Following the article published in the BMJ demonstrating that a whistleblower has revealed that the Pfizer pivotal COVID-19 vaccine (Phase III) trial was fundamentally compromised, there has been a huge global reaction amongst senior scientists.
Dr Michael Tomlinson a governance and quality assurance consultant says that this evidence, "Destroys the credibility of the research". In a message he goes onto explain, "It is the reddest of red flags. FDA knew about it and are culpable for not even mentioning it in their brief to the advisory committee that recommended approval." He goes onto point out, "Remember too that Pfizer led by the nose the authors of the trial report published in the NEJM: 'Pfizer was responsible for the design and conduct of the trial, data collection, data analysis, data interpretation, and the writing of the manuscript."
So, why were no questions raised by the FDA (publication or peer reviewers) about the integrity of the data? It would seem that the same party was judge, jury, executioner and recipient of the approval.
Dr Thomas Wickens commenting on Linked In says "dangerous not only for patients, but also the industry, investors ..anyone that relies on the credibility of industrial R&D". Dr Payal Keswarpu replying, "It is a practice which is against science, humanity and trust".
A published response comment on the BMJ says, "It's hard to understand how we can trust the safety data provided by Pfizer".
Dr Clare Craig on Twitter points out, "Whistleblowers claiming serious problems with Pfizer trial."
Many people have been raising questions over both the efficacy and safety of the mRNA treatments. More recent official government data is starting to show larger rates of infection in the the vaccinated compared with the unvaccinated. Although the claims have been increasingly dwindling to the point where it is now accepted that the jab does not offer the level of protection that was first claimed, the original efficacy claims were based on the reports from the Phase III clinical trials. It is therefore important that the results from these experimental clinical trials can be trusted.
Updates - latest official statistics comparing case rates:
The Lancet reports increasing rates of infections in vaccinated to around 60% of all symptomatic infections in over 60's. Also, no significant difference in viral load depending on vaccination status and variant type.
What are the revelations that have come to light?
Paul Thacker writing for the BMJ exposes a number of revelations that have now come to light with regard to how the clinical trials on the Pfizer vaccine were (mis) managed. If right, this raises serious questions over data integrity and the regulatory oversight that allowed the approval for the launch of this product. Paul states that his only competing interest in the publication of the piece is that he, "has been doubly vaccinated with Pfizer’s vaccine".
The key twelve points Paul covers are as follows:
1. There was a need for speed in the Texas labs (Ventavia Research Group) conducting the contracted research during Autumn 2020.
2. Speed may have come at the cost of data integrity and patient safety.
falsified data, unblinded patients, employed inadequately trained vaccinators
3. A regional director who was employed at Ventavia Research Group 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.
4. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding.
5. 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.
6. 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.
7. Jackson documented several matters late one night, taking photos on her mobile phone. One photo showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants.
8. Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to (theoretically) 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.
9. The company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control.
10. There were over one hundred outstanding queries requiring contact, “to ascertain further details and determine whether a site visit is clinically indicated.”
11. The FDA were notified of specific concerns, but took no action. These concerns included:
- 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.
Pfizer has subsequently hired Ventavia as a research subcontractor on four other vaccine clinical trials including COVID-19 vaccine in children and young adults, pregnant women, and a booster dose.
See also Astra Zeneca clinical trial reports from Concerned Doctors, expert panel on vaccine injuries.