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6 Sep 2008

16 June 2008

Acute toxicity tests challenged

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A working group of eighteen pharmaceutical companies and the government’s own National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs) recently announced that some short-term ‘acute toxicity’ tests on animals for new medicines, are unnecessary before clinical (human) trials. These tests involve giving animals very high drug doses to find the level that causes severe toxicity or death.

The companies admitted that information from specific acute toxicity studies is not actually used to inform the early drug development process or to set doses for the first clinical trials. The law states that an animal test may not be licensed where there is no clear scientific justification. Acute toxicity tests have long been criticised for being both unethical and unreliable for making human health decisions, however they continue to be licensed by the government.

The Dr Hadwen Trust is now actively engaged in discussions with the Home Office and the Medicines & Healthcare products Regulatory Agency. We believe that, with such a clear signal that even industry regards them as redundant in many cases, it’s time for the government to take action on acute toxicity tests.

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