignore a number of factors we have good reason (...) not to expect to be disruptive. I will also argue against an argument provided by Nancy Cartwright and Eileen Munro that RCTs should not be taken to deductively infer probabilistic causal claims, but ampliatively. The paper will end on a discussion of evidence hierarchies and a defence of the stance of evidence-based medicine that RCTs are the best available method to assess a treatment’s efficacy. (shrink)

Hospital acquired infections (HAIs) are a major threat to patient safety. This paper addresses the following question: given what is known about the causes of and possible interventions on HAIs, to whom or what should the moral responsibility for preventing these infections be attributed? First, we show how generating robust evidence on the effectiveness of preventive hygiene measures is a complex endeavour and review the existing evidence on the causes of HAIs. Second, we demonstrate that the existing literature on the (...) ethical aspects of infection control has focused on responsibility at the individual-level. Thirdly, we argue that these accounts do not accommodate systemic factors relevant for HAI prevention. We show that the notion of collective responsibility is useful for making understandable how systemic factors, such as employment conditions in hospitals, are both causally and ethically relevant in infection control. (shrink)

Traditionally, mechanistic reasoning has been assigned a negligible role in standard EBM literature, although some recent authors have argued for an upgrade. Even so, the mechanistic reasoning that has received attention has almost exclusively been positive—both in an epistemic sense of claiming that there is a mechanistic chain and in a health-related sense of there being claimed benefits for the patient. Negative mechanistic reasoning has been neglected, both in the epistemic and in the health-related sense. I distinguish three main types (...) of negative mechanistic reasoning and subsume them under a new definition of mechanistic reasoning in the context of assessing medical interventions. This definition is wider than a previous suggestion in the literature. Each negative type corresponds to a range of evidential strengths, and it is argued that there are differences with respect to typical evidential strengths. The variety of negative mechanistic reasoning should be acknowledged in EBM, and it presents a serious challenge to proponents of so-called medical hierarchies of evidence. (shrink)

COVID-19 presents many challenges, both clinical and philosophical. In this paper we discuss a major lacuna that COVID-19 revealed in our philosophy and understanding of medicine. Whereas we have some understanding of how physician-scientists interrogate the world to learn more about medicine, we do not understand the epistemological costs and benefits of the various ways clinicians acquire new knowledge in their fields. We will also identify reasons this topic is important both when the world is facing a pandemic and when (...) it is not. (shrink)

Establishing the effectiveness of medical treatments is one of the most important aspects of medical practice. Bradford Hill's viewpoints play an important role in inferring causality in medicine,...

In his book “Medical Philosophy: Conceptual issues in Medicine”, Mario Bunge provides a unique account of medical philosophy that is deeply rooted in a realist ontology he calls “systemism”. According to systemism, the world consists of systems and their parts, and systems possess emergent properties that their parts lack. Events within systems may form causes and effects that are constantly conjoined via particular mechanisms. Bunge supports the views of the evidence-based medicine movement that randomized controlled trials (RCTs) provide the best (...) evidence to establish the truth of causal hypothesis; in fact, he argues that _only_ RCTs have this ability. Here, we argue that Bunge neglects the important feature of patients being open systems which are in steady interaction with their environment. We show that accepting this feature leads to counter-intuitive consequences for his account of medical hypothesis testing. In particular, we point out that (i) the confirmation of hypotheses is inherently stochastic and affords a probabilistic account of both confirmation and evidence which we provide here; (ii) RCTs are neither necessary nor sufficient to establish the truth of a causal claim; (iii) testing of causal hypotheses requires taking into account background knowledge and the context within which an intervention is applied. We conclude that there is no “best” research methodology in medicine, but that different methodologies should coexist in a complementary fashion. (shrink)

In this talk I present the main results from Anta (2021), namely, that the theoretical division between Boltzmannian and Gibbsian statistical mechanics should be understood as a separation in the epistemic capabilities of this physical discipline. In particular, while from the Boltzmannian framework one can generate powerful explanations of thermal processes by appealing to their microdynamics, from the Gibbsian framework one can predict observable values in a computationally effective way. Finally, I argue that this statistical mechanical schism contradicts the Hempelian (...) (1958) thesis that the predictive power of a scientific theory is directly proportional to its explanatory potential, and vice versa. (shrink)

Anti-ageing medicines are products intended to extend lifespan and healthspan in humans that have a good potential use in public health policies. In the European Union, their development, production and consumption are dependent on regulatory science performed by the European Medicines Agency and its associated epistemic policies. They impose, among other things, an unfavourable burden of proof, a strict standard of proof and meta-methodological constrictions related to some theoretical issues. This results in a distribution of errors that tends to reduce (...) false positives while increasing false negatives, leading to a set of social consequences that are generally accepted when the focus is placed on conventional medicines. However, when the same epistemic policies are applied to anti-ageing medicines, the distribution of errors is imbalanced, and undesirable outcomes like research discouragement and waiting time extensions appear. Three possible strategies that policymakers could implement to unblock the situation are presented for future reflection: the consideration of ageing as a disease, the application of methodological asymmetry and the use of biomarkers during clinical research. (shrink)

