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Medicine Government United States

America's FDA Forced to Settle 'Groundless' Lawsuit Over Its Ivermectin Warnings (msn.com) 350

As a department of America's federal Health agency, the Food and Drug Administration is responsible for public health rules, including prescription medicines. And the FDA "has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19," they confirmed to CNN this week. "The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19."

But there was also a lawsuit. In "one of its more popular pandemic-era social media campaigns," the agency tweeted out "You are not a horse. You are not a cow. Seriously, y'all. Stop it." The post attracted nearly 106,000 likes — and over 46,000 reposts, and was followed by another post on Instagram. "Stop it with the #ivermectin. It's not authorized for treating #COVID."

Los Angeles Times business columnist Michael Hiltzik writes that the posts triggered a "groundless" lawsuit: It was those latter two lines that exercised three physicians who had been prescribing ivermectin for patients. They sued the FDA in 2022, asserting that its advisory illegally interfered with the practice of medicine — specifically with their ability to continue prescribing the drug. A federal judge in Texas threw out their case, but the 5th Circuit Court of Appeals — the source of a series of chuckleheaded antigovernment rulings in recent years — reinstated it last year, returning it to the original judge for reconsideration.

Now the FDA has settled the case by agreeing to delete the horse post and two similar posts from its accounts on the social media platforms X, LinkedIn and Facebook. The agency also agreed to retire a consumer advisory titled "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19." In defending its decision, the FDA said it "has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old."

That sounds reasonable enough, but it's a major blunder. It leaves on the books the 5th Circuit's adverse ruling, in which a panel of three judges found that the FDA's advisory crossed the line from informing consumers, which they said is all right, to recommending that consumers take some action, which they said is not all right... That's a misinterpretation of the law and the FDA's actions, according to Dorit Rubinstein Reiss of UC College of the Law in San Francisco. "The FDA will seek to make recommendations against the misuse of products in the future, and having that decision on the books will be used to litigate against it," she observed after the settlement.

"A survey by Boston University and the University of Michigan estimated that Medicare and private insurers had wasted $130 million on ivermectin prescriptions for COVID in 2021 alone."
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America's FDA Forced to Settle 'Groundless' Lawsuit Over Its Ivermectin Warnings

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  • Prescribing ivermectin for covid?

    Is there an MD here that could comment on this? Can doctors literally prescribe anything they want, for any condition? I thought there were guidelines that were required to follow, and breaking those guidelines had professional consequences?
    • by ArmoredDragon ( 3450605 ) on Sunday March 31, 2024 @03:09PM (#64359266)

      From what I know of how the law applies, doctors can and do prescribe drugs for off-label usage. For example, it's not unheard of for doctors to prescribe adderall for weight loss. Even though adderall is a controlled substance and thus considered high risk for abuse, they can still do that, and I doubt any kind of medical review board would treat it as some kind of malfeasance.

      I think one of the more crazy things I've seen used this way is a prescription for human milk being used to treat prostate cancer, which enabled the patient to obtain some from a hospital that keeps a supply of donor milk for neonatal care.

      • by Shaitan ( 22585 ) on Monday April 01, 2024 @02:22AM (#64360420)

        This is fairly common practice. The most common is to prescribe medications which are still going through red tape with the FDA but have already been established to be clinically safe and effective. It is also sometimes done in cases where the FDA won't approve anything (health spa doctors with aging related treatments, aging is not recognized as a disease by the FDA despite being the most common universal co-morbidity). There are even times a doctor will prescribe something rather than allowing the patient to go to black market and use what may be a fake or impure substance without qualified supervision [anabolic steroids are a common example of this].

        Ivermectin is highly effective against most rhinoviruses and is about as safe as prescription medications go so it is commonly tried for anything new. The FDA took a strong negative opposition to this for purely political reasons, especially given there wasn't and really still isn't an effective alternative treatment. In response most physicians stopped prescribing it but some continued to do so as a treatment of last resort. Frankly when a patient is facing inevitable death and other treatments have failed there is no reason to deny them the opportunity to try most any high risk treatment, let alone a virtually no risk treatment like Ivermectin. This is again something most everyone [save insurance companies] agrees on under normal circumstances but politics interfered with medicine once again.

