2. The FDA's controversial move on blood plasma
The Food and Drug Administration's decision to authorize the emergency use of blood plasma as a coronavirus treatment is one of its most controversial decisions of the pandemic.
How it works: Convalescent plasma has been used before, with other infections. And it has worked.
- Blood is drawn from people who have recovered from an infection — and who therefore have antibodies to fight that infection — and is then given to sick people.
Yes, but: The evidence that this approach will help with the coronavirus is limited.
- Some of the country's top medical scientists, including Anthony Fauci and NIH Director Francis Collins, have previously said they didn't think the data from the leading study of plasma for COVID-19, led by the Mayo Clinic, was strong enough to support an emergency authorization, according to the New York Times.
White House officials have leaned on the FDA to move faster. Economic adviser Peter Navarro told FDA officials last week, "You are all Deep State and you need to get on Trump Time," Axios' Jonathan Swan reports.
- Trump himself followed up over the weekend, also accusing "the deep state, or whoever" within the FDA of trying to delay therapeutics until after the election.
Between the lines: The closest parallel here would be hydroxychloroquine, which was granted an emergency use authorization early in the outbreak, only to have it revoked as more evidence piled up showing that the drug probably doesn't help, and may even be harmful.
- The concerns over plasma focus on the strength of the evidence that it works. Critics haven't suggested that it's unsafe.
The bottom line: It's clear what the White House wants from the FDA, and any apparent shortcut around the FDA's usual, rigorous standards will raise questions about the possibility of more harmful shortcuts in the future.