Pfizer Phase 3 clinical trial fraud allegations that should be immediately investigated by the FDA

Guest Post by Steve Kirsch

There are more than a dozen “smoking guns” that indicate that the Pfizer Phase 3 trial was not properly conducted. The FDA should investigate all these allegations, but they aren’t. Why not?

It is in the best interest of all parties to have transparency in these issues in order to restore public trust in the medical community and reduce vaccine hesitancy which are key goals of the CDC and FDA.

For example, Dr. Peter Marks recently stated:

“We do have a problem with vaccine uptake that is very serious in the United States and anything we can do to get people more comfortable to be able to accept these potentially life-saving medical products is something that we feel we are compelled to do,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research.

There are two things Dr. Marks can do to achieve his goal:

1. He can have an open discussion with the people who he alleges are the main spreaders of “misinformation.”
2. He can open an official FDA investigation into allegations of fraud in the Pfizer trial and produce a written report responding to each allegation.

Dr. Marks, like every other public health official, will not do #1. I understand why he won’t: the data isn’t supportive of the government narrative so he’d lose the debate very badly. This is why nobody at the FDA, CDC, or NIH will talk to any of my colleagues. In ignoring us, he is acting in a way inconsistent with what is expected which was outlined by UCSF Professor Vinay Prasad in this op-ed published 2 years ago, Scientists who express different views on Covid-19 should be heard, not demonized

But #2 is critically important. If there is fraud/ willful misconduct, the liability protection is removed. If the FDA is truly working for the people, these allegations must be investigated.

In order to help facilitate option #2, I personally am aware of over a dozen fraud allegations that should be investigated. This is not a complete list. There are dozens of articles like this one that highlight irregularities in the data that need to be investigated.

My suggestion is that, in addition to the allegations in this article, the FDA should solicit a list of irregularities via an open public process to ensure that all of the key allegations are considered and investigated in order to restore trust in the system. Why would they not want to do that?

Here is only a partial list:

1. Pfizer admitted in a US court proceeding that there was fraud and the FDA knew about it. An admission in a court like this of fraud is surely grounds for an investigation. Watch this 2 minute video where attorney Robert Barnes describes what happened in his federal court case against Pfizer.
2. 13-year old Maddie de Garay developed paralysis less than 24 hours after she was vaccinated. I know Maddie. I know her parents. Today, Maddie is confined to a wheelchair. She was perfectly healthy before she received the vaccine. Less than 24 hours after her second dose, she couldn’t walk off the school bus. Why were her symptoms reported to the FDA in the 12-15 trial results as “functional abdominal pain”? See FDA Buries Data on Seriously Injured Child in Pfizer’s Covid-19 Clinical Trial. I notified acting FDA Commissioner Janet Woodcock on Friday, June 25, 2021 6:21 AM. She promised me the FDA would investigate the fraud. To this day (Jun 14, 2022), the family was never contacted by anyone. I know the FDA is busy, but why has nobody reached out in the year since Commissioner Woodcock promised to investigate? If one child out of 1,000 ends up paralyzed for life, shouldn’t this be something the FDA should be concerned about?
3. There were 5 times as many exclusions in the treatment arm as in the placebo arm of the trial. It is statistically impossible for such an imbalanced number of exclusions to have happened by chance. It appears to be a deliberate culling of patients with adverse events which is not allowed. If it wasn’t a deliberate culling, then how do you explain such large numbers? The amount of the discrepancy is greater than the entire effect size of the trial. This is from page 18 of the December 10, 2020 VRBPAC meeting document:

   

4. Why were the allegations of data integrity documented by the BMJ never investigated by the FDA? This is published in a major medical journal yet there was no follow up from the FDA at all. I just talked to Brook Jackson on the phone. She now has 20 lawyers on his whistleblower case. Pfizer was able to get the judge in her case to stay discovery for 6 months so an FDA investigation is the only way to compel discovery. I asked her if anyone at the FDA ever contacted her about her allegations and she said nobody ever called to talk to her. Instead, on the very same day that she emailed the FDA about what happened, she was fired. She emailed the FDA about the issues at 9am on September 25, 2020 and she was fired from her job at Ventavia at 3pm. This suggests that the FDA tipped off Pfizer who notified Ventavia. There was no other way Pfizer could have known: Brook only contacted the FDA. Period. The FDA needs to find out who at that FDA tipped off Pfizer, and then who at Pfizer told Ventavia to fire Brook instead of investigating the allegations. There has to be a chain of custody here. We deserve to know what actions the FDA is going to take against that employee who notified Pfizer. Or to notify the public that this is the proper behavior by FDA employees receiving whistleblower complaints is to take actions to get the whistleblower fired. We need to understand how the leadership of the FDA feels about what happened and whether they intend to get to the bottom of it or simply ignore it.

