Ivermectin

The Story About Overdosing Ivermectin Patients Clogging Up Oklahoma Hospitals Was Too Good to Check

My latest Spectator column is about the fake news that circulated at the beginning of this week claiming that gunshot victims in Oklahoma were unable to get treatment in emergency rooms because ER doctors were too busy dealing with patients who’d overdosed on ivermectin. Incredibly, Jolyon Maughan invoked the story in a tweet urging Ofcom to investigate Calvin Robinson for promoting fake news! To date, the tweet remains undeleted and – who would have thunk it? – Twitter has not suspended him for trafficking in misinformation about COVID-19.

Here are the opening three pars of my column:

Last weekend, Rolling Stone ran a story about an interview an emergency room doctor had given to a local news station in which, according to the TV reporter, he’d said hospitals in his state were so swamped with patients who’d overdosed on ivermectin that gunshot victims were struggling to be seen. For context, ivermectin is an anti-parasitic drug used for deworming horses that has been touted by vaccine sceptics as an effective prophylactic against Covid-19. For boosters of the Covid vaccines, this story was manna from heaven. Here were a bunch of hicks so dumb they were stuffing themselves with horse pills rather than getting jabbed, with predictably disastrous results.

There was only one problem — it wasn’t true. A hospital in rural Oklahoma that had worked with the ER doctor issued a statement saying it hadn’t treated any patients with complications arising from taking ivermectin. Two days later, Rolling Stone issued a clarification saying it had been “unable to independently verify any such cases’”. Pity it didn’t try to verify the story before publishing it, but then it probably fell under the heading of ‘too good to check’. That was the attitude of various media organisations that rehashed the story without bothering to confirm it, including the Guardian, Newsweek, the New York Daily News, Business Insider, The Hill and MSNBC. Incredibly, the host of a show on CNN called No Lie repeated it, as did the best-selling author of a book debunking anti-vaccine myths. Perhaps the icing on the cake is that this little nugget of fake news was regurgitated by an academic at the University of Maryland who specialises in ‘mis/disinformation’.

Needless to say, Twitter didn’t suspend any of its users for trafficking in falsehoods and nor did any ‘independent fact-checkers’ on Facebook flag the story as wrong. This is the type of in-accurate anecdote that the self-appointed scourges of ‘mis-information’ are happy to ignore because it confirms their prejudices about vaccine sceptics being ignorant rubes. As a rule, any story that challenges the official narrative about coronavirus is scrutinised by these gatekeepers in forensic detail, while those that support it, like this one, are given a free pass. That explains why journalists at papers like the Guardian were quick to dismiss the lab-leak hypothesis about the origins of SARS-CoV-2, yet lapped up fanciful stories linking the Great Barrington Declaration to unscrupulous businessmen worried about their profits.

Worth reading in full.

The BBC’s Dishonest Attack on Ivermectin

The following article by Dr Edmund Fordham and Dr Tess Lawrie was first published by HART and is reproduced here by kind permission.

The July 3rd episode of Tim Harford’s More or Less: Behind the Stats, broadcast on BBC Radio 4 and the World Service, spread more medical disinformation with a piece entitled “Is ivermectin a Covid wonder drug?” Timed to follow publication of an article in Clinical Infectious Diseases by Roman et al on June 28th, this piece seems a clumsy attempt to discredit the landmark British study of Bryant, Lawrie et al which was published by the American Journal of Therapeutics in June and has recently appeared in the current (July) print edition.

Though published by British authors – based at Dr Tess Lawrie’s Evidence-Based Medicine Consultancy Ltd in Bath and the University of Newcastle — and despite these authors lacking any conflicts of interest, BBC Radio 4 made no attempt to contact any of the study authors for interview or ‘right of reply’, which is a fairness obligation under the Ofcom Broadcasting Code. Instead, Harford spoke to one Gideon Meyerowitz-Katz, an epidemiologist at the University of Wollongong in Australia.

Bryant et al have published the world’s first Cochrane-standards systematic review and meta-analysis of available randomised clinical trials of ivermectin in treatment and prevention of COVID-19. Review of 3,406 patients in 24 randomised trials demonstrated a mortality risk reduction of 62% on ‘moderate certainty’ evidence. The documentation is meticulous and comprehensive. Its restriction was to ‘randomised’ clinical trials because non-randomised studies are typically disregarded by regulatory authorities. There was no ‘cherry picking’: all available trials at the study cut-off date were included.

Meyerowitz-Katz referred to Roman et al, with an almost identical but not the same title, which also claims to be a systematic review and meta-analysis. The study surveys only 1,173 patients over 10 studies, with the remaining known randomised trials arbitrarily excluded. Moreover, the article misreports published clinical trial data in a way that verges on falsification of data, as an Open Letter to the Editor-in-Chief has detailed. The initial misreporting while on the preprint server medRxiv included a farcical reversal of the treatment and control ‘arms’ of the clinical trial of Niaee et al, drawing protest from Dr Niaee himself which can still be found in the comments section of medRxiv. Unfortunately for Clinical Infectious Diseases, further misreporting (undetected by the journal’s peer reviewers) remains, in a way that renders the article worthless. Further background on the sources can be found here.

