FDA and EU Approve Deadly, Kidney-Toxic Drug for ‘COVID’ Patients with Kidney Disease.
Anyone still think “The Great Culling” is just a conspiracy theory?
Remdesevir, aka “rem-death-is-near”, is a highly toxic antiviral drug with a long list of nasty side effects, not the least of which is death.
So naturally, on May 1, 2020, the industry-funded psychopaths at the US Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir to treat "suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease."
The FDA issued the EUA for remdesivir despite "limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19."
How reassuring.
Actually, remdesivir was already known to be a toxic drug, as I’ll explain in a moment.
The FDA claimed remdesivir "was shown in a clinical trial to shorten the time to recovery in some patients." (Bold emphasis added)
The FDA conveniently neglected to mention that in some other patients, remdesivir was shown to shorten the time to death.
Remdesivir: Unsafe and Ineffective
In December 2019 - just as the COVID-19 scam was kicking off in Wuhan – medicine’s most prestigious tabloid, the New England Journal of Medicine, published the results of an RCT examining "four promising experimental treatments" against ebolavirus: The monoclonal antibodies ZMapp, MAb114, REGN-EB3 or remdesivir.
It’s curious to observe how remdesivir is subject to very little mention in the paper, even though it produced the highest death rate in the study: 53.1% of those unfortunate enough to enroll in the trial and receive remdesivir died, compared to 33.5%-49.7% for the other also-questionable treatments.
I’m guessing the toxic remdesivir had already been chosen as a ‘treatment’ for the preorchestrated ‘pandemic’, and the authors of the study – thirteen of whom hailed from Fauci’s NIAID – carefully avoided saying anything about remdesivir, as there was nothing positive to say about it.
By the way, Fauci himself, along with numerous CDC and WHO researchocrats, was thanked by the authors "for leadership guidance".
When you’re being led and guided by someone like Anthony Fauci, rest assured it’s for no benevolent reason. Fauci, I should remind readers, was the same demonic character who pushed the highly toxic abandoned cancer drug AZT into routine use as an ‘AIDS’ drug. We all know how that turned out.
As journalist Celia Farber points out in Part 1 of The Real Anthony Fauci documentary, whenever there is an alleged outbreak of some ‘novel’ disease, you can count on Fauci to enthusiastically recommend the most toxic, unproven drug he can find.
The Remdesivir Ruse Continues
The May 2020 EUA for remdesivir was by no means the end of the story. Oh no.
On October 22, 2020, the FDA officially green-lighted Gillead's version of remdesivir, Veklury, as "the first drug approved to treat COVID-19, for use in adults and pediatric patients 12 years of age and older and weighing at least 40 kg (about 88 pounds) requiring hospitalization." This meant Veklury had made the transition from EUA drug to one that was fully approved for the treatment of the non-novel flu being renamed 'COVID'.
At the same time, the FDA also made it clear to the non-asleep that it was going after young kids. It revised the original May 2020 EUA for Veklury to permit the drug’s use for treatment of COVID “in hospitalized pediatric patients weighing 3.5 kg to <40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg."
This disgraceful sequence of events meant that even infants – essentially at zero risk of ‘COVID’ harm - were now eligible to be treated with the highly toxic remdesivir.
On April 25, 2022, the EUA for use of Veklury with infants and children under 40kg was transformed into full approval, and broadened to include non-hospitalized patients.
One of the unifying traits of psychopaths seems to be a complete lack of shame and the ability to unflinchingly recite the most ridiculous lies. The pharma-funded FDA is no different.
“Under FDA law,” said the fraudulent drug administrator, “approval of a new drug requires substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s). The approval of remdesivir (Veklury) for the treatment of patients hospitalized with COVID-19 met this legal and scientific standard.” (Bold emphasis added)
How do these cretins sleep at night?
Seriously?
‘COVID-19’ was billed as the deadliest health condition in the history of humankind, even though it had an infection survival rate of nearly 100%. To treat this largely non-fatal condition, the FDA approved a drug whose long, long list of side effects included death.
