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Special Section: Moving Forward in Animal Research Ethics
I am deeply indebted to David DeGrazia, Tom Beauchamp, and John Pippin for their careful review and helpful comments. The opinions expressed here are those of the author and do not represent the official position of the U.S. Food and Drug Administration or the U.S. government.
Introduction
Annually, more than 115 million animals are used worldwide in experimentation or to supply the biomedical industry.1Nonhuman animal (hereafter "animal") experimentation falls under two categories: basic (i.e., investigation of basic biology and human disease) and applied (i.e., drug research and development and toxicity and safety testing). Regardless of its categorization, animal experimentation is intended to inform human biology and health sciences and to promote the safety and efficacy of potential treatments. Despite its use of immense resources, the animal suffering involved, and its impact on human health, the question of animal experimentation's efficacy has been subjected to little systematic scrutiny.2
Although it is widely accepted that medicine should be evidence based, animal experimentation as a means of informing human health has generally not been held, in practice, to this standard. This fact makes it surprising that animal experimentation is typically viewed as the default and gold standard of preclinical testing and is generally supported without critical examination of its validity. A survey published in 2008 of anecdotal cases and statements given in support of animal experimentation demonstrates how it has not and could not be validated as a necessary step in biomedical research, and the survey casts doubt on its predictive value.3I show that animal experimentation is poorly predictive of human outcomes,4that it is unreliable across a wide category of disease areas,5and that existing literature demonstrates the unreliability of animal experimentation, thereby undermining scientific arguments in its favor. I further show that the collective harms that result from an unreliable practice tip the ethical scale of harms and benefits against continuation in much, if not all, of experimentation involving animals.6
Problems of Successful Translation to Humans of Data from Animal Experimentation
Although the unreliability and limitations of animal experimentation have increasingly been acknowledged, there remains a general confidence within much of the biomedical...