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Blackwell Science, LtdOxford, UKJEPJournal of Evaluation in Clinical Practice1365-2753Blackwell Publishing Ltd 20039

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Essay Review

Essay reviewM. Loughlin

Accepted for publication:

6 March 2003

E S S AY R E V I E W

Ethics and Evidence-Based Medicine: Fallibility and Responsibility in Clinical Science

[Kenneth Goodman, Cambridge University Press, Cambridge, ISBN 0 521 79653 9, £19.95 (pbk), ISBN 0 521 81933 4, £55.00 (hbk)]

Michael Loughlin PhD

Senior Lecturer in Health Philosophy, Manchester Metropolitan University, Manchester, UK

Introduction

Enthusiasts for evidence-based medicine (EBM) areoften criticized for being arrogant, for promotingsimplistic accounts of the nature of ‘evidence’, ‘sci-ence’ and ‘reasoning’ and treating their interpreta-tions of these contested concepts as if they were justplain obvious, for misunderstanding the nature andimportance of clinical judgement and consequentlyfor being dogmatic, moralistic or even evangelical inpromoting the goals of their EBM ‘movement’. (I donot claim this list of criticisms to be by any meansexhaustive.) A key goal of Kenneth Goodman’s

Eth-ics and Evidence-Based Medicine

is to underminethese and other criticisms, partially by arguing thatthey misrepresent the goals of what he calls (p. 1) the‘cause’ or ‘movement’, and partly by defending theviews about clinical judgement and reasoning that hedoes see as definitive of the movement’s philosophy.

Thus, Goodman protests, the point of EBM and itspromotion of evidence based on the ‘gold standard’of randomized controlled trials (RCTs), meta-analyses, systematic reviews, pooled analyses, etc. isnot to put an end to uncertainty in clinical decisionmaking or to attempt to give spurious ‘closure’ to sci-entific debates. Rather it is the development of a ‘newkind of evidence’ that is now an indispensable ‘tool’in ‘the management of uncertainty’. The ‘problem weare trying to solve for clinicians, policy makers andothers’ is ‘How should one make decisions in the faceof scientific uncertainty, especially when human life is

on the line?’ (p. 49) (Hence the subheading of thebook:

Fallibility and Responsibility in Clinical Sci-ence

.) Goodman directly follows this account of theproblem EBM exists to solve with the statement: ‘Ifevidence-based practice can reduce uncertainty andtherefore better inform clinical decisions, then itbecomes blameworthy not to bend one’s knee at thisaltar.’ Those who refuse to genuflect are accused of‘ignorance’ and ‘facile skepticism’. Such scepticism isat one point compared to the antiscientific stance ofcreationists, who obstinately ignore the evidence forevolution and irrationally treat the existence of dis-agreements between scientists as grounds to rejectscientific method altogether. (p. 101) In the PrefaceGoodman states that ‘the core theme of the book’ isthat ‘scientific knowledge’ and ‘morality’ are linked:‘Ignorance is blameworthy.’

In fairness to Goodman, he does also apportionsome blame to defenders of EBM who have treatedits methods as a panacea to the problems of clinicalpractice, failing to note or to take sufficiently seri-ously the conceptual problems in applying theresults of various forms of ‘data synthesis’ to thetreatment of particular and potentially unique casesin practice. Indeed, the inattentive reader might attimes form the impression of an author who takes a‘balanced’ view between proponents and detractorsof EBM, but really Goodman makes no secret of hisposition firmly within the EBM camp. This is par-ticularly obvious in Chapter 5, where the authormakes uncritical appeal to the simplistic dichoto-

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mies that define ‘EBM philosophy’. Goodmanderides the use of ‘intuition’ and ‘hunches’, for suchthings are ‘subjective’ and as such incompatible withobjectivity as characterized by the use of evidenceand logic. Subjective thinking is (by definition) illog-ical, irrational (or at least non-rational) and unscien-tific. While medical practice may sometimes need torely on such unscientific thinking, that is the resultof our present state of ‘collective ignorance’. Themore this can be replaced by rational, objective sci-ence, the better.

Evidence, ignorance and blame

Chapter 1 discusses the historical origins of EBM andcontains a definition of ‘evidence’ as that which pro-vides a ‘conceptual warrant’ for a belief or action. (p.2) ‘Information becomes evidence when it applies to,bears on, or constitutes a reason for (dis)believingthe truth of a proposition.’ (p. 4) As Goodman notes,this does not tell us how we go about determiningwhat sorts of information provide conceptual war-rants for what types of conclusion. Nor does it tell ushow to determine the quality of the evidence – that is,the strength of the warrant any given piece of evi-dence provides.

