France faults Bial and Biotrial for fatal drug

Portuguese drugmaker Bial and French laboratory Biotrial are at fault "on several counts" for a failed drug trial that left one person dead and five others hospitalized in January, French Health Minister Marisol Touraine said on Monday.

All trials of the drug, designed to treat mood and anxiety issues as well as coordination disorders linked to neurological issues, have since been suspended.

The victims were given the experimental drug made by Bial during a phase one trial at a private facility in Rennes, Brittany, run by France's Biotrial.

"A final investigation report confirms that the conditions under which the test was approved did not breach existing legislation," Touraine told journalists.

"Inspectors consider, however, that Bial and Biotrial are responsible on several counts; regarding the dosage prescribed (...) and the time taken to alert authorities," she said.

An initial inquiry in February had already established that Biotrial had been too slow to react when the first subject became sick.

Touraine said the five patients who had fallen ill after the trial were out of danger and no longer in hospital, but she criticized the way Biotrial had managed the crisis.

full story: www.reuters.com/article/us-fra…