clinical labor by melinda cooper and catherine waldby

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MELINDA COOPER & CATHERINE WALDBY

Clinical Labor

Tissue Donors and Research Subjectsin the Global Bioeconomy


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Clinical Labor


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Experimental Futures Technolo ical Lives, Scientic Arts, Anthropolo ical Voices A series edited by Michael M. J. Fischer and Joseph Dumit


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MELINDA C OOPER & CATHERINE WALDBY

Clinical Labor

Tissue Donors and Research Subjects

in the Global Bioeconomy

Duke University Press Durham and London 2014


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2014 Duke University Press All ri hts reserved

Printed in the United States of America on acid- free paper Desi ned by Courtney Lei h BakerTypeset in Whitman by Tsen Information Systems, Inc.

Library of Con ress Catalo in -in-Publication Data

Cooper, Melinda.Clinical labor : tissue donors and research subjects inthe lobal bioeconomy / Melinda Cooper and Catherine Waldby.pa es cm (Experimental futures)Includes biblio raphical references and index.

978-0-8223-5608-0 (cloth : alk. paper) 978-0-8223-5622-6 (pbk. : alk. paper)

1. Human reproductive technolo yEconomic aspects.2. Human reproductive technolo yMoral and ethical aspects.

3. Medical careTechnolo ical innovations. . Waldby, Cathy.. Title. . Series: Experimental futures.133.5. 669 2014

618.17806dc23 2013025654


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CONTENTS

Acknowledgments vii

PART I. What Is Clinical Labor? 1

. A Clinical Labor Theory of Value3

. The Historical Linea es of Clinical Labor18 Industrial Order, Human Capital, and the Outsourcing of Risk

PART II. From Reproductive Work to Regenerative Labor 33

. Fertility Outsourcin 37 Contract, Risk, and Assisted Reproductive Technology

. Reproductive Arbitra e62 Trading Fertility across Borders

. Re enerative Labor89 Women and the Stem Cell Industries


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PART III. The Work of Experiment:Clinical Trials and the Production of Risk 117

. The American Experiment123 From Prison- Academic-Industrial Complex to the Outsourced Clinic

. Speculative Economies, Contin ent Bodies159 Transnational Trials in China and India

. The Labor of Distributed Experiment195 User-Generated Drug Innovation

Conclusion 221 Notes 229 References 243 Index 273


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ACKNOWLEDGMENTS

The idea for this book occurred to us more or less simultaneously at the Bio-economies and Biovalue conference at Lancaster University in April 2006.

At that conference we rst encountered the work of Kaushik Sunder Rajan, who presented from his then forthcomin book Biocapital. For each of us,this presentation crystallized a train of thou ht that was latent in our re-spective work on markets, neoliberalism, and biomedical research. While

we had both contributed to the bur eonin critique of life sciences and con-temporary capital in various ways, we had, like all the existin commentary,focused on the uncanny hybridities of money, speculation, nancialization,and in vitro tissues. Listenin to Kaushiks presentation, we both realizedthat we, and the rest of the eld, had ne lected the question of labor. Whilethere was an extensive body of work on the expert co nitive labor of the sci-entist and its centrality to the knowled e economy, the labor of those whoprovide the in vivo platforms for clinical experimentation and tissue provi-sion did not ure in any account as labor . Or to be more precise, a bur eon-in literature did name these activities in passing as kinds of labor, but didnot probe what that mi ht mean, how it mi ht count, and what it mi ht tellus not only about the or anization of the bioeconomy but about the broaderor anization of labor and value today. So this became our task, and this bookis the result.

We have incurred many debts of ratitude to numerous collea ues, re-ceived enerous rant support, and presented work at a number of seminars,conferences, and workshops. Catherine Waldby would like to thank Renee Almalin , Warwick Anderson, Kathrin Braun, Nik Brown, Katherine Carroll,Gre Clancey, Adele Clarke, Raewyn Connell, Gail Davies, Donna Dicken-


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son, Maria Fanin, Peter Glasner, Herbert Gottweis, Erica Haimes, ElizabethHill, Linda Ho le, Klaus Hoyer, Isabel Karpin, Julie Kent, Ian Kerrid e, Char-lotte Krolkke, Rob Mitchell, Michel Nahman, Brett Neilson, Pat OMalley,

Alan Petersen, Anne Pollock, Barbara Prainsack, Nikolas Rose, Brian Salter,Loane Skene, Kaushik Sunder Rajan, Fredrik Svenaeus, Steve Wainwri ht, Andrew Webster, and Clare Williams. For their essential personal supportand love she thanks her family, David, Valerie, Gavan, and Jenny, and herpartner, Paul Jones, who had to live with the inevitable psychic demands ofthe writin process. While there are too many seminars to list, she wouldlike to particularly mention three that contributed stron ly to the formationof the books ar ument; the Symposium on Biocapital and Bioequity Insti-tute for Advanced Studies / Worldwide Universities Network, University ofBristol, 27 April 2011; The Body as Gift, Resource and Commodity workshop,Sdertrn University, Stockholm, Sweden, 56 May 2011; and the ClinicalLabour and the New Labour Studies seminar, University of Sydney, 2122May 2012. She thanks the participants in these workshops for their ener-ous colle iality.

Melinda Cooper would like to thank Lisa Adkins, Fiona Allon, Warwick Anderson, David Bray, Dick Bryan, Marina Cooper, Lucette Cysique, JillFisher, Louise Freckleton, Mark Gawne, Elizabeth Hill, Martijn Konin s,Randy Martin, An ela Mitropoulos, Brett Neilson, Pat OMalley, Anne Pol-lock, Michael Rafferty, Brian Salter, Kane Race, Kaushik Sunder Rajan,Mi uel Vatter, Jeremy Walker, and Terry Woronov for their enerosity intime, conversation, and intellectual support. Several workshops and con-ferences were crucial to the formation of the books ar ument. These in-clude Experimental Systems, States and Speculations: Anthropolo y at theIntersection of Life Science and Capital, University of California, Irvine,1315 April 2007; Life (Un)Ltd, or anized by Rachel Lee at Center forthe Study of Women, 912 May 2012; and the Clinical Labour and the NewLabour Studies seminar, mentioned above.

