One Person Brain Dead and Another Five Hospitalized in French Drug Trial Gone Horribly Wrong
According to reports, a private clinical drug trial in France went terribly wrong last night, landing at least six of its subjects in the hospital, with one patient confirmed brain dead.
The details are still scant, but it appears the subjects were healthy volunteers participating in a Phase 1 clinical trial administered by a European drug company at a licensed private institution in the northwestern city of Rennes. The drug they were testing, which has not been identified, was administered orally.
It’s still unclear what went wrong but the hospitalizations are highly unusual for a Phase 1 trial, which generally focuses on a drug’s safety, potential side effects and appropriate dosages.
In the meantime, the Times reports, the trail has been halted and the volunteers recalled. At least three agencies—the French Agency for the Safety of Health Products, the General Inspectorate of Social Affairs and the health branch of the Paris prosecutor’s office—are now reportedly investigating the incident.
France’s minister for social affairs, health and women’s rights, Marisol Touraine, issued a statement Friday expressing her “deep determination to shed light on this tragic accident and establish who was responsible.”
