FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommend

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"FDA Says Telling People Not to Take Ivermectin for COVID-19 Was Just a Recommendation
By Zachary Stieber
November 19, 2022 Updated: November 19, 2022

The U.S. Food and Drug Administration (FDA) telling people to “stop” taking ivermectin for COVID-19 was informal and just a recommendation, government lawyers argued during a recent hearing.

“The cited statements were not directives. 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,” Isaac Belfer, one of the lawyers, told the court during the Nov. 1 hearing in federal court in Texas.

“They use informal language, that is true,” he also said, adding that, “it’s conversational but not mandatory.”

The hearing was held in a case brought by three doctors who say the FDA illegally interfered with their ability to prescribe medicine to their patients when it issued statements on ivermectin, an anti-parasitic that has shown positive results in some trials against COVID-19.

Ivermectin is approved by the FDA but not for COVID-19. Drugs are commonly used for non-approved purposes in the United States; the practice is known as off-label treatment.

The FDA created a webpage in 2021 titled “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19” and later posted a link to the page on Twitter while writing: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” A second post stated: “Hold your horses, y’all. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

In a separate page, the FDA said: “Q: Should I take ivermectin to prevent or treat COVID-19? A: No.”

Those actions interfered with the doctors’ practice of medicine, violating the laws including the Federal Food, Drug, and Cosmetic Act, the lawsuit alleges.

It asked the court to rule the actions unlawful and bar the FDA from directing or opining as to whether ivermectin should be used to treat COVID-19.

Jared Kelson, an attorney representing the plaintiffs, told the court during the hearing that that informal claim “doesn’t explain the language they actually used: ‘Stop it. Stop it with the ivermectin.'”

The FDA’s actions “clearly convey that this is not an acceptable way to treat these patients,” he argued.

Plaintiffs in the case include Dr. Paul Marik, who began utilizing ivermectin in his COVID-19 treatment protocol in 2020 while he was chief of pulmonary and critical care medicine at Eastern Virginia Medical School and director of the intensive care unit at Sentara Norfolk General Hospital.

After the FDA’s statements, Marik was told to remove the protocol from the school’s servers while Sentara issued a memorandum to hospitals telling them to stop using ivermectin against COVID-19, with a citation to the FDA.

Marik was forced to resign from his positions because he couldn’t prescribe ivermectin due to the FDA’s statements, the suit alleges.

The government has moved to dismiss the complaint, asserting plaintiffs lack standing because the injuries cannot be traced back to the FDA.



"More From the Hearing

During the recent hearing, which was on the motion to dismiss, the government said the FDA could not be blamed for the injuries.

“Plaintiffs have also not shown that any of their claimed injuries are fairly traceable to defendants’ statements because their injuries were caused by independent third-party conduct that was not a predictable response to those statements,” Belfer, the government lawyer, said.

Belfer noted that the FDA’s pages say people can use ivermectin if their health care provider prescribes it, argued the statements “did not bind the public or FDA, did not interpret any substantive rules, and did not set agency policy,” and said the FDA’s position could change in the future if new data become available.

“They also do not have legal consequences for anyone but simply provide nonbinding recommendations to consumers,” he said.

Kelson disagreed.

“If the government is going to label ivermectin a horse medicine or a horse dewormer and promulgate the idea that it is only for animals, then the natural correlation is that doctors who prescribe it are horse doctors or quack doctors, which has played out,” he said. “That is enough of a harm to get into court,” or have the motion to dismiss rejected, he said.

Ivermectin is used on animals in addition to humans. The FDA used a picture of a horse in its Twitter posts and on one of its pages.

“The government engaged in a singularly effective campaign here to malign a common drug that has been used for a very long time and has been dispensed in billions of doses. It’s one of the most famously safe drugs in the history of human medicine. And when people did exactly what the FDA said to ‘Stop it. Stop it with the ivermectin,’ I don’t understand how that would not be traceable back to the FDA,” Kelson said.

U.S. District Judge Jeffrey Brown, a Trump appointee overseeing the case, said that he was most concerned about the social media statements because they did not include any qualifiers.

Belfer argued the statements were aimed at consumers and that the Twitter posts linked to one of the pages, which does include the qualifier.

“So it was predictable that if you include the link to the article, people will click on the link and will see the full article, which includes that disclaimer that if your doctor writes you a prescription, you should fill it exactly as prescribed,” he said.

“The plaintiffs, by their own admission, have continued to prescribe ivermectin. So they always had the authority. It may be that patients were not able to fill prescriptions, but the doctors themselves always had the authority,” he added later.

