Suspension Of Antibody Treatments 'Reckless,' Says FL Governor

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FLORIDA — Despite the Food and Drug Administration's assertion that the Regeneron and Eli Lilly coronavirus antibody treatments are useless for those infected with the omicron variant, Florida Gov. Ron DeSantis condemned President Joe Biden's decision to stop sending the treatments to states.

Earlier this month, the FDA announced that studies indicated the monoclonal antibody treatments that had saved the lives of so many unvaccinated and vulnerable residents who contracted the first variants of the coronavirus who ineffective against the omicron variant.

Despite that announcement, DeSantis placed an order for 15,000 more doses of the treatment as Florida saw record numbers of residents contracting the omicron variant of the virus.

Then, on Monday, Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, announced that the FDA was revoking its emergency use authorization for the Regeneron and Eli Lilly treatments.

As a result, Biden said he will no longer send the treatments to states requesting them.

During a news conference Tuesday, DeSantis called Biden's decision "reckless" and urged the Biden administration to reverse its decision.

“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 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.”

Florida Surgeon General Dr. Joseph Ladapo echoed DeSantis' concerns.

“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” said Ladapo. “The federal government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.'”

As a result of the FDA's decision, more than 2,000 appointments for Floridians to undergo the monoclonal antibody treatment were canceled Tuesday, DeSantis said.

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In light of the FDA's announcement, hospitals and doctor's offices have announced they will no longer provide the treatments. And state-and county-run antibody treatment clinics have closed as well.

Although the FDA and National Institutes of Health have released multiple statements that the treatments don't work for patients with omicron over the past several week, DeSantis blasted the FDA for making its decision to revoke the emergency approval for the treatment without advance warning, preventing states and health-care providers "from making real-time operational decisions that save lives."

Not true, said Cavazzoni. She said the treatments will be made available for regions that see a surge in earlier variants of the coronavirus, such as the delta variant.

"In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions," she said.

However, she said, the omicron variant is estimated to account for more than 99 percent of cases in the United States as of Jan. 15.

"Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time," Cavazzoni said. "This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious."

She said monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off viruses. But since the coronavirus has mutated into the omicron variant, those earlier treatment won't work.

Her decision is backed by the NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, which recently recommended against the use of Regeneron and Eli Lilly treatments.

However, there are several other antibody therapies that are expected to work against the omicron variant, she said. Cavazzoni said health-care professionals might want to consider using these new therapies to treat patients who are at high risk for hospitalization or death.

Among them is a new monoclonal antibody treatment called sotrovimab recently developed by GlaxoSmithKline and Vir Biotechnology Inc. The FDA has given emergency approval to use this treatment for the omicron variant and, although supplies are still limited, 55,000 doses of sotrovimab have being shipped to all states with an additional 300,000 doses of sotrovimab to be distributed this month.

She added that the antibody treatments were never intended to be an alternative to vaccines and boosters shots, both of which are a fraction of the cost of antibody treatments.

The federal government pays $3,000 to $5,000 a dose for antibody treatments, but pay only $32 to $37 per dose for COVID-19 vaccine.

"Data has clearly demonstrated that the available, safe and effective vaccines can lower your risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death," she said.

This article originally appeared on the Tampa Patch

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