‘Serious Accident’ In Medical Drug Trial


Posted on: Fri 15-01-2016

One person is “brain dead” and five others seriously ill after a “serious accident” during a medical drug trial in France.
 
Six volunteers are seriously ill in hospital after a medical trial at a private clinic in France.
 
One of the six is described as “brain dead” while the other five are critically ill, according to the newspaper Ouest France.
 
The trial is related to a cannabis-based painkiller, led by a European laboratory, the newspaper said.
 
A total of eight people, aged 30-50, had taken part in the trial, but two were given a placebo, according to reports.
 
“A serious accident took place during a therapeutic trial near Rennes,” Health Minister Marisol Touraine said.
 
She added that the trial had been halted and all volunteers taking part recalled.
 
The minister said the six patients had been in good health until taking the oral medication.
 
The study was a Phase I clinical trial, where healthy volunteers take medication to evaluate its safety for wider use.
 
Ms Touraine expressed her “deep determination to get to the bottom… of this tragic accident”.
 
The first volunteers to fall ill were taken into hospital earlier this week, French media said.
 
A statement issued by the French health ministry confirmed that one of the volunteers is in an “état de mort cérébrale”, or “brain dead.”
 
Medical lawyer Philippe Courtois told French media: “This is the most serious case I have come across.”
 
A formal investigation has been opened in Paris.
 
The emergency comes almost 10 years after six students were left seriously ill after a medical trial in London.
 
In that case, the six volunteers had a severe immune reaction which was triggered by the antibody drug, TGN1412.
 
They survived after intensive care treatment, but were told they faced a lifetime risk of cancer and arthritis.
 
One patient lost fingers and toes to gangrene following the trial at Northwick Park Hospital in London.
 
Source: Leadership News