Florida is so crazy about mAbs that Ron DeSantis wants to use mAbs that don’t work – Endpoints News

Florida Governor Ron DeSantis is working so hard to politicize the FDA and demonize the federal government that he stepped into an alternate universe on Monday night by describing a recent FDA action to restrict the use of two monoclonal antibodies, or mAb, treatments for Covid-19 that do not work against Omicron.

Without further ado, let’s break down its declaration last night, line by line, adjective by adjective.

First, he calls the FDA’s decision “sudden and reckless” and “abrupt and one-sided.”

In fact, Regeneron (more below) and Eli Lilly – two for-profit companies that have made billions from these mAbs and would fight if there was a fight to be fought – support the FDA’s decision to stop using their products. . They have also been candid that their mAbs do not work against Omicron, which now accounts for virtually all new Covid cases in the United States. The National Institutes of Health also updated their guidance on the matter, saying the same, as does all the others following.

Next, DeSantis claims that the FDA decision was made “without any clinical data”, and later in his statement he calls it “clinically unsupported”. Indeed, the FDA has made many decisions throughout the pandemic without clinical data. But in this case, nobody needs to conduct a clinical trial to understand that these mAbs do not work against Omicron.

A Regeneron spokesperson explained it very simply via email:

The original REGEN-COV antibody cocktail has been administered to millions of people, and we are extremely proud of the critical role this drug has played during the pandemic. However, it did not work against Omicron in lab tests, which tells us that unfortunately it will not work in people infected with this variant either. According to CDCover 99% of COVID-19 cases in the United States are now caused by the Omicron variant, so we believe the FDA’s decision to change the emergency use authorization was appropriate at this time.

Florida Lieutenant Governor Jeanette Nuñez later incorrectly referred to the monoclonal antibody treatment as Regeneron (Regeneron is the company that makes the cocktail), and the statement indicates that this FDA decision ” was made solely by Biden’s Food and Drug Administration (FDA) without prior warning to states or health care providers and without clinical data to support the decision.

If anyone in Florida is listening to the weekly calls from the HHS Office of the Assistant Secretary for Preparedness and Response about the distribution of Covid-19 treatment, then the DeSantis administration would have known this was coming, because the two mAbs were a frequent topic of conversation on recent calls.

New York’s Mount Sinai Hospital and others also stopped administering these mAbs in late December, as the companies announced that the mAbs did not work against Omicron.

But Regeneron, which also stressed that it “will continue to work closely with the FDA,” and others are still hard at work on other antibody and antiviral candidates that will need to be tested in humans to get new EUAs.

Until then, Florida and all other states will have to make do with an insufficient supply of mAb GSK (not mentioned by DeSantis), the antivirals Pfizer and Merck, remdesivir from Gilead and the prophylactic mAb AstraZeneca. It’s not a perfect situation, but no one knew what Omicron would look like until he arrived.

About Margie Peters

Check Also

Business news live today: latest economic news, market news, economic and financial news