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Science, politics, and health in the brave new world of pharmaceutical carcinogenic risk assessment: Technical progress or cycle of regulatory capture?

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  • Abraham, John
  • Ballinger, Rachel

Abstract

The carcinogenicity (cancer-inducing potential) of pharmaceuticals is an important risk factor for health when considering whether thousands of patients on drug trials or millions/billions of consumers in the marketplace should be exposed to a new drug. Drawing on fieldwork involving over 50 interviews and documentary research spanning 2002–2010 in Europe and the US, and on regulatory capture theory, this article investigates how the techno-regulatory standards for carcinogenicity testing of pharmaceuticals have altered since 1998. It focuses on the replacement of long-term carcinogenicity tests in rodents (especially mice) with shorter-term tests involving genetically-engineered mice (GEM). Based on evidence regarding financial/organizational control, methodological design, and interpretation of the validation and application of these new GEM tests, it is argued that regulatory agencies permitted the drug industry to shape such validation and application in ways that prioritized commercial interests over the need to protect public health. Boundary-work enabling industry scientists to define some standards of public-health policy facilitated such capture. However, as the scientific credibility of GEM tests as tools to protect public health by screening out carcinogens became inescapably problematic, a regulatory resurgence, impelled by reputational concerns, exercised more control over industry’s construction and use of the tests, The extensive problems with GEM tests as public-health protective regulatory science raises the spectre that alterations to pharmaceutical carcinogenicity-testing standards since the 1990s may have been boundary-work in which the political project of decreasing the chance that companies’ products are defined as carcinogenic has masqueraded as techno-science.

Suggested Citation

  • Abraham, John & Ballinger, Rachel, 2012. "Science, politics, and health in the brave new world of pharmaceutical carcinogenic risk assessment: Technical progress or cycle of regulatory capture?," Social Science & Medicine, Elsevier, vol. 75(8), pages 1433-1440.
  • Handle: RePEc:eee:socmed:v:75:y:2012:i:8:p:1433-1440
    DOI: 10.1016/j.socscimed.2012.04.043
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    References listed on IDEAS

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    1. Abraham, John & Reed, Tim, 2003. "Reshaping the carcinogenic risk assessment of medicines: international harmonisation for drug safety, industry/regulator efficiency or both?," Social Science & Medicine, Elsevier, vol. 57(2), pages 195-204, July.
    2. Abraham, John, 1998. "Regulating the cancer-inducing potential of non-steroidal anti-inflammatory drugs: Some lessons from the 1970s and 1980s," Social Science & Medicine, Elsevier, vol. 46(1), pages 39-51, January.
    3. Carpenter, Daniel P., 2004. "Protection without Capture: Product Approval by a Politically Responsive, Learning Regulator," American Political Science Review, Cambridge University Press, vol. 98(4), pages 613-631, November.
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    2. Patrick van Zwanenberg & Erik Millstone, 2014. "Taste and Power: the flavouring industry and flavour additive regulation," SPRU Working Paper Series 2014-15, SPRU - Science Policy Research Unit, University of Sussex Business School.

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