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Ex-FDA chief rebukes Trump over claim that "deep state" has slowed virus treatments

Former FDA commissioner Scott Gottlieb said Sunday that he rejects President Trump's claim that the "deep state" at the FDA is delaying coronavirus treatments and vaccines for political reasons, telling CBS News' "Face the Nation": "It is a foundational truth that what guides that agency is science."

Why it matters: Gottlieb served as FDA commissioner for two years under the Trump administration. He pushed back on claims from Trump and White House chief of staff Mark Meadows that the agency's bureaucrats don't understand the "urgency" of the moment, saying: "To say these products aren't moving at a historic pace I think is wrong."


Driving the news: Trump plans to announceat a press conference Sunday an emergency use authorization for convalescent plasma, which has already been given to more than 70,000 individuals, the Washington Post reports.

  • Many scientists and physicians say the convalescent plasma might be helpful in treating patients, but warn that it's far from a breakthrough. The plasma is rich in antibodies but there isn't enough evidence to conclusively say it works.
  • Last week, the New York Times reported that the FDA was close to granting an emergency authorization for plasma, but that top health officials intervened because they believed that data from recent trials was too weak.

What they're saying: "I think a lot of that was about plasma, that tweet," Gottlieb said. "There were perceived delays in authorizing plasma under emergency use authorization. It was reported this week that NIH had some misgivings about FDA going forward with that authorization."

  • "But there's reasons some people have some questions about that," he added. "The trial that that's going to be based on, 70,000 patients, wasn't a very rigorously done trial."
  • "I believe plasma's probably beneficial, it's probably weakly beneficial in the setting of this treatment. But I think some people wanted to see more rigorous data to ground that decision. I think that's part of what is going on here with respect to that tweet and questions about the FDA decision-making."

COVID-19 shows a bright future for vaccines

Promising results from COVID-19 vaccine trials offer hope not just that the pandemic could be ended sooner than expected, but that medicine itself may have a powerful new weapon.

Why it matters: Vaccines are, in the words of one expert, "the single most life-saving innovation ever," but progress had slowed in recent years. New gene-based technology that sped the arrival of the COVID vaccine will boost the overall field, and could even extend to mass killers like cancer.

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Beware a Thanksgiving mirage

Don't be surprised if COVID metrics plunge over the next few days, only to spike next week.

Why it matters: The COVID Tracking Project warns of a "double-weekend pattern" on Thanksgiving — where the usual weekend backlog of data is tacked on to a holiday.

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Trump pardons Michael Flynn

President Trump on Wednesday pardoned his former national security adviser Michael Flynn, who pleaded guilty in December 2017 to lying to the FBI about his Russian contacts.

Why it matters: It is the first of multiple pardons expected in the coming weeks, as Axios scooped last night.

This is a breaking story and will be updated with more details.

The emerging cybersecurity headaches awaiting Biden

The incoming administration will face a slew of cybersecurity-related challenges, as Joe Biden takes office under a very different environment than existed when he was last in the White House as vice president.

The big picture: President-elect Biden's top cybersecurity and national security advisers will have to wrestle with the ascendancy of new adversaries and cyberpowers, as well as figure out whether to continue the more aggressive stance the Trump administration has taken in cyberspace.

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Past friction between Biden and Erdoğan foreshadows future tensions

Ankara — The incoming Biden administration's foreign policy priorities and worldview will collide with those of the Turkish government on several issues.

Why it matters: The U.S. needs its NATO ally Turkey for its efforts to contain Russia, counter Iran and deal with other crises in the Middle East. But relations between Biden and Turkish President Recep Tayyip Erdoğan are expected to be strained.

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Tesla's wild rise and European plan

Data: FactSet; Chart: Axios Visuals

Tesla's market capitalization blew past $500 billion for the first time Tuesday.

Why it matters: It's just a number, but kind of a wild one. Consider, via CNN: "Tesla is now worth more than the combined market value of most of the world's major automakers: Toyota, Volkswagen, GM, Ford, Fiat Chrysler and its merger partner PSA Group."

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China's Xi Jinping congratulates Biden on election win

Chinese President Xi Jinping sent a message to President-elect Biden on Wednesday to congratulate him on his election victory, according to the Xinhua state news agency.

Why it matters: China's foreign ministry offered Biden a belated, and tentative, congratulations on Nov. 13, but Xi had not personally acknowledged Biden's win. The leaders of Brazil, Mexico and Russia are among the very few leaders still declining to congratulate Biden.

This story is breaking news. Please check back for updates.

College basketball is back

A new season of college basketball begins Wednesday, and the goal is clear: March Madness must be played.

Why it matters: On March 12, 2020, the lights went out on college basketball, depriving teams like Baylor (who won our tournament simulation), Dayton, San Diego State and Florida State of perhaps their best chance to win a national championship.

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