This blog is committed to well referenced writing. Today, and particularly in the COVID-19 age, it seems many news organisations have abandoned this principle. Take Forbes, a global media outlet, reporting on Joe Rogan’s COVID-19 experience. The MMA star turned wildly popular podcaster has come down with the disease and has taken ivermectin to treat it. It is not known whether Rogan has been vaccinated, nor is it particularly relevant, as both the vaccinated and unvaccinated are contracting COVID-19 and falling ill with it. Ivermectin is a drug which may or may not be useful in treating the disease once it is already contracted.
Besides the influx of great memes transforming Joe Rogan into a horse, this story has prompted yet more engagement in untruths and media spin during a pandemic. Forbes published an article by Joe Walsh headlined Joe Rogan Says He Has Covid — And Took Bogus ivermectin ‘Cure’.[1] The article goes on to describe the drug as ‘unapproved’ and ‘designed for farm animals’. Walsh quotes the FDA on Twitter advising the population that they are ‘not a horse’, ‘not a cow’, and in regard to taking ivermectin: ‘seriously, y’all. Stop it.’. Walsh also ties the drug to the presidency of Donald Trump – an association the writer believes will further discredit the drug, presumably.
Before getting into the detail of the article and making a critique, note that this link will take you to a robust discussion by medical doctors about the use of ivermectin for treating COVID-19: https://www.youtube.com/watch?v=lTDvEvagbPI&ab_channel=TheDoctors. In this discussion, it is noted that there are differences versions of ivermectin: a veterinary version, and one intended for use in humans. Joe Walsh at Forbes must have missed that detail when writing his own informative article on the drug.
Let us first check Walsh’s sources. The first reference he provides to support his claim, that there is ‘scant evidence’ of ivermectin’s effectiveness against COVID-19, is not a medical paper, but another Forbes article by a colleague (Robert Hart) making the same claims as he does.[2] Bizarrely, the article by Hart which Walsh chooses to reference is about the University of Oxford's upcoming trial to assess the effectiveness of ivermectin, which if anything lends credibility to the notion that the drug might work – not that it doesn’t work. The university's statement on the trial also dispels myths around ivermectin being a dangerous drug:
‘Professor Chris Butler, from the University Oxford’s Nuffield Department of Primary Care Health Sciences, Joint Chief Investigator of the PRINCIPLE trial, said, ‘Ivermectin is readily available globally, has been in wide use for many other infectious conditions so it’s a well-known medicine with a good safety profile, and because of the early promising results in some studies it is already being widely used to treat COVID-19 in several countries. By including ivermectin in a large-scale trial like PRINCIPLE, we hope to generate robust evidence to determine how effective the treatment is against COVID-19, and whether there are benefits or harms associated with its use.’[35]
Both of these Forbes writers have the same role: “I cover breaking news for Forbes” under the topic of “Business”.
The second reference Walsh provides for the same claim is, yet again, not a medical paper, but another journalist from Statnews who focusses on one discredited study by a professor Elgazzar in Egypt. This study showed extremely positive results for ivermectin, but the data was found to be manipulated and the study has been withdrawn from the platform on which it was hosted (Research Square). One bad study does not mean the opposite conclusion is proven by default. It also does not mean that there are no good studies showing the effectiveness of ivermectin. Another poorly referenced Forbes article, but at least this time it is not quite as incestuous as referencing another Forbes writer.
Walsh further misleads the reader, suggesting the ineffectiveness of ivermectin, by quoting National Institutes for Health (NIH) as saying there is “insufficient evidence” to recommend ivermectin, without providing the crucial context that they also do not recommend against it. The NIH actually says:
‘There is insufficient evidence for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against [emphasis added] the use of ivermectin for the treatment of COVID-19. Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.’[3]
In other words, the jury is out. The NIH acknowledges there is evidence indicating positive and negative results by the use of ivermectin and goes on to conclude that “Several clinical trials that are evaluating the use of ivermectin for the treatment of COVID-19 are currently underway or in development.”.[4]
The NIH also provide some background to ivermectin and its uses:
‘Ivermectin is a Food and Drug Administration (FDA)-approved antiparasitic drug that is used to treat several neglected tropical diseases, including onchocerciasis, helminthiases, and scabies.’[5]
The NIH’s reference to FDA approval might be confusing, as Walsh tells us that the drug is not FDA approved. The nuance is that ivermectin is not approved specifically for treating COVID-19, but it is already approved for use in humans for other diseases. The FDA itself confirms:
‘Ivermectin tablets are approved for use in people for the treatment of some parasitic worms (intestinal strongyloidiasis and onchocerciasis) and ivermectin topical formulations are approved for human use by prescription-only for the treatment of external parasites such as headlice and skin conditions such as rosacea.’[6]
The fact of ivermectin’s use in humans already debunks the attempt to discredit the drug by noting its use in animals. As mentioned prior, there is a veterinary version of the drug for which safety information around human consumption is lacking, and there is a version tested for use in humans. In truth, many drugs used on humans are also used on animals, including Diazepam, Morphine, Ketamine, Buprenorphine. Veterinarians can also prescribe drugs intended for humans, for animals.[7] Drugs are often tested on animals before humans, for effects are often similar across species. This ought not to be too surprising, as we are, after all, animals.
