Whistleblower Exposes Falsified Data & Regulatory Oversight Issues From Pfizer COVID-19 Jab Trials
It is clear to anyone that has the eyes to see, that Pfizer’s rush to get its COVID-19 “vaccine” trial in fall 2020 to gain Emergency Use Authorization of the experimental injection was a DISASTER. We are not talking about just a small disaster but one that is off the chart HUGE!
Now, everyone in the world is about to see the truth of what has happened thanks to a research whistleblower who posted these revelations in The British Medical Journal.
If you were not aware like most people and that includes me, the BMJ is among the world’s top medical journals, so the mainstream media can’t call any of us a crazy conspiracy theorist for sharing this information.
Former regional director of Ventavia Research Group, Brook Jackson, shed light on data integrity and regulatory oversight issues concerning the trials.
Based in Texas, Ventavia Research Group was responsible for testing the Pfizer COVID-19 jabs at multiple sites in fall 2020.
According to Jackson, Ventavia Research Group:
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. 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 responded by firing her.
Jackson blew the whistle by providing The BMJ with a multitude of internal documents, photos, emails, and audio recordings.
Read below for the investigation’s findings:
NEW: Our latest investigation hears from a whistleblower engaged in Pfizer’s pivotal covid-19 vaccine trial. Her evidence raises serious questions about data integrity and regulatory oversight https://t.co/Ho99hQhwRM
— The BMJ (@bmj_latest) November 2, 2021
Read now. Circulate widely please. BMJ article blows the lid on Pfizer and FDA. Whistleblower (fired when she spoke out) shows that Pfizer falsified data, unblinded patients, …" FDA doesn't care; lax oversight.https://t.co/Wpq2msSpbD
— Steve Kirsch (@stkirsch) November 2, 2021
https://twitter.com/loffredojeremy/status/1455558806759428101?ref_src=twsrc%5Etfw
The BMJ has posted a story that calls into question the reliability of the data generated by Pfizer's vaccine trials. It's based on dozens of documents, photos, audio recordings and emails supplied by a whistleblower. https://t.co/VYXVyb7DFo
— Toby Young (@toadmeister) November 2, 2021
THIS IS A BIG STORY: BMJ "Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight" https://t.co/ArbdvSLvcR
— Dr Anthony Hinton (@TonyHinton2016) November 2, 2021
https://twitter.com/DrEliDavid/status/1455581763800125446?ref_src=twsrc%5Etfw
From The BMJ:
Poor laboratory management
On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 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. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.
Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.
cont.
Concerns raised
In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. 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
- Mislabelled 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. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.
In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8
In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”
cont.
Other employees’ accounts
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. Both confirmed broad aspects of Jackson’s complaint. 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.”
She added that during her time at Ventavia the company expected a federal audit but that this never came.
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. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)
“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”
Share your thoughts below!
I just read an article about an ad by Pfizer directed at youngsters basically saying that if they get the “jab” it will make them stronger and healthier. That is is pure BS and Pfizer knows it but they are part of the misinformation miscreants that don’t really care about side effects or We the People as long as they sell their garbage!!
It`s not adding up, my brother in law had to go to the hospital because of colon problems, he was given a COVID test which was negative, he was then admitted, after some tests he was found to have colon cancer, he died. His doctor asked his wife if he could list his death as a COVID death, she told him no and if he did she would sue him, he didn’t list his death as a COVID death. My wife had a cousin in CA who died of an heart attract, his COVID test was also negative, but the doctor listed his death as a COVID death. My mother was in a nursing home, she passed away in the nursing home and the director sent her to the hospital claiming she had COVID, he tried to blame her death as a COVID death, the doctor said she died of old age with Dementia, she was 99 years old, I suspect the nursing home director wanted some extra money. One of my grandsons and his wife and their 5 year old daughter had COVID, their doctor gave them ivermectin, antibiotics and vitamins, they were cured in days. What is going on ? My wife and I are not going to take the vaccine as we have read that it destroys our immune system from very credible doctors, besides, these are not like the vaccines we gave our children when they were babies and toddlers, these work off our RNA and DNA, plus no on e knows the long term side effects, tests usually run front 8 to 15 years on the older vaccines, not the COVID vaccines.
Big Pharma is doing exactly what the liberal commie Democrats did in the last presidential election. They corrupted the system. It’s all about the money ($). The Wuhan Virus Vaccine was never intended to prevent one from getting the Wuhan Virus.
this is just outrageous and ILLEGAL, too many people coming forward and saying they are skewering the numbers, not reporting adverse reactions, leaving shit out in the open, I mean, c’mon man REALLY?
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