200;

This is to certify that the
dissertation entitled

ADVANCING AN ETHICS OF EVIDENCE: A CRITICAL
APPRAISAL OF EVIDENCE BASED MEDICINE AND
FEMINIST THEORIES OF EVIDENCE

presented by
MAYA J. GOLDENBERG

has been accepted towards fulﬁllment
of the requirements for the

Doctoral degree in Philosophy

Q1444 J:/ZW//“/AVL

 

 

v

Major Professor’ s Signature

 

MSU is an Afﬁrmative Action/Equal Opportunity Institution

 

 

 

-.—.~>--.— -.--..-

 

LIBRARY
Michigai‘. State

Univergity

 

 

 

PLACE IN RETURN BOX to remove this checkout from your record.
TO AVOID FINES return on or before date due.
MAY BE RECALLED with earlier due date if requested.

 

DATE DUE DATE DUE DATE DUE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6/07 p:/ClRC/DateDue.indd-p.1

ADVANCING AN ETHICS OF EVIDENCE:
A CRITICAL APPRAISAL OF EVIDENCE BASED MEDICINE
AND FEMINIST THEORIES OF EVIDENCE
By

Maya J. Goldenberg

A DISSERTATION

Submitted to
Michigan State University
in partial fulﬁllment of the requirements
for the degree of

DOCTOR OF PHILOSOPHY
Department of Philosophy

2007

ABSTRACT
ADVANCING AN ETHICS OF EVIDENCE:
A CRITICAL APPRAISAL OF EVIDENCE BASED MEDICINE
AND F EMINIST THEORIES OF EVIDENCE
By
Maya J. Goldenberg

Evidence based medicine (EBM), the coveted standard of best practice in most areas of
healthcare, holds the promise of systematizing clinical practice and improving patient
care by making healthcare more responsive to research evidence. EBM’S commitment to
highly controlled experimentation and methods of statistical analysis previously used
only for population-based research represents not only methodological innovation, but
also a novel regard of the reliability of various forms of medical knowledge. The
epistemic narrowing that results from the rigid hierarchy of evidence motivates my
proposed new direction for critical analysis of EBM: an ethical analysis of the
exclusionary and implicit normativity with respect to scientiﬁc knowledge in the context
of EBM. By being framed as “better science”, normative questions of meaning are
reduced to technical questions of measure.

This mode of critique diverges from the familiar tactic among EBM critics of
illustrating the untenable positivist construction of evidence underlying EBM.
Advancing an “ethics of evidence” broadens the current scope of the ethics of EBM by
demonstrating the ethical signiﬁcance of the‘epistemological challenge to EBM’S
objectivist account of evidence and science. I also further the epistemic challenge to

EBM by drawing on the work of feminist philosopher of science Sharyn Clough to

promote an alternative conﬁguration of evidence that avoids the objectivism—to-relativism

slide common to postpositivist science studies. I argue that while the critics rightly
challenge EBM’S objectivist account of evidence, they are unable to offer a decisive
alternative. Once the fallibility of empirical evidence and the underdetermination of
theory are properly recognized, the critics cannot offer guidance for adjudicating between
the competing subjective and interpretive ﬁlters that inescapably enter into clinical
decisionmaking. Clough’s critical reading of postpositivist science studies offers an
intriguing explanation for this difﬁculty in her indictment of representationalism, which,
she claims, necessarily leads critical epistemologies of science to relativism. I recast the
EBM critiques in light of Clough’s Davidsonian analysis, and while I reject Clough’s
prescribed abandonment of epistemic pursuits in favor of critical empirical science, I
support her effort to reinvigorate the normativity of evidence found in objectivist
epistemology without the objectivism while avoiding the relativism of evidence thought

to accompany contextualist theories of knowledge.

Copyright by
MAYA J. GOLDENBERG
2007

DEDICATION

This dissertation is dedicated with love to my grandmother.

ACKNOWLEDGMENTS
I would like to give special thanks to my dissertation committee, Jim Nelson (chair), Lisa
Schwartzman, Marilyn Frye, Judy Andre, and Fred Gifford for their critical attention to my
work. I also beneﬁted from the insights of Gideon Chemel, Jennifer Gibson, and Barbara
Secker in frequent discussions and readings of rough drafts. Thanks to my family and

friends for their support and patience.

vi

 

TABLE OF CONTENTS

LIST OF FIGURES .................................................................................. ix
KEY TO ABBREVIATIONS ..................................................................... x
INTRODUCTION .................................................................................. 1
CHAPTER ONE
WHAT’S NEW ABOUT EBM? EBM’S METHODOLOGICAL INNOVATION. . . . 14
The Origins of EBM ........................................................................... 16
What’s New about EBM? ........................................................................................... 19
IS EBM a New Paradigm? ........................................................................................... 21
The Novel Contents of EBM .................................................................. 27
The Hierarchy of Evidence .................................................................... 29
Randomized Controlled Trials: The “Gold Standard” of Medical Research ............ 32
Outcomes Measures: Clinical Effectiveness and the Quality Movement in
Medicine ..................................................................................... 40
In Conclusion .................................................................................... 45
CHAPTER TWO
INTRODUCING AN ETHICS OF EVIDENCE TO THE ETHICS OF EBM ............ 47
In Conclusion .................................................................................... 62
CHAPTER THREE
ON EVIDENCE IN EVIDENCE BASED MEDICINE: AN EPISTEMOLOGICAL
CRITIQUE .......................................................................................... 64
Evidence and Evidence Based Medicine .................................................... 67
Postpositivist Philosophy of Science ......................................................... 68
Postpositive Implications for EBM .......................................................... 72
Feminist Epistemologies of Science ......................................................... 76
Feminist Implications for EBM .............................................................. 83
Phenomenology of Science and Medicine .................................................. 87
Phenomenological Implications for Evidence Based Medicine ......................... 91
Distinguishing EBM from pre-EBM: Nothing New in the EBM Critique? .............. 96
On the Power/Knowledge of EBM: The Political Economy of Evidence Based
Decision Making ......................................................................... 98
In Conclusion .................................................................................. 115
CHAPTER FOUR
RETHINKING EVIDENCE AND THE PROBLEM OF RELATIVISM ............... 118
Antifoundationalist Epistemology: Scientiﬁc Holism and Relativism ................ 121
Antifoundationalist Science ................................................................. 123
Widening Evidence: Antifoundationalist and Holistic Accounts of Evidence ....... I32
Antifoundationalism, Evidence, and the Problem of Relativism ...................... 138
Rethinking the Evidence of EBM ......................................................... 144

Vii

In Conclusion ................................................................................... 145

CHAPTER FIVE

ADVANCING EVIDENCE: A DAVIDSONIAN REPAIR ................................ 148
Davidson’s Model of Language Use ....................................................... 148
Davidson on Evidence ........................................................................ 155
Rethinking Evidence: Differentiating Clough from Nelson .............................. 157
Beyond Epistemology: Empirical Inquiry, not EmpiricISM ............................. 160
A Pragmatist Approach to Science Studies ................................................ I64
Confronting the Critics ....................................................................... 168
In Conclusion .................................................................................. 177

CHAPTER SIX

RECASTING EBM AND ITS CRITICS ...................................................... 179
Return to the EBM Debate: Where We’ve Come From and Where We’re Going... 180
Pragmatism vs. Epistemology ............................................................... 182
EBM: Pragmatic and Epistemological ..................................................... 182
EBM Critics: From Fallibilism to Relativism ............................................. I92
Initiating an Alternative Health Research Agenda ....................................... 203
In Conclusion .................................................................................. 215

CHAPTER SEVEN

REVISITING THE ETHICS OF EVIDENCE: THE NORMATIVITY OF THE

TECHNICAL ...................................................................................... 217
The Ethics of Evidence ....................................................................... 218
Evidence Based Ethics ....................................................................... 220
In Conclusion .................................................................................. 234

CONCLUSION

ADVANCING AN ETHICS OF EVIDENCE ................................................ 237

BIBLIOGRAPHY ................................................................................ 245

viii

LIST OF FIGURES

Figure 1. Users’ Guide to Medical Literature hierarchy of evidence ...................... 30

Figure 2. Gupta’s characterization of the implicit values of EBM ......................... 52

ix

KEY TO ABBREVIATIONS

EBE ....................................... Evidence Based (Bio)Ethics
EBM ...................................... Evidence Based Medicine
EBWH .................................... Evidence Based Women’s Health
IRB ......................................... Institutional Review Board

RCT ........................................ Randomized Controlled Trial

INTRODUCTION

Evidence based medicine (EBM) is a systematic set of practices that aims to allow
physicians to make therapeutic recommendations that correspond to the best available
evidence of effectiveness. In its Short duration, it has come to be widely regarded as
offering a signiﬁcant and promising means for improving patient care and harnessing
healthcare spending. While both epistemological and ethical concerns have been raised
and examined within the comparatively small but growing critical literature on EBM,
they have been treated separately and the connections between the ethical and
epistemological issues have not been investigated. Whether cause or effect, these
segregated critiques reveal limited insight into EBM’S methodological, philosophical, and
sociological complexity. The ethics of EBM currently concentrates on how EBM affects
patient autonomy and care, but leaves the mounting critiques of the epistemology
underlying evidence based claims (especially concerning EBM’S conﬁguration of
“evidence”) to thinkers outside of the ethical forum.‘ In this investigation, I argue that
EBM’S construction of evidence needs to be placed at the heart of the ethical issues
surrounding patient care. For this reason, the ethics of evidence in EBM are examined
here.

Initiated only a decade and a half ago as a new paradigm in medical education and
practice, “evidence-based medicine” has come to be widely regarded as synonymous with
“best practices” in medicine. EBM purports to eschew unsystematic and “intuitive”

methods of individual clinical experience in favour of a scientiﬁcally rigorous and

 

' This will be discussed in chapter two.

methodical approach to clinical decisionmaking that is grounded in the best and most
current research evidence. EBM centres around ﬁve linked ideas:
1. clinical decisions should be based on the best available scientiﬁc evidence;

2. the clinical problem, and not the habits of clinicians or routine clinical
protocols, should determine the type of evidence to be sought;

3. identifying the best evidence means using epidemiological2 and biostatistical
ways of thinking;

4. conclusions derived from identifying and critically appraising evidence are

useful only if put into action in managing patients or making health care

decisions;

5. clinical performance should be constantly evaluated.3
EBM has strived to widely implement these goals into clinical practice by enlisting
numerous techniques for the management, evaluation, and application of data for use in
patient care. Its hallmark is the hierarchy of evidence that consistently places the
evidence derived from randomized controlled clinical trials on top.4 The synthesis of
large quantities of clinical trial data into manageable “clinical summaries” and “meta-
analyses”5 by the hardworking volunteers at the Cochrane Collaboration6 and other
institutional affiliates, and the proliferation of this information to clinicians, educators,
actuaries, and medical funding bodies Via EBM journals and electronic databases are

supposed to revolutionize medical practice and offer objective and politically transparent

criteria for funding decisions at the policy level. The political and professional capital of

 

2 Epidemiology was once reserved for public health research, but the EBM founders adapted its techniques
for use in individual patient care (“clinical epidemiology”).

3 Davidoffet 01(1995), "Evidence based medicine." _B_l\_dl 310(6987), p. 1085.

‘ Sackett er 01(1996), "Evidence-based medicine: what it is and what it isn‘t." M 312(7023), p. 72.

5 A meta-analysis is a systematic statistical analysis of research data from multiple studies that tries to draw
conclusions based on pooled data. Its purpose is to elucidate the answer to a single question

6 Based at Oxford, the collaboration is an international consortium of workers who construct an ever-
enlarging evidence database by contributing their own randomized trials, discoveries of unpublished trials,
and meta-analyses. The collected information extends through all branches of medicine and is the main
source of evidence for evidence based practice. .

EBM cannot be overstated, as it is thought to increase professional responsibility and
accountability, improve patient care, and make managed care and medical research more
cost effective by ensuring that only the most promising technologies are funded.

The critical literature interrogating EBM focuses primarily on the epistemology of
EBM, speciﬁcally the numerous concerns surrounding the “evidence” of evidence-based
medicine.7 This direction of critique seems ﬁtting, as the proposed practice of EBM calls
for the evaluation and use of the best available evidence for clinical use in patient care.
EBM offers a deﬁnitive interpretation of what counts as “best evidence” and encourages
its cultivation and application by a hierarchy of methods, clinical guidelines, and
authoritative evidentiary sources. Critics worry that because the data is derived almost
exclusively from randomized trials and meta-analyses, they do not include many types of
treatments or patients seen in clinical practice. The trial results are also problematic
because they show comparative efﬁcacy of treatment for an “average” randomized
patient, and not for pertinent subgroups formed by such cogent clinical features as
severity of symptoms, illness, and co-morbidity. Thus EBM brings forward evidentiary
quandaries that deserve critical attention.

The more philosophically-inclined critics charge EBM’s conﬁguration of
evidence with being reductionist,3 positivist,9 and foundationalist,l0 and share the general

conclusion that EBM’s “evidence base” is simply inadequate for properly capturing the

 

7 See, for example, the frequently cited paper, F einstein and Horwitz (1997), "Problems in the ‘evidence’ of
‘evidence-based medicine'." Am J Med 103(6).

8 Welsby (I999), "Reductionism in medicine: Some thoughts on medical education from the clinical front
line." J Eval Clin Prac 5(2); De Simone (2006), "Reductionist inference-based medicine, i.e. EBM." J Eval
Clin Prac 12(4). ‘

9 Goldenberg (2006), "On evidence and evidence-based medicine: Lessons ﬁ'om the philosophy of
science." W 62(11)

'0 Upshur (2002), "If not evidence, then what? Or does medicine really need a base?" J Eval Clin Prac

8(2).

 

complex nuances of medical decisionmaking in the clinical context.ll The debate
surrounding EBM has had the surprising effect of moving the epistemological question of
what is evidence from the conﬁnes of academic journals of philosophy and epistemology
to surface in the medical and healthcare trade journals. Conﬁgurations of evidence are
Signiﬁcantly tied to understandings of the structure of knowledge and epistemic
justiﬁcation; in medicine, the EBM debate fosters self-reﬂection regarding the nature,
goals, and scope of health care.

Intertwined within these epistemological concerns, there is a distinctive and
inescapable moral dimension to EBM. EBM is predicated on the moral imperative
widely held to drive health care: the duty to achieve health and alleviate human
suffering.12 Supporters View EBM as providing these means and so it is vigorously
endorsed as an approach to medicine that ought to be practiced.13 Critics are equally
concerned with the ethical implications of EBM. They challenge the alleged moral
mandate to practice EBM on the grounds that if the biases and judgments ignored by
EBM may insidiously inﬂuence the evidence upon which clinical decisions are made, the
practice of EBM could lead to worse rather than better patient care. '4 Furthermore, EBM
may have unwanted effects on access to health services and may deepen the inﬂuence of

private interests, at the expense of patient interests, in determining what services are

 

” Miles et 01(1997), "Evidence-based medicine: Why all the fuss? This is why." J Eval Clin Prac 3(2);
Miles et al (1999), "Advancing the evidence-based healthcare debate." J Eval Clin Prac 5(2); Miles et a1
(2002), "Critical advances in the evaluation and development of clinical care." J Eval Clin Prac 8(2);
Kerridge et al (1998), "Ethics and evidence based medicine." M 3 I 6(7 I 38).

'2 Ashcroft (2004), "Current epistemological problems in evidence based medicine." J Med Ethics 30(2).
'3 Ashcroft (2004), "Current epistemological problems in evidence based medicine." J Med Ethics 30(2);
Kerridge et 01(1998), "Ethics and evidence based medicine." M 316(7138).

" Christiansen and Lou (2001), "Ethical considerations related to evidence-based practice." Am J Occup
1191 55(3).

made available.15

Despite there being distinctive ethical features of EBM, however, ethics is
typically treated as an afterthought in the growing EBM discourse. The literature on the
ethics of EBM is sparse in comparison to the volume of scholarship into the
methodological and epistemological issues surrounding EBM. The ethics literature is
also narrow in its limited focus on the impact that EBM has on patient care. An
examination into the workings of EBM (in chapter one) will demonstrate that neither the
epistemic nor the ethical analyses of EBM can go on responsibly without each other. We
will see that there are some Signs of acknowledgment of the relation of ethics to
epistemology in more politicized commentaries on EBM’S knowledge producing
activities (such as the EBM critiques coming from feminist epistemology and political
economy perspectives), however the ethical relevance of epistemology has not yet been
advanced.

While bioethics holds patient advocacy and the protection of patient’s rights and
interests to be a fundamental preoccupation, this project aims to broaden the scope of the
ethics of EBM to include the epistemological debates. Given the methodological
innovation that EBM will be shown to present to medicine (see chapter one), as well as
the power/knowledge relation mentioned above, the ethical analysis of EBM must
address the epistemic issues surrounding this signiﬁcant knowledge technology. In a
study examining the relationship between EBM and patient autonomy, Molewijk et al. '6

illustrate how the bridging of ethics and epistemology is called for in the context of EBM.

 

'5 Gupta (2003), "A critical appraisal of evidence-based medicine: Some ethical considerations." J Eval
Clin Prac 9(2), p. 119.

'6 Molewijk et a! (2003), "Implicit normativity in evidence-based medicine: a plea for integrated empirical
ethics research." Health Care Anal 11(1).

The study investigated how patients with abdominal aortic aneurysm, a life-threatening
disease, responded to and incorporated evidence-based facts into their treatment
decisionmaking. Initially the researchers planned to begin the investigation only once
they had developed an evidence-based decision-support brochure detailing the relevant
facts and treatment options for patients, in consultation with their surgeons, to consider
for the decision-making process. The development of the brochure was thought to be
straightforward. However, during the process of translating the decision model into a
brochure, they realized that there are many different ways to produce and present
evidence-based facts and that choosing between them was a subjective process that led to
different moral consequences. '7 These brochures came to be recognized by the team as
anything but an objective presentation of statistical data, as any representation of clinical
information requires various selections and choices concerning, for example, what
information is clinically relevant, what are the appropriate inputs for the decision making
model, and how the information can be made understandable to the patient.‘8 The
authors concluded that there is “implicit normativity” in EBM, as the study highlighted
how both the production and presentation of scientiﬁc information in an evidence-based
decision-support contains implicit presuppositions and values which prestructure the
moral environment of the process of decision-making. As a consequence, “the evidence-
based decision support did not only support the clinical decisionmaking process, it also

transformed it in a morally signiﬁcant way.”19 This phenomenon was thought to

 

'7 Molewijk et 01(2003), "Implicit normativity in evidence-based medicine: a plea for integrated empirical
ethics research." Health Care Anal 11(1), p. 73.
"I Molewijk et a1 (2003), "Implicit normativity in evidence-based medicine: a plea for integrated empirical
ethics research." Health Care Anal 11(1), p. 74.
'9 Molewijk et a1(2003), "Implicit normativity in evidence-based medicine: a plea for integrated empirical
ethics research." Health Care Anal 11(1), p. 87.

undermine the common assumption within much of the literature on patient autonomy
that information disclosure is a conditional requirement before patient autonomy even
begins. Instead, patient autonomy is already inﬂuenced during the production and
presentation of information. The authors saw these results as establishing the need for an
increased responsibility by those who produce and present evidence-based facts.20 I see it
as also prompting more bioethical focus and analysis into the knowledge-producing
activities of biomedicine.

In this dissertation, EBM’s allegiance to an objectivist account of evidence and
the seeming modesty of its aim of gathering and applying the best evidence to clinical
practice will be demonstrated to obscure the normative dimensions of the evidence-based
approach by framing EBM as merely a technical ﬁx to the evidentiary deﬁcits in clinical
practice and the resulting limits to the effectiveness of patient care. The separation of the
technical and the normative in fact relies heavily on its construal of evidence, which
ignores the social features (i.e. value judgments and political interests) present in the
production and presentation of empirical evidence.

The bridging of ethics and epistemology is supported by some of the operating
assumptions of the medical humanities about the nature of medicine and its sociopolitical
importance as well as feminist scholarship in the epistemology of science. Medical
humanities research typically regards the activity of medicine as a productive cultural
force that is not morally neutral, as medicine reveals new meanings and enlarges

possibilities with respect to the human condition.21 The presumed cultural importance of

 

2° Molewijk et 01(2003), "Implicit normativity in evidence-based medicine: a plea for integrated empirical
ethics research." Health Care Anal 11(1), p. 69.

2' Hill (1994), "The cultural and philosophical foundations of normative medical ethics." Soc Sci Med
39(9). By “human condition”, I mean the philosophically complex phenomenon that encompasses the

medicine22 is technologically driven, as new advances constantly broaden the scope of
medicine’s role in society and challenges social conventions, including understandings of
life, death, human nature, and personal identity.23 Ethical analysis that focuses strictly on
the ends that medicine and medical technology serve is therefore severely limited. The
discipline of bioethics serves to help the medical establishment understand its place in a
culture and to help that culture measure the meaning of the medical practices going on
within it.24 It is, of course, technological developments that give direction to the
biomedical sciences, and so, bioethics must provide thoughtful and searching analyses of
the dynamics of signiﬁcant technologies like evidence-based decisionmaking.

In feminist scholarship, signiﬁcant attention has been paid to science because of
the recognized sociopolitical stakes of knowledge and knowledge production. The
exclusions and harms that have been suffered by women in the name of science have
made a feminist case for scientiﬁc revisioning. As I will argue, feminist epistemologists
of science have demonstrated that the experience and knowledge that we bring to bear on
scientiﬁc theorizing will be inﬂuenced by the social relations of gender, race, and class
that characterize our society. Stricter methodological controls cannot “ﬁlter out” these
factors and relationships.25 The call for more accurate accounts of the connections

between knowledge and sociopolitical relations (including our moral codes) broadens the

 

existential experience of being human and living human lives. Put simplistically, there are a series of
biologically determined events which are common to most human lives, and the ongoing way in which
humans react to and/or cope with these events is the human condition.

22 Medical sociologist George Weisz has made the claim that understanding the scope of medicine’s role is
fundamental for understanding our culture. Weisz, ed. (1990), Social science perspectives on medical
ethics.

23 Hill (1994), "The cultural and philosophical foundations of normative medical ethics." Soc Sci Med
39(9).

2" Engelhardt (1986), The foundations of bioethics.

25 Harding (1986), The science question in feminism; Longino (1990), Science as social knowledge:
Values and objectivig in scientiﬁc inquiry; Nelson (1993), "Epistemological communities." Feminist
epistemologies; Tuana, ed. (1989), Feminism and science; Longino (1989), "Can there be a feminist
science?" Feminism and science; Nelson (1990), Who knows: From Ouine to feminist empiricism.

 

 

factors relevant to our knowledge and undertakings, such as scientiﬁc inquiry, to
encompass social relations, politics, values, and other factors long regarded as a threat to
objectivity, if not the very antithesis to evidence.26 Thus feminist science studies provide
a valuable framework for analyzing the evidentiary quandaries surrounding EBM as well
as important conceptual tools for investigating the ethics/epistemology relation in the
context of EBM.

Overview of the Project

The overview of EBM in chapter one casts EBM as more than the Simple
application of research ﬁndings to clinical care and improved health outcomes, but rather
an umbrella term that harnessed a speciﬁc set of pedagogical objectives (some rather
radical) under a name that makes it difﬁcult to argue against; for unlike “outcome
measurement” or the use of computers by the bedside, who could possibly be against
evidence?27 Attention is also called to the hubris surrounding the EBM movement, which
is later demonstrated to allow EBM to be much more than a medical decision making
tool, but also a potential political device capable of promoting certain interests in
medicine. By this account, knowledge production is not a value-neutral endeavour and
“evidence” is not Simple concept.

This more nuanced understanding of EBM also reveals the shortcomings in what
have now become the standard ethical and epistemological debates surrounding EBM. In
chapter two, a review of the published material on the ethical issues surrounding EBM
reveals a sparse literature that is narrow in scope. The current parameters of the ethics of

EBM are limited to consequentialist analysis of the ends achieved by EBM with respect

 

2‘ Nelson (1993), "A question of evidence." Hypatia 8(2), p. 180.
27 Carr-Hill (1995), "Welcome? To the brave new world of evidence based medicine." Soc Sci Med
41(11); Lambert (2006), “Accounting for EBM: Notions of evidence in medicine." Soc Sci Med 62(1 1).

 

to patient care, namely whether EBM improves health outcomes and enhances patient
autonomy within the decisionmaking cOntext. The previous chapter’s analysis of EBM
exposes further moral dimensions than the current “ethics of EBM” permits, including
the moral signiﬁcance of the epistemology of EBM. The subsequent chapters investigate
the epistemological challenges to both EBM and its critics, while also incorporating
methodological and sociopolitical considerations into this layered critique. We only
return to the ethics of EBM in the last chapter for consideration of the moral dimensions
of these challenges.

As the name “evidence based medicine” should suggest, the complex picture of
health and well-being, medical authority, economics, political interests, and
sensationalism that constitutes the EBM discourse all hinge on “the evidence”. The EBM
critics have therefore focused considerable attention on the construction of evidence
underlying the evidence based approach. I will demonstrate in chapter three that in what
is largely a “postpositivist” critique of objectivist accounts of science, the critics have
signiﬁcantly destabilized EBM’S epistemic base. This line of criticism fails, however, in
numerous respects:

1. It fails to distinguish EBM from its biomedical predecessor, thus undermining

the critical conclusion that we must abandon EBM in favour of alternative

approaches;

2. By missing the important methodological and epistemic novelty that EBM
brings to medicine, important areas of critique are neglected;

3. The postpositivist epistemological critique does not, and I will show, cannot
offer an alternative account of evidence.

In chapter four, I consider the objection that critical science studies effectively

replaces the objectivist and positivist View of evidence underlying EBM with a relativist

10

account of evidence in the effort to encourage epistemic holism. This charge of
relativism has been frequently mounted against postpositivist epistemologies of science;
feminist epistemologies have been particularly criticized for introducing subjective
content and politics into science. Yet, against the charges of relativism, feminist
epistemologists insist that such inclusiveness in constructs of epistemology, science, and
even evidence does not undermine knowledge pursuing activities. Lynn Hankinson
Nelson, for instance, argues that the inclusiveness of evidence is inescapable, and
therefore acknowledging it does nothing to ﬁrrther the case for scepticism or relativism.
The alternative of a more supposedly objective or bounded account of evidence is no
more than an article of faith.28 She and others insist that feminist philosophy’s
emancipatory program demands normative content in its projects, and its commitment to
rethinking concepts clears space for investigation rather than stiﬂes it. I, however, follow
both Sharyn Clough’s insistence that feminist science studies does not overcome the
problem of relativism,29 as well as her attempts to resolve this problem using Donald
Davidson’s philosophy of language in my analysis of evidence.30
The problem of relativism is addressed in chapters four, ﬁve, and six of this
investigation into the ethics of EBM because relativism and the inescapable uncertainty
of our knowledge claims regarding the veracity of our beliefs is not only an epistemic

concern in the context of health care, but also a deeply moral problem. Medical

uncertainty and incorrect knowledge may inﬂict suffering, illness, disability, or death on

 

28 Nelson (1993), "A question of evidence." Hypatia a.8(2)

29 Clough (2003), Beyond epistemology: A pra gmatist approach to femini_st science studies; Clough
(2003), "A hasty retreat from evidence: The recalcitrance of relativism In feminist epistemology." Siblings
under the skin: Feminism, social justice and analytic philosophy.

3° For example, Davidson (2003), "A coherence theory of truth." Siblings under the skin: Feminism, social
justice and analytic philosotmy; Davidson (1974), "On the very idea of a conceptual scheme." Proceedings
and addresses of the American Philosophical Association.

 

II

those for whom health care professionals have a duty to care. While EBM’S quest to
manage and minimize medical uncertainty may be misguided due to its shoddy
epistemological basis (see chapter three), its motivation is certainly rational, admirable
and ethically desirable. Both proponents and dissenters noticeably agree that this pursuit
is worthwhile; the disagreement lies in its execution. Furthermore, the relativism
encountered by the critics’ postpositivist frameworks may discourage wary practitioners
from seeking alternatives to EBM, as clinicians ﬁnd themselves, in the end, needing to
act and needing to do so with justiﬁcation.

The ethics of evidence—the incorporation of the methodological (chapter one),
epistemological (chapters three to six), and sociopolitical concerns (chapter three)
surrounding EBM into an ethical analysis that appreciates EBM’S novelty and
complexity—is articulated in the last chapter of this dissertation. It does not focus solely
on the impact of EBM on health outcomes and patient care, but also considers the ethics
of knowledge and knowledge production in biomedicine.

Thus EBM, the authoritative standard of best practice in medicine over the past
ﬁfteen years, raises signiﬁcant epistemological and ethical issues. The philosophical
literature examining EBM has focused almost exclusively on the epistemology. Despite
EBM being the prevailing standard in biomedicine, and therefore indispensable to
bioethics, the ethics of EBM receives little attention. The work that is done focuses on
how EBM’S application affects patient choice, autonomy, and care, but does not broach
on the epistemological challenge to the objectivist account of evidence operating as the

coveted base of medicine. I aim to Show that the construction of evidence is at the heart

12

of the ethical issues surrounding patient care, and in this project, the ethics of evidence in

the context of EBM are investigated.

13

CHAPTER ONE
Nothing New About Evidence Based Medicine? EBM’s Methodological Innovation

Evidence based medicine is most popularly deﬁned as the “conscientious and
judicious use of current best evidence in the healthcare of individuals and populations.”3 1
EBM’S inﬂuential doctrine ﬁrst appeared in the Journal of the American Medical
Association as a brief polemic authored by the Evidence Based Medicine Working
Group:

A new paradigm for medical practice is emerging. Evidence based

medicine de-emphasizes intuition, unsystematic clinical experience,

and pathophysiologic rationale as sufﬁcient grounds for clinical

decision-making and stresses the examination of evidence from

clinical research. EBM requires new skills of the physician, including

efﬁcient literature searching and the application of the formal rules
of evidence.32

EBM rose quickly into prominence in medicine, with virtually every area of healthcare
now striving to become evidence based. PubMed currently has over 20,000 citations for
“evidence-based”. This is a considerable feat for a discipline that is described in the
EBM manifesto as largely reliant on conventions and habits of thought and practice.
Yet amidst the hubris, there is a certain obviousness to EBM that has prompted
critics to charge EBM with offering “nothing new”:33
“Evidence based medicine,” one chemist said to me, “What other kind of

medicine could there possibly be?” and a consultant physician said grufﬂy:
“We have always practiced evidence based medicine”.34

 

3 ' Sackett et a1 (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

32 Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2417.
33 See, for example, Benitez-Bribiesca (1999), "Evidence-based medicine: A new paradigm?" Arch Med
Research 30(2).

3" Hope (1995), "Evidence based medicine and ethics." .1 Med Ethics 21(5), p. 259; Hope is a supporter of
EBM who maintains that one sign of a movement being important is when its detractors indignantly
maintain that it is nothing new.

14

 

In this chapter, I offer a detailed examination of EBM, starting with a historical account
of its origins in clinical epidemiology, followed by the methodological innovations that
the evidence based approach brings to medicine, and its ties to the outcome movement
and policy initiatives. The purpose of this exercise is to distinguish EBM from its
biomedical predecessor and to determine the innovation that EBM brings to medicine.
This nuanced understanding of EBM will then serve to highlight some of the deﬁciencies
in the current ethical (chapter 2) and epistemological (chapter 3) critiques of EBM, as
both will be shown to fail to capture the intricate workings of this important
decisionmaking technology and therefore fail to properly account for many of the
concerns surrounding EBM.

I propose that EBM’S original contribution to medicine, or what separates EBM
from other approaches, is the priority it gives to certain forms of evidence, speciﬁcally
the randomized controlled trial. EBM offers a shift in the sort of evidence that is most
highly valued for diagnosis, therapy, and prognosis questions, as heavy emphasis is
placed on experimental controls and quantiﬁed measures, thus diminishing the previous
status of clinical experience and observational studies signiﬁcantly.35 This commitment
represents not only methodological change, but also a novel regard of the reliability of
various forms of medical knowledge. While not a paradigm change, EBM denotes an
important Shift in biomedical thinking and practice that is a signiﬁcant alternative to its
biomedical predecessor. EBM offers a new answer to medicine’s ﬁrndamental normative

question: how ought we to practice medicine?

 

3’ Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate." B C
Health Serv Res 3:14, p. 4.

15

 

The epistemic narrowing that results from the rigid hierarchical regard of
evidence is a crucial consideration for the new direction in EBM critical analysis being
proposed in this research project, namely an ethical analysis of the exclusionary and
implicit nonnativity with respect to scientiﬁc knowledge in the context of EBM. The
evidence based approach and the Cochrane databases that provide that evidence will be
argued to demonstrate intolerance towards alternative forms of knowledge. While the
EBM texts claim to appreciate qualitative research methods, for example, the databases
decree that acceptable research must be based on randomized trial design. Thus all other
health science research, which has been estimated to constitute as much as 98% of the
literature, is deemed scientiﬁcally imperfect.36 It becomes questionable whether EBM can
promote the multiple ways of knowing deemed important within most health disciplines.
With this streamlining of the decisionmaking process, EBM may also be deployed to
serve a governmental function, where ready-made and convenient “goals-and-targets”
can be used to justify cuts to healthcare funding.37

The OrLQinS ofEBM

 

The origins of the evidence-based medicine movement are traceable back to a
series of lectures given by epidemiologist Archie Cochrane in the early 19703, where he
argued that many popularly used medical practices were of dubious or unknown safety
and efﬁcacy. In these lectures, which were later compiled in Effectiveness and

Eﬂiciency: Random Reﬂections on Health Services,38 he detailed the harms that ensued

 

3° Holmes et al (2006), "Deconstructing the evidence-based discourse in health sciences: Truth, power and
fascism." lntJ Evid Based Healthc 4(3).

37 Holmes et al (2006), "Deconstructing the evidence-based discourse in health sciences: Truth, power and
facism." Int J Evid Based Healthc 4(3); Traynor (2002), "The oil crisis, risk, and evidence-based practice."
Nurs Ing 9(2).

3‘ Cochrane (1972), Effectiveness and efficiency. Random reﬂections on the health service.

16

from the prevalent use of unestablished medical interventions to both individuals and
populations, by way of iatrogenic injury, waste of resources, and failure to take up more
effective treatments. He argued that treatments Should be evaluated systematically using
unbiased methods of evaluation (such as the randomized controlled trial), and that
individual practitioners and the medical profession as a whole Should continuously
review and appraise their own state of knowledge. Aschcroft has noted the strong ethical
imperative behind Cochrane’s recommendations, as they were rooted in concern to do no
harm, to do one’s best for one’s patients, and to do so justly by eliminating waste.39
Cochrane’s programmatic outline was revitalized in 1990 by a group calling
themselves the “Evidence Based Medicine Working Group”, comprised of professors of
clinical epidemiology, medical informatics, and biostatistics at McMaster University in
Hamilton, Ontario, who introduced the phrase “Evidence Based Medicine” in a
ubiquitous 1992 manifesto as a “new paradigm” in medical education and practice.40 In
the document, the ethical promise was made that the Virtuous clinician “whose practice is
based on an understanding of the underlying evidence will provide superior patient

3"" While the ethical imperative to improve patient care remained central, the

care
promise to decrease medical uncertainty by systematic evaluation of the efﬁcacy of

current practices was particularly appealing to managed care organizations and health
policy analysts facing a crisis situation With respect to escalating healthcare costs and

spending. Added to the gamut of methodologies for data collection and analysis ﬁrst

recommended by Cochrane was the use of emerging information technologies to

 

39 Ashcroft (2004), "Current epistemological problems in evidence based medicine." J Med Ethics 30(2),

p}. 131.

Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17).
4' Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2421.

17

synthesize the large quantities of published studies and to proliferate the information and
increase accessibility through electronic databases. The combined picture of EBM as
ethically driven to improve patient care, ﬁscally responsible, and technologically up-to-
date likely drove the rapid integration of the movement into medicine, where ﬁfteen years
after the Evidence Based Medicine Working Group ﬁrst formed, EBM is now common
parlance within health care. As a burgeoning institution, academic centres42 and

journals43 dedicated to EBM’S advancement have been established with much fanfare,

 

42 Founded in 1993, The Cochrane Collaboration, whose motto is “The reliable source of evidence in
health care”, is an international not-for-proﬁt organization that provides up-to-date information about the
effects of health care. The Collaboration produces and proliferates systematic reviews of healthcare
interventions through the Cochrane Database of Systematic Reviews. The Collaboration also maintains the
Cochrane Library, which contains numerous regularly updated evidence-based healthcare databases and is
described as “the deﬁnitive resource for evidence-based health care” (www.cochrane.org). Other academic
centers committed to promoting evidence-based practices in healthcare include The Centre for Evidence-
Based Medicine (UK); Oxford Centre for Evidence-Based Medicine; National Institute of Clinical
Excellence (UK); American Family Physicians; Centre for Clinical Evidence Synthesis (USA); Centre for
Health Evidence (Canada); Joanna Briggs Institute (Australia). While the strongest EBM bases are found
in the UK and North America, EBM is still correctly described as an international movement. In China, for
example, the EBM network includes The Chinese Cochrane Centre, with both Chinese University of Hong
Kong and Si Chuan University branches; The Peking University EBM Centre; The Fudan Centre for
Evidence Based Medicine; The Clinical Epidemiology Society of the Chinese Medical Association; China
Epidemiology Network (ChinCLEN); and ﬁnally, in an interesting meeting of Western and Eastern
traditions, the Evidence Based Chinese Medicine Centre for Clinical Research and Evaluation at the
Beijing University School of Chinese Medicine. All of these Chinese institutions are part of a larger Asia
Paciﬁc EBM Network, whose member countries are Australia, China, India, Japan, New Zealand, Macau,
Malaysia, Pakistan, Philippines, Taiwan, and Thailand. The proceedings of the Network’s 6‘h annual
meeting, held December 8-10, 2006 in Hong Kong, can be accessed at: Asia Paciﬁc EBM Network (2006),
"Asia Paciﬁc EBM Network Conference 2006." http://www.sph.cuhk.edu.hk/hkcochrane/e-tapenet.htrn

43 EBM journals synthesize and comment on existing clinical evidence. Some of the signiﬁcant titles
include: ACP Journal Club, a bimonthly journal and was the original evidence-based secondary
publication featuring structured abstracts and commentaries supplied by experts of high quality studies that
are relevant to the practice of Internal Medicine. The journal is available in print as part of Annals of
lntemal Medicine or as part of the Ovid Evidence-Based Medicine Reviews database; Evidence-Based
Medicine is the BMJ Publishing group’s bi-monthly journal, surveying a wide range of international
journals in family practice, internal medicine, pediatrics, ob/gyn, psychiatry, and surgery. Practicing
clinicians assess the clinical relevance of selected studies and the key details of these essential studies are
presented in a succinct abstract with an expert commentary on its clinical application
(http://ebmbmiioumﬁcom); Bandalier is a monthly journal produced in Oxford for the NHS. lntemet
access is free (http://www.ir2.ox.ac.uk/bandolier/); Evidence-Based Practice is from the editors of the
Journal of Family Practice . Every article Starts with a clinical question chosen by practicing family
physicians. The answers are explained by members of the Family Practice Inquiries Network (F PIN), a
national consortium of academic and practicing family physicians, medical librarians, and others dedicated
to translating research into practice. FPIN Clinical Inquiries appear monthly in the Journal of Family
Practice. Evidence-Based Practice subscribers can access the FPIN database (www.cbponline.net);

I8

and the “evidence-based” movement has stretched beyond the health sciences44 to social
work,45 education,46 and other social science disciplines. It is even generating attention as
a promising new approach to bioethics (“evidence-based ethics”).47 The term “evidence-
based everything” has been used to describe the enthusiasm for this movement.48

What’s New about EBM?

Despite the fanfare, it is not immediately obvious that EBM offers something new
to medical practice. In response to EBM’S demand that medical decisions ought to be
based on stringent empirical evidence, critics ask, hasn’t modern medicine always been
evidence-based? Quite surely, and almost by deﬁnition, biomedicine has always been

grounded in the empirical sciences, which bases its claims on observational evidence. At

 

POEMS (Patient Oriented Evidence that Matters) is a regular feature of the Journal of F am ily Practice.
Editors review 80 primary care journals and identify studies with patient-oriented outcomes that have the
greatest potential to change clinical practice. These articles are then critically appraised by expert family
physicians, educators, and/or pharmacologists. POEMS is available by subscription at
http://www.infopoems.com/ and is also available as a PDA product called InfoRetriever. Other EBM
journal titles include: Eﬂectiveness Matters; Evidence-based Library and Information Practice; Advanced
Studies in Medicine; Clinical Evidence; Evidence-based Complementary and Alternative Medicine;
Evidence-based Dentistry; Evidence-based Dental Practice; Evidence-based Healthcare; Evidence—based
Healthcare & Public Health; Evidence-based Mental Health; Evidence-based Nursing; Evidence-based
Obstetrics & Gynecology; Evidence-based Oncology.

4" For example, Kovner et al (2000), "Evidence-based management (and commentaries)" Frontier Health
Serv Manag Summer 2000; McGuire (2005), "Evidence—based population health: A critical realist
framework." University of Toronto Compa_ra_tive Progrtun on Health and Society. Reilly et al (2004),
Evidence based practice in speech pathology; Von Zweck (1999), "The promotion of evidence-based
occupational therapy practice in Canada." Can J Occup Ther 66(5).

’5 For example, Coumoyer (2004), The evidence-based social work gills book; Howard et a1 (2003),
"Teaching evidence-based practice: Toward a new paradigm for social work education." Research on social
work practice 13(2); Torrey et al (2001), "Implementing evidence-based practices for persons with severe
mental illnesses." Psychiatr Serv 52(1); Webb (2001), "Some considerations of the validity of evidence-
based practices in social work." Brit] Socﬂ Work 31.

’6 For example, Exceptional Children, the official journal of Canada’s Council for Exceptional Children,
featured a special issue on “Criteria for Evidence-Based Practice in Special Education” (vol. 71, 8; Winter
2005). See also Davies (1999), "What is evidence-based education?" Brit J Edu Studies 47(2); Slavin
(2002), "Evidence-Based Educational Policies: Transforming Educational Practice and Research."
Educational Researcher 31(7).

’7 See, for example, Roberts (2000), "Evidence-based ethics and informed consent in mental illness
research." Arch Gen Psych 57(6); evidence-based ethics is analysed in detail in chapter seven of this
dissertation.

’8 Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5).

 

 

l9

the heart of empiricism is the widely held assumption that “only a thoroughly
observational procedure can exclude fanciful speculation and empty metaphysics as well
as the hope that an empiricist attitude is most liable to prevent stagnation and to further

the progress of knowledge.”49

Empiricist epistemology, from Hume onward, is guided
by the idea that observation provides a maximally certain foundation of empirical
knowledge, a foundation that supplies the basic premises of all our reasoning, and
without which there would not even be reliable knowledge claims. This foundational
picture of factual or a posteriori knowledge relies on a theory of observational evidence
playing a central role in observation obtaining objective empirical knowledge.

In its typical formulation, empiricism is predicated on the position that all
empirical knowledge is founded upon a set of independently intelligible and credible
observational claims. Observations are understood to both stimulate the formation and
regulate the testing of theories. In the role as stimulus, observation of perplexing or
surprising events prompts questions of why these things happen, and thereby leads to
theoretical explanations. Recurring phenomena call for an understanding of the
principles of organization and uniﬁcation—the theories—to make sense of the
observations. Observations serve to test hypotheses as the latter are corroborated by their
ability to predict what will actually be observed.

Observation is central to scientiﬁc practice because of the supposition that it is the
mechanism for acquiring knowledge about the world. Because observations are

generated ﬁom the world of objects, it is distinct from theories, which are understood to

originate from the minds of scientists. Observation is supposed to be public and

 

’9 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 922.

20

accessible to anyone willing to look, and therefore it is proposed to provide a source of
agreement and a common ground of information to arbitrate disagreements between
differing theoretical accounts. Because observation serves as our access to “the facts”, it
is the most promising foundation on which to build the objective basis of science. The
standardized understanding of “evidence” repeats this distinction between the internal
mind and the external world, as evidence is deﬁned in the Oxford English Dictionary as
“an observation, fact, organized body of information that supports a belief”.50

Because biomedicine is grounded in the natural and life sciences, the critics are
correct to think that EBM’S empirical commitments are not new to medicine’s ideal
practices (regardless of whether or not they are actually practiced). However, when
considering the question of whether EBM offers anything new, we must remember that
its proponents have explicitly denied the charge that EBM is “old hat”,5 1 and have even
been grandiose in their descriptions of EBM as being a “new paradigm” promising to
“revolutionize” medicine;52 this description suggests the evidence based approach to offer
something radically different from previous approaches, and so it is worth investigating
this alleged paradigm change.
Is EBM a New Paradigm?

To illustrate the unique workings of EBM, the new paradigm of medicine, the
Evidence Based Medicine Working Group presented the following clinical scenario:

A junior medical resident working in a teaching hospital admits a 43-year

old previously well man who experiences a witnessed grand mal seizure.

He had never had a seizure before and had not had any recent head
trauma. . .Findings on physical examination are normal. The patient is

 

5° The Concise Oxford English Dictionary (2002).

5' Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." BM; 312(7023), p. 71.

52 Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17); Sackett
et a1 (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

21

. “1,“; ‘ -. - s
' “' cf .. :‘I-x‘

I' ' 1 g, ”V
* Junta...“

«a; "

c it."

Aw . I-. ‘ s,“

. x, ‘ ‘eya‘ .

_ - I- - . .
. "1""IL"'.’C“ 1 . ,
l-IJ __ A

 

    
 

4::

:_’I - “(1.491

 

given a loading dose of phenytoin intravenously and the drug is

continued orally. A computed tomographic head scan is completely

normal, and an electroencephalogram Shows only non-speciﬁc ﬁndings.

The patient is very concerned about his risk of seizure recurrence. How

might the resident proceed?53
The Working Group explain that the resident practicing “the way of the past " (pre-EBM)
would consult the senior resident, who, supported in his View by the attending physician,
informs her that the risk of seizure recurrence is high, although its precise risk factor is
unknown to him. He instructs the resident to relay this information and the related
precautions to the patient. The resident does as she is told and the patient, still fearful, is
discharged.54 In “the way of the future ”, however, the EBM-trained resident asks herself
whether she knows the prognosis of a ﬁrst seizure and, realizing that she does not,
proceeds to the library and conducts a literature search on the Grateful Med search
engine. Her search on the medical subject headings “epilepsy”, “prognosis”, and
“recurrence” retrieves twenty-ﬁve titles, of which one is deemed by the resident to be
directly relevant. Exercising the critical appraisal Skills that She learned in medical
school, she reviews the paper, deems the study and its conclusions to be valid, and returns
to her patient after only thirty minutes. She conveys the risk of recurrence over time
post-incident, and recommends follow-up with his family physician. The patient leaves
“with a clear idea of his likely prognosis.”55

In their comparative analysis of EBM and its biomedical predecessor, Sehon and

Stanley argue that the EBM programmatic literature’s likening of their approach to a

 

5’ Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2420.
5’ Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2420.
5’ Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2420.

22

Kuhnian paradigm shift is a gross exaggeration.56 The authors contend that EBM is not a
new paradigm because Kuhn described such a large-scale scientiﬁc revolution as
involving dramatic changes of worldview and even a different world in which scientists
must operate.57 A Kuhnian paradigm is an “entire constellation of beliefs, values,
techniques, and so on shared by the members of a given community.”58 The new
paradigm will be incommensurable, to some extent, with the previous paradigm, a
condition that is not met with the evidence based approach in comparison to.
biomedicine’s “basic science approach”, which involves “studying the physiological
mechanisms of the body and the biochemical properties of drugs.”59
When EBM is suggested to be a new paradigm, this fosters the impression that an
entire set of beliefs, values, and techniques is to be left behind, “and that the whole world
of medical research and clinical practice is completely different than it was in the days
before EBM.”60 This impression is certainly false. Furthermore, the language of
paradigms suggests that health care practitioners must make a “stark choice” between
EBM and “traditional” biomedicine, where one can “accept the new regime and
completely reject the old, or defensively hold onto the old and dismiss EBM entirely?“
Aside from not being a productive atmosphere in which to hold a critical debate about

EBM, this polarization exaggerates the merits, demerits, and differences between EBM

and its biomedical “predecessor”.

 

5’ Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate." BMC
Health Serv Res 3:14.

’7 Kuhn (1996), The structupe of scientiﬁc revolutions, p. 210.

5' Kuhn (1996), The structure of scientiﬁc revolutions. p. 210.

59 Sehon and Stanley (2003 ), "A philosophical analysis of the evidence-based medicine debate." B_MC
Health Serv Res 3: 14, p. 3.

6° Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate."
Health Serv Res 3:14, p. 4.

6' Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate." M
Health Serv Res 3:14.

BMC

23

Numerous commentators have characterized the EBM debate as dredging up the
hoary “art versus science” dispute regarding the nature of modern clinical medicine. The
critics worry that EBM overemphasizes the latter at the expense of the former. Sullivan
and MacNaughton, for example, comment that

the doctor does not deal with illnesses alone but with people who are

ill, and for each individual the illness is unique in terms of his or her

experience of it and in its presentation to the doctor.62
Understanding the unique circumstances of the individual case is thought to involve a
form of practical knowledge or judgment quite different from the technical knowledge
offered by EBM. The “grey zones” of practicef’3 that is, areas where the evidence from
randomized trials about risk-beneﬁt ratios of competing clinical options is incomplete,
inconclusive, or contradictory and so clinical judgment must be relied on,64 are repeatedly
argued to be missing from EBM’s formulaic knowledge base.65 Indeed, EBM struggles
to account for the interpretive dimensions of clinical care, as evidence-based
decisionmaking is largely an effort to standardize and rationalize the application of
evidence to clinical care. It is no wonder that critics fail to be persuaded by EBM’S
conciliatory efforts, such as making the ﬁrst principle of EBM “evidence is never
enough”. It is also worth asking: if evidence is not the fundamental base of medicine, are

we still practicing evidence based medicine?

 

62 Sullivan and MacNaughton (1996), "Evidence in consultations: Interpreted and individualized." Lancet
348(9032), p. 941. _

6’ Naylor (1995), "Grey zones of clinical practice: Some limits to evidence-based medicine." Lancet
345(8953).

6" Among the procedures cited by Naylor to be in the “grey zone” are: carotid endarterectomy, upper
gastrointestinal (GI) endoscopy, hysterectomy, and percutaneous transluminal coronary angioplasty. RCTs
have been done in these areas, but the results have not produced unequivocal conclusions.

6’ Tanenbaum (1993), "What physicians know." N Engl J Med 329(17).

 

24

 

      
  
   
  

“.r— 1“ _‘
.-

._.-. 1“"
'5 "" .-

.‘r‘-.

3""- 1‘:-

  

:‘ {3355.553in
1" .. 5.4.1r

‘1
J
I!
-.
I!“

      
    

 

I ‘2'. ..
ntw‘u —

.., :5 "v3-

. "er

In light of these grey zones, EBM iS charged with creating and sustaining the idea
that evidence and practice are opposing concepts.66 Other dualisms reinforced in the
EBM literature include technical VS. experiential/intuitive knowledge, empirical vs.
theoretical knowledge, evidence based vs. patient-centred care, and, of course, EBM VS.
its biomedical predecessor, which is inappropriately referred to aS “traditional
medicine”.67 Adherence to these artiﬁcial bifurcations seems to misdirect the EBM
debate, as they promote undue polarization between EBM and its biomedical alternatives.
For instance, the references to pre-EBM as “traditional medicine” in some of the early
EBM programmatic literature68 is an obvious misnomer, as the term typically refers to
folk and alternative healing practices. The selection of this inappropriate term was
presumably deliberate, as it permitted the EBM originators to emphasize what they
alleged to be the widespread tendency of clinical medicine to operate without sufﬁcient
evidentiary support to establish the efﬁcacy of their practices. Pre-EBM biomedicine
was therefore “traditional” insofar as it is unscientiﬁc or at least insufﬁciently scientiﬁc.

Some support for this claim has been found in the phenomenon of small area variations

of healthcare practice among different geographical regions.69 However invoking

 

66 Wood et al (1998), "Achieving Clinical Behaviour Change: A Case of Becoming Indeterminate." §o_c
Sci Med 47(11); Pope (2003 ), "Resisting evidence: The study of evidence-based medicine as a
contemporary social movement." Health 7(3).

‘57 Accompanying these imposed bifurcations are, of course, efforts at integration, such as “evidence-based
patient centred care” (see Aggerty (2005), "Patient focused care in asthma." Practice Nurse 29(2)) or
“evidence-based patient choice” (see Hope (1996), Evidence based patient choice; Parker (2001), "The
ethics of evidence-based patient choice." Health Expect 4). An effort to overcome (or possibly deny) the
evidence/judgment divide is found in Downie et al (2000), Clinical judgment: Evidence in practice.

68 See Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17);
Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

69 Small area variation analysis is a research tool used by health services researchers to describe how rates
of health care use and events vary over well-deﬁned geographic areas. Signiﬁcant variation has been found
to exist, for example, in the rates of hospitalization for chronic obstructive lung disease, pneumonia,
hypertension, and in surgical procedures, such as hysterectomy, cholecystectomy, and tonsillectomy.
Potential sources of variation include differences in underlying morbidity, access to care, physician
judgment, quality of care delivered, patient demand for services, and random variation. Small area variation

25

“traditional medicine” is polemical (and distracting) in its misrepresentation of
biomedicine, as it cannot account for biomedicine’s modern scientiﬁc framework, its
signiﬁcant technological advances and achievements, and, of course, EBM’s ties to the
biomedical tradition.

Despite not invoking revolution (or comparable large-scale upheaval) in medical
practice, it will now be demonstrated that EBM certainly does bring something new to
medicine. The critics who deny this claim likely do so because they misunderstand EBM
as asking for no more than rigorous empirical research in medicine. Indeed, “evidence
based” will be shown not to be tantamount to “empirical”; the term “evidence based”
amounts to much more. While the evidence based approach certainly does call for
rigorous empirical research in medicine, this call is accompanied by novel accounts of
what counts as valid evidence and what qualiﬁes as the most rigorous methods of
empirical research. Rather than a revolution or paradigm change, EBM represents an
important shift in biomedical thinking and practice that is a Signiﬁcant alternative to its
biomedical predecessor. I propose that EBM offers a shift in the sort of evidence that is
most highly valued for diagnostics, prognostics, and therapeutics, in its emphasis on
experimental controls and quantitative research, which undermines previous regard of

clinical experience and observational studies70 signiﬁcantly.7| EBM’S hierarchy of

 

studies have been used to determine if signiﬁcant variation exists across geographic areas and to describe
relationships between the observed variation and potential causal factors. There are methodological
concerns within this area of study, such as the deﬁnition of small areas, deﬁning the at-risk population
within each small area, sample size, case mix adjustments, and stability of rates over time. For more on
small area variation studies, see Parchman (1995), "Small area variation analysis: A tool for primary care
research." Fam Med 272(4).

7° In research about diseases or treatments, this refers to a study in which “nature” is allowed to take its
course. Changes or differences in one characteristic, for example, whether or not people received a speciﬁc
treatment or intervention, are studied in relation to changes or differences in other(s), e.g. whether or not
they died, without the intervention of the investigator. There is a greater risk of selection bias than in
experimental studies.

26

evidence is at the service of outcomes research, which uses a cluster of statistical and
epidemiological methods for analyzing the therapeutic effectiveness of clinical
interventions.72 This commitment to highly controlled data and methods of statistical
analysis that were previously used only for population-based research (such as public
health) represents not only methodological change, but also a novel regard of the
reliability of various forms of medical knowledge.
The Novel Contents of EBM

Despite the revolutionary promises of eager EBM proponents, the unique content
offered to medicine by EBM remains difﬁcult for many to grasp. Hardly anyone can
disagree with the goal of getting clinicians to make “conscientious, explicit, and judicious
use of current best evidence” for decisions in patient care. Any expressions of doubt
about the EBM activities are usually greeted with vigorous accusations of disregarding
“today’s harsh realities”, or ignoring “what happens in clinical medicine”.73
Furthermore, critics are frequently denounced for erroneous beliefs that EBM only uses
evidence from RCTS, that it involves “merely the mindless application of the results of
megatrials”, and that “other forms of evidence are heavily discounted”.74 F einstein and
Horwitz have wisely suggested that the much of the confusion surrounding what EBM

actually stands for lies in the distinction between the contents of EBM itself and its

application in clinical practice. Furthermore, it is only when this distinction is blurred

 

7' Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate." BM_C
Health Serv Res 3:14, p. 4.

72 Gifford (I996), "Outcomes research: Upstream issues for downstream users." Hastings Cent Rep 26(2).
73 Sackett et al (1996), "Evidence based medicine. Authors’ reply." BM; 313(7049).

7’ Rosenberg, William M. C. and Donald (1995), "Evidence based medicine: An approach to clinical
problem-solving." BM; 310(6987).

27

that many clinicians claim EBM to offer “nothing new”.75 Most practitioners see little

novelty in EBM because they regularly assemble evidence, develop clinical judgment,
read medical literature, attend medical meetings, and have discussions with one another.
These activities seem entirely compatible with the statement that the practice of EBM
consists of “integrating individual clinical expertise with the best available external

clinical evidence from systematic research.”76

The activities surrounding the practice of
EBM also seems fairly standard, as the data informing evidence-based practice “is not
restricted to randomized trials and meta-analyses?”7 It contains “clinically relevant
research, often from the basic sciences of medicine” and it includes studies of diagnostic
tests, prognostic markers, and “the efﬁcacy and safety of the therapeutic, rehabilitative
and preventive regimes.”78 With this description of what is done when EBM is practiced
and with the overt acknowledgement by the EBM originators that EBM’S “philosophical

origins extend back to mid-19th century Paris and earlier,”79

clinicians can easily
conclude that EBM is not particularly novel, and may wonder why it has stirred so much
ﬁrss and controversy.80

The novelty lies, however, in the contents of what is assembled for use. Despite
the broad range of information permitted when EBM is practiced, the evidence collected
for EBM itself is conﬁned almost exclusively to randomized controlled trials (RCTS) and

the meta-analyses of those trials. Furthermore, the hierarchy of evidence conﬁrms this

privileging of the RCT. Because meta-analyses only aggregate and evaluate, but do not

 

7’ Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine’." Am J Med
103(6), p. 530.

7° Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." BM; 312(7023).

77 Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." B_MJ_ 312(7023).

7" Sackett et a1(l996), "Evidence-based medicine: what it is and what it isn't." B_MJ_ 312(7023).

79 Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." B_MJ 312(7023).

8° Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine'." Am J Med
103(6), p. 530.

