UK’s MHRA ‘Aware’ of Global Ivermectin Study & Plans on Reviewing the Evidence

UK’s MHRA ‘Aware’ of Global Ivermectin Study & Plans on Reviewing the Evidence

The Daily Mail, although not known for its probing scientific and medicinal journalism, has been around a long time—since 1896. In fact, achieving the distinction of highest-circulated daily newspaper in the UK, Daily Mail is considered “middle-market,” meaning it’s somewhere in the halfway point of a three-level continuum of journalistic seriousness from the high end, on the one side, to the sensationalist-minded consumer on the other. David Rose recently wrote a piece for the London-based group emphasizing the growing interest in ivermectin. Highlighting meta-analyses from three research sources TrialSite has followed closely: the Front Line COVID-19 Critical Care Alliance (FLCCC), Dr. Andrew Hill (University of Liverpool, UnitAid) and Dr. Tess Lawrie (Evidence-Based Medicine Consultancy), the British online media shared that the FLCCC Alliance authored study results are headed for full publication in the U.S. Journal of Frontiers of Pharmacology. Summarizing that ivermectin shows potential to cut SARS-CoV-2 infections by nearly 75%, the influential middle-market online media remind the world that the results from over 30 clinical trials worldwide point to a positive trend—‘repeated, consistent, large magnitude improvements in clinical outcomes’ across the stages of infection. Author Rose at the end confirms that the UK’s drug regulator, known as the Medicines and Healthcare Regulatory Agency or MHRA is not only aware of what is referred to as a “global study” involving ivermectin but that the agency would be reviewing the evidence associated with treating COVID-19. Already approved by the U.S. FDA, this drug has been used by billions of people over the last four decades or so.

TrialSite was formed just a little over two years ago to contribute to clinical trials transparency and accessibility. Health care, incredibly important as it is, necessitates in an advanced, market-based society an informed and educated public. This leads to greater amounts of trust, engagement and ultimately contributes to the advancement of biomedical research. While the Daily Mail has generated its fair share of controversy, none can deny its reach with over 1.13 million in circulation for its newspaper alone, and a number 4 ranking worldwide according to one index for total readership. Put another way, the mass English speaking audience is there.

Follow the link to the source for a brief review of key players in the unfolding ivermectin saga, including the comprehensive,  committed and courageous Dr. Tess Lawrie with the Evidence-Based Medicine Consultancy. TrialSite introduced Dr. Lawrie’s ivermectin meta-analysis and recently reported one of her online presentations; just the other day, this UK resident presented at a summit involving international experts involved in the review of unfolding data associated with the generic drug. She just submitted a 97-page report to the World Health Organization urging an immediate recommendation of the generic drug as a treatment for COVID-19.

It Started Down Under

The topic of ivermectin elicited interest among the TrialSite team back in April 2020 with the findings of lab experiments at University of Monash; that in a cell culture the economical, generic drug used by millions of people annually over time not only dramatically inhibits the novel coronavirus, but was responsible for a 5,000X reduction in COVID-19 RNA within 48 hours—that is, 99.8% of the virus was obliterated by this agent.

Dozens of Clinical Trials & Hundreds of Real World Data Points

Of course, this was just one lab experiment; and in the world of drug development, years of preclinical animal research typically follows prior to submission of an investigational new drug application. After all, safety, dosage, and a number of other factors must be understood. However, this drug is already approved by the U.S. FDA and other major economy regulators. In the quest for efficiency and robust drug development, the FDA and industry embraced real world evidence as a way to augment and support progression of treatments without the decades of cost and effort.

As TrialSite thereafter started chronicling various research, first case series and observational studies (think Dr. AlamDr. RedondoDr. Rajter) during the pandemic, but soon after randomized controlled studies, two things became crystal clear. 

Crystal Clear Persuasion

On the one hand, after dozens of completed clinical trials, interviews, and ongoing interactions with established physicians and researchers around the world, it couldn’t be denied that apex research agencies should be supporting or funding studies to investigate the use of a generic agent to augment global vaccination plans in addition to any breakthrough novel pharmaceutical products.

However, what also became very apparent was a completely resistant, recalcitrant stance of the majority of powerful influencers in medicinal research (extend this to government and media) to this emerging and evolving trend. It was beneath them—it didn’t originate from them nor was it of sufficient quality to be considered by them. This is despite a growing cry by a number of respected peers, not to mention sufficient data for inquiry.

Although data should be driving scientific research, what can be considered a complex matrix of vested interests—perhaps a biomedical research establishment—formulated the excuse to not bother too much. What with some technicalities here, a blemish there or another trifle across the studies, oppositional interests mounted an attack that made its way not only in the press (think Merck’s outright shocking press release) but also in social media algorithms as a form of censorship. TrialSite knows this first hand, as simply writing about Slovakia approving ivermectin for use against COVID-19—a fact—triggered that social media to suppress the TrialSite Facebook page. Yes, social media is being used as a censorship mechanism. The vested interests that pay in the aggregate hundreds of millions in advertising dollars must tightly control the narrative of the pandemic to the masses that get spoon fed their “news.”

Yes, these critics have found a number of technicalities to continuously elude and evade responsibilities associated with such a potential breakthrough—especially so in such a horrific pandemic. In the case of a novel therapeutic, if even a few studies demonstrated such promise, the prospect of a public investment of hundreds of millions would be a real prospect. But a cheap generic drug…not good.

Onward…Upward

Daily Mail’s embrace of this unfolding saga won’t change any powerful people’s mind. In fact, it may just encourage them to take an even more defiant, anti-scientific stance. After all, the true underlying driver of this research-centered human tragedy isn’t about science and saving people’s lives. Rather, it’s about security and comfort for those that have way too much of both. It could be said that the ivermectin story exposed bare naked the raw material interests involved in the development of medicines. But as TrialSite has commented, the pharmaceutical companies must earn a return or heads will roll; regulators and government agencies are nurtured on an industry-driven order—and for good reason, as it is an industry that develops drugs. The process of working to ensure that an economical and effective approach to fighting COVID-19 must continue until its fully proven that it is not a viable option.