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Abstract

Ignorance and knowledge are often thought of as opposite phenomena. Knowledge is seen as a source of power, and ignorance as a barrier to consolidating authority in political and corporate arenas. This article disputes this, exploring the ways that ignorance serves as a productive asset, helping individuals and institutions to command resources, deny liability in the aftermath of crises, and to assert expertise in the face of unpredictable outcomes. Through a focus on the Food and Drug Administration's licensing of Ketek, an antibiotic drug manufactured by Sanofi-Aventis and linked to liver failure, I suggest that in drug regulation, different actors, from physicians to regulators to manufacturers, often battle over who can attest to the least knowledge of the efficacy and safety of different drugs - a finding that raises new insights about the value of ignorance as an organizational resource.
The logic of strategic ignorance1
Linsey McGoey
Abstract
Ignorance and knowledge are often thought of as opposite phenomena. Knowl-
edge is seen as a source of power, and ignorance as a barrier to consolidating
authority in political and corporate arenas.This article disputes this, exploring the
ways that ignorance serves as a productive asset, helping individuals and institu-
tions to command resources, deny liability in the aftermath of crises, and to assert
expertise in the face of unpredictable outcomes.Through a focus on the Food and
Drug Administration’s licensing of Ketek, an antibiotic drug manufactured by
Sanofi-Aventis and linked to liver failure, I suggest that in drug regulation, differ-
ent actors, from physicians to regulators to manufacturers, often battle over who
can attest to the least knowledge of the efficacy and safety of different drugs – a
finding that raises new insights about the value of ignorance as an organizational
resource.
Keywords: Sociology of ignorance; knowledge alibis; regulatory failure;
pharmaceuticals; power
Introduction
In October 2010, Jérôme Kerviel, a former Société Générale trader, was sen-
tenced to five years in prison for breach of trust, forgery, and unauthorized
computer use.Two years earlier, he had carried out a series of trades resulting
in losses of nearly $7 billion for his employers. Since news of his actions first
broke, the line from senior staff at Société Générale has stayed the same:
Kerviel was working without the authorization of his superiors; they had no
knowledge of his behaviour. Kerviel disputed this, insisting his managers per-
sistently turned a blind eye to his actions as long as he continued to turn a
profit.
The effort among senior management to demonstrate non-knowledge of
Kerviel’s actions suggests that the most important managerial resource during
McGoey (Department of Sociology, University of Essex) (Corresponding author email: lmcgoey@essex.ac.uk)
© London School of Economics and Political Science 2012 ISSN 0007-1315 print/1468-4446 online.
Published by Blackwell Publishing Ltd, 9600 Garsington Road, Oxford OX4 2DQ, UK and 350 Main Street, Malden,
MA 02148, USA on behalf of the LSE. DOI: 10.1111/j.1468-4446.2012.01424.x
The British Journal of Sociology 2012 Volume 63 Issue 3
the scandal was not the need to demonstrate prescient foresight, or the early
detection of potential catastrophes. What mattered most was the ability to
insist such detection was impossible. For senior staff at SocGen, the most
useful tool was the ability to profess ignorance of things it was not in their
interest to acknowledge. Executives harnessed the uncertainty surround-
ing Kerviel’s risk-taking in order to absolve liability for the failures they
presided over.
A similar pattern can be seen in the collapse of the UK’s Barings investment
bank in the 1980s.The former derivatives trader Nick Leeson was just 27 years
old when he conducted a series of trades that resulted in losses of £860 million
for Barings,including the loss of £143 million in a single day,a catastrophe that
helped bankrupt the firm.‘In a sense’, sociologists Bridget Hutter and Michael
Power write, ‘the Barings Bank organization had all the information which
might have alerted it to Leeson’s unauthorized trading. Rather than act on this
information, they appear to have dismissed it as a result of‘senior management
preferences for optimistic, rather than pessimistic, interpretations’ of Barings’
economic performance in certain sectors (Hutter and Power 2005: 14; see also
Stein 2000).
The actions of senior staff at Barings and SocGen are reminiscent of
Michael Taussig’s assertion that‘knowing what not to know’ is one of the most
indispensable forms of social and political knowledge (Taussig 1999). Despite
the obviousness of such a point – evoking maxims such as ‘ignorance is bliss’ or
‘what you don’t know can’t hurt you’ – sociologists have largely failed to treat
ignorance as a social phenomenon warranting detailed empirical study.
Although a handful of analyses have explored the usefulness of ignorance as a
tool of governance and social control (c.f. Balmer 2012; Frickel and Vincent
2007; Gross 2007, 2010, 2012; Luhmann 1998; Merton 1987; Moore and Tumin
1949; Proctor and Schiebinger 2008; Schneider 1962; Ungar 2008), the rarity of
these articles suggests, as Andrew Abbott puts it, ‘a certain sociological igno-
rance of ignorance’ (Abbott 2010: 174).
In this article, I address this dearth of attention. I examine literature that has
explored the productive uses of ignorance, while reflecting on the relative
paucity of such efforts. I suggest that even recent analyses focused on the
problem of ignorance have tended to cement a dubious binary opposition
between knowledge and ignorance. Most articles, such as Ungar’s recent
article on the perils of increased public ignorance, tend to view ignorance as a
de facto negative phenomenon, something social actors have an obvious inter-
est in seeking to overcome or to eradicate, and which sociologists have an onus
to better identify so that actors are equipped to recognize and combat their
own ignorance (Ungar 2008).
I argue the opposite. Through a focus on a recent controversy over the
licensing of Ketek, an antibiotic drug linked to kidney failure, I explore how
actors seek to preserve ignorance rather than to dispel it. I argue that in the
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case of drug regulation, different actors often battle over who can prove to
have the least knowledge of the efficacy and safety of different drugs, some-
thing that raises new insights about the value of ignorance in organizations.
At various stages of the testing and licensing of Ketek, different parties 1)
employed risk-detection systems that seemed to obfuscate the very warning
signs manufacturers were ostensibly seeking to detect; 2) selectively disclosed
data in ways that increased the knowledge of some while compounding the
ignorance of others; 3) directed regulatory staff to remain silent about con-
cerns over drug safety; and 4) ignored the implications of known limitations to
methodologies for detecting drug risks.
