French newspaper Le Figaro has accused Portuguese pharmaceutical company Bial of having omitted crucial information to volunteers who took part in the Phase 1 drug trial in France that killed one previously healthy person in January, and left four others with “life changing disabilities”.
Months after it was revealed that three dogs had died in preliminary testing of Bial’s molecule BIA 10-2474 (click here), it now emerges that rats, mice and primates also suffered irreversible consequences.
But nowhere in the 13-pages of documentation that volunteers were asked to sign was any of this explained.
Indeed one who survived the trail claims people signing up for it were told it was “not dangerous”.
“When I read the text (provided by the Biotrial laboratory in Rennes) I relaxed”, he told Le Figaro. “I was told there was no danger. Of course we now know those affirmations to have been completely false”.
The paper claims to have spoken with an expert (who did not want to be identified) who affirmed Biotrial even assured volunteers that any “alterations provoked” in the trial could be tackled when “it was known that the action of the molecule could cause irreversible damage”.
The story that has now been picked up by almost every French media source follows a report earlier this week stressing that “an expert panel” tasked with investigating the “worst accident of its kind in French medical history” has concluded that Bial’s molecule “seemed clearly linked” to what went so horribly wrong (click here).
The panel added that it was “inexplicable” that the molecule’s toxicity was not flagged in animal testing, particularly as “the administration of BIA 10-2474 reveals itself to be 10 times more active in people than animals”.
BIAL REFUTES LE FIGARO’S STORY
With Le Figaro’s story already making it into the Portuguese news, Bial and Rennes laboratory Biotrial have refuted the claims, assuring that everything they did “conformed with regulations”.
Bial’s President Luís Portela told SIC television news that “there was no perspective in preclinical trials that would have suggested something like this could happen”.
Portela was speaking on the same day that investigators moved in on the offices of French medical safety agency ANSM – searching, says SIC, for documentation that supported the fatal trial.
SIC claims the French public ministry is focused on suspicions of “murder and involuntary wounding”, adding that a leaked internal ANSM report showed clearly that a “non-clinical” evaluation of Bial’s molecule pointed to risks to the central nervous system “due to effects and lesions observed in the dog, mice, rat and monkey”.
The alert did not stop ANSM from okaying the trial however, as the “non-clinical” evaluation was simply “not included in the clinical evaluation”.
Thus, the controversy not only threatens the reputations of Bial and Biotrial but also that of ANSM which up until now has been ‘supported’ by French health minister Marisol Touraine.