28

change the basic information, the RCTS themselves become the fundamental source to be
considered both for quality and scope of data, and for the range of topics contained in the
EBM collection.81 For “questions of therapy”, for instance, Sackett et al. write that

we Should try to avoid the nonexperimental approaches, since they

routinely lead to false-positive conclusions about efﬁcacy. . .The

randomized trial, and especially the systematic review of several

randomized trials. . .has become the “gold standard”.82
The analysis in the next three sections will further examine the novel contents of EBM
captured in its methodological privileging of (1) the hierarchy of evidence, (2) the
randomized controlled trial, and (3) outcomes measures.
The Hierarchy of Evidence

EBM originated with the pedagogical objective of familiarizing physicians with
basic critical skills derived from clinical epidemiology. The hierarchy of evidence is a
useful educational tool because it captures EBM’S basic methodological and epistemic
commitments in a fairly straightforward ranking of methods. EBM proponents strongly
hold that the trustworthiness or validity of evidence is a function of the design of the
study from which the evidence is obtained,83 and so the desire to use only the “best

evidence from clinical research” in the management of individual patients84 has resulted

in elaborate classiﬁcatory schemes for ranking the value of different types of studies.

 

8’ Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine’." Am J Med
103(6), p. 530.

‘2 Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

83 Sackett (1997), "A science for the art of consensus." J Natl Cancer Inst 89; Canadian Medical
Association (1994), "Canadian task force on the periodic health examination." Can Med Assoc J 150(12):
Sackett (1989), "Rules of evidence and clinical recommendations on the use of antithrombotic agents."
Chest 95 (2 Suppl.)Sackett et a1 (1991), Clinical epidemiology: A basic science for clinical medicine;
Sackett et al (1997), Evidence-based medicine: How to practice and teach EBM.

’4 Sackett and Haynes (1995), "On the need for evidence-based medicine." Evidence-Based Medicine I;
Sackett et al (1997), Evidence-based medicine: How to practice and teach EBM; Sackett et al (1996),
"Evidence-based medicine: what it is and what it isn't." BM; 312(7023).

29

Among the numerous published formulations,85 there is a consistent placement of
randomized controlled trials or the systematic review of these trials at the top,
retrospective studies well down the list, and clinical anecdotes are seen as providing little

if any evidence for the value of intervention.

A Hierarchy of Strength of Evidence for Treatment Decisions

0 N of 1 randomized controlled trial86

0 Systematic reviews of randomized controlled trials

0 Single randomized trial

0 Systematic review of observational studies addressing patient-important outcomes
0 Single observational study addressing patient-important outcomes

0 Physiologic studies (studies addressing blood pressure, cardiac output, exercise
capacity, bone density, and so forth)

0 Unsystematic clinical observations

Figure 1. Users’ Guide to Medical Literature hierarchy of evidence87

While EBM has advanced considerably from its early polemics of “a new paradigm” of
medicine to a more tempered self-regard as a technique for clinicians to manage the
explosion of medical research available for use in making clinical judgments,88 the core
belief that evidence can be ranked hierarchically with pride of place belonging to
systematic reviews of randomized trials remains undisturbed. In the evaluation of
treatment effects, for example, a large, well-designed, randomized controlled trial is

Considered more reliable than those ﬁndings from non-randomized prospective or

 

’5 See, for example, Centre for Evidence-Based Medicine (2006), "Levels of Evidence and Grades of
Recommendation." http://www.cebm.net/Ievels_of_evidence.asp; Canadian Medical Association ( 1994),
"Canadian task force on the periodic health examination." Can Med Assoc J 150(12).
’6 While a randomized controlled trial is performed on a group, the N of l randomized controlled trial is
performed on an individual.

7 Guyatt and Rennie, eds. (2002). Users' guides to the medical literature: A manual for evidence-based
clinical practice, p. 7.

88 See, for example, Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates
want health care providers and consumers to pay attention to?" BMC Health Serv Res 2(3).

30

retrospective studies.89 Similar schemes have been developed for the ranking of evidence
in other clinical categories such as prognosis, aetiology or diagnosis.90 At the bottom of
each of these clinical scales is evidence obtained from case reports and personal
experience.

Given the assumption that better evidence will lead to better health outcomes, the
logic behind the ranking of evidence is simple: the best way to distinguish between the
effects of active treatment from the effects of known and unknown potentially biasing
inﬂuences is Via random assignment of subjects to intervention and control groups.9| If
the chance that we will erroneously recommend ineffective or even dangerous therapy is
reduced when it is based on the results of randomized trials, it follows that we should
make every effort to identify and catalogue these studies. And this is exactly what is
happening. EBM proponents initially endorsed the teaching of critical analysis skills in
medical schools so that physicians can properly assess the quality of a study.92 The
hierarchy of evidence is one of the tools used in this task. It was quickly realized,
however, that more advanced informatics was needed in order for clinicians to manage
the massive amount of research data available. The Cochrane Collaboration has
undertaken the monumental task of identifying and evaluating more than a million
randomized trials.93 Systematic reviews and meta-analyses of the randomized trials in
particular areas of medicine are now widely available on EBM databases and in journals.

This emphasis on randomized trials and their systematic reviews underscores EBM’S

 

89 Sackett (1997), "A science for the art of consensus." J Natl Cancer Inst 89(2322).
90 Centre for Evidence-Based Medicine (2006), "Levels of Evidence and Grades of Recommendation."
http://www.cebm.net/levels_of_evidence.asp.; Sackett et al (1997), Evidence-based medicine: How to
practice and teach EBM.

I Peto and Baigent (I988), "Trials: The next 50 years." B_MJ 317(7167).
92 Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17).
93 US. Cochrane Center (2002), "Training manual for handsearchers."

31

questioning of the efﬁcacy of treatments based on evidence gathered from non-
randomized trials and the extrapolation of data from physiologic and pharrnacologic
studies.

The privileging of “hard” evidence—the quantiﬁed data that is generated by
RCTS—over knowledge generated from clinical experience94 and qualitative measures95
Speaks to an epistemic distrust of subjective or personal experience, which can never
establish the truth of a claim beyond a reasonable doubt. Certainty is thought to be
achievable by abstracting from the possible sources of cognitive deceit, and so such
methodological features as blinding, randomization, placebo, the use of large subject
populations, and the replicability of results increase epistemic certainty by guarding
against the confounding factors and bias that can enter one’s belief system. These
methods serve the purpose of abstracting from values to reveal empirical facts. Of the
types of trials available, clinical trials offer the strongest and clearest support for any
claim that a treatment is effective because they allow scientists to control extraneous
variables and test one factor at a time.96 The hierarchy of evidence is, by the founders’
own admission, based on levels of certainty, where the quantiﬁed and the scientiﬁc forms
of evidence are understood to be most resistant to sceptical refutation.97
Randomized Controlled Trials: The “Gold Standard” of Medical Research

Cochrane was regarded as something of a maverick among his peers for his

controversial theses, among them the View that the randomized control trial should be

used to test the effects of medical interventions and thereby correct the ineffectiveness

 

9’ Evidence Based Medicine Working Group (1992), "Evidence-based medicine." .IAMA 268(17).
9’ Gray (1997), Evidence—based health care.

9’ Schick and Vaughn (2002), How to think about weird things: Critical thinking for a new age, p. 180.
97 Sackett et a1 (1991), Clinical epidemiology: A basic science for clinical medicine.

32

and even the harrnfulness of contemporary medical practice (this was yet another
heretical position at the time). RCTS allow the effects of an intervention to be tested by
randomly allocating research subjects to either an intervention group, where they receive
the experimental treatment, or a control group, where the conventional treatment or a
placebo is administered. Ideally the trial is “double blinded”, where both the research
subjects and the researchers do not know which group receives the intervention or the
control. Cochrane argued that research evidence from such trials could be used to ensure
that only effective treatments were administered, thereby allowing national health
systems to be more efﬁcient in their spending.98 A decade later, support for use of the
RCT in health care research was growing among North American public health
researchers, epidemiologists, and health services researchers.99 The considerable
research effort that was directed toward the synthesis and proliferation of trial evidence
into not only public healthcare, but also clinical practice (by the newly energized
discipline of “clinical epidemiology”), allowed for the RCT to become a “yardstick by
which other sources of information were judged and ranked within a hierarchy of
evidence.”loo

The methodological debates that make up the bulk of the EBM literature revolve
around the general question whether the reﬁned focus on clinical evidence (as prioritized
in the EBM hierarchy of knowledge), or the search for secure knowledge in general,

improves our ability to decipher best practices and therefore prescribe the most effective

treatments or whether the methods leave out too many important features of clinical care

 

9’ Cochrane (1972), Effectiveness 1nd efﬁcierﬂ Random reﬂections on the health service.

99 Pope (2003), "Resisting evidence: The study of evidence-based medicine as a contemporary social
movement." Health 7(3), p. 271.

'00 Pope (2003), "Resisting evidence: The study of evidence-based medicine as a contemporary social
movement."_HeaIth 7(3), p. 270.

 

 

33

that are not readily measurable through evidence-based approaches. This leads to the
important further question of whether the RCT rightﬁrlly deserves the title of “gold
standard”.

The RCT is promoted by EBM advocates as the only valid way to distinguish
treatment effects is to control bias through randomization.101 The introduction of
randomized trials to medical research has been credited by Iain Chalmers, one of the
original founders of the Cochrane Collaboration,'02 and others for revolutionizing
therapeutic development and increasing the life expectancy of patients from three to

seven years over the past half century.103

When substantial uncertainty exists about
treatment effects, it is widely thought to be not only scientiﬁcally correct to answer it in a
study with the smallest amount of built-in bias, but also most ethical to expose patients to
alternative treatment options based on chance only and not upon the biased opinion of a
physician. '04

Many EBM critics point to the “experiential nature” of medical practice for being
not only inextricable from but also inappropriately maligned by the evidence based
approach.105 However, supporters of EBM insist that experiential knowledge is worth

minimizing because experience allows for the repetition of mistakes. EBM proponents

point to the data available suggesting human fallibility and bias in drawing conclusions

 

'0' Chalmers (1998), "Unbiased, relevant, and reliable assessments in health care." M 317(7167).

'02 Chalmers was knighted in 2000 for his activism in cumulating evidence in medical research.

'03 Chalmers (1998), "Unbiased, relevant, and reliable assessments in health care." B_MJ 317(7167).

m" Edwards, S. J. L. et al (1998), "Ethical issues in the design and conduct of randomized controlled
trials." Health Tech Assess 2(15); Frazier and Mosteller (1995), Medicine worth paying for: Assessing
medical innovations; Freedman (I987), "Equipoise and the ethics of clinical research." N Engl J Med
317(3); Lilford and Jackson (1995), "Equipoise and the ethics of randomization." J Royal Soc Med 88.
'05 Williams, D. D. R. and Garner (2002), "The case against 'the evidence': A different perspective on
evidence-based medicine." Brit J Psych 180(Jan); Tanenbaum (1993), "What physicians know." N Engl J
M 329(17).

 

34

based on uncontrolled experience. '06 Others argue that investigators with relationships or
experience with a subject form expectations with respect to treatment outcomes that make
them less able to produce objective reviews of scientiﬁc evidence than non-experts
trained in critical appraisal of evidence.107 A logical deductive framework for
interpretation of evidence is therefore argued to be needed if we are to avoid practicing
medicine based on uncontrolled experience, which may do more harm than good.'08 The
nature of research is meant to reduce uncertainty, even if it cannot be completely
eliminated.

The central goal behind the EBM movement is quality of care, and this goal
serves as the grounds for encouraging medical practice that utilizes the latest and best
evidence. These practices are thought to be the means to enhancing “effective and
efﬁcient” clinical decision-making. Critics contend, however, that what constitutes
“most effective” can refer not only to clinical effectiveness or cost-effectiveness, but also
the extent to which patient-cased outcomes indicate satisfaction with the treatment
provided. In light of their concerns regarding incorporating patients’ goals and
perspectives into healthcare decisionmaking,109 these critics display a general distrust of
guidelines. Guidelines can limit patient choicel ‘0 by leaving patients with a “take it or
leave it” option in their treatment decision-making. Evidence—based approaches have

been charged with representing a narrow reductionism and epistemic Silencing that

 

'06 Dawson and Arkes (1987), "Systematic errors in medical decision making: Judgment limitations." LEE
Int Med 2(3); MacCoun (1998), "Biases in the interpretation and use of research results." Ann Rev Psych
49.

'07 Oxman and Guyatt (I993), "The science of reviewing research." Ann NY Acad Sci 703.

'08 Sackett (1989), "Rules of evidence and clinical recommendations on the use of antithrombotic agents."
QM 95(2 Suppl.)

'09 See, for example, Rogers (2002), "Evidence-based medicine and practice: Limiting or facilitating patient
choice?" Health Expect 5.

”0 Rogers (2002), "Evidence-based medicine and practice: Limiting or facilitating patient choice?" Health

Expect 5.

35

lll

ignores physicians’ clinical judgment and experience as well as patients’ voices and

perspectivesI '2

in its overreliance on epidemiological and statistical methodology
(particularly the dogmatic adherence to the RCT).113 EBM, in relying solely on a strict
hierarchy of acceptable forms of evidence, prioritizes evidence of clinical effectiveness
and necessarily excludes subjective perceptions, including those of the potential or actual
recipients of care.1 '4 Patient narrative and the interpretive features of clinical practice are
thought to be crucial features of quality healthcare.1 '5
Furthermore, RCT design is better geared for certain kinds of intervention
questions. RCTS are ideal for the direct comparison between simple treatments such as
two Single drugs, and so the pronounced “hegemony of the double-blind randomized
controlled trial”l '6 can both undermine research into and use of complex interventions
and result in a failure to meet the complex needs of individual patients. Regarding the
former, the critics worry that because RCTS are increasing in favor, and because the

expectation to provide “best evidence” of effectiveness before implementing

interventions is growing, complex interventions are by default less likely to be supported

 

”’ Tanenbaum (1993), "What physicians know." N Engl J Med 329(17).

”2 Tonelli (2006), "Integrating evidence into clinical practice: An alternative to evidence-based
approaches." J Eval Clin Prey 12(3); Edwards and Elwyn, eds. (2001). Evidence based patient choice:
lnevitpble or impossible?

”3 Miles et al (1997), "Evidence-based medicine: Why all the fuss? This is why." J Eval Clin Prg 3(2);
Miles et al (1999), "Advancing the evidence-based healthcare debate." J Eval Clin Prgg 5(2); Miles et al
(2000), "New perspectives in the evidence-based healthcare debate." J Eval Clin Pm 6(2); Miles et al
(2001), "Recent developments in the evidence-based healthcare debate." J Eval Clin Prac 7(2); Charlton
(1997), "Restoring the balance: Evidence-based medicine in its place." J Eval Clin Prag 3(2); Tonelli
(1998), "The philosophical limits of evidence-based medicine." Acad Med 73; Greenhalgh (1999),
"Narrative based medicine: Narrative based medicine in an evidence based world." BM; 318(7179); this
point will be further discussed in chapter 3’s phenomenological critique of EBM.

"’ Malterud (.1995), "The legitimacy of clinical knowledge: Toward a medical epistemology embracing
the art of medicine." Theor Med 16; Rogers (2002), "Is there a tension between doctors' duty of care and
evidence-based medicine?" Health Care Anal 10(3).

”5 Greenhalgh and Hurwitz, eds. (1998). Niiyrative based medicine: Dialogue and discourse in clinical
practice; Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based
world." BM; 318(7179).

"6 Charlton (1991), "Medical practice and the double-blind, randomized controlled trial." Brit J Gen Prac
41(350), p. 335.

 

 

 

 

 

 

36

over time.I I7

As a result, behavioral, psychosocial, community based, and multiple-
component interventions lose out in favour of individual patient-based treatmentsl I8 and
resultant public health policy-setting increasingly focuses on individuals rather than on
groups. I I9

In the arena of individual patient care, critics argue that because EBM guidelines
are derived from controlled trials of Simpliﬁed clinical situations using criteria that often
exclude other complicating serious conditions, the evidence may not be applicable to
complex clinical situations. The “gold standard” of clinical research is widely thought to
have a problem of generalizability of its results to individual patient care. I20 Even
Cochrane recognized that while the RCT can measure effectiveness, its results may not
be directly replicable in clinical practice,I21 and so Dingwall et al. seem correct in their
suggestion that Cochrane’s ideas have been used somewhat selectively in EBM.I22 The
problem of generalizability begins with the narrow eligibility criteria for randomized
trials, which limit conclusions about a treatrnent’s effectiveness to patients who fulﬁll
those criteria.I23 In order to optimize the opportunity to demonstrate efﬁcacy,

randomized trials are often conducted in major medical centres using relatively

homogenous populations. Patients excluded from such trials can differ substantially from

 

III De Vries and Lemmens (2006), "The social and cultural shaping of medical evidence: case studies from
pharmaceutical research and obstetric science." Soc Sci Med 62(11).

III Dieppe (1998), "Evidence-based medicine or medicine-based evidence?" Ann Rheum Dis 57(7); Tallon
et al (2000), "Relation between agendas of the research community and the research consumer." Lancet
355(9220).

”9 Davey-Smith et al (2001), "How policy informs the evidence." M 322(7286).

I20 Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155); Britton et al (1998),
"Choosing between randomized and non-randomized studies: A systematic review." Health Technolog
Assess 2(13); Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine'."
Am J Med 103(6).

III Cochrane (1972), Effectiveness and efﬁciency. Rﬂom reﬂections on the health service. p. 2.

'22 Dingwall et al (1998), "Catching goldﬁsh: Quality in qualitative research." J Health Serv Resegep
Policy 3.

I23 Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine’." Am J Med

103(6).

 

 

37

study patients in a variety of ways that could inﬂuence treatment outcomes (i.e. disease
severity, comorbid conditions, gender, race).I24 Furthermore, the time periods covered in
clinical trials and the measures used to assess outcomes frequently differ from those used
to assess the success of a therapy in actual practice. In an effort to be efﬁcient, clinical
trials typically use the Shortest time possible for determining valid results, employing
surrogate endpoints rather than clinically relevant outcomes. Surrogate endpoints are
physiological or biochemical markers that can be ascertained quickly and taken to be
predictive of clinically meaningful endpoints—such as how a patient feels, functions, or
survives—that take much longer to observe. They are “surrogate” insofar as they are
outcome measures that are not of direct practical importance but are believed to reﬂect
outcomes that are clinically relevant. For example,_cholesterol studies frequently use
cholesterol reduction as a surrogate for reduced mortality. Direct demonstration of
mortality reduction requires lengthy trials using large subject populations, while
cholesterol reduction is known to be strongly associated with mortality beneﬁts, and can
be measured easily in smaller numbers of patients. Similarly, blood pressure is not
directly important to patients but it is often used as an outcome in clinical trials because it
is a risk factor for stroke and heart attacks.I25
Yet the requirement that surrogate endpoints reliably predict the overall effect of

the clinical outcome frequently fails in practice. One explanation for this failure is the

possibility that the disease process could affect the clinical outcome through several

 

IZ’ Britton et al (1998), "Choosing between randomized and non-randomized studies: A systematic
review." Health Technolog Assess 2(13); Tanenbaum (1995), "Getting from there to here: evidentiary
quandaries of the US outcomes movement." J Eval Clin Prac 1(2); We already saw this methodological
critique in chapter two, where feminist concerns were raised regarding the exclusion of women in clinical
trials. In this case, the critique is coming from practitioners, not (necessarily) women’s health advocates
and/or theorists.

I25 Bandolier Glossary of Terms, "Surrogate endpoints."

38

causal pathways that are not mediated through the surrogate, with the intervention’s
effect on these pathways differing from its effect on the surrogate. It is more likely,
however, that the intervention affects the clinical outcome by unintended, unanticipated,
and unrecognized mechanisms of action that operate independently of the disease
process. I26 Fleming and DeMets argue that surrogate endpoints frequently mislead
regarding the actual effects that treatments have on the health of patients. For instance,
although lipid levels, especially those of total cholesterol or its subfractions and
triglycerides, have long been known to be signiﬁcant predictors of cardiovascular-related
mortality, there is debate over the relation between lipid lowering and reduction in overall-
mortality. The noteworthy Coronary Drug Project (CDP) in the 19705 and numerous
trials since then have shown such drugs as cloﬁbrate and niacin to decrease cholesterol
levels, however neither agent reduced total mortality.I27

Taken together, the numerous controls utilized to guard against bias and promote
efﬁciency in medical research limits the relevancy of, and may even distort, the “best
evidence from clinical research” in the management of individual patients. While there
are differences of opinion regarding the challenges posed in making clinical evidence
applicable, EBM fails to engage signiﬁcantly with this problem. It is notable that EBM’S
penchant for methodological rigor may be at odds with the ad hoc nature of clinical
practice; Tanenbaum has even suggested that the precision of “best evidence” is

fundamentally irreconcilable with its clinical relevance, given the particularity of patients

 

I26 Fleming and DeMets (I996), "Surrogate end points in clinical trials: Are we being misled?" Ann Int
Mpg 125(77).
I27 Fleming and DeMets (1996), "Surrogate end points in clinical trials: Are we being misled?" Ann Int
Mpg 125(77).

39

and the Signiﬁcant improvisational dimensions of clinical practice. I28 The debate over
RCTS highlight that the problem of evidence in EBM does not only concern what
knowledge is missing from the evidence based decisionmaking framework, but also the
nature of the knowledge that does enter into consideration.
Outcomes Measures: Clinical Effectiveness and the Quality Movement in Medicine

EBM was introduced to healthcare in the wake of what has been famously
described as the “third revolution” in health care,I29 a turn toward assessment and
accountability in light of escalating health care costs creating a “crisis” situation in health
care spending throughout the industrialized world. Patients and payers widely subscribed
to a “waste theory” that described physicians squandering healthcare dollars on
unenlightened diagnostic tests and unproductive medical treatments.I30 The urgency with
which the public demanded physicians be apprised of what does and does not work—that
is, attention to medical outcomes—led to what soon became known as the “outcomes
movement” in health policy. Evaluating clinical effectiveness was seen as a ﬁscally
responsible means of only ﬁnancing the most promising therapies and research. EBM
facilitated the clinical data that outcomes research requires in order to evaluate best
practices.

99I3I

Eliciting EBM’s place within the “quality movement captures a Shift in

medical rationality/knowledge from previous incarnations of biomedicine by way of

 

I28 Tanenbaum (1995), "Getting from there to here: evidentiary quandaries of the US outcomes
movement." J Eval Clin Prac 1(2); Shaugnessy et al. refer to this improvisational feature as “clinical jazz”
in Shaughnessy et a1 (1998), "Clinical jazz: Harmonizing clinical experience and evidence based
medicine." J Fam Pract 47(6).

I29 Relman (1988), "Assessment and accountability: The third revolution in medical care." N Engl] Med
319(18).

I30 Tanenbaum (1994), "Knowing and acting in medical practice: The epistemological politics of outcomes
research." J Health Pol Polig Law 19(1), p. 27.

I3 I Bodenheimer (1999), "The movement for improved quality of health care." N Engl J Med 340(6).

40

EBM’S insistent epistemological privileging of standardized information over judgment,
quantiﬁed measurement over experience, epidemiology over bench science, and the
fragmenting of the therapeutic relationship. Furthermore, understanding EBM’S
grounding in clinical epidemiology and outcomes research in health policy has been
argued by many critics to situate the movement in a new scientism—economism—which
has transferred the dictates of positivism into late-capitalist discourse, thus Shifting

medical authority from the laboratory to the marketplace. I32

This latter point will be
discussed later in the political economy critique of EBM.

Paul Ellwood, the progenitor of managed care, ﬁrst coined the term “outcomes
management” in a 1988 publication in the New England Journal of Medicine, where be
deﬁned it as “a technology of patient experience designed to help patients, payers, and
providers make rational medical care-related choices based on better insight into the
effects of these choices on patient life.”I33 Outcomes research uses statistical analysis of
clinical data to determine if particular therapeutics are associated with particular
results.I34 By subsuming efﬁcacy and effectiveness research, including clinical trials, it
is a variety of clinical epidemiology, which seeks the broadest determination of what
health care dollars are buying. EBM is considered the course of clinical medicine
presented by such research.I35

The outcomes movement argues for the primacy of probabilistic knowledge

derived from statistical studies for medical practice and the vigorous adoption of this

 

I” See, for example, Frankford (I994), "Scientism and economism: regulating health care." J Health Pol
Policy Law 19(4).

I” Ellwood (1988), "Outcomes management: A technology of patient experience." N Engl J Med 318(23).
I” Tanenbaum (I994), "Knowing and acting in medical practice: The epistemological politics of outcomes
research." J Health Pol Policy Law 19(1) p. 28.

I” Tanenbaum (1995), "Getting from there to here: evidentiary quandaries of the US outcomes
movement." J Eval Clin Prac 1(2), p. 97.

41

position within health care indicates a radical shift in medical rationality. Polychronis et
al., for example, regard the ascendancy of EBM as the triumph of statistics over clinical
common sense based on deterministic reasoning.I36 Clinical epidemiology is now held
by some to be a basic medical science.137 Along with privileging aggregate measure,
EBM is charged with encouraging a “fragmented” picture of medical knowledge in its
support for “the separability of expertise from expert and of knowledge from knower, and
the distillation of medical truth outside the clinical encounter.”I38 By giving credibility to
the belief that better knowledge of what is efﬁcacious or appropriate medical action is
obtained outside the clinical encounter by individuals who have no direct familiarity with
the patient,139 the evidence-based approach to health care takes authority away from the
practitioner and silences any epistemic legitimacy that patients may claim to have
pertaining to their illness and treatment. I40

Epidemiology was, of course, a segment of public health research, as it focused
on population rather than individual or clinical aspects of medicine. The term “clinical

epidemiology” ﬁrst appeared in the 19305 to signal attempts by some epidemiologists to

 

I36 Polychronis et a1 (1996), "Evidence-based medicine: Reference? Dogma? Neologism? New
orthodoxy?" J Evﬁal Clin Prpp 2(2).

'37 Upshur (1999), "Priors and prejudice." Theor Med Bioeth 20(4), p. 321.

I” Tanenbaum (1995), "Getting from there to here: evidentiary quandaries of the US outcomes
movement." J Eval Clin Prep; 1(2), p. 102.

I39 Others are thought to be able to know better by having access to selective summary data about the
patient and the ability to compare such summary data for an individual to that of a p0pulation as a way of
determining the proper action for a given individual. This is proper course in epidemiology.

I40 In Cochrane’s Eﬂectiveness and Eﬂiciency, Cochrane reﬂects on his years imprisoned in a German
POW camp, where he was forced to serve as the only camp physician for 20,000 undernourished men.
Upon a denied request for more medical staff, where a German ofﬁcer proclaimed that doctors are
“superﬂuous”, Cochrane wrote, “I was furious and even wrote a poem about it; later I wondered if he was
wise or cruel; he was certainly right." See also “Superﬂuous Doctors” in Cochrane (1974), Poems from

prison.

42

move their expertise closer to the bedside. The disciplineI‘II came to prominence in the
19805 when a group of physicians who Shared a conviction that the scientiﬁc base of
clinical practice should be strengthened, published the ﬁrst edition of the key textbook
Clinical Epidemiology,I42 which was the precursor to “evidence based medicine”.

EBM distinguishes itself from pre—evidence based biomedicine by its orientation
toward outcomes research, while biomedicine is more dependent on bench science.
While biomedical research entails laboratory science that aims to reveal the mechanisms
of medical cause and effect in order to determine what ought to be effective, EBM seeks
to generate probabilistic knowledge regarding what is likely to work, for whatever
reason.'43 John Wennberg, director of the Centre for Evaluative Clinical Science at
Dartmouth Medical School and well known in the ﬁeld for developing a strategy for
studying the population-based rates of health resource allocation and utilization, regards
biomedical science to be at the service of evaluative science in treatment decisionmaking.
The role of the former is to generate ideas and technologies, while evaluative science
provides the necessary clinical information linking treatments to outcomes. I44

The consistent placement of the RCT at the top of the EBM hierarchy of evidence
is better understood in light of the biomedical versus evidence-based distinction, as this

research method serves the objectives of outcomes research by appearing bracket out a

whole range of scientiﬁcally and epistemologically difﬁcult questions about why

 

I“ Clinical epidemiology is described as an “apparent oxymoron” by Mykhalovskiy and Weir (op cit. 48)
for breeching what were well-established oppositional distinctions between public health and curative
medicine, epidemiological and clinical knowledge, and population vs. patient care (p. 1065).

I42 Sackett et al (1985), Clinical epidemiology: A basic science for clinical medicine.

I43 Tanenbaum (1994), "Knowing and Acting in Medical Practice: The Epistemological Politics of
Outcomes Research." J Health Pol Policy Law 19(1), p.28.

I“ Wennberg (1992), "AHCP and the strategy for health care reform." Health Affairs 11(1).

43

treatments work or do not work. I45 Rather than determining the properties that make an
intervention work, for example, RCTS establish efﬁcacy by comparing the outcomes
found in a similar subject population receiving a comparator intervention. The practical
and professional advantages of this pragmatic approach to health care decision making
are signiﬁcant. For starters, deﬁnitive evidence from a trial or meta-analysis of the
results of a set of trials appear to settle the question of whether a treatment works or not
without need for appeal to any deeper biological theory to explain why the treatment
works or not (as required in deterministic or bench medical science). I46 Furthermore,
deﬁnitive biological explanation has not always led to safe or beneﬁcial treatment of
actual patients. The RCT “acts as a practical ﬁlter permitting the calibration of scientiﬁc
good ideas against clinical reality (however that is constructed)?”7 Because RCTS entail
the comparative study of two or more competing courses of treatment (including placebo
when indicated), the RCT “offers a technique for dispute resolution within medicine:
where there is discord, let a trial be.”I48
Because EBM and outcomes research are closely allied, the concerns regarding
the latter are similar to those launched against the former. The task of outcomes research,
to solve the problems of quality and cost that beset the healthcare system and to do so by

scientiﬁc rather than political means raises the expected postpositivist concerns about the

tenability of value-free measures. Furthermore, Tanenbaum’s account of the

 

I” Ashcroft (2002), "What is clinical effectiveness?" Stud Hist Phil Biol & Biomed Sci 33(2), p. 220.

I“ Of course there are several ways in which “does it work?” can be construed. See Ashcroft et a1 (1997),
"Implications of socio-cultural contexts for the ethics of clinical trials." Health Technol Assess 1(9);
Ashcroft (2002), "What is clinical effectiveness?" Stud Hist Phil Biol & Biomed Sci 33(2).

I" Ashcroft (2002), "What is clinical effectiveness?" Stud Hist Phil Biol & Biomed Sci 33(2), p. 220-221.
I” Ashcroft (2002), "What is clinical effectiveness?" Stud Hist Phil Biol & Biomed Sci 33(2), p. 220.

 

 

44

“epistemological politics” of the US outcomes movementI49 brings into question whether
this research can ever be so benign that it merely “informs decision makers. . .and helps
them make better decisions.”I50 The championing of probabilistic knowledge to improve
clinical practice is argued to replace subjective professional judgment with
micromanagement by insurance companies and government.I51

While Tanenbaum is accused of pandering to the fears of physicians and other
professionals who perceive outcomes research to be a threat to autonomous practice,I52
her criticisms are not against outcomes research per se, as She recognizes the usefulness
of statistical analysis in evaluating medical care. Her target is rather the outcomes
movement, the organized effort of one research community and its champions to gain
special privilege for statistical evidence, to consider it the only true evidence of medical
effectiveness, and to predicate an accountable health care system on physicians’
adherence to norms of practice derived from outcomes studies. Similar to EBM, the
critics ﬁnd utility in outcomes research for improving patient care, but they question its
near-hegemonic status in inﬂuential health policy and administrative circles.
In Conclusion

While the so-called “new paradigm” in healthcare hardly proves to be
revolutionary, EBM represents a shift in clinical methodology away from bench science

toward epistemology. The evidence based approach is marked by the ﬂourishing

relationship that the evaluative sciences and informatics, once solely the domain of

 

I49 Tanenbaum (1994), "Knowing and acting in medical practice: The epistemological politics of
Outcomes Research." J Health Pol Policy Lag 19(1).

"0 Sage (1994), "Outcomes research [letter]." N Engl I Med 330(6).

'5 I Tanenbaum (1995), "Getting from there to here: Evidentiary quandaries of the US outcomes
movement." J Eval Clin Pra_c 1(2); Tanenbaum (1993), "What physicians know." N Engl J Med 329(17).
I52 Cangialose (I994), "Outcomes research [letter]." N Engl J Med 330(6).

 

45

business and managerial studies, now have with medicine, in EBM’S valuing of
standardized measures, aggregate behaviour, and radically fragmented medical
knowledge. The novelty that EBM brings healthcare will be shown in the next two
chapters to have considerable ethical and epistemological Signiﬁcance.

The standard ethical (chapter two) and epistemological (chapter three) arguments
launched against EBM will be demonstrated, however, to be deﬁcient in light of the
detailed discussion of EBM undertaken in this chapter. Both will be seen to capture only
part of the evidence based approach and therefore the analyses prove to be narrow.
Speciﬁcally, the ethical analysis focuses only on the impact of EBM on patient care in its
consequentialist considerations, and misses the ethical issues that arise in its operating
assumptions and intricate workings. The epistemological critique is also narrow in its
critique of the problematic objectivism underscoring EBM’s understanding of
“evidence”. We will see that this concern faults not only in narrowing the range of
epistemic considerations and concerns, but also in failing to distinguish EBM from its
biomedical predecessor, which has been similarly charged with a naive epistemology of

science.

46

CHAPTER TWO
Introducing an Ethics of Evidence to the Ethics of EBM

Along with presenting complex ethical challenges to patient care, evidence based
medicine introduces a new area of consideration for healthcare ethics—the ethics of
evidence—that brings the epistemological questions of what constitutes evidence and
how medical knowledge is justiﬁed into ethical consideration. Valerie Mike’ ﬁrst coined
the term “ethics of evidence” to denote the moral implications of developing and
applying evidence.I53 I similarly want to forge connections between the ethical and
epistemological challenges that the evidence-based approach brings to medicine.
Speciﬁcally, I want to broaden the ethics of EBM beyond its current focus on how
individual patient care will be affected by EBM with respect to quality of care and the
incorporation of patient values, priorities, and cultural needs into the healthcare encounter
to include how ethical and other action-guiding norms shape what counts as evidentiary
considerations. I aim to show in this dissertation that the current broad/abstract
epistemological challenges to EBM concerning the neutrality of science and EBM’S
objectivist account of evidence are ethically relevant.

A good place to begin is with EBM’S underlying philosophical commitments.
The Evidence Based Medicine Working Group offers a very limited accounting of the
philosophy of EBM in a brief essay entitled “The Philosophy of Evidence-Based
Medicine” that appears in their authoritative manual for evidence-based clinical practice,
the Users’ Guides to the Medical Literature.I54 In the brief (7 pages) introductory essay,

the authors offer two fundamental principles of EBM. The ﬁrst is “evidence is never

 

I53 Miké (1999), "Outcomes research and the quality of health care: The beacon of an ethics of evidence."
Eval Health Prof 22(1).

I54 Guyatt et al (2002), "Introduction: The philosophy of evidence-based medicine." Users’ guide to the
medical literature: A manual for evidence-based clinical practice.

 

47

enough” for clinical decisionmaking. Arguably in response to the common criticism that
EBM offers a “cookbook” approach to medical decisionmaking that relies too heavily on
evidence of treatment efﬁcacy,I55 the authors state that “decision makers must always
trade the beneﬁts and risk, inconvenience, and costs associated with alternative [patient]
management strategies, and in doing so, consider the patient’s values.”IS6 They admit,
however, to have made limited progress in incorporating such factors into the evidence-
based approach, and conclude that “addressing these issues constitutes an enormously
challenging frontier for EBM.”I57

The second fundamental principle of EBM is its subscription to a hierarchy of
evidence for use in evidence-based treatment decisionmaking that privileges the data
derived from randomized controlled trials over unsystematic (i.e. observational and
uncontrolled) methodologies. The Users ’ Guides ’ brief description fails to acknowledge
and explicate the implicit epistemological commitments regarding what constitutes
reliable knowledge built into this methodological hierarchy.158 The remaining four pages
of the essay are dedicated to EBM’S remaining commitments: “Clinical Skills,
Humanism, and Social Responsibility”. EBM originated as an innovative medical
curriculum at McMaster University,I59 and was quickly proliferated beyond the conﬁnes
of the medical school and its student body through a “How to Read Clinical Journals”

series published in several consecutive editions of the Canadian Medical Association

 

I” The Evidence Based Medicine Working Group object to the charges of “cookbook medicine” in Sackett
et al (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

I56 Guyatt et a1 (2002), "Introduction: The philosophy of evidence-based medicine." Usergguide to the
medical literature: A manual for evidence-based clinical practice, p. 5.

I” Guyatt et a1 (2002), "Introduction: The philosophy of evidence-based medicine." Users’ guide to the
medical literature: A manual for evidence-based clinical practice, p. 6.

I” The hierarchy of evidence and the epistemological commitments underscoring the ranking of
methodologies it will be discussed in the next two chapters.

I” Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17).

 

 

48

Journal in 1981II’0 and the “Users’ Guides to the Medical Literature” series in the Journal
of the American Medical Association from 1993-2000 (the JAMA series later became the
contents of the manual currently under discussion).I6I The clinical skills so strongly
promoted as a precursor to delivering the highest quality of patient care contain further
epistemological as well as methodological commitments underscoring the evidence based
approach that, once again, are not accounted for in the brief essay on the philosophy of
EBM. Lastly, the commitment to humane clinical practice—“compassion, sensitive

”I62___and

listening skills, and broad perspectives from the humanities and social sciences
the suggestion that physicians Should be concerned with the health system in which they
work and in broader policy issuesI63 suggests broad ethical and socio-political concerns
and commitments to be tied into the founders’ vision of evidence-based healthcare. Thus
the philosophy of EBM deserves more investigation than what is offered in the Users’

Guides to the Medical Literature’s brief exposition. Interestingly, the name of the

manual in which the philosophy of EBM essay was published—Users’ Guides to the

 

I60 Sackett (1981), "How to read clinical journals: 1. why to read them and how to start reading them
critically." CMAJ 124(5); Haynes (1981), "How to read clinical journals: [1. To learn about a diagnostic
test " CMAJ 124(6); Tugwell (1981), "How to read clinical journals: 111. To Ieam the clinical course and
prognosis of disease." CMAJ 124(7); Trout (1981), "How to read clinical journals: IV. To determine
etiology or causation." CMAJ 124(8); Sackett (1981), "How to read clinical journals: V: To distinguish
useful ﬁ'om useless or even harmful therapy." CMAJ 124(9).

'6' See, for example, Oxman et al (1993), "Users' guides to the Medical Literature, 1: How to get started."
JAMA 270(17); Richardson and Detsky (1995), "Users' guides to the medical literature, VII: How to use a
clinical decision analysis. A. Are the results of the study valid?" JAMA 273(16); Richardson and Detsky
(1995), "Users' guides to the medical literature, VII: How to use a clinical decision analysis. B. What are
the results and will they help me in caring for my patients? Evidence Based Medicine Working Group."
JAMA 273(20); Dans et a1 (1998), "Users' guides to the medical literature, XIV: How to decide on the
applicability of clinical trials results to your patient." JAMA 279(7); Hunt at al (2000), "Users' guides to the
medical literature, XXI: Using electronic health information resources in evidence-based practice." JAMA
283(14).

I62 Guyatt et al (2002), "Introduction: The philosophy of evidence-based medicine." Users’ guide to the
medical literature: A manual for evidence-based clinical practice, p. 9.

I63 Guyatt et al (2002), "Introduction: The philosophy of evidence-based medicine." Users’ guide to the
medic1a1 literature: A manual for evidence-based clinical practice, p. 9. This brief mention is presumably
what the authors meant by “Social Responsibility”.

 

 

 

 

49

Medical Literature—did not register with the authors as being fundamentally normative
and therefore ﬁlled with numerous philosophical commitments.
The more recent descriptions of EBM offered by its founders, the Evidence Based

Medicine Working Group, avoid the early polemics of “new paradigms”I64

and instead
promote it as a clinical tool for managing medical knowledge and improving clinical
practice. I65 This current pragmatic presentation of EBM should not be allowed to
obscure its substantial methodological, epistemological, and ethical assumptions.
Unpacking EBM’S concepts, methods, and philosophical commitments is an important
area of medical humanities research given the enormous uptake of the evidence based
approach throughout the health sciences. The future of biomedicine appears to be
evidence-based. This chapter will begin with EBM’s ethical assumptions and overview
the current scope of the “ethics of EBM” literature.

To begin, EBM starts with the ethical promise that it can improve patient care by
methodologically and accurately identifying the best, the useless, and the harmful
practices in healthcare. Much of the advocacy literature on EBM carries a moral tone to
it. One supporter, for instance, strongly states that “if evidence based practice can reduce
uncertainty and therefore better inform clinical decisions, then it becomes blameworthy
not to bend one's knee at this altar.”I66 Even members of the Evidence Based Medicine
Working Group, who did not identify any ethical principles among its fundamental
principles of EBM, used moralizing language in a 1995 promotional editorial for the new

journal Evidence Based Medicine:

 

I“ Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17).
I65 Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates want health care
providers and consumers to pay attention to?" BMC Health Serv Res 2(3).

66 Goodman (2003), Ethics and evidence-based medicine: F allibility and responsibility in clinical science,
p. 49.

50

ACP Journal Club and Evidence Based Medicine will publish the gold

that intellectually intense processes will mine from the ore of about 100

of the world’s top journals. Doctors owe it to themselves and their

patients to make sure that they keep up with what is new and important. I67
Both moral tone and religious connotation are found in many EBM endorsements despite
the difﬁculty that there is currently no empirical support for EBM’S claims to improve
health outcomes. I68

While this “paradox of EBM”I69—no evidence for evidence-based medicine—has
been conceded by supporters of evidence based practices, they refuse to recognize this
impediment as the philosophical trump card that some critics suggest it to be. Some
insistent EBM supporters have engaged in crude, if not zealous, avowals of EBM’S
methodological superiority, leading Brian Haynes, one of EBM’s founders, to caution
that without concrete empirical evidence, it is too early to conclude that EBM is morally
required.170 Due to these instances of “decerebrate genuﬂection at the altar of the
randomized controlled trial,”171 EBM proponents are criticized for failing in the end to

critically engage in the philosophical dimensions—particularly the epistemic

justiﬁcation—of EBM. I72 Buetow charges EBM with being unable to justify its faulty

 

“7 Davidoff et al (1995), "Evidence based medicine." pm 310(6987), p. 1086.
I“ EBM is unable to draw conclusions about its own effectiveness because there are so many confounding
variables, some of which cannot be eliminated. The originators of EBM recognized this impediment to
proving their own claims regarding improving patient outcomes early on, but maintained that “this proof is
no more achievable for the new paradigm than it is for the old, for no long-term randomized trials
[comparing the two] are likely to be carried out” (Evidence Based Medicine Working Group (1992),
"Evidence-based medicine." JAMA 268(17), p. 2424).
I69 Norman (1999), "Examining the assumptions of evidence-based medicine." J Eval Clin Pra_lg 5(4).
I70 Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates want health care
' providers and consumers to pay attention to?" BMC Health Serv Res 2(3).

7' Brody et a1 (2005), "Evidence-based medicine: Watching out for its friends." Persp Biol Med 48(4), p.
577.
I72 Tonelli (2006), "Integrating evidence into clinical practice: An alternative to evidence—based
approaches." J Eval Clin Prac 12(3); Buetow (2002), "Beyond evidence-based medicine: Bridge-building a
medicine of meaning." J Eval Clin Prac 8(2); Upshur (2005), "Looking for rules in a world of exceptions:
Reﬂections on evidence-based practice." Persp Biol Med 48(4)

 

51

Epistemic basis, I73 while Upshur encourages philosophical engagement by EBM
advocates in order to enable critical debate and discourage the current polemics.174
Haynes tries to minimize EBM’S philosophical weaknesses by pointing out that the
evidence based movement is more pragmatic than epistemological, I75 but this admission
hardly justiﬁes EBM’S theoretical deﬁciency. The entirety of this dissertation
demonstrates the signiﬁcant fallout from a ﬂawed philosophy of medicine.

In an innovative use of evidence-based methods, Mona Gupta, a critic of EBM,
has offered a critical appraisal of EBM’S philosophical commitments.I76 She proposes
that EBM carries a built-in moral mandate to engage in evidence-based approaches to
medicine that relies on the ethical premise that we ought to improve patient care and the
epistemological premise that EBM will lead us to this improvement:

Premise 1 (ethical): We ought to pursue the most effective means of achieving health

Premise 2 (epistemological): Only if we pursue EBM do we arrive at the most
effective means of achieving health

 

Conclusion: Therefore, we ought to pursue EBM

Figure 2. Gupta’s characterization of the implicit values of EBM177

Gupta suggests that if one accepts the basic value that the best care ought to be pursued
and the epistemic assumption that optimal patient care is best pursued via the evidence

based approach, one arrives at the moral conclusion that all clinicians ought to practice

 

I73 Buetow (2002), "Beyond evidence-based medicine: Bridge-building a medicine of meaning." J Eval
M 8(2)-

I74 Upshur (2005), "Looking for rules in a world of exceptions: Reﬂections on evidence-based practice."
Persp Biol Med 48(4).

I75 Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates want health care
providers and consumers to pay attention to?" BMC Health Serv Res 2(3).

7° Gupta (2003), "A critical appraisal of evidence-based medicine: Some ethical considerations." J Eval
M 9(2)-

”7 Gupta (2003), "A critical appraisal of evidence-based medicine: Some ethical considerations." J Eval
Clin Prac 9(2), p. 114.

52

EBM. The ﬁrst/ethical premise, by Gupta’s account, is fairly uncontroversial, as most of
us would agree that the best patient care ought to be pursued. The trouble for EBM
arises, according to Gupta, within the second/epistemological premise. The justiﬁcation
of EBM rests entirely on establishing the epistemological premise that EBM provides the
means for reducing uncertainty and improving health outcomes. EBM’S moral claim
therefore hinges on consideration of what constitutes clinical reasoning, knowledge,
authority, expertise, and of course, evidence. I78 It is therefore not surprising that the bulk
of the critical literature on EBM is on methodological and epistemological issues and the
ethics of EBM literature is sparse in comparison. EBM is understood to present an
epistemological challenge to biomedicine, with ethical issues regarded as a secondary
concern.

Biomedicine’s methodological dominance in the western world is grounded in its
claims of effectiveness in achieving health relative to other alternative medical systems.
EBM challenged biomedicine’s status on the grounds of its having a superior means of
pursuing health (the epistemological premise). In order to defend this contention, EBM
assrunes the veracity of two further claims. First, EBM assumes that only if we improve
the ratio of true to false beliefs about how medical interventions operate will we discover
the most effective means of achieving health. This is a fairly uncontroversial claim
among medical researchers and practitioners, as better health is thought to arise from
more truthful understanding of human physiology and pathology. Secondly, and more

controversially, EBM assumes that only if we pursue EBM] 79 do we maximize the

 

”8 Goodman (2003), Ethics and evidence-ba_5ed medicine: Fallibility and responsibility in clinical science.
. 14.

I)” Of course, we do not all agree on what “pursuing EBM” means. Brody et a1. distinguish between a

“crude” EBM endorsed and practiced by many genuﬂecting EBM enthusiasts which involves uncritically

 

53

likelihood of arriving at the truth about the effectiveness of medical interventions. It is
only with these two premises that we arrive at the initial epistemic claim in support of the
moral mandate to practice EBM, namely that EBM offers the most effective means of
achieving health.180

A review of the epistemological challenges to EBM in the next chapter will
illustrate, however, that the assumption that EBM is the method most likely to bring us
closer to medical truth is highly contentious. To presume this claim requires the further
assumption that research data generated by EBM-preferred methods is unlikely to reﬂect
biases and that the inferences culled from these data will similarly be unbiased. Critics
have challenged both EBM’S methodological ability to limit bias and the very epistemic
tenability of scientiﬁc objectivity (as it is popularly understood).

To return to the ethics, Gupta’s analysis should not be taken to suggest that the
ethics of EBM is somehow uncontroversial or decidedly secure. While slim in quantity,
there is ethical debate over the moral correctness of evidence-based practice. While the
duty to provide the best patient care is widely accepted within medical ethics, and where
EBM advocates and critics disagree is on its execution and not the value in itself, the
ethics literature illustrates that there is more to ethical medical practice than both the
effort to and the success in achieving health for patients. The considerable ethical

signiﬁcance placed on autonomy and justice, for instance, suggests that the value placed

 

accepting RCTS while rejecting all other forms of evidence, and a “sophisticated” EBM, which entails the
thoughtful application of the best available evidence, which does not come from the single RCT but rather
an “N of 1” RCT (Brody et al (2005), "Evidence-based medicine: Watching out for its friends." Persp Biol
Meg 48(4). p. 577). In the authoritative account of EBM found in the Users ’ Guide to Medical Literature,
a ranking of research methods lists the N of 1 trial ﬁrst and the single RCT as third, following systematic
reviews of randomized trials as number two (Guyatt and Rennie, eds. (2002), Users' guides to the medical
l_itpr_a_ture: A manual for evidence-based clinical prggtipe, p. 7).

I80 Gupta (2003), "A critical appraisal of evidence-based medicine: Some ethical considerations." J Eval
Clin Prac 9(2), p. 114.

54

on achieving health does not encompass the entire scope of the ethics of EBM.
Furthermore, the duty to deliver the best care possible frequently competes against other
prima facie equal duties, such as the duty to uphold patient autonomy. By broadening
“best patient care” to constitute more than achieving the best health outcomes and to also
incorporate patients values, beliefs, and preferences, the “ethics of EBM” brings into
focus the anticipated impact of EBM on individual patient care and not just the impact on
patient health outcomes.

A criticism of EBM that garners special ethical interest is that EBM’S
methodology makes it difﬁcult to apply medical evidence to individual patients, thereby
undermining the goals of patient choice and shared physician-patient decisionmakingII’I
Clinical data represents an average effect of the intervention on a homogenous trial
population that met admission criteria. Trial subjects typically must display few
comorbidities in order to meet the requirements of the research protocol and so the results
of such trials might not be applicable to patients with confounding variables.I82
Furthermore, when clinicians make decisions for individual patients, the information
needed for pertinent clinical subgroups formed by such clinical features as severity of
symptoms, illness, and comorbidity, may not be reported or made available. For
example, tPA and streptokinase can be expected to have different rates of both beneﬁcial
and detrimental effects when acute myocardial infarction is treated in a relatively elderly
man who also has congestive heart failure, or in a relatively young man without failure.

Clinicians and patients would want to know risk/beneﬁt appraisals for each treatment in

 

II” See, for example, Kerridge et al (1998), "Ethics and evidence based medicine." BMJ 316(7138), p.
1153.

I82 Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155), p. 830. This issue is discussed
in more depth later in this dissertation manuscript.

 

55

those subgroups, not just for an "average” acute myocardial infarction. I83 Feinstein and
Horwitz maintain that the randomized controlled trial, which originated in agricultural
research, was never intended to answer questions about the treatment of individual
patients. I 84

The point about subgroups can be pushed further—in a sense, aren’t we all a
subgroup of one? It needs to be asked how the signiﬁcance of group and individual
differentiation can be best taken into account in medical research and clinical practice. I85
The difﬁculty with EBM is that it appears to prematurely answer this question in its
allegiance to epidemiological and public health methods (i.e. population-based research).
The critics suggest that pre-EBM approaches to biomedicine demonstrated more variety
in its responses to the question of differentiation, as they did not subscribe to a rigid
hierarchy of evidence.

The question of applicability ties into the important ethical question whether
EBM supports or denies patient autonomy and choice. In “Evidence Based Medicine and
Ethics”, Hope frames EBM as an important means for upholding patient autonomy:

Patient choice goes beyond consent and should involve the patient in the

whole decision-making process. In order for such autonomous authorization

to be genuine, both the patient and the doctor need access to good quality

information. For this, if for no other reason, there is an ethical imperative

for support of the fundamental tenets of evidence based medicine.186

Miké similarly promotes EBM as a necessary precursor to ethical medical practice in her

version of “ethics of evidence”, as it is only with accurate information that decisions can

 

II” Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine’." Am J Med
103(6), p. 532.
I“ Feinstein and Horwitz (1997), "Problems in the ‘evidence’ of ‘evidence-based medicine'." Am J Med
103(6), p. 531.

Private correspondence with James L. Nelson.
II” Hope (1995), "Evidence based medicine and ethics." 1 Med Ethics 21(5), p. 259.

56

be properly informed and consent can be genuine. I87 Yet it has been argued by EBM
critics that the full implementation of EBM standards of best practices will lead to limited
lists of approved health care services determined by policy elites far removed from the
bedside.I88 Bad outcomes in cases in which care deviated from the guidelines could
become “a risk management nightmare.”I89 Thus, against the claim that EBM’s provision
of the most up-to-date and relevant evidence helps patients make informed choices,
critics have argued that informed consent requires not only current and relevant
information, but also an offering of genuine choice.190 The “fundamental principle of

EBM” that “evidence is never enough” is regarded as lip service by critics such as

191

Lambert, who accuses EBM proponents of co-opting the criticisms without genuinely

responding to the problem—for example, in empty slogans such as Hope’s “evidence-
based patient choice”.I92 Greenhalgh similarly describes a “sirenic accommodation” by
EBM advocates to the interpretive character of medicine in a manner that seductively
distracts attention from and de-emphasizes a hierarchy of evidence. I93 She refers
speciﬁcally to a widely quoted riposte by Sackett and colleagues to critics who accused
them of naive empiricism, where the EBM founders claimed that

the practice of evidence based medicine means integrating individual
clinical expertise with the best available external clinical evidence...
By individual clinical expertise we mean the proﬁciency and judgment

¥

I" Miké (1999), "Outcomes research and the quality of health care: The beacon of an ethics of evidence."

Eval Health Prof 22(1). Miké’s ethics of evidence will be examined in chapter 7 of this dissertation.

I88 See, for example, Brase (2004), "How technocrats are taking over the practice of medicine: A wake-up
call to the American people"; we will be returning to this important systemic issue in later chapters.

I89 Goodman (2005), "Ethics, evidence, and public policy." Persp in Biol Med 48(4), p. 550.

I90 This should not be understood to suggest that all options must be made available to the self-legislating
patient. For instance, the health practitioner is not obliged to, and may even be held culpable for, providing
treatment requested by the patient that she has good reason to think is harmful.

”I Lambert (2006), "Accounting for EBM: Notions of evidence in medicine." Soc Sci Med 62(11).

I” Hope (1996), Evidence based patient choice.

I” Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
M 318(7179).

57

that individual clinicians acquire through clinical experience and clinical
practice. I94

Sackett et al. were anxious to acknowledge that there is an art to medicine as well as an
objective empirical science but, Greenhalgh laments, they did not attempt to deﬁne or
categorize the “elusive quality” of clinical competence. She explores the dissonance
between the “science” of objective measurement and the “art” of clinical proﬁciency and
judgment,I95 and attempts to integrate these different perspectives on clinical method in
her system of “narrative based medicine”, which draws on the intuitive and subjective
aspects of clinical method as well as rigorous clinical data in order to generate integrated
clinical judgment.196 RogersI97 and Jones and SagarI98 express the moral concern that
patients might be discouraged from making choices that are regarded as less efﬁcacious
and therefore are not endorsed by EBM and its derivative clinical guidelines. When
making a decision about medical treatment, patients or substitute decisionmakers have to
compare different procedures and techniques and trade off the chances of beneﬁts and of
toxicities, and the severities of outcomes. Each patient will do this slightly differently
and may even come to prefer a treatment option that EBM and its derivative practice
guidelines suggest should be abandoned. I99 Furthermore, ethical patient care can never
rely solely on gauges of efﬁcacy. For instance, the use of restraints are effective in

preventing falls among institutionalized geriatric patients, but the loss of personal liberty

'94 Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023), p. 71.

I” We will return to these themes in the next chapter’s analysis of phenomenological critiques of EBM.

I96 Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
M 318(7179).

'97 Rogers (2002), "Evidence—based medicine and practice: Limiting or facilitating patient choice?" Health
Expect 5(1).

I98 Jones and Sagar (1995), "Evidence based medicine. No guidance is provided for situations for which
evidence is lacking." BMJ 31 1(6999).

I99 Jones and Sagar (1995), "Evidence based medicine. No guidance is provided for situations for which
evidence is lacking." B_MJ 311(6999).

58

and freedom of movement has prompted most institutions to ban the practice except in
rare circumstances.200

A common theme among the critics is that, against EBM’S highly rationalized and
algorithmic decisionmaking schemas, clinical decisionmaking relies on much more than
the evidence.201 In Culpepper and Gilbert’s argument that the nature of general practice
limits the extent to which EBM can be applied, they explain that

patients frequently present with problems related to difﬁculties in coping

with symptoms, their fears about their health, or early on in the natural

history of an illness when signs and symptoms are nonspeciﬁc. The

tools most helpful to the general practitioners include knowledge of both

the patient and the natural history of the illness.202
In such circumstances, the main determinants of the “best” course of action are the
physician’s judgment guided by clinical experience, limited scientiﬁc evidence, and the
patient’s preference.203 EBM appears to therefore err in trying to eschew clinical
judgment (the know-how that comes from practice and experience) ﬁom the healthcare
encounter.204 I

In contrast to Hope’s general acquiescence to the evidence based approach,

I.205 present a review of ethical concerns associated with EBM that hinge on

Kerridge eta
the fundamental counterclaim to EBM: the reliability of evidence does not lead to better
decisionmaking. They see the strongest ethical argument in support of EBM to be the

contention expressed by Hope (among others) that EBM improves our knowledge base

 

20° Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155), p. 830.

20' Kerridge et al (1998), "Ethics and evidence based medicine." M 316(7138).

202 Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155) p. 829.

20’ Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155), p. 829.

20’ We will return to the issue of clinical judgment later on. The issue of eliminating alternative sources of
knowledge will also prove to be crucial to the meeting of ethics and epistemology in the ethics of evidence
(see chapter 7).

’°’ Kerridge et al (1998), "Ethics and evidence based medicine." pm; 316(7138).

 

59

and therefore can improve health outcomes and engender more informed decisionmaking.
Yet EBM’S methodical approach can offer no mechanism for resolving such problems as:
(I) immeasurable outcomes and intangible values;206
EBM claims to provide a simple and logical process for reasoning and decisionmaking:
look at the evidence and decide accordingly. But to make balanced decisions, all the
relevant consequences of an action must be considered. This proves to be challenging.
Current measures of some outcomes of medical treatment, such as pain, are inadequate;
other outcomes, such as justice, may not be measurable; other complex outcomes, such as
quality of life, may not even be adequately deﬁnable.207

When comparing competing values in healthcare, the difﬁculty arises that some
values that are easily quantiﬁed into economic terms must be balanced against other
values that are not quantiﬁable as such. Bernard Williams has noted that

Again and again defenders of such values are faced with the dilemma

of either refusing to quantify the value in question, in which case it

disappears from the sum altogether, or else of trying to attach some

quantity to it, in which case they misrepresent what they are about and

also usually lose the argument, Since the quantiﬁed value is not enough

to tip the scale.208
The problems of immeasurable outcomes and intangible values surface in micro and
macro-levels of healthcare decisionmaking when we face the dilemma of providing a
costly, risky, yet potentially life-saving treatment to a terminally ill patient. In such
cases, how does one measure justice and then balance it against mortality outcomes or

cost?209

 

20° Kerridge et al (1998), "Ethics and evidence based medicine." B_MJ 316(7138), p. 1151.
207 Kerridge et al (1998), "Ethics and evidence based medicine." BALI 316(7138), p. 1151.
2"“ Williams (1972), Morality.

