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France clinical trial: One person 'brain dead' and five more in hospital after drug testing 'accident' in Rennes France clinical trial: One person brain dead and five in hospital after cannabis drug testing 'accident' in Rennes
(35 minutes later)
One person has been left “brain-dead” and five more have been hospitalised after a clinical trial went wrong in France. One person has been left “brain-dead” and five more have been hospitalised after a clinical trial on a cannabis-based drug went wrong in France.
The Ministry of Health said the trial was being undertaken in Rennes on Thursday but did not confirm what was being tested, France Info reported. The health ministry said the “serious accident” happened on Thursday, stopping the tests and forcing all volunteers to be recalled.
Marisol Touraine, the French health minister, said she was travelling to the hospital where the group are being treated after what she called a “very serious accident”. A statement released today did not confirm the name of the drug being tested but French media reports claimed it was a new cannabis-based painkiller.
Taken orally, it was undergoing a Phase 1 clinical trial at a licenced 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, the French health minister, said she was travelling to Rennes, where the group are being treated, today.
“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.