Drug trials in France leave 1 brain-dead, 5 critical
16 Jan 2016
One man is brain-dead and another five people are in hospital after an experimental drug was administered to 90 people in a French clinical trial.
There is no known antidote to the drug, Gilles Edan, the chief neuroscientist at the hospital in Rennes said.
Of the six men in hospital, three could have permanent brain damage, he added.
Reports that the drug is a cannabis-based painkiller have been denied by the health ministry.
A fifth man is suffering from neurological problems and a sixth man is being monitored but is not in a critical condition, Edan said.
The trial, which involved taking the drug orally and has now been suspended, was conducted by a private laboratory in Rennes.
The experimental drug was manufactured by the Portuguese company Bial.
All those who volunteered for the trial have been recalled and the Paris prosecutor's office has opened an investigation.
Health Minister Marisol Touraine pledged to "get to the bottom ... of this tragic accident". Touraine travelled to Rennes to monitor the incident.
"I was overwhelmed by their distress," she told reporters. "Their lives have been brutally turned upside down."
This trial has been taking place since July without such major events being reported. Generally in Phase I trials the dose is increased slowly over time, which could be why the side-effects are appearing now.
The hospitalised men started taking the drug regularly on 7 January and began showing severe side-effects three days later.
Three of the volunteers are now facing a lifetime of disability in this "accident of exceptional gravity".
The trial was conducted by Biotrial, a French-based company with an international reputation which has carried out thousands of trials since it was set up in 1989.
In a message on its website, the company said that "serious adverse events related to the test drug" had occurred.
The company insisted that "international regulations and Biotrial's procedures were followed at every stage".
According to the health ministry, the adverse effects occurred on Thursday.
The study was a Phase I clinical trial, in which healthy volunteers take the medication to evaluate the safety of its use, the ministry said.
Before any new medicine can be given to patients, detailed information about how it works and how safe it is must be collected.
Clinical trials are the key to getting that data - and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis.
Every year around the world thousands of people take part in clinical trials but incidents like this are very rare, the BBC's Hugh Schofield reports from Paris.
New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in 2018.
