By Mary Beth Pfeiffer
The COVID-19 patient was in critical condition and declining quickly. “Speak to your mom now,” the pulmonologist recalled telling her son, “because after this you may not be able to.” The son pleaded: Was there something else the doctor could do? Anything? That’s when Dr. Jean-Jacques Rajter shared a bit of medical homework he and his wife and partner, Dr. Juliana Cepelowicz Rajter, had done.
There was a well-known drug, but not approved for COVID, he told the son. In Australia, the drug had obliterated the virus in a laboratory culture test. It had cured millions worldwide of parasitic disease; in her native Brazil, Juliana Rajter recalled pediatricians giving it annually to entire families. It was safe. Rajter obtained informed consent – necessary when a patient is given essentially experimental treatment — and he gave the woman ivermectin. “After 12 hours, she stopped deteriorating,” Jean-Jacques Rajter said. “In 24 hours, she improved. In 48 hours, she didn’t need such a high level of oxygen.” The woman went home in a week.
The Rajters’ ivermectin success was replicated scores of times at four Florida hospitals in the next two months last spring. Their results: A 40 percent lower mortality rate in 173 COVID patients who received ivermectin and standard medications compared to 107 who got usual therapies only. The Rajters aren’t alone. Virtually every week, new reports are emerging of ivermectin’s success against COVID-19. A website tracker lists about 50 papers that are positing ivermectin as the next big thing.
On the WHO’s List of Essential Medicines, ivermectin earned its inventors the Nobel Prize in 2015 for its “immeasurable” role in quelling parasitic diseases like river blindness and lymphatic filariasis. In Africa, where “mass administration” of ivermectin is common to fight these devastating ailments, the drug is possibly having an unintended benefit: It “may be contributing to keeping COVID-19 cases in check and below projections, ” wrote parasitologist Claire Njeri Wamae, who has fought debilitating worms in Nigeria for 40 years.
In other corners of the world:
- In the Australian experiment, first reported in April, ivermectin prompted a 5,000-fold reduction in COVID-19 viruses in a petri dish, essentially killing all particles.
- One Bangladesh study found that 100 ivermectin-treated patients “tested negative and their symptoms improved within 72 hours.” Another retrospective review of 248 patients there, found that 115 who received ivermectin were far less likely to need oxygen or intensive care, or to die from COVID-19.
- In the Dominican Republic, a large medical system treated 1,300 COVID patients with ivermectin and azithromycin, and declared 99 percent cured.
- In Egypt, ivermectin played a “highly significant role” in protecting 203 family members of COVID patients; just 7 percent of treated people became infected with the virus compared to nearly 60 percent who were not treated.
Such findings have led Thomas Borody, an Australian doctor famous for a cure for stomach ulcers, to propose a COVID therapy of ivermectin, doxycycline and zinc. “It’s an easy virus to kill,” he told a TV interviewer.
Efficacy Must Be Proven
Most certainly, reports of ivermectin’s promise are preliminary, based mostly on studies that are not randomized controlled trials or peer-reviewed; some are anecdotal. So, please, take this with a grain of salt. But, given the global enthusiasm for ivermectin, along with its safety profile and known antiviral qualities, shouldn’t we try to find out if the potential is real? An early treatment and preventative could vastly defuse the coronavirus threat and let normal life resume. But that will happen only if we do the work. So far, we haven’t.
Of 54 ivermectin trials on clinicaltrials.gov, just three are based in the United States, none of them federally funded. Outpacing the U.S. are Egypt, with 10 trials; India, eight; Spain, five; and Argentina, four. Like the U.S., Brazil, Bangladesh and Mexico list three studies each. A generic pill used against parasites apparently holds little interest for investors, pharmaceutical companies or government funders. They cling instead to the almost mythical belief that vaccines are the answer to fighting viruses, despite a wealth of evidence that existing antimicrobials and antiparasitics can also kill them. Hence, the United States has committed $11.2 billion to COVID vaccine research, to the detriment of studies on existing drugs that might actually cure the infection. Ivermectin costs $10 to $20 per treatment — which may be a problem in a profit-driven health-care system.
