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Breaking down the tug of war over the FDA and convalescent plasma

A big story that slipped under the radar during last night's RNC: The FDA commissioner apologized for overselling the benefits of convalescent plasma for treating the coronavirus.

Why it matters: The FDA is supposed to be a Switzerland of neutrality within government, able to act based on science instead of pressure from politicians and big business.


  • "I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified," said FDA Commissioner Stephen Hahn.

The big picture: The Trump administration has publicly pressured the FDA on granting an emergency use authorization for plasma.

  • President Trump and trade adviser Peter Navarro have privately and publicly criticized the FDA for holding up authorization, accusing staffers of being part of the "deep state."
  • Trump said plasma "has proven to reduce mortality by 35%" in a Sunday press conference.
  • Hahn echoed Trump's comments, which he apologized for last night, saying what he "should have said better is that the data show a relative risk reduction not an absolute risk reduction."

Between the lines: Public health leaders made a public outcry against quick approval of the treatment.

  • That includes top NIH scientists Francis Collins, Anthony Fauci and H. Clifford Lane.
  • “The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Lane told the New York Times.
  • Hahn said yesterday that the final decision "was made by FDA career scientists based on data submitted a few weeks ago."

The bottom line: Hahn's predecessor Scott Gottlieb tweeted: "I am confident in the science part of the evaluation executed by CBER. The way the public part was handled will erode precious public confidence. You earn public confidence in small drops and you loose [sic] it in buckets."

Why the startup world needs to ditch "unicorns" for "dragons"

When Aileen Lee originally coined the term "unicorn" in late 2013, she was describing the 39 "U.S.-based software companies started since 2003 and valued at over $1 billion by public or private market investors."

Flashback: It got redefined in early 2015 by yours truly and Erin Griffith, in a cover story for Fortune, as any privately-held startup valued at $1 billion or more. At the time, we counted 80 of them.

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Scoop: Facebook's new moves to lower News Feed's political volume

Facebook plans to announce that it will de-emphasize political posts and current events content in the News Feed based on negative user feedback, Axios has learned. It also plans to expand tests to limit the amount of political content that people see in their News Feeds to more countries outside of the U.S.

Why it matters: The changes could reduce traffic to some news publishers, particularly companies that post a lot of political content.

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Scoop: Amazon quietly getting into live audio business

Amazon is investing heavily in a new live audio feature that's similar to other live audio offerings like Clubhouse, Twitter Spaces and Spotify's new live audio platform, sources tell Axios.

Why it matters: As with Amazon's efforts in podcasting and music subscriptions, the company sees live audio as a way to bolster the types of content it can offer through its voice assistant, Alexa, and its smart speaker products.

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Hurricane Ida exposes America's precarious energy infrastructure

The powerful hurricane that plunged New Orleans into darkness for what could be weeks is the latest sign that U.S. power systems are not ready for a warmer, more volatile world.

The big picture: “Our current infrastructure is not adequate when it comes to these kinds of weather extremes,” Joshua Rhodes, a University of Texas energy expert, tells Axios.

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"We must go further": 70% of adults in European Union are fully vaccinated

About 70% of adults in the European Union are fully vaccinated against COVID-19, Ursula von der Leyen, the president of the European Commission, said Tuesday.

Why it matters: The milestone makes the E.U. one of the world's leaders in inoculations, after an initially lagging vaccine campaign, the New York Times notes.

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What Elizabeth Holmes jurors will be asked ahead of fraud trial

Jury selection begins today in USA v. Elizabeth Holmes, with the actual jury trial to get underway on Sept. 8.

Why it matters: Theranos was the biggest fraud in Silicon Valley history, putting both hundreds of millions of dollars and thousands of patients' health at risk.

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