FDA overstepped against ivermectin
The last chapter has now been written in one of the strangest and most disturbing stories of the COVID pandemic era.
It's strange and disturbing because the
U.S. government intentionally misled the public about an approved drug that has been around long enough for a cheap generic version to be readily available.
The drug is ivermectin, and the “last chapter” is the settlement of a lawsuit by three doctors who charged that the Food and Drug Administration acted beyond its legal authority with its campaign to prevent the use of ivermectin to treat COVID.
While refusing to admit any wrongdoing, the FDA has now agreed to remove from its website a page titled, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19.” The agency will also remove its social media posts linking to that page, including two memes from August 2021 that featured pictures of horses. One was captioned, “You are not a horse. You are not a cow. Seriously, y'all. Stop it.”
“FDA is not a physician,” said the Fifth Circuit Court of Appeal. “Even tweet-sized doses of personalized medical advice are beyond FDA's statutory authority.”
The appeals court allowed the doctors' lawsuit to go forward, agreeing that the FDA does not enjoy sovereign immunity from lawsuits when it is acting beyond the authority it has been granted by law. After the appeals court refused to dismiss the lawsuit, the agency rushed to settle the case before it could move forward to the discovery phase, when the doctors would have been entitled to obtain documents and testimony under oath.
As background to this story, a few facts:
• Ivermectin is an FDAapproved drug for humans. (There is also a veterinary version.)
• Doctors have the legal authority to prescribe FDA-approved drugs for an “off-label” use, and they do this frequently.
• Under federal law, a new vaccine, drug or medical device cannot receive “Emergency Use Authorization” unless there are “no adequate, approved, and available alternatives.” That's according to the FDA's own website.
Because the government wanted to distribute the new mRNA vaccines for COVID, “Emergency Use Authorization” was necessary. But the vaccines and expensive new drugs to treat COVID could not receive emergency authorization if doctors were out there prescribing long-approved drugs and having success treating COVID with them.
In August 2021, the life-sciences data and analytics provider IQVIA released a National Prescription Audit Weekly report showed that retail pharmacies were seeing a surge in ivermectin prescriptions. That's when the government's effort to persuade the public that ivermectin was a dangerous “horse dewormer” began.
The doctors who brought the lawsuit against the FDA were Paul Marik, Robert L. Apter and Mary Talley Bowden.
From the Fifth Circuit decision:
“The Plaintiffs–Appellants in this case are three Doctors who have prescribed the human version of ivermectin to thousands of patients suffering from the coronavirus. The Doctors allege that the [FDA social media] Posts interfered with their individual `ability to exercise professional medical judgment in practicing medicine.' The Doctors also allege that the Posts harmed their reputations.”
Dr. Apter said he was referred to two state medical boards for prescribing ivermectin to treat COVID-19. Dr. Bowden lost her admitting privileges at a hospital after tweeting about using ivermectin to treat COVID-19 patients. Dr. Marik lost his positions at a medical school and a hospital for “promoting the use of ivermectin.”
How are we going to prevent this from ever happening again?
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