Man dies after drug trial goes wrong

A man left brain dead after a drug trial in northwest France died on Sunday, said the hospital where he was being treated.

French Health Minister Marisol Touraine said that in addition to treating pain, the drug was meant to ease mood and anxiety troubles as well as motor problems linked to neurodegenerative illnesses by acting on the endocannabinoid system.

In a statement Biotrial said: “The trial has been conducted in full compliance with the global regulations”.

In the trial, run by the private research company Biotrial, the 6 men starting taking the investigational drug January 7, in varying doses.

The Rennes University Hospital in France announced the death of the man who suffered from the toxic effect of a drug he took after taking part in the phase one clinical trial for humans on a painkiller and mood disorder pill a Portuguese pharmaceutical company, Bial, are developing.

Professor Pierre-Gilles Edan, head of the neurology department at the hospital where the sick volunteers were taken, said on Friday that there was no known antidote to the drug.

The incident is the worst of its kind ever to have taken place in France, which has launched three separate probes to determine whether the tragedy was caused by an error in the trial’s procedures or in the substance tested. As per French health authorities, three other participants who are now in the hospital could face the brain damage condition. The six men who were hospitalized were the group that received the highest dose. “Five will have medical exams closer to their homes”. Touraine said the drug was not based on marijuana or cannabis, as some reported. The Paris Prosecutor has opened an investigation.

“On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule”, he said.

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.