During the COVID-19 scamdemic, the FDA and the vaccine makers had a problem. That problem was that scientific studies had proven that ivermectin is a safe and effective (and inexpensive) treatment for COVID-19. To continue the emergency use authorization (EUA) for the COVID-19 vaccines, they needed to maintain that “that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition.” The FDA controls what is approved. All the FDA needed to do was not approve ivermectin, and the EUA for the COVID-19 vaccines would continue. And so, ivermectin had to go. Thus, the FDA has announced:
On what basis does the FDA make the judgment that ivermectin is not safe or effective? The FDA claims:
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.
That statement by the FDA is not true. There have been 63 studies on the safety and effectiveness of ivermectin in treating COVID-19. Meta-analysis of those studies found an average of 69% improvement for early treatment and 86% improvement for prophylaxis. Those numbers are probably conservative because researchers found a negative bias against ivermectin in a review of the studies. The researchers determined that the statistical probability for the studies to falsely portray a positive outcome for ivermectin is one in one trillion.
In the face of that evidence of ivermectin efficacy, the FDA claims that “[c]urrently available data do not show ivermectin is effective against COVID-19.” There is no other way to put it: the FDA is lying.
The FDA misleadingly portrayed ivermectin as a treatment for animals, with the message: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
The FDA’s campaign against ivermectin was utterly fraudulent. The misleading campaign, complete with a picture of a horse, suggested it was a veterinary medicine and not fit for humans. The FDA ominously warned that “[u]sing the drug ivermectin to treat COVID-19 can be dangerous and even lethal.” In reality, ivermectin is an FDA approved drug that has been proven safe and effective for human use. In 2015, the Nobel Prize for Medicine was given for the discovery of ivermectin.
In the case of Apter v. HHS, several doctors sued the FDA for its recommendation against taking ivermectin as a remedy for COVID-19. The doctors bringing the lawsuit alleged that the FDA’s recommendation that ivermectin not be used to treat COVID-19 interfered with the doctors’ ability to exercise professional medical judgment in practicing medicine. The FDA recommendation against ivermectin also harmed the doctors’ reputations. One doctor was referred for discipline to two state medical boards for prescribing ivermectin to treat COVID-19. Those disciplinary charges were founded on the FDA recommendation against ivermectin. The doctors further stated that pharmacies followed the FDA recommendation and refused to fill ivermectin prescriptions for their patients. One of the doctors lost her admitting privileges at a hospital after she tweeted about using ivermectin to treat patients with COVID-19. Another doctor lost his position at a medical school and a hospital because he promoted the use of ivermectin.
Andrew L. Schlafly, the Counsel for the Association of American Physicians and Surgeons (AAPS) wrote a powerful and to-the-point amicus curiae brief filed in Apter v. HHS, in the U.S. District Court for the Southern District of Texas. In 12 pages, he deconstructed the FDA’s campaign against ivermectin and revealed that the FDA emperor has no clothes. The AAPS brief states, in pertinent part:
Defendant FDA has improperly exploited misunderstandings about the legality and prevalence of off-label uses of medication, in order to mislead courts, state medical boards, and the public into thinking there is anything improper about off-label prescribing. Not only is off-label prescribing fully proper, legal, and commonplace, but it is also absolutely necessary in order to give effective care to patients. It has never been proper for the FDA to interfere with that essential part of the practice of medicine, and the FDA knows it. Yet it has engaged in a campaign of interference with the proper use by physicians of ivermectin, which has long been approved as fully safe for human use.
Defendant FDA lacks both the authority and the expertise to practice medicine, interfere with the practice of medicine, guide the practice of medicine, or advise about the practice of medicine. Federal law is clear about this, and common sense reinforces it. FDA employees are not practicing physicians, and are not treating patients. FDA employees, for the most part, are not even licensed physicians.
It follows, from the recognition by the Supreme Court that off-label uses are ethically required, that it is wholly improper for the FDA to interfere with such off-label practices. Ivermectin has long been a medication fully approved as safe for humans. That is where the FDA’s authority begins and ends. Beyond that, it is exclusively a matter of state law in authorizing physicians to prescribe approved-as-safe medications for the benefit of their patients. When a physician is fully licensed by a state to practice medicine, then he has the authority without interference by the FDA to prescribe an approved-as-safe medication such as ivermectin to treat Covid-19 or any other illness.
The FDA is without authority to interfere with prescriptions by physicians of this approved as-safe medication for treating Covid-19 or any other condition.
Despite the soundness of the doctors’ arguments, the federal district court ruled against the doctors in Apter v. HHS. The district court decided that the FDA has the authority to recommend against ivermectin. The doctors appealed. And the U.S. Court of Appeals for the Fifth Circuit reversed the district court ruling. The court of appeals ruled that the FDA acted outside its authority by recommending against taking ivermectin. The legal term for acting outside one’s authority is ultra vires. The court ruled that the FDA has no authority to endorse, denounce, or advise medication. The FDA may inform, announce, and apprise—but it cannot go beyond that to recommend for or against a medical treatment.
The court of appeals ruled that recommendation and medical advice are the province of the medical profession. The court concluded that the “FDA is not a physician. It has authority to inform, announce, and apprise—but not to endorse, denounce, or advise.” What the FDA did by giving medical advice for the public not to take ivermectin was the practice of medicine, and the FDA was not qualified to do that. The FDA acted ultra vires. Even tweets posted on Twitter violated the law. The court stated that “[e]ven tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.” The FDA acted illegally by advising the public not to take ivermectin to treat COVID-19.