Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging

[ThatRobGuy]

Federal appeals court revives lawsuit against FDA over COVID-19 ivermectin messaging

A federal appeals court ruled Friday that a lawsuit against the Food and Drug Administration (FDA) over its campaign against the use of ivermectin to treat COVID-19 can continue, reversing a lower …

thehill.com

A federal appeals court ruled Friday that a lawsuit against the Food and Drug Administration (FDA) over its campaign against the use of ivermectin to treat COVID-19 can continue, reversing a lower court decision.

Three doctors sued the FDA last year claiming that the agency’s anti-ivermectin campaign went too far, overstepping its authority and acting more as a medical body than a regulator.


A district court ruled that the suit could not continue, but the 5th Circuit Appeals Court revived the doctors’ hope in its Friday ruling, sending the case back to a lower court where it will be reconsidered.

“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett wrote for the appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”


I've been clear about my position that I don't think Ivermectin was a suitable treatment for covid, nor do I think it was a valid replacement for the vaccine in terms of a prophylactic measure. However, I agree with the court's ruling on this one. Putting out misleading messaging about the nature of the drug, combined with trying to smear anyone who promoted it, did step over a line.

 

[FireDragon76]

The hype around ivermectin was causing genuine supply problems for people that actually needed it.

 

[Tropical Wilds]

The FDA’s job is to inform and protect the public from false medical information related to the use of medications and combat misinformation about medication application. Based off what was information spread by non-medical professionals, enough people were engaging in the off-label, unsafe dosing of a medication and/or taking the incorrect version of a drug outside of medical supervision that it was the FDA’s responsibility to combat the misinformation. Given that the WHO also gave a safety statement because there was a 400% increase in reported Ivermectin-related injuries from 2019 to 2020 and a 500% increase from 2019 to 2021, the FDA did exactly as they should have done in the situation.

Just like the CDC spoke out about eating Tide Pods and the FDA made a statement against injecting yourself with bleach or taking Miracle Mineral Solution, they identified a trend based off of the reports of injury and made a statement that people shouldn’t be doing it.

 

[ThatRobGuy]

The FDA’s job is to inform and protect the public from false medical information related to the use of medications and combat misinformation about medication application. Based off what was information spread by non-medical professionals, enough people were engaging in the off-label, unsafe dosing of a medication and/or taking the incorrect version of a drug outside of medical supervision that it was the FDA’s responsibility to combat the misinformation. Given that the WHO also gave a safety statement because there was a 400% increase in reported Ivermectin-related injuries from 2019 to 2020 and a 500% increase from 2019 to 2021, the FDA did exactly as they should have done in the situation.

Just like the CDC spoke out about eating Tide Pods and the FDA made a statement against injecting yourself with bleach or taking Miracle Mineral Solution, they identified a trend based off of the reports of injury and made a statement that people shouldn’t be doing it.

One of the big questions, are regulatory agencies allow to use their own dishonest information in order to combat misinformation?

One of the things cited in the article stems from their statements that were clearly implying that Ivermectin was primarily a veterinary medicine (which obviously isn't true, over 200 million people took the drug, annually, prior to covid), and the case was brought by 3 doctors who were punished for prescribing it (the human drug, in human-safe doses).


With the Tide Pod analogy, if they identified a trend of a bunch of dumb kids eating it for some social media challenge, are they allowed to lie about what the nature of detergent pods are, or punish people who use laundry detergent for cleaning purposes outside of clothes in order to hammer the point home? Or are regulatory agencies still tasked with being honest about the nature of issues?

 

[FireDragon76]

One of the big questions, are regulatory agencies allow to use their own dishonest information in order to combat misinformation?

One of the things cited in the article stems from their statements that were clearly implying that Ivermectin was primarily a veterinary medicine (which obviously isn't true, over 200 million people took the drug, annually, prior to covid), and the case was brought by 3 doctors who were punished for prescribing it (the human drug, in human-safe doses).

The Ivermectin being sought during the pandemic was often veterinary formulations, so it's not wrong to describe ivermectin as a veterinary medication, because it is.

 

[wing2000]

However, I agree with the court's ruling on this one. Putting out misleading messaging about the nature of the drug, combined with trying to smear anyone who promoted it, did step over a line.

Do you have any other examples of the FDA's messaging?

