Philosophy of Epidemiology

Philosophy of

Epidemiology

Alex Broadbent

University of Johannesburg, South Africa

© Alex Broadbent 2013

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Contents

Preface

Series Editor’s Foreword

Acknowledgements

List of Abbreviations

Glossary

List of Cases

1 Why Philosophy of Epidemiology?

Introducing philosophy of epidemiology

Themes

Synopsis

2 Philosophical and Epidemiological Basics

Summary

The problem of induction

From induction to causation

Epidemiology: a potted history

Basic kinds of epidemiological study

Conclusion

3 The Causal Interpretation Problem

Summary

The causal interpretation problem

The search for the extra ingredient

The probabilistic approach

The counterfactual approach

The explanatory approach

Conclusion

4 Causal Inference, Translation, and Stability

Summary

What makes a good causal inference?

The myth of translation

The need for stability

What is stability?

Conclusion

5 Stable Causal Inference

Summary

Approaches to causal inference

Detecting stability

Stability and quality of evidence

Stability and mechanisms

Conclusion

6 Prediction

Summary

From causation to prediction

A mysterious omission

What is a good prediction?

Predicting reliably and predicting justifiably

Conclusion

7 Making and Assessing Epidemiological Predictions

Summary

Prediction and stability

Delivering stable predictions

Extrapolation

Inference from laws of nature

Knowledge of underlying mechanisms

Conclusion

8 Puzzles of Attributability

Summary

Two common errors in understanding attributable fraction

The exclusive cause fallacy

The counterfactual fallacy

Must excess fractions be causally interpreted?

Attributable to as explained by

Conclusion

9 Risk Relativism, Interaction, and the Shadow of Physics

Summary

Risk relativism

Arguments from statistical convenience

The uses of RR in causal inference

Are risk ratios transportable?

The shadow of physical law

Conclusion

10 Multifactorialism and Beyond

Summary

Epidemiology and the scope of medicine

Monocausal v. multifactorial models of disease

Why not catalogue risk factors?

The contrastive model of disease

Conclusion

11 Epidemiology and the Law

Summary

Why use epidemiological evidence in lawsuits?

Legal positions and contortions

A crucial distinction

What does epidemiological evidence say?

What can epidemiological evidence prove?

Conclusion

12 Conclusion: Thinking Is Good for You

Notes

References

Index

Preface

When I finished my doctoral thesis on counterfactual theories of causation, the then director of the PHG Foundation in Cambridge, Ron Zimmern, offered me research funding to look into epidemiology under the direction of my former supervisor, Peter Lipton. It was Ron’s conviction that there was some interesting philosophical work to be done, and Peter knew that I needed a job. I accepted in the private belief that I would be able to apply insights from the extremely serious philosophical work in which I was already engaged to this lighter practical concern without too much difficulty. I was privately wrong. Despite a very thorough knowledge of the philosophical literature on causation, I did not have ready answers to many of the questions that presented themselves when I started reading what epidemiologists had written about causation. I did not even recognise many of the questions that arose. Yet I could not deny that at least some were philosophical in nature or assert that they were all mere confusions.

This experience disabused me of the idea that philosophers can think of all philosophical problems and convinced me of the importance – the philosophical importance – of engaging with practical and professional contexts. These contexts produce problems which the imagination cannot be relied upon to identify. At the same time, the experience convinced me that philosophy and philosophers have something to contribute to these problems. Philosophy does not derive all of its value from its usefulness, but it can be useful if, as I believe, philosophical problems arise everywhere, not just in philosophy seminar rooms. They may, by their philosophical nature, be insoluble, but philosophers are trained to be sensitive to their difficulty, which is often a real help in itself. And as I read what epidemiologists had written about the philosophical problems of their discipline, it sometimes seemed to me that philosophers might be able to do more than recognise a problem. They might also be able to offer a way to handle it: perhaps not a solution, but at least a reasonable response. Hard practical problems cannot always be solved either; a reasonable response is often the best one can hope for. In this sense philosophical and hard practical problems are not so different.

