A researcher who was employed by a company that oversaw three clinical trial sites of Pfizer’s COVID-19 vaccine has raised issues about poor practices at the facilities that call the integrity of Pfizer’s data into question and also raise concerns about lax regulatory oversight.
The media report has been seized upon by multiple outlets of the Russian media, including the Russian news agency TASS and the Twitter account for the Sputnik vaccine.
Brook Jackson, a regional director who was employed by Ventavia Research Group, told British Medical Journal that the company “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events” reported in the pivotal phase III trial of the Pfizer-BioNTech vaccine.
Despite Jackson repeatedly informing Ventavia of the problems, the company allegedly took no corrective action. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA), the country’s top regulatory body in September 2020. Jackson was fired less than 24 hours after the complaint was lodged.
The FDA did not follow up on Jackson’s complaint. Though the regulator claims it doesn’t have the manpower to actively monitor and investigate all clinical trials, one person told the BMJ she was surprised that the agency didn’t inspect Ventavia even 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,” Jill Fisher, a former Ventavia employee, said. The revelations reported in the BMJ article are limited to three of more than 150 trial sites, which enrolled only 1,000 of around the 44,000 overall participants.
ARTICLE: PAUL MURDOCH
MANAGING EDITOR: CARSON CHOATE
PHOTO CREDITS: JAPAN TIMES
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