Individually, such practices cover well-examined terrain: deliberate con-
cealment; institutional suppression of dissent; blinkered trust in risk-detection
systems. Collectively, they suggest a phenomenon strangely sidelined in socio-
logical thought: the ways that cultivating ignorance is often more advanta-
geous, both institutionally and personally, than cultivating knowledge. I term
such practices of obfuscation and deliberate insulation from unsettling infor-
mation ‘strategic ignorance’, the mobilization of the unknowns in a situation
in order to command resources, deny liability in the aftermath of disaster,
and to assert expert control in the face of both foreseeable unpredictable
outcomes.2
The first use above – the value of ignorance in procuring more resources –
is perhaps the most studied to date. Particularly since Popper’s insistence that
science is strengthened by the admission of error, that science must prove its
own fallibility in order to distinguish itself from pseudo-science,there has been
increased recognition, even celebration, of the ways that ignorance and uncer-
tainty are integral to scientific discovery. As Smithson points out, ignorance
can serve as a prerequisite to learning or discovery; can help create a climate
of creativity and entrepreneurship; can be harnessed to enhance the general-
izability of findings or attain consensus; and can strengthen one’s reputation
for scientific cautiousness (McGoey 2012; Popper 1977; Smithson 1993).
Proctor has explored some of the unintended effects of the growing accept-
ance of the uncertainty of science, examining how industries appear to be
increasingly seeking to profit from uncertain evidence – what Donald Rums-
feld famously labeled ‘known unknowns’ – over a product’s adverse effects.
Proctor suggests the tobacco industry, for example, adopted a two-fold defence
when first faced with charges of tobacco’s health risks.
First, a ‘no proof’ defence, where manufacturers, in tactics reminiscent of
today’s climate change skeptics, continually stressed that much scientific
uncertainty shrouded claims of a causal link to cancer. ‘The idea of “no
proof,” ’ Proctor writes, ‘becomes one of the two main pillars of the industry’s
defense against lawsuits; the other being common knowledge: everyone has
always known about the dangers, so smokers have only themselves to blame
for whatever illnesses they may contract’ (Proctor and Schiebinger 2008: 13).
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Proctor’s point leads to an under-analysed aspect of ignorance:its usefulness
in maintaining expert control and expanding expert jurisdiction. It has long
been pointed out that a command of rarefied or exclusive knowledge is central
to the definition and the maintenance of expertise.3What is less studied is how
expert knowledge is also, to a lesser but still crucial degree, dependant on the
reluctance or inability to specify the empirical value of knowledge in practice.
Abstract knowledge is fundamental to a profession’s ability to first, maintain
autonomy, and second, to foster and enable professional expansion – the
ability to apply occupational expertise beyond immediate remits (Abbott
1988).
In order to move swiftly and flexibly to new areas, such knowledge often
requires a certain elasticity, and, as part of that elasticity, a lack of knowledge
of its limits in practice.4Expert status is often dependent on maintaining a
monopoly over what remains difficult or impossible to know empirically. I
suggest that ‘knowing what not to know’, in Taussig’s sense, is fundamental to
professional jurisdiction in Abbott’s sense. Previous work on ignorance has yet
to consider the ramifications of this point. Sociologists have underestimated
the extent to which strategic ignorance is fundamental to expert control and
disciplinary expansion.
To address this dearth of attention, I make two new claims.
First, I suggest that claims of authority are often contingent what I term
‘knowledge alibis’ – the ability to mobilize expert ignorance in order to testify
to an actor’s professional credibility. Second, I argue that we need more
attention to the importance of the scale of ignorance. Ignorance, I suggest, is
often more valuable to institutions and institutions the more pervasive it
becomes.
Below, I explore these claims further. Firstly, I review literature on the uses
of ignorance. Secondly, I turn to an analysis of the controversy over Ketek in
order to explore the uses of ignorance in practice. Methodologically, my analy-
sis draws on 23 in-depth interviews with current and former employees and
expert advisors at bodies such as the US Food Drug Administration (FDA),
the US Congress, the UK Medicines and Healthcare Products Regulatory
Agency (MHRA), and the UK National Institute for Health and Clinical
Excellence (NICE), as part of an ongoing study of the ramifications of recent
controversies over the safety of two classes of pharmaceuticals: SSRI antide-
pressants such as Prozac, and antibiotic drugs such as Ketek.
Fifteen of these interviews were carried out over 2005 and 2006, in the UK.
Eight further in-depth interviews were carried out in person and by phone
with FDA regulators and US policymakers in October and November 2009,
including David Ross, a former FDA official featured in the discussion below,
and David Graham, a current FDA drug safety officer well-known for calling
public attention to the risks of Vioxx, a painkiller removed from global
markets in 2004.
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Ignorance in the social sciences
In many ways, ignorance has been a central, though under-emphasized, focus
of social scientists who have explored the uses of selective knowledge in
justifying decisions in social life. Mary Douglas’ work on ‘structural amnesia’
has long pointed out that ‘certain things always need to be forgotten for any
cognitive system to work’ (Douglas 1986: 76), an insight echoed by Stanley
Cohen’s work on ‘states of denial’, his term for the methods and defences
individuals employ to avoid acknowledging things that feel psychologically or
culturally impossible to discuss openly (Cohen 2001).
Cohen and Douglas’ work illuminates how the desire not to know par-
ticular facts often stems from social taboos or disciplinary constraints that
make it difficult to process unsettling knowledge, something organizational
theorists such as Seibel, Weick and Vaughan have explored through work on
organizational disasters, where information is discounted by individuals who
have no place for the information ‘within prevailing modes of understanding’
(Smithson 1993: 140; see also Weick 1998; Vaughan 2005; Seibel 1996).
Indeed, many advances in the epistemology of knowledge have been
predicated on the realization that, as Michael Polanyi wrote of tacit knowl-
edge, ‘we know more than we can tell’ (Polanyi 2009), an insight echoed by
scholars as varied as Friedrich Hayek and Pierre Bourdieu. One of Hayek’s
fundamental, and often curiously ignored contentions was that formal eco-
nomic theory represented ‘only the visible tip of the vast submerged fund of
tacit knowledge, much of which is entirely beyond our powers of articula-
tion’ (see Gray 1998: 15; Hayek 1945). As John Gray argues, Hayek sus-
pected that ‘neglect of this dependency of our necessarily abstract theories
on a vast range of inarticulate background knowledge has led social science
astray in many fields’ (Gray 1998: 15; see also Friedman 2005, 2009; Riles
2010).5
Bourdieu was equally interested in the importance of unarticulated knowl-
edge, He explored the role unspoken knowledge plays in the socialization
process (he stressed that social norms were inculcated at a doxic, preconscious
level), and the importance of tacit knowledge in maintaining social and politi-
cal hierarchies.As he suggested, ‘the most successful ideological effects are the
ones that have no need of words, but only of laissez-faire and complicitous
silence’ (Bourdieu 1992: 133).
Influenced in part by Bourdieu, the 1960s onward has seen the growth of
sociologically subgenres such as,to name just two, the sociology of practice (c.f.
Benzecry and Krause 2010; Sennett 2008),and the sociology and anthropology
of memory (c.f. Mookherjee 2006; Zerubavel 2007) that have taken as a fun-
damental premise the idea that knowledge is striated: always partial, always
selective, and always vulnerable to dismissal or manipulation according to
varying personal interests and structural constraints.
