Published online by Cambridge University Press: 14 September 2015
This article discusses the use of animals for the safety testing of chemicals, including pharmaceuticals, household products, pesticides, and industrial chemicals. It reviews changes in safety testing technology and what those changes mean from the perspective of industrial innovation, public policy and public health, economics, and ethics. It concludes that the continuing use of animals for chemical safety testing should end within the decade as cheaper, quicker, and more predictive technologies are developed and applied.
1. Lewis, C. The “poison squad” and the advent of food and drug regulation. FDA Consumer 2002;36 Nov–Dec:12.Google Scholar
2. Balls, M. The wisdom of Russell and Burch: 1. The concept, sources and incidence of inhumanity and its diminution or removal through implementation of the three Rs. ATLA 2012;40:P15–P16.Google Scholar
3. Russell, WMS, Burch, RL. The Principles of Humane Experimental Technique. London: Methuen; 1959.Google Scholar
4. Medawar, PB. The Hope of Progress. London: Methuen; 1972.Google Scholar
5. See note 4, Medawar 1972; emphasis added.
6. Home Office, United Kingdom. Collection: Animals in Science Statistics; 2014 July 10; available at https://www.gov.uk/government/collections/animals-in-science-statistics (last accessed 20 November 2014). The U.K. Home Office publishes an annual report and provides Excel files detailing the use of animals in laboratories. Up until 1987, the reports counted the number of “experiments,” and then from 1987 onward the reports counted the number of “procedures.” The change in terminology resulted in an increase in numbers (approximately 20%) because the term “procedures” includes animal breeding in laboratory facilities.
7. See note 3, Russell, Burch 1959.
8. Stephens, ML, Goldberg, AM, Rowan, AN. The first forty years of the alternatives approach: Refining, reducing and replacing the use of laboratory animals. In: Salem, D, Rowan, AN, eds. State of the Animals. Washington, DC: Humane Society Press; 2001:121–35.Google Scholar
9. See note 8, Stephens et al. 2001.
10. See note 6, Home Office 2014.
11. Association of the British Pharmaceutical Industry. Did You Know? Facts and Figures about the Pharmaceutical Industry in the UK, 2011. 2nd ed.; 2011; downloaded 2014 Nov 22; available at http://www.abpi.org.uk/our-work/library/industry/Documents/Did%20you%20know_Jan11.pdf (last accessed 1 Mar 2015).
12. Collins FS. Reengineering translational science: The time is right. Science Translational Medicine 2011 July 6;3(90):90cm17:1–6, at 3.
13. European Commission. EU Directive, Ban on Animal Testing; 2013 Mar 11; available at http://ec.europa.eu/growth/sectors/cosmetics/animal-testing/index_en.htm (last accessed 1 Mar 2015).
14. European Commission. European Partnership for Alternative Approaches to Animal Testing; available at http://ec.europa.eu/enterprise/epaa/index_en.htm (last accessed 1 Mar 2015).
15. Be Cruelty-Free. Creating a Cruelty-Free World: Ending Animal Testing for Cosmetics [Infographic]; available at: http://www.hsi.org/issues/becrueltyfree/facts/infographic/en/?org=hsus&credit=web_332371083&__utma=151455910.938259451.1435612088.1435612088.1435612088.1&__utmb=151455910.6.10.1435612088&__utmc=151455910&__utmx=-&__utmz=151455910.1435612088.1.1.utmcsr=%28direct%29|utmccn=%28direct%29|utmcmd=%28none%29&__utmv=-&__utmk=19386872 (last accessed 15 February, 2015).
16. See note 15, Be Cruelty-Free.
17. Food and Drug Administration. Innovation and Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. Washington, DC; 2004; available at www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm076689.htm (last accessed 13 September, 2014).
