Perhaps Peru is the epicenter of the movement for off-label use of Ivermectin to treat COVID-19 patients. The doctors there swear by it. In fact, some of them curse the government for not embracing the anti-parasite drug sooner as they believe more lives could have been saved. With the advent of the COVID-19 pandemic, the Peruvian authorities had no interest in Ivermectin. Rather, they leaned toward the emerging standard of care that was circulated in medical circles from the World Health Organization (WHO). However, when a group of Australians at Monash University and Peter Doherty Institute performed lab tests revealing that the economical and available anti-parasitic medicine absolutely zapped the novel coronavirus, a local inquisitive Incan inquiry commenced. This grassroots medical movement for Ivermectin as a treatment for COVID-19 in many ways has been driven out of Peru as the story continues to unfold.
Peruvian Mysteries & A Disclaimer
For many weeks now, TrialSite News researchers heard a greater number of stories about the use of Ivermectin in both Bolivia and Peru. That Ivermectin has become an Incan, and for that matter, broader health movement cannot be denied for those that open their eyes and look in the right direction. TrialSite News has interviewed doctors around the world using the anti-parasitic drug to treat COVID-19 with significant success. However, the following disclaimer is required:
Although Ivermectin is now approved in Peru, it must be emphasized that that government’s decision was not based on formal, randomized controlled trials. Rather, an informal network of many doctors around Peru drove a kind of community movement to use the medicine to treat COVID-19. The government came to the conclusion that a sufficient number of experts in that country had formed a consensus that couldn’t be ignored.
The University Influence?
TrialSite News was able to secure some university-based documents floating around in Peru that may have led to the off-label use and, ultimately, the approval. However, it is possible that the university treatment protocols including Ivermectin may have been influenced by the community physician practitioners. Perhaps community-based doctors were using the drug off-label and, in response, the more established, conventional university-based physicians started buying into the treatment approach—we can’t be certain at this point.
The document titled “Therapeutic Plan that includes Ivermectin in the First Line of Action” included a table delineating different Ivermectin doses based on severity of the infection. It is this table that could very well have reflected what was already becoming common practice around the nation of 33 million people. The table titled “COVID-19 Therapeutic & Therapies Plan Potential” represented a recommendation by three physicians originating from some prominent universities there. Specifically, Gustavo A. Aguirre-Chang, MD, educated at Lima’s Universidad Nacional Mayor de San Marcos, who turned out to be an influential figure in the drive to make Ivermectin authorized.
Overcoming the Ivermectin “Stigma”
Peruvian physicians took note upon learning about the Australian ivermectin and COVID-19 preclinical research findings. However initially, Peruvian government wanted no part of Ivermectin. But Peruvians begged to differ. With an independent spirit arising out of an ancient Incan culture that goes back to the earliest stretches of human habitation in the New World, a local, grassroots, real-time observational case study commenced in pockets across the nation. Doctors went about using Ivermectin and reporting on positive results to colleagues. Conservative forces there resisted noting, after all, this drug was for animals.
For Animals: Humans Need Not Try
The Australian Ivermectin lab experiment clearly made some people nervous. Otherwise, why else would the U.S. Food and Drug Administration (FDA) almost immediately issue a very intriguing warning in the form of a “Q&A” notice. As it turns out, the first line of defense against this drug, at least in the developed “first world,” was that Ivermectin was an “animal drug.” This sort of bias was evidenced clearly by the FDA’s Ivermectin warning. Titled “FAQ : COVID-19 and Ivermectin Intended for Animals,” the FDA took overt advantage of a loaded headline to convey an underlying point. Of course, the FDA is the world’s leading heath regulatory agency and they indeed had to offer the other vantage point as well: if one bothered to read just a paragraph down, the agency not only acknowledged the Ivermectin Australian study but also conveyed to those interested in the value proposition of Ivermectin, that they could set up and conduct randomized controlled trials to determine the evidence. But did they think anyone would take them seriously?