To do this systematically, one would need todevelop a theory of clinical reasoning, explainingwhy some sources of information (for Goodman,those generating the ‘new kind of evidence’ he cham-pions) ought to be regarded as providing a betterwarrant for beliefs and practices than others (thoseGoodman condemns either as providing an inade-quate conceptual warrant or no warrant at all). In theabsence of any detailed and broadly acceptable the-ory of this sort, the issue of what constitutes goodclinical evidence must surely remain contested – thatis, there will be scope for rational persons to disagreeabout it. (That is not to say the issue is ‘subjective’ inany sense that means ‘non-rational’. Subjective dis-agreements tend to dissolve, on analysis, into differ-ences of preference – they are not real disagreementsat all. In contrast differences about what constitutesgood evidence are

bona fide

disagreements, not mat-ters of whim or preference.) Instead of developingsuch a theory, Goodman opts to ‘set aside’ philosoph-ical debates about rationality, knowledge, skill,authority and expertise to discuss instead how infor-

mation is communicated: ‘for this is where evidence-based practice must first hang its hat.’ (p. 14)

This seems rather to miss the point. If you want tocondemn others for acting without proper evidence,where this means without adequate reason or con-ceptual warrant, you had better be able to demon-strate that you have a better understanding of what itis to have a ‘reason’ or ‘conceptual warrant’ thanthose you condemn. Otherwise it is your criticismthat lacks an adequate conceptual basis, and to con-demn others without adequate grounds is surely irra-tional and probably immoral.

Even in the absence of a theory of clinical reason-ing, if there existed indisputable evidence that thesort of evidence-based practice Goodman approvesof produces consistently better results, and leads tofewer errors, than practice which (on Goodman’sassessment) is not ‘evidence-based’, this would surelyprovide an adequate warrant for his conclusions. Theauthor states that a ‘comprehensive research pro-gram that looked at the effect of evidence-basedpractice on error reduction would be a worthy andinteresting project’ but adds ‘. . . if we didn’t have ourhands full already.’ (p. 20)

That Goodman does wish to condemn others isvery clear. He states in a number of places that many(though not, these days, most) health professionalspractise without adequate evidence. Because indoing so they subject their patients to the avoidablerisk of harm they are, he concludes, morally culpable.

In support of this view Goodman makes a state-ment that the publishers chose to pull out and reprinton the back cover of the book: ‘At its core, evidence-based practice rests on a supposition which, whileprobably true, itself has unclear evidentiary support.’This seems like a peculiarly unfortunate claim for thepublishers to emphasize given the stance of the book.If a claim lacks evidentiary support, what rationalbasis can the author have for believing it ‘probablytrue’? (Not, one assumes, intuition.) The ‘likely’(though not evidence-based) claim at the ‘core’ ofEBM is that ‘most health care is (or, until compara-tively recently, was) not evidence based’. (p. 3) Thesupport for this claim is ‘a series of pronouncements’or ‘conjectures’, some of which can be found on a‘delightful and illuminating UK-based website’ about‘the percentage of medical decisions that areevidence-based’. The site reports a ‘humorous’

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exchange between Kerr White and Archie Cochranein which White claims that only 15–20% of doctors’interventions are based on objective evidence, andCochrane replies: ‘Kerr, you’re a damned liar! Youknow it isn’t more than 10%.’ While he accepts thatthese and other speculations do not constitute evi-dence, Goodman takes them sufficiently seriously tosuggest that such numbers should ‘leave us slack-jawed’ (p. 6) and he seems remarkably untroubledthat a belief at the ‘core’ of EBM should lack supportin terms of anything he could seriously call evidence.

Trust me, I’m a statistician

Chapter 2 discusses systematic reviews and meta-analyses and contains an interesting discussion of therelationship between trust and rationality. Citing theviews of the philosopher John Hardwig, Goodmannotes that in a complex society many beliefs have tobe accepted on trust, but it does not follow that theinhabitants of complex societies are thereby lessrational than members of simpler societies. Whilethere is a lot to be said for this view, it requires a moredetailed analysis than the author presents. It is by nomeans clear which sources of information one oughtto trust. Communication in complex societies isincreasingly characterized by official spin and system-atic distortion. In some circumstances, scepticism isindeed the more rational attitude than trust. (There isample evidence to suggest that the official rationalefor the decisions of governments and corporationsrarely corresponds to the real reasons for those deci-sions.) So what Hardwig’s arguments demonstrate isthat there is no immediately obvious and systematicrelationship between the concepts of rationality,scepticism and trust. The implications of this argu-ment for the debate about the sources of informationthe author does want us to trust are unclear.

Chapter 3 takes up this problem with reference tospecific challenges to the reliability of informationgenerated by RCTs and meta-analyses. However rig-orous the methods of data synthesis, the ‘dirty secret’which can sometimes embarrass exponents of EBMis that the data are sometimes poor, false and mis-leading. (p. 49) Bruce Charlton puts this point suc-cinctly: ‘condensed garbage is still garbage.’ (Miles

et al

. 2000) Goodman’s response to this and a num-ber of other methodological problems for EBM is

that we need ‘more science not less’, so he consis-tently calls for more formalization of the researchprocess: more formal guidelines, protocols, ‘scalesand checklists for quality assessment’ in the designand analysis of research. (p. 53) Clearly this begs anumber of questions regarding what counts as properscience and indeed good science. After a diversioninto the realm of bioethics in Chapter 4 (which addslittle of substance to the main arguments of thebook), Goodman returns to these central questionsin Chapter 5.

