At least six people have fallen seriously ill, one brain dead, after taking part in a medical drug trial, for an unnamed European pharmaceuticals firm, in France.
One person is brain dead and five more are seriously ill after taking part in a medical drug trial for an unnamed European pharmaceuticals firm at a clinic in France.
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.
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, northwest France.
The patients were admitted to hospital at the beginning of this week.
The health 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.
All trials on the drug at the clinic in Rennes, Brittany, have been suspended. The French state prosecutor has opened an inquiry.
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.