FDA shamed in court on Ivermectin - after a million dead Americans as a result

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The FDA has been shamed in court for their 3 year evil, irrational, vendetta against cheap generic ivermectin (and HCQ) protocols, even though competent treating physicians have been near 100% successful in early treatment of their elderly and high-risk COVID patients, ever since March of 2020.

See also the forum thread: Big Pharma's propaganda ministry, the FDA, horses around with IVM as COVID cure
https://www.covid-19forum.org/index.php?topic=1564.0

The three doctors mentioned in the following article that sued the FDA, are Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik. Certainly no bit players with Dr. Paul Marik having the #2 Critical Care and Emergency Medicine World Ranking.
See the forum thread: Meet a few of the medical professionals that we rely on for forum information
https://www.covid-19forum.org/index.php?topic=1554.0

The original forum thread from November 2020 on IVM: Ivermectin treatment is a ‘real killer of coronavirus’ - a "wonder drug"
https://www.covid-19forum.org/index.php?topic=461.0
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This article
https://www.westernjournal.com/fda-forced-walk-back-smug-anti-ivermectin-post-makes-huge-admission-drug/

"FDA Forced to Walk Back Smug Anti-Ivermectin Post, Makes Huge Admission About the Drug
 By Warner Todd Huston  August 12, 2023 at 1:08pm

After years of denigrating ivermectin as dangerous and as “horse medicine,” the U.S. Food and Drug Administration has been forced to retreat on its all-out attack on the medicine after three doctors sued the agency in federal court for impeding their right as medical providers to prescribe the medicine to their patients.

The FDA made a key admission in court during an Tuesday proceeding in which lawyers for the doctors asked the Fifth Circuit Court of Appeals whether doctors have a right to prescribe ivermectin since the FDA approved the drug for use in humans way back in 1986.

So, what was the FDA’s shocking admission?

“FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID,” Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said on Tuesday during the oral arguments in the case, the Epoch Times reported.

This seems to be a major retreat from the agency’s former antagonism toward the drug and the right of doctors to prescribe it.

Readers may recall that once the pandemic was in full swing, some doctors began reporting anecdotal evidence that ivermectin seemed to help some patients avoid or ease the symptoms of the coronavirus. But almost immediately, the FDA jumped into high gear to destroy the reputation of the drug and to persuade doctors to avoid prescribing it, discouraging pharmacies from selling it even with a doctor’s prescription.

In fact, the FDA was so adamant to stop people from considering the drug that it launched a cynical effort to label it “horse medicine” and, therefore, unfit for use in humans.

In reality, not only has ivermectin long been used in humans to treat several common infections, diseases, and ailments, but long before the pandemic began, its positive impact on the third world was so profound that the scientists who developed it won a Nobel Prize for the drug in 2015.

“Diseases caused by parasites have plagued humankind for millennia and constitute a major global health problem,” the Nobel Assembly at Karolinska Institutet wrote in 2015. “In particular, parasitic diseases affect the world’s poorest populations and represent a huge barrier to improving human health and well-being.”

So, the fact is, ivermectin has been used in humans for decades. Yes, the same style drug is also used in veterinary medicine, but it is not exclusively for animals, despite the FDA’s attempt to paint it as such.

Certainly, that laudatory history did not stop the FDA from its illicit campaign to cajole Americans into thinking that ivermectin is only for horses and cows.

The FDA even took to Twitter in August 2021 to blast the drug, writing, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

    You are not a horse. You are not a cow. Seriously, y’all. Stop it. https://t.co/TWb75xYEY4

    — U.S. FDA (@US_FDA) August 21, 2021

It was that post that doctors said amounts to illegal government interference in their right to prescribe ivermectin for their patients — especially since the FDA itself had years ago approved the drug for use in humans here in the U.S.A.

This case was originally dismissed by a Trump-appointed judge in 2022, but the doctors appealed to the Fifth Circuit, and that case was heard last week.