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If the importance of ignorance has only been implicitly suggested in studies
of tacit knowledge, a small number of studies have explicitly taken ignorance
as their focus of analysis. Anthropologists and sociologists within science and
technology studies have been at the forefront of such efforts, exploring what
Hess and Frickel have described as ‘undone science’, areas of inquiry deliber-
ately left unfunded, ignored or sidelined because the political implications of
exploring them may be dangerous or unpalatable to powerful authorities (see
Frickel and Vincent 2007; Hess 2007; High et al 2012; Kleinman and Sury-
anarayanan 2012).
Their work complements Knorr Cetina’s (1999) discussion of ‘negative
knowledge’, something she sees not as non-knowledge, or a void of knowing,
but as knowledge (whether unconscious or articulated) of the limits and the
adverse repercussions of knowledge. Negative knowledge is an awareness of
the things we have no incentive or interest in knowing about further. As
Matthias Gross writes in a seminal article on the epistemology of ignorance,
negative knowledge involves ‘active consideration that to think further into a
certain direction will be unimportant’ (Gross 2007: 749).
The concept of negative knowledge is relevant to the study of organizations,
where it has long been shown that bureaucrats often refuse more resources
when such resources might force them to implement policies they sense they
cannot manage effectively (see Carpenter 2010; Weick 1998). Declaring new
resources unnecessary or irrelevant is fundamental to meeting targets or
quotas beyond individual control. Ignorance can be the haven of personnel
burdened by knowledge demands.
Writing in 1949, Moore and Tumin were the first sociologists to make a
strong case for explicitly exploring the functionality of ignorance, enumerating
five main functions: 1) preserving privilege; 2) reinforcing traditional values;
3) preserving fair competition (justice and equal opportunity should be blind
to social or economic circumstance); 4) preserving stereotypes; and 5) incen-
tivizing hard work (ignorance of outcomes incentivizes more energetic
outputs) (Moore and Tumin 1949).6
The richness of their analysis failed to spur a watershed of sociological work
on ignorance. Only a handful of isolated analyses have emerged since, includ-
ing a sadly neglected 1962 article by Louis Schneider. Schneider suggests that
ignorance is implicitly central to much social theory, including Marx’s concep-
tion of commodity fetishism, which only‘makes sense’ if workers are willing to
ignore that commodities are inextricably linked to the social relations of their
production.
Two decades after Schneider’s article, Merton introduced a distinction
between ‘unspecified ignorance’ and ‘specified ignorance’ – in short, the dis-
tinction between things we don’t know we don’t know, and things we know we
don’t know. As Abbott writes, although it may serve as a useful empirical
characterization of much scientific practice, Merton’s distinction ‘presupposes
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a directionality to knowledge’ which belies the fluid way ignorance and knowl-
edge interact, overlap and outpace each other (Abbott 2010: 187).
A second problem with Merton’s distinction is that it implies a neat sepa-
ration between the things we do know and the things we don’t.This separation
fails to consider the organizational advantages of willfully magnifying one’s
own ignorance in order to avoid the repercussions of troubling knowledge. It
also fails to engage with the challenge of determining whether someone’s
ignorance is simply an unavoidable handicap, or whether it is a deliberately
wielded tool. In other words, whether ignorance is strategic or not.
As this article explores, this very difficulty – the challenge of proving
whether someone is actually ignorant or simply feigning ignorance – is what
underpins the usefulness of ignorance as an organizational resource. As I
suggest below, strategic ignorance is distinguishable from deception or the
suppression of data by virtue of the fact that unsettling knowledge is thwarted
from emerging in the first place, making it difficult to hold individuals legally
liable for knowledge they can claim to have never possessed. Strategic igno-
rance helps to girder and support plausible deniability, the creation of chains of
command and information trails that are informal enough to be denied if
questioned directly about the existence of inconvenient facts (see Lynch and
Bogen 1996).
Plausible deniability and strategic ignorance share the trait of being at
their most powerful when their machinations are least in evidence, when
claims of ignorance appear genuine rather than manufactured. The pyrrhic
challenge for scholars of ignorance is to prove the existence of something
for which the very ability to evade detection is a key criterion of success. I
call this challenge pyrrhic because to prove the utility of ignorance is to
demonstrate that ignorance has a material concreteness that undermines its
own ontological status. Ironically, once ignorance is defined, it loses its very
definition.
The difficulty of proving the strategic uses of ignorance does not dispel the
importance of conceptualizing the value of unknowns within organizations.
Rather, it magnifies the importance of understanding the organizational pres-
sures that render ignorance a lucrative asset, and to develop hypotheses for
why and how ignorance manifests itself in different environments.
A useful example is Heimer’s discussion of the uses of ignorance in HIV/
AIDs clinics so overwhelmed with the task of collecting and collating data that
fully processing data could thwart efforts to treat patients expediently. Heimer
suggests that the strategic deployment of ignorance encompasses two phenom-
ena: sequestered knowledge, where inconvenient facts are rendered less visible
through deliberate strategies, such as creating piles of bureaucratic paperwork
that obscure rather than clarify meaning; and distributed ignorance, where
individuals focus exclusively on their own work, isolating themselves from
exposure to unsettling information (Heimer 2012).
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Similar practices are visible in the Ketek case, where the very processes
oriented at dispelling unknowns succeeded in fomented more of them. Close
attention to the Ketek case illustrates this point.
The Ketek case
In 2004, a family practice doctor named Anne Kirkman-Campbell was sen-
tenced to 57 months in a federal prison for mail fraud. She was convicted for
forgery involving a clinical trial commissioned to test Ketek (telithromycin), a
ketolide antibiotic drug manufactured by Sanofi-Aventis (Hundley 2007).
At first glance,her imprisonment appears to be a tangible sign of the efficacy
of the legal infrastructure intended to curb and penalize fraud in drug testing.
It is a signal that when medical researchers commit malfeasance, they suffer
repercussions: a nearly five-year sentence is not an insignificant amount of time.
But behind her case lies less visible struggles over Sanofi-Aventis’s efforts to
license Ketek, a story of ignored warnings and professional reprimands that
caused at least two FDA medical officers to leave the agency over their
superior’s reluctance to acknowledge concerns over Ketek’s safety and efficacy.
Ketek was licensed by European Medicines Evaluation Agency in 2001, and
by the FDA in 2004, after undergoing three FDA reviews. During the first
review, FDA reviewers discerned a number of possible side-effects,including a
possible association with liver failure. An FDA anti-infective drugs advisory
committee recommended that Aventis obtain more safety evidence through a
large clinical trial before the drug could be approved. The company launched
Study 3014, a phase III trial involving over 24,000 patients, carried out by more
than 1,800 physicians across the USA.
