The FDA just handed quacks a massive propaganda victory on ivermectin

Late last week, there was a disturbance in the COVID-19 quack antivax Force, as multiple Substacks and antivax websites in the antivax crankosphere erupted in unison with a cry of victory against the FDA. The first example that I encountered came from the longtime “dumbest man on the Internet,” Jim Hoft (a.k.a. The Gateway Pundit) proclaiming FDA Loses its War on Ivermectin: Agrees to Remove All Related Social Media Content and Consumer Advisories on Ivermectin Usage for COVID-19. I soon encountered several other examples, for instance Byram Bridle exulting that FDA Rescinds Statement, “You are not a horse. You are not a cow. Seriously, y’all. Stop it”; The Vigilant Fox boasting that Lawsuit Drops Bombshell on FDA’s Orwellian Lie About Ivermectin; antivax “scientist” James Lyons-Weiler screeching BEST DAY EVER FOR ETHICAL PHYSICIANS AND PATIENTS – GAME OVER FOR FDA’S OUTRIGHT LIES AND DISINFORMATION ON IVERMECTIN!!!!!; Peter McCullough announcing BREAKING–Dr. Mary Talley Bowden Reacts to FDA Settlement on Ivermectin while describing the FDA as “capitulating”; and the Frontline COVID-19 Critical Care (FLCCC) gloating with a statement on its Substack, FLCCC Alliance Statement on the Settlement Reached in Case Against DHHS for Telling the Public to “Stop it” Regarding Taking Ivermectin to Prevent and Treat COVID-19.

It rapidly became apparent that what the antivax ivermectin crankosphere was celebrating involved the FDA having agreed to take down certain social media posts like the one featured in this exultant post/Tweet on X:

So what is really going on here. Because I am not a lawyer, I was happy to see that Dorit Reiss posted an article on why the antivax messaging regarding this settlement is profoundly misleading. The FDA has not “lost the war on ivermectin.” However, as I will discuss, through its decision to settle, the FDA does appear to have lost a major battle against misinformation and handed quacks a propaganda victory that will likely resonate for years, if not decades. It was an unforced error, and, although I can understand why the FDA might have wanted this lawsuit just to go away, I predict that the price in messaging for making this suit disappear will soon reveal itself to be just too high.

First, let’s look at the quack view of what happened.

Quacks rejoice over the “vindication” of ivermectin

Let’s start by going back to the dumbest man on the Internet since 2010, although I might argue that many have challenged Mr. Hoft for this title since then and he might not reign supreme anymore in terms of Internet stupidity. According to The Gateway Pundit, after the FDA had provided guidance and posted on social media that ivermectin was not (and still is not) an effective treatment for COVID-19, this happened:

A group of brave doctors had filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) over the agencies’ unlawful attempts to block the use of ivermectin in treating COVID-19.

The lawsuit, filed in the U.S. Southern District of Texas in Galveston, argues that the FDA has overstepped its authority and unjustifiably interfered with their medical practice.

The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, are contesting the FDA’s portrayal of ivermectin as dangerous for human consumption. They note that the FDA has approved ivermectin for human use since 1996 for a variety of diseases. However, they allege that with the advent of the COVID-19 pandemic, the FDA began releasing documents and social media posts discouraging the use of the anti-viral drug for COVID-19 treatment.

And, regarding the settlement:

On Thursday, the U.S. Food and Drug Administration (FDA) reportedly agreed to remove all its previous social media posts and consumer advisories that specifically addressed the use of ivermectin for the treatment or prevention of COVID-19.

What this suit actually claimed and how it played out, I will discuss in a moment. Right now, let’s just see how quacks are describing the settlement reached last week. First, I will admit that I’m not familiar with Robert Apter. However, I do know Paul Marik. Indeed, I’ve written about what a massive quack he is with respect to COVID-19, cancer, and everything else a number of times. I also know Mary Talley Bowden, although I haven’t written about her nearly as much. As for Robert Apter, he is an emergency medicine doc who claims to have treated 6,000 COVID-19 patients with ivermectin and claims a 99.98% survival rate, which is, of course, a relatively meaningless number without some sort of control group.