“The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no,” Jared Kelson, who is representing the doctors, told the appeals court, according to Courthouse News.

The doctors added that when the FDA told people to “stop it,” that amounted to a demand from a government health agency to stop prescribing, using, and selling ivermectin. And in many cases, that is exactly how doctors, hospitals and pharmacies took it — as a command to ban the drug issued by a government agency.

The agency also posted a long, involved warning to its website with an article entitled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.”

The FDA, though, claimed that with its offhanded tweet they were just trying to issue a “quippy tweet meant to share its informational article” and the “stop it” command was just a fun way to relay their concerns about the drug, the Epoch Times reported.

The tweet and its other statements “don’t prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose,” FDA lawyer Honold told the court.

“FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So they are not interfering with the authority of doctors to prescribe drugs or to practice medicine,” Honold added.

The judges were not convinced that the FDA was merely trying to inform and wasn’t launching a war against ivermectin.

“What about when it said, ‘No, stop it’?” asked Circuit Judge Jennifer Walker Elrod. “Why isn’t that a command? If you were in English class, they would say that was a command.”

The plaintiffs added that the FDA has never been allowed to offer medical advice, and they said the FDA’s actions to undermine ivermectin is exactly that. The FDA, the lawyers said, didn’t just offer information, they actively offered advice to “stop” using the drug.

This was a point that most of the judges on the panel seemed inclined to agree with. Judge Edith Brown Clement, for instance, said, “You’re not authorized to give medical advice.”

Whatever the government agency meant then, it is clear that now the FDA has quietly rewritten its “information” page to eliminate much of the overly alarming rhetoric. Its new page is far more dispassionate about the use of ivermectin and is couched far more in scientific and medical terms.

Indeed, on its original page, the FDA used phrases like “can cause serious harm” and “please beware,” called use of the drug an “unconventional treatment,” and repeatedly said it was for animals and not for use “in humans.” In short, the original page was filled with words and phrases meant to scare people away from the drug and tried to convey that it was really only for animals and could be dangerous for humans. Much of that language, though, is now gone in the updated page.

The new page also added a line at the end, saying, “Talk to your health care provider about available COVID-19 vaccines and treatment options. Your provider can help determine the best option for you, based on your health history.” It is a line that can now be construed to mean that the FDA is leaving the use of ivermectin up to your doctor. This is a line that was entirely absent in the original post.

This about-face is just another example of how the medical elites and the federal government are quietly and slowly backing away from the extreme statements and polices floated during the worst of the pandemic years. It’s another admission that much of what Biden’s regime was telling us about COVID was simply false.

No wonder fewer and fewer people every year trust what the government tells us, or for that matter, even trust what the “experts” say."

https://www.westernjournal.com/fda-forced-walk-back-smug-anti-ivermectin-post-makes-huge-admission-drug/

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https://www.courthousenews.com/ivermectin-proponents-ask-fifth-circuit-to-revive-lawsuit-against-fda/

"Ivermectin proponents ask Fifth Circuit to revive lawsuit against FDA

A government attorney likened the FDA’s warnings against treating Covid with ivermectin — a livestock dewormer approved in lower doses for human ailments — to its advice not to eat chicken cooked in NyQuil.
Cameron Langford / August 8, 2023

Forum Admin: How stupid or how much of an evil liar does that demonstrate the government attorney is and the quality our courts have degenerated to? To liken a doctor prescribing ivermectin - who would be familiar with IVM as one of the safest drugs on the planet, through billions of doses having been prescribed for humans for over 35 years, available over the counter in many free countries (and in Tennessee) - prescribing Ivermectin off label (as 40% of all medicines are), to some clown in their home kitchen cooking chicken with NyQuil? Is that the epitome of stupidity? Unfortunately it cannot be excused that easily. It's just more of the same Big Pharma/U.S. government/media collusion, that Americans have been victims of ever since early spring of 2020, that resulted in the completely unnecessary deaths of a million Americans and millions more worldwide, whose governments and public health officials were so weak that they blindly followed Fauci's and NIH, FDA, and CDC Big Pharma profiting lead, rather than that of near 100% successful early treating physicians ever since spring of 2020.
But blessedly, not all countries acted that stupidly.
https://www.covidtreatmentoptions.com/

(CN) — Counsel for three doctors who prescribe ivermectin to treat Covid-19 told the Fifth Circuit on Tuesday the Food and Drug Administration overstepped its authority with a public information campaign against taking the drug.

