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France clinical trial: 90 given drug, one man brain-dead

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.

16 January 2016, 9:21am
The chief neuroscientist at the hospital in Rennes said there was no known antidote to the drug
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.

Of the six 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.

A fifth man is suffering from neurological problems and a sixth man is being monitored but is not in a critical condition, Mr 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."

"I was overwhelmed by their distress," she told reporters. "Their lives have been brutally turned upside down."

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.

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