A man who was left brain-dead after a drugs trial in France, went seriously wrong has died, according to the hospital which had been treating him.
Five other volunteers were also hospitalized after taking the trial painkiller, initially said to be a new ‘synthetic cannabis,’ on January 7 are now ‘in a stable condition’, according to the statement released by the hospital in Rennes.
But three of the men are suffering a ‘handicap that could be irreversible’, according to Pierre-Gilles Edan, the head of the hospital’s neurology department, and another has neurological problems.
It is the worst incident of its kind in French medical history, and the country’s health minister Marisol Touraine called it ‘an accident of exceptional gravity… without precedence’.
The volunteers took part in a trial run by private laboratory Biotrial, to test a new pain and mood disorder medication for Portuguese pharmaceutical company Bial.
A total of 108 volunteers took part in the trial – 90 of which were given the drugs in varying doses while the rest were given placebos.
The six men who were hospitalized – who were aged between 28 and 49 and were healthy when the trial began – were in the group given the highest dose.
The other 84 volunteers exposed to the drug, which has no known antidote, had been contacted by the hospital. Of those, 10 came in to be examined but didn’t have the ‘anomalies’ seen in the hospitalized patients.
It was the first time the drug had been tested on humans, in what is known as a Phase 1 trial to test the drug’s safety.
Three separate investigations have now been launched to determine whether the tragedy was caused by an error in the trial’s procedures or in the substance tested.
Biotrial General Director Francois Peaucelle
Biotrial general director Francois Peaucelle said it was not yet known what caused the tragedy.
Bial is cooperating with the investigation and vows it followed ‘international best practice’ in developing the drug
‘Our principal concern, at the moment, is taking care of participants in the trial,’ said Bial in a statement.
Initial reports claimed that the drug contained cannabinoids, an active ingredient found in cannabis, but those claims have been dismissed.
Ms Touraine said the drug was meant to act on the body’s endocannabinoid system, which deals with pain.