Catherine Waldbys research was supported by two rants from the Aus-tralia Research Council: Human Oocytes for Stem Cell Research: Dona-tion and Re ulation in Australia, 0882054, and The Oocyte Economy:The Chan in Meanin s of Human Egs in Fertility, Assisted Reproductionand Stem Cell Research, 100100176. She also received support from anEconomic and Social Research Council International Visitin Research Fel-lowship and from the Re enerative Medicine in Europe: Emer in Needsand Challen es in a Global Context project, 7 project. MelindaCoopers research was supported by an Australian Research Council Grant


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100100543, Experimental Workers of the Worldthe Labour of HumanResearch Subjects in the Emer in Bioeconomies of China and India. Gen-erous additional funds were provided from the International Office and theFaculty of Arts and Social Sciences, Sydney University, and the Departmentof Sociolo y and Social Policy provided a stellar research culture and colle-

ial environment for this work.Some sections of chapter 5 are adapted from an earlier paper: Catherine

Waldby and Melinda Cooper (2010), From Reproductive Work to Re en-erative Labour: The Female Body and the Stem Cell Industries, FeministTheory 11(1): 322. A modied section of chapter 4 appears in Catherine Waldby (2012), Reproductive Labour Arbitra e: Tradin Fertility acrossEuropean Borders, in The Body as Gift, Resource and Commodity: ExchangingOrgans, Tissues, and Cells in the 21st Century, ed. Fredrik Svenaeus and MartinGunnarson, pp. 267295, Centre for Studies in Practical Knowled e, Sder-trn University. Sections of chapter 6 dealin with the history of informedconsent and tort law appear in Melinda Cooper (2011), Trial by Accident:Tort Law, Industrial Risks and the History of Medical Experiment, Journalof Cultural Economy 4(1): 8196. An abbreviated version of chapter 8 appearsin Melinda Cooper (2012), The Pharmacolo y of Distributed Experiment:User-Generated Dru Innovation, Body and Society 18(34): 1843.


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PART I

What Is Clinical Labor?


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ONE

A Clinical Labor Theory of Value

What is labor? The question is increasin ly salient to post- Fordist econo-mies, as forms of production and accumulation move further away from themass manufacture model that dened twentieth- century industrial capi-talism. The post-Fordist economies are dominated by the service sector, byknowled e creation and the culture industries, by nancial markets and in-formation capitalismbut also by new modes of biomedical production fo-cused on innovation value and newly dened contractual ri hts in the body.These are forms of productivity whose output is no lon er the standardized,mass-manufactured commodity but, rather, less easily speciable entitiesbrand equity, customer loyalty, trade marks, intellectual property. The indus-trial model of labor as exhaustible machine and entropic ener y (Walker2007), operationalized throu h the scientic mana ement of discrete timeand motion units, no lon er accounts for the activity of most employees inthe First World economies.

As manufacture is decentered from the former industrial, advancedeconomies, the proliferation of these other forms of production throws into


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question the established cate ories of economic analysis. In particular, itraises the question of how to understand the relationship between the laborprocess and the production of value when both domains are disentan ledfrom mass manufacture, with its tan ible use values and predictable econo-mies of scale. While the nancialization of economies has directed a reatdeal of critical attention to the ever more mercurial play of speculation in thecreation (and more recently the destruction) of capital value, a rowin bodyof scholarship is also en a ed in rethinkin the cate ory and subjectivity oflabor and its modes of productivity. Yet few have explored the new forms ofembodied labor (surro acy, the provision and sale of body tissues, partici-pation in clinical trials) that have proliferated at the lower ends of the post-Fordist biomedical economy. This book intends to investi ate these formsof labor as central to the biomedical innovation process, while reectin ,in turn, on how such a perspective mi ht challen e some of the foundinassumptions of classical, Marxist, and post-Fordist theories of labor.

Much of the sociolo ical and political economy literature focuses on thestructural chan es that typify advanced economies since the late 1970s, par-ticularly the decline in full-time, permanent positions for the industrial,male worker that characterized the Fordist model of production. Frenchsociolo ists Luc Boltanski and Eve Chiapello (2005) offer a detailed over-

view of the differences between Fordist labor re imes and post- Fordist ex-ible labor. As rms restructured in the 1980s and 1990s to take advanta e ofeconomic dere ulation and the transnationalization of supply and manufac-ture chains, they sou ht to divest themselves of their internal, permanent workforce and secure labor on the cheaper terms of just- in-time demand.Hence, companies increasin ly resorted to subcontractin out administra-tive, service, and even professional activities to external contractors andconsultants, substitutin xed- term for lon -term labor contracts. The e-neric post-Fordist worker is no lon er the employee, tied to the rm by alon -term contract of service, but the independent contractor, who movesfrom rm to rm and from client to client sellin contracts for service. As thestandard workin day and week are supplanted by intermittent call- work,ni ht work, overtime, nine-day fortni hts, weekend shifts, and annualized

work- times, a plethora of new contractual forms have emer ed to constrainlabor to constant work-readiness and volatile wa es (Mitropoulos 2012). Bydivestin itself of the lon -term contract of employment, the post- Fordist

workplace frees itself of the burdens of social insurance and outsources riskto independent contractors, who become responsible for insurin them-


