Conservative judges revive case on FDA’s “you are not a horse” ivermectin posts

You are still not a horse, but FDA will go to court over its authority to advise you.

See full article...

 

[DistinctivelyCanuck]

Genuinely curious:

how many times does an ars forum participant need to be downvoted to oblivion until they are deplatformed (understanding that things turn into a game of whack a mole)

(finally got around to tweaking my blocklist)

as to the article itself: I really wish we'd gotten more snark from Beth on this one: because we ARE talking about three doctors who are under multiple investigations for practice violations.

ugh.

 

[entropy_wins]

Poe's Law repellant, because there's always someone who doesn't understand:

Thalidomide is an anti-insomnia drug that was specifically prescribed to pregnant women in the 1970s. It turned out that Thalidomide was a major cause of birth defects, largely in the form of malformed extremities--in particular, underdeveloped hands essentially attached directly to the shoulder without a fully developed arm in the middle.

Thalidomide is a racemic mixture of left/right mirror images molecules. One of the enantiomer is toxic ,the other is a sedative

This molecule is used in grad-school to teach the importance (and difficulty) of molecular design.

I'm hoping the justices wake up before something really stupid gets decided, but the "Drs" in this case, sound quite dangerous enough already....

 

[Matthew J.]

Pretty sure the FDA doesn’t need authority to say “Horse Medicine is not for Humans.” It be like penalizing them for saying “going over the speed limit is bad for your’s and other’s health because you are more likely to get into an accident.”

I've never told anyone this before... but I actually am a horse.

 

[ColdWetDog]

"plaintiff Paul E. Marik lost his positions at a medical school and a hospital"

It's bad enough someone like him is practicing medicine, But training medical student!?

It isn't hard to get added to a medical school faculty as an 'adjunct professor'. It doesn't really mean all that much except that perhaps you supervised some medical students or residents. And depending on the circumstances, that may not be a big barrier. Certainly I've met my share of pretty wacko med school faculty. Not ivermectin level idiocy but perhaps not far off - especially in OB/Gyn Misogyny departments.

 

[CrystalCowboy]

"Conservative" or "batshit"? Is there a difference anymore?

True story from my local neighborhood Google Group: Someone is recently railing that a Democrat used insulting and disparaging language to describe another politician, who is currently an independent.

The verbiage at issue: she was described as "conservative."

 

[rando1234]

Poe's Law repellant, because there's always someone who doesn't understand:

Thalidomide is an anti-insomnia drug that was specifically prescribed to pregnant women in the 1970s. It turned out that Thalidomide was a major cause of birth defects, largely in the form of malformed extremities--in particular, underdeveloped hands essentially attached directly to the shoulder without a fully developed arm in the middle.

Thanks. I assumed it was sarcasm because of the high number of upvotes, but I still had to look it up myself to understand why.

 

[ColdWetDog]

Conservative whiners couldn’t care less about the actual guidance. The entire case is pivots off the single viral “you are not a horse” tweet, which was extraordinarily effective because the humor broke through to countless millions of Americans that would never read an FDA advisory, or even know what the letters in FDA stand for.

As Isaac Asimov said (at least I hope, quotes are getting difficult to validate these days):

Being intelligent is not a felony, but most societies evaluate it as at least a misdemeanor.

-- Heinlein

 

[Maestro4k]

If these conservative idiots want to kill themselves, then let them. Darwin awards for everyone and the planet will be better for it.

That'd be fine if they only killed themselves, but that's not the case. Many of them also applied this bullshit to their children and they also managed to convince low-information people into thinking it was a valid treatment. There's a very good chance that those "conservative idiots" got at least a few people killed by promoting Ivermectin as a treatment/preventative, especially the horse version.

It's not a Darwin award when you get someone else killed with your bullshit, it's homicide.

 

[Corporate_Goon]

Is the argument really that because you’re allowed to prescribe off-label, the FDA has no place commenting on such usage(s)? I’m not qualified to comment on any statute/precedent at play, but from a logical standpoint that sounds absurd to me. (That is, the law isn’t always logical, but that outcome would strike me as absurd.)

No, the argument is that the FDA doesn't have the authority to comment on how any approved drugs are used after it has completed that approval process, and doing so steps outside its statutory authority as a regulator and interferes with the authority of state medical boards and the discretion of individual doctors.

