Brook Jackson 💜 Profile picture
May 15 9 tweets 5 min read Read on X
💣You only need 6 documents to blow the lid off the scam! The video of lies is just a BONUS!

FDA rubber stamped an EUA, then handed Pfizer a license to kill—without ever verifying a shred of Pfizer’s data!

• 20Nov2020 EUA Memo

• 11Dec2020 EUA Letter

• 18May2021 BLA Clinical Review Memo

• 03Jun2021 First Committee Meeting Memo

• 13Aug2021 BIMO Review Memo

• 23Aug2021 BLA Approval Letter
20Nov2020 EUA Memo
Claim: "6 site inspections did not reveal problems impacting the data submitted in support of this EUA."

Reality: The FDA lied! They did go to 6 sites, but no problems were revealed because they NEVER looked; they DID NOT verify the data Pfizer submitted!

Next slide, please.Image
11Dec2020 EUA Letter
Claim: Criteria Met for Issuance of Authorization
**If you believe the load under Section 564(c) of the Act highlighted below.**

Reality: The EUA law DOES give the FDA more flexibility during review. What it DOES NOT do is allow FDA to lie about that discretion! There's a legal term for that, I'm sure.

Next slide, please.Image
18May2021 BLA Clinical Review Memo
Claim: Carry On!

⚠️Pg. 5 “The clinical information was not well organized and a summary document would be helpful... the clinical team thought they will likely have a safety data information request.”

Reality: Even the clinical reviewers were unsure they had what they needed—they hinted they’d have to circle back to Pfizer to actually get clarity.
**Spoiler: they didn’t before approval!

Next slide, please.
18May2021 BLA Clinical Review Memo Cont.

⚠️Pg. 19 "Because the primary source of pre-licensure study data to support vaccine safety and effectiveness is a single study, C4591001, FDA agreed with the Applicant’s proposal to include integrated summaries... The sections of the clinical memo usually reserved for review of these integrated summaries were not generated.”

Reality: The FDA did not verify or analyze key data inputs that were used to support the vaccine's safety and efficacy narrative!

"Therefore, FDA has not independently reviewed and confirmed the data or assessed the study designs for potential sources of bias."

Reality: WTAF!
No bias assessment and they’re admitting that part of the BLA application rests on unchecked claims from publications rather than validated trial datasets!

It gets worse, guys! Next slide, please.Image
18May2021 BLA Clinical Review Memo Cont.

⚠️Pg. 15 “Bioresearch Monitoring inspections of nine clinical sites in study C4591001 did not identify deficiencies that would affect the integrity of the clinical data submitted in this BLA.”

Reality: This sounds reassuring until...

Next slide, please.Image
03Jun2021 First Committee Meeting Memo

This is just indefensible! The whole statement...WOW!

Claim 1: "10 study sites were already conducted under the IND and EUA..."

Reality: 10? They sure? Hang tight....

Claim 2: “The BIMO team stated that the inspections that occurred under the IND and EUA did not inspect data integrity because there wasn't anything to inspect at the time..”

We will come back to this in the next slide, please.Image
13Aug2021 BIMO Review Memo

Claim 1: The 03Jun2021 Committee Memo said FDA inspected 10 sites, but this memo says only 9 sites were inspected for the BLA.

Reality:
They can’t even keep their story straight. Did one site vanish? Are they hiding it? This was never about actual oversight. This was about creating the illusion of it.
And these numbers matter because each site represents hundreds of human beings whose data the FDA claimed to have reviewed.

Claim 2: “The data integrity and verification portion of the BIMO inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND.”

Reality: Let’s be blunt! FDA walked into 9 sites, then turned around and walked tf back out!

Then they lied to the world. Lied to the media. Lied to Congress. Lied to the courts. They told us everything had been rigorously inspected and found to be in order. They told us it was safe and effective because that's what Pfizer told them.

Those 9 sites collectively enrolled nearly 4,000 participant! What if they had just done their job?
What if they had looked even once at what was happening at those sites? My sites. Maybe Maddie de Garay (Site 1007) wouldn’t be in a wheelchair today. Maybe thousands more would have been spared harm.

But they didn’t. Final slide, please.Image
23Aug2021 BLA Approval Letter

The FDA approved and promoted a vaccine based on clinical data it never verified, then misled the public about the rigor of its review. Internal documentation proves that:

The data verification never occurred.

Inspectors admitted there was “nothing to inspect.”

The data from thousands of trial participants was used to justify licensure without basic scrutiny.