Ivermectin: Oxford University to Trial Promising, Easily Available Drug as Early Treatment for COVID-19

The Principle trial at the University of Oxford has selected Ivermectin for inclusion in its study of repurposed drugs for treatment of COVID-19. It will be given to people with Covid symptoms to see if it can keep them out of hospital. The BBC has the story.

The Principle study will compare those given the drug to patients receiving the usual NHS care.

The drug has become controversial after being promoted for use across Latin America and in South Africa, despite being so far unproven.

Previous studies of Ivermectin have generally been small or low quality.

Most commonly used to treat parasitic infections such as river blindness, spread by flies, Ivermectin has also been shown to kill viruses in petri dishes in the lab – although, at much higher doses than would usually be prescribed to people.

Ivermectin has been championed by many doctors and scientists since its apparent effectiveness as a Covid treatment emerged early in April 2020, but has been snubbed by mainstream health bodies for reasons that are unclear, leading some to suspect ulterior motives such as sustaining a vaccine narrative or prioritising newer and more profitable treatments. Merck, which manufactures Ivermectin but also recently signed a $356 million deal to supply the US with a much more expensive, experimental anti-Covid drug, went so far as to issue a statement casting doubt on the drug’s safety, even though its safety profile is well known and mild. Scientists trying to publish studies on the drug found the door being shut in their faces with apparent political motives for the refusal. Finally in May, the American Journal of Therapeutics published a peer-reviewed article by Dr Pierre Kory and colleagues entitled “Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19“. Dr Tess Lawrie and colleagues’ meta-analysis, finding a 62% reduction in risk of death among those infected or at high risk of Covid infection (on moderate-certainty evidence), was published in the same journal last week.

While, in a pandemic, the precautionary principle would seem to recommend authorising the use of safe, repurposed drugs that (small) trials have shown appear to work, health authorities apparently did not agree and said there must be higher quality evidence for Ivermectin before it can be approved. Yet because there is little profit in a cheap, out-of-patent drug these higher quality trials have not been done, leaving the drug still without approval or definitive evaluation over 14 months after its apparent efficacy against COVID-19 was discovered. If it does turn out to be as highly effective as the early studies suggest, this will mean the delay will have been responsible for failing to prevent many thousands of deaths around the world.

Still, better late than never, and credit to Oxford for including it in its study despite the politics around it. The Principle trial should provide the definitive answer as to whether Ivermectin is effective at preventing the progression to serious coronavirus disease when used at an early stage.

People aged 18-64 with an underlying health condition or experiencing breathlessness, and anyone aged 65 or over, can sign up to the Principle trial within 14 days of having Covid symptoms or receiving a positive test.

“100% Effective in Preventing Hospitalisation and Death”: Repurposed Drug Fluvoxamine Shows Promise for Treating COVID-19

Steve Kirsch at TrialSiteNews has written an excellent new overview of the evidence on three COVID-19 treatments that have been unfairly overlooked or maligned by health authorities including the World Health Organisation and the U.S. National Institutes of Health. They are hydroxychloroquine, ivermectin, and fluvoxamine, and despite consistently good evidence of their effectiveness in early treatment, Western and global health authorities have remained either neutral about them or recommended against their use. Kirsch goes in some detail through the evidence on each and suggests governments should set aside the guidance of the WHO and NIH and “independently evaluate the evidence”.

The whole piece is worth reading in full, but I particularly want to highlight here the section on fluvoxamine, which is a promising drug that has not received the prominence the emerging data on it should warrant even among many with their ear to the ground on repurposed treatments.

Fluvoxamine, which is commonly used as an anti-depressant though has more general anti-inflammatory effects, is not acknowledged by the WHO at all in connection with COVID-19. However, Kirsch notes that the NIH is more up-to-date on this one.

The NIH is better; it is listed on the NIH’s Covid Treatment Guidelines, and the NIH  knows that there have been two quality randomised trials done by top US researchers (one trial was a DB-RCT, the other was quasi-randomised which the NIH categorises as “observational” but that’s a debate for another op-ed), both were published in peer-reviewed journals, and both papers were given a prestigious “Editor’s Choice” designation.

In other words, fluvoxamine has something that ivermectin and HCQ both lack: two quality studies, done by highly respected researchers associated with top-quality institutions, published in top peer-reviewed journals, both studies had statistically significant results on a critical clinical endpoint (hospitalisation), both were an interventional trial, both were randomised, and both studies were highlighted by the editors. It is for these reasons that the mainstream scientific community believes that the case for fluvoxamine is superior to the case for ivermectin and HCQ. 