This isn't a perfect analogy, but this is akin to the distinction between the FCC as the body that assigns over-air frequencies to particular broadcasters, and the FCC as the body that determines what is appropriate to be broadcast once those frequencies are assigned. The authority of the FCC to do the former is absolute, but the authority of the FCC to do the latter is significantly limited both by its statutory authority and by the US constitution.

These doctors are scumbags grasping at straws and are going to find they have both a standing issue and a damages issue if this goes further, but the question of the limits of FDA authority is a genuine legal question here and I can't help but think a lot of the people skimming this article and jumping right to the comments section are letting their own political biases blind them to that.

 

[Mechjaz]

I'm pretty good with English. I understand the difference between connotation and denotation; I recognize the passive voice, split infinitives, dangling participles, homophones, and plenty else. But this, even by the razor thin shapes the American legal system has hammered language into, doesn't make any goddamn sense (emphasis mine):

"FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise," Willett wrote for the panel in its decision."

One pair of those words is antonyms, so fair, I guess. How the fuck can you inform and apprise someone without advising?

"There's a shooter coming up the hallway."

"Which way are they coming from? What should we do? Which way should we go?"

"I can only inform that there's a shooter coming up the hallway. You are now apprised. I neither endorse nor advise that you leave, stay, hide, or any other activity such as might suggest that you have received advice, endorsement, inducement, encourage-or-discouragement from undertaking or not undertaking any course of action whatsoever on the basis of your interaction here today with the Food and Drug Administration."

Fifth Circuit leans back contentedly in chair
everyone dies in shooting or plague or complications with pregnancy
Fifth Circuit smiles

 

[Maestro4k]

Thalidomide is a racemic mixture of left/right mirror images molecules. One of the enantiomer is toxic ,the other is a sedative

This molecule is used in grad-school to teach the importance (and difficulty) of molecular design.

And they convert from one to the other in the body, so even if you manage to make a pill with only the safe entatiomer in it, it'll still cause birth defects.

 

[Honeybog]

I'm pretty good with English. I understand the difference between connotation and denotation; I recognize the passive voice, split infinitives, dangling participles, homophones, and plenty else. But this, even by the razor thin shapes the American legal system has hammered language into, doesn't make any goddamn sense (emphasis mine):



One pair of those words is antonyms, so fair, I guess. How the fuck can you inform and apprise someone without advising?

"There's a shooter coming up the hallway."

"Which way are they coming from? What should we do? Which way should we go?"

"I can only inform that there's a shooter coming up the hallway. You are now apprised. I neither endorse nor advise that you leave, stay, hide, or any other activity such as might suggest that you have received advice, endorsement, inducement, encourage-or-discouragement from undertaking or not undertaking any course of action whatsoever on the basis of your interaction here today with the Food and Drug Administration."

Fifth Circuit leans back contentedly in chair
everyone dies in shooting or plague or complications with pregnancy
Fifth Circuit smiles

I can apprise you to the fact that the parties involved are fucking dimwits. I, however, cannot advise you not to listen to fucking dimwits, nor can I denounce fucking dimwits as people that you should not take medical advice from.

 

[entropy_wins]

And they convert from one to the other in the body, so even if you manage to make a pill with only the safe entatiomer in it, it'll still cause birth defects.

Yep. As I wrote, it's used in grad-school of one of the many reasons it's hard to design drugs....

 

[SubWoofer2]

Thalidomide is an anti-insomnia drug that was specifically prescribed to pregnant women in the 1970s. It turned out that Thalidomide was a major cause of birth defects, largely in the form of malformed extremities--in particular, underdeveloped hands essentially attached directly to the shoulder without a fully developed arm in the middle.

1960's. The 1961 and 1962 kids a year or so ahead of me in school were the ones with fewer fingers, no arms, arms ending in stumps, etc. Grossly disfiguring birth defects. I missed it by about 8 months.

 

[Honeybog]

1960's. The 1961 and 1962 kids a year or so ahead of me in school were the ones with fewer fingers, no arms, arms ending in stumps, etc. Grossly disfiguring birth defects. I missed it by about 8 months.

It’s always amazing to me that the US—through truly good oversight, mostly avoided the effects of Thalidomide—but everyone is ignorant of it.

