Hostname: page-component-cd9895bd7-jn8rn Total loading time: 0 Render date: 2024-12-28T14:07:07.588Z Has data issue: false hasContentIssue false
  • English
  • Français

Clinical Trials Offshored: On Private Sector Science and Public Health

Published online by Cambridge University Press:  01 March 2007

Adriana Petryna
Adriana Petryna
Affiliation:
Department of Anthropology, University of Pennsylvania, University Museum 334, PA 19104, USA E-mail: [email protected]
Get access

Abstract

This article addresses the offshoring of clinical trials to middle- and low-income countries, and the complicated ways in which they have become integral to public health and quality of care in these contexts. I focus on the operations of United States-based contract research organizations (CROs), which make up a specialized global industry focusing on the recruitment of human subjects and investigators; they are key players in an outsourced world of clinical development ‘service providers’. To get an on-the-ground understanding of the offshored clinical trial, I worked with regulators, health services administrators, and research clinicians in Eastern Europe and Latin America, two clinical trial market ‘growth regions’. By addressing the strategies of evidence-making that inform clinical trial offshoring, this article identifies the context-specific calculations by which experimental groups are being identified. It also addresses aspects of the clinical trial operational model, in which the failure to predict safety outcomes or a paradigm of expected failure is being exported along with the offshored trial. By highlighting the uncertainties of clinical research, this article points to gaps in systems of human protection as it considers new forms of accountability in private sector science and public health.

Keywords

global pharmaceuticalsclinical trial environmentsoffshoringethical variabilityhuman subjectsresearch ethics
Type
Articles
Information
BioSocieties , Volume 2 , Issue 1: Special Issue: The Construction and Governance of Randomised Controlled Trials , March 2007 , pp. 21 - 40
Copyright
Copyright © London School of Economics and Political Science 2007