2’” Kerridge et a1 (1998), "Ethics and evidence based medicine." B_hﬂ 316(7138), p. 1152.

60

(2) competing claims by different interest groups;2 I0

For instance, Ruggeri and Tansella’s evaluation of outcome measures in mental
healthcare concluded that “studies should be comprehensive, to consider all parameters
on which an intervention should be effective, and multiaxial, to consider various views
by which the intervention would be considered effective”.2II The authors highlight the
need to consider biological, psychological, and social outcomes from everyone’s
perspectives, but the question arises: what if those perspectives differ? What if a
patient’s family and physician want to place an elderly patient with dementia in a nursing
home, while the specialist and social services do not? What evidence will then count?
Different stakeholders may disagree as to what facts are pertinent. And what is pertinent
seems like an evaluation: the evidence will not decide the matter.”2
(3) systematic bias inthe allocation of resources to those treatments for which there is
rigorous evidence of egéectiveness, or towards those for which there are funds available
to show effectiveness.

While EBM’S high standards of evidence are meant to ensure the reliability of healthcare
interventions, the time and cost associated with achieving this standard may limit the
availability of worthwhile treatment, prophylaxis, and diagnostic programs for which
there is limited evidence available. This is, of course, based on a conceptual mistake—
the absence of evidence of effectiveness is not the same as evidence of

ineffectivenesszI‘I—however EBM may still bias health policies in favour of industry-

funded innovative pharmaceuticals.

 

2'” Kerridge et al (1998), "Ethics and evidence based medicine." BMJ 316(7138), p. I 152

III Ruggeri and Tansella (1995), "Evaluating Outcomes in Mental Health Care." Current Opinion Psychol
8(3).

2'2 Hughes (1996), "Evidence-based medicine and ethics." 1 Med Ethics 22(1).

2'3 Kerridge et al (1998), "Ethics and evidence based medicine." BMJ 316(7138), p. 1153.

2" Goodman (2005), "Ethics, evidence, and public policy." Persp in Biol Med 48(4), p. 552.

 

61

The ethics of EBM reviewed in this chapter ends with this critical conclusion:
since EBM provides a focused approach to the interpretation of research ﬁndings and
translates them into clinical options, it provides the clinician with a valuable tool for
managing the knowledge base of medicine. However, this approach also focuses on
average and mean effects and rarely provides guidance to help the physician tailor care
and treatment to the individual patient. EBM also fails to provide guidance about how to
respond to an individual patient’s values, priorities, and socio-cultural needs.215
In Conclusion

The ethics of EBM’s current preoccupation is with the impact of EBM-on patient
care. This focus was argued to be narrow in scope, as the complex picture of EBM
illustrated in chapter one highlighted many other ethically relevant considerations. A
more robust ethical analysis of EBM requires us to “dig into” the workings of EBM. Yet
even within the current conﬁnes of the ethics of EBM, both the problems of application
of research evidence to individual care plans and the incorporation of patients’
preferences into evidence-based decisionmaking manage to challenge parts of EBM’S
epistemological basis on ethical grounds concerning patient care, thus forging initial
connections between the ethics and epistemology of EBM. In an effort to draw further
connections, the next chapter will turn the investigation toward the epistemological
debates surrounding EBM. The “ethics of evidence” was mentioned earlier to offer a
new area of investigation for healthcare ethics. Academic bioethics has been criticized
for rarely interrogating the nature of medical knowledge in its reasoning; medical
knowledge is frequently presumed to be scientiﬁc, uncontested, and imparted by the

2'5 See, for example, Culpepper and Gilbert (1999), "Evidence and ethics." Lancet 353(9155).

 

62

clinician onto the individual patient.2I6 In the context of informed consent, for example,
medical knowledge is pressed to be made accessible and understandable to lay persons,
however its “source”—a pool of clinically-derived and expert-sanctioned knowledge—
goes uncontested. In an interesting contrast, clinical ethics, in fact, regularly faces the
ethical challenges surrounding clinical uncertainty. I propose that the ethics of EBM
must be broadened to consider more than the impact EBM has on patient care, and in the
ﬁnal chapter of this dissertation, the moral relevancy of the epistemic and related
methodological issues surrounding EBM will be considered in a comprehensive review

of the ethics of EBM.

_‘

2'6 Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in

mental health." Rimming sanity: Ethical issues in ma_ngged mental health caLe.

63

CHAPTER THREE
On Evidence in Evidence Based Medicine: An Epistemology Critique217

As the term “evidence-based decision-making” should suggest, “evidence” plays
a prominent role in this particular conﬁguration of medicine and medical decision-
making. Quite surely, the founders of the EBM movement offered what is now the
standard deﬁnition of EBM: “the conscientious, explicit, and judicious use of current best
evidence in making decisions about the care of individual patients?”8 Yet standing in
tension with the movement’s fanfare as a new paradigm in medical education and
practice is the seeming obviousness of EBM’s claims. Modern medicine has, of course,
always been understood to rely on empirical evidence in its experimental and justiﬁcatory
practices. Despite the criticism that it offers nothing new, EBM has generated
considerable attention as an innovative decision-making technology and has come to be
widely regarded as the hallmark of “best practices” in medicine.219

To have evidence is to have some conceptual warrant for belief,220 and it is the
practice of basing all beliefs and practices strictly on (empirical) evidence that allegedly
separates science from other activities?” The EBM movement promotes a more
scientiﬁcally rigorous approach to medical practice via methodological clinical decision-

making based on examination of evidence derived from the latest clinical research. This

evidence is then proliferated using evolving information technologies, and evidence-

 

2" This chapter is based on: Goldenberg (2006), "On evidence and evidence-based medicine: Lessons from
the philosophy of science." Soc Sci Med 62(11).
:8 Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." BMJ 312(7023), p. 71.
9 The New York Times Magazine even named EBM as one of the most inﬂuential ideas of 200l.
22° Goodman (2003), Ethics and evidence-based medicine: Fallibility and responsibility in clinical science,

 

. 2.
£2] Husserl (1982), Ideas pertaining to a pure phenomenology and a phenomenological philosophy: First
990k: General introduction to a pure phenomenology; Kuhn (1996), The structure of scientiﬁc revolutions.

64

 

based medicine aﬁcionados, such as those found in the Cochrane Collaboration222 and on
the editorial boards of various evidence-based practice journals, describe the movement
as a new paradigm in medical education and practice, a description that carries with it a
science enthusiasm that has not been seen since the days of positivism.

The apparent obviousness of basing scientiﬁc medicine on the evidence has, of
course, not gone unnoticed, but this factor has made EBM difﬁcult to argue against. Few
doctors, one suspects, would be willing to assert that they do not attempt to base their
clinical decision making on available evidence. However the apparent obviousness of
EBM has been challenged on the grounds of how “evidence” has been problematized in
the philosophy of science. In this chapter, the positivist understanding of evidence as
“facts” about the world maintained in EBM is shown to be untenable, as such a picture of
science has been seriously undermined by “postpositive” philosophies of science. EBM’s
ability to guide healthcare decision making by appealing to “the evidence” as the bottom
line is attractive to many because it proposes to rationalize this complex social process.
Yet it does so through the positivistic elimination of culture, contexts, and the subjects of
knowledge production from consideration, a move that permits the use of evidence as a
political instrument where power interests can be obscured by seemingly neutral
technical resolve.

Logical positivism is a philosophical system that recognizes only scientiﬁcally
veriﬁable propositions as meaningful. This school of thought originated in Vienna in the
19205 by a group of philosophers and scientists concerned with the philosophy of formal

and physical science, however it was their attitude toward science and its relationship to

-_

222 Grimshaw (2004), "So what has the Cochrane Collaboration ever done for us? A report card on the ﬁrst
10 years." Can Med Assoc J 171(7).

65

philosophy that deﬁnes the “Vienna Circle”. Because the Circle rejected the possibility
of justifying knowledge claims that were “beyond” the scope of science, they dismissed
metaphysics and many of the claims made in theology and ethics as nonsensical (or
unveriﬁable). Emigration by many of the Circle’s members to Britain and the United
States during the early war years led to the strong inﬂuence of logical positivism on
Anglo-American analytic philosophy. The “post-positive” turn in the philosophy of
science refers to the critical examinations of scientiﬁc thought and practice that
originated in the second half of the 20th century by such historically-oriented
philosophers as Thomas Kuhn, Norwood Hanson, and Paul Feyerabend. Their historical
analyses of scientiﬁc change and progress undermined the positivist-empiricist
endorsement of the claims of science to provide a value-free understanding of the natural
world. Their examination of the relationship between science and values (and the denial
of their possible or even preferable separation) has been enriched by the insights of
feminist epistemologies of science and phenomenological investigations. Feminist
epistemologists have exposed the political stakes in knowledge production by
demonstrating the androcentric assumptions underlying conventional understandings of
scientiﬁc thought and practice, while phenomenologists have questioned the goals and
methods of scientiﬁc medicine (including what forms of evidence are pursued) through
examination of the patient’s lived experience of illness and dis-ease. Postpositivist,
feminist, and phenomenological epistemologies of science’s critiques of the presumed
“self-apparentness” of evidence have been deployed in undermining the conﬁguration of

evidence underlying the evidence based approach.

66

Evidence and Evidence Based Medicine

The popular histories of science recount scientiﬁc progress as having been
motivated by the evidence-based practices of innovative scientists. Rejecting the dogma
and superstition that pervaded their historical moment, these innovators let the evidence,
gathered through careful and unbiased experimental methods, dictate their beliefs and

scientiﬁc theories.223

Thus science purports to be a democratic enterprise insofar as the
beliefs of the Church, accomplished colleagues, or department chairs are subject to the
same critical inquiry as lay beliefs.

“Evidence-based” is typically read in medicine and other life and social sciences
as the empirically adequate standard of reasonable practice and a means for increasing
certainty. Evidence-based practices are therefore enormously appealing in the age of
moral pluralism; rather than relying explicit values that are likely not shared by all, “the
evidence” is proposed to adjudicate between competing claims. However the notion that
any claim (including scientiﬁc beliefs) can stand or fall in light of the evidence assumes a
“givenness” of evidence as “facts” about the world. Positivistic empiricists have
regarded evidence in this way: any bias that enters scientiﬁc inquiry in the context of
discovery is eradicated in the purifying process of the context of justiﬁcation. The
evidence left standing after scientiﬁc inquiry is assumed to be “facts” about the world and
therefore warrants the title scientific evidence.

EBM promotes such a scientistic conception of evidence in its endorsement of

evidence derived from systematic and methodologically rigorous clinical research and

maligning the use of intuition, unsystematic clinical experience, patient and professional

 

223 Harding (1986), The science question in feminism; Kuhn (1996), The structure of scientiﬁc revolutions.

67

values, and pathophysiologic rationale.224

This preference has prompted critics to detail
other sources of evidence that enter into clinical decision making225 and to defend the
unsystematic intuitions and expertise that arise from clinical experience as epistemically
signiﬁcant and indispensable to clinical decision-making.226 Yet even before we consider
the complex nature of clinical decisionmaking, we can question the very tenability of the
conception of evidence being assumed in evidence-based practice. In this chapter, I draw
on major lines of thinking in the philosophy of science over the past half century to
question the “evidence base” of EBM.
Postpositivist Philosophy of Science

Much of the philosophy of science over the last half century has been preoccupied
with challenging the positivist picture of scientiﬁc methodology on two grounds. In the
ﬁrst, Hanson,227 Kuhn,228 and Feyerabend229 have claimed that observation is theory-
laden. that is, our observations are “coloured” by our background beliefs and assumptions
(and therefore can never be, even under the most ideal circumstances or controlled

experimental settings, the unmitigated perception of the nature of things). In the second,

Pierre Duhem230 and W.V. Quine23 ' have argued that theories are underdetermined by

 

22“ Buetow and Keneally (2000), "Evidence-based medicine: Bridge-building a medicine of meaning." 1
Eval Clin Prac 6(2); Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA
268(17).

225 Buetow and Keneally (2000), "Evidence-based medicine: Bridge-building a medicine of meaning." J
Eval Clin Prac 6(2); Upshur et a1 (2001), "Meaning and measurement: an inclusive model of evidence in
health care." J Eval Clin Prac 7(2); Buetow (2002), "Beyond evidence-based medicine: Bridge-building a
medicine of meaning." J Eval Clin Prac 8(2).

”6 Tanenbaum (1993), "What physicians know." N Engl J Med 329(17).

227 Hanson (1958), P_attems of discovery.

22:; Kuhn (1996), The structure of scientiﬁc revolutions; Kuhn (1970), "Reﬂections on my critics."
Criticisms and the growth of knowledge.

229 Feyerabend (1978), Against method.

23° Duhem (1982), The aim and structure of physical theory.

23 ' Quine (1960), Word and object.

 

 

68

data. In other words, our theory choices are never determined exclusively by “the
evidence”.

The ﬁrst claim is damaging (if not devastating) to the positivist empiricist picture
because the principles of empiricism are tendered against the background presupposition
that, at least under carefully controlled and intersubjectively repeatable circumstances,
one’s perceptions are unaffected by the beliefs one has and by the assumptions one makes
about the objects that one is observing. These observations are supposed to provide a
maximally certain foundation of empirical knowledge, a foundation that supplies the
basic premises of all our reasoning and without which there would not even be any
probable knowledge. Empiricist epistemology, from David Hume’s232 18th century
conﬁguration onward, seems to rest on the assumption that there can be an absolutely
stable and invariant correspondence between perceptions and the stimuli which produce
them. Logical positivists advanced this position through their alternative linguistically-
oriented philosophical programme that disavowed metaphysics and promoted the
veriﬁability criterion of meaning. The veriﬁability principle asserts that a statement is
meaningful if and only if you can state what sense observations would determine whether
it is true or false (i.e. the statement must be empirically veriﬁable in order to be
meaningful). One intended consequence of the veriﬁability criterion is that all non-
empirical forms of discourse, including ethics'and aesthetics, are not “literally” or
“cognitively” meaningful, and thus belong to “metaphysics”.233 This basic tenet of

98234

logical positivism is attributed to the inﬂuence of Ludwig Wittgenstein Tractatus

 

232 Hume (1977), An enquiry concerning human understanding; Hume (2000), A treatise of human nature.
233 For a classic expression of this view, see Camap, "The elimination of metaphysics through logical
analysis of language." Logical positivim, pp. 60-81.

23‘ Wittgenstein was never a member of the Vienna Circle.

 

69

Logico-Philosophicus, which proposes a general theory of linguistic representation,
according to which propositions are “logical pictures” of possible facts. This implied that
a proposition is not meaningful unless it determines a precise range of circumstances in
which it is true. A partial exception to this theory of meaning was made for tautologies
(such as "Either it is raining or it is not raining") and contradictions (such as "It is raining
and it is not raining"), since such propositions say nothing: they are, respectively, true or
false in all possible circumstances. They show, however, the workings of the “logical
constants”: not, or, and, etc. In metaphysics, however, philosophers have often tried to
say something about reality as a whole, making claims so general and fundamental that
they are arguably indifferent to the particular facts of the world. On Wittgenstein's
theory of language, such claims are literally nonsensical words without meaning.23S

A. J. Ayer, the Circle member credited with introducing logical positivism to the
English-speaking world, formulated the veriﬁability criterion of meaning.

To be literally meaningful, while not analytic, a statement must be such

that an observation statement can be deduced from it in conjunction with

certain other premises, that could not be deduced from those premises

alone.236
Statements are only meaningful when they are directly veriﬁable (i.e. they are
observation statements) or they are derivable from observation statements. Because no
statement which refers to a “reality” transcending the limits of all possible sense-

experience can possibly have any literal signiﬁcance, he held that “our charge against the

metaphysician is not that he attempts to employ the understanding in a ﬁeld where it

 

2” Wittgenstein (2001), Tractatus logico-philosophicus.
23" Ayer (1936), Language, truth. and logic, p. 190.

70

cannot proﬁtably venture, but that he produces sentences which fail to conform to the
conditions under which alone a sentence can be literally signiﬁcant.”237

The postpositivist critics mentioned above object that observations can never be
“givens” or “data”, but are always the product of interpretation (in light of our
background assumptions). The idea of unambiguous objects of perception is simply a
myth, and so the positivist grounding of observational statements as foundational to true
knowledge, as well as the maligning of all areas of inquiry that use nonempirical (and
nonlinguistic) modes of analysis, creates a problematic epistemic framework.

The charge that theories are underdetermined by data—commonly referred to as
the “Duhem-Quine thesis” in the philosophy of science—concerns the claim that any
given body of evidence may support numerous, even contradicting, theories. The charge
once again undermines empirical science’s self-understanding as an objective enterprise
that progresses (i.e. accepts, reﬁnes, or rejects scientiﬁc theories) in light of how theories
stand up to empirical evidence. Since scientiﬁc theories are deductively underdetermined
by the data, scientists must adopt extraempirical criteria for what counts as a good theory
when deciding to accept one theory in preference over its empirically adequate rivals.
This “extraempirical criteria” can be subject to the whims, preferences, biases, and social
agendas of the researching scientists, and not the rigour of evidenced-based
adjudication.238

While the “theory ladenness” objection challenges the stability of observations

themselves, the “underdeterrnination” thesis undermines the stability of evidential

relations. Both accounts have seemed to permit the unrestrained expression of scientists’

 

237 Ayer, Language, truth, and logic, p. 182.
238 Of course, empiricists hold some extraempirical criteria to be more epistemically justiﬁable than others,

such as “theoretical simplicity” or vulnerability to refutation.

71

subjective preferences in the content of science. If observation is theory-laden, then it
cannot serve as an independent constraint on theories, thus permitting subjective elements
to constrain theory choice. Similarly if observations acquire evidential relevance only in
the context of a set of assumptions, a relevance that changes with a suitable change in
assumptions, then it is not clear what protects theory choice from subjective elements
hidden in one’s background assumptions. Although empirical adequacy (the ability of a
theory to predict empirical events) serves as a constraint on theory acceptance, it is not
sufﬁcient to pick out one theory from all contenders as the true theory regarding a
domain of the natural world.
Postpositive Implications for EBM

A 1995 publication in The Lancet documented the disagreement among members
of a research team regarding the interpretation of their trial results for streptokinase
treatment for acute ischemic stroke.239 Upon “agreeing to disagree”, the team presented
two views.240 No one position was seen to be wrong at least insofar as both sides
appeared to be supported by the clinical data.241 In the editorial introducing the opposing
conclusions, Richard Horton, the journal’s editor-in—chief, mused that

exposure of the sharp intellectual conﬂicts that developed in MAST-I

[Multicentre Acute Stroke Trial — Italy] reveals the interpretive ﬂuidity

of science, a state that is commonly unacknowledged in a published

scientiﬁc text and one that is often neglected when applying uncertain

. . . . . . 4
ev1dence, even from large randomized trials or meta-analyses, 1n the clinic.2 2

 

2” Horton (1995), "MAST-1: Agreeing to disagree." Lancet 346(8989).

240 See Candelise el al (1995), "Randomized controlled trial of streptokinase, aspirin, and combination of
both in treatment of acute ischemic stroke." Lancet 346(8989); Tognoni and Roncaglioni (1995), "Dissent:
An alternative interpretation of MASTl-l." Lancet 346(8989).

2‘“ Horton (1995), "MAST-I: Agreeing to disagree." Lancet 346(8989).

2‘2 Horton (1995), "MAST-l: Agreeing to disagree." Lancet 346(8989), p. 747.

 

 

 

72

Horton’s editorial recounted that there had been serious dispute among the writing
committee of the multi-centre trial about the presentation of MASTI-I regarding the
interpretation of the trial results. One camp held a guarded view of the applicability of
the ﬁndings to treatment while members of the other side were more optimistic about the
same evidence. A manuscript articulating the majority view was submitted to the Lancet
without comment on the disagreement. Horton recounts, however, one missed clue: in
the covering letter accompanying the submission, Dr. Candelise, the primary investigator,
had written that “the present version of the article has been approved by a majority of the
steering committee.”243 The journal editors only caught wind of the conﬂict when they
asked for commentary by the research group on contradictory reviews of the study by two
experts in stroke research that, in fact, mirrored the researchers’ dispute. The editorial
team proceeded to work up the manuscript for publication, but when the version of
MAST-I that was eventually accepted for publication was sent to the group to conﬁrm
authorship, two senior researchers, Drs. Tognoni and Roncaglioni, could not sign onto it.

The points of dispute were two-fold: ﬁrst, disagreement over the emphasis that
should be placed on subgroup analyses, and second, regarding the validity of statements
about efﬁcacy in a study that ran less than half its course. Horton maintained that the
issue of safety was an overriding concern for all investigators, but this priority may have
been diluted by including speculative comments about efﬁcacy. What is relevant to the
postpositivist claims about the nature of evidence is that the same data led to this
disagreement. The conﬂict was over the interpretation of evidence.

Horton closes with the editorial commentary that differences of opinion should

 

243 Horton (1995), "MAST-I: Agreeing to disagree." Lancet 346(8989) (my emphasis).

73

not be silenced. To encourage their explicit expression in future submissions to the
journal, he writes:

The Lancet encourages interpretive dissent between authors, ideally

within the conﬁnes of the ﬁnal research report. But if consensus cannot

be achieved, authors should be willing to agree to disagree. If an

anguished dispute over interpretation cannot be settled, [the editors] will

provide authors with the opportunity to publish their legitimate dissent

alongside their now orphaned article.244
Despite this advocacy of democratic debate within the medical literature, Horton
concedes that a worrying question remains about the validity of published trial data:
“how often are differences of interpretation about data suppressed in the ﬁnal published
record either by force of majority or personality?”245

Before drawing from the MAST-I case negative conclusions about EBM, it is
worth asking whether this problem of interpretation is unique to EBM or whether it
applies equally to non-evidence-based protocols. EBM, of course, does not use unique
methodology compared to its predecessors. However it does convey a clear
methodological preferencing. The MAST-I study is “evidence based” insofar as its
methodology would rank highly among EBM’s hierarchy of evidence: the study was
large, the subjects were randomized, and rigorous statistical methods were used for
comparative analysis. The MAST-I case is damning to EBM’s claims of methodological
superiority because here we have an instance of the evidence based approach failing to
“eschew unsystematic and intuitive methods” from medicine.

Yet even before the interpretation of evidence begins, empirical evidence

undergoes numerous subjective interpretations. Even within the conﬁnes of strictly

evidence-based practice, there is room for dispute regarding the design of a study on the

 

2‘“ Horton (1995), "MAST-l: Agreeing to disagree." Lancet 346(8989), p. 747.
2'” Horton (1995), "MAST-l: Agreeing to disagree." Lancet 346(8989).

 

74

grounds of measurement error, contaminated solution, malfunctioned equipment, poor
design, or bias, and there are no predetermined rules for the statistical interpretation of
the results of a test.246 Once the data is interpreted and the study is published—creating
another layer of selection—the highly prized meta-analysis provides a further level of
interpretation, one that is notably “high impact” insofar as it carries the institutional brand
“evidence-based medicine” and because individual practitioners that rely on these
summaries for evidence-based decision-making are no longer critically reading the trial
data. Finally, the practitioner must apply one more layer of interpretation in her
application of trial results to a speciﬁc patient. The formal methods promoted by EBM to
replace so-called “traditional” medicine’s over-reliance on intuition, habits, and
unsystematic clinical experience247 appear to repeat the misplaced effort to separate
science from values.

Even the evidence based approach involves a host of normative judgments
regarding what evidence is admissible and how strongly the different forms of admissible
evidence should be weighted. Thus judgments must be made at all levels of research,
data analysis, and application—Steven Goodman, for example, writes about a US policy
dispute over mammograms that faltered on what studies should be included or excluded
for evidentiary consideration.248 EBM offers only guidelines for conducting RCTS, and

249

there is currently no standard way of doing RCTS. Therefore, discord can arise

regarding what counts as a “sufﬁciently valid” RCT that should be included in policy

 

2“ Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Prac 3(2).
2‘7 Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17).

2411 Goodman (2002), "The mammography dilemma: A crisis for evidence-based medicine?" Ann Int Med
137(5).

249 Hoey (2006), "Editorial and scientiﬁc independence: Misreading the evidence, misleading the public."
Ruth Cooperstock Memorial Lectureship.

 

75

considerations.250 Goodman proposes that it is only when there is consensus on these
judgments—for instance, in studies where the data conﬁrming or denying a hypothesis is
strong—“that an illusion is created that the evidence is speaking for itself and that the
methods are objective.”25 1 Cases such as MAST-I and the “mammography dilemma”
should raise awareness that judgment cannot be excised from the process of evidence
synthesis.
Feminist Epistemologies of Science

Feminist philosophers endorse the post-positivistic conclusions derived from
analyses of the relations between observation, evidence, and theory and have taken the
critique of empiricist epistemology further to challenge empiricism’s “silent partner”: the
theory of the unconditioned subject. This unbiased observer is argued in feminist thought
to be the necessary companion to empiricist epistemology, and reﬂection on this subject’s
unusual and implausible ontology reveals further difﬁculties with positivist thought.
Positivism, therefore, not only errs in holding sensory observation in ideal observation
conditions as the privileged source of knowledge, but also inappropriately attaches a
dubious theory of epistemic agency in which knowers are detached and neutral spectators
separate from the objects of knowledge. Positivist empiricism does not, in fact, yield
neutral and universally valid conceptions of knowledge. Instead, knowledge is indelibly
shaped by its creators and attests to the speciﬁcities of their epistemic locations. Indeed,

it is because subjects are characterized as irrelevant to knowledge claims in positivist

 

25° Goodman (2002), "The mammography dilemma: A crisis for evidence-based medicine?" Ann Int Med
137(5).

25 ' Goodman (2002), "The mammography dilemma: A crisis for evidence-based medicine?" Ann Int Med
137(5), p. 364.

76

epistemologies that knowledge can appear to be veriﬁable by appeals to the evidence.252

Notions of evidence and theories of epistemic agency are, therefore, closely
related. Donna Haraway argues that the notion of “matters of fact” depends on many
kinds of transparencies in the grand narratives of the experimental way of life.253 The.
“modest witness”, the protagonist of the dramas of the Scientiﬁc Revolution who testiﬁes
without prejudice to new facts, had to be constructed in sufﬁciently detached and
abstracted terms to make plausible the unusual situation where his experiences could
somehow represent everyone’s and no-one-in-particular’s experiences. Notions of
evidence as “self-appearing” similarly rely on such a knower.254

Feminist epistemologies of science have demonstrated that the ideals of the
autonomous knower—the dislocated, disinterested observer—and the epistemologies
they inform are the artefacts of a small, privileged group of educated and prosperous
white men. Their material circumstances allow them to believe that they are autonomous
individuals without speciﬁc locations (i.e. gendered or raced) even in their positions of
privilege.255 Haraway’s postulation of such a “modest man”, whose narratives mirror
reality, requires invisibility, such that “such a man must inhabit the space perceived by its

inhabitants to be the ‘culture of no-culture’.”256

 

252 Code (1993), "Taking subjectivity into account." Feminist epistemologies, p. 17.

2” Haraway (1996), "Modest witness: Feminist diffractions in science studies." The disunity of science:
Boundaries, contexts, and power.

254 Nelson (1993), "Epistemological communities." Feminist epistemologies.

2” Feminist psychologists have argued that afﬂuent white boys are nurtured to embody the psychosocial
characteristics needed for detached and objective knowledge seeking, deliberation, and work. For example,
see Keller (1985), Reﬂections on gender and science and Bordo (1987), The ﬂight to obiectivm: Essays on
Cartesianism and culture. It should therefore be no surprise that they can come to see themselves as
disembodied rational beings.

25" Haraway (1996), "Modest witness: Feminist difﬁ'actions in science studies." The disunity of science:
Boundprles. contexts. and power, p. 429.

 

 

77

In this culture, the inhabitant’s contingencies can be established with all of the
authority, but none of the considerable problems, of transcendental truth. His modesty is
of a speciﬁcally modern, professional, European, masculine and scientiﬁc form (and is
therefore very different from the virtue typically attributed to women), and it imbues him
with a disguised epistemological and social power concealed by modernist ideals of
“rationality”, “objectivity”, and “value-neutrality”. His modesty guarantees his
legitimacy as an “authorized ventriloquist for the object world, adding nothing from his
mere opinions, from his biasing embodiment. And so he is endowed with the remarkable
power to establish the facts. He bears witness.”257

Feminist epistemologists of science charge that underlying the orthodox account
of scientiﬁc investigation and justiﬁcation is a presumed universality of experience (or at
least the potential for such universality through the reﬁned abilities of the modest
witness), which presumes, in turn, both a view of evidence and a view of knowers, where
individuals can have unmediated or unﬁltered access to a reality that itself admits of only
one systematization.258 In what appears to be an equation of “orthodox empiricism” with
nai've realism, Nelson, among others, proposes that it is only by positing this framework
of a shared reality experientially accessible to all sentient beings that anybody (or
everybody) can discover, observe, or witness truths about the world. While one’s faith in
such universality might be partly underwritten by similarities in sense organs, it also
requires that there is a unique, true theory of nature and that our sense organs are

sufﬁciently reﬁned to discover it and discriminate it from possible alternatives.259

 

2” Haraway (1996), "Modest witness: Feminist diffractions in science studies." The disunity of science:
Boundaries. contede men p. 429.

258 Nelson (1993), "Epistemological communities." Feminist epistemologies, p. 131.

259 Nelson (1993), "Epistemological communities." Feminist epistemologies, p. 132.

 

78

Experience alone, however, does not warrant the assumption that only one system could
organize the world or that the world is of a determinate nature, speciﬁable in categories
that our sense organs will lead us to discover. There is nothing in our experience to rule
out the possibility of a future theory that is commensurate with all of our experiences to
date but incompatible with the current theory. There is also nothing in our experience or
in our current knowledge about our sense organs to warrant the inference that they are
able to discriminate a “best” theory of nature (if, indeed, there is such a thing) from
multiple candidates.260
Feminist epistemologists are particularly resistant to the notion of shared
experience that supports orthodox empiricism because feminist investigations into the
lives of women reveal great diversity of experiences, many of which are distinctly
gendered, raced, classed, or mediated by numerous other social stratiﬁcations. For
orthodox empiricists (including positivists, who apply radical empiricist epistemology to
science), historical, gendered, and locational differences between and among knowers
reduce to bias or aberration and should be discounted in formal justiﬁcation procedures.
Feminists object that such reductions exclude and even harm women, as the so-called
universals that are thought to underlie the social context (and serve as the foundation of

scientiﬁc knowledge) are distinctly androcentric. This claim has been illustrated by

numerous documentations of gender bias in the natural and biological science.261 For all

 

260 It should be noticeable, at this point, that empiricists should presumably agree with this feminist
commentary, as empiricism is a fallibilist theory. Current science, for example, is merely the set of beliefs
that are currently the most reasonable to believe. Nelson advocates feminist empiricism, and F eyerabend
writes on “How to be a Good Empiricist” to highlight the need to deny the tendency among the
“orthodoxy” to subscribe to positivist/objectivist thinking.

26' For example, see Hubbard and Lowe, eds. (1979). Genes anLgender; Fausto-Sterling (1989), "Life in
the XY corral." Women's Studies Int Forum 12(3); Fausto-Sterling (1992), Myths of gender: Biological
theories about women and men; Keller (1985), Reﬂections on gender ﬁa_nd science; Haraway (1989),

 

79

of its alleged experiential grounding, the experience with which empiricism works is an
abstraction in which cognitive speciﬁcities are homogenized under one dominant
conception of what counts as knowledge and of who qualiﬁes as a knower. In practice,
those conceptions mirror and replicate the experiences that their (usually white, male,
prosperous, and educated) creators are positioned to regard as exemplary.262

The inexactness of the term “experience” seems to allow it to resonate in many
ways, to function as a universally understood category, and to create a sense of consensus
by attributing to it an assumed stable and shared meaning.263 By assuming it as a
foundational concept in empiricist epistemology, experience is protected from different
meanings and relativisms, and therefore establishes the possibility for objective
knowledge.264 This move effectively removes subjects from critical scrutiny as active
producers of knowledge, and it is this insistence of separation of meaning and experience
that is crucial. Epistemology constructs “truth” on the foundation of the speaker’s
irrelevance.265

That speaker is, of course, the modest witness. It has already been discussed how
he bears witness in his unbiased accounts of the world. His modesty authorizes him to do
so. His subjectivity, therefore, is his objectivity. Lorraine Code has argued that
“objectivity” is “a generalization from the subjectivity of quite a small group.”266

However, this group “has the power, security, and prestige to. . .generalize its experiences

and normative ideals across the social order thus producing a group of like minded

 

Primate vision: Gender, race, and nature in the world of modern science; Haraway (1991), Simians,
gtborgs. and women: The reinvention of n_ature.

262 Code (1991), Mt can she know? Feminist theon/ and the construction of knowledge.

263 Scott (1991), "The evidence of experience." Crit lnguig 178(3), p. 782.

2“ Scott (1991), "The evidence of experience." Crit lnguiigy 178(3), p. 785.

265 Scott (1991), "The evidence of experience." Crit lnguiry 178(3), p. 785.

2“ Code (1993), "Taking subjectivity into account." Feminist epistemologies, p. 22.

 

80

practitioners (‘we’) and dismissing ‘others’ as deviant and aberrant (‘they’).”267 Within
the privileged “culture of no culture”, the witness’s narratives “lose all trace of their
history as stories, as products of partisan projects, as contestable representations, or as
constructed documents in their potent capacity to deﬁne the facts.”268 The evidence of
experience is therefore called into question.

For positivist epistemologies, of which medicine retains its residue, sensory
observation and experience in ideal conditions is a privileged source of knowledge
offering the best promise of certainty. When experience is taken as the origin of
knowledge, the individual subject’s perception becomes the bedrock of evidence on
which explanation is built at the expense of inquiry into subject formation. Joan Scott
argues that reliance on experience precludes critical examination of the workings of the
ideological system itself, its categories of representation (such as man, woman,
homosexual, heterosexual), its premises about what these categories mean and how they
operate, and of its notions of subjects, origins, and cause. Instead “experience”
reproduces its terms: it does not allow us to see that it is not the individuals who have
experience, but subjects who are constituted through experience.269 By taking experience
to be a given, and ignoring how discourse and history structure one’s experiences, the
status quo—the same social order that maintains the privilege of the modest witness—is
leﬁ unexarnined.

Because knowers are understood to be collaborative agents, whose epistemic

projects are shaped by, and evaluated within, the communities where their knowledge-

 

267 Code (1993), "Taking subjectivity into account." Feminist epistemologies, p. 22.

2“ Haraway (1996), "Modest witness: Feminist diffractions in science studies." The disunity of science:
Boundaries. contexts. and power, p. 429.

269 Scott (1991), "The evidence of experience." Crit Inguig 178(3), p. 777.

 

81

producing practices occur, standards of evidence are by no means “self announcing”, but
rather socially and historically relative, dynamic, and of our own making.270 While
experience can remain central to our evidential claims, it must be understood to be
inherently social, for we experience the world through the lens of our projects, categories,
theories, and standards. Therefore, what constitutes evidence for speciﬁc claims or
theories includes not only experience, but also the knowledge and standards constructed
and adopted by epistemological communities?" Against the insistence of radical
empiricists, feminists contend that science is not a value-free enterprise. Even the notion
of empirical adequacy is conditioned by a set of beliefs which cannot be disentangled into
“factual” and “evaluative” categories.272 The beneﬁt of unmasking the assumptions,
norms, and values at play in scientiﬁc inquiry is that we can now address the important
socio-political question of which values ought to enter the scientiﬁc arena.

In sum, feminist insights tell us that rather than empirical evidence increasing
certainty by factoring out the subjective features of everydayness that bias our
understanding of things, the constructs of “objectivity”, “universality”, and “value-free”
instead obscure the subjective elements that inescapably enter all forms of human
inquiry. Since the evidence is by no means objective or neutral, but rather part of a social
system of knowledge production, many feminist epistemologists recommend social
models of scientiﬁc practice. This model entails recognizing our background

assumptions as playing a constitutive (and not a biasing) role in knowledge acquisition

and evaluation.273 Scientiﬁc inquiry cannot be value-free, as traditional empiricists

 

27° Nelson (1993), "Epistemological communities." Feminist epistemologies.

27' Nelson (1993), "Epistemological communities." Feminist epistemologies, p. 142.

272 Nelson (1993), "A question of evidence." Hypatia 8(2).

273 Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry.

82

required, for cultural and social values make knowledge possible. These values must, of
course, be subject to examination and critique, ideally by those from outside of the
community who do not share those cultural assumptions. Thus the evaluation of
scientiﬁc beliefs becomes more rigorous: in addition to demonstrating empirical
adequacy, scientiﬁc beliefs must be subject to public scientiﬁc inquiry, where the
background assumptions motivating the investigation are explicitly recognized and

therefore subject to the same critical scrutiny that “good empiricists”274

subject their
knowledge claims. This public activity not only raises the standards of theoretical
adequacy, but also better mediates the knowledge/power interplay in scientiﬁc
investigation. Once we recognize that an uninterrogated conception of empirical
adequacy is not sufﬁcient to act as a criterion of theory choice, we can turn to the
question of what epistemological virtues we want our theories to additionally display. A
feminist philosophy of science is explicitly political—as contrasted with the implicit
political character of other philosophies of science—as science is recognized to be a
vehicle for feminism’s emancipatory programme.
Feminist Implications for EBM

Against feminist misgivings about so-called objectivity, rationality, and value-
neutrality, EBM proposes to introduce rational order into the deliberative processes of
healthcare decision-making. The epistemic concerns of feminist scientists and

philosophers are accompanied by a feminist commitment to improving the lives of

women.275 Feminist critiques of science are driven by a deep concern that the

 

2" F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
LNIosophy of science: The cengal issues.

275 Of course, proponents of evidence based approaches to women’s health may similarly hold that desire
and testify to the improvements to women’s healthcare that can arise from the rigorous evaluation of

83

abstractions made in the names of scientiﬁc objectivity, generalizability, and
predictability harm women. These tendencies appear to resurface in the practice of EBM.

EBM promises consistent and impartial evidence about the beneﬁts and harms of
treatments due to the transparent use of high quality primary research in systematic
reviews and meta-analyses. These results are then applied in equally transparent
processes to make clinical decisions.276 Feminist insight reveals that the practices of
EBM are marked by potential or actual gender bias, which has led at least one critic—
Roger5277—to argue that EBM is bad for women’s health. Despite the idealistic
suggestion that evidence-based methods can improve women’s health by making
available more high quality data regarding the efﬁcacy of different treatments, thus
leading to more informed treatment choices by and for women, EBM, according to
Rogers, is in fact “superimposed upon current medical practice, repeating and reinforcing
existing biases against women, both in research and in treatment.”278 The shortcomings
of biomedicine for properly addressing women’s health needs, as articulated by feminist
scholars and allies of the women’s health movement over the past few decades, are not
corrected by evidence-based medical practice.

Because evidence-based clinical decision-making, policy determinations, and the
formulation of clinical guidelines rely upon existing clinical research, the movement
reﬂects any gaps or biases that currently exist in medical research. Women’s health

research has been marked by a sexist research agenda that over-focuses on women’s

 

current women’s health practices. There is disagreement within the ﬁeld of women’s health regarding the
advantages and disadvantages of evidence based women’s healthcare.

276 Rogers (2004), "Does evidence-based medicine offer fair beneﬁts for all?" Ethics J Am Med Assoc 6.
277 Rogers (2004), "Evidence-based medicine and women: Do the principles and practices of EBM further
women's health?" Bioethics 18(1).

278 Rogers (2004), "Evidence-based medicine and women: Do the principles and practices of EBM further
women's health?" Bioethics 18(1), p. 54.

 

84

reproductive-related issues (fertility, menstruation, menopause, and breast and
gynecological cancers) while failing to properly investigate gender dimensions of other
health problems that appear to have sex-differentiated causes, incidences, responses to
treatment, and prognoses due to a combination of biological factors, social conditions,
and social processes.279 Some examples include HIV/AIDS, coronary heart disease,
depression, and tuberculosis.

Gender bias also arises in the performance of research, where women have been

grossly underrepresented as subjects in clinical trials.280

This exclusion has been justiﬁed
on the grounds of the need for homogenous subject populations, the fear of harms to
pregnant women and offspring, the alleged difﬁculties accounting for women’s hormonal
ﬂuctuations in data analysis, and the purported difﬁculties recruiting women.281 Critics
insist, however, that biological differences between men and women are signiﬁcant
enough that research evidence is often not relevant to women and therefore the use of
medical technologies on and by female patients is dangerous. Despite robust criticism,
the bias towards male participants in research trials remains. In the US, 85% of research
participants are male; this rises to 95% in Canada.282
The fact that certain areas of women’s health are underresearched, others are
overresearched, and other areas of health research lack evidence relevant to women

suggests that the evidence that serves as the basis for evidence-based medicine may not

be helpful for women. EBM is implicated for the past mistakes of medicine because it

 

279 Rogers (2004), "Evidence-based medicine and women: Do the principles and practices of EBM further
women's health?" Bioethics 18(1).

28° Dresser (1992), "Wanted: Single, white male for medical research." Hastings Centr Rep 22(1); Merton
(1993), "The exclusion of pregnant, pregnable, and once-pregnable people (AKA women) from biomedical
research." Am J Law Med 19(4). NB: This is especially the case for women of colour and elderly women.
28' Dresser (1992), "Wanted: Single, white male for medical research." Hastings Centr he; 22(1).

232 Sherr (2000), "Women and clinical trials." Women. Health. and the Mind

85

presents much of this evidence as authoritative and even arguably reiﬁes much of the
thinking and methods that allowed for these egregious gaps in research to occur in the
ﬁrst place. While informed by feminist epistemological insight, this critique is largely
methodological rather than epistemological, as it demonstrates EBM to fail on its own
terms by not meeting its own standard of best evidence for women’s health. Irrespective
of the epistemological critiques of what constitutes the “evidence base” of EBM, the
evidence is only rigorous by EBM’s own standards for the select male populations that
are properly represented as research subjects in clinical trials. The internal or
methodological critiques of EBM was detailed in chapter one, where the pride of place
given to the randomized control trial as the “gold standard” of medical research was
chaﬂenged.

Feminist researchers have found bias against women not only in the production of
the research that informs EBM, but also in the purportedly fair methods used to analyze
and synthesize the evidence.283 A common critique of EBM’s pre-graded evidence
hierarchies is that they do not acknowledge that research methods must be tailored to the
question at hand, and that different questions gather best evidence from different research
designs. Leaving aside the gendering of the quantitative vs. qualitative debates in the
social sciences—with the former being regarded as “masculine” and the latter as

- - 2 4
“feminine” 8

—qualitative methods have been favoured by many feminist researchers for
allowing the voices of women to be heard in describing problems and in ﬁnding

solutions. The endorsement of an evidence hierarchy that discounts evidence from

qualitative research has implications for women’s health insofar as health interventions

 

283 Rogers (2004), "Evidence-based medicine and women: Do the principles and practices of EBM further
women's health?" Bioethics 18(1).
2“ Oakley (2000), meriments in knowing: Gender and method in the social sciences.

86

that recognize the social and political context contributing to women’s poor health have
consistently proven to be more effective in improving health outcomes. Because
judgment cannot be excised from the process of evidence synthesis, qualitative research
can be instrumental in deciphering the underlying assumptions that, say, policy makers
bring into their formulations of mammogram guidelines. Further research into how those
assumptions correspond with the expectations of the women being encouraged to partake
in screening regimes can ensure better policies and better rates of compliance. EBM
methodology in fact supports a reductionist model of health and disease that is not
amenable to the crucial social, political, and experiential determinants of women’s health.

Phenomenology of Science and Medicine

 

Phenomenological approaches to science and medicine further challenge notions
of evidence in evidence-based medicine by questioning why relevant evidence is
assumed to come primarily from clinical trials and other “objective” measures. They

285 also offers

argue instead that the patient’s self-understanding and experience of illness
a legitimate source of relevant medical knowledge. This theoretical approach is
grounded in the philosophy of Edmund Husserl and his followers who questioned the
philosophical completeness of natural sciences. They argued that Cartesian dualism,
which split the world into minds and bodies, the spiritual and the physical, was erroneous

and created a truncated body of science that exhibited impressive technological ability to

control nature but could not address questions of human self-understanding. This led to a

 

2” The emphasis on the patient’s experience of illness in medical phenomenology may seem, at ﬁrst, to be
at odds with feminist epistemology, where the evidence of experience is suspect. Feminists speak to
supposedly universal sensory experience, which is shared by ideal observers and grounds empiricist
knowledge claims, however, while phenomenologists focus on the very subjective experience of illness (or
the illness narrative).

87

“crisis of meaning”, which Husserl attributes to the failure of positivist natural science.286

The biomedical model is charged with suffering from similar problems, as the
technological abilities of modern medicine fail to address the existentiality of illness.
Self-proclaimed “medical humanists” like Stanley Reiser,287 David Reiser and David
Rosen,288 who lament the lost “art” of medicine, regard the well-documented increase in
patient dissatisfaction (despite the amazing technological advances) as a similar crisis.
The rising popularity of alternative medicine can be understood to be part of that
backlash, as patients increasingly seek out unorthodox practices despite the impressive
technological success of the orthodoxy. The biomedical model is grounded in the natural
sciences, and medical practice consists of the practical application of these sciences to
human illness and health.289 However, with the unity, predictive power, and exactitude
of scientiﬁc medicine comes the neglect of those components of human distress that
elude description in natural scientiﬁc nomenclature.290 It is demonstrated in the illness

29‘ and Oliver Sacks292 that these nonsomatic components of

narratives of Kay Toombs
human life that typically get disregarded as “subjective” features of illness stubbomly
remain crucial to the experience of illness and to recovery.

By taking seriously questions about the world as experienced rather than

scientiﬁcally described, phenomenologists seek to reunite science with life experience

and to explore the relationship between the abstract world of the sciences and the

 

2“ Husserl (1970), The crisis of European sciences and transcendental phenomenology.
287 Reiser (1978), Medicine and the reign of technology.
2” Reiser and Rosen (1984), Medicine as human experience.

289 Schwartz and Wiggins (1985), "Science, humanism, and the nature of medical practice: A
phenomenological view." Persp in Biol Med 28(3), p. 333.

9° Schwartz and Wiggins (1985), "Science, humanism, and the nature of medical practice: A
phenomenological view." Persp in Biol Med 28(3), p. 332.

9' Toombs (1993), The meaningof illness: A phenomenological account of the different perspectives of

physician and patient.
92 Sacks (1984), A leg to stand on.

 

88

concrete world of human consciousness. Toombs argues that as embodied beings, we
experience life in and through the body both before and after we develop cognitive and
symbolic structures for mapping experience and meaning.293 Phenomenologists typically
speak of “embodiment” instead of “the body” to deemphasize the physical body and the
assumed subject-object split that comes with anatomical description. They instead aim to
create an understanding of our bodies in their experiential “givenness”.

From this emphasis on the “lifeworld” rather than the scientiﬁc organization of
the world, a different account of illness ensues. When the body is no longer thought of as
merely an anatomical entity, but rather as the source of our experiences, illness becomes
a way of “being-in-the-world” that is best described as a sense of disorder, a loss of
control, of “things not being right in the world”. This embodied understanding of illness
resists medical classiﬁcation as these categories lack its existential qualities. In fact,
illness may not even be localized to any one place. Elaine Scarry has forcefully
described in The Body in Pain: The Making and Unmaking of the Worl 94 that pain
obliges a loss of the taken-for-grantedness of our bodies, and illness can be understood

as, similarly, the loss of the “at-handedness” or “everydayness”295

of things. Toombs’
philosophical reﬂections on living with MS lead her to conclude that health is not
experienced as the absence of disease, but rather as a state of unselfconscious being that

illness shatters. Illness is a problem of embodiment, as the usual effortless and

unselfconscious unity of the body and the self is disrupted, making one pay explicit

 

293 Toombs (1993), The meaning of illness: A phenomenological account of the different perspectives of
Dhysicigry and patient.

29" Scarry (1985), The body in pain: The milking and unmaking of the world.

29’ Heidegger (1996), Being and time.

89

attention to the body as suddenly problematic (and separate or alien from the self).296

Toombs examines the different ways that physicians and patients approach and
understand illness and encourages physicians to try to understand what illness means to
the patient.297 She advises that rather than trying to understand disease as a breakdown of
the objectiﬁed body-machine, the physician must try to approach illness as a disturbance
in the patient’s ability to relate to and function in the world, as it is one’s embodiment,
one’s capability of interacting with the world, that is damaged in the event of illness.

Such an approach to medical practice would reﬁgure both the goals of medicine
and the practices used to meet those ends. Once the patient and not the disease exemplar
becomes the subject of examination and treatment, the personal anecdotes, life
circumstances, and other subjective features of the patient’s circumstances become
crucial parts of the diagnosis.298 Diagnosis would therefore not be tailored to medical
categorization, as the goal of treatment would not be centred so much on the elimination
of disease, but rather the reintegration of the patient into the lifeworld. This is not to say
that the elimination of disease would not factor in as an important feature of treatment,
but it certainly would not be regarded as more important than, say, rehabilitation.299
This framework requires a different conﬁguration of evidence that does not presume the
scientiﬁc completeness of reductive categories and aggregate measures.
Phenomenological Implications for Evidence Based Medicine

Reﬂecting on how the popular idea of “patient-centred care” remains largely

 

296 Toombs (1993), The meaning of illness: A phenomenological account of the different perspectives of
physician and patient.
297 Toombs (1993), The meaning of illness: A phenomenological Qcount of the different perspectives of

physician and patient.

9” Greenhalgh and Hurwitz, eds. (1998), Ngrrative based medicine: Dialogue and discourse in clinical

practice.

99 To borrow a slightly overused expression, this model emphasizes care instead of cure.

9O

unrealized in clinical practice, R. G. Evans notes that while physicians are encouraged to
make diagnoses in physical, psychological, and social terms, “the evidence based
medicine that is currently promoted either restricts itself to physical evidence alone, or
casts such evidence at the top of a hierarchy that tends to devalue any evidence ‘lower
down’.”300 The hierarchy of evidence promotes a certain scientistic accounting of the
goals of medicine, which, the worry goes, is incommensurable with the proposed
reorientation of medical practice toward the patient’s search for meaning in the illness
experience. The bridging of scientistic “measure” and existential “meaning” has received
some attention in the critical EBM literature301 with the general consensus that we need
an “integrated” model of evidence that properly reﬂects modern health care’s constitution
by diverse academic traditions—including the humanities, social sciences, and the pure
and applied sciences—that rely on equally diverse notions of evidence.302
While EBM values evidence that is statistical in nature and general in its
application, and therefore places quantitative data derived through the application of
recognized study designs at the top of its pre-graded hierarchies of evidence, the
phenomenological approaches rooted in hermeneutics, ethnography, sociology, and
anthropology, regard evidence as primarily narrative, subjective, and historical in nature.

Unlike the impersonal and generalizable measures undertaken in EBM, this conception of

evidence is illustrated in case histories, clinical encounters, and qualitative studies such as

 

30° Evans, (2003), "Patient-centred medicine: Reason, emotion, and human spirit? Some philosophical
reﬂections on being with patients." Med Humanit 29(1), p. 8.

30' See, for example, Buetow (2002), "Beyond evidence-based medicine: Bridge-building a medicine of
meaning." J Evgl Clin Pra_1_c_ 8(2); Upshur et a1 (2001), "Meaning and measurement: an inclusive model of
evidence in health care." J Eval Clin Prac 7(2); Djulbegovic et a1(2000), "Evidentiary challenges to
evidence-based medicine." J Eval Clin Prac 6(2).

302 Upshur et a1(2001), "Meaning and measurement: an inclusive model of evidence in health care." J Eval
Clin Prac 7(2), p. 91.

91

in-depth interviews and focus groups.303 The features of the medical encounter and the
illness experience emphasized by medical phenomenologists and proponents of a more
“humane” medicine suggests the need to reconsider what constitutes the goals of
medicine304 and ﬂips EBM’s hierarchy of evidence on its head. The quantitative
measures and generalizations that come out of controlled trials and biostatistical analysis
are not conducive to the questions of meaning that medical phenomenology wants to
address and make central to medicine.

One notable exception to this view comes from Greenhalgh’s characterization of
“narrative based medicine”, where she denies the apparent irreconcilability between the
narrative nature of the illness experience and the intuitive and subjective aspects of
clinical method with the principles of EBM. She maintains that the positivist image
attributed to EBM is inaccurate; far from obviating the need for subjectivity in the
clinical encounter,

genuine evidence based practice actually presupposes an interpretive

paradigm in which the patient experiences illness in a unique and

contextual way. It is only within such an interpretive paradigm that a

clinician can meaningfully draw on all aspects of evidence—his or her

own case based experience, the patient’s individual and cultural

perspectives, and the results of rigorous clinical research trials and

observational studies—to reach an integrated clinical judgment.305
Rather than EBM being positivistic, the hermeneutic perspective is held by Greenhalgh to

resonate strongly with “the call from evidence based circles for the ‘truth’ of the

instrumental text (that is, the results of diagnostic tests) to be interpreted judiciously on

 

303 Upshur et a1 (2001), "Meaning and measurement: an inclusive model of evidence in health care." J Eval
Clin Prac 7(2) p. 94.

’04 Toombs (1995), "Chronic illness and the goals of medicine." Second Opinion 21; Toombs (1993), IM
meaning of illness: A phenomenological account of the different perspectives of physician and patient;
Cassell (1982), "The nature of suffering and the goals of medicine." N Engl Med 306(1 1).

30’ Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
M 318(7179), p. 325.

 

92

the basis of Bayesian pretest probabilities determined by the history and physical
examination.”306 Thus genuine evidence based practice “presupposes an interpretive
paradigm in which the patient experiences illness in a unique and contextual way.”307
Clinical method is explained to be a necessarily interpretive act which draws on
narrative skills to integrate the overlapping stories told by patients, clinicians, and test
results. Against the critics’ charges that “the evidence based approach to clinical
decisionmaking holds clinical observation to be totally objective and should, like all
scientiﬁc measurements, be reproducible”—she cites Tanenbaurn’s scathing indictment
of EBM’s “fundamental separability of expertise from expert and of knowledge from

knower”308

as an example—she protests that it was pre-EBM medical training that
incorrectly taught students to view medicine as a dispassionate science, where the doctor
served as impartial investigator and diagnostic decisionmaking followed an identical
protocol to scientiﬁc inquiry (the discovery of “facts about a patient’s illness”). 309 EBM,
in contrast, does not hold this understanding. To illustrate, she cites how in Clinical
Epidemiology,310 Sackett and colleagues, take interest in clinical disagreement between
clinicians, and argue that we should acknowledge and measure the amount of

disagreement between different clinicians in different circumstances rather than dismiss it

or attribute it to error or inexperience.

 

30° Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
B_MJ 318(7179), p. 325.

307 Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
M 318(7179), p. 325; my emphasis.

’08 Tanenbaum (1995), "Getting from there to here: evidentiary quandaries of the US outcomes movement."
J Eval Clin Prac 1(2), p. 102.

309 Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
B_MJ 318(7179), p. 323. -

3 '0 Sackett et a1 (1991), Clinical epidemiology: A basic science for clinical medicine.

93

This example, however, is not compelling, as calling attention to the phenomenon
of clinical disagreement is not necessarily a sign that the authors value the highly
interpretive art of clinical decisionmaking. In fact, the interest in understanding and
measuring clinical disagreement may be done with the intention of eradicating it by way
of more reliable diagnostic measures. A further difﬁculty with Greenhalgh’s defense of
EBM concerns her interpretation of how the EBM founders regard clinical observation.
EBM has been criticized for being silent on the workings of clinical observation and
practice while simultaneously being remarkably attentive to the generation of the
evidence that is supposed to serve clinical practice. This silence makes it difﬁcult to
substantiate Greenhalgh’s claim that they do not hold an objectivist understanding of
clinical method. The silence on the matter has understandably been interpreted by the
critics to suggest that clinical method follows suit with EBM’s objective evidentiary
schema.

Greenhalgh fails to persuade me that EBM has been grossly misunderstood in her
admission that

those who have studied the phenomenon of clinical disagreement, as

well as those of us who practice medicine in a clinical setting, know all

too well that clinical judgments are usually a far it? from the objective

analysrs of a set of emrnently measurable “facts”

For one, the authors of clinical epidemiology were not described as having studied the
phenomenon of clinical disagreement, but rather called attention to the need for its study.
Furthermore, EBM is a normative methodology that serves to challenge habits of thought

and practice in medicine. Thus anything that practitioners “know all too well” is open for

revision and change. Lastly, EBM’s rigid hierarchy of evidence will be demonstrated in

 

3” Greenhalgh (1999), "Narrative based medicine: Narrative based medicine in an evidence based world."
BMJ 318(7179), p. 323.

94

later chapters to be largely irreconcilable with the interpretive nature of clinical practice.
Greenhalgh’s defense of EBM’s phenomenological dimensions may be another example
of proponents appropriating the criticisms as having been done, understood, or
accommodated by EBM “all along”.3 '2 The fault therefore lies not in EBM, but in the
critics’ misunderstanding of EBM. While I challenge Greenhalgh’s characterization of
EBM as is, the question remains whether EBM can integrate the interpretive dimensions
of clinical practice with its evidentiary methods—what Greenhalgh calls “narrative based
medicine”—or whether such a union requires abandoning EBM and replacing it with a
different approach to medicine.

The model of medicine that arises from the phenomenological emphasis on
patient experience has been described as a “medicine of the intertwining” that negotiates
both the physiological and existential dimensions of illness, understanding them to be
mutually implicatory in their different contributions to the therapeutic encounter.313 This
intertwining presumes that our notions of disease and treatment would always involve “a
chiasmic blending of biological and existential terms”, where the terms are not ultimately
oppositional, but instead involved in intricate “logics” of information exchange.3 '4 When
disease is understood to have an existential dimension no less important than its
physiology, the methods and meanings of clinical diagnosis and treatment shift. This is
readily apparent in diseases with psychosocial dimensions.315 For instance, hypertension

cannot be properly treated without knowledge of and efforts to reduce the sources of

 

3'2 See Lambert’s criticism on p. 57.

3'3 Leder (1992), "A tale of two bodies: The Cartesian corpse and the lived body." The body in medical
thought a_nd pragztice. -

3 '4 Leder (1992), "A tale of two bodies: The Cartesian corpse and the lived body." The body in medical
thought and practice. p. 28.

3'5 Leder claims that this list is evolving. As research into the psychosocial dimensions of disease evolves,
very few conditions are being found to safely resist psychological and social dimensions.

