Actor Network Theory: A Tool to Support Ethical Analysis of

New Genetics and Society, Vol. 22, No. 3, December 2003

Actor-Network Theory: a tool to support ethical

analysis of commercial genetic testing

BRYN WILLIAMS-JONES* & JANICE E. GRAHAM†*Centre for Family Research & Homerton College, University of Cambridge, UK,†Department of Bioethics, Dalhousie University, Canada.

ABSTRACT Social, ethical and policy analysis of the issues arising from gene patenting andcommercial genetic testing is enhanced by the application of science and technology studies, andActor-Network Theory (ANT) in particular. We suggest the potential for transferring ANT’sflexible nature to an applied heuristic methodology for gathering empirical information and foranalysing the complex networks involved in the development of genetic technologies. Threeconcepts are explored in this paper—actor-networks, translation, and drift—and applied to thecase of Myriad Genetics and their commercial BRACAnalysis genetic susceptibility test forhereditary breast cancer. Treating this test as an active participant in socio-technical networksclarifies the extent to which it interacts with, shapes and is shaped by people, other technologies,and institutions. Such an understanding enables more sophisticated and nuanced technologyassessment, academic analysis, as well as public debate about the social, ethical and policyimplications of the commercialization of new genetic technologies.

Introduction

The commercialization of genetic testing services presents a challenge to healthcare professionals, policy analysts, and academics concerned with the social,ethical and policy implications of new genetic technologies. They are faced withquestions about the role of science and medicine in developing novel technolo-gies, the effect of private sector provision of medical technologies on publichealth care systems, the need for government regulation and oversight ofcommercial services, and evaluations of the proper scope for personal manage-ment of health care. An ethical analysis of these difficult questions, it will beargued, benefits from an application of Actor-Network Theory (ANT), anapproach that explores the taken for granted nature of technology by tracing thesocial and technical relations involved in the development and implementationof new technologies (Callon, 1986; Law & Callon, 1992). In particular, theheuristic methodology afforded by this ethical approach takes into account the

Correspondence to: Bryn Williams-Jones, Centre for Family Research, Faculty of Social and PoliticalSciences, Free School Lane, University of Cambridge, Cambridge CB2 3RF, UK. Email:[email protected]

ISSN 1463-6778 print/ISSN 1469-9915 online/03/030271-26 2003 Taylor & Francis LtdDOI: 10.1080/1463677032000147225

272 Bryn Williams-Jones & Janice E. Graham

social, moral and economic ambivalences of the multiple stakeholders (Single-ton, 1996; Singleton & Michael, 1993).

The paper will begin by describing three concepts: 1) actor-networks, whichare made up of human and non-human actors that constitute all institutions,groups, and technologies; 2) translation, the process whereby the interests ofactors in networks are aligned through change in order to stabilize (or disrupt)networks and reduce (or increase) complexity; and 3) drift, the transformationof a technology as it is translated into new contexts and used in ways notpreviously conceptualised by the actors involved in its initial development.These concepts will then be applied to the case of Myriad Genetics’ BRACAnal-ysis genetic test for hereditary breast cancer to demonstrate that ANT canprovide both the empirical and critical conceptual tools necessary to supportpractical, evidence-based research into the social, ethical and policy issuesassociated with the commercialization of genetic technologies.

Actor-network theory

In the early 1980s, Bruno Latour and Michel Callon at the Ecole des Mines inParis developed Actor-Network Theory (ANT) with the aim of explainingcomplex networks in scientific research settings. A branch of science andtechnology studies (Hess, 1997), ANT shares the conviction that greater criticalattention and empirical study should be conducted into the practice of science.Initially, the focus was on the laboratory setting (Latour, 1988; Latour &Woolgar, 1979), but more recent ANT analyses include investigations of scienceand technology development outside the laboratory, and in the public andprivate sectors (e.g., de Laet & Mol, 2000; Law & Callon, 1992).

ANT challenges some common epistemological convictions by rejecting es-sential subject/object, culture/nature, or society/technology distinctions. Entities,whether people or technologies, are not fixed and do not have significance inand of themselves. Instead, they achieve significance through relations withother entities, and ‘if differences exist it is because they are generated in therelations that produce them. Not because they exist, as it were, in the order ofthings’ (Law, 2001, 3). Individual actors are ‘ambivalent’ or ambiguous—to useSingleton’s helpful concept—not static or unitary; they will change over time,across social and political contexts, and in their relations with other actors(Singleton & Michael, 1993).

Humans and non-humans (e.g., technologies, institutions, corporations) aretreated as epistemologically equivalent for the purpose of critical analysis andare ‘actors’ inasmuch as they have the ability to act and be acted upon. Theagency of a human ‘actor’ is largely non-controversial, although it can becomean issue when, for example, a person’s independence is constrained by mentalillness or differential power relations such as class or gender (Evans et al., 1994).The characterization of objects, technologies, or organisations as having at-tributes of agency is less obvious for some. Closer examination of object-humaninteractions, however, demonstrates that objects and other non-human entities

Actor-Network Theory 273

do affect human behaviour. A telephone may appear to be an ordinary, passivetechnology, but this impression changes when the telephone rings. Even if onedecides to ignore the call, the telephone has still provoked a decision makingprocess and elicited a response (Callon & Law, 1995).

Actors are necessarily heterogeneous, embodying compromises at the social,political, psychological or economic levels, and have varying degrees of commit-ment, skill, prejudice, and constraints associated with them—they are oftenhybrids of the ‘social’, ‘technical’ and ‘personal’ (Latour, 1993). At the technicallevel, a genetic test for hereditary breast cancer (BRCA testing) may involve thefull sequencing of the two associated genes, BRCA1 and BRCA2, or analysis ofthe resulting proteins to search for early truncation (Hofmann & Schlag, 2000).The accuracy (sensitivity and specificity) of these tests is determined anddisputed by scientists, clinicians, and epidemiologists, and there may be betteror worse tests for detecting known mutations or others yet to be discovered(Evans et al., 2001). Access by patients to genetic testing may be restricted tocertain individuals and families based on professional standards in the medicalcommunity, which may nevertheless vary geographically (Carter, 2001; Goel &Crossroads 99 Group, 2001). To understand how these relations create mean-ing and describe the various actors (e.g., the disease, genetic test, patients,technicians, patent owners, clinicians, scientists, the general public, and policymakers), it is useful to think in terms of networks of relations, or morespecifically, actor-networks.

