OCEAN OF AVOIDABLE C19 DEATHS
Opinion: There's No Get Out of Jail Card for The FDA: Why – Because theres An ocean of avoidable C19 deaths, the FDA’s Blockades on IVM Condemns the FDA and makes them complicit to avoidable C19 deaths.
Epoch Times Reports: Doctors are free to prescribe #Ivermectin to treat #COVID19, a lawyer representing the FDA said this week.
ABSOLUTE IVM FACTS:
How long has ivermectin been in use for humans?
After more than 25 years of use, ivermectin continues to provide a high margin of safety for a growing number of indications based on its anti-parasitic and anti-inflammatory activities. Study PMID: 26954318
Is it safe to take ivermectin tablets?
Ivermectin tablets for humans, a well-known medicine, is widely used as an antiparasitic drug by the World Health Organization (WHO) in low- and middle-income countries to treat worm infections, scabies and lice. Ivermectin (0.2–0.4 mg/kg) is extremely safe for humans. Source
SAFE AND EFFECTIVE:
IVM was and is safe and effective for early treatment against Covid
Continuing with Epoch Times Editorial: "FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID," Ashley Cheung Honold, a Department of Justice lawyer representing the FDA, said during oral arguments on Aug. 8 in the U.S. Court of Appeals for the 5th Circuit.
The government is defending the FDA's repeated exhortations to people to not take ivermectin for COVID-19, including a post that said, "Stop it."
The case was brought1 by three doctors who allege the FDA unlawfully interfered with their practice of medicine with the statements. A federal judge dismissed the case2 in 2022
Prompting an appeal that was file3 2023 FEB 074.
"The fundamental issue in this case is straightforward. After the FDA approves the human drug for sale, does it then have the authority to interfere with how that drug is used within the doctor-patient relationship? The answer is no," Jared Kelson, representing the doctors, told the appeals court.
The FDA on Aug. 21, 2021, wrote5 on X, formerly known as Twitter: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
PURE GUILE:
The post, which linked to an FDA page6 that says people shouldn't use ivermectin to prevent or treat COVID-19, went viral7.
Shocking Truth Behind the FDA’s Ivermectin Crackdown | Facts Matter
FDA SHOULD HAVE NO OPINION FOR OFF LABEL USE:
that is a prerogative of the treating physician of the patient.
Yet in other statements, the FDA said that ivermectin: "isn’t authorized or approved to treat COVID-19" and “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”
SURE, LOOKS LIKE AN OPINION FOR OFF LABEL USE!
COMMAND OR NOT
"FDA made these statements in response to multiple reports of consumers being hospitalized, after self-medicating with ivermectin intended for horses, which is available for purchase over the counter without the need for prescription," Ms. Honold said.
FDA had approved ivermectin for human use prior Covid-19
A version of the drug for animals is available, but ivermectin is approved by the FDA for human use against diseases caused by parasites.
Ms. Honold said that the FDA didn't purport to require anyone to do anything or to prohibit anyone from doing anything.
"What about when it said, 'No, stop it'?" Circuit Judge Jennifer Walker Elrod, on the panel that is hearing the appeal, asked. "Why isn't that a command? If you were in English class, they would say that was a command."
Ms. Honold described the statements as "merely quips."
{4cm: Nah! Don’t Thinks So Ms. Honold}
Exposing the FDA’s Orwellian Lie About Ivermectin | Facts Matter
"Can you answer the question, please? Is that a command, 'Stop it'?" Judge Elrod asked.
"In some contexts, those words could be construed as a command," Ms. Honold said. "But in this context, where FDA was simply using these words in the context of a quippy tweet meant to share its informational article, those statements do not rise to the level of a command."
The statements "don't prohibit doctors from prescribing ivermectin to treat COVID or for any other purpose" Ms. Honold said. She noted that the FDA, along with the statements, said that people should consult their health care providers about COVID-19 treatments and that they could take medicine if it was prescribed by the provider.
"FDA is clearly acknowledging that doctors have the authority to prescribe human ivermectin to treat COVID. So, they are not interfering with the authority of doctors to prescribe drugs or to practice medicine," she said.
