A former clinical trial overseer for a contractor holding trials of Pfizer’s COVID-19 vaccine is pressing forward with a lawsuit against Pfizer and her former company despite the U.S. government declining to side with her.
Brook Jackson was fired by the contractor, Ventavia Research Group, in 2020. She came forward as a whistleblower in 2021.
Jackson filed a False Claims Act suit against Pfizer, Ventavia, and another company involved in the trial, ICON. It has been under seal for over a year, but is now public after the U.S. Department of Justice declined to intervene on behalf of Jackson.
Government lawyers did not explain the choice not to intervene and the Food and Drug Administration (FDA), which investigates alleged clinical trial fraud, did not respond to a request for comment.
The choice, though, has not deterred the whistleblower.
“We’re going to pursue the case without the help of the government,” Jackson told The Epoch Times.
She said she wasn’t surprised but felt “total disappointment” when, after over a year of putting off a decision, the government declined to intervene.
The odds of success aren’t good but “it’s just a chance I have to take,” Jackson said. “I just feel like somebody has to be held accountable.”
Jackson set off a firestorm when the British Medical Journal in November 2021 published a piece, based on documents, recordings, and other materials from Jackson, that outlined repeated failures by Ventavia to properly run sites for Pfizer’s COVID-19 vaccine trial before it received emergency clearance from U.S. drug regulators.
While the article did not include any of the materials, many were filed with the court and obtained by The Epoch Times, including emails that detail problems observed not just by Jackson, but other Ventavia workers.
For instance, Lovica Downs wrote on Sept. 18, 2020, to Jackson and another employee that she observed boxes containing patient information left on the counter “full[y]exposed to anyone that entered the room could see.”
Other missives described other problems. Marnie Fisher, Ventavia’s director of operations at the time, said on Sept. 21, 2020, that an investigation found multiple sites had left documents exposed, including a schedule with patient names on it; adverse events either “not being reported correctly or at all”; the vaccine and placebo “not being kept locked” in “disorganized” rooms; and informed consent errors.
The documents show that Ventavia employees were aware of serious problems arising during the trial, including vaccine administrators who were either described as having “no training” and “very little oversight” or lacking medical certifications or background. A Pfizer official was copied on, and answered some, of the emails.
Source: The Epochtimes