The widespread illness and deaths attributed to Covid-19, the respiratory illness caused by the coronavirus, have spawned some dubious treatment ideas.

Then-President Donald Trump infamously suggested in an April 2020 press briefing that injecting bleach might be a viable option to clear the virus out of one’s lungs.

That same month, a group of Australian medical researchers published the results of a study they concluded showed ivermectin — a drug used to treat and prevent parasites in horses and cows and approved by the FDA to get rid of parasitic worms in people — inhibits replication of the coronavirus.

The FDA has also authorized using the drug topically to treat head lice and skin conditions like rosacea.

But after receiving numerous reports of people ending up in the hospital after taking large doses of over-the-counter ivermectin intended for livestock, the FDA launched a public awareness initiative.

It published an advisory titled “Why You Should Not Use Ivermectin to Treat or Prevent Covid-19,” and sent letters to the Federation of State Medical Boards and National Association of Boards of Pharmacy directing them to read the missive.

It also spread the message on social media with pithy posts such as, “Ivermectin is only a horse dewormer. Don’t use a veterinary product to treat Covid-19,” and “You are not a horse. You are not a cow. Seriously, y'all. Stop it,” accompanied by juxtaposed photos of a veterinarian hugging a horse and a doctor examining a patient.

Three doctors who became proponents of ivermectin and prescribed it off-label to thousands of Covid patients sued the FDA, the Department of Health and Human Services and the agencies’ chiefs in Galveston federal court in June 2022.

They claim the FDA exceeded its authority and violated the Administrative Procedure Act by interfering with their practice of medicine, regulation of which, they argue, is the province of states.

One of the plaintiffs was referred to the doctor regulatory boards of Washington state and Arizona for disciplinary proceedings for prescribing the drug to treat Covid. Another was forced to resign her privileges by a Houston hospital system.

U.S. District Judge Jeffrey Brown, a Trump appointee, dismissed the lawsuit this past December. He determined plaintiffs’ allegations did not defeat the government’s sovereign immunity.

The doctors appealed to the Fifth Circuit and a panel of the New Orleans-based appellate court heard arguments Tuesday.

“The fundamental issue is straightforward,” the challengers’ attorney Jared Kelson of the Washington firm Boyden Gray & Associates began.

“After the FDA approves a human drug for sale, does it then have the authority to influence or interfere with how that drug is used within the doctor-patient relationship? The answer is no,” he added.

Kelson said the fact that these physicians are prescribing ivermectin off-label — for different purposes than the FDA has approved — makes no difference because federal law bars anything that would even deter off-label use, evidenced by the fact that nearly 40% of all U.S. prescriptions are for off-label use.

“That’s a bright line the FDA cannot cross,” Kelson stated.

But Justice Department attorney Ashley Honold argued that line between lawful FDA guidance on drugs and unlawful interference with doctors’ prescribing practices is not as clear-cut as the plaintiffs contend.

She characterized the agency’s ivermectin warnings as informational statements, and stressed they are not regulations, they have no legal consequences, and they don’t bar doctors from prescribing ivermectin to treat Covid or for any other purpose.

U.S. Circuit Judge Don Willett, a Trump appointee, pressed Honold to define the limits of the FDA’s jurisdiction.

“You concede the FDA has no authority to issue medical advice, correct? That is not arguable, right? The FDA cannot issue medical advice,” he said.

“No, your honor,” Honold replied. “The government is not conceding that in this case.”