Walsh’s article has a little bit of truth in it when it says that the drug is not Food and Drug Administration (FDA) approved for treating COVID-19. However, the FDA having a Twitter opinion on a drug does not mean it doesn’t work. The FDA not approving a drug also does not mean it doesn’t work – all drugs that do work take an average of 12 years to be approved by the FDA, from invention to market. Ivermectin already exists in the market and is used to treat disease in humans, so it wouldn’t take 12 years to approve its use for COVID-19, but this timescale gives a frame of reference for how slow the pace of the FDA is.
The FDA is extremely cautious and receives broad criticism that, since its remit was extended to verifying both the safety and efficacy of a drug before it could be approved, millions of people have died of diseases who otherwise would not have if the drug that would have saved them had been approved quicker. In other words, it is not clear, on net, that the FDA saves more lives than it costs in delaying medical treatment to sick people. In fact, it probably costs more lives than it saves, because most drugs are not unsafe and their average 12-year FDA-related delay is, in hindsight, unwarranted.
The thalidomide tragedy, also known as the Contergan Scandal, was an event in 1961-1962 which saw a drug intended to assist with morning sickness in pregnant women cause birth defects in their children. The highly visible harm and subsequent public uproar caused a political shift (the government must be seen to be ‘doing something’) which granted the FDA greater powers. The cost to society of the FDA’s expanded remit since 1962 is explained by economist Milton Friedman and his wife and co-author, Rose Friedman, in their 1980 book, Free to Choose:
‘[…] the number of “new chemical entities’ introduced each year has fallen by more than 50 percent since 1962. Equally important, it now takes much longer for a new drug to be approved and, partly as a result, the cost of developing a new drug has been multiplied manyfold. According to one estimate for the 1950s and 1960s, it then cost about half a million dollars and took about twenty-five months to develop a new drug and bring it to market. Allowing for inflation since then would raise the cost to a little over $1 million. By 1978, “it [was] costing $54 million and about eight years of effort to bring a drug to market” – a hundredfold increase in cost and quadrupling of time, compared with a doubling of prices in general. As a result, drug companies can no longer afford to develop new drugs in the United States for patients with rare diseases. Increasingly, they must rely on drugs with high volume sales.’[8]
Today, another twenty years later, costs of developing a new drug range from $143 million to $6.4 billion and the mean average cost is in excess of $1.3 billion.[9]
Most drugs are not unsafe because healthcare companies wouldn’t last very long if they had a habit of killing people. It is not in the interest of pharmaceutical companies or doctors to kill their patients. There were not swathes of people dropping dead due to dodgy drugs prior to the FDA’s gaining of sweeping regulatory powers after the thalidomide tragedy of 1961-1962. Any thinking person must accept the reality that medical mistakes and scandals have existed both before and after the rise of the FDA and will unfortunately continue to happen in future. These simple truths standing, why does the FDA continue to exist as a force which introduces high barriers and enormous costs to drug development? Why does the FDA plainly do more to inhibit the production of new and useful drugs than it does to prevent harmful ones? No better explanation can be given than the one given by the Friedmans:
‘Put yourself in the position of an FDA official charged with approving or disapproving a new drug. You can make two very different mistakes:
1. Approve a drug that turns out to have unanticipated side effects resulting in the death or serious impairment of a sizable number of persons.
2. Refuse approval of a drug that is capable of saving many lives or relieving great distress and that has no untoward side effects.
If you make the first mistake – approve a thalidomide – your name will be spread over the front page of every newspaper. You will be in deep disgrace. If you make the second mistake, who will know it? The pharmaceutical firm promoting the new drug, which will be dismissed as an example of greedy businessmen with hearts of stone, and a few disgruntled chemists and physicians involved in developing and testing the new product. The people whose lives might have been saved will not be around to protest. Their families will have no way of knowing that their loved ones lost their lives because of the “caution” of an unknown FDA official.’[10]
Put differently, approving a drug which causes harm is an action which has high visibility, damaging the organisation and the individuals who made the decision. The solution is to avoid the professional risk of approving drugs by making slower, and fewer, drug approvals. This solution, manifested in the FDA’s policies, increases risk to the public greatly. The FDA’s cost in lives is not obvious to the population.
A well written article by Conor Friedersdorf for The Atlantic makes the same point regarding the dangers of regulatory overreach, which is unusual for The Atlantic as a heavily left-leaning publication. Friedersdorf quotes the economist Alex Tabarrok, who described those dead due to FDA tardiness and ‘cautiousness’ as being in “an invisible graveyard”.[11]
In yet more perversity, the high barriers to entry to the healthcare market that the FDA erects perpetuate that evil which so many big-government, high-regulation types want to avoid: centralisation of corporate power. As Tabarrok wrote:
‘In my many years of writing about the FDA, I can’t recall a single instance in which a major medical organization told the FDA to use a smaller trial and speed up the process because FDA delay was endangering the safety of their patients.’[12]
Why would large pharmaceutical companies not be bothered by the highly prohibitive costs created by the FDA and its onerous regulations? They might pressure the FDA to approve their drugs from time to time, but they are clearly not suffering from the delay, operating quite happily with large profits under the current system. This is because these costs are not prohibitive, literally, to large companies like Pfizer. They can afford the costs of meeting the regulation and the cost in time (which costs money too, in capital invested and employees paid for the duration) for developing a drug. Once the drug is developed, the costs incurred development are passed on to the customer. Therefore, drugs are expensive. Firstly, then, the status quo does not impede big medical companies in a way that dents their profits, it only impedes the customer’s access to drugs.
