The Food and Drug Administration within the Department of Health Services is facing a lawsuit for the FDA’s stance against the use of ivermectin as a treatment for COVID-19.
FDA’s attempt at preventing the widespread use of the drug is based on the speculation that a version of the drug is formulated for animals and used for the treatment of parasitic worms in animals. Hence, the agency warned against its use, claiming that some individuals might purchase the one intended for animals in place of the one intended for humans.
In 2021, the FDA launched a web page titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” Since then, it has used its platforms to spread alleged misleading concerns over the drug.
However, plaintiffs Mary Talley, Paul E. Marik and Robert L. Apter maintained that the drug has successfully been used in the treatment of patients with COVID. Hence, the three doctors argued that the FDA’s moves to turn people away from the drugs were beyond its authority. According to them, the agency’s smear campaign on the drugs interfered with doctors’ ability to treat Covid.
“FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as ‘off-label’ use. The FDA also cannot advise whether a patient should take an approved drug for a particular purpose,” they stated.
Directing the public — patients and health professionals alike — to not use ivermectin to treat COVID-19 is wrong, according to the plaintiffs. And they are asking the court to cancel “any FDA actions that direct or opine on whether ivermectin is an appropriate treatment for COVID-19, declare such actions unlawful.”
The lawsuit also seeks to get permanent injunctive relief prohibiting the FDA from discouraging people from drugs in the future if they are fully approved for human use.
Supporters of the suit include the Front Line COVID-19 Critical Care Alliance and America’s Frontline Doctors. President and chief medical officer of the FLCCC Pierre Kory said the dangerous and lethal tag placed on ivermectin as a COVID-19 treatment was a coordinated disinformation campaign among the FDA, CDC and mainstream media.
“Multiple actions taken by the CDC and FDA, as well as the media over a two-week period were triggered by the release of data showing that there were 90,000 prescriptions being filled for ivermectin by the middle of August,” Kory said.
According to Kory, the propaganda campaign against ivermectin that put the term “horse dewormer” everywhere at some point is part of a fight against repurposed or off-label drugs.
Destroying the credibility of off-label drugs as COVID-19 treatment not only turned patients off the drug but also saw doctors refuse to prescribe it out of fear of losing their licenses for going against the agencies. The result, Kory said, all adds up to Big Pharma’s benefit.
While the original lawsuit filed in June last year was dismissed by a U.S. district court, the plaintiffs took the case to the Fifth Circuit Court of Appeals in hopes of a different outcome. To see to the doctors’ moves, AAPS and the FLCCC have filed an amicus brief.
FDA Ivermectin Lawsuit Dismissed, COVID Doctors Appeal
Dr. Mary Talley Bowden (who is still banned from Twitter) told me the fight is for medical freedom. My story: https://t.co/E8PF475Dmx
— Emily Miller (@emilymiller) December 12, 2022