95

stress in the patient’s life. Yet, even in cases with unambiguous organic etiologies—for
example, fractured bones sustained through a random and unpreventable accident—
phenomenological factors, while no longer implicated in causing this dysfunction, are
involved in constructing a response to treatment.3 '6

With this elevation of phenomenological dimensions of illness to be on a par with
the physiological factors, EBM’s hierarchized valuing of RCTS over qualitative methods
is both inappropriate and unjustiﬁed. Because the clinical data from RCTS represent an
average effect of the intervention on a homogenous trial population that met admission
criteria, the inescapable and important existential components of illness—considerations
that are necessarily subjective or personal—are excluded. The concerns over the
applicability of trial data to individual patient care are heightened in the context of
intertwined medicine. Recall that in the tPa case discussed earlier, the clinicians did not
have the necessary information for clinical subgroups and were therefore arguably
limited in their ability to provide the best treatment options. This spoke to the treatment
of the physiological components of the patient’s condition. The shortcomings of the
applicability of the evidence to patient care, and the possibility of an evidence based
medicine, are now two-fold with the additional challenge in addressing the existential
dimensions of illness that implicate clinical diagnosis and treatment response.
Distinguishing EBM from pre-EBM: Nothing New in the EBM Critique?

To summarize our ﬁndings so far, the epistemological critique of EBM reveals a
radical empiricist concept of evidence as “given” or “self-apparent” and a closely-linked

objectivist account of knowledge as (preferably) detached and disinterested. We saw that

 

3 '6 Leder, (1992), "A tale of two bodies: The Cartesian corpse and the lived body." The body in medical
thought and practice, pp. 29-32.

96

these positivist commitments have been severely discredited within the past half-century
of epistemology of science research for failing to properly capture the (social) nature of
knowledge production. This approach was thought to objectify the embodied patient as a
passive site for examination rather than as an active knowledge source, a move that leads
to impersonal/inhumane medical practice. While I generally concur with these
conclusions, their impact in discrediting the evidence based approach is limited because
these lines of criticism predate EBM. In this section, I offer another critical perspective
on EBM, political economy analysis, that manages to incorporate some features of the
postpositivist critique just offered with some of the new content that EBM brings to
medicine in a power/knowledge analysis that applies uniquely to EBM.

Biomedicine was criticized for supporting problematic positivist commitments
well before the advent of EBM, which is still a relatively new approach to medical
research and clinical decisionmaking. For example, in the Journal of Medicine and
Philosophy’s December 1978 edition on “Medicine and Knowledge”, which chronicled
emergent themes in medical epistemology, McWhinney3 ‘7 and Harding3 '8 pondered the
detriment to patient care that can accompany the rise of technology in biomedicine,
Reiser319 lamented the decline of clinical dialogue, and Savodnik320 called for humanity
and holism in medicine. The EBM debate’s well-wom distinctions between seientiﬁc
knowledge and clinical practice, and “algorithmic procedures” versus “human judgment”

98321

are even invoked in Wartofsky introductory editorial to the volume’s critical

examination of (pre-EBM) biomedicine. In light of these ﬁndings, one might conclude

 

3 '7 McWhinney (1978), "Medical knowledge and the rise of technology." J Med Phil 3(4).
3 Harding (1978), "Knowledge, technology, and social relations." J Med Phil 3(4).

3 Reiser (1978), "The decline of clinical dialogue." J Med Phil 3(4).

32 Savodnik (1978), "Psychosomatic medicine." J Med Phil 3(4).

3" Wartofsky (1973), "Editorial." J Med Phil 3(4), p. 268.

_—
COM

97

that some of the critics have been correct in charging EBM with offering nothing new to
medicine.322 A fair assessment of EBM certainly requires consideration of what unique
problems the decisionmaking technology brings to medicine, and not merely a rehearsal
of what equally challenged its biomedical predecessor. We must also recognize and
appreciate the momentous advancements in healthcare that are credited to scientiﬁc
medicine despite its epistemological difﬁculties when considering where medicine must
go from here.

On the Power/Knowledge of EBM: The Political Economy of Evidence Based Decision
Making

The controversies surrounding the ascendancy of formulaic guidelines and
population-based research and the diminishing of clinical judgment, patient perspectives,
and individual patient care are frequently framed as struggles over the locus of authority
in medicine, where power disputes are argued as debates over knowledge. This is not to
say that epistemic considerations are beside the point, only that the sociopolitics of EBM
are widely regarded as central analytic categories for understanding the evidence based
approach to medicine. Political economy incorporates forms of neo-Marxist analysis that
explore the relation of the social, political, and cultural to the organization of capitalist
economies.323 It is the most popular form of scholarly critique of contemporary macro-
relations of healthcare within the English literature, and this perspective has been central

to social science analyses that treat new developments in the healthcare ﬁeld as effects of

 

322 See, for example, Benitez-Bribiesca (1999), "Evidence-based medicine: A new paradigm?" Arch Med
895 30(2)-

323 Armstrong et a1 (2001), _U_npealthy times: Political economy perspectives on health and care in Canada,
pp. 10-15.

98

structural changes in relations between the state, capital, and professionals.324 While
frequently hinted at throughout this analysis, the social and political implications of the
evidence based approach to medicine will now be explicitly discussed in a political
economy critique of EBM.

It has already been noted that many of EBM’s methodological and epistemic
claims seem common sense. However, their seeming obviousness results from them
having been stripped of the social context of medical practice. Just as feminist
epistemologists have demonstrated how this alleged value-neutrality distorts scientiﬁc
practice, the same concerns arise in medicine. In an age where the institutional power of
medicine is suspect, a model that represents biomedicine’s power as disinterested (or
merely “scientiﬁc”) should give pause for thought. In this vane, Keith Denny reads EBM
as a discourse that problematically resists contemporary challenges to established medical
authority by consumer advocacy groups and proponents of complementary and
alternative medicine. While EBM may appear to question the authority of individual
physicians by demanding responsibility to the literature and in the epistemic silencing of
clinical judgment and experience, it actually reinforces this power by regulating the
conditions under which a physician may speak authoritatively about health and illness.
Furthermore, EBM does not question the institutional authority of medicine itself to the

rest of society, the way healthcare dollars are allocated for the necessary clinical research,

 

32" Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1060; see, for example, Armstrong et a1 (2001), Unhealthy times:
Politicgl economy mrgpectives on health and care in Canm; Armstrong and Armstrong (2002), Wasting
away: The undermining of Canadian health care; Leys (2001), "The British National Health Service in the
face of neoliberalism." Unhealthy times: Political economy perspectives on health and care in Canada;
Light (2001), "Comparative institutional response to economic policy managed competition and
governmentality." Soc Sci Med 52(8); Navarro, ed. (2002), The political economy of social inequalities:
Consequences for health and quality of life; Navarro (1993), Dangerous to your health: Capitalism in health
care.

99

and what role the pharmaceutical industry plays in setting the research agenda. EBM’s
pairing of medical science with the contemporary discursive alignment of
information/truth/freedom is argued to reassert a commitment to Western scientiﬁc
paradigms and to have permitted EBM’s dominant status in medicine.325 To understand
and appreciate Denny’s provocative thesis, more needs to be said about political
economy analysis and how it has been used in the context of EBM critique.

The priority setting and health policy literature has acknowledged a trend in
recent years toward greater transparency in decisionmaking, where increasing demand is
being placed on decisionmakers at all levels to use more explicit methods of
decisionmaking326 for the sake of accountability.327 Evidence based decisionmaking has
been proffered as a means for explicitly justifying solutions to the classic resource
allocation dilemma between the scarcity of resources and our potentially unlimited health
care wants.328 It has been argued that much of EBM’s appeal lies in its perceived
fairness. EBM seems to offer the promise of consistent and impartial evidence about the
beneﬁts and harms of treatments due to the transparent use of high quality primary
research in systematic reviews and meta-analyses. These results are then applied in
equally transparent processes to make clinical decisions. Justice in providing health care
is critically important, since equity in this area may go some way toward redressing
health inequalities, which are inescapably linked to socioeconomic and other

disadvantages both within and between countries.329 Evidence based approaches have

 

”5 Denny (1999), "Evidence-based medicine and medical authority." J Med Humanit 20(4).

37'" Coast et al (1996), Priority setting: The heglth cage debgep

327 Shore and Wright (2004), "Whose accountability? Govemmentality and the auditing of universities."
Parallax 10(2).

328 Dobrow et a1 (2004), "Evidence-based health policy: Context and utilization." Soc Sci Med 58(1), p.
207.

’29 Rogers (2004), "Does evidence-based medicine offer fair beneﬁts for all?" Ethics J Am Med Assoc 6.

100

come to play an increasingly important role in many national health systems. In addition
to guiding clinical practice, evidence based decisionmaking has also become instrumental
in shaping research agendas, formulating policy, and allocating ﬁnancial resources.330
The move from EBM to “evidence based health policy” represents a shift from the

individual/clinical to the population/policy level, where the decisionmaking context

becomes more uncertain, variable, and complex.331

The growing interest in evidence
based health policy332 has made it increasingly clear that existing models of evidence
based decisionmaking that focus largely on the “evidence base” (i.e. the quality of the
evidence) while neglecting the “decisionmaking context” are inadequate.3'33

The evidentiary focus of current evidence based decisionmaking models cannot
adapt to the contextual features of broader policy environments.334 Dobrow et al. propose
that conventional political decisionmaking is largely context-driven, with low evidentiary

input. The largely contextual political decisionmaking framework is placed in opposition

to EBM, which focuses on the quality of evidence while attempting to minimize the role

 

330See Lambert et a1 (2006), "Introduction: Gift horse or Trojan horse? Social science perspectives on
evidence-based health care." Soc Sci Med 62(11), p. 1. On the level of national health care, for example,
Britain’s Department of Health for the National Health Service, Canada’s Ministry of Health, and the
United States’ National Institute of Health and Agency for Health Care Policy and Research all have
mandates and health initiatives which stress the principles of EBM. For US and Britain, see Pope (2003),
"Resisting evidence: The study of evidence-based medicine as a contemporary social movement." Health
7(3); For Canada, see Ministry of Health (Canada) (2006), "Health Canada." http://www.hc-
sc.gc.ca/index_e.html

’3 ' Dobrow et a1 (2004), "Evidence-based health policy: Context and utilization." Soc Sci Med 58(1).

332 Black (2001 ), "Evidence based policy: Proceed with care." BMJ 323; Harries et a1 (1999), "Evidence-
based policy-making in the NHS: Exploring the interface between research and the commissioning
process." J Pub Health Med 21; Klein (2000), "From evidence-based medicine to evidence-based policy?" 1
Health Serv Res Policy 5; Maclntyre et al (2001), "Using evidence to inform health policy: Case study."
BMJ 322(7280); Dobrow et al (2004), "Evidence-based health policy: Context and utilization." Soc Sci
one 58(1)-

3” We have already seen EBM being charged with being too general because of its population based
methods and therefore challenged with respect to application to individual care. Here, the critics counter
EBM from the other direction, claiming that it cannot accommodate population-based or general level
concems either.

33" Dobrow et al (2004), "Evidence-based health policy: Context and utilization." Soc Sci Med 58(1), p.
216.

101

or impact of the decisionmaking context. Political decisionmaking frameworks generally
regard evidence as only one of a number of contributors to the decisionmaking process,
and it is both the internal and external contextual factors that provide the basis for
political decisionmaking. It also typically lacks a clear mechanism for deﬁning or
utilizing evidence appropriately or effectively, a tendency that is now being challenged in
the push for accountability.335 For example, for policy regarding implementing a
colorectal cancer screening program, traditional political decisionmaking would typically
address the relative need for a screening program, inﬂuenced largely by the interplay of
key internal contextual factors, such as purpose, participants, and process, and the impact
of external contextual factors, including the political and economic implications of a
population-wide program, extra-jurisdictional factors (i.e. do similar programs existing
other jurisdictions?) and disease-speciﬁc characteristics (i.e. which populations groups
stand to most beneﬁt by such a program?) The quality of the scientiﬁc evidence

1.336 The authors see in

available would be only one of several factors considered, if at al
evidence based health policy the potential of a middle ground between EBM and standard
political decisionmaking and they offer a framework for “context-based evidence based
decision making” to serve this end.337
Critics coming from the tradition of political economy critique worry that such an

effort at correcting the shortcomings of evidence based decisionmaking may be

inadequate and politically naive, as the decisionmaking technology is already a political

 

3” For further analysis of the relation between evidence and social policy, see Miller and Safer (1993),
"Evidence, ethics, and social policy dilemmas." Edu Pol Angl Arch 1(9).

33’ Dobrow et 01(2004), "Evidence-based health policy: Context and utilization." Soc Sci Med 58(1), p.
211.

337 The details of Dobrow et al.’s “context-based evidence based decisionmaking framework” will not be
discussed here. Like the example of “evidence based patient-centred care” provided earlier, this model
represents yet another attempt at integrating oppositional concepts in an effort to correct the shortcomings
of the evidence based approach.

102

instrument serving corporate interests in medicine. The EBM movement is characterized
by the likes of Rodwin338 and Belkin339 as the latest expression of “scientism”,
modernity’s rationalist dream that science can produce the knowledge required to
emancipate us from scarcity, ignorance, and error. These efforts are argued to disguise
political interests in the authority of so-called “scientiﬁc evidence”. The conﬁguration of
policy considerations and clinical standards into questions of evidence conveniently
transform normative questions into technical ones. Political issues are not resolved,
however, but merely disguised in technocratic consideration and language. Thus the
goals of medicine and other normative considerations lie just below the surface of these
evidentiary questions, and evidence becomes an instrument, rather than a substitute, for
politics.

Within this line of critique, the increased interest in transparent decisionmaking
and accountability is interpreted not as a push for democracy insofar as decision makers
are made answerable to their constituents, but rather a technocratic ﬁx for normative
issues that effectively silences democratic debate. In his writing on managed care, Gary
Belkin has argued that the particular organization of payer and provider introduced by
managed care organizations was not an inevitable response to cost control, economic
inefﬁciency, and a drive to improve medical practice, but instead ﬁts within a history of
appeals to standardized and ostensibly objective measures and models of human

behaviour to resolve contentious issues in complex and modern capitalist democratic

 

”8 Rodwin (2001), "The politics of evidence-based medicine." J Health Pol Policy Lgyy 26(2).
”9 Belkin (1997), "The technocratic wish: making sense and ﬁnding power in the "managed" medical
marketplace." J Health Pol Policy Law 22(2).

103

societies.340 Belkin urges us to pay attention to the historical moment in which we ﬁnd
ourselves, when the challenges and questions raised by the recreation of the medical
subject as an economic actor or average probability seem “obvious”.

The political economy tradition provides the analytic resources to examine EBM
as a political phenomenon. Indeed, this seems like a promising framework given the
signiﬁcant social impact of EBM. The remarkable enthusiasm that has met EBM on the
part of the elites in academic medicine—a group that is typically resistant to change“—
has led to the formal incorporation of EBM into editorial policies, spawned new journals,
and is now routinely taught in medical schools throughout North America and most of
Western Europe.342 The political economy perspective frames the EBM movement as a
constituent of both institutional transformation in healthcare and contests for power
associated with the neoliberal restructuring of the welfare state. Discussions tend to be
grand in scale, organized as abstract critiques of EBM rather than as empirical research of
particular cases of its development or use.343 EBM has, for instance, been represented as
an ideological resource that the medical profession uses to buttress its authority, primarily
by reinforcing the scientiﬁc character of medical practice344 and as a movement that

serves the interests of capital.345

 

34° Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in
mental health." Rationing sanigy: Ethical issues in managed mentgmmlth care, p. 14; see also Denny
(1999), "Evidence-based medicine and medical authority." J Med Humanit 20(4).

3‘” This phenomenon is seen, for instance, in the harsh opposition to alternative medicine expressed by
prominent members of the medical establishment. See, for example, the editorial co-authored by the New
England Journal of Medicine’s executive editor and editor-in-chief, Angell and Kassirer (1998),
"Altemative medicine--the risks of untested and unregulated remedies." N Engl J Med 339(12).

3’2 Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1060.

3’3 Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1061.

3"" See Denny (1999), "Evidence-based medicine and medical authority." J Med Humanit 20(4).

3“ See Rodwin (2001), "The politics of evidence-based medicine." J Health Pol Policy Law 26(2); Belkin
(1994), "Numbers and the politics of health care." J Health Pol Policy Law 19(1).

104

Within late modernity’s afﬁnity for resolving policy issues by transforming them
into problems of measurement,346 medical knowledge is argued to be reformulated,
replacing expert judgment with technical formulas, and face-to-face interaction with
standardized information shared by anonymous individuals.347 Interestingly, it satisﬁes
the strong wish that we have for open, reliable, and presumably objective methods for the
resolution of controversy. It also ﬁts into a history of employing aggregate measures and
standardized processes and products to mobilize and deploy large amounts of capital.348
The expansion of markets made opportunities for face-to-face interactions less possible.
In the grain trade, for example, grain grading was introduced to make pricing possible
without on-site inspection. The logic of standardized measurement is conﬁrmed by late-
20th and early-21St century capitalism. From this market phenomenon, a conﬁdence in
standardized measuring emerges, and so the epistemic problem of summing experience
(the “subject as aggregate”) to determine medical truth and reality can be comfortably
ignored.349

Statistical inference is pursued precisely for its superﬁciality and its ability to
measure broad rather than individual experience. Its ability to isolate more general
variables and phenomena that permit more open and egalitarian debate about social
questions caught the attention of democrats such as Auguste Comte and Otto Neurath.

Yet generalizations and standards contain implicitly socially framed and mediated values

 

3’6 Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in
mental health." Rationing sanity: Ethical issues in managed mentgl health care.

3’7 Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in
mental health." _Rgtioning sanity: Ethical issues in managed mental health care; Tanenbaum (1993), "What
physicians know." N Engl J Med 329(17).

‘3 Frankford (1994), "Scientism and economism: regulating health care." J Health Pol Policy Law 19(4);
Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in
mental health." Rationing sanig: Ethical issues in managed mental health care.

3’9 Belkin (2003), "Shifting the focus: the historical meaning of managed care and the search for ethics in
mental health." B_ationing sanity: Ethical issues in managed mental health care, pp. 12-13

 

105

with a range of implications that can order and enhance but also tyrannize aspects of our
lives. The success of generalization is achieved at the expense of contingent and
contextual knowledge that needs to be ﬁltered out. Certain critical lines of thinking in
science and technology studies hold the strong suspicion that quantiﬁcation is a tool to
manipulate objectiﬁed objects and create an illusory “natural” and often oppressive
language of normal and abnormal.350

The “technology of patient experience” is inherently limited insofar as only
certain kinds of experience can be quantiﬁed and only certain questions explored. The
challenge for those working in the evaluative sciences is to avoid developing measures of
patient experiences and treatment performance that ignore the contingent, probabilistic
and selective nature of such knowledge. In “Scientism and Economism in the Regulation
of Health Care”, F rankford argues that data-driven approaches to patient care narrow our
ability to effect actions in clinical encounters, as statements of averaged probability

become unquestioned laws of possibilities.351

They limit appreciation of the subtleties
and exceptions that characterize all efforts to diagnose and treat illness and displace the
critical and vast source of information for treatment, diagnosis and meaningful
management of illness that is found in human interaction. Furthermore, they ignore the
uncertainty and contingency of medical knowledge. Certainly efforts to capture such
encounters in aggregate terms have become increasingly sophisticated and thorough, yet

the limitations just mentioned are part and parcel of epidemiological methods and simply

cannot be overcome.

 

35° Hacking (1990), The Taming of chance.
35' Frankford (1994), "Scientism and economism: regulating health care." J Health Pol Policy Law 19(4).

106

In addition to the view of EBM as an ideological tool established to serve
corporate interests is the position that EBM is part of the rationalization of health
services. This understanding of EBM is informed by the longstanding concern about the
growing inﬁltration of health care by market relations,352 and it also relies on the
established conceptual resources of political economy research on health care, most
notably medical dominance, a state-centred conception of power, and the
state/capital/professions relation.353 For instance, consideration of the cost containment
imperative inﬂuencing healthcare decisionmakers at both the micro- and macro-level has
led some commentators to locate EBM practice guidelines within a trajectory of state
policies that draw on population-based knowledges to reduce the utilization of medical
services. From this perspective, evidence based guidelines are considered to be a form of
external control over medical practice, where physicians must place ﬁscal considerations
into their decisionmaking practices. In “The Politics of EBM”, Rodwin'positions EBM
within forms of quantitative aggregate knowledge that renders individual clinical
judgment vulnerable to administrative control.354 The market organization of managed
care is thought to encourage this transformation of medicine, now founded on population-
based research, into a complex series of protocols, guidelines, and other forms of
administrative management. These measures are all said to be justiﬁed by the public
interest in accountability and the widespread standardization and use of best practice

procedures.

 

”2 See, for example, Belkin (2003), "Shifting the focus: the historical meaning of managed care and the
search for ethics in mental health." Rationing sanity: Ethical issLues in mgnaged mental health cm;
Frankford (1994), "Scientism and economism: regulating health care." J Health Pol Policy Law 19(4).
”3 Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1061

35’ Rodwin (2001), "The politics of evidence-based medicine." J Health Pol Policy Law 26(2).

 

107

Operating in conjunction with the political economy perspective is the humanist
view that technology dehumanizes the patient. Frankford, for instance, situates EBM
within a long history of technologically inﬂuenced practice, which tends to “reduce
patients to technological objects and physicians to technocratic managers.”355 This
phenomenological perspective reads EBM as stripping patients of their stories and the
meaning of their experience, reducing them to passive recipients of healthcare. This
critique is performed in the name of holism and against the fragmentation and reiﬁcation

of the subject.356

Managed health care is thought to operate within the “technocratic
wish”,357 where technical solutions to what should properly be political debates over the
direction of the health system, making these questions into a matter of expertise to
resolve through population-based research. EBM is construed as subverting the integrity
of clinical reasoning and doctor-patient communication, subordinating these to health-
system goals that have not been decided upon through due democratic process.
Mykhalovskiy and Weir have proposed that political economy critiques of EBM
are helpful sources of discussion that explore how EBM is implicated in the broad
organization of healthcare, but that these analyses are signiﬁcantly ﬂawed. This analytic
perspective offers the important insight that during times of cost control, EBM, especially
in association with outcomes research, can render medicine vulnerable to administrative
scrutiny, whether by the state or private enterprise. The shortcomings of the political

economy analyses of EBM, however, are that much of the research is empirically thin

and the high levels of abstraction at which signiﬁcant claims are made are difﬁcult to

 

3” Frankford (1994), "Scientism and economism: regulating health care." J Health Pol Policy Law 19(4),
. 776.

E,“ See Denny (1999), "Evidence-based medicine and medical authority." J Med Humanit 20(4).

”7 Belkin (1997), "The technocratic wish: making sense and ﬁnding power in the "managed" medical

marketplace." J Health Pol Policy Law 22(2).

 

108

justify. The authors argue that the literature’s

rhetorical gestures involve broad characterizations of numerically

based knowledge that have an almost “anti-numbers feel”, and that

tend to overstate the subsumption of EBM within a bluntly formulated

economic or administrative squashing of medical judgment.358
The treatment of EBM as part of a justiﬁcatory regime is frequently more conjectural
than evidential, and has relied on a fairly narrow focus on the evidence based “protocol”,
which is taken to necessarily restrict physicians’ clinical autonomy.359 Political economy
discussions of EBM’s rationalization processes are charged with collapsing EBM and
outcomes/cost-effectiveness research within an overall project of rationalization directed
by healthcare management, a move that instrumentalizes EBM and ignores the varieties
of ways in which EBM is both understood and deployed.360 Also, while the technology
certainly has been deployed to achieve ﬁscal ends, EBM’s strategy for best practices does
not exclude the possibility of determining the most expensive treatment for any given
condition to be the most effective.

Furthermore, political economy analyses frequently focus on weak correlations
yet treat them like they determine causal connection. For example, the claim that EBM’s
valuing of standardized measures and aggregate behaviour) are consistent with the logic
of the medical marketplace and managed care may be taken to ground an underlying
corporate interest in EBM. This forging of sloppy connections between disparate

phenomena verges on what some refer to as “conspiracy theory”. Mykhalovskiy and

Weir maintain that their negative regard of political economy critiques of EBM is not

 

3” Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1061.

3” Berg (1997), "Problems and promises of the protocol." Soc Sci Med 44(8). The same concern regarding
protocols and professional autonomy is found among other healthcare professionals, for example nursing:
Winch et al (2002), "Governing nursing conduct: The rise of evidence—based practice." Nurs 1119 9(2).

36° Mykhalovskiy and Weir (2004), "The problem of evidence-based medicine: Directions for social
medicine." Soc Sci Med 59(5), p. 1061.

109

meant to excuse EBM from political analysis, but instead to propose that the relationship
of EBM to health services research and health management deserves further examination.
Political economy critiques raise signiﬁcant concern about how EBM can be used and
misused to achieve state and corporate interests at the expense of the users of any
healthcare system. However those worrisome incidents have yet to be established as
actualized. The authors argue that folding EBM into an established trajectory of
analyses, such as the focus on the power struggle among capital, the state, and the
medical profession, discourages the more mundane investigations into the workings of
EBM—what it is, how it works, how it has been used, how it can be deployed—as these
investigations may be regarded as pedantic or politically na'ive. They argue that a more
complex understanding of EBM invites better determinations of how its mechanisms are
implicated in contemporary relations of power in health care. The worry is that it is
rather the broad abstractions being taken and the unestablished correlations presumed
between a concept as complex as EBM to the equally complex sectors of health services
and management that inappropriately direct EBM analysis.

While the concerns raised regarding political economy critique are worthy of
consideration, I contend that Mykhalovskiy and Weir seem to condemn a certain na'l've
version of the political economy analytic perspective that—to use their phrasing, “folds
EBM into an established trajectory of analysis” with little regard for the actual workings
of the subject of analysis (EBM). Indeed, previous discussions have showed that EBM
appears to ﬁt within a political and economic model of healthcare rationalization that

encourages privatization of services and market-driven pricing to the detriment of public

110

access and market controls on healthcare costing (i.e. capitation).36' Furthermore, the
detection of EBM’s links to market-driven managed care is not premised on some
presumed inherently corrupted capitalist ethos, but on a faulty positivist-empiricist
epistemology that has been rebranded as “evidence based”. Lastly, the claim that the
valuing of standardized measures, aggregate behaviour, and radically fragmented medical
knowledge seems to be consistent with the market rationality that managed care ﬁrst
introduced to health care does not need to be understood to be conspiratorial—no causal
link is necessarily being suggested in the political economy critiques of EBM. Instead it
calls important attention to the politico-economic dimensions of the hubris of EBM. The
logic of the medical marketplace can be supported by such knowledge technologies as
clinical epidemiology, outcomes research, medical informatics, and, of course, evidence-
based medicine, all of which can further the economistic imperatives of the healthcare
marketplace in the name of “better science”. Cost—cutting strategies frequently
compromise patient care, and so EBM’s (actual or potential) connection to such political
agenda ought to be regarded with some level of suspicion. The enthusiasm for
standardized measures in clinical practice, consistency among professionals in
therapeutic interventions, and gold standards of clinical science reﬂect a medical
rationality that prefers abstracted measure over individualized history and pathology.
Medical authority is, therefore, no longer framed in scientiﬁc discourse but in late
20"‘learly-21St century capitalist discourse with its ideological extolling of the importance

of “information”———a move that co-opts demands for democracy and holism in

 

3" Compare, for example, the millions of uninsured Americans to Canada’s universal access. Also, the
higher cost for pharmaceuticals in the US compared to Canadian prices, which are government regulated.

111

medicine.362 This is done by appeal to “the evidence”—the unbiased bottom line.
Evidence can therefore serve as a tool to maintain power in its use to resolve politically
contentious issues.

With these considerations in mind, Denny’s thesis, presented at the start of this
discussion on political economy, becomes clearer. The proposal that EBM protects the
institutional authority of medicine in relation to society by presenting clinical discourse
as objective and uncontroversial ﬁts with emerging themes in political economy analysis
that question the democratic effects of accountability, transparency, information, and
other virtues of the “audit culture”.363 It was in the name of “better science” that
outcomes research was initially advanced primarily by prominent physicians and medical
institutions as a response to the noted economic irresponsibility in medicine;
effectiveness research was thought to promote more empirically-based practices and it
also seemed to legitimate physicians as arbiters of the health care dollar.364 However it
was precisely the scientistic enthusiasm of the emerging Health Services Research ﬁeld
that led to questioning the need for physicians at all in determining whether resources
were used appropriately. The completeness with which certain aggregate measures
deﬁne success and failure is extremely compelling given the grave consequences of
uncertainty in medicine. The cultural power and authority of knowledge derived from
reproducible gross measures was underestimated and the corporatization of health care

delivery was legitimated by this conﬁguration of scientiﬁc authority. Managed care was

 

362 Denny (1999), "Evidence-based medicine and medical authority." J Med Humanit 20(4), p. 260.

’6’ The “audit culture” refers to the widespread adoption of apparatuses of documentation and review at all
levels of governance in many large organizations. A critical discourse on the audit culture is growing
regarding its place within institutes of higher education. See, for example, Dentith (2002), "English and the
audit culture: An introduction." Higher Edu Acad On-Line Newsletter 3; Shore and Wright (2004), "Whose
accountability? Govemmentality and the auditing of universities." Parallax 10(2).

3“ Belkin (1997), "The technocratic wish: making sense and ﬁnding power in the "managed" medical
marketplace." J Health Pol Policy Law 22(2).

112

able to ascend as a viable means of distributing health care by such appeals to scientiﬁc
objectivity. Ellwood and his allies were wonderfully successful in constructing “a
universal language” to “bring order and predictability to the American health care
system”.365 Such knowledge upholds the image of medicine as universally accessible,
objective, and quantiﬁed knowledge, and thus manipulable and interpretable by persons
Lurinvolved in the processes the data describe. This knowledge can be detached quickly
from the context of the work of the experts who devise it.366 To argue that a symptom
checklist should be interpreted in a certain way and for speciﬁed purposes means
admitting the degree that medical practice is craft-work.367
When the felt ambivalence over the fairness and universality of measurement and
practice guidelines is coupled with the increased cynicism regarding the presumed
wisdom of the unfettered marketplace to allocate healthcare resources wisely and to

68 much of the initial “obviousness” of EBM begins to

enforce standards of care,3
diminish as it begins to look like a devise of the medical marketplace. Tanenbaum
reveals that the US outcomes movement has been invoked to support efforts to
increasingly privatize healthcare.369 Because EBM legitimates the distillation of medical
truth outside of the clinical encounter, where statistical information is privileged over the

physician in clinical decisionmaking, the logic of a healthcare marketplace populated by

independent and rational buyers and sellers is validated.

 

36’ Ellwood (1988), "Outcomes management: A technology of patient experience." N Engl J Med 318(23),
. 102.
966 The preferred distance between observer and observed is a telltale sign of positivist thinking and
methodology.
3'67 Belkin (1994), "Numbers and the politics of health care." J Health Pol Policy La_yv_ 19(1).
3“ Frankford (1994), "Scientism and economism: regulating health care." J Health Pol Policy Law 19(4),
. 803.
a” Tanenbaum (1995), "Getting from there to here: evidentiary quandaries of the US outcomes
movement." J Eval Clin Prac 1(2).

113

The motivation for Mykhalovskiy and Weir’s caution to avoid over general
abstractions and empirically-thin claims is appreciated, however, as, similar to me, the
authors want to decipher what is unique about EBM and what particular problems the
evidence based approach_brings to medicine. Fitting EBM into familiar trajectories of
analysis can obscure the unique content of EBM by, for instance, collapsing it into a
generic dehumanizing medical technology that merely furthers the technologizing of
biomedicine (and subsequent detriment to the practitioner-patient relationship) that has
been happening for decades. Brody et al., in fact, deny the alleged lOSS of the individual
patient via the evidence based approach on the grounds that there was no prior

370

“individual” to be lost. They draw from the popular critical histories of biomedicine to

argue that

at least since the triumph of anatomical pathology and the demise of
humoral medicine, conventional medicine. . .has approached the problems
of diagnosis and treatment of the individual patient by trying to
disassemble the patient into the component, lower-level natural systems
[i.e. cells, tissues, organs, organ systems].371

In doing so, conventional medicine directs its investigative attention away from the
features that make individual persons unique and instead attends to the parts that make us
the same. Illness and diseaseare framed as deviances from the norm (i.e. healthy lungs,
normal white cell count). Indeed,

if the hallmark of the diagnosis and treatment of adult-onset diabetes is

insulin deﬁciency and peripheral insulin resistance, for example, the

individual patient ceases to be an individual and becomes merely a

member of a population of humans, all of whose cells and tissues
function in comparable ways.372

 

37° For example, Foucault (1994), The birth of the clinic: An archaeology of medical pgrception; Vogel and
Rosenberg, eds. (1979), The therapeutic revolution: Essays in the sLial history of Americgn_ medicine.

37' Brody et al (2005), "Evidence-based medicine: Watching out for its friends." Persp Biol Med 48(4), p.
574.

114

The authors turn the tables on the popular criticism of EBM by proposing that EBM in
fact elevates the individual from its previous denigrated status. By refusing to discuss
diabetes solely in terms of cellular and tissue function observed in a controlled setting,
and insisting instead that outcome data from population-based studies must be addressed,
EBM in fact subverts the sub-specialized approach to diabetes research (endocrinology)
in favour of a broader perspective of the patient. With this shift in focus, the authors
propose,

the individual has in fact been promoted. Instead of being treated as a

bundle of tissues that demonstrate certain biochemical responses, the

patient is now a member of a population that demonstrates more or fewer

major complications of diabetes, such as premature death, blindness, and

loss of limbs.373
This “promotion” is, of course, not even close to the vision of patienthood being called
for by advocates of more humane and “patient-centred” medicine, as this new population-
based group membership is still impersonal. Brody et al. manage, however, to deftly
make the point that the criticism that EBM erases the individual needs rethinking. At the
very least, the proposal should not be framed as a desire to return to the holism of pre-

EBM.

In Conclusion

 

In chapter one, EBM was distinguished from alternative biomedical approaches,
with the differences lying in the strengthened reliance on the RCT, the hierarchy of
evidence, and the evidence-based penchant for applying epidemiological and statistical

methods to clinical medicine. We saw in this chapter that the various knowledge

 

3’72 Brody et al (2005), "Evidence-based medicine: Watching out for its friends." Persp Biol Med 48(4), p.
574.
373 Brody et a1(2005), "Evidence-based medicine: Watching out for its friends." Persp Biol Med 48(4), p.
575.

115

technologies utilized in the healthcare quality movement’s focus on ‘the acquisition and
use of knowledge and evidence in health care by way of outcomes research, clinical
epidemiology, and EBM, worries critics because they are taken together to initiate a new
program for medicine that supports use of “the evidence” as the reductive bottom line.
This positivist agenda is often accompanied with the rhetoric of pluralism and equity in
the advocacy of economic measures for justifying rationing decisions in healthcare
distribution.

The formulation of evidence used in EBM has been demonstrated to be
problematic by post-positivists, feminist epistemologists, and medical phenomenologists.
Relying on “the facts” or “the evidence” to adjudicate between competing clinical
practices or scientiﬁc beliefs assumes that the evaluative standards of EBM are
transparent, neutral, objective, and universal. The numerous accounts of scientiﬁc

knowledge as “situated knowledges”374

offered by post-positivist, feminist, and
phenomenological thinkers suggest that this understanding of evidence is far too simple
and no longer a tenable position in science studies. F urthermore, against the position that
modern science stands out as the only objective method of knowledge-gathering, feminist
epistemologists and phenomenologists demonstrate the biases implicit in the modern
scientiﬁc worldview and offer ways of conceiving evidence differently.

Evidence is not self-apparent or “given” when gathered from even the most
idealized and controlled observational setting. The critiques of positivist philosophy

contest the seemingly unproblematic nature of “evidence” that underlies EBM by

emphasizing different features of the social nature of science. The appeal to the authority

 

37’ Haraway (1988), "Situated knowledges: The science question in feminism and the privilege of partial
perspectives." Feminist studies 14(3).

116

of evidence that characterizes evidence-based practices does not increase objectivity but
rather obscures the subjective elements that inescapably enter all forms of human inquiry.
EBM’s privileging of quantitative over qualitative methods of research stems from a
picture of knowledge being more objective when it is distanced from experiential or
phenomenological ﬁlters. Abstracted from the social context of medicine, EBM seems
common sense and the connections between power and knowledge are obscured.

Relying on empirical evidence is, of course, not new to scientiﬁc medicine. However the
evidence based approach is uniquely charged with using “the evidence” not merely to
justify medical decisions, but to covertly introduce bold new normative content to
medicine.

We began this chapter with the acknowledgment that the question of what
constitutes evidence is undeniably central to the EBM discourse. Having uncovered
devastating problems with the current conﬁguration of evidence that underlies EBM, a
revised account is in order. The next chapter addresses the challenges surrounding

alternative theories of evidence.

117

CHAPTER FOUR
Rethinking Evidence and the Problem of Relativism

We have seen so far that the concept of evidence is being avidly embraced in
health care as a symbol of legitimacy, thoroughness, and truth. However, the crude
enthusiasm surrounding evidence based approaches has made evidence more like a
slogan or branding that draws people in with its seductive promises. Because EBM has
not yet overcome many methodological difﬁculties and has failed to provide insight and
direction into how to face the ethical, normative, and social dimensions of health care, its
integration into “patient centred” clinical care remains not only unrealized but also
uncharted. Without such a program, the movement’s acclaim appears to be premature.
By remaining silent on integration issues and on how to understand and incorporate
patient preferences, EBM has “stopped where the most urgent problems arise and the
need for creative and innovative thinking [is] most critical.”375

Within the many life and social science disciplines striving to become
increasingly evidence based, there is a minority of critical voices that have fairly
unifome identiﬁed inadequate conﬁgurations of evidence as the root of the problems
with evidence based practices.376 The critics do not want to abandon evidence, but desire
a more “honest” process for incorporating clinical research into patient care that

recognizes the social dimensions of medicine and the multiple facts of knowledge that

 

37’ Upshur (2005), "Looking for rules in a world of exceptions: Reﬂections on evidence-based practice."
Persp Biol Med 48(4), p. 488. The challenge of integrating patient perspectives into EBM will be further
discussed in chapter 5.

376 See, for example, Upshur (2005), "Looking for rules in a world of exceptions: Reﬂections on evidence-
based practice." Persp Biol Med 48(4); Upshur et al (2001), "Meaning and measurement: an inclusive
model of evidence in health care." J Eval Clin Prac 7(2); Djulbegovic et a1 (2000), "Evidentiary challenges
to evidence-based medicine." J Eval Clin Prac 6(2); Cott et al (2001), "Client-Centred Rehabilitation."
Arthritis community research and evaluation uglit; Holmes et a! (in press), "Necrospective: Evidence,
virulence, and the disappearance of nursing knowledge." Worldviews Evid Based Nurs.

 

118

informs the discipline. The goal of rethinking evidence is to provide a more nuanced
account that will correct the shortcoming of the evidence based approach to medicine.
We previously saw that in response to the constructive challenge of formulating
an alternative account of evidence, antifoundationalist thinkers working within critical
science studies have broadened the standards of evidence to properly admit the social
features of science that are missing from the evidence based perspective. The pragmatic
refusal to lay down pre-established limits of the scope of what counts as evidence also
acknowledges the multiple and interdependent sources of knowledge that inform
medicine. In this chapter, it will be argued that despite their critical effectiveness at
undermining the philosophical underpinnings of EBM, postpositivist views fail at the
constructive task of providing a defensible and useful alternative conception of evidence,
as the problem of relativism arises. The problem of relativism is the charge that the social
and historical contextuality of truth and knowledge renders these concepts epistemically
useless and/or meaningless. This is not only a philosophical problem, but also a failure to
provide a useful alternative concept for practitioners who may be wary of EBM’s claims
and methodologies, yet ﬁnd themselves still needing, in the end, to make a clearly
justiﬁed medical decision. The contemporary reconﬁgurations of evidence in critical

377

science studies offered by Longino in Science as Social Knowledge and Nelson in “On

”378 will be demonstrated to fail to offer guidance in medical decisionmaking—

Evidence
in fact, they may further complicate it—by being so unrestrictive regarding what counts

as evidence. As a result the evidence based program may be confounded rather than

corrected.

 

’77 Longino (1990), Science a_ts soci_al knowledge: Values and objectivity in scientiﬁc inquiry.
37:: Nelson (1993), "A question of evidence." Hypatia 8(2).

119

Longino and Nelson’s reconﬁgurations of evidence are both holistic insofar as
they widen the concept beyond the previous bounds of the so-called “factual” to include
“evaluative” categories. In this chapter, the inadequacy of holistic constructions of
evidence for furthering the EBM debate will be argued to be a consequence of certain
antifoundationalist epistemological commitments characteristic of critical science studies.
Speciﬁcally, epistemologist Sharyn Clough’s charge that critical science studies
relativizes evidence by retaining a representationalist metaphysics will be considered as
an explanation for the deﬁciency that I am proposing.379 The demonstration by
postpositivists that the divide between the objective and the social world is
insurmountable (that is, our interpretive lenses block access to “the real”) will be argued
to properly reign in the overstated veritistic capacity of empiricism by classical and
positivist empiricists, yet open up the persistent problem of relativism with respect to
effecting normativity in science, as theory choice now becomes relative to worldview.
Global scepticism is also made coherent under the representationalist framework. While
efforts within critical science studies to deﬂect accusations of relativism have been
valiant, they have required what Clough has called “a hasty retreat from evidence”, where
the representationalist’s inescapably ﬁltered access to reality forces her to attend to the
epistemic virtues and worldviews that she wants science to uphold rather than
investigating and interrogating evidence itself. This “hasty retreat” serves to explain why
the evidentiary accounts offered by postpositivist epistemologists of science fail to offer a
defensible alternative to EBM that is useable in the clinical setting and sets the stage for

the Davidsonian repair that will be offered in the next chapter.

 

’79 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies; Clough
(2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist epistemology." Siblings
gnder the skin: Feminim, social justice and analﬁic philosophy

120

Antifoundationalist Epistemology: Scientiﬁc Holism and Relativism

The link between evidence and empiricism was already made in chapter one in
the proposal that the dictionary deﬁnition of evidence—“ an observation, fact, organized
body of information that supports a belief”—betrays empiricist commitments, as it
presumes the existence of an external world of “fact” that comes to bear upon our
subjective beliefs. Evidence is thought to justify our beliefs about the existence of the
real world. However it does not justify our belief that the real world exists independently
of our cognitive and emotive processes. Quine380 refers to empiricism as, at bottom, a
theory of evidence and Lynn Nelson adds that there is currently no viable alternative
theory.33'

Quine and Nelson have already been identiﬁed in chapter three as post-positivist
thinkers that disavow conﬁgurations of empirical science that regard observational data
as foundational in its pretheoretical and objective representations of the external world.
Against the position that observational claims provide a platform on which to build the
objective basis of science (what Nelson refers to as the “autonomy of science”382),
observations are held to be unavoidably theory-laden. This charge that observations, by
their nature, cannot be pretheoretical has already been explained to be damaging to the
positivist-empiricist understanding of science, as the inﬂuence of theory (frameworks,
worldviews, etc.) on observation is regarded as a threat to the objectivity of the process of
testing and verifying theories. If theories are allowed to, indeed required to, select their

own evidence and then to give meaning and credibility to the observations, the testing

process could become unavoidably circular and self-serving. Discrediting the presumed

 

38° Quine (1981), "On the very idea of a third dogma." Theories and things
38‘ Nelson (1990), Who knows: From nine to feminist em iricism, p. 9.

332 Nelson (1990), Who knows: From Quine to feminist empiricism, pp. 79-80.

121

independence of theory and observation is thought to unavoidably strip science of its
objective knowledge-gathering capability and lead to the situation in which
incommensurable positions hold equal weight (relativism). This is why practitioners are
left without the basis that they need to justify their actions.

Proponents of the “theory-ladenness” thesis deny the claim, however, that the
scientiﬁc method is discredited by the reliance of observation on theory, and that because
science fails to meet its own standards of objectivity, scientiﬁc knowledge claims are just
relative. This recourse only seems surprising if one fails to notice that the criticisms
against the dominant picture of empiricism only challenge the foundationalist picture of
empirical knowledge, and not empiricism all together. The traditional account posits that
all empirical knowledge is founded upon a set of independently intelligible and credible
observation claims. The “theory ladenness” critique demonstrates that there are no such
“basic” claims, and that the doctrine that all empirical knowledge could rest on such a
claim is incoherent.

The difﬁculty that needs to be overcome is that the critical accounts of evidence
not only discredit EBM but also discredit evidence as such. What needs to be
rehabilitated is the idea of having good reason or justiﬁcation to select one explanation,
theory, or action over another. To get at why critical accounts of evidence falter (and
how evidence can be restored), the basic antifoundationalist philosophy of science

program will be established in the next section via Feyerabend’s programmatic essay

”383 9 S384

“How to be a Good Empiricist and Longino inﬂuential critical account of science

as social knowledge. The broad characteristics of a theory of evidence that arises from

 

’83 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues.
38" Longino (1990), Science gs social knowledge: Values and opiectivity in scientiﬁc inquiry.

122

93385

these epistemological commitments are then found in Longino contextualist analysis

of evidence and Nelson’s386

naturalized account of evidence. Both Longino and Nelson
also carry major themes of feminist epistemologies of science into theories of evidence

that are antifoundationalist, postpositivist, and holistic.

Antifoundationalist Science

 

Rather than regarding the theory-ladenness of observations as a potentially
destructive challenge to empiricism, Feyerabend387 argues that it is positivistic practices
in empiricism (which rely on the assumed division between observation and theory388)
that undermine the empiricist programme. Furthermore, the methodological
incorporation of the “theory-ladenness” thesis would in fact make us good empiricists, as
metaphysics stands to improve rather than hinder empirical knowledge. The role that
observations as facts or data plays in positivistic empiricism, namely as a motivator and a
test for theOry, is argued to decrease our empirical knowledge about the world by
reifying current theories and eliminating the alternative metaphysical schemes that are
needed for good critical inquiry and comprehensive fact-ﬁnding.

In his desire to retain the anti-dogmatic programmatic of empiricism that
allegedly spurred science into modernity, F eyerabend challenges us to become good
empiricists. He purports that modemist empiricism fails at its anti-authoritarian

knowledge-seeking agenda because the assumption that theories can be justiﬁed on so-

called “empirical grounds” is bound to lead to “dogmatic petriﬁcation” and the

 

3” Longino (1990), Science as social knowledge: Values grid objectivity in scientiﬁc inquiry.

3’6 Nelson (1993), "A question of evidence." Hypatia 8(2).

3’7 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
ﬂilosophy of science: The central issues.

388 Feyerabend challenges the empiricist privileging of observational statements over theoretical statements
in Feyerabend (1980), "Science without experience." Challenges to empiricism.

 

123

389

establishment of a rigid metaphysics. Much like modernity has been regarded as

totalitarianism in the name and guise of democracy by members of the Frankfurt

school,390

empiricism is thought to reify its metaphysics by its rejection of metaphysics
and penchant for supposedly democratic methods of experimentalism and knowledge
gained through “experience”. Empiricism’s enemy, by Feyerabend’s account, is no
longer the Church and medieval thinking, but logical positivism, as it is the latter that
works against scientiﬁc progress.391
The spectacular scientiﬁc advances of Galileo, Faraday, and Einstein, according
to Feyerabend, could not have been achieved within positivist empiricism’s method of
confirmation.392 Contrary to the popular regard of Galileo as a paradigm empiricist, who
rejected the empty speculations of the Aristotelians and based his own laws upon facts
which he carefully collected, Feyerabend argues that the observational-theoretical
dichotomy was not well maintained by either school of thought. In fact, the Aristotelians
engaged in observational experimentation, while the Copernican thesis regarding the
earth’s trajectory was not yet supported by independent observational data at the time of
Galileo. Furthermore, the thesis was inconsistent with numerous facts and highly
conﬁrmed physical theories at the time. Thus modern physics did not originate, as many

empiricists claim, as a strictly observational enterprise, but rather as an observationally

unsupported speculation that was inconsistent with highly conﬁrmed laws.393 This

 

’89 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 926.

390 For example, see Horkheimer and Adomo (2002), malectic of enlightenment: Philosophical fragments.
39' F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, pp. 922-3.

392 F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 165.

393 Feyerabend (1964), "Realism and instrumentalism: Comments on the logic of factual support." "_l‘_h_e
critical approach: Essays in honogr of Key—Popper

124

characterization of modern physics’ genesis signiﬁcantly undermines the positivists’
maintenance of the observational-theoretical divide, which is thought to be a natural
extension of the empirical hypothesis that experience is the only true source and testing
ground of knowledge.394 F eyerabend’s numerous accounts of actual scientiﬁc practice395
demonstrate that modern science has always relied on both observational and theoretical
content in its developments and advances.

“Dogmatic petriﬁcation in the name of [observation and] experience” is
understood to occur because good empiricism requires the availability of many
alternative fully-developed theories to compare against the current theory in question,
rather than having only a single point of view stand up against the evidence of
experience. Theoretical adequacy involves not only its comparison with the facts but also
conﬁ'onting metaphysical alternatives. Far from circumventing empirical research,
metaphysical systems are “the only means at our disposal for examining those parts of
our knowledge which have already become observational and which are therefore
inaccessible to a criticism ‘on the basis of observation’.”396

A science that alleges to be free from metaphysics becomes a dogmatic
metaphysical system because it endorses theoretical monism and therefore limits its
procedure for ascertaining theoretical adequacy to an insufﬁciently critical observational

method. By making theory only responsible to “the facts”, it is the facts—in their

assumed autonomy—that dictate the need for theory change (i.e. when incompatible facts

 

’94 This hypothesis is refuted in Feyerabend (1980), "Science without experience." Challenges to
empiricism.

’95 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The cen_tral issues; Feyerabend (1964), "Realism and instrumentalism: Comments
on the logic of factual support." The critical approach: Essays in honou_r of Karl Popper; Feyerabend
(1981), Problems of empiricism.

”6 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues.

125

arise), yet a critical look at incompatible alternatives would make the scrutiny more
rigorous?97 This call for methodological pluralism stems from John Stuart Mill’s

programmatic for critical philosophy, found in On Liberty.398

Mill insisted that a society
that contains many traditions side-by-side has a superior means of judging each single
tradition than a monistic society. It also enhances both the equality of the traditions and
the maturity of its citizens, as we can learn a lot from, say, the indigenous cultures about
the care of the elderly, social organization, and anthropology. These alternative traditions
contrast our own in a way that we can reﬂect critically on our own habits and taken-for-
granted practices.399
Feyerabend proposes that not only is the autonomy of facts implausible, and
scientiﬁc inquiry undermined by such an assumption, but empirical investigation is in
fact furthered by metaphysical pluralism, as some facts cannot be unearthed without an
alternative theory. For instance, quantum theory is a highly adaptable theory, as many

apparent empirical inadequacies can be accounted for in an ad hoc manner by adding

suitable mathematical Operators rather than recasting the whole structure.400 A refutation

 

”7 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The cenﬂl issues, p. 934.

39“ Mill (1989), "On liberty." On libel-g and other writings.

’99 For Feyerabend’s discussion on Mill, see Feyerabend (1981), "Two models of epistemic change: Mill
and Hegel." Problems of empiricism.

00 This has to do with the probabilistic nature of quantum mechanics, which stems from the act of
measurement. When a quantum system interacts with a measuring apparatus, their respective wave
functions become entangled, and so that the original quantum system ceases to exist as an independent
entity. 1n the formalism of quantum mechanics, the state of a system at a given time is described by a
complex wave function. This abstract mathematical object allow for the calculation of probabilities of
outcomes of concrete experiments. For example, it allows for the computation of the probability of ﬁnding
an electron in a particular region around the nucleus at a particular time. Unlike classical mechanics, one
cannot ever make simultaneous predictions of conjugal variables, such as position and momentum.
Electrons may be considered to be located somewhere within a region of space—a contour of probability or
“cloud” surrounding an atom’s nucleus—but their exact positions remain unknown. Faced with
unavoidable imprecision, mathematical modeling is used for computation in quantum mechanics.
Schrodinger ’s equation is a differential equation which describes the evolution of those wave functions that
characterize quantum particle when there is no force acting upon a particle. At this point, its potential

126

of the formalism of quantization would therefore demand proof to the effect that there is
no conceivable adjustment of the operators which makes the theory conform to a given
fact. Such a general statement can only be provided by an alternative theory.401
Therefore, Feyerabend suggests, empiricism severely limits its empirical investigation
when it subscribes to a reductionist consistency condition.402

Empiricism demands that the empirical content of our knowledge be increased as
much as possible and therefore the invention of alternatives is argued by Feyerabend to
constitute an essential part of the empirical method.403 The consistency condition, which
eliminates alternative theories, and the sole reliance on observation and experience as
“facts” to test a theory’s adequacy, are anti-empiricist since they hinder the grth of
empirical knowledge. Speciﬁcally, the refusal to consider alternatives can result in the
elimination of potentially refuting facts.4°” Furthermore, lack of fully developed
theoretical alternatives can lead to theory reiﬁcation, as the elimination of facts reinforces
the seeming uniqueness and truth of the current theory.405

Because many facts only become available with the help of alternative theories,406

 

energy is zero and the Schrbdinger equation for the particle can be exactly solved. The solution to this 'free'
particle can provide a useful way to ﬁnd approximate solutions to problems which otherwise could not be
easily solved.
40' F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues. p. 948. This alternative theory must of course be detailed enough
to allow for independent and crucial tests (see p. 187 of the same text).
402 The consistency condition eliminates alternative theories that are in disagreement with current scientiﬁc
knowledge (as they are deemed to be “theoretically implausible”). This method, while efﬁcacious, is
problematic in its assumption that the facts provide all of the testing that a theory needs.

3 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 936.
’04 F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 937.
’05 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues. p. 937.
4°” Postcolonial science studies similarly endorse such a position in the suggestion that there are laws of
nature that today’s‘modem sciences are ill-designed to discover. See, for example, Harding (1998), la
science multicrLural? Postcolonialisms, feminisms, and epistemologies.

127

and because these facts could potentially expose the faults, or even irreparable
inadequacy, of the current going theory, alternative theories are, therefore, the most
rigorous challenges available. Furthermore, Feyerabend proposes that this is precisely
the method which brought about such spectacular advances of knowledge as the
Copernican Revolution, and the transitions to both relativity and to quantum theory.407
Feyerabend advises the “good empiricist” not to “rest content with the theory that
is in the centre of attention and with those tests of the theory which can be carried out in a
direct manner.”408 The best critical tests for theory are produced with the help of
alternatives, and therefore the good empiricist should try to invent such alternatives.409
The elimination of metaphysics does not increase empirical content, but rather decreases
it and potentially turns theories into dogma. A good empiricist must therefore be a
critical metaphysician.“0
Similar to Feyerabend, Longino’” argues that the fact that evidence gains its
credibility or relevance from the context of inquiry and by background beliefs does not
make science relative. Even though science is socially constructed, it already has good
procedure for achieving objectivity. The integrity of empiricism no longer rests on the
neutrality of our observations, as Longino proposes a social conception of objectivity and

a contextual understanding of evidence, neither of which relies on a neutrality criterion.

The fact that evidential relations depend on the subjective beliefs of the individual

 

’07 See Feyerabend ( 1964), "Realism and instrumentalism: Comments on the logic of factual support." 113
critical approach: Essays in honou_r of Karl Popper

40’ F eyerabend ( 1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 943.

’09 F eyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 943.

"0 Feyerabend (1998), "How to be a good empiricist: A plea for tolerance in matters epistemological."
Philosophy of science: The central issues, p. 944.

4” Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry.

128

researcher is not incompatible with scientiﬁc objectivity when one recognizes that
scientiﬁc knowledge is the product of a community of scientists and. that evidence does
not need to be context- or value-free.

In her “contextual analysis of evidence”,412 Longino distinguishes between
constitutive values and contextual values and argues that values are only a problem for
scientiﬁc objectivity when scientists’ (inescapable) contextual values— the social and
practical interests that form background beliefs—ftmction as the constitutive or cognitive
values that determine what counts as good scientiﬁc judgment. When contextual values
are recognized as contextual values, we can identify these background beliefs
independently and demonstrate how certain states of affairs have been rightly or wrongly
taken as evidence for a hypothesis. Such processes are social and public, for they depend
upon a scientiﬁc community sharing a common language with which to describe
experience and intersubjective agreement that screens lollt idiosyncratic and subjective .

elements.“3

Most importantly, since the scientiﬁc community rather than the individual
scientist is the knower, enhanced attention to the role of criticism is crucial for
overcoming power imbalances within such a community that can result in the devaluation
of legitimate criticisms."l4
Longino and other proponents of the social view of science argue that scientiﬁc
progress requires two practices: (i) the widespread testing of theoretical hypotheses to

conﬁrm or invalidate current understandings, and (ii) the challenging of widely held

background assumptions. Most scientists engage in the ﬁrst type of activity, and the

 

412 See chapter 3 of Longino (1990), Science as social knowledge: Values and obiectivity in scientiﬁc
ingujgy.

413 Longino (1990), Science as m1 knowledge: Values and obiectivity in scientiﬁc inquiry, pp. 40-48.
“4 Longino (1990), Science as sogal knowledge: Values and obiectivity in scientiﬁc inquiry, p. 79.

 

129

second needs more engagement and a more diverse community of scientists to be done
effectively. Because science is understood to be an inherently self-critical activity that
welcomes collegial debate as a core practice, objectivity is gained by the communicative
practice of admitting a wide variety of assumptions and practices to critical investigation
by all qualiﬁed members of the community. It is in this respect that objectivity is social.
Scientiﬁc knowledge is therefore social knowledge. As such, it emerges through a
process of criticism, such as peer review, based on shared community standards.415 The
social nature of objectivity does not guarantee that science will be free from all subjective
preference, but if certain criteria are met—she lists four: (i) recognized avenues for
criticism; (ii) shared standards; (iii) community response; (iv) equality of intellectual

authority—science will be objective to that extent.416

Thus science can be objective if its
social organization permits and encourages criticism of its beliefs. Furthermore,
objectivity depends not on the methodological rules by which individuals judge and
select hypotheses, but on the way that the scientiﬁc community is organized. Longino
argues that successfully challenging widely held background assumptions requires a
culturally diverse community of scientists, as “alternative” perspectives can help
illuminate problems with assumptions that appear “natural” and unproblematic to those
who share the prevailing cultural perspective. These marginal perspectives are not

thought to be privileged in the sense of being closer to the truth. However the position as

“outsider” makes one more likely to perceive problematic aspects of the background

 

"5 Longino (1990), Science as social knowledge: Values and obiectivity in scientiﬁc inquiry, p. 69. She
calls this “contextual objectivity”.
“6 Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry, pp. 76-80.

130

assumptions.417 By bringing the dominant culture’s background assumptions into critical
view, alternative perspectives are supposed to facilitate correction of implicit errors, and
those modiﬁcations ultimately result in more reliable scientiﬁc theories. The neutrality
thesis is therefore challenged, as Longino claims that it is mistaken to assume that
contextual values necessarily compromise the objectivity of science.

