May 1, 2023

USA: FDA Says Telling People Not to Take Ivermectin for Covid Was Just a Recommendation. Hospitals Were Sued By Patients Because EXPERIMENTAL Remdesivir Was The Only Approved Drug.

The Epoch Times
written by Zachary Stieber
Saturday November 19, 2023

The U.S. Food and Drug Administration’s (FDA) guidance for people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin,” Isaac Belfer, one of the lawyers, said during a Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true. It’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for nonapproved purposes in the United States; the practice is known as an off-label treatment.

The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

On a separate page, the FDA stated: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.

It asked the court to rule the actions unlawful and bar the FDA from directing or opining as to whether ivermectin should be used to treat COVID-19.

Jared Kelson, an attorney representing the plaintiffs, told the court during the hearing that that informal claim “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.'”

The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he argued.

Plaintiffs in the case include Dr. Paul Marik, who began utilizing ivermectin in his COVID-19 treatment protocol in 2020 while he was chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital.

After the FDA’s statements, Marik was told to remove the protocol from the school’s servers while Sentara issued a memorandum to hospitals telling them to stop using ivermectin against COVID-19, with a citation to the FDA.

Marik was forced to resign from his positions because he couldn’t prescribe ivermectin because of the FDA’s statements, the suit alleges.

The government has moved to dismiss the complaint, asserting plaintiffs lack standing because the injuries can’t be traced back to the FDA.

More From the Hearing

During the recent hearing, which was on the motion to dismiss, the government stated that the FDA couldn’t be blamed for the injuries.

“Plaintiffs have also not shown that any of their claimed injuries are fairly traceable to defendants’ statements because their injuries were caused by independent third-party conduct that was not a predictable response to those statements,” Belfer said.

He noted that the FDA’s pages say people can use ivermectin if their health care provider prescribes it; argued that the statements “did not bind the public or FDA, did not interpret any substantive rules, and did not set agency policy”; and said the FDA’s position could change in the future if new data become available.

“They also do not have legal consequences for anyone but simply provide nonbinding recommendations to consumers,” he said.

Kelson disagreed.

“If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said. “That is enough of a harm to get into court” or have the motion to dismiss rejected, he said.

Ivermectin is used on animals in addition to humans. The FDA used a picture of a horse in its Twitter posts and on one of its pages.
“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.

U.S. District Judge Jeffrey Brown, a Trump appointee overseeing the case, said he was most concerned about the social media statements because they didn’t include any qualifiers.

Belfer argued the statements were aimed at consumers and that the Twitter posts linked to one of the pages, which does include the qualifier.

“So it was predictable that if you include the link to the article, people will click on the link and will see the full article, which includes that disclaimer that if your doctor writes you a prescription, you should fill it exactly as prescribed,” he said.

“The plaintiffs, by their own admission, have continued to prescribe ivermectin. So they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority.”

Brown said he appreciated the briefing from the parties and that he would rule “as quickly as we can for ya’ll.” As of Nov. 19, he hadn’t issued a ruling.
NBC4 Washington published December 15, 2021: Hospital Required to Treat COVID-19 Patient With Ivermectin. Northern Virginia Bureau Chief Julie Carey reports on a judge’s ruling that Fauquier Hospital should provide the drug Ivermectin as treatment to a patient suffering COVID-19.
WBNS 10TV published August 30, 2021: Judge orders Ohio hospital to treat COVID-19 patient with Ivermectin, despite CDC warnings. Despite a hospital's initial refusal, a judge ruled in favor of a woman seeking to have an animal dewormer drug given to her husband hospitalized with COVID-19.
WKBW TV | Buffalo, NY published January 18, 2021: Judge orders hospital to treat COVID patient with experimental drug.
Here is an important excerpt, "She was placed on a ventilator in late December. Initially hospital doctors gave her one dose of the controversial drug Ivermectin and she improved. Her attorney goes on to say, 'within 48 hours she is off the ventilator, out of ICU, onto a covid floor.' But her condition worsened and just days after the first dose, hospital doctors put her back on the ventilator. Lorego (her attorney) says the hospital REFUSED to give her more doses of Ivermectin drug. That's when he drew up more court papers that included a letter from the woman's doctor who wrote how she improved DRAMATICALLY after the first dose. State's Supreme Court judge ORDERED THE HOSPITAL to administer the Ivermectin drug.  BUT the hospital initially REFUSED. Her attorney said, 'I say to him you've got a court order. We've relieved you of liability. My people will sign a release and I go through the history of this lady. THEY STILL OBJECT'. (emphasis mine)
Last Updated: March 6, 2023

Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.1 For these indications, ivermectin has been widely used and is generally well tolerated.1,2 Ivermectin is not approved by the FDA for the treatment of any viral infection.

