How RESCUE Exposed FDA, NIH Lies

Our investigative reporting is part of a major lawsuit by Dr. Paul Marik et al. to stop government interference in ‘The Practice of Medicine’

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Dr. Paul Marik, the second-most-published critical care doctor in history, leads a major lawsuit against the federal government, fighting for the right for doctors to be doctors again.

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Stop it, y’all. We’re all tired of government lies.

An FDA webpage with photos of a horse, a man and a woman in medical scrubs, and a masked “patient,” has somehow become the highest-ranked and linked-to authority on the subject of ivermectin. It is also riddled with lies, both brazen (e.g., containing source code stating that the Nobel Prize-winning drug may be “lethal”) and implied (that ivermectin is primarily meant to treat livestock).

Titled Why You Should Not Use Ivermectin to Treat or Prevent COVID-19, this webpage and the wildly successful FDA social media posts surrounding it that have made up the agency’s “smear campaign” against this extraordinarily safe and cheap generic drug also figure prominently in an ongoing lawsuit.

That complaint, filed in June by the D.C. public policy firm of Boyden Gray & Associates on behalf of three top-level doctors with expertise in critical care and the treatment of covid—Paul Marik, Robert Apter and Mary Bowden—against the U.S. Food and Drug Administration and the Department of Health and Human Services, isn’t about whether ivermectin works against covid. More than a hundred clinical studies of more than 100,000 people have shown it’s the safest, most powerful drug for prevention and treatment of covid.

It’s not about whether ivermectin saved millions of lives and reduced or ended the pandemic in cities, regions, and countries around the world, including Mexico, Brazil, and India, whose life-saving stories and public health agencies were censored by Western media. It’s about how the FDA managed to break with both law and tradition by interfering with “the practice of medicine.” (The Federal Food, Drug, and Cosmetic Act, which was passed by Congress in 1938, specifically prohibits the FDA from interfering “with the authority of a health care practitioner to prescribe” drugs approved for human use.)

A ‘devastating effect’

The facts surrounding this case seem almost too wild to be true. Yet, the absolute acceptance of the FDA’s hokey but highly manipulative Tweets (“Hold your horses, y’all” ivermectin isn’t “authorized or approved to treat COVID-19”), Instagram posts (“You are not a horse, stop it with the ivermectin”), and other venues have become gospel for the general public, courts, comedians, media, health professionals, and, shockingly, even state medical boards. 

An investigative article by Mary Beth Pfeiffer and me that appeared last October in RESCUE is included as an exhibit in the lawsuit as part of the evidence against the FDA. In it, we exposed FDA emails that chronicled the agency’s delight as its Tweets linking to that high-ranking webpage spread worldwide and were read by millions of people. In another RESCUE article, Pfeiffer and I exposed CDC emails to show how a campaign that alleged there were thousands of ivermectin calls to poison control centers around the U.S. was built on a handful of reports to one state poison control center—and how the New Mexico Health Department was issuing bogus statements saying that several people there had died because they took ivermectin.

Originally published in March of 2021, the FDA webpage is currently the top result in Google searches and has been linked to more than 160,000 times by sites from Politifact to the Los Angeles Times to CNN to the American Medical Association. The page has a top “authority score” representing “trustworthiness and authority” using metrics that measure a webpage’s “quality and SEO performance,” according to Semrush, an Internet data company.

At stake is the ability of doctors to practice medicine without interference from the FDA, including keeping their authority to prescribe approved drugs “off label.” Despite the common, and quite legal, practice of prescribing drugs for purposes other than an FDA-approved condition (which applies to at least 21 percent of commonly prescribed drugs, over 36 percent of medications ordered in intensive-care settings, and over a quarter of those used in a surveyed pediatric emergency department), the FDA somehow managed to hoodwink the public at large into believing that if ivermectin wasn’t specifically approved to treat covid-19, it was risky and illegal to do so. For the icing on this fake cake, the agency made big use of the fact that ivermectin is also permitted for veterinary uses, something that’s also true of 167 other drugs approved by FDA for both animals and humans.

Recently filed in support of the case are two amicus briefs, one from the Association of American Physicians and Surgeons, and the other from America’s Frontline Doctors.

Calling it a “matter of great public importance,” AFLDS states that the FDA “illegally launched an anti-ivermectin propaganda campaign, in direct violation of federal law.” 

The AAPS notes that the Supreme Court has held that “off-label use is widespread in the medical community and often is essential to giving patients optimal medical care…”

The AAPS also remarks in its brief that “ivermectin has long been a medication fully [FDA] approved as safe for humans. That is where the FDA’s authority begins and ends,” it wrote.