During phase III trials, drugs demonstrated to be tolerable (something
determined in Phase I trials), and then efficacious in smaller groups of patients
(determined in phase II trials), are tested in large, randomized trials which aim
to prove the statistically significant benefit of a drug over a comparator, such
as a placebo or a comparator drug. As has become typical practice within the
global pharmaceutical industry (see Petryna 2007), the company hired a con-
tract research organization called Pharmaceutical Product Development Inc
(PPD) to carry out the clinical trial.
In 2004, the FDA was informed that data from Study 3014 had been com-
promised by safety violations at Kirkman-Campbell and at least 10 other
research sites. Despite this knowledge, the FDA awarded a license to Ketek
(Ross 2007).
Three years later, after dozens of reports of kidney failure linked to Ketek,
the FDA implemented label changes for the drug, banning its use for two of
its three previously approved indications (acute bacterial sinusitis and acute
bacterial exacerbations of chronic bronchitis), and insisting on a black-box
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warning for the sole remaining indication, the treatment of moderate to severe
community-acquired pneumonia.
Also in 2007, the US House of Representatives’ Committee on Energy and
Commerce launched a series of hearings to determine whether a range of
parties, from the FDA to Sanofi-Aventis, knew about the adverse risks of
Ketek before the drug was licensed in 2004 and chose to ignore them.
One of the individuals called before hearings was Ann Marie Cisneros, a
former research associate at PPD, the research organization hired to conduct
Study 3014. Introducing herself to the committee, Cisneros stated that she had
formerly serviced as medical technologist in the US Air Force, and had since
worked for eight years as a clinical research associate, first at PPD, and then
independently. While at PPD, she was tasked to monitor compliance at
Kirkman-Campbell’s site. Even before visiting Kirkman-Cambell’s site, she
detected a number of warning signs of possible fraud. Kirkman-Campbell,who
received $400 per patient enlisted in the trial, had enrolled over 400 patients,
which accounted for 1 per cent of the adult population of Gadsden, Alabama,
the home of Kirkman-Campbell’s practice. In comparison, another research
site in Gadsden had enrolled just 12 patients.
Alarmed by the volume of participants, as well as the fact that no patients
had withdrawn from the trial – something unusual for such high numbers –
Cisneros began investigating patient charts and found a number of
irregularities. Most of the informed consent forms looked as though they had
been initialed by someone other than the patient; most forms were dated by
someone other than the patient; one form had obviously been forged; most
patients diagnosed with chronic bronchitis had no history of the ailment, and
Kirkman-Campbell had enrolled her entire staff and most members of her
family in the study.
Concerned, Cisneros emailed a summary of her findings to the head of
quality assurance at PPD, copying Aventis personnel into the email. She then
took part in a teleconference call between PPD and Aventis where she dis-
cussed her concerns with Kirkman-Campbell’s data. She also notified Coper-
nicus, the for-profit Institutional Review Board (IRB) which had been
responsible for granting ethical approval for the study to go ahead. Cisneros
never received a reply from Copernicus regarding her concerns.During a later
FDA investigation,she was called twice by PPD lawyers who reminded her of
a confidentially agreement she had signed, and told not to speak with the FDA
without Aventis approval and PPD attorneys present.
After leaving PPD, a colleague still at PPD told Cisneros that Nadine
Grethe, an Aventis project manager, had coached Kirkman-Campbell on how
to explain away irregularities on the trial.7‘[W]hat brings me here today,’ she
stated during testimony before Congress, ‘is my disbelief at Aventis’s state-
ment that it did not suspect fraud was being committed. Mr.Chairman, I knew,
PPD knew it, Aventis knew it’.8
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Not only was Sanofi-Aventis not penalized by the court that sentenced
Kirkman-Campbell, but the court declared that the drug company had been
victim of her fraud. They ordered her to pay $925,000 in restitution to Sanofi-
Aventis. Kirkman-Campbell appealed the restitution order, arguing that
Aventis ‘had been made aware of the fraud at my site by PPD. At NO TIME
did they attempt to stop my participation’. Her motion was later denied
(Hundley 2007).
During government hearings, a member of the subcommittee pressed Cis-
neros, as well as Henry Loveland, an FDA criminal investigator assigned in
2006 to investigate whether Aventis had withheld information, about what
exactly they felt Aventis knew or didn’t know about Kirkman-Campbell’s
actions. ‘Do you believe Aventis intentionally ignored evidence of fraud’, the
representative asked, ‘or is it a matter that their processes and procedures or
verifying fraud were faulty and couldn’t have detected it?’
Cisneros’ reply was clear: ‘I personally believe they ignored evidence of
fraud. You had to have your head stuck in the sand to have missed this’.
Loveland’s response was more equivocal. In his view, the company had more
than ample information that should have alerted them to fraud at numerous
research sites. But rather than alert the FDA of concerns, Aventis they took
steps which, under the guise of seeking to examine Kirkland-Campbell’s prac-
tices, enabled them to avoid acting on the fraud:
Mr. LOVELAND. The decision-making process that Aventis used to evalu-
ate the warnings that Mrs.Cisneros and other PPD folks raised was illogical,
ineffective . . . From start to finish, their process for analyzing information
coming out of the trial was poor. When you get into a traffic accident, you
call a traffic cop. These folks came in and they said, We have indicators of
fraud, and they called a mathematician.A mathematician didn’t know what
fraud looked like, and he couldn’t identify it. He looked at all the data,
couldn’t figure out a rule to apply to the data set, came back and said,I don’t
see fraud. They took that to convince themselves that two of the most
serious allegations raised by Mrs. Cisneros and by other PPD folks weren’t
indicators of fraud.9
Aventis’s oversight system effectively made it more difficult, and not less, to
determine whether the company’s failure to act on Kirkman-Campbell’s
actions was itself fraudulent or not. Through the guise of vigilance, Aventis
managed to deflect the possibility of inconvenient findings, finding solutions
to the problem of how to remain convincingly ignorant of effects widely visible
to many.
I suggest that Aventis’s non-detection of unsettling facts is a form of strate-
gic ignorance in practice, the deliberate refusal to become informed of con-
clusive evidence that might be counterproductive to organizational or
individual aims. Strategic ignorance is different from deliberate concealment
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for it encapsulates the varied ways that individuals can seek to preclude
unsettling knowledge from emerging in the first place.
