Five volunteers are seriously ill in hospital after a medical trial of a new painkiller went wrong. One was described as “brain dead” in a hospital in France while the other four were critically ill. A sixth person was also taken to hospital in Rennes as a precaution. Some of those who have been taken ill were suffering from a “handicap that could be irreversible,” said French health minister Marisol Touraine, who called it “a serious accident”. The trial, being carried out by international drug-testing company Biotrial, was said to be for a cannabis-based drug, although that has been denied.
The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital.
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”, said Ms Touraine. In all 90 people were involved but those who became unwell were in good health until taking the oral medication, the minister said. The first of them to fall ill was taken to hospital earlier this week. Ms Touraine expressed her “deep determination to get to the bottom… of this tragic accident”. A formal investigation has been opened in Paris.
This is the most serious case I have come across
Medical lawyer Philippe Courtois