Animal testing "taken for granted" in drug development

A third of tests still use animals in spite of increasing evidence that the value is limited

In spite of increasing evidence that animal studies are unreliable indicators of the safety and efficacy of drugs in humans, around a third of all animal tests carried out each year in the EU are for drug development.

In an article published in Perpectives in Laboratory Animal Science (PiLAS) Dr Marlous Kooijman of the Copernicus Institute for Sustainable Development at Utrecht University, The Netherlands looks at the reasons why animal tests are still such a significant part of the pharmaceutical industry.

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

March 12, 2014

FRAME

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FRAME is the Fund for the Replacement of Animals in Medical Experiments.

It promotes the replacement of laboratory animals with non-animal methods, through better science. 

Its ultimate aim is the elimination of the need to use laboratory animals in any kind of scientific or medical procedures. 

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FRAME is an independent charity dedicated to the development of new and valid methods that will replace the need for laboratory animals in medical and scientific research, education, and testing. FRAME believes in the development of better scientific methods for the benefit of humans, animals and the environment. Its ultimate aim is the elimination of the need to use laboratory animals in any kind of medical or scientific procedures, but FRAME accepts that a total end to their use cannot be achieved immediately. However, the current scale of animal experimentation is unacceptable.

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Around a third of all animal tests carried out each year in the EU are for drug development.
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Dr Marlous Kooijman