FDA Commissioner Promotes Products Off Label, An Illegal Pharma Marketing Scheme Long Criticized By Democrats

Authored by Paul Thacker via The Disinformation Chronicle,

During his first stint as FDA Commissioner during the Obama administration, Dr. Robert Califf proposed allowing companies to advertise their products off-label. This marketing practice is illegal under FDA’s regulations that cover drug advertising, and Dr. Califf received pushback from Senator Ed Markey who sent him a stiff letter demanding that he address off label use of opioids.

“The FDA must not become complicit in the growing prescription fentanyl problem this country is combating,” Senator Markey wrote. Indeed, 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. Multiple federal agencies investigated Pfizer at that time, including the FDA’s Office of Criminal Investigations (OCI).

“We expect this agreement to increase integrity in the marketing of pharmaceuticals,” the Justice Department claimed in the settlement’s announcement.

When Biden chose Dr. Califf to run the FDA a second time in 2021, The New York Times reported that Obama officials had actually killed Dr. Califf’s attempt to allow increased off label promotion. “[T]he proposal, which many public health experts considered dangerous, was blocked by others in the Obama administration, according to a person familiar with it.”

But 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. A week before the Christmas break, Commissioner Califf posted a message on X, promoting COVID vaccines off label to allegedly protect children against long COVID.

“The FDA-approved and authorized coronavirus vaccines are indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2),” an FDA official emailed me. “The vaccines are not approved or authorized as a treatment for long COVID.” In follow up email, FDA clarified that the COVID vaccines are also not approved or authorized to “prevent” long COVID.

In his promotional post on X, Commissioner Califf linked to a news article in Nature Magazine as proof the vaccines prevent long COVID. And 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. Even more disturbing, Nature’s reporter supported this slim study with positive quotes sprinkled throughout the article from Dr. Jessica Snowden, a pediatric infectious-disease specialist at the University of Arkansas for Medical Sciences. However, Nature failed to provide readers with one rather important detail: Pfizer has disclosed paying Dr. Snowden to provide marketing talks for their COVID vaccine and she serves on the company’s advisory board. 

“She clearly should have disclosed her Pfizer funding, especially as her commentary could contribute to increased sales of Pfizer’s vaccines,” said Dr Barbara Mintzes, a professor of evidence-based pharmaceutical policy, at the University of Sydney. “Companies choose who to fund. They don’t fund experts who highlight a product’s limited effectiveness or have serious safety concerns.”

Science news or pharma advertising?

The December news article in Nature reported on a presentation given last October at a medical conference and that was led by a medical officer at the US Centers for Disease Control and Prevention (CDC). The study evaluated mRNA COVID-19 vaccines’ impact on children getting long COVID, but relied on self-reports of long COVID, not a physician’s diagnosis. The results that 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.

“This is really important data,” Dr. Snowden told Nature in one of her many quotes littered throughout the article. “This 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.”

In a 2018 report, Nature Magazine editor Richard Monastersky stated that Nature was updating their news section’s conflict-of-interest and ethics policies to make them more comprehensive. Last week, I sent several questions to Monastersky asking why Nature had not included Dr. Snowden’s ties to Pfizer and whether Nature reporters are required to look into an experts’ financial ties before quoting them in news pieces.

Read the rest here… (including details on payments from Pfizer)