But just when you think things couldn’t get any more absurd … they do.
Health Death Authorities Strike Again
On July 14, Gillead proudly announced that the FDA had approved use of Veklury in 'COVID-19' patients with severe renal impairment, including those on dialysis.
Proving that the EU hates its citizens too, the European Commission had extended the approved use of Veklury to treat COVID-19 in the exact same demographic three weeks earlier on June 26, 2023.
“The approval by the FDA of Veklury for the treatment of patients with renal impairment," said aspiring comedian and Gilead executive, Anu Osinusi, "... underscores the established safety profile for Veklury.” (Bold emphasis added)
Given the genocidal behaviour they’ve displayed thus far, one can only assume our ‘health’ authorities have developed a special resolve to get rid of kidney patients, because a common side effect of remdesivir is kidney damage and failure.
Remdesivir the Kidney Smasher, Now Here to Save Kidney Patients from ‘COVID’
On November 26, 2020, the day after the FDA claimed remdesivir met the "legal and scientific standard" of "effectiveness" and "safety", the BMJ and MAGIC Evidence Ecosystem Foundation released a "Rapid Recommendation" for remdesivir in patients with severe COVID-19, noting:
“Remdesivir is contraindicated in those with liver (ALT >5 times normal at baseline) or renal dysfunction (eGFR <30 mL/minute).”
“Potential adverse events associated with remdesivir include hyperglycemia, liver dysfunction, and renal failure.”
Numerous research groups have warned of the greatly increased risk for kidney dysfunction consistently associated with remdesivir use.
In April 2021, researchers from Nice in France performed an analysis of the World Health Organization international pharmacovigilance postmarketing database (VigiBase).
Compared with other drugs prescribed for COVID-19 (hydroxychloroquine, tocilizumab, and lopinavir/ritonavir), the reporting odds ratio of acute renal failure with remdesivir was a frightening 30-fold!
More recently, Orogun et al noted of RCTs and reviews examining remdesivir: “a common theme amongst these studies is that they fail to delve deeper into the safety outcomes of remdesivir. Where they are noted, they do not investigate specific ADEs nor consider their consequences."
To remedy this willful blindness, Orogun et al searched the FDA adverse event reporting system (FAERS) for adverse renal and cardiac events associated with remdesivir use by patients with ‘COVID-19’ between January 1, 2020, and November 11, 2021. The comparison group was other antivirals repurposed to treat ‘COVID’, including tocilizumab, baricitinib and ribavirin.
The researchers observed substantially increased odds of adverse renal and cardiac outcomes with remdesivir compared to the other antivirals. The remdesivir-associated reporting odds ratios for kidney failure and renal impairment were 2.8 and 3.45, respectively, while the reporting odds ratio for acute kidney injury was a hefty 16.11.
Previous reviews by researchers had attempted to shift the blame for these outcomes from remdesivir to 'COVID' itself, but those whitewashing attempts fail to explain why 'COVID' patients using drugs other than remdesivir enjoy far lower risks of adverse renal outcomes.
There’s no getting around it: Remdesivir is kidney-toxic junk.
How then, did the FDA justify its insane recommendation to use remdesivir in kidney patients?
That’s easy: It relied on two unpublished trials of remdisivir with kidney patients, both conducted by Gillead. Little information is publicly available for one of those trials, the other showed no benefit whatsoever for remdesivir compared to placebo.
Dismal Failure Leads to Another FDA Approval
According to the Gillead press release, one of these trials was dubbed “GS-US-540-9015”. I could find no further information online, but according to Gillead, it was a non-blinded Phase 1 study. These are small studies that test different dosages on human guinea pigs volunteers, making note of the dosage least likely to make participants keel over sideways. Gillead claimed “no new safety signals” were observed in the study, but given it was non-blinded and that Gillead are the kind of people that will sell kidney-toxic drugs to kidney patients, that statement means less than nothing to me.
The other study was a Phase 3, randomized, allegedly double-blind, placebo-controlled, multicenter study called REDPINE.