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Abramson, J. (2004). Overdosed America: The broken promise of American medicine. New York: HarperCollins.Google Scholar
Angell, M. (1988). Ethical imperialism? Ethics in international collaborative clinical research. New England Journal of Medicine, 319, 1081–1083.CrossRefGoogle ScholarPubMed
Angell, M. (1997). The ethics of clinical research in the Third World. New England Journal of Medicine, 337, 847–849.CrossRefGoogle ScholarPubMed
Angell, M. (2000). Investigators’ responsibilities for human subjects in developing countries. New England Journal of Medicine, 342, 967–968.CrossRefGoogle ScholarPubMed
Angell, M. (2005). The truth about the drug companies: How they deceive us and what to do about it. New York: Random House.Google Scholar
Angell, M. (2006). Your dangerous drugstore. New York Review of Books, 53(10). URL (accessed February 2007): http://www.nybooks.com/articles/19055Google Scholar
Avorn, J. (2004). Powerful medicines: The benefits, risks, and costs of prescription drugs. New York: Knopf.Google Scholar
Bayer, R. (1998). The debate over maternal-fetal HIV transmission prevention trials in Africa, Asia, and Caribbean: Racist exploitation or exploitation of racism? American Journal of Public Health, 88, 567–570.CrossRefGoogle ScholarPubMed
Biehl, J. (2001). Technology and affect: HIV/AIDS testing in Brazil. Culture, Medicine and Psychiatry, 25, 87–129.CrossRefGoogle Scholar
Biehl, J. (2006). Pharmaceutical governance. In Petryna, A.Lakoff, A. & Kleinman, A. (Eds), Global pharmaceuticals: Ethics, markets, practices. Durham, NC: Duke University Press.Google Scholar
Botbol-Baum, M. (2000). The shrinking of human rights: The controversial revision of the Helsinki Declaration. HIV Medicine, 1, 238–245.CrossRefGoogle ScholarPubMed
Christakis, N. (1992). Ethics are local: Engaging cross-cultural variation in the ethics for clinical research. Social Science and Medicine, 35, 1079–1091.CrossRefGoogle ScholarPubMed
Cohen, L. (1999). Where it hurts: Indian material for an ethics of organ transplantation. Special issue on ‘Bioethics and beyond’, Daedalus, 128, 135–165.Google Scholar
Crouch, R.A., & Arras, J.D. (1998). AZT trials and tribulations. Hastings Center Report, 28, 26–34.CrossRefGoogle ScholarPubMed
Das, V. (1999). Public good, ethics, and everyday life: Beyond the boundaries of bioethics. Special issue on ‘Bioethics and beyond’, Daedalus, 128, 99–134.Google Scholar
Das, V., & Das, R.K. (2006). Pharmaceuticals in urban ecologies: The register of the local. In Petryna, A.Lakoff, A. & Kleinman, A. (Eds), Global pharmaceuticals: Ethics, markets, practices. Durham, NC: Duke University Press.Google Scholar
de Zulueta, P. (2001). Randomised placebo-controlled trials and HIV-infected pregnant women in developing countries: Ethical imperialism or unethical exploitation? Bioethics, 15, 289–311.CrossRefGoogle ScholarPubMed
Dickersin, K., & Rennie, D. (2003). Registering clinical trials. Journal of the American Medical Association, 290: 516.CrossRefGoogle ScholarPubMed
Epstein, S. (1996). Impure science: AIDS, activism, and the politics of knowledge. Berkeley: University of California Press.Google ScholarPubMed
Etkin, N. (1999). The rational basis of ‘irrational’ drug use: Pharmaceuticals in the context of development. In Hahn, R.A. (Ed.), Anthropology in public health: Bridging differences in culture and society, 165–182. New York: Oxford University Press.Google Scholar
Farmer, P. (1999). Infections and inequalities: The modern plagues. Berkeley: University of California Press.Google Scholar
Farmer, P. (2002). Can transnational research be ethical in the developing world? The Lancet, 360, 1301–1302.CrossRefGoogle ScholarPubMed
FDA (Food and Drug Administration) (2004). Innovation/stagnation: Challenge and opportunity on the critical path to new medical products. March. Washington, DC: Dept of Health & Human Services.Google Scholar
Geertz, C. (2000) [1984]. Anti anti-relativism. In Available light: Anthropological reflections on philosophical topics, 42–67. Princeton, NJ: Princeton University Press.Google Scholar
Goozner, M. (2004). The $800 million pill: The truth behind the cost of new drugs. Berkeley: University of California Press.CrossRefGoogle Scholar
Gorman, J. (2004). The altered human is already here. New York Times, 6 April: F1.Google Scholar
Guess, H.A., Kleinman, A., Kusek, J.W., & Engel, L.W. (Eds) (2002). The science of the placebo: Toward an interdisciplinary research agenda. London: BMJ Books.Google Scholar
Harkness, J.M. (1996). Nuremberg and the issue of wartime experiments on US prisoners: The Green Committee. Journal of the American Medical Association, 276, 1672–1675.CrossRefGoogle ScholarPubMed
