An incredibly controversial topic, ivermectin is a drug for which the inventors won the Nobel Prize. It was found to zap SARS-CoV-2 in an Australian lab (Monash University) early on in the pandemic. From there, many low- and middle-income countries commenced real-world case series, observational studies, and in some cases, regional population health initiatives based on a risk-benefit analysis.
For example, in Bangladesh at the Bangladesh Medical College, Dr. Tarek Alam led a case series and then observational and randomized studies. He has treated thousands of people successfully. Alam informed TrialSite that in Bangladesh they referred to ivermectin/doxycycline combination as the “people’s medicine.”
In the Dominican Republic, Dr. Jose Natalio Redondo, president of the Rescue Group, which is the largest private hospital chain in the Dominican Republic, treated thousands of Dominicans with COVID-19 with the drug. In an interview with TrialSite, Redondo shared that the drug helped with the vast majority of their patients.
Ivermectin was used in Peru extensively, (TrialSite made a documentary) while parts of Brazil and many other places, mostly in low- and middle-income countries, embraced the drug. In the meantime, dozens of studies were ongoing by the summer of 2020. Most of them demonstrated positive effects, but the medical establishments in North America, Europe, and other advanced economies were highly skeptical.
A U.S. case series study called the ICON study, conducted at Broward County Health in Florida showcased significant efficacy lowering mortality. The National Institutes of Health (NIH) referred to the study but declared it wasn’t randomized, so its evidentiary weight was limited.
By the fall of 2020, hundreds of thousands of people (if not more) were treated with the drug with accumulating positive data points. A website tracked study results and, to date, that number is at 84 studies.
By November 2020, U.S. physicians were expanding the use of ivermectin off-label even though the NIH and Food and Drug Administration (FDA) only recommended usage during clinical trials. The Front Line COVID-19 Critical Care Alliance (FLCCC) started embracing the use of ivermectin as did hundreds of other physicians in North America by the start of 2022. Senator Ron Johnson held hearings at the end of 2021, and another one in early 2022 to learn more about early treatment. By early 2021, the NIH COVID-19 recommendation panel met with ivermectin researchers, including Dr. Pierre Kory and Dr. Andrew Hill from the UK. Both Kory and Hill conducted a meta-analysis demonstrating efficacy. After the meeting at the NIH, the Panel changed their recommendation from recommending against the use of ivermectin except for clinical trials to a neutral position (declaring there wasn’t sufficient data).
Although UK-based Dr. Andrew Hill was bullish on the ivermectin meta-study, his sponsor, Unitaid, is purported to have made final revisions to the recommendations, declaring more research was needed before usage. Hills' work influenced the World Health Organization’s outlook. Critics alleged that the whole affair hinted at conflicts of interest.
The nation of Slovakia authorized the use of ivermectin on an emergency basis, representing the first European country to formally authorize the drug provisionally for the treatment of COVID-19.
In 2021, ivermectin physician off-label prescriptions for COVID-19 exploded in the U.S. from about 3,000 per week in the U.S. to nearly 90,000 per week. Thereafter, the FDA and medical societies became increasingly hostile to physicians prescribing the drug. The FDA initiated a campaign to dissuade doctors from embracing the drug off-label for COVID-19 while they wrote letters to medical and pharmacy licensing bodies informing them to monitor for misinformation, including the touting of ivermectin as a treatment for COVID-19. The momentum for ivermectin as a low-cost, off-label treatment slowed.
Meanwhile, in what seemingly was an amazing effort in India, the public health agencies in India’s most populated state of Uttar Pradesh openly embraced the use of public health teams who scoured villages and towns across Uttar Pradesh in an aggressive testing and treatment regimen using a home medicine kit of ivermectin, doxycycline, and supplements similar in effect to the “People’s Medicine” of Bangladesh. Uttar Pradesh experienced a dramatic turnaround—so much so that the World Health Organization touted the effort in a press release, sharing everything about the program except the specific medicines in the medicine kit. Why the WHO sought to hide that information is up for debate. See TrialSite’s take on this.
Merck, a producer of ivermectin and contributor to the Mectizan program (with a billion+ doses given to fight river blindness in Africa), openly bashed the use of ivermectin, declaring it may not be safe. In parallel, Merck received $356 million from the U.S. government to develop the antiviral molnupiravir. They received, thereafter, orders worth $1.2 billion. Many suspected a conflict of interest.
Meanwhile, many dozens, if not hundreds, of lawsuits unfolded from mid-2021 through 2022 as patients hospitalized with COVID-19 were put on hospital protocols that failed and family members requested ivermectin as a last attempt to save their loved ones. Attorneys like Ralph Lorigo made a name for themselves suing hospitals on behalf of the patient and their families to get them access. In 2020, Lorigo was on a winning streak, but with the Biden administration, there seemed to be a change in fortune with hospitals now getting the upper hand on appeals.
A few high-profile clinical trials such as TOGETHER failed to show efficacy, and this became a major blow to the ivermectin movement for acceptance while access continued to tighten due to intensified pressure from regulators and licensing bodies on physicians.
In fact, one physician in Maine was forced into a psychiatric evaluation for promoting ivermectin and other information deemed “misinformation.” Interestingly, however, some conservative states, such as Tennessee, passed laws in 2022, making ivermectin available anyway. Multiple states are now trying to pass ivermectin laws.
Just recently, the NIH COVID recommendation panel changed their guidance again, declaring they recommend use only in clinical trials. The medical establishment—again, federal health agencies, regulators, apex research institutes, and organized medicine—has been unilaterally opposed to the use of ivermectin off-label during the pandemic. The use of ivermectin around the world represented a more bottom-up community medicine approach.
There is certainly a lot of real-world data that the drug appears to help, but there isn’t any hard evidence at this point. From the top-down medical establishment's point of view, the drug doesn’t help treat COVID-19. The safety profile is well known, but critics point out that if doses go significantly higher than at indication for various parasite-born conditions, it could raise safety issues. The debate rages on, but again, much of the medical establishment has moved on from the topic.
Ivermectin Use Now
Yes, at this point, only a small minority of doctors in America openly discuss and prescribe ivermectin. However, based on the number of state legislatures trying to pass ivermectin treatment laws, the number of doctors could be in the many thousands. Meanwhile, depending on the country, ivermectin may be used more extensively. For example, the drug was approved nationwide on a provisional basis in India for several months before being withdrawn from national guidance. Mexico City conducted a large public health initiative treating over 200,000 COVID-19 patients with the drug.
The FDA and NIH declare the drug should only be used targeting COVID-19 in a clinical trial. Worldwide, the WHO has been opposed to any usage other than in clinical trials.
https://www.trialsitenews.com/a/a-whirlwind-generic-drug-tour-use-of-ivermectin-as-early-treatment-for-covid-19-ea630f85