Thursday, February 24, 2022

DOJ to sit out whistleblower lawsuit accusing Pfizer of 'cutting corners' in COVID vaccine trial

The U.S. government is not getting directly involved in a whistleblower lawsuit alleging that Pfizer's COVID-19 vaccine clinical trials included fraud, though it might try to dismiss the lawsuit later.

Pdf Jackson accuses Pfizer and two contractors of "Cutting corners in clinical trials" and falsifying clinical trial documents in their "Race to secure billions in federal funding and become the first to market." The result, she claims, was millions of Americans receiving "a misbranded vaccination which is potentially not as effective as represented." Pfizer delegated management of the worldwide clinical trial to Icon and hired Ventavia Research Group to run Phase 3 test sites in Texas.

As Ventavia regional director, Jackson oversaw its trials in Fort Worth and Keller.

Ventavia "Allowed the majority of violations to continue unabated" and fired Jackson hours after she called the FDA's hotline Sept. 25, 2020, to report trial protocol violations and patient safety concerns, the suit claims.

"Ms. Jackson worked for us for only 18 days and, as a result, did not complete the requisite training for the role for which she was hired. We are confident in our practices and procedures in conducting clinical trials, and, should her case move forward, we will respond to the litigation accordingly." Pfizer and Icon didn't respond to Just the News queries.

In one recording, executives reportedly say Ventavia is finding "Something new every day" in trial paperwork errors and dreading a possible FDA site visit.

Another clinical trial veteran told Thacker that Ventavia was a "Helter skelter" work environment and its data were a "Crazy mess." Journalist Matt Taibbi said he listened to a recording on which a Ventavia executive referred to its trial data problems as "Cleanup on aisle five" and seemed to quiz Jackson about whether she had spilled the beans to outsiders.

Facebook throttled the BMJ report and warned users not to share it because the social media company's contracted fact-checker, Lead Stories, claimed the reporting would not "Disqualify" the overall Pfizer COVID vaccine trial.

That's because Pfizer repeatedly designated the trial as "Rigorous" despite its familiarity with Ventavia's problems, Thacker told Just the News.

Surgeon General Vivek Murthy did the same when discussing why the FDA was reviewing a vaccine for younger children despite poor results from Pfizer's two-dose trial.

One of Jackson's claims is that Ventavia had too few employees to handle the volume of trial participants.

https://justthenews.com/government/federal-agencies/us-passes-whistleblower-lawsuit-accusing-pfizer-cutting-corners-covid 

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