In this case,Aventis employed a statistician to investigate data where signals
of fraud were least likely to be visible. Early on during Study 3014, as Loveland
states in a FDA report,Aventis and PPD ‘detected protocol violations which
were significant enough to potentially affect the integrity of data at a minimum
of eleven sites’. Aventis then directed a statistician,William Stager, to perform
an analysis of Kirkman-Campbell’s lab data. In a document later provided by
Aventis to the FDA on in March 2003, Stager concluded that data from
Kirkman-Campbell’s sites were similar to data from the next two highest
enrolling sites, and thus were not suspicious.10
The problem, as Loveland argued, is that statistical analyses are not capable
of discerning mundane discrepancies, such as ‘ink irregularities’, the ad hoc
reworking of adverse effects written in different coloured ink after data are
first recorded. Such irregularities, which act as a warning flag to regulators that
adverse effects might have been manipulated or deliberately erased, are per-
ceptible to those dealing with handwritten reports, not to statisticians working
with computerized data sets. The sanitization of irregularities, the creative
ways such irregularities are obscured from public view through the very act of
seeking to find them, demonstrates decoupling in practice: the effort to fulfill
formal institutional requirements while insulating inner practices from scru-
tiny (see Meyer and Rowan 1977).
Stager’s expertise is noteworthy here. Despite appearing to be, in hindsight,
the least able to discern fraud, his conclusions were privileged over PPD staff
such as Cisneros. Politically, the reasons are obvious. He confirmed what
Aventis wanted to hear. Epistemologically, the implications deserve more
scrutiny. The value of Stager’s testimony lies less in what he found – which is
nothing – than in how well-placed he was to find it. Stager had access not
simply to Kirkman-Campbell’s data, but to multiple sites. His tools of analysis
were more sophisticated than someone such as Cisneros. Once he couldn’t
find a problem, it became more plausible for Aventis to assert there was
nothing to find.
Knowledge alibis
Sociologists have long pointed out the dangers of ignorance, seeing it as a
‘deadly social problem with potentially deadly consequences’ (Ungar 2008:
301). I am not disputing this: willful ignorance in the Ketek case resulted in a
number of deaths.What is disputable is the subsequent inference: the assump-
tion that curbing or minimizing ignorance is a primary goal of organizations
and their members. In practice, the converse is often true. Actors thrive from
what I term knowledge alibis: the ability to defend one’s ignorance by
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mobilizing the ignorance of higher-placed experts. A curious feature of know-
ledge alibis is that experts who should know something are particularly useful
for not knowing it. This is because their expertise helps to legitimate claims
that a phenomenon is impossible to know, rather than simply unknowable by
the unenlightened. If the experts didn’t know it, nobody could.11
Closer attention to Aventis’s decision to commission Stager’s statistical
analysis helps to elaborate on this point. An outstanding question is, did
Aventis deliberately try to avoid unsettling information, or was Stager’s mis-
perception of Kirkman-Campbell’s fraud simply a convenient finding for
them? It is difficult to know. In previous controversies over drug safety,such as
in the case of antidepressants, leaked memos of internal strategy have pro-
vided conclusive evidence that companies deliberately withheld unfavorable
trial results from regulators (see McGoey and Jackson 2009).
In this case,Aventis’s apparent vigilance in hiring Stager helped to shield the
company from similar conclusive findings. Despite Cisneros’s insistence that
the company was complicit in Kirkman-Campbell’s fraud, and Kirkman-
Campbell’s insistence that Aventis knew of her own actions and never once
tried to halt her, their testimony is viewed as anecdotal or personally moti-
vated and therefore more dismissible. Stager’s ignorance trumps Cisneros’s
knowledge. Finding an expert who knew ‘what not to know’ was crucial to
Aventis’s ability to defend their own purported non-liability.
During debates over Ketek, and pharmaceutical safety in general,a common
theme emerges: claimants often struggle over who can attest to the least
knowledge of a drug’s effects, or of irregularities carried out during its testing,
and in doing so,seek to harness the ignorance of others in order to defend their
own. Such struggles emerge at every stage of a drug’s development and mar-
keting, often in slightly ironic ways. The lead author, for example, of a 2003
article on the benefits of Vioxx, removed from global markets in 2004, sought
to excuse himself from liability for under-reporting the risks of heart attack by
pointing to the fact that the article had been ghostwritten by Merck and not by
him. The published article stated that there was no significant difference
between Vioxx and the control group, despite a five-fold higher rate of heart
attacks on the Vioxx arm.
As Sergio Sismondo describes,the author’s rationale for the underreporting
was his own ignorance, stating that
Merck designed the trial, paid for the trial, ran the trial . . . Merck came to
me after the study was completed and said, ‘We want your help to work on
the paper.’The initial paper was written at Merck, and then it was sent to me
for editing. (Quoted in Sismondo 2009: 172)
The usefulness of ignorance in drug regulation reached its pinnacle in a legal
principle known as FDA preemption,incorporated into FDA policy during the
administration of George W. Bush. In practice, the policy states that FDA
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approval of a product should immunize a manufacturer from liability suits by
injured patients, with the rationale being that if FDA staff were not knowl-
edgeable of risks, and did not warn patients, companies should not be held not
responsible (Annas 2009).
Consumer groups have long fought the policy, pointing out that companies
have routinely withheld data from the regulator, actively fomenting FDA
ignorance even as they benefited legally from it.12 Preemption was effectively
struck down last year by Wyeth vs Levine, a Supreme Court case where the
court ruled that a drug ‘manufacturer must carry responsibility for the content
of its label at all times’ (Annas 2009: 1207). Although the legal doctrine has
suffered recently, the ethos that behind it, the assumption that,to put it crudely,
‘what you don’t know can’t hurt you’, remains a significant resource, perhaps
the greatest resource, in drug licensing and regulation more generally – a
rather obvious point that is only surprising for how persistently its implications
are ignored.
The mobilization of ignorance at the FDA
One of the first FDA employees to raise flags over Ketek was David Ross,then
a medical officer at FDA and now National Director of Clinical Public Health
for the US Department of Veterans Affairs. Ross worked at the FDA for ten
years,serving in a range of positions, from primary medical reviewer of new drug
applications,to a member of the senior leadership team at the FDA’s Office of
New Drugs. With other colleagues, Ross has called attention to three main
concerns with the FDA’s licensing of Ketek: the FDA’s failure to disclose to an
advisory committee that data from Study 3014 was suspected to be fraudulent;
the reliance on noninferiority trials in licensing Ketek; and the refusal to listen
to internal concerns once evidence of post-market adverse effects arose.
The first concern emerged in 2003, during the FDA’s second major pre-
licensing review of Ketek. At that time, a routine safety investigation first
alerted to FDA to problem at Kirkman-Campbell and other research sites for
Study 3014. Despite knowing that data from the study was fraudulent, the
FDA presented the data to its anti-invective advisory committee without
mentioning that a criminal investigation was underway. Based on results from
the study, the committee voted 11–1 to recommend approval of Ketek (Ross
2007).
