The company’s recurrent inability to adequately operate facilities for Pfizer’s COVID-19 vaccination study has been clearly documented. This has led to emergence of COVID vaccine trial whistleblower Brook Jackson filing a lawsuit against Pfizer for false claims.
Despite the US government’s refusal to support her, an ex clinical trial overseer for a contractor conducting COVID-19 vaccination studies is pursuing a case against Pfizer and her former firm.
In 2020, the contractor, Ventavia Research Group, dismissed Brook Jackson. In 2021, she stepped forth as a whistleblower.
Jackson is suing Pfizer, Ventavia, and ICON, a business participating in the trial, under the False Claims Act. This had been kept under wraps for more than a year, but it has finally been publicly disclosed after the US Department of Justice failed to intercede on Jackson’s behalf.
The decision not to intervene was not explained by government attorneys, and the FDA, which investigates potential clinical trial misconduct, didn’t answer to a request for clarification.
The whistleblower, however, has not been discouraged by the choice.
“We’re going to pursue the case without the help of the government,” Jackson told the mediia.
She was not even startled, but expressed “total disappointment” once the government refused to act after more than a year of deliberation.
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.”
When the British Medical Journal printed a piece in November 2021 founded on records, videos, and other information from Jackson, it documented Ventavia’s recurrent inability to adequately operate facilities for Pfizer’s COVID-19 vaccination study before it gained emergency authorization from US drug regulators.
While none of the papers were included in the materials, several were submitted in the court and acquired, notably emails that describe issues not only Jackson but many other Ventavia employees have encountered.
For example, on Sept. 18, 2020, Lovica Downs wrote to Jackson and another employee, saying she saw packages with patient data lying on the counter “fully exposed to anyone that entered the room could see.”
Additional communiques detailed different issues. An inquiry showed numerous sites had chosen to leave files exposed, including one with a scheduling system with patient identities on it; adverse events “not being reported correctly or at all”; the vaccine and placebo “not being kept locked” in “disorganised” rooms; and informed consent inconsistencies, according to Marnie Fisher, Ventavia’s operations director at the time.
The documents demonstrate that Ventavia workers were fully conscious of major issues that arose during the trial, such as vaccination administrators who were defined as possessing “no training” and “very little oversight” or as lacking medical credentials or background in the documents. A Pfizer employee was copied on a few of the emails and responded to some of them.
Fisher could not be contacted, and Downs refused to respond. Inquiries for clarification from ICON and Pfizer were not returned. Jackson worked at Ventavia, but “no part of her job responsibilities concerned the clinical trials at issue,” spokeswoman Lauren Foreman told the press.
On February 11, Foreman revised his statement, saying, “Although Jackson was hired to oversee certain sites and aspects of clinical trials, she was only employed with Ventavia for 18 days, and, as a result, did not have the longevity with the company to complete the training for the role for which she was hired.”
Jackson’s attorney reportedly threatened to sue Ventavia for defamation over the publication’s depiction of her job.
Last year, the FDA made a statement via email saying, “Although the agency cannot comment further at this time in this ongoing matter, FDA has full confidence in the data that were used to support the Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.” Upon being contacted for an update on Monday, spokespersons did not respond.
Jackson was dismissed just hours after submitting a petition with the Food and Drug Administration. Per the text messages received, a Pfizer employee contacted Jackson personally for further information within weeks.
According to the government, the complaint was filed under the False Claims Act, which allows Americans to sue on behalf of the state “against those who have defrauded the government.” As of the fall of 2021, upwards of $5.6 billion had been recovered via actions brought under the legislation.
The suit states that Pfizer, ICON, and Ventavia “deliberately withheld crucial information from the United States that calls the safety and efficacy of their vaccine into question.”
“Namely, Defendants concealed violations of both their clinical trial protocol and federal regulations, including falsification of clinical trial documents,” it also says. “Due to Defendants’ scheme, millions of Americans have received a misbranded vaccination which is potentially not as effective as represented.”
Jackson is requesting that the court grant her damages and back pay, as well as restore her to her Ventavia position.
Read the exhibits in the case below: