The Fifth Circuit Court of Appeals in New Orleans has given new life to a lawsuit brought by three doctors claiming the U.S. Food and Drug Administration (FDA) overstepped its authority and acted as a medical doctor rather than as a regulating authority in the agency’s campaign promoting a ban on the use of the drug Ivermectin in the treatment of COVID-19.1
The court’s decision overturned U.S. District Judge Jeffrey Vincent Brown’s lower court’s order dismissing the doctors’ lawsuit. Judge Brown agreed with the government that it was protected from the lawsuit due to sovereign immunity.2 Sovereign immunity provides that the government may not be sued without its consent. The purpose behind the legal doctrine of sovereign immunity is to protect the government from being forced to change policies should someone disagree with them and bring legal action.3
The medical doctors, Mary Bowden, Paul Marik, and Robert Apter, argue that the FDA’s actions of interfering with their prescribing of Ivermectin harmed their reputation caused punitive action to be taken against them, and interfered with the practice of medicine, which included pharmacies failing to fill their prescription orders for Ivermectin.
Jared Kalson, the lawyer for the plaintiffs argued:
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. 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.4
Court Rules “FDA Not a Physician”
The plaintiffs appealed the lower court order to the Fifth Circuit Court of Appeals. The panel of three appellate judges, including Judge Don Willet, Judge Jennifer Walker Elrod, and Judge Edith Brown Clement agreed with the plaintiffs that the FDA committed government agency overreach and allowed the doctors to proceed with their lawsuit.5
The Order read,:
FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. As such, the doctors can use the APA to assert their ultra vires claims against the agencies and the officials.6
Judge Willet took issue with the FDA’s Aug. 21, 2021 Twitter post stating, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The judge wrote, “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.”7
How a Licensed Inexpensive Antiparasitic Drug Helped Treat COVID
Merck originally marketed Ivermectin, which was licensed in 1981, as a veterinary antiparasitic drug. By the late 1980s, Ivermectin became the most widely used antiparasitic drug in both animals and humans and has been especially useful in Africa to effectively and safely control malaria.8 9 A Nobel prize-winning drug, doctors have been prescribing Ivermectin to patients for decades.10
So how did a cheap, accessible antiparasitic become such a popular drug used to treat SARS-CoV-2 infections during the COVID pandemic?
In 2020, Australian researchers from the Biomedicine Discovery Institute (BDI) at Monash University made the discovery that Ivermectin could neutralize the novel SARS-CoV-2 virus within 48 hours. The study, a joint effort between Monash Biomedicine Discovery Institute, Monash University in Clayton, Australia, and the Peter Doherty Institute of Infection and Immunity—a joint venture between the University of Melbourne and the Royal Melbourne Hospital, both in Melbourne, Australia—found that, in vitro, the drug proved effective against a number of viruses, including HIV, dengue, influenza, and Zika. The findings suggested that just a single dose of Ivermectin could remove or significantly reduce viral RNA within 24 to 48 hours of SARS-CoV-2 .
Dr. Kylie Wagstaff, Monash Biomedicine Discovery Institute scientist and leader of the study said: “We found that even a single dose could essentially remove all viral RNA by 48 hours and that even at 24 hours there was a really significant reduction in it.”
A study was published in 2021 in the American Journal of Therapeutics providing evidence that the use of Ivermectin reduces morbidity and mortality from SARS-CoV-2 infections, including time to recovery and viral clearance.11 In addition, Ivermectin is being investigated as an option for treating certain other human viral infections like latent Epstein Barr, which can be reactivated in some individuals when they are infected with SARS-CoV-2 and lead to long COVID.12 13 14
Ivermectin Showed Antiviral Effects Against Omicron and Other Variants
Off-label use of Ivermectin has been the source of much scrutiny among many public health officials throughout and even following the pandemic. And while historically prescribed as an antiparasitic for humans and animals, the drug did show and other variants in 2022 during joint nonclinical research conducted by Japanese pharmaceutical company, Kowa Co. Ltd.15
Additionally, another study published in The Lancet in 2021 found Ivermectin to incite “antiviral activity against SARS-CoV-2 and provides insights into the type of evaluations to be considered in the assessment of antiviral drugs for the control of COVID.”16
Popular podcast host and health and wellness influencer Joe Rogan posted a video only days after the FDA urged people to stop taking the drug to prevent or treat COVID-19 to share he was taking Ivermectin after contracting the virus. He said that taking Ivermectin in conjunction with monoclonal antibodies, prednisone, azithromycin, a NAD drip, and a vitamin drip, a protocol he shared with his followers, helped him feel “great” only three days later.