Drawing from both Longino and F eyerabend, we see that the antifoundationalist
program, in the end, entails a picture of empirical science as a self-critical activity that
does not require the neutrality of observations (and therefore can accommodate the
“theory ladenness” of observations). Longino’s social view of science emphasizes the
sociality of the pursuit of knowledge, as it is practiced in cooperation with others in the
context of a set of shared background assumptions and according to shared beliefs about
appropriate method. Central to these background beliefs and values of science is a self-
critical picture of science that welcomes collegial debate as a core practice and is rigorous
and thorough in its attempts to test hypotheses and evaluate interpretations. F eyerabend
expands on the actual practices of a critical science, suggesting that it is metaphysical
inquiry and not the elimination of metaphysics (in favour of objective observational
methods) that increases empirical knowledge. The theory-ladenness of observation is
therefore not a challenge to the plausibility of empiricism, but testimony to the actual
nature of objective scientiﬁc practice as critical metaphysics. This thesis is partly
normative, as it suggests that the foundationalist picture ought to be abandoned for being
both inaccurate and misleading. Similarly, “evidence based” has been found to entail a

questionable and seemingly innocuous technique of deferral to the evidence that obscures

 

“7 Here, Longino’s position sounds very similar to standpoint theory. See Harding, ed. (1993). Rethinking
standpoint apistemology: What is strong obiectivity?; Harding, ed. (2004). The feminist standpoinjphceow
reader; Quine (1981), "On the very idea of a third dogma." Theories and things.

131

the multiple and complex considerations that unavoidably go into health care decision-
making.
Widening Evidence: Antifoundationalist and Holistic Accounts of Evidence

So far, attention has been given to a critical account of science. However our
interest is in the conﬁguration of evidence that arises out of the antifoundationalist

epistemological purview. Longino’s4 ’ 8

contextualized analysis of evidence is one source,
where she draws from her social account of science to argue that background
assumptions must be acknowledged in evidential reasoning. Longino proposes that
contextual values play an active role not just in the context of discovery, but also in the
context of justiﬁcation.“9 Given that theory is always underdetermined —that is, theory
choice is always based on something more than the data—an accurate theory of evidence
must include the role of contextual values in mediating from data to theory.420
Longino’s move of widening evidence to include background beliefs into the
evidential equation is characteristic of the antifoundationalism of critical science studies
in its contestation of the possibility of value-free objectivity. What counts as evidence is
understood to be conditioned by sets of beliefs which cannot be neatly disentangled into
so-called “factual” and “evaluative” categories. The antifoundationalist call for self-
critical and anti-dogmatic science has been taken up by many within critical science
studies via naturalized and pragmatic approaches—thus making Quine an important

ﬁgure—as both naturalism and pragmatism are thought to be unassuming in their

methods of empirical investigation by offering no prior established theoretical

 

“8 Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry.

“9 This claim about contextual value is similar to Kuhn’s on paradigms. Kuhn (1996), The structure of
scientiﬁc revolutions.

’20 Longino (1990), Science as social knowledge: Values and objectivip/ in scientiﬁc inquiry, p. 57.

132

99 421

3

commitments. Such an evidentiary account is offered in “A Question of Evidence
where Lynn Nelson outlines a naturalized422 and holistic conﬁguration of evidence. By
Nelson’s account, standards of evidence emerge within the processes through which we
generate knowledge; these processes have been demonstrated by feminist epistemologists
to be numerous and diverse in their origins from broad sources of experience and
understanding that extend well beyond the traditional scope of analytic epistemology.423
The naturalized view of epistemology endorsed by Nelson424 views knowledge
production as radically interdependent with other knowledges and undertakings. Nelson
proposes that just as individual theories are thought to neither develop nor face
experience in isolation, empirical evidence should be similarly contextualized. The
relevant evidence available to us is in fact broader in scope than previously
acknowledged and includes such factors as our going theories, assumptions, projects, and
values. This view of evidence is holistic in its inclusive scope, as it does not erect
artiﬁcial boundaries between politics and science, and recognizes a broad system of
theories and practices, including those of science, “everyday” experiences and events,
and politics, as constituting part of the evidence for reasonable beliefs. This account is
also naturalistic, for the expansion of evidence to include such factors as politics has

emerged concomitantly with feminist experience and knowledge.

 

42' Nelson (1993), "A question of evidence." Hypatia 8(2).

’22 By “naturalism”, 1 refer to naturalistic epistemology, an approach to the theory of knowledge that
emphasizes the application of methods, results, and theories from the empirical sciences. It contrasts with
approaches that emphasize a priori conceptual analysis or ignore scientiﬁc insight into cognition. Quine is
credited with initiating the contemporary wave of naturalistic epistemology with his essay, “Epistemology
Naturalized.” In that essay, he argues for conceiving epistemology as a “chapter of psychology,” and for
seeing epistemology and empirical science as containing and constraining one another. See Quine (1998),
"Epistemology naturalized." Epistemology: The big questions.

423 See Alcoff and Potter, eds. (1993), Feminist epistemologies.

’24 Nelson (1990), Who knows: From Ouine to feminist empiricism: Nelson (1993), "Epistemological
communities." Feminist epistemologies; Nelson (1993), "A question of evidence." Hypatia 8(2).

 

133

Feminist science studies have demonstrated that the experiences and knowledge
that we bring to bear on scientiﬁc theorizing will include those shaped by such social
relations of gender, race, and class that characterize our society. Furthermore, stricter
methodological controls cannot (and should not) “ﬁlter out” these factors and
relationships.425 Within epistemology, the call for more authentic accounts of the
connections between knowledge and sociopolitical relations426 broadens the factors
relevant to our knowledge and undertakings (including science) to encompass social
relations, politics, values, and other factors long regarded as a threat to objectivity, if not
the very antithesis to evidence.

To demonstrate the workings of this holistic account of evidence, Nelson provides
the example of subatomic particles, which are never observed directly yet are regarded in
physics as real entities. Their existence is inferred from the detectable electromagnetic
“tracks” left from collisions by particles in a high-tech detector. What supports the view
that electromagnetic tracks and debris are evidence of new subatomic particles is a body
of theory, accepted practices, and methodological commitments in physics, mathematics,
and technology. Furthermore, a theory that posits subatomic particles is supported in part
by so-called “common sense” knowledge of macroscopic objects and events, such as
what happens when these objects collide at high speeds. It is only by analogy that the
instrument readings within the detector can offer explanation of particle movement and

therefore evidence for subatomic particles. There is also the further presumption of broad

 

’25 Harding (1986), The science question in feminism; Harding (1991), Whose science? Whose
knowledge? Thinking from women's lives; Longino (1990), Science as social knowledge: Values and
olaiectivity in scientiﬁc inquiry; Nelson (1990), Who knows: From Quine to feminist empiricism; Tuana,
ed. (1989). Feminism and science: Seigfried (1990), "Second sex: second thoughts." Hypatia reborn:
Essays in feminist @ilosophy.

’26 For example, Nelson (1990), Who knows: From Quine to feminist empiricism, p. 49.

134

metaphysical commitments such as the existence of objects and events that are not
directly observable, the belief that these objects explain systematically what happens on
the macroscopic level, and the notion that macroscopic events like instrument readings
are evidence of this.

This is one example illustrating that the theories, methods, and commitments that
have emerged as supportive of knowledge claims about subatomic particles — some
within science and some of broader reach—constitute a larger part of the evidence for
those claims.427 According to coherentist theories of knowledge, knowledge claims ﬁt

”428

within a “web of beliefs where each theory, practice, or other broad epistemological

commitment serves as a “piece” supporting (serving as evidence for) and being supported

429

by others. Knowledge about subatomic particles is not isolatable from a larger system

of theories, practices, and standards of evidence. Hence there is no discrete piece of
evidence that warrants them.430
Feminist philosophers have paid signiﬁcant attention to science because they
recognize political stakes in knowledge. The exclusions and harms that have been
suffered by women in the name of science underscore the need for normative content in
feminist revisioning of science. Nelson points out that her account of evidence manages

to underwrite certain important themes from feminist scholarship: ﬁrst, that knowledge is

socially constructed but still constrained by empirical evidence, and second, that social

 

427 See also Nelson (1993), "Epistemological communities." Feminist epistemologies.

’28 Quine (1960), Word and obiect.

‘29 Quine (1960), Word and obiect.

43° Further justiﬁcation will need to be given, of course, to support the feminist science studies’ claim that
that gender shapes theory formation. The presumption listed above in the example of particle physics,
namely that there are non-observable events, is rationally supportable, while presumptions based on
existing gender relationships, in contrast, are presumably not rationally defensible. The justiﬁcation of this
feminist claim will be discussed by example of “man-the-hunter” versus “woman-gatherer” archaeological
theories in the next chapter.

135

relations, including gender, race, and class, are epistemologically signiﬁcant. This view
from here rather than nowhere denies the possibility of observational evidence being
“given” or pretheoretical; the empirical or sensory underpinning also protects against
what Nelson regards (unfairly, I think) as the postmodern view from anywhere.43 '
Without pretheoretic notions of evidence, standards, or methods laid down prior
to theory construction to explain and predict experience, notions and standards of
evidence emerge within and concomitantly with the unfolding of our various
epistemological projects in daily life, science, philosophy, or politics. Pragmatism is also
associated with Quine, and it involves a rejection of foundationalism and a commitment
to the empiricist position that that evidence is ultimately sensory. In naturalized accounts
of epistemology, the property at issue is not truth, but justiﬁcation by the empirical
evidence (as reasonable belief is not derived from unshakable foundations or certitude).
This is why Quine understands empiricism to be a theory of evidence and not a theory of
truth.432 Critics such as Clough maintain that because naturalized epistemology is still
philosophically normative, the distinction between truth and justiﬁcation is difﬁcult to
maintain‘m—this point will become clearer as we progress with the argument. Quine’s
naturalized empiricism permits this theory of evidence only “after physics, physiology,

and psychology, not before,”434

and is supposed to support the position that all
knowledge is socially constructed while precluding wholesale scepticism about evidence

by permitting a robust realism regarding the existence of an independent external world.

Naturalism reconciles the “barren scene” of social constructivism with an “unswerving

 

43' Nelson (1993), "A question of evidence." Hypatia 8(2), p. 173; Nelson (1990), Who knows: From
Qaine to feminist empiricism, p. 42.

432 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 172.

’33 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 9.

43" Quine (1966), "On mental entities." The ways ofypar_adox and other essays, p. 212.

 

 

136

belief in external things - people, nerve endings, sticks, stones. . . .” by recognizing that “it
is within science itself, and not in some prior philosophy that reality is to be identiﬁed
and described.”435

This coherence theory of evidence is therefore supposed to retain the normativity
that is commonly thought to be lost when the one-to-one correspondence of theory and
the world is denied. Nelson demonstrates, for example, that this account provides
stronger support for the feminist charges of sexist bias within mainstream science. The

”’37 claims that research into sex-

evidence supporting Ruth Bleier436 and other feminists
differentiated lateralization is unwarranted, for instance, is no longer limited to
methodological ﬂaws and sloppy androcentric assumptions that are incorporated into the
research, but also includes the historical context of the suspicious fascination within the
sciences to study or establish sex differences, the history of dubious biologically-based
explanations invoked to explain women’s cognitive inferiority and lower social status,
and the political implications of how this interest in sex difference research intensiﬁes
during periods of public debates about women’s status and social position.438 This
example strongly supports the fundamental point running through the critical perspectives
discussed above: the broadening of the scope of relevant evidence does not render it
arbitrary or unable to be evaluated. While there is no simple formula for distinguishing

viable theories or research programs for nonviable ones, the inevitable need for extensive

and multifaceted evaluation does not amount to relativism.

 

’35 Quine (1981), "Things and their place in theories." Theories and things, p. 21.

’36 Bleier (1984), Science and gender.

437 Longino (1990), Science as social knowledge: Values and obiectivity in scientiﬁc inquig; Nelson
(1990), Who knows: From Quine to feminist empiricism.

433 Nelson (1993), "A question of evidence." Hypatia 8(2), pp. 183-184.

 

137

Antifoundationalism, Evidence, and the Problem of Relativism

Despite Nelson and Longino’s claims to the contrary, Clough439

argues that the
critical science studies literature has relativized evidence. She maintains that regardless
of whether one posits a priori or concludes a posteriori (through naturalized inquiry) the
existence of an independent external world, a separation between “the objective” and “the

social” (or “content” and “scheme”) is created,440

and this metaphysical gap hinders our
ability to rethink evidence. The methodological holism found in critical science studies
highlights the interrelatedness of content and scheme. However, it still holds them to be
distinct entities, as seen in the postpositivist position that we always comprehend the
world through language, culture, ﬁlters, or standpoints.441 The demonstration by post-
positivists that the divide between the objective and the social world is insurmountable
(that is, our interpretive lenses block access to “the real”) properly reigns in the
overstated veritistic capacity of empiricism by classical and positivist empiricists, yet
opens up the persistent problem of relativism with respect to effecting normativity in
science, as theory choice now becomes relative to worldview. In this framework,

political preferences alone support the selection of feminist over androcentric explanatory

theories in science. Global scepticism is also made coherent within the

 

’39 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies; Clough
(2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist epistemology." Siblings

under the skin: Feminism, social justice and analﬂic philosophy

“0 Davidson refers to this phenomenon as “representationalism” in Davidson (2003), "A coherence theory
of truth." Siblings under the skin: Feminisms. social justice and analytic philosophy

4‘" The concept of explanatory or interpretive ﬁlters is puzzling to some (myself included). James L.
Nelson has asked: if these ﬁlters allow us to comprehend the world, how is it that we comprehend the
presence and content of these ﬁlters themselves? Is a meta-ﬁlter required or do we simply understand the
ﬁlter through the ﬁlters we have. If it is the latter, then our ﬁlters are apparently transparent with respect to
ﬁlters. Therefore, we really do see through ﬁlters that all seeing goes through ﬁlters and we really can
understand what’s true about ﬁlters, even though we can only know ﬁlters through ﬁlters. (Private
correspondence with James L. Nelson, May 2006)

138

representationalist framework. What results is “a hasty retreat from evidence”,442 where

our inescapably ﬁltered access to reality forces us to attend to the epistemic virtues and
worldviews that we want science to uphold rather than investigating and interrogating
evidence itself.

The popular position within critical science studies seems to be that once we
recognize an uninterrogated conception of empirical adequacy to be insufﬁcient to act as
a criterion of theory choice, we need to pay attention to what epistemological virtues we
want our theories to additionally display.443 Feminist epistemologists of science seize
this important opportunity, as it is here that it is possible for our philosophy of science to
be explicitly politicized, and cognitive and social aims brought into play to ensure that
our scientiﬁc narratives are answerable to the evaluations and commitments of the
communities they serve.444

Clough charges critical science studies with an inappropriate reliance on
empiricist epistemology,445 where foundationalism has been identiﬁed as the problem in
the devastating critiques of classical and positivist empiricism while the empiricist core
has been retained. Feyerabend and Longino certainly followed this course, as their
critical accounts of scientiﬁc practice interrogated the inﬂuence of the subjective (society,

culture, theory, etc.) on the integrity of scientiﬁc investigation without challenging the

 

“2 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
Epistemology." Siblings under the skin: Feminism. social iustice and analytic philosoplnt

See, for example, Harding (1991), Whose science? Whose knowledge? Thinking from women's lives;
Longino (1990), Science as social knowledge: Values and obiectivity in scientiﬁc inqyuiry; Code (1993),
"Taking subjectivity into account." Feminist epistemologies. The notion of epistemic virtues does not,
however, seem to originate with the postpositivist turn in science studies. Scientists and philosophers of
scientists had long encouraged such virtues as “simplicity” and “repeatability” in scientiﬁc practice.
4‘“ Lennon (1998), "Natural sciences." A companion to feminist philosophy, p. 192.
“5 Lynn Nelson has correctly pointed out that many of the critiques of empiricism focus on “naive”
(classical or positivist) forms of empiricism and not the contemporary reformulations inspired by Quine.
When 1 address “empiricism”, I refer to features of this epistemology that are present in foundationalist and
nonfoundationalist accounts (such as feminist empiricism).

 

139

empiricist-realist thesis of an independent external world of facts and evidence. I propose
that this serves to explain why postpositivist critiques of science are so capable of
pointing to major ﬂaws in EBM by undermining the positivist notion of evidence
underlying the approach (see chapters one and two), yet fall short in providing an
alternative conception of evidence that corrects the deﬁciencies of EBM. In the context
of EBM, the evidence based approach has been criticized for valuing the quantitative at
the expense of the qualitative, and the aggregate over the personal. However, Clough’s
thesis proposes that many contemporary antifoundationalist epistemologies in fact
inadvertently support this evidentiary preferencing, as they do not contest the framework
in which the qualitative and the personal are less reliable or are relative.

h446

Cloug argues that because foundationalism is the sole critical focus, the

situation arises where while evidence is at issue in post-positivist critiques, attention is
deﬂected instead to such foundationalist concepts as “objectivity”, “observation”,
“experience”, and “epistemic individualism”. “Evidence” is seen as safely empiricist and
therefore does not receive the attention that the foundationalist concepts just mentioned
do. Therefore it is not rigorously rethought. She proposes that when antifoundationalists
dispute objectivism by claiming that no one can access the “real” world unbiased by
one’s cultural presuppositions or interpretive lenses, they make a troubling move: they
accept the empiricist presupposition that interpretation is the barrier to the real/true. Thus
they retain the empiricist-realist dualism between “the social” (theories, worldviews, etc.)

and the physical world. This division between the world and the worldview supports the

evidence based approach’s reductive understanding of evidence by hindering the

 

4’6 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies; Clough
(2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist epistemology." Siblings

under the skin: Feminism, social justice and analytic philosophy.

 

140

possibility of meaningful alternatives. The problem of relativism hinders consideration
into the interpretive features of evidence and the truth—value of anecdotal and testimonial
evidence.

I propose that this charge of a “hasty retreat from the evidence” extends even to
Longino’s and Nelson’s efforts to retheorize evidence, as their epistemic commitments
narrow their ability to rethink and challenge the concept. In the end, they produce not
much more than inclusive accounts of evidence that fail to offer much to the EBM
debate. Both Longino and Nelson exhibit the representationalism that Clough regards as
promoting relativism. Indeed, Longino even admits that her position relativizes
evidence.447 To begin with Longino’s contextual analysis of evidence, Longino explains
that background assumptions must be included in our conception of evidence because
“explanatory models serve as background assumptions against which data are ordered, in
light of which data are given status as evidence for particular hypotheses and as a context
within which studies gain signiﬁcance.”448 This separation of content (“data”) and
scheme (“explanatory models”) in Longino’s exegesis of evidence indeed leads, by the
author’s own admission, to the relativism of evidence. She admits that her disavowal of a
direct correspondence between theory and evidence relativizes what counts as evidence,

and that “by relativizing what counts as evidence to background beliefs or assumptions,

 

’47 Standpoint theory encounters the same problem, as the proposal that all beliefs are ﬁltered through the
social standpoint of the believer forces theorists like Harding to disavow the claim that the standpoints of
women or feminists will produce true beliefs about reality—just less partial and less distorted ones than
those produced by “anti-liberatory interests” (p. 185 of Harding (1991), Whose science? Whose
knowledge? Thinking from women's lives. See also Harding, ed. (1993). Rethinking standpoint
epistemology: What is strong oljectivity?) Since values cannot be separated from science, many feminist
thinkers recommend that we need to consider which values ought to enter. This prescription is somewhat
tenuous and feminist epistemologists not surprisingly ﬁnd themselves defending their claims ﬁ'om
criticisms of relativism.

“8 Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry. p. 195.

141

hypothesis acceptance on the basis of evidence is also relativized.”449 In this admission,
correspondence remains the ideal sort of relation to bridge the metaphysical gap between
the world and us, yet the promise of theory-independent standards of evaluations is
unreachable. She adds that “in the absence of that clear and distinct perception of the
truth of assumptions. . .the choice of background assumptions is as relative as the
determination of evidential relations.”450

In light of such a grim prognosis for science, Longino’s refusal to abandon
objectivity seems courageous. In chapter four of Science as Social Knowledge, she
introduces a restricted notion of “contextual” objectivity that, she claims, avoids the
pitfalls of relativism and scepticism by being relative to the social dynamics of various
science communities. She argues that the role of background assumptions in evidential
reasoning

is grounds for unbridled relativism only in the context of an individualist

conception of scientiﬁc method and scientiﬁc knowledge. If our

conception of the methods of knowledge construction in science is

broadened to embrace the social activities of evidential and conceptual

criticism, we see how individual subjective preferences are minimized in

the ﬁnal products.45 1
In the end, her call for more democratic science, that is, the expansion of the scientiﬁc
community to include more diverse perspectives, is somewhat uninspiring, as it offers a
far weaker substitute for scientiﬁc evidence’s now discredited rigorous adjudicative
ability. Objectivity for Longino is “by degree”—it is the least subjective method for

judging which conceptual schemes, ﬁlters, and interpretive frameworks make for the

least opaque ﬁlter between us and the world. Clough argues that within this framework

 

“9 Longino (1990), Science as socijal knowledge: Values and obiectivity in scientiﬁc inquirv. p. 61.
45° Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry, p. 61.
’5' Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry, p. 216.

 

142

of contextual objectivity, global scepticism looms, as the possibility that all
representations may be unbridgeable must be entertained.452

Nelson also commits to a representationalist metaphysics when she makes the
claim that “we experience the world through the lens of our going theories.”453 Her
representationalism is tied into her naturalism: “our collective experience indicates that
nature is a point of resistance with which we need to contend, and the hypothesis that
there is a world that constrains what is reasonable to believe is woven through most of
our theories because it makes the most sense of what we experience.”454 Using the
language of “lenses”, Nelson, like Longino, proposes that our subjective conceptual
schemes ﬁlter our gathering of evidence in belief acquisition. This presumes a
representationalist scheme where “the evidence” and our feminist “political values”
emanate from two metaphysically separate spheres: the objective external world and the
subjective internal mind.

It is, therefore, somewhat surprising that Nelson’s difﬁculty with the
correspondence theory of truth is the very representationalism that Davidson ﬁnds in
Quine (and, by extension, Quineans like Nelson). Correspondence, Nelson writes, is
“beset with problems. Not the least of these is that correspondence presumes a dualism

(19455

of ‘organizing schemes and that which is waiting to be organize 3’456 According to

 

’52 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the skin: Feminism, social justice and analytic philosophy, p. 100. To
continue the previous comments regarding the puzzling nature of conceptual ﬁlters (see nn. 441), it remains
unclear how it is that Longino (and her allies in critical science studies) can know what makes a ﬁlter more
or less opaque. What is the epistemic character of the evidence they use to support their assessment of the
opacity or otherwise of their ﬁlters? (Personal correspondence with James L. Nelson, May 2006).

4 3 Nelson (1990), Who knows: From Quine to feminist empiricism, p. 112.

Nelson (1993), "A question of evidence." Hypatia 8(2), p. 176.

4” Davidson (1974), "On the very idea of a conceptual scheme." Proceedings and addresses of the
American Philosophical Association.

’56 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 176.

 

454

143

Clough’s Davidsonian account, Nelson’s coherence theory of evidence repeats the same
offence. It is ironic that Nelson promotes the empiricist framework as best suited for
feminist science scholarship because empiricism is supposed to save social
constructivism from the problem of relativism.457 The postpositivist admission that we
can never access the real (due to the theory-ladenness of observational evidence) invites
scepticism regarding the justiﬁcation of knowledge claims.458 Sensory experience is
thought to assist with the problem of relativism by limiting what counts as reasonable
belief.459 In this antifoundationalist formulation, empirical adequacy no longer acts as the
criterion for theory choice, but rather as a constraint on our creative theory production.
Clough indicts the representationalism underlying feminist empiricism as inviting
sceptical doubt and undermining feminist advances in science studies.

Rethinking the Evidence of EBM

 

The difﬁculty with the antifoundationalist broadening of the standards of evidence
is that the radical holism promoted by critical science studies diminishes the relevance of
evidence in medical decisionmaking. While social critique effectively humbles us in our
knowledge pursuing activities, it often leaves us without guidance on what to believe.
The task of epistemology is to investigate what normative criteria might be used to
adjudicate between competing knowledge claims, and these widened accounts of
evidence offer a fairly open-ended answer: all data and relevant (however deﬁned)
background assumptions, including political values. Rather than residing solely in the

factual, evidence now straddles two metaphysically distinct spheres, which leads to

 

457

Nelson (1993), "A question of evidence." Hypatia 8(2), p. 174.

”8 Knowledge claims can, at best, be deemed trustworthy through democratic debate or comparison to
alternatives.

’59 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 174.

144

challenges in application. Evidence's normative ability is presumably lessened by the
increased complexity of the concept, as there will undoubtedly be disputes regarding
what factors get included into any given evidentiary analysis. While a pre-graded
hierarchy of evidence is not the solution (Nelson would call the desire for such certainty
of be an “article of faith”460), these accounts of evidence do not seem to offer much for
furthering the debates in EBM. Instead of offering a more nuanced concept of evidence
for use in medical decisionmaking, these holistic accounts may instead confound such
decision-making efforts. In applying this theory of evidence, how do we adjudicate
between competing claims regarding what constitutes relevant epistemic criteria? If
broadening the community of knowers makes this response less subjective, how broad
must that community be? While these questions may be necessary and worth the effort
of pursuing, we must acknowledge that we have moved far away from the questions
about therapeutic efﬁcacy that EBM is interested in."’61

Yet, as we direct our search for more prescriptive accounts of evidence that
support the clinical context, we do not want to fall (back) into pernicious scientism. Thus
it important not to lose the valuable negative project, namely the demonstration of EBM’s
untenable evidence base discussed in chapter three. Any workable alternative account of
evidence must not undermine the important critical insight offered by postpositivist and
antifoundationalist insight into science studies.
In Conclusion

By not questioning the inescapable separation of “the objective” and “the social”

in empiricism (and not just positivism), the question of evidence leaves

 

“’0 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 181; Nelson (1993), "Epistemological

communities." Feminist epistemologies, p. 133.
46' Clinicians also need fast and clear methodologies to keep up with the demanding pace of clinical care.

145

antifoundationalist theorists with the following conundrum: while it is positivist (and,
therefore, problematic) to think that evidence can resolve the uncertainties that
accompany medical practice, we are left with the predicament where anything less than
the one-to-one correspondence relativizes evidence. Even holistic conceptions of
evidence retain the metaphysical gap between the world and our worldviews. Because
we cannot access the real or unﬁltered world, we are forced to attend to the ﬁlters in our
justiﬁcatory practices. This drives us away from evidence question. Post-positivist
critiques invest their energies into non-evidentiary considerations and leave “the evidence
question” untouched for the most part.462

While answerability of theory to evidence remains central to critical scientiﬁc
inquiry, this postpositivist widening of what counts as evidence creates challenges for
application, as the range of epistemological virtues that our sciences should promote in
addition to empirical adequacy is highly contested. This challenge forces attention to the
constitution of scientiﬁc communities by whose practices these virtues become
established. For Nelson, our assessment of evidence is a communal enterprise, and “my
claims to know are subject to knowledge and standards constructed by the various
communities of which I am a member.”463 For Longino,464 such a community must
contain diversity to enable the background assumptions, against which an assessment of
relevant evidence is made, to be visible. Even for standpoint theorists like Harding,465

attention to the perspectives of those who have been marginal in the production of

 

’62 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." iblings under the skin: Feminism, social justice and analytic philosophy.

4 3 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 186.

46’ Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry; Longino
(1993), "Subjects, power, and knowledge: Description and prescription in feminist philosophies of

science." Feminist epistemologies.
’65 Harding (1991), Whose science? Whose knowledge? Thinking from women's lives.

 

146

knowledge brings into relief sources of evidence invisible to dominant groups, makes
explicit background assumptions which are otherwise taken for granted, and exposes
ideological structuring of narratives. What is shared here is the “hasty retreat from
evidence”, where investigating what counts as evidence requires us to attend to
considerations other than the evidence, such as the makeup of epistemic communities.
The postpositivist theorists discussed in this chapter presumably do not see the
relativism that they are inviting because it is an inherent feature of empiricist
epistemology, and not just positivism or foundationalism. In the end, the presumed
existence of an independent external world by empiricists supports EBM’s reductionist
understanding of evidence by hindering the possibility of meaningful alternatives. In the
next chapter, an alternative account of evidence will be forwarded that draws from
Donald Davidson’s work in the philosophy of language and Clough’s advancement of
Davidson’s nonrepresentationalist themes within the philosophy of science and
epistemology. It will be demonstrated that Davidson’s rejection of the scheme/content
divide permits evidence to be broadened beyond the current positivistic empiricist
framework, but without lapsing into the relativism seen among the postpositivist
positions examined thus far. Davidson’s nonrepresentationalism will then be deployed in

chapter six for a re-understanding of EBM and a rethinking of its critiques.

147

CHAPTER FIVE
Advancing Evidence: A Davidsonian Repair

After articulating the evidentiary relativism that arises out of the
antifoundationalist representationalism of critical science studies, Clough attempts to
salvage evidence by applying Davidson’s holistic model of language use to a theory of
meaning and evidence.466 Clough draws from Davidson’s theory of language an
evidentiary thesis that, like others in critical science studies, acknowledges the social and
contextual features of evidence,”’67 but avoids the problem of relativism by denying the
relativist use of the underdetermination thesis. This is the position that two opposing
theories are equally supported by the evidence and therefore theory choice depends on
nonevidential considerations like political commitments and subjective preferences.
Instead, no two theoretical beliefs can both conﬂict with each other in drastic ways and
have the same truth conditions. Davidson’s non-representationalist theory of evidence
will be outlined in this chapter and then demonstrated in the next chapter to be more
useful for resolving the evidentiary difﬁculties surrounding EBM than what has been
previously offered in critical science studies. Davidson’s position reclaims the
adjudicative force of evidence from relativism without promoting an untenable
objectivism, and so the framework is not only epistemically defensible but also clinically
useful and useable.

Davidson’s Model of Language Use
Davidson’s theory of evidence begins similarly to other postpositivist

epistemologies with respect to his denial of the objectivist view that sensory data can be

 

“’6 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the skin: Feminism, sociaLiustice and apalytic philosophy, pp. 102-110.

4 7 This is important to the overall EBM critique, because we are assured that the Davidson ﬁ'amework can
still support the critical perspectives offered by the postpositivist critique.

148

used to justify beliefs. Davidson distinguishes himself, however, by faulting this
positivist understanding of evidence for failing to incorporate our awareness of the
detection of sense data. Because this awareness is simply another belief, there is no
possibility for sensory data to stand as an evidential entity independent from our
beliefs.468

What separates Davidson from the other antifoundationalist views is that his
rejection of objectivism does not lead him to concede the relativism of evidence. Instead,
he retains a justiﬁcatory scheme for empirical beliefs by committing to a non-
representationalist metaphysics. Antifoundationalists like Longino and Nelson are
charged with supporting the representationalist claim about the belief-independence of
empirical evidence in their allegiance to the existence of cultural ﬁlters that block our
access to the real. By committing to the underdetermination of theory by evidence, and
claiming that adjudication between theories can only be made on the basis of our political
values, they presume a representationalist view that the “evidence” and our “political
values” emanate from two metaphysically distinct spheres—the ﬁrst from the objective,
external world and the second from the subjective internal mind(s). Davidson’s
metaphysical monism also avoids the metaphysically troubling “ﬁlter”, which is neither
empirical nor a belief.469

Davidson’s position that the marshalling of empirical evidence in support of a
belief or theory requires awareness 0f empirical evidence, and that awareness is itself
another belief, distinguishes him from representationalists because this account of

epistemic justiﬁcation does not involve an independent evidentiary entity that stands

 

’68 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 103.
469 See nn. 441 in the previous chapter.

149

outside of our belief system (to which we may or may not be able to directly appeal).
The evidence for a belief must itself be a belief, and so both our political values and our
more straightforwardly empirical commitments are beliefs of this evidential sort. On
Davidson’s model, even Longino and Nelson’s feminist political beliefs must have some
web-like relation to empirical evidence if they are to have any content.

Davidson invokes the concept of the “radical interpreter” as a device for
describing the condition of the possibility of interpretation and for furthering a model of
language use that provides a “reason for supposing most of our beliefs are true that is not
a form of evidence.”470 The reason is that detection of false beliefs requires that we have
a background of true beliefs against which the error of false beliefs can be measured.

The radical interpreter is a derivative of the “radical translator” ﬁrst introduced by
Quine‘m to explain the means of translation between mutually incomprehensible
languages. Quine argued that linguists might produce translation manuals with terms
which are empirically equivalent - they “pick out the same scattered portion of the world”
- yet incompatible in meaning. Therefore we can never be assured of success in
translation. In his famous example, we could never determine whether it was correct to
translate the word “gavagai”, used whenever a rabbit appears, as “rabbit” or as
“undetached rabbit part”. Being empirically equivalent, there is no further fact to decide
between them. Much like different translation manuals, our embedded view of the world
is relative to a frame of reference. Deciding among equivalent systems of the world turns

ﬁnally on pragmatic grounds such as simplicity, refutability, fecundity and generality

 

47° Davidson (2003), "A coherence theory of truth." Siblings under the skin: F eminisms, social justice and
analytic philosophy. p. 126.
47' Quine (1960), Word and object.

150

(and not transcendent metaphysics).472 In this thought experiment, we see the seeds of
the evidentiary relativism that concerns Clough: the notion of incomplete access to the
“real” provided by the available evidence leaves us in the predicament where
adjudication between theories or hypotheses require consideration of nonevidentiary
considerations or “frames of reference”.473 Davidson objects to the indeterminacy of
radical translation (where a single sentence must always be taken to have more than one
different meaning) proposed by Quine, and introduces the alternative and charitable
“radical interpreter” to avoid the scepticism regarding successful or accurate translation.
Like the radical translator, Davidson’s radical interpreter ﬁnds herself in a foreign
land where she must learn the language by observing the native speakers. Because the
speakers’ semantic content is not directly accessible to the radical interpreter,474 she
learns by watching for correlations between the types of sounds uttered by the speakers
and the kinds of events that prompt the utterances. At this early stage, she does not have
any preconceived notion of the particular semantic role that is played by any particular
noises uttered by the native speakers. Rather, it is the radical interpreter’s accurate
identiﬁcation of the environmental reference that prompted the native speakers’
utterances, which provides those noises with semantic content in the ﬁrst place.475

Language use develops at this early stage via a shared causal relationship between

the interpreter, the native speakers’ utterances, and the objects and events in the world

 

472 Feminist readings of Quine have added political grounds too. Nelson argues that this feminist addition
is consistent with Quine’s theoretical framework in Nelson (1990), Who knows: From Quine to feminist
empiricism.

473 This is the relativist use of the underdetermination thesis.

’74 Radical translation occurs when a linguist endeavors to translate a target language into her home
language without the beneﬁt of consultation with bilinguals. The linguist therefore has only observable
stimuli and responses to go on.

’75 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 104.
Davidson (2001), "Radical interpretation." Inquiries into truth and interpretation Lphilosophical essays of

Donald Davidson], pp. 125-39.

151

that prompt these utterances. What is also required is that the interpreter assmnes the
native speakers are speaking truthfully about their beliefs. While this does not guarantee
that the assertions are true, the assumption must be made that belief and truth correlate in
order for interpretation to occur. This “principle of charity”476 is regarded by Davidson
to be necessary because in order for the radical interpreter to identify her teachers as
having any beliefs, she must assume the beliefs they hold to be true. It is only once she
has established an empirical base of correlations between their sentences and hers that
she can start to make judgments of inconsistency and falsehood. Davidson undercuts
global scepticism by maintaining that before that point, identifying her teachers’ beliefs
as false would deplete the empirical base for which she needs to begin her interpretive
project in the ﬁrst place. Language and interpretation are founded on a coordinate of
shared meaning and this requires the charitable interpretation—the presumption in favour
of truth.477

If the principle of charity is a precursor for successful interpretation, this means
that truth must be held primitive for words and sentences to be meaningful. The meaning
of an utterance is given by its truth conditions, and not the reverse. The radical
interpreter is invoked to support Davidson’s extensionalist claim that in the simplest
cases of beliefs, the events and objects that cause those beliefs (the extension of the

beliefs) also determine their contents or meanings (the intension of the beliefs).478 This

means that in the simplest cases, there cannot be wholesale slippage between our

 

’76 Davidson (2003), "A coherence theory of truth." Siblings under tlLakin: Feminisms, sociaLiustice and
analjaic philosophy, p. 128.

’77 Davidson (2003), "A coherence theory of truth." Siblings under the skin: F eminisms, social justice and
analytic philosophy. p. 130.

’78 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the skin: Feminism. social justice and analytic philosophy. p. 105.

152

understanding the meaning of a sentence and our understanding of the conditions that
would make that sentence true. Most of our basic beliefs cannot be false because we do
not ﬁrst form concepts and then discover what they apply to; rather, in the basic cases,
the application determines the content of the concept.479 In these cases, the meaning of
the radical interpreter’s utterances is determined by their being used correctly in the
presence of another speaker and the event in the world that caused the utterance.

In response to Davidson’s position that most of our beliefs must be true, one
might insist that just because there must be agreement between the radical interpreter and
the native speakers about the truth of basic beliefs, this does not guarantee that those
beliefs are in fact true. The Davidsonian response is to examine the concept of truth
itself.480 The very concept of objective truth, he explains, comes from shared language;
unless a language is shared, there is no way to distinguish between using the language
correctly and using it incorrectly. Only communication with another can supply an
objective check. Communication, of course, only starts by assuming agreement on what

makes utterances true — the principle of charity.48'

 

’79 Davidson (1991), "Epistemology naturalized." Dialectica 45(2), p. 195.

’80 Davidson (2003), "A coherence theory of truth." Siblings under the akin: Feminisms, socyiarlylstice and
mlytic philosophy. p. 132.

48' For the sake of clarifying the different positions held by the logical positivists, Quine, and Davidson,
their different linguistic approaches to philosophical inquiry are worth highlighting. They are all part of
the “linguistic turn” in 20lh century analytic philosophy, where language and linguistic analysis came to be
seen as the primary tools for resolving philosophical problems. Both the members of the Vienna Circle and
Quine tend towards a linguistic “formalism” (although Quine greatly differs signiﬁcantly from the former
in his famous rejection of reductionism as the “second dogma” of modern empiricism), where philosophical
problems are resolved by forrnalizing the way in which philosophical statements are made. We have
already seen that logical positivism entails an idealized view of scientiﬁc knowledge (where all knowledge
is scientiﬁc knowledge), which originated in 19‘" century positivist thought. This scientism was coupled
with the ideal-language meta-philosophical and methodological current in 20th century analytic philosophy
(logical atomism). This union of idealized scientiﬁc knowledge and language is apparent in the veriﬁcation
theory of meaning, a novel way of dismissing certain non-scientiﬁc views by declaring them not merely
wrong or false, but meaningless. Along with (early) Wittgenstein, the logical positivists concluded that the
bulk of traditional philosophy consisted in meaningless pseudo-problems generated by the misuse of
language, and that the true role of philosophy was to establish and enforce the limits of meaningful

153

To claim that beliefs are by their nature generally true is to separate true belief
from what constitutes knowledge, as Davidson’s general presumption of truth does not
make beliefs “globally right”.482 What it does do is provide “the background against
which we can accuse them of error.”483 Davidson’s causal analysis of belief provides us
less-than-radical interpreters with a presumption in favor of the truth of any particular
belief, but not a guarantee. Davidson cheerfully admits that the truth of each particular
belief is up for grabs, though not all or even most of these beliefs can be up for grabs at
once. It is the veridicality of beliefs generally, as understood through his causal account,
that makes “meaningful disagreement” over particular beliefs possible.484 Our beliefs
have no content unless we have established a common convergence between ourselves,
another speaker (or speakers), and a shared environmental stimulus. We know that
because radical translation and interpretation is undertaken without the beneﬁt of
bilingual speakers, the linguist has only observable stimuli and responses to go on. The
most obvious utterances to begin translating are those that seem most tied to observable
events conspicuous to both the linguist and the native. Initial hypothesis testing will,

99 485

therefore, concern assent to and dissent from such “occasion sentences , which provide

the entry points for the desired convergence between speaker, interpreter, and the world.

 

language through linguistic analysis. In Wittgenstein’s Tractatus, the world is conceptualized as the
existence of certain states of affairs, all of which can be expressed in the language of ﬁrst-order predicate
logic. It follows that a fairly comprehensive picture of the world can be built up by expressing atomic facts
in atomic propositions, and linking them using logical operators. Davidson, in contrast, uses a naturalized
linguistic approach, where one comes to understand philosophical ideas by a close and careful examination
of the natural language used to express them — usually with some emphasis on the importance of common

sense in dealing with difﬁcult concepts—and not by examining the abstract logic of language.

’82 Davidson (2003), "A coherence theory of truth." Siblings under the skin: Feminisms, social justice and
analytic philosophy. p. 133.

’83 Davidson (2003), "A coherence theory of truth." Siblings under the skin: Feminisms, social justice and
analytic philosophy.

"’8’ Davidson (1974), "On the very idea of a conceptual scheme." Proceedings and addresses of the
American Philosophical Association.

“5 See §7-9 of Quine (1960), Wordjand obiect.

154

Once we have established a pattern of successful convergence, or semantic “ﬁmrness”,
then we can say of any particular belief that it is false. One has to be right about a large
background of beliefs before the validity of particular beliefs can be critically examined.
Similarly, successful communication with others indicates that you know many things
about your world.486
Davidson’s position undermines global scepticism by demonstrating that on the
model of the radical interpreter, the precondition for such wholesale doubt—a
metaphysical gap between language users and the world—is unthinkable. On the
representationalist view, beliefs are conceived as “inner” or subjective representations of
the outer natural realm. In contrast, Davidson makes the case for viewing beliefs as the
production of a triangular causal relationship between ourselves, other speakers, and our
shared environment. From the perspective of the radical interpreter, our ability to use
language comes from direct, unmediated causal contact with the world, which in turn,
guarantees that we have an established background of true beliefs against which our false

beliefs can be measured.

Davidson on Evidence

 

Without the looming problem of global scepticism, Davidson does not need to
concede the evidentiary relativism that stymied efforts to reconceptualize medical
evidence in the context of EBM. Applying Davidson’s model of language use to a theory
of language, we are cautioned against the metaphysical bifurcation of inner, subjective,
political reasons for scientiﬁc beliefs from external objective, evidential reasons for these

beliefs. In support of Davidson’s position that empirical evidence and beliefs are

 

’86 Davidson (1989), "The myth of the subjective." Relatmm: Interpretations and confrontations;
Davidson (1990), "The structure and content of truth." J Phil 87(6).

155

metaphysically similar entities (as evidence for a belief is itself a belief, and our political
values have empirical content), Clough revisits Longino’s treatment of the “man-the-
hunter” versus “woman-the-gatherer” archaeological interpretations of certain chipped
stones. Longino claims that both explanatory accounts are equally supported by the
evidence (the stones) and therefore theory choice is relative to our underlying political
commitments, namely androcentrism or feminism, respectively.487 Clough argues instead
that feminist political values are themselves beliefs with empirical content that can, in
turn, provide good evidential reasons for rejecting the man-the-hunter interpretation.
Rejection of this interpretation is not relative to the extra-evidential world of feminist
politics.

The evidence supporting the “woman-the-gatherer” thesis includes feminist
political analyses of past scientiﬁc practices, which have revealed the well-documented
pattern that theories of human bodies and behaviour that ignore women ’s bodies and
behaviour are inaccurate. The feminist archaeologist who disputes the man-the-hunter
theory, in spite of the equivocal evidence provided by the chipped stones, still has good
inductive evidence based on her feminist political views to support her decision. The
man-the-hunter theory leaves out the role of women in the human development of
technology and culture. The feminist archaeologist who chooses to interpret the chipped
stones on the basis of a theory that includes or even highlights the role of female agrarian
behaviour is making her choice based on past evidence that ignoring the role of women is
to get the “human” story drastically wrong. Her decision is not merely relative to

feminist politics; it is not based on some nonevidentiary belief entity brought in when all

 

’87 Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiyy, chapter six;
p. 109.

156

the objective evidence, independent of belief, is equivocal. Rather it is a decision well
supported by inductively observed instances of past scientiﬁc errors.

On Clough’s nonrepresentationalist view, then, the man-the-hunter and the
woman-the-gather interpretations are not equally well supported by the evidence. The
former is not supported by feminist analyses of past scientiﬁc practice. It is not the case,
as Longino suggests, that faced with interpretations equally well supported by the “belief-
independent” empirical evidence, we are forced to rely on our inner belief world of
politics to make our choice. Neither is it the case that feminist normative beliefs are
supported by the historical evidence, derived from past feminist analyses, that a theory of
human development that cannot account for women’s activities fails as an explanatory
theory. Davidson’s proposal is that normative beliefs are evidentiary; to propose that the
latter supports the former invokes the scheme/content split that was demonstrated in the
last chapter to invite relativism.

Rethinking Evidence: Differentiating Clough from Nelson

Clough’s Davidsonian evidentiary defense of the “woman-the-gatherer”
archaeological theory seems, at ﬁrst glance, somewhat similar to the evidentiary support
that was provided by Nelson of feminist science studies’ repudiation of sex-based
lateralization.488 There are, however, important points of difference between the two that
allows the former to avoid the evidentiary relativism found in the latter. These
differences begin with Clough and Nelson’s respective allegiances to Davidsonian and
Quinean models of language use. Davidson regards the key difference between Quine’s
method of radical translation and his own method of radical interpretation to be the

choice of causes that govern interpretation. While Quine understands interpretation to

 

4” See p. 137 of this dissertation.

157

depend on patterns of sensory stimulation, Davidson makes it depend on the external
events and objects the sentence is interpreted as being about. Thus Quine’s notion of
meaning is tied to sensory criteria, which he also treats as evidence. This leads Quine to
assign epistemic signiﬁcance to the distinction between observation sentences and other
sentences, since the former are supposed, by their direct conditioning to the senses, to
have a kind of extra-linguistic justiﬁcation. Davidson argues that sensory stimulations
are indeed part of the causal chain that leads to beliefs, but cannot, without confusion, be
considered to be evidence or a source of justiﬁcation for the stimulated beliefs.489
While Nelson and Clough similarly invoked past feminist analyses as evidentiary
support for the respective hypotheses proposed in feminist science studies, only Clough
regarded those theories as directly tied to the empirical world. Nelson broadened the
scope of relevant evidence when she proposed that “part of the evidence for objects is
provided by the larger systems of theories and practices in which such objects ﬁgure”,490
but did not challenge the metaphysical bifurcation between the empirical “objects” that
traditionally comprised evidence in its entirety and the intersubjective “theories and
practices” that she had just introduced into the evidentiary fold. Nor did she see that not
doing this led to evidentiary relativism in the end. Clough proposes that feminist political
values are beliefs with empirical content; thus they do not merely ﬁlter the real, but
actually constitute part of it. Unlike the ﬁltering conceptual schemes invoked in the
writings of Longino, Nelson, and F eyerabend, Davidson views our language use as a

guarantee of an unmediated causal relationship between most of our beliefs and the

world. Unlike correspondence theories, however, this unmediated contact does not

 

’89 Davidson (2003), "A coherence theory of truth." Siblings under the skin: Feminisms, social justice and

analﬂic philosophy, p. 131.
’90 Nelson (1993), "A question of evidence." Hypatia 8(2), p. 183.

158

justify particular beliefs. Davidson’s model does not regard empirical beliefs as having
better metaphysical links to the outer, independent objective world than do our political
beliefs,49' just as our political beliefs are no more closely related than our
straightforwardly empirical beliefs to our inner subjective world. But this is because, on
Davidson’s view, there is no inner or outer world and no metaphysical bifurcation. There
is only a world, an objective view of which can be made meaningful only by the language
users who are part of it.

One might object that because all beliefs have a causal relation to the world, there
are features of the world that prompt the development of not only feminist beliefs, but
misogynist theories too. Furthermore, because most beliefs are presumed to be true,
more needs to be said about how political views are sorted out. However, Davidson’s
general presumption of truth does not guarantee the veracity of particular beliefs. It only
provides the backdrop for judging theories to be false. This permits the honest and
comparative evaluation of competing theories, where neither option can be selected based
on one’s political allegiances or preferences, as evidence cannot equally justify yet
undermine both theories. Additionally, the argument has been made that the rigour of
empirical inquiry is increased by consideration of alternative theories and metaphysical
systems. The comparison of competing theories is far more challenging than limiting
testing to observational examination.

Davidson’s truth-theoretic treatment of meaning, where the meaning of an ’
utterance is given by its truth, ensures that changes in empirical beliefs can, and must, in

principle, affect more theoretical beliefs, even if the effect is only slight. Therefore, no

 

49' This distinguishes Davidson from Quine, who regards observation sentences as situated on the periphery
of the web of beliefs, while other more theoretic sentences reside closer to the centre (see Quine (2003), From
a logical point of view).

159

two theoretical beliefs can both conﬂict with each other in drastic ways and have the
same truth conditions; the radical interpretation model denies the relativist interpretation
of the underdetermination thesis: the condition where two opposing theories are equally
supported by the direct evidence and therefore theory choice depends on nonevidential
considerations like political commitments and subjective preferences. This is denied
because the commitments and preferences are evidential—they are of the same kind as
empirical evidence. Furthermore, because all beliefs depend on a causal relationship with
the external world, all beliefs can be adjudicated by the radical interpreter via the
identiﬁcation of the beliefs causal history, a move that avoids the relativism that Nelson
and other feminist epistemologists of science fall into when they cannot strongly justify
the primacy of their feminist worldviews over other androcentric ﬁlters.

2
9 as she,

Thus Clough can make a stronger case for feminist science than Nelson,4
unlike Nelson, does not need to justify the legitimacy of our feminist interpretive filters;
instead she argues for the truth of feminist science. There is no need for us to doubt the
evidence of our feminist political values as long as we conceive of such evidence as that
which is provided by other beliefs in our web. Clough proposes that “our scientiﬁc
theories and our beliefs about oppression and justice are not merely relative to our
feminist conceptual schemes, they are justiﬁed by the evidence and they are true.”493
Beyond Epistemology: Empirical Inquiry. not EmpiricISM.

The natural conclusion of Davidsonian repair is abandonment of traditional

epistemological pursuits—hence the title of Clough’s book, Beyond Epistemology. The

 

’92 Recall that this is important to this investigation into EBM because feminist epistemology was identiﬁed
early on as offering the tools for investigating the relation between epistemology and ethics/social.
’93 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist

epistemology." Siblings under the skin: Feminism. socianstice and analﬂic philosophy, p. 110.

 

160

entirety of the Western epistemological pursuit has been proposed by Rorty to be framed
by representationalist metaphors,494 a framework that Clough suggests to result in an
“objectivism-to-relativism” slide where anything less than a one-to-one correspondence
of theory and the world amounts to relativism.495 Given this antagonistic relationship
between epistemology, representationalism, and self-refuting scepticism, she
recommends that feminist science studies forsake its current preoccupation with
epistemology in favor of a return to the local, empirical research that characterized early
feminist science studies (hence the subtitle of her book, A Pragmatist Approach to
Feminist Science Studies).

Clough maintains that epistemology is an unworthy focus because the discipline
is premised on the coherence of global scepticism and consistently fails to defeat it.496
This begins with the representationalist metaphysics underlying both foundationalist and
antifoundationalist epistemologies of science. It has already been discussed that both
foundationalists and antifoundationalists view beliefs or theories as representing the
world. The ontological task presented by the representationalist model is then the
identiﬁcation of those normative properties that indicate the level of interference or
ﬁltering between the representations and their (real) referents.497 Epistemology is a
process of adjudicating between representations, based on the detection of these

. . . 9
norrnatrve relational properties.4 8

 

49" Rorty (1991), "Pragmatism, Davidson, and truth." Obiectivism. relativism, and truth: Philosophical
papers, volume 1; Rorty (1991), "Representation, social practice, and truth." @ectivism. relativism. and
truth.

49’ Clough (2003), Beyond epistemology: A pragmatist apprcach to feminist science studies, chapter 5
49" Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, chapter 2.
’97 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings larder the akin: Feminism. sociayljustice and analytic philosophy, p. 89.

4 8 Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the akin: Feminism. social justice and analytic philosophy. p. 90.

161

Yet scepticism arises from this representationalist model of the relationship
between knowers and the world. If beliefs are only internal copies or representations of
the external world, then it is possible that somewhere in the copying process an error
might have occurred, rendering the copy inaccurate. Indeed, all of our representations
could be inaccurate because their content has been ﬁltered through the schemes of our
perceptual apparatus, language, cultural worldview, and/or theoretical allegiance. We
can never be sure of the ﬁdelity of our representations because we do not have direct
access to the empirical world that caused them. The epistemological search for the set of
properties that is deﬁning of knowledge,499 in other words, the relational properties that
ensure the reliability of our representations of reality, therefore arises as a response to this
global scepticism. The possibility of wholesale independence of our theories and the
world can only be avoided by specifying the normative relational properties that anchor
them together. In the ongoing epistemological debate between objectivists and
relativists, objectivists hope to defeat scepticism with various theories of correspondence,
while relativists seem resigned to the sceptical view that the ﬁltering of our beliefs make
truthful representations impossible and coherence between beliefs our only hope.500 It is
representationalism that makes coherent the sceptic’s worry that the two worlds may not
be bridgeable—all of our subjective theories about external reality may be inaccurate—
and it is this worry that necessitates epistemology, the speciﬁcation of normative

relational properties that secure our theories to the “bits of the world they purport to

 

’99 The set of properties are typically abstracted from context, subjects, and practices. Some exceptions
include DeRose (2003), "Contextualism and knowledge attributions." Epistemology: The big questions;
Code (1993), "Taking subjectivity into account." Feminist epistemologies; Tanesini (2003), "The practices
of justiﬁcation." Epistemology: The big questions.

50° Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies. pp. 12-13.

162

describe”.501

While there are few epistemologists who would still claim that the identiﬁcation
of normative criteria increases our certainty in our beliefs, the search for these criteria
continues in numerous scaled-back forms. It is the motivation for this search that
concerns Clough, as she sees epistemology to be motivated by the threat of global
scepticism, more speciﬁcally, the threat that our beliefs about the world may be
disconnected from the truth about the world.502 If it were otherwise, we would be able to
abandon the epistemological pursuit. Within the epistemology of science, scepticism
arises as the concern that if the criteria for detecting normative properties cannot be
identiﬁed, then knowers will have no way to rationally adjudicate between competing
knowledge claims. If, as Longino argues, the evidence for our scientiﬁc theories is
continually ﬁltered by our gendered background beliefs, then we need epistemology to
provide normative guidelines for minimising the resulting error.503

Davidson argues that what stands in the way of global scepticism of the senses is
the fact that in the context of basic beliefs and simple occasion sentences, we must “take
the objects of a belief to be the causes of that belief. And what we, as interpreters, must
take them to be is what they in fact are.”504 Thus the scepticism invited by the
representationalist model can never be answered from within epistemology — only a

nonrepresentationalist approach avoids the pitfalls of relativism. Because it is

unencumbered by the demand of answering to sceptical doubt, it invites a pragmatic

 

50' Clough (2003), "A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the skin: Feminism, social justice and analytic philosophy. p. 90.

5 2 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 10.

’03 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, pp. 9-10.

50’ Davidson (2003), "A coherence theory of truth." Siblings under the s_kin: Feminisms, social justice and
analytic philosophy. p. 131.

163

approach to science studies.
A Pragmatist Approach to Science Studies

Clough’s concern is that when feminist epistemologists of science embark on the
quest for normative ontological properties and the best epistemic methods for their
detection, they invite sceptical doubt: when the adjudication of knowledge claims are
construed as an epistemic process prior to and independent from the local, empirical
justiﬁcation of those claims, we unnecessarily invite the worry that our claims about the
oppression of women, for example, while well supported by empirical evidence, might
not meet the epistemic criteria that stands independent of this evidence. Yet, Davidson’s
argument is that the measure for true belief is other true beliefs, not extemalist
evidentiary properties or reliable belief-fonning processes. Thus epistemology’s task of
specifying the normative relational properties that make a theory maximally objective
“remains separate from the everyday ad hoc question whether any particular knowledge
claim is justiﬁed by the evidence.”505

Clough recommends refocusing feminist science studies away from its current
preoccupation with epistemology to the more mundane questions of justifying particular
beliefs, as epistemological investigations are less effective at promoting the interests and
avoiding the harms of women through science. Speciﬁcally, the feminist move from
science to epistemology has entailed a shift in focus toward overgeneral accounts of

“science” and/or “method” and away from the speciﬁc agents responsible for harming

people.506 Clough endorses the methodological inquiries that characterized early feminist

 

50’ Clough (2003), "A hasty retreat ﬁ'om evidence: The recalcitrance of relativism in feminist
epistemology." Siblings under the skin: Feminism, social justice and analytic philosophy, p. 90 (my
emphasis).

’06 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 121.

 

164

interventions in science as properly capturing this pragmatic direction. Most of the
feminist interventions from the mid-nineteenth to the early twentieth centuries were
directed at the level of methodological critique, attempting on a case-by-case basis to
counter faulty sexist and racist practices with more accurate data and methods. Early
feminist criticisms of science, such as Mary Calkins507 and Helen Thompson Woolley,508
addressed the methodological ﬂaws underlying various Darwinian claims, including
claims about the inferiority of European women and non-European women and men. The
late 19708 and 19803 saw a shift, as feminist scientists and science commentators moved
away from empirical critique toward more philosophical diagnoses and treatment.
Harding,509 for example, advocated this shift from “feminist critiques of bad science” to
the more philosophical feminist critiques of “science as usual” or “science at its best”
because identifying individual cases of bad science as laden with sexist values and
ideology misses the larger point that all our science, even that produced within the
highest of our current evidential standards, is value-laden or ideological.5 '0 Clough is
critical of this philosophical focus and argues that epistemology is not the most effective
focus for feminist science criticism. Speciﬁcally, philosophical examinations of truth,
method, and evidence do not clearly assist in identifying and addressing those scientiﬁc
practices that systematically disadvantage marginalized people.5 ” Furthermore, many
epistemological problems are unanswerable because of the scepticism invited by the

representationalist model (which, it has been argued, cannot be overcome within

 

507

Calkins (1896), "Community of ideas of men and women." Psych Rev 3(4).

50’ Woolley (1910), "Psychological literature: A review of the recent literature on the psychology of sex."
Psych Bul 7(10).

509 Harding (1986), The science question in feminism.

5'0 Harding (1986), The science question in feminism, pp. 21-24.

5” Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, pp. 1-2.

 

165

epistemology).

