The FDA authorized Pfizer’s COVID vaccines for use in American adults and children based on data from a committee whose members are paid by Pfizer.
Vaccine manufacturer Pfizer Inc. identifies Dr. Kathryn M. Edwards (MD), Professor of Pediatrics at Vanderbilt University, as a member of its “external data monitoring committee” in company documents, upon which the U.S. Food and Drug Administration (FDA) “based its decision” to authorize the use of COVID-19 vaccines in the country. Those documents were only made available after a federal judge in Texas ordered the FDA to make public the data it relied on to license Pfizer’s COVID jab.
Dr. Edwards’ endorsement of Pfizer’s vaccine was necessary to allow the sale of the drug, which went on to make $81.3 billion in revenue in 2021, roughly double its 2020 revenue. Pfizer announced in July of this year that it expected to make $50 billion by the end of 2022. But not only was Edwards a paid advisor to Pfizer before joining the company’s data monitoring committee, she also received “payments, speaking fees, or funding” from “numerous pharmaceutical companies, including Moderna, Merck, and Smith-Kline Beecham,” according to Informed Consent Action Network (ICAN).
During a recent cross-examination, Aaron Siri, an attorney for Civil Rights and ICAN, asked Dr. Edwards to confirm whether she was simultaneously a paid advisor to Pfizer and a member of the “independent” board the vaccine manufacturer used to determine whether its vaccine is safe or not.
“Yes, sir,” Edwards responded to Mr. Siri. “I have been an advisor to Pfizer and I’ve been working very, very closely with Pfizer, particularly their COVID vaccines, and going over lots of reactions and adverse events. So, yes, I am working and being paid by Pfizer for my assessment of vaccine safety.”
“That’s supposed to be an independent data safety monitoring board, correct?” Siri asked Edwards.
“It is an independent data safety monitoring board,” she answered.
“That’s the board that all of us in America are hoping on and relying upon […] to independently make sure that safety is properly assessed as the clinical trial for that Pfizer COVID-19 vaccine is ongoing. Is that correct?” asked Siri.
“That’s true,” Edwards said before going on to emphasize that her group had “worked very hard” to assess the vaccine safety data.
Siri pressed Edwards, asking her whether it’s “critical” that the members of that independent data safety monitoring board “are in fact independent of the pharmaceutical company that is being evaluated.”
“That’s correct,” she said.
“But isn’t it true that directly before becoming a member of the independent data safety monitoring board of the Pfizer COVID-19 vaccine, you were an advisor to Pfizer?” asked Siri, implying that Dr. Edwards’ receiving compensation from Pfizer while also serving as a member of the group that determines whether Pfizer’s own products will be considered by the U.S. government to be authorized for widespread use represents a conflict of interest.
“Pfizer pays me to evaluate the safety of their vaccines because I’m an expert,” she said. “So, I do get paid to do the work that I’ve been doing,” adding that she had been doing so “conscientiously and comprehensively.”
Siri pressed back, “My question was, before you became a member of the independent data safety monitoring board of the Pfizer COVID-19 vaccine, isn’t it true that you were separately, before you held that independent position, you were an advisor to Pfizer?”
“Yes, sir,” answered Edwards, before defending herself. “But I think what you’re presuming is that because I’ve been an advisor, makes me on their dole, or makes me going to say [sic] what they want me to say. That is not and has never been a part of my being. I say what I believe based on my expertise.”
“So you don’t think that financial incentives can sway people’s judgments at all?” asked Siri.
“It does not sway my judgment, sir,” said Edwards, not denying that the financial incentive does exist.
“Why bother having an independent data safety monitoring board? Why doesn’t Pfizer just have some of its employees on [the board]?” asked Siri.
“Because we are independent,” she stated.
“Meaning folks who were never advisors to Pfizer?” Siri asked.
“We are independent from Pfizer in this assessment,” said Edwards.
Siri spoke with American Faith, arguing that Pfizer did not carry out a truly independent analysis of its COVID vaccine’s safety data. “A pharmaceutical company seeking licensure of a vaccine conducts the trial for its experimental vaccine to gather the trial data that it then submits to the FDA for approval,” he explained. “In that regard no clinical trial for vaccines is independent.”
But Siri also underscored the importance of the individual’s right to choose whether or not to take a medical product, including vaccines, without coercion. “This just adds to why, among other reasons, including liability protection the pharmaceutical industry has for vaccine injuries, it is critical that everyone always have the inalienable right to choose, without coercion, whether or not to take a medical product,” said Siri. “Nobody should be mandated or coerced to take a medical product they don’t want.”
