David Webb, president of the British Pharmacological Society, says that new revelations at a recent conference proved that the investigators from Portuguese biotech Bial were “flying blind” when they started a trial which left one patient dead and four others with lingering neurological damage.
The revelation, reports Nature, is that Bial overlooked the pharmacodynamic data on a low dose of BIA 10-2474 before taking the dose higher.
“Without the PD data, they were flying blind. That’s when accidents happen,” says Webb. “I think that was negligent.”
Bial, though, denies the allegation:
“All official reports about the trial were inconclusive and all have considered this event as unpredictable, and that there was no indication whatsoever, including in the pre-trials, that could have predicted this outcome.”
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