Thousands of rodents saved from drug testing

The firms, a list of which reads like a who's who of pharma, got together with the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (UK NC3Rs) to examine a particular toxicity test and found it was redundant. The process was supported by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Already the companies involved have cut the number of animals used in acute toxicity tests by 70 per cent and the NC3R will be hoping more firms follow suit. However, toxicity tests utilise 500,000 rats and mice every year and cutting this test will only reduce that number by 15,000. "​While we recognize that this reduction represents a small proportion of the total, it is an important step in the right direction,"​ said the leader of the review, Dr Sally Robinson, AstraZeneca. The single dose acute toxicity test is normally used to identify the minimum lethal dose of a medicine. However, following four years of data collection, the working group decided that the information obtained from the test had little or no value in assessing the risk to humans. "Appropriate safety testing with animals is a worldwide regulatory requirement, providing protection to the public and providing doctors with important information on how to administer new medicines,"​ explained Robinson. It was crucial that a number of pharma firms signed up to the review process as, for it to be worthwhile, data on as many different drugs as possible needed to be shared. In the end, preclinical and clinical data from 74 compounds was put under the spotlight. "Impressive results can be achieved when companies share appropriate data in a focused way and the NC3Rs has adopted a similar approach in other areas of animal use,"​ said Dr Kathryn Chapman, co-ordinator of the project, NC3Rs. The reviewers asked themselves if there was a better way to conduct this type of test. Writing in the latest edition of the Regulatory Toxicology and Pharmacology journal, they concluded that toxicity information "can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development."​ The next step is to change the regulations that require this test to be carried out and discussions with regulatory bodies have already begun. "This novel approach shows that significant progress can be made by going back to first principles and examining the need for a particular test, rather than trying to replace the test with non-animal methods,"​ added Chapman. The paper is entitled 'A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development'​ and includes authors from AstraZeneca, Roche, Eli Lilly, Johnson & Johnson (J&J), Pfizer, Novartis, Sanofi-Aventis, GlaxoSmithKline (GSK), Bayer Schering Pharma, Boehringer Ingelheim, Servier, Charles River Laboratories, Covance Laboratories, Nycomed, Aptuit, MDS Pharma Services and Huntingdon Life Sciences.