Clinical trial of new drug in France leaves one brain-dead, five others critically ill

Reports say one person is brain dead and five others are seriously ill after taking part in a drug trial for an unnamed pharmaceutical firm at a clinic in north-west France.

 
According to the French Health Ministry, the six patients had been in good health until taking the oral medication. It did not say what the new medicine was intended to be used for, but a source close to the case revealed that the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants.

 
Health Minister, Marisol Touraine, said on Friday (today) that the six had been taking part in a “trial of an oral medication being developed by a European laboratory” in Rennes, Brittany. The patients were admitted to hospital at the beginning of this week.

 
The ministry said the test was carried out by a private establishment “specialised in carrying out clinical trials”. However, local media reported that the trial took place at the Biotrial clinic.

 
The trial was intended to test for side-effects of the new drug. All trials on the drug at the clinic have been suspended and 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. She is travelling to Rennes where she will give a press conference on this afternoon.

 

 

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.

 

 

Every year thousands of volunteers, often students looking to make extra money, take part in such trials. Mishaps are relatively rare, but in 2006 six men fell ill in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia.

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