A private clinical research company involved in the Pfizer Wuhan coronavirus (COVID-19) vaccine trial in the fall of 2020 falsified phase-three trial data and neglected participants who experienced adverse events.
This is according to the testimony of whistleblower Brook Jackson, a clinical trial auditor with more than 15 years of experience in clinical research coordination and management. Jackson worked for Ventavia Research Group, a clinical research company based in Texas, for two weeks in Sept. 2020.
During her stint at Ventavia, Jackson repeatedly alerted her employer to the overwhelming number of problems in quality control of the trial. She even emailed her complaints to the Food and Drug Administration (FDA). But all of her concerns were ignored and her employer fired her on the same day she reported her concerns to the FDA.
Paul. D. Thacker, who handled the BMJ’s report on Jackson’s testimony, wrote that the medical journal is in possession of “dozens of internal company documents, photos, audio recordings and emails” – thanks to Jackson.
One of the photos in the BMJ’s possession reportedly shows “vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.”
Keeping trials double-blind is an important aspect that maintains the integrity of randomized control trials. It protects data from being influenced by bias, and researchers dedicated to science and facts should at all times maintain the blinding of research facilitators and participants.
But when Jackson took the photo of the packaging materials, Ventavia executives questioned her and reprimanded her.
Patrick Delaney, writing for Life Site News, pointed out that some clinical research companies may have financial incentives to break research protocols and unblind participants to produce outcomes favorable to their clients. “In this case, Pfizer, and their knowledge of trial participants’ status may bias them in how they collect data,” he wrote.
According to Jackson’s email to the FDA, she had many other issues regarding Ventavia’s Pfizer trial, including:
- Post-injection participants were ignored by clinical staff.
- Patients who experienced adverse reactions to the vaccinations were not followed-up with on time.
- Protocol deviations were not being reported.
- Vaccines were not stored at proper temperatures.
- Laboratory specimens were routinely mislabeled.
- Ventavia executives harassed staff who reported concerns about the way the trial was conducted.
Corruption in clinical trials is an old issue due to Big Pharma
Dr. Aseem Malhotra, a British cardiologist and author, called the BMJ’s investigation “devastating” to Pfizer. “Where is the FBI? Why is there not a criminal investigation looking into this?” he asked.
Malhotra pointed out that, as a doctor who has long campaigned against Big Pharma, the fact that the BMJ‘s investigation is being swept under the rug is not surprising.
“It’s not really that surprising, even though it’s shocking, because if you look at the history of drug companies generally, there has been a problem for a very long time with corruption of data, hiding data on harms, not sharing data,” he said. “Which then means that doctors and patients are basically having to make decisions on biased information.”
“And when I say that this hasn’t been rectified, that’s the other issue,” continued Malhotra. “Between 2009 and 2014, for example, most of the top 10 [largest] pharmaceutical companies paid a total $13 billion in fines for criminal activity, which involves hiding data on harms and illegal marketing of drugs, for example. There’s nothing being done to rectify this situation.”
During a different interview, Malhotra called the BMJ’s report “absolutely shocking.”
“This should be major international news,” he said. “That Pfizer trial, that pivotal trial because of that data, millions and millions of people have taken the vaccine.”
Malhotra himself said that Pfizer’s phase-three clinical trial data convinced him to receive both doses of the vaccine “very early on” despite the fact he was not high risk, to protect his parents from getting COVID-19.
“What’s now very clear is that there’s no significant reduction in transmission from taking the vaccine,” he said.
Malhotra pointed out that until effective intervention or sanctions are placed upon the largest players in the pharmaceutical industry, the publication of corrupted trial data by Big Pharma will most likely continue.
He cited the example of GlaxoSmithKline, a British Big Pharma company that was fined $3 billion in 2012. “They made $25 billion in profit during the period covered by the settlement,” he said. “Nobody was fired, nobody was jailed. So this is business as usual for many of these companies.”