But it was Created for Humans
In reality, Ivermectin was in fact created for humans. In Peru, doctors are treating COVID-19 patients with one drop every 24 hours for two days and many physicians report within a month they see patients fully recovered. Ivermectin was found to have animal use cases over time. For example, it could be used to kill ectoparasites in cattle and in dogs. In people, it has been used as an anti-parasitic drug (e.g. head lice) but also as a treatment against River Blindness and for conditions such as scabies and even atopic dermatitis in some cases. Here is a U.S. Food and Drug Administration (FDA) label for a variety of Ivermectin called Stromectol from Merck.
Peruvian Grassroots Chatter to a Global Movement
In the meantime, Peru was getting hit by the deadly pathogen as the COVID-19 pandemic barreled south toward South America, meandering through jungle river valleys and up into mountainous villages, towns and cities. Currently with 214,788 cases and 6,109 deaths, doctors increasingly took matters into their own hands commencing community observational studies in towns and rural villages across at least parts of Peru.
Once the Peruvian doctors got wind of the Australian preclinical lab study, there were reports of Ivermectin use across the region. This was seen in not only Peru but Bolivia (where TrialSite News reported hundreds of thousands of treatments were handed out) to the Dominican Republic, Mexico, Brazil and across the world in places such as Bangladesh, India and the United States in small pockets of off-label experiments.
Prominent researchers and industry observers were obviously skeptical and downplayed the Monash findings, arguing that studies in humans weren’t feasible due to dosage and other factors. However, in nations that struggle with poverty and lack of access to more expensive drugs, such as remdesivir, physicians had to chart their own course.
Hence, dozens if not hundreds of doctors around the world are prescribing ivermectin in COVID-19 patients; Peru perhaps can be considered the epicenter of that movement. TrialSite News has interviewed a handful of these doctors and they all report the same thing: that the anti-parasite drug used for decades by humans for conditions such as head lice actually works better than remdesivir. This finding is heard from doctors all over the world; TrialSite News has interviewed physicians in Bangladesh, France, India, Brazil and the United States not to mention Peru, Bolivia and Mexico.
Even prominent research institutions, such as Johns Hopkins University and University of Kentucky, have decided to organize randomized controlled trials including Ivermectin.
A Small Observational Case Study
Dr. Gustavo A. Aguirre-Chang was mentioned earlier as a key physician that produced the Ivermectin therapy plan. As it turns out, he is an important player in the Peruvian Ivermectin experiment. Recently active in Reddit, the doctor reports again on the influence of the Australian preclinical lab study and delves into a description of Peruvian off-label use of the anti-parasite drug to treat COVID-19. In mid May, Aguirre-Chan commented in the Reddit group that his group had treated 39 COVID-19 cases and that the Ivermectin regimen was quite successful for “those who complete the indicated treatment and undergo medical follow-up.” Dr. Aguirre-Chan reported that 1) patents with the disease were showing improvement within 2 and 3 days of starting treatment (100% of the 36); 2) fever resolution rate at 36 hours of taking ivermectin was at 94% and 3) resolution rate of dyspnea (difficulty breathing) at 72 hours was 86%.
Chanchamayo Off-Label Use
A physician named Dr. Gustavo Elera Arevalo, operating in the northern regions of Peru, has treated 1,200 patients with Ivermectin in what is reported in the Peruvian news outlet “La Industria” as leading to incredible results if this is accurate. All 1,200 were infected with COVID-19 and were located in La Merced, Chanchamayo and Junin.
In a serous critique of the Peruvian government, Dr. Elera Arevalo first administered early-stage COVID-19 patients with the standard protocol promulgated by the health authorities in that South American nation. He now has deep regrets based on what he has learned from treating patients with Ivermectin. Unfortunately, according to the news account, the doctor attributes the “thousands of deaths” in the country to not using Ivermectin; he directly holds the Ministry of Health accountable for not taking appropriate actions to consider what has actually worked in the field.
