Recently, the National Institutes of Health (NIH) got around to formally addressing ivermectin in their COVID-19 Treatment Guidelines. Although their only recommendation is for use in clinical trials, that’s a start. TrialSite has been working tirelessly to chronicle and accumulate data centering on the off-label use, case series, observational and randomized clinical trial information possibly pointing to the future acceptance of this cheap and available drug as but one possible contributing way to help fight COVID-19. TrialSite has reported that in at least three randomized clinical trials (Egypt, Bangladesh, and Iraq), the use of the drug targeting early-stage COVID-19 patients leads to positive results; in addition to several observational and hospital approved case series efforts, TrialSite applauds the nation’s research institution for at least taking the time to acknowledge and review the recent Broward County study led by Dr. Jean Jacques Rajter. The apparent fact that this generic drug, which costs about $7 per pill in the US, may be useful as a treatment to alleviate symptoms of COVID-19 is given traction in the mainstream media in the United States as the Miami Herald recently embraced the topic showcasing the Broward County physician and his ICON study results. They also emphasized several doctors in Florida who are prescribing the drug, including Key West-based Dr. Bruce Boros, who reports that he is using the drug successfully to help COVID-19 patients in South Florida.
It all Starts in Australia
TrialSite commends the Miami Herald and journalist David Goodhue for making a good faith attempt to introduce this controversial topic to the mainstream in a relatively fair and balanced way. The scientific roots of the interest in ivermectin go back to the spring, during the onset of the pandemic when researchers in Australia were working furiously to explore possible ways to fight off this novel coronavirus. The result of a collaborative study led by Monash Biomedicine Discovery Institute (BDI) with the Peter Doherty Institute of Infection and Immunity (Doherty Institute)—a joint venture of the University of Melbourne and Royal Melbourne Hospital—revealed that ivermectin kills SARS-CoV-2.
Back in early April, TrialSite first reported on these findings. The response was overwhelming—in aggregate, some of the articles received well over a hundred thousand visits. The Monash-led study revealed that this anti-parasitic drug widely available worldwide could destroy the SARS-CoV-2 virus within 48 hours in a cell culture. The university showed the importance of, and urgency for, clinical research funding to support an effort to find effective dosages that are safe for humans. Ivermectin, FDA approved, is widely used in the tropics today to combat parasite-born disease. The Monash University-led collaborative study was published in Antiviral Research, a peer-reviewed medical journal published by Elsevier.
Use of Ivermectin Targeting COVID-19 Expands: But Why?
TrialSite chronicled how the use of ivermectin spread around the world right after the Monash findings, especially in low and middle-income countries (LMICs), but also in the United States and France. From the Andes to India, from the Amazon to Bangladesh, the use of ivermectin spread rapidly. But why? Was it simply based on the early-stage research of Monash, or was there additional evidence? No one knew with any certainty. In a quest to learn more, TrialSite monitored the press, medical reports, national regulatory and research agencies worldwide and conducted a series of interviews. We brought in Carlos Chaccour, one of the world’s top ivermectin specialists, heavily involved with significant research. TrialSite showcased the work Bangladesh Medical College’s Dr. Tarek Alam, who observed considerable success with treating COVID-19 with ivermectin—reporting a 98% success rate in Dhaka. An interview with Dr. Jose Natalio Redondo, president of Dominican Republic’s leading private hospital network, Grupo Rescue, revealed a near 100% success rate; Dr. Redondo declared at the time of the interview that the health system had documented clear success in treating 1,300 early-stage COVID-19 patients with ivermectin.
TrialSite researchers became more intrigued and tracked and monitored ivermectin research around the world, including the production of an original documentary “How Peru Uses Ivermectin” to help get to the bottom of why the use of this drug was accelerating worldwide. Based on a substantial amount of research, it becomes apparent that at least in many LMICs and even in some cases in the US, the urgency of the pandemic led to a grass roots, physician-driven push to explore the use of the drug targeting COVID-19, at least in the early stages of the disease. Medical professionals needed to act, as patients were dying and with a lack of any established, approved, and effective medication, the Monash study incited a wave of “real world” experimentation during the pandemic.
All involved physicians, from Peru to Bangladesh to India and Mexico to the US, agree that we need randomized controlled trials. That is the net takeaway from the TrialSite Peru documentary as well.
From LMICs to Key Largo
The only difference between the position of the US FDA and NIH on the one hand, and the community-based physicians around the world on the other, are the practicalities on the ground—in a pandemic situation, there often isn’t the time, the money, or the resources in many parts of the world to conduct research and then clinical practice in a serial fashion (e.g., first lengthy randomized trials and then treatment). Rather many felt compelled based on health urgency to work in parallel. That is, they knew the safety profile of ivermectin and hence prescribed off-label, carefully monitoring, documenting, and continuing assessing results. Thus far, the results have been overwhelmingly positive, but this is not evidence for purposes of a listing under the NIH COVID-19 Treatment Guidelines. Yet Dr. Bruce Boros operates a clinic in Key Largo, Florida, and The Miami Herald reports he has become a proponent for using the drug to treat COVID-19 patients—much like Dr. Rajter to the north in the Fort Lauderdale area. The cardiologist owns and operates Advanced Urgent Care clinics on the island chain. A pragmatic physician and businessman, Boros was an early advocate warning about the danger of COVID-19—he was apparently pro-social distancing and other measures such as stopping tourism early on in the pandemic’s trajectory.
Ivermectin Part of the Broward County Drug Portfolio
The Miami Herald’s Goodhue introduces one Dave Lacknauth, executive director of pharmacy services and system integration at Broward Health, a four-hospital network. Again, it was this health system that approved the use of ivermectin for the Dr. Jean Jacques Rajter/ICON study. The Miami Herald uncovered that the South Florida health system maintains a “portfolio” of drugs used by its doctors to treat patients infected with SARS-CoV-2, the virus behind COVID-19. These include not only ivermectin, but also the controversial drugs hydroxychloroquine and remdesivir. None of these therapies, including those approved for emergency use authorization (e.g., remdesivir or convalescent plasma), are “cures.” As mentioned previously, the Miami Herald story reminds the reader that absolutely no clinical evidence exists for the effective use of the drug. Rather health systems and providers in various parts of the world are doing their part to do their best to save lives with imperfect science.
TrialSite notes that the US currently spends billions of dollars on vaccines and high-priced therapies that are also scientifically unproven. NIH should adapt to include some real-world studies; there are over 30 clinical trials of ivermectin ongoing in multiple countries, including the US. A few of these trials are completed and evidence positive results. And of course, there may be more money to be made in new therapies backed by the massive government and private funds, versus the humble ivermectin. Given the severity of the pandemic worldwide, why wouldn’t governments around the world be more curious about prospective low-cost, economical options to inhibit this insidious pathogen?
Call to Action: Read the Miami Herald story by David Goodhue. Although TrialSite has certain critiques, the fact of the matter is that the publication and the journalist showed the courage to raise the topic, and for that, they are commended.