Secondly, an upstart drug researcher, smaller company, or individual doctor would find it virtually impossible to bring a drug to market without securing billions in funding. The costs imposed by the FDA are prohibitive, literally, for smaller players. Pfizer does not need to beg and plead for funding, because it already has billions to invest. This leaves the big players the ones in the game – in other words, high regulation eliminates competition to ‘Big Pharma’. Without effective competition, innovation slows, research into rarer diseases becomes scarce, and costs fail to decline.
This fact feeds into another concern that the FDA is not effective in its remit because it is majority funded by the largest pharmaceutical companies in the form of user fees (fees to get their drugs approved) and is therefore subject to a major conflict of interest. ‘Big Pharma’, and the FDA, are clearly not in a check-and-balance type relationship, or in competition, but partners.
Many drugs prescribed routinely by doctors are not FDA approved for the use intended by the doctor, because the approval process is so restrictive, onerous, and expensive.[13] The FDA approves a specific drug for a specific intended use, according to safety and efficacy, meaning the number of approvals that must be made is so gargantuan that many are simply not done. When a medicine is prescribed for a non-approved purpose, it is prescribed 'off-label'. 10 to 20 percent of all prescriptions are written off-label,[28] so it is dishonest to say that ivermectin is unsafe only because it has not been approved for treating COVID-19.
In the case of ivermectin - is it plausible that large pharmaceutical companies would rather sell more expensive treatments for COVID-19, and are influencing the FDA in advising against cheaper alternatives? Perhaps, but even without corruption at play there is plenty enough room for government incompetence to be the explanatory factor.
Consider hydroxychloroquine, a drug FDA approved for malaria. It is now most regularly used in the United States to treat rheumatoid arthritis and lupus, but is FDA approved for neither. It is 'off-label' treatment, and it is highly effective. It has only developed a bad reputation in recent times, firstly because the name came out of Donald Trump's mouth, and secondly because of media condemnation of any medicinal solution to COVID-19 suggested other than vaccines. This is much the same problem facing those advocating for ivermectin who disagree with the FDA, NIH, and CDC.
Dr Pierre Kory said of the situation:
‘I am severely troubled by the fact that the NIH, the FDA and the CDC - I do not know of any task force that was assigned or compiled to review repurposed drugs in an attempt to treat this disease. Everything has been about novel and/or expensive pharmaceutically engineered drugs [...] We have a hundred years of medicine development, we are expert in all the medicines we use, and I do not know of a task force that has been focussed on repurposed drugs.
Every decision I make therapeutically, it involves exactly that question - it is a risk-benefit analysis. And so, if the therapy I have is either low-cost/low-resource or extremely safe, and its potential for benefit is high, it would win the risk-benefit analysis [...] with these agents the answer is unequivocally 'yes' . When you look at the mortality and morbidity of this disease, which is unparalleled, we are seeing countless deaths and its horrific, the way they are dying, and you look at these safe and low-cost agents - it seems like a no-brainer that you should try it.
You have to understand something about ivermectin: 3.7 billion doses have been administered since it was first developed in 1987 - 3.7 billion. Something like over 60 percent of Sub-Saharan Africans take it on a yearly basis. It has an unparalleled safety profile with almost no side effects. The only side effects that have been attributed to it are those that are considered to be part of the diseases they treat which is the ridding of the parasites.’ [14]
The efficacy of ivermectin in treating COVID-19 is contested, but its safety record is not. References to the billions of uses it has had, its hugely positive impact on healthcare worldwide, and its reputation as a safe drug, are made in innumerable medical papers.[34] If one has trouble trawling through medical papers, does one really believe that the University of Oxford would carry out a trial using ivermectin to treat COVID-19 if it was in fact dangerous?[35] If the University of Oxford's test subjects were recklessly put in harm's way, its reputation would be severely damaged. If one does not trust Dr Kory, they can be reassured by the University of Oxford that “Ivermectin is a safe, broad spectrum antiparasitic drug which is in wide use globally to treat parasitic infections.”.[35]
Kory broadly discussed ivermectin as one of the repurposed drugs he would recommend for fighting COVID-19, describing it a 'miracle' drug for the present pandemic situation. The Front Line COVID-19 Critical Care Alliance, of which Kory is a member, added the following in a published summary:
‘We support the FDA’s direction that humans should never take medication formulations meant for animals. We also agree that self-dosing of medications without the guidance of a physician is potentially dangerous and could cause serious harm.
However, the FLCCC feels that other statements recently made by the FDA are misleading and serve to alarm the public about using Ivermectin as a treatment prescribed by a physician.
The FDA consumer guidance statement admits that they have not reviewed data on the use of Ivermectin to treat or to prevent COVID-19. However, the agency felt compelled to use language to discourage any discourse and interest in using Ivermectin as a front-line treatment of COVID-19. To do this is to ignore the growing body of scientific evidence from peer-reviewed research, over 40 medical trials, and results from Ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.
FDA approval would only come many months to years from now after a very large Phase III trial is done and our patients cannot wait for that.
