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FDA Violated Agency Guidelines by Promoting Off-Label Use of COVID Shots to Treat Long COVID

By Michael Nevradakis, Ph.D.

 

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf promoted the off-label use of drugs and vaccines to treat conditions such as “long COVID” — a process illegal under the FDA’s rules, according to an investigative report by independent journalist Paul D. Thacker, published Tuesday in The Disinformation Chronicle.

Thacker’s investigation also found that Califf’s promotion of the off-label use of COVID-19 vaccines to treat long COVID were based on a non-peer-reviewed conference presentation by a scientist, Dr. Jessica N. Snowden, a pediatric infectious-disease specialist at the University of Arkansas for Medical Sciences. Snowden did not disclose her financial ties to Pfizer.

Nature magazine presented the same conference presentation as proof that COVID-19 vaccines prevent “long COVID” — also without revealing Snowden’s ties to Pfizer.

Thacker told The Defender that such practices are commonplace.

“There’s not been an FDA commissioner in the history of the FDA with so many ties to corporations [as Califf],” he said. “I think Public Citizen put out his ties. They’re just enormous. He dwarfs every other commissioner.”

According to Thacker, Califf’s corporate ties likely date back to his time as an adjunct professor of medicine in cardiology at Duke University and former director of the Duke Clinical Research Institute.

“He comes out of Duke University, which is one of the sleaziest medical schools in the U.S.,” Thacker said, noting that a former chancellor of Duke University “was caught up in a scandal. He was on the board of [opioid maker] Purdue Pharma and was named by multiple attorneys generals for helping the Sacklers in their push to basically addict America to opioids.”

Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense (CHD) scientific advisory committee, said Califf is likely attempting to shield Big Pharma companies from prosecution.

She told The Defender:

“It is difficult for the Department of Justice [DOJ] to prosecute drugmakers for hiding data or making false claims about safety and efficacy. But it has been relatively easy to prosecute them for marketing their drugs outside very narrow, prescribed guidelines. This is how the multi-billion-dollar awards have usually been obtained by DOJ.

“What Califf is attempting to do is to close off this avenue for prosecuting pharmaceutical manufacturers. Doing so would allow drug and vaccine manufacturers to market their products for anything they like, mimicking the snake oil salesmen of yore. It would increase sales, while blocking the major way in which they are prosecuted — an extraordinary double win for Pharma, worth many billions of dollars yearly.”

Kim Witczak, a drug safety advocate and consumer representative to the FDA’s Psychopharmacologic Drugs Advisory Committee, told The Defender that the FDA and Centers for Disease Control and Prevention (CDC) are exceeding the bounds of their authority by promoting off-label use of drugs.

“Why invest in advertising when the top leaders of the FDA and CDC are promoting your product?” she asked. “This isn’t the role the FDA should be playing. We need regulators, not marketers. It appears we have an industry fox running the henhouse, concerned more with the pharmaceutical and political agendas than their mission to protect the public.”

To protect the public against unauthorized, untested and potentially risky uses of drugs, drugmakers and the FDA are prohibited from promoting drugs and vaccines for off-label use.

Physicians, on the other hand, are legally allowed to prescribe medications for off-label on the basis of their proven efficacy for certain. This includes prescribing ivermectin and hydroxychloroquine to treat COVID-19…

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