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Published on: November 26, 2015
Systematic reviews of animal experiments demonstrate poor contributions toward human healthcare
1Animal Consultants International, 91 Vanbrugh Ct., Wincott St., London SE11 4NR, UK. info@AnimalConsultants.org
Abstract:
Widespread reliance on animal models during preclinical research and toxicity testing assumes their reasonable predictivity for human outcomes. However, of 20 published systematic reviews examining human clinical utility, located during a comprehensive literature search, animal models demonstrated significant potential to contribute toward the development of clinical interventions in only two cases, one of which was contentious. Included were experiments expected by ethics committees to lead to medical advances, highly-cited experiments published in major journals, and chimpanzee experiments-the species most generally predictive of human outcomes. Seven additional reviews failed to demonstrate utility in reliably predicting human toxicological outcomes such as carcinogenicity and teratogenicity. Results in animal models were frequently equivocal, or inconsistent with human outcomes. Consequently, animal data may not generally be considered useful for these purposes. Regulatory acceptance of non-animal models is normally conditional on formal scientific validation. In contrast, animal models are simply assumed to be predictive of human outcomes. These results demonstrate the invalidity of such assumptions. The poor human clinical and toxicological utility of animal models, combined with their generally substantial animal welfare and economic costs, necessitate considerably greater rigor within animal studies, and justify a ban on the use of animal models lacking scientific data clearly establishing their human predictivity or utility.
Insights
Animal models show limited predictive value for human clinical outcomes and toxicity. Greater scientific rigor and validation are needed, with a potential ban on models lacking demonstrated human predictability.
Area of Science:
- Biomedical research
- Toxicology
- Preclinical studies
Background:
- Animal models are widely used in preclinical research and toxicity testing.
- Their predictivity for human outcomes is a key assumption in drug development and safety assessment.
Purpose of the Study:
- To evaluate the human clinical and toxicological utility of animal models.
- To assess the validity of assumptions regarding animal model predictivity.
Main Methods:
- Comprehensive literature search of systematic reviews examining animal model utility.
- Analysis of studies on clinical interventions and toxicological outcomes (carcinogenicity, teratogenicity).
Main Results:
- Only two of 20 systematic reviews found significant potential for animal models in clinical intervention development.
- Seven reviews showed poor utility in predicting human toxicological outcomes.
- Animal model results were often equivocal or inconsistent with human outcomes.
Conclusions:
- Current animal models generally lack demonstrated human clinical and toxicological utility.
- Assumptions of predictivity are invalid.
- Increased rigor and validation are necessary, with a ban on models lacking proven human predictability.
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