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Shares of biotech giant Gilead spiked more than 2% in Friday trading after the company claimed that its coronavirus treatment, Remdesivir, reduced COVID-19's death risk in a new study. But there are many nuanced and unanswered questions about the data, as the company itself and public health experts pointed out, and the drug should still not be perceived as a silver bullet.
Remdesivir was the first treatment given the Food and Drug Administration (FDA) emergency approval for the treatment of critically ill patients with COVID-19. Several studies ̵
In its latest release, Gilead says the study shows that remdesivir can reduce the risk of mortality for coronavirus patients by 62%. However, this figure is an assessment of relative risk, which is different from absolute risk.
Without wading too deeply into the mathematical weeds, this generally means that comparing the percentages of patients dying with a therapy versus another course of treatment is not an end to the treatment effectiveness. You can lower a death rate from 10% to 8%. There is technically a relative reduction of 20%; but at an absolute level, you still have 8% of people dying.
In Gilead's case, the company claims that for patients treated with remedies, the 14-day mortality rate dropped to 7.6% versus 12.5% for those treated with the existing standard of care.
There is a noticeable difference. But the nuances persist, as said by experts in Gilead's own press release. The study was not randomized (meaning it pooled different data pools together, which could lead to discrepancies), and there was no placebo arm to test true effects on the mortality front.
That does not mean that there is completely insignificant information. But that means a lot more data in more stringent clinical settings, in line with the NIH study showing remedies, can at least cut the recovery time for seriously ill COVID patients.
"Although not as diverse as a randomized controlled trial, this assay is important from a real-world perspective and serves as an important complement to clinical trial data," said Dr. Susan Olender, of Columbia University Irving Medical Center, in Gilead's statement.
Former FDA Commissioner Scott Gottlieb echoed the sentiment of balancing hope and scientific caution in a tweet . "This is very encouraging, but needs to be confirmed in a future lawsuit," he wrote, referring to the need to conduct a lawsuit that is not based on analyzes from various sources.
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