November 18, 2022 from Vinay Prasad's Observations and Thoughts

It's a free country, and everyone's entitled to their opinion. However, if you're the commissioner of the US Food and Drug Administration, it's a reasonable to think you'll hold yourself to a high standard.

The US FDA regulates the ability of pharmaceutical companies to advertise their products. That advertisement must be truthful. If it is not truthful, companies can be fined.

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Recently the commissioner of the FDA tweeted the following:

Ruh Roh

First of all, 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.

Second, 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.

Simply put: The US FDA would never permit a drug company to make these marketing claims based on the available evidence. In fact, they could fine the companies for making such statements.

And yet, here you have the US food and drug’s chief administrator essentially serving as a marketing arm of Pfizer.

Before COVID19, I have never seen the FDA commish push specific drug products. Here is another example.

Again, he left out one important fact: in UNVACCINATED people. There are no good data in vaccinated Americans. Once again, this statement shatters norms of the FDA commish.

It is bad and dangerous for FDA commissioners to push specific drug products. It is crazy for the FDA to make statements about long covid that are false. We are entering uncharted territory where the White House subverts regulatory institutions to push products with weak evidence, and the FDA serves as a Pfizer billboard.

Vinay Prasad's Observations and Thoughts is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber.

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https://vinayprasadmdmph.substack.com/p/bob-califfs-tweets-as-commissioner
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