Dan Sultanescu: Suntem citati de Politico Europe 🙂 #cpd #snspa
The rise and fall of a coronavirus ‘miracle cure’
As people reach for doses of the anti-parasitic meant for horses, drug regulators step in.
In just 12 months, an affordable anti-parasitic has made its way from a humble head-lice treatment to being touted as a „miracle cure” for coronavirus — getting an audience before the U.S. Senate and making its way into official government guidelines.
Veterinarians have seen a rush on doses of ivermectin meant for large animals as people battle to get hold of doses meant for humans, while black markets cash in and a fervent media campaign pushes inconclusive research.
The Czech Republic now allows its off-label use, while Slovakia imports tens of thousands of doses. Promising research on the drug’s potential to treat and prevent coronavirus, combined with desperation over rising case numbers and deaths and a tidal wave of disinformation, has led to use of the drug skyrocketing in Central and Eastern Europe, as well as Latin America and South Africa.
Along with treating animal parasites, the medication 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 the drug’s discoverers, William C. Campbell and Satoshi Ōmura, were awarded the 2015 Nobel Prize in medicine due to its ability to treat multiple diseases.
The catch: The world’s leading medicines regulators have consistently warned against its use for coronavirus. Last week, the European Medicines Agency stated that the evidence doesn’t support its use for coronavirus outside of clinical trials, and warned that toxicity at high doses „cannot be excluded.” The U.S. Food and Drug Administration warned on March 5 that overdosing on the drug could even lead to death, noting multiple reports of patients being hospitalized after self-medicating.
“All good conspiracy theories or lies have a bit of truth to it — that’s what makes them good,” said Carlos Chaccour, assistant research professor at Barcelona Institute for Global Health and one of the first researchers to raise concerns about the drug’s use for coronavirus.
In this case, it’s known that ivermectin has some antiviral properties — so researchers were right to investigate it at the start of the pandemic, he said.
In fact, Chaccour knows ivermectin better than most. He began work on the drug’s ability to kill malaria vectors in 2007, and when people began dying around the world from a new virus early in 2020, Chaccour turned to the area in which he is an expert.
His work both supports the possibility that ivermectin could be used against coronavirus and debunks dodgy studies on the drug. This has made him an enemy to both sides, and even led to his wife receiving threats. Chaccour said he’s been named „an assassin on the payroll from big pharma” and conversely „naive and advocate [for ivermectin].”
Last month, to take a break from the frenzy, he even quit Twitter for Lent.
Getting off on the wrong foot
It all started in March 2020, when an in-vitro study from Australian scientists indicated that ivermectin was an inhibitor of coronavirus. But there was one big problem, said Chaccour: The scientists used concentrations so „huge” that they weren’t naturally found 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 didn’t make it beyond the pre-print stage, so even though some academics raised questions about the validity of the study, they were never officially acknowledged by a reputable journal.
At that time, the use of ivermectin remained mostly confined to Latin America. Peru had included the drug in its national therapeutic guidelines for coronavirus (which it later removed), while hundreds of thousands of people were administering it in Bolivia. Chaccour believes that the drug’s take-up there was linked to its widespread use for both animals and humans, combined with the presence of local manufacturers.
There were some pockets of use elsewhere as well. Hungary, for example, reported in November that veterinarians were seeing an increase in interest for ivermectin.
But that would all change when the drug was put on its most global platform yet — the U.S. Senate.
Big Bad Pharma
The bombshell arrived on December 8, when U.S. physician Pierre Kory spoke before a Senate hearing on early outpatient treatment for coronavirus. Ivermectin, alongside other medicines such as vitamin C, zinc and melatonin, could „save hundreds of thousands of people,” he testified, citing more than 20 studies.
Kory also questioned why remdesivir — a pricey drug that has shown some limited efficacy in severely ill coronavirus patients — was able to secure a compassionate use authorization from U.S. regulators while ivermectin was not.
