Mar 14, 2019

Axios Vitals

By Caitlin Owens
Caitlin Owens

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1 big thing: Experts want to pump the brakes on gene editing

Illustration: Rebecca Zisser/Axios

Everybody freaked out last year after a Chinese scientist claimed that a pair of twins had been born from embryos he genetically modified. And now, Axios' Eileen Drage O'Reilly writes, the calls for a moratorium on that kind of gene editing are getting louder.

Why it matters: Scientists had already been wrestling for years over the ethics of of using gene-editing tools to save a child from pain and suffering, without crossing the line into so-called "designer babies."

  • Chinese scientist He Jiankui short-circuited that debate when he said he had used the gene-editing tool known as CRISPR to "close a door" through which HIV one day could have entered. The simple act of creating a gene-edited baby was a shocking development, made even more controversial by the fact that he hadn't used the technology to address an immediate medical need.

Driving the news: National Institutes of Health director Francis Collins and top science and ethics experts in the U.S. and 6 other countries yesterday called for a 5-year moratorium on editing the type of genes that are passed on to future generations.

What they're saying: "Certainly, the framework we are calling for will place major speed bumps in front of the most adventurous plans to re-engineer the human species. But the risks of the alternative — which include harming patients and eroding public trust — are much worse," scientific and ethics experts wrote in Nature.

  • The inventors of CRISPR previously called for a similar moratorium.

Go deeper: The ethical red flags of genetically edited babies

2. The FDA's vaping plan is here

Photo: Scott Olson/Getty Images

After what seemed like a million incremental announcements, the Food and Drug Administration formally released its proposal yesterday to restrict the sale of flavored vape products, in the hopes of curbing their popularity among teens.

The big picture is pretty much what we expected: Physical stores must either keep out everyone younger than 18 or keep their e-cigarette supplies in a separate room inaccessible to underage customers. Online retailers must use age-verification tools.

Who's mad: Convenience stores are mad.

  • "They are picking winners and losers in the marketplace while handing a government monopoly to other channels of trade," the National Association of Convenience Stores said, per AP.
  • Some public-health advocates are also mad, criticizing the FDA for not banning flavored products outright, and for exempting mint and menthol flavors from its new rules. The agency said those flavors appeal primarily to adult smokers (though it's also planning to ban menthol cigarettes).
  • The American Lung Association, for one, said the FDA "continues to nibble around the edges."

How it works: The FDA doesn't have direct regulatory authority over convenience stores. Instead, the agency told e-cigarette makers that it could pull their products from the market unless they're sold under these new conditions.

What's next: The public will have 30 days to comment on the draft the FDA released today before it's finalized.

  • Don't be surprised if convenience stores challenge the policy in court, accusing the FDA of overstepping its legal authority and putting brick-and-mortar retailers at a unique disadvantage.
3. First look at health CEOs' 2018 pay

My colleague Bob Herman has been busy digging through newly filed proxy documents for large health care corporations, which provide a glimpse into how much top executives made in 2018.

Between the lines: CEO pay in this analysis is based on actual realized gains of stock. Bob compared those numbers, as well as the average median employee compensation, to 2017's results. Here's how it stacks up:

Intuitive Surgical

  • CEO Gary Guthart: $99.2 million (up 210% from 2017)
  • Median employee: $163,552 (up 4% from 2017)

Johnson & Johnson

  • CEO Alex Gorsky: $46.4 million (up 55% from 2017)
  • Median employee: $75,000 (up 14% from 2017)

AbbVie

  • CEO Richard Gonzalez: $28.5 million (down 62% from 2017)
  • Median employee: $148,823 (down 5% from 2017)

Humana

  • CEO Bruce Broussard: $27.2 million (down 20% from 2017)
  • Median employee: $70,498 (up 23% from 2017)

Centene

  • CEO Michael Neidorff: $21.1 million (down 15% from 2017)
  • Median employee: $66,021 (down 1% from 2017)
4. Purdue overdose treatment fast-tracked

Purdue Pharma is getting a fast-track review from the Food and Drug Administration for a new product to treat opioid overdoses.

The intrigue: Purdue is under fire on multiple fronts for its role in the opioid crisis, namely the sales and aggressive marketing of OxyContin.

  • The company said it would not profit from its overdose-reversal drug, if the FDA ultimately approves it.

Details: Purdue says its drug would last longer than naloxone, which is currently the leading emergency treatment for overdoses. Its version is an injection; naloxone is available as both an injection and a nasal spray.

5. Insys may not survive

Another prominent opioid manufacturer — Insys Therapeutics — may be nearing the end of its financial rope, Reuters reports.

  • You've probably heard about Insys most recently because its executives are on trial over the marketing of Subsys, a powerful opioid, and that trial included a mock music video with a dancing bottle of fentanyl.

Driving the news: Insys said in a financial filing yesterday that "its auditor raised doubts on the drugmaker's ability to continue as a going concern," per Reuters.

  • The company is looking for ways to bring in some cash, but if that doesn't work, it said it would need to "curtail some or all of our product development, commercialization and strategic plans."
Caitlin Owens