The FDA Settled With Us Because They Knew They Were Going To Lose

After 4 years of catastrophic health agency tyranny, physicians finally score a legal victory. I think the FDA settled because their Pharma masters were terrified of discovery. Here is the backstory.

In my book, The War on Ivermectin, Chapter 33 is called “The Horse Dewormer PR Campaign.” I invite you to see this previous post where I detail the campaign’s highly coordinated and sequentially timed actions between the FDA, CDC, AMA, APHA and corporate controlled media (i.e. late night hosts, news broadcasts, newspapers etc). Clearly, the goal of the campaign was to convince the public that ivermectin was a dangerous and ineffective horse dewormer.

In the wake of that campaign, pharmacies stopped filling valid, legal prescriptions and hospitals removed ivermectin from their formularies. Never had an FDA approved drug, one of the (if not the) safest prescribed medications in history ever been vilified or restricted to this extent. Just like hydroxychloroquine, ivermectin had to be stopped.

The FDA’s role in that campaign started with the posting of the below tweet on August 21, 2021, a week after the report on the below left came out, showing a massive rise in ivermectin prescriptions in the U.S during the deadly Delta wave.

The rise in prescribing terrified the Covid cartel because if further knowledge of ivermectin’s efficacy were to be gained “on the ground” (i.e from the direct, lived experience of physicians and patients) it would limit the impacts of their corrupted trials and negative statements by corrupted agency heads and professional societies.

Obviously my readers know why “they” had to bury the evidence of efficacy of ivermectin at all costs: little ‘ole ivermectin threatened both the EUA for the vaccines and the global vaccine market (north of a $100 billion). It also threatened the markets for all the competing pricey, patented, pipeline pharmaceuticals like Remdesivir, Paxlovid, molnupiravir and the monoclonal antibodies (also massive global markets in the many billions).

Pharma’s greatest weapon to attack ivermectin is the FDA. Pharma (and especially Pfizer) has near complete control of the FDA (and the CDC and the NIH). But the FDA couldn’t do it all by themselves so they called in the CDC to do some dirty work: 5 days after the FDA tweet the CDC sent out a warning advisory to all the state medical boards (which was then forwarded to every licensed physician in the country):

Problem (but not really): the CDC memo was full of false and misrepresented data on a rise of “calls to poison control centers.” My close colleagues Mary Beth Pfeiffer and Linda Bonvie, both investigative journalists, did a deep dive into the CDC advisory and published the real truth:

Literally, that is all they had to start a war with? A tiny number of calls to poison control centers from people asking questions about ivermectin? It turns out it is all they needed because that is when Weber Shandwick launched an all out PR campaign across the worlds media.

Anyway, 3 days after the CDC memo they then trotted Fauci out on national TV to state absurd, easily disprovable lies (please watch, it is short).

Then 2 days after that, they got three major professional societies to call for an end to using fentanyl (err, I mean ivermectin):

And then they called in for mass media firepower:

I believe (without evidence) that the tweet and the entire PR campaign was devised and executed by Weber Shandwick, the massive PR firm that simultaneously works for the CDC, Moderna, and Pfizer (at the risk of foreshadowing, I also believe, without evidence, that the entire reason the FDA settled this case is because discovery would be severely damaging to many people involved).

I do have to hand it to Weber Shandwick though because they devised a highly effective (lethal) campaign to end the use of ivermectin. That tweet went absolutely viral and became the FDA’s most popular tweet in history. I believe that tweet was the opening shot that completely turned from what had been isolated “battles” against ivermectin into an all-out war (my book details the more covert preceding actions by big Pharma).

To wit, way before the FDA’s famous horse tweet, in March of 2021 they posted this page on their website, later updated December of 2021:

Although the way it was written was nonsensical (conflating human and animal ivermectin and saying that taking large doses can be dangerous (duh)) it still proved highly successful in its objective: to get everyone to know that the largest health regulatory agency in the world felt that ivermectin was dangerous, ineffective, and to remind everyone that they do not “authorize or approve” of its use in Covid.

Anyway, after the tweet started to go viral it apparently thrilled the FDA Commissioner Janet Woodcock (emails obtained through FOIA by Linda Bonvie):

Their prideful celebration did not end there. Check out these FDA officials celebrating their cleverness and how “their idea” (not) for the tweet was triggered by the CDC memo regarding Mississippi:

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Anyway, lets get to the case now. The case was actually initiated by Clayland Boyden Gray, a famous lawyer who founded one of the highest-powered law firms in Washington D.C. He formerly worked as White House Counsel from ‘81-93 and later as an Ambassador to the European Union. He also founded the law firm Boyden Gray and Associates and he was a lovely gentleman revered by his employees and partners (I know this because he later became a patient of mine before he unfortunately died suddenly in May of 2023).