In the 40 years since it was first approved for use, more than 3.8 billion people have been treated with an average of only 160 adverse events reported per year. This is a better safety record than several vitamins.’ [29]
Kory presented the following slides in support of his argument at the Senate hearing, the first of which shows the death rate for COVID-19 in Mexican states, one of which (Chiapas, in green) has widely distributed ivermectin while the rest have not; the second of which shows the death rate for COVID-19 in Paraguayan states, one of which (Alto Parana, the blue line on the chart) has widely distributed ivermectin while the rest have not; the third of which shows the death rate for COVID-19 (the red line on the chart) in people above age 60 (to dispense with the possibility that it is a youthful population versus an ageing population which is the cause of apparently low death rates) in eight Peruvian states plotted against the point in time that ivermectin was distributed en masse (where the background of the chart turns from grey to white); the fourth of which shows the death rate for COVID-19 in the eight Peruvian states (the blue peaks), which had ivermectin distributed, plotted against the death rate for COVID-19 in Lima (the red peaks), where ivermectin was not distributed:
These charts provide compelling circumstantial evidence for the efficacy of ivermectin in reducing the death rate of COVID-19. If it turns out that all the data coming out of Latin America is flawed, then these charts will no longer be compelling; but to presume the data coming from poorer or foreign-language countries is bad smacks of bigotry.
Circumstantial evidence which indicates ivermectin distribution to be life saving at policy level does not constitute the gold-standard of research which some demand, and even the inclusion of random controlled trials which do show ivermectin to be effective is not enough to convince the FDA/NIH/CDC, but this is the crux of the problem with authorities gatekeeping drugs. We are not talking about proving somebody of murder, with evidence showing guilt beyond a reasonable doubt, nor are we talking about proving the Higgs boson. We are assessing the efficacy of a well-established drug for a new purpose. Waiting for some standard beyond what many medical experts would demand upon before even permitting the use of a drug costs lives. If ivermectin is shown to be a life saving drug when used to treat COVID-19, meeting the gold-standard after many trials, proving itself clinically, in random controlled trials, and circumstantially, then those dead due to the withholding of ivermectin and government advice against its use during this time will be the blood price paid for the politicisation of medical science.
Note that no professional person is claiming these drugs ought to replace vaccines, but that statement is only valid where vaccines are available. Drugs like ivermectin may be a worthy replacement of vaccines in countries which cannot afford and/or do not have access to vaccines. In countries where ventilators are extremely scarce, the prevention of hospitalisation is of paramount importance. For some, the choice is between a repurposed drug, or no treatment at all. It ought to go without saying, but lives in the third world and the developing world are also worth saving, no matter how upset a rich westerner gets about a doctor prescribing a drug which is unapproved by government agencies.
If a drug is permitted for use, that does not mean that everyone must take it. If an individual does not want to take the drug because they are unconvinced that it is safe, they need not take it. However, in cases where a person does want to take it, they ought to be allowed. In cases where the patient is at death's door anyway, what is the harm in trying? Unfortunately, common sense does not trump the power of government regulation and the threat of litigation and/or job-loss, as Dr Orient explained:
‘The physician is working for the good of his patients, like it says in the oath of Hippocrates, not for the good of the organisation, or society, or the political party, or the advancement of science, but each individual patient is the doctor's first priority, and the doctor has to have the authority to go along with his responsibility to that patient, to look into the best methods [...]
We found that physicians in independent practice are able to do this, but once a doctor has an employer, or he has a managed care plan, or he is restricted to what is on the drop-down menu, then his hands are really tied. If the NIH is the authority that their employer respects then, if he goes outside those rules, no matter how much his patient needs it, he is putting his life at risk [...]
We used to worry about malpractice liability but that is a minor thing compared with [...] being before the licensure board because you deviated from the standard of care, which used to be determined by what doctors in a similar situation - rational, well-trained people - would do, but now is dictated more and more by single authorities from on high [...] Occasionally a patient will tell me: "I begged and pleaded with the hospital to do 'this' for my husband who is dying - please please will you give him some intravenous vitamin C"; and, sometimes, the patient's suggestion works. I mean, it doesn't always, but if the doctor's afraid, that he dare not do something, that's even very safe, or even been clinically trialled, or reported in literature, even if a long time ago, that he will lose his job, then he has every incentive to say: "well, there is nothing more that I can do".’[14]
The problem of government overreach in the work of medical practitioners has prompted a policy drive in America called 'the right to try' - the right of doctors to try medicine they think may help, even if it does lie outside the guidance of regulatory authorities. The comments above were made during a Homeland Security hearing where a numerous doctors advised the government to approve cheap drugs with anti-viral properties (like ivermectin) – advice which has been ignored and branded as ‘bogus’ in mainstream media (such as Forbes).[14] In fact, the meeting was boycotted by many representatives and the expert witnesses pilloried in the media in general.
The politically motivated condemnation these people receive from media organisations is so broad that it amounts to censorship. Nobody can look up the names of these highly qualified and widely published doctors, or search for the studies they cite, without being bombarded with articles, much in the style of the ones under review in this essay, which lazily brand them as 'anti-vaxxers' or 'dangerous' people. One such article, by Beatrice Dupuy, was published in the Associated Press (AP News).[27] AP News issued a 'fact check' on Dr Kory's comments, and branded them “false”, asserting that there is “no evidence ivermectin has been proven a safe or effective treatment against COVID-19”. Perhaps this 'fact check' was carefully, disingenuously worded on purpose, because it does not make a great deal of sense to ask for 'evidence of proof'. Evidence and proof are two different things, and to ask for evidence that something is proven is really just to ask if it is proven or not. The claim Kory makes could be evidenced and not conclusively proven, which actually appears to be the reality. The wording of the 'fact check' makes it sound as though there is no evidence that ivermectin is effective in treating COVID-19, which is untrue, but it really only says that it is not proven, which is probably true at this stage. It is as though they are trying to convince the reader with strong words while technically refraining to commit to a scientifically difficult position.