Nothing To Offer The Infected
With no approved early treatment, symptomatic patients are told to hydrate, take palliatives and quarantine. That works mostly for young, healthy bodies that spend lots of time in the sun. But a week into the infection, too many other patients show up in Dr. Charles Thompson’s emergency room in Columbia, S.C. These include patients with low Vitamin D levels – even young ones — or pre-existing conditions like diabetes, hypertension or cardiovascular disease. “They are clutching at their chest, gasping for breath and begging you to save them,” Thompson, a pulmonologist, told me. “I’m sick of watching people die this way. It’s a travesty.”
Why? Because it’s unnecessary. Since late February, Thompson has treated perhaps a thousand outpatients with hydroxychloroquine, azithromycin, zinc and supplements, to which, in May, he added ivermectin. Just one of his patients has been hospitalized — for COVID-related diarrhea. A voracious reader of the medical literature, Thompson is in awe of the “elegant” way that ivermectin functions, working, he and others have learned, both in early and later COVID stages.
While the virus is multiplying in early infection, ivermectin is believed to inhibit a key receptor that opens the door for viral proteins to enter the nucleus of cells and replicate. Later on, the drug may inhibit the virus from adhering to CD147 receptors on red blood cells and forming clumps, the process that can lead to dangerous clots and stroke. Thompson is among a dozen practitioners I have spoken with who believe that hydroxychloroquine has been maligned and miscast – it is effective and safe, they hold. Many see ivermectin as an unheralded up-and-comer. Yandy Palenzuela-Rodriguez, 31, is a physician assistant in internal medicine who worked with Dr. Rajter at Broward Health Medical Center in Fort Lauderdale, Fl., when COVID emerged.
“Early on, we saw less of his patients went to ICU and RCU” — intensive and respiratory care units, he said. “More of his patients went home quicker.” As with too many front-line health workers, Palenzuela-Rodriguez, 31, got COVID in July. That’s when his pulse oxygen level plummeted, and he interrupted Rajter’s dinner with a call for help. He took ivermectin and experienced what his own patients had. “The big kick I felt in terms of improvement was after the ivermectin,” he said.
Works In Late Disease
Significantly, Rajter and Palenzuela-Rodriguez were seeing ivermectin work in hospitalized patients already ravaged by the virus. Imagine the suffering and money that could be saved if such a drug was used early, as it was for a woman in Chicago who awoke on day 4 of COVID symptoms feeling “like there was an elephant on my chest.” The inhaler and anticoagulant from an ER visit weren’t helping, she told me, and she struggled to breathe. She started ivermectin.
“Literally eight hours later, by that night, I was breathing normal. I’m not exaggerating,” said the woman, who works in pharmaceuticals and asked that her name not be used. “It was a life-saving treatment for me.” “You can avoid the entire cascade of inflammatory changes,” Rajter told me. “They don’t even get admitted to the hospital.” Some, but not enough, U.S. doctors are quietly using ivermectin for COVID, often combining it with hydroxychloroquine, azithromycin and zinc. “When someone’s sick, there’s more likely a synergy between these agents,” said Dr. Steven Phillips of Wilton, Ct. Some patients got better on antibiotics alone, Phillips said, while others told him ivermectin wasa “game changer.”
“Obviously, more studies need to be done,” said Dr. Richard Horowitz of Hyde Park, N.Y., who has treated about 30 COVID patients. “But patients are responding well to the drug in my practice, and it has been safe and well tolerated.” Pre-COVID, Lyme disease specialists like Phillips and Horowitz knew both ivermectin and hydroxychloroquine for their roles in treating the effects of tick-borne illness. But few doctors in the U.S. have such experience or willingness to treat. Which is why a report on NPR’s WHYY on the excitement about ivermectin was headlined: “So why hasn’t anyone heard of it?”
Ivermectin’s Downside: It’s Cheap
“Its major ‘disadvantage’ is its low cost and general availability,” Dr. Jose Natalio Redondo, a hospital executive in the Dominican Republic, told me. “There is no major revenue for those large pharmaceutical industries to invest in new research and production of this drug.” Poorer countries, without the resources or self-importance of the U.S., are trying the drug, with success reported, for example, in Iraq, where a small study found “significantly lower” length of hospital stay in ivermectin patients. In Brazil, some municipalities have distributed “COVID kits” with hydroxychloroquine and ivermectin, and the minister of health has authorized its use. Patients are also taking the drug in Peru, Bolivia and India, where the state of Uttar Pradash has sanctioned use for treatment and prevention.
