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HomeTalking PointsIvermectin is not a ‘miracle drug’ against COVID. Vaccines are

Ivermectin is not a ‘miracle drug’ against COVID. Vaccines are

Ivermectin may well prove to be useful in the battle against COVID-19 but it’s no “miracle drug”, write Claire Berlinski and Yuri Deigin in Quillette. We already have those. They’re called vaccines.

Berlinski and Deigin write:

Bret Weinstein, a former professor of biology at Evergreen State College, is best known for being hounded off his own campus in 2017 by a horde of social-justice zombies who seemed to resemble nothing so much as a lab accident gone wrong. Having become a martyr of hyper-progressive ideological mania, Weinstein resigned, sued, won, starred in a documentary about the experience, and embarked upon a new career as a podcaster.

Since then, Weinstein has become an influential public figure, with 350,000 subscribers on YouTube. Many consider his voice a credible one in life- and-death debates about the COVID-19 pandemic. Recently, Weinstein has graduated from entertaining theories that might not be right but could do no harm, to theories that cannot be right and are sure to do harm.  His promotion of outright quackery, during a pandemic that has killed more Americans than any catastrophe since the Civil War, is immoral.

In early June, Weinstein began to claim that Ivermectin, a genuinely remarkable anti-parasitic drug Could be applied to “eradicate” COVID-19. He invited physicians from a group called the Front Line COVID-19 Critical Care Alliance (FLCCC) to join him in what he called “an emergency podcast” to “save the world”.

He and his guests offered the claim that Ivermectin is “99% effective” in treating COVID-19; that it could be used as a prophylaxis against infection; and that were it widely used, the pandemic would end in “a month”. These truths, they suggested, had been suppressed by a conspiracy. They did not specify the mechanism by which the supposed conspiracy works, but they were clear about its object: selling COVID-19 vaccines.

YouTube, rotely enforcing its Terms of Service provisions and COVID-19 medical misinformation policy promptly took down the podcast. To Weinstein and many of his followers, this was evidence of the conspiracy. Had Weinstein stopped there, it would have been nutty, destructive, and misleading, but otherwise inoffensive.

Ivermectin is generally a safe drug. Itʼs unlikely his listeners will kill themselves with it. Itʼs the next step he took thatʼs so deadly. On the same podcast, he and his guests argued that the Pfizer and Moderna mRNA vaccines, as well as the AstraZeneca adenovirus-vector vaccine, are so unsafe that the vaccinated are secretly dropping like flies from their effects.

He also has avowed, on both the podcast and his Twitter feed, his trust in a UK physician named Tess Lawrie who has published a phenomenally insane paper that calls COVID-19 vaccines “unsafe for human use”. The paper advises that “Preparation should now be made to scale up humanitarian efforts to assist those harmed by the COVID-19 vaccines”.

Weinstein and another physician affiliated with the FLCCC, American critical-care physician Pierre Kory, then visited Joe Roganʼs podcast to argue that because large pharmaceutical companies make more money by bringing new, untested drugs to the market than by selling repurposed drugs such as Ivermectin, they have convinced government officials and social-media companies to obscure or suppress the evidence of the trail of death and misery these COVID-19 vaccines are leaving in their wake.

Consequences will be ruinous

It is Weinsteinʼs right to say all of this. But letʼs not confuse a right to say something with something being right to say. The consequences of Weinsteinʼs caper will be ruinous. COVID-19ʼs Delta variant, twice as contagious and possibly more lethal than the original strain, is ravaging the world. Its effects have been devastating in India, and among the unvaccinated in the UK.

That children can die from COVID-19 is a point worth stressing, given the emphasis that Weinstein and other vaccine sceptics have placed on the vaccinesʼ risks to children.  Clearly, COVID-19 is a killer. Last year, it made the top-10 list of causes of paediatric death in the United States.

If even a few thousand of Weinsteinʼs listeners have been convinced by him to avoid being vaccinated, we can reasonably estimate, based on the patterns of infection weʼve so far seen, that many of them will acquire the disease, and roughly 1.8% of those will die. Many of the survivors will suffer permanent damage.

There are risks associated with COVID-19 vaccines, of course. They are well-documented. Most significantly, rare blood-clotting disorders have been tentatively linked to the AstraZeneca (AZ) vaccine. We write “tentatively” because the numbers are so small that it is hard to know if the link is statistically meaningful.