Whatever the slipperiness of the fact-checker's language, the more important point to note is that Dupuy has gone to no effort to rebut any of the claims made by Kory. It is simply asserted that he is wrong and that there is no evidence for his claims, without offering a single counterargument. As with the Forbes articles, the AP News writer simply repeats some selectively mined parts of the FDA and NIH's position on ivermectin, states that it is not FDA approved or NIH endorsed, and lists some standard listed side effects for the drug which are common to many drugs (skin rash, nausea, vomiting). Dupuy goes to the effort of quoting another medical expert, Dr Amesh Adalja, who does not say that ivermectin 'doesn't work', but that “We need to get much more data before we can say this is a definitive treatment". This is a perfectly reasonable, professional opinion, which is not nearly as brazen as the AP News fact checkers'.
Dupuy then ropes in hydroxychloroquine and references a bizarre story from Arizona where a couple ingested an additive used to clean fish tanks resulting in the death of the man and illness in the woman. This is a strawman argument. The doctors researching or advising the use of ivermectin or hydroxychloroquine are recommending its dispensation by doctors, not self-medication, and not self-medication by random products which share some ingredients. To hold up this example, of a person dying after ingesting chloroquine phosphate, for why hydroxychloroquine should remain inadvisable or even banned, is akin to holding up an example of a person dying after injecting heroin as an argument for why doctors should not give their patients morphine.
Another article in The Guardian headlined “Anti-vaccine doctor to testify at Senate committee hearing on Covid mandates" effectively libels Dr Orient.[30] None of the doctors testifying said there should not be vaccines, or that they should not be administered - they simply advocated for repurposed drugs to be used where they could prove useful. Vaccines and other drugs can and do coexist, and the zeal with which some attack any medicine which is not a vaccine is quite concerning.
The article goes on to qualify its sensationalist headline, providing a brief but more accurate representation of Dr Orient's 'anti-vaccine' view, which is simply that she opposes federal vaccine mandates on the basis that it intrudes on individual freedom and states' rights to legislate on healthcare. This is not a medical position per se, but an ethical and political one. Both individual freedom and the sovereignty of the states are issues of great importance in the United States. Both issues featured heavily in the movement to the country's independence and in the founding documents of the nation, and have been central themes in politics and the organisation of government since. Such a position is not even controversial in Europe, where the proposition of national vaccine mandates has been met with fierce opposition - only, there appears to be greater acceptance of a nuanced view in European countries universally, and such a position is not branded 'anti-vax'.[32] That is to say, both American and European news outlets treat American opposition to vaccine mandates as an 'anti-vax' position, meanwhile treating the same position among Europeans as 'a balanced view' which is typically not newsworthy.
If any person makes any suggestions which do not align with a very narrow political view of the pandemic in the United States, endorsing vaccines exclusively as the medicinal solution, mask mandates, lockdowns and the like, then they are an 'enemy'. Interestingly, Dr Kory and his daughter are reported to have both contracted COVID-19, to the delight of some.[31] He is taking his own advice, taking ivermectin, and there is no indication as yet that either he or his daughter have been hospitalised with the disease as yet.
What is worrying about AP News' and Forbes’ brand of lazy journalism is that people read it, believe it, and enjoy it. These articles would not be so ubiquitous if they were not popular. For Forbes alone, Joe Walsh wrote the first subject article of this piece, Robert Hart wrote the article which Walsh referenced as a source, and a third article by Steven Salzberg bluntly claims that “ivermectin doesn’t work.”.[15] Yet again, in this third article, no medical source is provided to back up the claim made. Specific detail is gleefully given, once more, to that discredited and retracted study from Egypt which wrongfully claimed ivermectin to be wildly effective – but, again, one bad study does not mean the opposite conclusion is proven by default nor that there are not also good studies to observe (which we shall come to later). The only medical sources these writers do provide are from the same places (the FDA, CDC, NIH, all government agencies which are typically cautious and slow-moving) and advise the same thing in summary fashion: that ivermectin’s effectiveness against COVID-19 is not proven. Despite this, the writers claim quite brazenly and unequivocally that it does not work. Exactly what medical expertise these three men have, to overrule the medical consensus, I do not know.
Just because the evidence of ivermectin’s effectiveness in treating COVID-19 is not sufficient to satisfy proof for the FDA, CDC, and NIH, does not mean there is no evidence of its effectiveness. A study by the Barcelona Institute for Global Health published in The Lancet found the following:
‘Among patients with non-severe COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 72 h of fever or cough onset there was no difference in the proportion of PCR positives. There was however a marked reduction of self-reported anosmia/hyposmia, a reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials.’[16]
Put in simpler terms, the drug did not prevent infection, but it lessened symptoms, reduced the amount of the virus in the patient’s blood, and therefore a lesser antibody response occurred. The trial was relatively small, and one trial is not enough to conclusively prove efficacy – but an honest presentation of the current scientific data would be a great deal more useful than Forbes’ journalism.
