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Dem senator who fought off-label drug marketing silent when FDA chief does it for COVID vaccines

Commissioner Robert Califf faced far more opposition when promoting looser rules under Obama. Nature quotes Pfizer-paid pediatrician in praise of kids' vaccine-long COVID study without disclosing her affiliation.

Published: January 11, 2024 11:00pm

How does the Food and Drug Administration feel about the so-called "off-label use" of approved drugs? The answer apparently depends on whether those drugs are COVID-19 vaccines and which official is speaking.

FDA Commissioner Robert Califf's promotion of a study that found mRNA-vaccinated children had a lower likelihood of developing long COVID – an FDA official tacitly encouraging an off-label use – contradicts the agency's crusade against ivermectin to treat or prevent COVID.

But it's also bringing renewed attention to Califf's push as President Obama's FDA commissioner to allow pharmaceutical companies to market off-label uses, which means prescribing a drug for a different purpose than what the agency approved.

That prompted pushback from Sen. Ed Markey, D-Mass., who urged Califf not to become "complicit" in what were then widespread off-label prescriptions for fentanyl.

Because Califf pointed to a Nature news report on the study's abstract – the full version hasn't been published yet – the influential science journal is also under scrutiny for repeatedly quoting Jessica Snowden, who praised the study and its findings, without disclosing her Pfizer connection.

Snowden, vice dean for research at the University of Arkansas for Medical Sciences, received about $8,600 from Pfizer in 2022 to hawk its licensed Comirnaty vaccine, according to a government database that tracks financial relationships between drugmakers and some healthcare providers. 

She has also served on Pfizer's pediatric vaccination steering committee since 2022, according to her curriculum vitae, but the relationship isn't mentioned on Snowden's LinkedIn profile.

The long-COVID study "will demonstrate to families how important it is that we protect our kids, not just from acute COVID, but from the longer-term impacts of COVID as well" by vaccinating them, Snowden told Nature.

Ongoing mild variants are "not a guarantee. And so anything we can do to protect our children from the long-term impact of COVID is critical."

The omissions were revealed by former Senate Finance Committee investigator Paul Thacker, who previously exposed secret payments from pharmaceutical companies to doctors. He also found COVID vaccine papers coauthored by Snowden, published last year in the Journal of American College Health and Pediatrics, that claim she has no conflicts of interest.

The FDA and Nature didn't respond to Just the News queries Tuesday. Neither did Markey's office when asked whether the senator had the same concerns about Califf's off-label promotion of COVID vaccines.

"Disclosures were provided to both the [National Institutes of Health] and our university about Dr. Snowden’s previous appointment to the Pfizer Advisory Board," Leslie Taylor, vice chancellor of communications and marketing at UAMS, told Just the News in an email. 

"It is the common practice of both institutions and of Dr. Snowden to disclose funding she receives from any company," Taylor wrote, "We all take transparency and disclosure very seriously. UAMS trusts Dr. Snowden takes disclosure and transparency just as seriously."

The journal in which the Nov. 27 study appeared also has yet to correct its most obvious error, that the tables refer to Pfizer's antiviral Paxlovid and older adults who took it, not its vaccine in children. Open Forum Infectious Diseases didn't respond to queries for an explanation.

Califf doesn't appear to be heeding criticism from doctors and COVID analysts who say he's actually worsening vaccine hesitancy by fearmongering to those with previous vaccinations that they are "unprotected" without the latest booster.

He coauthored a "viewpoint" in the Journal of the American Medical Association with the agency's vaccines chief, Peter Marks, urging "the clinical and biomedical community to redouble its efforts to provide accurate plain-language information regarding the individual and collective benefits and risks of vaccination" amid declining rates across all vaccinations.

He blamed a "wealth of misinformation available on social media and the internet" for challenging findings from "various studies" that COVID vaccines saved "tens of millions of lives" and that "all ages who are up to date on vaccination benefit and have a lower risk of developing long COVID."

Califf was a controversial pick for Obama, then President Biden, Democrats, because of his deep pharmaceutical connections, consulting for drug companies and receiving most of his Duke University research institute's funding from industry. Upon his nomination from Biden, The New York Times reported Califf's previous colleagues blocked his off-label marketing plan.

But the FDA went the other way when some doctors started prescribing ivermectin, approved as an anti-parasite drug, to treat or prevent COVID, repeatedly telling the public to avoid the antiviral with a long safety record and conflating its human and livestock dosages.

The 5th U.S. Circuit Court of Appeals didn't buy its argument that these denunciations were "merely quips" and reinstated an "unlawful interference" lawsuit against the agency by doctors. Congress helped the FDA circumvent the courts months later by granting new authority to regulate at least some off-label uses.

Califf is helping Pfizer circumvent the Justice Department and the FDA's own criminal investigations office by promoting its vaccine for long COVID, according to Thacker, noting the company paid a record $2.3 billion and pleaded guilty to a felony in 2009 to settle charges for off-label marketing of several drugs

Centers for Disease Control and Prevention Director Mandy Cohen also promoted the study on her official X account and was even more explicit than Califf, telling the public Dec. 21 the latest formulation of COVID vaccines "reduces your child’s risk of developing #LongCOVID!" 

Neither agency answered queries on how their leaders' use of social media to promote off-label drug use related to FDA and CDC social media policies for employees.

Before Pfizer hired Snowden to hawk its vaccine and brought her in as an adviser, she publicly praised the FDA's authorization of its vaccine for children 5-11, then frowned at the FDA delaying authorization for children under 5 to evaluate data on the performance of three doses. (Two doses didn't work against the then-new Omicron variant.)

"I hear from lots of parents every day asking, 'Do you know, do you know? When’s it going to be approved?'" Snowden told the Times in February 2022, when she led the pediatric infectious disease division at Arkansas Children’s Hospital. "Think about how fast a new variant can spread."

Snowden told Thacker that NIH knows about her advisory work for Pfizer and that she disclosed the connection in two presentations last year.

While her "publications and interviews are product agnostic" – in other words, not promoting a specific vaccine – the missing Pfizer disclosures in Nature and her coauthored work were "oversights" and she is "working to have them all corrected," Snowden said.

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