Post by icemandios on Oct 1, 2023 16:29:17 GMT
[The FDA, IMO, has some culpability. While trashing Ivermectin, they granted an EUA for Remdesivir without any supporting trial data, and without consulting their own advisory committee.]
Early FDA Authorization
The U.S. Food and Drug Administration (FDA) granted emergency authorization to Gilead for remdesivir in May 2020, primarily based on results from a government-sponsored trial in which researchers changed the endpoint midway. Critics said the change was done in order to garner positive results. The trial found remdesivir quickened recovery time from COVID-19.
The agency made the move without consulting its advisory committee on antimicrobial drugs.
The FDA approved remdesivir in October 2020 and expanded its allowable use to outpatient settings and children.
Soon after, a large trial run by the World Health Organization found remdesivir did not quicken recovery time or reduce mortality. The group recommended against using remdesivir in hospitalized patients, which ran counter to the recommendation in the United States.
The U.S. Food and Drug Administration (FDA) granted emergency authorization to Gilead for remdesivir in May 2020, primarily based on results from a government-sponsored trial in which researchers changed the endpoint midway. Critics said the change was done in order to garner positive results. The trial found remdesivir quickened recovery time from COVID-19.
The agency made the move without consulting its advisory committee on antimicrobial drugs.
The FDA approved remdesivir in October 2020 and expanded its allowable use to outpatient settings and children.
Soon after, a large trial run by the World Health Organization found remdesivir did not quicken recovery time or reduce mortality. The group recommended against using remdesivir in hospitalized patients, which ran counter to the recommendation in the United States.