Man dies after taking part in French drug trial
Howard Alexander - News Editor
French Health Minister Marisol Touraine, left, and Professor Gilles Edan, the chief neuroscientist at Rennes Hospital, address the media during a press conference held in Rennes, western France, Friday, Jan. 15, 2016. Six previously healthy medical volunteers have been hospitalized — including one man who is now brain dead — after taking part in a botched drug test at the Biotrial lab in western France, the French Health Ministry said Friday.
Image Credit: AP Photo/David Vincent
January 17, 2016 - 9:34 AM
PARIS - A man died in a French hospital Sunday after taking part in a drug trial for a painkiller based on a compound similar to cannabis, and five other participants remain hospitalized.
The Rennes University Hospital announced the death in a statement, but didn't identify the patient, who had already been in a state of brain death.
He was among six male volunteers between 28 and 49 hospitalized last week after volunteering to take the experimental drug. French health authorities have said three of the hospitalized volunteers face possible brain damage, and an investigation is underway into what French Health Minister Marisol Touraine called "an accident of exceptional gravity."
The trial, which began Jan. 7, involved 90 healthy volunteers who were given the experimental drug in varying doses at different times.
The hospital said it has contacted the 84 other volunteers exposed to the new painkiller. Ten of those volunteers underwent medical exams Saturday but the hospital found no anomalies, the statement says. It said another five will have medical exams closer to their homes.
The drug, based on a natural brain compound similar to the active ingredient in marijuana, 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 the Portuguese pharmaceutical company Bial.
In addition to treating pain, the drug was intended to ease mood and anxiety troubles as well as motor problems linked to neurodegenerative illnesses by acting on the endocannabinoid system. In this system, natural brain compounds act on specific receptors to exert their effects.
It's rare for volunteers to fall seriously ill during Phase 1 trials, which study safe usage, side effects and other measures on healthy volunteers, rather than drug effectiveness.
News from © The Associated Press, 2016