Actor-networks

Actor-networks are shifting systems of alliances, ‘performed’ into existence bythe actors involved, and necessarily include human and non-human elements.These networks are inherently unstable over-time (i.e., ambivalent), have to becontinually maintained through the engagement (enrolment) of the actorsinvolved, and may fail and be replaced by other networks. Of interest are theactions of actors and networks, and the interactions between social institutions,individuals, groups and techno-science. If we wish to know the origins of powerand structure in a network, that is, what drives the network or brings it intobeing, then we need to consider all the components that collaborate, co-operate,compete, and lead to proliferation, persistence, or perishing of that network.The challenge of ANT then is to ‘unpack’ and better understand the underlyingprocesses and components of actors and networks that may not be readilyapparent (Strathern, 1999).

To start following actor interactions, it is necessary to develop a preliminarysketch of the network. Figure 1 maps some of the central actors involved in thedevelopment of BRCA testing, one of the networks in which they are engaged,and some of the connections. But this task is complicated by actors participatingin many networks that may or may not overlap with the network underinvestigation (Busch, 1997). One might think of an actor-network as beingfractal and expanding or contracting infinitely, with each actor a node in another


FIGURE 1. Development of BRCA testing.

network (Law, 1999). Given this density, separating foreground from back-ground becomes difficult; a network viewed as fractal is unwieldy, complex, andall but useless for coherent analysis.

The challenge of simplifying actor-networks has been addressed by the idea of‘punctualization’ or the creation of ‘black boxes’ (Akrich, 1992). At the risk ofoversimplification, as networks become stronger and more stable, they can forthe purpose of analysis be treated as points in a larger network—the supportingnetwork is ‘black boxed.’ In Figure 1, each of the boxes could also be expanded(opened) to produce their own complex networks, as illustrated for BRCA Testsand Public Health Care Services. This compartmentalisation does not reduce anetwork to an essential capturing of the whole; indeed it is the ‘partial connec-tions’ that allow for the diasporic translations and pluralities (Law, 1999, pp.10–11) that acknowledge the uncertainties of ANT, and which are mostcelebrated. The complexity of the network remains, but for heuristic purposesof analysis it can be moved to the background. As is the case for many otherfields of research, the focus of inquiry to some extent drives the choice of themost appropriate scale of analysis. While the network illustrated in Figure 1 maybe only one of many networks that could usefully contribute to the study of the


social, ethical and policy implications of commercial BRCA testing, it isnonetheless a discrete and manageable focus of analysis and an important locusfor further investigation.

ANT is also focused on the performative aspect of multiple alignments thatlink together the influencing factors that affect an actor and establish a network(Mol, 1999). But it does not take for granted that an actor or network has to bea certain way. In the case of technology development, for example, a technologycould always have been different (Bijker & Law, 1992). It might not serve thepurpose of its target audience and be resisted; in other circumstances, such asif the social, political or economic climate were more hospitable, the technologymay be accepted—we might now be using Beta instead of VHS (Cusumano etal., 1992). So what is it that brings actors together in a network and keeps themparticipating?

Translation

Every actor in a network is essentially independent and capable of resistance oraccommodation, so there must be some ‘glue’ that encourages them to beinvolved in a network—this glue is translation. Each actor (whether a person,group, company, machine, nation) has its own diverse set of interests, thus anetwork’s stability will result from the continual translation of interests. Betweenhumans, translation is analogous to negotiation of common interests; betweenhumans and non-humans, the interaction will be through design of scripts (tobe discussed below). Policies, behaviours, motivations, and goals are translatedfrom one actor to another; and actors are themselves translated and changed intheir interactions with others (Callon, 1986).

Callon proposes a set of ‘moments’ in translation: problematization, interesse-ment, enrolment, and mobilization. For our purposes ‘interessement’, whichCallon describes as ‘the group of actions by which an entity … attempts toimpose and stabilize the identity of other actors it defines through problematiza-tion’ (Callon, 1986, p. 208), is useful for seeing how a group of actors can bebrought together around a particular goal, and the resulting network stabilized.Resistance to social change is met by translation, the re-organizing of relationsin actor-networks. Disagreement or counter-claims on actors in a network mayarise that threaten ongoing stability. Competing claims require strengtheningties (interests) to the actors, while also weakening links between these actors andother entities. If this process is successful, then the actors are ‘enrolled’ in thenetwork.

Interactions between actors are the building blocks of networks. Ongoingtranslation at a variety of levels is a key source of social order, generatinginstitutions, governments, organisations and agents that exist over time. Butcontrol by any given actor—even by the author of a network—is necessarilylimited because power is diffused amongst the actors (Latour, 1986). Networksmetamorphose in ways likely not predicted by the authors as they are translatedby the multiple actors within. It is important, nevertheless, to recognise the


influence and contribution of controlling elements and to expose the underlyinginequities and power relations behind technology development.

Technology development is inherently a process of translation. In aligning thegoals of the designer with those of the manufacturer, marketer, and end user,the technology will necessarily change. Technologies are not simply passive andare never value neutral, but always exist in value-laden social and technicalrelations. During the design phase, objects have embedded within them a‘script’ or set of instructions that determine how the technology will functionand the extent to which it may be shaped by other actors. Technical andnormative values built into the technology (and its supporting documents,advertising, etc.) attempt to prescribe specific patterns of use while restrictingothers (Prout, 1996). A passenger elevator in a hotel, for example, has embed-ded within it a set of principles about distributive justice that determine in whatorder passengers are transported between floors. The elevator might respond tothe first call and go to the requested destination, wait for a pre-determinednumber of calls and then proceed to pick up passengers in order, or respond tothe first call and ignore all others—the underlying rules according to whichelevators do (or should) operate are non-trivial (MacDonald, in press). Yetwhile scripts may affect human behaviour as well as a range of other social andtechnical interactions, the scripts are not necessarily fixed. Scripts (and thus thetechnology) may be translated by other actors in ‘ambiguous’, uncertain waysnot intended by the designers (Singleton, 1996; Singleton & Michael, 1993)—the technology may ‘drift’ (Martin, 1999).

Technological drift as innovation

The concept of ‘drift’ originates in the field of evolutionary biology—specificallyas genetic drift (Thompson et al., 1991, pp. 158–60)—but has been adapted toother fields such as health services research (e.g., drift as the off-label use of aleprosy drug to treat dementia (Jones, 2000)) and corporate information tech-nology (e.g., the American military ARPANET drifting to become the Internet(Kristula, 1997)). Drift is useful for thinking about one aspect of translation,that is the situation in which a technology is used differently from the designer’sintent. The purpose of a given technology, from the design perspective, will beembedded in the initial script. But the script may not succeed, the technologymay be used in unanticipated ways, or its implementation may give rise to acompeting script that makes the technology a failure from a design standpoint.

