The U.S. Food and Drug Administration (FDA) reportedly agreed to remove all its previous social media posts and consumer advisories that specifically addressed the use of ivermectin for the treatment or prevention of COVID-19.
The drug which was authorized and has been used to treat humans since 1996 came under fire by the FDA when they issued a statement at the time, “Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.”
This was the same drug that the FDA encouraged to use African migrants in 2015 and was praised in several scientific journals.
The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, contested the FDA’s portrayal of ivermectin as dangerous for human consumption. They note that the FDA has approved ivermectin for human use since 1996 for a variety of diseases. They allege that with the advent of the COVID-19 pandemic, the FDA began releasing documents and social media posts discouraging the use of the anti-viral drug for COVID-19 treatment.
Bowden was one of thousands of doctors who sought treatment options for COVID19 after the disease spread into the United States in 2020. Bowden has testified that she kept thousands of patients out of the hospital by using ivermectin and other medications and supplements, but that because of the FDA campaign against ivermectin — which has been approved for human use by the agency since 1987 — many pharmacists were refusing to dispense the drug and insurance companies would not cover the costs.
Judge Jeffrey Brown for the U.S. Southern District Court in Texas initially dismissed the case ruling that the FDA had “sovereign immunity,” but his ruling was overturned by the 5th Circuit last September and remanded back to the lower court.
“FDA is not a physician. It has authority to inform, announce, and apprise-but not to endorse, denounce, or advise,” wrote Judge Don Willett for a panel of three 5th Circuit judges last year. “The doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”
Brown later found that only Bowden had standing to sue the FDA, excluding Drs. Robert Apter and Paul Marik, but before the case could proceed the HHS asked the plaintiffs’ attorneys for a settlement.
According to the agreement, the case has been dismissed “with prejudice.” Within 21 days the FDA must remove “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and delete related posts on X, LinkedIn, and Facebook.
Currently, 101 Ivermectin COVID-19 studies have been done showing a 62% lower risk in early treatment in patients.
The lawsuit alleged that the FDA overstepped its authority and unjustifiably interfered with their medical practice as well as released documents and social media posts discouraging the use of the antiviral drug for COVID-19 treatment.
U.S. law was cited in the complaint, including the provision that the FDA “may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”
According to the plaintiffs, the landmark case sets an important precedent in limiting FDA overreach into the doctor- patient relationship.
Over the past decade, the global scientific community began to recognize the value of ivermectin, which was discovered in 1973 by Satoshi Ōmura, of Tokyo’s prestigious Kitasato Institute. Omura received the 2014 Gairdner Global Health Award and the 2015 Nobel Prize in Physiology or Medicine, which he shared with a collaborating partner in the discovery and development of the drug, William Campbell of Merck & Co. Incorporated.
The microorganism that produces the avermectins, from which ivermectin comes, was sent to Merck laboratories to be run through a specialized screen for anthelmintics in 1974 and the avermectins were found and named in 1975. Ivermectin, was subsequently commercialized, entering the veterinary, agricultural and aquaculture markets in 1981.
The drug’s potential in human health was confirmed a few years later and it was registered in 1987 and immediately provided free of charge (branded as Mectizan)—‘as much as needed for as long as needed’—with the goal of helping to control Onchocerciasis (also known as River Blindness) among povertystricken populations throughout the tropics. Uses of donated ivermectin to tackle other so-called ‘neglected tropical diseases’ soon followed, while commercially available products were introduced for the treatment of other human diseases.
The benefits of ivermectin have been and are currently being researched for a wide range of diseases and infections, including viruses and cancer and other medical diagnosis.