BUT IVERMECTIN is not without controversy, and hence, despite the high levels of coronavirus worldwide, neither the FDA nor the World Health Organization have been willing to approve it for use in the fight against the virus.
Prof. Ya’acov Nahmias, a Hebrew University of Jerusalem researcher, has questioned the safety of the drug.
“Ivermectin is a chemical therapeutic agent, and it has significant risks associated with it,” he said in a previous interview. “We should be very cautious about using this type of medication to treat a viral disease that the vast majority of the public is going to recover from even without this treatment.”
During Schwartz’s study, there was not any signal of significant side effects among ivermectin users.
Only five patients were referred to hospitals, with four of them being in the placebo arm. One ivermectin patient went to the hospital complaining of shortness of breath on the day of recruitment. He continued with the ivermectin treatment and was sent back to the hotel a day later in good condition.
The FDA said on its website it “received multiple reports of patients who have required medical support and been hospitalized after self-medicating with ivermectin.”
The “FDA has not approved ivermectin for use in treating or preventing COVID-19 in humans,” it said. “Ivermectin tablets are approved at very specific doses for some parasitic worms, and there are topical (on the skin) formulations for head lice and skin conditions like rosacea. Ivermectin is not an antiviral (a drug for treating viruses). Taking large doses of this drug is dangerous and can cause serious harm.”
The World Health Organization has also recommended against using the drug except in clinical trials.
IN CONTRAST, Schwartz said he was very disappointed that the WHO did not support any trial to determine whether the drug could be viable.
Last month, Oxford University announced a large trial on ivermectin effectiveness.
Schwartz said he became interested in exploring ivermectin about a year ago, “when everyone was looking for a new drug” to treat COVID-19, and a lot of effort was being put into evaluating hydroxychloroquine, so he decided to join the effort.
“Since ivermectin was on my shelf, since we are using it for tropical diseases, and there were hints it might work, I decided to go for it,” he said.
Researchers in other places worldwide began looking into the drug at around the same time. But when they started to see positive results, no one wanted to publish them, Schwartz said.
“There is a lot of opposition,” he said. “We tried to publish it, and it was kicked away by three journals. No one even wanted to hear about it. You have to ask how come when the world is suffering.”
“This drug will not bring any big economic profits,” and so Big Pharma doesn’t want to deal with it, he said.
SOME OF the loudest opposition to ivermectin has come from Merck Co., which manufactured the drug in the 1980s. In a public statement about ivermectin on its website in February, it said: “Company scientists continue to carefully examine the findings of all available and emerging studies of ivermectin for the treatment of COVID-19 for evidence of efficacy and safety. It is important to note that, to date, our analysis has identified no scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies; no meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and a concerning lack of safety data in the majority of studies.”
But Merck has not launched any studies of its own on ivermectin.
“You would think Merck would be happy to hear that ivermectin might be helpful to corona patients and try to study it, but they are most loudly declaring the drug should not be used,” Schwartz said. “A billion people took it. They gave it to them. It’s a real shame.”
And not moving forward with ivermectin could potentially extend the time it takes for the world to be able to live alongside the virus, he said.
“Developing new medications can take years; therefore, identifying existing drugs that can be re-purposed against COVID-19 [and] that already have an established safety profile through decades of use could play a critical role in suppressing or even ending the SARS-CoV-2 pandemic,” wrote the researchers in the American Journal of Therapeutics. “Using re-purposed medications may be especially important because it could take months, possibly years, for much of the world’s population to get vaccinated, particularly among low- to middle-income populations.”