The list goes on...

Meanwhile, public-facing statements told Americans and global regulators the exact opposite.

This constitutes regulatory fraud and demands immediate oversight, accountability, and corrective legislative action.

The end.

...unless you want me to tell you how Moderna did it-@SecKennedyImage

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More from @IamBrookJackson

May 10
⁉️What Does “Data Cleaning” in a Clinical Trial Mean?🧵

It can be as innocent or nefarious as the intent behind it.

Let’s break this down at 3 levels: Trial sites, Sponsor/CRO, Regulatory submission. 

1. Trial sites—Staff enter data collected from each patient into a study database.  

Cleaning here means:

Correcting typos or formatting issues, filling in missing information, answering questions from monitors (called data queries), etc. 

The goal is to ensure the data is complete & reflects what actually happened with the patient.
2. Sponsor (pharmaceutical company) or their Contract Research Organization (CRO)

Once the data from the site is clean, the Sponsor/CRO reviews it.

Cleaning here means:

Making sure the data is consistent across all sites, handling missing values in a standardized way, deciding which patient records meet the trial protocol (e.g., removing people who dropped out early), review and reclassification of adverse events (e.g. changing “probably related” to “not related”), etc.

The goal is to prepare a dataset that meets regulatory & scientific standards for analysis.
3. Regulatory Submission (Before data is submitted to regulator)

At this stage, the sponsor prepares the final version of the data to submit. 

Cleaning here means:

Applying statistical methods to summarize the data, defining analysis groups (like who “counts” in the final safety/efficacy numbers), making sure all data is formatted according to regulatory requirements, etc.

The goal is to present a clear, well-organized summary of the trial results that regulators can evaluate.
Read 5 tweets
May 5
Don’t ask why! Ask how many… times since 2000 the U.S. government has dismissed pharmaceutical fraud cases using the “we already knew about the fraud” excuse! 🧵
Petratos v. Genentech— 2017

Petratos alleged that Genentech suppressed data indicating that its cancer drug, Avastin, had more severe side effects than reported, leading to Medicare reimbursements for treatments that were NOT "reasonable and necessary."

FDA continued to approve Avastin for various indications & did not take regulatory action against Genentech despite being informed of the allegations.
Thomas Jefferson v. Hoffmann-La Roche Inc.—2014

Dr. Thomas Jefferson, a public health researcher affiliated with the Cochrane Collaboration, alleged that Roche misrepresented the efficacy of Tamiflu (oseltamivir).

The dismissal followed the government's continued position that it did not consider itself defrauded.
Read 7 tweets
Apr 23
Trump deploys Harvard alum, 30-year DOJ operative Charles W. Scarborough to bury me & all evidence of the illegal 2020 biowarfare experiments & vaccine mandate abuse. Image
Scarborough has spent decades defending the indefensible.

He defended the DoD in Doe v. Rumsfeld, where service members were forced to take an anthrax vaccine never approved for “inhalation”exposure.

The court halted the program, but Scarborough & FDA just quietly reapproved it—case dismissed.
He also defended the CIA & Pentagon in Vietnam Veterans of America v. CIA, where soldiers were unknowingly drugged and tested with chemicals.

Ever hear about MK-Ultra? This case is that. Same playbook, same experiments, similar drugs, same “scientists”.

MK-Ultra Never Ended. It Just Lawyered Up.

Scarborough is MK-Ultra’s legal custodian—he wasn’t there when the crimes happened, but he was there to make sure the justice never did.

Scarborough’s argument? National security overrides your right to sue.
Read 7 tweets
Dec 24, 2024
Officially in with Trump’s new DOJ!

Below is our request to extend the due date of the initial brief.

If his administration is compromised in ANY way, this case will NOT be supported and Pfizer wins.

1/5
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Read 5 tweets
Jun 28, 2024
UPDATE: We just filed a Notice of Supplemental Authority which supports our opposition to DOJ’s Motion to Intervene & Dismiss.

1. United States v. Academy Mortgage Corp.

The govt must show “good cause” to intervene/dismiss. Since Pfizer failed to get the job done, DOJ now claims “because we said to” is good enough cause. It’s not.
2. National Rifle Association of America v. Vullo

SCOTUS held that govt officials cannot use their power selectively to punish or suppress speech based on viewpoint discrimination.

