FDA and WHO Conflicted on Coronavirus Drug

How can two organizations looking at similar data come up with different opinions?

This week, the World Health Organization (WHO) announced that Remdesivir is no longer recommended as a treatment for COVID-19.


https://www.webmd.com/lung/news/20201120/who-says-no-to-remdesivir-as-covid-19-treatment A panel of experts analyzed COVID-19 treatment results from four randomized trials covering over 7,000 hospitalized patients. They stated that there was no evidence that Remdesivir improves patient outcomes. This is not to say that Remdesivir provides no benefit, just no evidence of clinical improvement.

The United States Food & Drug Administration (FDA) approved Remdesivir as a treatment for COVID-19 last month. (https://www.fda.gov/drugs/drug-safety-and-availability/fdas-approval-veklury-remdesivir-treatment-covid-19-science-safety-and-effectiveness) Obviously, the FDA reviewed many studies proving a benefit existed before approving the drug for COVID-19 treatment.

FDA Approval

The FDA analyzed three randomized controlled clinical trials of hospitalized COVID-19 patients. One clinical trial involved over 1,000 patients with mild to severe COVID-19. The recovery period for the group using Remdesivir was ten days compared to the placebo group’s 15 days to recover.

A second clinical study used no placebo group. Two patient groups were treated – one for five days and another for ten days. The two Remdesivir groups had similar results regardless of the number of days the drug was used.

A third clinical study used no placebo group. It also used a five-day and a ten-day Remdesivir protocol. There were no statistically significant differences in recovery rates or mortality rates between the two groups.

Remdesivir is an expensive drug. A five-day protocol ($3120) is half as expensive as the ten-day treatment.

What Now?

https://www.bmj.com/content/371/bmj.m4457 That question is begging for answers. The drug is expensive and must be administered intravenously. Lots of money has already been invested in stockpiles of the drug.


Doctors who perceive the value and benefit of Remdesivir will continue to authorize the treatment for their COVID-19 patient. With FDA approval, there is no reason not to. Additional clinical studies will have to prove the COVID-19 patient benefits from reduced time in the hospital to lower ventilator usage and reduced mortality statistics.

Maybe the real benefit of Remdesivir is related to how quickly the five-day or ten-day protocol starts. My research shows that the earlier a patient is treated, the quicker that patient recovers.

Live Longer & Enjoy Life! – Red O’Laughlin – RedOLaughlin.com



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