Here is the key point: COVID-19 itself causes blood clots. Study upon study has confirmed this. A meta-analysis published in November concluded that one in five COVID-19 patients develops blood clots. This risk is orders of magnitude greater than any blood-clot risk associated with vaccination.

If there were no pandemic, Weinstein and other vaccine sceptics would be perfectly right to say that getting vaccinated is riskier than not getting vaccinated. But why would one be vaccinated at all if there had been no pandemic to begin with? We donʼt live in a fictional universe. There is a pandemic, and a deadly one.

So back to Ivermectin, which has shown promise in some studies and flopped in others. The quality of the evidence for its efficacy is limited and low. Some studies that sounded promising collapse on closer inspection.

On Weinsteinʼs podcast, for example, listeners were told of an “Argentinian” study, presumably a reference to the IVERCAR study. Lead author Héctor Carvallo, an Internal Medicine specialist, and three other authors report recruiting 1,195 healthcare workers from four major Argentinian hospitals, of whom 788 were given a combination drug regimen that included Ivermectin. They say that after three months, the 407 workers who did not receive Ivermectin had an infection rate of about 58%. Among the 788 workers who received Ivermectin, the infection rate, they reported, was zero: no cases observed whatsoever.

Does this pass the smell test?

Not at all. In the initial phase of the study, the workers who received Ivermectin were dosed every four hours for two weeks. Weʼre asked to believe that none of them tested positive for SARS-CoV-2 during this two-week period. Weʼre also asked to accept that none tested positive during the three weeks that followed.

Whatʼs the problem with this? The measured half-life of Ivermectin is only about 18 hours. In a follow-up study, the authors replaced the five-times-a-day regimen with a once-weekly dose. Apparently, the control group in one of the hospitals reported a 92% incidence of new infections while the Ivermectin group again reported zero. If this were true, Ivermectin would indeed be a miracle drug, in the very narrow sense of the word, because thereʼs no physical way it could work like this.

A systematic review of all available research, published in the BMJ, concluded that it was “very uncertain whether Ivermectin … reduces the risk of laboratory confirmed infection”, in part “because of serious risk of bias and very serious imprecision” in the studies so far conducted. Does this mean it doesnʼt work? No. It means we do not know.

This might explain why the US Food & Drug Administration “has not approved Ivermectin for use in treating or preventing COVID-19 in humans”. The thesis is much more plausible than the notion of a massive conspiracy involving a vast number of people and institutions, all behaving in ways contrary to the interests of humanity, to pad the pockets of Big Pharma.

No one is arguing against Ivermectin as a means to help fight COVID-19. We wouldnʼt be surprised if it proves to be a useful therapeutic, on its own or in some combination of drugs. If itʼs even marginally beneficial, tens of thousands of lives might be saved as the world waits, in desperation, for vaccines. Even if itʼs not effective at all, the placebo effect could offer real benefits to patients who sincerely believe itʼs a miracle drug.

But it isnʼt a sugar pill. To achieve the effects Ivermectin has been shown to have on the virus in cultured monkey cells in a laboratory, Ivermectin must be taken at doses far above the dose we know to be safe. It causes testicular dysfunction, which is why itʼs often prescribed with vitamin E and selenium to prevent testicular toxicity (and nota bene: deficiencies of selenium may result in worse outcomes among COVID-19 patients, a confounding variable for which the studies we have do not account).

Ivermectin is a known teratogen: it is dangerous for pregnant women to be exposed to it, no less to take it, especially in high doses. Predictable reports of liver failure owing to self-administered Ivermectin have already made the news. The drug has been linked to rare but serious neurological adverse events.

The excitement surrounding Ivermectin originated in a study published by Australian researcher Leon Caly and co-authors showing that if you take cells derived from the kidney of an African green monkey, infect them with SARS-CoV-2, and dose them with very high concentrations of Ivermectin, the virus is reduced, within 48 hours, to insignificance.

But the dose levels required to achieve these results through in-vitro experiments are vastly higher than the maximum reported plasma concentration we can achieve in human subjects, a level that is itself many times higher than the safe dose for anti-parasitic uses. Killing viruses in-vitro is much easier than doing the same thing in-vivo without also killing the organism. Often, cell or animal studies in-vitro offer promising results but yield no benefit in humans. And adverse effects, or a lack thereof, in animals do not necessarily translate to the same effect in humans.

