State closes all monoclonal antibody treatment sites
The Florida Department of Health closed all state-run monoclonal antibody treatment sites after the U.S. Food and Drug Administration earlier Monday revoked infusion drugs from Regeneron and Eli Lilly because they didn’t work against the omicron coronavirus variant that now accounts for nearly all U.S. infections.
The move drew strong condemnation from Florida Gov. Ron DeSantis, who along with his Surgeon General Dr. Joseph Ladapo, have advocated the treatment's use to fight COVID-19.
"This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives," DeSantis said in a news release.
Late Monday, the state health agency said it canceled appointments at its five sites, including near Boynton Beach, until further notice "as a result of this abrupt decision by the federal government." The agency noted those with appointments have been contacted, including 2,000 scheduled for Tuesday.
The federal government has purchased the two treatments, shipping two antibodies doses to treat more than 300,000 patients via intravenous. The Regeneron drug cost $2,100 per dose.
Hospitals also administer the drugs but many hospitals, including Boca Regional, stopped because of ineffectiveness.
If the two drugs prove effective against future variants, the FDA said it could reauthorize their use.
The FDA noted that doctors have alternate therapies to battle early COVID-19 cases, including injections from GlaxoSmithKline and Astra Zeneca that still have emergency authoritization. And there are two recently approved antiviral pills from Pfizer and Merck that are being shipped to states for the first time this week.
These treatments are intended to prevent severe disease and death by supplying concentrated doses of one or two antibodies early in an infection. Then-President Donald Trump received Regeneron's antibody combination after he tested positive for the coronavirus in early October 2020.
The FDA decision drew rebuke from DeSantis.
"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," DeSantis said in the news release. "There are real-world implications to Biden's medical authoritarianism — Americans' access to treatments is now subject to the whims of a failing president."
The FDA said the National Institutes of Health COVID-19 Treatment Guideline Panel, an independent panel of national experts, recently recommended against the use of the two treatments "because of markedly reduced activity against the omicron variant and because real-time testing to identify rare, non-omicron variants is not routinely available."
The CDC has estimated that omicron accounts for more than 99% of cases in the U.S. as of Jan. `15. The treatments have been effective against the Delta variant and the original strain.
"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," the FDA said in the news release. "This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant."
DeSantis set up infusion sites, effective last Tuesday, in five counties: Palm Beach, Broward, Miami-Dade, Duval and Seminole. They were open seven days a week.
"As a result of this abrupt and clinically unsupported action, the appointments for more than 2,000 Floridians to receive this treatment were canceled on January 25, 2022, alone," DeSantis said. "This decision was made solely by Biden's Food and Drug Administration (FDA) without advance warning to states or health providers and without clinical data to support the decision. The deliberate decision by the Biden administration to make this announcement effective immediately, through a press release, actively prevents states and health care providers from making real-time operational decisions that save lives."
Ladapo, the state surgeon general who was appointed in Sept. 21 but hasn't been confirmed by the Senate, has advocated the use of the treatments over vaccines.
"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," Ladapo said. "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.'"
But Dr. Gerald E. Harmon, the president of the American Medical Association, said in a statement that "we are pleased that the FDA is following the scientific evidence and limiting the use of monoclonal antibody treatments to those that are effective against the omicron variant. Limiting the use of these treatments will help ensure patients receive the best available therapy."
Last week, the FDA delivered 4,392 doses made by Regeneron and 3,580 by Eli Lilly as well as 3,996 by GlaxoSmithKline and 4,656 by Astra Zeneca, also injectables.
This week the agency is shipping fewer doses by GSK, 3,216, but more by Astra Zeneca, 4,680, and for the first time two recently approved treatments in pill form: 21,080 by Merck and 5,240 by Pfizer.
"We encourage states and providers to continue offering effective treatments to Americans who get sick with COVID-19, and HHS remains committed to providing these to states at no cost," Seth Schuster, regional communications director at the White House, said in a statement.
The U.S. government temporarily stopped distributing the two drugs in late December, as omicron was becoming the dominant variant. But officials resumed distribution after complaints from Republican governors, including DeSantis, who claimed they helped some omicron patients.
The FDA and CDC has said drugs are not a substitute for vaccination and are generally reserved for vulnerable people, including seniors, transplant recipients and those with conditions like heart disease and diabetes.
Regeneron and Lilly previously announced they were developing new antibodies that target omicron.
Remdesivir, an antiviral medication developed byGilead Sciences, was the first drug approved to treat COVID-19.
Remdesivir had been limited to hospitalized patients but on Friday, the FDA adults and children with early COVID-19 who face a high risk of ending up in the hospital.
HHS said it will have about 4 million doses of all anti-body products available in January alone.
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