From the linked article:
The FDA’s campaign, which included viral signs reading “You are not a horse,” emphasized agency recommendations that ivermectin — an anti-parasite medication often used for horses but sometimes prescribed to humans — should not be used to treat COVID-19.

As I recall, many people were purchasing and consuming invermectin intended for horses.

 

[ThatRobGuy]

The Ivermectin being sought during the pandemic was often veterinary formulations, so it's not wrong to describe ivermectin as a veterinary medication, because it is.

Amoxicillin is also a drug that's used in both humans and animals...

If people were using that off-label for something, would the FDA be able to say, in a blanket fashion, "you're not a dog, don't take it"? Or should their job still be to explain the risk of both off-label use and non species-appropriate use?


To clarify, them cautioning is fine. It's the less-than-honest messaging campaign that seems to be the sticking point for this case.

There's lots of off-label uses of drugs happening today that are risky and should have more information provided so that people understand those risks, but the CDC & FDA don't get to lie about it.


Without going off too far in the weeds or derailing into another topic...
Hormone blockers are being used in an off-label fashion, something that comes with risks.

Should the FDA/CDC simply inform and provide caution where needed? Or should they make a tweet saying "You're not a 53 year old woman with breast cancer, don't take the stuff"?

 

[FireDragon76]

Amoxicillin is also a drug that's used in both humans and animals...

If people were using that off-label for something, would the FDA be able to say, in a blanket fashion, "you're not a dog, don't take it"? Or should their job still be to explain the risk of both off-label use and non species-appropriate use?

People shouldn't be ordinarily consuming drugs formulated for non-humans. The government has a responsibility to warn people about the risks and dangers of doing so, and to generally discourage the consumption of non-human drugs. That isn't lying or dishonest.

 

[ThatRobGuy]

Do you have any other examples of the FDA's messaging?

From the linked article:
The FDA’s campaign, which included viral signs reading “You are not a horse,” emphasized agency recommendations that ivermectin — an anti-parasite medication often used for horses but sometimes prescribed to humans — should not be used to treat COVID-19.

As I recall, many people were purchasing and consuming invermectin intended for horses.

Unfortunately, I don't know that we'd be able to find good information on the percentage of people taking the human version vs. the veterinary version.

However, what initially sparked the CDC/FDAs response was observing trends from retail pharmacies (in mid-August 2021)
Prescriptions for ivermectin have seen a sharp rise in recent weeks, jumping to more than 88,000 per week in mid-August from a prepandemic baseline average of 3,600 per week, according to researchers from the Centers for Disease Control and Prevention.

...and a few days later is when they released this:

So their Aug 21st release, based on the timing, was seemingly a response to (or possibly amid) the rapid increase they saw among people getting prescriptions for the human form from retail pharmacies. It's possible that the two forms of incorrect use were increasing simultaneously. But given that they were seeing 88k prescriptions filled per week, I think it's safe to assume a fair number of people were consuming the human version at human appropriate doses as they wouldn't be going to their doctor for an Rx and getting it filled at Walgreens for the "horse paste" version.

 

[ThatRobGuy]

People shouldn't be ordinarily consuming drugs formulated for non-humans. The government has a responsibility to warn people about the risks and dangers of doing so. That isn't lying.

Right...but there's a difference.

"Don't take veterinary Ivermectin"
vs.
"Ivermectin is for horses"

...aren't the same thing.

 

[FireDragon76]

Ivermectin's use in treating human disease was restricted to Lyme disease, besides parasite infections.

The notion that it is useful for COVID rests on poor evidence. The fact people were taking it was evidence enough the government needed to keep messaging the importance of following actual science-based medical advice.

The "ivermectin is horse medicine" is meant to ridicule the notion that somehow ivermectin is an appropriate human treatment for COVID-19. Which is accurate and good and effective messaging.

 

[ThatRobGuy]

Ivermectin's use in treating human disease was restricted to Lyme disease, besides parasite infections.

The notion that it is useful for COVID rests on poor evidence. The fact people were taking it was evidence enough the government needed to keep messaging the importance of following actual science-based medical advice.

I'm not disputing that...

Nor am I suggesting that they should've had no messaging surrounding it. The appeals court ruling was based on the notion that the regulatory agencies have certain lines they have to stay within, and lying in order to discourage a behavior steps outside of those lines.


For instance, public health agencies are perfectly justified in cautioning people about risks associated with eating too much cake. What they shouldn't be doing is lying about it (via hyperbole and exaggeration) in order to dissuade that behavior.

