The Scientific Problems with Using Non-Human Animals to Predict Human Response to Drugs and Disease

Abstract

Drawing on theoretical principles, based on evolutionary biology and complex systems, and based on extensive empirical evidence, the position that animal modeling has predictive value for human response to drugs in general has been falsified. tsmt is a theory, and, like all scientific theories, it is consistent with this definition from the National Academies of Science Engineering Medicine (2016): "In everyday usage, theory often refers to a hunch or a speculation. When people say, I have a theory about why that happened, they are often drawing a conclusion based on fragmentary or inconclusive evidence. The formal scientific definition of theory is quite different from the everyday meaning of the word. It refers to a comprehensive explanation of some aspect of nature that is supported by a vast body of evidence. Researchers who aim to improve human outcomes cannot continue to treat humans and non-human animals as simple systems and expect results based on non-human animals to translate to human patients. tsmt is the first comprehensive theory that explains the past failures and apparent successes of animal modeling and also explains why animal models will never achieve predictive value and, thus, should be abandoned. We acknowledge that the scientific community as a whole is not yet familiar with tsmt; but we are confident that, in time, a consensus will be reached. Kramer and Greek (2018) explain the obstacles that must be overcome to ensure that drug development and the study of diseases are based on sound science. This will require changes to the regulations that currently mandate the use of animal models. Furthermore, Kramer and Greek (2018) discuss modern techniques that fall under the heading of personalized medicine, which offer treatments and cures that are customized to a patient's individual genetic make-up and, hence, sidestep the significant risks associated with the continued blind reliance on methods arising from the use of animal models.