Robin Hood Was A Thief said:
cisgenderedAggie said:
I'm not sure what it's claiming was misrepresented to the FDA. FDA gets the data and does their own analyses. Sometimes they agree with the Sponsor, sometimes they don't. Either way, their own analysis is what matters.
You're not sure? Pfizer allegedly reported it as "functional abdominal pain." This child was put into a wheel chair and given a feeding tube.
It's hard to make much of that small clip without seeing the rest of the documentation. It reads like a high level summary.
When you report AEs in a study, you have to categorize them according to a standardized medical dictionary, usually MedDRA. For something unusual, there's not always a good fit and a best attempt has to be made. The categorization will be made by the investigator (not Pfizer) in collaboration sometimes with the medical monitor (likely a physician at pfizer). Those categories are used in summary tables and high level summaries of the events.
When a Serious Adverse Event is reported, it must have an investigation and a narrative written to describe what occurred. This is because regulatory agencies are very attentive to SAEs and it is known that a MedDRA term is not particularly descriptive. That investigation and narrative is not described here. That bullet also doesn't describe causality, which is a required assessment. That's another indication that information is missing. What the slide does do is refer to it as a serious reaction. "Reaction" necessitates that the event was believed to have been caused by the treatment.
I don't think there's anything about what is presented in the slide deck that indicates that FDA was unaware or that Pfizer tried to hide it.