I must give credit to Andrew L. Schlafly, who is the Counsel for the Association of American Physicians and Surgeons (AAPS). He wrote a powerful and to-the-point amicus curiae brief that was filed in Apter v. HHS, 3:22-cv-194 (JVB) (2022) in the U.S. District Court for the Southern District of Texas. In 12 pages he deconstructed the FDA’s campaign against ivermectin and in the process 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.
One thing that went unmentioned in the brief was the motive for the FDA to undermine the use of ivermectin.
The FDA and the vaccine makers have a problem. And that problem is that scientific studies have proven that ivermectin is a safe and effective (and inexpensive) treatment for what is being called COVID-19. To continue the EUA for the COVID-19 vaccines, they need 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 needs to do is not approve ivermectin, and the EUA for the COVID-19 vaccines continue. And so, ivermectin must go. Thus, the FDA has announced:
On what basis does the FDA make that judgment that ivermectin is not safe or effective? The FDA claims:
That statement by the FDA is not true. There have been 63 studies of the safety and effectiveness of ivermectin in treating COVID-19. Meta-analysis of those studies found an average of 69% and 86% improvement for early treatment and 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. And the amicus brief filed by the AAPS establishes that fact.