Meanwhile, you can’t travel to a place like the UK without seeing or hearing about the effects of it.

The US had a single, smart administrator want to see clinical trials before authorizing a drug and managed to avoid a generation of children affected by it, but now we get people suing for the right to take horse drugs.

 

[Maestro4k]

One pair of those words is antonyms, so fair, I guess. How the fuck can you inform and apprise someone without advising?

In this case the advise is meant in relation to medical treatment. The FDA does not have the authority to advise people what treatments they should/shouldn't undertake, only what drugs should/shouldn't be allowed on the market. Only medical doctors are allowed to advise people of what drugs to take for various ailments.

But the FDA wasn't advising patients on a course of treatment, they were warning them that 1. There was no proof Ivermectin helped COVID-19 at all (and clinical trials later showed it didn't) and 2. Taking livestock-grade Ivermectin is really damn dangerous for humans, so the judges are still full of bullshit.

 

[Eurynom0s]

I'm not a horse? Neigh!

 

[Chuckstar]

Poe's Law repellant, because there's always someone who doesn't understand:

Thalidomide is an anti-insomnia drug that was specifically prescribed to pregnant women in the 1970s. It turned out that Thalidomide was a major cause of birth defects, largely in the form of malformed extremities--in particular, underdeveloped hands essentially attached directly to the shoulder without a fully developed arm in the middle.

Importantly, it was never approved in the U.S., in spite of a lot of pressure brought to bear against the FDA employees involved. There were, unfortunately, a dozen or more babies born with Thalidomide-related birth defects, which occurred during clinical testing.

 

[Mechjaz]

And they convert from one to the other in the body, so even if you manage to make a pill with only the safe entatiomer in it, it'll still cause birth defects.

Off topic:

I still have no idea how stereoisomers and enantiomers work. A little light digging (ahem google page 1) suggests a reversal in optical polarity but I still don't understand why they behave chemically differently. I can cram my left hand in a right hand glove (for some gloves, anyway), although it is not pleasant. I guess I don't get how (made up example, I have no idea what I'm talking about) a Cl coming off the left of a C means toxin but the right means sedative. They're still sharing the same bonds, yeah? Is it really about the physicality of the molecule?

...I wonder if Veritasium has something on this, though he's usually physics.

 

[radulov]

About damn time. How many pregnant mothers have had to suffer through insomnia because these liberal FDA zealots “denounced” and “advised” against Thalidomide?

Sadly, our reality is much worse than that now ... how many died because they followed the advice of those wanting political power over them?

 

[arkhanist]

Poe's Law repellant, because there's always someone who doesn't understand:

Thalidomide is an anti-insomnia drug that was specifically prescribed to pregnant women in the 1970s. It turned out that Thalidomide was a major cause of birth defects, largely in the form of malformed extremities--in particular, underdeveloped hands essentially attached directly to the shoulder without a fully developed arm in the middle.

Strictly speaking, thalidomide is two drugs. Chirality is where the structure of a chemical compound can have two mirrored versions - a 'left handed' and 'right handed' enantiomer. For thalidomide, one of these (the (R)-enantiomer) is an effective sedative; the other (the (S)-enantiomer) can cause birth defects.

While chirality was known about prior to Thalidomide, for chiral drugs at the time it was thought one enantiomer was usually inactive, with the other being the useful drug. Certainly in the 1950s, when Thalidomide was introduced, creating or separating different handed versions of a drug was extremely hard, so you just went with a 50/50 mix and increased dosage accordingly, because half the drug did nothing important. This assumption in the case of Thalidomide proved to be very, very wrong.

These days, not least because of Thalidomide, chiral drugs that are a mixture of both enantiomers are significantly rarer; it's generally desirable to only have the active version and avoid the risk of additional side-effects and requiring a higher dose; and both versions are definitely tested, including screening tests that would have flagged the danger of Thalidomide during development.

Though even if it had been possible at the time, a 100% R-Thalidomide still wouldn't have been safe as rather unusually, it is capable of switching chirality in the body - so even a pure R-Thalidomide becomes a mixture of R- and S- once taken.

Thalidomide does actually have current FDA approval for use as part of 1st line leprosy treatment, and as an anti-cancer drug. But obviously not for pregnant women...