Of the most respected scientists I know, 100% would choose fluvoxamine in a heartbeat over the other two drugs if they got Covid and had to pick a treatment based on the evidence available today. A top medical school looked at fluvoxamine and other options and the consensus was that the case for fluvoxamine was clearly the strongest. I also know of a DB-RCT study, not yet published, which compared the efficacy of fluvoxamine against ivermectin and fluvoxamine had the greater benefit by far.

The consistent superior rating by mainstream scientific experts is important because if a country adds ivermectin and/or HCQ to their treatment recommendations, then adding fluvoxamine should be a “no brainer.” Unfortunately, this isn’t the case today, anywhere in the world. However, the FLCCC did add fluvoxamine to their early outpatient treatment guidelines based on the evidence and the experience with doctors all over the world with the combination.

Fluvoxamine’s safety record is also known and good, Kirsch says.

Ivermectin: Cheap Covid Treatment Shown to be Highly Effective in New Peer-Reviewed Study

A new peer-reviewed study by Dr Pierre Kory and colleagues on Ivermectin has been published in the American Journal of Therapeutics. Entitled “Review of the Emerging Evidence Demonstrating the Efficacy of Ivermectin in the Prophylaxis and Treatment of COVID-19“, it provides a new authoritative overview of the evidence to date and calls for the widely available drug to be “globally and systematically deployed in the prevention and treatment of COVID-19”.

The study summarises the impressive evidence base for the use of Ivermectin.

1. Since 2012, multiple in vitro studies have demonstrated that Ivermectin inhibits the replication of many viruses, including influenza, Zika, Dengue, and others.
2. Ivermectin inhibits SARS-CoV-2 replication and binding to host tissue through several observed and proposed mechanisms.
3. Ivermectin has potent anti-inflammatory properties with in vitro data demonstrating profound inhibition of both cytokine production and transcription of nuclear factor-κB (NF-κB), the most potent mediator of inflammation.
4. Ivermectin significantly diminishes viral load and protects against organ damage in multiple animal models when infected with SARS-CoV-2 or similar coronaviruses.
5. Ivermectin prevents transmission and development of COVID-19 disease in those exposed to infected patients.
6. Ivermectin hastens recovery and prevents deterioration in patients with mild to moderate disease treated early after symptoms.
7. Ivermectin hastens recovery and avoidance of ICU admission and death in hospitalised patients.
8. Ivermectin reduces mortality in critically ill patients with COVID-19.
9. Ivermectin leads to temporally associated reductions in case fatality rates in regions after ivermectin distribution campaigns.
10. The safety, availability, and cost of ivermectin are nearly unparalleled given its low incidence of important drug interactions along with only mild and rare side effects observed in almost 40 years of use and billions of doses administered.
11. The World Health Organisation has long included ivermectin on its “List of Essential Medicines.”

The quality of the evidence for Ivermectin has been challenged, leading many countries including the U.K. and U.S. not to recommend its use for COVID-19. The study takes this criticism head-on.

Although a subset of trials are of an observational design, it must be recognised that in the case of ivermectin (1) half of the trials used a randomised controlled trial design (12 of the 24 reviewed above) and (2) observational and randomised trial designs reach equivalent conclusions on average as reported in a large Cochrane review of the topic from 2014. In particular, OCTs that use propensity-matching techniques (as in the Rajter study from Florida) find near identical conclusions to later-conducted RCTs in many different disease states, including coronary syndromes, critical illness, and surgery. Similarly, as evidenced in the prophylaxis and treatment trial meta-analyses as well as the summary trials table, the entirety of the benefits found in both OCT and RCT trial designs aligns in both direction and magnitude of benefit. Such a consistency of benefit among numerous trials of varying sizes designs from multiple different countries and centres around the world is unique and provides strong, additional support.

A hint of the politics around Ivermectin can be gleaned in the discussion section, where the authors wonder how much more evidence a cheap, safe drug like Ivermectin needs in an international emergency before it can be approved.

The continued challenges faced by health care providers in deciding on appropriate therapeutic interventions in patients with COVID-19 would be greatly eased if more updated and commensurate evidence-based guidance came from the leading governmental health care agencies. Currently, in the United States, the treatment guidelines for COVID-19 are issued by the National Institutes of Health. Their most recent recommendation on the use of ivermectin in patients with COVID-19 was last updated on February 11th, 2021, where they found that “there was insufficient evidence to recommend for or against ivermectin in COVID-19”. For a more definitive recommendation to be issued by major leading public health agencies (PHA), it is apparent that even more data on both the quality and quantity of trials are needed, even during a global health care emergency, and in consideration of a safe, oral, low-cost, widely available and deployable intervention such as ivermectin.