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selves a ainst the whole spectrum of life risks that were once taken in char e(albeit partially) by the welfare state. Under these conditions, the wa e itselfhas become somethin of a speculative propositioncontin ent, in manycases, upon unspecied hours of unpaid work-readiness, conditional uponthe achievement of performance indicators, or fully inte rated into the vo-latilities of the stock market (as in the case of stock options as supplementsto traditional wa es). As the or anizational form that emer ed from the oil shocks and reces-sions of the mid-1970s, post-Fordism presides over the breakdown of thepolitical and economic cate ories that structured the mid- twentieth-centuryKeynesian era. In response to the return of middle- class women to the paidlabor force from the late 1960s, and the correspondin disinte ration of thebreadwinner household with a full- time, unpaid housewife, post- Fordisteconomies blur the boundaries between the reproductive and productivespheres. Domestic tasks, sexual services, care provision, and, as we will see,the process of biolo ical reproduction itself have mi rated out of the pri-

vate space of the family into the labor market and are now central to post-industrial accumulation strate ies. The New Household Economics devel-oped by Chica o School economist Gary Becker represents one of the rstattempts to theorize this process within the limited framework of orthodox,neoclassical economics: not incidentally, its exponents have been some ofthe keenest champions of commercial markets in blood, or ans, and repro-ductive tissues, alon side other forms of human capital (Posner 1989; R. A.Epstein 1995; Becker and Elias 2007). As both theorists of the New House-hold Economics and their critics have observed, post-Fordist economies in-ternalize the boundaries that the mid- twentieth- century social state placedon commodication, pushin back at the limits between production andsocial reproduction, production and consumption, production and circula-tion, to turn even the most intimate of bodily functions into exchan eablecommodities and services (Becker 1981; Radin 1996). A wide- ran in social science and humanities literature now reco nizesthe multifarious ways that the biotechnical processes of life itself (Rose2007) are involved in networks of commercial transaction and capital accu-mulation. This literature has explored the speculative accumulation strate-

ies of the pharmaceutical and biomedical industries (Parry 2004; Thacker2005; Sunder Rajan 2007; Brown et al. 2011); the lo ics of biocommodica-tion and commercial markets in tissues, or ans, reproductive cells, or ans,and (Franklin and Lock 2003; Parry 2004; Waldby and Mitchell 2006;


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Brown et al. 2011); lobal markets in pharmaceuticals and enetic data(Thacker 2005; Petryna et al. 2006); and the political economy of clinicaltrials (Fisher 2009; Petryna 2009).

Alon side this literature, and at a much more eneral level of analysis,theorists associated with the tradition of Italian autonomist or post- workeristMarxism point to the ways in which the time of life (that is, the time re-served for nonwork or unpaid reproductive labor under Fordist conditions)has become ever more closely enmeshed in the circuits of capital accumu-lation. The transition to post- Fordism, they ar ue, has undermined the con-ceptual and practical boundaries between the time of work and the time oflife, inau uratin a transition from capital-labour to capital-life (Lazzarato2004). Most recently, Andrea Fuma alli has proposed the term co nitivebiocapitalism as a means of radicalizin the autonomist critique of politicaleconomy. For Fuma alli, co nitive biocapitalism is bioeconomic production:it is bioeconomy (2011: 12). Post-Fordist capitalism puts life itself to work,overcomin theseparation between production and reproduction to constitutea new form of biolabor (12). Under these conditions, any theory of the

value of work must become a theory of the value of life (12). Sugestive as itis, the extreme enerality of this literature means that it fails to pose the mostsalient questionwhat exactly was life itself under Fordist conditions of(re)production? What, in other words, were its endered and racialized divi-sions of labor? And in what sense does the actual production of bioeconomic

value in the knowled e- intensive life science sector reect or interact withthese wider shifts in how the scene of reproduction is or anized? Alon side these critical literatures, public policy discourse has identiedthe bioeconomy as a key site of strate ic investment and a decisive stakein the nascent competitive standoff between the advanced postindustrialeconomies and the emer in economies of China and India. The Or anisa-tion for Economic Co-operation and Development ( ), the EuropeanUnion ( ), and now the United States have all published policy directivesdesi ned to foster the emer ence of a new lon wave of postindustrial eco-nomic rowth based on the inte rated bioeconomy of the a ricultural,medical, and industrial life sciences (European Commission 2005; 2006; White House 2012). Echoin a discourse that is now at least four de-cades old, these directives call for a new eneration of bio-based technolo-

ies capable of transcendin the limits of industrial, petrochemical produc-tion in a riculture, transport, and medicine. Much of the focus of this policya enda is on the speculative value of as- yet- unrealized technolo ical inno-


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vationbiofuels, synthetic biolo y, experimental cell therapiesand theirpotential to propel the advanced economies out of economic recession.

Yet despite the conceptual ination of the bioeconomic in contempo -rary policy and theoretical discourse, few have explored the very material ways in which the in vivo biolo y of human subjects is enrolled into the post-Fordist labor process, throu h either the production of experimental data orthe transfer of tissues. We contend that such forms of in vivo labor are in-creasin ly central to the valorization process of the post-Fordist economy.The pharmaceutical industry demands ever reater numbers of trial sub-jects to meet its innovation imperatives, and the assisted reproductive mar-ket continues to expand as more and more households seek fertility servicesfrom third-party providers amete vendors and surro atesand sectorsof the stem cell industries seek out reproductive tissues. The life scienceindustries rely on an extensive yet unacknowled ed labor force whose ser-

vice consists in the visceral experience of experimental dru consumption,hormonal transformation, more or less invasive biomedical procedures,ejaculation, tissue extraction, and estation. In the United States alone, theepicenter of the lobal pharmaceutical industry, rowin numbers of contin-

ent workers en a e in hi h-risk Phase 1 clinical trial work in exchan e formoney, while uninsured patients may take part in clinical trials in exchan efor medication that would otherwise be unaffordable. With the expansion ofassisted reproductive technolo ies, the sale of tissues such as egs and spermor reproductive services such as estational surro acy has also emer ed as aourishin labor market, one that is hi hly stratied alon lines of class andrace. We refer to these forms of work as clinical labor .

