FDA Commissioner Promotes Products Off Label

Written by Paul D. Thacker on January 13, 2024. Posted in Current News

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news story discusses a small, observational study that had been presented at a conference some months prior and has not been peer reviewed.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.

Monastersky emailed back that he would pass my query off to another editor and then ceased responding to emails. “Nature’s news team strives for the highest standards of journalism and is guided by principles that ensure our reporting is accurate, fair and independent,” a spokesperson for Nature emailed yesterday, after I further pressed Monastersky for answers. “This includes considerations of conflicts of interest.”

While the CDC’s small observational study is expected to be published in a peer reviewed journal in coming months, 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.

I then sent an email last week to 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.

“I’m not sure I’ve ever seen a CDC Director promote any products for off label use,” I emailed the CDC. “Are there other examples of this that you can point me to?”

The CDC has not responded to repeated requests for comment.

Pfizer Payments

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. (Full disclosure: I first drafted and pushed through the law that led to this database, a story which you can read about in Nature Magazine. Irony, no?)

But before Pfizer hired her in late 2022, Dr. Snowden was already a confirmed advocate for COVID vaccines, favoring them for children in several media outlets. Shortly after the FDA provided emergency use for Pfizer’s COVID vaccine for children in late 2021, Dr. Snowden published a commentary praising the FDA’s verdict:

Being a doctor-mom means there are lots of things that look a little different in my home compared to when I was growing up. The day the COVID-19 Pfizer vaccine was approved for emergency use in ages 5-11, my ten-year-old, Oliver, came bounding down the stairs excitedly asking, “Is it shot day?” is a perfect example. While he has always been pretty good with vaccines and any other medical procedures, this is the first time he’s been looking forward to something like this. I asked him why he was so excited, and in a perfect mix of doctor’s kid and typical ten-year-old, he said, “I’ll be safe, and keep everyone else safe, and I can go back to eating inside restaurants again and normal stuff!” There have been so many hugs and smiles in our house over the last week as we watched each step of vaccine review get us closer and closer to “shot day.”

But when the FDA reversed their decision some months later, deciding to further scrutinize the data before a full rollout to kids, Dr. Snowden expressed concern about the delay to the New York Times. “I hear from lots of parents every day asking, ‘Do you know, do you know? When’s it going to be approved?’” Dr. Snowden told The New York Times in February 2022. “Think about how fast a new variant can spread.”

Later that year, Pfizer hired Dr. Snowden to give marketing talks.

Dr. Joel Lexchin, a physician and professor emeritus at York University, who studies corporate influence in medicine, told me that most physicians don’t feel they have a conflict of interest after taking pharma payments.

“What drug companies are doing is finding doctors who have independently formed favourable opinions about a drug and then the drug companies are giving them money to reach large audiences to tell other doctors about their opinions,” Dr. Lexchin explained. “Therefore, the doctors who are doing the speaking don’t feel conflicted because these are opinions that they genuinely hold.”

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

Beginning last week, I sent several questions to Dr. 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 the University of Arkansas where she serves as vice dean for research for the medical college.

I also asked Dr. Snowden why she has not disclosed her Pfizer payments in at least two studies she recently published. Last June, Dr. Snowden co-published a study on COVID mitigation behaviors, including vaccination, among college students in Arkansas. None of the study authors reported having a conflict of interest. And in an October study on COVID-19 vaccine hesitancy in parents, that Dr. Snowden co-published in the journal Pediatrics, she reported “no conflicts of interest relevant to this article to disclose.”

In an email, Dr. Snowden explained that the NIH is aware of her appointment to Pfizer’s advisory board and that she only discusses COVID vaccinations, not specific vaccine products.

My publications and interviews are product agnostic. These are practices I take seriously, and can only explain as to why the disclosures weren’t published in the Nature article or the examples you provided as oversights. I am currently working to have them all corrected.

Along with her statement, Dr. Snowden attached the papers for two presentations given at conferences in the last year, where she disclosed membership on Pfizer’s advisory board, and payments for giving talks and serving as an expert witness. (Note: I do not believe companies disclose expert witness payments in the federal database.)

“Disclosure is important because it allows the reader to know if the cited expert has received funding from the manufacturer of a product or products they’re discussing,” said Mintzes. “If Pfizer was quoted saying that their product should be used more widely, a reader would likely take this message with a large grain of salt.”

Source: Substack

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