Man dies after taking part in French drug trial

The man who was left brain-dead after a botched drug test in Rennes in northwest France died on Sunday, the regional hospital center CHR announced Sunday afternoon.

In total 128 had taken part in the trial – 90 were given the drug at different dose levels and the others received a placebo.

He had been admitted a week earlier suffering from side-effects incurred during a trial for a pain and mood disorder medication developed by a Portuguese company, Bial, and tested at the Biotrial private laboratory in the western French city.

He was among six male volunteers between 28 and 49 hospitalized last week after volunteering to take the experimental drug.

The Portuguese pharmaceutical company testing the drug, Bial, said in a statement that it’s working with health authorities to determine what caused “this tragic and unfortunate situation”.

Five other men who had been hospitalized after participating in the drug trial were in stable condition, the hospital said. Four have “neurological problems” and one has no symptoms but is still being monitored.

“This accident caused the hospitalisation of six of the volunteers at the University Hospital of Rennes“.

The experimental drug is based on a natural brain compound similar to the active ingredient in marijuana.

Three of those in hospital could have been left with permanent brain damage, according to doctors in Rennes, where the men are being treated. Ten of them came in to be examined and did not have the “anomalies” seen in the hospitalised patients.

The trial conducted by drugs company Biotrial, which began on 7 January, has now been halted.

In a statement, Biotrial says the clinical trials were done following global rules and its own procedures.

French Health Minister Marisol Touraine said the incident was unprecedented in France, and promised the French government would do everything to understand what had happened.

France’s public body Oniam, responsible for compensating the victims of medical accidents, said it had in its files only about 10 cases of accidents during drug trials over the past 15 years, and “with consequences infinitely less serious” than the case in Rennes.