Regulatory objectivity and the generation and management of evidence
in medicine*
Alberto Cambrosio,a Peter Keating,b Thomas Schlich,a & George WeiszaabDepartment of Social Studies of Medicine, McGill University, Montreal
Department of History, University of Quebec, Montreal

The evolution of Western medicine since World War II may be described as arealignment of biology and medicine that has resulted in the emergence of
new practices based on the direct interaction of biology and medicine. Thisdevelopment amply justifies the use of an apparent syncretism, the term
biomedicine (Keating & Cambrosio, 2003). The post-war realignment of
biology and medicine has in turn been accompanied by the emergence of a
new type of objectivity. While philosophers of science have tended to treat
objectivity as a logical, ahistorical category, recent work in the history ofscience has shown how we can in fact historicize the notion of objectivity anddescribe both different periods of scientific development and different kinds ofscientific activity in terms of the forms of objectivity that they embody. (Daston,
1992; 1999a; 1999b; Daston & Galison, 1992; Galison, 1998; Porter, 1992;
1995). Building on this work, we claim in this paper that modern biomedicine
incorporates a novel form of objectivity that we call regulatory objectivity andthat is based on the systematic recourse to the collective production ofevidence (Callon, 1991). By “collective,” we refer to the kind of evidence thatis produced, for example, by inter-laboratory studies, multi-center clinical trials
and research consortia that develop collective devices such as mouse models
of disease, genetic maps or clinical and laboratory guidelines (Vinck, 1992;
Cassier, 1998; Cambrosio, Keating & Mogoutov, 2004). The notion of thecollective production of evidence also includes those bodies of evidence thatare embedded and archived in a growing collection of institutions such as
open-access genome libraries and tissue banks.
Our claim, in a nutshell, is that unlike forms of objectivity that emerged inearlier eras — with which it now co-exists — regulatory objectivity consistently
results in the production of conventions, sometimes tacit and unintentional but
most often arrived at through concerted programs of collective action. These
actions incorporate unprecedented levels of reflexivity, in the sense thatbiomedical practitioners in their debates and discussions take into account theconventional dimension of their endeavors. We do not claim, of course, thatevery single medical practice is now governed by regulatory objectivity, but
we maintain that this form of objectivity corresponds to a new regimen of
coordination of medical practices that increasingly operates as a condition of
possibility for the very existence of these practices.
The emergence of biomedicine
Like the practices it describes, the term biomedicine is of relatively recent
coinage. Although dictionary definitions exist prior to World War II, the generaluse of the term as a descriptor for Western medicine is mainly a post-war

2phenomenon. The neologism is as much projective as it is descriptive.
Reducing medicine to a branch of biology and creating a single homogenous
science remains an ambition rather than a fait accompli. While the genomic
sciences are presently the most high-profile purveyors of the proposed
reduction, other sciences have since the Second World War aspired toreorder the material and discursive relations between these two domains. One
need only recall the different research programs and agenda of life sciencessuch as biophysics, biochemistry, immunology, and molecular biology. The
problematic nature of the project becomes apparent when the term is used inits polemical form to advocate a strict reduction of medicine to biology. On
these occasions, defenders of the autonomy of clinical research have nothesitated to denounce the term as a smoke screen intended to hide theclinical origin of many biological breakthroughs and to divert funds fromclinical to more basic research (Schechter, 1999).
And yet the term biomedicine is not simply a rhetorical device invented by,say, molecular biologists in the search of a larger slice of the medical
research funds pie. Early use of the term in the immediate post-war era
suggested that biomedicine would be some sort of hybrid of biology andmedicine and not the reduction of one to the other. The hybridization was tobe accomplished not only by the application of biological theories andmethods to the problems of pathology but also by the creation of new
domains of study involving the interaction of “normal” humans with“pathological” environments such as those resulting from radioactive
contamination or space travel. The development of civil and military atomic
research and the conquest of space provided the opportunity for the creationof a panoply of biomedical instruments that would soon find more mundane
applications in clinical medicine not only in such fields as nuclear medicine but
also in numerous automation programs that targeted both routine diagnostics
activities and new endeavors such as the monitoring and screening of actualand potential patient populations.
By the 1960s, the term biomedicine had acquired a political and administrative
meaning, as is indicated by the work of the prominent medical researcher andreformer, Lewis Thomas. In an often overlooked yet extremely insightful paperon the relations between technology and medicine written at the beginning of
the 1970s, Thomas pointed out that, contrary to current wisdom, true “hightech” medicine would ultimately not be based on technologies derived fromphysics and chemistry such as X-rays and radiotherapy. These technologies,
he argued, simply papered over our lack of understanding of the biologicalmechanisms at the origin of disease. The high-tech medicine of the future —a biomedicine — would be more likely to profit from a better understanding of
disease mechanisms and would probably use newly emerging biological tools(antibodies, enzymes, hormones, and, more recently, genes) in both
diagnosis and therapy. For this to occur, according to Thomas, it was
imperative to fund fundamental and strategic research in order to overcome
the institutional barriers that separated biological and clinical research(Thomas, 1972). As we now know, Thomas’ vision was largely turned into
reality, albeit with unexpected twists and quirks, the most important of which

