PolitiFact

PolitiFact: DeSantis Doesn't Tell Full Story About Evidence for FDA Move on Monoclonal Antibody Treatments

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What to Know

  • The now-limited monoclonal antibody treatments are not lifesaving, nor are they effective against omicron. Eli Lilly’s treatment became nearly 3,000 times less effective against the variant, and REGEN-COV was more than 1,000 times less effective. The drug companies acknowledged this and stated that they’re working to provide updated treatments. 
  • Other medicines are still available, including another monoclonal antibody treatment called sotromivab, Paxlovid, molnupiravir and remdesivir.

Florida Gov. Ron DeSantis has prioritized access to monoclonal antibody treatments as a way to help Floridians deal with COVID-19 while downplaying the use of vaccines as a way to minimize infections. 

So when the federal government announced it was reducing deliveries of two of these treatments because of the omicron outbreak, DeSantis was mad. The state health department said it would be forced to close 25 sites that were administering monoclonals to people in the early stage of COVID-19.

DeSantis said the call was based on President Joe Biden’s "whims."

"Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments," he tweeted.

DeSantis has a point that clinical data did not drive the decision. But that obscures a number of lab studies and admissions from the drugmakers themselves that these treatments were not helping people infected by the omicron variant — nowadays, that’s what almost every COVID-19 patient has.

In other words, these drugs were no longer "lifesaving."

Monoclonal antibodies: What they are, and what the FDA did

Earlier in the pandemic, access to monoclonal antibody treatment was scarce. Former President Donald Trump praised one of the treatments, made by Regeneron, for his recovery after he caught the coronavirus in October 2020, but it was not widely available at the time. 

This type of therapy, infused with an IV, or administered via subcutaneous injection, is most effective when given quickly after a COVID-19 diagnosis. Ideally, it makes symptoms more manageable and keeps people out of the hospital.

As the treatments became more available, the FDA authorized their use for people 12 and older with mild to moderate COVID-19 symptoms and who were at risk of developing severe illness. 

Regeneron and Eli Lilly made two of the more well-known monoclonal antibody treatments. But on Jan. 24, the Food and Drug Administration restricted their use "to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments."

According to CDC surveillance, more than 99.9% of COVID-19 cases in the country are omicron. Unlike previous strains, the disease caused by this variant does not respond as well to these two monoclonal antibody drugs. 

"Data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States," the FDA said. Limiting the use of these treatments "avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious."

Both Eli Lilly and Regeneron acknowledged that their drugs were ineffective against omicron. 

DeSantis said in a press conference that some people could still be contracting the delta variant of COVID-19, and they deserve access to the drugs.

The thing is, it is difficult to say which strain of COVID-19 a person has without more advanced lab testing. A rapid or PCR test will not reveal whether someone has the delta or omicron variant.

The FDA announcement did not rule out monoclonal antibody treatments altogether. Sotromivab, a monoclonal antibody made by GlaxoSmithKline and Vir Biotechnology, is still in play. Three other drugs may also be used to treat infections: Paxlovid and molnupiravir, which are pill medications obtained through a prescription, and Veklury (remdesivir), an antiviral drug given by IV infusion.

While the federal government pulled back on its shipments of the Eli Lilly and Regeneron drugs, it’s ramping up the distribution of others. An FDA spokesperson said the government is sending more than 3,200 doses of sotromivab to Florida for the last week of January. That’s in addition to 4,680 doses of the preventative treatment Evusheld, more than 21,000 doses of mulnipiravir and more than 5,200 doses of Paxlovid. All together, Florida is set to receive over 34,000 doses of medicine for the week that ends Jan. 30.

Evidence for the decision

DeSantis talked about the absence of "clinical data," which is a careful choice of words. Clinical data is collected and analyzed in real time from patients or through clinical trials involving people. 

But this obscures the volume of lab evidence showing the two drugs were ineffective against omicron.

"Evidence from lab tests is not the same as clinical evidence, which the governor’s tweet referenced," said DeSantis press secretary Christina Pushaw. "We have seen patients are still benefiting from monoclonal antibody treatment."

According to studies listed in FDA fact sheets for both drugs, Eli Lilly’s treatment was nearly 3,000 times less effective against omicron, and Regeneron’s was more than 1,000 times less effective. Both drugs were "unlikely to be active against variants from this lineage," the fact sheets say.

Pushaw acknowledged that omicron is the dominant strain, but said delta variant cases still exist and all monoclonal antibodies have been effective against that strain.

"Even if you decide to take the FDA at their word, without clinical evidence, why would the FDA pull these treatments off the market when we know that decision will harm Delta patients?" she said.

Thomas Unnasch, distinguished health professor at the University of South Florida, said policy needs to adapt to the changing threats of the pandemic. 

"The answer to that eventuality is to admit that the treatment no longer works and to emphasize those things we know work," Unnasch said. He noted that this includes getting fully vaccinated.

He pointed to five lab studies, including an unedited study published in the open access journal Nature on Dec. 23, 2021, which determined that omicron evaded the antibody treatments. Researchers used scientific technology called "high-throughput yeast display screening" to test how well the treatment could neutralize the variant, and found that omicron "escaped" the neutralizing antibodies.

"Lab tests against an Omicron ‘pseudovirus’ showed a large reduction in REGEN-COV’s neutralization activity," said Regeneron spokesperson Alexandra Bowie. "This tells us that, unfortunately, it is also not going to be able to neutralize the virus in people infected with this variant."

Our ruling

DeSantis said the FDA was blocking the use of "lifesaving" monoclonal antibody drugs "without a shred of clinical data."  

That wording obscures the full story: There were several scientific studies — including ones from the drugmakers themselves — that found that the drugs from Regeneron and Eli Lilly are ineffective against the omicron variant. Omicron accounts for over 99% of new cases, and this class of drugs only works when given soon after diagnosis. While these drugs helped earlier in the pandemic, they are no longer lifesaving.

The agency still allows four other drugs to be used against COVID-19, including another monoclonal antibody treatment called sotromivab, that do work against omicron.

We rate the statement Mostly False.

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