Ross’s second major concern with Ketek was on the methods used to test its
efficacy. Since the 1960s, the FDA has insisted new drugs must be tested
through RCTs in order to earn licenses. For some diseases, a drug must be
shown to be better than a comparator drug or a placebo in order to earn a
license. For most antibiotics, the FDA has relied predominantly on ‘noninfe-
riority’ trials,where a drug simply has to be shown not to be significantly worse
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than an available drug (Mathews 2006). Such trials have been a boon to
manufacturers seeking to market me-too drugs similar in composition to avail-
able medicines. It is a design where demonstrating efficacy is ‘easy to win on’,
as one former FDA medical officer said to me. By the time of Ketek’s
approval, 68 antibiotics had been approved for indications similar to Ketek,
leading some staff to worry the risks of Ketek outweighed its negligible effi-
cacy over available treatments.
Regardless of internal concerns with Study 3014 and growing FDA worries
that noninferiority trials were inappropriate tests of a new drug’s benefit and
risks,the FDA approved Ketek in 2004.Three years later, in a letter to the New
England Journal of Medicine,the FDA admitted that noninferiority trials were
considered ‘no longer acceptable for two for the three indications for which
Ketek was originally approved’ (Soreth et al. 2007: 1676).
From 2004 until 2007, despite knowing that Ketek had been licensed on the
basis of a trial methodology later deemed inadequate for determining drug
efficacy and safety; despite growing reports of lethal side-effects, and despite
persistent complaints from staff such as Ross over Ketek’s safety, the FDA
maintained a front of silence, cautioning staff to stay equally silent or face
repercussions to their job.In 2006, a number of FDA reviewers, including Ross,
were summoned to a meeting with the then FDA Commissioner Andrew von
Eschenbach. During the meeting, von Eschenbach compared the FDA to a
football team and told reviewers that if they publicly discussed problems with
Ketek outside the agency, they would be ‘traded from the team’.13
That same year, Rosemary Johann-Liang, a former deputy division director
in the Office of Surveillance and Epidemiology, wrote an internal memo sug-
gesting that the FDA should move to halt pediatric trials testing Ketek in
children, or at least warn parents about the risks of the drug,asking ‘how does
one justify balancing the risk of fatal liver failure against one day less of ear
pain?’ Today, Johann-Liang, like Ross,has left the agency, citing her frustration
with being reprimanded for raising concerns, and telling media, ‘I really advo-
cate for drug safety, and a lot of times the agency doesn’t want to hear that
there are problems’ (see Harris 2006b; Rubin 2007).
Between 2004 and 2006, more than five million prescriptions were written
for the drug in the USA. During those years, as the New York Times states,
fourteen adult patients suffered liver failure after taking Ketek, at least four of
whom died. Twenty-three others suffered serious liver injury. Each of the
patients was otherwise healthy (Harris 2006a). The people prescribed Ketek
were individuals such as Ramiro Obrajero Pulquero, a 26-year-old construc-
tion worker with a wife and two daughters.He went to his physician complain-
ing of a cold, and was prescribed Ketek.Three weeks later he was dead of liver
failure (Hundley 2007).
Why would the FDA ignore internal concerns over drug safety? The reasons
are complex, stemming from a mixture of financial and reputational pressures.
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Social scientists such as Daniel Carpenter have pointed out that reputational
concerns may compromise the ability of regulatory to swiftly remove a drug
from market even when safety concerns are evident (Abraham 1994; 1995;
Abraham and Sheppard 1999; Carpenter 2010; Light 2010; McGoey 2007).
When the same agency is responsible for pre-market licensing and post-
market surveillance,evidence of a drug risks calls attention to the possibility of
regulatory negligence in licensing a drug to begin with. When that happens, as
a healthcare lobbyist once said to me,‘are you going to admit a liability? Or are
you going to keep your head down. And the answer is, so far as I can see, that
the regulator just keeps its head down’.14 Carpenter’s work emphasizes the
same point:
it’s perhaps audacious to claim, and certainly difficult to prove, that reputa-
tional incentives weaken the [FDA] Office of New Drugs’ willingness to
scrutinize drugs that have already been approved. Yet characterizations to
this effect have been with us for 50 years – from medical reviewer John
Nestor’s 1963 testimony before Congress that FDA medical reviewers were
discouraged from revisiting past approval decisions, to David Graham’s
lament that ‘the new drug reviewing division that approved the drug in the
first place and that regards it as its own child, typically proves to be the single
greatest obstacle to effectively dealing with serious drug safety issues. (Car-
penter 2006: 404)
Another reason why senior FDA staff members tend to suppress internal
concern over drug risks is the challenge of measuring those risks.The difficulty
in measuring risks can render strategic ignorance not simply a useful tactic in
jurisdictional and reputational battles, but a necessary one.
The scale of ignorance
Since the 1940s, when the first randomized trial in medicine took place, RCTs
have become the obligatory mechanism for determining the risk-benefit
profile for new medicines. RCTs are seen as the ‘gold standard’ for determin-
ing drug safety and efficacy, valued because the uses of control groups helps to
determine whether the drug itself, or an external variable – such as the specific
physiology of individual patients, or environmental factors – produces the
treatment’s effect (see Daemmrich 2004; Epstein 1995; 2007; Greene 2007;
Marks 1997; Timmermans and Berg 2003; Will 2009).15
In practice, a number of factors restrict the ability of most RCTs to deter-
mine a drug’s clinical usefulness, such as the fact that RCTs are often tested in
populations which are unlikely to receive the drug clinically, and the fact that
most RCTs have too few participants to reveal adverse risks that often appear
once a drug is on the market (Healy 2001; Lakoff 2007; McGoey 2010).Despite
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widespread awareness of the limits of RCTs for determining clinical effects,
the status of RCTs as the perceived gold standard has led to situations where
if an adverse drug effect does not appear on a randomized trial, regulators tend
to view it as less alarming or worthy of immediate action.
Regulators know most trials are too short to reveal adverse drug effects.
It is a fact acknowledged by Paul Leber, a former head of the FDA neuro-
pharmacology branch. In a 1996 memo to Robert Temple, at the FDA’s
Office of Drug Evaluation, Leber states that ‘too few patients are exposed to
a drug during commercial development to capture adverse drug induced
reaction’.16
Partly to combat this problem, the FDA invests substantial resources in
post-market epidemiological studies intended to identify adverse effects. Typi-
cally, however, staff members at the Office for New Drugs, the office respon-
sible for drug approvals,tend to dismiss epidemiological studies as less reliable
than RCTs (Carpenter 2010). When adverse effects are not detectable on
randomized trials, staff feel that such risks should be ignored.
David Graham, an associate director at the FDA’s Office of Surveillance
and Epidemiology, suggested to me that many FDA staff will
only believe – this has been said to me more than once by people from the
Office of New Drugs, very high level people – they will only believe that an
adverse effect is real when a controlled clinical trial has been done that
shows an effect with a p value of less than 0.05.