3

was the merging of physico-chemical and electronic instruments withbiological technologies.
While Thomas placed biomedicine at the interface between the normal andthe pathological, he did not explain what the socio-epistemic relations
between the two domains should be. Several alternatives are available. One
may choose, for example to view the relations between the normal and thepathological in terms of subordination leading ultimately to the reduction of thepathological to the normal. It is also possible to view the relationship between
the two as one founded on the generation of relations of mutual enrichment
within a novel space of representation and intervention. We would suggestthat recent work in the history and sociology of the biomedical sciences tends
to support the latter position (e.g., Löwy, 1996; Rheinberger, 1997; deChadarevian & Kamminga, 1998; Gaudillière, 2002). Biomedicine differs
greatly from the small-scale or largely programmatic attempts in the 19th
century to link biology and medicine. The biomedicine that emerged in the
post-war era features a complex interweaving of the diverse material andepistemic components of the life sciences. Although an occasionallyoverblown rhetoric claims that biology is the ultimate explanation of the origin
and mechanisms of disease, biology has clearly not replaced, in the
reductionist sense, pathology (Keating & Cambrosio, 2004a).
Indeed, multiple observations show that the last fifty years have seen theconstitution of a biomedical space wherein the tools and experimental
systems used in pathology and biology tend to deploy both normal andpathological entities interchangeably to the point where, more often than not,they largely overlap. In other words, despite the fundamental differences
between physiological and pathological processes, the last fifty years havewitnessed a convergence in the methods used to intervene in theseprocesses and in the entities held to be the principal actors both in health anddisease. Moreover, given the interchange of actors and methods, thebiological or clinical relevance of deploying an experimental system in biology
or pathology cannot be known in advance. A clinical trial tracking a biological,
prognostic variable, for example, is equally likely to say something about thebiology of human beings as about the pathology of the disease being studied.
Redefined as surrogate markers for pathological processes, biologicalvariables (i.e., cell surface markers, chromosomes, genes, proteins, etc.),
make possible both mass screening and the automation of screening
techniques (consider the Pap test; see Keating & Cambrosio, 2005a; Kaufert,
2000; Casper & Clarke, 1998; Singleton & Michael, 1993). They thus redefine
the relations between individual patients, pathological singularities andpopulations. Consequently, the automation of diagnostic activities represents
more than the simple use of technologies to more rapidly achieve the same
results as manual methods. Automation modifies the content of medical
practices and the nature of the judgments that arise in these practices. It doesso by supplanting qualitative analyses with quantitative analyses, by upsetting
the relations between structure and function, and by resorting to computer
generated representations that change both the type and means of circulationof biomedical entities (Baird, 2004; Keating, Limoges & Cambrosio, 1999).

