⁉️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.

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.

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. 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.

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.

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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.

🚨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.

Redux & Fen-phen: These weight-loss medications were withdrawn from the market in 1997 due to reports of heart valve damage & pulmonary hypertension. The withdrawal was linked to scientific fraud and misconduct in clinical trials, where the risks were downplayed and not adequately reported. Raxar (grepafloxacin): This antibiotic was withdrawn from the market in 1999 due to reports of serious cardiac events, including QT prolongation & torsades de pointes. Scientific misconduct was suspected in the clinical trials & safety data was misrepresented.

🚨The World vs Pfizer (case update)

“The right to search for truth implies also a duty; one must not conceal any part of what one has recognized to be true.” - Albert Einstein

As indicated by the quote above, inherent in the scientific search for truth is a duty to disclose, and not conceal, any part of what is shown to be true.

Relator Jackson alleged Pfizer abandoned the scientific method and the search for truth to induce FDA’s authorization of its modRNA biologic to enable it to sell the United States 100M doses (for $1.9B). Ms. Jackson has alleged Pfizer engaged in fraud in the design, conduct, analysis and reporting of its clinical trials, and in statements it made to FDA. In her Second Amended Complaint (SAC), Ms. Jackson details her knowledge of the particular circumstances in which Pfizer engaged in clinical trial fraud to induce FDA’s issuance of the EUA.

Among other things, this includes a trial design to avoid disclosure on immunity and transmission; short-cutting the study to conceal negative efficacy and serious adverse events; manipulation of inclusion and exclusion determinations to reach predetermined results; unblinding of subject status and then falsely reporting the occurrence or non-occurrence of adverse events based on the subject’s disclosed status; and suppression of available alternatives (Ivermectin).

Pfizer Court Case Update: Because we still have a pending motion before the district court that Judge Truncale has not ruled on since May, we filed a combined request for stay until he does & alternatively for an extension of time to file our initial brief due to the appellate… https://t.co/dZeYsDmocJtwitter.com/i/web/status/1…

How Pfizer Violated the False Claims Act:

Count 1 - Fraudulent Presentment
Pfizer presented false claims to the government for payment of a product Pfizer never delivered nor ever intended to deliver.

· Pfizer's invoices sought payment for delivering a safe, effective, vaccine… twitter.com/i/web/status/1… Count 2 - Fraud by Express False Certification
Pfizer made express certifications to the government that the product would be delivered according to the contractual terms when it wasn't.

· Pfizer won billions of taxpayer money, and then their product caused the deaths and… twitter.com/i/web/status/1…

1/This is Josh Hodges, he used to work for HHS Admin for Community Living back in the day, but is now Chief Customer Officer of National Council on Aging. Today, he announced $50M in federal funding from his old buddies at HHS. The largest grant in their history! To do what? 2/Well, provide funding to “hundreds of diverse community-based organizations, enabling them to conduct tailored outreach, host vaccine clinics & offer services many older adults need to get vaccinated.”

1/After the initial 60 day seal expired in Mar. 2021, the DOJ requested an addt’l 6 months to “investigate” Pfizer. I reluctantly agreed b/c I was told I needed the DOJ. The weight & guilt of knowing what Pfizer did but warned not say anything was & still is unbearable at times. 2/I remember telling Joel, my former atty over & over, no more extensions! 6 months gave DOJ until Sep. 2021 or that if FDA approved the vaccine for children, I was done! I planned to go public no matter what. On Aug. 25, 2021, I sent him this email. Sorry for the language 🤷🏻‍♀️

1/
Email between myself and Joel Androphy, former counsel—June 23, 2021

J: Did u read Pfizer report?

B: The report about cardiac inflammation?

J: Yes, need to follow. Bad news for public but good news for our case!

