Branded as a wonder drug by some and a danger to health by others, the drug has been used to fight coronavirus. In a world where the man on the street has access to almost the same information as regulatory bodies, should we have the right to take it if we want to, asks Theo Panayides
We’ve heard a lot about public health in the past 15 months – but what about personal health? What of a person’s right to decide how to take care of their own health – and what are the limits on that right?
That hugely important question is now coming to the fore once again with reference to ivermectin.
What is ivermectin? It’s a cheap, repurposed drug that’s been around since the 1980s, has been included on the WHO’s list of essential drugs (alongside the likes of paracetamol), and increasingly looks – to some people – like it might be able to treat Covid-19.
That was never its original purpose, of course. Ivermectin is primarily known as an anti-parasitic, not an antiviral. A Cyprus Mail source in Greece (where the drug is sold under the brand name ‘Scaball’) was told by a pharmacist that it’s used against tropical diseases, as prescribed by a doctor.
Why in Greece? Well, that’s the point. Ivermectin is indeed sold in our neighbour country, and in most other countries (often without a prescription). However, with the exception of a lotion – which is useless for Covid, and may not even be on the market anyway – it’s entirely unapproved and unavailable in Cyprus.
Let’s ignore, for the moment, the question of how effective the drug is. Let’s assume that a patient – or not even a patient, since it’s also used for prophylaxis, i.e. to prevent you getting Covid – let’s assume that someone reads about ivermectin, and wants to get hold of it. How might they go about it? And should they even be allowed to?
The second question is an interesting one. On the one hand, we all have the right to make decisions regarding our own body. On the other, as lawyer Nicoletta Charalambidou points out, “the right to health is a social right”. If you choose to take a dangerous drug, and get sick as a result, then you’re going to be a burden on the health service – and, by extension, on all those other people who played by the rules and stuck to the medicines supplied by the system. ‘It’s my body’ only goes so far.
Then again, if that argument were airtight, it would also apply to the vaccines. Those who refuse to be vaccinated, and get Covid as a result, may indeed end up needing expensive hospital treatment. Yet it’s still accepted that people can’t be forcibly vaccinated, on Nuremberg Code principles. The right to physical integrity trumps good social management, at least in this case.
But then, if you have an absolute right to refuse a treatment – whether medicine or jab – why don’t you also have a right to choose a treatment?
One could also argue that ivermectin is a safe drug, having been prescribed billions of times since the 80s. The question, however, is ‘Who decides?’. The state has a clear regulatory role when it comes to health – and should arguably have the final say on what gets approved, as long as its decisions can be justified objectively.
Could this decision be justified? Absolutely. Not only is ivermectin unapproved by the WHO and EMA (European Medicines Agency), but its safety profile for Covid is still quite new. Its Wikipedia page even claims that “doses much higher than the maximum approved or safely achievable for use in humans would be required for an antiviral effect”. This is apparently a misunderstanding, based on results in vitro (i.e. in a lab); the drug’s mechanism allows it to inhibit Covid from binding to cells in vivo (i.e. in humans) at normal doses. Still, the debate rumbles on.
The primacy of the state also answers the first question above, namely ‘How might a person in Cyprus get hold of ivermectin, if they thought it could help them?’.
The usual route, for an unapproved drug, is for a doctor to apply for one-off use for a particular patient, says Yiannis Kkolos, a pharmacist at the health ministry. The application is made to the Medicines Board, comprised of 11 doctors, civil servants and pharmacists. The procedure takes a few days, however (time is of the essence for Covid patients) – and of course, given the official line that no effective antiviral exists for Covid, it’s easy to see how the request might be denied.
Kkolos himself is quite scathing about ivermectin: “We heard the same things about hydroxychloroquine, about colchicine. Unfortunately, with all these repurposed drugs, we haven’t seen any amazing results that would justify their use.”
Why does he say that?
“Because there are review articles, when you go to the global medical literature, which say exactly that. Studies have been done, and it’s clear that these drugs aren’t effective against Covid… The most effective tool we have right now is for people to get vaccinated.”
Kkolos says he’s researched the subject on PubMed – an online medical database – and wasn’t impressed. “It’s too bad,” he adds with feeling. “I wish some wonder drug would appear, so we could be done with this whole mess! For the moment, though, we’re still looking.”
If an effective drug existed, “wouldn’t we have heard about it?” agrees Dr Costas Schizas, a GP who admits to being unfamiliar with ivermectin. “Wouldn’t it be on TV? Wouldn’t we [doctors] be getting letters from pharmaceutical companies advertising it?”
The snag, of course, is that ivermectin is out of patent so Merck, its original manufacturer, no longer stands to make money out of it – not to mention that Merck is in Phase III clinical trials for a brand-new Covid drug called molnupiravir. In fact, there are clear incentives for drug companies to keep quiet about cheap repurposed drugs. Merck has actually gone a step further, putting out a statement in February saying it’s found “no scientific basis” for ivermectin use against Covid-19.