Its profit picture aside, ivermectin’s similarities to hydroxychloroquine, as safe old drugs with antiviral potential, are also working against it. After President Trump endorsed HCQ for COVID, the drug was caught up in a political, media-fueled firestorm that hammered away at findings of failure and ignored promising reports. Although many studies were riddled with flaws – using the drug too late, as in a Veterans Affairs study, and drawing on unverifiable data that forced a Lancet retraction – its image of failure lingers.
This may explain why the Rajters’ observational study, written with four colleagues, was rejected by two journals. A third journal put it through three peer reviews, all of them positive, but then sought a fourth reviewer, who asked for changes. It has been resubmitted. Dr. Peter Hibberd, an emergency room physician in Florida, said: “The bottom line is patients were getting phenomenal results yet no one would accept his publication.”
‘Wonder Drug’ or Dud?
Not all of the early studies of ivermectin for COVID are positive, among them a small study from Bangladesh; patients who got a single ivermectin dose on top of “usual care” recovered quicker than controls, though not in in terms of statistical significance. Nor is there universal agreement on ivermectin’s potential for treating COVID. Andy Crump, a visiting professor at two Tokyo universities, has worked and published with ivermectin’s discoverer, Satoshi Omura, for 15 years. He is pessimistic about ivermectin for COVID, despite his 2017 scientific review that called it a “wonder drug” with “extraordinary” antibacterial, antiviral and anti-cancer potential.
In an email from Japan, Crump wrote, “Personally, I do not expect ivermectin will be of any use in combatting SARS-CoV-2 or Covid-19, based on past experiences and my knowledge of the current situation.” He gave several reasons, including the need for “huge concentrations” of the drug to fight the virus – though treating doctors dispute this — along with the reality that “ivermectin has been shown to be active against a variety of viruses in vitro but has not been developed to combat any of them,” including Zika, dengue, and yellow fever.
Further, he pointed to the lack of interest in the drug for COVID by either Merck, the pharmaceutical giant whose scientist, William Campbell, shared in the Nobel Prize, or China, which he said is the world leader in “the development, production, delivery and use of ivermectin.” He wrote at another point, “Approving its use in Latin America and testing it on people with COVID-19 is not scientifically sensible or ethically acceptable.” Omura has nonetheless helped secure funding for a clinical trial of ivermectin at Kitasato University Hospital in Tokyo, Crump said.
FDA Urges Caution
On its website, the FDA states: “While there are approved uses for ivermectin in people and animals, it is not approved for the prevention or treatment of COVID-19.” The agency warned against taking ivermectin formulations meant for animals – it is used to prevent heartworm in dogs, for example — noting more studies are needed to determine whether it works for COVID-19 in people. The question is: Will we get them? In the meantime, doctors still may use ivermectin off-label, a common practice in which drugs are prescribed for other-than approved ailments.
A 28-year-old OB-GYN resident named Adeline Marie Fagan died on Sept. 9, seven months after contracting COVID-19. She is one of many healthcare workers who have succumbed to an infection for which medicine purports to have no cure. Maybe. Maybe not. Dr. Fagan’s death in Houston may have been made more likely, as many others are, by a previous illness. She had a neurological condition as a child that left her in a wheelchair though she later played varsity lacrosse and made four humanitarian trips during medical school to Haiti. Who can say if this woman with a future filled with promise and hope would have survived if treated early and effectively?
But the Rajters and Thompson, who together have treated some two thousand patients, told me that many had serious, compromising illnesses such as cardiovascular disease and diabetes. For patients with severe pulmonary disease in the Rajters’ study, the mortality rate in the group that got ivermectin was half that of the group that did not— 39 percent versus 81 percent. The U.S. government’s research agenda for COVID-19 has four priority areas: virus research; diagnostics; treatments, and vaccines. Under treatments, it calls in part for “identifying and evaluating drugs already approved for other conditions that could be repurposed to treat COVID-19.” Ivermectin is one such drug.
Mary Beth Pfeiffer is an investigative journalist, science writer and author of “Lyme: The First Epidemic of Climate Change.”