FDA’s hardline could indeed influence future vaccine approvals, setting a precedent for ensuring that trial designs align directly with population-specific clinical realities.
My lawyers once remarked: "When you have 'em by the balls their hearts and minds will follow."
I sure hope that "agency capture" will end once and for all. I'm counting on our friend RFK, Jr. to be reminded of his dad ( whom I knew) when he said:
"People say I am ruthless. I am not ruthless. And if I find the man who is calling me ruthless, I shall destroy him.
The FDA should've demanded and required that data to be in their hands BEFORE they provided ANY approval for that product. They shouldn't have waited until after millions upon millions of people had been utilized as guinea pigs for an entirely experimental product. It's good that they are holding the line NOW, but they should've done it THEN. It's too late to close the door of the barn once the cows are already out. Even if Moderna's product is pulled from the market because of their failure to provide the data, it won't matter. They've already made BILLIONS of dollars on that product, and that product has already harmed heaven only knows how many people.
When the FDA finds out a company has been shady like this, they should IMMEDIATELY rescind approvals. They have the power to do so much to keep people safe, but they don't seem to do jack when they should.
are there any double blind, inert placebo safety trials for any of these new drugs? The faux excuse that it is unethical should not be acceptable. There are plenty that chose to be unvaccinated that can be included in a control group.
It would only be "double blinded" if everyone in the study received a shot and no one knew who got the new drug and who got the placebo. That is until the trial length was completed and the "unmasking" takes place.
Wouldn't it be great if these so called regulators insisted that all trial patients were matched with a control group who don't even get any injection at all, then compared for adverse events with diligent follow up? I can dream, can't I? Of course, the trials would need to be independent of pharma, apart from them paying for it to be done.
The intervention is immunologically, fundamentally flawed. Insane to even conduct a trial.
So all this discussion exposes incompetence on both sides, FDA CBER and Moderna.
Safety critical products must be DESIGNED FOR SAFETY using FMEA. Moderna are incompetent tinkerers fooling with trial and error approaches.
ERVEBO Ebola vaccine will create a rice allergy epidemic, add to numerous autoimmune diseases, cancer and make Ebola disease even more severe. Design for safety and vaccine safety regulation remain abject failures. Incompetence or indifference?
That the FDA approves any vaccine, especially deadly mRNA poisons, is a crime against humanity and life.
My lawyers once remarked: "When you have 'em by the balls their hearts and minds will follow."
I sure hope that "agency capture" will end once and for all. I'm counting on our friend RFK, Jr. to be reminded of his dad ( whom I knew) when he said:
"People say I am ruthless. I am not ruthless. And if I find the man who is calling me ruthless, I shall destroy him.
I’m grateful for your assessment- as always! Well done once again!
The FDA should've demanded and required that data to be in their hands BEFORE they provided ANY approval for that product. They shouldn't have waited until after millions upon millions of people had been utilized as guinea pigs for an entirely experimental product. It's good that they are holding the line NOW, but they should've done it THEN. It's too late to close the door of the barn once the cows are already out. Even if Moderna's product is pulled from the market because of their failure to provide the data, it won't matter. They've already made BILLIONS of dollars on that product, and that product has already harmed heaven only knows how many people.
I agree. But FDA ALSO can rescind any determination based on new data. Moderna is under the regulatory microscope.
When the FDA finds out a company has been shady like this, they should IMMEDIATELY rescind approvals. They have the power to do so much to keep people safe, but they don't seem to do jack when they should.
are there any double blind, inert placebo safety trials for any of these new drugs? The faux excuse that it is unethical should not be acceptable. There are plenty that chose to be unvaccinated that can be included in a control group.
It would only be "double blinded" if everyone in the study received a shot and no one knew who got the new drug and who got the placebo. That is until the trial length was completed and the "unmasking" takes place.
Wouldn't it be great if these so called regulators insisted that all trial patients were matched with a control group who don't even get any injection at all, then compared for adverse events with diligent follow up? I can dream, can't I? Of course, the trials would need to be independent of pharma, apart from them paying for it to be done.
That's great suggestion! Better than saline.
Someone did a great placebo controlled study for hip impingement surgery where the placebo group couldn't tell they didn't have the actual surgery...
https://youtu.be/plSC4C-u3ws?si=vtRXUZvgi7ho6Q-z
The intervention is immunologically, fundamentally flawed. Insane to even conduct a trial.
So all this discussion exposes incompetence on both sides, FDA CBER and Moderna.
Safety critical products must be DESIGNED FOR SAFETY using FMEA. Moderna are incompetent tinkerers fooling with trial and error approaches.
ERVEBO Ebola vaccine will create a rice allergy epidemic, add to numerous autoimmune diseases, cancer and make Ebola disease even more severe. Design for safety and vaccine safety regulation remain abject failures. Incompetence or indifference?
https://zenodo.org/records/3595021
Great post - I have shared it on <a href="https://meme-river.com">meme-river.com</a> and <a href="https://memeriver.substack.com">memeriver.substack.com</a>