DOJ’s motion is based on my viewpoint regarding Pfizer’s clinical trial practices & the safety/efficacy of their product, which constitutes this type of discrimination. Haters.
3. Federal Drug Administration v. Alliance for Hippocratic Medicine

There are no other effective avenues for redress against the FDA’s actions regarding Pfizer’s EUA. This underscores the need for rigorous judicial oversight, protection of constitutional rights, and the role of the FCA in allowing private individuals to bring actions on behalf of the govt. I still believe!❤️
Read 4 tweets
May 1, 2024
🚨NEW: One of the most powerful legal briefs I have ever read.

To my team of attorneys — thank you for your tireless efforts, your patience, your commitment to excellence and the rule of law. The principles of humanity have been evident in every action you've taken, ensuring that justice is served with integrity. I totally admire that!

RELATOR’S SUR-REPLY TO GOVERNMENT’S LATE REPLY RE MOTION TO INTERVENE AND DISMISS

TO THE HONORABLE JUDGE OF THE COURT:

Relator Brook Jackson (“Relator”) hereby requests that the Court consider this sur-reply to the late reply of the United States of America (“Government” or “DOJ”) to Relator’s opposition to the DOJ’s motion to intervene to dismiss.

INTRODUCTION

In its effort to gain permission to intervene and dismiss this extraordinarily important False Claims Act case, the DOJ asserts several misleading half-truths. Yes, Brook Jackson’s qui tam action is brought in the name of the Government and the United States is the real party in interest. But, in making the False Claims Act “the Government’s primary litigative tool for combating fraud” “in modern times,” Congress partially assigned rights directly to relators like Brook Jackson, equipping them with authority to litigate qui tam claims without control or even direct participation of the DOJ.

Brook Jackson does not need approval of the DOJ or agency executives to fulfill her role before this Court.
Yes, Congress provided in 31 U.S.C. § 3730(c)(3) a mechanism for the Government to file a motion seeking dismissal of the qui tam action notwithstanding a relator’s objections. But, as the Supreme Court made clear, the Government first must show good cause to intervene to become a party to the action, and even then, the Government must “offer[] a reasonable argument for why the burdens of continued litigation outweigh its benefits.”

Congress intended that False Claims Act claims be dismissed for legitimate government purposes, and not as a result of fraud, illegality, or lack of political will.

And yes, the courts have, both before and after Polansky, found “good cause” for intervention under § 3730(c)(3) based on the Government’s reason for moving to dismiss under § 3730(c)(2)(A), “itself.” But in each and every case, the Government was able to show a reasoned basis for intervention and dismissal, grounded in a valid governmental purpose as exemplified in the Granston Memo.

Never before has the DOJ sought to dismiss a meritorious case like Brook Jackson’s case here, where the relator can demonstrate a strong basis to recover substantial damages for harms caused to the United States by fraud and false claims on the public fisc.

And, never before has the Government failed to even articulate a legitimate reason for dismissal.
In its late reply, the DOJ waives key points and authorities raised in the opposition. The catastrophic harms caused by Pfizer’s ineffective and unsafe modified RNA biologic, the loss of credibility in agencies and the DOJ as they abdicate public policy to partner up with corporate interests, and the essential role courts hold keeping our Government functioning in the face of executive failures, are all now undisputed.

The DOJ continues to assert an unfettered right to dismiss any qui tam action whenever it wants, without mention of the Granston Memo. It offers no explanation for how this lawsuit seeking to hold Pfizer accountable for proven fraud in the design, conduct, analysis and reporting of the clinical trials is contrary to national health policy.

The Government does not deny that dismissal would undermine the Act by sending a chilling signal to future relators that exposing fraud on the United States is futile when agency executives want that fraud kept secret. Nor does it deny that this is its true motive for seeking dismissal. The DOJ does not address Rule 24 of the Federal Rules of Civil Procedure, or the requirement under subdivision (d)(3) of that Rule that the Court consider prejudice to Brook Jackson as the original party in determining whether to grant permissive intervention. And, it completely ignores constitutional arguments regarding content-based infringement of Brook Jackson’s First Amendment right to petition, the disordering of the separation of powers to protect corporate and executive actors, and the lack of a rational basis under due process and equal protection.

While the Government possesses the authority, indeed obligation, to make a “later date” intervention to dismiss qui tam actions on good grounds based on legitimate government purposes consistent with the False Claims Act, no such showing is made here.

The DOJ’s motion should be denied without prejudice on this record. In the event that the Government seeks to intervene post-seal period based on actual evidence and articulated grounds, the Court should allow limited discovery and hold an evidentiary hearing under § 3730(c)(2)(A) and (c)(3).
Read 10 tweets

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