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The alleged issues apply to only a small subset of the clinical sites/volunteers in the trial: > In her 25 September email to the FDA Jackson wrote that Ventav
by sterlind 5y ago
The alleged issues apply to only a small subset of the clinical sites/volunteers in the trial:
> In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres.
Ventavia looks sketchy, but this affects 1/44th of the patients and 3/153 of the sites. There's nothing to suggest they fudged the numbers in Pfizer's favor either, only that they were sloppy.
- AndrewBissell 5y agoThe greater cause for concern is the fact that the whistleblower submitted a report to the FDA which was ignored, and was then fired in retaliation. That suggests the possible presence of systemic weaknesses with much broader impact beyond Ventavia. The inability to swab 477 trial participants to test for SARS-CoV-2 infection is also pretty bad given that confirmed symptomatic cases of COVID were the metric used to establish the efficacy numbers in the trial.
- sterlind 5y agodid someone in the FDA disclose the whistleblower's identity to Ventavia? or did they figure it out on their own? retaliation either way, but I didn't see any evidence of conspiracy in the article.
- AndrewBissell 5y agoYeah the article doesn't make it clear. In my own reading I had assumed Ventavia figured it out on its own.
- mewpmewp2 5y agoThere's countless of other questions and concerns this article brings up in my view. You must really give benefit of the doubt to Pfizer to not expect there to be something wrong with the final data.