Star Trek

epistemology

As noted already, protagonists of EBM can be iden-tified by their adherence to a position in epistemol-ogy based on certain absolute dichotomies. Thesedichotomies derive from the strict empiricism of thelogical positivists but they have been popularized by(amongst other things) the science fiction series

StarTrek

, to which Goodman explicitly alludes – with areference (p. 96) to the characters of Dr McCoy andMr Spock. For readers unaware of the numerousextensive data bases which exist to document everydetail of the

Star Trek

universe, Spock is a Vulcan,which means that his thinking is objective: it is ratio-nal, scientific, logical and concerned only with evi-dence. Spock has no time whatsoever for gut feelings,hunches based on personal experience and intuition,because these things are subjective and thereforeirrational or non-rational. McCoy stands for all ofthese things.

Goodman accepts that it might be necessary fordoctors with limited knowledge to appeal to McCoy’stechniques, but he is equally convinced that onlySpock’s methods of thinking have any chance of gen-erating

justified

and

scientific

beliefs, and henceknowledge of the real world. All subscribers to EBMphilosophy tacitly (or, in Goodman’s case, explicitly)assume

Star Trek

epistemology, and base their think-ing about the philosophy of science upon it. Theyassume that doctors in an ideal world would bemodel scientists like Spock, while doctors in the realworld are more often like McCoy. But the simplisticdichotomy between such ‘subjective’ ideas as ‘intu-ition’ on the one hand and ‘objective’ ideas like‘logic’ on the other hand is a relic of logical positivismand not philosophically sustainable.

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As I have argued more extensively elsewhere(Loughlin 2002), the terms ‘intuitive thinking’ and‘rational thinking’ do not represent two different andmutually exclusive types of thought. Properly under-stood, they are not ‘alternatives’ at all. Rather, intu-ition and rationality are both essential componentsof human thinking, and the meaningful employmentof each requires the other. The poet and the com-poser of music rarely pause to consider the complexrelationships between symbol and sound that maketheir respective activities possible. These activitiesare no less intuitive for being highly structured. Tothink that they must be is to embrace a false dichot-omy. Similarly scientists, mathematicians and philos-ophers (including logicians) cannot do withoutsound intuitions. Often one needs to ‘sense’ thedirection in which to look for a proof

before

onefinds it, and this is how the most significant advancesare made.

To cite just a couple of examples. The work of thebrilliant 20th century logician Saul Kripke has hadprofound and lasting effects on our thinking aboutthe interpretation of referring expressions, and theimplications of Kripke’s work for a number of philo-sophical questions (such as the nature of mentalstates) are well documented. In

Naming and Neces-sity

(Kripke 1980), Kripke persistently describes his‘rigid designation’ theory of naming as an ‘intuitivethesis’. Ultimately, the only way one can possiblygrasp the fundamental logical laws on which Kripke’sarguments depend (such as Leibnitz’s law of theindiscernibility of identicals) is intuitively. Logic andintuition are inseparable. To point out (as Goodmandoes) that an activity is ‘rule governed’ does notmean it is not also intuitive.

With regard to science and intuition, Einstein’svarious references to the intuitive basis for his think-ing in physics include the delightful claim that ‘. . .real science and real music demand one and the samethought process.’ (cited in Loughlin 1998) Even thework of the great empiricist J.S. Mill provides the

basis for a refutation of the simplistic positivismassumed by proponents of EBM. [cf. Mill’s thoughtsin

A System of Logic

(Mill 1879) on the ‘broad’ con-ception of logic as ‘The Science and Art of SoundReasoning’.] I am constantly amazed that defendersof a doctrine that places such great store upon theneed for up-to-date research can owe so much to aposition in epistemology whose refutation has beenso well documented.

Goodman’s remaining chapters include discus-sions of ‘evidence-based policy’, ‘evidence-basedgenetics’ and human subjects research. The tendencyto adopt an overly scientific tone (in Spock’s ratherthan Einstein’s sense of ‘scientific’) is reflected in theoveruse of the ugly and profoundly misleadingphrase ‘to ethically optimize’. (To use it even once is,in my view, to overuse it.) Goodman is at his bestwhen he abandons such quasitechnical terminologyin favour of a good old-fashioned tirade. I found hisearly polemics against overpublishing in academiaenjoyable and entirely justified. There is a very crueljibe against philosophical antirealists and relativiststucked away in footnote 7 of Chapter 2. (Goodmanasks whether such people would want someone oflike epistemological mind to treat their child’s can-cer.) Unfortunately such things need to be said –though perhaps not in a book aimed primarily at aclinical audience.

References

Kripke S. (1980)

Naming and Necessity.

Basil Blackwell,Oxford.

Loughlin A.J. (1998)

Alienation and Value-Neutrality

.Ashgate Publishing Ltd, Aldershot.

Loughlin M. (2002)

Ethics, Management and Mythology

.Radcliffe Medical Press, Oxon.

Miles A., Hampton J.R. & Hurwitz B., eds. (2000)

NICE,CHI and the NHS Reforms

. Aesculapius Medical Press,London.

Mill J.S. (1879)

A System of Logic

. Longmans Green,London.