Data relied on by vaccine maker Pfizer to prove the safety and efficacy of its Covid-19 vaccine was manipulated and falsified, a scientist working at a lab conducting vaccine clinical trials claims.
The allegations were outlined in the British Medical Journal earlier this month and come from researcher Brook Jackson, who worked for two weeks at Texas-based Ventavia Research Group in 2020 where she claimed to have observed numerous forms of malfeasance.
According to Jackson, Ventavia “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,” whose data was referenced prior to Pfizer’s emergency approval.
“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,” reported British Medical Journal researcher Paul D. Thacker.
Jackson, a highly accredited clinical trial auditor with over a decade of experience, says she began documenting evidence of data integrity issues with her phone camera after Ventavia failed to address numerous glaring problems.
“One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box,” Thacker writes. “Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants [of double-blind studies].”
The latter is particularly worrisome as unblinding trial participants means researchers could easily see who was given a placebo and who was administered a vaccine, possibly opening the door to data manipulation.
According to Thacker, Ventavia failed to conduct basic follow-ups on data entry queries, with over 100 outstanding queries stacking up at one point in a three-day period when they were supposed to be addressed within 24 hours.
Evidently, issues of falsifying data were present before Jackson joined the company.
“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,” the BMJ reports.
After Ventavia failed to act on Jackson’s reported issues, she reached out to the FDA with a letter detailing the issues at the lab.
In her letter, Jackson noted the lab was slow to follow up on adverse reactions, failed to properly monitor patients post-jab, did not store vaccines at the appropriate temperatures, mislabeled specimens, and added that Ventavia targeted employees who highlighted the issues.
“Ventavia fired her later the same day,” the BMJ reports, telling her she was “not a good fit.”
Later, the whistleblower’s reports were corroborated by former co-workers, who claimed the problems Jackson identified continued after her departure.
“After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported Covid-like symptoms, to test for infection,” the BMJ noted, despite “Laboratory confirmed symptomatic Covid-19” being the trial’s primary focus.
Commenting to media outlet The Conversation, a Ventavia spokesperson acknowledged they were aware of the BMJ article and denied Ms. Jackson’s “job responsibilities concerned the clinical trials at issue.”
“These same accusations were made a year ago, at which time Ventavia notified the appropriate parties. The allegations were investigated and determined to be unsubstantiated. Ventavia takes research compliance, data integrity, and participant safety very seriously, and we stand behind our work supporting the development of life-saving vaccines,” the company responded.
Despite the objections raised by Jackson, Pfizer “made no mention of problems at the Ventavia site,” Thacker reports. “The next day the FDA issued the authorisation of the vaccine.”
In follow-up reports this year, the FDA claimed to have inspected nine Pfizer phase III clinical trial sites out of 153, none of which were Ventavia’s lab.
“Pfizer has since hired Ventavia to work on four other vaccine clinical trials, including for children and young adults, pregnant women, and booster doses,” reports News.com.au.
Speaking to London radio station LBC, British cardiologist Dr. Aseem Malhotra called the outrageous report of falsified data “absolutely shocking.”
“This should be major international news,” Malhotra said.
“That Pfizer trial, that pivotal trial … because of that data, millions and millions of people have taken the vaccine.”
Malhotra, who admitted to being fully vaccinated, added that he’s grown skeptical of the vaccine rollout, especially with evidence showing waning efficacy and the fact Covid is still transmissible post-vaccination.
“I’m pretty convinced the vaccine most likely does prevent serious illness and death, and we’ve got some real-world data to support that, but it changes the conversation because we then start looking at lower-risk groups and whether they should take the vaccine, and this also applies to mandates,” the British cardiologist noted.
Discussing the accusations against Ventavia, Malhotra said they’re “not that surprising if you look at the history of research integrity from the pharmaceutical industry going back many years,” and that many drug approvals were “made on incomplete, biased and in many cases potentially corrupted data”.
“Unfortunately the reason it hasn’t been tackled is because there have not been any effective interventions or sanctions put on the pharmaceutical industry,” Malhotra noted.
“Between 2009 and 2014, most of the top 10 pharmaceutical companies have paid fines [for] criminal activity of around $US13 billion for hiding data on harms, illegal marketing of drugs, manipulation of results, and nothing really seems to have changed in the system.”
“So this is business as usual for many of these companies.”
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