Animal Test Details Emerge in French Drug Trial Death

A new report details how preclinical drug experiments on animals failed to predict the death of one man and the hospitalizations of others in a Phase 1 clinical trial in France in January.

Rats, mice, dogs, and monkeys were all used in the preclinical toxicity tests, but “no ill-effects were noted in the animals, despite doses 400 times stronger than those given to the human volunteers,” according to the Agence France-Presse. In the affected human patients, the drug had “astonishing and unprecedented” reaction in the brain that was “unlike anything seen before.”

Learn more about the issue in “FDA: Accept human-focused preclinical tests to improve drug safety,” a new blog by Elizabeth Baker, Esq., the Physicians Committee’s senior science policy specialist for toxicology and regulatory testing.