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France clinical trial: 90 given drug, one man brain-dead | France clinical trial: 90 given drug, one man brain-dead |
(about 1 hour later) | |
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. | 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, the chief neuroscientist at the hospital in Rennes said. | There is no known antidote to the drug, the chief neuroscientist at the hospital in Rennes said. |
Of the five men in hospital, three could have permanent brain damage, Gilles Edan added. | Of the five men in hospital, three could have permanent brain damage, Gilles Edan added. |
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 trial, which involved taking the drug orally and has now been suspended, was conducted by a private laboratory in Rennes. | 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. | 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". | Health Minister Marisol Touraine pledged to "get to the bottom... of this tragic accident". |
"I was overwhelmed by their distress" she told reporters. "Their lives have been brutally turned upside down". | "I was overwhelmed by their distress" she told reporters. "Their lives have been brutally turned upside down". |
Analysis | |
By James Gallagher, health editor, BBC News website | |
This is the bitter price of the new medicines we take for granted. Testing such experimental drugs, at the cutting edge of science, can never be completely risk-free. | |
The safety and effectiveness of these drugs are rigorously tested in animals. The risks are low but there must still be a leap of faith when they are tried in people for the first time. | |
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". | |
It is a high price to pay, but thousands of people do safely take part in similar trials each year. | |
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 adverse effects occurred on Thursday. | According to the health ministry, the adverse effects occurred on Thursday. |
Clinical trials | Clinical trials |
Trials typically have three phases to assess a new medicine for safety and effectiveness | Trials typically have three phases to assess a new medicine for safety and effectiveness |
Has drug trial safety improved? | |
German medics challenge new EU clinical drug trials | |
Why 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 2018. |