        • by 14erCleaner ( 745600 ) <FourteenerCleaner@yahoo.com> on Monday April 01, 2024 @10:58AM (#64361388) Homepage Journal
          There's little evidence that ivermectin works against viruses; the quacks shifted to flu and RSV when their COVID scam business fell off. https://wapo.st/3vDeoaj [wapo.st] (non-paywalled link)

          First, the group of doctors championed ivermectin as a covid panacea. It failed to live up to the hype. Now, they're promoting the anti-parasitic to prevent and treat the flu and RSV. The Front Line Covid-19 Critical Care Alliance, formed in 2020 to "prevent and treat covid," is touting ivermectin for common respiratory infections amid a dramatic drop in prescriptions for the drug as clinical trials undermined claims of its efficacy against covid. There is no clinical data in humans to support using ivermectin for flu or RSV, according to the Centers for Disease Control and Prevention and other medical experts. And yet, the alliance publishes "treatment protocols" promoting the use of ivermectin for flu, RSV and covid that it says have been downloaded more than a million times. It also recommends a network of hundreds of medical providers and pharmacies that can provide prescriptions for ivermectin, often through virtual visits that can run hundreds of dollars.

    • by vivian ( 156520 ) on Sunday March 31, 2024 @03:17PM (#64359282)

      I think doctors can prescribe anything for anything - as long as they have a valid DEA license - but they have to be able to justify that in a court of law if things go wrong and they get sued for malpractice, and run the risk of getting struck off (ie. banned from practicing medicine).
      If a patient was prescribed ivermectin for COVID, then suffered severe known side effects while not making any difference to their covid condition, the doctor might be in trouble if the patient sued.

      • That's not quite correct. The license to prescribe medications comes from the State medical licensing boards and is subject to each State's civil code regulating medical practice. The laws and rules are similar among all the states. If you prescribe medicines without a valid state medical license, you are breaking the law and subject to state prosecution.

        The federal DEA regulates distribution and use of "Scheduled drugs", i.e. "controlled substances", which includes narcotics, certain psychotropics, and

    • by NomDeAlias ( 10449224 ) on Sunday March 31, 2024 @03:43PM (#64359340)
      I'm not a doctor but it's called off-label prescriptions. They can't prescribe anything but they can prescribe a drug that's already approved for human consumption for a use other than what it was originally approved to treat. One in five prescriptions written is off-label.
    • by taustin ( 171655 ) on Sunday March 31, 2024 @04:18PM (#64359440) Homepage Journal

      The thing to keep in mind is that ivermectin was, in fact, approved for human use, just not for COVID. And doctors do regularly prescribe medications for off label use, sometimes when there's little science to support it.

      For the FDA to imply that ivermectin wasn't safe for human use when they had approved it to be, they should have been sued.

      Given that the government has basically infinite resources in a lawsuit like this, the only reason they'd settle is because it will cause them less embarrassment than going to trial and losing.

      • Re: (Score:2, Interesting)

        by thegarbz ( 1787294 )

        For the FDA to imply that ivermectin wasn't safe for human use when they had approved it to be, they should have been sued.

        Except they did no such thing. They specifically said you're not a horse and not a cow, a direct reference to people who were buying off the shelf ivermectin for treating animals, which if you follow the suggestion on the packaging puts you way above the recommended dose for humans.

        They said it wasn't authorised for use against COVID, and it wasn't. That doesn't mean it was unsafe for its other purpose.

    • by tpjunkie ( 911544 ) on Sunday March 31, 2024 @04:44PM (#64359476) Journal
      Yes. I can write a script for any fda approved substance (and for a DEA controlled substance by appending my DEA number to the Rx). Whether your insurance decides to pay for it is another thing entirely. Source: am physician
    • Any doctor that prescribes an antiparasitic drug that works by binding to glutamate-gated chloride channels that are common to invertebrate nerve and muscle cells to treat a viral infection honestly shouldn't keep their medical license. There is nothing about that mechanism of action that would suggest ANY efficacy against viruses (which don't have nerves OR muscles), and there IS a certain level of toxicity in mammals, where past a certain threshold it can pass the blood-brain barrier and have deleterious

    • by ceoyoyo ( 59147 )

      Most places, yeah, pretty much. You might get sued of course, but that's what insurance is for.

      Medicine is funny. It's old, and relies very much on individual expertise and experience rather than collective professional knowledge and experience. That's why you want to make sure you get a good physician, wheras nobody gives a thought to who's sitting in the pilot seat or who engineered the bridge you just drove over.

  • by magzteel ( 5013587 ) on Sunday March 31, 2024 @03:07PM (#64359256)

    It wouldn't be wrong to say Ivermectin was not being recommended for the treatment of Covid-19. But implying it was only for use in horses and cows is dangerously wrong. It is recommended by the CDC for treatment of immigrants from many countries. Sending a message that it is for animals only can create a backlash from the people who should be taking it

    • by wyHunter ( 4241347 ) on Sunday March 31, 2024 @03:18PM (#64359286)
      Exactly. Its big thing was curing river blindness, which has saved the sight of millions. However, looking at the pubmed NIH site for papers on ivermectin, there's a lot of research using treating it for a lot of things.
    • Ivermectin is great for treating parasites. So yeah it’s a valid use.

