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French drug trial volunteer dies: hospital

According to the hospital that had been treating him, five other volunteers admitted a week ago when the drug trial went wrong are “in a stable condition”.

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The six men aged between 28 and 49 who were hospitalised were the group which received the highest dose of the test drug.

A man has passed away a week after he was declared brain-dead following his participation in a drug trial for a painkiller based on a compound similar to cannabis.

The Biotrial laboratory in Rennes, western France, where a clinical trial of an oral medication left one person dead and hospitalised another five.

The study was a Phase I clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, French Health Minister Marisol Touraine said in a statement on Friday.

BIAL issued a communiqué stating that “it is strongly committed to ensuring the well-being of all the participants in this trial and intends to determine the causes behind this situation”.

The French body responsible for compensating victims of such accidents said in the past 15 years, it had reports of only 10 cases of problems with drug trials, and none had had such dire effects on volunteers.

Brassier, head of Rennes University Hospital’s medical commission, announced that neither clinical nor radiological anomalies were found in 18 other volunteers checked so far. The activity was held on a clinic in France headed by the research company Biotrial according to The Guardian.

A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses, while the rest of the people were given placebos.

Francois Peaucelle is the Managing Director of Biotrial, a drug evaluation company working on behalf of Portuguese pharmaceutical company Bial, which manufactured the drug.

The controversial drug was also meant to ease mood and anxiety troubles.

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Brain scans show 4 volunteers may have suffered serious neurological damage, and the hospital says there is no treatment to reverse their side effects.

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