   

5. Why are there more deaths in the trial report than the document Pfizer submitted to the FDA? Shouldn’t they be the same since they are reporting on the same Pfizer study? Here is another article questioning the numbers.
6. There were more deaths in the treatment arm than in the placebo arm. How does the FDA know for certain that the people who died in the treatment arm did not die as a result of the drug? Did they ever look at the data from Pfizer on this? If so, what convinced them the deaths were not related? Can we see the written report which certified this? Pfizer says the deaths were unrelated, but we are never told how they determined this. Were the same tests done as Dr. Walter Lang did (see this video and also this article) and that Dr. Bhakdi and Dr. Burkhardt did? Dr. Peter Schirmacher also discovered that at least 30% to 40% of the deaths shortly after vaccination were likely caused by the vaccine. Schirmacher’s family’s life was then threatened if Schirmacher said anything more publicly. Did Pfizer use the same methodology as Dr. Schirmacher, Bhakdi, Burkhardt, and Lang? Why did Schirmacher, Bhakdi, Burkhart, and Lang all find a huge rate of causality but Pfizer found nothing. They cannot both be right. How will the FDA resolve the discrepancy and assure the public they found the truth?
7. A report Pfizer filed with the FDA entitled “Summary Basis for Regulatory Action” contains the following statements which are in conflict with data in the VAERS system which is reporting unprecedented increases in adverse events. There are more adverse and serious adverse events reported for the COVID vaccines than for all vaccines combined over the past 32 years. Therefore, the VAERS data and this report simply cannot both be true. The FDA needs to find out which is giving inaccurate data and correct the problem:

   

8. Mysterious blood clots are only being found in vaccinated cadavers and have never been investigated by the CDC or FDA. Why are these blood clots only happening in vaccinated people if the vaccines are safe and effective? See also this article: EXCLUSIVE: Shocking microscopy photos of blood clots extracted from those who “suddenly died” – crystalline structures, nanowires, chalky particles and fibrous structures. Will someone at the FDA provide public assurances that they have investigated these clots and can explain them?
9. If the vaccines are safe as represented then why does the blood of vaccinated patients look dramatically different under a darkfield microscope?
10. If the vaccines worked as in the trials, how can double-masked, quadruply vaccinated Tony Fauci get COVID?
11. The Pfizer data shows nobody became disabled, yet we had 1.8M people added to the disability system after the vaccines rolled out. If the trial data is correct, how did this happen? The trial was large enough to detect a signal this large, so how could it have gone undetected?
12. The documents released by Pfizer show a large number of discrepancies that are impossible to explain if the trial was executed as stated. Can you investigate all the discrepancies pointed out in articles such as this and this?
13. Brook Jackson’s whistleblower suit against Pfizer has not been dismissed by the court.
14. The story of patient Augusto Roux needs to be thoroughly investigated. Please see Is Subject #12312982 the Key to Proving Pfizer Vaccine Trial Fraud?
15. Why is Sudden Adult Death Syndrome only affecting people who have been vaccinated with the COVID vaccines? Is there a counter-example?
16. Why are athletes dying at 22X the normal rate? And why is this only happening after the vaccines rolled out?
17. Why are there more deaths reported associated with the COVID vaccines in VAERS than for all vaccines combined in the 32 year history of the VAERS system? It isn’t over-reporting because the deaths for all other vaccines for all years is still completely normal as you can see from this chart:

    

18. Shouldn’t the FDA and CDC call for a protective order to prevent retribution by state medical boards against physicians who are reporting adverse events and death following vaccination on social media? Clearly, the CDC and FDA are extremely safety conscious and would want to know about these incidents? So why not make a statement encouraging licensed MDs to speak out?
19. Why are there so few autopsies? And why are the detailed autopsies showing causality ignored? And why is the CDC not warning people about the risk of death?
20. Why is the public not permitted to see the assessments made of the 13,225 US deaths reported in the VAERS system that were determined to be not linked to the COVID vaccines?
21. Nearly 500 articles in the peer-reviewed medical literature have been written about vaccine adverse events from the mRNA vaccines. That isn’t consistent with a vaccine found to have fewer adverse events than the placebo. Someone is lying. Is it hundreds of authors of peer-reviewed papers? Or was the study flawed? The FDA should investigate this because this needs to be resolved ASAP.
22. Dr. John Su at the CDC appears to be a co-conspirator with Pfizer to hide the safety data. Whenever he presents, he never mentions that the VAERS data should be multiplied by the appropriate under-reporting factor (URF). This allows the vaccines to look 100 times safer than they actually are. He knows he shouldn’t be doing this, but this hasn’t inhibited his actions at all. The FDA and CDC refuse to acknowledge what the VAERS URF is for these vaccines and they stonewall newspaper reporters who ask about it. How is that being transparent?
23. Anecdotal data from physicians. There is simply too much anecdotal data from formerly pro-vax physicians who report patients who are previously healthy become “unhealthy” (new disease, existing disease reoccurs, or cognitive decline, or menstrual issues) shortly after being vaccinated. How can that be if the rates are the same before and after the vaccine?

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