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The Readout

Can you incarcerate a unicorn?


Is Sarepta Therapeutics worth $10 billion? Is Elizabeth Holmes going to jail? And how many jobs can one man reasonably hold?

We discuss all that and more in the latest episode of “The Readout LOUD,” STAT’s biotech podcast. Tune in for a conversation about the implications of Sarepta's big week on Wall Street and an examination of the legal predicament (and romantic entanglements) of Theranos. Andreessen Horowitz venture capitalist Vijay Pande joins us to discuss how discerning biotech investors approach artificial intelligence, and then we talk about Atul Gawande's work-life balance, the risks of biotech exuberance, how how to get rich on "right to try."

You can listen to it here. And you can expect another episode next Thursday evening — and every Thursday evening — so be sure to sign up on iTunes, Stitcher, Google Play, or wherever you get your podcasts.

(Almost) no one likes 'right to try'


This week, BrainStorm Cell Therapeutics told the world of its plans to sell an unapproved therapy to patients with amyotrophic lateral sclerosis, an effort made possible by the recently enacted “right-to-try” law. The idea is to build a “semi-commercial enterprise with modest profits” while BrainStorm carries out late-stage trials of the treatment.

Yesterday, we asked readers: Is that good?

And most of them said no. Roughly 87 percent of responders said BrainStorm’s effort essentially nullifies the FDA, which has for decades functioned as the gatekeeper between ambitious drug companies and the often desperate patients awaiting new therapies. The remaining 13 percent said the model was acceptable so long as BrainStorm maintains its commitment to actual clinical development.

Drug developer Derek Lowe believes BrainStorm’s plot is just the start of a broader shift, warning that “the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices.”

Can 23andMe reunite families separated at the border?


STAT's Rebecca Robbins asked that very question — of both 23andMe and Ancestry — and the answer is complicated.

Scientifically, yeah, sure. The mass-market spit tests sold by those two companies are already used to spot familial linkages between long-lost cousins or children separated by adoption.

But when it comes to ethics and logistics, things get problematic. Getting consent, from parents and from children, would be deeply challenging. And, considering how many children and parents remain actually obtaining saliva samples could be impossible.

F____ and Drug Administration


The Trump administration wants to rename the FDA, it says here, stripping the agency of most of its food-regulating powers and rebranding it as the "Federal Drug Administration," presumably to avoid the cost of printing new business cards.

Which is funny and all, but, as STAT's Ike Swetlitz points out, it comes amid a fairly serious turf war between the FDA and the USDA. As it stands, the two agencies split the responsibility of regulating food along fairly nebulous lines (the FDA regulates fish, but not catfish, which is for whatever reason the jurisdiction of the USDA).

The White House says the current system "introduces greater risk, inefficiency, and inconsistency into the important work of ensuring food safety," and so it wants to integrate the whole endeavor into something called the "Federal Food Safety Agency."

That would fundamentally change the FDA — and the tweeting habits of its commissioner.

Plants + space = drugs?

Space Tango is a company, headquartered in Kentucky and led by a man named Twyman Clement, with plans to shoot plants into space in the holy name of biotech.

As STAT's Eric Boodman explains, the idea is that introducing natural products into the gravity-free environs of space will compel them to produce molecules that could never come to life here on Earth — molecules that light the way to novel treatments for disease.

Read more.

More reads

  • Wanted: wrinkled men not afraid of needles for ‘Brotox’ revival. (Bloomberg)
  • Six biotech startups raise $568 million in 24 hours. (Xconomy)
  • For health care incumbents, naming Atul Gawande to lead health nonpofit is a relief. (Forbes)
  • New study supports long-dismissed idea: Herpes viruses could play role in Alzheimer’s. (STAT)

Thanks for reading! Until next week,


Friday, June 22, 2018


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