It was just a recommendation, bro!

Apparently the FDA's demonization of Ivermectin and doctors was not a mandate, but rather just a "recommendation" for the public.

A few months ago a lawsuit was brought forth by 3 doctors against the FDA’s targeting of Ivermectin, and how the agency’s messaging directly affected these doctors’ abilities to practice medicine.

The allegations include a few messages and tweets put out by members of the FDA, including the all-too familiar “not a horse” tweet.

As the lawsuit alleges, the FDA serves as an ephemeral gatekeeper to medications and how doctors practice medicine, so such castigations made by a prominent agency are likely to influence the perception of these medications and inhibit a doctor’s right to freely practice medicine based on their own accord.

A few points from the lawsuit include the following (it’s difficult to copy from a pdf so I’m only taken a screencap of a few points):

By all accounts this isn’t a point of contention. It’s a generally held belief that the FDA has huge sway over the public’s perceptions of drugs due to its power and establishment as a federal agency.

Dr. Drew has lamented many times that the FDA and CDC have generally put forth guidelines, but have never actually interfered with a doctor’s ability to practice, which only changed during COVID and this incessant need to control the flow of information under the guise of preventing so-called “misinformation” or “bad science”.

Therefore, it’s not too far-fetched to see that the FDA holds a lot of influence in the dissemination of information and the perception of medications.

Ironically, the lawyers for the FDA have recently filed for dismissal of the doctors’ complaint, and in this dismissal are some rather choice words used suggesting that the agency’s remarks on Ivermectin were just “recommendations”.

Outlets such as The Epoch Times have reported on this story with the following comment:

The government defended the Twitter post, and another that was posted in 2022, during a recent court hearing. Lawyers said the statements “were not directives” but “recommendations.”

The hearing was on a motion to dismiss a lawsuit filed by three doctors, who said the FDA’s statements on ivermectin unlawfully interfered with their work.

Several other outlets have taken to reporting on this story, and of course some “fact checkers” have come out to make the claim that these remarks were always recommendations and that the FDA is not backtracking on its position:

Click on the image for a link to the article.

So did the FDA backtrack, or were these remarks from the FDA just “guidelines” and “recommendations” all along?

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Several outlets have reported on comments made by one of the FDA’s lawyers, Isaac Belfer, which alludes to these having always been “recommendations”. However, I can’t corroborate these quotes and would therefore rather not use them.

However, some of the language in the dismissal alludes to this idea that the FDA never really made prohibitions, but only provided recommended guidelines against using Ivermectin (emphasis mine):

The cited FDA statements are not “agency action” because they are not “the whole or part of an agency rule, order, license, sanction, relief, or the equivalent or denial thereof, or failure to act.” 5 U.S.C. § 551(13). Instead, they were “purely informational.” Sprint Nextel Corp. v. FCC, 508 F.3d 1129, 1132 (D.C. Cir. 2007) (“purely informational” press release was not reviewable agency action). The cited statements simply communicated FDA’s views about the risks of using ivermectin to prevent or treat COVID-19 and its nonbinding advice that consumers “should not use ivermectin” for that purpose (not “may not” or “must not”). Ex. 1 at 2 (emphasis added); see Ex. 2 at 2; Ex. 3 at 2; Ex. 4 at 2; Ex. 6 at 2; Ex. 7 at 2; Ex. 19 at 2; Ex. 22 at 2. As the Amended Complaint implicitly concedes, the cited statements “discourag[ed],” but did not prohibit, “the use of ivermectin to treat or prevent COVID-19.” Am. Compl. ¶ 86. The September 2021 article and April 2020 FAQ also encouraged consumers to follow their doctors’ advice: “[i]f 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.” Ex. 1 at 3; see also Ex. 2 at 2. The article also recommended that consumers “[t]alk to your health care provider about available COVID-19 vaccines and treatment options” because “[y]our provider can help determine the best option for you, based on your health history.” Ex. 1 at 4 (emphasis added).

There’s that legalese differentiation between should and must. This sort of language pervades the dismissal, and generally emphasizes the point—from the perspective of the FDA—that the FDA never truly put pressure on doctors to not use Ivermectin, or to take disciplinary action against doctors that chose to do so:

The cited statements simply communicated FDA’s recommendations regarding the use of ivermectin to prevent or treat COVID-19. They “neither require[d] nor forb[ade] any action on the part of” Plaintiffs or anyone else, Summers v. Earth Island Inst., 555 U.S. 488, 493–94 (2009), nor did they direct that Plaintiffs face any adverse consequences for prescribing or promoting ivermectin to prevent or treat COVID-19.