A larger trial done in India (40 people receiving ivermectin, 45 a placebo, published as a pre-print), found:
‘[...] in this exploratory randomized placebo-controlled trial of a single oral administration of Ivermectin elixir at two different dosage strengths (12 mg and 24 mg) in patients with mild and moderateCOVID-19, a trend towards higher negativity of RT-PCR at day 5 was observed with the use of Ivermectin24 mg, while the decline in viral load was similar in all three arms. Reassuringly, there were no safety concerns with the use of Ivermectin at either dose. Larger studies employing different dosing regimens of Ivermectin are required to further elucidate its potential role in treatment of COVID-19.’[33]
Why aren’t there more large trials investigating the above? According to nature, an answer was given by a member of the Barcelona Institute for Global Health and an author of the above study, Carlos Chaccour, who said that funders and academics in wealthy countries haven’t supported studies of ivermectin and that he suspects existing trials of ivermectin have been largely dismissed by wealthy countries because they have been done in lower-income countries.[17]
A meta-analysis study in the American Journal of Therapeutics found that using ivermectin in COVID-19 afflicted patients provides a “significant survival benefit”.[18] Unlike the picture the Forbes writers paint for ivermectin as a purely antiparasitic drug, these researchers note the drug’s exhibition of “antiviral activity against a wide range of RNA and some DNA viruses, for example, Zika, dengue, yellow fever, and others”.[19] The researchers summarise their findings as such:
‘Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using ivermectin. Using ivermectin early in the clinical course may reduce numbers progressing to severe disease. The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.’[20]
They placed the average reduction in deaths by using the drug at 62 percent (a 2.8 percent risk of death using ivermectin, against a 7.8 percent risk of death where ivermectin was not used, in hospitalised patients).[21]
At this point, it is important to note that this meta-analysis includes data from the discredited Egyptian ‘Elgazzar’ study. It is on this basis that some – including our friends at Forbes, no doubt – would throw out the whole meta-analysis as unreliable. However, the beauty of a meta-analysis is that an individual study can be discarded from it. Indeed, one of the authors of the meta-analysis said that if the ‘Elgazzar’ study is shown to be unreliable, the meta-analysis will be revised, and that study removed. Nonetheless, even with its removal, the meta-analysis would still show that ivermectin causes a significant reduction in the death rate of COVID-19. The ‘Elgazzar’ study accounted for 15.5 percent of the reduction in the death rate, so the remaining studies still demonstrate a 46.5 percent reduction. Any writer who really cared about facts, good information, presenting data with integrity, and in this case saving lives, would take seriously that 46.5 percent reduction in the death rate.
The researchers also make comment on the international picture, noting that poorer countries where vaccines are not widely available have seen significant reductions in deaths by using ivermectin:
‘Peru had a very high death toll from COVID-19 early on in the pandemic. Based on observational evidence, the Peruvian government approved ivermectin for use against COVID-19 in May 2020. After implementation, death rates in 8 states were reduced between 64% and 91% over a two-month period. Another analysis of Peruvian data from 24 states with early ivermectin deployment has reported a drop in excess deaths of 59% at 30+ days and of 75% at 45+ days. However, factors such as change in behavior, social distancing, and face-mask use could have played a role in this reduction.’[22]
It is necessary for the authors to caveat the latter statement, as they did, because it would be unscientific to claim ivermectin accounted for the entirety of the reduction in the death rate. However, it is probably safe to assume it accounted for most of it – social distancing and mask wearing for two months have not accounted for a 64 to 91 percent reduction in deaths anywhere else in the world, nor would one expect them to. There is also no indication that the Peruvian healthcare system underwent a miracle overnight. One either must accept that ivermectin worked in this instance, or that COVID-19 deaths spontaneously reduced, indicating the disease to be a substantially lower threat to life than is currently purported, coming in waves of severity and benignity which are largely unaffected by our best efforts. Neither of these conclusions are acceptable to the person politically bent towards believing COVID-19 an apocalyptic plague, mandating masks, and mandating vaccines.
For mask wearing in particular, there is no conclusive evidence by scientific trials that they are effective in preventing transmission. Even studies which are long, narrative efforts at showing mask efficacy admit that direct evidence is ‘inconclusive’.[24] Papers which recommend masks rely on the notion that they might work based on mechanistic reasoning rather than clinically obtained or real-world data. Mechanistic reasoning amounts to saying, ‘masks ought to prevent transmission by capturing droplets from people coughing and sneezing, so we will assume that they work’. This reasoning is attractive, based in germ theory and ballistics, but may be flawed in several ways. Firstly, the size of the particles which must be stopped by the mask are too small for the mask's specifications. The size of SARS-CoV-2 particles are as small as 20nm, while N99 masks are only capable of halting particles of 300nm in size.[36] This is not to say that masks are therefore useless - they may be highly effective, even if not entirely effective - but this is a far-cry from the suggestion that wearing a masks means one "cannot breathe the virus in".
