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Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
bmj.com ^ | November 2, 2021 | Paul D Thacker

Posted on 11/02/2021 1:23:35 PM PDT by ransomnote

[H/T Tatown]

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. Paul D Thacker reports

SNIP

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.” 

 
MORE AT LINK


TOPICS: Miscellaneous
KEYWORDS: anthonyfauci; chinavirusvaccine; clinicaltrial; covidstooges; obamacare; pfizer; phaseiiitrial; vaccinedata; vaccinemandates; vaccinetrialdata; whistleblower

1 posted on 11/02/2021 1:23:35 PM PDT by ransomnote
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To: ransomnote

#evil


2 posted on 11/02/2021 1:37:47 PM PDT by aMorePerfectUnion (Fraud vitiates everything ᡕᠵ᠊ᡃ࡚ࠢ࠘ ⸝່ࠡࠣ᠊߯᠆ࠣ࠘ᡁࠣ࠘᠊᠊ࠢ࠘𐡏⁻ )
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To: ransomnote

They didn’t follow the protocols because they already knew they would get approval no matter what. The fix was in.


3 posted on 11/02/2021 1:38:28 PM PDT by Boogieman
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To: Cathi; Unrepentant VN Vet; metmom; Fractal Trader; SecAmndmt; bagster; doc maverick; ...

PING


4 posted on 11/02/2021 1:42:28 PM PDT by ransomnote (IN GOD WE TRUST)
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To: ransomnote

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


5 posted on 11/02/2021 1:50:09 PM PDT by House Atreides
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To: ransomnote

You don’t say…..


6 posted on 11/02/2021 1:54:22 PM PDT by metmom (...fixing our eyes on Jesus, the Author and Perfecter of our faith…)
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To: House Atreides; ransomnote

Ransomnote’s thread stalker shows up, like clockwork. 🧐

Do you keep her posts on some sort of RSS feed?


7 posted on 11/02/2021 1:55:30 PM PDT by Jane Long (What we were told was a “conspiracy theory” in 2020 is now fact. 🙏🏻 Ps 33:12 )
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To: ransomnote
...during the two weeks she was employed at Ventavia in September 2020...

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.

8 posted on 11/02/2021 1:55:53 PM PDT by semimojo
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To: House Atreides
House Atreides wrote:

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

9 posted on 11/02/2021 1:59:09 PM PDT by ransomnote (IN GOD WE TRUST)
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To: Jane Long

Well, I’ve fired incompetent recent hires during their agreed upon probationary periods… but NEVER at two weeks. Two weeks? She must have been a doozy.


10 posted on 11/02/2021 2:00:42 PM PDT by House Atreides
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To: House Atreides

Ha ha HA….not surprising, you did not answer my question.


11 posted on 11/02/2021 2:07:55 PM PDT by Jane Long (What we were told was a “conspiracy theory” in 2020 is now fact. 🙏🏻 Ps 33:12 )
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To: ransomnote

Remember this, those who Mandate experimental jabs have no ethics.


12 posted on 11/02/2021 2:09:55 PM PDT by patriot torch
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To: ransomnote

13 posted on 11/02/2021 2:22:10 PM PDT by CheshireTheCat ("Forgetting pain is convenient.Remembering it agonizing.But recovering truth is worth the suffering")
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To: ransomnote

NEW - U.S.-based pharmaceutical giant #Pfizer is "making a killing" amid pandemic, now expects $36 billion (up 7.5%) of vaccine sales this year after Q3 update.— Disclose.tv (@disclosetv) November 2, 2021


14 posted on 11/02/2021 2:41:16 PM PDT by CheshireTheCat ("Forgetting pain is convenient.Remembering it agonizing.But recovering truth is worth the suffering")
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To: semimojo
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?


15 posted on 11/02/2021 3:18:06 PM PDT by bagster ("Even bad men love their mamas".)
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To: Whenifhow; null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; ...

p


16 posted on 11/02/2021 6:36:38 PM PDT by bitt (<img src=' 'width=50%>)
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To: Whenifhow; null and void; aragorn; EnigmaticAnomaly; kalee; Kale; AZ .44 MAG; Baynative; bgill; ...

p


17 posted on 11/04/2021 10:40:41 AM PDT by bitt (<img src=' 'width=50%>)
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