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

https://childrenshealthdefense.org/defender/fda-off-label-covid-shots-long-covid/

According to an investigative report by independent journalist Paul D. Thacker, U.S. Food and Drug Administration Commissioner Robert Califf promoted the off-label use of COVID-19 vaccines to treat “long COVID,” basing the recommendation on a non-peer-reviewed conference presentation by a scientist with financial ties to Pfizer.

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.

However, despite Califf’s attempt to justify his promotion of COVID-19 vaccines to prevent long COVID, the FDA was quick to ridicule doctors who promoted ivermectin to treat COVID-19, and medical boards sought to discipline and delicense doctors who recommended anything other than FDA-authorized vaccines and treatments such as Pfizer’s Paxlovid.

Safety oversight, scientific evidence for off-label drug use ‘lacking or absent’

According to Thacker, Califf first began advocating for off-label drug advertising during his first tenure as FDA commissioner, under the Obama administration in 2016-2017, when he proposed allowing companies to advertise their products off-label — a marketing practice that is illegal under FDA drug advertising regulations.

At the time, “Dr. Califf received pushback from Senator Ed Markey [D-Mass.] who sent him a stiff letter demanding that he address off-label use of opioids,” Thacker wrote.

Highlighting the illegality of this practice, Thacker added, “Pfizer pled guilty to a U.S. criminal charge and paid a record $2.3 billion in 2009 for illegally marketing over a dozen drugs off-label.”

Witczak said she began vocally opposing the off-label promotion of drugs after her husband, who had no history of depression or mental health issues, took his own life weeks after taking the antidepressant, Zoloft, off-label for insomnia.

This included confronting Califf at hearings in 2016 debating off-label drug promotion.

“When FDA Commissioner Califf 1.0 pushed to allow pharmaceutical companies to legally promote off-label in 2016, I participated in the two-day hearings opposing this practice,” Witczak said. “I reminded him that most of the large litigation fines stemmed from the pharmaceutical companies’ illegal off-label marketing.”

Witczak added:

“Physicians already have the ability to use FDA-approved products off-label. Allowing pharmaceutical companies to legally promote off-label usage, where scientific evidence and safety oversight are often lacking or absent, would only make things worse.”

According to Witczak, efforts to permit off-label marketing of drugs are tied to major financial interests.

“We must not forget pharmaceutical companies are in the business to sell products and expanding potential uses only helps to increase their market share and profits,” she said. “Besides, they have already found ways to circumvent these regulations by utilizing Key Opinion Leaders (KOLs) to advocate off-label product usage.”

Witczak, who has a marketing background, said these key opinion leaders “are outside companies that specialize in identifying highly regarded doctors or researchers deemed ‘experts’ in specific diseases or product categories. These are individuals who have great influence within the medical establishment and the media.”

Thacker wrote that when Califf returned to the FDA for a second tenure as its commissioner, “The New York Times reported that Obama officials had actually killed Dr. Califf’s attempt to allow increased off-label promotion.”

“The proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration,” the Times wrote in 2021.

Yet, “with his critics now in the rearview mirror, Dr. Califf is speeding forward with his ‘dangerous’ proposal. And this time, the Commissioner himself is promoting products off label,” Thacker wrote, highlighting a Dec. 23, 2023, tweet where Califf wrote that children who received a COVID-19 vaccine have a lower incidence of “long COVID.”

In response to an email sent by Thacker, an FDA official denied that the agency is promoting the off-label use of COVID-19 vaccines.

“The FDA-approved and authorized coronavirus vaccines are indicated for active immunization to prevent COVID-19 caused by … SARS-CoV-2. … The vaccines are not approved or authorized as a treatment for long COVID,” the official wrote.

Nass said that, in the event such approval is granted, the public would not benefit.

“The only loss would be to the consumer, to whom drugs would be marketed for diagnoses they had not been tested for or approved for by FDA,” she said. “If Dr. Califf is trying to reduce trust in his agency even more, he could not have chosen a better way to do so.”

Thacker told The Defender that such practices on the part of the FDA should be investigated by Congress.

“I don’t know why Congress is not investigating this,” he said. “I don’t know what Congress is doing anymore. They seem to all just be kind of jumping about, looking for some headline reacting to whatever’s going on.”