Elsewhere, Byram Bridle challenges “disinformation gurus”;

How long are you going to keep chomping at the bit about ivermectin only being a drug for horses and other veterinary species? Are you willing to start admitting that it has long been approved for administration to humans? How about the ever-growing body of literature showing its benefits against diseases beyond those caused by parasites; like its anti-viral and anti-cancer properties? You might want to remove all your links to the above-mentioned propaganda. These ‘exquisite pieces of high quality scientific evidence’ [read with great sarcasm] can no longer be used to underpin your ‘informed’ ‘expert’ opinions. That is what happens when one relies on secondary hearsay ‘evidence’ from agencies instead of primary scientific data.

There are so many straw men there. No one says that ivermectin is just a veterinary drug. We “disinformation gurus” do, however, point out that antivaxxers, quacks, and desperate patients did use the veterinary version of ivermectin, as, for example, I discussed here, noting that, for example, equine ivermectin comes packaged in syringes with “1.87% ivermectin paste. 6.08 g syringe treats up to 1,250 lbs. Safe for horses of all ages, pregnant mares, breeding stallions.” Another formulation comes as a 1% solution to be given 1 ml/110 lbs of weight. Basically, in horses the dose of ivermectin can be up to 1.200 mg, while the human dose recommended is only around 3 mg. When ivermectin promoters state that ivermectin is “very safe” for humans, they are correct, but only at the dose recommended for humans. And, make no mistake, in 2021, encouraged by quacks spreading disinformation and unable to get ivermectin formulated for humans, people were turning to using the horse paste version of ivermectin to treat COVID-19.

But let’s go to some of the most active COVID-19 quacks and grifters out there, the FLCCC, whose statement notes:

A settlement has been reached between the Food and Drug Administration (FDA) and the plaintiffs in a groundbreaking case filed in federal court to decide if the FDA violated its authority as a federal health agency in telling the public to stop taking ivermectin, a safe, well-studied, and proven drug for the prevention and treatment of COVID-19.

In the settlement, the FDA agreed to remove website and social media posts that make statements about using ivermectin for COVID-19.

The only two thing that is accurate in this above passage are that the FDA did reach a settlement with the plaintiffs that involved agreeing to remove the social media and website posts about ivermectin for COVID-19. Note the wording, though. As you will soon see, the FDA never actually admitted to violating its authority in telling the public not to take ivermectin for COVID-19, but the FLCCC is trying its damnedest to imply that that’s what happened. Moreover, ivermectin is not a “safe, well-studied, and proven drug for the prevention and treatment of COVID-19,” although it is now well-studied. Unfortunately, the studies show that, unlike the case for diseases caused by roundworms, ivermectin doesn’t work against COVID-19. I’m not going to retread that evidence yet again, because I’ve discussed it many times, before, but ivermectin doesn’t work against COVID-19.

Unfortunately, thus far all I can find is a stipulation of dismissal, which doesn’t tell us much other than that the lawsuit was dismissed based on a settlement in which the FDA agreed to do the following in the next three weeks:

• Retire FDA’s Consumer Update entitled, Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, originally posted on March 5, 2021, and revised on September 7, 2021 (ECF No. 12, Ex. 1), while retaining the right to post a revised Consumer Update.
• Delete and not republish (1) FDA’s Twitter, LinkedIn, and Facebook posts from August 21, 2021 (ECF No. 12, Exs. 4, 5), that read, “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”; (2) FDA’s Instagram post from August 21, 2021 (ECF No. 12, Ex. 6), that reads, “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.”; (3) FDA’s Twitter post from April 26, 2022 (ECF No. 12, Ex. 7), that reads, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”; and (4) all other social media posts on FDA accounts that link to Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 (ECF No. 12, Ex. 1).

So how did this result come about, and why did the FDA agree to this settlement? The next section relies on analysis of the original decision to dismiss the suit and its reversal by the appeals court in September, as well as the settlement announced last week, in by Dorit Reiss for the legal aspects, but I will speculate a bit on what I think the FDA’s reasons might have been to settle, rather than to keep fighting.

Quacks win a massive propaganda battle

The case in question is Apter et al v. Department of Health and Human Services et al, and Dorit wrote about how legally flawed a September decision on the case was when it was first announced. I think it’s useful here to quote a part if the article on the FDA website that particularly irked these litigious quacks:

However, the FDA has received multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.

