A potential treatment for COVID-19 exists but is unavailable in Canada, and the government won’t examine the evidence. Why? 

Having chased the drug shortage for more than a decade, I am used to being baffled. But the shortage of ivermectin has me more perplexed than usual. Coupled with what I’m observing as a volunteer contact tracer, this shortage is also alarming. Mounting evidence suggests that the Nobel Prize-winning drug, ivermectin, can also prevent and treat SARS-CoV-2 infection.

Since early January, Dr Kanji Nakatsu, retired Queen’s University pharmacologist, has attempted to alert public health, political leaders (provincial and federal), and the public of the potential value of ivermectin for COVID-19. He warns of the limitations of putting all our eggs in the vaccine basket. But he has received only “thank-you-for-your-message” replies. So, he has launched a petition urging the government to “urgently examine the evidence in favour of ivermection and give due consideration to making ivermectin available immediately to Canadians.” You can see and sign it here.

Dr Nakatsu’s rationale is based on our situation and on the evidence.

Situation: The pandemic will be with us for some time, during which we are all vulnerable. Vaccine protection takes weeks to develop, many won’t receive the shot for months, and we still have no plan for protecting children. Meanwhile, new more contagious and aggressive variants are spreading and may resist current vaccines. Yet as we enter a third wave, some provinces are opening up. More people will fall ill, and more variants arise. We should be interested in anything that might help manage this scourge.

Evidence:

  • Ivermectin is safe. A third of the world’s population (2.5 billion) has taken it for parasitic infections. In almost thirty years from 1992, the World Health Organization and Uppsala University VigiAccess pharmacovigilance database report only 16 deaths and 4673 adverse effects.
  • Ivermectin is readily available, sometimes without charge, in several countries, including Argentina, Bangladesh, Belize, Bolivia, Brazil, Bulgaria, Czechia, Dominican Republic, Egypt, El Salvador, Guatemala, Honduras, India, Iran, Japan, Lebanon, Mexico, Nicaragua, Panama, Peru, Portugal, Slovakia, South Africa, Venezuela, and Zimbabwe.
  • Owing to this ubiquity of use and the reduced COVID-19 impact some of these same countries, multiple trials have examined ivermectin as prophylaxis and treatment (summarized here) Dr. Tess Lawrie founder of the British Ivermectin Recommendation Development Panel conducted a World Health Organization analysis of these trials concluding that ivermectin use corresponds to 86% fewer cases and 68% fewer deaths. She argues that future studies could refine dosing but should not use placebo control because it would be unethical not to offer everyone some of the active drug. 
  • Ivermectin is already approved in Canada as an anti-parasitic; it is generic and inexpensive. 

But there is more. 

Merck, the single licensed producer of Canada’s human formulation has let it slip into shortage and does not expect re-supply before 31 December 2021. Numerous over-the-counter veterinary preparations are advertised online, tempting risky behavior.

While ivermectin carried Satoshi Omura and William Campbell to the 2015 Nobel, some say that the honour was conditioned not only by excellent science and effectiveness, but also by the remarkable way in which this drug was distributed. After all, the idea of extracting an antimicrobial from streptomyces bacteria was already well known and had garnered a Nobel in 1952. It was the generous distribution that was novel and effective: its maker, Merck, distributed it free or at low cost to nations plagued with the dreadful diseases of river blindness and elephantiasis. 

Now Merck is promoting a shiny new antiviral drug, molnupiravir, which is potentially more lucrative, although its trials are not especially convincing. Has Merck lost interest in its own reliable but less profitable ivermectin? Could it be that having no ivermectin makes us more likely to purchase the expensive new antivirals? Curiously, however, in the best scenario, the much-touted remdesivir appears to be far less effective than ivermectin.

What’s more, a bizarre coalition of naysayers, including the American FDA and Europe’s EMA, are throwing shade all over ivermectin, citing dangerous side effects and foolish overdosing, and casting aspersions on extant trials. Pressure may be coming from the pharma industry. JAMA recently published a notoriously underpowered trial and in an unusual, late move, Frontiers in Pharmacology rejected an ivermectin trial that it had originally accepted. Why?

It feels awkward to allude to conspiracy theory–and even worse to seemingly promote apparent snake oil. Nevertheless, I’ve got to ask: if the trials are not robust enough, why doesn’t Canada conduct a good trial and settle this matter once and for all?  We will soon have enough cases in the burgeoning third wave to provide a viable proving ground. 

Arguments that this innocuous drug may be lethal are derisory. Let’s get real people: one can overdose and die from over-the-counter Aspirin or Tylenol. We are grown up enough to read the labels. But to get ivermectin and have it sporting a proper label, we need Health Canada to study the evidence, alter the indication if justified, specify the dose, and above all explain the shortage and fix it. It’s COVID-19 that kills people and life as we knew it.

Update June 2021 to June 2022

Dr Nakatsu’s petition received almost 5000 signatures and by 1 June 2021 it was presented in the House of Commons with no change in its status or shortage in Canada. A reply was expected by mid-July, but when the September 2021 election was called, the petition died.

On 17 June 2021 a Cochrane-standard meta-analysis of ivermectin for COVID-19 supported its use (see here).

On 23 June 2021, Oxford University announced that it has launched a large-scale research study to assess ivermectin in COVID-19.

By July 2021 certain scientists were claiming that evidence in favour of ivermectin was either sloppy or fraudulent.

In September, to counter these criticisms, some pointed to the favorable outcomes in Kerala India after ivermectin use had been authorized, although no study was produced to document or confirm its role.

Disappointing results continued to come from trials held in the following months. In May 2022, a study of more than a thousand patients, published in the New England Journal of Medicine, showed that early treatment with ivermectin made no difference to the course of the disease.

By June 2022, a study reported (pre-publication in the New York Times) by Duke University and Vanderbilt University, tested more than 1,500 people with Covid, about half getting the drug and the others a placebo; ivermectin made no difference. However, the authors reported that 90 people with severe disease seemed to fare better than those on placebo–although the differences were not statistically significant. The authors promise to keep studying the drug at higher doses, given its “favorable safety profile and continued public interest.”

Others continue to either cite or criticize the reports by Tess Lawrie, Andrew Hill, Pierre Kory and Peter McCullough. Failing to advance the ivermectin concept, the latter has coupled his advocacy of the drug with misinformation about vaccines, provoking a lawsuit from his former employer, Baylor.

An organization in Canada tries to help people find supplies of ivermectin, at the same time, it discredits vaccines, which casts doubt upon its advocacy of ivemectin. Meanwhile, those desperate to have access to the drug have taken to using veterinary preparations, leading to dangerous overdosing and a shortage of the drug for its approved purposes for animals and caution from the FDA.

Ivermectin remained in short supply in Canada even for its original uses until 19 May 2022. Meanwhile molnupiravir reached completion and received FDA approval for emergency use in late 2021, despite slim to no evidence that it actually works. The UK, Bangladesh, and Israel followed suit. It is still under review by Health Canada.