Ivermectin: Why is the FDA Opposed to Using it to Treat COVID?

IVERMECTIN in white bottle packaging with scattered pills. Isolated on blue background. Horizontal shot
The drug ivermectin is safe, has been used billions of times and basically “obliterates transmission” of Covid-19. So why doesn’t the FDA want you to use it?

Doctors and researchers rarely use the term “wonder drug,” but where ivermectin is concerned it’s rated right up there with penicillin in having had the greatest impact on the “well-being of Mankind.”

And up until a group of experts in critical-care medicine announced last year that ivermectin should be a “core medication in the prevention and treatment of Covid-19” it appears that no health authorities had any hesitation about the safety of this miracle drug.

Since its introduction in 1987 as treatment for a parasitic disease, the World Health Organization has called it a safe and effective medication that “has single-handedly transformed the lives of millions…” That same year, its manufacturer, Merck, announced it would mount an unheard-of humanitarian effort by donating ivermectin to certain tropical countries for as long as it was needed. In 1996 the FDA approved its use in humans (it had been previously OK’d for animals) for two types of parasitic infections, and in 2015 the two researchers, one with Merck, who developed ivermectin won the Nobel Prize in medicine.

Quite an impressive history, to say the least. But now it may take a court order to be treated with ivermectin should you happen to find yourself in a hospital being treated for Covid.IVERMECTIN in white bottle packaging with scattered pills. Isolated on blue background. Horizontal shot

Take the case of Nurije Fype, a 68-year-old Covid patient who has been in the ICU unit of a suburban Chicago hospital since early April. As her condition deteriorated, she was placed in a coma and on a ventilator at the end of last month.

Fype’s daughter, Desareta said she had been fighting with hospital authorities to get her mother dosed with ivermectin (off-label prescribing is a legal and common practice) starting on her second day in the hospital and every single day since April 20, finally taking them to court.

The judge agreed with her, and when bizarrely no health-care workers affiliated with the hospital would administer ivermectin to Fype, officials there were told by the judge to “get out of the way” and allow any licensed doctor to administer it. (According to her daughter, Fype, although still hospitalized, is slowly heading in a good direction since receiving several doses of ivermectin.)

And Fype’s case isn’t the only one.

In Buffalo, 80-year-old Judith Smentkiewicz’s family also had to go to court to get her treated with ivermectin. As her son Michael recounted, the hospital told him that they “don’t experiment on patients.” The family persisted, however, and the hospital gave Judith just one dose of ivermectin in January, after which she showed enough improvement (within 48 hours) to be taken off a ventilator and moved from the ICU.

That “miracle,” however, was short-lived. When Judith started going downhill again, Michael’s pleas for more doses of ivermectin hit a brick wall. Taking the matter before a judge with reams of research as well as backing from Judith’s family physician, they obtained a court order for ivermectin to be administered. But even that was met with resistance from hospital attorneys, who claimed that the court doesn’t have the power to “prescribe medications.”

After additional legal skirmishes with the hospital, Judith received three more doses of the drug and “turned around,” according to Michael. She is now recovering back home, saying that she had “no idea any of this was going on.”

As the family attorney Ralph Lorigo said, “so many people are dying today, and this gives them a chance.” Lorigo has successfully represented several other Covid patients, including 81-year-old John Swanson, who was taken off a ventilator after just one dose of ivermectin.

Why it should be so difficult to have a family member receive a potentially lifesaving drug that has been safely used for more than 30 years and billions of times may never be known.

But what we do know about ivermectin and Covid is easily available, all thanks to a group of highly respected doctors who set out in early 2020 to research protocols in treating and preventing Covid-19.

Follow the Science

Most of the data being presented to courts, doctors and hospitals on behalf of Covid-19 patient protocols involving ivermectin comes from the Front Line COVID-19 Critical Care Alliance (FLCCC), a group of “highly published” critical-care specialists hailing from major academic medical centers. Basically, these are the guys anyone would be extremely lucky to have on their medical team.

The founding members include Dr. Paul Marik, head of pulmonary and critical care at the Eastern Virginia Medical School in Norfolk (and creator of the “Marik cocktail” that has saved untold numbers of lives from sepsis). Dr. G. Umberto Meduri, professor of medicine at the University of Tennessee and pulmonary and critical care specialist at the Memphis V.A. Medical Center, and other recognized experts from the U.S. and beyond.

Then there’s Dr. Pierre Kory, president of FLCCC whose impassioned plea about ivermectin before a Senate hearing in December of 2020 should have turned the tide.

Dr. Kory, board-certified in critical medicine, pulmonary diseases and internal medicine, who has cared for Covid patients across the country utilizing the FLCCC protocols, calls ivermectin “a drug that has proven to have a miraculous impact,” adding, “and I don’t use that term lightly. That is a scientific recommendation based on mountains of data.”

During Kory’s testimony last December, he told the Senate committee how he was deeply troubled that the National Institutes of Health (NIH), CDC and FDA did not convene any type of task force to study “repurposed drugs to treat Covid. Everything has been about novel and expensive pharmaceutically engineered drugs,” he said, whereas the medicines the FLCCC reviewed are known quantities that doctors have many decades of experience in using.

Ivermectin quickly surfaced at the top of the list as a potential treatment. By the end of last year, the group had what Dr. Kory repeatedly referred to as “mountains of data” on ivermectin. “It basically obliterates transmission of this virus. If you take it, you will not get sick,” he said.

But aside from being used to prevent Covid, what Dr. Kory called “the most profound evidence” about ivermectin involves hospitalized patients.

In those cases, using ivermectin will significantly lower the chances of dying. “It has proven to be a wonder drug,” he said. Aside from observational trials, that was also demonstrated in four randomized controlled trials, he told the committee.

As far as Dr. Kory’s reason to testify last year, that, he said, was for the purpose of imploring the NIH to review his group’s data and revise its treatment guidelines on ivermectin. And the NIH did. In January, its official designation for ivermectin to treat Covid-19 was changed from “against,” to “neither for nor against.”

That, the FLCCC stated in a press release at the beginning of the year, was great progress that may “clear its path towards FDA emergency-use approval.”

Well, not exactly.

As of this writing the FDA continues to reject ivermectin use for Covid-19, even posting a “consumer update” headlined “Why you should not use ivermectin to treat or prevent Covid-19.” As to why, that’s not exactly clear. The posting at the FDA website warns that if you take a dose of ivermectin meant for a horse, it will make you sick. Any logical doubts and warnings (other than taking a horse-size dose or ivermectin meant for animals) aren’t stated, nor is any of the available evidence supporting ivermectin use in Covid patients even noted.

The FLCCC website makes available practically everything you or your doctor would need to know about ivermectin, including information on research, trials, the group’s protocols for various stages of Covid infections and how to obtain an Rx for ivermectin, what Dr. Kory calls “one of the world’s safest, cheapest and most widely available drugs.”

As Dr. Kory said back in December, “Any further deaths are going to be needless deaths.”

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Comments (4)

I remember reading about a country that was supposedly giving out prophylactic doses of Ivermectin to their population? Was this India, and if so how did that work and what is happening now?

This pertains to Ivermectin in Africa — https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7968425/

Ivermectin has been used widely as a treatment in India; and India–despite having a population in excess of 3 times that of the United States, has half the COVID death rate as the U.S.

What is the FDA’s agenda. Are they being paid big $ by Big Pharma??

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