18. Kaitin, KI, DiMasi, JA. Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000–2009. Clinical Pharmacology and Therapy 2011;89(2):183–8.CrossRefGoogle ScholarPubMed
19. National Research Council. Toxicity Testing in the 21st Century: A Vision and a Strategy. Washington, DC: National Academy Press; 2007.Google Scholar
20. Collins, FS, Gray, GM, Bucher, JR. Transforming environmental health protection. Science 2012;319:906–7.CrossRefGoogle Scholar
21. Future Tox II: In Vitro Data and In Silico Models for Predictive Toxicology. Chapel Hill, NC; 2014 Jan 16–17; available at http://www.toxicology.org/slc/SLC_AnnualReport_2014.pdf (last accessed 29 Jun 2015).
22. Olson, H, Betton, G, Robinson, D, Thomas, K, Monro, A, Kolaja, G, et al. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regulatory Toxicology and Pharmacology 2000;32:56–67.CrossRefGoogle ScholarPubMed
23. Hay, M, Thomas, DW, Craighead, JL, Economides, C, Rosenthal, J. Clinical developmental success for investigational drugs. Nature Biotechnology 2014;32:40–51.CrossRefGoogle Scholar
24. See note 22, Olson et al. 2000.
25. Vogel F. Comment. In: Burm SM, Prins J-B, Langermans J, Bajramovic JJ. Workshop report: Alternative methods for the use of non-human primates in biomedical research. Altex 2014;14:520–9, at 521.
26. Environmental Protection Agency ToxCastTM program. See http://www.epa.gov/ncct/toxcast/ (last accessed 1 Mar 2015).
27. See note 19, National Research Council 2007.
28. Thomas, RS, Black, MB, Li, L, Healy, E, Chu, TM, Bao, W, et al. A comprehensive statistical analysis of predicting in vivo hazard using high-throughput in vitro screening. Toxicological Sciences 2012;128:398–417CrossRefGoogle ScholarPubMed.
29. See note 22, Olson et al. 2000.
30. See note 19, National Research Council 2007.
31. See note 26, Environmental Protection Agency 2015.
32. See note 22, Olson et al. 2000.
33. See note 28, Thomas et al. 2012.
34. Hayden EC. The $1,000 genome. Nature 2014;507:7492; available at http://www.nature.com/news/technology-the-1,000-genome-1.14901 (last accessed 1 Mar 2015).
35. Organization of Economic Cooperation and Development. Guidance Document on Developing and Assessing Adverse Outcome Pathways. Series on Testing and Assessment No. 184. Paris: OECD; 2013; available at http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2013)6&doclanguage=en (last accessed 1 Mar 2015).
36. On the DARPA program, see 10 human organs on a chip to be developed by DARPA and Harvard. 33rd Square; 2012 July 25; available at http://www.33rdsquare.com/2012/07/10-human-organs-on-chip-to-be-developed.html (last accessed 1 Mar 2015).
37. On the Innovative Medicines Initiative, see http://www.imi.europa.eu/ (last accessed 1 Mar 2015).
38. Weil, CS, Scala, RA. Study of intra- and inter-laboratory variability in the results of rabbit eye and skin irritation test. Toxicology and Applied Pharmacology 1971;19:276–360.CrossRefGoogle Scholar
39. Piesing M. How tech could spell the end of animals in drugs testing. The Observer 2014 Aug 23; available at http://www.theguardian.com/science/2014/aug/23/tech-end-animals-drugs-testing#start-of-comments (last accessed 1 Mar 2015).
40. Leist, M, Hasiwa, N, Rovida, C, Daneshian, M, Basketter, D, Kimber, I, et al. Consensus report on the future of animal-free systemic toxicity testing. Altex 2014;31:341–56CrossRefGoogle ScholarPubMed; available at http://dx.doi.org/10.14573/altex.1406091 (last accessed 1 Mar 2015).
41. Judson, RS, Martin, MT, Reif, DM, Houck, KA, Knudsen, TB, Rotroff, DM, et al. Analysis of eight oil spill dispersants using rapid, in vitro tests for endocrine and other biological activity. Environmental Science and Technology. 2010;44(15):5979–85.CrossRefGoogle ScholarPubMed
42. See note 12, Collins 2011.
43. See note 19, National Research Council 2007.
44. Lindsley, CW. New statistics on the cost of new drug development and the trouble with CNS drugs. ACS Chemical Neuroscience 2014;5:1142.CrossRefGoogle ScholarPubMed