Pfizer’s WhistleBlower Reveals Vaccine Data Integrity Issues
Pfizer is in the spotlight again questions arise about the company’s data integrity and regulation after some new data about poor conduct at a contract research company that helped Pfizer carry out its covid vaccine trial.
According to the BMJ, in September 2020, Pfizer’s chairman and chief executive officer, Albert Bourla, wrote an open letter to billions of people worldwide expressing the hope that the world would return to normal.
“As I’ve said before, we are operating at speed of science,” Bourla wrote, explaining when a vaccine from Pfizer could be approved in the United States.
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Patient Safety And Data Integrity
Researchers at a few Texas sites testing Pfizer’s vaccine during that fall may have compromised “data integrity and patient safety” by trying to go as fast as possible.
In a recent report published in the British Medical Journal, the regional director of Ventavia Research Group explained he discovered critical cases such as:
“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.”
Ventavia, regional director, Brook Jackson, in response, emailed a complaint to the US Food and Drug Administration (FDA).
Her employment with Ventavia was terminated later that day. Another vital point to note is the fact that Jackson provided The BMJ with thousands of photos, audio recordings, and internal company documents.