Bob Califf's tweets as commissioner of the US FDA are problematic
Bob Califf's tweets as commissioner of the US FDA are problematic
If the company did it, they could be fined for false advertisement
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.
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.
As I noted in Sensible Medicine, it is absolutely unclear whether long covid exists and if so whether it is any different from the post-any-virus syndromes/symptoms people have had for decades.
The list of long covid symptoms now numbers 200. That is virtually anything felt by anybody. Not surprisingly, it is virtually the same as the list of symptoms for fibromyalgia/CFS -- and affecting primarily similar populations. One learns in medical school that when there is a disease with 200 drugs to treat it, the only thing known for sure is that none of them work. Similarly, a disease with 200 symptoms is likely non-existent or improperly characterized and certainly not understood.
Rob spent his off time between his two FDA stints at Google. But this is even unexpected behavior from him. Completely unsupported and even worse, unsupportable.
Pretty hard after reading this about Califf not to say the following: "We nominate and appoint Vinay to be the FDA Commissioner effective tomorrow morning at 0800 hours Eastern time. The incumbent is to hand in office keys, turn in his ID badge, put his stuff in the single cardboard box provided, and be off Federal property before 1200 hours Eastern Time".