To better understand Clough’s differentiation of epistemology of science from a
pragmatic approach to science (or empiricism from empirical inquiry), consider the
different research questions explored. Epistemological investigations, she explains,
explore the question “By what normative criteria can we adjudicate between competing
knowledge claims?” or “Do these criteria indicate the presence of normative properties
such as truth or (at least) maximal objectivity?”, while pragmatic scientiﬁc inquiry asks
the narrower empirical question, “is this scientiﬁc theory true?”. Answering questions
about the truth or justiﬁcation of any particular knowledge claim or set of knowledge
claims has already been proposed to be a separate task from the broader epistemological
questions about the properties that make beliefs true, maximally objective, or even
empirically justiﬁed. Speciﬁcally, empirical inquiry involves a local assignment of truth
and justiﬁcation. It is only when we elevate empirical investigation of a speciﬁc claim to
the prescriptive level of empiricist epistemology that we encounter scepticism and
relativism.“2

Empirical inquiry involves the fairly uncontroversial practice of comparing the
knowledge claim in question with the current ongoing theories and experiences of the
world. Examinations of the empirical question are typically dynamic, and often ad hoc,
processes of comparing the speciﬁc theory in question with an ongoing body of theories
and with past and present experiences and data. The assignment of truth, evidential

justiﬁcation, or maximal objectivity, is site-speciﬁc and is adjusted as new information

comes in; that is, it is fallibilistic. For example, Helen Montague and Leta Stetter

 

5’2 Clough (2003), Beyond epistemology: A pragmtist approach to feminist science studies, p. 15.

166

Hollingsworth513 are noted by Clough for providing important empirical critique of sexist
conclusions drawn from evolutionary theory regarding white European men’s superior
physiological and mental capability. By conducting careful empirical testing on infants
(to control for confounding sociological factors) of both sexes, the scientists disproved
the theory that human males presented with greater physiological variability over
females. The slim empirical data indicating mental variability were found to be better
explained sociologically than biologically.514 Such sound empirical challenges capture
the localized form of inquiry customary to the pragmatic approach to science. Because
global scepticism is not a threat within the Davidsonian evidentiary scheme, there is no
reason to elevate investigation from the mundane empirical to the level of
epistemological inquiry.5 ’ 5

Philosopher of science, Arthur Fine, has argued that epistemologists

see science as a set of practices in need of an interpretation, and they see

themselves as providing just the right interpretation. [However] science

is not needy in this way. Its history and current practice constitute a rich

and meaningful setting. In that setting, questions of goals or aims or

purposes occur spontaneously and locally.5 '6
The pragmatic approach to science involves the truth of our individual beliefs and
scientiﬁc theories being assigned locally, and of course, fallibly. This sort of empirical

assignment is typically ad hoc and dynamic — the criteria are always being adjusted as

new information comes in. Davidson holds that while empirical data plays a causal role

 

5 '3 Montague and Hollingsworth (1914), "The comparative variability of the sexes at birth." Am J Soc
20(1).

5 '4 Clough concedes that the shift in feminist science studies to larger philosophical questions were largely
the result of such sound empirical challenges to sexist science as offered by Montague and Hollingworth
being ignored by the scientiﬁc community. She still insists that pragmatic science is preferable for feminist
liberatory mandates because it at least does not damage feminist credibility in science. See Clough (2003),
Beyond epistemology: A pragmatist approach to feminist science studies. pp. 19-20.

5 '5 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, pp. 15-19.

5'6 Fine in Clough (2003), Beyond epistemology: A pragmatist applmch to feminist science studies. P. 121.

167

in establishing the content of all beliefs, those causal connections to the empirical world
are not normative properties contained by those beliefs that are true or maximally
objective. Davidson’s nonrepresentationalist view of belief entails causal connections

517

playing no epistemological or justificatory role. Thus scientiﬁc inquiry is not a

valuable pursuit because it provides privileged access to truth. Instead its ability to
establish the truth of particular beliefs comes from its democratic tenor. Rorty518
endorses a pragmatic view of scientiﬁc investigation as a set of open and democratic
values that seeks truth in the local sense, where “the best way to ﬁnd out what to believe
is to listen to as many suggestions and arguments as you can.”5 '9 This is not a
metaphysical claim about the connection between human reason and the nature of things.
As language users, we have direct causal contact with our world, but this connection does
not justify the truth of any one belief. This causal connection only ensures that we cannot
be wrong in all beliefs. Davidson and Clough’s endorsement of democratic scientiﬁc
practice rather than epistemology is not supported by metaphysical or epistemological
assurance of our connection with reality. Instead, Davidson “simply makes the point that
if we try to give up the world, we must also give up language.”520
Confronting the Critics

As one might expect, Clough’s provocative reading of feminist science studies

and her radical suggestions for repair have been contested. Speciﬁcally, the accuracy of

Clough’s characterization of certain feminist philosophers of science as Davidsonian

 

5 '7 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 110.

5" Rorty (1991), "Science as solidarity." Obiectivism. relativism and truth: Philosophical papers, Volume
_1_.

5 '9 Rorty in Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p.
122.

52° Ramberg in Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies. p.
110.

 

168

representationalists has been challenged, as has the utility of feminist thinkers going
“beyond epistemology”. These challenges will be reviewed in this section, and their
impact on the question of evidence in EBM considered.

We have seen so far that the representationalist view involves the ontological split
between sensory ‘data’ that is completely unconceptualized and values that are non-
cognitive (i.e. not amenable to evidence or reason). The human mind must ﬁlter this
unconceptualized “stuff” through concepts before the stuff can be understood as anything
(red, smooth, a ball, etc.). Minds have no direct access to the world except through these
conceptualized data or “representations”.52' Feminist scholars are charged by Clough
with keeping the vestiges of this position by maintaining that theories of science depend
upon the political schema and values scientists use to interpret data. Relativism arises
insofar as theories are relative to political and other such values, and this outcome is self-
defeating since feminist critics of science still hold that some theories are better than
others. While the feminist theorists examined explicitly reject relativism, “each is left
with a watered-down prescription for feminist scientiﬁc method that is restricted to
detecting how the ﬁlter of culture intervenes between the world and scientiﬁc
knowledge” and advocating that scientists pick feminist views.522 Not only does this
position hinder feminist liberatory projects, but the metaphysical split is false. Values,
Clough argues, are not different in kind from factual beliefs, as both are based on
experience and reason. The notion of a ﬁltering process that underlies both objectivism
and relativism is therefore incoherent, as the value-laden schemes that structure and

organize beliefs are themselves also empirical beliefs. Denying the dualism, and

 

52' Potter in Potter et al (2006), "On the very idea of a feminist epistemology for science. [Review
3 mposium]." Metascience 15(1), p. 1.

5 2 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 92.

169

therefore avoiding the traditional debate between objectivism and relativism, would
recognize the success of human cognitive practices, such as science, and also substantiate
the value of at least some feminist perspectives. Instead of seeking universal
epistemological standards, Clough argues that science studies must accept local empirical
practices and standards and use these to test or evaluate competing accounts of the world.
Feminist scholars should therefore stop doing epistemology.

In a 2004 review symposium of Beyond Epistemology,523 Elizabeth Potter and
Moira Howes challenged Clough’s reading of Longino and Ruth Bleier as
representationalists. Potter contests Longino’s alleged representationalism on the bases
that Longino does not regard conceptual ﬁlters to be non-cognitive values and she does
not see data as pretheoretic. In Science and Social Knowledge, Longino proposes that
there is no unique or intrinsic evidential relationship between evidence and the hypothesis
or model for which it functions as evidence. Instead, the connections or regularities we
appeal to in assessing evidential relations are connections or regularities from some point
of view and always subject to change. The objects, events, and states of affairs providing
evidence for hypotheses are not empirically apparent; instead, how one determines
evidentiary relevance depends upon one’s background beliefs or assumptions.524 Longino

25

says that a background belief enables us to see evidence for a hypothesis;5 in other

 

’23 The symposium, featuring Elizabeth Potter, Moira Howes, Nancy McHugh, Catherine Hundleby, and
Sharyn Clough, took place at the inaugural meeting of the Association for Feminist Epistemologies,
Methodologies, Metaphysics, Science Studies in Seattle, November 2004. The proceedings of the
symposium later appeared in print as Potter et al (2006), "On the very idea of a feminist epistemology for
science [Review symposium]." Metascience 15(1).

52’ Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry, pp. 43-45.
52’ Longino writes that background assumptions are “beliefs in the light of which one takes some x to be
evidence for some h and to which one would appeal in defending the claim that x is evidence for h” in
Longino (1990), Science as social knowledge: Values and objectivity in scientiﬁc inquiry, p. 44.

170

words, our background assumptions make the evidence for a given hypothesis
plausible.526

Furthermore, the “man-the-hunter vs. woman-gatherer” example examined by
Clough reveals, according to Potter, that Longino does not regard data to be
unconceptualized. Here the data are already conceptualized as chipped stones; it is only
from there that they can be further interpreted as tools used either by men for hunting or
by women for food preparation. Thus the data are not the unconceptualized “stuff” of
representationalism, but already identiﬁed as objects (chipped stones).

Potter maintains that while Longino does argue that the available anthropological
data are so few as to underdeterrnine the choice of hypothesis regarding the chipped
stone’s use, and so the majority support for “man-the-hunter” interpretation comes in part
from unexamined gender assumptions, this does not indicate social and political values to
be non-cognitive. Longino in fact rejected the distinction between cognitive and non-
cognitive values in favour of a distinction between constitutive and contextual values,
that is, those values that constitute recognized criteria for theory choice, such as
simplicity or consistency, and those non-constitutive values arising from the context in
which knowledge is produced.527

Similar to Potter, Howes defends a feminist philosopher of science, this time Ruth
Bleier, from Clough’s charge of representationalism. Howes proposes that the Bleier’s

“sceptical sounding” language that is ﬂagged by Clough does not demonstrate

representationalist commitments, but rather deeply self-critical tentativeness about

 

52’ Potter et al (2006), "On the very idea of a feminist epistemology for science [Review symposium]."
Metascience 15(1), pp. 3-4.

’27 Potter et al (2006), "On the very idea of a feminist epistemology for science [Review symposium]."
Metascience 15(1), p. 4.

171

Bleier’s own susceptibility to bias. Howes concedes that Bleier’s language certainly
makes her vulnerable to Clough’s charges of scepticism in her use of such tentative
language as:

I actually engage in the very activity I warn readers to question, if not

distrust. Put differently, I present ‘facts’ to refute “facts”, which I claim

have been made [up] in the interests of the dominant group — white men.

I offer feminist interpretations to replace patriarchal interpretations, which

I say reﬂect the ideology, desires, and necessities of a particular interest

group. I am indeed caught in my own trap!528
But, Howes argues, Bleier follows this admission with a statement that suggests that she
sees her critiques to be amenable to conﬁrmation, correction, and falsiﬁcation in light of
evidence:

But perhaps I am not. As I will try to maintain throughout my work, I see

any theory —— feminist or patriarchal — as ﬂexible and open to change. In

fact, as a scientist and a political being, my mind lingers with pleasure

when I encounter theories that allow for constant change, interaction,

contradiction, ambivalence.529
Bleier is characterized by Howes as standing ﬁrm in her ability to evaluate scientiﬁc
theories, not merely to prefer certain values over others. In Science and Gender, she
demonstrates a number of basic conceptual and methodological ﬂaws in sociobiology, for
instance, setting standards that are neither relativist nor sceptical in nature.530 The
language interpreted by Clough to court scepticism can instead be read as deep concern
over critical self-reﬂection. Bleier speaks of

the courageous and difficult task of examining and questioning all of our

assumptions and the structure of our thought processes, all clearly born

and bred within a profoundly stratiﬁed, hierarchical, patriarchal culture.53 '

 

52’ Bleier (1984), Science and gender, p. 13.

’29 Bleier (1984), Sciencgnd gender, p. 13.

53° Howes in Potter et a1 (2006), "On the very idea of a feminist epistemology for science [Review
symposium]." Metascience 15(1), p. 11.

5 ' Bleier (1984), Science and gender. p. 206.

 

172

She sees this self-reﬂection to be problematically missing from androcentric scientiﬁc
thinking, and its addition as enhancing rather than hindering or relativizing science.

In Clough’s response to the charge that she misapplies the representationalist
label to feminist philosophers of science, she insists that Longino does in fact construe
data to be unconceptualized in her representatalist characterization of data as “dumb” and
her claim it is our conceptual frameworks that give the data voice as evidence.532 Clough
outlines a two-step detection process for determining thinkers to be representationalist.
She instructs us to ask, ﬁrst, whether the facts construed as separate from, because they
are ﬁltered by, values. Second, if values are ﬁlters for facts, does this indicate that the
analysis is invoking an ontological split between internal, ﬁltered, representations and the
external world that is represented, or was the ﬁltering language used merely as a
metaphor describing the complex relationship between beliefs about values and beliefs
about facts, making clear that the two sorts are ontologically continuous? The latter use
is ﬁne by Clough, and she admits that it is frequently used. For instance, “we safely use
this sort of ﬁltering language. . .when we want to acknowledge the fallibilistic nature of
our own beliefs, including those of our beliefs that act inappropriately as biases affecting
the acquisition of new beliefs.”533 She agrees with Howes that Bleier and many other
feminists use this ﬁltering language to acknowledge their own biases, thereby modeling a
laudable level of intellectual honesty. The trouble is that Bleier, in particular,

mixes this more innocuous discussion of ‘biases as ﬁlters’ with what. . .is

a more metaphysically dangerous vocabulary that moves her beyond the .
acknowledgement of the fallibility of any given belief, to a Cartesian

 

53" Longino (1990), Science as Sign knowledge: Values and obiectivity in scientiﬁc inquiﬂ, p. 111.
’33 Clough in Potter et al (2006), "On the very idea of a feminist epistemology for science. [Review
symposium]." Metascience 15(1), pp. 35-36.

173

skepticism about belief acquisition simpliciter.534
In fact, the bias-as-ﬁlter language can even lead feminist theorists to an unnecessary level
of scepticism. The language permits an easy slide from a proper attitude of fallibilism
about our beliefs to a more sceptical and relativistic position whereby values (sexist or
feminist) are construed not as beliefs but as ﬁlters that organize beliefs, a conceptual
distinction that “keeps us from treating our feminist values as the well-justiﬁed beliefs
that they are.”535

A difﬁculty for even the most careful reader of Clough is that her schema allows
for non-representationalist use of “ﬁltering” language to explain our beliefs about ‘facts’
and our beliefs about ‘values’, both of which are testable against the evidence of our
experience and our ongoing theories. These non-representationalist ﬁlters have the same
metaphysical status as empirical evidence and “can be understood as very complicated
nodes of empirical information that function in much the same way as representational
ﬁlters in the distortion of evidence.”536 The empirical status of these ﬁlters means that
they are amenable to correction and improvement. As Clough’s two-step deciphering
process indicated, the presence of “ﬁltering language” does not necessitate
representationalist metaphysics. That language needs to be evaluated in order to
determine whether the values being invoked are beliefs about the world, available to

objective adjudication (non-representationalist ﬁlters) and not cognitive ﬁlters for beliefs

(representationalist ﬁlters). The opposing readings of Longino and Bleier—both of

 

53’ Clough in Potter et al (2006), "On the very idea of a feminist epistemology for science. [Review
symposium]." Metascience 15(1), p. 35.
5 5 Clough in Potter et al (2006), "On the very idea of a feminist epistemology for science. [Review
symposium]." Metascience 15(1), p. 36.
5 6 Howes in Potter et ,al (2006), "On the very idea of a feminist epistemology for science. [Review
symposium]." Metascience 15(1), p. 12.

174

which seem like plausible interpretations—demonstrate the difﬁculty of making this
determination, and so disagreement regarding who is and who is not a representationalist
will certainly be tough to overcome. Because it is also easy for the non-
representationalists to unwittingly slide into representationalism, we may even need to
permit degrees of commitment to or intentional versus unintentional representationalist
metaphysics. A thorough reading of all science studies texts in question would be
required to create a tentative and contestable separation of representationalists and non-
representationalists. This delineation is beyond the scope of this project; Howes’s
suggestion that Clough must work to further clarify the distinction between
representationalist and non-representationalist ideological ﬁlters in feminist critiques of
science seems warranted.

Thus we must leave undecided the question of whether Longino’s and Nelson’s
antifoundationalist accounts of evidence were unhelpful in our effort to rethink evidence
in the context of EBM because they were representationalist For now, it stands as a
plausible explanation for the problem. What may be more crucial for our investigation,
however, is whether Clough’s proposal to abandon epistemology is appropriate course for
alleviating the difﬁculties surrounding EBM. A surprising feature of Clough’s project is
her characterization of epistemology as largely deﬁned by the question “by which
epistemic criteria might we adjudicate between competing knowledge claims?”537 Such a
characterization is particularly surprising in the context of feminist science studies, as

feminist epistemologists seem to be interested in other questions, such as “who

 

5’7 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies. p. 120.

175

9,,538

knows?/what can she know. and “what don’t we know?”.539 Clough is charged with

envisioning epistemology too narrowly—i.e. that she is not referring to all epistemology,

540

but only “modem” or “mainstream” epistemology, according to Nancy McHugh, and

541

“positivist” epistemology, according to Catherine Hundleby —and therefore she does

not see the other avenues that epistemology has taken through pragmatist and feminist

science studies.542

McHugh criticizes Clough for only relying on neo-pragmatists in her
investigation, and proposes that for classical pragmatists like Dewey, James, Locke, and
Mead, epistemology was a political and social project rooted in the methodology of
experimental inquiry that demanded an engagement with the material world. In Charlene
Seigfried’s historical treatment of feminism and pragmatism, pragmatist epistemology is
argued to make clear that theorizing about knowledge, and doing it as embodied and
socially embedded knowers that recognize the political stakes involved in getting to label
who knows, how she goes about knowing, and what she should and does know, is too
important for us to relinquish.543 Not to engage in pragmatist epistemology means losing
the import of the relation between knowing and doing that was so essential for social and

political change and so important for knowing and doing “better”.544 Feminist scientists

and philosophers of science, according to McHugh, recognize a signiﬁcant stake in the

 

5” Nelson (1990), Who knows: From Quine to feminist empiricism: Code (1991), ﬂat can she know?
Feminist theory and the construction of knowledge.

’39 I am alluding to Charles Mills’ “epistemology of ignorance.” See Mills (1997), The rﬁial contra_ct. See
also McHugh’s treatment of Mills in her critical review of Beyond Epistemology in Potter et al (2006), "On
the very idea of a feminist epistemology for science [Review symposium]." Metascience 15(1).

54° McHugh in Potter et al (2006), "On the very idea of a feminist epistemology for science [Review
symposium]." Metascience 15(1), p. 16.
' Hundleby in Potter et al (2006), "On the very idea of a feminist epistemology for science [Review

symposium]. " Metascience 15(1), p. 23.

5’2 McHugh 1n Potter et al (2006), "On the very idea of a feminist epistemology for science [Review
symposium]. " Metascience 15(1), p. 20.

5” Seigfried (1996), Pragmatism and feminism: Reweaving the social fabric.

’4 McHugh in Potter et a1 (2006), "On the very idea of a feminist epistemology for science [Review
symposium]." Metascience 15(1), p. 17.

 

176

link between epistemology, science, and ethics, and going “beyond epistemology” would
problematically detract liberatory projects with respect to knowledge production.
McHugh’s trepidation about abandoning epistemology seems justiﬁed, given that
doing so would mean the loss of numerous intellectual tools for identifying and
correcting power/knowledge imbalances. Furthermore, the suggested turn toward
empirical projects has limited utility in the context of EBM, as the evidence for EBM has
already been discussed to be not only lacking, but potentially impossible to generate (see
p. 14). And wouldn’t this effort to gather the evidence supporting or refuting EBM take
us right back to the rudimentary epistemological question regarding what evidence
counts? Perhaps it is because EBM is an epistemology of medicine that the
epistemological questions cannot be ignored and/or overcome. Thus, it is in the interest
of interrogating EBM that I would not follow the suggestion to go beyond epistemology,
and instead support the overarching pragmatist project of “an epistemology that is
produced by material bodies in transaction with a material world confronting the
epistemological problems that are characteristic of political, scientiﬁc and social
”545

discourse and action.

In Conclusion

 

The appeal of the Davidsonian account to the current investigation into EBM is
that it surpasses prior postpositivist evidentiary conﬁgurations by not only calling
attention to the social and contextual features of evidence, but also providing a
framework for retaining this more holistic evidentiary accounts’ adjudicative force. It

was argued that in the ongoing epistemological debate between objectivists and

 

5’5 McHugh in Potter et al (2006), "On the very idea of a feminist epistemology for science [Review
symposium]." Metascience 15(1), p. 19.

177

relativists, objectivists hope to defeat scepticism with various theories of correspondence,
while relativists seem resigned to the sceptical view that the ﬁltering of our beliefs makes
truthful representations impossible and coherence between beliefs our only hope. This
resigned relativism is not only epistemically troubling, but also impractical for clinicians
who are forced to act and to do so with justiﬁcation. So far, this investigation into
Davidson’s theory of evidence has been largely an assembly of key critical positions.
The next step is evaluation in the context of EBM. In the next chapter, the “Davidsonian
repair” undertaken in this chapter is applied to the EBM debate in order to offer a usable

and defensible theory of evidence for clinical practice.

178

CHAPTER SIX
Recasting EBM and its Critics

In this chapter, we return to the EBM debate bearing the conceptual tools
advanced by Clough’s Davidsonian framework. While I ended the previous chapter
rejecting the suggestion to abandon epistemological pursuits, Davidson’s distinction
between epistemology and pragmatic science proves to be useful in this investigation and
will be deployed in this chapter to recast both EBM and its critics. As a caveat, however,
I would rename the distinction to be between objectivist epistemology and pragmatic
epistemology. Reframing the EBM discourse in light of this distinction will be shown to
allow for a more nuanced analysis of EBM than previously offered that is not “either/or”
in its evaluation of the decisionmaking technology as either iconoclastic or creedal. This
new eye on EBM also brings the shortcomings of the standard EBM critiques into relief.
Speciﬁcally, the challenges to EBM have focused almost exclusively on the positivistic
features of EBM—namely, its narrow and reductive account of evidence—with disregard
of EBM’s pragmatic methodological commitments and tendencies. Aside from offering
an incomplete account of EBM, the popular critiques of EBM’s standard of evidence lead
to the problem of relativism. Speciﬁcally, the critics’ championing of the fallibility of
scientiﬁc knowledge serve to challenge some of EBM’s methodologies and epistemic
assumptions, but fail to enable the formulation of alternative decisionmaking models.
Much like the feminist epistemologists examined by Clough, the EBM critics ﬁnd
themselves unable to justify any one schema for managing the social and interpretive
dimensions of both science and evidence.

The EBM critics are redirected towards non-representationalism in order to avoid

the relativism that can accompany acknowledging the fallibility of knowledge. I propose

179

that just as Clough offered evidence that the woman-as-gatherer theory was more
defensible, a framework can be established where medical decisions can be made through
the evaluation of the relevant evidence. Rather than being “evidence based”, however,
this model relies on the Davidsonian position that all theories have a causal relation to the
world. Methodological pluralism and openness to different traditions can assist in
evidentiary investigations, and so the evidence based ranking of research methods must
be rejected (as it will only limit this effort). A broad range of health research—basic
science, epidemiology, social science, humanities—and a genuinely transdisciplinary,
collaborative, and integrative agenda will be recommended in order to establish these
causal connections.
Return to the EBM Debate: Where we’ve Come From and Where we’re Going

To recap and review the present investigation, the current vogue of evidence-
based practices in both life and social sciences has been demonstrated to warrant critique
regarding the overreliance on a rigid hierarchy of evidence to dictate best practices. The
critique is two-fold: ﬁrst is the pragmatic criticism that EBM’s stratiﬁcation of evidence
is unlikely to lead to better recommendations for therapy because of considerations such
as the gap between clinical trial populations and actual patient populations seeking care.
Second, we have the overlapping yet distinct epistemological criticism that focuses on
the role of values and contingent social practices in belief formation and justiﬁcation. It
is within this critical orientation that the problems of positivism and relativisms arise.
The evidence based approach has been criticized for valuing the quantitative at the
expense of the qualitative, and the aggregate over the personal. While the

antifoundationalist epistemology critiques characteristic of critical science studies were

180

able to undermine the positivistic conﬁguration of evidence underlying EBM, they could
not provide an adequate framework for formulating alternatives. Clough’s critical
reading of postpositivist science studies offers an intriguing explanation for this problem
in her indictment of representationalism.546 She ﬁnds in many critical epistemologies of
science inadvertent support for EBM’s evidentiary preferencing, as they do not contest
the framework in which the qualitative and the personal are less reliable or relative.
When postpositivist thinkers dispute obj ectivism by claiming that no one can access the
“real” world unbiased by one’s cultural presuppositions or interpretive lenses, for
example, they are conceding too much: they accept the empiricist presupposition that
interpretation is the barrier to the real/true. By doing this, they retain the
representationalist dualism between “the social” (theories, worldviews, etc.) and the
physical world. This metaphysical bifurcation can be argued to unintentionally support
EBM’s reductive understanding of evidence by hindering the possibility of meaningful
alternatives. Consideration into the interpretive features of evidence and the truth-value
of anecdotal and testimonial evidence are marred by the problem of relativism. Davidson
and Clough offer an alternative framework for understanding evidence that is consistent
with the critical anti-positivist dimensions of the former critiques, but differs with respect
to human judgment not needing to distort the real but rather forming part of its valid
foundation. In this framework, evidence is not the link between theory and the world;
rather it is the foundation on which the real is framed. The discourse surrounding EBM

will be reconsidered in light of this new insight.

 

5’6 The confrontation with Clough’s critics in the previous chapter should have afﬁrmed my general support
for Clough’s position, however I recognize that her framework is still incomplete. For example, more work
must be done to distinguish between representationalist and nonrepresentationalist ﬁlters in the major
science studies texts. With more clarity in this area, there will be less room for disagreement regarding
who is and who is not a representationalist.

181

Pragmatism vs. Epistemology

Davidson’s pragmatic approach to science involves the truth of our individual
beliefs and scientiﬁc theories being assessed locally and, of course, fallibly. This sort of
empirical assignment is typically ad hoc and dynamic — the criteria are always being
adjusted as new information comes in. These features are part of what separates a
pragmatist empirical project from the troublesome (objectivist) epistemological attempt
to identify and apply general normative recipes for truth, or its functional equivalents, in
science. Clough proposes that our energies can instead be devoted to the empirical task
.of analyzing the causal relations between our theories and the world. However, to the
extent that we construct epistemological guidelines for identifying which features of the
causal stories indicate truth, we will continually be chasing after new recalcitrant
features. The very scepticism the epistemological position was constructed to solve will
be reintroduced leaving us to doubt the general reliability of our connections with the
world around us.547
EBM: Pragmatic and Epistemological

When the distinction between pragmatic science and epistemology is brought to
bear upon EBM, EBM noticeably demonstrates afﬁnity to both. EBM demonstrates clear
allegiance to scientiﬁc inquiry in its preference for experimental methods of inquiry that

bracket past habitual thinking in favour of purely empirical investigation. Indeed, “the

application of the best research evidence to medical decisionmaking” could have been

 

5’7 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 5; l have
mentioned already that I reject Clough’s disavowal of epistemology. Not only does (some forms of)
epistemology seem like a worthwhile pursuit, but Clough does not seem to be actually rejecting all forms.
Instead she condemns only objectivist epistemology. Interestingly, in her reply to the critics at the Beyond
Epistemology review symposium, Clough conceded that she was mistaken in her use of nomenclature. She
supports nonobjectivist epistemology, such as pragmatism, providing that it is built upon a
nonrepresentationalist understanding of the world. See Clough in Potter et a1 (2006), "On the very idea of a
feminist epistemology for science. [Review symposium]." Metascience 15(1).

182

achieved by strictly pragmatic scientiﬁc methodology. The critics who charge EBM with
being “nothing new” certainly think that this is all there is to EBM. Furthermore, the
randomized controlled trial is a pragmatic methodology in certain respects. RCTS
temporarily suspend prior knowledge of human physiology, disease, and pharmacology —
knowledge that might allow for inferences regarding the effectiveness of a particular drug
in treating a given condition — and determine whether a treatment works by trying the
treatment in a large number of cases under controlled conditions.548 Because RCTS are
unhindered by the pretheoretic expectations and commitments that can more readily bias
the deductive methods of basic science and the less systematic experimental methods of
clinical experience and observational studies, RCTS are thought to best promote the
democratism of empirical science. Without the inﬂuence of anticipated outcomes,
scientists should be more open, when faced with recalcitrant empirical data, to revising
even well-established views about treatment efﬁcacy.549

Against this pragmatic spirit, however, the examination in chapter two of what is
unique to EBM drew from the movement’s epidemiological origins to highlight the
famed hierarchy of evidence. This feature of EBM is notably non-pragrnatic, as
pragmatism carries no pretheoretical notions of evidence. Quine insisted that no
standards or methods are laid down prior to the business of constructing theories to
explain and predict what we experience. There is simply “no simple formula for

distinguishing viable theories or research programs from nonviable ones”, but rather an

 

’48 Sehon and Stanley (2003), "A philosophical analysis of the evidence-based medicine debate. " B_C
Health Serv Res 3:14.

5’9 1n Sehon and Stanley’ s (op cit. 548) analysis of EBM as a new Quinean web of belief (rather than a
Kuhnian paradigm shift), they promote RCTS as the most reliable of the alternatives, namely clinical
experience or observational studies. In Quinean terms, the controls imposed by RCTs give us ﬁrmer
observational checkpoints and stronger inferences from observations to conclusions, particularly
conclusions about interventions.

 

183

“inevitable need for extensive and multifaceted evaluation.”550 RCTS, for instance, have
proven their worth for answering certain intervention questions, but its placement at the
top of a rigid hierarchy of evidence has yet to be justiﬁed by anything other than a priori
epistemic speculation.55 1 Davidson and Clough would add that not only is the hierarchy
non-pragmatic, but it is also distinctly epistemological, that is, it offers an a priori
normative guide for ensuring the maximal objectivity of our representations of the world.

The open-ended and ad hoc style of pragmatic scientiﬁc inquiry stands in contrast
to the rigid and rule-based hierarchy of evidence. The analysis of the hierarchy
undertaken in chapter three demonstrated the ranking to be based on levels of certainty.552
The hierarchy of evidence stands as EBM’s point of departure from pragmatic science to
epistemology, as the protocols and pre-graded methodological rankings move EBM away
from the mundane question of justifying particular biomedical theories and beliefs to the
epistemological provision of normative guidelines for minimizing the resulting error that
our representations can incur.

The hierarchy of evidence also distances EBM from the pragmatist emphasis on
democracy in science. Classical and feminist pragmatism’s political stake in “getting to
label who knows, how she goes about knowing, and what she should and does know”553
clashes with the supposed universality of the hierarchy. Within the EBM critiques, the
hierarchy is the point at which evidence based methodology is charged with

authoritarianism. Amidst the EBM discourse reviewed so far, there has been politicized

debate regarding whether EBM presents a democratizing or repressive force in

 

55° Nelson (1993), "A question of evidence." Hypatia 8(2), p. 184.

55' We will return to this point momentarily.

”2 Sackett et al (1991), Clinical epidemiology: A basic science for clinical medicine.
”3 See previous chapter, p. 153.

184

biomedicine. EBM certainly proposed to be iconoclastic in its programmatic literature
and it invoked pragmatic methods meant to rid medicine of unwarranted habits of thought
and practice. Yet EBM also committed to the rigid hierarchy of evidence that is
supported by a positivistic view of evidence and an objectivist account of science. As a
result, EBM struggles to account for the social features of medicine and is ethically
tenuous due to its admitted difﬁculties incorporating patient values into its decision-
making schemas.554 Furthermore, the extension of EBM into the domain of health policy
has generated the worry that this technology will be used as a political tool for corporate
interests in biomedicine.

EBM’s initial manifesto captured the movement’s anti-authoritarian spirit. The
Evidence Based Medicine Working Group stated that

the new paradigm puts a much lower value on authority. The underlying

belief is that physicians can gain the skills to make independent assessment

of evidence and thus evaluate the credibility of opinions being offered by

experts.555
In Upshur’s recollections of his medical training in clinical epidemiology at McMaster
University by many of the faculty members who later initiated the Evidence Based
Medicine Working Group, he remembers being attracted to its critical rationality. Druing
rounds, students and residents where challenged to explicitly justify their proposed
diagnostic strategy or therapeutic regimen with the pointed question, “what is your

evidence?” The call for evidence in this context “was a call for something more than

preference or convention, a call to an external standard that could be adjudicated and

 

5” Rogers (2002), "Evidence-based medicine and practice: Limiting or facilitating patient choice?" Health
Expect 5; Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates want health
care providers and consumers to pay attention to?" BMC Health Serv Res 2(3).

”5 Evidence Based Medicine Working Group (1992), "Evidence-based medicine." JAMA 268(17), p.
2421.

185

discussed.”556 The transparency and accountability of critical appraisal techniques and
EBM’s procedural emphasis on enhancing the cognitive skills of clinicians suggested a
certain democratic iconoclasm that greatly appealed to earnest new physicians like
Upshur.

We would read it for ourselves and make our own judgments whether to
get prostate-speciﬁc antibodies as screening for prostate disease on all
men or not. Clinical Evidence went even further. It made no judgments.
It assembled the evidence in one spot so that the practicing doctors could
judge and decide for them. Practicing doctors were expected to be

able to think and judge. You might not do it for every case, but you could
look up the evidence on women's incontinence today and screening for
colon cancer tomorrow.557

Despite EBM’s apparent populism, numerous critics (including Upshur) associate EBM
with authoritarianism. Rosenfeld tracks EBM’s historical movement from populism in its
early years to its authoritarian present. She argues that “evidence-based medicine at ﬁrst
promised to be a popularistic movement, bringing the fruits of research to all practicing

physicians. Instead it has created its own religion and dogma, further codifying daily

- 5
practrce.”5' 8

During the last 3 years, EBM has gone from a tool to a religious doctrine
and ﬁxed dogma. There are its priests — men and women who are known
for practicing and preaching EBM and changing the books and literature.
You have to have one of these priests on every board and journal, or you
are not up to date. Anyone who speaks against these priests is blaspheming
EBM, and obviously unscientiﬁc or backward. There are thousands of
acolytes, those who have heard the word and will accept nothing else. 559

 

5’6 Upshur (2005), "Looking for rules in a world of exceptions: Reﬂections on evidence-based practice."
Persp Biol Med 48(4), p. 480.

’57 Rosenfeld (2004), "The view of evidence- based medicine from the trenches: Liberating or '
authoritarian?" J Eval Clin Pra_c 10(2), p. 154.

’53 Rosenfeld (2004), "The view of evidence- based medicine from the trenches: Liberating or
authoritarian?" J Eval Clin Pra_c; 10(2), p. 153.

”9 Rosenfeld (2004), "The view of evidence-based medicine from the trenches: Liberating or
authoritarian?" J Eval Clin Praa 10(2), pp. 154-155.

 

186

6
”5 0 where

As a result, she argues that “we have come full circle to faith-based medicine,
we have replaced one form of authority, namely the habits and opinions passed down
from one generation of clinicians to the next, with another—EBM. This charge of EBM
dogmatism is legitimated in part by EBM proponents’ conﬁdence in evidence based
methodology despite no empirical evidence being available to demonstrate EBM’s
superiority.561 In a 2004 special edition of the British Medical Journal dedicated to
philosophical issues surrounding EBM, one contributor surmised:

Few would disown the EBM hypothesis—providing evidence-based

clinical interventions will result in better outcomes for patients, on

average, than providing non-evidence-based interventions. This

remains hypothetical only because, as a general proposition, it cannot be

proved empirically. But anyone in medicine today who does not believe

it is in the wrong business.562

When pressed to locate the point where EBM shifted from being iconoclastic to
becoming a creed, the critics typically point to the hierarchy of evidence as well as
EBM’s penchant for guidelines and the resulting codiﬁcation of daily clinical practice.
Both similarly eschew EBM’s initial democratic and iconoclastic spirit by legitimating
the expert opinion of EBM proponents over the reasoned arguments of skilled individual

clinicians. The hierarchy of evidence, interestingly, promotes methodological

transparency and encourages reasoned argument by providing a highly rationalized

 

56° Rosenfeld (2004), "The view of evidence-based medicine from the trenches: Liberating or
authoritarian?" J Eval Clin Prac 10(2), p. 153. See also De Simone (2006), "Beyond ‘faith-based medicine’
and EBM." J Eval Clin Prac, 12(4).

56' Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates want health care
providers and consumers to pay attention to?" BMC Health Serv Res 2(3); Upshur and Tracy (In Press),
"Precision versus clinical experience: Family medicine does not need more evidence-based medicine than
at present." Ideological debates in family medicine. The near impossibility of empirically demonstrating the
superiority of EBM over any other mode of medical care by the methods regarded as persuasive by EBM
itself has been recognized from the outset. EBM’s initial manifesto states: “The proof of the pudding of
evidence-based medicine lies in whether patients cared for in this fashion enjoy better health. This proof is
no more achievable for the new paradigm that it is for the old, for no long-term randomized trials of
traditional and evidence-based medicine are likely to be carried out” (Evidence Based Medicine Working
Group (1992), "Evidence-based medicine." JAMA 268(17), p. 2424.

’6’ Reilly (2004), "The essence of EBM." M 329(7473), p. 991; my emphasis.

187

method for evaluating clinical research, yet the hierarchy itself has no empirical
legitimacy. The entire ediﬁce of evidence hierarchies has been argued by Upshur and
Tracy not to be based on systematic research or empirical data, but upon expert judgment
or consensus. They charge that

the structuring of evidence according to a hierarchy is by no means natural,

intuitive, or even logically justiﬁed. In other words, the warrant or

justiﬁcation for viewing evidence on such a hierarchical structure rests on

what EBM proponents consider the lowest form of evidence: the beliefs of

a few.563
They propose that the initial creation of an evidence hierarchy was intended to link the
quality of evidence to the soundness of the recommendations based on the evidence. This
stance was grounded in an unsubstantiated epistemological position that favours certain
study designs (randomized controlled trials and meta-analyses) on the belief that these
methods are less susceptible than observational designs to bias. The key is the ability of
randomization to eliminate selection bias and the unprovable claim that randomization
balances all relevant known and unknown factors in a probabilistic sense.564 The
hierarchy attributes lower reliability to expert judgment, and speciﬁcally subordinates
theory and pathophysiological reasoning to designs with randomization. The reasoning
behind the latter subordination is unclear, as pathophysiology often provides more

fundamental understanding of causation, and is in no way scientiﬁcally inferior. Thus,

the authors conclude, the hierarchy has been advanced on the basis of expert opinion

 

5’3 Upshur and Tracy (In Press), "Precision versus clinical experience: Family medicine does not need
more evidence-based medicine than at present." Ideological debates in family medicine
56" Worrall (2002), "What evidence is evidence-based medicine?" Phil Sci 69(3).

188

rather than reasoned argument—a move unbeﬁtting of evidence based thought and
practice.565
EBM guidelines and clinical summaries invoke charges of authoritarianism for
codifying daily practice and creating a hierarchy of EBM expertise. Given the demands
of keeping up with the literature, the time associated with evaluating the abundance of
clinical research, and the importance of “getting it right”, it did not take long for EBM to
replace its call for individual critical appraisal of the evidence by practicing clinicians
with a veritable industry of systematic review and meta-analysis. While thought by many
to be timely and useful, the availability of meta-analyses and clinical summaries
immediately derails EBM’s early anti-authoritarian programmatic. The initial program of
equipping all practicing physicians with critical appraisal skills was intended to ’
democratize medicine by discarding the hierarchical nature of expert opinion and
received wisdom. That very authoritarianism is argued to be restored by the creation of
“expert” EBM sources that proliferate clinical guidelines, meta—analyses, educational
products, electronic decision support systems, and all things worthy of the brand name
“evidence based medicine” to a captive and paying audience of clinicians who desire to
be “evidence based practitioners”. The various EBM organizations, such as the Cochrane
Collaboration, Best Evidence, and the Task Force are further criticized for being secretive

institutions.566 Rosenfeld asks,

Who are these people? We know where they are located and sometimes
their names, but we must blindly believe in their methods. They come up

 

5’5 Upshur and Tracy (In Press), "Precision versus clinical experience: Family medicine does not need
more evidence-based medicine than at present." Ideological debates in family medicine.

’66 This system not terribly different from the prior methods of peer review with respect to assuring credible
professional literature, however the internalizing of medical expertise within the various evidence based
institutions diminishes the likeliness of receiving disinterested (i.e. external) reviews. Even if the current
system creates evidence that is no worse than before, EBM had proposed that it could do better.

189

with conclusions that are published and then the conclusions become

codiﬁed. The Cochrane conclusions and abstracts are published on the web,

but only those who pay can get the full written method and evidence. Few

practicing doctors will pay for access to the Cochrane database. Who

knows how Problem-Oriented Evidence that Matters (POEMS) decide

their evidence? The practicing doctor has little access to these articles.

Even Clinical Evidence, that source that believed the practicing doctor can

make his or her own conclusions, has published “Concise” conclusions.

Are we too busy, too stupid, or too unreliable to use EBM for ourselves?567
Rosenfeld’s chronicle suggests that similar to EBM’s hierarchy of evidence, there is now
a hierarchy of EBM. Speciﬁcally, “only a few sources are now considered ‘true’ or
reliable EBM. Some organizations list 11—15 ‘proper’ and ‘acceptable’ sources of EBM.
All else, including good research, books, and reviews, are not evidenced-based, and may
not be used.”568 This EBM structure is indeed commercially proﬁtable, and has
generated concern about ﬁnancial conﬂict of interest and publication bias within the
medical literature. Upshur et al., for example, expose the BMJ Publishing Group’s
signiﬁcant stake in the EBM market through its production and sales of costly EBM
textbooks and evidence databases. The conﬂict of interest is suggested by the authors’
ﬁnding that a signiﬁcantly greater number of EBM studies have been published in the
British Medical Journal as compared to the similarly ranked New England Journal of
Medicine, which has no commercial investment in EBM.569

While it would be premature to suggest that there is a link between epistemology

and authoritarianism, the threat of global scepticism that motivates the former can

certainly minimize tolerance of fallibilism and ad hoc and local investigative practices—

 

567 Rosenfeld (2004), "The view of evidence-based medicine from the trenches: Liberating or

authoritarian?" J Eval Clin Prac 10(2), p. 155.

’68 Rosenfeld (2004), "The view of evidence-based medicine from the trenches: Liberating or
authoritarian?" J Eval Clin Prac 10(2), p. 155.

’69 Upshur, Ross E. G. et al (2006), "Can academic and clinical journals be in ﬁnancial conﬂict of interest
situations? The case of evidence based incorporated." J Eval Clin Prac 12(4).

190

the very characteristics of science proper—among more ideological proponents of
science. This sort of patterning has been invoked to explain the appeal and rapid uptake
of EBM. We have seen how the positivist account of evidence underlying EBM is
criticized for not recognizing the fallibility of scientiﬁc evidence in its untenable
objectivism. The worry that all of our representations could be wrong can motivate the
search for epistemic certainty, and trouble arises because this quest is undertaken using a
method of inquiry that is supposed (and even desirable) to be irrevocably fallible. Critics
argue that this promise of medical certainty is unrealistic and suggest that evidence-based
decision-making must be replaced with a more nuanced model of knowledge translation
that can grapple with contingency and the uncertain path of application of knowledge in
practice.570

The proposal that the quest for certainty drives science and scientiﬁc medicine is
a familiar thesis within critical science studies. Feyerabend has described science as

5“ while in

being obsessed with its own mythology of objectivity and universality,
medicine, Katherine Montgomery has argued that medicine mis-speciﬁes itself as a
science with an image of science that is antiquated and that does justice to neither
medicine nor science.572 Science has also been described as a repressing ideology that
started as a liberating movement. 573 EBM reinforces these images, to a certain extent,
with its objectivist account of scientiﬁc medicine and rigid hierarchy of evidence. If the

hierarchy of evidence was put in place to refute scepticism and ensure certainty, it stands

as an example of what Feyerabend abhorred: science making claims to truth well beyond

 

57° Champagne et al (2004), "Introduction: Toward a broader understanding of the use of knowledge and
evidence in health care." Using knowledge and evidence in health care: Multidisciplinary perspectives.
57' Feyerabend (1978), Against method.

572 Montgomery (2006), How doctors think.

’73 Feyerabend (1978), Against method.

 

191

its actual capacity. Science, the critics insist, cannot fulﬁll this epistemic quest for
certainty. Science is at best - and is at its best when it is recognized to be - democratic,
ad hoc, and fallible.

However, the philosophical obsession with scepticism is not necessarily the driver
of EBM. The knowledge problems motivating the evidence based approach are regarded
by some to be much more local and modest, for instance, the presence of small area
variations, and the desire for increased reliability and access to the best conﬁrmed
interventions. Brody et al.’s distinction between “crude” versus “sophisticated” EBM
distinguished between the different ways in which EBM has been employed by
supportive practitioners.574 It also manages to capture the ideological/truth-seeking
versus practical motivation for adopting an evidence based approach to medicine. The
more “practical” users being described here are those clinicians who ﬁnd in EBM no
more than a tool to assist in clinical decisionmaking, a task fraught with difﬁculties for
the very reason that the context always carries elements of uncertainty. We see here that
it is inappropriate for both supporters and detractors to ascribe the appeal of EBM to one
mindset or sensibility among its clinical following.

EBM Critics: From Fallibilism to Relativism

In addition to the importance assigned to democracy in science, the Davidsonian
theme of fallibilism is also present in the EBM critiques. However, recognizing the
fallibility of science will be demonstrated to be insufﬁcient for advancing critical
alternatives to EBM. The EBM critics, who challenge EBM on the grounds of the
fallibility of empirical evidence and the underdetermination of theory, cannot offer

guidance for adjudicating between competing subjective and interpretive ﬁlters that

 

57’ Brody et a1 (2005), "Evidence-based medicine: Watching out for its friends." Persp Biol Med 48(4).

 

192

inescapably enter into clinical decisionmaking. Thus, Davidson’s evidentiary account not
only provides for a more nuanced critical account of EBM, where the movement’s
positivism and objectivism were admonished and its nonpositivist features vindicated, but
also highlights the ﬂaws within the standard postpositivist and critical science studies
EBM critiques. The EBM critics typically over focus on the positivist features of EBM
in their epistemic critique and miss important and even desirable dimensions of the
technology/movement.

Fallibilism was highlighted in the previous chapter as an important theme in
Davidson’s account of evidence and promotion of pragmatic science. Davidson claims
that “as beliefs are by their nature veridical, all beliefs are justiﬁed in this sense. This
leaves open as an empirical question the issue of whether any particular belief, or set of
beliefs, is justiﬁed in some particular context.”575 The pragmatic approach to science,
which was also sketched in the last chapter, serves to investigate those particular
scientiﬁc theories and beliefs. According to Davidson, external, empirical data provides
the basis for synthetic knowledge, but empiricism cannot be used as an epistemological
theory for deciding which particular data are normatively foundational. By re-
establishing the causal connection between beliefs and the world, contra the
postpositivists, yet denying the foundationalist position that this connection establishes
truth, contra the positivists, the scientiﬁc method is vindicated from postpositivist
critique.576

Fallibilism is maintained through adherence to ad hoc, site-speciﬁc rules, such as

repetition and controls. Clough insists that such experimentalism sufﬁciently provides

 

57’ Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 109.
’76 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 110.

193

the knowledge-seeking framework required for scientiﬁc inquiry. Problems only arise
when empiricists and obj ectivists use those methods to try to answer the epistemological
questions. F allibilism admits to local and tentative assignments of truth, while
epistemologists have in mind the higher standard of satisfying any and all future sceptics.
Obj ectivists, for instance, seek to articulate, either a priori or from a naturalized
perspective, those properties of our methods and theories that would indicate truth or a
normatively functional variant such as objectivity.577 Difﬁculties arise because no matter
what normative property we identify in a particular theory, we still must fallibly
acknowledge that future evidence might show the theory to be false. What Clough is
describing is nothing more than empirical science proper, where experimental methods
identify the most reliable knowledge, but not the truth. Objectivism involves the
overextension of science to answer questions of truth by discovering unequivocal and
certain knowledge. EBM has been demonstrated to fall into this scientiﬁc objectivism
through its scientistic hierarchy of evidence.

Within the critical EBM literature, Upshur attempts to raise the EBM discourse
away from earlier polemics by characterizing medical evidence as ultimately fallibilistic
in nature.578 He proposes that acknowledging the fallibilism of medical evidence will
improve our understanding of the role of evidence in clinical practice and health policy.
Medical evidence, by his account, is: (1) Provisional; (2) Defeasible; (3) Emergent; (4)
Incomplete; (5) Constrained; (6) Collective; (7) Asymmetric. These “seven
characteristics of medical evidence” are used by Upshur to support a theory of fallibilism

and underdetermination. The provisional, defeasible, and emergent properties of

 

’77 Clough (2003), Beyond epistemology: A pragmatist approach to feminist science studies, p. 120.
’78 Upshur (2000), "Seven characteristics of medical evidence." J Eval Clin Pug 6(2).

194

evidence show that the ultimate structure of medical evidence is fallibilistic. F allibilism
is thought to best describe the nature of health care evidence because it captures how our
opinions and beliefs about the external world may turn out to be false, and so our
deliberations always involve some level of uncertainty. He cites Charles Peirce and Karl
Popper as major proponents of the fallibilistic account of science. Pierce, in particular,
held that natural science could only rest on experience, and experience can never result in
absolute certainty, exactitude, or universality.579

While the fallibilism highlighted by Upshur is notably missing from the evidence
based approach, which has been demonstrated to operate with a positivist account of
evidence, it is not logically inconsistent with the tenets of EBM. EBM is foundationalist
in its commitment to making empirical evidence the basis of medical decisionmaking,
thus minimizing, if not denying, the interpretive dimensions of clinical practice.
However, there is nothing about EBM’s methodology that fundamentally entails an
objectivist (non-fallible) understanding of empirical evidence. Empiricism “proper”
recognizes the fallibility of evidence and science and therefore seeks maximal reliability
in our beliefs. There is no inconsistency in an evidence based approach to medicine that
strives for added reliability and not truth or certainty in its evidence and practices.

When I presented this observation to Upshur in a private conversation, he
responded that he had written the “Seven Characteristics” paper “back in the days” when
he felt more optimistic about the possibility of both engaging in a genuine critical

discourse with EBM and creating a more philosophical account of EBM. The paper

served as an effort to move EBM away from foundationalism to see that a Peircean

 

’79 Upshur (2006), "The complex, the exhausted and the personal: reﬂections on the relationship between
evidence-based medicine and casuistry. Commentary on Tonelli (2006), Integrating evidence into clinical
practice: an alternative to evidence-based approaches." J Eval Clin Prac 12(3) p. 96.

195

fallibilism was more in keeping with clinical reasoning. Upshur agrees that EBM could
logically/without inconsistency drop its pursuit of truth and certainty in favour of the
(properly) empirical pursuit of maximally reliable beliefs. However, the mix of
personalities, hubris, and politics within “EBM Inc.”580 makes him think that this more
moderate pursuit will never be recognized.581

Returning to the seven characteristics of evidence, the incomplete and constrained
(#4 and #5) properties of evidence show that explanatory theories are underdetermined by
the evidence. Consequently, Upshur argues that there is an interpretive dimension to the
understanding of evidence that is neglected by proponents of EBM, who seem to believe
that an algorithm or decision tree will precisely determine the meaning and interpretatiOn
of evidence.582 Lastly, the collective and asymmetric (#6 and #7) features indicate that
evidence is a social process subject to the forces and vagaries of social life. This ﬁnding
draws attention to the importance of reﬂecting on the unarticulated or unacknowledged
extra—evidential considerations such as values and ideological commitments that factor
into evidentiary analysis.583

To ask whether EBMers can be Piercian is to question whether or at least to what

extent EBM can accormnodate the numerous challenges put forward or does a theory of

medical decisionmaking that properly incorporates the interpretive and fallible

 

58° Upshur et al. (2006). Can academic and clinical journals be in ﬁnancial conﬂict of interest situations? The
case of evidence based incorporated. J Eval Clin Prac 12(4).

’8' My own far briefer involvement within the EBM debate has generated some concurring experiences,
notably having my published views on the positivist tendencies within EBM (Goldenberg (2006), "On
evidence and evidence-based medicine: Lessons ﬁom the philosophy of science." Soc Sci Med 62(1 1))
being fervently and angrily denied by a professor of medicine at Brown University as “postmodemists take
another whack at EBM” in a posting on a large evidence based health list serve in November 2006. The
hostility of the posting was surprising—no doubt, I had pushed some buttonsl—and consistent with
Upshur’s above comments on the unwillingness of many EBM supporters to critically reﬂect on the
approach.

5 2 See Upshur (1999), "Priors and prejudice." Theor Med Bioeth 20(4).

’83 Upshur (2000), "Seven characteristics of medical evidence." J Eval Clin Frag 6(2), p. 96.

 

196

dimensions of evidence require abandoning EBM and starting from the beginning. This
is a difﬁcult question to evaluate given the different interpretations of what EBM
represents, what it can involve, what it does involve, what it should involve. We will
focus, instead, on what characteristics an account of clinical reasoning should exhibit.

The seven characteristics of evidence espoused by Upshur legitimate the shared
themes of critical science studies: the antifoundationalism, underdetermination, and
sociality of science. Upshur concludes that, against the evidence based approach, there
are inherent limitations of basing clinical practice solely on evidence. Here we see
difference between Upshur’s endorsement of fallibilism and Clough’s. While both would
agree with the general critique that EBM leaves interpretive practices out of its decision
making schemas, Clough would not endorse the position that clinical decision making
and practice must be based on other things than evidence—the “extra-evidential
considerations”. Instead, there is nothing else that clinical practice can be based on, as all
evidence is belief, and all beliefs are empirically based (and are, therefore, evidentiary).
To suggest that there is anything out there in the world that is not evidentiary is to
commit to a representationalist metaphysical gap and an objectivism-to-relativism slide.
We saw that Upshur argued for an interpretive dimension to the understanding of
evidence, and similarly, that theory could be underdetermined by the evidence.

This different invocation of fallibilism, which Clough would characterize as
representationalist versus non-representationalist, is of practical consequence, as the
EBM critique in fact leads to the relativism that worried Clough. In “A Popperian
Perspective of the Term ‘Evidence-Based Medicine’,” Shahar similarly invoked a theory

of fallibilism to critique the EBM account of evidence. Drawing from the work of

197

Popper, he makes the case against the logical possibility of medicine being based on the
evidence. Popper’s well-known theory of falsiﬁcation demonstrates that evidence cannot
prove scientiﬁc theories, but only falsijy them. Thus medicine needs much more than
evidence in order to make informed treatment decisions. Scientiﬁc hypotheses are
forever conjectural and open to refutation. This has to do with the incompleteness of
experiential evidence; no number of successful trials provides logical support to the
theory that a treatment is always superior to a placebo, just as no number of negative
trials can support the theory that the treatment is never superior to placebo. Popper and
others have relentlessly argued against the possibility of constructing a system of
inductive logic.584 Similar to Upshur, the incompleteness of evidence and the fallibility
of our theories and beliefs are invoked to make the case that even when the latest, best,
and most relevant clinical research is consulted, more goes into medical decision making
than the (experimental) evidence.

Shahar does not end his critique with the many practical problems of applying
evidence to medicine, and instead continues with the difﬁculties surrounding the
production and interpretation of clinical data. The current challenges to trial design and
statistical analysis will not be discussed here;585 what is signiﬁcant to this discussion is
the fact that there is no unanimity within the scientiﬁc community regarding how
research questions ought to be tested, and how the resulting trial data ought to be
interpreted.586 While there are certain broad rules of experimentation to minimize

methodological bias, scientists must rely heavily on subjective preferences regarding

 

5” Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Prac 3, pp.
110-111.

58’ Some of those issues were already discussed in chapter one.

5“ Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Prac 3(2),
pp. 112-113.

198

experiment design or data interpretation and practical constraints, such as budget and
available resources, when conducting scientiﬁc trials. The next step of interpretation of
trial data adds another level of subjective content, as cases have been documented where
the same data generates more than one, even opposing, conclusions, as researchers
disagree on the meaning of the data.587

These problems are recognized by Shahar to similarly apply to both EBM and
pre-EBM. Furthermore, he ﬁnds the term “evidence based medicine” to
indistinguishable from “medicine” (i.e. nothing new about EBM). He ﬁnds problem in
the term “evidence based”, however, as “evidence” is a term that is linked with the
assumption that it is scientiﬁcally objective and readily discerned by trained scientists.
As we have seen already, EBM is problematic in part because of its either untenable or
unrealized promises of objectivity and democracy in science.

Shahar’s challenges to the supposed objectivity of clinical trials lead him to the
pessimistic conclusion that

the results of a clinical trial hardly deserve the title evidence, not only

because every interested scientist can question various statistical and

design aspects, but also because the whole process of data analysis,

presentation, and interpretation contains many subjective elements.588
Of course, the theory-ladenness of evidence and the underdetermination of theory by the
evidence do not comprise the entirety of Shahar’s challenge of the evidence of evidence-

based medicine. Even in instances where the data is consistent and there is agreement

regarding the interpretation of data, it is still unclear “at what point of time we have

 

’87 This, of course, will be true of pre-EBM scientiﬁc medicine. However, these ﬁndings certainly
challenge the self-professed superiority of EBM.

5’8 Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Prac 3(2),
p. 113.

199

gathered ‘enough evidence’ to justify an action.”589 F urtherrnore, when is there “‘enough
evidence’ to practice evidence-based medicine. . .?”590 For Shahar, “the answer is simple:
there is enough evidence. . .whenever the mind of a doctor decides so.”59' In some cases,
all doctors similarly decide and agree on a proposed endpoint. However, in cases where
disagreement arises, those who espouse EBM will accuse doctors with opposing
interpretations of practicing non-EBM. He concludes that

there is no rule of logic that can help us decide whose interpretation of

empirical experience is the evidence, [instead] we can formulate many

rules of preference.592
Shahar fears that since preferences have no logical content, use of the term “evidence
based medicine” calls for a new type of authoritarianism in medicine.593 He detects a
theoretical deﬁcit hidden beneath the mantra of “evidence based medicine” that permits
certain interests and agendas to go unchecked.

Shahar’s conclusion that clinical trial data “hardly deserves the name evidence”
puts scientiﬁc medicine in a precarious place. If clinical research cannot justify medical
treatment decisions, what does? He writes that the “permanent uncertainty” that cloaks

medical decisionmaking require doctors to decide “on the basis of some interpretation of

empirical experience - a subjective exercise with no universally accepted logical

 

”9 Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Frag 3(2),

. 114.
go Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Praa 3(2),

. 114.
i)” Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Praa 3(2),

. 114.
B” Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Praa 3(2),

. 114. ’
1’93 Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Pra_c 3(2),
p. 115.