Judge Elrod is on the panel with Circuit Judges Edith Brown Clement and Don Willett. All three were appointed under President Donald Trump.
FEDERAL LAW
The plaintiffs are Drs. Paul Marik, Mary Bowden, and Robert Apter. They say they were professionally harmed by the FDA's statements, including being terminated over efforts to prescribe ivermectin to patients.
Dr. Marik has noted that a number, of studies supports using ivermectin against COVID-19, as the FDA itself has acknowledged8 Some other studies show little to no effect.
Federal law enables the FDA to provide information, such as reports of adverse reactions to drugs, but not medical advice, Mr. Kelson said.
"This is something the FDA has never been able to do. And it's a bright line," he told the court, adding later: "The clearest examples of where they have gone over the line are when they say things like, 'You are not a horse, you are not a cow. Seriously, y'all. Stop it.'"
Judges indicated they agree that the FDA lacks the power to give medical advice; Judge Clement said, "You're not authorized to give medical advice."
But Ms. Honold said the government "isn't conceding that in this case."
She also argued that Congress has empowered the FDA to protect public health and make sure regulated products are safe and effective, giving it the "inherent authority to further its mission by communicating information to the public about safe uses of drugs."
A ruling in favour of the doctors would prevent the FDA from reporting on consumers suffering after cooking chicken with NyQuil or that opioid addiction is a problem, she claimed.
Mr. Kelson said that wasn't accurate. "It's when they step beyond that [and] start telling people how they should or should not be using approved drugs," he said.
Ms. Honold also said that the courts can't hold agencies accountable when they provide false or misleading information: "The FDA is politically accountable, just like all other executive agencies."
RELATED STORIES:
[EPOCH TIMES EDITORIAL] 2022 JUN 06 | Doctors Suing Food and Drug Administration Over Ivermectin | By Alice Giordano READ HERE
[EPOCH TIMES EDITORIAL] 2023 APR 04 | Doctors Appeal Ruling in Favour of FDA Over Ivermectin Posts, Urge Court to Intervene READ HERE
ACKNOWLEDGEMENTS:
Lead Short Epoch Times Clip WATCH HERE
Lead Short Epoch Times Clip Tweet Here
[Editorial] Doctors Can Prescribe Ivermectin for COVID-19: FDA Lawyer9 By Zachary Stieber | 8/10/2023 | Epoch Times | Editorial & Tweet.
Explained: “Close” the stable door after the horse has bolted.10
Editorial: Doctors Suing Food and Drug Administration Over Ivermectin SEE URL: https://www.theepochtimes.com/us/doctors-suing-food-and-drug-administration-over-ivermectin-4515103
Editorial: Judge Rules on Lawsuit Against FDA Over Ivermectin SEE URL: https://www.theepochtimes.com/us/lawsuit-against-fda-over-ivermectin-dismissed-by-judge-4906931
Read Filed Feb Brief HERE https://www.documentcloud.org/documents/23739251-apter-appellants-brief
READ Editorial: Doctors Appeal Ruling in Favour of FDA Over Ivermectin Posts, Urge Court to Intervene SEE URL: https://www.theepochtimes.com/article/doctors-appeal-ruling-in-favor-of-fda-over-ivermectin-posts-urge-court-to-intervene-5168320
Editorial: @US_FDA SEE URL: https://twitter.com/us_fda/status/1429050070243192839
Editorial: Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 SEE URL: https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19
Editorial: FDA Was Excited by Response to 'Edgy' Ivermectin Twitter Post, Documents Show SEE URL: https://www.theepochtimes.com/us/fda-was-excited-by-response-to-edgy-ivermectin-twitter-post-documents-show-4884257
Editorial: FDA Says Ivermectin Doesn’t Work Against COVID-19 but Points to Studies That Show It Does | 2022 DEC 08 SEE URL: https://www.theepochtimes.com/health/fda-says-ivermectin-doesnt-work-against-covid-19-but-points-to-studies-that-show-it-does-4903968
Ashley Cheung Honold DoJ FDA Lawyer
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