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1. News & Views
2. Covid-19: Researcher...
3. Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s
vaccine trial

Feature BMJ Investigation

COVID-19: RESEARCHER BLOWS THE WHISTLE ON DATA INTEGRITY ISSUES IN PFIZER’S
VACCINE TRIAL

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November
2021) Cite this as: BMJ 2021;375:n2635

READ OUR LATEST COVERAGE OF THE CORONAVIRUS PANDEMIC

* Article
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1. Paul D Thacker, investigative journalist

Author affiliations

1. Madrid, Spain
2. thackerpd@gmail.com

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

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an
open letter to the billions of people around the world who were investing their
hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve
said before, we are operating at the speed of science,” Bourla wrote, explaining
to the public when they could expect a Pfizer vaccine to be authorised in the
United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas
during that autumn, speed may have come at the cost of data integrity and
patient safety. 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.
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.

Early and inadvertent unblinding may have occurred on a far wider scale.
According to the trial’s design, unblinded staff were responsible for preparing
and administering the study drug (Pfizer’s vaccine or a placebo). This was to be
done to preserve the blinding of trial participants and all other site staff,
including the principal investigator. However, at Ventavia, Jackson told The BMJ
that drug assignment confirmation printouts were being left in participants’
charts, accessible to blinded personnel. As a corrective action taken in
September, two months into trial recruitment and with around 1000 participants
already enrolled, quality assurance checklists were updated with instructions
for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two
directors a Ventavia executive can be heard explaining that the company wasn’t
able to quantify the types and number of errors they were finding when examining
the trial paperwork for quality control. “In my mind, it’s something new every
day,” a Ventavia executive says. “We know that it’s significant.”

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

WORRIES OVER FDA INSPECTION

Documents show that problems had been going on for weeks. In a list of “action
items” circulated among Ventavia leaders in early August 2020, shortly after the
trial began and before Jackson’s hiring, a Ventavia executive identified three
site staff members with whom to “Go over e-diary issue/falsifying data, etc.”
One of them was “verbally counseled for changing data and not noting late
entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia
executives discussed the possibility of the FDA showing up for an inspection
(box 1). “We’re going to get some kind of letter of information at least, when
the FDA gets here . . . know it,” an executive stated.

Box 1

A HISTORY OF LAX OVERSIGHT

When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of
Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the
agency’s oversight capacity is severely under-resourced. If the FDA receives a
complaint about a clinical trial, she says the agency rarely has the staff
available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen,
along with dozens of public health experts, filed a detailed complaint in July
2018 with the FDA about a clinical trial that failed to comply with regulations
for the protection of human participants.4 Nine months later, in April 2019, an
FDA investigator inspected the clinical site. In May this year the FDA sent the
triallist a warning letter that substantiated many of the claims in the
complaints. It said, “[I]t appears that you did not adhere to the applicable
statutory requirements and FDA regulations governing the conduct of clinical
investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations
and independent clinical research facilities,” says Jill Fisher, professor of
social medicine at the University of North Carolina School of Medicine and
author of Medical Research for Hire: The Political Economy of Pharmaceutical
Clinical Trials.

VENTAVIA AND THE FDA

A former Ventavia employee told The BMJ that the company was nervous and
expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher
told The BMJ, but added that the agency rarely does anything other than inspect
paperwork, usually months after a trial has ended. “I don’t know why they’re so
afraid of them,” she said. But she said she was surprised that the agency failed
to inspect Ventavia after an employee had filed a complaint. “You would think if
there’s a specific and credible complaint that they would have to investigate
that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector
General released a report on FDA’s oversight of clinical trials conducted
between 2000 and 2005. The report found that the FDA inspected only 1% of
clinical trial sites.6 Inspections carried out by the FDA’s vaccines and
biologics branch have been decreasing in recent years, with just 50 conducted in
the 2020 fiscal year.7

RETURN TO TEXT

The next morning, 25 September 2020, Jackson called the FDA to warn about
unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her
concerns in an email to the agency. In the afternoon Ventavia fired
Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year
career in research.

CONCERNS RAISED

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled
more than 1000 participants at three sites. The full trial (registered under
NCT04368728) enrolled around 44 000 participants across 153 sites that included
numerous commercial companies and academic centres. She then listed a dozen
concerns 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.

Within hours Jackson received an email from the FDA thanking her for her
concerns and notifying her that the FDA could not comment on any investigation
that might result. A few days later Jackson received a call from an FDA
inspector to discuss her report but was told that no further information could
be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting
held on 10 December 2020 to discuss Pfizer’s application for emergency use
authorisation of its covid-19 vaccine, the company made no mention of problems
at the Ventavia site. The next day the FDA issued the authorisation of the
vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA
published a summary of its inspections of the company’s pivotal trial. Nine of
the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the
nine, and no inspections of sites where adults were recruited took place in the
eight months after the December 2020 emergency authorisation. The FDA’s
inspection officer noted: “The data integrity and verification portion of the
BIMO [bioresearch monitoring] inspections were limited because the study was
ongoing, and the data required for verification and comparison were not yet
available to the IND [investigational new drug].”

OTHER EMPLOYEES’ ACCOUNTS

In recent months Jackson has reconnected with several former Ventavia employees
who all left or were fired from the company. One of them was one of the
officials who had taken part in the late September meeting. In a text message
sent in June the former official apologised, saying that “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. Both confirmed
broad aspects of Jackson’s complaint. 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.”

A second employee also described an environment at Ventavia unlike any she had
experienced in her 20 years doing research. She told The BMJ that, shortly after
Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the
vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020,
Pfizer has hired Ventavia as a research subcontractor on four other vaccine
clinical trials (covid-19 vaccine in children and young adults, pregnant women,
and a booster dose, as well an RSV vaccine trial; NCT04816643, NCT04754594,
NCT04955626, NCT05035212). The advisory committee for the Centers for Disease
Control and Prevention is set to discuss the covid-19 paediatric vaccine trial
on 2 November.

FOOTNOTES

* Provenance and peer review: commissioned; externally peer reviewed.

* Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for use in accordance with BMJ's website
terms and conditions for the duration of the covid-19 pandemic or until
otherwise determined by BMJ. You may use, download and print the article for any
lawful, non-commercial purpose (including text and data mining) provided that
all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

REFERENCES

1. ↵
Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer.
https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.

2. ↵
Ventavia. A leading force in clinical research trials.
https://www.ventaviaresearch.com/company.

3. ↵
Citizens for Responsible Care and Research Incorporated (CIRCARE).
http://www.circare.org/corp.htm.

4. ↵
Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018.
https://www.citizen.org/wp-content/uploads/2442.pdf.

5. ↵
Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902.
May 2021.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.

6. ↵
Department of Health and Human Services Office of Inspector General. The
Food and Drug Administration’s oversight of clinical trials. Sep 2007.
https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.

7. ↵
Food and Drug Administration. Bioresearch monitoring.
https://www.fda.gov/media/145858/download.

8. ↵
FDA takes key action in fight against covid-19 by issuing emergency use
authorization for first covid-19 vaccine. Dec 2020.
https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

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Thacker P D. Covid-19: Researcher blows the whistle on data integrity issues
in Pfizer’s vaccine trial BMJ 2021; 375 :n2635 doi:10.1136/bmj.n2635

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