This book represents an effort to live out the perhaps paradoxical ambition of offering genuinely philosophical analysis which may nonetheless prove useful in some way. The demands of philosophical rigour and originality are often at odds with the demands of saying something that just might, however indirectly, be useful for a practical discipline like epidemiology. I am not sure that my efforts to resolve this constant tension have been successful. But they have certainly shaped my own thinking about philosophical topics, and I hope the reader will be open to the same thing herself, even if the ideal of a thoroughly philosophical yet thoroughly engaged treatment remains elusive.

Series Editor’s Foreword

The intention behind this series is to offer a dedicated publishing forum for exciting new work in the philosophy of science, work that embraces novel directions and fresh perspectives. To this end, our aim is to publish books that address issues in the philosophy of science in the light of these new developments, including those that attempt to initiate a dialogue between various perspectives, offer constructive and insightful critiques, or bring new areas of science under philosophical scrutiny.

Alexander Broadbent fulfils these aims with an innovative study in the philosophy of medicine, one that introduces a new subgenre in the philosophy of science: the philosophy of epidemiology. As he points out, epidemiology is a hugely significant yet philosophically neglected subject, and his book not only subjects it to philosophical scrutiny but illustrates how it casts new light on a range of issues in the philosophy of science.

Thus he emphasises how the focus in epidemiology is on causation and explanation: when epidemiologists map the distribution of a disease and seek its determinants, what they are doing is hunting its causes. In that regard, then, epidemiology offers a useful crucible in which various philosophical positions can be refined. However, Broadbent argues, it is the explanation that is actually the more useful concept and should be brought to the fore. Indeed, the core of the book has to do with the nature and role of explanation and prediction in epidemiological analyses.

Epidemiology does not conform to the standard philosophical picture of science, however. It does not rely on controlled experiments, for example, but instead uses observational studies. Hence the so-called experimental turn of philosophy of science over the last thirty years or so finds little purchase here. More profoundly, perhaps, epidemiology, Broadbent insists, does not involve theory, in the sense of some cumulative notion of epidemiological theorising. The expertise of epidemiologists lies not with theorising or designing-controlled experiments but with methodology. This is worth analysing not just for the sake of arriving at a more inclusive philosophy of science but because of the ethical implications; as Broadbent notes, failing to get the cause of some terrible epidemic right can have disastrous consequences.

Broadbent also offers a critical stance on certain tendencies within epidemiology. Thus he criticises the tendency to prefer relative over absolute measures of risk and rejects attempts to establish a univocal measure of causal strength, preferring instead to advocate a context-dependent explanatory measure. More generally he argues that epidemiology should not try to emulate physics, since its strength lies in not doing so. And finally, looking at the way epidemiological research is drawn upon in legal cases, he argues that confusion has arisen from a failure to distinguish the question of what epidemiological evidence says from how the law ought to react.

Broadbent’s overall conclusion is that thinking about the conceptual foundations of epidemiology is good for both philosophy and epidemiology. But as he notes, there are many more issues still to be addressed and his book is only a start in this direction. Nevertheless, it not only illuminates in a new and striking way a range of core issues in the philosophy of science but also offers a skilful and incisive analysis of a fundamentally important area of science. Given epidemiology’s wide-ranging significance, Broadbent’s work will have important implications for further research and policymaking in this area. It is precisely the sort of book that the editorial board and I aim to publish in the New Directions series, and we are sure that it will have a major impact not only in the philosophy of science but beyond.