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At the institutional level, this transformation has been accompanied by an
unprecedented rise in the public funds invested in biomedical research and by
the creation of institutions like the National Institutes of Health in the UnitedStates. Less visible but equally significant changes include the expanded roleaccorded research in medical schools which, by 1980, awarded almost 40%of the Ph.D.s in the biological sciences (Rothstein 1987: 251). Similarly
revealing was the 1995 change to the American Journal of Pathology which
added the subtitle: Cellular and Molecular Biology of Disease. In keeping with
the idea of biomedicine as an ongoing project, one of the current themes ofthe present direction of the NIH is to harness the knowledge in the life
sciences produced at the NIH in a more direct fashion in the treatment ofdisease. The much vaunted “Roadmap” that is presently reorienting researchat the NIH constitutes the latest stage in the continual realignment of biology
and medicine and the persistent concern with the translation of biology into
medicine that has animated numerous projects since the advent of
biomedicine. To take just one example from the Roadmap, in recognition of
the distributed nature of genomic biology on the one hand and the problemsof organizing multi-center clinical trials, on the other, Roadmap designers
propose that clinical research in turn will have to be reorganized and suggestthat “clinical research needs to develop new partnerships among organizedpatient communities, community-based health care providers, and academic
researchers. In the past, all research for a clinical trial could be conducted in
one academic center; that is unlikely to be true in the future.”iWith regards to routine clinical activities, the second half of the 20th century
has witnessed (especially in Europe because of the devastation caused by
the War) a transformation of hospital architecture. The pavilion system ofarchitecture based on the segregation of patients into separate pavilions
according to medical specialty was gradually replaced by so-called platform
hospitals where high-rise patient towers sit on technical platforms containing
highly automated analytic laboratories (Verderber & Fine, 2000). Most of theanalyses are diagnosis-related, as a common feature of post-war clinicalmedicine has been the sharply increasing number of diagnostic tests. So
many, in fact, that observers generally concur that diagnosis has in many
instances outdistanced the therapeutic capabilities of clinical medicine,leading yet other observers to suggest that the diagnostic enterprise hasachieved a relative autonomy with regards to other clinical objectives (Sournia,
1995). Similarly, isolated clinical specialists have, in many instances, been
replaced by multi-disciplinary teams that are avid consumers of biologicaldiagnostic tests, and by a complex web of interdependencies between sub–areas of specialization (Gosselin, 1985). In the case of emerging domains,such as predictive genetics and cancer, the collective production of diagnosis
has meshed imperceptibly with the collective production and management of
medical judgment and medical decision-making (Bourret, 2005).
To sum up: as used in this paper, the term biomedicine refers to a material,
institutional and epistemic configuration that cannot be reduced to medicine(the pathological) or biology (the normal). This novel configuration is properly
described as biomedical to the extent that it is the result of the realignment

5(not fusion) of practices concerned with the production of the normal and thepathological. Biomedicine offers, in other words, a new space ofrepresentation allowing for the coexistence of biomedical entities (antibodies,oncogenes, genetic signatures, etc.) that participate simultaneously in normal
and pathological processes. As we will see in the next section, thesebiomedical entities function within a regulatory framework and their(re)production depends upon a network of conventions that express a newkind of objectivity. In this respect, the highly-publicized movement forevidence-based medicine (Daly, 2005; Timmermans & Berg, 2003; Weisz
2005) is but one of the many expressions of a deeper and more wide-ranging
transformation.
Biomedicine and regulation
The central role assumed by diagnostic tests in biomedicine has prompted a
growing concern about their reliability and utility. Numerous studies conductedby state agencies and professional bodies such as, in the United States, theCenters for Disease Control or the College of American Pathologists havecontributed to the discussion and convinced legislators, health care providers
and health care administrators that standards and quality control measures
are urgently needed. Despite the seemingly mundane nature of suchdiscussions, we must not forget that norms and standards of quality control
are much more than a means of controlling the activities of diagnostic test
technicians. They are part of a larger domain of activity, regulation, which
contributes to the constitution of the entities and the practices that it regulates.
The following example will make the recursive nature of these relations
explicit.ii
Over the last thirty years, new biomedical entities known as cell surface
markers have figured prominently in the diagnosis, prognosis and therapy of asteadily growing number of pathologies. The best known of these markers is
CD4 whose detection serves to identify types of white blood cells such as
macrophages and T4 cells that are the common targets of the AIDS virus.
Numerous other markers (there are presently more than 200, all designatedby the acronym CD followed by a number) play a major role in research andclinical domains as diverse as cancer — especially the leukemias and thelymphomas — transplantation, and diseases of the immune system. The
markers are detected using specific antibodies tagged with fluorescent
substances which, in turn, are measured by computerized equipment
produced by a growing biomedical instrumentation industry. The domain of
surface markers developed very quickly in the 1970s and a number oflaboratories and commercial enterprises marketed antibodies with different
names and different specificities. This quickly raised the question of whichantibodies recognized which markers and consequently of inter-laboratory
and inter-company comparability. In 1980, in order to resolve a situation thatrisked sliding into chaos, a group of researchers began organizing a series ofinternational workshops to create a standardized nomenclature for use byclinicians, researchers and commercial enterprises (Cambrosio, Keating &Mogoutov, 2004).

