A drug trial in France commissioned by Portuguese pharmaceutical company Bial has left one man brain-dead and five others have been rushed to hospital.
The trials in Brittany involved six people tested with an oral medication being developed by a European laboratory in Rennes where the “serious accident” happened, according to French Health Minister, Marisol Touraine.
Early French media reports indicate the trial was for a painkiller containing a cannabis derivative.
The study was being carried out by research company Biotrial on behalf of Bial (Portela e Cª, S.A.) based in Trofa, Oporto.
The study was a Phase I clinical trial where paid volunteers take the drug to "evaluate the safety of its use, tolerance and pharmacological profile of the molecule", Touraine said.
The use of human guinea-pigs is essential in these trials, as is a high level of external scrutiny, if the drug is to receive the go-ahead for production and sale but this is the first time a trial in France has gone so disastrously wrong.
The Paris prosecutor’s office said that an investigation has been started but it is unclear as to which laws, if any, have been broken.
Bial is an international Pharmaceutical Group of companies selling products in 40 countries. The Phase I clinical trial of BIA 10-2474, a drug targeting the endocannabinoid system, was said to involve a “cannabis-based painkiller,” a description denied by the French Health Ministry.
Marisol Touraine, French minister of social affairs and health, expressed her deep determination to discover the facts behind the tragic accident.
A drug trial accident in London in 2006 quickly became known as the ‘elephant man’ trial due to the catastrophic, multi-organ inflammation suffered by participants. All survived, but one had his toes and fingers amputated.
The accident caused the bankruptcy of TeGenero, the German company whose TGN1412 drug was being tested.
Prof Jayne Lawrence of the UK’s Royal Pharmaceutical Society, said of the French trial, “This type of incident is tragic but very rare in the world of clinical trials. There are very strict regulatory standards across the EU.”
