14 Comments
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Dr. Mathew Maavak's avatar

The FDA should be renamed the Falsification of Data Administration. How many times have we come across travesties like these in the past three years alone?

mauvi3's avatar

It's not incompetent. They're just phama shill

Niki's avatar

At this level is not incompetence, it is corruption, and criminal behavior.

Lawrence Butts's avatar

It is surreal to listen to this conversation with the FDA (big wigs). It's like Moe, Larry and Curly with a fancy vocabulary.

Elizabeth Stone's avatar

You're listening a couple of 20-second snippets with one or two people unnamed people at FDA, likely at the Division level.

There's TV doctor drew, an ER doc., Jessica and someone else.

As stated FDAs "real world data" include post marketing surveillance and open-label safety followup data - after tens (or hundreds) of millions of administered doses. Fraiman focuses exclusively on SAEs reported in the pre-EUA randomized, placebo-controlled Phase-III trials

Fraiman looks at SAEs in

18,801 vaccine doses in Pfizer trials and 15,185 in Moderns trials

FDA/CDC looks at above plus all data from extended study followup periods plus over a year's real-world administration in hundreds of millions of people.

So surreal ...

Lawrence Butts's avatar

What is surreal is YOU calling people like this randos.... really? Jessica Rose? Maybe you should just go somewhere else that is better suited to you? Maybe get another booster... the new ones are out. You need to be up-to-date on your injections.

Elizabeth Stone's avatar

Okay - TV doctor drew, an ER doc, Jessica Rose and some other guy.

You're obsessed with vaccines. Don't want 'em. Don't get 'em.

Lawrence Butts's avatar

Troll somewhere else. Get your boosters

Lawrence Butts's avatar

Did you watch this? They play comments from the big wigs in the FDA. They say they are all senior (top) level management. You should really watch this entirely before making silly comments like this.

"Shocking FDA incompetency recorded on tape!" is in the title to this post.... Pretty surreal I think?

Ozkar's avatar

FDA cherry picking data?

Elizabeth Stone's avatar

Very much the opposite. Frainan is not so much cherry picking as excluding hundreds of millions of post-EUA exposures

It's good to see that you learned to parrot a term.

Ozkar's avatar

“In the FDA meeting, when discussing Dr. Fraiman's findings, the officials disregarded them, claiming that "Real World Data" didn't match their findings.”

Elizabeth Stone's avatar

Pasting too? Your special needs teachers will be so pleased with your progress. Keep up the strong work and one day you might qualify for a job at Boehringer Ingelheim.

Pond23's avatar

Well done.