But let us say, for argumentʼs sake, that taking Ivermectin at the required dosage were safe and practical. And letʼs also imagine that it may be effective at preventing and treating COVID-19. Should those of us lucky enough to live in countries with access to mRNA-based vaccines take Ivermectin instead? No: that would be bonkers.

The evidence that mRNA-based COVID-19 vaccines are safe, and that they work, is about as solid as medical evidence gets. Sure, no one can prove that in 10 yearsʼ time, you wonʼt suffer ill effects. But nor is there any reason to fear this.

By early June, 1.7 billion doses of these vaccines had been administered around the world, to humans, we stress, because, as Weinstein and his guests correctly point out, this is the most important kind of data. Many well-conducted, randomised, observer-blinded, placebo-controlled trials have shown the vaccines to be more than 90% effective on the original strains of the virus, and nearly 100% effective in protecting you from the most serious adverse effect of the disease: death.

An mRNA vaccine study published in the New England Journal of Medicine, for instance, found 94.1% efficacy at preventing COVID-19. Of the 30,420 volunteers who took part in the study, “severe COVID-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group". The authors report that “aside from transient local and systemic reactions, no safety concerns were identified”.

Numerous other studies report similar findings, all based on randomised, high-volume, peer-reviewed studies. (It is still unclear how well the vaccines protect against infection by the Delta variant, but Israelʼs health ministry reports that the Pfizer mRNA vaccine is 93% effective in preventing serious illness and hospitalisation.) If youʼre looking for a “miracle drug” to protect you from COVID-19, look no further: this is it.

How does the evidence for the prophylactic efficacy of Ivermectin stack up against the vaccines?

Itʼs not even close. Remember: we donʼt yet know that the drug provides any significant benefit. A high-quality study published in JAMA found that in a randomised clinical trial that included 476 patients with mild COVID-19, “a 5-day course of Ivermectin, compared with placebo, did not significantly improve the time to resolution of symptoms”.

But again, for the sake of argument, letʼs go with the most generous interpretation of available experimental results. This site, which purports to offer a (highly dubious) “real-time meta-analysis” of Ivermectin studies, claims the drugʼs aggregated prophylactic efficacy is 85%. Even if this were true, this would mean your odds of developing COVID-19 while taking Ivermectin are about 6.67 times lower than those of a counterpart in the control group.

If youʼve received an mRNA vaccine, however, your odds are 20 times lower. Even if we accept the statistics offered by Ivermectinʼs most enthusiastic advocates, those very figures indicate that you would get triple the protection from the vaccine. Moreover, to get the protective benefits of Ivermectin, youʼd have to take it daily for months, years, or decades. Two doses of an mRNA vaccine, by contrast, will protect you for months, and probably years.

If the evidence changes, our minds will change with it. It may yet be shown that Ivermectin cures COVID-19. It may yet be shown that it cures cancer, for all we know. But as of today, we have no good evidence it does, and a lot of evidence that the Delta variant will cause carnage in unvaccinated populations.

The Ivermectin brigade is not apt to be persuaded by this. They will insist that the evidence isnʼt there yet because researchers didnʼt use the right dose levels, or administered it at the wrong time, or that the studies that prove theyʼre right have been blocked. Or theyʼll fall back on the idea that the pharmaceutical companies are powerful enough to force every medical journal and regulatory agency in the world to stand up, salute, and take dictation.

Theyʼll also claim that vaccines make you miscarry (nope), or harm your fertility (no), and curdle your breast milk (sorry). These theories wonʼt die. But, alas, the same isnʼt true of the people spouting them, and those who get taken in.

To put things simply: we have proof that Ivermectin is terrific for river blindness and head lice. But if youʼre taking it to prevent COVID-19 because you heard it was “99% effective” on a podcast, while foregoing an mRNA vaccine, because you think thatʼs too dangerous, youʼve been misled, and youʼre endangering yourself, your family, your community, and your country.

No one disputes Bret Weinsteinʼs right to embrace the theory that Ivermectin is a miracle drug, or to regale his listeners with vaccine horror stories and conspiracy theories. But the rest of us reserve the right to be appalled by his judgment and ethics.

 

Full Quillette story (Open access)

 

See more from MedicalBrief archives:

 

Merck warns on Ivermectin for COVID: No evidence of efficacy and safety

 

Fact File: Making sense of the Ivermectin controversy

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