 

200

rules.”594 Shahar provides an account of the numerous layers of subjective interpretation
that go into the formulation of empirical or experiential evidence and into the subsequent
clinical decision-making process. He concludes that the underdetermination of theory
requires that we ask the important question: whose evidence is the evidence? While there
is wisdom in this recommendation, he also states that no interpretation of empirical
evidence “deserves a special place of honour.”595 This admission is alarming, as we
presumably want our treatments to be based on more than the whims and preferences of
physicians. This is precisely how EBM advocates characterized pre-EBM or
“traditional” biomedicine, and the proposal to make medical decisionmaking more
rational and justiﬁed was what made EBM so appealing. If Shahar is correct that EBM is
no better than pre-1990’s biomedicine, and if there is no way to decide which ﬁlters,
interpretive frameworks, or standpoints are preferable, then all patients are in a terrible

predicament.596

Then again, if the successes in biomedical patient care seem to be
grounded in something more than luck, then Shahar is perhaps overstating the problem.
In “Who’s Evidence? Lessons from the Philosophy of Science”, Harari similarly
takes the “lesson from the philosophy of science” to be the inadequacy of positivist
empiricism’s account of knowledge production, on which he claims the evidence-based
approach is predicated. Against the misplaced conﬁdence in the power of empiricist
principles to determine what constitutes reliable knowledge, Harari echoes Upshur’s

theme of fallibilism in characterizing clinical practice as requiring

intellectual ﬂexibility, tolerance of ambiguous and discordant information

 

59" Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Pry 3(2),

. 115.
£95 Shahar (1997), "A Popperian perspective of the term 'evidence based medicine'." J Eval Clin Prac 3(2),

. 114.
B” We will see in the next chapter that this is not just an epistemic, but also an ethical, concern.

201

obtained by different methods from differing viewpoints at different

conceptual levels, the judicious yet knowingly fallible, theory-derived

construction, selection and interpretation of observations and empathically

derived experiences.597
Similar to both Upshur and Shahar, he concludes with the representationalist statement
that “a plurality of theoretical moves have to be made beyond the observation statements
themselves to explain any particular set of observations.”598 His metaphysical bifurcation
between observation statements and all other statements leads him to the same sceptical
doubt as Shahar about the truth of our knowledge claims: “we cannot understand ‘facts’
free from the inﬂuence of previous learning and conceptual framework that selects and
organizes the observations at different conceptual or epistemic levels.”599 The “lessons
from the philosophy of science” apparently do not include a way out: an account for how
to manage the social and interpretive dimensions of both science and evidence.

Thus we see the familiar situation among EBM critics where, much like the
feminist epistemologists of science in the previous chapter, chastising EBM’s objectivism
and articulating the fallibilism of evidence, while critically important, does not open up
possibilities for alternatives to EBM.600 The critics cannot offer alternative
decisionmaking frameworks that can adjudicate between the competing conceptual ﬁlters
that invariably enter into clinical decisionmaking. We saw in the previous chapter that

Clough allows for a proper “attitude” of fallibilism about our beliefs—that is, the self-

critical recognition that our beliefs can be false—but lamented the easy slide from such a

 

”7 Harari (2001), "Whose evidence? Lessons from the philosophy of science and the epistemology of
medicine." Austr N Zea J Psychfm 35(6), p. 729.

’98 Harari (2001), "Whose evidence? Lessons from the philosophy of science and the epistemology of
medicine." Austr N Zea J Psychiatry 35(6), p. 726.

’99 Harari (2001), "Whose evidence? Lessons from the philosophy of science and the epistemology of
medicine." Austr N Zea J Psychiatry 35(6), p. 728.

60° In fact, it’s worse. It leaves us apparently unable to explain the rational superiority of modem to
premodem medicine.

202

position into scepticism where values act as non-belief ﬁlters. She distinguished between
representationalist ﬁlters, where ﬁlters are for beliefs, and non-representationalist ﬁlters,
where ﬁlters are beliefs about the world. While there certainly are difﬁculties with
distinguishing between the two—recall the opposing readings of Longino and Bleier—
because of the same “ﬁltering language” being used in both instances, Clough is indeed
proposing two distinct ontological positions. We have seen so far that the non-
representationalist position is preferable because it avoids the puzzling metaphysics of a
ﬁlter being neither empirical nor a value. This framework is also supposed to avoid the
relativism encountered by the EBM critics by making the interpretive frameworks that
invariably accompany all production, presentation, and utilization of clinical evidence
open to evaluation. The success of this non-relativist framework in addressing the
challenges of EBM is yet to be determined, of course, as considerable work must be done
to establish the causal links for beliefs. In the next section, I will initiate a health
research program to establish the broad empirical research that establishes those links.
Initiating an Alternative Health Research Agenda

Clough advocated going beyond epistemology because the epistemological
program invited scepticism by limiting the intellectual terrain to either obj ectivism or
relativism. She endorsed a pragmatic framework because evidence could maintain its
normativity without subscribing to scientiﬁc objectivism. While I have already denied
Clough’s prescribed strategic reversal of abandoning epistemological pursuits in favour
of the critical empirical science of early feminist science studies,601 I support her effort to

reinvigorate the normativity of evidence found in objectivist epistemologies without the

 

60' While feminist science’s shift from critical empirical science to epistemology was seen by Clough to be
understandable within its historical context, Clough advocates a strategic reversal because epistemology
created more problems than it solved.

203

objectivism while avoiding the relativism of evidence thought to accompany contextualist
theories of knowledge.

Just as Clough denied Longino’s conclusion that the feminist interpretation of
archaeological ﬁndings was politically preferable but evidentially equivalent to its
androcentric challenger, Shahar’s resignation that no one social ﬁltering of medical
evidence should be honoured over another can be similarly rejected. Medical decisions
should be made through the evaluation of the relevant evidence. All theories, according
to Davidson, have a causal relation to the world. Because all evidence involves belief,
and all beliefs are evidential, a plurality of methods is needed to establish the relevant
causal connections. As a result, medical research must not be pared down to a rigid, pre-
graded hierarchical methodological system. Instead, a broad range of health research,
which includes basic science, epidemiology, social science, and humanities, and a cross-
disciplinary and integrative research agenda are required to establish these causal
connections.

The details of the course of investigation into the use of evidence in medical
decisionmaking still need to be established. We have seen that the epistemological
investigation undertaken in this project unpacks some of the background presuppositions
and preoccupations that play into the question of evidence and offers certain avenues for
further pursuit while denying other possible directions. In the next chapter, we will
return to the ethical analysis of EBM found to be wanting in chapter one, but now
enriched by a more substantial understanding of the “evidence” that plays so centrally in
an “ethics of evidence”. Already, a link between the epistemology and the ethics is

being forged. Underlying this broad health research programme is the assumption that

204

methodological pluralism and openness to different traditions can only assist in
evidentiary investigations. In the interest of democratic science, research agendas and
funding formulas should not be shaped by questions that can ﬁt into evidence-based ,
criteria. Instead the evidentiary criteria should be made to ﬁt the question that needs to
be addressed. Medical research cannot be constrained by narrow accounts of evidence
and the limited range of methodologies capable of gathering this data set. Instead health
research must be construed more broadly and incorporate the efforts of variously trained
health scientists, clinicians, and medical humanities researchers.

F eyerabend has, in fact, insisted that methodological pluralism is part and parcel
of scientiﬁc inquiry and investigation. In both Against Method602 and Science in a Free
Society,603 he argues that there have historically been no methodological rules which are
always604 used by scientists. Examining episodes in science that are generally regarded
as indisputable instances of progress, such as the Copernican revolution, he demonstrated
that all common prescriptive rules of science were violated to some extent.“ He adds
that attempts to adhere to the rules in those historical situations would actually have
prevented scientiﬁc revolution. Thus, not only does he offer a controversial description
of science, but he objects to science’s ideal of methodological uniformity. He objects to
any single prescriptive scientiﬁc method on the grounds that any such method would
limit the activities of scientists, and hence restrict scientiﬁc progress. Democratic

science, he proposes, requires “theoretical anarchism”: methodological pluralism,

 

”02 Feyerabend (1978), Against method.

60’ Feyerabend (1979), Science in aﬁee society.

60" But one can still allow that there were more popular or preferable methods.
’0’ F eyerabend (197 8), Against method, pp. 93-98.

205

openness to alternative traditions, and input from non-scientiﬁc domains.606 The beneﬁt
to scientiﬁc inquiry gained by such anarchistic measures is that pluralistic methodology
that involves making comparisons between competing theories forces defendants to
improve the articulation of each theory.607 In this way, scientiﬁc pluralism improves the
critical power of science.

More now needs to be said to justify this appeal to epistemological anarchism, as
F eyerabend’s position is very controversial and has invoked hostile reactions by many
within science studies, most notably the famous labeling of the author as “the worst
enemy of science”.608 One of F eyerabend’s most contentious theses is the “principle of
proliferation”, which advocates the generation of incommensurable alternatives to current
orthodox theories. His endorsement of such provocative slogans as “anything goes” and
“epistemological anarchism”, not to mention his impassioned defenses of witchcraft,
astrology, and faith-healing, no doubt contributed to Feyerabend’s notorious reputation of
being antiscientiﬁc, irrational, antirnethodological, antireason, and a relativist.609
Elizabeth Lloyd has persuasively argued, however, that F eyerabend’s statement
“anything goes” should not be read as an anarchistic (anti-)methodological
recommendation for the conduct of scientiﬁc research, but rather as a reductio against
certain forms of rationalism.‘510 F eyerabend himself stated that “ ‘anything goes’ does not

express any conviction of mine, it is a jocular summary of the predicament of the

 

6"“ Feyerabend (1978), Against method, p. 17.

”07 Feyerabend (1978), Against method, p. 47.

60’ Theocharis and Psimopoulos (1987), "Where has science gone wrong." Nature 329(6140).

”09 On Feyerabend’s anti-science reputation, see Lloyd (1996), "The anachronistic anarchist." Phil Studies
81(2).

6'0 Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of science? Essays in memory of
Paul Feyerabend.

206

rationalist.”6H Speciﬁcally,

if you want universal standards, I say, if you cannot live without

principles that hold independently of situation, shape of world,

exigencies of research, temperamental peculiarities, then I can give you

such a principle. It will be empty, useless, and pretty ridiculous—but it

will be a “principle”. It will be the “principle” “anything goes”.612
Thus, Lloyd maintains, the slogan does not represent F eyerabend’s own positive
methodological program. However, the misreading likely stems from his genuine belief
that the proliferation of all views and methods adds value to science. It has already been
mentioned that Feyerabend frequently traces his arguments for the importance of
proliferation to Mill’s essay, On Liberty.613 He endorsed Mill’s position that pluralism is '
supposed to lead to truth“ and often quoted the following passage from On Liberty:

The peculiar evil of silencing the expression of opinion is that it is

robbing the human race. . .If the opinion is right, they are deprived

of the opportunity of exchanging error for truth: if wrong, they lose,

what is almost as great a beneﬁt, the clearer perception and livelier

impression of truth, produced by its collision with error.“5
It is in this vain that Feyerabend wrote, in Science in a Free Society, that “the only way of
arriving at a useﬁrl judgment of what is supposed to be the truth, or the correct procedure,
is to become acquainted with the widest possible range of alternatives?“6 While his

subsequent defenses of witchcraft, astrology, and other nonscientiﬁc worldviews may

make one question how much tolerance to alternative ideas is meaningful to the pursuit of

 

6” Feyerabend (1978), Against method, p. 188.

6'2 Feyerabend (1978), Against method, p. 188.

6'3 See pp. 125-126 of this dissertation.

6” Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of science? Essays in memory of
Paul Feyerabend.

6" Mill (1989), "On liberty." On libem and other writings, p. 20. See also chapter 2, “Of the Liberty of
Thought and Discussion”. Mill's arguments for the freedom of expression of opinions cannot be discussed
here. For an excellent overview, see Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of
science? Essays in memory of Paul Feyerabend, pp. 117-119. For Feyerabend’s appropriation of Mill in
the context of science, see pp. 119-121 of the same essay.

6'6 Feyerabend (1979), Science in a free society, p. 86.

207

truth, they should not be read as a total disregard of empirical evidence by F eyerabend.
Instead they are part of a Mill-inspired rejection of blind belief in the superiority of
scientiﬁc expertise as being themselves strong enough to rule out alternative forms of
expertise. Indeed, Feyerabend continued his (above) endorsement of proliferation in
order to arrive at truth with the statement: “the reasons [for proliferation] were explained
by Mill in his immortal essay On Liberty. It is not possible to improve upon his
arguments?“7

Lloyd proposes that seeing F eyerabend as attempting to enact and embody these
views of Mill provides a valuable interpretive framework for his more peculiar actions
and extreme views, such as his defense of astrology. Mill held that a position can only be
rationally held once one has heard and sincerely considered both arguments in favour and
against it. This requires consultation with proponents of altematiVe views, so that the
seeker of truth

brings [the arguments] into real contact with his own mind. He must be

able to hear them from persons who actually believe them; who defend

them in earnest, and do their utmost for them. He must know them in their

most plausible and persuasive form; he must feel the whole force of the

difﬁculty which the true view of the subject has to encounter and dispose

of; else he will never really possess himself of the portion of truth which

meets and removes that difﬁculty.618
Furthermore, “if opponents of all important truths do not exist, it is indispensable to
imagine them, and supply them with the strongest arguments which the most skilful
devil’s advocate can conjure up.”6'9 Feyerabend, Lloyd proposes, followed Mill’s

mandate by championing minority views for the sake of rational discussion. When

questioned about his support of astrology, Feyerabend tellingly stated:

 

6'7 Feyerabend (1979), Science in a free society. p. 86.

6'8 Mill (1989), "On liberty." On libem and other writings, pp. 38-39.
6'9 Mill (1989), "On liberty." On libepty and other writings, p. 39; my emphasis.

208

My use of examples from astrology should not be misunderstood.

Astrology bores me to tears. However it was attacked by scientists,

Nobel Prize winners among them, without arguments, Sigiply by a

show of authorlty and in this respect deserved a defense.

Lloyd’s interpretation of Feyerabend as a champion of Mill’s pluralist agenda has
a few hints of weakness. For one, On Liberty focuses explicitly on religious cases where
there was no promise of factual evidence to which appeal could be made. Furthermore,
Mill’s treatise on scientiﬁc reasoning, System of Logic,621 is recognized by Lloyd to
conﬁgure “physical science” more narrowly in terms of norms and expectations than
Feyerabend allows it to be. Thus Feyerabend may have misappropriated Mill’s
arguments or Lloyd may be misreading Feyerabend. Yet, Lloyd defends F eyerabend’s
move, arguing that Mill explicitly stated that On Liberty was not primarily about the
limits of government interference.622 On Liberty focused on the cultivation of attitudes
and skills needed for the genuine ﬂourishing of human intelligence and creativity, such as
tolerance and nonconformist attitudes, and Mill explicitly included the sciences in his
recommendation of “absolute freedom of opinion and sentiment on all subjects, practical
and speculative, scientiﬁc, moral, or theological.”623 This is meant not only to support
the principle of liberty, but for attaining scientiﬁc truth, as “even in natural philosophy,

there is always some other explanation possible of the same facts; some geocentric theory

instead of heliocentric, some phlogiston instead of oxygen.”624 Lloyd concludes that

 

62° Feyerabend (1991), Three dialogues on knowledge. p. 165.

62' Mill (1974), A system of logic, ratiocinative and inductive: Being a connected view of the principles of
evidence and the methods of scientiﬁc investigatm

’22 Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of science? Essays in memory of
Paul Feyerabend. p. 121.

623 Mill (1989), "On liberty." On libem and other writings, p. 52.

62“ Mill (1939), "On liberty." On libeay and other writings, p. 33.

209

Feyerabend’s application of Mill’s views to science is consistent and appropriate.625

Feyerabend’s reading of Mill can in fact be justiﬁed on ﬁrrther grounds than those
offered by Lloyd, speciﬁcally the normativity of science ﬁts it under the jurisdiction of
Mill’s principle of liberty. In On Liberty, Mill was principally concerned not with
protecting minority religious views from the interference of government, as Lloyd
”correctly indicates, but about social norms, where he claimed that protection is needed
against “the tyranny of prevailing opinion and feeling.”626 The political reading of EBM
that has been rehearsed throughout this dissertation—underscored by a compelling
picture of science as social knowledge—supports this reading of F eyerabend as a disciple
of Mill in his promotion of radical pluralism. Even if Mill did fail to appreciate the full
scope of science’s social normativity (as suggested by his System of Logic), Feyerabend’s
rereading is defendable in light of more contemporary interpretations of science.

Thus the alleged worst enemy of science has been argued to instead be science’s
most eccentric defender—a tactician that aimed to promote rational discussion, critical
consideration, and even the pursuit of scientiﬁc truth through the expression of
alternative methods and views. While Lloyd laments being unable to ask Feyerabend just

627 It

how extensive his intentions were to enact the wide context of alternative positions,
is fair to assume that Feyerabend would have strongly objected to EBM’s silencing of
certain forms of knowledge through its methodological hierarchies.

It is with the same concern regarding hegemonic discourses that Holmes et al.

argue that the widespread endorsement of the Cochrane Collaboration’s hierarchy by so

 

62’ Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of science? Essays in memory of
Paul Feyerabend, p. 122.

62" M111 (1939), "On liberty." On liberty and other writings. p. 9.

’27 Lloyd (2000), "Feyerabend, Mill, and pluralism." The worst enemy of science? Essays in memory of

Paul Feyerabend, p. 124.

 

210

many of the health science’s academic institutions has served to exclude of certain forms
of knowledge production. The authors, most of whom are professors of nursing, charge
that

it is becoming increasingly evident that an unvarying, uniform language —

an ossifying discourse - is being mandated in a number of faculties of

health sciences where the dominant paradigm of evidence-based health

science has achieved hegemony. This makes it difﬁcult for scholars to

express new and different ideas in an intellectual circle where

normalization and standardization are privileged in the development of

knowledge.628
Because dissenters risk being marginalized by their colleagues, and because the evidence-
based approach now represents the “ladder of success” in academic and research settings,
the challenges associated with resisting the dominant discourse are great. The authors
object to EBM’s exclusivity with respect to scientiﬁc knowledge not only because of the
hindrance to intellectual freedom, but also because this stratifying and segmenting
tendency goes against the general belief that health sciences research requires a plurality
methods and views.629 They argue that “scholars have not only a scientiﬁc duty, but also
an ethical obligation to deconstruct these regimes of power.”630 Against the intellectual
violence that they see arising ﬁ'om EBM’s silencing of alternative knowledges, they
recommend a resurgence of free speech and a plurality of views and methodologies
within the health sciences.

Many EBM critics emphasize the value of methodological pluralism in health

research. Worrall, for example, insists that EBM’s methodological hierarchy is ﬂawed in

 

’28 Holmes et 01(2006), "Deconstructing the evidence-based discourse in health sciences: Truth, power and
facism." Int J Evid Based Healthc 4(3), p. 182.
62’ Holmes et a1 (2006), "Deconstructing the evidence-based discourse in health sciences: Truth, power and
facism." Int J Evid Based Healthc 4(3), p. 182.
63° Holmes et al (2006), "Deconstructing the evidence-based discourse in health sciences: Truth, power and
facism." Int J Evid Based Healthc 4(3), p. 180.

 

211

 

 

 

its failure to recognize that non-experimental evidence, such as observational studies, and
the range of qualitative methodologies, are as important and informative to family
medicine as RCTS, and will be necessary to address the problem of applying population
based research onto individual patient care.63 I Davidson’s nonrepresentationalist
metaphysics expands the scope of “non-experimental evidence” to include such formerly
non-evidentiary considerations as ethics, politics, and sociology (and, of course, crystal
gazing, tea leaves, and wishful thinking; some constraints seem appropriate). This move
avoids the relativism previously encountered when forced to adjudicate between
competing social ﬁlters or standpoints.

To illustrate, Davidson’s evidentiary account can assist EBM with its difﬁculty
integrating patient values and perspectives into its model of clinical decisionmaking.632 It
has been noted that “nowhere in the EBM process is listening to patients and their
concerns and legitimizing their questions regarded as important.”633 While EBM’s model
of clinical decisionmaking offers steps for posing the clinical question, searching the
terms in order to ﬁnd the best evidence, and ﬁnally, applying it to the individual patient,
there is no point in which the voice of the patient is heard (except insofar as it voices
pathological information that can be transformed into searchable terms). In what has
634

been referred to as an “extract and apply” method of clinical decisionmaking, it is no

wonder that EBM still struggles to integrate patient values and perspectives into its

 

 

63' Worrall (2002), "What evidence is evidence-based medicine?" Phil Sci 69(3)
’32 Tonelli (2006),"1ntegrating evidence into clinical practice: An alternative to evidence-based
approaches. " JEval Clin Prac12(3).

Upshur (2005), "Looking for rules in a world of exceptions. Reﬂections on evidence-based practice."

Persp Biol Med 48(4), p. 480.
63’ Upshur and Tracy (2004), "Legitimacy, authority, and hierarchy: Critical challenges for evidence based

medicine." Brief Treatment Crisis Intervention 4.

212

methods.635 Because EBM is focused on finding and applying ‘evidence ’, however
deﬁned identijying something as non-evidentiary suggests from the outset that it is less
valuable than those bits of information considered “evidentiary Indeed, patient values
and perspectives are considered to be nonevidentiary. Gupta has made the interesting
move of challenging this status. She begins with the observation that when the EBM
literature mentions (and struggles with) integrating patient values, it is writing from the
point of view of the practitioner, where the notion of “patient values” refers to the fact
that people have values, and not the content of the actual values themselves.‘536 This
insight can be taken further: EBM’s scope of evidence is limited to medical evidence—
coming from the “third person” scientiﬁc perspective only, with no consideration given
to the ﬁrst person phenomenological perspective of the patient’s lived experience.637
Thus, patient perspectives are nonevidentiary on two counts: they are anecdotal, and
therefore methodologically ﬂawed, and they are outside of the scope of relevant evidence
because they do not offer clinical evidence.

Gupta argues that patient values can, in fact, be (scientiﬁcally) evidentiary in
certain cases. Certain treatment options may be opened up or closed by the patient’s
perspective regarding, say, the withdrawal of life-sustaining treatments or the use of

assisted reproductive technology. What counts as evidence, in this context, is determined

by the knowledge or information in question being evidence for something, and does not

 

6” See, for example, Haynes (2002), "What kind of evidence is it that evidence-based medicine advocates
want health care providers and consumers to pay attention to?" BMC Health Serv Res 2(3)
6” Gupta (2006), "Beyond 'evidence'. Commentary on Tonelli (2006), Integrating evidence into clinical
practice: an alternative to evidence-based approaches." J Eval Clin Prac 12(3), p. 249.

37 This distinction between third- and ﬁrst-person perspectives comes from Husserl’s important
phenomenological division between the scientiﬁcally described world of natural science and the
“lifeworld” of everyday experience. See Husserl (1970), The crisis of European sciences and

transcendental phenomenology.

213

depend on where or how it was derived.638 In this case, the context permits the patients’
values to be relevant evidence for treatment decisionmaking and certain prognostic
considerations (such as the patient’s likely compliance with the treatment regiment),
despite the data being low on the hierarchy of evidence. Gupta’s characterization of
evidence as being any information that can support an inference converges with
Davidson’s evidentiary account because it does not permit any knowledge source to be
predetermined as always, never, or minimally evidentiary in the context of
decisionmaking about individual patient care. Just as a patient’s values can be
evidentiary, clinical data can, in some cases, be ﬂawed to the point of lacking in
credibility or unlikely to increase the probability of some inference being true.

Yet Gupta’s position may seem overstated if the distinction between ﬁrst and
third person evidentiary perspectives is not kept in mind. The evidence offered by
patients’ preferences is typically not treatment evidence, which is the evidence in which
EBM is interested. Patient values frequently do not provide evidence in favour or against
a course of treatment, but instead are simply dispositive. For instance, it is not a matter
of evidence but rather a matter of moral respect that bars a clinician from implementing a
treatment regime against the wishes of a competent patient. But the matter of compliance
mentioned by Gupta is a matter of the evidence that some treatments will work while
others will not. Thus EBM’s maligning of anecdote (clinical or otherwise) is further
destabilized. Furthermore, the challenge to EBM is that an evidence based
decisionmaking technology should not be resistant to phenomenological evidentiary

perspectives when negotiating the clinical context for the very reason that the clinic is the

 

’38 Gupta (2006), "Beyond 'evidence'. Commentary on Tonelli (2006), Integrating evidence into clinical
practice: an alternative to evidence-based approaches." J Eval Clin Prac 12(3), p. 250.

214

site where research evidence meets actual patients.
In Conclusion

EBM has been argued to maintain both pragmatic and epistemological
allegiances. EBM is pragmatic in its commitment to the comparative analyses offered by
RCTS rather than basic science’s interest in causal understandings of treatment
interactions. On the other hand, EBM’s hierarchy of evidence delves into non-pragmatic
epistemology as the pre-graded ranking of research methods offers a priori normative
properties for ascertaining maximal objectivity. Davidson and Clough would presumably
propose that EBM’s pragmatic features are worth keeping, while the rigid hierarchy of
evidence, as we saw, leads to considerable problems for EBM. The EBM critics, writing
from the postpositivist philosophy of science tradition, have amply demonstrated these
problems. Yet just as the representationalism of the Western epistemological framework
led critical epistemologists of science to relativism, the EBM critics, who challenge EBM
on the grounds of the fallibility of empirical evidence and the underdetermination of
theory, similarly fall into relativism. The critics can offer no guidance for adjudicating
between the competing subjective and interpretive ﬁlters that inescapably enter into
clinical decisionmaking.

Following Davidson’s advancement of a normative but non-objectivist account of
evidence, the argument was made that medical decisions can be made through the
evaluation of the relevant evidence. The key is not to narrow “evidence” into an
authoritarian hierarchy that is supported by a rigid and confused epistemology of science.
Health research must be construed broadly in both scope and methodology. It is in this

spirit of methodological pluralism, where evidence is construed broadly (but still

215

empirically) to include the cultural ﬁlters that befuddled EBM critics and encouraged a
“hasty retreat from the evidence”, that I will revisit the ethical analysis of EBM in the
next (and ﬁnal) chapter to synthesize the epistemic, methodological, and political

challenges to EBM that have been examined throughout this dissertation.

216

CHAPTER SEVEN
Revisiting the Ethics of EBM: On the Normativity of the Technical

A plausible explanation for why considerations of the ethics of EBM has been
limited to consequentialist considerations regarding EBM is because this underdeveloped
area of research treats EBM instrumentally; EBM is regarded as a morally neutral tool or
means for either achieving or hindering the independently derived goals of medicine.

The entirety of this dissertation has forwarded a more philosophically complex
understanding of the evidence-based approach in its investigation of the rationale for
grounding a philosophy of medicine in the supposed objectivity of evidence. EBM has
been demonstrated to introduce new epistemological commitments to medicine, thus it
plays a part in creating the aims and goals, and not just carrying them out. The ethical
analysis undertaken in this chapter aims to incorporate this broadened understanding of
EBM and its moral signiﬁcance.

EBM has been widely criticized for being blind to the social context that it
operates in, which renders invisible its inherent values and norms. An ethical analysis of
EBM that uncovers and evaluates those obscured features could advance the EBM debate
signiﬁcantly. I undertake this task by examining evidence based ethics, the application of
the evidence based approach to bioethical deliberation. Because ethics is an explicitly
value-laden and normative enterprise, examining evidence based ethics assists this
investigation by bringing the internal logic and inherent values of the evidence based
approach into stark relief. It also illustrates the limited purview of the current ethics of
EBM discourse, which focuses exclusively on the consequentialist analysis of EBM’s

effect on health outcomes. Thus this “detour” into evidence based ethics will be brought

217

to bear on the ethics of EBM, which I have broadened to include consideration of the
ethics of evidence.
The Ethics of Evidence

In “Outcomes Research and the Quality of Health Care: The Beacon for an Ethics
of Evidence”,639 Valerie Mike’ advocates the rigorous development and proper use of
evidence as an integral part of medical ethics. She coins the term “ethics of evidence” to
denote the moral implications of developing and applying evidence and to promote the
role of statistical evidence in ethical medical decision making.

Miké’s “ethics of evidence” offers an approach for managing medical uncertainty.
The ethics of evidence calls for the creation, dissemination, and use of the best possible
scientiﬁc evidence as a basis for every phase of medical decision making, as high quality
evidence is regarded to be integral for ethical practice in medicine. True to her
profession, Miké, a biostatistician, holds that the best evidence comes from carefully
controlled trials and statistical inference. Without accurate evidence, she explains, the

”640 cannot be upheld. A patient’s autonomy cannot

four “principles of biomedical ethics
be respected via the informed consent process if, say, the pr0posed procedure has not
been properly evaluated. The principles of beneﬁcence and nonmaleﬁcence also
implicate the quality of evidence as they call for consideration of the risks and beneﬁts of
a course of treatment or nontreatment. It is presumably unethical to use powerful
medical procedures without careful evaluation of their safety and effectiveness. Mike

suggests that studies without proper statistical design are in violation of the Nuremberg

Code’s stipulations that experiments “should be such as to yield fruitful results for the

 

’39 Miké (1999), "Outcomes research and the quality of health care: The beacon of an ethics of evidence."
Eval Health Prof 22(1).
64° Beauchamp and Childress (2001), Principles of biomedical ethics.

 

218

good of society” (Rule 2) and that they “should be so designed. . .that the anticipated
results will justify the performance of the experiment” (Rule 3).”4' Lastly, the principle
of justice, which Miké interprets to call for increased access to high quality health care,
could be furthered via better evaluation of all medical procedures and the subsequent
elimination of those that are worthless and even harmful. Similar to the “waste theory”
described in chapter one, Miké proposes that clinical evidence could be used to alleviate
the ﬁscal crisis in health care and relieve funds to cover the poor.

Because EBM is the formalization of the aim to promote health care based on
evidence, it is hardly surprising to see Miké regard EBM as promoting “wonderful
initiatives for achieving excellence in health care.”642 However, “EBM is only as good as
the available evidence.”643 The solution, of course, is more outcomes research. In the
end, Mike’s ethics of evidence establishes a moral imperative for outcomes research in
ethical medical decisionmaking. The Behnont principles are argued to rely on the
application of the most reliable medical evidence, which the author takes to be
statistically-derived evidence.

In the next section, “evidence based ethics” will be examined as a contrast to the
ethics of evidence in order to bring into question the increased certainty allegedly gained
by the evidence based approach in light of the evidentiary concerns that arose in previous
chapters. The ethical implications of the normative obfuscation that must take place in

order for EBM to ground decisionmaking in the supposed objectivity of the evidence will

 

6'“ Nuremberg Code (1949), "Trials of war criminals before the Nuremberg Military Tribunals under
Control Council Law no. 10."

(”2 Mike (1999), "Outcomes research and the quality of health care: The beacon of an ethics of evidence."
Eval Health Prof 22(1), p. 18.

“’3 Miké (1999), "Outcomes research and the quality of health care: The beacon of an ethics of evidence."
Eval Health Prof 22(1), p. 18.

219

also be investigated.
Evidence Based Ethics644

In an editorial introducing two qualitative studies determining the effectiveness of
current ethical oversight of research involving children, Jeremy Sugarman insists that
“the time is ripe for evidence-based ethics.”645 The ﬁrst study, “Commrmication of
Randomization in Childhood Leukemia Trials”, evaluated the transfer of information
from investigator to parent regarding her child’s participation in a randomized trial.
Interviews conducted shortly after the investigator-parent conference in which consent
forms were signed revealed that 50% of parents did not understand randomization. The
authors concluded that to make informed consent more effective, future research must
seek to improve communication during this critical interchange.646 The second study, a
telephone survey assessing how 188 randomly selected Institutional Review Board (IRB)
chairpersons apply the federal risk standards for pediatric research to a series of ﬁctitious
cases, found the chairs’ application of the federal risk and beneﬁt categories for pediatric
research to vary signiﬁcantly. Some applications even contradicted the available data on
risks and the regulations themselves. The researchers concluded that to protect children
from excessive risks while allowing appropriate research, IRB chairpersons need
guidance on applying the federal risk and beneﬁt categories and also need data on the
risks children face in daily life and during routine physical or psychological tests.647

Sugarman commends the authors of both papers for offering “reasonable”

 

6‘“ A similar version of this section on evidence based ethics appears in publication as Goldenberg (2005),
"Evidence-based ethics? On evidence based practice and the "empirical turn" from normative bioethics."
BMC Med Ethics 6(11).

64’ Sugarman (2004), "Determining the appropriateness of including children in clinical research: how
thick is the ice?" JAMA 291(4), p. 495.

’46 Kodish et al (2004), "Communication of randomization in childhood leukemia trials. " JAMA 291(4).
6’7 Shah et al (2004), "How do institutional review boards apply the federal risk and beneﬁt standards for
pediatric research? " JAMA 291(4).

220

recommendations for improving protections for children. However “these
recommendations would have even more utility if they were subjected to rigorous testing,
preferably with randomization when ethically permissible to do so”.648 Sugarman fails to
explain what role he thinks randomization will play in increasing the utility of these
recommendations. Instead, he ends the editorial with a rehearsing of the evidence based
mantra:

in both medical and ethical investigations, it is important to ‘raise the bar’
on what evidence is acceptable to determine the most effective approaches.649

Moreover, “data derived by using more rigorous methods [RCTS] would be privileged in
[both of] these venues.”650 I
Given the currency of EBM, it is hardly surprising to ﬁnd the evidence based
approach being considered as an innovative strategy for moral decisionmaking.65 I
“Evidence based ethics” (EBE) is also supported by the “empirical turn in bioethics”, a
growing interest over the past two decades in empirical methods of research in bioethics.
Examining the norms and implications of both empirical approaches to bioethics and

EBM, however, reveals the evidence based approach to be incompatible with bioethics’

normative mandate and therefore EBE should not be pursued. This conclusion will then

 

6’8 Sugarman (2004), "Determining the appropriateness of including children in clinical research: How
thick is the ice?" JAMA 291(4), p. 496.

6’9 Sugarman (2004), "Determining the appropriateness of including children in clinical research: How
thick is the ice?" JAMA 291(4), p. 496

’50 Sugarman (2004), "Determining the appropriateness of including children in clinical research: How
thick is the ice?" JAMA 291(4), p. 496.

6’ ' Jansen (1997), "Evidence-based ethics and the regulation of reproduction." Hum Reprod 12(9); Roberts
(2000), "Evidence-based ethics and informed consent in mental illness research." Arch Gen Psych 57(6);
Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1); Major-
Kincade et al (2001), "Training pediatric house staff in evidence-based ethics: an explanatory controlled
trial." J Perinatol 21(3); Halpem (2005), "Towards evidence based bioethics." M 331(7521); Kim, Scott
Y. H. (2004), "Evidence-based ethics for neurology and psychiatry research." J Am Soc Exper
NeuroTherapeutics 1(3).

221

be brought to bear on the ethics of EBM, as many of the challenges to EBE serve to
destabilize the presumed moral mandate to practice EBM.

Empirical research in bioethics (or “empirical ethics”) is “the application of
research methods in the social sciences (such as anthropology, epidemiology,
psychology, and sociology) to the direct examination of issues in [bioethics].”652 In
contrast to normative bioethics, which employs the analytic methods of Anglo-American
moral philosophy to answer the ethical questions that arise in health care, empirical
approaches aim to describe (rather than prescribe) “particular state[s] of affairs that
[have] some moral or ethical relevance.”653 Empirical bioethics also proposes to enrich
bioethics by calling attention to the social, cultural, and cross-cultural aspects of morality
accessed via the opinions, interests and beliefs of patients, families, physicians, nurses
and others involved in care-giving.654 For example, empirical research can help describe
cultural beliefs about the appropriateness of informing the patient of a diagnosed life-
threatening illness, which will inform deliberation about the extent to which it is morally
important for clinicians to provide comprehensive information to patients in different
cultural contexts.655 Similarly, empirical research can delineate popular attitudes and
experiences related to contentious issues such as abortion, cloning, stem-cell research,
and physician-assisted suicide for consideration in discussions and policy formulations.656
Empirical investigation can also map the effects of particular interventions aimed at

improving how clinicians or policy makers attempt to meet ethical obligations, such as

whether a particular method of presenting health related information to a patient actually

 

652
653

Sugarman et al (2001), "A decade of empirical research in bioethics." Methods in medical ethics. p. 20.
Sugarman et al (2001), "A decade of empirical research in bioethics." Methods in medical ethics, p. 21.
65" Hoffrnaster (1992), "Can ethnography save the life of medical ethics?" Soc Sci Med 35(12).

6’5 Sugarman (2004), "The future of empirical research in bioethics." J Law Med Ethics 32(2), p. 227.

6’ Sugarman (2004), "The ﬁrture of empirical research in bioethics." J Law Med Ethics 32(2), p.227

0‘

222

improves the patient’s understanding of her circumstances and the quality of informed

consent.657
It is likely because proponents of empirical approaches to bioethics focus on

differentiating this area of bioethics from normative ethics that the literature tends to use

”658

such loose overarching descriptors as “an amalgam of empirical contributions and

“methodological roots in social sciences. . .to gather quantitative and qualitative data

. . 5
about ethlcal lssues”6 9

when characterizing empirical ethics. The ease with which both
empirical ethics is generalized and the differences between the various social scientiﬁc
disciplines represented under this heading are glossed over may also be assisted by the
common presumption that empirical research presents “only the facts”. This
understanding leads to underappreciation of the values typical to each discipline as well
as the beliefs of the individual practitioner that inﬂuence the data gathering and
interpretation.660 While presumably no one would deny the different orientations,
research agendas, and methods, of, say, psychology and sociology, the emphasis placed
on similarities or shared features in order explain the novelty of empirical ethics and
distinguish it from philosophical approaches to bioethics takes important attention away
from the relevant differences between the social scientiﬁc disciplines that may render
some empirical approaches incompatible with the goals of ethical inquiry. I aim to show
this to be the case with one method of empirical ethics—evidence based bioethics—

which is grounded in clinical epidemiology and supported by the discipline’s most

distinctive application, EBM.

 

’57 Sugarman (2004), "The future of empirical research in bioethics." J Law Med Ethics 32(2), p. 228

6” Sugarman (2004), "The future of empirical research in bioethics." J Law Med Ethics 32(2), p. 230.

6’9 Borry et al (2005), "The birth of the empirical turn in bioethics." Bioethics 19, p. 41.

“’0 Nelson (2001), "Knowledge, authority, and identity: A prolegomenon to an epistemology of the clinic."
Theor Med 22(2), p. 13.

223

Some commentators on the “empirical turn in bioethics” have regarded the
interest in empirical research as representing a loss of conﬁdence in the typical normative
and analytic methods of bioethics.66' While many describe those “typical” methods
inaccurately—offering “straw man” accounts of applied ethics where absolutely no
empirical considerations are included in the deductive process of ethical deliberation662—
they are at least correct in recognizing a felt ambivalence regarding the possibility of
negotiating competing values in a pluralist society that respects difference. Evidence
based decision-making offers what seems like a solution to this so-called “postmodern”
problem, as it proposes to ground decisions in something concrete and universal, namely
the evidence. The allure of evidence should not be underappreciated, as it is thought to
be able to assist us in seeing past our habits, biases, and mistakes to decipher “best
practices”. The rapid ascendancy of the evidence based movement, which started in
medicine and quickly spread to other professional disciplines, speaks to the movement’s
enormous appeal.”63 There are considerable difﬁculties with an “evidence based”
approach to bioethics, however, that require consideration.

While evidence based ethics arises within the momentum of the empirical turn, it
draws unique content from EBM. Evidence based ethics has been deﬁned in the
literature as follows:

As in medical decisions based on EBM, ethical decisions based on

evidence based ethics would involve conscientious and judicious use
of the best evidence relevant to the care and prognosis of the patient to

 

66' Ashcroft (2000), "Giving medicine a fair trial." M 320(7251).

662 For example, see Hedgecoe (2004), "Critical bioethics: beyond the social science critique of applied
ethics." Bioethics 18(2).

“’3 As I write this, the incredible popularity of the CS] television series—which depicts “evidence based”
police work par excellence—demonstrates how the stability, fairness, and truth of “the evidence” have
captured our imagination.

224

promote better informed and better justiﬁed ethical decision making.664
What this actually entails in practice is somewhat vague, as there are numerous ways in
which empirical research can inform ethical decision making, numerous types of .
evidence that are relevant to the care and prognosis of patients, and numerous measures
of best evidence. What is clear, however, is evidence based ethics’ close methodological
proximity to EBM, as the language of “conscientious and judicious use of best evidence”

is recognizably lifted from the early programmatic literature on EBM.665

The implications
of this relationship are the focus here, as EBM offers a distinct accounting of the nature
of evidence, what evidence counts, and what role the evidence plays in the decision-
making process. Understanding evidence based ethics requires comprehension of the
evidence based approach to medicine.

Sugarrnan’s prior appeal for rigorous methods and his attention to experimental
methodology recall the hierarchy of evidence’s consistent privileging of randomized
controlled trials and systematic review of these trials over less objective measures such as
surveys or qualitative research. The founding of EBM by clinical epidemiologists and
biostatisticians explains this methodological privileging, as randomized controlled trials
produce the clinical data required for health outcomes research.

Keeping in mind evidence based ethics’ subscription to the “evidence based”
doctrine, it becomes apparent that the term “evidence based ethics” has been

misunderstood and misused by some of its alleged proponents. In Robert Jansen’s

“Evidence-Based Ethics and the Regulation of Reproduction”,666 the author uses the term

 

“’4 Major-Kincade et a] (2001), "Training pediatric house staff in evidence-based ethics: an explanatory
controlled trial." J Perinatol 21(3).

665 See Sackett et al (1996), "Evidence-based medicine: what it is and what it isn't." M 312(7023).

6”” Jansen (1997), "Evidence-based ethics and the regulation of reproduction." Hum Reprod 12(9).

225

to mean the testing of ethical arguments, statements, and the background assumptions
informing those arguments, by means of empirical research. Jansen argues that Canada’s
prohibitions on sex selection for human reproduction relies on the untested empirical
claim that sex selection often leads to some index of family dysfunction. He ﬁnds it
ironic that Canada insists on evidence based approaches for medical services but not for
the social restrictions on reproductive medicine proposed by the Report of the Royal
Commission on New Reproductive Technologies, which, he claims, made determinations
of “women’s true interests” without properly surveying the relevant attitudes and
behaviours exhibited by the public. Against what Jansen perceived as the Commission’s
“hijacking” of ethical questions and their treatment of empirically veriﬁable hypotheses
about the social consequences of permissive policies as “self-evident moral truths”, he
recommends a publicly accountable empirical approach that encourages debate and the
determination of facts.

J ansen’s understanding of evidence based ethics seems to be no different from the
empirical ethics already in circulation insomuch as it serves to inform moral deliberation
(and therefore does not introduce a new empirical/ethics relation).667 It is worth noting
that even prior to the incipience of empirical ethics, empirical content always informed
ethical deliberation, whether to determine the actual or probable consequences of actions
for consequentialist reasoning or to specify the norms of deontological consideration. In
bioethics, surveys or in-depth interviews that gauge patients’ or clinicians’ attitudes or

behaviours often serve as the data that philosophically-trained bioethicists reﬂect on in

 

“’7 This is not to say, however, that this “informational” model, where empirical data informs moral
deliberation, is without certain difﬁculties. While the failings of the qualitative tendencies in empirical
ethics are beyond the scope of this dissertation, Ashcroft offers a thoughtful analysis of how social research
evidence plays a part in the construction of the social order in: Ashcroft (2003), "Constructing empirical
bioethics: Foucauldian reﬂections on the empirical turn in bioethics research." Health Care ﬂ 11(1).

226

order to draw moral conclusions.668 Jansen’s call for more empirical ethics is appropriate
for the situation he describes considering that the Commission failed to bring in the
relevant empirical content to their deliberative process. This, however, is not evidence
based ethics.

The EBM hierarchy of evidence’s maligning of the very techniques that empirical
ethics so often employs suggests dissimilarity between empirical ethics and evidence
based bioethics. The surveys and in-depth interviews that are commonly used to
determine the attitudes and behaviours of patients, clinicians, or the general public
regarding bioethical issues are less valued and are ranked lower than the carefully
controlled and quantiﬁed evidence that is derived from randomized controlled trials and
other more objective methods. This suggests evidence based ethics to be a distinct
moment within the “empirical turn in bioethics” rather than, as Pascall Borry and
colleagues’ historical account seems to suggest, more of the same.669

The second sense in which evidence based ethics is used is as “the necessary

grounding of ethical decisions in the best available scientiﬁc evidence.”670 Jon Tyson’s671

’3672 work on clinical determinations of whether or not to

and Terri Major-Kincade et al.
treat severely disabled premature newborns enlist this use of the term “evidence based
bioethics”, which I read to. be a more accurate interpretation of the term because of its

consistency with the methods of EBM. Tyson’s and Major-Kincade et al.’s work offers

decision-making techniques for determining whether or not to treat the patient that rely

 

(’68 An exhaustive account of the difﬁculties with this division of labour along “fact” and “value” or
“empirical” and “normative” lines is beyond the scope of this chapter.

(’69 Bony et al (2005), "The birth of the empirical turn in bioethics." Bioethics 19(1).

’70 Bony et al (2005), "The birth of the empirical turn in bioethics." Bioethics 19(1), p. 68.

67' Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1).

’72 Major-Kincade et a1 (2001), "Training pediatric house staff in evidence-based ethics: an explanatory
controlled trial." J Perinatol 21(3).

227

almost exclusively on the projected survival and disability outcomes of these infants.
Major-Kincade et al. even employ a controlled trial to demonstrate the efﬁcacy of their
educational curriculum for teaching evidence based ethics to NICU residents.
Addressing his peers in the Journal of Perinatology, Tyson laments the difﬁculty
of making treatment decisions for severely compromised newborns, which involves
“highly complex medical and ethical issues.”673 He ﬁnds the US. legislation on the
issue—the Child Abuse and Treatment Act (Public Law 98-457), often referred to as the
revised Baby Doe regulations—to be unsatisfactory in what he determines to be skewed
promotion of disability rights over the suffering of the infant and family and the ﬁnancial
burden of expanding neonatal intensive care programs.674 Furthermore, many state laws
seem to contradict the federal legal standard by putting more emphasis on quality-of-life
considerations and parental decisionmaking.675 Tyson also ﬁnds problems with the
perinatologist’s other decisionmaking support, the hospital bioethics committee.676 Its
members might not know enough about the patient’s medical problems or might be
biased by institutional concerns. He recognizes that these committees might be useful as
advisory bodies to address ethical questions by clinical staff or disagreement between

parents and physicians. However he does not think they should routinely participate in

 

67’ Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 166.
67" In one surprising statement, Tyson proposes that the negative effect of the Baby Doe regulations
“appears to be exactly those intended by its proponents—diminished parental autonomy, reduced
consideration of infant suffering and future quality of life, and expanded use of neonatal intensive care”
(page 162; my emphasis). This suggests that Tyson reads sinister intent rather than unfortunate outcome in
this child protection act.

67’ Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 162.
67’ While nomenclature varies in different healthcare institutional settings, Jansen is referring to what is
frequently called the “clinical ethics” committee, the body responsible for addressing ethical issues that
arise in clinical practice. Hospitals also have separate “research ethics” committees—called “Research
Ethics Boards” in Canada and “Institutional Review Boards” in the U.S.—which monitor the research that
takes place in healthcare institutions.

228

treatment decisions for high-risk neonates.677 With the legal and ethical instruction being
so feeble, Jansen presumably does not ﬁnd it surprising to discover considerable
variations in practices among North American and Western European NICUs. The scope
ranges from clinics that treat almost all high-risk neonates, as the prognosis is believed to
often be indeterrninable at birth, to much more selective administration of treatment,
depending on the projected clinical beneﬁt to the patient.678

It is hardly surprising that, faced with the perceived problem of small area
variations, unhelpful legislation, and ethics committee that may lack knowledge and hold
bias, the evidence based approach is brought to the rescue. Tyson’s diagnosis of the
challenges to ethical decisionmaking mirror the account of the troubles surrounding to
medical decisionmaking held by EBM proponents. It follows that he similarly supports
their solution:

Under the usual rules of evidence in medicine, the only mandatory

interventions are those for which there is credible evidence that the

beneﬁts outweigh the hazards and burdens. Evidence-based decision

making allows consideration of the level of care that is reasonable, based

on the quality of evidence available; the identiﬁed beneﬁts, hazards, and

costs of treatment, and as is crucial in a pluralistic society, the values and

preferences of the patient or surrogate. Thus, medical reasonableness is

a more broadly acceptable criterion than is futility for deciding whether to

forego or administer neonatal intensive care.679

Tyson describes evidence based ethics as involving multiple considerations in its
determination of what constitutes “reasonable care” that include: (i) the quality of
evidence available; (ii) the identiﬁed beneﬁts, hazards, and costs of treatment; and (iii)

the values and preferences of the parent or surrogate. In Major-Kincade et al’s

complementary paper detailing the implementation of an evidence based ethics

 

677 Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 164.
67" Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 161.
67” Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 164.

229

educational intervention, the “evidence” was speciﬁed to mean mortality and disability
outcomes for infants that receive intensive care.

Given that Tyson claims to appreciate that treatment decisions for extremely
premature infants involve highly complex ethical issues and multiple considerations, it
comes as a surprise when he proposes, in the end, an algorithm680 for instances of
“mandatory”, “unreasonable”, and “optional” treatment based entirely on the projected
outcomes (that is, survival rates and disability-free years) for neonates of particular birth
weights, gestational ages, and health conditions. Even the professed importance of
considering the parents or surrogates’ values and preferences is limited to situations
where the infant’s clinical indicators ﬁt her into the category of “optional” treatment.
While the description of the multiple considerations that go into evidence based ethical
decision-making sounded reasonably comprehensive at ﬁrst glance, certain limitations on
how evidence is understood, what constitutes a “beneﬁt” or a “harm” and who determines
and measures them, and even when the parents’ values play in, all narrow the deliberative
process to a decision based on projected outcomes and an imposed cost per value
calculation of Quality Adjusted Life Years and Disability Adjusted Life Years relative to
ﬁnancial cost of treatment. Mandatory treatment, for example, occurs when there is
“credible evidence that beneﬁts outweigh burdens”,681 with no mention of who

determines these criteria and how they are measured. These determinations were

formulated against the backdrop of standardized clinical protocols being simply assumed

 

’80 Despite defenders of EBM’s considerable attempts to deﬂect accusations of offering “cook book
medicine”, that is, treating patients strictly according to a formula or algorithm derived from a research
study, even Brian Haynes, one of the movement's founders, admits that much of the programmatic
literature regarding evidence-based medicine does not “clearly emphasize that evidence from research can
be no more than one component of any clinical decision” Haynes (2002), "What kind of evidence is it that
evidence-based medicine advocates want health care providers and consumers to pay attention to?" BMC
Health Serv Res 2(3).

68' Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 164.

 

230

to be preferable, more transparent, and fairer than case-by-case decision-making. These
assumptions will soon be demonstrated to be consistent with the “epidemiological and
biostatistical ways of thinking” that the founders of EBM so strongly promoted.

The evidence based doctrine problematically assumes that the presence of reliable

evidence ensures that better decisions will be made.682

Medical decision-making,
however, draws upon a broad spectrum of knowledge (or multiple dimensions of
evidence), including scientiﬁc evidence, personal experience, personal values, economic
and political considerations, and philosophical principles. It is not always clear how
practitioners integrate these factors into a ﬁnal decision, but what is clear is that medicine
can never be entirely free of value judgments.683 Normative content seems to enter at all
levels of decision-making, even in the production and presentation of the scientiﬁc
evidence that is supposed to univocally inform evidence based decisions.684 The very
notion of evidence and the boundaries of what counts as evidence is a social construct, as
evidence is always the product of a socially produced question. Even “evidence based” is
a normative concept.

The fact that EBM has a naive epistemology does not, of course, deny the
possibility that its methods could improve patient care. Prior to EBM, defenders of bench
science made momentous medical advancements despite being having poor philosophical

understanding and epistemic justiﬁcation for their practices. My proposal, however, is

that the evidence based disregard of its value judgments and underlying theoretical

 

(’82 It would be acceptable to defend the claim that reliable evidence tends to improve decisionmaking. But
because EBM offers so little on how better data could improve medical decisionmaking (the “knowledge
translation” part of the decisionmaking process), they appear to be making the stronger and, as I stated,
problematic claim that better evidence necessarily leads to better decisions.

‘3 Kerridge et al (1993), "Ethics and evidence based medicine." _B_1yl_J 316(7138), p.1151.
6” Molewijk et al (2003), "Implicit normativity in evidence-based medicine: a plea for integrated
empirical ethics research." Health Care Anal 11(1).

231

presuppositions hinders patient care and does so because of ﬂaws unique to EBM. For
instance, in Tyson’s attention to systematic measures and formulaic approaches, he
glosses over the value judgments that go into the evaluation of “reasonable” and
“unreasonable” actions. He similarly takes as “given” the implicit normativity in his
“medical cost relative to value” formula for deciding how to use limited health care
resources. In his accounting, the cost utility of neonatal intensive care is expressed as the
cost per quality-adj usted life-year (QALY) gained as a result of neonatal intensive care.
The life-years gained are then reduced according to the number of disabled survivors and
the severity of those disabilities. While Tyson seems to think that deferral to
measurement is transparent and fair—presumably because the life circumstances of
individual families do not bias the clinical evaluation—the values implicit in these
measures go unchecked. Even his recognition of “the fact that it is difﬁcult to know how
to adjust appropriately for disability and disease, in part because quality of life in the
presence of handicaps and chronic illnesses may be rated higher by those affected than by
other persons” does not seem to deter him from formulating an evidence based decision-
making algorithm and assuming the justice of measurement in general.

By this account of evidence based ethics, one might ask how evidence based
ethics differs from EBM, as both involve making health care decisions based on the best
evidence, where evidence is narrowly deﬁned as having to do with systematic
observations from certain types of scientiﬁc research. Alternatively, one might question

. . . . . . 685
whether ev1dence based ethrcs represents a mlsapproprlatron of the word “ethrcs”.

 

68’ This suggestion was made by a member of the audience at a presentation of my work on evidence based
ethics at the annual meeting of the Canadian Society for the Study of Practical Ethics in June 2005 in
London, Ontario.

232

r—‘L‘J‘TFE ’1‘]
t.

 

 

While “evidence based” is typically read in medicine and other life and social
sciences as the empirically-adequate standard of reasonable practice and as a means for
increasing certainty, the evidence based movement in fact gains consensus by displacing
normative discourse with aggregate or statistically-derived empirical evidence as the
“bottom line”. Whether applied to medicine or bioethics, the techniques invoked in the
name of “evidence based” decision-making require a positivistic reliance on “the
evidence” in its epistemological promise to ascertain increased certainty by examination
of the evidence. These techniques act to obscure the multiple and complex
considerations that unavoidably go into health care decisions at both the micro- and
macro- level and allows for the promotion of particular political agendas and interests
under the guise of “better science”.686 In health care justice and policy, we see appeals by
liberal thinkers to allegedly neutral markers like “species normal functioning”. We
know, of course, that these measures are not neutral, as people with disabilities and
chronic illnesses and elderly people consistently fare poorly in this political calculus.
Popular thinking holds, however, that if it is neutrality that is desired, numbers are the
pinnacle. In this age of the ascendancy of health outcomes research, where statistical
analysis dominates health policy decisionmaking, “evidence” is tantamount to measure
and not meaning.

Bioethicists are typically attuned to the multiple dimensions of the illness
experience that eludes quantiﬁcation and measurement. Science, according to medical
humanists, is just one layer of description of the phenomenological world. EBM’s
reliance on scientiﬁc evidence has been criticized for mischaracterizing modern health

care’s constitution by diverse academic traditions and knowledges—including the

 

’86 Goldenberg (2005), "Against evidence based bioethics [Letter]." BMJ 331(7521).

233

humanities, social sciences, and the pure and applied sciences—that rely on equally
diverse notions of evidence.687 While bioethicists attend to the normative features of
medical decision-making, evidence based ethics suggests a moment of inattentiveness to
the normativity of moral decision-making. Recognition of the plurality of values and
meanings in operation complicates our use of moral and ethical terms and categories;
however, the quick turn to various truth-producing strategies labeled “empirical” that has
taken place warrants careful consideration. While the “empirical turn” in bioethics
signals a need for reconsideration of the methods used for moral evaluation and
resolution, the options should not include obscuring normative content by seemingly
neutral technical measure.

In Conclusion

 

In this chapter, the numerous epistemological challenges to EBM were introduced
into the ethical analysis of EBM, thus broadening the initial consequentialist investigation
of the impact of EBM on patient care into an ethics of evidence. How one understands
the nature and role of evidence was demonstrated to have ethical import, as seen in the
differences between Miké’s “ethics of evidence” and “evidence based ethics”. It is also
the hubris surrounding the largely uncritical adoption of EBM that invites application of
the evidence based approach onto moral decisionmaking, with results that are morally
disconcerting. Tyson’s evidence based approach to resolving the vexing ethical problems
surrounding the treatment of severely disabled newborns minimized the difﬁcult
negotiation of values and social considerations in favour of a systematic measure of

projected clinical outcomes. This case therefore supports the earlier proposal that

 

687 Upshur et al (2001), "Meaning and measurement: an inclusive model of evidence in health care." J Eval

Clin Prac 7(2).

234

L:—‘.

 

evidence based approaches obscure normative issues under the guise of technical
consideration and language.688 Just as an “evidence based” ethics would threaten
bioethics’ normative mandate, an “evidence based” medicine threatens to obscure the
normative dimensions of medicine in favour of technical resolve.

Jansen’s misuse of the term “evidence based ethics” was also instructive, as there
is confusion regarding what exactly EBM is. It has already been discussed that it is at
times understood to represent no more than reliance on the evidence in medical
decisionmaking, a deﬁnition that warrants the charge of “nothing new”. Yet we have
already seen that this understanding is incorrect, as EBM introduces epistemological and
methodological innovation to medicine. By doing so, it also narrows the range of
questions that can be investigated. What Jansen was calling for was empirical ethics—
surveys, interviews, and other qualitative modes of data gathering—as randomized
controlled trials cannot produce the information that Jansen wants to know. This is not to
say that RCTS could never provide any data of ethical interest, of course.

Lastly, Jansen’s and Tyson’s call for evidence based ethics shared a similar
motivator: the perceived injustice and irresponsibility of ethically-charged legislation by
ill-informed bureaucrats who enforce regulations “without demonstrating broad societal

support, a consistent or coherent rationale, or a manifest commitment to improving the

 

’88 My proposal that problems associated with evidence based ethics are similar to those confronted by
evidence based medicine will likely encounter initial resistance. The warnings against an evidence based
approach to moral decisionmaking may be more easily accepted as warranted, given that bioethics is
understood to have a fundamentally normative mandate. Medicine, however, is also a normative discipline,
as the culture of science and medicine has been argued to be a dominant force in social life. The
relationship between science and values (and politics) receives considerable attention within science
studies, and many of the arguments regarding their inseparability have been rehearsed in this dissertation
vis-a-vis EBM.

235

 

[lives of patients].”689 The original anti-authoritarian spirit of EBM, as well as the
spectre of justice pervading much of the evidence-based health policy discourse, strongly
mark the rationale for an evidence based ethics. Yet much like positivism threatened
ethics by rendering it “senseless”, an “evidence based” approach proposes to make moral
deliberation redundant by co-opting the normative issues with supposedly neutral

technical measures.

