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French drug trial: one person brain dead and five critically ill One person brain dead after 'cannabis-based painkiller' medical trial in France
(35 minutes later)
Six people are seriously ill after taking part in a medical trial for a drug at an unnamed European laboratory in France. One person is brain dead and five others are seriously ill after taking part in a medical drug trial at a pharmaceutical firm at a clinic in north-west France.
The French health ministry did not say what the medicine was intended to be used for, and that the six patients, one of whom was brain dead, had been in good health until taking the oral medication. The French health ministry said the six patients had been in good health until taking the oral medication. The ministry did not say what the new medicine was intended to be used for. French media reported that the trial was for a cannabis-based painkiller.
French media reported that the trial was for a cannabis-based painkiller. The health minister, Marisol Touraine, said the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, Brittany.
“This test was carried out at a private establishment specialised in carrying out clinical trials,” the ministry said. The patients were admitted to hospital at the beginning of this week.
All trials on the drug at the clinic in Rennes, Brittany, have been suspended. The French state prosecutor has opened an inquiry. The ministry said the test was carried out by a private establishment “specialised in carrying out clinical trials”. The trial was intended to test for side-effects of the new drug.
The health minister, Marisol Touraine, is travelling to Rennes where she will give a press conference this afternoon. All trials on the drug at the clinic have been suspended and the French state prosecutor has opened an inquiry.
This is a breaking news story, please check back for further updates The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, Touraine said.
Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.
Touraine is travelling to Rennes where she will give a press conference this afternoon.
Agence France-Presse contributed to this story