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Posted On: 10/23/2020 12:43:17 PM
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I could not access your article due to pay wall. I did see article linked below which was probably similar. Here are some excerpts:
Weighing in on the approval, two prominent doctors said the data don’t yet support the FDA's decision. The green light was “astonishing,” Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes, wrote on Twitter.
“Of the three included studies, one lacked control, two lacked blinding, all three lacked inclusion of current standard of care,” he wrote. The results were mixed, he pointed out, and a randomized study larger than the three touted by the FDA combined was “entirely negative."
For his part, Eric Topol, M.D., director of the Scripps Research Translational Institute, wondered how the drug could get a full approval based on the “mixed data.” It’s unclear whether the med works early or late, and there’s still much “unresolved,” Topol wrote.
WHO designed its trial to rapidly evaluate treatments in large patient groups. Gilead argued the broad patient group makes it “unclear if any conclusive findings can be drawn from the study results.”
Before that, a study led by the U.S. government showed the med, tested against placebo, improved recovery times, reduced chances of patients progressing to more severe stages of illness and significantly cut the risk of death in patients on low-flow oxygen. Patients on the drug recovered five days faster than those on placebo on average, and severe patients recovered seven days faster.
For patients on low-flow oxygen, investigators recorded 70% fewer deaths in the remdesivir group than in the placebo group.
https://www.fiercepharma.com/pharma/gilead-sc...pike-again
Weighing in on the approval, two prominent doctors said the data don’t yet support the FDA's decision. The green light was “astonishing,” Peter Bach, director of Memorial Sloan Kettering's Center for Health Policy and Outcomes, wrote on Twitter.
“Of the three included studies, one lacked control, two lacked blinding, all three lacked inclusion of current standard of care,” he wrote. The results were mixed, he pointed out, and a randomized study larger than the three touted by the FDA combined was “entirely negative."
For his part, Eric Topol, M.D., director of the Scripps Research Translational Institute, wondered how the drug could get a full approval based on the “mixed data.” It’s unclear whether the med works early or late, and there’s still much “unresolved,” Topol wrote.
WHO designed its trial to rapidly evaluate treatments in large patient groups. Gilead argued the broad patient group makes it “unclear if any conclusive findings can be drawn from the study results.”
Before that, a study led by the U.S. government showed the med, tested against placebo, improved recovery times, reduced chances of patients progressing to more severe stages of illness and significantly cut the risk of death in patients on low-flow oxygen. Patients on the drug recovered five days faster than those on placebo on average, and severe patients recovered seven days faster.
For patients on low-flow oxygen, investigators recorded 70% fewer deaths in the remdesivir group than in the placebo group.
https://www.fiercepharma.com/pharma/gilead-sc...pike-again
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