B: How is that good news for our case, Joel? cont… 2/
It’s not new news. Initial reports of this event were published months ago and seen in the clinical trials. Yet the FDA is still highly encouraging OUR youth to get the vaccine because of the risk/benefit ratio. Dang! Why do I even try to find angles? cont…

1/PFIZER FILES - Narratives and the Pfizer Guy Who Wrote Them

Here's one way you might trip up an FDA reviewer and/or clean the data: two participants in Pfizer's clinical trial--both dead. Note the reason for the narrative; one death, one safety-related subject withdrawal. 2/I reviewed Subject 11621327 earlier today. Poor man🥹 Btw, @sonia_elijah has done a ton of excellent reporting on this too, so be sure to give her a follow. But while I'm here I'll review 11521497 too. Would be great to have his case report forms & the raw data @pfizer!

🚨PLEASE READ/RETWEET #2
1/
Pfizer participant 60 y/o m w/pertinent med hx of obesity (since 2010), traumatic brain injury (2011 recovered), depression (since 2011) & hip replacement (2015). Concomitant meds: venlafaxine (from 2015) & aripiprazole (from 2011), both for depression 2/
Rcv'd Dose 1 on 10Sep 2020. The trial site rcv'd a police report indicating police visited the participants home to perform a welfare check on 13Sep2020 (Day 4 post Dose 1) and found him dead. It was reported that the body was cold w/visible lividity.

🚨1/These agreements exist between the US & most govts and their drug regulators-just ask the Argentine MOH.
What the MHRA & FDA are discussing is BREAKING. The EUA dated 11Dec2020 references 2 cases of anaphylaxis in the UK but claim none were identified in the clinical trials.

https://twitter.com/JudicialWatch/status/1624055566216708099

2/THIS IS A LIE. Pfizer & FDA were hiding the cases of anaphylaxis in the clinical trials. In the same EUA document, they do acknowledge adverse events, those that are defined as serious & 6 deaths. There are 7 actually-they forgot about subject 11521497.
fda.gov/media/144416/d…

Legal Theory 2: The mRNA products are bioweapons, not pharmaceutical, gene therapy, biologics or vaccines w/in the purview of FDA regulation. We have evidence to demonstrate they were never subject to FDA procedures regulating/monitoring certified Good Clinical Practice (cGCP) 1/ certified Good Manufacturing Practice (cGMP), certified Good Laboratory Practice (cGLP), certified Good Distribution Practice (cGDP) dispensing, labeling, etc.

To defend, US Govt must take one of two positions:

1. The products ARE pharmaceutical drugs, gene therapy or 2/

1/Americans were misled about all Covid-19 “countermeasures,” including those products marketed as “vaccines.” Covid policy was managed by the NSC acting on war footing & countermeasures were contracted for by the DoD & BARDA w/o any effective regulatory oversight at any stage. 2/The activities passing as “regulatory processes” appear to have been fraudulent attempts to create color of law & avoid liability for what were clearly criminal acts. These multiple overlapping & mutually reinforcing violations of federal law have imposed serious harms.

Need a good laugh? I was writing up a legal summary and skimming the Motion to Dismiss by @pfizer.
I STAND BY EACH ONE OF THESE TWEETS!
1/She airs that dissent publicly and repeatedly on her Twitter profile (@iambrookjackson), which has accumulated more than 37,000 followers. 2/Her anti-vaccination and anti-Government views are unmistakable. For example, she has tweeted that “there’s no way in hell she would let a Covid jab” near her children, even though CDC recommends the vaccine for everyone 5 years of age and older.

1/
An NIH funded, interventional, randomized, parallel treatment assignment clinical trial completed enrollment of 17,828,769 subjects in just 37 days.

Were you "treated" and just don't know it? 2/
The study distributed videos of health professionals encouraging Covid-19 vaccination to a large sample of Facebook users to test the most effective ways to maximize diffusion of vaccine-related content to increase vaccination rates.

1. This is going to be fun! @pfizer @moderna_tx

Baylor College of Medicine
Principal Investigator (PI):
Hana El Sahly, MD

Cincinnati Children’s Hospital Medical Center
PI: Robert Frenck, MD

Emory University
PIs: Nadine Rouphael, MD, Evan Anderson, MD & Carlos del Rio, MD 2. Kaiser Permanente
Washington Health Research Institute
PI: Lisa Jackson, MD

New York University School of Medicine
PI: Mark Mulligan, MD

Saint Louis University
PI: Daniel Hoft, MD

University of Maryland School of Medicine
PI: Karen Kotloff, MD