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.
By Nick Corbishley and cross-posted from Naked Capitalism.
The evidence backing ivermectin’s efficacy against Covid-19 continues to stack up, as the world eagerly awaits the results of a number of large randomised controlled trials. The last two months have seen the publication of three peer-reviewed meta-analyses demonstrating clear benefits. A review by the Front Line COVID-19 Critical Care Alliance summarised findings from 27 studies on the effects of ivermectin for the prevention and treatment of COVID-19 infection, concluding that ivermectin reduced deaths by 75%. 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. 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. That means that only large pharmaceutical companies with deep pockets can afford to push forward medications for FDA or EMA approval — medications that they themselves have developed. It also makes it difficult to get generic medications that are approved for other purposes for new indications. 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.” It 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 the Bill and Melinda Gates Foundation. As readers are no doubt aware, the Gates Foundation is one of the world’s biggest backers of vaccine research, as well as the second largest funder of the World Health Organization (WHO). As well as founding and funding the Vaccine Alliance (GAVI), the Bill & Melinda Gates Foundation is a passionate defender of pharmaceutical companies’ intellectual property rights.
Since the pandemic began, Bill Gates has been working tirelessly to help maximize pharmaceutical profits, even if that meant preventing poorer countries from gaining cheaper access to COVID-19 treatments and vaccines. 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.
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 jeopardise the emergency use authorisation granted to the COVID-19 vaccines. One of the basic conditions for the emergency use authorisation granted to the vaccines currently being use against covid is that there are no alternative treatments available for the disease. As such, if ivermectin or some other promising medicine were green-lighted, the vaccines could be stripped of authorisation…