Friday, January 15

French drug trial turns disastrous, leaving 1 brain dead and 5 hospitalized

Health Minister Marisol Touraine, pictured, told reporters that she was overwhelmed by the distress of the harmed volunteers. "Their lives have been brutally turned upside down," she said. (credit: Journée Besoin de Gauche)

French authorities opened an investigation on Friday into an early-stage drug trial that went tragically awry, leaving one trial participant brain dead, five hospitalized, and several others with neurological disorders. Of the five hospitalized, three are suspected of having permanent brain damage.

The injured are among a group of otherwise healthy male volunteers participating in a phase I drug trial, which began in June. The trial was testing the safety of an oral medication made by Portuguese drug maker BIAL.

In a statement, BIAL described the drug as a pain medication, specifically an FAAH enzyme inhibitor, but the company provided little other details. Early reports by media suggest that the test drug may be compound BIA 10-2474, which BIAL describes as designed to treat “neurological and psychiatric pathologies.”

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