According to the U.S. Food and Drug Administration (FDA), 92 percent of all drugs that are shown to be safe and effective in animal tests fail in human clinical trials, either because they are too toxic or not effective. Of the 8 percent of drugs that do pass clinical trials and receive FDA approval, half are later withdrawn from the market or relabeled for side effects not identified in animal researches. Based on these concepts and some others, where is the limit of animal testing? Is it really cost-effective and logical affair? Do you still believe in these kinds of experiments? Can we use modern in vitro and safe human-based methods instead of animal models to accurately test the safety and effectiveness of drugs in all directions?
In vitro test models often fail to detect systemic effects, because in vitro models do not reflect the systemic regulatory and feedback systems that occur in the whole animal. For some physiological systems, such as endocrine systems, there is a greater reliability between results in test animals and humans. If we can understand more about toxicity and specificity of actions, then we can improve computer models to replace animal testing for many drugs. We are just not at that point yet, but we may do better in the future as data are shared..
Human metabolic pathways as well as immune response genes are entirely different from animals. Any drug tested on rodents should never be considered safe and effective for human use. However, drugs tested on monkeys may be considered significantly safe and effective in humans.
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