The rise and fall of a ‘miracle cure’ for coronavirus – POLITICO

The rise and fall of a 'miracle cure' for coronavirus - POLITICO

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In just 12 months, an affordable pest control has gone from humble head lice treatment to being touted as a ‘miracle cure’ for coronavirus – getting a hearing in the US Senate and making its way under official government guidelines .

Vets have seen a rush in ivermectin doses for large animals as people battle for doses for humans, as black markets cash in and a fervent media campaign pushes inconclusive research.

The Czech Republic now authorizes its off-label use, while Slovakia imports tens of thousands of doses. Promising research into the drug’s potential to treat and prevent coronavirus, coupled with desperation in the face of rising cases and deaths and a tidal wave of misinformation, has led to a surge in the use of the drug in Central and Eastern Europe, as well as Latin America and South Africa. .

In addition to treating animal parasites, the drug has also been used for many years in pill and cream form for humans to treat a variety of conditions such as scabies, head lice, and river blindness. It has long been hailed as a wonder drug, and its discoverers, William C. Campbell and Satoshi Ōmura, received the 2015 Nobel Prize in Medicine for its ability to treat multiple diseases.

The catch: The world’s leading drug regulators have constantly warned against its use for the coronavirus. Last week, the European Medicines Agency said the evidence does not support its use for the coronavirus outside of clinical trials, and warned that toxicity at high doses “cannot be ruled out.” The United States Food and Drug Administration warned on March 5 that an overdose of the drug could even lead to death, noting several reports of patients hospitalized after self-medication.

“All good conspiracy theories or lies have a bit of truth – that’s what makes them good,” said Carlos Chaccour, assistant research professor at the Barcelona Institute for Global Health and one of the first researchers to be concerned about the use of the coronavirus drug. .

In this case, ivermectin is known to have antiviral properties – so researchers were right to study it early in the pandemic, he said.

In fact, Chaccour knows ivermectin better than anyone. He started working on the drug’s ability to kill malaria vectors in 2007, and when people started dying around the world from a new virus in early 2020, Chaccour turned to the field in which he is an expert.

His work both supports the possibility that ivermectin could be used against the coronavirus and debunks questionable studies on the drug. This made him an enemy on both sides and even led to his wife receiving threats. Chaccour declared that he had been named “an assassin on the wage bill of the big pharma” and conversely “naive and lawyer [for ivermectin].  »

Last month, to take a break from the frenzy, he even quit Twitter for Lent.

Start off on the wrong foot

It all started in March 2020, when an in vitro study by Australian scientists indicated that ivermectin was an inhibitor of the coronavirus. But there was a big problem, Chaccour said: Scientists used concentrations so “huge” they weren’t found naturally in humans.

Part of the research that emerged was a study using data from Surgisphere – the group behind the now infamous hydroxychloroquine study that was retracted by The Lancet after concerns about the data. However, the study did not get past the pre-print stage, so although some academics raised questions about the validity of the study, they were never officially recognized by a reputable journal.

At that time, the use of ivermectin remained mainly confined to Latin America. Peru had included the drug in its national treatment guidelines for the coronavirus (which it later removed), while hundreds of thousands of people administered it in Bolivia. Chaccour believes that taking the drug there was linked to its widespread use for animals and humans, combined with the presence of local manufacturers.

There were also use pockets elsewhere. Hungary, for example, reported in November that veterinarians were seeing increased interest in ivermectin.

But that would all change when the drug was put on its most global platform yet – the US Senate.

Big Bad Pharma

The bomb arrived on December 8, when US doctor Pierre Kory spoke to a Senate hearing on early outpatient treatment for the coronavirus. Ivermectin, alongside other drugs such as vitamin C, zinc and melatonin, could “save hundreds of thousands of people,” he said, citing more than 20 studies.

Kory also asked why remdesivir – an expensive drug that has shown limited efficacy in severely coronavirus patients – was able to get compassionate use clearance from U.S. regulators when ivermectin was not.

