The global clinical trial, (REMAP-CAP (NCT02735707), is supported by multiple international funding organizations, including the Canadian Institutes of Health Research, the Australian National Health and Medical Research Council, the Health Research Council of New Zealand, the National Institute for Health Research (UK), UPMC, the Translational Breast Cancer Research Consortium, the Pittsburgh Foundation, and the PREPARE and RECOVERY consortia (EU). This trial has been given urgent public health research status by the Department of Health and Social Care in the UK. In Ireland, hospitals are participating in this large path-breaking program as well. Now an Irish-based news source, Independent.IE, reports the clinical trial sponsors have embraced Ivermectin as a study drug to determine if that treatment can help hospitalized COVID-19 patients. Apparently, at least some Irish patients admitted into the ICU for COVID-19 will be administered the generic drug already approved by Irish and American drug regulators for indications associated with parasites.
Ivermectin Use in Ireland
According to local Irish press, prominent physicians report at least some hospitals are using ivermectin now as a treatment for COVID-19. This hasn’t been authorized by regulators but rather represents a situation similar to the United States where physicians can and are prescribing the drug off label for COVID-19 at their discretion.
The medical and research establishments in Ireland, much like most everywhere else with wealthy economies, are precluding much clinical research now completed around the world. Actually an impressive accumulation of study data indicates, according to some experts, positive efficacy and safety in relation to COVID-19. But prominent medical and research institutions look at ivermectin through a conventional and some believe increasingly narrow lens—for example, the Royal Irish Academy embraces a position similar to many such prestigious institutes, harkening back to when the first Australian-based lab studies revealed the powerful impact ivermectin has on the SARS-CoV-2 virus.
Skeptics Look Back to April—but Ignore All that’s Chronicled in the TrialSite
Professor Alistair Nichol, an intensive care doctor at St. Vincent’s Hospital in Dublin, and an investigator in the REMAP-CAP trial, noted in the recent press that the use of ivermectin has “…crept into practice without a huge amount of evidence to support it.” Sharing what most established regulators and apex research bodies also tout, Nichol acknowledged that there have been “some clinical trials but they have not been of the highest quality.”
Of course, the interest in ivermectin started with the lab work at the Monash University and the Doherty institute; some enterprising researchers there reported on their findings demonstrating that the drug obliterates COVID-19 within 48 hours. But the doses were at a high concentration—more than could be used for humans. Given normal, non-pandemic times, considerable preclinical animal studies could follow. As the drug is approved and overall has a very well known safety profile (in use for approximately four decades), SARS-CoV-2 was new; applying some generic used for parasites to such a dangerous new pathogen seemed quite out there to most researchers.
But these are not normal times. In the West, drug and vaccine development has been accelerated like never before—with at least $15 billion of public tax payer money pumped into the effort. In the developed-to-middle income world, no such luxury is available. Soon, case series and observational studies emerged in various countries and as TrialSite covered in a documentary shot totally in Peru, that country even authorized the use of the drug prior to any formal research. Some experts claimed that a fraudulent Surgisphere paper was the trigger, but the evidence actually pointed around the world to a community-based research approach, where doctors and researchers used safe dosage amounts and incorporated in studies. That occurred in America with the ICON observational study (Broward County).
However, since then, over 40 clinical trials all involving dosages at safe levels for humans have demonstrated significantly positive results—see the link for a clean ongoing trial summary.
As TrialSite has chronicled these studies since the Spring of 2020, physicians started looking into the findings. Many meta analyses followed, including by Dr. Andrew Hill (University of Liverpool/UnitAid), Dr. Tess Lawrie (The Evidence-Based Medicine Consultancy), and in America, the Front Line COVID-19 Critical Care Alliance (FLCCC). The latter group was invited to present at the National Institute of Health (NIH) COVID-19 Treatment Guidelines panel. And just over a week after that meeting, the NIH’s Panel updated their recommendation to a more neutral position.
When Will the ‘Ivory Tower’ take Notice?
Of course, this has been a similar theme—in pandemic times, where over 2.5 million people have died worldwide, (over half million in America alone) mostly low to middle-income countries (LIMICs)-based researchers and physicians took on the research of ivermectin in a bid to investigate those Monash findings further.
With less resources and capital, they did bring a high degree of moral and ethical commitment to save lives; and institutions from Bangladesh to India, Columbia, to Mexico and Spain to Egypt to now Israel and even the notable observational study in America mentioned above amounts to far more than just “some” trials. And the quality, prominent researchers such as Dr. Tess Lawrie, have put their professional reputations on the line declaring the evidence is in and it is good.
The recent BIRD meeting is a case in point. Convened by Dr. Tess Lawrie and large group of internationally respectable scientists, researchers, and other experts now overwhelmingly recommend the use of ivermectin and have sent their rigorous findings to the World Health Organization. They also happen to look at the same studies with seasoned, experienced points of view and see something very different than a majority of experts. While the “quality” of the underlying ivermectin trials are consistently challenged, few critics delve into any real tangible details. And the ones they do raise are refutable by another rationale point of view. Why is this the case—why such division? After all, in times of pandemic, wouldn’t it be good to have such a promising option? Wouldn’t apex research authorities want to also invest public monies into such studies?
TrialSite starts to suspect that a confluence of interests, many quite well-intentioned, others perhaps not as much so, converge to challenge the growing interest and open embrace of the drug. The recent Merck press release positions a sweeping declaration contrary to considerable mounting data leading toward evidence, and the safety of their own drug (they gave away hundreds of millions to billions of doses), evidence such a subjective, possibly pecuniary interest, perhaps conducive as much to commerce as it is to science.
But also the level of what could be considered ego-driven hubris from select government and academic ivory tower occupants may combine and conflate with a market-based system that at times offers perverse incentive that may actually counteract and contradict a growing scientific-based finding. Could a combination of economic interest and academic ego not only counter but also supersede a possibly positive, complementary, and economical serendipitous treatment pathway?
Back to REMAP-CAP, regardless of skepticism, Professor Nichol participates in the study and clearly has an interest in objectively assessing the outcomes. If the drug actually works in this large trial context then perhaps it will finally be accepted by broader medical establishments in the wealthy GDP nations.
The REMAP-CAP trial recently contributed to medicinal evidence targeting COVID-19. Most recently, their work results in evidence that critically ill patients with COVID-19 receiving organ support in ICUs benefit from treatment with the IL-6 receptor antagonists tocilizumab and sarilumab—including survival. These results were recently published in the New England Journal of Medicine (NEJM).
Call to Action: TrialSite will reach out to the study team as well as monitor the study for more details.