Brown said he appreciated the briefing from the parties and that he would rule “as quickly as we can for ya’ll.” As of Nov. 19, he has not issued a ruling."

[admin]

Looks like the courts are beginning the process of helping the FDA, CDC, NIH and Anthony Fauci, see the crowds streaming toward them with pitchforks and torches in hand who had friends and relatives, a million of whom died completely unnecessary and easily avoidable, miserable, deaths at the hands of Big Pharma and their captured Anthony Fauci and the NIH, FDA and CDC and the hospital illness Industry and negligent malpracticing doctors. Knocking them off their thrones and helping them see what their future should be, first in U.S. courts and then in a Nuremberg styled world court for crimes against humanity, for having been directly responsible for killing millions of people worldwide - sacrificed on the alter of Big Pharma profits:

[admin]

Looks like Big Pharma's propaganda arm, the FDA, hasn't gotten around to quietly removing their demonization of IVM from their site yet:
Big Pharma's propaganda ministry, the FDA, horses around with IVM as COVID cure



Or the FDA's Twitter account:
https://twitter.com/us_fda/status/1429050070243192839

“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”

https://duckduckgo.com/?q=%E2%80%9CYou+ ... =h_&ia=web
 
The LYING FDA is denying that they ever said NOT to take Ivermectin, nor told doctors they could not prescribe it.

So "Seriously, y’all. Stop it." isn't telling people not to take IVM?

How about: "Why you should not use ivermectin to treat or prevent COVID-19. Using the drug ivermectin to treat COVID-19 can be dangerous and even lethal. The FDA has not approved the drug for that purpose."

Meanwhile, mass treatment of all of the COVID positive testing among 230 million people, 310,783 cases April, cut 97.1% in June, just 22 cases August were treated with no known significant adverse side effects.

While a WHO Bulletin states that Mass treatment with ivermectin underutilized public health strategy

[admin]

video:
https://worldcouncilforhealth.org/multimedia/paul-marik-flccc-lawsuit-employer/

Dr. Paul Marik – FLCCC’s founding member details lawsuit against his employer
Dr. Paul Marik: Lawsuit filed as hospital handcuffs doctors’ ability to save dying Covid-19 patients
Dr. Paul Marik, M.D., FCCM, FCCP, is a Professor of Medicine who has been treating Covid-19 patients in a critical care setting. He joins WCH’s General Assembly meeting to discuss his lawsuit against Sentara Healthcare System after they instituted a policy preventing him and other physicians from administering proven, life-saving treatments.
Legal filing: Dr. Paul Marik v. Sentara Healthcare
This is an edited segment from the weekly live General Assembly on November 15, 2021

Transcript
https://worldcouncilforhealth.org/multimedia/paul-marik-flccc-lawsuit-employer/

A bit about Dr. Paul Marik:

Dr. Paul Marik - Critical Care and Emergency Medicine World Ranking: #2

Dr. Marik has written over 500 peer-reviewed journal articles, 80 book chapters and authored four critical care books. His efforts have provided him the distinction of the second most published critical care physician in the world. He has been cited over 43,000 times in peer-reviewed publications and has an H-index of 77. He has delivered over 350 lectures at international conferences and visiting professorships. As a result of his contributions, he has been the recipient of numerous teaching awards, including the National Teacher of the Year award by the American College of Physicians in 2017.

Meet a few of the medical professionals that we rely on for forum information
https://www.covid-19forum.org/index.php?topic=1554.0

[admin]

Best read at link:
https://childrenshealthdefense.org/defender/doctors-fda-ivermectin-patients/

06/06/22

COVID › News
Doctors Sue FDA, Allege Crusade Against Ivermectin ‘Unlawfully Interfered’ With Their Ability to Treat Patients

In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.
By 
The Defender Staff
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Three physicians are suing the U.S. Food and Drug Administration (FDA) for launching what they allege is a “crusade” against ivermectin as a treatment for COVID-19 that “unlawfully interfered” with the doctors’ ability to practice medicine.

In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.

The suit, filed in the U.S. District Court, Southern District of Texas, Galveston Division, also names the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra and Robert Califf, acting FDA commissioner.

According to the complaint:

“The FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as ‘off-label’ use.

“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship.

“Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”

The plaintiffs said their lawsuit isn’t about whether ivermectin is an effective treatment for COVID-19. It’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.

In their complaint, they site an FDA publication, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” and tweets from the FDA — including one implying that ivermectin is intended only for animals — among examples of the FDA discouraging the use of ivermectin.

