Remdesivir has not shown any effectiveness in reducing deaths and doctors have warned that approval of the drug does not mean it’s an effective treatment.
The United States on Thursday recorded more than 76,000 new cases of COVID-19 and nearly 1,200 deaths, as evidence mounts that the pandemic is entering its most dangerous phase yet.
Those grim figures pose a stark contrast to the picture painted by President Donald Trump on Thursday night, who for the umpteenth time claimed the nation was moving past the virus.
“We’re rounding the corner. It’s going away,” Trump said of the virus during the third and final presidential debate in Nashville, Tennessee.”
In reality, cases are surging in 33 states and eight states set records for their highest ever single-day caseloads on Thursday, according to the New York Times. Over the past week, 13 states have added more cases than in any other seven-day period during the pandemic. More than 41,000 Americans are currently hospitalized with the virus, according to the COVID Tracking Project.
The surge is stretching the limits of many hospital systems, especially in rural states. In North Dakota, hospitals are at nearly 88% capacity, according to the state department of health, while Wisconsin hospitals are at 85% capacity. The spike in cases is so dire, that the state opened an emergency field hospital on the Wisconsin State Fair grounds.
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While the fatality rate of the virus has decreased substantially in recent months—due in part to more standardized treatments and better courses of care—the rising caseloads have alarmed public health experts.
“We’re seeing a distressing trend here in the United States, with COVID-19 cases increasing in nearly 75% of the country,” Jay Butler, MD, the deputy director for infectious diseases at the CDC, said during a Wednesday media call with reporters. “Smaller, more intimate gatherings of family, friends, and neighbors may be driving transmission as well, especially as they move indoors.”
Butler acknowledged that people were likely growing weary of restrictions related to the virus, but also urged Americans not to become complacent. “We’re tired of wearing masks, but it continues to be as important as it has ever been, and I would say even more important than ever as we move into the fall season.”
Masks are now considered so critical that a new study from the University of Washington’s Institute for Health Metrics and Evaluation projected that universal mask adoption could prevent about 130,000 deaths from COVID-19 in the US between now and the end of February.
The pandemic’s continued spread also comes as the US Food and Drug Administration on Thursday announced it had formally approved remdesivir as the first drug to treat COVID-19. The antiviral drug can now be used to treat all hospitalized COVID-19 patients ages 12 and over who weigh at least 88 pounds.
“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” FDA commissioner Dr. Stephen Hahn said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
The agency previously granted remdesivir emergency authorization for severely ill patients hospitalized with COVID-19 back in May after a research trial found that it helped reduce the amount of time patients spent in the hospital. That authorization was later expanded in August to include all hospitalized patients, even if their case wasn’t severe.
The drug has not shown any effectiveness in reducing deaths, however, and doctors have warned that approval of the drug does not mean it’s an effective treatment.
“It is absolutely not a blockbuster drug or a miracle drug,” Megan Ranney, associate professor of emergency medicine and public health at Brown University, told BuzzFeed News. “We give it to hospitalized COVID patients because we don’t have anything better, which is frustrating.”
In fact, a new international study of more than 11,000 people from 30 countries sponsored by the World Health Organization found that remdesivir had no effect on the length of hospital stays and did not help save the lives of patients with COVID-19. That study, which has yet to be peer reviewed, has come under scrutiny, however, for not having a placebo group and for not having complete data.
Still, the treatment is likely to be used in increasing numbers as hospitalizations continue to rise.