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Portuguese drugs company refutes French criticism over medical trial tragedy

After French newspaper Le Figaro accused Portuguese drugs company Bial of “having lied to volunteers” in a medical trial that ended with the death of one and life-changing disabilities in four others, France’s health minister has agreed that Bial – as well as the Rennes laboratory Biotrial – were “responsible in many ways” for the tragedy.

But Bial is hitting back.

In a statement issued today (Monday), the company that is Portuguese largest pharmaceutical concern said that “decisions relating to the scale of doses were adequately taken”.

Bial claims this latest report is just another one that “does not allow for any conclusion as to the concrete cost of the accident, nor to the death of one of the volunteers who took part in the clinical trial”.

The company insists that to this day it has not been given free access to the medical history of volunteers who took part in the fated trial in January (click here), particularly with regard to the autopsy of the volunteer who died.

Such details are “essential for a thorough investigation” to take place, says the company which also asks why Monday’s report “did not clarify the actions” of Rennes Hospital which, it claims, were “fundamental” to the way the accident was managed.

Outlining Bial’s reluctance to take any kind of blame, noticiasaominuto refers to the fact that the French health ministry report “did not question the approval” of the trial protocol by French medical safety authority ANSM.

But at no point in Bial’s arguments is any mention made of the Le Figaro report last month which revealed that not only had three dogs died in preliminary testing of Bial’s molecule BIA 10-274, but also rats, mice and primates had suffered “irreversible consequences”.

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