France clinical trial: One person brain-dead and five in hospital after drug testing 'accident' in Rennes
The health ministry has not yet confirmed what the drug undergoing testing was
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Andrew Feinberg
White House Correspondent
One person has been left “brain-dead” and five more have been hospitalised after a clinical trial on an experimental drug went wrong in France.
The health ministry said the “serious accident” happened on Thursday, stopping the tests and forcing all volunteers to be recalled.
A statement released today did not confirm the name of the drug being tested but French media reports claimed it was a new cannabinoid-based painkiller.
Marisol Touraine, the French health minister, later said that the pill did not contain cannabis or its derivatives but acted on the body's endocannabinoid system.
Taken orally, the drug was undergoing a Phase 1 clinical trial at a licensed private European laboratory that specialises in clinical trials, the French health ministry said.
The trial aimed to evaluate the “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers.
“Marisol Touraine wants to express her solidarity and deep determination to get to the bottom of what happened and establish responsibility for this tragic accident,” a statement added.
One of the six volunteers is currently in intensive care at Rennes University Hospital, where the other five are also being treated.
France’s medicines agency (ANSM) has launched an investigation into the laboratory.
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