Robert Califf, commissioner of the Food and Drug Administration (FDA) is hell bent on ridding the internet of misinformation.

In a series of public appearances, Califf has claimed that “misinformation is now our leading cause of death.” 

When I asked the FDA for evidence to support his claim, the agency drew a blank, admitting that Califf’s statement “cannot be proven.”

Califf has since made attempts to tweak his public statement.

This week, CBS News reporter Alexander Tin pressed him for an explanation, to which Califf replied, “I want to modify my statement. And I’ll keep working on this, to try to get it right. I would say I actually believe it is the leading cause of premature death…”

Jessica Adams, an expert in drug regulatory affairs said, “It’s ironic. Califf is spreading misinformation about the leading cause of premature death in the US, while promoting the need to counter misinformation.”

“It’s unbelievable for him to make these assertions with no scientific backing,” she added.

Adams said it’s not the FDA’s job to police medical misinformation online.

“The FDA should be assessing drug approvals, overseeing post-marketing studies and ensuring product labels are up to date – not promoting vaccines and antivirals as if it’s the marketing arm of the drug industry,” said Adams. 

The FDA sent me its website providing Califf’s reasoning for why he believes misinformation is the leading cause of premature death. It states:

“Most of the COVID-19 deaths since vaccines and antivirals became available were preventable if people had gotten updated on their vaccination status and, if high risk and infected, had they been treated with an authorized antiviral.”

“He’s failed to cite any sources to substantiate his claims and Califf keeps saying that it is just his ‘belief’…Are we supposed to just accept that?” said Adams, criticising his “obsession” over the boosters.

“It’s as if the FDA thinks that people don’t want the vaccines because they are misinformed, when it might just be that they are not persuaded by the data,” she added.

Adams also said the FDA is misinforming the public by “over-inflating” the benefit of the more recent bivalent vaccines.

“They’re now promoting the bivalent boosters which are based on much less data than the original [monovalent] vaccines and authorised on the basis of antibodies, which is not a fully validated correlate of protection,” said Adams.

This is not the first time the FDA has made misleading scientific claims to the public.

In August 2021, the FDA attempted to dissuade people from using ivermectin as an off-label, early treatment for COVID-19 by suggesting it was a livestock drug. The agency tweeted “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

But critics were quick to condemn the misinformation by pointing out that ivermectin is not only a medicine used to deworm livestock, it is also FDA-approved for parasitic treatment in humans.

Califf also spread misinformation in a Nov 2022 tweet which stated, “preliminary epidemiological findings point to the distinct possibility of the bivalent vaccines and antivirals reducing risk of long Covid.”

Vinay Prasad, Professor of Epidemiology and Biostatistics, and a practicing Haematologist Oncologist at San Francisco General Hospital wrote a scathing criticism of the tweet.

“For bivalent vaccines, he’s making things up. There are no relevant clinical data in human beings for bivalent vaccines, certainly not for the end points of long covid symptoms. Ergo that claim is 100% false; essentially a lie,” wrote Prasad.

“For antivirals, such as Paxlovid, this endpoint has not been assessed in randomized control trials. There are some poorly done observational studies that conflate ICD-10 codes with long covid symptoms and make bold, unsupported claims, but there is no robust evidence,” he added.

Traditionally, the FDA has regulated health misinformation to protect consumers from misbranded and adulterated products, but this new proposed “misinformation oversight” seems to extend to overseeing any online health-related issue.

“The FDA has always maintained that it does not want to regulate the practice of medicine, but lately it’s behaving as if it’s the Surgeon General – America’s doctor – making drug recommendations and promoting vaccines,” said Adams.

If the FDA wants to curb the spread of misinformation, it should start by looking at its own behaviour.

Despite the criticism, Califf remains defiant. Recently, he boasted to a crowd of journalists that he is “relatively impervious to critique.”

Source – https://maryannedemasi.substack.com/p/fda-chief-spruiks-misinformation