Even if masks were capable of stopping the passage of viral particles sufficiently that infection was made impossible or extremely rare, one is still left with the problem of human behaviour. The impact of people wearing and carrying around their masks all day, transferring the collected viral particulates from the mask onto their hands and other surfaces, is unknown. The impact of people lowering their masks to eat and to speak; putting their masks on tables; leaving their reused masks unwashed for days, weeks, and months on end, is unknown. The impact of mask mandates which prescribe the wearing of a mask in area ‘A’ but not in area ‘B’, despite the same people moving around both areas, is unknown. Members of the public do not and cannot act like they are a surgeon in a hospital in their day to day lives, binning their mask every time they touch it and washing their hands before donning a new one. Handkerchiefs have long been thought of as unhygienic, yet the average person carries around their mask like a covidian handkerchief and believes themself safe. There are even suggestions that the inefficacy of masks could be due to the virus not being transmitted quite as is currently believed. Some scientists say that COVID-19 is transmitted by faecal-oral transmission, like Norovirus, which would make hand-washing and good personal hygiene a far more effective mitigation technique than mask-wearing.[23]
Despite the lack of evidence of the efficacy of mask wearing, I would hazard a guess that our Forbes friends would insist on everyone doing it – a double standard against ivermectin, one might think. No doubt the counterargument would be that masks do not endanger anyone, whereas, according to the ‘news breakers’ at Forbes, ivermectin is dangerous. However, this is also untrue, as pointed out earlier, and as published by numerous experts in the American Journal of Therapeutics:
‘Ivermectin is not a new and experimental drug with an unknown safety profile. It is a WHO “Essential Medicine” already used in several different indications, in colossal cumulative volumes.’[25]
In addition to not pointing out that neither masks nor ivermectin are particularly dangerous compared with other garments and drugs respectively, it is also worth noting that there is no evidence that masks prevent deaths from COVID-19, while there is some evidence that ivermectin does. Perhaps the best policy would be to allow people to do what is best for them – managing their own risk, deciding whether they will wear a mask, whether they will take ivermectin or any other drug, whether they will get vaccinated, whether they will leave the house etc.
None of this is to say that ivermectin is effective at treating COVID-19, but nobody in the right mind could positively say that it is not, at this stage. It will be shown in time whether it works or not. As Carlos Chaccour has said, it is “our duty to exhaust all potential benefits […] Ultimately, if you do a trial and it fails, fine, but at least we tried”.[26]
It seems quite transparent that the ‘journalists’ under scrutiny in this essay are not writing as news breakers or public informers, but as polemicists, railing against what they see as a basket of deplorables, Trump-supporters, Rogan-fans, anti-vaxxers, conspiracy theorists, and right-wingers. Joe Walsh does not know that ivermectin is a ‘bogus cure’, nor does Steven Salzberg know that ivermectin ‘doesn’t work’. Be wary of those who claim knowledge that nobody has.
[1] Joe Walsh, Joe Rogan Says He Has Covid — And Took Bogus ivermectin ‘Cure’, Forbes, 1st September 2021 https://www.forbes.com/sites/joewalsh/2021/09/01/joe-rogan-says-he-has-covid---and-took-bogus-ivermectin-cure/?sh=1e102ef52506 [2] Robert Hart, Ivermectin – Widely Used To Treat COVID-19 Despite Being Unproven – Is Being Studied In The U.K. As A Potential Treatment, Forbes, 23rd June 2021 https://www.forbes.com/sites/roberthart/2021/06/23/ivermectinwidely-used-to-treat-covid-19-despite-being-unprovenis-being-studied-in-the-uk-as-a-potential-treatment/?sh=e4fd5496b308 [3] National Institutes for Health, COVID-19 Treatment Guidelines, ivermectin, updated 11th February 2021, accessed 6th September 2021 https://www.covid19treatmentguidelines.nih.gov/therapies/antiviral-therapy/ivermectin/ [4] Ibid. [5] Ibid. [6] U.S. Food and Drug Administration, FDA Letter to Stakeholders: Do Not Use Ivermectin Intended for Animals as Treatment for COVID-19 in Humans, 10th August 2021, accessed 6th September 2021 https://www.fda.gov/animal-veterinary/product-safety-information/fda-letter-stakeholders-do-not-use-ivermectin-intended-animals-treatment-covid-19-humans [7] U.S. Food & Drug Administration, Frequently Asked Questions about Animals Drugs, accessed 7th September 2021 https://www.fda.gov/animal-veterinary/safety-health/frequently-asked-questions-about-animal-drugs [8] Milton Friedman & Rose Friedman, Free to Choose, Harcourt, Inc., 1990, p. 206. [9] Olivier J. Wouters, Martin McKee, Jeron Luyten, Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018, American Medical Association, 3rd March 2020, accessed 7th September 2021, doi:10.1001/jama.2020.1166https://jamanetwork.com/journals/jama/article-abstract/2762311 [10] Ibid., p. 208. [11] Conor Friedersdorf, The Death Toll of Delay, The Atlantic, 23rd August 2021, accessed 6th September 2021 https://www.theatlantic.com/ideas/archive/2021/08/fda-delays-carry-death-toll/619871/ [12] Alex Tabarrok, The American Academy of Pediatrics Tells the FDA to Speed Up and Stop Endangering Patients, accessed 7th September 2021 https://marginalrevolution.com/marginalrevolution/2021/08/81683.html [13] Child Mind Institute, Is It Safe to Use Medications Without FDA Approval?, accessed 6th September 2021 https://www.understood.org/articles/en/is-it-safe-to-use-medications-without-fda-approval [14] WATCH: Homeland Security hearing on early outpatient treatment for COVID-19, uploaded by PBS NewsHour on 8th December 2020, accessed 7th September 2021 https://www.youtube.com/watch?v=jxEDU3BoRm8&ab_channel=PBSNewsHour [15] Steven Salzberg, No, Ivermectin Cannot Treat COVID-19, Forbes, 30th August 2021, accessed 6th September 2021 https://www.forbes.com/sites/stevensalzberg/2021/08/30/no-ivermectin-cannot-treat-covid-19/?sh=5aa87a673c03 [16] Carlos Chaccour, Aina Casellas, Andrés Blanco-Di Matteo, Iñigo Pineda, Alejandro Fernandez-Montero, Paula Ruiz-Castillo et al, The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial, The Lancet, accessed 6th September 2021 DOI:https://doi.org/10.1016/j.eclinm.2020.100720 https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(20)30464-8/fulltext [17] Sara Reardon, Flawed ivermectin preprint highlights challenges of COVID drug studies, nature, 2nd August 2021, accessed 7th September 2021 https://www.nature.com/articles/d41586-021-02081-w#ref-CR4 [18] Bryant, Andrew MSc; Lawrie, Theresa A. MBBCh, PhD; Dowswell, Therese PhD; Fordham, Edmund J. PhD; Mitchell, Scott MBChB, MRCS; Hill, Sarah R. PhD; Tham, Tony C. MD, FRCP, ivermectin for Prevention and Treatment of COVID-19 Infection: A Systematic Review, Meta-analysis, and Trial Sequential Analysis to Inform Clinical Guidelines, American Journal of Therapeutics, Vol. 8, Issue 4, pp. 434-460, July/August 2021, accessed 6th September 2021, DOI: 10.1097/MJT.0000000000001402 https://journals.lww.com/americantherapeutics/fulltext/2021/08000/ivermectin_for_prevention_and_treatment_of.7.aspx [19] Ibid. [20] Ibid. [21] Ibid. [22] Ibid.