The terminolo y is novel because, enerally speakin , tissue donationand research participation are not understood or analyzed as forms of work.Rather, these forms of productivity are re ulated throu h the conceptualand institutional framework of bioethics, in which tissue providersthose

who surrender blood, semen, oocytes, embryos, kidneys, and other forms oflive tissueare cast as altruistic donors who ive for the public ood, evenin cases where they are paid a fee or their tissues are commercialized (Tober2001; Waldby and Mitchell 2006). Clinical trial participants are understoodto be volunteers who receive compensation rather than wa es; nominally thecompensation rates, set by Institutional Review Boards ( s) and HumanResearch Ethics Committees, are kept low to discoura e economic coercion,but in practice the rates are often hi her than minimum- wa e rates for un-skilled labor (Elliott 2008). The historical mission of bioethics, encoded in


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its many national and international instruments and review processes, isprecisely to protect research subjects and tissue donors from market forces,enshrinin the principles of donation, voluntarism, informed consent, andfreedom from coercion as the uidin principles of ethical research. Statere ulation of tissue donation and human subject experimentation routinelystipulate that the donor or volunteer should be compensated rather thanpaid a wa e and that such compensation should not represent a form of co-ercion or undue inuence.

Nevertheless, as we demonstrate at len th in this study, these key ele-ments of bioethical re ulation have proved remarkably adaptable to thetask of overnin an informal clinical labor market. In many of the cases weexamine, the ethical insistence that the biological should not be waged onlyserves to facilitate atavistic (yet fully functional) forms of labor contract anddesultory forms of compensation. Even in the mid- twentieth century, wear ue, bioethics served to place human subject experimentation and tissuedonation under an exceptional re ime of labor, one that justied variousexemptions from the standard protections of twentieth- century labor law.Ironically, as the protections offered by the statutory labor contract becomemore residual, the precarious nature of clinical labor increasin ly resemblesother kinds of informalized labor in todays market. Throu hout this book,therefore, we have sou ht to include bioethics within our eld of analysisrather than presume its cate ories as points of departure. As such, we re-contextualize the claims of bioethics by considerin its historical relation-ship to labor law, contract, tort, and social welfare, and the particular ways itintersects with these more familiar instruments for re ulatin the economicrisks of workers.

We reco nize that the cate ory of labor cannot account for all the circum-stances in which patients donate tissues or participate in clinical trials, par-ticularly when these exchan es take place primarily within a well-re ulatedand well-insured therapeutic system, as does much solid or an donation andcertain classes of hospital-based clinical trials for cancer dru s, for example,

which offer last- resort, fully insured forms of care. Rather, we sugest thatsuch services should be re arded as labor when the activity is intrinsicto the process of valorization of a particular bioeconomic sector and whentherapeutic benets to the participants and their communities are absent orincidental. Indeed, much clinical labor consists precisely in the enduranceof risk and exposure to nonpredictable experimental effects that may be ac-tively harmful, rather than therapeutic. We also include the situation whereclinical labor is performed in exchan e for health care, recon ured as an


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in kind compensation for service, comparable to workfare, where thepayment of welfare benets is made contin ent upon the obli ation to work.

Our research focuses on two of the lar est, best-established, and transna -tional markets in clinical laborthose represented by assisted reproductivelabor (includin the sale of oocytes and sperm, and estational surro acy),on the one hand, and the labor of human research subjects en a ed in phar-maceutical dru trials, on the other. By all estimates, these markets are vast.Clinical labor sustains some of the most patent-intensive sectors of the post-industrial economy, yet most of this workforce intersects with the lowestechelons of informal service labor, recruitin from the same classes mar-

inalized by the transition from Fordist mass manufacture to post- Fordistinformatic production. Human research subjects and tissue vendors occupya liminal but critical position in the postindustrial biomedical economy. Un-like the service workers who provide cleanin , caterin , and other kinds oflow- level contract work for the knowled e economy (Sassen 2002), theirlabor is fully internal to the value chains of the pharmaceutical and biomedi-cal industries. The data enerated by human research subjects is incorpo-rated, in an immediate sense, into the investi ational new dru applicationthat needs to be submitted to re ulatory authorities before a dru is ap-proved for marketin . Eg and sperm vendors and estational surro atesprovide the livin tissues and in vivo services that sustain a thrivin economyof public and private fertility medicine and stem cell research.

These forms of transaction, however, do not ure in economic analysesof labor in the life sciences. Almost invariably, such investi ations concernthemselves with the professional divisions of labor within the laboratory andclinic and do not extend to the in vivo labor that sustains the innovation pro -cess (Arora and Gambardella 1995; Ni htin ale 1998; Gambardella 2005).This oversi ht is all the more si nicant iven thatthe life science businessmodel is organized around a classical (Lockean) labor theory of value which iden-ties the co nitive labor of the scientist as the technical element necessaryto the establishment of intellectual property in livin matter. The scientistsinventive step in isolatin or creatin a cell line from ex vivo tissues istreated in innovation economics and patent law as the moment that createsboth property ri hts and appreciable commercial value from dumb biolo i-cal materials (Boyle 1996). In this account, the bodily contribution of tissueproviders and human research subjects appears as an already available biologicalresource, as res nullius, matter in the public domain, even while in practice themobilization of these providers and subjects represents a rowin lo isticalproblem for the life science industries.


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This constitutive blind spot re ardin in vivo production is also to befound in contemporary critical studies of the labor process. Even the mostinterestin theories of postindustrial labor, those that point to the centralityof the immaterial, co nitive, or affective within post- Fordism, ultimatelypaper over the divisions of labor that exist within the postindustrial innova-tion economies (Lazzarato 2002; Fuma alli 2007). In this book, we wish toexplore the le al, social, and technical forms of value production that haveconver ed to enroll in vivo biolo ical processes (from metabolism to sper-mato enesis and estation) in a labor relation. In what follows, we turn toMarxs labor theory of value and consider its potential usefulness (and limi-tations) for thinkin throu h the question of bioproduction today.