In fact, Dr. Elera Arevalo attributes the growing evidence of Ivermectin’s efficacy not only in Peru but in other locations across South and Latin America, not to mention other continents where the health ministry made its move to not only approve the drug but to make the large purchase.
What about the Evidence?
When asked, however, about evidence, the physician retorts COVID-19 is a new disease so evidence worldwide is hard to find. But he emphasizes the 1,200 he has treated in jails, among first responders and others deemed “at risk.” The observational study has led to phenomenal results. Why isn’t that evidence in a pandemic? Dr. Arevalo plans on publishing their findings with his partner in this ongoing treatment effort—a young Peruvian physician named Dr. Fernando Polanco.
The Peruvian Government Goes Ivermectin Shopping
Growing anecdotal evidence from the wide-spread, community off-label use of Ivermectin led to a grassroots victory for those in Peru believing in this approach. And by May 8, 2020, the Peruvian government, despite the lack of evidence from randomized controlled trials, proceeded to approve the use of both Ivermectin and hydroxychloroquine. That declaration and associated treatment approval can be seen here.
Moving forward, Ivermectin could be used in both mild to more severe cases. In the latter scenario, it is to be combined with hydroxychloroquine with Azithromycin.
Several days ago, President Martin Vizcarra and, shortly thereafter, Health Minister Victor Zamora moved to procure 490,000 ivermectin treatments in a bid to contain COVID-19, reported La Industria.
Among questions pertaining to lack of evidence the Health Minister now moves full throttle defending the move to purchase the medicines, declaring, “This pandemic is marked by uncertainty and little knowledge of the disease. For that, we have a committee of experts that have recommended that we continue with the Hydroxychloroquine and include Ivermectin” noting to PTR Connection.
And the approval could be making a difference for those most in need. By June 1, 2020, the government implemented a mission to contain COVID-19, especially in some lower income areas in urban areas in Lima. High risk urban centers were a primary concern, reported the press outlet andina, where populations, such as the elderly struggle with considerable comorbidity challenges, representing high risk for COVID-19 caused hospitalization and death.
In a bid to rapidly supply tests and administer treatment, including Ivermectin and hydroxychloroquine, the Peruvian government moved swiftly, fearful that what happened in places such as Italy or New York could happen there.
In this world of pervasive, 24X7 communications, even villagers in Peru can plug into satellite TV or the internet, and many did, watching in absolute horror what happened to so many people in Italy and New York. From the Peruvian point of view, these are wealthy, extremely successful nations and societies. That so many people could die so quickly and in such shocking ways—such as in overcrowded hospitals or packed nursing homes for the elderly—concerned Peruvians. With the new drug approvals in hand, the government has responded with targeted, directed operations to save lives and avoid hospital crisis’ of the kind that happened elsewhere. Ivermectin is a Tayta Operation treatment.
TrialSite News recently interviewed a contact in Peru, a PhD in Public Administration and Computer Science, that happens to be active in the Ivermectin movement there. He reports that in the city of Iquitos, a place known for scary tropical diseases, the widespread use of Ivermectin has led to a steep drop in the number COVID-19 cases.
TrialSite News has requests outstanding for interviews with a number of physicians, including Dr. Gustavo Aguirre. Initially, the government in Peru wanted nothing to do with Ivermectin—much like most governments around the world today. However, perhaps out of fear, desperation, or maybe a determination to avoid the casualties of Italy or New York, waves of community-based physicians began experimenting with off-label Ivermectin to treat COVID-19.
The momentum became so great that the national government there did a turn-around and declared both the anti-parasitic drug and hydroxychloroquine as authorized for use. They did this despite the lack of evidence from randomized controlled trials. TrialSite News aligns with the principal that randomized controlled trials are a key contributing factor to medical progress, as is real-world experience.
In Peru, the government has followed the community clinicians lead in a pragmatic bid to economically and expeditiously save lives. Growing numbers of them declare in concert that the treatment is working. There are no widespread reports of adverse events but that doesn’t mean they don’t occur. The research and fact finding in Peru isn’t done yet.