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, 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 Anti-Parasitic Drug Helped Treat COVID
Merck originally marketed Ivermectin, which was licensed in 1981, as a veterinary anti-parasitic drug. By the late 1980s, Ivermectin became the most widely used anti-parasitic 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 anti-parasitic 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 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 anti-parasitic 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 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, 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:1 Robertson N. Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging. The Hill. Sept. 2, 2023.
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.
14 Responses
My experience with Ivermectin was that one dose stopped my Covid infection – within 30 minutes all symptoms vanished.
The only reasons that the FDA is blocking its use are
1) if it is recognized as a safe, effective treatment of Covid, then the Covid jabs cannot be given since they are neither safe nor effective and the reasoning they were allowed at all was “there are no effective treatments”
2) the money and influence will be lost related to Covid jabs
Yep, “follow the money” Shame on them.
We are so thankful to have found a medical professional who prescribed my wife and myself, after a tele-visit analysis, a prescription of Ivermectin for us. We both had previously contracted a very mild case of Covid which has provided our natural immunity. We’ve only taken one J@J vaccine shot and will not take another.
Thanks for all you do!
Thank you trio of doctors!!
I have friends and family that have used Ivermectin as a preventative, and a treatment against Wuflu; it works. The mere fact that the FDA tried to keep this treatment from the public is disturbing.
Thank you for telling us the truth. More power to you and keep up the great work you’re doing for us all.
And so, those at the top of the FDA (i.e., political appointees) should be prosecuted as contributing to the mass murder here in the US (and by extension, anywhere else the assumed authoritative voice of the FDA was accepted as gospel). And further extensions should apply to the NIH, CDC and most of the top layers of the current administration (and the previous one). Denial of effective care in the face of a “health emergency” is constructive manslaughter or its more severe legal cousin, “murder with malice aforethought.”
How can one not conclude that there were serious “kickbacks” of cash, that enabled this travesty to play out?
The FDA has lost its esteem, if it ever had any to begin with.
Saying “You are not a horse. You are not a cow. Seriously y’all. Stop it.” is a way of saying only hillbilly hicks believe this animal dewormer works.
It’s insulting to hillbillies number one who in my opinion are the last people on earth to fall for anything.
And number two it reveals their lack of esteem for those of us out here who can assess our own health needs, thank- you very much.
Especially when we, as had been my experience, only get help when its the Dr’s idea but not when we know somethin’ ain’t right…….
This cannot end here…There is no forgive and forget for negligent homicide which has killed thousands…The cdc, nih and the fda need to be charged and tried and sentenced for what they have done…There is no sovereign immunity when it comes to genocide…Let NUREMBERG 2 begin!!
Pleased to see that Australian researchers showed that Ivermectin was effective against COVID. Just a pity that our Government and their agencies did not listen to them and made it hard for us to procure Ivermectin. It appears that nebulisers using hydrogen peroxide or silver colloid or using an FScan frequency synthesiser are also beneficial.
Interesting article and comments. Just a few housekeeping notes here. The Austrailian researchers, like many others, were merely following a standard scientific method, to test if well known widely available, proven safe and effective substances such as ivermectin would work in this particular case with this particular pathogen. Try this, try that, this other one is known to have broad spectrum effective nature, see if this works on a particular pathogen. Smart researchers turn to what is already known to work for similar scenarios, which is why they turned to ivermectin. Only the captured agencies of the ‘civilized world’ were blissfully unaware of this substances broadly effective nature around the world, and decade long track history.
Of course, understanding these facts illustrates the gross incompetency of such a large portion of our medical and regulatory establishment today. In their group think and pre programmed willingness to promote pharmaceuticals over herbal and low cost affordable substances which can not be patented, the medical community at large was revealed to the masses as being blatantly biased and helplessly ignorant. aka; captured agencies.
Get your mind around the cold hard facts that there is no independence in regulatory agencies, their guidance and approval directives are handed down by the very same corporate entities they supposedly regulate. The government may not be able to sue itself, but to hell with all the corrupted special interests and persons within government whom deal that way. The people within government share no such immunity as they go about their daily tasks. They can and should be held liable.
Where as the most effective regulator is the people in a free market, where masses drive trends based on what actually works, rather than what is most profitable to the provider. Educate and protect yourself, and in turn save this entire country by understanding the difference. In a free market, the people choose. What is best for the people naturally comes to broader public awareness, because the people support the product and voluntarily pay for it. In a socialistic market, the choice is made for you and one has no choice but to subscribe. Then you get millions of dead people due to incompetent NIH policies which were formed around desire for more profit rather than care. Mandates are for communists.
There is already cures to cancer and many other ailments, which the FDA and their henchmen routinely chase down and harass anyone promoting the alternatives, because their corporate pharmasuetical bosses can not stand the idea their entire cancer care empire could be dismantled by something they could no longer patent and profit from. Dr Burnzynski with his anti neo plaston treatments out of Texas, curing brain tumors left and right. The Rife therapy and curing via wavelengths and frequency, saving the lives of people already diagnosed as terminal. That’s the Quantum Pulse Device, and you can rent or buy one to this very day from Gene Koonce up in Greeley Colorado. The Taheebo Tea, aka Paul De Arc, the incan miracle cure. Run From The Cure, the Rick Simpson story. Make anti cancer phoenix tears at home using a gallon of pure alcohol, a rice warmer, and of course, some hemp. That cbd you’re buying at the store, mostly likely is not full spectrum. Processing is what keeps the captured agencies in the drivers seat, everything has to be processed.