This chapter addresses the problem of ranking available drugs in guideline development to support clinicians in their work. Based on a pragmatic approach to the notion of evidence and a hierarchical view on different kinds of evidence this chapter introduces a decision aid, HiDAD, which draws on the multi criteria decision making literature. This decision aid implements the wide-spread intuition that there are different kinds of evidence with varying degrees of importance by relying on a strict ordinal ordering of kinds (...) of evidence. In order to construct a ranking every pair of drugs is first compared separately on all kinds of evidence. Next, these quantitative comparisons are then aggregated into an overall comparison between drugs based on all the available evidence in a way which avoids that evidence of less importance is trumped by evidence of the higher levels. Finally, these overall comparisons are used to determine the final ranking of drugs which then informs the process of guideline writing. Properties, modifications and applicability of the decision aid HiDAD are discussed and assessed. (shrink)

The COVID-19 pandemic has been the scene of several epistemic battles at the science-society interface, creating deadlocks that have been hard to overcome. To cut through the paralysing elements of these discussions, we present an analysis of three epistemic battles, concerning empirical evidence, expertise, and model projections. Our analysis singles out a crucial factor that drives unhelpful disputes like these: the contested prioritisation of specific types of scientific knowledge, which are considered adequate for policy only if they meet predetermined standards. (...) To move beyond these deadlocks, we introduce the conceptual tools of epistemic pluralism and contextualism, which give concrete indications in the three controversies we discuss and show us the way forward in debates on science-based policy. (shrink)

Evidence hierarchies are lists of investigative strategies ordered with regard to the claimed strength of evidence. They have been used for a couple of decades within EBM, particularly for the assessment of evidence for treatment recommendations, but they remain controversial. An under-investigated question, from critics and adherents of evidence hierarchies alike, is what the order in the hierarchy means. Four interpretations of the order are distinguished and discussed. The two most credible ones are, roughly expressed, "typically stronger" or "ideally stronger". (...) The well-known GRADE framework seems to assume some "typically stronger" reading. Unfortunately, even if the interpretation of an evidence hierarchy were established, hierarchies appear to be rather unhelpful for the task of evidence aggregation. Nevertheless, a specification of the intended order relation may be helpful in sorting out disagreements in debates on evidence hierarchies. Therefore, proponents and adversaries of evidence hierarchies are equally obliged to specify the order interpretations they are assuming in their arguments. (shrink)

The thesis consists of an introduction and two papers. In the introduction a brief historical survey of empirical investigations into the effectiveness of medicinal interventions is given. Also, the main ideas of the EBM movement are presented. Both included papers can be viewed as investigations into the reasonableness of EBM and its hierarchies of evidence. Paper I: Typically, in a clinical trial patients with specified symptoms are given either of two or more predetermined treatments. Health endpoints in these groups are (...) then compared using statistical methods. Concerns have been raised, not least from adherents of so-called alternative medicine, that clinical trials do not offer reliable evidence for some types of treatment, in particular for highly individualized treatments, for example traditional homeopathy. It is argued that such concerns are unfounded. There are two minimal conditions related to the nature of the treatments that must be fulfilled for evaluability in a clinical trial, namely the proper distinction of the two treatment groups and the elimination of confounding variables or variations. These are delineated, and a few misunderstandings are corrected. It is concluded that the conditions do not preclude the testing of alternative medicine, whether individualized or not. Paper II: Traditionally, mechanistic reasoning has been assigned a negligible role in standard EBM literature, although some recent authors have argued for an upgrading. Even so, mechanistic reasoning that has received attention has almost exclusively been positive -- both in an epistemic sense of claiming that there is a mechanistic chain and in a health-related sense of there being claimed benefits for the patient. Negative mechanistic reasoning has been neglected, both in the epistemic and in the health-related sense. I distinguish three main types of negative mechanistic reasoning and subsume them under a new definition of mechanistic reasoning in the context of assessing medical interventions. Although this definition is wider than a previous suggestion in the literature, there are still other instances of reasoning that concern mechanisms but do not count as mechanistic reasoning. One of the three distinguished types, which is negative only in the health-related sense, has a corresponding positive counterpart, whereas the other two, which are epistemically negative, do not have such counterparts, at least not that are particularly interesting as evidence. Accounting for negative mechanistic reasoning in EBM is therefore partly different from accounting for positive mechanistic reasoning. Each negative type corresponds to a range of evidential strengths, and it is argued that there are differences with respect to the typical strengths. The variety of negative mechanistic reasoning should be acknowledged in EBM, and presents a serious challenge to proponents of so-called medical hierarchies of evidence. (shrink)

This thesis analyses the use of 'Evidence-Based' methodologies of evidence assessment and intervention and policy design from medicine, and their use in sport and exercise science. It argues that problems exist with the application of Evidence-Based methodologies in sports science, meaning that the quality of evidence used to inform decision-making is lower than is often assumed. This thesis also offers realistic solutions to these problems, broadly arguing for the importance of taking evidence from mechanistic studies seriously, in addition to evidence (...) from RCTs. (shrink)