FDA’s Condemnation of Ivermectin-Blocked Doctor Prescriptions for COVID Patients
Judge Willet further pointed out that Ivermectin is available in both animal and human form and that doctors have been prescribing the drug to patients for decades. However, after the FDA’s condemnation of Ivermectin as an ineffective and potentially dangerous treatment for COVID-19, pharmacies across the country began refusing to fill doctors’ prescriptions for patients.
A Department of Justice attorney, Ashley Cheumg Honold, clarified the FDA’s position to the court stating…
FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID.17
Despite the FDA’s statement that doctors have the authority to prescribe Ivermectin to treat COVID, pharmacies continue to refuse to fill prescriptions for the drug, leaving patients scrambling. Dr Bowden told The Epoch Times:
This needs to come to an end. In telling my patients what medicines they can and cannot have access to, we effectively have a large group of pharmacists practicing medicine without a license. They have no accountability for this yet they are allowed to dictate patient care. … I see it every single day. Enough is enough.18
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Click here to view References:
2 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
3 What Is Sovereign Immunity? Definition and Examples. ThoughtCo.
4 Stieber Z. Judge Rules on Lawsuit Against FDA Over Ivermectin. The Epoch Times. Dec. 6, 2022.
5 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
6 Ibid.
7 Ibid.
8 Laing R, Gillan V, Devaney E. Ivermectin – Old Drug, New Tricks? Trends Parasitol June 2017; 33(6): 463-472.
9 Foy BD, Alout H, Seaman JA et al. Efficacy and risk of harms of repeat Ivermectin mass drug administrations for control of malaria (RIMDAMAL): a cluster-randomised trial. The Lancet 2019; 393 (10180): 1517-1526.
10 Santin AD, Scheim DE, McCullough PA et al. Invermection: a multifaceted drug of Nobel prize-honoured distinction with indicated efficacy against a new global scourge, COVID-19. New Microbes New Infect 2021; 42.
11 Kory P, Meduri GU, Varon J et al. Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19. Am J Ther 2021; 28(3).
12 Gold JE, Ikyay RA, Licht WE, Hurley DJ. Investigation of Long COVID Prevalence and its Relationship to Epstein-Barr Virus Reactivation. Pathogens 2021; 10(6).
13 Na L, Zhao L, Zhan X. Quantitative proteomics reveals a broad-spectrum antiviral property of ivermectin benefiting for COVID-19 treatment. J Cell Physiol 2021; 236(4): 2959-2974.
14 Bernal KDE, Whitehurst CB. Incidence of Epstein Barr virus reactivation is elevated in COVID-19 patients. Virus Res 2023; 334: 199157.
15 Reuters. Ivermectin shows ‘antiviral effect’ against COVID, Japanese company says. Jan. 31, 2022.
16 Krolewiecki A et al. Antiviral effect of high-dose ivermectin in adults with COVID-19: A proof-of-concept randomized trial. The Lancet June 17, 2021.
17 Lysiak M. ‘FDA Is Not a Physician’: Appeals Court Sides With Doctors on Ivermectin for COVID-19. The Epoch Times Sept. 2, 2023.
18 Lysiak M. Doctor: Pharmacists Continuing to Refuse Ivermectin Prescriptions, Raising Ethical Concerns. The Epoch Times. Sept. 1, 20223.