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Briefly, the system worked as follows: at regular intervals, new antibodies (orold ones requiring reclassification) were distributed to the hundreds ofparticipating laboratories which, following testing, sent the results to be pooled
for statistical analysis. Statisticians were thus able to define, on this basis,clusters of antibodies (hence the acronym CD for “cluster designation”) thatreacted similarly and thus presumably attached themselves to the same cellsurface marker (which received the same CD number). We are less interested
here in the details of the system than the fact that in such a system, the CD
numbers depend upon the establishment of an international network for the
express purpose of creating the CD categories that separate one antibody
and its corresponding cell surface maker from another. A single laboratory
could not possibly establish the differences that make up the system. The
system in turn depends upon the mobilization of a series of statistical andorganizational conventions and standard laboratory protocols. The
conventions not only separate one marker from another but make it possible
to assign biomedical meaning to the CD category. The regulations, in otherwords, create the entities they regulate.
But there is more. As mentioned above, using antibodies with a CD
designation entails the use of sophisticated laboratory instruments. Given thatthese instruments are produced by a variety of commercial suppliers, is it
possible, clinicians and researchers asked at the time, that different
instruments run by different operators in different institutions produce different
results? It turned out that the answer was yes. Consequently, there is yet
another network of rules, regulations and conventions that target the reagentsused, the samples tested, the instruments and the instrument operator, andthat must be followed if one wishes to compare, for example, blood samples
taken from patients enrolled in multi-center clinical trials (Keating &Cambrosio, 1998). The absence of absolute standards in this field means thatthe establishment of conventions concerning the proper performance of thelaboratory test in question is the only way of assuring that test results arecomparable and that they attain the status of fact. What counts, in other words,
is not whether or not the results produced by a particular laboratory are true,in some absolute sense, but whether or not they are compatible (withinconventionally determined statistical limits) with results produced by otherlaboratories.iii
National and international organizations such as the World HealthOrganization are quite conscious of the significance of these different layersof regulation which run the gamut of formality from unofficial rules of thumband different forms of internal quality control that allow a single laboratory tocompare results over time, to external quality control measures that makepossible inter-laboratory comparisons. Complex networks of regulation thatmobilize intricate metrological infrastructures have thus been established inorder to create, where possible, reference standards. In cases of unstablestructures like blood, systems of control have been established that assurethat laboratory analyses maintain a minimum of consistency between
laboratories and over time. iv As the authors of one of these standardizing
enterprises point out:

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A genuine assessment of accuracy is not possible without true reference
standards which do not exist for any of the formed elements [cells] of theblood. The only available indicator of accuracy is therefore the degree ofconsensus on samples analyzed in different laboratories. (Kidd and Vogt:
4)
Readers of Canguilhem (1989) will recall that the normalization process does
not presuppose the existence of a norm. Rather, norms are the result of
normalization which entails the establishment of a set of conventions and,increasingly, the development of methods that provide the framework for the
production of those conventions.
The following statement issued by the International Committee onStandardization in Hematology (ICSH) gives an idea of the kinds of problems
confronting such an enterprise in the real world:
A deﬁnitive method is one which has no known source of inaccuracy or
ambiguity. A reference method is less certain than a deﬁnitive method
but it is a clearly and exactly described technique which provides
sufficiently accurate and precise laboratory data for it to be used toassess the validity of other laboratory methods. A selected method is
one which is recommended for routine use having been shown to be
sufficiently accurate and precise for its intended purpose and to bepractical enough on the grounds of economy of labour and materials andease of operation. Unfortunately even the selected method may be
impractical under certain circumstances so that a simple routine method
may be used albeit not recommended by ICSH. (Lewis 1990)
Our concept of regulatory objectivity is not restricted to the diagnostic phaseof biomedicine that we have thus far emphasized. When a patient consults a
medical practitioner or is admitted to hospital, s/he sets out on a non-linear
trajectory divided into diagnosis, treatment, and evaluation stages where theresults of one stage may feed back into a previous stage as when the resultsof therapy modify the initial diagnosis or prognosis (Berg, 1992). A diagnosis
implies not only the examination of the patient and bodily samples; it alsoentails the existence of nosographical categories that allow clinicians to namethe disease and to evaluate the results of various diagnostic tests (and,subsequently, of prognostic measurements and therapeutic interventions).
Consider, now, the field of migraines: some of the most significant therapeuticadvances in the past two decades owe their existence to the internationalclassification of migraines which has made possible a whole series of novel
clinical trials and created the grounds for their comparison (Popowycz, 2004).
Nosographical entities are themselves subject to frequent redefinition
implicating yet other biomedical entities. Consider, for example, the leukemias.
Initially diagnosed on the basis of clinical and morphological criteria throughthe examination of stained cells and tissues under a microscope, they arepresently defined in terms of cell surface markers (CD) and are currently inthe process of being redefined in molecular biology terms (Keating &Cambrosio, 2000).