Kory’s appearance reverberated around the world. A YouTube video of her testimony went so viral that it was removed as part of the platform’s COVID-19 disinformation policy. As Chaccour said, the video immediately made some people wonder, “Why are they killing us if there’s this life-saving drug?” Why is Big Pharma pushing for its own solutions? ”

“And that sparked the whole second wave of interest,” Chaccour said.

Several kilometers away, in South Africa, a black market for ivermectin quickly emerged. In Romania, stocks of ivermectin in human and veterinary pharmacies ran out in January.

The implication that Big Pharma is blocking the use of ivermectin fits into the larger pattern of seeing “some kind of grand conspiracy” against us ordinary people, ”explained Jonáš Syrovátka, program director at the Prague Institute for Security Studies.

Who is most inclined to believe such misinformation? Researcher Dan Sultănescu, from the Center for Civic Participation and Democracy at the Romanian National School of Political and Administrative Studies, highlighted “the less confident”.

It’s not just health, he noted – trust in Western institutions such as NATO and the EU also fell last year, a “period of vulnerability” for many countries. , including his native Romania. the media have become “the battleground right now” as various groups with special interests fight for coverage.

But in Slovakia and the Czech Republic, it was not just two doctors pushing ivermectin, but the government itself.

In January, the Slovak Ministry of Health began authorizing the use of ivermectin to treat and prevent the coronavirus. In March, while noting the limited evidence of its effectiveness against the coronavirus, the Czech health ministry approved doctors prescribing ivermectin at their own discretion.

Geography also plays a role in the popularity of ivermectin, argued Sultănescu. Its members are not in the big cities or near the levers of power, but “are on the outskirts of certain centers,” he said. “You have this in areas where people are frustrated because the results are not under their control, the solutions are not under their control. ”

In the Czech Republic, meanwhile, Syrovátka sees growing desperation over the current dire situation with the virus as another factor, as people search for “easy solutions” to escape the crisis. Adding to the confusion, inconsistent government communication throughout the pandemic, made worse by the passage of three different health ministers in just two months, he noted.

Conflicting messages

As Europeans flocked to pharmacies and vets for ivermectin, research on the drug continued.

A preprint from dozens of academics around the world, including Chaccour, was published in January and made headlines that loyal ivermectin supporters could only dream of. The Financial Times said that the “cheap pest control” could reduce the risk of death from the virus by up to 75%.

The pre-print, which has yet to be peer reviewed, does indeed indicate that ivermectin could have a dramatic impact on deaths. But this also comes with a big caveat: the meta-analysis has shown that the drug must be “validated in larger randomized trials and appropriately controlled before the results are sufficient to be reviewed by the authorities.” regulatory ”.

Then in March, the drugs took their next hit. The journal Frontiers in Pharmacology has revoked the provisional acceptance of an article written by Kory and others in his group, the Front Line COVID-19 Critical Care Alliance. The journal noted that “the article made a series of strong and unsupported claims based on studies with insufficient statistical significance, and sometimes without the use of control groups.” He also took issue with the authors promoting their own specific ivermectin treatment, which Frontiers deemed “inappropriate” for a review article and against its editorial policy.

Kory took aim at the decision, telling Scientist the decision was “censorship” and accusing the newspaper of allowing “some kind of outside critic to comment on our article.”

At around the same time, US and European regulators stepped in – both warning that there was not enough evidence for the drug’s use to treat or prevent the coronavirus. The European Medicines Agency also noted in its statement, released on March 22, that while laboratory studies showed hope for ivermectin, they were based on doses much higher than those currently allowed – and that results of clinical studies were varied.

“Further well-designed randomized studies are needed to draw conclusions about the efficacy and safety of the product in the prevention and treatment of COVID-19,” added the EMA.

Trials like these are currently underway and Chaccour estimates that in the next three or four months more concrete data will start to emerge. Indeed, despite the drug’s turbulent history, even Chaccour hopes it may turn out to be the wonder drug it once promised.

“When you have these trolls harassing you, it makes me want to say, ‘I hope this doesn’t work’,” he said with a wry laugh. “But that’s not what I want. I would be really very happy if it works. ”

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