Bioproduction and the Labor Theory of ValueFor Marx, writin in the rst volume of Capital, free, contractual wa elabor is to be found wherever the worker seeks to sell, for a limited periodof time, the livin -power which exists in his own livin body (Marx 1990[1867]: 272). Marx describes labor-power as a curious commodity, uniquein that it is a source not only of value, but of more value than it has itself(1990 [1867]: 301). It is this incipient temporal disjuncture that capital availsitself of when it distin uishes between the socially necessary time neededto maintain the life of the worker (hence the minimum wa e payable for the

workers time) and the labor time it appropriates free of char e, as a sourceof surplus value. Decisive for understandin the eni ma of labor is Marxsinsistence that the determination of socially necessary labor time is theoutcome of on oin political strugles. It follows that there is no law of

value in the sense of some transcendental or natural equilibrium re ulat-in the relationship between price and labor. The calculation of the price oflabor must be understood as historically contin ent yet fully operative as aninstrument of discipline.

Here we follow those theorists who understand Marxs theory of value asan immanent critique, not an extrapolation or revision, of the labor theoryof value developed by his classical liberal predecessors (Rubin 1972; Elson1979; Postone 1993). Adam Smith identied labor as the ultimate, transhis-torical source of all social wealth, while David Ricardo, revisin Smith, pos-tulated that it was labor time that constituted both the source and measureof exchan e value. For Marx, on the contrary, there is no intrinsic value tolabor that we mi ht want to reco nize or valorize a ainst the fetishisms ofthe market, and there is no automatic correspondence between labor time


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and price. If it is labor time that constitutes value, as Ricardo ar ued, it isonly by virtue of its abstraction from all particular use values of labor, its e-neric exchan eability as abstract, socially avera e time (Marx 1990 [1867]:129). To develop the concept of capital, Marx writes in the Grundrisse, itis necessary to be in not with labor but with value, and, precisely, with ex-chan e value in an already developed movement of circulation (1973: 259).It is not throu h some natural transformation of use value into price, butretroactively, throu h the abstraction of money in circulation, that the valueof labor is determined.

Havin established the retroactive lo ic, however, Marx insists that thedetermination of the value of labor is a political decision, the outcome, thatis, of on oin conicts between labor and capital. Labors value containsa distinct historical and moral element, manifest in the particular formsof temporal measure that overn labor in any iven moment (Marx 1990[1867]: 275). If exploitation is essentially a form of temporal discipline, it isnot surprisin that labor strugles have historically tar eted the social or a-nization of timenot only the len th of the workin day, as Marxists havetraditionally pointed out, but also the division between the time of produc-tive labor (work) and the time of reproductive labor (life), and the social dis-tribution of accidental time or risk.

Thus far, our readin of Marx is closely ali ned with that of theoristssuch as Isaak Rubin and Moishe Postone, who point to the centrality of tem-poral abstraction in Marxs labor theory of value. We differ from these per-spectives, however, by insistin that the abstract and the material (indeed,embodied) dimensions of labor cannot be theorized in isolation. In theirattempt to distin uish Marxs theory of labor from the substantialist con-ceptions of the classical liberals, these theorists seek to divorce the conceptof abstract labor time from the historically specic, physiolo ical forms as-sumed by the concrete labor process in any iven order of production. In sodoin , however, they risk reinstatin a reductive, ahistorical conception ofthe physiolo ical in its place.

In any event, we would sugest, the structural cate ories of Marxs theoryof value cannot be so easily abstracted from the biotechnical conditions oflabor that characterized the mid- nineteenth century. Far from represent-in a merely metaphoric aspect of Marxs thinkin , the technical vocabu-lary of early industrial production shapes the very conceptual frameworkof the theory of value, ivin rise, for example, to the distinctions betweendead and livin labor, variable and constant capital. These distinctions reston the assumption that the technical or machinic composition of capi-


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tal is necessarily inanimate and that the human or variable component ofcapital resides in the livin labor of the workers body, conceived as anor anic whole. Early twentieth-century developments in biomedicine fun-damentally challen e these cate ories by inventin what Hannah Landecker(2007) has called livin technolo iesin vitro tissues and cell lines thatare both livin and machinic in the sense that they can be cultured outsidethe body and form part of the technical composition of science. The twenti-eth century brin s the production process inside the body and puts or ans,blood, and cell lines into circulation outside the body, scramblin the classi-cal Marxist distinction between the livin and the dead (Cooper 2002). Inearlier work, we theorized the emer ence of livin commodities (the com-mercial exchan e of or ans, blood, and cell lines outside the body) and livincapital (the patented cell line as enerative of surplus value) (Waldby andMitchell 2006; Cooper 2008). In this book, we trace the relocation of thelabor process to the subor anismic level of the body, via the mass experimen-tation of randomized controlled trials ( s) and the contractualization ofassisted reproductive services. What we are proposin here is not a biolo ical labor theory of value inthe classical, pre-Marxist tradition, as if the ultimate use value and sourceof all wealth could be located in the intrinsic enerativity of livin biolo y.Rather, we understand clinical labor as the process of material abstrac-tion by which the abstract, temporal imperatives of accumulation are putto work at the level of the body. The temporal abstraction that Marx identi-ed as characteristic of exchan eable labor (and hence the denin featureof labor under the capitalist mode of accumulation) can also be detected inthe lon history of twentieth-century interventions into the biolo ical body.

