In late June, the University of Oxford announced that PRINCIPLE, one of the U.K. Government's national priority platform trials of COVID-19 treatments, would be evaluating Ivermectin, the seventh treatment to be investigated in the PRINCIPLE trial. Along with the influenza antiviral drug favipiravir, Ivermectin, the "safe, broad-spectrum antiparasitic drug," was added as part of the trial's focus on treatment for people in the U.K. who have recently developed symptoms of COVID-19. Yet, suddenly, without an explanation from Merck—who is a key manufacturer of the generic, readily available drug Ivermectin—MedPage Today reports that PRINCIPLE's trial on the drug is paused, stating:
"The Ivermectin arm of the U.K.'s PRINCIPLE trial is "currently paused due to temporary supply issues."
Screenshot / PRINCIPLE
With over 5,000 people signed up for the study, participants were randomly assigned to receive a three-day course of Ivermectin treatment. The trial was set to offer meaningful and much-anticipated data. And despite the current demand for Ivermectin, a robust supply is typically available, making the supply issue challenging to understand. Without question, the market caused by off-label usage has been substantial as prescriptions in the U.S. went from a few thousand per week pre-pandemic to nearly 90,000 per week during the pandemic. Nonetheless, this drug is straightforward to produce, and there are multiple suppliers.
MedPage Today, which boasts Marty Makary, MD, MPH as its Editor-in-Chief, reached out to both PRINCIPLE and Merck for a full explanation of the trial's pause. By press time, according to MedPage Today, neither had offered more details. MedPage Reporter Jennifer Henderson wrote that Merck did not comment directly on any supply chain issues affecting PRINCIPLE'S trial. However, the pharmaceutical giant offered MedPage Today a longer statement in an email, saying:
"[It has] concluded that the probability of Ivermectin providing a potentially safe and efficacious treatment option for SARS-CoV-2 infection is low and have prioritized internal efforts towards the development of alternate candidates that provide a higher probability of success for the treatment of COVID-19. If clinical data emerge providing definitive evidence for a positive benefit-risk assessment of the use of Ivermectin in COVID-19, we stand ready to provide our expertise and resources as needed."
Notably, as multiple experts proclaim the extremely positive benefits of early treatment with Ivermectin in COVID-19, Merck's declaration that the probability of effective treatment with Ivermectin is "low" is suspicious. It would be careless to neglect to mention that Merck and Ridgeback Biotherapeutics recently signed a $2.2 billion agreement with the U.S. government to purchase 3.1 million courses of molnupiravir, which the company began focusing on in April 2021 after the discontinuation of the development of MK-7110 for the treatment of COVID-19 patients in the hospital. In a Nov. 9, 2021 press release to announce the agreement, Merck declared:
"We're honored that the U.S. government has chosen to purchase more than 3 million courses of molnupiravir, our promising oral antiviral, so that molnupiravir, if authorized, will be among the vaccines and medicines available to fight COVID-19 as part of our collective efforts to bring this pandemic to an end. In light of the continued impact of the pandemic on hundreds of thousands of people every day, all of us at Merck are moving with urgency and rigor to bring molnupiravir, with its compelling data showing a significant reduction in death and hospitalizations, to patients as quickly as we can."
With its authorization in the U.K. in early November, molnupiravir became the world's first antiviral pill for COVID-19. Molnupiravir is currently under consideration for emergency use authorization (EUA) in the U.S., along with Pfizer's paxlovid. As pointed out by Nature (whose writings on gain-of-function in early 2020 arguably helped set the narrative for the origin of SARS-CoV-2), on Nov. 30, an FDA advisory committee voted 13 to 10 in favor of an EUA for molnupiravir, readying the way for an approval decision in the coming weeks. The European Medicines Association is reviewing molnupiravir too, and an application from Pfizer there is imminent.
Screenshot / C19ivermectin.com; Database of all Ivermectin COVID-19 studies. 135 studies, 87 peer-reviewed, 70 with results comparing treatment and control groups.
Funded by taxpayers, the U.S. government's procurement of molnupiravir will be supported entirely with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), in collaboration with the DOD Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND).
Indeed, as the COVID-19 pandemic persists under the relentless perseverance of government agencies, their billion-dollar contracts with influential pharmaceutical companies leave inexpensive, proven effective treatments such as the Nobel Prize-winning "wonder drug" Ivermectin in the dust. Meanwhile, patients are needlessly dying as they await the life-saving treatment. As previously reported by UncoverDC and reiterated by TrialSite News (but entirely ignored by mainstream media), one could argue there is a "seemingly orchestrated public relations propaganda campaign to delegitimize the drug [Ivermectin] and all those who supported further research or off-label usage."
