Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

A regional director who was employed at the research organisation Ventavia Research Group has 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. 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 fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

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.

SNIP

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.”

House Atreides wrote:

“… needles discarded in a plastic biohazard bag instead of a sharps container box….”
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The horror…. the horror.

What part escapes you?

The fact that standard procedures require used needles to be put in a box instead of an easily punctured bag?

The fact that those working in medical settings don't want to be punctured by needles contaminated with patients' assorted bacterial and viral pathogens?

Or the fact that your side forgets we're all supposed to pretend that Covid is almost as dangerous as Ebola, and so supposedly a needle puncture in a Covid trial is a severe risk of grisly death-by-CDC-Covid-protocol.

I suspect there's more to this story. Two weeks is pretty quick to get oriented, figure out what's really going on and start accumulating documents and pictures.

Beg pardon, the liberal troll formerly known as Mojo, but your sorry excuses are getting more laughable by the day.

Does the desperation burn?

Pressure from management?

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