 

[FireDragon76]

Right...but there's a difference.

"Don't take veterinary Ivermectin"
vs.
"Ivermectin is for horses"

...aren't the same thing.

I'm not disputing that...

Nor am I suggesting that they should've had no messaging surrounding it. The appeals court ruling was based on the notion that the regulatory agencies have certain lines they have to stay within, and lying in order to discourage a behavior steps outside of those lines.


For instance, public health agencies are perfectly justified in cautioning people about risks associated with eating too much cake. What they shouldn't be doing is lying about it (via hyperbole and exaggeration) in order to dissuade that behavior.

I don't see it as lying. Just a dramatic form of messaging that hammers home that the drug isn't approved to treat COVID-19 in humans, and there's no good medical evidence it is effective.

 

[wing2000]

Unfortunately, I don't know that we'd be able to find good information on the percentage of people taking the human version vs. the veterinary version.

However, what initially sparked the CDC/FDAs response was observing trends from retail pharmacies (in mid-August 2021)
Prescriptions for ivermectin have seen a sharp rise in recent weeks, jumping to more than 88,000 per week in mid-August from a prepandemic baseline average of 3,600 per week, according to researchers from the Centers for Disease Control and Prevention.

...and a few days later is when they released this:
View attachment 335631

So their Aug 21st release, based on the timing, was seemingly a response to (or possibly amid) the rapid increase they saw among people getting prescriptions for the human form from retail pharmacies. It's possible that the two forms of incorrect use were increasing simultaneously. But given that they were seeing 88k prescriptions filled per week, I think it's safe to assume a fair number of people were consuming the human version at human appropriate doses as they wouldn't be going to their doctor for an Rx and getting it filled at Walgreens for the "horse paste" version.

Clearly, there was a need for public health messaging as I also recall at least one account of a person dying after taking dosages intended for a horse. As you note, however, the court isn't questioning the need for public health messaging. They are questioning the messaging used by the FDA:


“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett wrote for the appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

That's a pretty find line the Judge is attempting to draw. The subtext of the "You are not a horse...." social media post notes: "Using the drug Ivermectin to treat COVID-19 can be dangerous and even lethal. The FDA has not approved the drug for that purpose."

 

[FireDragon76]

Clearly, there was a need for public health messaging as I also recall at least one account of a person dying after taking dosages intended for a horse. As you note, however, the court isn't questioning the need for public health messaging. They are questioning the messaging used by the FDA:


“FDA is not a physician. It has authority to inform, announce, and apprise — but not to endorse, denounce, or advise,” Judge Don Willett wrote for the appeals court. “The Doctors have plausibly alleged that FDA’s Posts fell on the wrong side of the line between telling about and telling to.”

That's a pretty find line the Judge is attempting to draw. The subtext of the "You are not a horse...." social media post notes: "Using the drug Ivermectin to treat COVID-19 can be dangerous and even lethal. The FDA has not approved the drug for that purpose."

It sounds to me like the judge is playing around with something he has no expertise in.

But this is what happens when you pack the courts with Federalist society ideologues...

 

[Tropical Wilds]

One of the big questions, are regulatory agencies allow to use their own dishonest information in order to combat misinformation?

One of the things cited in the article stems from their statements that were clearly implying that Ivermectin was primarily a veterinary medicine (which obviously isn't true, over 200 million people took the drug, annually, prior to covid), and the case was brought by 3 doctors who were punished for prescribing it (the human drug, in human-safe doses).

[/QUOTE]

I read the article in question and it does no such thing.

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

Using the Drug ivermectin to treat COVID-19 can be dangerous and even lethal. The FDA has not approved the drug for that purpose.

www.fda.gov

It says that clinical trials show it’s ineffective, it’s an off-label use, and if you do get an RX for it, take it exactly as prescribed and get it filled from a reputable place, and that veterinary meds are not a human equivalent. None of that is wrong.

With the Tide Pod analogy, if they identified a trend of a bunch of dumb kids eating it for some social media challenge, are they allowed to lie about what the nature of detergent pods are, or punish people who use laundry detergent for cleaning purposes outside of clothes in order to hammer the point home? Or are regulatory agencies still tasked with being honest about the nature of issues?