There are numerous examples of drift in the computer industry, wheretechnologies have been hacked by knowledgeable users. In one notable case,Netpliance introduced the i-opener—a small, user-friendly, e-mail access com-puter—for non-technical consumers. Sold for a nominal fee ($99US), the intentwas for users to pay a monthly subscription to access their e-mail. Buttechnophiles quickly discovered they were under no obligation to subscribe, andthat with simple hardware modifications they could gain full access to a cheap


Internet-ready Pentium computer (Tseng, 2000). From a marketing perspec-tive, the i-opener was an abject failure as the costs of the hardware quicklyoutpaced subscription revenue, and after some failed attempts to regain controlNetpliance terminated production. The initial script, which constructed thetechnology for a non-technical general public, was subverted by a competingscript that transformed the technology into a cheap computer for technophiles.The ‘meaning of an innovation is not entirely given a priori, but rather,progressively constructed through social practices’ (Lehoux et al., 1999, p. 440).Technology is ambivalent and can drift as a result of decisions made by manydifferent actors, and the need to integrate into pre-existing social and techno-logical contexts (Holmstrom & Stalder, 2001).

Positioning ANT in genetic testing

To understand technology development and implementation, it is necessary tomove beyond a linear model of technology diffusion or transfer—a simple binarymodel of technology-push and market-pull is insufficient. The complex interac-tion between the social and the technological often renders the two inseparable.In implementing a new technology, it may be necessary to ‘allow’ it to drift intounexpected situations; if the technology is going to ‘work’, it must be open tochange. Innovations configure the user, defining who may use it and how, butthey also modify existing social structures and create new ones. The powerstructures present in a network will affect the ability of actors and end-users tocontest the initial problematization of a technology. For example, MyriadGenetics’ American, Canadian and European patents on the BRCA1 andBRCA2 genes are sufficiently broad that they allow Myriad to control any useof the BRCA genes for testing and therapeutics. Other BRCA testing methodsthat may compliment or provide different (or more comprehensive) informationthan Myriad’s BRACAnalysis test are not available to patients from otherproviders without prior agreement from Myriad—provision of such testingwithout Myriad’s agreement would constitute an infringement of their patents.Nevertheless, restricted choice of testing methodology does not necessarilyconstrain the way in which patients can use the test. As will be discussed below,patients use BRCA testing for reasons not anticipated by the designers (ormarketers)—an apparently stable network, on closer inspection proves to beambiguous.

Any translation of a network or technology may fail (or succeed in undeter-mined ways), and it is in these failures of technology and of the networksunderlying them that the embedded norms and values are often best revealed(Holmstrom & Stalder, 2001; Law & Callon, 1992; Lehoux et al., 1999). Forexample, the initial success of Myriad in dominating the American market forBRCA testing likely made company executives confident that they would havesimilar success in Canada and Europe. Myriad executives could not haveexpected the failure of most Canadian provinces or European countries to adopt


the BRACAnalysis test, not to mention the mounting widespread public andprofessional opposition to the patents and the commercial test (F. Benowitz,2002; Check, 2002; Lindgren, 2002; Rabson, 2003).

In ANT terms, there may have been insufficient translation to incorporatedifferences in the social and political contexts in Canada and Europe. Funda-mental principles supporting universal public health care systems, or ideologi-cally based reactions against yet another example of American or multinationalhegemonic control in enforcing patents and threatening national domesticsovereignty of health care service and delivery, were not accounted for in theoriginal reckoning. But even in this opposition there is ambivalence, witnessedby the contradictory nature of a socially and economically conservative ‘pro-business’ government in Ontario strongly opposing Myriad’s Canadian patents(and more generally questioning the application of patent law to biologicalmaterial), while a formerly (pre-2002) social democratic government in BritishColumbia accepted these same laws.

Critique

A major criticism of ANT is levelled against the radical symmetry betweenhuman and non-human actors (Lee & Brown, 1994; Murdoch, 2001; Pickering,1992). Surely, it is argued, humans have different (superior) moral status frommachines or corporations, and thus are due special regard? But the purpose oftreating humans and non-humans as symmetrical is to aid in a detailed descrip-tion of the network, and does not imply or require that all entities be treated asidentical for all purposes, nor that the various relations between actors beegalitarian. In fact, part of the benefit of laying out a network will be tracing thetypes of relations between actors and determining the flow of power and control.

The ANT approach to evaluating technology development has also beenstrongly criticized because of the theory’s apparently value-neutral stance.ANT’s focus on empirical case studies that provide a rich description ofnetworks has been accused of ignoring the larger social and political context,and thereby undermining the possibility of effective social, ethical and politicalcritique. In this view, ANT perpetuates a functionalist, problem-solving descrip-tion of networks that can result in collusion with dominant ideologies, such asindustry, government, or patriarchy (Fuller, 2000; Star, 1991).

For example, an ANT-based analysis of the networks involved in commercialgenetic testing might suggest how a particular implementation scheme failedand so provide the information necessary for commercial interests to stabilizetheir networks and expand their market. In the Myriad case, an ANT analysismight highlight the negative response in Canada and Europe to a competitivemarket approach and point to the need for closer engagement with clinicians,administrators and patient groups, to lobby governments for public funding ofBRCA testing. This information could be extremely useful for Myriad inre-framing their approach to these markets. But this analysis would have failedto critique the equity and social justice of private provision of health care


services such as genetic testing, the potential for negative effects of two-tieredhealth care, or the manner in which the patent system is used to constrainmedical research and the implementation of health care technologies.

It is specifically this anti-moral charge against ANT, led by sociologists ofscientific knowledge (SSK) Harry Collins & Steven Yearley, that we seek toaddress in this paper. Collins & Yearley persist in maintaining a nature-societyspectrum rather than adopt the radical, or extended symmetry of ANT. ANT,as practiced by Callon & Latour, studies relations between all actors, bothhuman and non-human. By ANT’s removal of the human, or society, from thepivotal role and allowing equal consideration of nature, Collins & Yearley(Collins & Yearley, 1992) argue that natural science regains the privileged statusthat SSK had originally deconstructed. Callon & Latour rebut that, ‘We havenever been interested in giving a social explanation of anything, but we want toexplain society, of which the things, facts and artefacts, are major components’(Callon & Latour, 1992, p. 348). ANT is interested in the ‘coproduction ofsociety and nature’, while the argument of Collins and Yearley reflects ‘naivesocialism’ by simplistically reducing scientists to a ‘naive realism’, according toCallon & Latour (Callon & Latour, 1992, p. 353).