And such alternatives abound around the world, but such voices and treatments are silenced in the face of ‘regulatory agencies’. These agencies may have started out as public service utilities but have now transmorphed into captured agencies who’s core purpose is to protect the pharmasuetical and medical supplier establishment. The game is simple; Take effective treatments from nature, patent the substance and molecules, then resell them for gross markups as synthetics instead. Anything which can not be patented and resold as a synthetic is shelved and discredited without a moments concern.
Think back to when the FDA was proposing that regular vitamins be made illegal… These particular emperors have been naked for some time now, more than most people reading these articles may have been alive. These conflict of interest issues trace back to arguments against the FDA forming in the first place, as even well over a century ago, many wise Americans understood the government can not be a sound steward of health care and medicine. Here is a novel concept; FDA never had any authority in the first place because the very nature of government agencies controlling marketplaces is unconstitutional. As predicted, the agency now serves a monopolistic function to restrict access to competition, and the government now serves private interests rather than the best interests of the people in this regard. An inevitable conclusion of ongoing government expansion. Or as we like to say; The very last place we turn to for product safety advisement is the government.
Dr’s in Africa prescribe ivermectin as the first step for a multitude of different ailments. They call it the sunday pill or something, as it is effective against malaria and many other illnesses. The reason why Africans had lowest cases of covid and fewer deaths, a vast portion of the populace was already routinely taking ivermectin, as it’s an every day over the counter substance just like aspirin. Then one reviews the history of ivermectin, and how this substance has long since been known to also have a high probability of curing cancer. The old timey back channel preppers may recall how one of the miracle low priced solutions, in a hypothetical apocalypse scenario where public services broke down, was to stock up on certain aquarium products which contain ivermectin, as well as other farm products such as the pastes and washes meant for horses, sheeps, and other mammals.
Keep your colloidal silver up but don’t dare try to make that at home with a simple electro static process, or you’ll turn green. Lol, the bs stories the ‘regulators’ dream up to keep the people corralled into their systems. Back when our coins we used for everyday payments had real silver in them, everyone was far better protected because the entire populace absorbed silver through their skin, while paying for every day product transactions.
FYI, ivermectin like analogs and other malaria type drugs are produced dirt cheap in the third world in buckets and bathtubs for pennies on the gallon. If the postulations that cancer is a parasitic event are accurate, then you’ll better understand why the establishment does not want ivermectin being used as a cure all for other ailments, as it specifically targets parasites, even those on the sub micro scale… And now you know why the regulatory establishment chose profit over effective treatments and pushed back against ivermectin. The ignorant masses whom trust the government simply played the tune which was handed down for them to play. You are what you eat. Food is medicine. An apple a day keeps the Dr away. Thanks for reading the Vaccine Reaction blogs!
These things like Ivermectin, hydroxychloroquine, Fenbendazole and other antiparasitics prevent and treat cancer on the cheap. Can you imagine the money loss to the cancer industry?
America has lost its way. Whatever is prominent on the fake news is what the masses believe. There are millions of people who have no idea nor do they care, believe or have the time to research on their own what the outliers are saying. I first learned of the dangers of vaccines in 2000. I attended a conference Hosted by Concerned Women of America in Branson, Missouri, which is close to my home. There I heard my first testimony about vaccine injury. From that time on I did my research, found NVIC, Dr. Mercola and others that, thank God, are not afraid to speak truth and suffer persecution for it. I began my research immediately regarding the mRNA shot and Ivermectin even listening to a three-hour discussion with Dr. Robert Malone, Bret Weinstein and one other man, sadly I can’t remember his name. I asked our medical doctor who is part of one of our local hospital systems if he would prescribe Ivermectin. To my astonishment, he said yes, but only after a confirmed Covid 19 diagnosis. The next day the end of June of 2021, I tested positive and he prescribed Ivermectin for me and prophylactic for my husband. I do not believe that Dr. Fauci or many others will ever be prosecuted because they are too powerful, more than I believe, we realize. Yes and yes, it is all about money. No real care for the individual person, just like with routine vaccines. I believe that most sincere medical doctors, nurses and other healthcare professionals know the truth, but either fear persecution for stepping outside the box, desire the money, or they fear persecution for past injuries if they speak the truth. All stand in their way. One last statement…the specialty drug industry is a money making machine. They advertise non-stop on TV. One right after the other. Proof positive there is money. Note, the potential side effect risks are always more than with the seemingly one benefit of the drug itself. I have neighbors that didn’t hesitate to take the Covid 19 shot(s). If millions believe something…better take the road least traveled before jumping on the bandwagon. The real heroes in the Covid19 pandemic are those who have stood strong and told the truth. I give my sincere gratitude to The Frontline Doctors, Dr. Mercola, Dr. McCullough, NVIC and many doctors in our own areas that were willing to follow the Covid19 protocol apart from the shot. Thank you all and God bless your courage.