Portuguese drugs company Bial has received the news it was dreading. An investigation into the devastating effects of a clinical trial that took place in France earlier this year – killing one volunteer and leaving four others with brain damage – has been opened by the French public ministry. The announcement today (on Tuesday) comes five months after what was termed “the worst accident of its kind in French medical history” (click here).
It also follows news almost two months ago that experts deemed the disaster “clearly linked” to Bial’s molecule 10-2474, rather than possible mistakes on how the drug was administered or its dosage (click here).
“The most likely hypothesis,” said the investigators’ report, “is that the molecule itself is toxic”.
But Bial is certainly not rolling over.
The flagship national pharmaceutical company has already issued a statement saying that the volunteer who died had “a long time before his participation in the trial, a hidden vascular intracranial pathology able to explain his fatality”.
Bial is thus said to be insisting it is privy to all the private medical details of volunteers said to have suffered life-changing disabilities as a result of their participation in the Phase 1 trial.
As the statement released today by France Presse explained, French public prosecutors will now have to decide whether what went wrong in the trial was caused by actionable failings, or “random scientific occurrence”.
