Remdesivir trial results: NEJM, NIAID, and Gilead provide co
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Information shared by the three stakeholders — NEJM, NIAID, and Gilead — about whether the Remdesivir drug’s ability to reduce mortality is statistically significant and which category of patients benefit, are both confusing and conflicting.

~ April 29, 2020: The results were subsequently published in the NEJM journal & made public.
~ May 1, 2020: The U.S. Food and Drug Administration gave remdesivir an emergency use authorization to treat COVID-19 patients.

#1 Is reduction in mortality statistically significant?

• Researchers led by a team from NIAID says in the NEJM paper: “…Those who received remdesivir had a median recovery time of 11 days as compared with 15 days in those who received a placebo.”

• Elsewhere in the paper, the authors clearly mention this: “Mortality was numerically lower in the remdesivir group than in the placebo group, but the difference was not significant.” A press release from the NIAID also clearly states that the “difference in mortality was not statistically significant”.

• But a tweet from NEJM reads surprisingly does not mention that the mortality reduction was not statistically significant. It says. (Attached Image 2)

#2 Who benefits from Remidesivir?

• But the emergency use authorization by the FDA has approved the drug for treating “suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease”.

• Surprisingly, the NIAID release is not clear in indicating the category of patients who might not benefit from the drug, while the Gilead release is clear. Here, compared the two releases:

• “Investigators found that remdesivir was most beneficial for hospitalized patients with severe disease who required supplemental oxygen,” the NIAID release says.

• And here is what Gilead says in its release: “These findings support the use of remdesivir in this population, with the largest benefit observed among individuals who required oxygen supplementation but were not mechanically ventilated.”

• The authors caution saying: “Given high mortality despite the use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”

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Dr. T●●●●z H●●●●●●i and 8 others like this2 shares
Dr. S●●●●●m S●●●●y P●●●●●l
Dr. S●●●●●m S●●●●y P●●●●●l General Medicine
I am delighted to see PlexusMd also highlighting the ping pong problems of conflicting drug trial results. Interesting read indeed.
Jun 8, 2020Like2