FDA Approves Remdesivir in Kidney Patients after Failed Trial
By Peter A. McCullough, MD, MPH | Courageous Discourse | July 21, 2023
In a move that defies all regulatory convention, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. 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 but has no efficacy data to support its administration.
Gilead: July 14, 2023 FDA Approves Veklury® (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis
The phase 3 REDPINE trial failed to recruit sufficient subjects to assess efficacy. Instead of properly rejecting the application, the FDA went ahead and approved the drug with insufficient safety and efficacy data. The drug has struggled in recent years as patients commonly decline the antiviral since the November, 2020, WHO warning against inpatient use. Remdesivir can cause both kidney injury and liver damage, thus with no mortality benefit, many believe it should not be used.
The FDA approval action defies logic and will be added to a long list of acts that will be considered malfeasance and will be up for review when the commissioner and agency is finally called to justice.
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From the Archives
Genetic baloney in thick slices
MAYBE COULD BE INC.
By Jon Rappoport | No More Fake News | July 8, 2021
Gene research companies tend to come and go. They start out banging and popping like fireworks in the sky, and then they fade out—selling themselves to larger outfits who’ve hired better liars…
Once upon a time, it sounded easy. Start with a disease, find the gene responsible for the disease, and correct the problem.
Then, researchers wondered, was disease the result of one gene or a group of genes acting together?
Either way, the proof would be in devising cures for diseases using gene therapy. “Not yet, but soon…”
And regardless, the major need was: money. Lots and lots of money.
This need required good PR people. “We have to pump up the idea that we’re on the edge of tremendous breakthroughs. We’re always on that edge…”
This hype also needed to obscure the fact that there wasn’t (and isn’t) ANY gene cure for ANY disease. … continue
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