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France

Nothing to justify stopping clinical trials, says French health minister

media French Health Minister Marisol Touraine says there is no justification to stop clinical trials in France. REUTERS/Stephane Mahe

France’s health minister Marisol Touraine supported the continuation of clinical trials in France despite the death of a man during testing for a new drug.

“There is a major problem – massive, unprecedented in France – and we must understand what happened, but there is nothing to justify stopping clinical trials,” Touraine told RTL radio today.

Touraine however 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. Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly,” she said.

Six people were hospitalised after taking part in a Phase I trial for a new pain and mood disorder medication developed by a Portuguese company, Bial, and tested at the Biotrial private laboratory in the western French city of Rennes.

One person died on Sunday after being left brain dead following the trial. Five other volunteers remain in hospital in stable condition.

The Rennes university hospital announced the man's death on Sunday.

He had been admitted a week earlier suffering from side-effects incurred during a trial for a pain and mood disorder medication. The five other men who had taken the highest dose of the drug remained in hospital on Sunday.

Three of them were suffering a “handicap that could be irreversible” and another had neurological problems, the neurology department head, Pierre-Gilles Edan, said on Friday.

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 hospitalised 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.

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