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12 March 2013

In vivo testing biopharmaceuticals leads to useless animal deaths

Animal testing of biopharmaceuticals, i.e. human proteins produced by biotechnology, often is a useless exercise, according to Professor Huub Schellekens of the Netherlands based Utrecht University.

Biopharmaceuticals are very specific: they each bind to only one specific human protein, and since animals often don't possess this protein, safety studies will yield irrelevant data. However, because of the foreign nature of the biopharmaceutical, an immunological reaction will likely occur and thus disturb the test itself. For this reason, predicting immunological side effects in humans from this kind of testing is a futile exercise.

Safety testing of biopharmaceuticals in certain apes might seem logical, because some types of non-human primates can indeed possess proteins similar to humans. According to researcher Peter van Meer, however, 'even in these cases, one can never be sure that the results can be translated to the human situation in a meaningful way. Besides, because of ethical and financial issues when testing on apes, usually such a small number is being tested that the statistical relevance of the outcome is highly questionable'.

For the prediction of side effects, which are unwanted secondary activities of biopharmaceuticals, animal testing also is for the most part unnecessary, according to Van Meer and colleague researcher Marlous Kooijman. 'Side effects caused by biopharmaceuticals primarily arise as a result of their pharmacological action, so that they can be perfectly well studied in vitro, i.e. in a test tube instead of in an animal.' In addition, Van Meer and Kooijman propose to replace many tests now performed on animals by micro-dosing (i.e. at very low concentrations) tests in humans.

According to the researchers it should be possible to transition towards a situation without useless animal testing. 'Nowadays animal testing has become a routine with no or very little information being gained from most of these tests. According to Schellekens the number of uselessly killed animals amounts to the staggering number of 100.000 on a yearly basis: 'This is a very rough, but also very conservative estimate'.

Click here to read the EOS Magazine article.

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Hugo Hurts
Director/Secretary of the Medicines Evaluation Board

Hugo Hurts
Director/Secretary of the Medicines Evaluation Board

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