Dr. Mario Pellegatti convincingly argues that large pharmaceutical companies are at once the current obstacle and future solution for reducing and replacing the use of dogs and nonhuman primates (NHPs) in pharmaceutical research Citation[1].
Dr. Pellegatti acknowledges that scientists have the responsibility to explore any opportunity to replace the use of animals in experiments, including actively promoting the validation and use of non-animal methods. His reasoning in encouraging particular attention to dogs and NHPs is clear: public opinion may be so disturbed by continued use of these particular animals that the pharmaceutical industry will be faced with legal mandates to halt their use before sufficiently developed non-animal replacements are available for them. The fading support for animal experimentation that Dr. Pellegatti references is clear, but it is true for experimentation involving all species – not only dogs and NHPs Citation[2]. If public opinion is the gauge by which we make goals for developing improved preclinical testing strategies, experiments using any species of live animal should be earmarked for replacement.
We agree that the development of replacements has been disappointingly slow and agree with Dr. Pellegatti's proposals for ways companies can contribute in solving this problem with the addition that these proposals should be extended to all animals. Researchers have repeatedly observed that it is simple to find a correlation between animal and human studies retrospectively, but accurately and prospectively predicting when the animal results are relevant to humans is nearly impossible because of interspecies differences Citation[3]. As a consequence, preclinical research using animals has not proven to be an effective approach in guiding the pharmaceutical industry toward new therapies that improve human health. To make matters worse, many methods that are developed and validated by regulators for use in place of animal experiments are simply not taken up by the very industries that could dramatically reduce the number of animals used in painful procedures by doing so Citation[4].
To move preclinical science toward a predictive and effective approach, Dr. Pellegatti's recommendations should be heard by pharmaceutical companies and applied to all in vivo preclinical studies. These recommendations should be accompanied by diligent agreements to transition away from the use of animals as non-animal approaches are developed. In his words, the goal is ‘not to replace all the presently used tests with new ones requiring fewer animals but to devise a totally new set of tests more predictive of human effects'. We could not agree more.
Declaration of interest
The author is employed by an animal protection organisation.
Author’s response
I thank Mr. Jeffrey Brown for his kind comments.
Although I do not share some of his opinions, for instance, I think that preclinical in vivo tests can be relevant to predict human responses in many cases, I do believe that only constructive dialogue among all the stakeholders: regulatory authorities, pharma industry, scientific community, animal welfare associations, patients' associations and politicians, can accelerate the pace toward reduction and replacement of animal tests.
As for the suggestion not to limit the discussion to NHPs and dogs, the best may be the enemy of the good in this case. Of course, one wishes that newly devised non-animal tests completely supersede animal experiments; unfortunately, replacement of preclinical in vivo tests is a tremendously difficult task and we are far from achieving it, as I mentioned in the paper. Replacement of all tests in mammals may well be the vision for the long-term future, but I, for myself, would be happy if I saw a substantial reduction in the use of primates and companion animals in my lifetime.
Mario Pellegatti
Independent DMOK Scientist,
37100 Verona, Italy [email protected]
Bibliography
- Pellegatti M. Dogs and monkeys in preclinical drug development: the challenge of reducing and replacing. Expert Opin Drug Metab Toxicol 2013;9(9):1171-80
- Goodman J, Borch C, Cherry E. Mounting opposition to vivisection. Contexts 2012;11:68
- Fletcher A. Drug safety tests and subsequent clinical experience. J R Soc Med 1978;71(9):693-6
- Dozier S, Brown J, Currie A. Bridging the gap between validation and implementation of non-animal veterinary vaccine potency testing methods. Animals 2011;1(4):414-32