And with Ivermectin, they identified a trend of dumb people using it because of social media. They didn’t lie about the nature of Ivermectin, nor did they punish people for using it. It doesn’t even say that doctors shouldn’t or are wrong for prescribing it, just that it’s off-label and if it is prescribed, to take it as the doctor directs. So if you do get a doctor who doesn’t care that it’s off label and believes he knows more than science and believes it does work, the FDA doesn’t forbid it, it just says take it as directed.

I don’t think an FDA statement to the effect of “stop taking horse dewormer for COVID because your doctor won’t give you an RX” is an unreasonable or misleading statement.

Nobody was arrested for prescribing it, there were no calls for people to be arrested for prescribing it, no pharmacists refused to fill it, and nobody was punished for taking it. Perhaps you’re confused and thinking of birth control pills or the morning after pill or mail order abortion pills.

 

[Tropical Wilds]

Unfortunately, I don't know that we'd be able to find good information on the percentage of people taking the human version vs. the veterinary version.

However, what initially sparked the CDC/FDAs response was observing trends from retail pharmacies (in mid-August 2021)
Prescriptions for ivermectin have seen a sharp rise in recent weeks, jumping to more than 88,000 per week in mid-August from a prepandemic baseline average of 3,600 per week, according to researchers from the Centers for Disease Control and Prevention.

...and a few days later is when they released this:
View attachment 335631

So their Aug 21st release, based on the timing, was seemingly a response to (or possibly amid) the rapid increase they saw among people getting prescriptions for the human form from retail pharmacies. It's possible that the two forms of incorrect use were increasing simultaneously. But given that they were seeing 88k prescriptions filled per week, I think it's safe to assume a fair number of people were consuming the human version at human appropriate doses as they wouldn't be going to their doctor for an Rx and getting it filled at Walgreens for the "horse paste" version.

Did you read the linked article?

 

[Pommer]

The FDA’s job is to inform and protect the public from false medical information related to the use of medications and combat misinformation about medication application. Based off what was information spread by non-medical professionals, enough people were engaging in the off-label, unsafe dosing of a medication and/or taking the incorrect version of a drug outside of medical supervision that it was the FDA’s responsibility to combat the misinformation. Given that the WHO also gave a safety statement because there was a 400% increase in reported Ivermectin-related injuries from 2019 to 2020 and a 500% increase from 2019 to 2021, the FDA did exactly as they should have done in the situation.

Just like the CDC spoke out about eating Tide Pods and the FDA made a statement against injecting yourself with bleach or taking Miracle Mineral Solution, they identified a trend based off of the reports of injury and made a statement that people shouldn’t be doing it.

Exactly.
The agency tasked with making sure that the medical community is acting in good faith whilst hawking their wares did as they should have done but are now being sued for this because “normal” is OUTRAGEOUS now.

 

[Tropical Wilds]

Exactly.
The agency tasked with making sure that the medical community is acting in good faith whilst hawking their wares did as they should have done but are now being sued for this because “normal” is OUTRAGEOUS now.

The statement in the contested article doesn’t even police the prescribing of the stuff by doctors. It says it’s off-label use, no studies support it (implying that’s why doctors aren’t prescribing it), and if you do get an RX for it, get it filled from a legitimate and safe place and don’t use the veterinary version since it’s not safe. It doesn’t even police the medical community, just inform the public as to best practices… Perhaps the confusion is that pre-2016, things like “don’t take veterinary drugs” and “don’t inject yourself with bleach” and “aquarium chemicals are not for internal human use” were kind of a given that didn’t require an FDA statement. People didn’t have to be told to not do it, it was a common sense thing.

 

[Pommer]

The statement in the contested article doesn’t even police the prescribing of the stuff by doctors. It says it’s off-label use, no studies support it (implying that’s why doctors aren’t prescribing it), and if you do get an RX for it, get it filled from a legitimate and safe place and don’t use the veterinary version since it’s not safe. It doesn’t even police the medical community, just inform the public as to best practices… Perhaps the confusion is that pre-2016, things like “don’t take veterinary drugs” and “don’t inject yourself with bleach” and “aquarium chemicals are not for internal human use” were kind of a given that didn’t require an FDA statement. People didn’t have to be told to not do it, it was a common sense thing.

Aquarium antibiotics are fine **if** one knows how to titrate the dosing.
Those are formulated to treat a forty liter (or more) aquarium so that the “human dose” would be much much less.