If we accept that every description is to some extent performative, then thereis always a risk of bringing into being that which is under study (Law, 2001), aconcern not only for ANT but also for any descriptive project. But with theconcept of translation, ANT draws attention to the inevitable change in tech-nologies, actors and networks. There is no one ‘right’ way for a network to bestable, nor is there only one network. Instead, there are a multiplicity ofnetworks making up a technological actor and different visions of how this actorshould function or behave. As will be discussed below, while it is sometimesuseful to think of the ‘BRCA test’ as a specific technology or actor, there are infact many different tests (e.g., family pedigree analysis, PTT, SSCP, CSGE, fullDNA sequencing1) for determining risk for hereditary breast cancer. It isdifficult to support charges of ANT being a functionalist, problem-solvingapproach to technology development if the device in question is seen to bepresent in many different forms, be situated in very different social and politicalcontexts, or drift in unexpected directions beyond the control of the designers.As in Singelton’s example of the UK’s Cervical Screening Programme, tech-nologies are experienced and valued in a multitude of ways, both by individualsand between the range of actors (e.g., patient, physician, health nurse) (Single-ton & Michael, 1993).

ANT is an approach that is interested in the tensions between actor, networkand technology, and how they manifest in practice (Latour, 1996; Law, 1999).Failed networks are thus often a fruitful place for study, because it is here thatthe actor-networks reveal themselves and the norms and values built intotechnologies are made apparent. Science can be seen as inextricably linked topolitics; human and non-human actors are necessary parts of networks; andtechnologies are inherently value-laden—important insights that enable compre-hensive ethical analysis and social critique. ANT could be used for a strictly


functionalist analysis, but it can also be used as a way of undermining thefunctionalist and determinist models of network building (Law, 1999). Thuswhile ANT does not explicitly include ethical analysis of institutions, technolo-gies, or actors, such analysis is not precluded, and we suggest here is in factconsiderably augmented.

In its 1980’s centering tendencies—specifically it’s emphasis on value-neu-trality—ANT would not have been concerned with ethical problems. We havethus taken as the jumping off point for a new after-ANT analysis (Law &Hassard, 1999), work by Singleton & Michael (Singleton, 1996; Singleton &Michael, 1993) informed by feminist directions and Strathern’s partial connec-tions (Strathern, 1991), that argue for the necessity of considering the complexpatterns and translations of multiple actors. This approach decentres ANT andaccentuates the inevitable ambiguities (Singleton’s ambivalence) of actor-net-works. Our intent then is to lend the value-neutral theory/methodology of ANTto an ethical approach to new genetic technologies. In so doing, we do notprivilege particular stakeholders, relationships, or technologies. Instead, for onecase study we follow the relations among the entities, both human and non-hu-man, and their performance together (Law, 1999). A neutral stance to themultiple actors permits a radical symmetry that more accurately, and we hopetransparently and without prejudice, describes (explains the relations, not asocial explanation) Myriad’s commercial BRCA test, in order to performpractical and useful analysis of the social, ethical and policy implications ofcommercial genetic testing. ‘And with facts it is the same. The secret of theirsuccess lies not in the laws of nature but in the intricacies of history’ (Mol, 1999,p. 76).

Myriad genetics and commercial genetic testing

In the preceding sections, three concepts—actor-networks, translation, anddrift—were briefly explored to see how they might contribute to an understand-ing of the various interactions between individuals, organizations, and technol-ogy. In the following, Myriad Genetics’ BRACAnalysis test for hereditary breastcancer will serve as the focal point for elucidating what is occurring in actor-net-works, specifically the networks which led to the technology being developedand later integrated (or failing in this task) as part of public and for-profit healthcare in Canada and internationally. Tracing the path of this technological actorhighlights the numerous, complex social and ethical issues associated withcommercial genetic testing.

Technological actors

To see how an actor such as BRACAnalysis interacts with other actors in anetwork (including other testing methods), it is necessary to understand whatthe technology is and does—its black box must be opened to examine theunderlying actor-network. Genetic testing for hereditary breast cancer involves


the analysis of two genes, BRCA1 and BRCA2, to search for mutations (e.g.,individual base-pair or large-scale deletions or re-arrangements) which havebeen associated with an increased risk of developing cancer. The particulartesting methodology, however, will vary greatly depending on the laboratoryconducting the test. Many European and Canadian laboratories use a two-stepmethod. The protein truncation test (PTT), for example, may be used as aninitial screen to see whether the BRCA proteins are shorter than expected(truncated by mutated alleles), followed by sequencing of specific regions of thegene to detect individual mutations. Other laboratories may use techniques suchas conformation sensitive gel electrophoresis (CSGE) or single stranded confor-mational polymorphism (SSCP), which locate mutations by evaluating thestructure of paired single-stranded DNA moving in gel electrophoresis(www.genetests.org, accessed August 27, 2003). Myriad’s BRACAnalysis test,by contrast, is a single-step approach based on full DNA sequencing of thecoding regions of the two BRCA genes to check for deleterious mutations, e.g.,frameshift, nonsense or splice-site mutations.

The sensitivity and specificity of the test, that is, its ability to differentiatebetween those people who have BRCA mutations and those who do not, willdepend in large part on the technology used, but also on the skills and experienceof the technicians and geneticists in the laboratories providing testing (Geisler etal., 2001). There is significant debate, particularly between those researchers (andMyriad) who favour the full sequencing approach and those using other lessexpensive approaches such as PTT or SSCP, about which method is moreaccurate. While full DNA sequencing has been evaluated as having a diagnosticsensitivity of approximately 85% (Carter, 2001), Myriad claimed that theirBRACAnalysis test ‘has greater than 99% analytical sensitivity and greater than99% analytical specificity’ (http://www.mascollaborate.com/hcp/genetic/breast/08.html) and thus should be considered the ‘gold standard’. It is important tonote, however, that in the context of genetic testing, analytic sensitivity andspecificity refer to whether the test is positive when the gene being tested isactually present and whether the test is negative when the gene is absent. This isdifferent from clinical or diagnostic sensitivity and specificity, which is the proba-bility that the test will be positive in people with or who will get the disease, andthe probability that the test will be negative in people without or who will not getthe disease (Holtzman & Watson, 1997). Other testing methods in developmentmay have similar or better accuracy than full DNA sequencing. For example, anew approach to using SSCP (which has been historically criticized for having ananalytic specificity below 80%) in combination with other technical advancessuch as capillary electrophoresis, may reach 95% analytic sensitivity in BRCAmutation detection (Kozlowski & Krzyzosiak, 2001).

