It is one of the central aims of the philosophy of science to elucidate the meanings of scientific terms and also to think critically about their application. The focus of this essay is the scientific term predict and whether there is credible evidence that animal models, especially in toxicology and pathophysiology, can be used to predict human outcomes. Whether animals can be used to predict human response to drugs and other chemicals is apparently a contentious issue. However, when one empirically (...) analyzes animal models using scientific tools they fall far short of being able to predict human responses. This is not surprising considering what we have learned from fields such evolutionary and developmental biology, gene regulation and expression, epigenetics, complexity theory, and comparative genomics. (shrink)

Animals can be used in many ways in science and scientific research. Given that society values sentient animals and that basic research is not goal oriented, the question is raised.

The current use of animals to test for potential teratogenic effects of drugs and other chemicals dates back to the thalidomide disaster of the late 1950s and early 1960s. Controversy surrounds the following questions: 1. What was known about placental transfer of drugs when thalidomide was developed? 2. Was thalidomide tested on animals for teratogenicity prior to its release? 3. Would more animal testing have prevented the thalidomide disaster? 4. What lessons should be learned from the thalidomide disaster regarding animal (...) testing for teratogenicity? We review the literature in order to address these questions. (shrink)

Background: The requirement that animals be used in research and testing in order to protect humans was formalized in the Nuremberg Code and subsequent national and international laws, codes, and declarations.DiscussionWe review the history of these requirements and contrast what was known via science about animal models then with what is known now. We further analyze the predictive value of animal models when used as test subjects for human response to drugs and disease. We explore the use of animals for (...) models in toxicity testing as an example of the problem with using animal models.SummaryWe conclude that the requirements for animal testing found in the Nuremberg Code were based on scientifically outdated principles, compromised by people with a vested interest in animal experimentation, serve no useful function, increase the cost of drug development, and prevent otherwise safe and efficacious drugs and therapies from being implemented. (shrink)

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical studies from (...) journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (shrink)

Dear Editor,The April 2014 issue of Theoretical Medicine and Bioethics [1] presented eight essays regarding the use of nonhuman animals in biomedical research. While I appreciate the essays concerning contemporary research—which were well written and offered new thinking from the fields of ethics and ethology—I believe the journal, via the topics and the authors chosen, failed to communicate the most important fact regarding the current science pertinent to the use of nonhuman animals in research.The foundational reason for using chimpanzees and (...) other animals in research is their predictive value for human response to drugs and disease. This was alluded to by several of the authors when they discussed the necessity of using nonhuman animals. For example, Smith writes: “A common assumption in the selection of nonhuman animal subjects for research and the approval of research is that, if the risks of a procedure are too great for humans, and if there is a so-called scientific necessity, .. (shrink)

We argue that the recommendations made by the Institute of Medicine’s 2011 report, Chimpanzees in Biomedical and Behavioral Research : Assessing the Necessity, are methodologically and ethically confused. We argue that a proper understanding of evolution and complexity theory in terms of the science and ethics of using chimpanzees in biomedical research would have had led the committee to recommend not merely limiting but eliminating the use of chimpanzees in biomedical research. Specifically, we argue that a proper understanding of the (...) difference between the gross level of examination of species and examinations on finer levels can shed light on important methodological and ethical inconsistencies leading to ignorance of potentially unethical practices and policies regarding the use of animals in scientific research. (shrink)