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The redefinition of disease entities by means of biomedical entities also hasrecourse to what might be termed institutions of meta-regulation such asconsensus conferences (Ferguson & Sherman, 2001) and groups or networks
of experts that establish clinical guidelines and recommendations (Castel &Merle, 2002; Burgers, Grol, Klazinga, Mäkelä, & Zaat, 2003; AGREE
Collaborative Group, 2000) that have varying degrees of force (Willems,
1998). Numerous critiques have denounced these initiatives as a form of
unwanted meddling in medical practice (even though it is physicians
themselves who are usually behind such undertakings) and studies haveraised doubts about the extent to which recommendations and guidelines are
actually followed. Because methods of achieving consensus are frequently
local and informal, efforts are currently underway to develop and promoteinternational guidelines for producing guidelines (Graham, Beardall, Carter,
Tetroe & Davies, 2003; AGREE Collaborative Group, 2000). Despite suchdifficulties that call into question its practical import, our notion of regulatory
objectivity retains its validity in this domain as well. Even if nobody followed
clinical guidelines or recommendations, and even if clinicians were guided bysheer intuition, clinical diagnosis and intervention would still call upon normal
and pathological entities and procedures whose clinical existence andmeaning depend upon regulatory objectivity.
Biomedicine and regulatory objectivity
As previously noted, recent historical studies have transformed objectivity into
a subject of historical inquiry. They have shown how different historicalperiods have produced different types of objectivity which have subsequently
persisted either as autonomous forms or in combination with other types ofobjectivity. Thus, whereas the objectivity of a statement was once guaranteedby the knowledge and experience of the author of the statement, later periods
have tended to privilege mechanical or instrumental objectivity that replaces
experts’ subjectivity with mechanically produced inscriptions (Daston &Galison, 1992; Baird, 2004). Similarly, Daston (1992) has described theemergence of a type of objectivity predicated upon the absence of any
viewpoint or perspective and which culminates in the systematic recourse toquantitative measures (Porter, 1992; 1995). Each form of objectivity stands in
opposition to some other form of (equally historically contingent) subjectivity
and embodies a distinctive moral economy (Daston, 1995).
Elements of these different types of objectivity — collective expertise,scientific instruments and their inscriptions, and statistical measurements —have played and continue to play a central role in the development of modern
biomedicine. We wish, however, to claim that biomedicine now incorporates a
new type of objectivity based on regulation and systems of conventions(Thévenot, 1984; 1997; Dodier, 1995). v These conventions are constitutive
not only of clinical practices but also of the knowledge emerging from bothclinical and laboratory settings. The CD example is just one instance of how
the production of biomedical knowledge has been redefined by theestablishment of new modes for the production and management of