    You are not a horse. You are not a cow. Seriously, y’all. Stop it. https://t.co/TWb75xYEY4

    — U.S. FDA (@US_FDA) August 21, 2021

The plaintiffs also argued if the FDA is allowed to interfere with the practice of medicine now, using the pandemic as a cover, “this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”

“This lawsuit, brought by three eminently qualified physicians, is a welcome development,” said Mary Holland, Children’s Health Defense president and general counsel.

Holland told The Defender:

“These doctors rightfully assert that the FDA, assisted by corporate media, have unlawfully interfered in the doctor-patient relationship and the appropriate treatment for individual patients. Regulating the doctor-patient relationship is an area of well-established state, not federal, law.

“I hope these plaintiffs will enjoin the FDA from continuing to restrict access to ivermectin and from penalizing healthcare practitioners who use this licensed drug for their patients.”

The plaintiffs: well-respected in their field, high success rate treating COVID patients

Apter, who is licensed to practice medicine in Arizona and Washington and has a COVID-19 patient survival rate of more than 99.98%, was referred to the Washington Medical Commission and Arizona Medical Board for disciplinary proceedings for prescribing ivermectin to treat COVID-19.

In a press release, Apter said, “If doctors are freed to treat patients according to their best judgment and unprejudiced evaluation of the medical literature, many thousands more deaths and serious disabilities will be averted.”

Apter said the FDA’s pronouncements against the use of ivermectin “have been the basis for disciplinary actions against doctors, interfere with the doctor-patient relationship, and have had a severe chilling effect on the use of life-saving medication for a deadly disease.”

In the lawsuit, Apter argued that government pressure, “largely through the FDA,” also led pharmacies — especially in large corporate chains — to refuse to fill ivermectin prescriptions for COVID-19, because that position is supported by the FDA.

Bowden, who according to the lawsuit has 40 years of experience in emergency medicine, began recommending ivermectin to treat COVID-19 in early 2020. She treated more than 3,900 patients for COVID-19, with a success rate of over 99.97%.

She said the FDA’s actions regarding ivermectin, specifically its directives to stop using the drug to treat COVID-19, harmed Bowden’s ability to practice medicine and treat patients.

Bowden’s employer, Houston Methodist Hospital, last year forced her to resign by suspending her privileges for spreading “COVID misinformation.”

 

Bowden said she is “fighting back — the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.”

In an interview earlier this year with The Defender, Bowden said she was all for the COVID vaccines when they first came out — it was only when she started seeing what was happening with all the breakthrough cases that she wondered, “Why am I seeing so many COVID cases among the fully vaccinated?”

Then her patients began having adverse reactions. “If I hadn’t seen that firsthand, I would still think the vaccine was the way to go,” she said.

As the pandemic evolved, Bowden developed protocols for preventing and treating COVID patients. She said she’s seen excellent results.

“The basis of it is ivermectin,” she said. “And also vitamins C and D, quercetin and zinc, and black seed oil. It’s nothing complicated — and it’s just like with anything in medicine — not one size fits all — protocols are guidelines.”

The controversy over prescribing ivermectin was initially “intimidating and isolating,” she said. “I thought I was a little bitty island in a huge ocean, and now I realize that I’m part of at least half a continent.”

Marik, author of more than 750 publications, was professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia, from 2009 through 2021. He also served as a director of the intensive care unit at Sentara Norfolk General Hospital.

He developed a protocol for EVMS for treating COVID-19, called the EVMS COVID-19 Management Protocol, which included the MATH+ Protocol.

However, according to the lawsuit, Marik was forced to resign from his positions at EVMS and Sentara Norfolk General Hospital for promoting the use of ivermectin — “as well as other safe, cheap, and effective off-label FDA-approved drugs” — to treat COVID-19 following the FDA’s attempts to stop use of those drugs for that purpose.

Marik alleged in the lawsuit that refusing to allow patients to receive effective early treatment for COVID-19 “led to innumerable hospitalizations and deaths, and caused extreme distress for patients, their families, and health professionals.”

Boyden, Gray & Associates, a Washington, DC-based law firm, is representing the plaintiffs.

Ivermectin was developed in the 1970s as a veterinary medicine to treat parasitic diseases in livestock, but a decade or so later was hailed as a “wonder drug” and received approval for human use as a therapeutic against diseases such as river blindness — or onchocerciasis — and lymphatic filariasis, according to Newsmax.

Since 1987, it has been used safely in 3.7 billion doses worldwide. William Campbell and Satoshi Omura won the 2015 Nobel Prize in Physiology or Medicine for their research on the drug.

Studies show ivermectin is associated with lower COVID-19 death rates, but the FDA — with help from mainstream media — continues to state the drug is ineffective for treating COVID."