Steven French

Professor of Philosophy of Science

University of Leeds

Acknowledgements

This book has benefited from an unusual number of unusually generous readers. All of the following read at least a chapter of manuscript at some stage of production and, in several cases, the whole thing: Nancy Cartwright, Jackie Cassell, Colin Chasi, Adrian Erasmus, Sander Greenland, Dan Heard, Stephen John, Thaddeus Metz, Chris Miller, Alfredo Morabia, Nathan Schachtman, Sandy Steel, David Spurrett, and Richard Wright. I am extremely grateful to all of them and am sorry only that I could not write a book that better reflected the quality of the excellent comments they gave me. Alfredo Morabia deserves special mention for his continual encouragement and guidance. Shortcomings of the book remain entirely attributable to me. Further helpful comments came from Richard Ashcroft, Roger Bernier, Ron Zimmern, and anonymous referees. Ron Zimmern deserves special mention for directing me to the philosophical study of epidemiology in the first place. I am also grateful to a number of interlocutors at conferences and other meetings who shaped my views or contributed comments, especially the participants at the Philosophy of Epidemiology Conference, hosted by the University of Johannesburg in December 2011 and funded by a grant from the National Research Foundation of South Africa, and participants in a series of four workshops during 2010 titled Epidemiology, Risk and Genomics and funded by the PHG Foundation (www.phgfoundation.org). I am also grateful to Adrian Erasmus for his help preparing the index and readying the final manuscript for publication. And I owe a lasting intellectual debt to my former supervisor, the late Peter Lipton.

The book has benefited from the financial support of the PHG Foundation through the project Epidemiology, Risk and Genomics; from the National Research Foundation of South Africa through the Blueskies grant for the project Philosophy of Epidemiology; and from research funds made available by the University of Johannesburg. These institutions have all treated me very well.

Chapter 7 substantially develops material first briefly explored in a paper in Preventive Medicine (Broadbent 2011a). Chapter 10 uses material first developed in a paper in Studies in the History of the Biological and Biomedical Sciences (Broadbent 2009a). Both, published by Elsevier, are reproduced and developed here, with thanks, under the rights retained by authors. Chapter 11 uses material first developed in a paper in Legal Theory (Broadbent 2011b), reproduced here with permission of Cambridge University Press, with thanks.

Finally I thank my wife Nicole, for numerous long discussions and for her love and support. She has contributed more to this endeavour than she realises and has made the time of writing a happy one.

List of Abbreviations

Glossary

Many of the definitions listed here have been arrived at after discussion in the text. The meaning of both epidemiological and philosophical terms can be controversial, so please consult the relevant parts of the text for discussion.

attributable: See fraction.

attributable fraction: See fraction, attributable.

case-control study: A study comparing how often an exposure of interest occurs in cases, i.e. persons with a health condition of interest, compared to controls, i.e. persons free of the condition of interest.

cohort study: A study following a cohort, or population of people, over an extended period of time, and recording exposures of interest and outcomes of interest; a cohort study was formerly sometimes known as a prospective study, but it is possible to study a cohort using historical data.

confirmation: The term used in philosophy of science for the relation that evidence bears to a theory when it supports the theory. Confirmation does not imply conclusive proof.

hypothetico-deductive: A hypothesis deductively entails the confirming evidence, perhaps invoking auxiliary hypotheses for the deduction. The hypothetico-deductive model of confirmation holds that this is the logical nature of the confirmation relation.

confounder or confounding variable: Any factor that influences an outcome of interest in a study other than the exposure whose effect on that outcome is being assessed.

contrastive: Employing contrasts. See also disease, contrastive model of; explanation.

counterfactual or counterfactual conditional: A sentence that can in principle be expressed in the form If it were / had been the case that P, then it would be / would have been the case that Q.

counterfactual dependence: The relation that obtains between the matters denoted by the antecedent and consequent of a counterfactual conditional; the matters denoted by the consequence counterfactually depend on the matters denoted by the antecedent.

deduction: See inference, deductive.

disease: Minimally understood as the absence of health.

contrastive model of: A theory about the nature of disease. On this view, D is a disease if and only if (i) cases of D exhibit symptoms of ill health which are absent from controls; (ii) these symptoms are caused by a set of defining causes C1, ... Cn together; and (iii) at least one of C1, ... Cn is absent from a defined group of controls; see Chapter 10.

monocausal model of: A theory about the nature of disease. On this view, for D to be a disease it must satisfy two requirements: (i) some cause C is a cause of every case of disease D (the necessity requirement); and (ii) given certain circumstances, which are not sufficient to cause D, every occurrence of C causes a case of D (the sufficiency requirement).

multifactorial model of: A theory about the nature of disease. On this view, a disease D does not have to satisfy any numerical requirements on the number of its causes nor any requirements on the necessity or sufficiency of any cause or set of causes for bringing about D.

