Wednesday, July 14, 2021

Guess Who's Blocking Ivermectin In Captive "Clinical Trials"?

nakedcapitalism |  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.

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