British Medical Journal Vaxxine Trial Report
By London Times
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial, Revelations of poor practices at a contract research company
Pfizer’s pivotal covid-19 vaccine trial, raise questions about data integrity and regulatory oversight.
Autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla As I’ve said before, we are operating at the speed of science
Researchers were testing Pfizer’s vaccine at several sites in Texas A regional director, Brook Jackson has told The BMJ that the company falsified data unblinded patients employed inadequately trained vaccinators 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. US Food and Drug Administration (FDA) were informed Ventavia fired her later the same day. The BMJ has been provided with dozens of internal company documents, photos, audio recordings, and emails. She repeatedly informed her superiors poor laboratory management patient safety concerns data integrity issues that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel (later corrected) company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control ICON, the contract research organisation.
ICON then highlighted over 100 outstanding queries older than three days Worries over FDA inspection Concerns raised 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 Targeting of Ventavia staff for reporting these types of problems. FDA advisory committee meeting held on 10 December 2020 Problems at Ventavia not mentioned The next day the FDA issued the authorisation of the vaccine In August this year, after full FDA approval of Pfizer’s vaccine FDA published that 9 of the trials 153 sites were inspected FDA, full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19 Other employees’ accounts 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 I don’t think it was good clean data It’s a crazy mess Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials covid-19 vaccine in children and young adults pregnant women a booster dose an RSV vaccine trial NCT04816643, NCT04754594, NCT04955626, NCT05035212).
Here’s what others had to say:
Steve PHL
Next topic, John, should be the undue influence that big pharma has on the very medical journals that are supposed to be scrutinizing the studies.
Joan Hyde
Whistleblowers should be protected from reprisals.
swwsww2
This study has stark similarities with Arthur Anderson’s approval of Enron’s accounting practices. If you pay for the study (approval) you get what you want.
Thomas Long
One thing is obvious; that 95% efficacy is misleading by more than a bit
Shalinee2212
It’s funny seeing Dr Campbell’s reaction as he processes this report. it’s like someone wandering around a dark room and suddenly finding the light switch. This is just the tip of the iceberg. More to come out, John. Start digging and let the truth emerge.
Ron Jon
May I just add…. The BMJ article talks about the credibility of the whistleblower..Brook… also. She is highly qualified in her position as a quality controller in this field of science. Which was the exact reason she was hired. And it appears that she was honest and forthright with her critical reporting to Phizer and they immediately discharged her…she was only there two weeks. And the takeaway is as the good doctor says…Well that’s not good….because we need qualified inspection and monitoring of all clinical trials.
Following Believer
This looks criminal. Now we see why they don’t want to be held accountable.
Nathan Allones
Dr John is trying very hard to keep this video up by keeping his comments tame. It’s clear he knows the score now despite being optimistic about the V’s. Big respect to his efforts!
D-22
This study is damning, especially when it’s exposing the same pharmaceutical company which was hit with one of the biggest criminal fines in history.
joe sols
Dr John: your review begs comment and questions: Why do you have to give such a soft-ball commentary on something so serious??? How can you use phrases like ‘sub-optimal’, ‘not ideal’, ‘not what we really want’, ‘things don’t sound totally ideal’, ‘falsified data would not be good’, etc. etc. If you are genuinely medically unbiased you would be using phrases like ‘not acceptable’, ‘completely unethical’, ‘dangerous’, ‘criminal’, etc. Just like you do when talking about whether to aspirate or not. That would be more in line with someone who has medical truth and an unbiased fact based helpful opinion to give to his audience without feeling obliged to stick with the pro vaccine narrative taken for months. Imagine someone finding out that an airline had been doing bad maintenance on their planes or just no maintenance at all, and using unqualified pilots and technicians to rush to get planes in the air regardless. Would you still be saying ‘dont worry, we would hope that they are doing better now and have a nice flight”. That’s what you seem to be doing in the face of this new evidence! Isnt it time for harder questions to be asked and stronger opinions given about the mess big pharma and the medical profession seem to have made of this?