effect-measure modification: See heterogeneity of effects; interaction.

epidemiology: The study of the distribution and determinants of disease and other health states in human populations by means of group comparisons for the purpose of improving population health.

epistemic: Concerning knowledge.

epistemological: Concerned with epistemology.

epistemology: The theory or philosophical study of knowledge.

evidence: Information bearing on the truth of a claim.

excess fraction: See fraction, excess.

experiment: A study in which the investigator makes some sort of intervention on the subject of study.

controlled: An experiment in which the investigator compares the situation in which she has intervened with a situation in which she does not intervene but which is otherwise as similar as practicable or with a situation in which she intervenes in ways whose effects are already known.

explanation: The activity aimed at producing understanding or the product of that activity.

causal: An explanation that cites one or more causes of the fact to be explained and so explains it.

contrastive: An explanation of a contrast, one given in answer to a question (perhaps implicit) of the form why P rather than Q?

deductive-nomological: An explanation that cites one or more laws of nature and uses them to deduce the fact to be explained; a deductive-nomological explanation may additionally cite non-laws among the premises of the deduction.

exposure: A catch-all term denoting any factor that epidemiologists study as a potential cause of a disease or other condition of interest.

fraction

attributable: A fraction of a risk is attributable to an exposure if and only if the exposure explains why the corresponding net difference between exposed and unexposed risks arises. An attributable fraction is normally an excess fraction (see fraction, excess) that meets this criterion; see also Chapter 8.

excess:

population attributable: Normally a population excess fraction (see fraction, population excess) that is attributable to the exposure (see fraction, attributable); see also Chapter 8.

population excess: , or the difference between the total population risk and the risk in the unexposed portion of the population as a fraction of the total population risk.

heterogeneity of effects: Occurs when the measure of effect of an exposure differs according to the presence or absence of another exposure. See also interaction.

homogeneity of effects: Absence of heterogeneity of effects.

hypothesis: A claim or theory.

incidence: See risk.

induction: See inference, inductive.

inference:

causal: An inference whose conclusion is a causal claim.

deductive: A deductive inference is one such that if the premises are true, the conclusion is necessarily true (i.e. it cannot possibly be false). A deductive argument may have one or more false premises; in that case, the conclusion may be either true or false, unless it is a contradiction or logical truth.

inductive: An inductive inference fails to be deductive yet still exerts some demand for rational assent. The definition of induction is a philosophically contested matter; see also Chapter 2.

interaction (statistical): A potentially ambiguous term used in this book to designate heterogeneity of effects, which occurs when the measure of effect of an exposure differs according to the presence or absence of another exposure. See also heterogeneity of effects.

additive: Additive interaction occurs when the sum of the risk differences under each of two exposures is not equal to the risk difference under both exposures together.

multiplicative: Multiplicative interaction occurs when the product of the relative risks under each of two exposures is not equal to the relative risk under both exposures together.

metaphysical: Concerning metaphysics.

metaphysics: The philosophical study of what exists and its nature, in respects that cannot be settled by empirical evidence.

Observational Study: A study in which the investigator does not make an intervention relating to the exposure(s) of interest but observes the exposure(s) and outcome(s) of interest as they occur without her intervention (cf. experiment).

odds: With reference to disease, the number of cases divided by the number of non-cases, in a defined group over a defined time interval.

odds ratio: The ratio between the odds of a disease in two groups, usually an exposed and unexposed group respectively.

philosophy: An ancient and diverse intellectual pursuit, roughly characterised in the modern context by seeking knowledge about matters that cannot be or have not been settled either by appeal to empirical evidence or by deductive inferences from readily acceptable premises.

placebo: A substance or treatment given to a patient in a clinical trial, intended to be causally inert with respect to relevant outcomes, so as to prevent the patient knowing whether she is receiving the treatment under test or not.

population attributable fraction: See fraction, population attributable.

population excess fraction: See fraction, population excess.

possible world: A logically coherent totality of non-modal facts; a way the world might possibly be.

randomised controlled trial: An experimental study in which subjects are randomly allocated to one or more treatment or control groups, with the treatment group(s) receiving the treatment(s) under test and the control group receiving either a placebo (see placebo), or a standard treatment; see also Chapter 2.

relative risk: , or exposed risk divided by unexposed risk.

risk: The number of new cases of an outcome of interest as a proportion of the total population during a specified time period.

risk ratio: See relative risk.

semantic: Concerning meaning.

theory: A claim or hypothesis. Note that as philosophers of science use the term, there is no implication that a theory is tentative or uncertain, as in some common uses.