Only where ivermectin is involved, it apparently doesn’t.

The agency’s External Affairs Department, thrilled by its viral success via Twitter, LinkedIn, Instagram, and other platforms with messaging that implied ivermectin was an unapproved drug and only intended for horses and cattle, shared high-fives in emails with then Acting Commissioner Janet Woodcock. The agency’s August 2021 “Not a Horse” tweet, said to be “the most popular post we’ve ever had on Twitter” by FDA staff, reached over 23 million people in just two days.

That tweet “had a devastating effect,” said Dr. Paul Marik, one of the plaintiffs in the lawsuit, “It basically shut down ivermectin.”

The “Not a Horse” tweet, he added, “is what precipitated the beginning of my decline at the medical school.” Marik is referring to his position as a professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, Virginia, a position he held from 2009 to 2021. And despite being at first lauded for developing a successful protocol for covid—one that included ivermectin—after the tweet everything changed.

“As soon as that tweet came out I was persona non grata, no one would talk to me,” he said. “I was isolated, I was shunned, and I was basically told, despite being tenured, to keep quiet.”

The other two plaintiffs in the case, Dr. Mary Talley Bowden, a Texas physician, and Dr. Robert Apter, who practices in Arizona and Washington state, have found themselves facing similar attacks. Despite both having a nearly 100 percent survival rate for the thousands of patients they treated and consulted with for covid, the fact that they endorsed ivermectin had a devastating effect on their medical careers. 

Dr. Apter is currently facing disciplinary proceedings before the Washington Medical Commission and the Arizona Medical Board. Dr. Bowden was forced into resigning her position at the Houston Methodist Hospital after the hospital suspended her privileges, announcing the suspension on Twitter. 

The “Not a Horse” tweet also coincided with pharmacies around the country refusing to fill ivermectin prescriptions. 

“They said they couldn’t [dispense it], saying that was coming from the head office,” said Dr. Marik, “but we found out that none of the big chains had a policy prohibiting the dispensing of ivermectin.”

“They [pharmacists] were asking for codes, and if the ivermectin prescription was for covid, they were refusing them, which is beyond their authority,” he said. 

“There is no question that [tweet] was a turning point,” he added, one that has led to the deaths of hundreds of thousands of people.”

But if the “Not a Horse” tweet was a turning point, the FDA’s Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 webpage is the agency’s anti-ivermectin cornerstone.

Purely informational?

According to a battery of attorneys representing the FDA and HHS, however, who responded with a motion to dismiss the complaint at the end of August (that will be heard by Judge Jeffrey V. Brown on November 1), that top-ranked webpage was “purely informational” and the social media posts merely used “informal language.” 

“The cited statements simply communicated FDA’s views…that consumers ‘should not use ivermectin’ for that purpose (not ‘may not’ or ‘must not’),” the dismissal motion states.

Despite all the legal language attempting to prove that FDA was simply sharing its opinion on ivermectin, the webpage itself appears to have been planned to deliver a clear message.

Hidden code added to the back end of the page for the “snippet”—the short description that turns up in search results (currently showing in Microsoft’s Bing)—states: “Using ivermectin to attempt to treat COVID-19 can be dangerous and even lethal.”  

And even the rationale behind the creation of the page in the first place, that FDA “received multiple reports of patients who required medical attention…after self-medicating with ivermectin products intended for livestock,” falls short. 

My investigative colleague Pfeiffer, who has written extensively on ivermectin, asked the FDA in March of 2021 what it meant by “multiple reports.” The agency responded that it was aware of four such reports.

But publishing such misleading information about ivermectin is now the norm. Cloaked with confusing terminology or “informal language” such as “Hold your horses y’all,” FDA has led the charge in disorienting and frightening consumers about the drug and its amazing safety profile and value in saving lives from covid. FDA head Califf told health journalists during a talk this spring that “misinformation is now our leading cause of death,” with people taking ivermectin cited as a prime example.

For plaintiff Dr. Mary Bowden, “fighting the system has been a much bigger challenge than fighting the disease…the FDA’s smear campaign against ivermectin continues to be a daily hurdle to overcome.

“I am fighting back,” she said of the current legal battle to halt the official suppression of a medication proven to be both safe and effective in staving off a virus that the medical community continues to insist remains a threat to the lives of Americans on a daily basis—and for which it continues to recommend experimental injections that have been shown to be neither.