We would not be able to speak of clinical labor as such without the import-in of mass production methods into the a ricultural sciences in the earlytwentieth century, the development of instruments for culturin livin celllines outside the body, the use of statistics in the experimental clinical sci-ences, the invention of methods for suspendin and freezin biolo ical time(cryobiolo y) in the 1950s, and the perfection of infrastructures for the massstora e of tissues, or ans, and cells (Clarke 1998; M. Edwards 2007; Gaudil-lire 2007; Landecker 2007). Developed in parallel with the European sci-ence of labor and American Taylorist methods of time mana ement, eachof these interventions render the biolo ical newly pliable to the exi enciesof abstract, exchan eable, or statistical time. At the same time, and increas-in ly so with the advent of post- Fordist methods of exible specialization,such biomedical infrastructures also serve to isolate and culture that which


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is contin ent, unpredictable, and plastic in the unfoldin of biolo ical tem-porality. The is ri orously Taylorist in its application of social statisticsto the biomedical events affectin the massied body of the population, butit also serves to isolate the unpredictable or contin ent biomedical event(the unexpected side effect, for example) a ainst the back round of the nor-mal distribution. Increasin ly (as we will see in chapters 6 and 8) it is thenonstandard temporality of the contin ent event that has come to dene the

work of biomedical innovation. With the advent of stem cell biolo y, cell development is no lon er understood to follow a predetermined path of pro-

ressively limited specializations but is cultured as a source of exible, non-exclusive potentialities, any one of which can be materialized in practice. Inthis way, the statistical abstraction of labor that Marx saw as characteristic ofthe industrial mode of production now coexists with a form of speculativematerialism, which demands that the contin ent event be embodied in theunfoldin of biolo ical time.

What we are proposin here is a theory of material abstraction that isneither dialectic nor representational in nature ( pace the Marxist theoristof real abstraction [Colletti 1973]), but experimental and interventionist. Asthe practical turn in recent science studies mi ht sugest, if the scien-tic hypothesis is effective, it is not as a theoretical proposition projectinitself onto an inert matter but as a method for inhabitin and modulatinthe already immanent possibilities of livin matter (Hackin 1983; Simon-don 1995; Rheinber er 1997b). The experimental intervention works to sus-pend, freeze, culture, replicate, reverse, accelerate, slow down, and amplifythe already-existin temporalities of the entities it works with (cell lines,metabolic processes, tissue cultures), promptin them to become other thanthey were in vivo or to live differently in time, in the words of HannahLandecker (2005). Biomedical technolo y can be understood as a practiceof controlled decontextualization that is able to provoke unsuspected or as

yet unrealized actualizations from its livin materials by exposin them tonovel environmental conditions. In this respect it is always both an abstractand a material intervention into a spectrum of already available material ab-stractions; an attempt to modulate the multiple differentiations open to aparticular cell, for example.

In pointin to the importance of the material and experimental dimen-sion of bioproduction, however, we do not wish to sugest that the creationof a market in clinical labor is reducible to its technical conditions. As we

will explore in detail in this study, even when the necessary material prem-ises have lon been available, le al innovations such as the tort law concept


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of informed consent, in the early twentieth century, and the contractualiza-tion of family law, in the late twentieth century, have played a critical rolein determinin when and how these biotechnical possibilities are realizedas labor. In a similar way, the emer ence of a nancialized mode of biomedi-cal and pharmaceutical innovation in the early 1980s was not so much theresult of a technical revolution as a studied political maneuver on the partof private corporations, research universities, and policy elites. The nan-cialization of the life science business model was enabled by a series of keyre ulatory and le al interventions into the realms of patent law, securitiesle islation, and consumer protection standards.

We differ from most approaches to the eld by understandin bioethics asa crucial component of the normative and le al infrastructure re ulatin thepolitical economy of the life sciences,even when bioethics assumes a principledopposition to the bodys commodication. Whether it is framed in a liberal or ahuman ri hts re ister, we contend that bioethics as discourse and practiceis internal to the political economy of the life sciences. Within the marketfor clinical labor, for example, we ar ue that informed consent plays muchthe same role that Marx ascribed to the doctrine of the free wa e contractunder classical liberalism. As such, we are not interested in improvin in-formed consent by ar uin for more or less ethical conditions of consentor for reater autonomy on the part of the consentin subject. Instead, weunderstand informed consent as an enablin re ulatory condition for themarket in clinical labor, one that has evolved alon side si nal twentieth-century developments in labor law and social insurance to dene the spe-cic form of unequal exchan e that overns commercial transactions inthe clinic.

Organization of the ArgumentIn order fully to realize a historically contextual value theory of clinical labor,our study en a es in a longue dure analysis, which considers the relation-ship between the modern history of labor as it is conventionally dened andthe shadow history of clinical labor. In the next chapter, The Historical Lin-ea es of Clinical Labor, we reframe some of the major transformations inthe or anization of twentieth- and twenty- rst- century labor as momentsin the or anization of biopolitical risks and capacitiesthose associated with the life risks of illness, accident, and reproductionas well as mo-ments in the orderin of production. In particular, we track the move towardlabor outsourcin , the contractin out of services, and the rise of human


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capital theory, in which workers are constituted as entrepreneurs of theirown productive, and indeed reproductive, capacity. These are crucial pivotpoints in the transformation from an industrial re ime of statutory laborprotections to a neoliberal re ime of reprivatized contractual relations. Wear ue that the evolvin institutional and le al forms of clinical labor bear

witness to this transformation in the most material of ways. We then turn to a more specic investi ation of the historical and con-temporary conditions of clinical labor. As we will see, reproductive and ex-perimental labor emer e from the mar ins of the Fordist industrial modeland Keynesian welfare state, in the product- testin re imes of the andthe various forms of reproductive service performed by the unpaid house-

wife or the paid domestic servant (cook, nanny, or wet nurse). Our analysistraces the pro ressive spatial reor anization of clinical labor as reproductiveand experimental services move from the sequestered spaces of the verti-cally inte rated Fordist institution to the distributed spaces of post- Fordistcontract labor. Until the 1980s, clinical trials were conducted within theconnes of the academic research hospital or the prison. Durin the sameperiod, the unpaid reproductive labor of the housewife took place within thesequestered space of the Fordist household. Each of these cate ories of workblurred the boundaries between the free and the unfree contract of laborand involved more or less coercive forms of connement or state nancin .Unpaid reproductive labor was indirectly subsidized by the state throu h theinstitution of the family wa e. Prison-based clinical trials represented one ofthe few opportunities for earnin a wa e in prison at a time when there weresevere restrictions on prison labor, and hospital- based trials were subsidizedby the introduction of social insurance for the elderly and the poor (Medi-care and Medicaid) in the mid- 1960s. Located in the peripheral spaces ofthe household, the hospital, the warfront, and the prison, these experimen-tal and reproductive forms of value eneration were sharply separated fromthe scene of formal industrial labor.