The egregious problem with this assumption lies in the fact that, even if the FDA has a legal case for dismissal of these lawsuits, it doesn’t negate the fact that the court of public opinion is where most of the FDA’s opinions have made the greatest, lasting effect.

In essence, the FDA can argue that they technically never made any claims to clamp down on Ivermectin use, but that doesn’t matter if the public assumes that such comments are intended to be taken as fact to be utilized in practice, rather than an opinion and a broad, opinionated guideline.

There’s no doubt that the intended language was meant to be used as justification by doctors and other influential figures to push a narrative and disincentive doctors from practicing as they see fit.

Because by all accounts, the FDA didn’t do much to provide nuanced opinion that relegated the practice of medicine to doctors, but instead fanned the flames of demonization for those who were Ivermectin proponents.

Why else would such absurd tweets be allowed to have been posted? Someone at the agency had to provide some approval to allow the young tech guru at the FDA to make such a post.

And even if it was done by some rebellious, young individual with access to the FDA’s Twitter profile, the FDA never made any remarks to attenuate the damaging messaging that was “horse dewormer”, which became a lasting, divisive meme in the COVID discourse.

Which makes this comment in the dismissal patently absurd, because apparently the dismissal alleges that we, the public, clearly should have known that those tweets were referring to livestock Ivermectin and not people Ivermectin:

Plaintiffs do not plausibly allege that anyone would have understood the informal language in the cited tweets and Instagram post to be “order[s],” 5 U.S.C. § 551(13), prohibiting the use of ivermectin to prevent or treat COVID-19. Moreover, FDA’s “Stop it” and “Hold your horses” statements plainly referred to taking animal-use ivermectin, especially given that both tweets and the Instagram post included images of horses. See Exs. 4, 6–7. Plaintiffs do not allege that they prescribe or promote animal-use ivermectin for human use, nor that doing so would fall within the “practice of medicine.” Am. Compl. ¶ 1 (alleging that FDA “generally cannot ban” off-label “uses of [approved] human drugs”). And both tweets linked to the cited article,23 which included an image of a horse and explained that it was prompted by “multiple reports of patients who have required medical attention, including hospitalization, after self-medicating with ivermectin intended for livestock.” Ex. 1 at 2–3; see Ex. 19 at 2. The cited article also advised consumers to fill an ivermectin prescription “through a legitimate source such as a pharmacy, and take it exactly as prescribed.”

So were we in the public really supposed to understand that the tweet and article included were in reference to animal Ivermectin, or was the use of such an image with the “you’re not a horse” comment meant to infer that only animals take Ivermectin, which we clearly are not and therefore should not take said drug?

I would argue the fact that “horse dewormer” became such a pronounced derogatory phrase against Ivermectin would infer the latter being true, once again alluding to the fact that the FDA is being extremely disingenuous in having the audacity to argue that the public really knew what they [the FDA] were referring to in said tweets.

It doesn’t help that the actual article doesn’t do much to differentiate animal and human use of Ivermectin, and just makes the following comment about this supposed widespread animal Ivermectin use:

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

Remember that such reports may have been overexaggerated and been a case of misinformation themselves:

From Reason

Oh, and let’s also not forget that when Joe Rogan got COVID the media perpetuated the idea that he was taking “horse dewormer” when he actually had a prescription for the human form of the drug.

I don’t recall the FDA making any sort of attempt to attenuate this misinformation, and in reality the FDA never made any remarks at all that provided that additional context.

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So has the FDA actually backtracked, or has there always been some fine-print evidence to suggest that these have actually been recommendations all along?

At the end of the day, I really don’t care which position is correct.

The FDA could be in the right in that these have always been, technically, recommendations and not dictates.

But that doesn’t change the fact that the court of public opinion is where all narratives and ideas either live or die.

It really doesn’t matter if the FDA receives a legal win on this front, because their actions have clearly tainted the already toxic discourse around early COVID treatments and the ability for doctors to be doctors.

So they can go around and tout that they never told people to target doctors’ licenses, or to use regulatory bodies to tattle on those who steered away from the approved COVID treatments, because quite frankly they didn’t need to.

The FDA knew what they were doing in sending those tweets out and the ramifications it would have on public opinion. They didn’t have to relegate themselves to discussions of recommendations or dictates, because they only need to taint the discourse and plant the seeds in others so that they can do the bidding of the FDA while the agency itself can wash their hands of any implication.

And so the FDA can yell “recommendations” all day and night. It doesn’t change the fact that many people took their words to heart and acted accordingly.

The power and influence of the FDA, as well as other agencies, extend far outside the scope of any legal or technical details. It’s the public discourse which truly shapes the opinion and perspective of the layperson, and it’s clearly here where the FDA has done serious, lasting damage.

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