PARIS: Six previously healthy medical volunteers were hospitalised last week_ including one man who is now brain dead _ after taking part in a botched drug test at a private clinic in western France, the French health ministry said on Friday.
The prosecutor’s office has opened an investigation into what French Health Minister Marisol Touraine called “an accident of exceptional gravity ... without precedence” in France at the Biotrial lab in Rennes.
The drug trial, which was testing a new painkiller compound, involved 90 healthy volunteers who were given the experimental drug in varying doses, she told reporters at a news conference in Rennes. All six hospitalized men were between 28 and 49 and were healthy when the trial began on Jan 7, she said, adding that one man now classified as brain dead was admitted to the Rennes hospital on Sunday.
The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said there was no known antidote to the experimental drug that Biotrial was testing. It’s rare for volunteers to fall seriously ill when testing new drugs.
Researchers generally start with the lowest possible dose for humans after extensive drug tests on animals. The French ministry statement said those who fell ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers.
Biotrial, with headquarters in Rennes and offices in London and New Jersey, United States, said it had over 25 years of experience in clinical trials and always used “state-of-the-art facilities.”
Published in Dawn, January 16th, 2016
