Drug-Trial in France Leaves One Brain Dead, Five Seriously Injured

(Reuters/AP) —

One person has been left brain dead and five others are in serious condition after taking part in a clinical trial in France of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

Gilles Edan, chief neurosurgeon of Rennes, the city in western France where the clinical trial took place, said that in addition to the one man that is brain dead, four others have “neurological problems” — of which three could have ‘irreversible’ brain damage. The sixth man is being kept in the hospital, but is in a less-critical state.

The French Health Ministry said that the six volunteers in Rennes had been in good health until taking the oral medication at a private facility that specializes in carrying out clinical trials.

The brain-dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.

The volunteers are all men aged 28 to 49, French Health Minister Marisol Touraine told a news conference. They started taking the drug on Jan 7. One person started feeling ill on Sunday and the other five afterwards.

In total, 90 people have taken part in the trial, taking some dosage of the drug, she said, adding that others took a placebo.

All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

 

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