Unless there is evidence from randomized trial that an adverse effect was
caused by a drug, FDA reviewers have difficulty accepting that a drug’s risks
may be severe – even though staff members know that most trials are too short
to reveal those very risks.Absence of RCT evidence is taken as evidence that
no risks exist: even when epidemiological data indicates a drug may be killing
people in the thousands. Graham suggested the FDA has developed an ‘asym-
metric approach to safety’ where unless a drug is shown not to work, regulators
assume it is both safe and effective:‘The drug is effective until you prove to me
it’s not. The drug is safe until to you prove to me it’s not. It’s a very warped
standard, one that doesn’t protect the public’.
Faith in RCTs as the gold standard of drug testing leads to a sort of institu-
tionally sanctioned strategic ignorance of warning signs that emerge once a
drug is on the market. Graham put it this way,
people can be blinded. They can believe so strongly in a product that they
explain away things.They say, oh that was observational data,or, that person
shouldn’t have been in the clinical trial to start with because they didn’t
make the entry criteria.
Such rationalizations have led to two curious paradoxes. One is that RCTs
have never been more powerful in drug regulation than today, when observers
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increasingly acknowledge their limitations in practice (McGoey 2010). A
second is that those who have most vocalized concerns with RCTs have tended
to face more negative professional consequences than those who deliberately
ignore concerns.
Over the last decade, FDA staff have been reprimanded for raising safety
concerns in the case of antidepressants drugs, Vioxx, and, most recently,
Avandia, a bestselling diabetes drug found to increase the risk of heart attack
by almost 50 per cent (see Bass 2008; Harris 2010; Lenzer 2004; Lenzer and
Brownlee 2008; Shorter 2009).The number of FDA staff penalized for calling
attention to problems with a licensed drug suggests a truism that is both
obvious and yet strangely neglected. Within large organizations, individuals
often have more to lose than to gain by calling attention to dysfunction within
organizations which, by necessity, tend to thrive on not articulating their own
weaknesses.
Those who threaten to shatter the collective denial of unsettling problems
are treated as disloyal, as whistleblowers, or as von Eschenbach stated, as poor
‘team players’. Strategies are swiftly invoked to silence those who dare break
codes of silence.The decision to expose deliberate ignorance, to draw attention
to palpable problems is, rather perversely, treated as the most inexcusable act.
Exposing problems is often more personally dangerous than quietly perpetu-
ating them.
This reality is visible in a range of organizations and professional milieus,
such as the global finance sector, where, as Gillian Tett suggests, early warning
signs of systemic failure that led to the system’s collapse were obscured
through the social silence which prevailed around the potentially catastrophic
effects of derivatives (Tett 2009). It is not that problems were not visible, but
that tangible problems were left unarticulated by groups whose social solidar-
ity was dependent on the willingness to ignore information that was not
personally or institutionally advantageous to discuss openly. Ignorance is most
convincing when it is shared.
Two individuals who exemplify the value of ignorance during the 2008
financial collapse are Ralph Cioffi and Matthew Tannin, former Bear Stearns
hedge fund managers accused in a New York court of lying to investors
about the fragile state of the funds they managed, leading clients to lose $1.6
billion when the funds collapsed in the summer of 2007. As Davies and
McGoey (2012) write, the prosecution’s case turned on emails which, at first
glance, seemed to offer irrefutable evidence that the fund managers knew
their funds were spiraling downwards – and sought to hide their knowledge
from clients.
After a three-week trial, the defendants were acquitted. Jurors stated that
the former Bear Stearns staff may have made bad investments, but that was
not a crime. ‘The entire market crashed’, a juror later told media. ‘You can’t
blame that on two people’ (Davies and McGoey 2012; Kouwe and Slater 2009).
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Pointing to their own ignorance was valuable to those who had something to
gain by purporting that knowledge of impended market collapse was impos-
sible to predict.
This point both expands upon and challenges Donald MacKenzie’s work on
the limits of knowledge during the financial crisis. MacKenzie has demon-
strated the ways that knowledge gaps and asymmetries were a key culprit of
market unrest (MacKenzie 2011). While insightful, his analysis implies, mis-
guidedly, that such information gaps were an aberration from the norm, some-
thing actors have an obvious interest in overcoming through the application or
development of more knowledge.
His analysis sidesteps the question of the organizational advantages of
information gaps, the ways that the harnessing evidence of one’s lack of
knowledge, as Cioffi and Tannin’s legal team did, is a useful strategy, one
rendered more convincing the greater the number of actors engaged in the
same strategies of willful ignorance.17 In the case of the recent financial crisis,
the failure to act on warning signs became simultaneously more surprising in
hindsight (as in, how could individuals miss such obvious signs?) and more
exonerating the larger the problem became (people missed them because
everyone else did). Magnifying perceptions of one’s ignorance is often more
useful than gaining more information of things one might be penalized for
better understanding.
‘It is not the quantity of ignorance that matters’, suggestsAbbott.‘It is rather
the quality’ (Abbott 2010: 188). He is correct in pointing out the multifaceted
nature of ignorance. But he underestimates the importance of the scale of
ignorance. As I have shown, strategic ignorance is often more institutionally
advantageous the more widely it is individually mobilized.The more pervasive
strategic ignorance becomes,the harder it is to challenge or to expose, whether
one is deliberately restrained, as in the case of von Eschenbach’s dictate not to
discuss problems publically, or whether strategic ignorance stems from uncon-
scious adherence to institutional norms, as in the case of FDA staff who have
little incentive for better understanding how their methods are inadequate.
Conclusion
Through a focus on Ketek, this article has explored the strategic uses of
ignorance, the deliberate effort to preclude, obfuscate or deflect knowledge
from emerging. I have suggested we need more attention to the scale of
ignorance, and the ways that, contrary to popular logic, increased ignorance
does not necessarily act as an impediment to the smooth functioning of dif-
ferent organizations. On the contrary, organizations often function more effi-
ciently because of the shared willingness of individuals to band together in
dismissing unsettling knowledge.
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Of course, one could argue that institutions or sectors that thrive on sus-
tained ignorance of their own inadequacies eventually suffer repercussions.
The recent financial crash is a case of point. Ignorance of the risks individuals
were taking eventually imperiled the financial system’s stability.
Here, however, is where the value of ignorance becomes most visible. After
the system stabilized, collective ignorance – believable because of its sheer
magnitude – has been a useful alibi, helping to deflect accountability for those
who precipitated the crash. It has proved remarkably difficult to hold particu-
lar financial actors liable for systematic risks that few have admitted to under-
standing or perceiving. Ignorance has a double usefulness. First, widespread
social silence enabled the perpetuation of highly profitable, however ulti-
mately destructive, activities. Second, earlier silences were exploited in order
to exonerate the actions of individuals claiming risks were impossible to
detect. It was logical to claim ignorance both before and after the collapse.