None of these various methods is 100% accurate, and interpretation of testresults will be closely tied to a detailed evaluation of the patient’s family history,without which the technical results are not considered informative. WhileMyriad may claim to provide the ‘gold standard’ of testing, the science to backthis claim is ambiguous. But more importantly, even for very accurate testing


methods such as Myriad’s full DNA sequencing, only 20–25% of patients witha strong family history will have a positive mutation detected, a 2002 study byresearchers working for Myriad Genetics detected BRCA mutations in only17.2% of 10,000 individuals tested (Frank et al., 2002). In other words, for75–80% of patients, the heritable component of their cancers remains unknown(Carter, 2001). Given these figures, Myriad’s BRACAnalysis test looks to be aspeculative technology at best, exploiting a climate of genetic determinism andthe public’s misunderstanding/anxiety of predisposition, susceptibility, pene-trance, probability and risk. ‘In seeking to avoid misfortunes we create newambiguities and uncertainties’ (Lock, 1998, p. 7).

The technology ‘BRCA testing’ is comprised of complex actor-networks thatinclude technicians, geneticists, counsellors, patients, families, reagents, se-quencers, accuracy of measuring instruments, laboratories, corporate interests,and stockholders. The changing nature of each of these actors, e.g., through thediscovery of new mutations (Gad et al., 2001) or novel approaches to genetictesting and counselling, will mean that the technology itself will continue tochange, both regionally and over time. A technology assessment of BRCAtesting to decide which test is best for a particular group of patients, or acost-effectiveness analysis to determine which test should be funded as part ofpublic health insurance, would need to evaluate the full range of actors andnetworks, and the pros and cons of the various testing methods in relation to,for example, sensitivity, specificity, positive predictive value, and cost.

Context and history

The development of BRCA testing has a history, a larger social-context thatcontinues to shape this actor-network in the broader health care setting. In thehunt for the BRCA genes, hundreds of scientists from across the United States,Europe, Japan and Canada were involved in more than a decade of research.Importantly, this work would not have been possible without the participationof many thousands of individuals and families at risk for hereditary breast andovarian cancer who donated blood samples and family histories (Davies &White, 1995). Financial support came from both national agencies such as theUS National Institutes of Health (NIH)—which provided $5 million to theUniversity of Utah team—as well as from investments by the private sector.Commercial interests in this research arise because of laws, regulations, andgovernment policy, such as the 1980 US ‘Bayh-Dole Act’ (Cook-Deegan, 1999;Kuyek, 2002; Malinowski & Littlefield, 1999), and a shift in university scienceresearch cultures from focusing on ‘knowledge production’ to ‘technologytransfer’ and ‘economic growth’ (Cohen et al., 2001; Etzkowitz et al., 2000).These elements have facilitated, and even strongly encouraged, publicly fundedresearchers to commercialize their work. Research universities in the US,Canada and Europe now have technology transfer offices to patent and licensediscoveries, and according to one US study, by 1995 40% of gene patents werefiled by public institutions or charities (Thomas, 1999).3


A few central figures emerge who had a major influence on the developmentof BRCA testing. Mark Skolnick, a researcher at the University of Utah’s Centerfor Cancer Genetics Epidemiology, led a consortium of US researchers to isolateand sequence the BRCA genes. Skolnick helped launch Myriad Genetics, wasinstrumental in obtaining the gene patents, and is currently the company’s ChiefScientific Officer (University of Utah, 2001). In the UK, Michael Stratton at theInstitute for Cancer Research led another group (part of the Breast CancerLinkage Consortium) also searching for the BRCA genes and is named onvarious UK and EU patents for BRCA2. The race to discover these genesbecame heated with the involvement of commercial interests such as Myriadand pharmaceutical giant Eli Lilly (Davies & White, 1995). Skolnick’s groupwas the first to sequence BRCA1 (and later part of BRCA2), which they thenpatented for Myriad. In contrast, gene patenting presented a disturbing scenarioto many of the researchers involved in the hunt for the BRCA genes (Murray,1999). Researchers were concerned by the ability of a company to ‘own’ genesand the resulting susceptibility or diagnostic tests, when the genes had beendiscovered as a result of many years of international collaborative research. Thisconcern also manifested in national differences (notably between the US and theUK), both in researcher attitudes and government policy about the extent towhich the results of academic research should be commercialized (Watson,2001). While there was opposition from many UK researchers to patenting, itwas agreed that a patent was nonetheless necessary to prevent Myriad from alsogaining control of BRCA2. A UK patent was filed by CRC Technology, thecommercial arm of the Cancer Research Campaign (CRC) charity that hadfunded much of the UK BRCA research. In contempt of Myriad’s response, thepatent on BRCA2 was then licensed free of charge to the National HealthService for genetic testing (Meek, 2000).

The US patents on BRCA1 and BRCA2 (filed in 1994 and 1995) providedMyriad with the resources to leverage increased venture capital and continuegene discovery research (Davies & White, 1995). Once a genetic test wasproduced (first marketed in 1996), the monopoly granted by their patents—which Myriad has vigorously protected—permitted the company to stop othercommercial laboratories (including hospitals) from providing BRCA testing inthe US. More recently, Myriad has made similar moves in Canada and Europewith the objective of controlling the provision of all testing, including thatoffered through public laboratories (Williams-Jones, 2002).

Myriad’s efforts to enforce US and international patents has much to do withthe company’s financial situation. Despite expanding the market for BRCAtesting in North America and Europe and implementing genetic tests for heartdisease and colorectal cancer (predictive testing revenues of US$34.7 million for2003, up from US$26.8 million for 2002), Myriad still posted a net loss ofUS$24 million in 2003 (Myriad Genetics, 2003). The company has entered intopartnerships with a range of pharmaceutical companies to develop productsbased on patented genes, and is expanding into the area of proteomics, throughtheir subsidiary Myriad Proteomics. BRCA testing may have served to establish


the company and build a market presence, but the test is only one part of theircurrent portfolio of products, and it is these other projects that are likely to becentral to the company’s long term profitability. The larger political andhistorical context in which BRCA testing was developed is a crucial element ornode in the network, and must be clarified for effective social an ethical analysis.

Actors and normative values

Genetic technologies are not simply passive entities developed by scientists,prescribed by clinicians and used by patients. A genetic test will shape and beshaped by human behaviour, relations, and society. However, it is only a subsetof these issues—the psycho-social effects of genetic testing—that tend to be ofconcern in the social and ethical literature. For example, how do individuals andfamilies deal with the complex risk information resulting from genetic testing(Codori, 1997; Marteau & Lerman, 2001; Marteau & Richards, 1996)? Howdoes this information affect their personal lives, friendships and family relations(Cox & McKellin, 1999; Evans et al., 2001; Hallawell et al., 2003)? What are thebroader effects of genetic information in terms of discrimination and stigmatiza-tion (Lemmens & Bahamin, 1998; Wertz, 1999)?

