British Medical Journal – one of the oldest, peer-reviewed, general medical journals in the world has just published a shocking report titled: “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial”
According to the report, Brook Jackson, a former regional director at Ventavia Research Group – a contractor hired by Pfizer to conduct vaccine trials, was fired after she emailed a complaint to the Food And Drug administration about the practices of Ventavia.
Jackson had 15 years of experience in clinical research coordination and management before coming to Ventavia. After Jackson lost her job when she raised her concerns about poor practices at Ventavia, she decided to blow the whistle and share internal documentation and her accounts with British Medical Journal about the situation:
“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.”
Worries over FDA inspection
Jackson provided documents to BMJ showing that problems had been going on for weeks at Ventavia:
“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.”
Read the full report here
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