Here, the FDA made it very clear that what it was addressing was the use of veterinary-grade ivermectin, not ivermectin formulated for humans. It then emphasized the following:

• The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals. Ivermectin is approved for human use to treat infections caused by some parasitic worms and head lice and skin conditions like rosacea.
• Currently available data do not show ivermectin is effective against COVID-19. Clinical trials assessing ivermectin tablets for the prevention or treatment of COVID-19 in people are ongoing.
• Taking large doses of ivermectin is dangerous.
• If your health care provider writes you an ivermectin prescription, fill it through a legitimate source such as a pharmacy, and take it exactly as prescribed.
• Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous.

None of this is the least bit objectionable from a scientific and medical standpoint. To my mind, neither are the social media posts that so irked Apter and his fellow quacks, which included:

• “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” 
• “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID.” 
• “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.” 

These posts included images of horses and in my mind were fairly amusing and effective social media messaging, but they clearly hit home for Apter, Bowden, and Marik, who filed suit in U.S. District Court on June 2, 2022, claiming that the FDA had acted outside of its legal authority and illegally interfered with the plaintiffs’ ability to practice medicine through its aggressive effort to stop the use of ivermectin to prevent and treat COVID-19. The case was initially dismissed by the court, which said that the FDA had “sovereign immunity” from harm or wrongdoing in directing the public, including health professionals and patients, not to use ivermectin to treat COVID-19. Unfortunately, last September, that dismissal was reversed on appeal by the U.S. Court of Appeals for the Fifth Circuit, which noted that the FDA “is not a physician,”

However, Apter and other quacks were upset and sued, retorting in their complaint:

Or so the Food and Drug Administration (“FDA”) alerted millions of Americans via social media, midway through the COVID-19 pandemic. The agency had discerned that some people were treating their symptoms using the animal version of a drug called ivermectin. FDA decided to target that practice via the “horse” message—and others like it. The messaging traveled widely across legacy and online media. Left unmentioned in most of that messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose. The Appellants are three medical Doctors who prescribed the human version of ivermectin to thousands of their patients. Each Doctor says that FDA’s messaging interfered with their own individual medical practice. The Doctors sued FDA and the Department of Health and Human Services (together, the “Agencies”). They also sued two governmental employees in their official capacities (the “Officials”). The Doctors argue that FDA’s “horse” message and similar public statements (together, the “Posts”) violate FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. We disagree.

In its statement, the FLCCC had made this same claim in its statement about the lawsuit:

U.S. law is cited in the complaint, including the provision that the FDA “may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship.”

Notice something? This passage, 21 USC 396: Practice of medicine, is about devices. Pharmaceutical drugs are not mentioned. Moreover, it also states:

This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

Curious, right? Indeed, the appeals court ruling even noted that this section only mentions medical devices, not drugs, and that the original court had therefore (correctly, in my non-lawyerly opinion) ruled that it was inapplicable to the doctors’ claims. Yet, the appeals court still ruled against the FDA. Now, again, I’m not a lawyer, but I am a physician and surgeon, which makes my reaction to this basically “WTF?”

If you’re interested in the details, Dorit Reiss discussed in depth and at length why the legal reasoning that led the appeals court to rule that the FDA did not have sovereign immunity in this case and had acted ultra vires, or outside its legal statutory mandate in publishing its website and social media posts that warned people that ivermectin was not approved to treat COVID-19 and that using veterinary ivermectin could be harmful to humans was so flawed. A lot of it is kind of technical and above my understanding of the law, but the conclusion last fall was not:

The Fifth Circuit Court of Appeals’ decision about ivermectin is legally wrong, ignoring the statutory authority of the FDA that could cover issuing recommendations in addition to information and is in tension with longstanding FDA practice upheld by the courts.

It is bad on policy grounds: it could make it harder for expert agencies to translate information into practical guidance people can use, and it could undermine the goal of Congress in setting up the FDA to issue such information, to protect people from imminent danger or fraud. All it does is give a talking point to doctors seeking to provide an ineffective treatment to COVID-19 patients for personal gain; it is not even clear it will be helpful to these doctors in their lawsuit, since the claims may well be dismissed on other grounds.

