In spite of an ongoing and increasing public outcry about laboratory use of animals for drug research, and in spite of growing evidence that animal test data is not valid for humans, the practice goes on in at least a third of all drug development in the EU.
Dr. Marlous Kooijman of Utrecht University’s Copernicus Institute for Sustainable Development in The Netherlands has published an article in the journal Perspectives in Laboratory Animal Science (PiLAS) that explains in part why this is still going on, and offers some suggestions about how it can be stopped or drastically reduced.She says: “The value of animal studies to predict risks for humans has never been extensively established. In fact, many studies indicate that the value of animal studies is often limited.”
European law (Directive 86/609/EEC) requires that alternatives to animals must be used where they are available. In spite of the development of many new techniques since the Directive was implemented, only a minority have replaced animal testing.Dr Koojiman’s review revealed that animal studies are locked-in to research, because they are embedded in a well-aligned set of regulations, norms and values that are taken for granted, normatively endorsed, and backed up by regulatory authorities.
She has made a series of recommendations to try to overcome the reluctance to change:
a) Governments should create incentives for the pharmaceutical industry to develop and use methods that can substitute animal studies; incentives could be created by rewarding the use of innovative methods and discouraging the use of animal studies.
b) The acceptance of patented innovative methods in regulation will accelerate the innovation process; the patenting of new methods will enable the costs of the development and validation to be recovered.
c) The revision of the validation process will contribute to the implementation of innovative methods; humane endpoints should be used as the reference for validation.
d) ‘Smart’ regulation, enabling science-driven drug development will contribute to the reduction of animal studies; smart regulation provides the opportunity to deviate from the drug development requirements, and thereby enables the use of innovative methods that are not validated.
e) Research on the predictive value of animal studies will increase the innovation process; if more research shows that the predictive value of animal studies is limited, then the legitimacy to use animals as models for humans will decrease, and this will provide opportunities for the implementation of innovative methods.
For further information see the full article at http://pilas.org.uk/why-animal-studies-are-still-being-used-in-drug-development/
Perspectives in Laboratory Animal Science (PiLAS) is published by the Fund for the Replacement of Animals in Medical Experiments as part of its scientific journal ATLA ( Alternatives to Laboratory Animals )