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Science & Tech


‘FALSIFIED DATA’: PFIZER VACCINE TRIAL HAD MAJOR FLAWS, WHISTLEBLOWER TELLS
PEER-REVIEWED JOURNAL

by Zero Hedge
November 2nd 2021, 2:02 pm

Claims Phase III trials at several sites in Texas last year falsified data,
broke fundamental rules, and were 'slow' to report adverse reactions.
Image Credit:
Artur Widak/NurPhoto via Getty Images
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A whistleblower involved in Pfizer’s pivotal phase III Covid-19 vaccine trial
has leaked evidence to a notable peer-reviewed medical publication that poor
practices at the contract research company she worked for raise questions about
data integrity and regulatory oversight.

Brook Jackson, a now-fired regional director at Ventavia Research Group,
revealed to The BMJ that vaccine trials at several sites in Texas last year had
major problems – including falsified data, broke fundamental rules, and were
‘slow’ to report adverse reactions.



When she notified superiors of the issues she found, they fired her.

> 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. -The BMJ

Poor laboratory management

Jackson, a trained clinical trial auditor with more than 15 years’ experience,
says she repeatedly warned her superiors of poor laboratory management, patient
safety concerns, and data integrity issues. After she was ignored, she started
documenting problems with the camera on her mobile phone.

> One photo, provided to The BMJ, showed needles discarded in a plastic
> biohazard bag instead of a sharps container box. Another showed vaccine
> packaging materials with trial participants’ identification numbers written on
> them left out in the open, potentially unblinding participants. Ventavia
> executives later questioned Jackson for taking the photos.

The unblinding was potentially far more severe as well. Per the trial’s
design, unblinded staff prepared and administered either Pfizer’s Covid-19
vaccine or a placebo. This was done to preserve the blinding of trial
participants and other staff – including the principal investigator. At
Ventavia, however, Jackson says that drug assignments were left in participants’
charts and accessible to blinded personnel. The breach was corrected last
September, two months into the trial at which point there were around 1,000
participants already enrolled.



Jackson recorded a September 2020 meeting with two Ventavia directors, at which
an executive can be heard saying that the company couldn’t quantify the types
and number of errors with their testing.

“In my mind, it’s something new every day,” they said, adding “We know that it’s
significant.“

According to the report, Ventavia also failed to keep up with data entry – as a
Sept. 2020 email from Pfizer partner ICON reveals.

> “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.” According
> to the trial protocol a telephone contact should have occurred “to ascertain
> further details and determine whether a site visit is clinically indicated.”

FDA Inspection woes

Other documents provided to The BMJ reveal that Ventavia officials were worried
about three employees . In an email in early August 2020, an executive
identified three site staff members with whom they need to “Go over e-diary
issue/falsifying data, etc.”

One of the employees was “verbally counseled for changing data and not noting
late entry,” a note reveals.

During the September meeting, Ventavia executives and Jackson discussed the
potential for the FDA to show up for an inspection. On former Ventavia employee
told The BMJ that the company was petrified over the potential for an FDA audit,
and were in fact expecting one over the Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher
told the journal, adding however that the agency rarely does anything except
review paperwork – usually months after a trial is over. “I don’t know why
they’re so afraid of them,” she added – saying that she was surprised that the
agency failed to inspect Ventavia following an employee complaint.

“You would think if there’s a specific and credible complaint that they would
have to investigate that.”

FDA notified

Jackson sent a Sept. 25 email to the FDA in which she wrote that Ventavia had
enrolled over 1,000 participants at three sites, out of the full trial’s 44,000
participants across 153 sites which included various academic institutions and
commercial companies. She raised concerns over issues she had witnessed,
including:

 * 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.

Hours later, the FDA emailed her back, thanking her for her input but notifying
her that they would not comment on any investigation which may result.

That said, in August of this year, the FDA published a summary of its
inspections of Pfizer’s pivotal phase III trial. They looked at just nine out of
the trial’s 153 sites, and did not look at any of Ventavia’s operations.
Further, no inspections were conducted following the December 2020 emergency
authorization of the vaccine.

Other employees corroborate Jackson’s complaints

Two former Ventavia employees spoke with The BMJ anonymously, and confirmed
‘broad aspects’ of Jackson’s account.

> One said that she had worked on over four dozen clinical trials in her career,
> including many large trials, but had never experienced such a “helter skelter”
> work environment as with Ventavia on Pfizer’s trial.
> 
> “I’ve never had to do what they were asking me to do, ever,” she told The BMJ.
> “It just seemed like something a little different from normal—the things that
> were allowed and expected.”
> 
> She added that during her time at Ventavia the company expected a federal
> audit but that this never came.
> 
> After Jackson left the company problems persisted at Ventavia, this employee
> said. In several cases Ventavia lacked enough employees to swab all trial
> participants who reported covid-like symptoms, to test for infection.
> Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint,
> the employee noted. (An FDA review memorandum released in August this year
> states that across the full trial swabs were not taken from 477 people with
> suspected cases of symptomatic covid-19.)
> 
> “I don’t think it was good clean data,” the employee said of the data Ventavia
> generated for the Pfizer trial. “It’s a crazy mess.” -The BMJ

The second employee told The BMJ that working at Ventavia was unlike any
environment she had experienced in 20 years of research.

Since her firing, Jackson has reconnected with several Ventavia employees who
either left or were fired themselves. One of them sent her a text message, which
reads “everything that you complained about was spot on.”

Meanwhile, since Jackson reported issues with Ventavia to the FDA in September
2020, Pfizer has contracted with the company for four other vaccine clinical
trials.

One has to wonder – if the FDA is auditing less than 10% of trials, how many
more potential whistleblowers could there be?

--------------------------------------------------------------------------------



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