No Reason To Stop Drug Trials Despite Death: French Health Minister

Despite the death of a man during an experimental drug trial in France, the country’s health minister said there is no reason to stop medicine trials.

"There is a major problem -- massive, unprecedented in France -- and we must understand what happened, but there is nothing to justify stopping clinical trials," Marisol Touraine told France's RTL radio.

Pharma Company�s Experimental Drug Trial Turns Fatal in France
Biotrial was testing a new pain and mood disorder medication for Portuguese pharmaceutical company ‘Bial’ on humans for the first time to test the drug's safety.

‘On behalf of Portuguese pharmaceutical company Bial, the phase I trial for a new pain and mood disorder medication was tested by French laboratory Biotrial.’

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Touraine voiced concern that she was only informed of the accident four days after the patient who later died was rushed to hospital.

"A quicker alert would have been appreciated," she said.

"Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly."

Three Investigations Launched into the Tragic France Drug Trial
French authorities launched three investigations at a research laboratory in Rennes after a drug trial conducted there left one person brain-dead.

Six people were hospitalized after taking part in a Phase I trial for a new pain and mood disorder medication being tested by French laboratory Biotrial on behalf of Portuguese pharmaceutical company Bial.

One died on January 17 after being rendered brain dead. The other five, aged 28 to 49, were said to be in a stable condition.

Drug Trial Tragedies Are Very Rare in Clinical Trials
Six volunteers were hospitalised in France's western city of Rennes after taking part in the Phase I trial of a new medication meant to treat mood disorders.

A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses while the rest were given placebos. Those hospitalized had received the highest dose.

Three separate probes have been launched to determine whether the tragedy was caused by a procedural error or by the substance.

One Brain-Dead, Five Hospitalized in French Drug Trial: Health Minister
A 'serious accident' during a drugs trial in France has left one person brain-dead and five hospitalized, Health Minister Marisol Touraine said Friday.

Biotrial, which has been carrying out drug trials since 1989, said Sunday that the situation is "even more upsetting given that there is as yet no explanation".

Source-AFP