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DeSantis demands COVID treatments deemed ineffective by FDA

·Senior White House Correspondent
·7 min read
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WASHINGTON — Florida Gov. Ron DeSantis is charging that the White House is withholding a COVID-19 treatment that could save lives in a state that has already lost 64,000 to the pandemic, even though medical experts have deemed the therapy ineffective against the variant currently dominant in the United States.

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 The Food and Drug Administration has withdrawn approval for monoclonal antibody treatments from Regeneron and Eli Lilly for treatment of Omicron-caused illness, but DeSantis has persisted in his demands.

During the Delta wave of the pandemic, Florida Gov. Ron DeSantis announced the opening of a Regeneron clinic in Pembroke Pines
During the Delta wave of the pandemic, Florida Gov. 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,” White House press secretary Jen Psaki said on Tuesday.

“We’ve seen, unfortunately, from the beginning, in our pandemic response, a range of steps or pushes that have been made through social media platforms, unfortunately from the mouths of elected officials, advocating for things that don’t work even when we know things do work,” Psaki said.

Monoclonal antibodies essentially provide the immune system with extra armaments against the coronavirus, though they are not as effective as the antibodies produced as a result of vaccination. There are also pills produced by Merck and Pfizer that are highly effective against severe or critical illness. 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 decision. The state’s controversial surgeon general, Dr. Joseph Ladapo, criticized the decision, arguing on Twitter and in a press release that the move was not justified. Kyle Lamb, a former Ohio sports blogger who has trafficked in coronavirus conspiracies and was subsequently hired by DeSantis to work on pandemic response, charged on Twitter that the Biden administration was “denying treatments” to Floridians.

Ron DeSantis
Florida Gov. Ron DeSantis vows to keep restaurants open during the pandemic at a news conference in West Palm Beach, Fla., 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 in favor of vaccines, as opposed to one reliant on an ineffective treatment. “You'd rather prevent something than get an illness,” says Andy Slavitt, who served as a top Biden administration pandemic adviser until June. Slavitt added that neither Eli Lilly nor Regeneron had countered the findings that their antibody products don’t work well against Omicron.

“This is not a controversial opinion,” Slavitt told Yahoo News.

Still, the governor’s office has maintained its desire to see more Regeneron shipments to Florida from the federal stockpile. “All Floridians at risk of COVID complications, vaccinated and unvaccinated alike, should have access to treatment with lifesaving potential,” DeSantis spokeswoman Christina Pushaw told Yahoo News in an email Tuesday afternoon.

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

Conclusive evidence can indeed be difficult to come by in a pandemic marked by unending evolution. But early evidence does indicate that the FDA was justified in withdrawing authorization for how Regeneron and Eli Lilly products are used. A study published last week found “an almost complete loss of neutralizing activity” against Omicron by the monoclonal antibodies produced by those two companies, raising the question of why DeSantis would press so insistently for the treatment.

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

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

Florida officials maintain that Regeneron does have a role in the state’s pandemic response. “We know all MABs are effective against Delta, and though Omicron is prevalent, it’s not 100% — Delta still exists and can cause severe illness that could be prevented with any kind of MAB treatment,” DeSantis spokeswoman Pushaw told Yahoo News.

Yet data from the Centers for Disease Control and Prevention contradict the notion Delta represents a statistically meaningful share of new infections. In its genomic surveillance for the Southeast, the CDC found that Omicron accounted for 99.9 percent of all new infections in Florida and neighboring states.

“There are plenty of effective therapeutics that they are getting, that we are 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 bigger populations, Texas and California, saw more doses of therapeutics flow their way from the federal government.

“There’s no logic to this,” said Slavitt, the former White House adviser, of DeSantis’s demand.

A likely contender for the presidency in 2024, DeSantis has overstated the extent to which the vaccinated are subject to breakthrough infections. He recently refused to say whether he had received a booster shot, leading former President Donald Trump — who has touted vaccines and boosters to his supporters — to label the governor “gutless,” in a remarkable rebuke of one of his most prominent protégés.

A healthcare worker prepares a dose of the Pfizer-BioNTech vaccine
A health care worker preparing a dose COVID vaccine in Miami. (Eva Marie Uzcategui/Bloomberg via Getty Images)

The White House is also wondering why DeSantis has been so enthusiastic about Regeneron when it is widely agreed that encouraging vaccines is the most effective means of preventing illness. His spokeswoman, Pushaw, argued to Yahoo News that vaccines don’t “stop infection or spread of Omicron,” a point DeSantis himself is fond of making. While it is true that the variant does cause more breakthrough infections than previous strains, those infections tend to be mild. More serious infections are almost exclusively among the unvaccinated.

During the Delta surge of the coronavirus, DeSantis traveled the state opening Regeneron treatment centers, though most public health officials counseled that vaccines, which prevent infection as opposed to treating the sickness infection causes, were a more effective means of keeping people safe. Back then, too, he accused the Biden administration of not giving Florida enough doses of Regeneron, which was effective against the then prevalent Delta variant.

At the time, the Associated Press reported that the hedge fund Citadel, which was founded by top DeSantis donor Ken Griffin, holds $16 million in Regeneron shares as part of a $39 billion portfolio. DeSantis denounced the report as a “partisan smear,” part of his broader campaign against mainstream media outlets he believes do not cover him and his administration fairly.

The Delta surge subsided in Florida by mid-September. Cementing his status as a leading critic of pandemic safety measures, DeSantis hired Ladapo, who was concurrently granted tenure at the University of Florida (thus paving the way for him to be selected as Florida’s top doctor) under intense political pressure. Ladapo quickly made headlines of his own by refusing to wear a mask around a legislator who was undergoing cancer treatments. More recently, he has denounced “testing psychology,” reviving the Trumpian argument that testing only increases infection rates.

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

“He’s playing games. He's playing politics,” says Slavitt. “He knows better."

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

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