Healy, D. (2003). Lines of evidence on the risks of suicide with selective serotonin reuptake inhibitors. Psychotherapy and Psychosomatics, 72, 71–79.CrossRefGoogle ScholarPubMed
Juni, P., Nartey, L., Reichenbach, S., Sterchi, R., Dieppe, P.A., & Egger, M. (2004). Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. The Lancet, 364, 2021–2029.CrossRefGoogle ScholarPubMed
Kahn, J.P., Mastroianni, A.C., & Sugarman, J. (1998). Beyond consent: Seeking justice in research. Oxford: Oxford University Press.CrossRefGoogle Scholar
Kassirer, J.P. (2004). On the take: How medicine’s complicity with big business can endanger your health. Oxford: Oxford University Press.Google Scholar
Kent, D., Mwamburi, M., Bennish, M., Kupelnick, B., & Ioannidis, J. (2004). Clinical trials in sub-Saharan Africa and established standards of care: A systematic review of HIV, tuberculosis, and malaria trials. Journal of the American Medical Association, 292, 237–242.CrossRefGoogle ScholarPubMed
Kim, J.Y., Mukherjee, J.S., Rich, M.L., Mate, K., Bayona, J., & Becerra, M.C. (2003). From multidrug-resistant tuberculosis to DOTS expansion and beyond: Making the most of a paradigm shift. Tuberculosis, 83, 59–65.CrossRefGoogle ScholarPubMed
Lasagna, L.Prisoner subjects and drug testing. Fed Proc 1977 Sept 36(10): 2349–2351.Google ScholarPubMed
Lemmens, T., & Freedman, B. (1997). Ethics review for sale? Conflict of interest and commercial research ethics review. Milbank Quarterly, 78, 547–584.CrossRefGoogle Scholar
Lexchin, J., Bero, L.A., Djulbegovic, B., & Clark, O. (2003). Pharmaceutical industry sponsorship and research outcome and quality: Systematic review. British Medical Journal, 326, 1167–1170.CrossRefGoogle ScholarPubMed
Lurie, P., & Wolfe, S.M. (1998). Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries. New England Journal of Medicine, 337, 853–855.CrossRefGoogle Scholar
Lurie, P., & Wolfe, S.M. (2000). Letter to the National Bioethics Advisory Commission regarding their report on the challenges of conducting research in developing countries (HRG Publication #1545). URL (accessed January 2007): http://www.citizen.org/publications/release.cfm?ID=6746Google Scholar
Macklin, R. (1999). Against relativism: Cultural diversity and the search for ethical universals in medicine. Oxford: Oxford University Press.CrossRefGoogle Scholar
Marks, H. (1997). The progress of experiment: Science and therapeutic reform in the United States, 1900–1990. Cambridge: Cambridge University Press.Google Scholar
Marks, H. (2000). Where do ethics come from? The role of disciplines and institutions. Paper presented at the Conference on ‘Ethical Issues in Clinical Trials’, University of Alabama at Birmingham, 25 February.Google Scholar
Marks, H. (2002). Commentary. 3rd Annual W.H.R. Rivers Workshop, ‘Global Pharmaceuticals: Ethics, Markets, Practices’, Harvard University, 19– 21 May.Google Scholar
Masters, B., & Kaufman, M. (2004) Painful withdrawal for makers of Vioxx. Washington Post 18 October, A01.Google Scholar
Moynihan, R., & Cassels, A. (2005). Selling sickness: How the world's biggest pharmaceutical companies are turning us all into patients. New York: Nation Books.Google Scholar
Office of the Inspector General, Department of Health and Human Services (2001). The globalization of clinical trials: A growing challenge in protecting human subjects. Boston, MA: Office of Evaluation and Inspections.Google Scholar
Petryna, A. (2002). Life exposed: Biological citizens after Chernobyl. Princeton, NJ: Princeton University Press.Google Scholar
Petryna, A. (2005). Ethical variability: Drug development and the globalization of clinical trials. American Ethnologist, 32, 183–197.CrossRefGoogle Scholar
Petryna, A. (forthcoming) The human subjects research enterprise. Princeton, NJ: Princeton University Press.Google Scholar
Petryna, A., & Kleinman, A. (2006). The pharmaceutical nexus: An introduction. In Petryna, A.Lakoff, A. & Kleinman, A. (Eds), Global pharmaceuticals: Ethics, markets, practices. Durham, NC: Duke University Press.Google Scholar
Rothman, D. (2000). The shame of medical research. New York Review of Books, 47(19), 60–64.Google ScholarPubMed
Sim, I., & Detmer, D.E. (2005). Beyond trial registration: A global trial bank for clinical trial reporting. PLoS Medicine, 2, e365.CrossRefGoogle ScholarPubMed
Temple, R. (2002). Placebo-controlled trials and active controlled trials: Ethics and inference. In Guess, H.A.Kleinman, A.Kusek, J.W. & Engel, L.W. (Eds), The science of the placebo: Toward an interdisciplinary research agenda, 209–226. London: BMJ Books.Google Scholar
Wardell, W., & Lasagna, L. (1975). Regulation and drug development. Washington, DC: American Enterprise Institute for Public Policy Research.Google Scholar