Florida clashes with Biden FDA after agency de-authorizes two monoclonal antibody drugs

AP Photo/Marta Lavandier

Both sides have arguments in their favor in this dispute but DeSantis’s case isn’t being helped by conspiracy theorists who’ve concluded that a national policy decision by the FDA to de-authorize Regeneron’s and Eli Lilly’s antibody treatments is some sort of plot against Republicans in Florida specifically.

A suspicion shared by people in his own office, apparently.

From the first days of Omicron’s emergence in Africa, scientists worried that current monoclonal antibody treatments wouldn’t work against the strain. The new variant was publicly identified on the day before Thanksgiving and in less than a week preliminary testing showed that Regeneron’s and Eli Lilly’s drugs were unlikely to provide much defense against it. Vaccines produce polyclonal antibodies, which can recognize a virus even if it’s mutated heavily. Synthetic monoclonal antibodies are more limited. A new strain that looks meaningfully different from the original one will be able to fool them.

That seems to be what happened with Omicron. Last month German researchers conducting lab tests found that the two companies’ drugs lost most of their effectiveness against the new strain. (Notably, GlaxoSmithKline’s antibody treatment remained effective against it.) Regeneron and Eli Lilly each conceded that their treatments had diminished potency against Omicron. Major hospitals in New York City stopped giving the drugs to people sick from COVID a month ago.

Last night the FDA revoked the emergency use authorization for both drugs, reasoning that at this point they’re doing more harm than good. Omicron now causes more than 99 percent of all COVID infections, almost guaranteeing that patients seeking the treatments will carry a strain of the virus that’s resistant to them. And some might have allergic reactions to the drugs, generating a cost to their health without any real benefit.

Florida’s public health bureaucracy was outraged by the decision, having just opened five new sites for mass administration of monoclonal antibodies.

DeSantis issued a statement too:

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” said Governor Ron DeSantis. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

It’s true, the studies so far on Regeneron and Eli Lilly have been lab studies, not clinical trials. (Partly that’s because the variant is so new that there hasn’t been time to pull a clinical trial together.) It’s also true that Delta is still out there and the two companies’ drugs do work on that variant — although according to the CDC, Omicron now represents 99.5 to 99.9 percent of all COVID cases in Florida’s region of the country. And while Regeneron and Eli Lilly may have much-reduced efficacy against Omicron, it’s not clear that they have no efficacy. A patient with COVID is better off with a drug that’ll give them a small benefit than no drug at all, right?

The answer to that is that there are superior alternatives on the market right now, which makes it foolish to keep funneling people towards antibody drugs that mostly don’t work. How many who go to one of Florida’s administration sites for a dose of Regeneron will also seek out a prescription for Pfizer’s much more beneficial COVID pill, Paxlovid? We should be steering people towards the therapies that will help them the most.

But there’s a counter to that point too: People can’t find the Pfizer pill! Demand is too high and supply too scant. In a month or two, as the drug becomes more available, it might make sense to revoke the EUA for Regeneron and Eli Lilly and force people to look for the better drug instead. But now?

Hold on, though, because there’s also a counter to that argument. What about remdesivir? That was the first drug authorized for the treatment of COVID and it still works against Omicron, at least for those with mild cases. It’s not a world-beater like the Pfizer pill looks to be, but if it’s more effective than Regeneron and Eli Lilly then why isn’t Florida opting for that drug as a stopgap instead?

A likely answer via the Times: “The treatment must be given via intravenous infusion over three consecutive days, generally at a hospital or clinic. That is easy enough for patients who are hospitalized, but much harder to do for medically vulnerable patients who are ill and at home. Doctors who are already overwhelmed by the Omicron surge have said the treatment is difficult to launch amid widespread staffing shortages.”

Not many good solutions here.

Lurking behind this dispute is the broader subject of vaccine politics, with Democrats suspicious of DeSantis’s motives. A spokesman for HHS took a swipe at him last night:

DeSantis’s spokesman fired back that most people seeking antibody treatments for Omicron infections are vaccinated, which is doubtless true. But it’s also true that DeSantis’s COVID rhetoric over the last six months has been noticeably lighter on vaccine promotion than it was earlier in the pandemic, after his pro-vax public appearances began to alienate the anti-vax populists whose votes he’s coveting in 2022 and 2024. Since last summer he’s devoted most of his energy trying to make amends by resisting mandates of all sorts and promoting monoclonal antibodies, which he surely knows are seen by some anti-vaxxers as an alternative to vaccination (even though they’re not). Case in point, one of his own spokesmen dropped this tweet this morning:

Claiming that the vaccines lack efficacy against Omicron is exactly what pro-vaxxers worry about with DeSantis and his comms team. The vaccines don’t prevent infection by the variant but they’re highly, highly effective against the important stuff:

New data from the CDC last week showed that boosters are highly effective against severe illness from Omicron specifically. It’s strange to look at the numbers on hospitalization and death and wonder, even rhetorically, why the FDA hasn’t yanked its authorizations for the vaccines when the vaccines may still save your life while the Regeneron and Eli Lilly treatments don’t seem to do much anymore. But this is where vaccination politics has left us in 2022.

I’ll leave you with this. Even Eli Lilly thinks its drug shouldn’t be used at this point.