Fake Data, Broken Rules! FDA Never Investigated Firm Involved in Pfizer COV Trials

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A whistleblower involved in Pfizer’s pivotal phase III Covid-19 vaccine trial has leaked evidence to a prominent peer-reviewed medical publication, The BMJ, that poor practices at the contract research company she worked for raise serious questions about data integrity and regulatory oversight, Zerohedge reports

Brook Jackson was fired as regional director at Ventavia Research Group after she revealed that vaccine trials at several sites in Texas last year had major problems. The problems included falsified data, broke fundamental rules, and ‘slow’ to report adverse effects.

When she told superiors of the issues she found, they fired her.

Jackson is a trained clinical trial auditor with more than 15 years of experience. She says she repeatedly warned her superiors of poor laboratory management, patient safety concerns, and data integrity issues. After she was ignored, she started documenting problems with the camera on her mobile phone.

Her supervisors questioned her about that.

UNBLINDING

In one photo, participants were unblinded and that can be serious. It taints the trial data. They eventually corrected it but it took two months.

Jackson recorded a September 2020 meeting with two Ventavia directors, at which an executive can be heard saying that the company couldn’t quantify the types and number of errors with their testing.

“In my mind, it’s something new every day,” they said, adding “We know that it’s significant.”

FALSIFIED DATA

According to the report, Ventavia also failed to keep up with data entry – as a Sept. 2020 email from Pfizer partner ICON reveals.

Other documents provided to The BMJ reveal that Ventavia officials were worried about three employees. In an email in early August 2020, an executive identified three site staff members with whom they need to “Go over e-diary issue/falsifying data, etc.”

One of the employees was “verbally counseled for changing data and not noting late entry,” a note reveals.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told the journal, adding however that the agency rarely does anything except review paperwork – usually months after a trial is over. “I don’t know why they’re so afraid of them,” she added – saying that she was surprised that the agency failed to inspect Ventavia following an employee complaint.

“You would think if there’s a specific and credible complaint that they would have to investigate that.”

FDA NEVER INVESTIGATED

Jackson sent a Sept. 25 email to the FDA in which she wrote that Ventavia had enrolled over 1,000 participants at three sites, out of the full trial’s 44,000 participants across 153 sites which included various academic institutions and commercial companies. She raised concerns over issues she had witnessed, including:

  • Participants were placed in a hallway after injection and not being monitored by clinical staff
  • Lack of timely follow-up of patients who experienced adverse events
  • Protocol deviations not being reported
  • Vaccines not being stored at proper temperatures
  • Mislabelled laboratory specimens, and
  • Targeting of Ventavia staff for reporting these types of problems.
  • Hours later, the FDA emailed her back, thanking her for her input but notifying her that they would not comment on any investigation which may result.

They NEVER even looked at Ventavia’s sites after being informed.

OTHERS AGREE

Two former Ventavia employees spoke with The BMJ anonymously, and confirmed ‘broad aspects’ of Jackson’s account.

One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter-skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

The second employee told The BMJ that working at Ventavia was unlike any environment she had experienced in 20 years of research.

Since her firing, Jackson has reconnected with several Ventavia employees who either left or were fired themselves. One of them sent her a text message, which reads “everything that you complained about was spot on.”

Pfizer has since contracted with the company on four other trials.


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