Applying an ANT analysis and thinking of genetic tests as actors in a networkexpands the scope of issues for consideration. As with other technologies (e.g.,the telephone or elevator), there are normative values embedded in the scriptswhich define how genetic tests are marketed and implemented. There may, forexample, be genetic essentialist or reductionist views present that promote theidea that genes are the most significant cause of disease (Kerr & Cunningham-Burley, 2000; Lippman, 1991; Nelkin, 2001). Myriad’s online resources forpatients and physicians about risk information and the probability of developingbreast cancer focus primarily on the role of genetics in disease, and much lesson how breast cancer can be strongly influenced by other non-genetic factorssuch as an unhealthy diet, low activity level, stress, psycho-social issues, or purechance (Baird, 2001). In Myriad’s marketing of BRACAnalysis, such as theiradvertisement featuring a woman saying, ‘Doctor, I need to know’ (Hull &Prasad, 2001; Myriad Genetics, 1997), issues of patient or consumer autonomyand freedom of choice are highlighted. There is little attention in either theadvertisements or the ‘educational’ material to the impact of genetic testing onfamilies, community, culture or society. Built into the BRACAnalysis test is theview—which may also be part of the larger, and inseparable social context—thatthe resulting genetic information is necessarily valuable because it permits theconsumer or patient to make informed choices about treatment or life plans(Chadwick et al., 1997). This may also play up the ‘need’ for genetic infor-mation, and in a context of heightened public concern about breast cancer,there is the potential that patients and consumers may feel responsible for theirown health care and negligent for not pursuing ‘necessary’ genetic testing(Lippman, 1991; Nelkin & Lindee, 1995).

While a genetic test as technological actor may have embedded in its scripts


notions of autonomy and individual responsibility, there may be countervailinginfluences—other actor-networks that become apparent on a broader analysis—that diffuse some of this focus on consumer independence. Access to impartialgenetic counselling may help patients to understand some of the limitations oftesting, and after discussing a variety of individual and familial concerns with acounsellor, patients often decide that they do not want testing (Lynch et al.,1997). Myriad also restricts access to BRCA testing to the extent that a patient’sphysician must order the test and provide the results and some level ofcounselling support. This restriction arose only after criticisms by the medicalcommunity of Myriad’s initial attempt to market BRCA testing as an ‘over thecounter’ test-kit. Fears of liability should a patient be harmed by receiving theinformation without the benefit of counselling were likely a factor.

The various actor-networks in the broader context have a direct effect on howthe technology is implemented. While Myriad seeks to provide the best or ‘goldstandard’ testing technology, ensuring the highest standards of test accuracy isparadoxically and ambiguously undermined by Myriad’s broad gene patentssince these permit Myriad to control and potentially retard research anddevelopment that would otherwise improve testing methods (Institut Curie,2001). In terms of provision of counselling, Myriad has invested heavily inpatient and physician ‘education’, providing extensive online resources andsupporting Continuing Medical Education programs for physicians so theycan better counsel their patients (Myriad Genetics, 1999). Their recent direct-to-consumer marketing campaign for BRACAnalysis, launched in two UScities (Atlanta and Denver) is even framed as an awareness generating publicservice ‘designed to alert women with a family history of cancer to recentadvances in cancer prevention and early disease detection’ (Myriad Genetics,2002).

Despite this support, physicians will still lack sufficient medical education andunderstanding of genetics (Emery & Hayflick, 2001; James et al., 1998), ortraining in how to address the complex social and family issues associated withgenetic information necessary to provide effective counselling. That is, access totesting via one’s physician can lead to problems in the translation of test resultsto a public not familiar with the languages of statistics, risk and genetics, such asprobabilities, susceptibility, and penetrance (Gollust et al., 2002). Further, withthe primary source of information about the test coming from the supplier, as isincreasingly the case with knowledge about new pharmaceuticals (Mintzes et al.,2002), physicians may have insufficient evidence to critique the accuracy or utilityclaims made about the testing methodology (Caulfield & Gold, 2000a).

A technology will also shape the social context in which it is implemented.The commercialization of BRCA testing has significant consequences for theequitable provision of genetic testing services in Canada (Williams-Jones &Burgess, in press). The broad nature of the BRCA patents and the need forMyriad to develop profitable services has led the company and its Canadianlicensee MDS Laboratory Services to send ‘cease and desist’ letters to all theCanadian public laboratories providing testing. In British Columbia, the Minis-


try of Health Services decided to comply with Myriad’s request for a period oftwo years (2001–2003), the Hereditary Cancer Program (HCP) at the B.C.Cancer Agency ceased provision of BRCA testing and referred all patients toMyriad or MDS. Commercial BRACAnalysis testing is substantially moreexpensive and due to budgetary considerations the HCP decided it could notafford to provide BRCA testing to patients out of the HCP’s limited operatingbudget (Kent, 2001). The HCP continued to provide counselling free of chargefor patients at risk for hereditary breast cancer, regardless of whether theypurchased genetic testing. This situation led to two categories of patients, thosewho could and those who could not afford the test—patients were treateddifferently depending on the province where they lived.

In a bid to circumvent restrictions on provision of and access to testing—whilealso avoiding legal challenges for infringing the patent—the HCP brokeredpatient access to an Ontario run hereditary breast cancer research project. Forthose patients who qualified for the research protocol, they could receive BRCAtesting from the Ontario laboratory (although based on a less comprehensivemethod than was used by the HCP) and obtain results privately, which theycould then share with the HCP staff as part of post-test counselling andinterpretation (CBC, 2002). A competing network (operating on the principle ofequitable access to needed health care services), was initiated in BC to worksaround and potentially undermine the one (a stance based on intellectualproperty rights and consumer-choice) that Myriad had attempted to stabilise inCanada. In February 2003, the B.C. Government reversed its position on genepatenting and the Minister of Health Services authorized the resumption ofin-house BRCA testing, stating that “it is completely unethical to use patentsbased on genetic sequencing to block patients’ access to their own geneticinformation” (British Columbia Ministry of Health Services, 2003). Moreover,the Minister called on the federal government to follow the lead of countriessuch as France and the Netherlands and oppose the Myriad patents and revuethat patenting of DNA more generally.

Competing scripts and drifting tests

Myriad’s move to take over the provision of BRCA testing from public healthcare providers in Canada has been met with opposition on a range of fronts.Concerned by the mounting costs of patented genetic tests, the Ontario govern-ment and former Premier Mike Harris have taken a strong stance against genepatents, arguing that they constitute a threat to the provision of affordablehealth care (Eggertson, 2002; Lindgren, 2002). Other provinces—apart fromQuebec4 which performs some mutation testing locally but sends index testingto Myriad for full analysis—appear to be taking a ‘wait and see’ approach onpatent enforcement and are continuing to offer testing (e.g., Lemire, 2002);British Columbia is the only province to have complied (even if temporarily)with Myriad’s patents. In Europe, there are ongoing challenges of the Europeanpatents by the French Institut Curie (Benowitz, 2002; Institut Curie, 2001), the


French parliament (ERA-News, 2002), and other European countries (Wad-man, 2001). And in Malta, a local biotechnology firm is planning to launch itsown commercial BRCA test, arguing that as Malta is not a signatory to theEuropean Patent Convention, the company will not be infringing Myriad’s EUpatents (Check, 2002).

