Florida to Allow Doctors to Use Off-Label Drugs for Early Treatment of COVID-19

Florida Gov. Ron DeSantis speaks at a news conference at the Broward Health Medical Center in Fort Lauderdale, Fla., on Sept. 16, 2021. Wilfredo Lee/AP Photo

Repurposed drugs that have been shown to prevent or treat COVID-19 may be prescribed by physicians, the Florida Department of Health said in its new COVID-19 guidance for health care practitioners.

The guidance, published on Feb. 24, says that health care practitioners are encouraged to provide early treatment for COVID-19 patients with federally approved generic drugs that they find will work. That’s in addition to the outpatient treatments granted emergency authorization usage (EUA) for people at risk of developing a serious illness.

“When recommending COVID-19 treatment options for patients’ individualized health care needs, physicians should exercise their individual clinical judgment and expertise based on their patient’s needs and preferences,” the guidance states. “These options may include emerging treatments backed by quality evidence, with appropriate patient informed consent, including off-label use or as part of a clinical trial.”

The new guidance is an effort by Republican Gov. Ron DeSantis to offer health care practitioners protection from lawsuits. He said that it’s important for doctors to be able to have access to these drugs.

“We want people to be able to have a right to access these medications, especially if they’re in a situation where nothing else has worked,” DeSantis said in a video announcing the new changes to the COVID-19 guidance.

The guidance also states that doctors can make a report to the Agency for Health Care Administration if their hospital prevents them from treating their patients who wish to try certain medications not recommended by the federal health agencies.

Gov. Ron DeSantis (L) announced Florida's new surgeon general Dr. Joseph Ladapo on Sept. 21, 2021. Courtesy of Governor's Press Office

“So now doctors who practice medicine in the way that they think is most appropriate for their patients, when they receive pushback from hospitals, we have an avenue for them to file a complaint with our Agency for Health Care Administration,” said Florida Surgeon General Dr. Joseph Ladapo.

Florida is the first and only state to go against the Centers for Disease and Prevention’s (CDC) recommendation of staying home and only going to the emergency department when symptoms become severe unless the individual is at high risk, then they may be eligible for treatment with an authorized antiviral or monoclonal antibody.

The CDC did not reply to a request by The Epoch Times for comment.

Dr. Pierre Kory, president and co-chief medical chief officer of the Front Line COVID-19 Critical Care (FLCCC) Alliance, claims that many people have died unnecessarily during the pandemic, as COVID-19 is a treatable disease. He also said that it didn’t make sense that the government continues to focus only on pushing the vaccines.

“We know there have been hundreds of thousands of deaths in the U.S. and all for a treatable disease,” Kory said at a panel discussion on COVID-19.

“We have identified effective treatments, for now two years, and those effective treatments that are widely available generic repurposed [drugs], they continue to increase. And yet, we are still trying to vaccinate people with a 2-year-old vaccine against an Omicron variant, which is absolutely absurd,” he added.

As early as March 2020, doctors at FLCCC Alliance developed a COVID-19 treatment protocol for hospitalized patients, later adding the I-MASK+ protocol, using ivermectin as a core medication for the prevention and early treatment of COVID-19 in October 2020.

Kory also alleged that the EUA antiviral drugs for early treatment of COVID-19 are toxic.

“We’re still perpetuating these toxic novel pharmaceutical company concoctions like Paxlovid and molnupiravir. Molnupiravir does not work and Paxlovid is poisonous,” Kory said.

Paxlovid, a Pfizer's coronavirus disease (COVID-19) pill, is seen manufactured in Ascoli, Italy, in this undated handout photo obtained by Reuters on Nov. 16, 2021. Pfizer/Handout via Reuters

Paxlovid can be fatal when taken with common medications such as blood thinners, statins, and some antidepressants. One component of Paxlovid prevents the breakdown of other drugs leading to an increased level of these drugs causing toxic effects.

There are also concerns that the CCP (Chinese Communist Party) virus that causes COVID-19 may develop resistance to the antiviral drugs because each only attacks one part of the virus instead of multiple fronts like its inexpensive federally approved competitor, ivermectin.

For an antiviral to successfully eliminate the CCP virus, it must target “two key pieces of a virus’s biological machinery, a polymerase and a protease, both of which are essential for viral replication,” according to an article in Nature.

Molnupiravir, developed by Merck and Ridgeback Biotherapeutics, targets only the RNA polymerase, while Pfizer’s Paxlovid just inhibits the virus’s main protease.

For a 5-day treatment course consisting of two pills per day, molnupiravir costs the United States government $530 and $700 for Paxlovid. Whereas ivermectin costs as low as $29.72 and as high as $93.77 for 20 tablets, according to GoodRx.

In a report (pdf) examining the outpatient treatments for COVID-19 from the Institute for Clinical and Economic Review (ICER), a drug-pricing research organization, the authors raised concerns about the effectiveness and safety of the drugs due to lack of long-term data.

“While the clinical trials of all four agents [Paxlovid, molunupiravir, the monoclonal antibody treatment sotrovimab, and fluvoxamine that is waiting for a EUA] demonstrate statistically significant benefits of treatment, there remains substantial uncertainty regarding the comparative effectiveness of each drug in the current U.S. landscape,” the authors wrote. “Some of this uncertainty is due to the preliminary nature of the evidence base, which for several drugs include only data that has not yet progressed through peer review.

They added, “As of January 2022, the Phase III RCT [randomized control trial] evidence for sotrovimab is only available as a pre-print (i.e., without peer review) and the evidence for Paxlovid is based on the manufacturer’s press release and the EUA factsheet for health care providers. This lack of data makes it difficult to fully evaluate these drugs.

“Such issues are compounded by each treatment being supported by only one Phase III RCT.”

The Food and Drug Administration (FDA) issued emergency authorization usage for both molnupiravir and Paxlovid in December 2021 and recommends against ivermectin for COVID-19. The drug regulator says the “most effective ways to limit the spread of COVID-19 include getting a COVID-19 vaccine” and “following current CDC guidance.”

Pfizer and Merck did not reply to a request for comment by the time of publishing.