The Truth about Hydroxychloroquine and Ivermectin- The PRINCIPLE Trial


The Mayo clinic page further clearly implies that Ivermectin is a veterinary drug and should not be used on humans. This is factually false. It is very different for someone to take Ivermectin pills intended for human use and using Ivermectin paste intended for livestock, but the FDA makes no such distinction. Ivermectin is on the World Health Organization list of essential drugs with billions of doses given, and has a safety profile so high that it can be given to practically anyone. It is also extremely inexpensive compared to such drugs as Remdesivir and Paxlovid.

As to Hydroxychloroquine, the Mayo site states, “These malaria drugs were authorized for emergency use by the FDA during the COVID-19 pandemic. However, the FDA withdrew that authorization when data analysis showed that the drugs are not effective for treating COVID-19. They can also cause serious heart problems.” This is blatant misinformation. Hydroxychloroquine is much more than an anti-malarial drug and is used for a variety of illnesses, including rheumatoid arthritis and lupus. It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). Rheumatoid arthritis and lupus are autoimmune diseases. Another autoimmune condition is cytokine storm. This is the severe reaction that has been postulated as the cause of most deaths from Covid. The Mayo site refers to the absence of data supporting use of Hydroxychloroquine for Covid and the risk of cardiac complications. These come from studies published in two of the most prestigious medical journals in the world, the New England Journal of Medicine and Lancet in the UK. Both were later retracted due to having presented falsified or misleading data, an almost unprecedented move.  

Ivermectin and Hydroxychloroquine are two of the most commonly prescribed drugs in the world and among the safest. Both have been demonized when used for Covid. Those who have real world experience with both say they need to be used in early Covid to be most effective and readily admit they do not work well in patients with serious disease and who are already hospitalized.

In the final analysis, is there any data from a gold standard study, the randomized, controlled trial (RCT) supporting use of either drug in early Covid? Sadly, no and this is both inexplicable and inexcusable. The matter should have been settled once and for all long before now.

We are now two years into the largest RCT on repurposed drugs for Covid, the Platform Randomized Trial of Treatments in the Community for Epidemic and Pandemic Diseases, known as the PRINCIPLE trial. This United Kingdom trial tested seven drugs for Covid. Hydroxychloroquine was withdrawn from the trial after the Lancet study which, as noted above, was later retracted. Ivermectin remains in the trial yet no report on this has been published, not even any preliminary data. In contrast, two antibiotics-azithromycin, doxycycline- and one anti-inflammatory- colchicine,have been shown to be ineffective and one inhaled steroid- budesonide, has been found to reduce recovery time by three days.

Why no word on Ivermectin after two years and why was hydroxychloroquine not reinstated after the retractions by Lancet and New England Journal of Medicine? Given that we continue to learn new things about Covid, these are questions that deserve to be asked and answered using, to quote Anthony Fauci, “real science.”    

Richard T. Bosshardt, MD, FACS

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