Recently Andreea Molnar, MD from the Charles E. Schmidt College of Medicine, Florida Atlantic University and colleagues published a commentary in the journal Therapeutic Innovation & Regulatory Science calling for a moratorium on the prescribing of ivermectin.
A team of authors from both FAU’s Schmidt College of Medicine and the University of Wisconsin, School of Medicine and Public Health collaborated to propose blocking all ivermectin prescriptions for COVID-19 patients. Other authors included the highly published Charles H. Hennekens, MD, DrPH.
TrialSite has chronicled the research behind ivermectin since the original Australia-based lab study early on in the pandemic. As studies in low-and-middle-income countries (LMICs) such as Bangladesh, Brazil, Egypt and several other places showed promising results a case series study in the U.S. at Broward County Health also demonstrated notably positive outcomes (although that ICON study wasn’t a randomized controlled trial). This media covered the turnaround in India’s largest state—Uttar Pradesh. Even Israel’s top tropical medicine expert led a small study advocating for its potential.
Of course, lots of controversy and drama have unfolded with this seemingly innocuous generic drug, including the emergence of a relatively small, but committed group of doctors across America that prescribe the FDA—approved antiparasitic drug off label. Once known as the “Wonder Drug,” the developers of the drug won a Nobel Prize. It has been shown to be safe with billions of doses administered in tropical locations as part of the Mectizan program for example. There the drug has helped to significantly fight on River Blindness and Lymphatic Filariasis.
As TrialSite reported prescriptions skyrocketed from just over 3,500 per week to nearly 90,000 per week representing what this media estimated was over $300 million per annum in sales. One University of Michigan-led study alone pegged the insurance reimbursement at $130 million (this precluded cash payments).
With transparency into the unfolding magnitude associated with the growing demand a purge commenced led often indirectly by the federal government via the U.S. Food and Drug Administration (FDA). The Gold Standard agency got directly involved in social network campaigns—some even allege they were part of an intricate misinformation campaign including major media.
A couple of high-profile studies showed no efficacy (although critics raise various problems with at least some of these studies) and given growing medical establishment and regulatory pressure prescriptions now have declined to about $39,102 per week. Now a group of doctors associated with a couple of academic medical centers hope to bring that sales total to zero.
Proposed Suspension
Florida Atlantic University’s Dr. Molnar and colleagues call for an outright moratorium on any prescriptions to treat COVID-19. They make an exception for supplying any randomized controlled trials such as the U.S. government-sponsored ACTIV-6 trial.
Rather Molnar et al. declares physicians should tell their patients now receiving ivermectin prescriptions to get vaccines and wear masks. And of course, they remind all about the new COVID-19 therapies on the market from both Merck and Pfizer. Those therapies do have limitations and some national health leads have expressed concerns about molnupiravir.
The authors don’t address fundamental concerns involving waning immunity, or evading immunity associated with Omicron nor is the science for masks solidified (and in fact most states are dropping mask mandates) yet these elements are deemed necessary by the authors to doctors are “doing better than harm.”
It would appear Dr. Molnar earned her MD in Romania and is somehow affiliated with Florida Atlantic University but is not listed in the directory. In a LinkedIn profile, Dr. Molnar appears to be affiliated with a research project called “Metflix” as well as studies with the Lumen Foundation. As mentioned, other authors include respected physicians and academicians at both Florida Atlantic University and University of Wisconsin.