Could a maverick doctor nonetheless bypass the Medicines Board and import ivermectin on their own initiative? Probably; doctors prescribe drugs for ‘off-label’ (i.e. unapproved) use all the time, and perfectly legally. The problem, once again, seems to be a lack of information and the institutional bias against the drug, leading to an understandable reluctance by most medics to take such a risk.
“If I gave it and something happened to the patient, I’d end up in court,” says Dr Schizas, adding that it should be up to the Board to make these decisions. “Imagine if every doctor just decided to bring whatever medicine they wanted. It’d be chaos.”
That just leaves the option of people obtaining the drug by themselves, whether to take prophylactically or stash in their medicine cabinet. Would that be legal? “It can’t be imported in Cyprus without a doctor’s prescription,” warns Maria Kyprianou from the Costas Papaellinas Organisation, an agent for many pharmaceutical companies. “You can’t just order it yourself and get them to put it in a box and send it to you.”
Charalambidou, the lawyer, disagrees, opining that if a drug is legal in other EU countries it would also be allowed here, even if not officially approved. The trouble is that ivermectin isn’t legal for Covid – and besides, how would someone in Cyprus get a prescription from a doctor in Greece for a drug against tropical diseases? One could always order online, of course – but websites can be dodgy, not to mention that you’d be taking it (probably) against the advice of your GP, and without a doctor to monitor you.
It’s a lot of trouble for a medicine that remains controversial – and of course that’s the elephant in the room, namely just how effective is ivermectin?
The data is out there – but it wouldn’t be right to supply a definitive answer here. Personal health (unlike public health) means personal responsibility. Everyone needs to read up and make an informed decision, without assuming that those in authority know best.
On the one hand, there are now 57 trials for ivermectin, including 29 randomised trials. (The most recent was from Lebanon a few days ago: 50 patients were given the drug, 50 were not; the ivermectin group showed better results after 72 hours, including only three with loss of smell – as opposed to 16 in the control group – and zero hospitalisations, as opposed to three.) Mexico City used the drug en masse in January 2021, monitoring around 200,000 patients, and discovered “a significant reduction in hospitalisations among patients who received the ivermectin-based medical kit” against those who didn’t, according to a pre-print by lead author Jose Merino, the reduction being between 52 and 76 per cent.
A recent study by Dr Pierre Kory and others, titled ‘Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19’ and published in the American Journal of Therapeutics, lays out the science quite clearly. Dr John Campbell, a YouTube favourite with 977,000 subscribers, has done interviews with Kory (April 26) and Dr Tess Lawrie (especially April 7, where she discusses the WHO report). Bret Weinstein and Heather Heying discussed ivermectin on their Dark Horse podcast on May 15. A recent article by Michael Capuzzo called ‘The Drug That Cracked Covid’ is worth reading. A Twitter user called ‘Covid19Crusher’ supplies a regular stream of links and articles from all over the world.
On the other side, the WHO, EMA and FDA (in the US) have refused to approve ivermectin for Covid-19, with the FDA in particular warning that it might be unsafe. Wikipedia describes support for the drug as “misinformation” and warns that “no reliable evidence exists to back up such claims”. Studies with positive results have been dismissed as too small, insufficient, unscientific, or not rigorous enough. The New York Times ran an article on March 4 (their only article on ivermectin) titled ‘Popular Drug Does Not Alleviate Mild Covid-19 Symptoms, Study Finds’. A recent pre-print by scientists from Peru, Brazil and the University of Connecticut (‘Ivermectin for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials’) analysed 10 trials and found no significant benefit.
Both sides have their advocates. That said, there is a possible tie-breaker. Both sides claim to debunk the other’s findings – but what can’t be debunked is the strange and draconian behaviour by regulators and tech companies.
Doctors in the Netherlands have been threatened with huge fines for prescribing the drug. Facebook posts (including one by the Slovak Ministry of Health) and YouTube videos (including Dr Kory’s testimony to the US Senate) have been taken down and flagged as misinformation. Just using the word ‘ivermectin’ can apparently get you warned on Twitter.
This is curious – because the simplest way to stop the ivermectin hype in its tracks would quite obviously be not to suppress the drug, but the opposite. The extremely obvious solution is to make it widely available (at safe doses), indeed to arrange for maximum media coverage of those doctors who insist on prescribing it. Once it becomes clear that the drug doesn’t work – once their Covid patients get hospitalised and die, in other words – the whole fuss will be over.
Unless, of course, the drug does work.
This pandemic has been an eye-opener, for many reasons. It’s always been the case that if you got sick, you went to the doctor and were given an approved medicine. No-one ever questioned why that medicine was approved, or whether a better one might be available.
The emergence of a new disease, however – in conjunction with the power of the internet – means that, for the first time, we’re all learning together. The WHO, previously a generic institution like the UN, can now be seen as a flawed organisation making decisions which the man or woman in the street might legitimately question. Anyone can read the studies on ivermectin, check the numbers, and make up their own mind.
Despite the emphasis on public health, we may actually be at the dawn of a new emphasis on personal health. From the perspective of empowering patients, this can only be a good thing.