President Trump, FDA commissioner Stephen Hahn and HHS Secretary Alex Azar. Photo: Pete Marovich/Getty Images

The National Institutes of Health on Tuesday released a statement undercutting the Food and Drug Administration's emergency authorization of convalescent plasma as a coronavirus treatment — an escalation of an extraordinary public disagreement between federal agencies.

Why it matters: Thankfully, the main question surrounding the treatment is whether it works, not whether it's safe. But this feud could erode public trust in any future coronavirus treatments and vaccines, potentially for good reason.

Driving the news: An NIH panel of experts reviewed the existing evidence on convalescent plasma, including the FDA's analysis, and determined that "there are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of COVID-19."

  • Although it said that serious adverse reactions to convalescent plasma are rare, the panel wrote that it's still unknown whether the treatment makes patients more susceptible to reinfection.

What they're saying: "The public is best served when health agencies are aligned in the kind of advice they're giving to providers and patients. Different agencies can have different interpretations of data, but the actionable advice should reflect a consensus view so patients have clear guidance," former FDA commissioner Scott Gottlieb told Axios.

  • Another former FDA commissioner, Robert Califf, told Bloomberg that "if you just took random data and divided it into enough subgroups just by chance alone you would find differences."
  • The translation, via Bloomberg's Anna Edney: "It seems the agency did what it doesn't like pharma cos to do — analyze the data a bunch of different ways until something works."

The other side: "Surprised by media uproar on Treatment Guidelines on convalescent plasma for #COVID19. Guidelines mirror EUA: possible benefit, seems safe, randomized trials needed. ... No news here," NIH director Francis Collins tweeted last night.

Go deeper: The FDA plays defense on its coronavirus actions

Go deeper

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Florida fully lifts coronavirus restrictions on restaurants

Photo: Don Juan Moore/Getty Images

Florida Gov. Ron DeSantis (R) announced Friday the state will completely reopen its economy, allowing restaurants to operate at full capacity and barring localities from ordering businesses to close.

Why it matters: The state became one of the world's epicenters for the virus in July, forcing DeSantis to pause its first round of reopening.

Updated 3 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 12:30 p.m. ET: 32,626,165 — Total deaths: 990,134 — Total recoveries: 22,523,822Map.
  2. U.S.: Total confirmed cases as of 12:30 p.m. ET: 7,040,313 — Total deaths: 203,918 — Total recoveries: 2,727,335 — Total tests: 99,488,275Map.
  3. States: U.S. reports over 55,000 new coronavirus cases — "We’re not closing anything going forward": Florida fully lifts COVID restaurant restrictions.
  4. Health: Young people accounted for 20% of cases this summer — The long-term pain of the mental health pandemicFewer than 10% of Americans have coronavirus antibodies.
  5. Business: Millions start new businesses in time of coronavirus.
  6. Education: Summer college enrollment offers a glimpse of COVID-19's effect.

America on edge as unrest rises

Louisville on Wednesday. Photo: Jon Cherry/Getty Images

Rarely have national security officials, governors, tech CEOs and activists agreed as broadly and fervently as they do about the possibility of historic civil unrest in America.

Why it matters: The ingredients are clear for all to see — epic fights over racism, abortion, elections, the virus and policing, stirred by misinformation and calls to action on social media, at a time of stress over the pandemic.