Health

Former Contract staff and Whistleblower exposes damaging report and fake data on the parts of Pfizer’s COVID-19 vaccine trial

A bombshell report by The BMJ, calls out Pfizer for poor practices and quality control during its COVID-19 vaccine trials.

Brook Jackson, a regional director at Ventavia Research Group, an organization tasked with testing Pfizer’s vaccine at several sites in Texas, reported to The BMJ that the company falsified data, unblinded patients, was slow to follow up on adverse events, and was overwhelmed with quality control issues.

Jackson filed a complaint to the FDA but was fired shortly after. Jackson has supplied The BMJ with documents that support her claim, including emails, photos, internal documents, and audio recordings.

Jackson’s Email to the FDA & the FDA Response:

Jackson is not a rookie to clinical research. She is a trained clinical trial auditor with more than 15 years of experience managing clinical trials. In her September letter to the FDA, Jackson listed multiple safety and quality concerns she had witnessed at 3 COVID-19 trial sites under Ventavia’s watch.

The story published this week in the British Medical Journal lays out issues raised by a now-former employee of Ventavia Research Group, one of the companies contracted to help run some of Pfizer’s Phase III clinical trials.

The employee, former regional director Brook Jackson, told the publication that some paperwork may have been left out in the open, potentially unbinding some of the participants. Among her other concerns: Participants were not properly monitored by clinical staff after their injections, vaccines not being stored at the right temperature and mislabeling of specimens.

Paul Thacker, the investigative journalist who wrote the story, told CBS 17 that it raised questions about “what was this process like? Was this good data?”

Peter Doshi, the publication’s senior editor, said Thacker’s story was subject to the same rigorous peer review that scientific studies published by The BMJ are.

Ventavia spokeswoman Lauren Foreman said in a statement that the company is investigating the allegations made by Jackson.

“Ventavia takes research compliance, data integrity, and participant safety very seriously and stands behind its important work supporting the development of lifesaving vaccines and is conducting its investigation accordingly,” she said.

The report was making rounds on social media, with vaccine skeptics pointing to it as justification for their skepticism.

Even Thacker acknowledged that “people are going to use this to push a political position because that’s what they’re interested in.”

But Fisher — who has authored books on the subject of clinical trials and was quoted in Thacker’s story — says that’s the wrong takeaway.

“I think that’s definitely a narrative that’s out there,” she said. “And I don’t think that’s necessarily a fair narrative.”

With millions of North Carolinians — and billions of people around the globe fully vaccinated — researchers have plenty of real-world data that show the safety and efficacy of the vaccines.

The Pfizer Phase III trial involved 44,000 people and 153 locations. From August 2020 through Sept. 17, 2020 — when she was fired — Jackson told CBS 17 that Ventavia accounted for at least 1,200 of those people and accounted for three sites.

“If all of the clinical trial data were dependent on one particular site, and that site’s data were called into question, I think it would be a much bigger concern,” Fisher said.

The more important takeaway, she said, is the need for improved oversight in clinical trials.

“We’re really interested in the story because it is about COVID-19. And it’s about vaccines. But I think it’s really a much more important story about just how clinical research is done, what kinds of organizations and companies are part of it,” Fisher said. “And really, I think it also points to the fact that the FDA is incredibly under resourced, and they just cannot do the kinds of inspections and investigations that might be required.”

Brook Jackson is not the only person who exposed the pharmaceutical company.

Two unnamed Ventavi employees recalled their experience with working in the facility.

In an interview with BMJ, one employee said that she never saw such helter shelter work in her 50 clinical trial experiences. She believes the data is not clean.

Another employee with 20 years of experience admitted that it was the most careless she had ever seen.