If successful, these various challenges could be financially devastating forMyriad due to the costs of fighting multi-year, multi-million dollar legal battleson a number of fronts. Success of the European challenges may well galvanizeopposition in Canada and internationally and seriously threaten Myriad’s con-tinued solvency. The commercial elements built into the initial script of Myr-iad’s BRACAnalysis test—that it is a patented product, priced at triple the costat which most public laboratories could provide testing—are being rejected.Increasing numbers of scientists, clinicians and public health care institutionsare challenging the view that the BRCA genes can and should be owned byMyriad, or that genetic tests on these genes should only be made availablecommercially through Myriad or one of its licensees, and not through publichealth care institutions.

Technologies are not simply marketed and taken up by passive consumers,but are shaped by consumers in how they respond to and translate thesetechnologies for their own purposes. From the perspective of many medicalprofessionals, genetic tests are useful and appropriate only if they provide riskinformation that will help individuals and families make informed decisionsabout treatment, prophylactic measures, or life choices. While genetic testingremained restricted to the domain of medical professionals in public health careinstitutions, patients were limited in the extent to which they could translatetesting to meet their own needs. Medical professionals were able to control whocould have access to testing, and what would be considered reasonable accesscriteria (Carter, 2001).

But genetic tests are beginning to drift from this more restricted usage to asituation where anyone with the financial resources and know-how can purchasea range of tests from a variety of sources (especially given increased accessthrough the Internet), regardless of clinically determined risk status (Gollust etal., 2003; Williams-Jones, 2003). Individuals and families seek diagnostic orsusceptibility testing even when medical professionals do not deem them to beat sufficient risk, or where the risk information is considered to be of littleclinical benefit; people may want to use risk information for very differentreasons, such as anxiety reduction, initiation of family dialogue, or other‘non-clinical’ uses (Burgess & Hayden, 1996; Cox & McKellin, 1999). Theoriginal reasons for the use of the technology have shifted.

One factor supporting this drift has been the commercialization of geneticservices—companies have an interest in selling their services to as large a marketas possible, and so are not likely to have particularly strict access criteria (Carteret al., 1997). The BRCA testing provided by Myriad requires only that aphysician determine that their patient would benefit from testing (Birmingham,1997; Smith, 1997; Gollust et al., 2002). In contrast, public health care


institutions such as the BC Hereditary Cancer Program, have guidelines requir-ing that a patient present with factors of populations at risk, such as a strongfamily history with multiple cases of cancer, or early age of onset (e.g.,pre-menopausal), or membership in a specific ethnic group (e.g., AshkenaziJewish) (Carter, 2001). BRCA testing has drifted in two senses: the reasons forwhich testing is used have become more expansive and patient-centred, thoughthis might well be market driven in the guise of being patient-centred; andprovision of testing has moved outside the domain of medical genetics or cancerclinics and into the offices of general practitioners as a privately purchasedservice.

In being translated and seen as ‘consumer goods’, medical technologies maysatisfy some human desires but also cause harms (Graham, 2001). They mayhave effects on the collective well being, such as on the sustainability of publiclysupported health care5, or may result in inequitable public access to services—those who can afford commercial testing may jump queues for diagnosticevaluation or monitoring. Translated technologies may also create a ‘need’ forother new technologies. New technologies may either replace existing ones orenter the market as novel products that at first have little practical use. Thosetechnologies that survive may become part of consumers’ daily lives, metamor-phosing from toys to instruments, from being seen as luxuries to necessities;they may become integrated into existing networks and be stabilized, domesti-cated, and eventually taken for granted (Pantzar, 1997).

Genetic testing has yet to reach the level of domestication of personalcomputers, for example, and the general population still does not routinely seekBRCA testing at a medical check-up, or shop for it online before planning avacation. But genetic testing has clearly had an impact on the way medicine ispractised. A host of predictive and diagnostic technologies (e.g., ultrasound,amniocentesis, or the triple screen for alpha-fetoprotein) are routinely used inprenatal testing for conditions such Down syndrome. Some diseases can now bepredicted or diagnosed based on DNA analysis; others may even becomeclassified as ‘genetic diseases’ that are strongly associated with particular ‘diseasegenes’, where once they were simply ‘familial’ diseases.6 Genetic testing has alsoincreased the need for a range of other medical services and technologies:genetic counsellors to help interpret risk information, online web resources forwhen counsellors are not available, and access to ancillary non-DNA basedgenetic diagnostic and screening tests such as ultrasound or mammography.Genetic tests are evolving over time, changing the networks in which they arecurrently situated and affecting a range of actors. Where genetic technologieswill drift is an open question, but the fact that they will is a certainty.

The drift of genetic technologies (and the ambivalence of their use), particu-larly if aligned with other movements in health care such as privatization,obviously have important implications for current health care policy. If patientsare to become empowered to make more health care decisions, then developingappropriate regulations to ensure accurate and understandable consumer infor-mation will be essential. Direct-to-consumer advertising, if allowed at all in


Canada, would need to be very closely regulated. Companies have a stronginterest in promoting the use of their products and services (Harper, 1995;Mintzes et al., 2002; Myriad Genetics, 2002), but unlike most consumer goods,people do not have the necessary experience or understanding to make free andinformed choices about health care services that are often complex and poten-tially harmful (Burgess, 2001). Regulations regarding the accuracy, safety, andusefulness of genetic testing will also be needed and they must be able to adaptto an ever changing social, scientific and political terrain (Baird, 2002; Caulfieldet al., 2001; Secretary’s Advisory Committee on Genetic Testing, 2000).

Nevertheless, one should not underestimate the ability of consumers toevaluate, control, accept, reject or modify new technologies. Inherent in theconcept of drift is the view that effectiveness and uptake of new technologies willdepend to a large extent on whether the technology in question meets consumer‘needs’, as defined by the consumer (Graham, 2001). These perceived needs aresubject to manipulation by companies through marketing and other socialpressures (i.e., the aforementioned ‘public service’ marketing by Myriad ofBRCA testing). Rejecting a technology may not always be possible, especially ifit is so built into social life that we cannot simply decide not to use it even if itdoes not meet our personal ‘needs’. Technologies will still be accepted, but theywill also be adapted and translated by users for their own purposes; if unable tomeet these ends, the technology may be rejected. The developer and the policymaker will be unable to predict with certainty the direction of drift, thus if theywish to influence the ultimate use of the technology, there must be ongoingfeedback and interaction with the end-user or consumer. Critical evaluation ofthe broader social, ethical, political, and economic contexts in which thetechnology is developed and situated, as has been touched on in this briefdiscussion of Myriad’s BRACAnalysis test, will be essential for effective policyand regulation of new genetic technologies (Williams-Jones & Burgess, in press).

Conclusion

Thinking about the development of genetic technologies in terms of actor-net-works highlights the need to analyse the diverse elements involved. The benchscientist in the race to discover and patent the BRCA genes is inextricably linkedthrough a host of complex networks to issues about the pursuit of academic andcommercial science, power struggles amongst individual researchers, publicperceptions of national research agendas, and international politics and patentlaw (Caulfield & Gold, 2000b). As for the tools of genetic research, they too areinseparable from larger networks (Fujimura, 1996). The development of BRCAtesting is the result of interactions between a complex network of actors asdiverse as research scientists, universities, patients, the patent system, MyriadGenetics, health care professionals, and consumers. These actor-networks areneither uniform nor stable, but will be ambivalently changing, coming into andout of existence, and the subject of numerous stresses and forces. To under-stand what is happening in the development of commercial genetic testing, it is


essential to study in detail the various complex networks and sub-networks. Thisentails analysis of all the elements, from the scientist and the genetic test, to thecorporate executive, government official, patient and consumer, as well as theinterests, goals, and relations that link these actors together.

Science and technology studies generally, and for our purposes Actor-Net-work Theory, can destabilize the dominant stories and ideologies. By unpackingthat which has been simplified or buried, a rich, complex empirical understand-ing of a case develops that enables sustained social and ethical critique. Whetheror not this was explicitly intended in the analysis, ANT and STS provide a novelmeans to challenge the perceived order and facilitate engagement in the politicalenterprise (Jasanoff, 1996). Commercial genetic tests cannot be seen simply aspassive, value-neutral technologies that have no effect on consumers, a publichealth care system or society in general. As has been shown in our analysis ofthe case of Myriad Genetics, the development and marketing of a commercialgenetic test for hereditary breast cancer raises serious social and ethical concernsabout continued affordable and equitable access to BRCA testing, the place forcommercial service providers in a public health care system, and the role ofpatents in facilitating or restricting health care research and technology develop-ment. Genetic tests do not exist apart from the social world, but are developedand accessed for a variety of complex personal and social reasons. By applyingthe concepts of ‘actor-network’, ‘translation’, ‘drift’ and ambivalence to thedevelopment and implementation of commercial genetic technologies, it ispossible to better see the complex and multifaceted nature of the networks inwhich they are situated. One of the strengths of Actor-Network Theory is thatit shows how certain effects are produced, including the connection to otherdiverse interests. The resulting rich detailed empirical information—which hasonly been briefly outlined in this paper—can help account for inter-relationalinterests and enable a more nuanced, comprehensive and sophisticated ethicalanalysis of the development, commercialization and implementation of genetictechnologies.

Acknowledgements

This paper is based on a chapter from Williams-Jones’ 2002 dissertation, GeneticTesting for Sale: Implications of Commercial BRCA Testing in Canada, Universityof British Columbia. The authors would like to thank Michael Burgess, Timo-thy Caulfield, and Patricia Baird, Fern Brunger and Susan Cox for their helpfulcomments on drafts of this paper; the two journal reviewers for their positiveand constructive critiques and Lori Sheremeta, Patricia Kaufert, Doug Hors-man, Karen Panabaker, and Mary McCullum for help with background infor-mation about the law, politics and science of providing genetic testing forhereditary breast cancer. Many of the ideas here have benefited from discussionswith the Genetics and Ethics Research Group at the W. Maurice Yang Centrefor Applied Ethics, University of British Columbia. Bryn Williams-Jones wassupported by fellowships from the Canadian Health Services Research Foun-


dation, the Social Sciences and Humanities Research Council of Canada, theQuebec Fonds pour la Formation de Chercheurs et l’Aide a la Recherche, andthe W. Maurice Yang Centre for Applied Ethics. Janice Graham was supportedby Career Investigator Award from the Canadian Institutes of Health Research(1999–2002), by the Social Sciences and Humanities Research Council grant#828–199–1050, and a Canada Research Chair in Bioethics (2002). [Contact:Bryn Williams-Jones, Centre for Family Research, Faculty of Social and Politi-cal Sciences, Free School Lane, University of Cambridge, Cambridge CB23RF, UK. Email: [email protected]]

Notes

1. PTT: Protein truncation test; SSCP: single stranded conformational polymorphism; CSGE:conformation sensitive gel electrophoresis. The application of these various tests will bediscussed in more detail below.

2. This statement formerly appeared on Myriad’s Health Professionals Information website(www.myriad.com/med/brac/physician/08.html) but is now no longer present, it does stillappear on the website of their Canadian partner MDS Laboratory Services.

3. Maynard Olsen’s article on the Human Genome project (Olsen, 2002)—which follows CraigVenter’s testimony before the hearing of the US House of Representatives Subcommittee onEnergy and Environment of the Committee on Science (June 17, 1998) to determine whetherCelera would affect the public program of the Human Genome Project—shows how in apre-Enron, corporate speculative Bear Market of the 1990s, incredibly erroneous informationcould be widely disseminated (as part of Celera’s PR campaign), involving claims that werenot met and suggesting technological superiority where in fact there was none, and be boughtinto by major media figures (NY Times’ Nicholas Wade). While not explicitly an ANTanalysis, the actants are there, including ideas, acts and entities, what Hacking calls ‘manufac-tures’ (Hacking, 1992) and Latour & Woolgar called ‘inscription devices’ (Latour & Woolgar,1979).

4. This acceptance by Quebec, however, is not without the appearance of conflict of interestconsiderations. Importantly, this province serves as the Canadian headquarters of severalmultinational pharmaceutical and biotechnology companies.

5. Drift of genetic tests from medically defined ‘clinical utility’ to patient-centred utility hasimportant implications for public health insurance. Simply because some people may ‘want’a test does not mean that the test is either cost-effective or of sufficient clinical utility towarrant funding; at the same time, while a test may not be clinically useful for a particularpopulation, this does not necessarily mean that members of the population should not havethe right to purchase it privately (Burgess, 1999).

6. While these technologies may have become routine in the clinical setting, it does not meanthat the broader social and ethical issues, such as whether one should be offering prenataltesting for Down syndrome, have been addressed (Levitt, 2001).

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Actor Network Theory: A Tool to Support Ethical Analysis of