Clinical trials lawyer calls for accountability following deeply saddening events in France
A French drug trial has left one participant brain dead and five others in a critical condition.
The six participated in a trial of an oral medication in Rennes, Brittany. The Guardian reports the patients were admitted to hospital at the beginning of the week following what the French Health Minister, Marisol Touraine, describes as a “tragic accident”.
Ms Touraine explained the trial was a Phase One clinical trial, intended to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule” in healthy volunteers. The drug has not been named, but is reported by the French daily Le Figaro to be a painkiller containing cannabinoids, an active ingredient found in cannabis plants. The volunteers were said to be in good health before taking the drug at home.
The French health ministry confirms the drug was developed by a European laboratory which was licensed to operate, but has not named the developing Pharmaceutical group. The tests were carried out at a private establishment reported to be specialised in carrying out clinical trials. All trials on the drug at the clinic have been suspended, and all volunteers taking part recalled.
Ms Touraine has expressed her “deep determination” to “establish responsibility” for the incident. She will give a press conference in Rennes at 16:30 this afternoon. France’s medicines agency (ANSM) has launched an investigation into the laboratory.
“A well-regulated clinical trial regime is crucial to the safe development of new drugs, and most drug trials are carried out successfully and without any dangerous side-effects for the people involved.
“However, when drug trials go wrong the results can be catastrophic. My clients who were injured in the Northwick Park drug trials were left with serious health problems.
Sadly, any regulatory investigation or prosecution will be of little comfort to the volunteers who have suffered catastrophic and life changing injuries.
I hope that the people who have been injured in France receive swift and adequate compensation to help them recover from their ordeal.”