Proposed Mechanism of Action and Rationale for Use in Patients With COVID-19

Ivermectin has been shown to inhibit replication of SARS-CoV-2 in cell cultures.3 However, pharmacokinetic and pharmacodynamic studies suggest that achieving the plasma concentrations necessary for the antiviral efficacy detected in vitro would require administration of doses up to 100-fold higher than those approved for use in humans.4,5

The safety and efficacy of ivermectin for the prevention and treatment of COVID-19 have been evaluated in clinical trials and observational cohorts. Summaries of the studies that informed the COVID-19 Treatment Guidelines Panel’s (the Panel) recommendation can be found in Table 7b. The Panel reviewed additional studies, but these studies are not summarized in Table 7b because they have study design limitations or results that make them less definitive and informative.


The Panel recommends against the use of ivermectin for the treatment of COVID-19.


The Panel’s recommendation is primarily informed by adequately powered, randomized trials of ivermectin that reported clinical outcomes. Studies that randomized participants to ivermectin or a matched placebo had the greatest impact on the Panel’s recommendation.6-13

Trials have failed to find a clinical benefit from the use of ivermectin for the treatment of COVID-19 in outpatients. In TOGETHER, an adaptive platform trial conducted in Brazil, there was no apparent difference between the ivermectin and placebo arms for the primary outcome of risk of emergency department visits or hospitalization (14.7% vs. 16.4%).14 In addition, there was no statistically significant difference between the ivermectin and placebo arms in mortality (3.1% vs. 3.5%). In COVID-OUT, a randomized factorial trial, the use of ivermectin when compared with a matched control (5.7% vs. 4.1%) did not reduce occurrences of a composite outcome of emergency department visits, hospitalization, or death.6

The ACTIV-6 trial was an adaptive platform trial conducted in outpatients with mild to moderate COVID-19 in the United States.15,16 Participants were randomized to an ivermectin regimen (either 400 μg/kg for 3 days or 600 μg/kg for 6 days) or a matching placebo. In the 400 μg/kg phase of the study, the median time to sustained recovery was 12 days for the ivermectin arm and 13 days for the placebo arm. In the 600 μg/kg phase of the study, the median time to sustained recovery was 11 days for both arms.

I-TECH, an open-label trial conducted in Malaysia, found no difference between the ivermectin and standard of care arms (21.6% vs. 17.3%) for the primary outcome of risk of progression to severe COVID-19.17 The ivermectin arm had a lower risk of mortality than the standard of care arm (1.2% vs. 4.0%) (relative risk 0.31; 95% CI, 0.09–1.11; P = 0.09), but this difference was not statistically significant.

The study populations in most of the reviewed trials were patients with mild to moderate COVID-19 who had a relatively low risk for disease progression, and the number of deaths was low (as expected). In these randomized trials, completely excluding an effect of ivermectin on COVID-19 disease progression is difficult because the trials were not powered to detect differences in secondary outcomes, such as death. However, data from these trials do not provide evidence that the use of ivermectin is effective for the treatment of COVID-19. For this reason, and because other medications now have demonstrated clinical benefit for the treatment of COVID-19, the Panel recommends against the use of ivermectin for the treatment of COVID-19 ().

Drug Availability

Ivermectin is not approved or authorized by the FDA for the treatment of COVID-19.
🚨👇 BONUS because he loves attention 👇🚨
Fauci: I am the science.
CNN published April 26, 2023: Hear what Dr. Fauci says hampered US response to Covid-19 pandemic. Dr. Fauci joins "CNN This Morning" to discuss the missteps -- and missed opportunities -- that characterized the pandemic response in the US before he retired as head of the National Institute of Allergy and Infectious Diseases
UPDATE 5/3/22 at 1:15pm: Added info below.

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