Vaccine trial whistle blower

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

This was the original paper

Autumn 2020

Pfizer’s chairman and chief executive, Albert Bourla

As I’ve said before, we are operating at the speed of science

Ventavia Research Group

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).

[dojufitz]

"If you have to be persuaded, reminded, pressured, lied to, incentivized,
coerced, bullied, socially shamed, blackmailed, guilt-tripped, threatened, punished and criminalized...

If all of this is considered necessary to gain your compliance

-- you can be absolutely certain that what is being promoted is not in your best interest.”

- Ian Watson

[joanhyde]

Whistleblowers should be protected from reprisals.

[spartacus]

How many more alarm bells need to ring before cognitive dissonance is broken?

[BuddhaBeanie]

I worked for a major pharma manufacturing company that begins with the letter ‘P’.
Everyone knew at least a week ahead of time when the FDA were coming to inspect. So, things looked great by the time they got there.

[saltysarge]

The only thing that matters to the pharmaceutical companies is the 100% immunity from prosecution or liability.

[jfrankk]

He kind of whispered it, and it's worth highlighting... When her concerns were not being addressed by the research company she worked for, she filed a complaint with the FDA and was FIRED/SACKED/TERMINATED for doing so... this is a huge 🚩 🚩🚩🚩🚩

[stultuses]

Over time John's faith in the system is going down

It's hard for him to give up on a system that has worked well for many people and for many decades, but times have changed

Now he's starting to see why lots of people are saying no to vaccine mandates

[jerimiewest]

When you sign a waiver that dismisses the responsibility on the provider and puts it on the patient, that's a bit alarming. That would be like me running a business and telling the customer it's their fault because you trusted me. Wow! People are impressive. Whatever right.

[nikoscosmos]

Money is the constant in the speed of science.

[justsomenobody]

As much as it saddens me, I am happy to hear this story coming to light, especially in as reputable a journal as BMJ. I have worked in scientific research in the US, and my experience in academia left me severely disillusioned with the state of science in this country. Often people who are not in science will act as though science is incorruptible by its very nature, and that incompetence isn’t permitted ... hopefully this article will open the eyes of some people. As long as science costs money and is being performed by humans, it’s corruptible.

[magicstixr]

Imagine that, a company that has been called a "habitual offender" and been charged $3 billion in fines over the past 20 years for falsifying data has a whistleblower claiming they're falsifying data...

[sweetkicker]

Got the Pfizer jab in april - may 2021. Two weeks after the 2nd shot, had a vertigo event that landed me in the hospital for 4 days, thinking it was a stroke. Diagnosis was BPPV. Before that I was a very healthy 64 year old man. Never had any issues with balance before. December 2021 got the Pfizer booster, several weeks later, rt hand tremors. Later diagnosed in June of 2022 with Parkinson's disease. Again, before the jab, a healthy active 64-65 male. I stopped the boosters and I have stabilized my symptoms but the PD remains.

[stevephla]

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.

[ronjon]

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 take away is as the good doctor says…Well that’s not good….because we need qualified inspection and monitoring of all clinical trials.

[sydludwig]

This is just another example as to why the public doesn't trust what's going on. And they call us crazy.

[dakotadad]

One of the only channels on YouTube where you get actual information with someone who at the least questions the situation we’re all in. It’s beyond me how this channel still exists on this platform and thank god they haven’t removed it

[joshwilliams]

I've read it. It's beyond shocking Dr Campbell.

[followingbeliever]

This looks criminal. Now we see why they don’t want to be held accountable.

[swwsww]

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.

[SassyOnline]

Got to appreciate a guy like this purely sharing knowledge and not pushing his opinion or lies on people. Dedicating his time just to find and share the truth alone and nothing more. Great fella.