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The political dimensions of carcinogenic risk assessment of medicines
journal contributionposted on 2023-06-08, 04:51 authored by John Abraham
In the last 15 years carcinogenic risk assessment of pharmaceuticals has been challenged and re-shaped more than at any time since the late 1960s and early 1970s. Often these developments are represented as purely a consequence of technical advances in genetics. However, this presentation will highlight the political aspects of these changes. It will be argued that institutional, commercial and political interests have driven the effort to transform carcinogenic risk assessment, while technical advances have been sought to satisfy those interests. I shall argue that the reduction in carcinogenicity testing from two long-term (`lifespan¿) studies in two rodent species to one plus a short-term test is likely to compromise patient safety even by the technical standards evident within toxicology itself. The nature of technical uncertainty regarding mechanisms and genetic explanations for cancer will be considered in relation to assessing the risk of possible or suspected non-genotoxic carcinogenic pharmaceuticals. Notably, the changes involving these `new¿ alternative tests were adopted by ICH before they had been validated. Indeed, the very meaning of validation regarding carcinogenic risk assessment is a highly political issue. The political nature of the belated validation process will also be examined in terms of the institutions involved and the interpretative frameworks employed. Finally, my presentation will suggest that there is a need for a toxicological science driven more clearly by the interests of public health, and that this implies many priorities other than solely the ostensible acceleration of marketing approval of, and access to, new pharmaceuticals.
JournalToxicology Letters: Abstracts of the 44th Congress of the European Societies of Toxicology
Department affiliated with
- Sociology and Criminology Publications
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