The FDA is rightly on trial for their deadly actions related to ivermectin. This quick 49-minute court hearing on August 8, 2023 — Apter vs. HHS, filed by Drs. Apter, Bowden, and Marik — was instructive and astonishing.
Several times, the judges had to insist that the FDA’s attorney, Ashley Cheung Honold, answer a question rather than obfuscate.
As Jared Kelson, the attorney for the three physicians (plaintiffs) said, “The fundamental issue in this case is straight forward.” He noted that nearly 40% of prescriptions prescribed in the U.S. are for off-label use and said: “After the FDA approves a human drug for sale, does it then have authority to influence or interfere with how the drug is used within the patient-doctor relationship? The answer is no.” He further stated that Congress prohibited it.
But the FDA’s attorney, who carefully referred only to ivermectin for animals as though that will exempt them from the impact their statements had on availability of ivermectin for humans, made several astonishing claims:
- JUST HAVING FUN: The FDA’s “You’re not a horse…Stop it” tweet was “merely quips.”
- NOT A COMMAND: “In some contexts those words could be construed as a command, but in this context where FDA was simply using these words as a quippy tweet meant to share its information article, those words do not rise to the level of a command.”
- NO SCIENTIFIC PROCESS: Regularly claimed to the judges that scientific analysis of ivermectin had been performed but then admitted, “I don’t think there’s anything in the record that specifically tracked FDA’s process.”
- NOT YOUR BUSINESS: “It’s not the role of the court to police the statements of an agency charged by Congress with making sure that drugs are safe or effective.” [Since ivermectin is safe and effective, why not say so?]
- ROGUE: When challenged about the FDA’s authority to give its views, whether scientifically tested or not, “There’s nothing in the multiple sources of authority that I’ve cited that require FDA to go through any formal process.”
- MEDICAL ADVICE: “No, your honor, the government is not conceding [that it cannot give medical advice]…It is not only permissible, but it is imperative that the FDA be able to inform the public about their scientific view about safe uses of drugs.”
- WE HAD NOTHING TO DO WITH IT: When asked if FDA had obligation to speak up when hearing that hospitals and pharmacies were denying ivermectin based on FDA’s statements: “No, your honor, those hospitals and pharmacies are sophisticated independent third parties who are not controlled by the FDA.”
- COURT HAVE NO ROLE: When asked who should hold FDA accountable if courts can’t: “The public can elect its government officials and FDA like other government agencies have politically accountable heads of the agency who are held accountable by the political process. It’s not the role of the courts to fact-check the FDA’s scientific statements meant to further their mission to protect the public from dangerous use of this drug.”
If the judges’ questions are any indication, the physicians will win in this case. Stay tuned. I expect this case to be appealed, whatever the decision. To hear the FDA’s attorney making these audacious claims of authority and innocence, start at the 17:30 minute mark.
Good News on Ivermectin Safety
The FDA knew how safe ivermectin was. And now, a first-ever study verifies thesafety of ivermectin. An April 2023 study of ivermectin poisoning out of Cameroon found that a young woman trying to commit suicide took 400 pills of ivermectin (3 mg/each), which is about 100 times the recommended dose. Her neurological and gastric symptoms were treated at the hospital for five days and she was released. She has passed the baccalaureate test and entered the university.
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