In their defense, the situation is that they have to look at the data. Pfizer conducts the trial. No one else is going to spend 100s of millions to conduct a large-scale phase 3 clinical trial for a product that may fail except the guy developing it. So, that's the data we get to work with. Hopefully, the team conducting the trial is honest. There are a ton of checks in place, but ultimately, it comes down to trusting the reputations of the people presenting the data. And they can lie. There are lots of incentives: 1) publish or perish pressure, 2) desire for career advancement of developing new drugs, 3) profit motive, 4) ego motive, 5) fear motive if they deliver negative, unpublishable results of a failed drug. Their jobs may very well seem to be on the line.
And the company of course has incentive to get presentable results. 1) the world was watching, panicked, hoping for a "cure", 2) financial motive to be the first to FDA approval because that means control of market share, 3) PR motive to be able to position yourself as the "savior of Man", the "deliverer of life-saving medication". The CEO's job is very much riding on his ability to produce RESULTS for the shareholder.
We put perverse incentives on everyone involved, so no one wanted to be the one to hold up the safety data and say "this isn't good enough", not even the FDA. They knew the trial was rife with errors. Procedural inconsistencies (like they weren't measuring the damn primary end point!) were reported and ignored by the FDA because they had pressure on themselves to produce RESULTS. They needed something to bring to the American people to say "we're working for you." So, they used the EUA. Comirnaty never should've been approved.
And the data needs to be made 100% public. ALL of it.
There's no defense because even a cursory glance of how Pfizer managed the studies gave a multitude of indications that chicanery was involved. Their efficacy measurement was rigged (PCR COVID test that is known to be broken). Side effects that were known to occur were removed from data collection. Finally, when the stats teetered in Pfizer's favor they broke the blind and ended data collection. Of course, this led to long term effects never being analyzed.
After getting approval, VAERS reports quickly showed these products were doing awful things, but FDA/CDC/WHO/NIH buried their heads and kept pushing the product.
FDA also buried known, effective alternative treatments. Simple Vitamin D supplements likely would have rendered Wu-Flu damage nearly nonexistent, but were blocked from discussion by scientists, health experts, and journalists.
There's no excuse for the FDA. Many will be hanged after Nuremberg 2, and a hanging is better than they deserve.
In their defense, the situation is that they have to look at the data. Pfizer conducts the trial. No one else is going to spend 100s of millions to conduct a large-scale phase 3 clinical trial for a product that may fail except the guy developing it. So, that's the data we get to work with. Hopefully, the team conducting the trial is honest. There are a ton of checks in place, but ultimately, it comes down to trusting the reputations of the people presenting the data. And they can lie. There are lots of incentives: 1) publish or perish pressure, 2) desire for career advancement of developing new drugs, 3) profit motive, 4) ego motive, 5) fear motive if they deliver negative, unpublishable results of a failed drug. Their jobs may very well seem to be on the line.
And the company of course has incentive to get presentable results. 1) the world was watching, panicked, hoping for a "cure", 2) financial motive to be the first to FDA approval because that means control of market share, 3) PR motive to be able to position yourself as the "savior of Man", the "deliverer of life-saving medication". The CEO's job is very much riding on his ability to produce RESULTS for the shareholder.
We put perverse incentives on everyone involved, so no one wanted to be the one to hold up the safety data and say "this isn't good enough", not even the FDA. They knew the trial was rife with errors. Procedural inconsistencies (like they weren't measuring the damn primary end point!) were reported and ignored by the FDA because they had pressure on themselves to produce RESULTS. They needed something to bring to the American people to say "we're working for you." So, they used the EUA. Comirnaty never should've been approved.
And the data needs to be made 100% public. ALL of it.
There's no defense because even a cursory glance of how Pfizer managed the studies gave a multitude of indications that chicanery was involved. Their efficacy measurement was rigged (PCR COVID test that is known to be broken). Side effects that were known to occur were removed from data collection. Finally, when the stats teetered in Pfizer's favor they broke the blind and ended data collection. Of course, this led to long term effects never being analyzed.
After getting approval, VAERS reports quickly showed these products were doing awful things, but FDA/CDC/WHO/NIH buried their heads and kept pushing the product.
FDA also buried known, effective alternative treatments. Simple Vitamin D supplements likely would have rendered Wu-Flu damage nearly nonexistent, but were blocked from discussion by scientists, health experts, and journalists.
There's no excuse for the FDA. Many will be hanged after Nuremberg 2, and a hanging is better than they deserve.
What's fascinating to me is that anyone still believes in Nuremberg 2.0