The ‘very, very bad look' of remdesivir, the first FDA-approved COVID-19 drug (ethical, drugs)
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An article from Science. How Fauci lied, misled American public to get this drug approved, which probably cost many Americans their lives.
Quote:
But both decisions baffled scientists who have closely watched the clinical trials of remdesivir unfold over the past 6 months—and who have many questions about remdesivir's worth. At best, one large, well-designed study found remdesivir modestly reduced the time to recover from COVID-19 in hospitalized patients with severe illness. A few smaller studies found no impact of treatment on the disease whatsoever. Then, on 15 October—in this month's decidedly unfavorable news for Gilead—the fourth and largest controlled study delivered what some believed was a coup de grâce: The World Health Organization's (WHO's) Solidarity trial showed that remdesivir does not reduce mortality or the time COVID-19 patients take to recover.
Science has learned that both FDA's decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee (AMDAC), mixes infectious disease clinicians with biostatisticians, pharmacists, and a consumer representative to review all available data on experimental treatments and make recommendations to FDA about drug approvals—yet it has not convened once during the pandemic.
The European Union, meanwhile, decided to settle on the remdesivir pricing exactly 1 week before the disappointing Solidarity trial results came out. It was unaware of those results, although Gilead, having donated remdesivir to the trial, was informed of the data on 23 September and knew the trial was a bust.
"This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness," says Eric Topol, a cardiologist at the Scripps Research Translational Institute who objected to remdesivir's FDA approval.
I remember when the original study came out from the NIH, and the Chinese came out shortly thereafter. I called it then on this forum, Remdesivir does not work.
Quote:
An interim analysis from a large-scale, placebo-controlled clinical trial carried out by the National Institutes of Health (NIH), announced on 29 April, tempered expectations but also emphasized that remdesivir had promise. The drug reduced the median time that severely ill, hospitalized COVID-19 patients took to recover from 15 days to 11 days. It was a modest gain, but NIH noted in a press release that treated patients "had a 31% faster time to recovery than those who received placebo." Remdesivir, which must be repeatedly infused intravenously, also seemed to lower the risk of death, but that difference could have arisen by chance. (A peer-reviewed, final report of the study published 8 October in The New England Journal of Medicine reduced the time to recovery for the 531 treated patients to 10 days.)
A second, smaller placebo-controlled study of remdesivir on hospitalized COVID-19 patients in China, published online by The Lancet also on 29 April, found no statistically significant benefit from the treatment—and the antiviral surprisingly had no impact on levels of the coronavirus.
Quote:
Many researchers point out that another crucial piece of data is missing entirely from FDA's statement on remdesivir's approval: evidence the drug reduces the amount of SARS-CoV-2 in the body, the viral load. "I've been working in antivirals for 30 years. Every time you study an antiviral, you show an effect on the virus and you publish it," says Andrew Hill, a clinical pharmacologist at the University of Liverpool. "Surely Gilead has done that. Where are the data? It is very, very strange."
Now our good friend and liar Fauci:
Quote:
Fauci emphasized that the study’s primary endpoint was time to recovery. He called it “highly significant….A 31 percent improvement doesn’t seem like a knockout 100 percent, but it is very important proof of concept.” We’ll come back to the primary endpoint issue at the end of this piece.
He said the mortality rate “trended” towards being better but “has not yet reached statistical significance.”
So, why was the announcement made so soon? Fauci said, “We have an ethical obligation to let people in the placebo group know so they can have access.”
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Finally, though, many on social media – but noticeably few in mainstream news media – have pointed to the fact that primary endpoints or outcomes were shifted by the researchers in the NIH trial just within the past two weeks. Fauci didn’t acknowledge that in his upbeat pronouncement at the White House. He said that the study’s primary endpoint was time to recovery. Yes, that has been the primary endpoint for the last two weeks. But not before that.The trial started February 21.
What percentage of this is a surprise? None. The FDA has proven to be a captured agency and Fauci has long proved himself to be corrupt, a fool, and a liar. He’s paid to say whatever they want and flips/flops with no consequence.
People who don’t know history are doomed to repeat it. Fauci was responsible for many deaths during the HIV crisis. Even then, his goal was to get famous and more rich.
We will find the same tricks have been played with the vaccines too. Just read the EUA and LoA and it’s clear that there’s something strange afoot. Iirc NIH gets royalties on the Moderna shot. Is it any wonder that they are pushing these things?
He will get away with all of this because the American public has butter for brains and the collective memories of goldfish.
I remember when the original study came out from the NIH, and the Chinese came out shortly thereafter. I called it then on this forum, Remdesivir does not work.
I remember when the original study came out from the NIH, and the Chinese came out shortly thereafter. I called it then on this forum, Remdesivir does not work.
From ICU nurse, 1 yr COVID unit included - remdesivir gives zero result. And yes, is very expensive/lucrative.
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