She said when people are using drugs in unsafe ways, leading to hospitalizations, it “is not only permissible, it is imperative that the FDA be able to inform the public of its scientific views about safe uses of drugs.”

For example, Honold said, the FDA recently issued advisories warning people it is not safe to eat chicken cooked in the cough syrup NyQuil — a recipe that spread on the social media app TikTok. And in 2014, Honold noted, the FDA cautioned against using lidocaine off-label as a numbing agent for teething babies because it can cause seizures and deaths for them.

“The FDA has to be able to make these kinds of public safety statements. Under plaintiffs’ theory, FDA would not be able to communicate to the public in this way,” Honold argued.

At the end of the 40-minute hearing, U.S. Circuit Judge Jennifer Walker Elrod, a George W. Bush appointee, asked Kelson to address the government’s contention that a ruling in his clients’ favor could gut the FDA’s ability to warn the public about dangerous drug use.

Kelson insisted the agency had gone too far with ivermectin.

“The doctors have not challenged the FDA’s authority to communicate when they receive adverse medical reports. It’s when they step beyond that and tell people how they should or should not be using approved drugs,” he said.

Senior U.S. Circuit Judge Edith Clement Brown, another George W. Bush appointee, rounded out the panel. The judges did not say when they would rule on the appeal."

[admin]

https://www.prnewswire.com/news-releases/doctors-sue-fda-over-unlawful-attempts-to-prohibit-ivermectin-use-301560501.html

Doctors Sue FDA Over Unlawful Attempts to Prohibit Ivermectin Use

Published: Jun 02, 2022
     
GALVESTON, Texas, June 2, 2022 /PRNewswire/ -- Boyden Gray & Associates PLLC -- Today, a group of doctors filed a lawsuit against the Department of Health and Human Services, Xavier Becerra in his official capacity as Secretary of Health and Human Services, the Food and Drug Administration, and Robert M. Califf in his official capacity as Commissioner of Food and Drugs, over the FDA's unlawful attempts to prohibit the use of ivermectin to treat COVID-19.

The plaintiffs, Drs. Robert L. Apter, Mary Talley Bowden, and Paul E. Marik argue the FDA acted outside of its authority and illegally interfered with their ability to practice medicine by directing the public, including health professionals and patients, to not use ivermectin, a drug that has received full FDA approval for human use.

Dr. Mary Bowden responded to today's filing, stating: "Since the pandemic began, I have had one mission - help my patients. I provided access to testing when testing was hard to find. I provided treatment when other doctors told my patients to stay home. I have kept over 3,900 patients out of the hospital, but it hasn't been easy. Sadly, fighting the system has been a much bigger challenge than fighting the disease. Despite my excellent track record treating COVID patients, the FDA's smear campaign against ivermectin continues to be a daily hurdle to overcome. I am fighting back - the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship."

"If doctors are freed to treat patients according to their best judgment and unprejudiced evaluation of the medical literature, many thousands more deaths and serious disabilities will be averted," said Dr. Robert Apter. "Pronouncements from the FDA against the use of ivermectin have been the basis for disciplinary actions against doctors, interfere with the doctor-patient relationship, and have had a severe chilling effect on the use of life-saving medication for a deadly disease."

"The FDA's public statements on ivermectin have been misleading and raised unwarranted concern over a critical drug in preventing and treating COVID-19. The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19. To do this is to ignore both statutory limits on the FDA's authority and the significant body of scientific evidence from peer-reviewed research, over 80 medical trials, and results from ivermectin's use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19," said Dr. Paul Marik.

The full complaint can be viewed here.

SOURCE Boyden Gray & Associates PLLC

https://www.prnewswire.com/news-releases/doctors-sue-fda-over-unlawful-attempts-to-prohibit-ivermectin-use-301560501.html

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All pharmacies that refused to dispense ivermectin or hydroxychloroquine that was prescribed by a physician, should be sued into bankruptcy by the survivors of those that died or are struggling with long COVID or other injury as a result.