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Friday, January 07, 2022

Pfizer filed 2 tons of paperwork. The FDA didn't read it.

Raiders Of The Lost Ark has one of the boldest conservative endings in movie history.

After tracking down the Covenant of the Ark and wresting it from the Nazis, Indiana Jones turns the most important relic in Jewish history over to the U.S. government, which then packs it up and ships it to a warehouse filled with who-knows-what treasures.

I suggest Steven Spielberg make a new sequel, Raiders of the Lost Pfizer Files, because next to the Ark likely are the 450,000 pages of documents that the FDA claims it based its decision to approve the Pfizer covid vaccine on. The huge documentation proves that the approval is based on nothing more than Pfizer's word because none of the FDA commissioners read the 450,000 pages that backed the vaccine.

We know this because Public Health and Medical Professionals for Transparency is suing the FDA to get the 450,000 pages released.

The FDA said it would take 75 years to do so.

A ream of paper weighs 5 pounds.

That means the 450,000 pages weigh 4,500 pounds, or a little more than 2 tons.

In the lawsuit, the court originally said the FDA could release the documents at a pace as low as 500 pages a month, which would take 75 years to fully release. Aaron Siri, lawyer for the plaintiffs, got the court to speed that up to 55,000 pages a month. That means they would get the documents in 8 months.

Siri wrote, "On behalf of a client, my firm requested that the FDA produce all the data submitted by Pfizer to license its Covid-19 vaccine.  The FDA asked the Court for permission to only be required to produce at a rate of 500 pages per month, which would have taken over 75 years to produce all the documents. 

"I am pleased to report that a federal judge soundly rejected the FDA’s request and ordered the FDA to produce all the data at a clip of 55,000 pages per month!

"This is a great win for transparency and removes one of the strangleholds federal 'health' authorities have had on the data needed for independent scientists to offer solutions and address serious issues with the current vaccine program – issues which include waning immunity, variants evading vaccine immunity, and, as the CDC has confirmed, that the vaccines do not prevent transmission."

Good job. The awful publicity over the 75-year release helped.

450,000 pages is a lot of reading to do. If it takes 8 months to photocopy all this stuff, how could it be read in a few days' time?

Especially when the FDA was making decisions at the same time about vapor cigarettes, vitamins, and sundry other medications.

I am cool with the vaccines. The media and the government oversold their use while hiding the side effects.

But what I am not cool with is pretending the FDA did anything except rubber-stamp the vaccine. The politicians and Big Pharma wanted the vaccine. The FDA did not stand up for science. It's all office politics. The appointees to the FDA will go work for Big Pharma when their appointments expire. 

Why bother having an FDA if it is a rubber stamp and a collector of documents?

Trump's plan for the development of vaccines was Operation Warp Speed.

The FDA's plan for the release of the documents was Operation Snail's Pace.

Open the Ark and be done with the FDA.

26 comments:

  1. As to the Pfizer and Moderna covid vaccines, neither has been approved by the FDA. I have a copy of the letter which the FDA sent to Pfizer (I can send it if you'd like) which only extends the emergency use authorization, but quite explicitly does not grant approval. This is consistent with what was published in the New England Journal of Medicine about the phase 2 clinical trials of both vaccines. The control (placebo) group was vaccinated part way through the trial. This breaks the trial and makes it invalid. To approve any medicine, three phases of trials have to be completed successfully and then reviewed. These vaccines cannot be approved until phase 2 trials are repeated and then phase 3 to follow.
    In my professional career, I was involved in quite a few clinical trials, and I know from personal experience that treating the control group breaks the trial. No one would ever break a trial on purpose unless they were ordered to. Clinical trials are a ton of work and cost. Nobody with good intent would monkey-wrench a trial.

    ReplyDelete
  2. My brother in NJ just got over omniron. Age 66 and in excellent health, vaxxed and boostered.

    Symptoms were minor throat irritation and a slight runny nose. Some tiredness.
    Lasted 6 days.

    ReplyDelete
  3. My fiance was told she was positive...for which Greek letter, one will not know. These are silly days. She had a rough 36 hours...some sneezing, coughing...then today she just performed the entire Ann Margret "A Lot of Livin' To Do" dance in pink leotard in the den. We're back on track.

    ReplyDelete
  4. Sadly, this is an admission that Donald Trump had to know that he was waving vaccines through without proper review. To say the least, that's not a good look.

    Even after all of their cheerleading and authoritarian actions, look for the left to try to turn the vax failures, which are becoming more obvious with each passing day, back on Trump.

    ReplyDelete
    Replies
    1. Unless you can prove he ordered testing to be short cut, Jeffery, you're blowing your usual smoke.

      Delete
    2. All the left has to do is CLAIM that Trump KNEW that there were shortcuts in testing (without proof, of course), and that if he didn't know he SHOULD have known.

      I'm generally supportive of Trump, but my eyes are open. I believe Trump is vulnerable on this, but I hope I'm wrong.

      Oh, and my name isn't Jeffery, which I'm guessing is some kind of chicken-bleep go-to pejorative. How does resorting to that benefit this comment section?

      Delete
    3. Mmatters, he's our resident liberal pretending to be a conservative. He never seems to check back on replies to his drivel.

      Delete
  5. Another corrupt agency has been exposed.

    I feel like Diogenes - looking for an honest agency. I think I know the answer.

    ReplyDelete
  6. Archaeologists say the ending is very true to life although we may have just learned how the good guys (minus the Commies, of course) won WWII.

    It's what happens when you have Top Men.

    Top.
    Men.

    ReplyDelete
  7. "450,000 pages is a lot of reading to do" is a tad overstated. It very likely includes case report forms, manufacturing documents, quality control tests and results, toxicology studies, etc. Having had several years experience in the pharma world, I feel pretty safe stating that there are not 450,000 pages of single spaced text divided into paragraphs. I also note that submissions like these are split among multiple reviewers and sub-reviewers, who will read and pass on to higher management their concerns and conclusions.

    ReplyDelete
  8. Columbia study: "Results from fitted regression slopes (p<0.05 FDR corrected) suggest a US national average VFR of 0.04% and higher VFR with age (VFR=0.004% in ages 0-17 increasing to 0.06% in ages >75 years), and 146K to 187K vaccine-associated US deaths between February and August, 2021."

    ReplyDelete
  9. The "Lost Ark" analogy is great.Having been employed by and been a Government contractor .
    You quickly learn that eventually, no one cares.

    ReplyDelete
  10. I'm with Bob up at the top. I know the business too. Right now, everyone who has been vaccinated are in a huge half-assed Phase 4 trial. That's when we get the complete ADR's (Adverse Drug Reports). All I know is that I and my wife will not be getting a fourth dose of any Wuhan shot.

    ReplyDelete
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    ReplyDelete
  12. Don. How could you be "cool" with the vaccine and in the same breath say it was "rubber stamped". There's a cognitive dissonance there. I'm not "cool" with anything that was pushed through without undergoing the typical effort and time frame needed to prove medicines are safe and effective.

    ReplyDelete
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