Jesse Gelsinger was 18 when he entered a study that tested the safety of gene therapy in kids with severe genetic mutations in the liver. Like the other children in the study, he had been born with a condition called OTC that prevented his liver from eliminating enough ammonia, which the researchers tried to fight by injecting him with a cold virus. But one high dose of the medicine would be Gelsinger’s last. On September 17, 1999, his symptoms quickly spiraled from jaundice, to organ failure, to brain death.

Trivia: Gene Therapy Clinical Trial
Trivia: Gene Therapy Clinical Trial

The FDA dug into this death and found a few eerily irresponsible actions on the part of the administrators. First, Gelsinger was in the final group of patients, and every group before him had suffered severe reactions to the drug. Yet the study continued. Secondly, Gelsinger’s levels of ammonia were so high that they should have disqualified him from the trial in the first place. He was originally intended as an alternate, but a patient dropped out, and he was hastily included in the study.

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