The emergence of genetically-engineered animal models in carcinogenicity testing of pharmaceuticals: a case-study of process innovation

In this article, we explain the emergence of new short-term tests for carcinogenicity involving genetically engineered animals for the purposes of pharmaceutical regulation. Drawing on some long-standing theories of technological innovation, we argue that the alteration of carcinogenic risk assessment of pharmaceuticals, which occurred from 1998, did not result solely, or perhaps even mainly, from internal logical and technical developments in the experimental sciences of toxicology or genetics. Rather, this process innovation in regulatory science resulted from a complex interaction between scientist activism around molecularization of toxicology in powerful US government institutions, on the one hand, and a powerful research-based trans-national pharmaceutical industry committed to deregulatory mobilization, on the other, seeking to reduce carcinogenicity testing of its products and capable of marshalling significant support from governments and regulators, especially in Europe and Japan, to achieve that goal. The new techno-scientific basis for regulatory decisions about whether pharmaceuticals are carcinogenic risks to the public was, in effect, an accommodation in “bio-political“ trading between two power-blocks of expert scientists. Those from industry and their regulatory allies in Europe and Japan, who sought reductions in “the burden“ of drug testing, on the one hand, and FDA scientists, who did not accept the simple “reduction“ agenda, but were interested in shifting the paradigm of carcinogenicity testing toward geneticization, on the othe

Power, expertise and the limits of representative democracy: genetics as scientific progress or political legitimation in carcinogenic risk assessment of pharmaceuticals?

In modern ‘representative’ democratic states, the legitimacy of governments’ actions rests on their publicly declared commitment to protect the interests of their citizens. Regarding the pharmaceutical sector in most democracies, new drug products are developed and marketed by a capitalist industry, whose member firms, via shareholders, have commercial interests in expanding product sales. In those democracies, states have established government agencies to regulate the pharmaceutical industry on behalf of citizens. State legislatures, such as the US Congress and European Parliaments, have charged government drug regulatory agencies with the legal responsibility to protect public health. Yet, this paper argues that government drug regulatory agencies in the EU, Japan, and USA have permitted the pharmaceutical industry to reshape the regulatory guidance for carcinogenic risk assessment of pharmaceuticals in ways that are not techno-scientifically defensible as bases for improved, or even equivalent, protection of public health, compared with the previous techno-regulatory standards. By adopting the industry’s agenda of streamlining carcinogenicity testing in order to accelerate drug development and regulatory review, it is contended that these regulatory agencies have allowed the techno-regulatory standards for carcinogenic risk assessment to be loosened in ways that are presented as scientific progress resulting from new genetics, but for which there is little evidence of progress in public health protection