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The Readout Damian Garde

The newsletter will be taking a break for the holidays, and will be back in your inbox on Thursday, Jan. 2.

Matt's take: Facing the realities of drug pricing

There’s simply no logic to America’s drug-pricing system, but cutting drug prices will undeniably make a major dent in future R&D. The end result? Fewer new drugs. Biopharma is under intense scrutiny for good reason, but recent pricing legislation has sent the industry into panic mode. 

How did it all come to this? STAT’s Matt Herper opines, giving a lay of the pricing landscape — and looking to potential paths forward.

“What’s scariest about the new House bill, to biopharma executives, is that it would fix prices based on how drugs are priced in other countries, forcing them into an unpredictable, multi-faceted dance in launching their products,” he writes. “And no, it’s not fair for the U.S. to pay more than other countries, but that has no effect on whether science gets done.” 

Read more.

The FDA sure is approving drugs quickly

On Friday, the FDA approved a new breast cancer treatment from AstraZeneca a full four months ahead of schedule. And over the past two months, it has OK’d six treatments an average of 3.25 months before their promised decision dates.

What’s unclear is whether this means anything. When you zoom out, FDA approval timelines have been pretty consistent at the median. What swings the year-to-year average are the sporadic super-fast approvals, which almost always go to drugs that treat cancer or rare diseases.

It’s tempting to look at the past few months as a sign that the FDA is deliberately accelerating its review process. And, hey, maybe that’s true. But it’s worth noting that all of the above treatments are indicated for cancer or rare disease, and so it’s also possible that the agency is doing what it’s always done; there just happened to be a bolus of the kind of drugs that get approved quickly.

Scaling precision medicine requires industrialization

Benchwork can certainly be compelling, particularly in the precision medicine space — where new insights are gleaned on how individual biochemistries influence disease. But in order to make personalization a reality, bespoke therapies need to be industrialized, according to Amy DuRoss, CEO of Vineti, a software company that focuses on streamlining the back end of advanced therapies. 

As she points out in a new First Opinion for STAT, breakthrough techs like CAR-T therapy may inspire us, but they are “unsustainably expensive, difficult to manufacture, and complicated to deliver.” The solution, she writes, is to standardize how individualized medicine is developed — so it can be scaled.

Read more.

Identity theft + pharma greed = jail

We see plenty of fraud in medicine; it’s not uncommon for biopharma or hospital employees to try to pull a fast one over health insurers. What we don’t see so much: identity theft. 

Mark Moffett, a sales rep for Aegerion Pharmaceuticals, was convicted Friday by a federal jury in Boston for both defrauding insurers and using the identities of physicians to commit that fraud. 

Moffett was pushing the drug Juxtapid, which costs more than $300,000 and carries a black box warning. It’s been approved only to treat homozygous familial hypercholesterolemia, but Moffett convinced doctors to prescribe the drugs for patients without that indication.

He managed to build out fake clinical histories for fake patients, who were given fake prescriptions by real cardiologists whose identities Moffett stole. He made $11,000 in bonus bucks for each Juxtapid prescription he ushered into being — but now faces up to two decades in prison.

More reads

  • Most Americans misunderstand approvals and FDA’s role in overseeing drug ads. (STAT)
  • A genetic test led seven women in one family to have major surgery. Then the odds changed. (Wall Street Journal)
  • Congress showers health care industry with multibillion-dollar victory after wagging finger at it for much of 2019. (Washington Post

Thanks for reading! See you in the new year,

Monday, December 23, 2019

STAT

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