Breaking News

Abortion pill questioning, resurrecting Galapagos, & a warning on using algorithms to deny care

May 18, 2023
Reporter, Morning Rounds Writer
Good morning. We have word from the abortion pill hearing, two warnings about depending on algorithms, and news of potential movement on methadone access.

reproductive Health

Judges focus on FDA's authority in abortion pill hearing

During a federal appeals court hearing yesterday on a commonly used abortion pill, the judges asked questions about the pill's safety and about decision-making at the FDA, which approved it more than 20 years ago. There was no ruling made yesterday and there is no deadline, so a decision could come at any point. The review was prompted by a legal challenge to the FDA's approval of mifepristone. Last month, the U.S. Supreme Court upheld a stay that kept the drug on the market, but its future rests with the appeals court. 

"I don't understand this theme [that] 'the FDA can do no wrong,'" Judge James Ho said after hearing from U.S. Deputy Assistant Attorney General Sarah Harrington and a lawyer for Danco Laboratories, which makes the pill. The judges also interrogated plaintiffs' claim that doctors who object to abortion were being forced to provide care under current mifepristone regulations. STAT's Sarah Owermohle has more.


insurance

Senators decry Medicare Advantage plans for denying care based on algorithms

In March we told you about a STAT investigation that found Medicare Advantage insurers were denying care for patients based on proprietary algorithms rather than patient records documenting their conditions. Instead of using the technology to guide care, many plans use it to avoid paying for care and to discharge patients home as soon as possible — even if patients are not ready. At a congressional hearing on the issue yesterday, Sen. Richard Blumenthal (D-Conn.) warned the insurers involved.

"I want to put these companies on notice," he said. "If you deny lifesaving coverage to seniors, we are watching. We will expose you. We will demand better. We will pass legislation if necessary. But action will be forthcoming." Senators who appeared in the hearing agreed Medicare Advantage denials are a problem, but they didn't necessarily agree on a solution. STAT's Bob Herman and Casey Ross have more.


addiction

White House explores improving access to methadone

There's a paradox in addiction medicine. Methadone, the most effective drug to treat opioid use disorder, is out of reach for many patients who need it. It's available only through specialized methadone clinics, but as opioid overdose deaths soar, doctors, patient advocates, and public health experts have pushed for methadone to become available at a doctor's office or pharmacy.

Now the federal government is exploring how to increase access, a key Biden administration official told STAT's Lev Facher. "All options are on the table right now," Rahul Gupta, the director of the White House Office of National Drug Control Policy, said about expanding methadone access. "We're looking into whether people could be prescribed at an [opioid treatment program] but be dispensed at a pharmacy." Methadone vans and take-home methadone are also being considered as HHS and DEA, two agencies with jurisdiction over the drug, join the conversation. Read more.



Closer Look

A renowned drug hunter returns to resurrect a biotech

stat_galapagos_f1_2000x1125

Mike Reddy for STAT

"Turnaround" seems too mild a term to describe what Belgian biotech Galapagos needs. As Emily Field, an equities analyst at Barclays, puts it, "Basically the company is being valued as though they are lighting that cash on fire." Enter Paul Stoffels, renowned for his career hunting promising drugs and acquiring them for J&J. He's emerging from retirement to run Galapagos, a company he co-founded in the 1990s.

Galapagos spent its first 20 years inventing drugs, but now it's borrowing from Project Playbook, a bull's-eye-inspired guide that Stoffels created at J&J. Its first deals involve two companies working on CAR-T treatments for cancer. "Putting all your money on one or two big acquisitions is very risky in our position," Stoffels told STAT's Damian Garde. The strategy is not to "bet the ranch" on the center of the bull's-eye, he said, but to make strategic wagers out on the margins. Read more.


infectious disease

Giving a single antibiotic dose to household contacts cuts risk of leprosy, study says

Leprosy still infects about 200,000 people a year, mostly in Southeast Asia. It's been treatable for decades, thanks to a multidrug therapy dating to the 1980s, but when someone has the chronic infection, people sharing the same household have the greatest risk of also becoming infected. That's because the bacteria spread through close contact over months. New research has found that a single dose of an antibiotic can dramatically lower that risk. 

The trial, conducted in China and reported in NEJM yesterday, showed that rifapentine, used to treat tuberculosis, was more effective than another antibiotic, rifampin, typically given under current WHO guidelines for what's known as post-exposure prophylaxis. "Providing protection in close contacts is a potential game changer in leprosy prevention," David Scollard, the former director of the National Hansen's Disease Program in Baton Rouge, wrote in an editorial published with the NEJM study. STAT's Andrew Joseph has more.


health inequities

Tools miscalibrate risk of type 2 diabetes by race

Algorithms are only as good as the data they are based on, a lesson underscored by a new PLOS study examining tools to predict risk for type 2 diabetes. Researchers studied three: the Prediabetes Risk Test from the National Diabetes Prevention Program, the Framingham Offspring Risk Score, and the ARIC Model to see if they showed racial bias between white and Black people. They followed nearly 10,000 people without diabetes from 1999 to 2010 to see how risk was calibrated across racial groups.

The Framingham score overestimated type 2 diabetes risk for white people and underestimated risk for Black people while the PRT and the ARIC models overestimated risk for both races, but more so for white people. That could mean overdiagnosis and over-treatment for white people, but more dangerous under-recognition and under-treatment for Black people, the authors write, pinning the cause on underrepresentation of people of color in studies used to create the models.


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • Young Americans are dying at alarming rates, reversing years of progress, Wall Street Journal

  • Warning issued on surgery in Mexican border city after suspected cases of meningitis, 1 death, Associated Press

  • Could an upcoming Supreme Court case make the FDA slower? STAT
  • Genetic predisposition toward higher blood pressure, cholesterol may be linked to Alzheimer's risk, study finds, CNN

  • PTC Therapeutics's PKU drug succeeds in trial, but bigger hurdles for company are ahead, STAT

Thanks for reading! More tomorrow,


Enjoying Morning Rounds? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2023, All Rights Reserved.

No comments