FDA Claims Drug Will Treat Covid-19 in Kidney Failure Patients Without Placebo-Controlled Trials
In July 2023, the U.S. Food and Drug Administration (FDA) expanded approval for remdesivir, an experimental antiviral drug used for COVID-19 since 2020, for patients with severe kidney (renal) impairment, including those on dialysis. Gilead Sciences, which sells remdesivir under the brand name Veklury, applauded the decision in a press release: “With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease.”
The FDA’s decision is based on a few uncontrolled Gilead studies, along with a clinical trial including only 243 patients, not statistically significant, and was shuttered early; coupled with interim results from a National Institute of Allergy and Infectious Diseases (NIAID) trial, which appeared to show that remdesivir shortened recovery time.
The scientists who conducted clinical investigations and drug safety studies (of WHO and FDA data) have raised the alarm over significant risks, especially for acute kidney injury, which they call “a serious, early and potentially fatal adverse drug reaction of remdesivir.” The authors went so far as to issue a correction to their analysis of WHO data. It wasn’t that remdesivir caused 20 times more renal failure than other Covid drugs; it caused 30 times more. All-cause mortality – as well as most major adverse events including acute kidney injury, sepsis and septic shock, hypotension and acute respiratory failure– were slightly higher among patients who completed the remdesivir course, compared to the control group.
The latest peer-reviewed guidance for physicians acknowledges the drug does not offer a clear or consistent “major clinical benefit.” And while placebo-controlled trials have found remdesivir has no impact on mortality in Covid patients, other evidence suggests it may cause kidney failure.
In April 2020, a placebo-controlled trial in China published a piece in the Lancet that found “no clinical benefit,” and in which the drug was stopped early due to adverse events in 12 percent of remdesivir patients. In October 2020, the World Health Organization published its SOLIDARITY trial, which looked at four repurposed drugs and included data from more than 11,000 patients in 30 countries. It found no reduction in mortality, hospital stay or recovery time in patients using remdesivir. Later that same month, the FDA approved remdesivir. In November 2020, the WHO issued an advisory against remdesivir.
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