Ivermectin is a key drug for early COVID-19 treatment, Dr. Paul Marik says.
The Front Line COVID-19 Critical Care Alliance (FLCCC), which Marik helped start, features ivermectin and hydroxychloroquine in its early treatment protocol.
“Ivermectin is a remarkable drug,” Marik told EpochTV’s “American Thought Leaders” during a recent conference.
“It’s antiviral, so it works against a whole host of RNA viruses. This is indisputable. It is anti-inflammatory. We know that there are multiple studies showing that ivermectin is a very powerful anti-inflammatory drug. We know that what it does is it stimulates a process called autophagy, which is very important in the process of healing. And it’s one of the main mechanisms that we use to help patients get rid of spike protein. And ivermectin, believe it or not, stimulates autophagy. The other thing it does, which is important, is it changes [and] improves the microbiome,” Marik added.
Ivermectin is used off-label to treat COVID-19 in the United States. It is approved by the U.S. Food and Drug Administration (FDA) to treat conditions caused by parasites. The FDA says ivermectin should not be used to treat COVID-19, pointing to studies that have found little or no benefit for the drug against the disease. Other research has found ivermectin can be effective as a preventative and a therapy, including one from FLCCC doctors that found the drug lowered mortality rates.
Health care providers can prescribe drugs “off-label.” That means a drug is used for a purpose other than that for which it is authorized or approved.
“From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient,” the FDA says on its website.
But a number of medical boards and other health bodies intervened during the pandemic, restricting or banning prescriptions for drugs used off-label for COVID-19, such as ivermectin.
Marik said he thinks many people misunderstand off-label, and aren’t aware that many hospitals use off-label drugs every single day.
“It’s common practice. And in fact, the FDA promotes—the FDA themselves, if you go to their website—promotes the use of off-label drugs. And what they say is that doctors are fully entitled to use FDA-approved off-label drugs at their own discretion at the discretion of the physician,” Marik said.
“But suddenly, with COVID, the rules changed. You couldn’t use an off-label drug. And you have to ask why. And obviously, they don’t want people to use off-label drugs, they want you to use, firstly, the expensive drugs and it obviously would compete with the mandate for the vaccine, because if there were cheap, effective drugs that could treat COVID, why would you want to be vaccinated with an experimental vaccine whose safety has never been established?”
Early treatment using off-label drugs, he added, was a “valid alternative for people who wanted a choice.”
Marik is one of the doctors who sued the FDA in June for allegedly violating the law by interfering with doctors who sought to treat patients with ivermectin. The case is still ongoing.
Developing the Protocols
Marik and colleagues founded FLCCC after seeing U.S. authorities fail to provide or recommend COVID-19 treatments early in the pandemic.
Even after months into the pandemic, no treatments were advised for patients, even those admitted to hospitals. Remdesivir was authorized for hospitalized patients on May 1, 2020.
Further, when hospitalized patients’ conditions worsened, they were placed on ventilators. Many of the patients who ended up on ventilators died.
“It just goes against the basic foundation of medicine, that you would have a disease, which had a high fatality rate and you wouldn’t try something—something—just to treat these patients,” Marik said.
The doctors figured out that COVID-19 attacks the lungs, causing fatal lung failure, inflammation, and clotting.
They turned to known anti-inflammatories like methylprednisolone, a type of corticosteroid that also helps with the lung issues. Heparin, used to prevent blood clots, was also part of the inpatient protocol, which became known as MATH+.
“At that time, we were heavily criticized, for firstly, using corticosteroids and then Heparin,” Marik recounted. “People said, ‘You can’t do it, it’s a viral disease, you’re gonna kill people.’ They were outraged. But we saw it worked. We were at the bedside. There’s nothing like being a doctor at the bedside, seeing what happens. And then, of course, six months later, the RECOVERY trial came around and showed, believe it or not, corticosteroids save lives. So unfortunately, in that study, they use the wrong steroid and the wrong dose. But steroids are so potent that it actually was was able to reduce mortality. So we were vindicated.”
At the time, Marik was chair of the Eastern Virginia Medical School’s Division of Pulmonary and Critical Care Medicine, and helping treat patients at Sentara Norfolk General Hospital.
The protocol helped save lives, Marik said.
The group later developed a list of drugs effective for early, outpatient treatment for people who contracted COVID-19. The main goal was to prevent hospitalizations.
The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel says multiple trials indicate corticosteroids help people hospitalized with COVID-19. The panel also recommends against using ivermectin against COVID-19 except in clinical trials.
Under “first line agents,” FLCCC lists hydroxychloroquine with ivermectin. Hydroxychloroquine is approved as an antimalarial, but it and a similar drug, chloroquine, are not recommended by U.S. authorities for treating COVID-19. Similar to ivermectin, some studies have shown efficacy while others have not, with debates raging regarding proper dosing and timing. And similar to ivermectin, the drug is cheap because generic versions are widely available.
Aspirin, another anti-coagulant, is also advised with vitamin D3 and melatonin. Zinc, vitamin C, and antiviral mouthwash are among the other aspects of the first phase.
The NIH panel does not advise for or against vitamins C, D, or zinc due to what it describes as insufficient evidence.
If symptoms persist for five or more days, FLCCC recommends a second set of treatments. They include sotrovimab, a monoclonal antibody; fluvoxamine, an anti-depressant; and spironolactone, typically used to treat high blood pressure.
The panel has no guidance on spironolactone. It previously recommended sotrovimab but does not any longer because it says the monoclonal does not perform well against newer Omicron subvariants. The panel also says there is not enough evidence to recommend for or against fluvoxamine. The FDA rejected a request from a doctor to authorize fluvoxamine for COVID-19.
Marik believes the emphasis always should have been on repurposed drugs, which have repeatedly been downplayed or ignored by U.S. authorities.
“If you kind of think about a pandemic, what you want to control it are repurposed drugs, because by their very nature these are cheap, inexpensive, easy to manufacture. And since this is a global issue, it then is very easy to distribute these drugs around the entire world and control the pandemic, which was the obvious answer, is the use of cheap, repurposed, effective, safe drugs,” he said. “Hydroxychloroquine is safe, if you use it in the right dose, which is really important. And ivermectin is exceedingly safe, you could use 10 times the recommended dose and it’s safe. And vitamin D, vitamin C, nigella sativa, there’s a whole host of medications—melatonin—that are highly effective as a repurposed drug for controlling this disease. But it went against the narrative.”
Marik used the example of chloroquine, which was effective against SARS-CoV-1, and touted by the NIH as one of a number of drugs effective against MERS. But once COVID-19, or SARS-CoV-2, came around, “that didn’t apply anymore,” Marik said. “And clearly there were severe conflicts of interest. It was inconvenient. It was inconvenient for them.”