On Saturday, The Epoch Times posted the following headline:
FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation
The article reports:
The U.S. Food and Drug Administration (FDA) telling 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, told the court during the Nov. 1 hearing in federal court in Texas.
“They use informal language, that is true,” he also said, adding that, “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 non-approved purposes in the United States; the practice is known as off-label treatment.
This is a link to a CDC Health Advisory put out on August 26, 2021. I suspect that as this case moves forward, this Advisory may disappear, so I will quote some of it here:
Recommendations for the Public
• Be aware that currently, ivermectin has not been proven as a way to prevent or treat COVID–19.
• Do not swallow ivermectin products that should be used on skin (e.g., lotions and creams) or are
not meant for human use, such as veterinary ivermectin products.
• Seek immediate medical attention or call the poison control center hotline (1–800–222–1222) for advice if you have taken ivermectin or a product that contains ivermectin and are having
symptoms. Signs and symptoms include gastrointestinal effects (nausea, vomiting, abdominal pain, and diarrhea), headache, blurred vision, dizziness, fast heart rate, and low blood pressure.
Other severe nervous system effects have been reported, including tremors, seizures, hallucinations, confusion, loss of coordination and balance, decreased alertness, and coma.
• Get vaccinated against COVID–19. COVID–19 vaccination is approved by FDA and is the safest and most effective way to prevent getting sick and protect against severe disease and death from SARS–CoV–2, the virus that causes COVID–19, including the Delta variant.
• Protect yourself and others from getting sick with COVID–19. In addition to vaccination, wear masks in indoor public places, practice staying at least six feet from other people who don’t live in your household, avoid crowds and poorly ventilated spaces, and wash your hands often or use hand sanitizer that has at least 60 percent alcohol.
The article at The Epoch Times concludes:
“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 that he was most concerned about the social media statements because they did not 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,” he added later.
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 has not issued a ruling.
The government did everything it could to prevent the use of Ivermectin. The problem with Ivermectin is that it is cheap and the pharmaceutical companies do not make a lot of money on it. The medical profession has sold its soul for money, and people around the world have did because of it. Accountability is in order.