Is the FDA now certifiably as an agency, INSANE? It is clear by its latest REMDESIVIR (Veklury®) action, that it is corrupted, inept, incompetent, and simply reckless & dangerous with the health of
by Paul Alexander
the American people; McCullough waxes brilliantly on the FDA's recent move in approving Remdesivir in kidney patients with no credible data knowing full well it's kidney and liver toxic (failed trial)
Remember, the study itself was stopped early due to feasibility issues and reportedly underpowered to assess efficacy.
‘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.
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.’