Since the WHO publicized its finding that Gilead's overhyped remdesivir treatment, which was "repurposed" by the company after initially being developed to treat Ebola, the pharmaceutical company has been pushing back, trying to cast what many scientists - including former FDA head Dr. Scott Gottlieb - have described as "high quality" trial data in a negative light.
Gilead claimed that the WHO's data were "inconsistent" with earlier studies that found the drug could potentially reduce the length of hospital stays. These data were widely touted by Gilead, which had planned to charge $3,000 for a course of the drug before "science" got in the way. In fact, as the FT effectively pointed out at the time, the company appeared to be whitewashing data being shared with the public, while the FT reported early trial data showing the drug was a "flop".
That Gilead believes it can fool the public and regulators with this argument despite the WHO data is hardly surprising. Early data shared by the company were apparently convincing enough to fool Dr. Fauci, who claimed that data shared by the company showed the drug's impact was "statistically significant."
Here's more from Reuters.
Gilead Sciences Inc., the U.S. company that developed the drug, said the findings appeared inconsistent with evidence from other studies validating the clinical benefit of remdesivir, which was used to treat U.S. President Donald Trump’s coronavirus infection.
"We are concerned the data from this open-label global trial has not undergone the rigorous review required to allow for constructive scientific discussion,” Gilead said.
Richard Peto, an independent statistician hired by the WHO to 'kick the tires' of its study data, dismissed Gilead's criticisms of the Solidarity trial data.
"It’s a reliable result, don’t let anybody tell you otherwise, because they’ll try to,” Peto told reporters. “This is real world evidence."
The massive international study also found that three other potential therapeutics had no impact on mortality in seriously ill COVID-19 patients, though trials on hydroxychloroquine and an HIV treatment were abandoned earlier this year.
Gilead claims that other smaller trial data showed the drug reduced recovery time by 5 days and even helped reduce mortality in patients needing oxygen. However, if these effects were real, then why didn't they surface in the WHO trial?
The company didn't have an explanation for this - or at least it wasn't included in the Reuters story - and Peto, a professor emeritus at Oxford, said the results of those studies could have been mere "chance," explaining that trials with "large numbers" of test subjects - more than 11,000 patients participated in the WHO trial - are the only way to achieve reliable data.
“The real disappointment is that remdesivir has also failed in a larger number of cases and in the ‘real world setting’,” Clemens Wendtner, Chief Physician of Infectiology and Tropical Medicine at Munich’s Schwabing Clinic, said. “A major clinical breakthrough looks different and warns us that the battle against COVID-19 is far from won.”
Not that any of this is all that surprising. From the beginning, "experts" like Dr. Fauci expressed optimism about remdesivir, despite the paucity of clinical rial data. This view led to Gilead striking several lucrative deals with governments - deals that will most likely now be abandoned - to sell what many decried as an overpriced drug.
Earlier, former FDA Director Dr. Scott Gottlieb reminded viewers that President Trump was administered a full course of the drug during his battle with COVID-19, but added that it would be impossible to determine whether the drug actually benefited the president.
Even one scientist who agreed that drug could benefit from more scrutiny told Reuters that the WHO's results are clear: Remdesivir is "no panacea".