Since the 1980s, however, the institutional spaces of Fordist clinical laborhave been subject to on oin reform. At stake in the transition from Fordismto post-Fordism, we ar ue, is not only the vertical disinte ration of nationalproduction and the lar e rm but also the horizontal contractualization ofservices once performed in the conned spaces of the household, the hos-pital, and the prison. These once internalized labor forces have been sup-planted by a model of contractual outsourcin that dele ates clinical laboron a case-by-case basis to the independent contractor for in vivo services. Itis durin this period that we see the decomposition of the family wa e, pre-


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cipitated by womens mass exodus from obli atory domesticity and into the workforce. As the unpaid domestic labor of the housewife is supplanted by

an entire service sector specializin in contract-based affective, sexual, andcare labor, the biolo ical process of reproduction is itself subject to a form of(le al, technical, and commercial) fra mentation. Once the technical reper-toires of midcentury animal reproduction are adapted to human patients viathe development of in vitro fertilization ( ) and other assisted reproduc-tive technolo ies ( s), the processes of ovulation, spermato enesis, con-ception, and estation are opened out to third- party provision, drawin onsurro ates and amete suppliers outside the family proper. While many juris-dictions prohibited the commercialization of reproductive services, others,particularly in the United States, refused to frame re ulations. As a conse-quence, particular jurisdictions have witnessed the emer ence of a repro-ductive service sector framed almost entirely throu h private contract law.It is now possible to outsource discrete moments and functions of the repro-ductive process to independent contractors beyond the boundaries of thefamily and the nation without underminin the le al entity that is the post-Fordist family. It is this contradiction between the technolo ical fra menta-tion of the family and the correspondin tendency toward its le al reasser-tion that we will address in the second part of the book, From Reproductive

Work to Re enerative Labor.Durin the same period, the prohibition of prison- based trials, followed

by mana ed-care-inspired reforms of the academic research hospital, com-bined to push clinical trials into the private sector. The mass institutionaltrials of the postWorld War II era have been pro ressively replaced byprivate-contract-based trials that are brokered and mediated by a new kindof research institutionthe contract research or anization or . Thelon -term connements required by Phase 1, rst- in-human trials now takeplace in private research units, while later- phase trials on patients are per-formed by private physicians under contract to the pharmaceutical industry.In keepin with these institutional shifts, the contractual conditions thatshape clinical trial work have also chan ed, even while the racial and classprole of the clinical trial subject remains remarkably static. The pharmaceu-tical industry now looks for its research subjects outside the state-subsidizedspaces of the prison and the hospital, locatin new sources of experimentallabor in the various forms of risk exposure enerated by neoliberal labor and welfare reform. Today, contract research or anizations habitually recruitPhase 1 research subjects from amon the underemployed, day laborers, ex-prisoners, and undocumented mi rants, precisely those classes of worker


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who routinely endure the most hazardous and contin ent of labor condi-tions. Later-phase trials are increasin ly dependent on the rowin numbersof underinsured, chronically ill patients who can access medicines only ifthey also a ree to en a e in clinical trials. Under post-Fordist conditions of

eneralized labor informalization, clinical trial work is contin ent labor parexcellencelabor that is dened by the freedom to bear risks of the most

visceral kind. It is this problematic of experimental labor that we will exam-ine in the third part of the book, The Work of Experiment: Clinical Trialsand the Production of Risk.

In each section, we be in with a historical account that sets out the con-ditions for emer ence of reproductive and experimental clinical labor in thetwentieth century. We then ive an account of the transnationalization ofclinical labor, as both reproductive services and clinical trial work are off-shored to less expensive locations beyond the borders of northern Europeand North America. We then consider the development of distributed, ex-tensive forms of clinical labor in the more innovation- driven sectors of thebioeconomy, examinin the role of women as donors of surplus reproduc-tive tissues in the stem cell industries and of patients as self-experimental re-sources for pharmaceutical innovation. In what follows, then, we provide anaccount of clinical labor that simultaneously maps its historical conditions,its political economy, and its contemporary trajectory. We hope to show thatthis form of work, far from representin an exceptional or extreme mani-festation of the under round economy, is emblematic of the conditions oftwenty-rst-century labor.


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NOTES

ONE. A Clinical Labor Theory of Value 1 The exceptions here are recent eldwork studies that have provided important ac-

counts of particular sectors, includin amete vendin (Almelin 2011; Vora 2011)and Phase 1 clinical trial work (Sunder Rajan 2008).

2 Bioethics is a broad discipline, as well as a re ulatory discourse, and we acknowl-ed e that a critical and feminist bioethical scholarship has pursued some of the

questions and issues we raise in this book (e. ., Elliot 2008; Dickenson 2007;Baylis and McLeod 2007). 3 For example, the Nurember Code (1949), the Declaration of Helsinki (World

Medical Association 1964), the Belmont Report (National Commission for theProtection of Human Subjects of Biomedical and Behavioral Research 1978), andthe European Convention on Human Ri hts and Biomedicine Council of Europe(1997).

4 The Belmont Report, for example, stipulates that informed consent requiresconditions free of coercion and undue inuence. Coercion occurs when an overt

threat of harm is intentionally presented by one person to another in order to ob-tain compliance. Undue inuence, by contrast, occurs throu h an offer of an ex-cessive, unwarranted, inappropriate or improper reward or other overture in orderto obtain compliance (National Commission for the Protection of Human Sub-jects of Biomedical and Behavioral Research 1978).

5 This resemblance is not lost on popular current affairs media, where more andmore documentaries and news items feature sensationalized accounts of impov-erished students or the newly unemployed sellin egs or si nin up for Phase 1clinical trials to make ends meet in the postnancial crisis world. Indeed, the

self-evidence of such clinical labor is treated in the news media as an index of thenew economic realities faced by youn people in particular. Nevertheless, it re-mains opaque to most bioethical analysis.

