Wednesday, April 03, 2024

Doctors Force FDA To Remove False Statements About Ivermectin

The U.S. Food and Drug Administration (FDA) has agreed to remove social media posts and webpages that urged people to stop taking ivermectin to treat COVID-19, according to a settlement dated March 21

The FDA has already removed a page that said:

“Should I take ivermectin to prevent or treat COVID-19? No.”

Within 21 days, the FDA will remove another page titled, “why you should not use ivermectin to treat or prevent COVID-19,” according to the settlement announcement, which was filed with federal court in southern Texas.

“The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals,” the page currently states. It also says that data do not show ivermectin is effective against COVID-19, despite how some studies it cites show ivermectin is effective against the illness.

The FDA in the settlement is also agreeing to delete multiple social media posts that came out strongly against ivermectin, including one that stated:

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

In exchange, doctors who sued the agency are dismissing their claims, the filing states.

“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history,” Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”

“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” added Dr. Paul Marik, chief scientific officer of the FLCCC Alliance and another plaintiff.

“The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”

An FDA spokesperson told The Epoch Times in an email that the agency:

“has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”

“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said.

“FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”

Ivermectin was approved by the FDA in 1996 to treat several conditions, including onchocerciasis, a tropical disease caused by a parasitic worm.

In the United States, it’s common for doctors to prescribe medicine off-label, or for a different purpose than the one for which the medicine is approved.

After some doctors began prescribing ivermectin for COVID-19, the FDA ramped up its campaign, including the Aug. 21, 2021, post on Twitter, now known as X.

Dr. Bowden and two other doctors sued the FDA, arguing the agency’s actions went beyond its authority, as conferred on it by Congress.

U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling that the FDA did not act outside the authority. But an appeals court in 2023 ruled in favor of the doctors, finding that the agency “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
Between the time of the ruling and the settlement, the FDA refused to change any of its statements on ivermectin, and asked for a fresh dismissal of the suit.

The Case

Drs. Robert Apter, Bowden, and Marik brought the case in 2022. They said they suffered repercussions after prescribing ivermectin to patients with COVID-19, and that the FDA was to blame.

Dr. Apter, for instance, said that pharmacists refused to fill the prescriptions, citing the FDA.

“This refusal delays his patients in obtaining their prescribed treatment—when early intervention is paramount—while they look for a pharmacy to fill their prescription, if they can find one at all,” the suit states.

He also said that insurance companies were refusing to pay for ivermectin to treat COVID-19.

The suit said the FDA illegally interfered with the relationships between the doctors and patients. The doctors said with regard to ivermectin, the FDA overstepped the authority conferred on it in the Federal Food, Drug, and Cosmetic Act.

Government lawyers argued that the FDA was acting within the confines of the law, and succeeded in getting the dismissal.

Judge Brown, appointed under President Donald Trump, said the FDA’s powers were only limited with regard to medical devices.

“As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he wrote in his ruling. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.”

A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit disagreed, finding that the law did not authorize the FDA to give medical advice.

“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, appointed under President Trump, wrote for the court.

The appeals court remanded the case back to the district court.


Another Outlandish Overreach by the CDC

Easter weekend was lovely in every way.

And yet I could not stop thinking about the strange manner in which the Centers for Disease Control and Prevention (CDC) has had such an outsized role in the ruination of American rights and liberties. This agency is supposed to be tracking infectious disease and finding ways out. This mandate became the leverage to allow them to impose nationwide mask mandates, a rental moratorium, a shutdown of the cruise industry, and otherwise send the whole country into fits of hysterics for two years and more.

So it occurred to make an inquiry into how the CDC handles questions of election processes. This is rather important in a democracy. This is how we select our leaders and the central way in which we can claim that the people have some influence over the regime that rules us. It is because of elections that we can claim to be better than ancient despotisms or medieval feudalism. We rule ourselves through the vote. That’s the whole idea.

As it turns out, the CDC had quite a large role in guiding election processes. Not that you can find the evidence on their website now. Nope, it’s all been scrubbed. However, if you look at the Wayback Machine, you can find an interesting little point. The CDC strongly recommended mail-in, absentee, and early voting as a means of disease control.

The theory was that people gathering in a polling place would be a super-spreader event. What science did they cite to demonstrate this? None at all. So far as I know, and I’ve looked far and wide, there is not a single study anywhere that purports to show some relationship between disease spread and in-person voting. The CDC just made that up... for whatever reason.

The day was March 12, 2020. This was the same day that President Trump went on national television in the evening to announce that there would be no more travel from the United States to Europe, the UK, and, later, Australia and New Zealand. He further said that all Americans living abroad needed to come home right away or be stuck.

That was a pretty shocking announcement. Nothing like this had ever happened in American history, not even this broadly in wartime. It seemed to come out of nowhere, our rights to travel suddenly deleted.

It seems that President Trump was following the advice of his scientific advisors who later turned out to be snake oil salesmen. Indeed, he seemed extremely uncomfortable making this announcement, almost like he knew that it was weird and probably unwarranted. Strange night.

As it turns out, earlier that day, the CDC decided that the whole country really ought to be voting by mail. They went into the website and edited the page that very day and produced the following checklist.

You can see for yourself at the Archive link. So far, the CDC has not proven itself powerful enough to scrub also its bread crumbs from the archive source, not yet in any case. The time might come. If they succeed, their role in creating the biggest voting scandal in a hundred years might never have been known by future generations.

There is simply no way that the CDC could not have known about the uncertainties and vagaries created by absentee ballots. They are banned by half the countries in the world for that reason. Those that do allow them govern them very strictly. You have to request a ballot. They are sent to your home. You have to provide extensive identity verification. You have to have a darn good excuse. It’s only for hardship cases and never the norm.

It was the CDC that decided to throw all that in the trash. Who even cares about the whole history of democracy, because, after all, there is a virus floating around! It’s amazing that this happened. But just as amazing is the idea of throwing out property rights, which they also did. But there it is.

To be sure, they could not actually force this result. But they sure could grant some scientific heft behind the idea. It also helped that only 10 days later, the U.S. Congress voted $2 trillion in payments to the states, a portion of which was to implement CDC recommendations. Most states were happy to do so, again, with full knowledge that this strategy would yield results that were sketchy at best.

As it turns out, of course, it was the mail-in ballots that might have made the difference in the election, or seemed to in any case. Everything got so much mixed up that it’s hard to say. And it’s not like people did not have warning signs of trouble. The primary season of that spring and summer yielded a slew of controversies about what was and was not true. There were more than enough controversies swirling about by the time of the general election.

The crucial point here is that the CDC massively overstepped the bounds of its mandate by intervening in the processes by which Americans select its leaders, strongly pushing a method that was a known source of fraud. Nor has the CDC ever been held to account for this, not to my knowledge in any case.

They were sued over the rent moratorium and the evil nationwide mask mandate. They lost both cases. But there has been no litigation against the CDC for disrupting the whole system by which we regulate elections. One might suppose that if an executive agency were to do something like this, they would have needed some permission from somebody. Surely such a gigantic change would and should require more than a low-level employee with logins to change a website text.

Speaking of which, who actually did this and why? Aren’t these interesting questions? Why is no one asking them? Where are the investigations? Where is the outrage?




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