One of the world’s biggest vaccine proponents and strident defender of intellectual property rights is funding, directly and indirectly, large trials into cheap, off-patent, off-label COVID-19 treatments, including ivermectin.
The evidence backing ivermectin’s efficacy against Covid-19 continues to stack up, even as most health authorities refuse to approve its use. The last two months have seen the publication of three peer-reviewed meta-analyses demonstrating clear benefits. A review by Pierre Kory et al summarised findings from 18 randomized controlled treatment trials, concluding that ivermectin produced “large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance.” Another study, led by Doctor Andrew Hill, a well-respected international medical researcher reported a 56% reduction in mortality together with favourable clinical recovery and reduced hospitalisation.
A third study, by Andrew Bryant et al, analysed the existing data from clinical trials according to conservative Cochrane meta-analysis standards — a gold-standard in science. Published in the American Journal of Therapeutics, the study found that “ivermectin prophylaxis reduced COVID-19 infection by an average 86%”. The study concluded that “large reductions in COVID-19 deaths are possible using ivermectin”, adding that “the apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”
Still in Limbo
But national and supranational health authorities continue to drag their feet. The US Food and Drug Administration, together with the European Medicines Agency (EMA) and the World Health Organization, insist that there is still not enough good quality data to approve ivermectin as an off-label treatment against Covid. Its use, they say, should therefore be restricted to well-designed, randomised control trials.
Over 20 countries around the world, including India, Bolivia, Mexico and Slovakia, have ignored that advice and are using the medicine, to some degree or another, largely with significant success. The latest country to do so is Indonesia, which is in the grip of its biggest wave of infections to date. In most countries, however, the drug is still in limbo as their respective health authorities await the outcome of large randomised controlled trials.
The problem is that large randomised trials are prohibitively expensive, costing millions of dollars to conduct. As a result, they tend to be funded by large pharmaceutical companies seeking FDA or EMA approval for the drugs they themselves have developed. It also makes it difficult to secure new indications for generic medications that are already approved for other purposes. After all, who is willing to invest millions of dollars testing a drug that is likely to generate little, if any, financial return?
But with the world fighting a losing battle against a fast-spreading, rapidly evolving coronavirus that has sent the global economy spinning, desperate times call for desperate measures. Money has been found and mobilised. According to Hill et al, there are at least five large, placebo-controlled clinical trials on the use of ivermectin for COVID-19 currently underway.
One of them, dubbed the TOGETHER trial, is being conducted at McMaster University in Ontario, Canada. The trial has been running since last summer. The goal, according to the trial’s official website, is to “identify which repurposed therapies are most effective, in order to slow the pandemic while many countries await the delivery of vaccines.”
The trial has already tested and “dropped” hydroxychloriquine, lopinavir/ritonavir (an antiretroviral medication used in the treatment and prevention of HIV/AIDS) and metformin (an anti-diabetes medication). It is currently testing fluvoxamine (an anti-depressant), interferon-lambda (a regulator of intenstinal viruses), doxazosin (used to treat prostatic hyperplasia and hypertension) and ivermectin and will report its findings in the coming months.
There’s only one potential problem: where it gets its money.
The Together Trial has received millions in funding from three main sources: the Rainwater Foundation; Fast Grants, an American charity that provides funding for scientific research whose donors include Arnold Ventures, The Chan Zuckerberg Initiative, Jack Dorsey and Elon Musk; and last but not least, the Bill and Melinda Gates Foundation.
The Gates Foundation, as readers are no doubt aware, is one of the world’s biggest backers of vaccine research, as well as the second largest funder of the World Health Organization (WHO). It is also heavily invested in large pharmaceutical companies, including Pfizer and BioNTech, the joint manufacturers of the world’s most profitable Covid-19 vaccine, and Merck, the original manufacturer of ivermectin which has an antiviral compound, molnupiravir, in Phase 3 clinical trials for COVID-19.
As well as founding and funding the Vaccine Alliance (GAVI), the Gates Foundation is a passionate defender of pharmaceutical companies’ intellectual property rights. For months the world’s largest private foundation blocked attempts to temporarily lift coronavirus vaccine patent protections, preventing poorer countries from gaining cheaper access to COVID-19 vaccines, until it was finally forced to reverse course. As for McMaster, it is developing homegrown vaccines to fight COVID-19 in its “specialised lab and production facilities.”
In other words, an organisation that is hugely committed and invested in vaccine development is running one of the world’s largest clinical trials into one of the biggest threats facing COVID-19 vaccines: existing off-label medicines. To top it off, the trial is being part-financed by arguably the world’s biggest vaccine cheerleader whose interests are closely aligned with the world’s biggest pharmaceutical companies, some of which it is directly invested it.
The potential for conflicts of interest is huge. If a cheap, off-patent drug like ivermectin were approved for use against COVID and if it worked as effectively and as safely as most trials suggest, it would pose a direct threat to novel treatments being rolled out by pharmaceutical companies whose safety data is no match for ivermectin’s. It could also even jeopardise the emergency use authorisation granted to the COVID-19 vaccines, one of the basic conditions for which is that there are no alternative effective treatments available for the disease. As such, if ivermectin or some other promising medicine were green-lighted, the vaccines could be stripped of authorisation.
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Nick Corbishley 