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.
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The trial involved 90 healthy volunteers who were given the experimental drug in varying doses at different times, she told reporters at a news conference in Rennes.
Biotrial, a private laboratory, was testing the drug, developed by Portuguese pharmaceutical company Bial, to treat mood swings and panic attacks. The men, in their 30s and 40s, started taking the drug on January 7 and started showing severe side-effects three days later.
Six male volunteers between 28 and 49 years old have since been hospitalized, including one man now classified as brain dead, Touraine said, adding that the other 83 volunteers were being contacted. Unfortunately for the six volunteers, there is no known treatment for the effects of the painkiller, says Gilles Edan, chief neuroscientist at Rennes Hospital.
Ten of those volunteers underwent medical exams on Saturday but the hospital found no anomalies, the hospital statement said. It said another five will have medical exams closer to their homes, but didn’t say whether the others are being monitored or tested.
The experimental drug is based on a natural brain compound similar to the active ingredient in marijuana.
The study was a Phase I clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, the French health ministry said in a statement.
The drug was given orally to healthy volunteers as part of a Phase 1 trial by Biotrial, a drug evaluation company based in Rennes, on behalf of Bial.
In a statement, Biotrial says the clinical trials were done following worldwide rules and its own procedures.
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Such serious mishaps are rare during the development of a drug, which begins in the laboratory before being animal tested and then three phases of human trials before it can be brought to market.
