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Sunder Rajan 2007 - Experimental Values

Sunder Rajan 2007 - Experimental Values

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new left review 45
 
may june 2007
 
67
kaushik sunder rajan
EXPERIMENTAL VALUES
Indian Clinical Trials and Surplus Health
T
wo prominent indian
physicians recently described theclinical trials of new drugs in India as a ‘new colonialism’. Inan article published by a leading
us
medical journal, SamiranNundy and Chandra Gulhati drew particular attention to‘illegal and unethical trials’ conducted without regulatory approval.
1
Buta moral critique of this kind, however legitimate in its own terms, doesnot adequately grasp the network of economic and social relations thatthe international health industry has established on a global scale. Evenif all clinical trials conducted in India or other Third World countriesadhered to the letter of the law and the spirit of ethical codes, the verystructure of this network would remain one of exploitation. I shall out-line here the dynamics of clinical trials in India, focusing especially onthe huge capacity currently being built up in anticipation of the transferof global trials to the subcontinent. This will provide a basis for inter-preting the phenomenon in terms of concepts developed by myself andothers currently researching this field, particularly those of 
biocapital 
 and
surplus health
.
1. the landscape of clinical trials
Clinical trials are the set of practices required to certify a new drug mole-cule as safe and efficacious for the market.
2
In the United States, theclinical-trials procedure is an elaborate one, conducted in a number of stages and contributing to the immense time, risk and expense of thedrug development process. First, there is pre-clinical toxicological testingof a potential new drug molecule. This is usually performed on animals,
 
68
 
nlr 45
in order to determine whether the molecule being tested is safe enoughto put into a living system. The second stage is that of dosage studies,designed to come up with a metric for the dose of the drug to be admin-istered. Predictably, the efficacy of a drug increases with its dose, but sotoo does its toxicity; the aim is therefore to find an optimum range withinwhich efficacy is maximized without too greatly compromising safety. If the drug is too toxic when tried on animals, the trial will not proceed anyfurther, but if acceptable dose ranges can be determined, the third stageis a three-phase trial in humans. Phase 1 trials are conducted on a smallnumber of healthy volunteers to test the drug’s basic safety, since drugsthat seem safe in animals may still show adverse effects in humans. Phase2, which serves as a bridge, involves larger, scaled-up efficacy and safetytrials on as many as a few hundred subjects, who may be either patientsor healthy individuals. Phase 3 involves large-scale randomized trials onseveral thousand people, usually patients suffering from the ailment forwhich the therapy has been developed. These trials are frequently co-ordinated across multiple centres, increasingly on a global scale.The sponsors for trials are generally biotechnology or pharmaceuticalcompanies, since drug development in the
us
and most other parts of the world is undertaken largely by the private sector. Universities andpublicly funded laboratories play a major role in the early stages of discovery—the identification of potential lead molecules and the conductof pre-clinical tests—but the institutional structure of drug develop-ment is such that they increasingly license promising molecules tocorporations that take them through clinical trials. This means that thebiomedical and experimental rationales for clinical trials are completely
1
Samiran Nundy and Chandra Gulhati, ‘A New Colonialism?—ConductingClinical Trials in India’,
New England Journal of Medicine,
vol. 352, no. 16 (2005),pp. 1633–6.
2
Clinical trials have become a site of keen interest in the anthropology of science.See especially Melinda Cooper, Brian Salter and Amanda Dickins, ‘China andthe Global Stem Cell Bioeconomy: An Emerging Political Strategy?’,
RegenerativeMedicine
, vol. 1, no. 5 (2006); Joseph Dumit,
Drugs for Life,
Durham,
nc
forth-coming; Jill Fisher, ‘Human Subjects in Medical Experiments’, in Sal Restivo, ed.,
Science, Technology and Society
, Oxford 2005; Wen-Hua Kuo, ‘Japan and Taiwan inthe Wake of Bio-Globalization: Drugs, Race and Standards’, PhD dissertation,
mit
 2005; Adriana Petryna, ‘Ethical Variability: Drug Development and GlobalizingClinical Trials’,
American Ethnologist 
, vol. 32, no. 2 (2005), pp. 183–97; and Petryna,‘Drug Development and the Ethics of the Globalized Clinical Trial’, PrincetonInstitute for Advanced Study Occasional Paper 22 (Oct 2005).
 
sunder rajan:
 
Clinical Trials
 
69entwined with the market value these companies see in the drugs thateventually get developed, and the market risk that attends the drug devel-opment process. According to the Healthcare Financial ManagementAssociation’s newsletter, ‘twenty years ago, 80 per cent of clinicalresearch trials were conducted through academic medical centres. In1998, estimates indicated the number of [these] centres as investigatorsites had dropped to less than half.’
3
Health research and production isthus progressively captured by capital, and now needs to be seen as asemi-autonomous branch of it.
4
The organizational complexity of clini-cal trials does however mean that it has been hard for pharmaceuticalcompanies to manage them, leading to the emergence of an entirely newsector devoted to the management and administration of clinical trials.These companies, known as clinical research organizations (
cro
s), arenow an integral part of the overall biomedical economy.
A plurality of actors
The movement of clinical trials to international—non-
us
—locationsstarted in earnest in the mid-1990s. Adriana Petryna cites figures thatpoint to a dramatic growth in the number of human subjects recruitedinto these trials, from 4,000 in 1995 to 400,000 in 1999.
5
A recentstudy by the consulting firm A. T. Kearney shows that roughly half of the 1,200
us
clinical trials in 2005 made use of an international site.
6
Inthe 1990s, as Petryna notes, most of this growth occurred in countriesthat had agreed to harmonize standards in commercial drug testing withthe guidelines set by the International Conference on Harmonization of 
3
Indeed, law and policy scholars Tracy Lewis, Jerome Reichman and Anthony Sohave argued for public funding of clinical trials as a crucial mechanism to makeessential therapeutics more accessible—and therefore to move health away frombeing an abstract market value towards being about healthiness. See Tracy Lewis,Jerome Reichman and Anthony So, ‘The Case for Public Funding and PublicOversight of Clinical Trials’,
The Economists’ Voice
, vol. 4, no. 1 (2007). For theHealthcare Financial Management Association’s figures, see Jennifer Jones andAlan Zuckerman, ‘Clinical Research Trials: Creating Competitive and FinancialAdvantages’,
Managing the Margin Newsletter 
, available at www.hfma.org.
4
This is an example of what Etienne Balibar has described as the continual expan-sion of the value form and the infinite process of accumulation. Etienne Balibarand Immanuel Wallerstein,
Race, Nation, Class: Ambiguous Identities
, London andNew York 1992, p. 180.
5
Petryna, ‘Drug Development’.
6
A. T. Kearney Report, ‘Make Your Move: Taking Clinical Trials to the BestLocation’, 2006; available at www.atkearney.com.

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