DeSantis demands COVID treatments deemed ineffective by FDA

WASHINGTON — Florida Governor Ron DeSantis accuses the White House of withholding potentially life-saving COVID-19 treatment in a state that has already lost 64,000 to the pandemic, even though medical experts have ruled ineffective therapy against the currently dominant variant in the United States.

The White House hit back with a mix of mystification and frustration, pointing out that the treatment in question — monoclonal antibodies, or MABs, made by Regeneron — has been shown to be ineffective against infection with Omicron, the variant that accounts for almost all new infections across the United States. The Food and Drug Administration has withdrawn its approval for monoclonal antibody treatments from Regeneron and Eli Lilly for the treatment of disease caused by Omicron, but DeSantis persisted in his claims.

During the Delta wave of the pandemic, Florida Governor Ron DeSantis announced the opening of a Regeneron Clinic in Pembroke Pines

During the Delta wave of the pandemic, Florida Governor Ron DeSantis announced the opening of a Regeneron clinic in Pembroke Pines. (Cindy Krischer Goodman/Sun Sentinel/Tribune News Service via Getty Images)

“Let’s just take a step back here just to realize how crazy this is,” White House press secretary Jen Psaki said on Tuesday.

“We have seen, unfortunately, from the beginning, in our response to the pandemic, a series of measures or pressures that have been taken through social media platforms, unfortunately from the mouths of elected officials, advocating for things that do not work. not even when we know things are working,” Psaki said.

Monoclonal antibodies essentially provide the immune system with additional weaponry against the coronavirus, although they are not as effective as the antibodies produced as a result of vaccination. There are also pills produced by Merck and Pfizer which are very effective against serious or critical illnesses. Both remain effective against Omicron.

On Monday, Florida was forced to close the Regeneron treatment centers it had opened throughout the fall in response to the FDA’s decision. The state’s controversial surgeon general, Dr. Joseph Ladapo, criticized the decision, arguing on Twitter and in a press release that this decision was not justified. Kyle Lamb, a former sports blogger from Ohio who doctored coronavirus conspiracies and was later hired by DeSantis to work on the pandemic response, accused on Twitter that the Biden administration was “denying treatment” to Floridians.

Ron DeSantis

Florida Governor Ron DeSantis pledges to keep restaurants open during the pandemic during a press conference in West Palm Beach, Fla. on Dec. 15, 2020. (Michael Laughlin/South Florida Sun Sentinel/Tribune News Service via Getty Images)

Most epidemiologists and public health experts agree that Floridians would have been better served by a campaign for vaccines, as opposed to one that relied on ineffective treatment. “You’d rather prevent something than catch a disease,” says Andy Slavitt, who served as a top pandemic adviser to the Biden administration through June. Slavitt added that neither Eli Lilly nor Regeneron contradicted the findings that their antibody products did not work well against Omicron.

“It’s not a controversial opinion,” Slavitt told Yahoo News.

Still, the governor’s office maintained its desire to see more Regeneron shipments to Florida from federal stock. “All Floridians at risk for COVID complications, vaccinated and unvaccinated, should have access to potentially life-saving treatment,” DeSantis spokeswoman Christina Pushaw told Yahoo News in an email Tuesday after -noon.

“There is no conclusive evidence that Regeneron and Lilly MABs are ineffective against Omicron, so the Biden administration had no justification for stopping these shipments to the states,” she continued.

Conclusive evidence can indeed be hard to come by in a pandemic marked by endless evolution. But early evidence indicates that the FDA was justified in withdrawing authorization for use of Regeneron and Eli Lilly products. A study published last week found “almost complete loss of neutralizing activity” against Omicron by the monoclonal antibodies produced by these two companies, raising the question of why DeSantis would push so hard for the treatment.

Colorado patient receives monoclonal antibody therapy

A Colorado patient receives monoclonal antibody therapy for the treatment of COVID-19. (PR Newswire/AP)

“Continuing to use Regeneron and Lilly is not without risk,” a Department of Health and Human Services official told Yahoo News in an email. “The products can have side effects, including difficulty breathing, nausea, or even serious adverse reactions like anaphylaxis. Subjecting patients to these risks while knowing the products are ineffective is of great concern.”

Florida officials argue that Regeneron plays a role in the state’s response to the pandemic. “We know that all MABs are effective against Delta, and although Omicron is widespread, it’s not 100% – Delta still exists and can cause serious illness that could be prevented with any type of treatment. MAB,” DeSantis spokeswoman Pushaw told Yahoo News.

Yet data from the Centers for Disease Control and Prevention contradicts the notion that Delta accounts for a statistically significant share of new infections. In its genomic monitoring for the Southeast, the CDC found that Omicron accounted for 99.9% of all new infections in Florida and surrounding states.

“There’s a lot of effective treatments that they’re getting, that we’re sending them,” the HHS official told Yahoo News, pointing to a shipment of 34,000 doses of other treatments to Florida this week alone. Only two states with much larger populations, Texas and California, have seen more doses of therapeutics pouring in from the federal government.

“There’s no logic in that,” Slavitt, the former White House adviser, said of DeSantis’ request.

Likely candidate for president in 2024, DeSantis exaggerated the extent to which vaccinees are prone to breakthrough infections. He recently declined to say whether he had received a booster shot, leading former President Donald Trump – who has touted vaccines and booster shots to his supporters – label the governor “gutless”, in a remarkable reprimand from one of his most prominent proteges.

A healthcare professional prepares a dose of the Pfizer-BioNTech vaccine

A healthcare worker prepares a dose of COVID vaccine in Miami. (Eva Marie Uzcategui/Bloomberg via Getty Images)

The White House also questions why DeSantis has been so enthusiastic about Regeneron when it is widely accepted that encouraging vaccines is the most effective way to prevent disease. His spokeswoman, Pushaw, argued to Yahoo News that vaccines “do not stop the infection or the spread of Omicron,” a point DeSantis himself likes to make. While it is true that the variant causes more breakthrough infections than previous strains, these infections tend to be mild. The most serious infections occur almost exclusively in unvaccinated people.

During the coronavirus delta outbreak, DeSantis scoured the state to open Regeneron treatment centers, though most public health officials advised that vaccines, which prevent infection instead of treating causes of disease infection, were a more effective way to ensure people’s safety. Also at the time, he accused the Biden administration of not giving Florida enough doses of Regeneronwhich was effective against the then prevalent Delta variant.

At the time, The Associated Press reported that the Citadel hedge fund, founded by DeSantis’ top donor Ken Griffin, owns $16 million in Regeneron stock as part of a $39 billion portfolio. DeSantis denounced the report as “partisan libel,” part of his broader campaign against the mainstream media, which he says does not cover him and his administration fairly.

The thrust of the Delta calmed down in Florida in mid-September. Solidifying his status as a leading critic of pandemic safety measures, DeSantis hired Ladapo, who simultaneously earned a tenure at the University of Florida (which paved the way for him to be selected as Florida’s top doctor). under intense political pressure. Ladapo quickly made headlines in refuse to wear a mask around a legislator who was undergoing cancer treatments. More recently, he denounced the “psychology of testing,” reigniting the Trumpian argument that testing only increases infection rates.

None of this has hurt DeSantis’ standing with a conservative base whose opposition to vaccines and masks has only hardened. The refusal to cede ground on Regeneron could also serve political purposes.

“He plays games. He plays politics,” says Slavitt. “He knows better.”

This article has been updated to more accurately describe Citadel’s investments in Regeneron.

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