      • by hawk ( 1151 )

        >Ivermectin is great for treating parasites.

        *now* you tell us. Maybe it's not too late . . .

        Oh Donnnald. Here, Donald-Donald. We have a treat for you . . . and you, to Joe. It tastes like ice cream. C'mon, you two; get over here! :)

    • by thegarbz ( 1787294 ) on Sunday March 31, 2024 @05:47PM (#64359606)

      But implying it was only for use in horses and cows is dangerously wrong.

      That wasn't what was implied. What was implied is that people should stop going to animals shops and buy tubes of the stuff designed for horses. There's nothing dangerously wrong about that advice. You're not a horse, stop buying drugs with pictures of horses on them.

    • You forgot the part where Ivermectin was on WHO's list of essential medicines as well.
  • by HamidPayaamAbbasi ( 7143815 ) on Sunday March 31, 2024 @03:07PM (#64359260)
    It is a great tell, as soon as someone starts talking about Ivermectin I know to completely ignore them.
    • by Calydor ( 739835 )

      As an actual horse owner, though, the product does come up in conversation every couple of years.

    • I won't. I will wholeheartedly support and reinforce their stance.

      I consider it a public service in cleaning the gene pool.

  • If it was groundless then how did they lose? This is double-speak. Typical mental contortions required to spin the propaganda so the tax slaves swallow it no matter how wrong it is.
    • You haven't been paying attention to the American legal system for the past few decades, huh?
      • The US federal government has infinite money. They only settle for two reasons. A)They want their opponents to win, which is virtually every EPA settlement or 2)They know beyond a shadow of a doubt that they will lose.

    • by ceoyoyo ( 59147 ) on Sunday March 31, 2024 @08:35PM (#64359984)

      They didn't lose. They won, and in Texas yet. Then an appeals court sent it back for reconsideration. The FDA likely decided that it was in the public's interest to delete a couple of tweets rather than continue to pay lawyers.

      • They didn't win. The suit was initially thrown out on sovereign immunity grounds. The appeals court went nope, the law that established the FDA and the Administrative Procedures Act both authorize this type of lawsuit. Now go back and try the case on the merits.

  • The main problem (Score:3, Insightful)

    by gtall ( 79522 ) on Sunday March 31, 2024 @03:52PM (#64359362)

    The main problem here is the 5th circuit. Those bozos have delivered judgements that only a maga dolt could love....well, they would seeing as they are maga dolts themselves. Even the right wing-nuts on the Supreme Court are getting tired of them....except for Alito and Thomas.

    • The main problem here is the 5th circuit. Those bozos have delivered judgements that only a maga dolt could love....well, they would seeing as they are maga dolts themselves. Even the right wing-nuts on the Supreme Court are getting tired of them....except for Alito and Thomas.

      What does MAGA mean?

  • by athe!st ( 1782368 ) on Sunday March 31, 2024 @04:30PM (#64359454)
    The UKs national Principle trial tested Ivermectin and it works, here is a summary https://c19ivm.org/principleivm.html [c19ivm.org]

    Here is their write up, they don't really want to say it's effective https://www.journalofinfection.com/article/S0163-4453(24)00064-1/fulltext [journalofinfection.com]
    • by whoever57 ( 658626 ) on Sunday March 31, 2024 @06:16PM (#64359700) Journal

      The first link is from an ivermectin-promoting site and it seriously misrepresents the results of the actual trial report.

      The actual trial isn't a good study, since no placebo was used. People knowingly taking ivermectin self-reported feeling better, shocker! Note that a significant proportion of the population of the trial were essentially self-selected, so it's likely a high proportion of people on the trial expected ivermectin to work.

      So, no, that study provides no evidence that ivermectin is effective against Covid.

      But, hey, take your snake oil if you want.

    • Probably because it’s not.

  • by Orphic_Egg ( 556751 ) on Sunday March 31, 2024 @04:50PM (#64359488)
    The Courts curtailing Federal government over reach is now "chuckleheaded antigovernment rulings" according to MSN? Seems a bit pro big government.
    • LA Times is the lowest quality "newspaper" in the land - the quote you shared is evidence of that. Except for tribal blindness everyone here would have agreed in 2014 that it's poor journalism.

      So many people here who never read the DARPA papers on betacoronaviruses.

      Which is fine at this point, four years after the lockdowns.

      Booster #10 is past due!

      (they don't actually believe it themselves just mindlessly following the cult).

