The National Institutes of Health COVID-19 Treatment Guidelines for Ivermectin have changed once again. Published based on the recommendations of the NIH’s COVID-19 Treatment Guidelines Panel (the Panel) based on what is deemed the most recent information regarding the optimal management of COVID-19, this is the third change involving the existing Food and Drug Administration (FDA) approved drug. The Panel first recommended the drug as an early treatment for COVID-19 only for clinical trials. TrialSite reported, however, that in early 2021, the NIH’s Panel met with ivermectin researchers, including Dr. Pierre Kory, co-founder of the Front Line COVID-19 Critical Care Alliance (FLCCC), and thereafter modified the recommendation to a neutral position. After the meeting, the Panel stated there wasn’t sufficient information for a recommendation for or against. Just this month, the Panel once again modified the recommendation for ivermectin, suggesting it only be used for COVID-19 in clinical trials.
Since the pandemic began, 83 studies involving ivermectin as a treatment for COVID-19 actually indicate some positive findings about the drug. In total, these studies have included 129,864 patients in 27 countries and include 34 randomized controlled studies showing a 55% improvement. Large real-world public health actions using ivermectin are associated with a dramatic turnaround in the delta variant surge, such as in Uttar Pradesh, India. For an overall chronology of the struggle for acknowledgment of early treatment, find the TrialSite piece authored May 22.
The Panel points out two recent prominent randomized controlled trials, including the controversial TOGETHER trial. The Panel writes that these studies “showed that the use of ivermectin did not provide a clinical benefit for patients with mild to moderate COVID-19.” Consequently, the Panel now recommends against the use of the drug except in clinical trials.
Panel members are listed here. Some critics have noted the fact that many of the Panel members have financial ties to the pharmaceutical industry. Yet many academic medical researchers participate in industry-sponsored studies—it’s not appropriate to immediately accuse such Panel participants as conflicted merely because they did previous industry research work.
While a small number of physicians still prescribe the drug off-label for COVID-19, pressure against doing so has intensified based on recommendations from the U.S. Food and Drug Administration (FDA), medical societies, and licensing boards. Now it’s exceedingly difficult for patients to access the drug off label for COVID-19 unless they live in a state where the legislature has created a law making it acceptable, such as in Tennessee.
TrialSite chronicled intensified pressure against the off-label use of ivermectin once a study surfaced indicating prescriptions of ivermectin on a weekly basis went from 3,000 per week pre-pandemic to nearly 90,000 per week during the middle of the pandemic. A follow-up study showcased the amount of insurance payments allocated to the drug for off-label COVID-19 use.
https://www.trialsitenews.com/a/national-institutes-of-health-covid-19-treatment-guidelines-panel-again-modifies-ivermectin-recommendationonly-for-clinical-trials-461a98d3