French drug trial disaster leaves one brain dead, five injured
One person has been left brain dead and five others have been hospitalised after taking part in a clinical trial in France of an experimental drug made by Portuguese drug company Bial, French Health Minister Marisol Touraine said on Friday, according to Reuters.
In total, 90 people have taken part in the trial, taking some dosage of the drug aimed at tackling mood and anxiety issues, as well as movement coordination disorders linked to neurological issues, Touraine said.
The six men aged 28 to 49 had been in good health until taking the oral medication at the Biotrial private facility that specialises in clinical trials, she said.
"This is unprecedented," Touraine told a news conference after meeting volunteers and their families in Rennes, western France. "We'll do everything to understand what happened."
Prosecutors have opened an investigation into the case.
The six men started taking the drug on Jan. 7. The brain-dead volunteer was admitted to hospital on Monday, the minister said.
For three of the five others - who went in on Wednesday and Thursday - there are fears of irreversible handicap, doctor Gilles Edan said, though he still hoped that would not be the case. One of the six had no symptoms but was being carefully monitored, he said.
Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.
All trials on the drug have now been suspended and all volunteers who have taken part in the trial are being called back, the health ministry added.