[23] Jordan Hindson, COVID-19: faecal-oral transmission?, Nature Reviews Gastroenterology & Hepatology, 25th March 2020, accessed 7th September 2021 https://www.nature.com/articles/s41575-020-0295-7 [24] Jeremy Howard, Austin Huang, Zhiyuan Li, Zeynep Tufekci et al., An evidence review of face masks against COVID-19, Proceedings of the National Academy of Science of the United States of America, 26th January 2021, accessed 7th September 2021 https://doi.org/10.1073/pnas.2014564118 [25] Ibid. [26] Sara Reardon, Flawed ivermectin preprint highlights challenges of COVID drug studies, nature, 2nd August 2021, accessed 7th September 2021 https://www.nature.com/articles/d41586-021-02081-w#ref-CR4
[27] Beatrice Dupuy, No evidence ivermectin is a miracle drug against COVID-19, 11th December 2020, accessed 7th September 2021 https://apnews.com/article/fact-checking-afs:Content:9768999400
[28] Katrina Furey and Kirsten Wilkins, Prescribing "Off-Label": What Should a Physician Disclose?, American Medical Association Journal of Ethics, June 2016, accessed 7th September 2021 https://journalofethics.ama-assn.org/article/prescribing-label-what-should-physician-disclose/2016-06
[29] Front Line COVID-19 Critical Care Alliance, FLCCC Alliance Statement on Misleading FDA Guidance on Ivermectin, 7th March 2021, accessed 7th September 2021 https://covid19criticalcare.com/wp-content/uploads/2021/03/FLCCC-Alliance-Statement-on-Misleading-FDA-Guidance-on-Ivermectin-March7-2021.pdf
[30] Kenya Evelyn, Anti-vaccine doctor to testify at Senate committee hearing on Covid mandates, 7th December 2020, accessed 7th September 2021 https://www.theguardian.com/world/2020/dec/07/anti-vaccine-doctor-testify-coronavirus-senate-hearing-jane-orient
[31] Dr. Pierre Kory gets COVID-19 despite taking ivermectin prophylaxis AGAINST WHO / CDC / FDA advice!, uploaded by Tech ARP on 3rd September 2021, accessed 7th September 2021 https://www.youtube.com/watch?v=Gn03VESw7tM&ab_channel=TechARP
[32] Jasmine Cameron-Chileshe, Boris Johnson faces growing backlash over Covid passports, 1st August 2021, accessed 7th September 2021 https://www.theguardian.com/society/2021/aug/01/parliament-should-be-recalled-over-covid-vaccine-passports-says-tory-mp-andrew-bridgen
[33] Anant Mohan, Pawan Tiwari, Tejas Suri, Saurabh Mittal, Ankit Patel et al., Ivermectin in mild and moderate COVID-19 (RIVET-COV): a randomized, placebo-controlled trial, 2nd Feb 2021, accessed 7th September 2021 https://doi.org/10.21203/rs.3.rs-191648/v1
[34] Satoshi Ōmura, Ivermectin, 'Wonder drug' from Japan: the human use perspective, Proceedings of the Japan Academy, Series B Physical and Biological Sciences, 10th February 2011, accessed 7th September 2021 https://doi.org/10.2183/pjab.87.13
[35] University of Oxford, Ivermectin to be investigated as a possible treatment for COVID-19 in Oxford's PRINCIPLE trial, 23rd June 2021, accessed 7th September 2021 https://www.ox.ac.uk/news/2021-06-23-ivermectin-be-investigated-possible-treatment-covid-19-oxford-s-principle-trial [36] Benedette Cuffari, The Size of SARS-CoV-2 and its Implications, News Medical, accessed 7th September 2021 https://www.news-medical.net/health/The-Size-of-SARS-CoV-2-Compared-to-Other-Things.aspx
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