9knowledge that are based on regulatory objectivity. Similar forms of regulatory
objectivity are expressed in such knowledge creation projects as theaforementioned multicentered clinical trials or in the more recent bio-clinicalcollectives involved in cancer genetics (Bourret, 2005; Bourret, Mogoutov,
Julian-Reynier, & Cambrosio, submitted) and genomic medicine moregenerally.vi
Some readers might object that the configuration that we have described is
not new. This is true to the extent that regulatory objectivity implicatessystems of measure and standardized objects such as the metric system,high purity chemical reagents (Analytical Reagent Grade or Analar), electricalstandards and so on, whose invention dates back to the 19th century andwhich are also based on conventions (Schaffer, 1992; O’Connell, 1993;
Gooday, 2004). In this regard, regulatory objectivity could be construed as
little more than a pre-condition of mechanical objectivity. Our view ofregulatory objectivity is not, however, restricted to the establishment ofstandard measures. It incorporates the use of these measures as a basis forclinical judgment. Thus, for example, the establishment of standards allowing
clinicians to identify pathological cells (blasts) in the blood of leukemia
patients has led to the creation of standard criteria for the definition of specificstages of the disease (the blast crisis). These stages are then used as ameans to render objective clinical judgments in clinical trials. There has
therefore been a reversal of objectivity: whereas mechanical objectivity
displaces the bearer of objectivity from the human expert to the object,regulatory objectivity displaces the focus from objects back to human experts,
or, rather, to collective forms of human expertise combining people (clinicians,
researchers, administrators, patients, …) and objects (entities, instruments,
tools, techniques, …) connected by specific coordination regimens.
Depending on the domain under consideration, these human and non-humanelements are attributed a differential weight (Dodier, 1995). In a field likesurgery, for instance, in spite of the development of surgical instruments that
embody specific operating techniques, the face-to-face transfer of operatingskills plays a crucial regulatory role at the expense of more impersonal tools
such as guidelines (Schlich, 2002). Similarly, animal models and clinical trials
do not perform the same regulatory function in surgery as compared tooncology. More generally, the various sectors of medical science and practice
may differ substantially in the degree to which they incorporate regulatory
objectivity.
The heuristic value of our approach thus lies in the fact that it allows us toinvestigate not only the dynamics of different forms of regulation but also theconstitution of the entities and processes that are the subject of regulation.
Regulatory objectivity targets not only specific instruments or practices andindividual representations but also those configurations of practices,
instruments, knowledge, and clinical expertise known as biomedical platforms(Keating & Cambrosio, 2003). The notion of regulatory objectivity alsoenriches our understanding of medical history. The well-known developmental
sequence according to which medicine moves though a series of stages ortypes running from bedside medicine to clinical and laboratory medicine(Ackerknecht, 1968; Jewson, 1976; Pickstone, 1994) can now be extended to10include the latest stage of multi-centered medicine, a stage saturated byconvention-based forms of regulation. Its predecessor in this scheme,
laboratory medicine, relied heavily on mechanical objectivity which proposedthat there were indeed “true measures” that corresponded to the quantitative
characteristics of the substances present in the body. Under the regime of
regulatory objectivity, biomedicine suspends the search for “true values” andreplaces it with the establishment of conventions. As we previously mentioned
with regards to laboratory standards, for biomedicine it is less important toarrive at a truth (analytic or otherwise) than to ensure compatibility between
different laboratories and different hospitals. As one of the participants at aconference on the international harmonization of in vitro tests pointed out, it isa question of providing consistent resources for “patients [who] travel globally,acquire global diseases and will eventually request global healthcare”(Carneiro, 2001: 17). In this sense, regulatory objectivity also reflects thevalues of globalization and free information flow that has driven international
standardization since World War II (Timmermans & Berg, 2003: 17).
Within the framework of regulatory objectivity, the way in which practitioners
reach a consensus is as important as the object of the convention. It might beargued that, henceforth, regulation has its own dynamic as demonstrated by
the emergence of “regulatory science” (Bodewitz, Buruma, & De Vries 1987)
as an interface between top-down and bottom-up forms of regulation.
Regulatory objectivity is thus more than a simple metrological infrastructure(Star & Ruhleder, 1996) of the kind that permeated mechanical objectivity.
Those implicated in the regulation of biomedical practices are not bureaucrats
but scientists and clinicians whose work uses the same tools and know-how
utilized in the practices themselves; the work, as we have seen, is recursive.
Regulation generates results, raises questions and produces phenomena
whose significance feeds back into the practices that are the subject ofregulatory activities. Regulation is also at the centre of the production andmaintenance of biomedical platforms which are the motor of contemporary
biomedicine.