List of Cases

American

Daubert v. Merrell Dow Pharmaceuticals, Inc. 509 U.S. 579 (1993)

Scottish

McTear v. Imperial Tobacco Ltd. [2005] CSOH 69

English

Barker v. Corus U.K. Ltd. [2006] UKHL 20, [2006] 2 A.C. 572

Barnett v. Kensington & Chelsea Hosp. [1969] 1 Q.B. 428

Cork v. Kirby Maclean, Ltd. [1952] 2 All E.R. 402

Fairchild v. Glenhaven Funeral Services Ltd. & Others [2003] 1 A.C. 32

McGhee v. National Coal Board [1973] 1 W.L.R. 1 (H.L.)

Novartis Grimsby Ltd. v. John Cookson [2007] EWCA (Civ) 1261

Sienkiewicz (Administratrix of the Estate of Enid Costello Dcd.) v. Greif (U.K.) Ltd. [2009] EWCA (Civ) 1159

Sienkiewicz (Administratrix of the Estate of Enid Costello Dcd.) v. Greif (U.K.) Ltd. [2011] UKSC 10

XYZ & Others v. Schering Health Care Ltd. [2002] EWHC 1420 (Q.B.)

1

Why Philosophy of Epidemiology?

Introducing philosophy of epidemiology

Epidemiology makes headlines more often than most other sciences. Every time you hear that something is good for you or bad for you, either there is an epidemiological study involved, or there is an epidemiological study being planned to check whether the claim is true. (If neither of these is the case, you should get your news somewhere else.) Yet many people have never heard of epidemiology.

Epidemiology is traditionally defined as the study of the distribution and determinants of disease and other health states in human populations for the purpose of improving the health of those populations (for similar definitions see Rothman, Greenland, and Lash 2008, 32; Last 1995). More exact definitions tend to include the manner of study – that is, the use of group comparisons – to emphasise the fact that epidemiology does not merely study the health of individuals or groups but makes comparisons between groups and draws inferences from these comparisons (more on this when epidemiological study designs are examined in Chapter 2). Accordingly the definition we will work with is this:

Epidemiology is the study of the distribution and determinants of disease and other health states in human populations by means of group comparisons for the purpose of improving population health.

No doubt this could be improved, but it covers the central features of the science.

Epidemiology is not usually taught at school or at undergraduate level, except as a component of medicine, where it typically occupies only a small proportion of the syllabus. Even well-educated, scientifically literate people are often hard pressed to say what epidemiology is, unless their Greek is good enough for them to guess.

Maybe this explains why philosophers of science have neglected epidemiology. It is true that there are some philosophers who have thought about epidemiology and many more who have used epidemiological examples without identifying them as such (some of them will be discussed in later chapters). There are also a number of epidemiologists who have taken courses in the philosophy of science at some stage during their training, then sought to apply what they learned to their own discipline (these too will be discussed). But there have been no extended efforts to apply philosophical inquiry to the science of epidemiology in a thoroughgoing way, as has been done with physics, biology, psychology, and a number of other sciences. Although a few philosophers have studied epidemiology, there have been no philosophical studies of epidemiology.

Epidemiology is as philosophically interesting and as worthy of philosophical study as physics, biology, or psychology. As in physics, biology, and psychology, the philosophical issues arising in epidemiology are a mix: some are fresh slants on old problems, and some are specific to the discipline, thrown up in the course of its work. There is no sharp distinction between philosophy of the special sciences and philosophy of science in particular, nor between philosophy of science and philosophy more generally. So this book is not an exercise in intellectual territorialism. Nonetheless, philosophers in general, and philosophers of science in particular, need material