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France clinical trial: One brain-dead, five seriously ill France clinical trial: 90 given drug, one man brain-dead
(35 minutes later)
A clinical trial of a new drug in France has left one person brain-dead and another five people in hospital, in a serious condition. 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.
The drug was administered to some 90 people, France's Health Minister Marisol Touraine said. There is no known antidote to the drug, the chief neuroscientist at the hospital in Rennes said.
The oral trial, which has now been suspended, was conducted by a private laboratory in the city of Rennes. Those in hospital are in serious condition, the French Health Minister Marisol Touraine said.
Reports that the drug is a cannabis-based painkiller have been denied by the health ministry.Reports that the drug is a cannabis-based painkiller have been denied by the health ministry.
The oral trial, which has now been suspended, was conducted by a private laboratory in the city of Rennes. All volunteers have been recalled.
The Paris prosecutor's office said an investigation had been opened.The Paris prosecutor's office said an investigation had been opened.
Ms Touraine pledged to "get to the bottom... of this tragic accident".Ms Touraine pledged to "get to the bottom... of this tragic accident".
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.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.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".The company insisted that "international regulations and Biotrial's procedures were followed at every stage".
According to the health ministry, the drug effects occurred on Thursday.According to the health ministry, the drug effects occurred on Thursday.
The worst of those affected is brain dead, it said, while the other five are described as being in a critical neurological condition.
Clinical trialsClinical trials
Trials typically have three phases to assess a new medicine for safety and effectivenessTrials typically have three phases to assess a new medicine for safety and effectiveness
Has drug trial safety improved?Has drug trial safety improved?
German medics challenge new EU clinical drug trialsGerman medics challenge new EU clinical drug trials
Why some new drugs cost so muchWhy some new drugs cost so much
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.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.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.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.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 May.New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.