The studies above show that this is not rocket science. Why is Dr. Fauci still talking about anecdotal evidence?
Why did he not retract what he told CNN on Wednesday, May 27, referring to what became the May 22 Lancet scandal?
"Clearly the scientific data is really quite evident now about the lack of efficacy for it."[xvi]
The corporate arm of the triad: Gilead's checkered past
To begin with a snapshot of where Gilead's remdesivir studies stood when on June 29 the US DHSS purchased $1.6 billion worth (500,000 doses, the world supply until the end of August) - the excerpt below from a June 24 article in the British Medical Journal assesses the problems:
"A serious imbalance in covid-19 research strongly favours the study of drug treatments over non-drug interventions, with many studies too small or too weak to produce reliable results. Equally concerning is the release of partial or preliminary findings before peer review-often through commercial press releases-that is distorting public perceptions, ongoing evaluations efforts, and political responses to the pandemic.
Remdesivir is a key example. The antiviral drug, made by US company Gilead, was unapproved at the start of the pandemic, but in early April the New England Journal of Medicine published a small descriptive study of a compassionate use scheme for patients with covid-19. Gilead funded the study, a third of the authors were Gilead employees, and Gilead's press release reported "clinical improvement in 68% of patients in this limited dataset." Despite being a non-randomised, uncontrolled, company funded study of just 53 patients, media headlines described "hopeful" signs and reported "two thirds" of patients showing improvement.[xvii]
Two weeks later, the Lancet published a randomised placebo-controlled trial of remdesivir from China, finding no statistically significant clinical benefit in the primary outcome of time to clinical improvement. Twelve per cent of participants taking remdesivir stopped treatment early because of adverse events, compared with 5% taking placebo. The trial was stopped before meeting recruitment targets."[xviii]
The only study demonstrating even marginal efficacy shows remdesivir to reduce hospital recovery times 31%, from 15 days to 11 days.[xix] In light of this benefit, Gilead's Chairman Daniel Oday explained on June 29 how the company had priced the drug - which had little to do with its cost of $10 per dose to manufacture,[xx] or concern for the cost to the patient, but everything to do with what the market of desperate governments during a pandemic would bear:
"In normal circumstances, we would price a medicine according to the value it provides. The first results from the NIAID study in hospitalized patients with COVID-19 showed that remdesivir shortened time to recovery by an average of four days. Taking the example of the United States, earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. Even just considering these immediate savings to the healthcare system alone, we can see the potential value that remdesivir provides"
We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial. Based on current treatment patterns, the vast majority of patients are expected to receive a 5-day treatment course using 6 vials of remdesivir, which equates to $2,340 per patient"
At the current price of $390 per vial, remdesivir is positioned to achieve the aim of providing immediate net savings for healthcare systems. The price for U.S. private insurance companies, will be $520 per vial. At the level we have priced remdesivir and with government programs in place, along with additional Gilead assistance as needed, we believe all patients will have access."[xxi]
Incredibly, none of the studies published before this purchase had mentioned side effects of the drug, although in the China study, kidney injury had led to discontinuation for one patient, and in its original use for Ebola, liver risks had been identified.[xxii] On July 5Â , a public health official reported that "remdesivir is showing reports of liver damage in patients across India."[xxiii]
On June 30, the day after the DHSS $1.6 billion purchase, an International Journal of Infectious Diseases (IJID) preprint reported that two of five patients in a hospital enrolled in the French Discovery trial had to be put on dialysis for renal insufficiency caused by remdesivir toxicity.[xxiv] That's 40%.
To summarize the problems with remdesivir:
1. The very few control trials were poorly designed, influenced by vested interests, lacked precision, provided low-quality evidence, or produced negative results.
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