All of which is quite true, particularly that last part about giving a talking point to quacks. Indeed, in retrospect, given the recent settlement and the messaging coming from it, Dorit was eerily prescient, because of the messaging that’s already exploded over social media. Moreover, while it is true that state medical boards, not the FDA, have jurisdiction over the practice of medicine, it is hard to imagine why the FDA would not be able to make public statements about a potentially harmful and definitely useless treatment that was being promoted. Indeed, as a scholar whom Dorit cited said, “The FDA is one of the few federal agencies in government which is specifically required and authorized by law to use publicity.” In this case, it was well-justified to share information that ivermectin was not approved to treat COVID-19 and that veterinary ivermectin can be dangerous to humans.

So the dismissal was reversed and the case was sent back to the lower court for a more in depth hearing. Fast forward to last week, and the FDA settled, with the stipulations I listed earlier in the post that it remove and archive (according to federal law) the “offending” article on its website and the even more “offensive” (to quacks) social media posts.

But why? Why would the FDA agree to such as settlement, which could cause it headaches for decades to come, instead of fighting on? Dorit found an Epoch Times article republished as an NTD article that might explain:

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.”

Yes, these statements are two to four years old, but are they any less true today than they were when they were originally published?

Also:

“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.”

Remember what I said about the language used by the FLCCC about this settlement? Basically, even though part of the settlement was that the FDA did not admit any violation of the law or wrongdoing and still disagrees with the allegation that it had exceeded its authority, quacks are trying to claim that the settlement constitutes a “capitulation” of the FDA and and admission that it had violated the law. I tend to agree with the former—it is indeed a deplorably cowardly capitulation by the FDA—the latter is definitely not true. The FDA admitted nothing, including that it violated the law, which it did not. Rather, the FDA made a tactical decision that continuing to litigate old statements and charges like this was not a good use of its legal resources and time, and the settlement allows the FDA to rewrite its guidance on ivermectin and COVID-19.

Even so, from my perspective it was a bad, bad move, a completely unforced error. While I, like Dorit, can understand why the FDA just wants this lawsuit to go away, the price is too high. As Dorit points out:

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. I understand why it’s not looking to continue to fight over things long done, and expect it will put up a new consumer advisory that will repeat that Ivermectin is not clinically supported as a treatment for COVID-19. But it would have been worth fighting to clarify that it had this authority to make recommendations. This is not the first bad decision from the Fifth Circuit the Supreme Court would have been called upon to fix, and the justices have fixed some other mistakes of that circuit. 

Even worse, here’s an area where the quacks are kind of right, as when Bowden pointed out that the case could serve as a precedent in future cases against the FDA to limit what it can say regarding treatments doctors use, or, as Dorit put it:

But Dr. Bowden has a point that the Fifth Circuit’s bad decision – which the FDA did not appeal – can be used in other cases to combat the FDA’s recommendations about other products, which is why I think not appealing it was a mistake.

Bowden has gone even further than this:

“A pharmacist cites CDC and US FDA as why she will continue to deny filling prescriptions for ivermectin. On Tuesday, the FDA’s attorney declared the FDA has no problem with doctors prescribing ivermectin off-label. It’s time for them to make a formal announcement and set the record straight,” Bowden wrote on Thursday.

Funny, but Bowden says this as though it were a bad thing for pharmacists to listen to the FDA and to question dubious “off-label prescribing.” Of course, the settlement includes no such requirement that the FDA make a “formal announcement” reversing its previous advisement and “setting the record straight,” and likely Bowden knows this. She also knows, however, that her audience likely does not and will lap her quack propaganda up.

In addition, I fear that it is not just COVID-19 quacks and antivaxxers who are salivating over this decision to settle. It wouldn’t surprise me if cancer quack Stanislaw Burzynski has taken note of how he might apply this to the FDA’s numerous statements about how his antineoplastons have never been shown to be safe and effective treating cancer and how the are therefore not FDA-approved to treat cancer. Heck, pharmaceutical companies and device manufacturers might even find a use for this decision as well.

I fear that the FDA has shot itself in the foot. Not only has it handed a legal weapon to quacks who don’t like its public statements about the use of unapproved drugs, but it’s handed quacks and antivaxxers a potent talking point for their propaganda that they will be using probably the rest of my life.