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Clinical Research | Big Pharma Whistleblower
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Jun 28 • 4 tweets • 1 min read
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.
May 1 • 10 tweets • 8 min read
🚨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.
Feb 19 • 11 tweets • 2 min read
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.
Dec 20, 2023 • 14 tweets • 6 min read
🚨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).
Aug 1, 2023 • 6 tweets • 2 min read
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…
Image Image
May 27, 2023 • 4 tweets • 2 min read
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…
May 2, 2023 • 7 tweets • 3 min read
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? Image 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.”
Apr 4, 2023 • 5 tweets • 2 min read
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 🤷🏻‍♀️
Apr 3, 2023 • 10 tweets • 2 min read
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…
Mar 13, 2023 • 7 tweets • 3 min read
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. Image 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!
Mar 13, 2023 • 5 tweets • 1 min read
🚨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.
Feb 10, 2023 • 6 tweets • 3 min read
🚨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. Image 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…
Feb 8, 2023 • 5 tweets • 1 min read
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/
Jan 20, 2023 • 19 tweets • 3 min read
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.
Jan 10, 2023 • 5 tweets • 2 min read
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.
Jan 10, 2023 • 11 tweets • 4 min read
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.
Dec 29, 2022 • 10 tweets • 3 min read
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
Dec 27, 2022 • 4 tweets • 2 min read
Moderna - why do you keep allowing Ventavia to conduct your clinical trials? Let's look at these monitoring reports! Why is @advarra not reporting these to @FDACBER or is FDA not in compliance?@moderna_tx @TheJusticeDept
Dec 21, 2022 • 16 tweets • 7 min read
Everyone in the world should be familiar with The Strategy & The Players:
aspr.hhs.gov/PHEMCE/2022-SI… Xavier Becerra, Secretary of Health and Human Services, preceded by Alex Azar and Norris Cochran
hhs.gov/about/leadersh…
Nov 19, 2022 • 7 tweets • 5 min read
An @OIGatHHS Report - 2008
•Serious gaps in NIHs oversight of researchers Financial Conflicts of Interest (FCOI)
•Could not provide accurate count of FCOI during FY 2004-2006
•NIH is not aware of the types of FCOI that exist w/in grantee institutions
oig.hhs.gov/oei/reports/oe… An @OIGatHHS Report - 2009
Increased oversight is needed to ensure that these conflicts are managed appropriately, the research conducted using Federal funds is not biased by any conflicting FCOI & human subjects are not subjected to unnecessary risks.

oig.hhs.gov/oei/reports/oe…
Jul 2, 2022 • 4 tweets • 2 min read
Psst, @FDA, @pfizer, @NEJM, et al..the responsibilities of Stephen Thomas, coordinating investigator of ALL trial sites for C4591001, was documented prior to the study starting.

Was one of those responsibilities to co-author this publication?

nejm.org/doi/full/10.10… and there’s this. He has other conflicts of interest I’ll tell you more about soon.