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Tuesday, November 8, 2016

The Readout by Damian Garde & Meghana Keshavan

Happy Election Day! We'll be updating you as results roll in throughout the night at STAT. Follow us on Twitter: @damiangarde@megkesh, and @statnews. Now, on to today's biotech news:

What's at stake for biotech today

PILL SPLITTING IS ALSO A THING IN REAL LIFE (MOLLY FERGUSON for STAT)

The campaigning ends today, but the contentious issue of drug prices won't evaporate. STAT contributors Luke Timmerman and Meg Tirrell break down how we got here and where we go next in their special Election Day Signal podcast.

(We might add that tuning in will be a great way to calm your Election Day jitters.)

Here's a primer on what we'll be watching most closely tonight:

  • Will pharma's investment in divided government pay off? Wary that a Democratic tidal wave could usher in a drug pricing crackdown, pharmaceutical PACs have spent six times more money backing Republicans in competitive House races this election season. But pharma has also put a lot of money behind Hillary Clinton.
  • Will California voters try to rein in high drug prices? This one's going to be a nail biter. With final polls deadlocked, we'll be up late to find out the fate of the measure that Bernie Sanders said this week "could be the shot heard ‘round the world in taking on the big money interests in health care." 
  • Will industry favorites prevail in North Carolina and Minnesota? Pharma executives and lobbyists have spent big to help Republican Senator Richard Burr of North Carolina fend off a Democratic challenger. Same thing in Minnesota's third district, where four-term Republican Congressman Erik Paulsen has been boosted in a tough race by his friends in the medical device industry.

A new approach to compassionate use

the future of compassionate use? (molly ferguson for stat)

When an experimental therapy proves particularly promising, patients clamor for access to it. Typically, the ones who win out are the wealthy, or the well-connected, or those savvy enough to run a social media campaign. Everyone else is out of luck.

When Johnson & Johnson ran into that problem with its experimental drug daratumumab for multiple myeloma, it sought another way. The company asked bioethicist Arthur Caplan to create an objective system, based on anonymous patient records, to allocate the drug.

J&J calls the panel a success, as do patient advocates. And Caplan is eager to expand the model. But the approach has raised some ethical questions. For example, what if Stephen Hawking needed access to an experimental drug? Should he be treated like anyone else, or should we favor him in the name of saving one of the earth's most brilliant minds? 

Read more.

Understanding antibiotic resistance — and then actually doing something about it

Tim van Opijnen is using the process of elimination to learn about antibiotics: He’s got more than 10,000 mutant strains of Streptococcus pneumoniae, each with a different gene disabled. 

He’s trying to understand exactly how a pathogen mutates to gain resistance to bacteria, as STAT's Shayla Love reports. Then he's looking for chinks in that armor.

Of course, understanding resistance and developing an effective, well-tolerated antibiotic are two disparate things.

Take Cempra’s new antibiotic, solithromycin, which barely squeaked past an FDA advisory panel late last week, thanks to toxicity risks. There’s a huge need to build a better antibiotic, and gaining a better understanding of pathogens might help. But making it work in the clinic? Another hurdle entirely.

Clearing your mind, quite literally

Stanford’s Karl Deisseroth — you may know him for his work with optogenetics — has a new side project. His startup, ClearLight Diagnostics, is working to commercialize his method for making make tissues, such as brains, transparent.

It’s just licensed RNA interrogation technology as well as a form of light sheet microscopy from Stanford University, with the goal of making DNA, RNA, and protein imaging more visible to scientists.

Quite the ingenious idea. Of course, in the back of our minds, we’re wondering if another quiet researcher, in a small university lab, might be working on a similar project — and not get credit.  

More reads

  • Martin Skhreli's defense strategy: Blame it on his lawyers. (Bloomberg)
  • Oral arguments set for next month in CRISPR patent case. (STAT)
  • Good data on spinal muscular atrophy therapy sends Biogen stock up. (Boston Globe)

Correction: Yesterday's Readout mistakenly identified arginine as an enzyme. It is, of course, an amino acid.

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Thanks for reading! Until tomorrow,

Damian & Meghana

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