 

6’9 Tyson (1995), "Evidence-based ethics and the care of premature infants." Future Child 5(1), p. 162.

236

CONCLUSION
Advancing an Ethics of Evidence
Throughout this project, there has been some variety in the accounts of what
precisely constitutes EBM. EBM has been represented both in the literature and in this
investigation as a technology, a host of methodologies, a paradigm, a tool, and a

690

movement, all of which are intended for varied usage in clinical decisionmaking,

depending on how EBM is initially construed. For instance, a tool for organizing mass

r.

quantities of clinical data plays a far more modest role than does a hierarchical decision-
support technology, paradigm, or movement in the decisionmaking process. While some
critics have accused EBM proponents of capitalizing on the ambiguities surrounding
what EBM is and how it is practiced to fend off criticismf’gl as critics are easily rebuffed
for allegedly misunderstanding EBM,692 I propose that there is some accuracy in all of
the representations of EBM. It may be most ﬁtting to describe EBM as a philosophy of
medicine, a rich concept that incorporates practical methods and goals, as well as abstract
commitments, such as an ontology of medicine, an epistemological framework, and an
ethical rationale. It has already been stated that some components of the evidence based
philosophy of medicine are being admirably worked out in the critical literature, while
others, speciﬁcally the ethical issues surrounding EBM, are thin in content. The call for a
more robust ethical analysis acknowledges the broader ethical relevance of EBM, as there

are connections between the components comprising EBM.

 

69° Jennifer Gibson pointed out this variety of descriptors after reading an earlier draft of this dissertation,
leading me to consider how they did or did not ﬁt together.

69' Lambert (2006), "Accounting for EBM: Notions of evidence in medicine." Soc Sci Med 62(11)/

692 See, for example, Sullivan and MacNaughton (1996), "Evidence in consultations: Interpreted and
individualized." Lancet 348(9032); Evidence Based Medicine Working Group (1992), "Evidence-based
medicine." JAMA 268(17); Goodman (2005), "Ethics, evidence, and public policy." Persp in Biol Med
48(4).

 

237

We saw in chapter two that the ethics of EBM is currently limited to questions
regarding the impact EBM has on patient care. Supporters view EBM as signiﬁcantly
contributing to patient autonomy and informed consent, while detractors view the
evidence-based standards of best practices and clinical protocols as limiting patient
choice to “take it or leave it” by eliminating therapeutic options that patients may have
reason to favour because it is not supported by the evidence. Yet the complex
understanding of EBM just proposed, and what we saw to be signiﬁcant epistemological
and methodological novelty brought to medicine by the evidence based approach,
supports the plausibility of the working hypothesis that the ethics of EBM is far more
extensive than its current narrow scope. The actual extent of EBM’s ethical relevance
can be determined by critically analyzing EBM. The examination in chapters one and
three revealed eight distinct yet overlapping challenges to the evidence-based approach.

1. EBM ’s construal of evidence ignores the social and political factors present

in observations and the evaluation of the evidence. Empirical evidence is not

self-apparent or “given ” even when gathered in the most rigorously controlled
settings.

2. EBM fails at its methodological task of providing “best evidence” because of

the shortcomings of randomized controlled trials, the problems of application for

individual care, especially for patients who are not properly represented among
research subject populations, and the bias that can arise due to ﬁmding and
publication bias.

3. EBM is reductionist and privileges quantitative over qualitative data.

4. The privileging of quantitative over qualitative research occurs because EBM

values knowledge that is divorced from personal experience and non-

phenomenological.

5. EBM promotes the separation of technical and normative and the silencing of
democratic debate.

6. The clinical judgment and experience of practitioners are subordinated in
EBM ’s overreliance on epidemiological and statistical methodology.

238

 

 

7. EBM promotes a political and economic model of health care rationalization
that is premised on a faulty positivist-empiricist epistemology.

8. EBM ’s fusion of positivism and market capitalism validates a view of
healthcare as consisting of independent rational buyers and sellers.

At the heart of the critiques of EBM is dissatisfaction regarding what counts as evidence
(#1). From here, further epistemological as well as methodological problems arise

concerning what EBM regards as legitimate and valid knowledge and how such

a .. “3

knowledge is best attained (#2- #4). These ﬁndings lead to political critique regarding L
the minimizing of physicians’ and patients’ input within the decisionmaking context, as
well as the quelling of democratic debate over normative questions regarding rationing
and healthcare spending (#5, #6). Finally, this quieting of political debate in healthcare
can potentially allow for the promotion of certain political interests under the guise of
“best practices” (#7, #8). The more politicized critiques (#5-#8) denote a return to the
individual, not as a subject of experience or as a phenomenological being (see critique
#4), but as an individual qua citizen (#5), consumer (#8), and client. This new
subjectivity is linked to the epistemic objectivism criticized in #1 via feminist
epistemology’s critique of atomistic individualism and the notion of the modest witness’s
unbiased and pure empirical gaze. The criticism that EBM promotes a political and
economic health care rationalization that is premised on a faulty positivist-empiricist
epistemology (#7) rounds out this critical investigation by tying the political commentary
to the initial epistemic claim.

As the name “evidence based” should suggest, evidence is key to the model of
medical practice being promoted. Thus the construction of evidence surely has ethical

relevance beyond the impact on patient care. The problem of relativism and the

239

 

uncertainty of our knowledge claims regarding the veracity of our beliefs was examined
in chapters three, four, and ﬁve of this ethical analysis of EBM because evidentiary
problems are not only an epistemic concern in the context of health care, but also a
deeply moral problem. Medical uncertainty and incorrect knowledge may inﬂict
suffering, illness, disability, and death on those for whom health care professionals have a
duty to care.

The shortcomings of EBM’s notion of evidence are readily apparent. However,
rethinking evidence proves to be difﬁcult. EBM critics effectively utilize major lines of
postpositivist thought in the philosophy of science to demonstrate the inadequate
conﬁguration of evidence underlying the evidence based approach. Despite the critical
effectiveness of those views, they fall short when it comes to providing a defensible and
useful conception of evidence. The more holistic accounts of evidence provided by
feminist philosophers of science, Longino and Nelson, counter the narrow conﬁguration
underlying EBM, but in fact fail to offer concrete guidance in medical decisionmaking.
These concepts may even further complicate the process by being so unrestrictive
regarding what counts as evidence. As a result, the evidence based program may be
confounded rather than corrected by this critical undertaking. Discrediting the presumed
theoretical independence of evidence is thought to unavoidably strip science of its
objective knowledge-gathering capability and lead to the situation in which
incommensurable positions hold equal evidentiary weight. Regardless of whether there is
an antiquated understanding of science operating here, practitioners are faced with the
more tangible problem that they do not have the basis on which they need to act.

Longino’s call for more democratic science, and Nelson’s reassurance that the

240

‘n .

 

unconstrained and uncontained theory of evidence is unavoidable, may come across as
fanciful or impractical to clinicians, as it offers a far weaker substitute for scientiﬁc
evidence’s now discredited rigorous adjudicative ability. This result may keep even
enlightened clinicians from straying from the evidence based curriculum, as the critical
science perspectives do not help with the decisions that have to be made and the literature
that needs to be synthesized.693

The turn to Davidson’s evidentiary account Opens up possibilities by resolving the
loss of adjudicative force in evidence. The Davidsonian feminist pragmatism constructed
by Clough manages to not only address the ﬁrst and third critiques regarding social
features of knowledge production and the legitimacy of qualitative research, but to also
respond to #4 by ascribing comparative value to subjective experience and
phenomenological knowledge.”94

In the ﬁnal chapter, the largely epistemological challenges to EBM were ﬁnally
brought to bear on the ethics of EBM. The nature of evidence and the idealized hierarchy
of knowledge motivating this evidentiary preferencing do not solicit much attention in
bioethics. However its effect on the goals, scope, and practices of medicine suggests that
it warrants critical attention. Indeed, there is something peculiar about EBM’s promotion

of a rigid pre-graded hierarchy of evidence, considering that the EBM programmatic

literature explicitly states that “the clinical problem. . .must determine what type of

 

69’ Jim Nelson has suggested that it may be worse yet. In this situation, clinicians may reasonably argue
that, since it is beyond doubt that scientiﬁc evidence rigorously adjudicate between many kinds of
important alternatives, any view that implies otherwise must be false. (Private correspondence with James
L. Nelson)

69" To be clear, acknowledging the comparative value of experiential knowledge is not to say that all beliefs
stand in equally powerful evidentiary relationships to each other. Ethical beliefs may be evidentiary, but
will not provide much evidence toward, say, resolving the question whether streptokinase is more effective
at busting blood clots after CVA.

241

 

evidence should be sought”.695 To have evidence is to have some warrant for belief or
action, and the kind of evidence needed will typically depend on the belief in question.
Medical research, especially “evidence based” medical research, however, converges
resoundingly on a single methodology—the double-blinded randomized controlled trial—
as the bona ﬁde “gold standard” of medical investigation, despite the wide range of
hypotheses being tested. The supposed objectivity gathered from evidence based
methods is epistemically untenable and troubling in the way that political agendas can be
introduced into healthcare decisionmaking under the guise of best practices and
accountability. The potential compromise to patient care is far greater than the loss of
choice in the decisionmaking context. Against the claim that EBM offers “nothing new”,
EBM promotes innovative methodological practices and epistemological commitments
that must be considered on ethical grounds.

Drawing from the philosophical work on evidence (see chapters two, four, and
ﬁve) and the application of evidence in the context of clinical decisionmaking (chapters
three and six), it seems fair to conclude that the concept of ‘evidence’ may be resistant to
a single analysis applicable to all circumstances in which we use the term. The task of
EBM critics therefore should not be to replace EBM’s singular account of evidence with
an equally singular alternative to be readily applied to a host of health research problems.
Instead, a broad framework must be established for context-speciﬁc, and content-rich,
integrated health research.

This call for integrated health research led to the formulation of my postdoctoral
research project, an investigation into evidence based approaches to women’s health

(EBWH) from an embodiment perspective. Within the women’s health community, there

 

69’ Davidoff et al (1995), "Evidence based medicine." BMJ 310(6987); See also p. l of this dissertation.

242

 

is currently disagreement regarding the utility of the evidence based approach.
Supporters argue that EBWH will improve health outcomes by critically analyzing the
evidence base of women’s health research. Critics worry that the new methodology will
limit meaningﬁrl research into the sociopolitical determinants of women’s health by
narrowing the range of admissible research methods and the types and sources of reliable
evidence. Similar to other debates over evidence based approaches, the disagreement is
thought to largely hinge on how one understands evidence. Embodiment has not yet been
a point of analysis within the EBWH debates, as this philosophical framework is not
thought to offer insight into evidence and evidence based approaches. Here, the
conceptual divide between qualitative and quantitative perspective is seen to be ﬁrmly in
place. Drawing from the groundwork covered in this dissertation, I will challenge the
low evidentiary status of embodiment perspectives in women’s health. EBWH holds out
the promise of offering the best evidence for women’s health. If women’s health is a
distinct specialty in medicine because of its unique patient population, EBWH must
properly account for the embodied subjectivities, differences, and life experiences of the
women it serves. 696
There are numerous measures of “best evidence” within the broad healthcare

literature; EBM focuses on controlled measures of therapeutic effectiveness, while more

holistic and alternative healing models frequently lean toward such patient-centred

 

696 Embodiment studies theorize the body, and this area of scholarship is important to health research
because conceptions of the body are understood to be inextricably interconnected with deﬁnitions of health
and illness, constructions of disease etiology, and with corollary notions of appropriate care. Thus it
provides important nuanced perspectives to an evidentiary investigation into women’s health research. On
embodiment theory, see Price and Shildrick, eds. (1999), Feminist theory and the body: A reader.

243

 

measures as individual experiences and sensations.697 Controls such as blinding are
thought to disrupt the healing context rather than ensure objectivity. Thus EBM can and
has been challenged on the grounds of Feyerabendian “incommensurable alternatives”,
that is, medical modalities and discourses that fail to ﬁt into medicine’s evidence base. In
some cases, it is over disputed evidentiary criteria. For instance, many advocates of
complementary and alternative medicine challenge EBM’s methodology on the grounds
that holistic healing practices cannot ﬁt into the reductive conﬁnes of experimentalism. 6'98
People living with chronic conditions frequently insist that they offer invaluable
experiential insight into the management of their condition.699 Other problems arise
regarding the uptake of evidence. Marginalized healthcare techniques sometimes ﬁnd
that their evidence fails to be incorporated into policy, such as the case of positive
outcomes for midwife-led births in the US.700 The broad health research agenda being
advocated here encourages investigation into instances of ill-ﬁt as well as plural
perspectives in accounting for evidence. The ethics of evidence, which examines the
production and presentation of empirical evidence and the establishment of credible
knowledge from an ethics perspective, calls attention to the signiﬁcant concern about the

power/knowledge relationship that arise from a seemingly innocuous clinical

decisionmaking tool.

 

’97 Barry (2006), "The role of evidence in alternative medicine: Contrasting biomedical and
anthropological approaches." Soc Sci Med 62(11);Leibovici (1999), "Alternative (complementary)
medicine: a cuckoo in the nest of empiricist reed warblers." BMJ 319(7225).

69" Barry (2006), "The role of evidence in alternative medicine: Contrasting biomedical and
anthropological approaches." Soc Sci Med 62(11).

’99 Toombs (1995), "Chronic illness and the goals of medicine." Second Opinion 21(1).

70° Bodgan-Lovis and Sousa (2006), "The contextual inﬂuence of professional culture: Certiﬁed midwives'
knowledge and reliance on evidence-based practice." Soc Sci Med 62(11).

244

r:-

 

BIBLIOGRAPHY

Aggerty, S. (2005). Patient focused care in asthma. Practice Nurse: 29, 38-44.
Alcoff, L. and Potter, E., eds. (1993). Feminist epistemologies. New York: Routledge.

Angell, M. and Kassirer, J. (1998). Alternative medicine--the risks of untested and
unregulated remedies. New England Journal of Medicine: 339, 839-841.

Armstrong, P. and Armstrong, H. (2002). Wasting away: The undermining of Canadian
health care. Toronto: Oxford University Press.

Armstrong, P., Armstrong, H., and Coburn, D. (2001). Unhealthy times: Political
economy perspectives on health and care in Canada. Toronto: Oxford University
Press.

Ashcroft, RE. (2004). Current epistemological problems in evidence based medicine.
Journal of Medical Ethics: 30, 131-135.

---. (2003). Constructing empirical bioethics: F oucauldian reﬂections on the empirical
turn in bioethics research. Health Care Analysis: 11, 3-13.

---. (2002). What is clinical effectiveness? Studies in the History and Philosophy of
Biological and Biomedical Sciences: 33, 219-233.

---. (2000). Giving medicine a fair trial. British Medical Journal: 320, 1686.
Ashcroft, R.E., Chadwick, D. W., Clark, S. R., et al. (1997). Implications of socio-
cultural contexts for the ethics of clinical trials. Health Technology Assessment:

1, i-iv, 1-65.

Asia Paciﬁc EBM Network. (2006). Asia Paciﬁc EBM Network Conference 2006.
http://www.sph.cuhk.edu.hldhkcochrane/e-tapenethtm (Accessed July 1, 2006).

Ayer, A. J. (1936). Language, truth. and lqgi_c. London: V. Gollancz.

Bandolier Glossary of Terms. Surrogate endpoints.
http://www.ir2.ox.ac.uk/bandolier/booth/glossary/surrog.html (Accessed
September 15, 2006).

Barry, CA. (2006). The role of evidence in alternative medicine: Contrasting biomedical
and anthropological approaches. Social Science and Medicine: 62, 2646-2657.

Beauchamp, T. L. and Childress, J. F. (2001). Principles of biomedical ethics. New York:
Oxford University Press.

245

 

Belkin, G. (2003). Shifting the focus: the historical meaning of managed care and the
search for ethics in mental health. Rationing sanity: Ethical issues in managed

mental health care. Nelson, J. L., ed. Washington: Georgetown University Press,
9-27.

---. (1997). The technocratic wish: Making sense and ﬁnding power in the "managed"
medical marketplace. Journal of Health Politics, Policy. and Law: 22, 509-532.

---. (1994). Numbers and the politics of health care. Journal of Health PoliticsLPolicy.
and Law: 19, 3-5. [
l

Benitez-Bribiesca, L. (1999). Evidence-based medicine: A new paradigm? Archives of
Medical Research: 30, 77-79. . E.

Berg, M. (1997). Problems and promises of the protocol. Social Science and Medicine:
44, 1081-1088.

Black, N. (2001). Evidence based policy: Proceed with care. British Medical Journal:
323, 275-279.

Bleier, R. (1984). Science and gender. New York: Pergamom Press.

Bodenheimer, T. (1999). The movement for improved quality of health care. New
England Joumal of Medicine: 340, 488-496.

Bodgan-Lovis, E. and Sousa, A. (2006). The contextual inﬂuence of professional culture:
Certiﬁed midwives' knowledge and reliance on evidence-based practice. Social
Science and Medicine: 62, 2681-2693.

Bordo, S. (1987). The ﬂight to objectivity: Essays on Cartesianism and culture. Albany:
SUNY Press.

Borry, P., Schotsmans, P. and Dierickx, K. (2005). The birth of the empirical turn in
bioethics. Bioethics: 19, 49-71.

Brase, T. (2004). How technocrats are taking over the practice of medicine: A wake-up
call to the American people. St. Paul, MN: Citizens' Council on Health Care.
httjy//www.cchconline.org/pdfreport/index.php (Accessed June 24, 2006).

Britton, A., McKee, M., Black, N. et al. (1998). Choosing between randomized and
non-randomized studies: A systematic review. Health Technological Assessment:
2, 1-19.

Brody, H., Miller, F. G. and Bogdan-Lovis, E. (2005). Evidence-based medicine:
Watching out for its friends. Perspectives in Biology and Medicine: 48, 570-5 84.

246

 

Buetow, SA. (2002). Beyond evidence-based medicine: Bridge-building a medicine of
meaning. Journal of Evaluation in Clinical Practice: 8, 103-108.

Buetow, SA. and Keneally, T. (2000). Evidence-based medicine: Bridge-building a
medicine of meaning. Journal of Evaluation in Clinical Practice: 6, 85-92.

 

Calkins, M. (1896). Community of ideas of men and women. Psychological Review: 3,
426-430.

Canadian Medical Association. (1994). Canadian task force on the periodic health
examination. Canadian Medical Association Journal: 150.

Candelise, L., Aritzu, E., Ciccone, A., Ricci, 8., and Warlaw, J. (1995). Randomized
controlled trial of streptokinase, aspirin, and combination of both in treatment of
acute ischemic stroke. Lancet: 346, 1509-1514.

 

Cangialose, CB. (1994). Outcomes research [Letter]. New England Journal of Medicine:

330, 435.

Camap, R. (1959). The elimination of metaphysics through logical analysis of language.
Logical positivism. Ayer, A. J ., ed. New York: Free Press, 60-81.

Carr-Hill, R. (1995). Welcome? To the brave new world of evidence based medicine.
Social Science and Medicine: 41 , 1467-1468.

Cassell, E.J. (1982). The nature of suffering and the goals of medicine. New England
Journal of Medicine: 306, 639-645.

Centre for Evidence-Based Medicine. (2006). Levels of Evidence and Grades of
Recommendation. http://www.cebm.net/levels_of_evidence.asp (Accessed
February 20, 2006).

Chalmers, I. (1998). Unbiased, relevant, and reliable assessments in health care. British
Medical Journal: 317, 1 167-1168.

Champagne, F., Lemieux-Charles, L., et a1. (2004). Introduction: Toward a broader
understanding of the use of knowledge and evidence in health care. Using
knowledge and evidence in health care: Multidisciplinary perspectives. Lemieux-
Charles, L. and Champagne, F ., eds. Toronto: University of Toronto Press, 3-17.

Charlton, B. (1991). Medical practice and the double-blind, randomized controlled trial.
British Journal of General Practice: 41, 335-336.

Charlton, B.G. (1997). Restoring the balance: Evidence-based medicine in its place.
Journal of Evaluation in Clinical Practice: 3, 87-98.

247

1“"

 

Christiansen, C. and Lou, J. O. (2001). Ethical considerations related to evidence-based
practice. American Journal of Occupational Therapy: 55, 345-349.

Clough, S. (2003). Beyond epistemology: A prgmatist approach to feminist science
studies. Lanham, MA: Rovvrnan & Littleﬁeld.

---. (2003). A hasty retreat from evidence: The recalcitrance of relativism in feminist
epistemology. Siblings under the skin: Feminism. social justice and analytic
philosophy. Clough, S., ed. Aurora, CO: The Davies Group Publishers, 85-116.

Coast, J., Donovan, J ., and Frankel, S. (1996). Priority settig: The health care debate.
Toronto: Wiley.

Cochrane, A. I. (1974). Poems from prison. Chepstow: C. P. Healey.

---. (1972). Effectiveness and efﬁciency. Random reﬂections on the health service.
Oxford: The Nufﬁeld Provincial Hospitals Trust.

Code, L. (1993). Taking subjectivity into account. Feminist epistemologies. Alcoff, L.
and Potter, E., eds. New York: Routledge, 15—48.

 

--- . (1991). What can she know? Feminist theory and the construction of knowledge.
Ithaca, NY: Cornell University Press.

Cott, C.A., Boyle, J. Fay, J ., et al. (2001). Client-centred rehabilitation. Arthritis
Community Research and Evaluation Unit 1-57.

Coumoyer, B. R. (2004). The evidence-based social work skills book. Indianapolis, IN:
Allyn & Bacon.

Culpepper, L. and Gilbert, T. T. (1999). Evidence and ethics. Lancet: 353, 829-831.

Dans, A.L., Dans, L. F. Guyatt, Gordon H. and Richarson, W. S. (1998). Users' guides to
the medical literature, XIV: How to decide on the applicability of clinical trials

results to your patient. Journal of the American Medical Association: 279, 545-
549.

Davey-Smith, G., Ebrahim, S. and Frankel, S. (2001). How policy informs the evidence.
British Medical Journal: 322, 184-185.

Davidoff, F., Haynes, R. B., Sackett, D. L., et al. (1995). Evidence based medicine.
British Medical Journal: 310, 1085-1086.

Davidson, D. (2003). A coherence theory of truth. Siblings under the skin: Feminismg

social justice and anmtic philosophy. Clough, S., ed. Aurora, CO: The Davies
Group, 117-140.

248

---. (2001). Radical interpretation. Inquiries into truth and interpretation (philosophical
essays of Donald Davidson). New York: Oxford University Press, 125-139.

---. (1991). Epistemology naturalized. Dialectica: 45, 191-202.
---. (1990). The structure and content of truth. Journal of Philosophy: 87, 279-328.

---. (1989). The myth of the subjective. Relativism: Interpretations and confrontations.
Krausz, M., ed. Bloomington: Indiana University Press.

---. (1974). On the very idea of a conceptual scheme. Proceedings and addresses of the
American Philosophical Association (47). New York: pp.5-20.

Davies, P. (1999). What is evidence-based education? British Journal of Educational
Studies: 47, 108-121.

Dawson, NV. and Arkes, H. R. (1987). Systematic errors in medical decision making:
Judgment limitations. Journal of General Internal Medicine: 2, 183-187.

De Simone, J. (2006). Beyond ‘faith-based medicine’ and EBM. Journal of Evaluation in
Clinical Practice: 12, 438-444.

 

 

 

---. (2006). Reductionist inference-based medicine, i.e. EBM. Journal of Evaluation in
Clinical Practice: 12, 445-449.

De Vries, R. and Lemmens, T. (2006). The social and cultural shaping of medical
evidence: Case studies from pharmaceutical research and obstetric science.
Social Science and Medicine: 62, 2694-2706.

Denny, K. (1999). Evidence-based medicine and medical authority. Journal of Medical
Humanities: 20, 247-263.

Dentith, S. (2002). English and the audit culture: An introduction. The Higher Education
AcademyOn-Line Newsletter: 3.

httgﬂwwwcnglish.heacademy.ac.uk/explore/publications/newsletters/newsissue3/denti
th.htm (Accessed September 12, 2006).

DeRose, K. (2003). Contextualism and knowledge attributions. _Epistemolqgg The big
questions. Alcoff, L., ed. Oxford: Blackwell, 109-123.

Dieppe, P. (1998). Evidence-based medicine or medicine-based evidence? Annals of
RheumatolﬂicaI Disease: 57, 385-386.

Dingwall, R., Murphy, E.,Watson, P., et al. (1998). Catching goldﬁsh: Quality in
qualitative research. Journal of Health Services Research and Policy: 3, 167-172.

249

Djulbegovic, 8., Morris, L. and Lyman, G. (2000). Evidentiary challenges to evidence-
based medicine. Journal of Evaluation in Clinical Practice: 6, 99-109.

Dobrow, M.J., Goel, V. and Upshur, R. E. G. (2004). Evidence-based health policy:
Context and utilization. Social Science and Medicine: 58, 207-217.

Downie, R. S., Macnaughton, J ., and Randall, F. (2000). Clinical judgment: Evidence in
practice. London: Oxford University Press.

Dresser, R. (1992). Wanted: Single, white male for medical research. Hastings Center
Repprt: 22, 24-29.

Duhem, P. (1982). The aim and structure of physical theog. Princeton University Books:
Princeton.

Edwards, A. and Elwyn, G. (2001). Evidence based patient choice: Inevitable or
impossible? Oxford University Press: Oxford.

Edwards, S. J. L., Lilford, R. J ., Braunholtz, D. A., et al. (1998). Ethical issues in the

- design and conduct of randomized controlled trials. Health Technological
Assessment: 2, l-130.

Ellwood, P. M. (1988). Outcomes management: A technology of patient experience.
New England Journal of Medicine: 318, 1549-1556.

Engelhardt Jr., H. Tristram. (1986). The foundations of bioethics. New York: Oxford
University Press.

Evans, R. G. (2003). Patient-centred medicine: Reason, emotion, and human spirit? Some
philosophical reﬂections on being with patients. Medical Humanities 29, 8-14.

Evidence Based Medicine Working Group. (1992). Evidence-based medicine.
Journal of the American Medical Association: 268, 2420-2425.

Fausto-Sterling, A. (1992). Myths ofgender: Biological theories about women and men.
New York: Basic Books.

---. (1989). Life in the XY corral. Women's Studies International Forum: 12, 319-331.

F einstein, AR. and Horwitz, R. I. (1997). Problems in the ‘evidence’ of ‘evidence-based
medicine'. American Journal of Medicine: 103, 529-535.

Feyerabend, P. (1998). How to be a good empiricist: A plea for tolerance in matters
epistemological. Philosophy of science: The central issues. Curd, M. and Cover, J.
A., eds. New York: Norton, 922-949.

250

---. (1991). Three dialogues on knowledga. Oxford: Basil Blackwell.
---. (1981). Problems of empiricism. Cambridge: Cambridge University Press.

---. (1981). Two models of epistemic change: Mill and Hegel. Problems of empiricism.
Feyerabend, P., ed. Cambridge: Cambridge University Press, 65-79.

---. (1980). Science without experience. Challenges to empiricism. Morick, H., ed.
Indianapolis: Hackett, 160- 1 64.

---. (1979). Science in a free society. New York: Routledge.

---. (1978). Against method. London: Verso.

---. (1964). Realism and instrumentalism: Comments on the logic of factual support. _T_ha
critical approach: Essays in honour of Karl Popper. Bunge, M., ed. Glencoe, IL:

The Free Press, 280-308.

Fleming, TR. and DeMets, D. L. (1996). Surrogate end points in clinical trials: Are we
being misled? Annals of Internal Medicine: 125, 605-613.

Foucault, M. (1994). The birth of the clinic: An archaeology of medical perception. New
' York: Vintage Books.

Frankford, D.M. (1994). Scientism and economism: Regulating health care. Journal of
Health, Politics. Policy & Law: 19, 773-799.

Frazier, H. S. and Mosteller, F. (1995). Medicine worth paying for: Assessig medical
innovations. Cambridge: Harvard University Press.

Freedman, B. (1987). Equipoise and the ethics of clinical research. New Enwd Journal
ofMedicine: 317, 141-145.

 

Gifford, F. (1996). Outcomes research: Upstream issues for downstream users. Hastings
Center Report: 26, 38-44.

Goldenberg, M. J. (2006). On evidence and evidence-based medicine: Lessons from the
philosophy of science. Social Science and Medicine: 62, 2621-2632.

---. (2005). Against evidence based bioethics [Letter]. British Medical Journal: 331, 901.

---. (2005). Evidence-based ethics? On evidence based practice and the "empirical turn"
from normative bioethics. BMC Medical Ethics: 6:11.

 

Goodman, K.W. (2005). Ethics, evidence, and public policy. Perspectives in Biology and
Medicine: 48, 548-556.

251

---. (2003). Ethics and evidence-based medicine: Fallibility and responsibility in clinical
science. Cambridge University Press: Cambridge.

Goodman, S. N. (2002). The mammography dilemma: A crisis for evidence-based
medicine? Annals of Internal Medicine: 137, 363-365.

Gray, J. A. M. (1997). Evidence-based health care. New York: Churchill Livingstone.

Greenhalgh, T. (1999). Narrative based medicine: Narrative based medicine in an
evidence based world. British Medical Journal: 318, 323-325.

Greenhalgh, T. and Hurwitz, B., eds. (1998). Narrative based medicine: Dialogale and
discourse in clinical practice. London: BMJ Publishing Group.

Grimshaw, J. (2004). So what has the Cochrane Collaboration ever done for us? A report
card on the ﬁrst 10 years. Canadian Medical Association Journal: 171, 747-749.

Gupta, M. (2006). Beyond 'evidence'. Commentary on Tonelli (2006), Integrating
evidence into clinical practice: an alternative to evidence-based approaches.
Journal of Evaluation in Clinical Practice: 12, 248-256.

---. (2003). A critical appraisal of evidence-based medicine: Some ethical considerations.
Journal of Evaluation in Clinical Practice: 9, 111-121.

Guyatt, G. H. and Rennie, D., eds. (2002). Users' guides to the medical literature: A
manual for evidence-based clinical practice. Chicago: AMA Press.

Guyatt, G. H., Haynes, R. B., et al. (2002). Introduction: The philosophy of evidence-
based medicine. Users’ guide to the medical literature: A manual for evidence-
based clinical practice. Guyatt, G. H. and Rennie, D., eds. Chicago: AMA Press,
3-47.

Hacking, I. (1990). The taming of chance. New York: Cambridge University Press.

Halpem, S. D. (2005). Towards evidence based bioethics. British Medical Journal: 331,
901 -903.

Hanson, N. R. (1958). Patterns of discovery. Cambridge: Cambridge University Press.

Harari, E. (2001). Whose evidence? Lessons from the philosophy of science and the
epistemology of medicine. Australian and New Zealand Journal of Psychiatry:
35, 724-730.

Haraway, D. (1996). Modest witness: Feminist diffractions in science studies. lha

Disunity of Science: Boundaries, Contexts, and Power. Galison, P. and Stump, D.,
eds. Stanford: Stanford University Press, 428-442.

252

---. (1991). Simians, cyborgs, and women: The reinvention oﬂlature. New York:
Routledge.

---. (1989). Primate vision: Gender, race, and nature in the world of modern science.
London: Routledge.

---. (1988). Situated knowledges: The science question in feminism and the privilege of
partial perspectives. Feminist Studies: 14, 575-579.

Harding, S. (2004). The feminist standpoint theor_'y reader. New York: Routledge.

---. (1998). Is science multicultural? Postcolonialisms. feminisms. and epistemologies.
Bloomington: Indiana University Press.

---. (1993). Rethinking standpoint epistemology: What is strong objectiviyl. New York:
Routledge.

---. (1991). Whose science? Whose knowledge? Thinking from women's lives. Ithaca.
NY: Cornell University Press.

---. (1986). The science question in feminism. Ithaca, NY: Cornell University Press.

---. (1978). Knowledge, technology, and social relations. Journal of Medicine and
Philosophy: 3, 346-358.

Harries, U., Elliot, H. and Higgins, A. (1999). Evidence-based policy-making in the
NHS: Exploring the interface between research and the commissioning process.
Journal of Public Health Medicine: 21, 29-36.

Haynes, RB. (2002). What kind of evidence is it that evidence-based medicine advocates
want health care providers and consumers to pay attention to? BMC Health
Services Research: 2.

 

---. (1981). How to read clinical journals: II. To learn about a diagnostic test Canadian
Medical Association Journal: 124, 703-710.

Hedgecoe, A. (2004). Critical bioethics: Beyond the social science critique of applied
ethics. Bioethics: 18, 120-143.

Heidegger, M. (1996). Being and time. Albany, NY: SUNY Press.

Hill, T.P. (1994). The cultural and philosophical foundations of normative medical ethics.
Social Science and Medicine: 39, 1149-1154.

Hoey, J. (2006). Editorial and scientiﬁc independence: Misreading the evidence,

253

misleading the public. Ruth Cooperstock Memorial Lectureship. Toronto: October
5, 2006,

Hofﬁnaster, B. (1992). Can ethnography save the life of medical ethics? Social Science
and Medicine: 35, 1421-1431.

 

Holmes, D., Murray, S. J ., Perron, A., et al. (2006). Deconstructing the evidence-based

discourse in health sciences: Truth, power and facism. International Journal of
Evidence Based Healthcare: 4, 180-186.

Holmes, D., Perron, A. and O'Byme, P. (in press). Necrospective: Evidence, virulence,
and the disappearance of nursing knowledge. Worldviews on Evidence-Based

Nursing.

Hope, T. (1996). Evidence based patient choice. London: King's Fund London.
--- (1995). Evidence based medicine and ethics. Journal of Medical Ethics: 21, 259-260.

Horkheimer, M. and Adomo, T. W. (2002). Dialectic of erﬂhtenment: Philoscﬂlical
fragments. Palo Alto, CA: Stanford University Press.

Horton, R. (1995). MAST-I: Agreeing to disagree. Lancet: 346, 1504.

Howard, M. O., McMillen, C. J. and Pollio, D. E. (2003). Teaching evidence-based
practice: Toward a new paradigm for social work education. Research on Social
Work Practice: 13, 234-259.

Hubbard, R. and Lowe, M. (1979). Genes and gender. New York: Gordian Press.

Hughes, J. C. (1996). Evidence-based medicine and ethics. Journal of Medical Ethics:
22, 55-56 [Letter].

Hume, D. (2000). A treatise of human nature. Oxford: Oxford University Press.

---. (1977). An enquiry concerning human understanding. Indianapolis: Hackett.

Hunt, D. L., Jaeschke, R. and McKibbon, K. A. (2000). Users' guides to the medical
literature, XXI: Using electronic health information resources in evidence-based
practice. Journal of the American Medical Association: 283, 2829-2836.

Husserl, E. (1982). Ideas pertaining to a pure phenomenology and a phenomenological
philosophy: First boolg: General introduction to a pure phenomenology. The

Hague: Nijoff.

---. (1970). The crisis of European sciences and transcendentalphenomenology.
Evanston, IL: Northwestern University Press.

254

Jansen, R. (1997). Evidence-based ethics and the regulation of reproduction. Human
Reproduction: 12, 2068-2075.

Jones, G. W. and Sagar, S. M. (1995). Evidence based medicine. No guidance is provided
for situations for which evidence is lacking [Letter]. British Medical Journal: 311,
258.

Keller, E. F. (1985). Reﬂections on gender and science. New Haven: Yale University
Press.

Kerridge, 1., Lowe, M. and Henry, D. (1998). Ethics and evidence based medicine.
British Medical Journal: 316, 1151-1153.

Kim, Scott Y. H. (2004). Evidence-based ethics for neurology and psychiatry research.

The Journal of the American Society for Experimental NeuroTherapeutics: 1,
372-377.

Klein, R. (2000). From evidence-based medicine to evidence-based policy? Journal of
Health Services Research and Policy: 5, 65-66.

Kodish, E., Eder, M., Noll, R. B. et al. (2004). Communication of randomization in
childhood leukemia trials. Journal of the American Medical Association:
291, 470-475.

Kovner, A. R., Elton, J. J ., Billings, J ., et al. (2000). Evidence-based management (and
commentaries). Frontiers of Health Services Management: Summer 2000, 12-55.

Kuhn, T. (1996). The structure of scientiﬁc revolutiona. Chicago: University of Chicago
Press.

---. (1970). Reﬂections on my critics. Criticisms and the growth of knowltﬂga. Lakatos,
I. and Margraves, A., eds. Cambridge: Cambridge University Press, 231-278.

Lambert, H. (2006). Accounting for EBM: Notions of evidence in medicine. Social
Science and Medicine: 62, 2633-2645.

Lambert, H., Gordon, B. J. and Bogdan-Lovis, E. A. (2006). Introduction: Gift horse or
Trojan horse? Social science perspectives on evidence-based health care. Social
Science and Medicine: 62, 2613-2620.

Leder, D. (1992), A tale of two bodies: The Cartesian corpse and the lived body. m
body in medical thoght and practice. Leder, D., ed. The Netherlands: Kluger
Academic Press, 17-35.

Leibovici, L. (1999). Alternative (complementary) medicine: a cuckoo in the nest of
empiricist reed warblers. British Medical Journal: 319, 1629-1631.

255

Lennon, K. (1998). Natural sciences. A companion to feminist philosophy. Jaggar, A. M.
and Young, 1. M., eds. Oxford: Blackwell Publishers, 185-193.

Leys, C. (2001). The British National Health Service in the face of neoliberalism.
Unhealthy times: Political economy perspectives on health and care in Canada.
Armstrong, P., Armstrong, H., et al, eds. Toronto: Oxford University Press, 66-
90.

Light, D. (2001). Comparative institutional response to economic policy managed
competition and govemmentality. Social Science and Medicine: 52, 1151-1166.

Lilford, R. J. and Jackson, J. (1995). Equipoise and the ethics of randomization. Journal
of the Royal Society of Medicine: 88, 552-559.

Lloyd, E. A. (2000). Feyerabend, Mill, and pluralism. The worst enemy of science?
Essa/s in memory of Paul Feyerabend. Preston, J. and Munevar, G., et al, eds.
New York: Oxford University Press, 115-124.

---. (1996). The anachronistic anarchist. Philosophical Studies: 81, 247-261.

Longino, H. (1993). Subjects, power, and knowledge: Description and prescription in
feminist philosophies of science. Feminist epistemologie_s. Alcoff, L. and Potter,
E., eds. New York: Routledge, 101-120.

---. (1990). Science as social knowledge: Values and obiectivity in scientiﬁc inquiry.
Princeton: Princeton University Press.

---. (1989). Can there be a feminist science? Feminism and science. Tuana, N., ed.
Bloomington: Indiana University Press, 45-57.

MacCoun, R. J. (1998). Biases in the interpretation and use of research results. Annual
Review of Psychology: 49, 259-287.

Maclntyre, S., Chalmers, I., Horton, R., et al. (2001). Using evidence to inform health
policy: Case study. British Medical Journal: 322, 222-225.

Major-Kincade, T., Tyson, J. and Kennedy, K. (2001). Training pediatric house staff in
evidence-based ethics: an explanatory controlled trial. Journal of Perinatology:
21, 161-166.

Malterud, K. (1995). The legitimacy of clinical knowledge: Toward a medical
epistemology embracing the art of medicine. Theoretical Medicine: 16, 83-98.

McGuire, W. (2005). Evidence-based population health: A critical realist framework.

University of Toronto Comparative Program on Health and Society. [Paper
Presentation]: February 9, 2005.

256

McWhinney, I. R. (1978). Medical knowledge and the rise of technology. Journal of
Medicine and Philosophy: 3, 273-304.

Merton, V. (1993). The exclusion of pregnant, pregnable, and once-pregnable people
(AKA women) from biomedical research. American Journal of Law and
Medicine: 19, 369-451.

Mike, V. (1999). Outcomes research and the quality of health care: The beacon of an
ethics of evidence. Evaluation and the Health Professions: 22, 3-32.

Miles, A., Bentley, P., Polychronis, A., et al. (1997). Evidence-based medicine: Why all
the fuss? This is why. Journal of Evaluation in Clinical Practice: 3, 83-86.

Miles, A., Bentley, P., Polychronis, A., et al. (2001). Recent developments in the
evidence-based healthcare debate. Journal of Evaluation in Clinical Practice: 7,
85-89.

Miles, A., Bentley, P., Polychronis, A., et al. (1999). Advancing the evidence-based
healthcare debate. Journal of Evaluation in Clinical Practice: 5, 97-101.

Miles, A., Charlton, 3., Bentley, P., et al. (2000). New perspectives in the evidence-based
healthcare debate. Journal of Evaluation in Clinical Practice: 6, 77-84.

Miles, A., Grey, J ., Polychronis, A., et al. (2002). Critical advances in the evaluation and

development of clinical care. Journal of Evaluation in Clinical Practice: 8, 87-
102.

Mill, J. S. (1989). On liberty. On liberty and other writiﬁrs. Collini, 8., ed. Cambridge:
Cambridge University Press, 1-115.

---. (1974). A system of logic, ratiocinative and inductive : being a connected view
of the principles of evidence and the methods of scientiﬁc investigation. London:
Routledge & Kegan Paul.

Miller, S. I. and Safer, L. A. (1993). Evidence, ethics, and social policy dilemmas.
Educational Policy Analysis Archives: 1, 1-14.

Mills, C. (1997). The racial contract. Ithaca: Cornell University Press.

Ministry of Health (Canada). (2006). Health Canada. http://www.hc-sc.gc.ca/ index_e.
htrnl (Accessed May 11, 2006).

Molewijk, A. C., Otten, W., Dupuis, H. M., et al. (2003). Implicit normativity in

evidence-based medicine: a plea for integrated empirical ethics research. Health
Care Analysis: 11, 69-92.

257

Montague, H. and Hollingsworth, L. S. (1914). The comparative variability of the sexes
at birth. American Journal of Sociology: 20, 335-3 70.

Montgomery, K. (2006). How doctors think. Oxford: Oxford University Press.

Mykhalovskiy, E. and Weir, L. (2004). The problem of evidence-based medicine:
Directions for social medicine. Social Science and Medicine: 59, 1059-1069.

Navarro, V. (2002). The political economy of social inequalities: Consearences for
health and qualitmf life. Amityville, NY: Baywood.

---. (1993). Dangerous try your health: Capitalism in health care. New York: Monthly
Review Press.

Naylor, C. D. (1995). Grey zones of clinical practice: Some limits to evidence-based
medicine. Lancet: 345, 840-842.

Nelson, J. L. (2001). Knowledge, authority, and identity: A prolegomenon to an
epistemology of the clinic. Theoretical Medicine: 22, 107-122.

Nelson, L. H. (1993). Epistemological communities. Feminist epistemologies. Alcoff, L.
and Potter, E., eds. New York: Routledge, 121-160.

---. (1993). A question of evidence. Hypatia: 8, 172-190.

---. (1990). Who knows: From Quine to feminist empiricism. Philadelphia: Temple
University Press.

Norman, G. R. (1999). Examining the assumptions of evidence-based medicine. Journal
of Evaluation in Clinical Practice: 5, 139-147.

Nuremberg Code. (1949). Trials of war criminals before the Nuremberg Military
Tribunals under Control Council Law no. 10. Washington: US. Government

Printing Ofﬁce.

Oakley, A. (2000). Experiments in knowing: Gender and method in the social sciences.
Oxford: Polity Press.

Oxman, A. D. and Guyatt, G. H. (1993). The science of reviewing research. Annals of
New York Academy of Science: 703, 123-131.

Oxman, A. D., Sackett, D. L. and Guyatt, G. H. (1993). Users' guides to the Medical
Literature, 1: How to get started. Journal of the American Medical Association:
270, 2093-2095.

Parchman, M. L. (1995). Small area variation analysis: A tool for primary care research.

258

Family Medicine: 272, 272-276.

Parker, M. (2001). The ethics of evidence-based patient choice. Health Expectations: 4,
87-91.

Peto, R. and Baigent, C. (1988). Trials: The next 50 years. British Medical Journal: 317,
1170-1171.

Polychronis, A., Miles, A. and Bentley, D. P. (1996). Evidence-based medicine:
Reference? Dogma? Neologism? New orthodoxy? Journal of Evaluation in
Clinical Practice: 2, 1-3.

Pope, C. (2003). Resisting evidence: The study of evidence-based medicine as a
contemporary social movement. Health: An Interdisciplinary Journal for the

Social Study of Health, Illness, and Medicine: 7, 267-282.

Potter, E., Howes, M., McHugh, N., et al. (2006). On the very idea of a feminist
epistemology for science. [Review symposium]. Metascience: 15, 1-37.

Price, J. and Shildrick, M., eds. (1999). Feminist theogy and the body: A reader. New
York: Routledge.

Quine, W. V. (2003). Epistemology naturalized. Epistemology: The big questions.
Alcoff, L., ed. Oxford: Blackwell, 253-264.

---. (2003). From a logical point of view. Cambridge: Harvard University
Press.

---. (1981). On the very idea of a third dogma. Theories and thinga. Cambridge: Harvard
University Press.

---. (1981). Things and their place in theories. Theories and things. Cambridge: Harvard
University Press.

---. (1966). On mental entities. The ways oQaaradox and other essays. New York:
Random House.

---. (1960). Word and obiect. Cambridge: MIT Press.
Reilly, B. M. (2004). The essence of EBM. British Medical Jouraal: 329, 991-992.

Reilly, S., Douglas, J. and Oates, J. (2004). Evidence based practice in speech pathology.
Sydney: Wiley.

Reiser, D. and Rosen, D. (1984). Medicine as human experience. Baltimore: University
Park Press.

259

Reiser, S. J. (1978). The decline of clinical dialogue. Journal of Medicine and
Philosophy: 3, 305-313.

--- (1978). Medicine and the reign of technolggy. New York: Cambridge University
Press.

Relman, A. S. (1988). Assessment and accountability: The third revolution in medical
care. New England Journal of Medicine: 319, 1220-1222.

Richardson, W. S. and Detsky, A. S. (1995). Users' guides to the medical literature, VII:
How to use a clinical decision analysis. A. Are the results of the study valid?
Journal of the American Medical Association: 273, 1292-1295.

Richardson, W. S. and Detsky, A. S. (1995). Users' guides to the medical literature, VII:
How to use a clinical decision analysis. B. What are the results and will they help

me in caring for my patients? The Journal of the American Medical Association:
273, 1610-1613.

Roberts, L. W. (2000). Evidence—based ethics and informed consent in mental illness
research. Archive of General Psychiatry: 57, 533-538.

Rodwin, M. (2001). The politics of evidence-based medicine. Journal of Health Politics,
Policy. and Law: 26, 439-445.

Rogers, W. A. (2004). Does evidence-based medicine offer fair beneﬁts for all? Ethics
Journal of the American Medical Association: 6. www.mna-assnorg/ama/pub/
category/ 14295.html (Accessed January 19, 2005).

---. (2004). Evidence-based medicine and women: Do the principles and practices of
EBM further women's health? Bioethics: 18, 50-70.

---. (2002). Evidence-based medicine and practice: Limiting or facilitating patient
choice? Health Expectations: 5, 95-103.

---. (2002). Is there a tension between doctors' duty of care and evidence-based medicine?
Health Care Amrlyysis: 10, 277-287.

Rorty, R. (1991). Pragmatism, Davidson, and truth. Obiectivism. relativism, and truth:
Philosophicagrapers, volume 1. Cambridge: Cambridge University Press, 126-
150.

---. (1991). Representation, social practice, and truth. Obiectivism. relativism. and
truth: Philosophical papers. volume 1. Cambridge: Cambridge University Press,
151-161.

---. (1991). Science as solidarity. Obiectivism. relativism, and truth: Philosophical paper;

260

m

 

volume 1. Cambridge: Cambridge University Press, 35-45.

Rosenberg, William M. C. and Donald, A. (1995). Evidence based medicine: An
approach to clinical problem-solving. British Medical Journal: 310, 1122-1126.

Rosenfeld, J. A. (2004). The view of evidence-based medicine from the trenches:

Liberating or authoritarian? Journal of Evaluation in Clinical Practice: 10, 153-
155.

Ruggeri, M. and Tansella, M. (1995). Evaluating outcomes in mental health care.
Current Opinions in Psychology: 8, 116-122.

Sackett, D. L. (1997). A science for the art of consensus. Journal of the National Cancer
Institute: 89, 1003-1005.

---. (1989). Rules of evidence and clinical recommendations on the use of antithrombotic
agents. Chest: 95, 28-4S.

---. (1981). How to read clinical journals: 1. why to read them and how to start reading
them critically. Canadian Medical Association Journal: 124, 555-558.

---. (1981). How to read clinical journals: V: To distinguish useful from useless or even
harmful therapy. Canadian Medical Association Journal: 124, 1156-1162.

Sackett, D. L., Guyatt, G. H. and et al. (1996). Evidence based medicine. Authors' reply.
British Medical Journal: 313, 170-171.

Sackett, D. L. and Haynes, R. B. (1995). On the need for evidence-based medicine.
Evidence-Based Medicine: 1, 5-6.

Sackett, D. L. and Haynes, R. B., et al. (1991). Clinical epidemiology: A basic science
for clinical medicine. Boston: Little Brown & Co. Inc.

Sackett, D. L. and Richardson, W. S., et al. (1997). Evidence-based medicine: How to
practice and teach EBM. London: Churchill Livingstone.

Sackett, D. L. and Rosenberg, W. M. C. (1995). On the need for evidence-based
medicine. Journal of Public Health: 17, 330-334.

---. (1995). On the need for evidence-based medicine. Health economics: 4, 249-254.

Sackett, D. L., Rosenberg, W. M. C., Gray, J. A. M., et al. (1996). Evidence-
based medicine: what it is and what it isn't. British Medical Journal: 312, 71-72.

Sackett, D. L., Tugwell, P., and Haynes, R. B. (1985). Clinical epidemiology: A basic
science for clinical medicine. Boston: Little Brown & Co.

261

Sacks, O. (1984). A leg to stand on. New York: Summit Books.

Sage, W. M. (1994). Outcomes research [Letter]. New England Journal of Medicine:
330, 434-435.

Savodnik, I. (1978). Psychosomatic medicine. Journal of Medicine and Philosophy: 3,
331-345.

Scarry, E. (1985). The body in pain: The making and unmaking of the world. Oxford:
Oxford University Press.

Scharff, R. C. and Dusek, V. (2003). Philosophy of technology: The technologgal
condition. An anthology. Malden, MA: Blackwell Publishers.

Schick, T. and Vaughn, L. (2002). How to think about weird things: Critical thinking for
a new age. New York: McGraw-Hill.

Schwartz, M. A. and Wiggins, O. P. (1985). Science, humanism, and the nature of

medical practice: A phenomenological view. Perspectives in Biology and
Medicine: 28, 331-361.

Scott, J. (1991). The evidence of experience. Critical Inquiry: 178, 773-797.

Sehon, S. R. and Stanley, D. E. (2003). A philosophical analysis of the evidence-based
medicine debate. BMC Health Services Research: 3:14.

Seigfried, C. H. (1996). Pragmatism and feminism: Reweaving the social fabric. Chicago:
Chicago University Press.

---. (1990). Second sex: second thoughts. Hypatia reborn: Essays in feministyphilosophy.
Al-Hibri, A. and Simons, M., eds. Bloomington: Indiana University Press.

Shah, S., Whittle, A., Wilfond, B. et al. (2004). How do institutional review boards apply
the federal risk and beneﬁt standards for pediatric research? Journal of the
American Medical Association: 291, 476-482.

Shahar, E. (1997). A Popperian perspective of the term 'evidence based medicine'.
Journal of Evaluation in Clinical Practice: 3, 109-116.

Shaughnessy, A. F ., Slawson, D. C., and Becker, L. (1998). Clinical jazz: Harmonizing
clinical experience and evidence based medicine." Journal of Family Practice: 47,
425-428.

 

Sherr, L. (2000). Women and clinical trials. Women, health, and the mind. Sherr, L. and
St. Lawrence, J ., eds. Chichester: Wiley, 77-90.

262

 

Shore, C. and Wright, S. (2004). Whose accountability? Goverrrmentality and the
auditing of universities. Parallax: 10, 100-116.

Slavin, R. E. (2002). Evidence-based educational policies: Transforming educational
practice and research. Educational Researcher: 31, 15-21.

Sugarman, J ., Faden, R., et al. (2001). A decade of empirical research in bioethics.
Methods in Medical Ethics. Sugarman, J. and Sulmasy, D. R., eds. Washington:
Georgetown University Press, 19-33.

Sugarman, J. (2004). Determining the appropriateness of including children in clinical
research: How thick is the ice? Journal of the American Medical Association:
291 , 494-496.

--- (2004). The future of empirical research in bioethics. Journal of Law, Medicine and
Ethics: 32, 226-231.

Sullivan, F. and MacNaughton, R. (1996). Evidence in consultations: Interpreted and
individualized. Lancet: 348, 941-943.

Tallon, D., Chard, J. A. and Dieppe, P. A. (2000). Relation between agendas of the
research community and the research consumer. Lancet: 355, 2037-2040.

Tanenbaum, S. J. (1995). Getting from there to here: evidentiary quandaries of the US
outcomes movement. Journal of Evaluation in Clinical Practice: 1, 97-103.

---. (1994). Knowing and acting in medical practice: The epistemological politics of
outcomes research. Journal of Health Politics, Policy and Law: 19, 27-44.

---. (1993). What physicians know. New Ergland Journal of Medicine: 329, 1268-1271.

Tanesini, A. (2003). The practices of justiﬁcation. Epistemology: The bigquestions.
Alcoff, L., ed. Oxford: Blackwell, 152-164.

The Concise Oxford English Dictionary. (2002). New York: Oxford University Press.

Theocharis, T. and Psimopoulos, M. (1987). Where has science gone wrong. Nature:
329, 595-598.

Tognoni, G. and Roncaglioni, M. C. (1995). Dissent: An alternative interpretation of
MASTI-I. Lancet: 346, 1515.

Tonelli, M. R. (2006). Integrating evidence into clinical practice: An alternative to

evidence-based approaches. Journal of Evaluation in Clinical Practice: 12, 248-
256.

263

---. (1998). The philosophical limits of evidence-based medicine. Academic Medicine:
73, 1234-1240.

Toombs, S. K. (1995). Chronic illness and the goals of medicine. Second Opinion: 21,
11-19.

 

--- (1993). The meaning of illness: A phenomenolagical account of the different
perspectives of physician and patient. Dordrecht: Kluwer Academic Publishers.

Torrey, W. C., Drake, R. E., Dixon, L., et al. (2001). Implementing evidence-based
practices for persons with severe mental illnesses. Psychiatric Services: 52, 45-
50.

Traynor, M. (2002). The oil crisis, risk, and evidence-based practice. Nursing Inquiry: 9,
162-169.

Trout, K. S. (1981). How to read clinical journals: IV. To determine etiology or
causation. Canadian Medical Association Journal: 124, 985-990.

Tuana, N. (1989). Feminism and science. Bloomington: Indiana University Press.

Tugwell, P. X. (1981). How to read clinical journals: 111. To learn the clinical course and
prognosis of disease. Canadian Medical Association Journal: 124, 869-872.

Tyson, J. (1995). Evidence-based ethics and the care of premature infants. Future of
Children: 5, 161-166.

U.S. Cochrane Center. (2002). Training manual for handsearchers. U.S. Cochrane Center.
http://www.cochrane.us/documents/Training%20Manual%20for%20Handsearchers%20F
inal.pdf (Accessed September 19, 2006).

Upshur, R. E. G. (2006). The complex, the exhausted and the personal: reﬂections on the
relationship between evidence-based medicine and casuistry. Commentary on
Tonelli (2006), Integrating evidence into clinical. practice: an alternative to

evidence-based approaches. Journal of Evaluation in Clinical Practice: 12, 291-
298.

---. (2005). Looking for rules in a world of exceptions: Reﬂections on evidence-based
practice. Perspectives in Biologyand Medicine: 48, 477-489.

---. (2002). If not evidence, then what? Or does medicine really need a base? Journal of
Evaluation in Clinical Practice: 8, 113-119.

---. (2000). Seven characteristics of medical evidence. Journal of Evaluation in Clinical
Practice: 6, 93-97.

 

---. (1999). Priors and prejudice. Theoretical Medicine and Bioethics: 20, 319-327.

264

Upshur, R. E. G., Buetow, S., Loughlin, M., et al. (2006). Can academic and clinical
journals be in ﬁnancial conﬂict of interest situations? The case of evidence based
incorporated. Journal of Evaluation in Clinical Practice: 12, 405-409.

Upshur, R. E. G. and Tracy, C. S. (In Press). Precision versus clinical experience:
Family medicine does not need more evidence-based medicine than at present.
Ideological Debates in Family Medicine.

---. (2004). Legitimacy, authority, and hierarchy: Critical challenges for evidence based
medicine. Brief Treatment Crisis Intervention: 4, 197-204.

Upshur, R.E.G., VanDenKerkhof, E. G. and Goel, V. (2001). Meaning and measurement:
an inclusive model of evidence in health care. Journal of Evaluation in Clinical
Practice: 7, 91-96.

Vogel, M. J. and Rosenberg, C. E. (1979). The therapeutic revolution: Essays in the

social history of American medicine. Philadelphia: University of Pennsylvania
Press.

Von Zweck, C. (1999). The promotion of evidence-based occupational therapy practice
in Canada. Canadian Journal of Occupational Therapy: 66, 208-213.

Wartofsky, M. W. (1978). Editorial. Journal of Medicine and Philosophy: 3, 265-272.

Webb, S. A. (2001). Some considerations of the validity of evidence-based practices in
social work. British Journal of Social Work: 31, 57-79.

Weisz, 6., ed. (1990). Social science perspectives on medical ethics. Dordrecht, The
Netherlands: Kluwer Academic Publishers.

Welsby, P. D. (1999). Reductionism in medicine: Some thoughts on medical education
from the clinical front line. Jouraal of Evaluation in Clinical Practice: 5, 125-131.

Wennberg, J. E. (1992). AHCP and the strategy for health care reform. Health Affairs:
11, 67-71.

Williams, B. (1972). Morality. Cambridge: Cambridge University Press.

Williams, D. D. R. and Garner, J. (2002). The case against 'the evidence': A different
perspective on evidence-based medicine. British Journal of Psychiatry: 180, 8-12.

Winch, S., Creedy, D. and Chaboyer, W. (2002). Governing nursing conduct: The rise of
evidence-based practice. Nursing Inquiry: 9, 156-161.

Wittgenstein, L. (2001). Tractatus logico-philosophicus. New York: Routledge.

265

Wood, M., Ferlie, E. and Fitzgerald, L. (1998). Achieving clinical behaviour change: A
case of becoming indeterminate. Social Science and Medicine: 47, 1729-1738.

Woolley, H. T. (1910). Psychological literature: A review of the recent literature on the
psychology of sex. Psychological Bulletin: 7, 353-343.

 

Worrall, J. (2002). What evidence in evidence-based medicine? Philosophy of Science:
69, 8316-8330.

266

   

liiiiililiijjiiilijjliit