Painkiller drug trialin turns tragic at Rennes University Hospital in northwestern France

January 16, 2016 6:17 am

Three of the participants critically injured in a botched drug trial in northwestern may have irreversible brain damage. A fourth man has already been declared brain dead.
The clinical trial was testing a painkiller based on a natural brain compound similar to the active ingredient in marijuana.


The trial was taking place at Rennes University Hospital in northwestern France. Photo / iStock

Professor Gilles Edan, chief neuroscientist at Rennes University Hospital, where the trial took place, confirmed today that the four men had “neurological problems”. In three cases the damage might be irreversible. The other man was already brain dead.
French Minister Marisol Touraine said the trial involved 90 healthy volunteers who were given the experimental drug in varying doses.
The man who is now brain-dead was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.
The trial had been stopped and all participants had been recalled.

The French state prosecutor has opened an inquiry.
Biotrial, a research company for the reported drug manufacturers, Bial, has defended its drug-safety testing record following the incident. A spokesman said the trial had been conducted in “full compliance with international regulations” and its own procedures, which included monitoring of the participants’ health.

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