Court decision awaited in legal challenge to FDA, NIH over suppression of ivermectin
By Linda Bonvie
On November 1st a hearing was held in a Galveston courtroom concerning the future of one of the most significant, yet outrageously underreported lawsuits in the era of Covid.
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.”
The complaint, filed against the U.S. Food and Drug Administration and the Department of Health and Human Services 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 – is over the Nobel Prize-winning drug ivermectin.
But it isn’t about whether ivermectin works against 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.)
Although the FDA wields significant authority, being the most powerful regulatory agency in the country (if not the world), there are still limits to its wide-ranging powers. So perhaps in this age of Internet influencers it shouldn’t be too surprising that that the FDA crossed the line of what it can and can’t do in a calculated, all-out 2021 social media blast, with its biggest results coming from a pivotal tweet.
The all-powerful FDA Tweets
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.
Ivermectin, approved for human use by the FDA in 1996 for the treatment of intestinal parasites, has recently been the subject of more than a hundred clinical studies of more than 100,000 people for use as an anti-viral. Again and again, it has been found to be the safest, most powerful drug for prevention and treatment of Covid, for which it would be considered an “off-label” use.
But despite the common, and quite legal, practice of prescribing drugs for purposes other than an FDA-approved condition (which applies to at least 21% of commonly prescribed drugs, more than 36% of medications ordered in intensive-care settings, and more than 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.
The FDA’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 internal agency 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 more than 23 million people in just two days. “Even I saw it!” Woodcock told her team.
A ‘devastating effect’
That tweet “had a devastating effect,” Dr. Paul Marik, one of the plaintiffs in the lawsuit told me in an interview. “It basically shut down ivermectin.”
The “Not a Horse” tweet, he said, “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, 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 that tweet, he maintained, 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.
(Author’s note: A New Jersey pharmacist told me in December of 2021 when presented with a valid doctor’s prescription for ivermectin that they couldn’t fill it as they “were told not to stock [ivermectin]…we got a very scary notice from the Board of Medical examiners,” he said, adding that ivermectin is “not approved for use in human beings.” When I told him that it most certainly is approved, he said “not in this case it isn’t,” and advised me to “take it up with the FDA.”)
“There is no question that [tweet] was a turning point,” Marik added, one that has led to the deaths of hundreds of thousands of people” who were subsequently denied treatment with this life-saving med.
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.
Displaying photos of a horse, a man and a woman in medical scrubs, and a masked “patient,” it has become the highest-ranked and linked-to authority on the subject of ivermectin. It is also riddled with disinformation, both brazen (e.g., containing source code stating that the drug may be “lethal”) and implied (that ivermectin is primarily meant to treat livestock).
Originally published in March of 2021, the Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 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.
The November hearing, before Judge Jeffrey V. Brown at the Galveston Federal Courthouse was a result of a motion to dismiss the lawsuit (as of this writing Judge Brown has yet to render a decision) filed by FDA and HHS, citing a variety of legal arguments such as lack of standing to sue, “sovereign immunity” (in essence that the federal government cannot be sued without its consent, i.e., “the King can do no wrong”), and that the plaintiffs should have taken their disputes directly to the FDA with a citizens petition before filing a lawsuit.
The FDA was represented at the hearing by a trial attorney out of the Department of Justice Consumer Protection branch (which along with protecting consumers also protects the FDA by having the “special role” of defending the agency in civil litigation), who repeatedly said that the FDA’s comments on ivermectin did not represent a “decision-making process,” and “did not say you may not do it…(that) it’s prohibited or it’s unlawful.” As for the viral Tweets and other social media posts, those simply used “informal conversational language,” the attorney argued, with Judge Brown interjecting “Well, they very flippantly say ‘stop it’ in the tweet.”
Interestingly enough, however, the DOJ attorney also argued that the high-ranking Why You Should Not Use Ivermectin webpage contained a “disclaimer” saying if your doctor provides you with a prescription for ivermectin “take it exactly as prescribed.”
But the webpage in question is so deliberately mangled in its content, starting out with a photo of a horse, and using hot-button key words such as “dangerous,” “unsafe,” “misinformation,” and “overdose,” that the so-called “disclaimer” has little meaning. The only reasonable take-away from the webpage is quite simple: you should NOT use ivermectin. As the plaintiff’s attorney said, the “‘you are not a horse, you are not a cow’ campaign…started labeling doctors (who prescribe ivermectin) as essentially…quack(s).”
And even the rationale behind the creation of the page in the first place – that the FDA had “received multiple reports of patients who required medical attention…after self-medicating with ivermectin products intended for livestock” – falls short.
Investigative journalist Mary Beth 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 only four such reports.
Despite all the legal language attempting to prove that the 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.”
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,” the 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. For example, FDA head Califf told health journalists during a talk this past 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.
Disclaimer: These statements have not been evaluated by the Food and Drug Administration. The contents of this post are for informational purposes only and are not intended to be a substitute for professional medical advice, diagnosis or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.