An investigative journalist looking at Pfizer’s study protocols in its COVID-19 vaccine trials writes in The BMJ that a whistleblower who questioned the drug company’s safety, data integrity and other trial practices was fired.
“Speed may have come at the cost of data integrity and patient safety,” says Paul D. Thacker, an American journalist specializing in science, medicine and environmental reporting.
Thacker’s allegations are not ones to be taken lightly: “A regional director who was employed at the research organization 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,” Thacker writes.
Poor lab management, data integrity and patient safety concerns were major concerns, he says. Needles were improperly discarded, and vaccine packaging materials were left in the open with patient identification information clearly visible.
Unblinding of the patient profiles and the drugs they received was also discovered in other ways, to the point that company officials couldn’t “quantify the types and number of errors they were finding,” he says. Correct follow-up protocols with patients reporting severe adverse reactions weren’t followed either.
When an employee took photos of the missteps and reported the unsound practices to the FDA, she was fired. The FDA acknowledged her concerns — more than a dozen of them — but handed Pfizer an emergency use authorization (EUA) for the jab anyway, without mentioning the whistleblower’s concerns.
Speaking off the record, other employees confirmed that the fired employee’s concerns were valid, with one confiding, “I don’t think it was clean data. It’s a crazy mess.”
SOURCE: The BMJ November 2, 2021