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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.
Highlights
Consistent with capture theory, we suggest that the regulatory resurgence, which followed, exhibited reduced concern to accommodate industry interests and was an attempt by regulators to reassert their reputation as guardians of a regulatory science intended to screen out carcinogenic dangers to public health, rather than solely a result of learning more about the science
Capture theory’s first phase is irrelevant here because the Food and Drug Administration (FDA) long pre-dated carcinogenicitytesting standards, while the European Medicines Agency (EMA) resulted from Europeanization politics, rather drug disasters (Abraham & Lewis, 2000; Carpenter, 2010)
We maintain that developments in carcinogenicity-testing standards since ICH can be understood in terms of the second and third phases, namely, ‘capture’ and ‘regulatory resurgence’, albeit with some theoretical innovations
Summary
Most social scientists researching pharmaceuticals have devoted attention to clinical trials and post-marketing experiences of medicines, which involve patients/users directly (Abraham & Davis, 2010; Abraham & Sheppard, 1999; Daemmrich, 2004; Epstein, 1996; Fisher, 2009; Healy, 2004; Hedgecoe, 2004; Light, 2010; Pearce, 2007; Petryna, 2009). That deregulatory legislative reforms in the last 15e20 years by EU and US governments have rendered capture theory irrelevant because they have mandated their respective drug regulatory bodies, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), to facilitate many industry goals Those reforms emphasized regulators’ role in promoting health by approving new drugs on to the market, as well as protection of public health from unsafe drugs. Often put forward by official representatives of drug regulatory agencies and the pharmaceutical industry, is that the introduction, validation, and use of GEM tests was an example of industry and regulators working and learning together in a scientific quest to improve carcinogenic risk assessment On this view, the trajectory of regulatory agencies’ action should be understood as that of a ‘learning regulator’ in the face of unfolding scientific developments, rather than in terms of capture theory (Carpenter, 2004). To examine the interest-politics of the introduction of GEM tests into drug development, and the applicability of capture theory therein, we investigated the financial/organizational control, methodological design, and interpretation of results, of the GEM tests’ validation process; and considered the types of GEM tests selected for use by industry, the issues that attended industry use, and the responses by regulators and experts to the outcomes of such use
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