Regulatory Toxicology and Pharmacology 70 (2014) 733–734

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Letter to the Editor Rebuttal to the commentary regarding: The sympathy of policy-makers towards animal rights activists, and the future of biomedical research

In their letter to the editor (‘‘The sympathy of policy-makers towards animal rights activists, and the future of biomedical research’’), Vivarelli et al. (2014) seemingly miss the point of the European Directive 2010/63/EU on the protection of animals used for scientific purposes. They are stuck in the dark ages of science with little understanding of animal welfare, modern research technology and the abject failure of animal experimentation to help humans. The Directive was adopted following input from a Technical Expert Working Group, with the goal of replacing the use of animals in research whilst ensuring a high level of protection for animals used during progression toward that goal. The European community and the Directive recognise that animals are sentient beings who science has definitively shown routinely experience pain, suffering, depression, and anxiety in laboratories. Our responsibilities to protect them have become enshrined in the core values of the European Union. Following the European Parliament vote to revise the Directive, former European Environment Commissioner Janez Potocˇnik said, ‘‘. . .everyone agreed that it is vital to improve the situation for animals still needed in scientific research and safety testing, whilst maintaining a high standard of research and improving the focus on finding alternative methods to animal testing. The European Union will soon have the highest standards of experimental animal welfare in the world.’’ Whilst PETA and many in the scientific community dispute the notion that animals are ‘‘needed’’ for research, the Directive laudably aims to harmonise standards across Europe by raising Member States to a minimum level of care and protection. Given all we know of routine laboratory conditions confounding data obtained from animals, more standardisation of animal welfare measures would only improve the quality of science. Whilst Vivarelli et al. (2014) rail against modestly improving living conditions for animals in laboratories, an extensive body of literature shows that environmental enrichment reduces the development and frequency of abnormal behaviours and physiological and behavioural parameters of stress, fear and anxiety (Würbel and Garner, 2007). Environmental enrichment has been found to have no effect on the internal and external reproducibility of results (Wolfer et al., 2004; Würbel and Garner, 2007). Furthermore, enrichment can reduce the incidence of type II errors (failing to detect a significant effect when such an effect exists) (Macrì et al., 2013). If scientific results are not robust against minor variations in the housing and management of animals in laborato-

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ries, then the results, which already have questionable relevance to humans, are meaningless. Vivarelli et al. (2014) defend their regressive stance on animal welfare with the sweeping and unsupportable claim that ‘‘progress in biomedical research necessitates experiments on animals.’’ As the US Institute of Medicine states regarding the use of chimpanzees in experiments, ‘‘past use fails to predict future necessity.’’ Indeed, Pound and Bracken (2014) demonstrate that experiments on animals – from mice to monkeys – systematically fail to benefit humans. The past quarter century has brought us greater understanding of how biological processes work, allowing the development of superior testing and research methods that look directly at cellular mechanisms rather than at crude ‘‘black box’’ results from using animals. Forward-thinking scientists are developing and implementing methods for studying and treating diseases and testing products that do not entail the use of animals and are relevant to human health. Researchers have developed human cell-derived skin models, ‘‘organs-on-chips,’’ in silico models and other methodologies that can replicate human physiology, diseases, drug responses, and chemical exposure more accurately than experiments on animals (see PETA, 2014 for a review). Scientific and ethical considerations are turning the tides against experiments on animals. For everyone’s benefit, researchers should focus their considerable talent, time, money and energy on moving away from archaic animal use instead of strapping themselves in tighter on a sinking ship.

References European Commission, 2010. Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Available at: (accessed 18 July 2014). Macrì, S., Ceci, C., Altabella, L., Canese, R., Laviola, G., 2013. The Directive 2010/63/ EU on animal experimentation may skew the conclusions of pharmacological and behavioural studies. Sci. Rep. 3, 2380. PETA, 2014. Alternatives to animal testing. Available at: (accessed 24 July 2014). Potocˇnik, J., 2010. EU revises laws to better protect animals used in scientific experiments. Press Release, 9th September 2010. Available at: (accessed 18 July 2014). Pound, P., Bracken, M., 2014. Is animal research sufficiently evidence based to be a cornerstone of biomedical research? BMJ 348, g3387. Vivarelli, F., Sapone, A., Canistro, D., Paolini, M., 2014. The sympathy of policymakers towards animal rights activists, and the future of biomedical research. Regul. Toxicol. Pharmacol. 70, 577–578. http://dx.doi.org/10.1016/j.yrtph.2014. 07.005 [epub ahead of print].

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Letter to the Editor / Regulatory Toxicology and Pharmacology 70 (2014) 733–734

Wolfer, D.P., Litvin, O., Morf, S., Nitsch, R.M., Lipp, H., Würbel, H., 2004. Laboratory animal welfare: cage enrichment and mouse behaviour. Nature 432, 821–822. Würbel, H., Garner, J.P., 2007. Refinement of rodent research through environmental enrichment and systematic randomization. National Centre for the Replacement Refinement Reduction of Animals in Research #9, pp. 1–9. Available at: (accessed 18 July 2014).



Julia Baines Gilly Stoddart People for the Ethical Treatment of Animals Foundation, PO Box 70315, London N1P 2RG, United Kingdom ⇑ Corresponding author. E-mail address: [email protected] (J. Baines) Available online 27 August 2014

Rebuttal to the commentary regarding: The sympathy of policy-makers towards animal rights activists, and the future of biomedical research.

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