Sunday, 17 November 2024

FDA loses its war on Ivermectin: Must remove all related social media content and consumer advisories


fda tweet ivermectin horse cow
© U.S. FDA/X
In December 2021, the FDA warned Americans not to use Ivermectin, which "is intended for animals" to treat or prevent COVID-19.

"Never use medications intended for animals on yourself or other people. Animal ivermectin products are very different from those approved for humans. Use of animal ivermectin for the prevention or treatment of COVID-19 in humans is dangerous," FDA said at the time.

This was a very controversial statement at the time since the FDA pushed the drug on African migrants back in 2015, and the drug was praised in several scientific journals.

There have now been 101 Ivermectin COVID-19 controlled studies that show a 62% lower risk in early treatment in COVID-19 patients.

ivermectin studies covid
© c19ivm.org
A group of brave doctors had filed a federal lawsuit against the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) over the agencies' unlawful attempts to block the use of ivermectin in treating COVID-19.

The lawsuit, filed in the U.S. Southern District of Texas in Galveston, argues that the FDA has overstepped its authority and unjustifiably interfered with their medical practice.

The plaintiffs, Drs. Mary Talley Bowden, Paul E. Marik, and Robert L. Apter, are contesting the FDA's portrayal of ivermectin as dangerous for human consumption. They note that the FDA has approved ivermectin for human use since 1996 for a variety of diseases. However, they allege that with the advent of the COVID-19 pandemic, the FDA began releasing documents and social media posts discouraging the use of the anti-viral drug for COVID-19 treatment.
ivermectin studies covid
© c19ivm.org
"We're suing the FDA for lying to the public about ivermectin," said Dr. Bowden.

Claims were made that the initial article misrepresented the law by stating the FDA's official stance against Ivermectin use without mentioning that doctors were allowed to administer the medicine.

U.S. law is cited in the complaint, including the provision that the FDA
"may not interfere with the authority of a health care provider to prescribe or administer any legally marked device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship."
On Thursday, the U.S. Food and Drug Administration (FDA) reportedly agreed to remove all its previous social media posts and consumer advisories that specifically addressed the use of ivermectin for the treatment or prevention of COVID-19.

"FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history. This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship," Dr. Bowden wrote on her social media.

The plaintiffs have recently received the signed court order and are preparing to issue a press release about it later today.

The Gateway Pundit previously reported that during a hearing, the agency's lawyers argued that the FDA was only giving advice and it was not mandatory when it told people to "stop" taking Ivermectin for COVID-19.

"The cited statements were not directives," said Isaac Belfer, one of the lawyers. "They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it's prohibited or it's unlawful. They also did not say that doctors may not prescribe ivermectin."

"They use informal language, that is true... It's conversational but not mandatory," he continued.

However, the statement from the lawyer contradicted the FDA's social media post, stating, "You are not a horse. You are not a cow. Seriously, y'all. Stop it," and another tweet says, "Hold your horses, y'all. Ivermectin may be trending, but it still isn't authorized or approved to treat COVID-19."

Both tweets displayed the title of "Why You Should Not Use Ivermectin to Treat or Prevent COVID-19" and included a link to that publication.

Last year, Doctors Mary Talley Bowden, Paul Marik, & Robert Apter appeared in the Fifth Circuit Court of Appeals as part of their lawsuit.

"The FDA is not your doctor. Yesterday we took them to court to remind them of that," Dr. Bowden wrote.

"A pharmacist cites CDC and US FDA as why she will continue to deny filling prescriptions for ivermectin. On Tuesday, the FDA's attorney declared the FDA has no problem with doctors prescribing ivermectin off-label. It's time for them to make a formal announcement and set the record straight," Bowden wrote on Thursday.

During the oral argument, Ashley Cheung Honold, a Department of Justice lawyer representing the FDA stated that the agency "explicitly recognizes" that doctors do have the authority to administer ivermectin to treat COVID.

""FDA explicitly recognizes that doctors do have the authority to prescribe ivermectin to treat COVID," said Honold.

"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," Honold said.

"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."

"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.

It can be recalled that Houston Methodist launched an investigation into Bowden and suspended her for defying health authorities and exercising free speech.

The hospital excoriated Bowden for "using her social media accounts to express her personal opinions about the COVID-19 vaccine and treatments," NBC News reports. The suspension barred the physician from admitting or treating patients at the hospital.

Bowden repeatedly warned that it is "wrong" to mandate the experimental mRNA vaccines and continuously touted Ivermectin as a safe and effective treatment amid threats from public health officials against prescribing the drug.

Bowden was forced to resign. In her resignation letter, Bowden doubled down on the efficacy of Ivermectin.

"I have worked hard to provide early treatment for victims of COVID-19. My efforts have been successful. I have treated more than 200 COVID-19 patients, including many with co-morbidities, and none of these patients have required hospitalization. This is a testament to the success of my treatment methods," she wrote. "Throughout this pandemic, there has been no FDA-approved treatment for COVID. Therefore I have done my best to care for patients and save lives in the absence of a clear scientific consensus."

"Early treatment must still be part of any strategy for patient care. That is why physicians and hospitals should pay more attention to medications such as Ivermectin, which significant research and my clinical experience indicate is effective," she continued. "I have decided to part ways with Houston Methodist because of the accusation that I have been spreading "dangerous information." This is false and defamatory. I do not spread misinformation, and my opinions are supported by science. There is substantial evidence for the efficacy of Ivermectin in treating COVID-19, and no evidence for serious or fatal side effects associated with the doses used to treat COVID-19."
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