 

[Mad Klingon]

All this ruling really means is the 3 doctors get to proceed to trial on some of their original claims. Unless there is some sort of out of court settlement, we should get some clarification on just were the line is between inform and advice. Probably a good line to define but a really stupid subject to use to reach that result.

I remember walking through a couple of farm supply stores during that period and seeing the ivermectin shelves(empty) behind newly constructed security glass and being unsure whether to laugh or cry.

 

[wastrel]

Those conservative judges, too, are not horses... but they are horses' asses.

 

[Bernardo Verda]

Thalidomide is a racemic mixture of left/right mirror images molecules. One of the enantiomer is toxic ,the other is a sedative

This molecule is used in grad-school to teach the importance (and difficulty) of molecular design.

I'm hoping the justices wake up before something really stupid gets decided, but the "Drs" in this case, sound quite dangerous enough already....

And they convert from one to the other in the body, so even if you manage to make a pill with only the safe entatiomer in it, it'll still cause birth defects.

TIL: That's a couple of details I hadn't been aware of. Thanks.

 

[TheWerewolf]

I've said it before and I'll say it again: The GOP is a death cult.

 

[ardentsonata]

Genuinely curious:

how many times does an ars forum participant need to be downvoted to oblivion until they are deplatformed (understanding that things turn into a game of whack a mole)

(finally got around to tweaking my blocklist)

as to the article itself: I really wish we'd gotten more snark from Beth on this one: because we ARE talking about three doctors who are under multiple investigations for practice violations.

ugh.

I don’t believe getting downvoted to oblivion will get you deplatformed on Ars ever unless it’s also tied to a bunch of other rule breaking. There’s definitely some people who I’ve ignored that I see routinely pop up to spout anti-trans BS on any article that it’d be tangentially related to.

 

[qazwart]

When the trio appealed, a conservative panel of three horses at the 5th U.S. Circuit Court of Appeal in New Orleans

Not the entie horse. Just a part of the horse anatomy.

 

[uberDoward]

So they're suing because the FDA, in telling people that Ivermectin was ineffective against COVID, and specifically in telling people that Ivermectin doses formulated for livestock were not safe for human consumption, affected their ability to make money off suckers they prescribed Ivermectin to treat COVID?

Seriously, they are talking about someone stopping them from making money by doing something that threatened the health of their patients, and they expect us to side with them.

Oh, it's much worse. People are actually siding with them and think those "doctors" were wronged.

I'm not sure how, but Idiocracy may be an improvement over where we are heading.

 

[UweHalfHand]

Off topic:

I still have no idea how stereoisomers and enantiomers work. A little light digging (ahem google page 1) suggests a reversal in optical polarity but I still don't understand why they behave chemically differently. I can cram my left hand in a right hand glove (for some gloves, anyway), although it is not pleasant. I guess I don't get how (made up example, I have no idea what I'm talking about) a Cl coming off the left of a C means toxin but the right means sedative. They're still sharing the same bonds, yeah? Is it really about the physicality of the molecule?

...I wonder if Veritasium has something on this, though he's usually physics.

I am not a biochemist, so I can’t tell you all the fussy (and very important) details, but basically it comes down to the shape of the molecule in relation to all the other molecules that make up you me and all life. It’s not the absolute orientation, you could have (I believe) a mirror world where all of the chiral molecules in all of our bodies were reversed, and in that mirror world it would be the other isomer that would be toxic. (This ignores possible extremely subtle left/right asymmetries in elementary particle physics, but I doubt that such asymmetries would propagate upward to the relatively huge and slow level of molecules — but I’m also not a particle physicist; I could be wrong.)

 

[TonyJ588]

What we are observing is the fall of the American Empire (1945 - 2030?). And it's being done with Twatter, TikTok, Facebook, Youtube and an extremely lethal dose of stupid Conservatism. Fuck I'm glad I don't live there.

 

[Deleted member 388703]

Reminder: The only reason anyone heard of "Ivermectin" and "covid" together is because of this pack of far-right frauds:

https://time.com/6092368/americas-frontline-doctors-covid-19-misinformation/

 

[Deleted member 388703]

at the time, the FDA were very disingenious the way they posted that horse tweet, almost insinuating that ivermectin was only for animals.

...said nobody mentally competent, ever.

 

[Ivanp91v]

[removed]