Kory’s appearance reverberated across the globe. A YouTube video of his testimony went so viral that it was removed under the platform’s COVID-19 disinformation policy. As Chaccour put it, the video immediately prompted some people to ask: „Why are they killing us if there’s this life saving drug out there? Why is Big Pharma pushing for their own solutions?”
„And that sparked the whole second wave of interest,” said Chaccour.
Many miles away, in South Africa, a black market for ivermectin soon emerged. In Romania, stocks of ivermectin at both human and veterinary pharmacies were reported to be depleted in January.
The implication that Big Pharma is blocking the use of ivermectin fits into the broader pattern of seeing „some sort of big conspiracy ‘against us ordinary people,’ ” explained Jonáš Syrovátka, program manager at the Prague Security Studies Institute.
Who’s most inclined to believe such disinformation? Researcher Dan Sultănescu, of Romania’s National School of Political and Administrative Studies’ Center for Civic Participation and Democracy, pointed to “people with lower degrees of trust.”
It’s not just about 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. People only listen to sources that they trust, and the media has become „the battleground right now,” as various groups with vested interests fight for coverage.
But in Slovakia and the Czech Republic, it wasn’t just a couple of doctors pushing ivermectin, but the government itself.
In January, the Slovakian health ministry began allowing the use of ivermectin for treating and preventing coronavirus. In March, while noting the limited evidence on its efficacy against coronavirus, the Czech health ministry approved doctors prescribing ivermectin at their own discretion.
Geography also plays a role in ivermectin’s popularity, argued Sultănescu. Its adherents aren’t in major cities or close to the levers of power, but „are on the periphery of some centers,” he said. „You have this in areas where people are frustrated because the results are not in their control, the solutions are not in their control.”
In the Czech Republic, meanwhile, Syrovátka sees the rising desperation due to the current dire situation with the virus as another factor, as people hunt for „easy solutions” to escape the crisis. Adding to the confusion is the government’s inconsistent communication throughout the pandemic, made worse by going through three different health ministers in just two months, he noted.
Conflicting messages
While Europeans have flocked to pharmacies and veterinarians for ivermectin, research into the drug has continued.
A pre-print from dozens of academics around the world, including Chaccour, was published in January and led to the headlines that ivermectin’s staunch supporters could only dream of. The Financial Times declared that the „cheap antiparasitic” could cut chance of virus deaths by up to 75 percent.
The pre-print, which has yet to be peer reviewed, does indeed state that ivermectin could have a dramatic impact on deaths. But it also comes with a big caveat: The meta-analysis showed that the drug needs to be „validated in larger, appropriately controlled randomized trials before the results are sufficient for review by regulatory authorities.”
Then in March, the drug took its next hit. The Frontiers in Pharmacology journal reversed the provisional acceptance of a paper penned by Kory and other members of his group, the Front Line COVID-19 Critical Care Alliance. The journal noted that „the article made a series of strong, unsupported claims based on studies with insufficient statistical significance, and at times, without the use of control groups.” It also took issue with the authors promoting their own specific ivermectin-based treatment, which Frontiers found „inappropriate” for a review article and against its editorial policies.
Kory took aim at the decision, telling The Scientist the decision was „censorship” and accusing the journal of allowing „some sort of external peer reviewer to comment on our paper.”
Around the same time, the U.S. and EU regulators stepped in — with both warning that there isn’t enough evidence for use of the drug to treat or prevent coronavirus. The European Medicines Agency also noted in its statement, issued March 22, that while lab studies showed hope for ivermectin, they were based on much higher doses than those currently authorized — and that results from clinical studies were varied.
„Further well-designed, randomized studies are needed to draw conclusions as to whether the product is effective and safe in the prevention and treatment of COVID-19,” the EMA added.
Trials such as these are now underway, and Chaccour estimates that in the next three or four months, more concrete data will start to emerge. Indeed, despite the drug’s checkered history, even Chaccour hopes that it could turn out to be the wonder drug it was once promised to be.
„When you have these trolls harassing you, it makes me want to say, ‘I hope it doesn’t work’,” he said with a wry laugh. „But that’s not what I want. I would actually be very happy if this works.”
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