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British Medical Journal Publishes Whistleblower Data Integrity Issues in Pfizer’s COVID-19 “vaccine” Tests
By: David Deschesne
Fort Fairfield Journal, November 17, 2021
On November 2, 2021, the British Medical Journal published a revealing article by investigative reporter, John D. Thacker which described a whistleblower’s allegations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 “vaccine” safety trial raising questions about data integrity and regulatory oversight.
Thacker reported that researchers for Pfizer’s vaccine at several sites in Texas during that autumn, have noted that speed may have come at the cost of data integrity and patient safety. “A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial,” wrote Thacker. “Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson, emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.”
According to their website, Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work. “But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management.”
“In a recording of a meeting in late September, 2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control,” wrote Thacker. “‘In my mind, it’s something new every day,’ a Ventavia executive says. ‘We know that it’s significant.’”
“Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.
“When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE), says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.”
Thacker then reported that another former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.
“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.
“In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites,” wrote Thacker. “Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.”
Thacker reports that Fisher then tried to warn the FDA about the nefarious and substandard testing procedures going on at the Pfizer sub-contracted testing facility; “[On] 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed ‘not a good fit,’ according to her separation letter. Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.”
Thacker noted that in her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. She then listed a dozen concerns she had witnessed, including:
- Participants 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
- Mislabeled laboratory specimens, and
Targeting of Ventavia staff for reporting these types of problems.
“Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result.”
“In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that ‘everything that you complained about was spot on.’”
“Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community.”
Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials; covid-19 vaccine in children and young adults, pregnant women, a ‘booster’ dose, as well an RSV vaccine trial.
The FDA recently granted Emergency Use Authorization for Pfizer’s experimental drugs to be tested in children across the U.S. to see what the long term adverse side effects will be at the expense of children's’ health. So far, FDA data shows over 18,000 deaths in the U.S. from the “vaccines.”