The Readout Loud

We’re devoting our entire episode this week to one controversial and impactful topic: the FDA’s decision to block the review of Moderna’s mRNA flu shot.

STAT was the first to report that Vinay Prasad, the agency’s top regulator of vaccines, overruled the head of the FDA’s vaccine office and other staffers in making that decision. Prasad’s unilateral action has renewed concerns about the FDA’s regulatory posture under the Trump administration.

To help us dig deeply into this important story and its ramifications, we bring on STAT reporters Lizzy Lawrence and Matthew Herper. We also chat with Moderna President Stephen Hoge and former FDA official Jesse Goodman.

On this week’s episode of The Readout LOUD: two starkly different financial outlooks from Novo Nordisk and Eli Lilly, a psychedelics drug from Compass Pathways encountered a roadblock with the Trump White House, and a closer look at why manufacturing problems have slowed the rollout of a crucial sickle cell treatment.

It’s our pre-Super Bowl show, which triggered some co-host squabbling. Adam Feuerstein is all Patriots, Elaine Chen is Team Seahawks, while Allison DeAngelis, raised in Seattle but now a Boston denizen, struggles with dual loyalties. Our special guest this week is STAT reporter Jason Mast. And if you get a chance, wish Adam a happy birthday.

This is an episode of Drug Story, a podcast by Thomas Goetz. You can find the rest of the series at https://www.drugstory.co/podcast

Once you turn 40, it seems like half the people you know are taking a statin drug. You know, because their cholesterol is high, and to prevent heart disease down the line. It makes sense: better safe than sorry. This is a huge triumph for preventive medicine. Statin drugs have saved (or improved) the lives of millions of people because they acted early. This is how medicine (and public health) is supposed to work.

But the devil is in the details. Like all drugs, statins have side effects. And when they are prescribed for many millions of people, the math means that millions of people will not, in fact, get any benefit from the drug. It turns out that atorvastatin (and other statin drugs) may be the most over-prescribed drugs in the history of medicine. And therein lies a Drug Story. This episode includes perspective from Rita Redberg, MD, cardiologist and former editor in chief at JAMA Internal Medicine.

Biotech company UniQure is set to meet with the Food and Drug Administration to discuss the path forward for its gene therapy for Huntington's disease, and the outcome could be potentially devastating for patients.

That's what patient advocate Lauren Holder says on the latest episode of “The Readout LOUD,” STAT’s weekly biotech podcast. Holder joins the podcast for an in-depth discussion of how the regulator's changing perspective on UniQure's trial affects patients, and patients' attempts to petition the agency to reverse course.

Adam, Elaine, and Allison also chat about the latest news in the life sciences, including the new slate of drug prices negotiated by Medicare, a rise in pharmaceutical industry lobbying, and a halt on another gene therapy trial.

Why is the U.S. at risk of losing its measles elimination status? How are health officials reacting to the measles outbreak? And what did top Centers for Medicare and Medicaid Services official Mehmet Oz tell hospital executives at a fancy yacht party in San Francisco?

We discuss all that and more on this week's episode of "The Readout LOUD," STAT's weekly biotech podcast. We bring on our infectious disease reporter Helen Branswell to talk about the ongoing measles outbreak in South Carolina and what it means for the U.S. more broadly.

We also chat with our hospitals and insurance reporter Tara Bannow about the financial troubles afflicting nonprofit hospitals and how they spent their time at the J.P. Morgan Healthcare Conference.