Systems of evidence
As we have seen, regulatory objectivity is based on the use of a variety ofdifferent systems for the production of evidence (clinical trials, consensus
conferences, etc.) that are linked to standard substances and standardpractices (quality control procedures, practice guidelines, clinicalrecommendations, etc.) which are themselves organized into systems; asingle measure, in other words, has no meaning when isolated from othermeasures in the system. The systems themselves can in turn be articulated
within a larger system. In spite of potential variations between medical
domains, the formal procedures that constitute evidence-based medicine, forexample, explicitly recognize a hierarchy between different systems ofevidence and their components: a randomized double-blind clinical trial isconsidered of greater value than a non-randomized clinical trial or an expert
opinion. In other situations, such hierarchies remain implicit. Of criticalimportance is that, regardless of the level of formalization, the tools used to11produce objectivity are not handled on an individual basis but function ascomponents of a larger system and are explicitly understood to do so.
Clinical medicine, which to inattentive observers may appear somewhat
homogeneous, is, in reality, shot through with multiple differences (Berg & Mol,
1998) and clinical practice consequently presupposes the ability to correlatedifferent systems of evidence. Doctors, of course, have in the guise of clinicaljudgment always evaluated different kinds of evidence on an individual andinformal basis. Such processes, however, are now increasingly collective,
specialized and formalized (Gosselin, 1985; Berg, 1997; Mol, 2002, Bourret2005). Consider the relatively simple example of prostate cancer diagnosis. In
the course of making such a diagnosis, the practitioner draws together clinicalsigns (rectal exam), biochemical laboratory tests (PSA test), andhistopathological examinations following surgical biopsy. Each of thesedifferent kinds of evidence calls upon different specialties and techniques. Inturn, the results are interpreted both sequentially and conjointly. A high PSA
level may be cause for a biopsy but does not alone signify cancer. Regulatory
objectivity seeks out not only correlations between the different componentsof the diagnosis, but also seeks standards that allow such comparisons to be
made. This includes not only setting out the conditions that must be respected
in order to produce reliable test results, (quality control, etc.) but also theconditions that define the relations (within a clinical context) between the
different diagnostic elements as well as the consequences of such relations
on clinical judgment. In the case of prostate cancer, PSA tests, the mostrecent of a panoply of tests in this domain, are presently the subject of much
regulatory work. The target is not so much the individual patient as thecollective patient or, in other words, the population of potential patients onwhom the test will be used. Present regulatory investigations consequently go
beyond individual clinical judgments and establish conventions based on
biology and biological know-how. At the same time, the PSA test, as a
biological test and not as a determinative diagnosis displaces the question of
the diagnosis of the cancer patient. By opening up the possibility of monitoringa biological variable in a population, the PSA test sets up the possibility of
prevention through the calculation of risk and thus leads the clinician into a
dense thicket of statistical and biological conventions. Such calculations may
end up undermining the very premises on which PSA testing in based(Stamey, Caldwell, McNeal, Nolley, Hemenez, & Downs, 2004).
In addition to its impact on research, diagnosis, treatment, prognosis andscreening, regulatory objectivity has had a profound effect on the reward
system or the moral economy (Daston, 1995) of modern medicine andresearch. The change in scale engendered by collective research practices
has provoked numerous questions about the proper distributions of credit inresearch publications. The distributed nature of the biomedical researchenterprise raises further issues of trust or, as Hardin (2002) would caution,
trustworthiness, with respect to data production and interpretation (e.g.,
Hilgartner, 1998). While we can go no further here, there is no doubt aninteresting story to be told about the conventions that guide and maintain thetrustworthiness of a single datum along the interpretive trail from its origin
through the various data managers (a recent invention), into a medical journal

12(which routinely employ their own statisticians to check data) and on into a
consensus conference (e.g., Healy, 2004).

Conclusion
In conclusion, we would like to emphasize that our analysis touches upon adomain that is not merely socio-epistemic but that broaches a number ofpolitical, economic and ethical controversies. In the last case, many present
discussions in medical ethics (for a recent example, see Richman 2004) areunable to account for the dynamics of medical practice insofar as they reduce
the latter to a physician-patient encounter which they denounce as “dehumanizing” thus treating the objectivity of laboratory medicine as a form of
mechanical objectivity. This attitude displays a remarkable lack of reflexivity,
since ethical problems as they are framed today, far from leading an
independent existence in the realm of transcendental human values, are thehistorically contingent products of the clinical research enterprise itself(Keating & Cambrosio, 2005b). We would, thus, treat ethical debates as oneof the elements entering into the constitution of contemporary biomedical
practices as defined by regulatory objectivity (Tournay, 2005).
With regards to the socio-economic aspects, we have noted that the tools
used to manage and produce conventions are articulated within different
systems of evidence. The latter, in turn, make possible interventions that areperceived as having an outside source (state or otherwise). Much has been
written of late about the evaluation, rationalization and quality of health care
(Hafferty & Light, 1995; Mossé, 1998; Setbon, 2000; Robelet, 2001). The
concern for the quality of health care delivery has lately been informed byrecognition of the heterogeneity of medical practice and, in particular, of
significant inter-hospital and inter-regional variations in clinical decisions. As
Robelet (2001) has noted, the heterogeneity of medical practices becomes aproblem for administrators and practitioners when it is construed as anindicator of sub-standard performance in terms of both economics and theoverall goal of ensuring the temporal and geographic continuity of medicalcare. According to Robelet (1999), the application of systems of quality
management signals a profound transformation in the mode of regulation of
medical practice, namely the decline of professional self-regulation and therise of industrial modes of regulation.
No one would deny that medicine faces “external” interventions that areexperienced by doctors as a loss of power. We would suggest, however, thatthese interventions are made possible by the development of a number ofendogenous regulatory practices that, taken together, make up what we havetermed regulatory objectivity and that are inextricably linked to thedevelopment of modern biomedicine. This claim does not amount to yet
another attempt to separate the wheat of medicine and science from the chaffof politics and society. Rather, we seek to delineate the mutually constitutiveroles politics and medicine play in producing both medical and social practices.