The primary objective of REDPINE, according to its entry at ClinicalTrials.gov, was to evaluate whether remdesivir reduced the composite risk of death or invasive mechanical ventilation during 29 days of treatment in participants with severely reduced kidney function hospitalized for 'COVID-19'. Participants were enrolled at study sites in Brazil, Portugal, Spain, the UK, and US.
Despite the participation of multiple sites in five countries, only 258 participants were screened. Of these, 166 subjects were allegedly randomized to the remdesivir group, and only 83 to the placebo group.
The study, states the ClinicalTrials.gov entry, was terminated early due to “study enrollment feasibility.”
"This decision," claims the entry, "is not based on efficacy or safety concerns."
So goes the official party line.
Seventy-one (43%) remdesivir subjects did not complete the study, compared to 33 (40%) of the placebo subjects.
Fifty-one (30.7%) of the remdesivir subjects did not complete the study due to death, compared to 25 (30.1%) of placebo participants.
Gillead claims nine remdesivir subjects were "Lost to Follow-up", compared to only 3 placebo subjects.
An adverse event leading to discontinuation in the study occurred in four remdesivir patients, compared to 0 placebo patients.
Another two remdesivir subjects were disappeared from the study at "Investigator's Discretion", while another remdesivir subject was booted for "Protocol Violation", compared to 0 in the placebo group.
Keeping in mind there were twice as many drug subjects, that still means some ten extra subjects in the remdesivir group were booted from the trial on somewhat vague grounds. Was their exclusion genuine, or was the attrition section used as an anonymous repository for remdesivir subjects who experienced serious adverse events or death, a la Pfizer's fraudulent gene therapy trial?
Even if we accept the results at face value, the REDPINE trial shows remdesiver was a complete failure in its stated goal of reducing death or invasive mechanical ventilation - or any other of the numerous outcomes.
The researchers cite the all-cause mortality up to last follow-up visit (maximum of 15 weeks); a total of 55 of 166 (33.1%) remdesivir subjects died, compared to 26 of 83 (31.3%) placebo subjects.
The researchers claimed a similar proportion (50%) of subjects in each group suffered serious adverse events. Based on what we know about remdesivir, that's a claim I regard with abundant suspicion.
At any rate, this trial failed to show any efficacy whatsoever for remdesivir. It must be noted these pitiful results occurred despite the placebo group being disadvantaged by a higher proportion of subjects aged 65 years and older (57.1% in the remdesivir group versus 72.5% in the placebo group).
Yet the FDA used this small, aborted and unsuccessful trial as an excuse to grant approval for the use of kidney toxic remdesivir in kidney patients with ‘COVID’!
Drug Regulation is a Racket
Even if you have showroom-condition kidneys, you should take careful note of the utterly unscientific manner in which new drug approvals are handed out nowadays. Whether it be statins, antidepressants, or toxic gene therapies marketed as ‘vaccines’, many drug approvals are granted in spite of the fact the drug in question is ineffective and causes more harm than good.
“Remdesivir should never have been approved in the first place,” Dr. Paul Marik, critical care physician and author of more than 500 peer-reviewed journal articles, told The Epoch Times. “Gilead had to cook the data to be approved. The World Health Organization’s (WHO) own data shows it increases the risk of kidney failure twentyfold,* so why you would approve it for someone with renal dysfunction is obscene.”
The WHO published a bulletin in 2020 recommending against using remdesivir to treat COVID-19. The WHO’s recommendations were based on a review of evidence published in the BMJ, including data from four international trials covering more than 7,000 hospitalized COVID-19 patients. The WHO found no evidence that the treatment helped hospitalized patients recover or improved their outcomes.
Dr. Marik said the National Institutes of Health and Gilead “cooked the first study” that formed the initial basis of FDA authorization in October 2020 because remdesivir was “so toxic.”
“They committed scientific fraud in a single clinical study that provided data to the FDA, changing the endpoint halfway through the study to try and prove the drug had any benefit,” he added.
“The FDA is a proxy for Big Pharma. It has no interest in public health.”
*The increased risk was in fact thirty-fold, as the study authors stated in a corrigendum.