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Morning Rounds Megan Thielking

Drug warning case heads to the Supreme Court

The Supreme Court is hearing oral arguments today in a court fight over a common legal strategy that drug makers use to sidestep patient lawsuits. Here’s the rundown:

  • The case: Merck Sharp & Dohme Corp. v. Doris Albrecht started as a series of lawsuits filed by more than a thousand patients who used the osteoporosis drug Fosamax. The patients say the drug maker didn’t properly warn them that the drug might make them more likely to fracture their femurs.

  • The counterargument: The drug maker argues that it offered to warn patients by tweaking the drug's label — but the FDA wouldn't allow it. The Supreme Court is set to weigh in on how companies can use that defense, which the industry often uses to quickly resolve cases.

  • The stakes: “Regardless of the outcome of the case, this is going to be a very big deal, because [this defense is] a really important issue with respect to drug manufacturer liability,” says Patti Zettler, a Georgia State University law professor who previously worked in the FDA’s office of chief counsel.

Biotech's biggest conference gets underway

The biotech industry’s biggest and most important conference is in full swing in San Francisco today. Thousands of biotech executives, investors, and other players in the industry will be networking and making deals at this week’s J.P. Morgan Healthcare Conference. And while women represent a bigger slice of the speakers at this year’s conference compared to last year, they’ll still be massively outnumbered on biotech’s biggest stage. Men represent 90 percent of the 553 executives who are giving corporate presentations at the conference, down from 94 percent last year. But unlike last year, there are more female CEOs presenting at the conference than men named Michael.

Health technology takes the stage in Las Vegas

Meanwhile, digital health companies are converging on Las Vegas this week for the massive Consumer Electronics Show. And while CES isn’t a medical conference, it’s increasingly become a place for health technology companies to highlight new advances aimed at tackling tough health problems. This year, there’s a particular focus on chronic disease, including heart monitoring, digital diabetes care, and chronic pain management. One thing to keep in mind: Much of the event tends to be heavy on marketing and thin on peer-reviewed, robust studies of new technology.

STAT’s Casey Ross, who will be at CES this week, took a look at some of the technologies likely to take the spotlight. Read here.

Inside STAT: Our child received a devastating diagnosis before birth. We decided to protect her


(maria fabrizio for stat)

Allison Chang and her husband, both medical students, knew the gravity of the diagnosis when they found out their unborn daughter had trisomy 18, a rare genetic disorder that often leads to death before birth. "And so, at 15 weeks of gestation, we made the painful decision to end our very wanted pregnancy," she says. Chang and her husband received genetic counseling, had their medical costs covered by their insurance, and were able to take their daughter’s ashes home in a small urn. "For such a heartbreaking event, we had the best-case scenario," Chang writes. "But other families aren't as lucky as mine." Chang explores how abortion restrictions affect women who decide to terminate their pregnancies due to severe fetal health problems in a First Opinion for STAT — read here.

Food allergies are common — but not as common as people think, study suggests

Millions of U.S. adults have a food allergy — but far more think they do and likely don't, according to a new study. Researchers surveyed more than 40,000 adults about whether they thought they had food allergies and if they did, what kinds of symptoms they experienced. They ruled a person food-allergic if they experienced certain symptoms, such as hives, throat tightening, and chest pain. They didn't count gastrointestinal problems. The study found that while 19 percent of adults reported a food allergy, only 11 percent actually had one. The researchers say it's important for adults who think they have food allergies to get tested. A note: One of the study's funders was Aimmune Therapeutics, which is developing food allergy treatments.

Stroke patients often experience income loss

New research published in CMAJ suggests that people who have had a heart attack, stroke, or cardiac arrest are much less likely than their healthy peers to be working three years after hospitalization. The study — which looked at roughly 25,000 cardiac patients in Canada and a large control group — also found that those who were working three years after a cardiac event or stroke often suffered significant income losses. "These outcomes have consequences for patients, families, employers and governments," the authors write, adding that there's a need for policies and programs to help cardiac patients return to work when possible.

What to read around the web today

  • U.S. officials warn health researchers: China may be trying to steal your data. New York Times
  • Health advocates say schizophrenia should be reclassified as a brain disease. Politico
  • When medicine makes patients sicker. Kaiser Health News
  • New hearts forge friendships for transplant recipients. Associated Press

Thanks for reading! More tomorrow,


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Monday, January 7, 2019


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