He added, “You have the FDA commissioner, who is the ultimate authority for enforcing the FDA regulations on off-label promotion, and he’s engaged in off-label promotion.”

Public health agencies ‘totally allow conflicts of interest’

Thacker noted that Califf’s Dec. 23, 2023, tweet “linked to a news article in Nature Magazine as proof the vaccines prevent long COVID,” adding that “here’s where the story gets even weirder.”

“Nature’s news story discusses a small, observational study that had been presented at a conference some months prior and has not been peer-reviewed,” Thacker wrote.

Thacker wrote that the December 2023 Nature story contained “positive quotes sprinkled throughout the article from Dr. Jessica Snowden.” Yet, Thacker noted, Nature failed to provide readers with one rather important detail: Pfizer paid Snowden to provide marketing talks for its COVID-19 vaccine and Snowden serves on the company’s advisory board.

What Nature relied on was not a published, peer-reviewed study, but “a presentation given last October at a medical conference,” Thacker wrote. That presentation was led by a CDC medical officer and was based on a study evaluating the impact of mRNA COVID-19 vaccines on children getting “long COVID.”

Thacker noted that the study “relied on self-reports of long COVID, not a physicians’ diagnosis,” and “found a positive correlation with vaccination were based off 28 kids who either self-reported or were reported by a parent to have long COVID.”

“I was thinking, how did Nature find out about this presentation at a conference? And why would they latch on to this? How did this one presentation out of everything that was presented at this conference end up as a news story in Nature? It’s just weird,” Thacker told The Defender.

According to Thacker, even though Snowden’s conference presentation has not yet been published in a peer-reviewed journal, “Nature’s news piece promoting the CDC’s findings somehow caught the attention of CDC Director Dr. Mandy Cohen, who then posted it on X” as part of a retweet of a post from Nature promoting its article.

Thacker wrote that he contacted the CDC “asking why Director Cohen was promoting the COVID vaccines for off label use, and whether any CDC Director has done so in the past,” but did not receive a response.

“They totally allow conflicts of interest,” Thacker told The Defender. “It’s rampant, these issues where you see these secret advocates getting highlighted and platformed in different outlets. I think we all know this, and this is actually why people have so much doubt and so much concern around the vaccines and around FDA and CDC decisions.”

“You don’t need an advanced degree or a Ph.D. in biostatistics to understand that something that looks like news actually comes across like a commercial for Big Pharma when you look at it carefully,” he added.

‘I don’t call it journalism. I call it science writing.’

Thacker noted that Snowden’s research, in addition to not being peer-reviewed, also lacked mention of her financial ties to Pfizer — a disclosure also missing from the Nature article.

“Pfizer’s payments to Dr. Jessica Snowden can be found in the federal government’s Open Payments database, which notes the company paid Dr. Snowden to give 4 marketing talks promoting their Comirnaty COVID vaccine,” Thacker wrote, noting that he had “first drafted and pushed through the law that led to this database” when he was a lead investigator for the U.S. Senate.

According to the Open Payments data, Snowden has received eight payments from Pfizer totaling $8,628.17.

Thacker told The Defender that cases like this are “the reason why I first drafted that law, which, oddly enough, was reported on in Nature.”

“They reported on the investigations that I ran, and now they’re totally ignoring the database that was put together to help them uncover these problems,” he added.

According to Thacker, even before Pfizer hired her in late 2022, Snowden was already a confirmed advocate for COVID-19 vaccines, speaking favorably in several media outlets about the use of the vaccines for children — including in a late 2021 commentary praising the FDA’s decision to grant Emergency Use Authorization to Pfizer’s COVID-19 vaccine for children in late 2021.

Snowden wrote: “The day the COVID-19 Pfizer vaccine was approved for emergency use in ages 5-11, my 10-year-old, Oliver, came bounding down the stairs excitedly asking, ‘Is it shot day?,’” and saying “‘I’ll be safe, and keep everyone else safe, and I can go back to eating inside restaurants again and normal stuff!’”

A few months later, “Pfizer hired Dr. Snowden to give marketing talks,” Thacker wrote.

