Mar 11, 2019

FDA responds to report of secret database

The FDA publicly swung into action Friday after Kaiser Health News illuminated a secret database that kept serious safety issues out of the public eye.

How it works: The FDA maintains a public database of injuries or other problems caused by medical devices. It's a valuable tool for researchers, and also for doctors, who want to assess devices' safety before using them in patients.

  • But KHN reported last week that the FDA also has a separate reporting system, whose contents are not publicly available. Roughly 100 products are allowed to use that channel, which has collected more than 1 million reports since 2016.
  • Doctors and researchers don't know about issues raised in those reports; a former FDA commissioner told KHN he didn’t even know the system existed.

Driving the news: A mountain of reports about surgical staples and staplers have piled up in the secret system, outside of public view, leaving doctors unaware of the products' risks.

  • "I don't want to sound overdramatic here, but it seemed like a cover-up," said one doctor who queried the FDA's public database — and came up empty — after experiencing problems with a surgical stapler.

A day after that story ran, the FDA sent a letter to doctors saying it's concerned about the safety of surgical staples and staplers.

The agency said it has received reports of 366 deaths, over 9,000 serious injuries and over 32,000 malfunctions.

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Bob Iger stuns media world with sudden departure as Disney CEO

Photo: Jeff Kravitz/FilmMagic

In a move that shocked the media industry, Bob Iger said Tuesday he would step down from his role as CEO of the Walt Disney Company after leading the entertainment giant to unprecedented success during his 15-year run in the job.

Why it matters: Iger is credited with having successfully led Disney through a series of risky but highly-successful acquisitions that not only solidified the company's entertainment dominance, but also ultimately reshaped the entire media landscape.

Sanders hits new stratosphere of online interest

Data: NewsWhip; Chart: Chris Canipe/Axios — Note: Hover over the weekly rank on desktop to see articles and interactions for each candidate and issues.

For the second straight week, Bernie Sanders has hit the high watermark for online attention in the Democratic primary, according to data from NewsWhip provided exclusively to Axios.

Why it matters: It's not just quantity. The sentiment of the top stories about Sanders has been more positive than his top Democratic rivals — particularly Michael Bloomberg, whose recent online attention has been overwhelmingly negative.

Global coronavirus cases spread as U.S. soldier tests positive in South Korea

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens.

A 23-year-old American soldier stationed at Camp Carroll in South Korea has tested positive to the novel coronavirus, as the outbreak spreads to more countries.

The big picture: COVID-19 has killed more than 2,700 people and infected over 81,000 others. By Wednesday morning, South Korea had the most cases outside China, with 1,146 infections. Europe's biggest outbreak is in Italy, where 322 cases have been confirmed.

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