6 Here we limit ourselves to a brief survey of ures available for assisted reproduc-


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tive markets and clinical trials in the United States, takin into account the factthat little data exists for some of the less-re ulated kinds of clinical labor, such asthe sale of oocytes and sperm. Accordin to research conducted by the NationalInstitutes of Health ( ) and the Center for Information and Study on Clini-

cal Research Participation ( ), in 2006, close to 800,000 Americans wereenrolled in overnment-funded clinical trials and close to 900,000 in industry-funded trials (Phases 13) ( 2011). The market value of the US infertilityservices sector was estimated to have reached 4.4 billion in 2008 (MarketdataEnterprises 2009). As of 2008, the United States housed more than 100 spermbanks and 483 fertility clinics, most of them run by small medical practices orhospital-based clinics (althou h there is one lar e provider chain, Inte raMed,that operates several dozen clinics). The Centers for Disease Control and Preven-tion ( ) reported that 17,697 donor egs were transferred to infertile women in

2009 (Centers for Disease Control and Prevention 2011). produced more than50,000 children per year via 142,000 procedures (Marketdata Enterprises2009).

7 Accordin to the common law doctrine ofres nullius, persons do not have propertyri hts in their own bodies and cannot sell a part of themselves. The human bodyand its parts are considered beyond commerce and outside of contract, and oncetissue has left the body, it is understood to belon to no one. Patent law in the lifesciences relies in turn on a notion of property ri ht derived from Lockepropertyri hts can be established by addin labor to unimproved or natural land or materi-

als, transformin them into useful entities. For an extended treatment of the Lock-ean idea of labor and property see Waldby and Mitchell 2006.

8 This move is most a rant in Rubin (1972), who dismisses the ener etic con-ception of labor as an ahistorical readin of the labor theory of value. What Rubinmisses is the very historicity of the concept of ener y, its close connection to thethermodynamic science of industrial production, and its deployment as a cate oryof labor discipline. In other words, a historically sensitive perspective on the ma-terial abstraction of labor would need to investi ate how ener y (or, for example,affect) come to constitute the socially determined measure of labor value within a

given order of production. See Vatin 1993 for an example of this kind of perspective. 9 We use the term speculative materialism in a critical sense. From our perspec-

tive, much of the current philosophical literature on speculative materialism sub-stitutes ontolo y for critique and fails to en a e with its proximity to the contem-porary form of capitals material abstraction. See, for example, Bryant et al. 2011.

10 Throu hout this work, we deploy the concept of free wa e labor in the criticalsense intended by Marx. In other words, we insist that Marxs theory of labor wasa critique of liberal political economyand therefore a critique of liberal theoriesof freedom of contractnot a continuation of Ricardian political economy, as the

more technocratic and statist elements in the Marxist tradition would later cometo interpret him. We reco nize that Marx made free wa e labor the tar et of hiscritique precisely because it escaped the critical purview of nineteenth- centuryliberals, who were quite happy to denounce the unfree labor of the slave but


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stopped short of examinin the exploitation involved in freedom of contract. How-ever, Marxs almost exclusive critical focus on the free wa e contract means thathe ne lects the various forms of unfree laborbonda e, indenture, and cover-turethat continued alon side the expansion of industrial labor throu hout the

nineteenth century. At his most reductive, Marx dismisses such forms of unfreelabor as residues of an archaic feudal order, destined to be overcome by the lonmarch of history. We ar ue instead that free and unfree labor presuppose eachother and are equally constitutive of the capitalist labor relation. For an extensiveand illuminatin discussion of this question, see van der Linden 2008.

TWO. The Historical Lineages of Clinical Labor 1 The Court interpreted the Due Process Clause of the Fourteenth Amendment, a

postCivil War Reconstruction amendment, as enshrinin freedom of contract. 2 Lieberman writes, Southern Democrats, committed to preservin both racial se -

re ation and the distinctive re ional labor market, found themselves in a majoritycoalition durin the New Deal with urban Northerners and or anized labor, who

were demandin a social democratic pro ram of national social and employmentpolicy. This coalition . . . created a national welfare state aimed at its constitu-ent class roups, industrial workers and white Southern planters, and it did so bybuildin new institutions on a foundation of racial inequality. . . . [The act createdexclusions,] in some cases by excludin the occupations in which most African

Americans worked [a ricultural and domestic workers], in others by drawin stricteli ibility criteria that many African Americans could not meet, and in still othersby preservin local autonomy (Lieberman 1998: 2425).

3 What we are referrin to here is the canonical version of the labor theory of value expounded in the rst volume of Capital. We reco nize that, in other texts,

Marx proposes a more nuanced understandin of the full spectrum of contractualand social conditions at play in capitalist labor relations. In his Theories of SurplusValue, for example, Marx ar ues a ainst Adam Smith that productive (surplus-

value- eneratin ) labor extends beyond the material production of commodities

to include the processlike performance of personal services. By this denition,all kinds of service work ran in from the lowest forms of menial, domestic, andsexual labor (the mass of menial servants, cooks, prostitutes) to the hi h-est forms of professional, bureaucratic, or scientic labor (state officials, militarypeople, artists, doctors, priests, jud es, lawyers) can potentially be consideredproductive labor if they enter into a labor relation that enerates surplus value.See Marx 1969: 165, 174. Here a ain, however, Marx fails to account for the persis-tence of domestic servitude within the capitalist order of production, by classifyintasks performed on a personal basis within the household as feudal remnants.

4 In Australia, the Commonwealth Court of Conciliation and Arbitration awardedthe rst male breadwinner wa e in the Harvester Jud ement of 1907.

5 For a detailed account of the various theorists associated with Chica o School neo-liberalism, see Horn et al. 2011.

clinical labor by melinda cooper and catherine waldby

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