A man who was left brain-dead after a drug trial in France has died, the hospital treating him has confirmed.
He was one of six volunteers who suffered serious side effects from the Phase I trial, which was testing a new pain and mood disorder medication on humans for the first time.
Three of the men are suffering a “handicap that could be irreversible” while another is suffering neurological problems, said Pierre-Gilles Edan, head of the neurology department at the Rennes hospital. The sixth man has no symptoms but is being monitored.
Of the 108 volunteers who took part in the trial, run by private laboratory Biotrial, 90 were given the drug at varying doses (the remainder were given placebos).
The six men who were hospitalised received the highest dosages in the trial; the other 84 volunteers exposed to the drug have been contacted, the hospital said, but the ten who have come in to be examined so far have not had the “anomalies” seen in the other hospitalised.
Three separate probes have been launched to determine what caused this tragedy.
