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

by Steve Kirsch

https://stevekirsch.substack.com/

June 17, 2022

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. Read this article for more: Pfizer admits to COVID vaccine clinical trial fraud in federal court.
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:

   

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