Drug Development

Bial accused of negligence in lethal drug trial — Nature

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 16,000+ biopharma pros who read Endpoints News articles by email every day. Free subscription.

Quick Subscribe

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.

Early Edition is a skimmable digest of original sources you need to see by ~7:15a ET, and our Main Edition is the daily chronicle of biotech, with every story inside the email ~11:55a ET.
2x/weekdays. Privacy policy