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