Power and Greed Behind FDA’s Promotion of Remdesivir
Despite studies showing its danger, the U.S. government is pushing a kidney-toxic drug on vulnerable patients
Earlier this month 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 recent 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.”
And yet, placebo-controlled trials have found remdesivir has no impact on mortality in Covid patients, while other evidence suggests it may cause kidney failure. Even the latest peer-reviewed guidance for physicians acknowledges the drug does not offer a clear or consistent “major clinical benefit.”
This story may seem obscure compared to more high-profile debates in the media today about Covid, including the impact of lockdowns on schoolchildren, and the origin of the virus.
But remdisivir is the biggest medical scandal you’ve never heard of. Public’s investigation, several months in the making, finds that the approval and marketing of remdisivir are now threatening the lives of vulnerable people. Meanwhile, mounting reports of patients who died after receiving the drug – often without consent – paint a bleak picture.
Consider Gina Sheridan. When she was admitted to a California hospital with Covid symptoms in July 2021, doctors immediately put her on remdesivir. A few days later, they noticed acute kidney injuries and began hemodialysis.
“When your kidneys start to fail, your body can’t process fluids anymore,” her son, Christopher, told Public. “Your body inflates, you start to swell, and those fluids build up in the lungs and pretty much everywhere else.”
Sheridan emphasized that his mother had no history of kidney problems.
“She essentially drowned in her own body fluids,” he said.
Variations of this horror have played out in hospitals across the country. As bereaved families began searching for answers in their loved ones’ medical records, they discovered that doctors had prescribed remdesivir.
In some cases, health care providers turned over incomplete records, or refused to provide them at all. Some were shocked to find that doctors had given remdesivir to loved ones with pre-existing kidney conditions, which would have been contraindicated.
Still others learned that their relations had never been diagnosed with Covid to warrant the drug in the first place.
Despite its prevalence, remdesivir was widely considered an abject failure in the treatment of Covid-19.
On October 19, 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 was the largest of its kind. It found no reduction in mortality, hospital stay or recovery time.
And yet the FDA ignored the results and approved the drug anyway — three days later.
In November 2020, the WHO issued an advisory against remdesivir. But that did little to dissuade U.S. regulators.
The FDA approved the drug without public debate, serious scrutiny by the mainstream news media, or even the consultation of a panel of experts, which typically weighs in on complex antiviral drugs.
The agency based its approval on interim results from a National Institute of Allergy and Infectious Diseases (NIAID) trial, which appeared to show that remdesivir shortened recovery time, and two smaller, uncontrolled Gilead studies. (None of these studies showed a statistically significant mortality benefit or provided clinical virology data).
The FDA also ignored a placebo-controlled trial in China, published in the Lancet in April 2020, that found “no clinical benefit,” and in which the drug was stopped early due to adverse events in 12 percent of remdesivir patients.
What’s more, scientists who conducted clinical investigations and pharmacovigilance, or “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, or corrigendum, 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.
Some have taken note. In October 2020, Science Magazine noted the “very, very bad look of remdesivir,” including an approval process that “baffled scientists” who followed the clinical trials and had “many questions” about its efficacy. The same article also referenced safety investigations into a high incidence of adverse events underway in Europe and the U.S.
Subsequent reporting highlighted its “possibly toxic” high dosage, its outright failure against Ebola and Covid, and the fact that it was never held to normal approval standards. In April 2020 even the New York Times reported on the chilly reception, among scientists, of Fauci’s “standard of care” announcement.
Critics of this renewed scrutiny of Remdesivir might wave off anecdotal reports of kidney failure, even as they multiply.
Could all the increased renal failure be due to Covid itself? The virus’ characteristic cytokine storm is known to cause multisystem organ failure.
Some working on the frontlines saw a clear distinction. “I’ve treated over 20,000 Covid patients,” said Dr. Brian Tyson, a board-certified California physician with decades of both ER and hospital experience. “I have never seen kidney failure in Covid-19.”
Hospitalized patients may still have had multi-system organ failure from Covid, one critical care nurse told Public. “But to have a patient that’s been there for two months and not be on dialysis and all of a sudden go on remdesivir and have to go on dialysis and decline?”
The same nurse, who has two decades of experience and worked in ICUs on state-of-emergency government and private contracts in three states during the pandemic, said the problem with Remdesivir was quickly evident.
“Our facility didn’t use it long, maybe a month,” said the nurse, who wished to remain anonymous. “I was at a teaching hospital…It didn’t take long before they realized our patients were not getting better and it was harming them, not helping them.”
He recalled the intense emotions of that time. “I had critically ill stable patients that may or may not live, and then when remdesivir came along, it was significantly more sick patients that I couldn’t fix,” he said. “If you’re an ICU nurse, you know, they’re already the sickest of the sick. But to take away my ability to actually make someone better is devastating.”
Critics like Dr. Richard Amerling, a nephrologist, or kidney specialist, who volunteered at New York University’s Bellevue Hospital during the first pandemic wave, argue remdesivir should never be used at all, let alone for kidney patients.
“Remdesivir is known to be nephrotoxic, and if you’re already starting with impaired function, it doesn’t require a big hit to push you into end stage, or complete kidney shutdown, to the point where you require dialysis,” Amerling said.
This is hardly news: By 2020, it was clear from preclinical studies and compassionate use case studies that the drug’s marked nephrotoxicity was an important potential risk factor, according to Gilead itself.
And yet, the FDA expanded the drug’s approval for patients with severe kidney impairment based on a single clinical trial by Gilead, which included only 243 patients, was not statistically significant, and was shuttered early.
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.
What’s going on? Why is the FDA pushing a kidney-toxic drug on the sickest kidney patients in the country? And why, a few articles aside, have so few people heard about this brewing medical scandal?
Power, Greed, and Tony Fauci
