To put it bluntly, Pfizer’s rushed COVID-19 jab trial in fall 2020 to gain Emergency Use Authorization of the experimental injection was a DISASTER.
How much of a disaster?
Thanks to a research whistleblower whose revelations appear in The British Medical Journal (The BMJ), the public has greater insight on this train wreck.
The BMJ is among the world’s top medical journals, so the mainstream media can’t call you 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.
The revelations expose the lack of FDA oversight on the experimental COVID-19 injections.
Researchers falsified data and the federal agency didn’t care.
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
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
I’ve pulled key pieces of text from the article to read below.
The link briefly failed to load earlier Tuesday evening.
So, I wanted to highlight the shocking revelations while they’re still available.
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.”
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