13

Tools like medical records make hospital work possible, but simultaneously
facilitate and foster administrative or judicial audits (Berg, 1996; Howell, 1995).
Any biomedical action including those undertaken by a solitary practitioner
presupposes the existence of a range of conventions concerning the entities(bacteria, viruses, antibodies, genetic mutations, etc.) at work in pathologicalprocesses. These entities define the types of events that must be taken into
consideration when diagnostic and prognostic routines are deployed, whether
individually or collectively. Therapeutic interventions in turn presuppose anequally wide range of conventions with regards to pharmacologicalsubstances. These myriad interlocking conventions create the conditions for aclinical objectivity that relies on the existence of entities produced andmaintained far outside the intimate encounter between doctor and patient(Bourret, 2005). Regulatory objectivity thus aligns the clinic with other sociotechnical domains and links clinical questions with those of public health(Berlivet, 1999) in novel ways that break down the porous barriers between
medical and political institutions and give rise to hybrid initiatives. In thisrespect regulatory objectivity operates on a different plane and in a differentmode from those suggested by analysts who treat all regulation as a form ofrationalization imposed upon medicine from without.

14

Endnotes*

ACKNOWLEDGMENTS: A preliminary version of this paper was presented
at the V ESOCITE Meeting (Universidad Autónoma del Estado de México,
Toluca, March 2004) and is scheduled to appear (in French) in theproceedings of that meeting. We thank Antonio Arellano for inviting the firstauthor to Toluca. Research for this paper has been made possible by grants
from the following agencies: the Canadian Institutes of Health Research(CIHR), the Social Sciences and Humanities Research Council of Canada(SSHRC) and the Fonds Québécois de recherches sur la société et la culture(FQRSC). The first author gratefully acknowledges additional support fromINSERM (France) and would like to thank members of the INSERM Unit 502(CERMES) for their comments on a preliminary version of this text.
i
http://nihroadmap.nih.gov/clinicalresearch/index.asp (last access: December2004).
ii
Our example concerns the clinical practice known as immunophenotyping.
The remarks made there are equally applicable to more recent practices, suchas the use of molecular probes and microarrays (Keating & Cambrosio,
2004b).
iii
Attempts to harmonize international regulations in the in-vitro diagnostic field
have revealed interesting differences between United States and Europe. The
US tends to accept as inevitable the differences between methods andAmerican regulators limit themselves to efforts to create conventions tocompensate for differences. The Europeans, however, insist that it is better toundertake a search for “analytical truth” which can be achieved through theuse of reference substances and the establishment of a chain of traceability
linking the samples on which measures are taken (Powers, 2000).
iv
Unlike the standardization of the Wassermann test analyzed by Fleck in the
1930s, present-day tests no longer require a “thought collective”; it is sufficientto have a consensus group. The difference between the two resides in thefact that the latter arrives at a consensus in a self-conscious and explicit
manner. In this regard, we can consider the standardization of theWasserman test as part of the beginnings of regulatory objectivity.
vBerg, Horstman, Plass, & van Heusden (2000) have already drawn
connections between medical practices and different types of objectivity but
have, despite considerable intuition and insight, restricted themselves to thesomewhat marginal case of insurance medicine. We treat the question as
fundamental to the development of biomedicine as a whole.
viSee, for example, the plans set out in Collins, Green, Guttmacher & Guyer(2003).

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