Ivermectin, again...

[Jolly]

From Epoch Times:

Doctors are free to prescribe ivermectin to treat COVID-19, a lawyer representing the U.S. Food and Drug Administration (FDA) said this week.

"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 during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.

The government is defending the FDA's repeated exhortations to people to not take ivermectin for COVID-19, including a post that said "Stop it."

....

The case was brought by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements. A federal judge dismissed the case in 2022, prompting an appeal.

"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, representing the doctors, told the appeals court.

The FDA on Aug. 21, 2021, wrote on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” The post, which linked to an FDA page that says people shouldn't use ivermectin to prevent or treat COVID-19, went viral.

In other statements, the FDA said that ivermectin "isn’t authorized or approved to treat COVID-19" and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Command or Not..

"FDA made these statements in response to multiple reports of consumers being hospitalized, after self medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription," Ms. Honold said.

A version of the drug for animals is available, but ivermectin is approved by the FDA for human use against diseases caused by parasites.

Ms. Honold said that the FDA didn't purport to require anyone to do anything or to prohibit anyone from doing anything.

"What about when it said, 'No, stop it'?" Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked. "Why isn't that a command? If you were in English class, they would say that was a command." Ms. Honold described the statements as "merely quips."

...

"Can you answer the question, please? Is that a command, 'Stop it'?" Judge Elrod asked.

"In some contexts, those words could be construed as a command," Ms. Honold said. "But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command."

The statements "don't prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose" Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the

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," she said.

Judge Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.

Federal Law..

The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA's statements, including being terminated over efforts to prescribe ivermectin to patients.

Dr. Marik has noted that a number of studies support using ivermectin against COVID-19, as the FDA itself has acknowledged. Some other studies show little to no effect.

Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.

"This is something the FDA has never been able to do. And it's a bright line," he told the court, adding later: "The clearest examples of where they have gone over the line are when they say things like, 'You are not a horse, you are not a cow. Seriously, y'all. Stop it.'"

[George K]

Two years later, we're still litigating this?

I don't have much of a problem with docs prescribing off-label use of drugs. Look no farther than the explosion of Ozempic for that.

But, I've yet to read a study that shows that ivermectin, though safe, and largely without serious side effects, is of any benefit in treating COVID-19.

If a doc were to prescribe insulin to treat a foot infection, that would certainly be off-label, but it wouldn't be justified.

[Jolly]

Can docs prescribe off-label?

That seems to be the underlying issue.

[George K]

@Jolly said in Ivermectin, again...:

Can docs prescribe off-label?

That seems to be the underlying issue.

Yes, they can, and do. Goodness knows, I've given drugs off-label. And, as you say, that's what this case is about.

But, because you can doesn't mean you should.

[Jolly]

True.

But in this and others, I do not want Ax's benevolent government dictating medical treatment.

[George K]

@Jolly said in Ivermectin, again...:

I do not want Ax's benevolent government dictating medical treatment.

Yah, let the insurance companies decide!

[Jolly]

I hold them in almost as much contempt as the government.

Most missed the actual point of much of the article I posted recently, where it stated that a large portion of senior medical debt is due to insurance companies manipulating the provider/payer system.

[kluurs]

@George-K said in Ivermectin, again...:

Yah, let the insurance companies decide!

i.e. Our current system of death panels.

[Axtremus]

@Jolly said in Ivermectin, again...:

But in this and others, I do not want Ax's benevolent government dictating medical treatment.

Supposedly your "others" do not include pregnancy termination or gender change related treatments.

[Jolly]

@Axtremus said in Ivermectin, again...:

@Jolly said in Ivermectin, again...:

But in this and others, I do not want Ax's benevolent government dictating medical treatment.

Supposedly your "others" do not include pregnancy termination or gender change related treatments.

The first rule of medicine is do no harm.

I don't consider murder and mutilation valid medical treatments.

[Doctor Phibes]

@Jolly said in Ivermectin, again...:

True.

But in this and others, I do not want Ax's benevolent government dictating medical treatment.

OK, but how do we stop crazy doctors prescribing stuff that doesn't make any sense?

At some point somebody has to be able to say "Hey, this guy doesn't know what the fuck he's doing", even if he does have a medical degree.

[Jolly]

@Doctor-Phibes said in Ivermectin, again...:

@Jolly said in Ivermectin, again...:

True.

But in this and others, I do not want Ax's benevolent government dictating medical treatment.

OK, but how do we stop crazy doctors prescribing stuff that doesn't make any sense?

At some point somebody has to be able to say "Hey, this guy doesn't know what the fuck he's doing", even if he does have a medical degree.

How do you stop them? You don't.

If they are too far out of line the tort system will catch up with them.

[Copper]

And most of our legal resources are tied up with the various Trump cases.

[Axtremus]

@Jolly said in Ivermectin, again...:

I don't consider murder and mutilation valid medical treatments.

So you want the benevolent government to prescribe what qualifies as a “valid medical treatment.”

[Jolly]

Did you get your ass whipped much as a kid?