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.”
Get Endpoints News in your inbox
News reports for those who discover, develop, and market drugs. Join 13,500+ biopharma pros who read Endpoints News articles by email every day. Free subscription.
You're subscribing to Endpoints News
John Carroll, Editor and Co-Founder
We produce two daily newsletters designed to give you a complete picture of what's important in biopharma.