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The Readout Damian Garde

Did you hear about Scott Gottlieb?

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Heavy is the shin that wears the novelty sock. (CHIP SOMODEVILLA/GETTY IMAGES)

Turns out he’s resigning from the top post at the FDA after two years on the job, and we have some questions.

  • Why? According to Gottlieb himself, the weekly commute from his family home in Connecticut to FDA headquarters in suburban Maryland proved increasingly difficult. “There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from family,” he wrote in a letter to staff.
  • What does this mean for the drug industry? Gottlieb was widely admired in biopharma circles, both for his work and for the fact that he was a steady hand in an otherwise tumultuous administration. His departure, STAT’s Matt Herper and Adam Feuerstein write, “will give biotech a panic attack.” And like him or not, STAT's Ed Silverman writes, Gottlieb did speak his mind.
  • Now what? Within minutes of the Gottlieb news began speculation, serious and otherwise, over who will replace him. On the one hand, biotech considers health secretary Alex Azar as a pragmatist who will advocate for a qualified successor. On the other hand, biotech does not consider President Trump that way.

A new depression treatment arrives

Ketamine — or a chemical related to it — is officially set to become a part of the pharmaceutical repertoire to treat depression. 

The FDA late yesterday approved Janssen's esketamine, the first major depression treatment to reach U.S. market in decades. Delivered as a nasal spray, the treatment will include a warning that patients who take it will be at risk for sedation and issues with attention, judgement, and thinking. 

Janssen, a subsidiary of Johnson & Johnson, said the cost of the treatment will depend on the dose used per session and how many sessions a person will need, both of which can vary. The wholesale acquisition cost: between $590 and $885 per treatment session. 

Read more.

Gilead’s endless oncology pivot continues


Back in 2017, when Gilead Sciences’ long-promised embrace of oncology had largely amounted to disappointment, the company brought in a Novartis veteran named Alessandro Riva to preside over a pivot. And he did, playing what the company said was a “critical role” in the $12 billion acquisition of Kite Pharma and its CAR-T therapies.

And yet now, four days into the tenure of Gilead’s new CEO, Riva is leaving to lead a spin-off of Glenmark Pharmaceuticals

The timing is curious. Kite’s first CAR-T, approved about 18 months ago, hasn’t lived up to investors’ expectations in terms of revenue. And Roche, where Gilead CEO Daniel O’Day spent the last three decades, was among the few major cancer drug developers to avoid investing in CAR-T altogether.

Gilead said it has yet to pick Riva’s successor, but whoever takes the job will inherit Big Biotech’s longest-running challenge: turning oncology into a reliable pillar of the company’s future.

Big Genome is too white


The thrilling promise of widely available genetic testing is that it might create a huge bank of information that could improve global health. But that’s only possible if the patients represented actually look like the world.

As 23andMe’s Joyce Tung points out, people of European descent make up more than three-quarters of the participants in genome-wide association studies, despite accounting for less than a quarter of the global population. And that’s problematic, Tung writes, both as a matter of social justice and as a barrier to scientific progress.

“In order for everyone to benefit from sequencing the human genome, genetic studies must be conducted in people of all ethnicities — as well as all genders, ages, incomes, and sexual orientations,” Tung writes in STAT. “It’s a simple concept that seems to be fiendishly difficult to apply.”

Read more.

Your questions on ‘real-world evidence,’ answered


Are data gathered outside a clinical trial actually reliable? How stodgy is the FDA? And when will algorithms replace placebos?

We locked STAT’s Matt Herper in a room for an hour and forced him to answer these and many more questions about the rise of so-called real-world evidence, a catch-all term for medical findings that don’t arrive through the golden gates of randomized clinical trials.

If you’re curious about regulatory dogma, the future of personalized medicine, and whether the idea of a synthetic control arm is more hype than reality, you can take a deep dive right here.

More reads

  • Patient advocacy groups in Canada with ties to pharma are big boosters for government coverage. (STAT Plus)
  • For Big Pharma, a history of profiting from manufactured addiction. (UnDark)
  • Colonialists are coming for blood — literally. (Wired)

Thanks for reading! Until tomorrow,

Megan

Wednesday, March 6, 2019

STAT

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