Dispensed: Complaints of broken EpiPens, what pharma thinks of Amazon, and research-less unicorns

Pills 2 (2)Hollis Johnson/Business Insider

Hello,

Welcome to the polar vortex edition of Dispensed, Business Insider's weekly newsletter giving you a dose of pharma, biotech, and healthcare news. I do not miss being in the Midwest this week - the last time a polar vortex hit in 2014, I was in Evanston, Illinois, trying to put out the daily student newspaper with the breaking news that classes were canceled.

First, I'm curious to hear what you thought of some of the funding headlines that came out this week, like Clover Health's $500 million round, and Hims' reported unicorn status. Sounds like it's shaping up to be another big year for investing in health insurance startups and direct-to-consumer healthcare players. Also keeping us busy this week: the news that Anthem's launching IngenioRx, its home-grown pharmacy benefit manager, sooner than expected, as it looks to cut ties with now-Cigna-owned Express Scripts. Certainly seems like the health insurer-PBM lines are clicking into place - just in time for the Trump administration's proposed rebate regulation.

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Anyways, on to the good stuff. For starters, Emma Court's been poring through documents to bring you this story of how it took 3 years and the FDA to get involved for changes to happen after EpiPen users complained about malfunctioning devices.

Bookmark this as your weekend long read!

epipen manufacturing flaws 4x3Yuri Gripas/REUTERS; Samantha Lee/Business Insider

Hundreds of EpiPen users complained about problems with the lifesaving device. It still took 3 years and a top regulator stepping in before serious change - with potentially deadly outcomes

  • People with life-threatening allergies rely on the EpiPen in emergencies.
  • Complaints about EpiPens not working or arriving in bad shape began to mount in 2013 and 2014.
  • The manufacturer, Meridian Medical Technologies, didn't properly look into those complaints, FDA inspectors warned as far back as 2014. Meridian didn't make significant changes to its complaint-investigation process until three years later, after a major voluntary recall of EpiPens.
  • "In fact, your own data show that you received hundreds of complaints that your EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died," the FDA said in a 2017 letter.
  • Pfizer responded by saying that "no evidence has been found of a causal link between patient deaths and reports of failure of EpiPen units to activate."
  • This occurred as Mylan, the drugmaker that markets and distributes the EpiPen, hiked the price, which sparked controversy. As a result of the FDA's warning letter, new processes at EpiPen factories have contributed to an EpiPen shortage.
  • Business Insider is first to report on the FDA's 2014 warnings, the action taken by Meridian, and critical details of how Meridian handled the complaints that would lead to the recall.
  • Pfizer told us that "since the inspection in 2017, the Meridian manufacturing site has been diligently implementing all commitments made to the FDA."

Next, while out at the JPMorgan healthcare conference, I went around asking my interviewees my favorite set of questions of the moment: What will Amazon do in healthcare and how will that impact your business? I got some pretty insightful answers from the pharmaceutical executives and VCs I spoke to during my week of meetings.

Amazon's playbook for upending healthcare is getting clearer, and pharmaceutical companies can't wait for the tech giant to make its move

  • Amazon is getting into the healthcare business. Every move has sent pharmacy and wholesaler stocks into a tizzy.
  • But it remains to be seen what impact this has on drugmakers.
  • We spoke to more than half a dozen top executives at pharmaceutical companies such as Novartis and Eli Lilly about Amazon's entry into healthcare.
Erin Brodwin took a look at a new paper published this week that found that more than half of the healthcare startups that have a $1 billion + valuation (unicorns, if you will), haven't had peer-reviewed publications. Considering that was the main critique of Theranos before its unraveling, it's worth noting.

More than half of today's unicorn health startups haven't published any influential research - and some experts say that raises the risk of another Theranos

  • A new study suggests that many of the highest-valued healthcare startups - from buzzy health insurance companies like Oscar to biotechs with record-breaking IPOs like Moderna- are failing to publish quality scientific research.
  • That could put us on the brink of the next Theranos, say the authors of the study, who hail from Stanford and New York University.
  • While it isn't perfect, peer-reviewed research is a critical source of vetting for any startup whose product could put people's lives at risk.

Out at Davos, BI Executive Editor Matt Turner got some frank answers about the actual uses and limitations of artificial intelligence in 2019 from executives at Novartis and Microsoft.

Also if anybody's looking for an excuse to stay off social media this weekend, Erin's got a great article outlining her departure from Instagram and how it changed the way she experienced a vacation.

With that, I'm technically off today after working last Saturday putting out big posts like this one - in case you missed it - on why the head of Microsoft's healthcare strategy first thought taking the position would be a "career-ending move". Now, he's completely sucked in.

Thoughts? Tips? Fun polar vortex experiments? You can find me at lramsey@businessinsider.com or the whole healthcare team at healthcare@businessinsider.com.

- Lydia

Get the latest Microsoft stock price here.

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