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| France clinical trial: One person brain-dead and five in hospital after cannabis drug testing 'accident' in Rennes | |
| (about 2 hours later) | |
| 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. | 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 health ministry said the “serious accident” happened on Thursday, stopping the tests and forcing all volunteers to be recalled. | 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 cannabis-based painkiller. | 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. | 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. | 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, 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. | “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. | 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. | France’s medicines agency (ANSM) has launched an investigation into the laboratory. |