COVID-19 treatment without research to back it up

'Without evidence': Once again, FDA expands use of COVID-19 treatment without research to back it up The U.S. Food and Drug Administration late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although there is no data to support such use. Karen Weintraub USA TODAY

The U.S. Food and Drug Administration late Friday allowed the drug remdesivir to be used on all patients hospitalized with COVID-19, although no published research supports such widespread use.

The approval allows doctors freedom to prescribe the antiviral earlier. But it comes less than a week after the agency approved use of convalescent plasma without published scientific support, fueling concerns the agency is yielding to political pressure.

"It seems to be a pattern of approval without science, without data, without evidence," said Dr. Eric Topol, vice president for research at Scripps Research in La Jolla, California and a national expert on the use of data in medical research.

In May, the FDA allowed remdesivir to be used for hospitalized adults who need oxygen, but not those sick enough to require ventilation. A government study published that month in the New England Journal of Medicine found those patients recovered faster than those who hadn't gotten the drug, though there was no evidence that it saved lives.

Earlier this month, the Journal of the American Medical Association published a study of less severely ill hospitalized adults, showing that five days of treatment with remdesivir was better than standard care, though "the difference was of uncertain clinical importance."

No other studies have been published supporting more widespread use of remdesivir. Yet the FDA said the data is now compelling enough to expand its use to all hospitalized patients, including children.

"The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus," FDA Commissioner Dr. Stephen M. Hahn said in a prepared statement announcing the agency had granted an emergency use authorization for remdesivir.

"The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus," FDA Commissioner Dr. Stephen M. Hahn said in a prepared statement announcing the agency had granted an emergency use authorization for remdesivir.

The FDA uses that process to approve products that, based on scientific evidence, it is “reasonable to believe … may be effective.” An emergency use authorization can be issued only during an emergency, such as the COVID-19 pandemic, when there are no adequate, approved and available alternatives. ...