  • by Tony Isaac ( 1301187 ) on Sunday March 31, 2024 @05:14PM (#64359526) Homepage

    The fact that a drug is used on horses and cows, isn't really relevant to its effectiveness in humans, for any purpose. There are many medicines that are used for horses, cows, and people. Though antibiotics are often misused in animals as a growth stimulant, they are in fact effective at fighting bacteria in both animals and humans.

    Whatever the effectiveness of ivermectin related to COVID, the fact that it's a medicine used to treat livestock has nothing to do with it.

    • That is not what they were referring to. They were referring to the people running out and buying tubes of the stuff meant for lifestock. You're not a horse, don't buy drugs with pictures of horses on them. The dosage instructions are completely wrong.

      • It was a tweet. Here it is, in its entirety.

        You are not a horse. You are not a cow. Serious y’all. Stop It.

        You can't assume they were talking only about people "running out and buying tubes of the stuff meant for livestock." They didn't say that. You don't get to read your own meaning into their one-liner.

    • The fact that a drug is used on horses and cows, isn't really relevant to its effectiveness in humans, for any purpose.

      That's true, but irrelevant. The issue is that formulations meant for horses may not be safe for humans.

      • And that is what a doctor is for, to determine whether this is true. Drugs are approved by the FDA based on their chemical formulation. The human version of the chemical cannot differ from the animal version, if it's approved as the same drug. Doctors are legally allowed to prescribe drugs off-label, if they have determined that the formulation is safe and the doctor believes it will be effective.

        • I don't think you understand the concept of a "formulation".

          Let me help:
          https://www.ncbi.nlm.nih.gov/b... [nih.gov]

          • Yes. the formulation can make a difference. That is what doctors are for, to determine the correct formulation. If a doctor prescribes a bad formulation, that's malpractice. But it is legal and (generally speaking) ethical for a doctor to prescribe medicines off-label, if in his judgment it's the right thing for the patient.

    • We were laughing at the people buying it from Tractor Supply.

  • "Stop it with the #ivermectin. It's not authorized for treating #COVID."

    There is a reason why it was never allowed OR even testing done to see if it could, If it was found to actually be effected vs covid then Big Pharma would lose the ability to sell its drugs like the jab and other "treatments". If an effective treatment was found then the EUA that jab had would end and RIP that 10's of bllions $ in profits likes of Pfizer etc would be making for a drug that costs Penny's to make. Only likes of those c
    • I will Point out the FDA's funding for human drug approval, 2/3rds of their funding comes from the companies they regulate aka Pfizer, moderna etc. They heve $ incentive to make sure those companies stay happy and make $ as a lot of people that work for FDA seem to go work for said companies.

      Source: https://www.fda.gov/media/1756... [fda.gov]
  • The headline "America's FDA Forced to Settle 'Groundless' Lawsuit Over Its Ivermectin Warnings" is inaccurate.

    The FDA wasn't forced to do anything, they chose to settle rather than defend their actions in court.

    Plaintiffs make such choices for a variety of reasons including (but not limited to):

    1. Fears that they will lose on the merits
    2. To avoid litigation costs
    3. Fear of being embarrassed by evidence such as documents revealed during discovery
    4. The defendant actually believes that the plaintiff is correct
    • they went the less embarrassing route if they fought it then it would gone to discovery which a lot of very dirty laundry would come out showing how much of puppets of big pharma they really are.
      • they went the less embarrassing route if they fought it then it would gone to discovery which a lot of very dirty laundry would come out showing how much of puppets of big pharma they really are.

        Bingo

  • by devloop ( 983641 ) on Monday April 01, 2024 @12:06AM (#64360272)
    This lawsuit is not about COVID. It is about the FDA engaging in misinformation by portraying Ivermectin, a drug on the WHO's List of Essential Medicines, as a "horse" or "cow" medication, implying that it was not safe for human consumption.
  • by seeker ( 9636 ) on Monday April 01, 2024 @11:23AM (#64361478)

    Ivermectin is a widely proscribed drug for humans. The WHO describes it as an essential medicine, and its discovery led to a Nobel Prize (https://en.wikipedia.org/wiki/Ivermectin).

    Whether it is effective on COVID is not clear. You can find studies that say it is unclear (https://www.nejm.org/doi/full/10.1056/NEJMoa2115869) or that it is effective for early cases (https://pubmed.ncbi.nlm.nih.gov/33278625/). Given the now admitted hostile actions of the FDA, I am sure there are studies saying it is not effective particularly for late stage cases.

    It is very common for a single drug to have multiple applications, this is why off-label prescriptions exist

    The FDA wrongly characterized Ivermectin and wrongly satirized it's use in at a time when the CDC had bungled COVID testing and the FDA was acting in an overtly political manner.

    The FDA chose to take it's medicine like a child: whining that it did not want to.

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