Thacker told The Defender that, as he was investigating the issue, he researched Snowden and found “she’s all over the media, giving these affirming quotes for the vaccine for kids, and she’s this researcher at a not-very-well-known medical school. I’m like, ‘How is she getting into the media?’”

“I found that she had been paid by Pfizer to give marketing talks, and it’s not in any of these stories where you find her name. So the whole thing, to me, comes off looking like it was a PR campaign. That’s the only thing that can put it together.”

“And then, out of the blue, out of all the things that just happen to catch the eye of the CDC Director, it just happens to be this one news story in Nature,” Thacker added. “I mean, it’s just funny when you look at it.”

Thacker’s story quoted Barbara Mintzes, Ph.D., a professor of evidence-based pharmaceutical policy at the University of Sydney, who said Snowden “clearly should have disclosed her Pfizer funding, especially as her commentary could contribute to increased sales of Pfizer’s vaccines.”

“Companies choose who to fund,” Mintzes said. “They don’t fund experts who highlight a product’s limited effectiveness or have serious safety concerns.”

According to Thacker, Nature updated its conflict-of-interest and ethics policies in 2018. Yet, when he contacted Nature’s editor, Richard Monastersky, to inquire why Snowden’s ties to Pfizer were not disclosed, he “emailed back that he would pass my query off to another editor and then ceased responding to emails.”

Instead, Thacker received a generic response from a Nature spokesperson.

“Nature’s behavior throughout this pandemic has been horrific,” Thacker told The Defender. “They have done nothing but helped to cover up.”

According to Thacker, Nature has “platformed all these virologists who had conflicts of interest and ties to Wuhan to cover up the possibility that there could have been a lab accident to start this pandemic. They’ve continued it throughout all of their coverage, where they platform these crazy individuals who have enormous financial conflicts of interest. And they’re quoted as if they’re normal.”

“This is now a normal part of how Nature does their journalism,” Thacker continued. “It’s why I don’t call it journalism. I call it ‘science writing,’ because they don’t report. They write, and what they write are narratives.”

Witczak compared Nature’s journalism to the practice of “ghostwriting,” saying that “it’s imperative for both the public and healthcare professionals to be aware of these ties to the industry. This awareness needs to be the filter through which such medical information is perceived. Companies will only hire individuals who help, not hurt their sales. It’s a strategic marketing tool.”

Thacker’s story quoted an FDA spokesperson, who told Thacker, “FDA does not have specific guidance but does assess prescription drug promotional communications made by or on behalf of drug companies … That includes spokespersons to ensure compliance with applicable legal requirements that the FDA administers.”

Witczak compared the FDA’s lack of concern with Snowden’s ties with her own experience working with the FDA.

“I find it perplexing that the FDA raises no concerns about Dr. Julie Snowden while I was ousted from serving on an FDA Advisory Committee reviewing Pfizer’s request to remove a serious black box warning on the smoking cessation drug Chantix, citing an ‘intellectual bias,’” Witczak said.

According to Witczak, “I was concerned about safety issues, particularly after lawsuits were settled, underscoring the very reasons behind the initial black box warning on the product.”

“There appears to be a glaring double standard in the application of ‘intellectual bias’ when it comes to safety,” Witczak said. “This bias is selectively applied, seemingly goes unquestioned when individuals are part of Pfizer’s vaccine advisory committee, involved in presentations, studies and media appearances.”

Thacker wrote that he sent “several questions” to Snowden, “asking her to explain Pfizer’s payments for her marketing talks, why she had not disclosed this money to Nature Magazine, and how she handles financial conflicts of interest” at her university, as well as “why she has not disclosed her Pfizer payments in at least two studies she recently published.”

According to Thacker, Snowden replied to his questions, explaining “that the NIH is aware of her appointment to Pfizer’s advisory board and that she only discusses COVID vaccinations, not specific vaccine products,” adding that her interviews and publications “are product-agnostic.”

But for Witczak, “nothing is product-agnostic when there is pharmaceutical company money behind it.”

“The ongoing decline in FDA standards continues in its persistent advocacy for policies that favor industry interests but aren’t friendly to the public, the very constituency it supposedly serves,” she told The Defender.