This relates to my overarching point, which is that we need to resist the
customary assumption that knowledge is more powerful than ignorance, or
that social actors have an obvious interest in expanding knowledge and eradi-
cating ignorance. Such an assumption limits understanding of the ways that
ignorance is intentionally fostered and maintained, deflecting attention from a
key social knowledge – the knowledge of what individuals aspire and struggle
not to know.
(Date accepted: May 2012)
Notes
1. Many thanks to Eamonn Carrabine,
Nicolas Guilhot, Peter Jacobson, Lisa Stamp-
nitzky, Catherine Will and Scott Vrecko for
comments on the article. My analysis of
the Ketek case has been enhanced through
discussions with members of the Pharmaceu-
tical Dissent project, Kate Weiner, Sujatha
Raman, and Catherine Will, as well as
research assistance on Ketek from Shadreck
Mwale. This article was written through the
support of a James Martin fellowship in
science and technology studies at the Univer-
sity of Oxford, as well as a visiting fellowship
at the Brocher Foundation, Geneva. Thanks
to the Oxford STS group, past and pre-
sent, in particular Noortje Marres and Tanja
Schneider.
2. I first use the term strategic ignorance
in McGoey 2007. Allison Bailey (2007) has
separately used the term to discuss simi-
lar phenomena: the ways that ignorance is
strategically maintained to serve various
social and political objectives. Recently,
Carol Heimer (2012) has built on the
notion.
3. See, for example, work by Eyal and
Buchholz (2010) for a recent discussion of
sociologies of expertise in a range of fields,
from science and technology studies of
‘boundary work’, to governmentality per-
spectives on the links between knowledge
and power, to work on epistemic communi-
ties within international relations. All have
as a starting point the equivalence of exper-
tise with exclusivity. Far less explored are the
ways that experts seek to preserve their own
ignorance – perhaps as aggressively as they
struggle to gain new knowledge.
The logic of strategic ignorance 571
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4. See Guilhot 2011 for a discussion of
how a discipline or profession’s authority can
be augmented and expanded to other arenas
– in Guilhot’s analysis, the expansion of
game theory beyond economics –through
de-formalizing its underlying theory. In other
words, through a refusal to adhere to, or to
propagate,concrete or narrow axioms,tenets
or formula, disciplinary knowledge is ren-
dered more marketable to different spheres.
The inability or reluctance to know or to test
a proposition empirically becomes a key pro-
fessional asset – whether that advantage is
kindled consciously or not. This resonates
with Abbott’s perception of how ‘in a pecu-
liar way, relatively less organized professions
have distinct advantages in workplace com-
petition. Because they lack a clear focus and
perhaps a clearly established cognitive struc-
ture,they are free to move to available tasks’
(see Abbott 1988: 83).
5. Work by Nassim Nicholas Taleb (2004)
helps underscore the gravity of the failure of
many economists to appreciate the limits of
their own knowledge.
6. Earlier sociological work on secrecy
serves an obvious precursor to current work
on ignorance. Simmel, for example, was fas-
cinated by human interest and reliance on
secrecy and the ‘unknown’, something he
deemed ‘the typical error according to which
everything mysterious is something impor-
tant and essential’(Simmel 1964: 333).
7. By law, IRBs must oversee clinical
trial research in the USA, ensuring investi-
gators adhere to good clinical practice,
such as obtaining informed consent from
participants. Copernicus’ apparent neglect
of safety concerns raises the wider question
of whether for-profit IRBs, which have
become increasingly prevalent in the USA
over recent years, are more lax in general in
vetting trial protocols than their non-profit
equivalent. See Emanuel et al. 2006 and
Fisher 2009.
8. Testimony of Ann Marie Cisneros
before the Subcommittee on Oversight and
Investigations of the Committee on Energy
and Commerce.Feb 12, 2008,pg 15. US http://
frwebgate.access.gpo.gov/cgi-bin/getdoc.
cgi?dbname=110_house_hearingsanddocid=
f:48587.pdf
9. See the testimony of Henry Loveland,
US Subcommittee on Oversight and Investi-
gations of the Committee on Energy and
Commerce. Feb 12, 2008, pg 19. US http://
frwebgate.access.gpo.gov/cgi-bin/getdoc.
cgi?dbname=110_house_hearingsanddocid=
f:48587.pdf
10. Loveland’s FDA report is available
here:http://archives.energycommerce.house.
gov/Investigations/KetekExhibitBinder/
10001.PDF
11. The exonerating value of ignorance is
not limited to pharmaceutical controversies.
Numerous political catastrophes have been
mitigated or justified through official insist-
ences of ignorance. Power’s work (2001) on
the 1994 genocide in Sudan is exemplary on
this point.
12. For cases where manufacturers have
withheld data from regulators, see Abraham
and Sheppard 1999 and McGoey and
Jackson 2009.
13. The meeting with von Eschenbach is
described by Ross during his testimony
before the subcommittee hearing into Ketek.
When he was later called before the subcom-
mittee himself, von Eschenbach said that he
had been trying to impress on staff that FDA
was a place where, much like a pre-game
locker room, ‘completely different perspec-
tives on an issue or problem can come
together with mutual respect and vigorously,
even aggressively, debate and discuss those
issues.
14. The source was referring to the
British drug regulator’s handling of SSRI
antidepressants,in a case remarkably similar
to the FDA’s treatment of Ketek.
15. Sociologists and ethicists have paid
considerable attention to detriments and
advantages of the increasing use of RCTs in
medicine. For enlightening discussions, see
work by Timmermans and Berg and Will.
16. The quote is taken from the following
AHRP presentation, available at http://
www.fda.gov/downloads/Drugs/DrugSafety/
UCM173472.pdf. I submitted a Freedom of
Information (FOI) request to the FDA for a
572 Linsey McGoey
© London School of Economics and Political Science 2012 British Journal of Sociology 63(3)
copy of the memo, and was informed by the
FDA that a search ofTemple’s files found no
such memo. Later on, the Alliance for
Human Research Protection, a NGO based
in the USA, sent me a copy of the memo.
17. One exception is MacKenzie’s brief
mention of Goldman Sachs’ remarkable
proficiency at escaping virtually financially
unscathed from the crisis, a feat he suggests
might be attributable to the deliberate
harnessing of Bourdieussian ‘complicitous
silence’ in the face of warning signs. He
then largely dismisses the import of his
own assertion, noting that efforts to prove
his point are hampered by the problem of
access. I suggest we need more attention to
the ways that firms thrive from the very
strategies – complicitous silence; strategic
ignorance – that sociologists often ignore
because intentionality is hard to docu-
ment. Otherwise, we become guilty of the
very problems facing FDA staff: equating
absence of evidence with evidence of
absence.
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