Paris : A “serious accident” during a trial in France of a cannabis-based painkiller has left one person brain-dead and five hospitalised, said Health Minister Marisol Touraine, reports AFP.
She said the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, northwest France.
“A serious accident took place,” the minister said, adding the study had been halted and all volunteers taking part recalled. The Paris prosecutor’s office said an investigation had been opened.
Clinical trials typically have three phases to assess a new drug or device for safety and effectiveness. Human participation in such trials and scrutiny by outside watchdogs are essential for getting market authorisation.
The study was a Phase I clinical trial, in which healthy volunteers take a prototype medication to ‘evaluate the safety of its use, tolerance and pharmacological profile of the molecule’, the minister added in a statement.
