Pedro Ruiz Gallo National University, based in Chiclayo in the north of Peru, has committed to the production of free ivermectin to be distributed throughout this northern coastal region of Peru. Employing specialists and students out of the university’s Faculty of Chemistry and Food Industries, the operation was recently validated by the regional government as Victor Echeandia, Lambayeque Health Manager, inspected the production operation. The final product will be delivered via rapid response teams as well as first-level responders. Ivermectin has been accepted in Peru as a treatment for COVID-19, and although powerful medical establishments to the North don’t yet accept the off-label approach, production and distribution around the world grows to satisfy market demand as real world data accumulates. Research talent in the U.S. is desperately needed to validate this effort, as low to middle income countries aren’t yet in a position to produce the overwhelming evidence necessary to activate powerful pharmaceutical enterprises. The companies that intelligently embrace the novel and the unorthodox will build unprecedented, monetizable, worldwide brand cachet. COVID-19 necessitates dynamic, data-driven disease management solutions as the economic and social implications of the status quo grow worse by the day. On the ground, Peru, with less resources and capital, does what it can to keep patients from progressing to the severe and critical stages.
COVID-19 Crisis in Peru
Peru’s condition isn’t stable as that country of 32 million people registers 322,710 COVID-19 cases and at least 11,682 deaths. As TrialSite News reported, not all regions have embraced the FDA-approved anti-parasitic drug, but as will be revealed in a forthcoming TrialSite News report, the regions are in a furious move to diversify available treatment options to aggressively and proactively stop disease progression to the severe to critical state. Peru is a relatively poor country and doesn’t have the health infrastructure necessary to support large scale pandemic crisis on the scale that occurred in New York City or is now happening in places like Houston, for that matter. With 32 million people, Peru has a total of 1,002 intensive care unit (ICU) beds reported in May 2020.
As health authorities work furiously to increase the ventilator stock from 40 to a goal of 540, they also face shortages of much needed oxygen supply and in parallel have required military intervention. For some perspective, the state of Utah, with about 3.2 million people, had 1,298 ventilators in June 2020. Consequently, treatments such as ivermectin and hydroxychloroquine are deemed essential to support an emergency pandemic policy response in Peru—and many other low to middle income places.
Meanwhile, the economic implications of this crisis aren’t even understood at this point, neither in Peru nor in the United States, for that matter. Tens of millions in the U.S. are out of work, but there has been at least some relief in the form of stimulus packages. In Peru, which doesn’t have the vast wealth of America, the toll on the low-wage demographic will be severe, and protests against the government have increased. With a GDP at about $244 billion according to IMF records, Peru ranks 50th worldwide, and government lockdowns have led to a 40% reduction in economic output. The country’s chief industry, mining of gold, silver and copper, teeters on the verge of economic disaster from the pandemic. President Martin Vizcarra has called COVID-19 the “most serious crisis in our history.”
Rapid Response Teams
For TrialSite’s American audience, the move to ivermectin must be understood in the context of that region (Peru) and the specific conditions that merit serious looks at real-world data. Health authorities there urgently must stop the disease spread and progression, as the COVID-19 critical-care infrastructure lacks scale.
Starting in the Ancash Region in the central coastal part of this South America country, a regional agency known as the “South Pacific Health Network” now distributes packages of medicine kits containing ivermectin, azithromycin, hydroxychloroquine and acetaminophen immediately to those suspected of being SARS-CoV-2 positive. Marlon Tello Juarez has led this specific effort in the region of about 1.2 million residents, directing both the rapid response and clinical-follow-up team, reports Andina. The goal: treat the disease early and rapidly to lower the viral load in a bid to avoid disease progression. Such execution is facilitated by an intensive level of regional collaboration. The Nuevo Chimbote District Municipality offered up the local sports center facilities to serve as an operations center for the regions five rapid response teams, four clinical follow-up teams, and a call center.
Now, this rapid regional and community-driven care model moves north to the 1.2 million inhabitants of the Lambayeque region, centering around the ivermectin production at Pedro Ruiz Gallo National University in Chiclayo. Producing the drug in drop form, the regimen will be delivered by teams, in a way similar to the south in the Ancash area. The university is producing enough for 1,000 daily doses, reports regional government lead Victor Echeandia. A total production of 30,000 doses of the drug is planned. The government’s goal is to treat as many people as possible for free.
Real World Evidence
TrialSite News is currently taking a deeper dive into Peru to better understand the data associated with ivermectin usage in that nation. TrialSite has followed with great interest the evolving use of this very common, FDA-approved anti-parasitic drug. It has a very well-known safety profile, and it is administered to large numbers of people every year for different indications. Clearly others are interested, with the level of requests now for suggested investigations.
Based on interviews and reports, not to mention results from a few studies now (although not peer reviewed and not yet embraced by globally influential medical communities in the U.S.), the prognosis looks decent for this economical and available approach for early treatment (at least in low to middle income nations). But there is not sufficient data that will move the powerful medical establishments of America and Europe to promote more investment in an attempt to better understand evidence.
Fundamental public health-minded questions arise: can health authorities in Peru, via health records, correlate statistically a reduced viral progression to those populations that have been treated with ivermectin versus other treatments? The hope is that U.S.-based, more well-funded, talented research groups will get involved as more studies are completed (there are at least 30 clinical trials involving ivermectin now ongoing) and real-world data accumulates to help show the potential of this drug.
An important point underlying all of this is that COVID-19 isn’t going away anytime soon. Depending solely on a vaccine in the short run is a seriously questionable approach, and other breakthroughs could be helpful in severe to critical situations, considering the results of the Dexamethasone study. Innovative companies such as Regeneron relentlessly propel their R&D apparatus forward and are producing powerful investigational treatments (e.g. REGV-CoV2), and health authorities in the developed world should be open minded, intellectually curious and mindful that the model and paradigm that worked yesterday may not work today. A flexible and pragmatic approach should be employed depending on the region, economic wherewithal and political and cultural dynamics.
Should ivermectin (or for that matter Favipiravir, hydroxychloroquine or other breakthroughs such as REG-COV2) turn out to be safe and effective at reducing the severity of the infection early on, first movers should swoop in and produce and distribute the drug in an intense effort to reduce the progression of this deadly pathogen. Hence, companies that focus on worldwide, low-cost, and effective “disease management” approaches will build an enormous brand cachet that will propel their goodwill in health care for a generation. The monetization opportunities will be endless. On the other hand, failing to meet this challenge “head on” might result in the current economic challenges morphing into political and social calamities worse than the devastation of World War 2, and thereby the foundations of our society could be at risk.
About Pedro Ruiz Gallo National University
With approximately 12,500 students, Pedro Ruiz Gall National University ranks 39th in Peru according to one source. Founded in 1960, the non-profit public higher education institution is officially accredited by the Education Ministry at the national level.