Wednesday, January 12, 2022

How the Food & Drug Administration Can Reduce Animal Testing

Federal bureaucracies are like molasses or worse! Members of the U.S. Congress are not much better! The issue addressed in this article has been known for several decades!


"... If the FDA prioritizes science, health, and ethics over political considerations, it should support the development of sophisticated in vitro and computational approaches to curtail animal testing ...
The number of annually required animal tests is staggering. Over 110 million mice and rats are killed every year in the name of science in the U.S., as are other animals, including monkeys, rabbits, pigs, guinea pigs, cats, and dogs.

And the benefits are not always apparent. When the KHA [Kefauver–Harris Amendments (KHA) to the Federal Food, Drug and Cosmetic Act] was passed [in 1962], it was the scientific standard of its time. Sixty years later, scientists have learned that the results of animal tests are not necessarily useful or predictive in humans. Approximately 90 percent of early-phase clinical trials fail after extensive animal testing has already been conducted. Despite this, the FDA requires animal tests to be performed for almost every IND [Investigational New Drug] it reviews, regardless of utility. ...
Animal tests are often unnecessary. Aside from the many animal species and breeds involved, the variety of metabolic pathways and drug metabolites in animals leads to variation in efficacy, toxicity, disease latency, and dosing schedules. Often, the results are only loosely relevant to human beings. For example: isotretinoin, also known as Accutane, causes birth defects in rabbits, monkeys, and humans, but not in mice or rats. ..."

How the FDA Can Reduce Animal Testing | City Journal The agency should support sophisticated in vitro and computational approaches that can curtail—and potentially even replace—the practice.

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