It deeply saddens me that he isn’t alive to witness his firms stunning legal victory. Note that he had a long history of suing federal and regulatory agencies for wrongdoing and he saw that what the FDA had been doing against ivermectin was illegal and harmful.

Boyden wanted to put a stop to this as he knew they were overstepping their statutory authority. But he needed plaintiffs to bring the suit and so he called my partner Paul Marik as well as Dr. Robert Apter and the amazing physician and activist Mary Talley Bowden. Mary actually had the most standing in the case as she had recorded calls and videos of pharmacists declining to fill her prescriptions by arrogantly citing the FDA’s “opinion” on ivermectin.

As we all know, the FDA’s “opinion” was misleading and deceptive - once a drug receives FDA approval for a disease, it can legally be used to treat any other disease, a practice called “off-label” prescribing. The FDA knows this full well. They knew that no physician needed a Covid-specific “approval” or “authorization.”

Know that 20% of outpatient prescriptions and 30% of inpatient prescriptions are written in this off-label manner, and the FDA literally champions the practice for very sound reasons:

*I think it is important to note this page above was last edited in 2018. I suspect they will disappear that page soon.

Basically, many medicines have multiple pharmacologic mechanisms of action and so can be useful in different diseases. Ivermectin probably has the broadest applicability of any medicine that I am aware of (anti-parasitic, anti-viral, anti-bacterial, anti-inflammatory, and anti-tumor). As Professor Satoshi Omura, the Nobel Prize winning discoverer of the drug said in his Nobel acceptance speech, it truly is a “Wonder Drug.”

Now, beyond the tweet, the FDA also went on the warpath across all other major social media. For example, check out what they now have to pull down from the internet and not republish (from the actual settlement document):

(1) FDA’s Twitter, LinkedIn, and Facebook posts from August 21, 2021 “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, that reads, “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”;

(4) all other social media posts on FDA accounts that link to Why You Should Not Use Ivermectin to Treat or Prevent COVID-19

The above social media campaign was not the only thing they did. Remember, this was an all-out war on one of the safest drugs in history. Although the initial salvo started on social media, it didn’t end there.

4 months later, in another attempt to influence the practice of medicine, they sent letters to the Federation of State Medical Boards and the American Board of Pharmacy. If you read the below, you will see they completely over-hype the dangers of ivermectin by listing the almost unimaginably rare and more severe side effects, with the most severe only occurring in massive accidental overdoses (3rd paragraph).

This is what I mean by them being on the warpath:

Now when the lawsuit was first filed, obviously the FDA moved immediately to dismiss, and they did so by arguing that they cannot be sued because they have “sovereign immunity.” You can’t make this stuff up. What you also can’t make up is that the District Court judge… agreed with them and… dismissed the case. What?

But Boyden Gray doesn’t play. He immediately appealed the case because he knew that, although Federal law actually does gives the government immunity against legal actions, there are some exceptions such as “ultra vires,” a term describing when an official acts outside their authority. Plaintiffs challenging the acts must show that the official was “acting without any authority whatever,” or without any “colorable basis for the exercise of authority.”

Our amazing FLCCC lawyer, Alan Dumoff wrote an amicus brief submitted by our organization (found here on the FLCCC website) and although extremely long, the table of contents lays out the arguments powerfully:

Boyden’s decision to appeal was spot on because the appeals court judge was truly miffed at the FDA and immediately ruled that the plaintiffs had standing and that the lawsuit could proceed. This was a huge win back then in “our” court of public opinion, largely because the FDA lawyer had to admit in open court that physicians did indeed have every right to prescribe ivermectin off-label for Covid.

It gets even better because in the appeals court opinion, the Judge went off on the FDA with the following statements:

• “FDA can inform, but it has identified no authority allowing it to recommend consumers ’stop' taking medicine”

• “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.”

• “Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority” (Ed: I love this one).

Now that the FDA has to take down every single one of their posted and/or published advice against using ivermectin in Covid, in our FLCCC Press release today, I think Paul Marik said it best:

“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” said Paul E. Marik, M.D., FCCM, FCCP, a plaintiff in the case, chief scientific officer of the FLCCC Alliance (FLCCC) and former Chief, Pulmonary and Critical Care Medicine at Eastern Virginia Medical School.  “The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’” 

However, it is my opinion that, because the case ended in a settlement, we cannot claim total victory because it allows the FDA to continue to lie with statements like this one today claiming they are not guilty of wrongdoing:

“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.

But I trust the wider public can see right through such a statement. I mean, who will believe that they can claim innocence when they were forced to settle? You only settle when you know you are going to lose in court or… you cannot risk going through the discovery process. Like I said above, my bet is that they wanted to avoid discovery at all costs.

Either way, the plaintiffs, Boyden Gray and Associates, and the FLCCC landed a big victory today against one of our most captured federal health agencies. A win against tyranny really. They certainly don’t come often of late but lets see if we can turn this into a streak!

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