April 6, 2023

Brian Frank for STAT

It's the topic everyone at Stanford knows about but few want to discuss. Marc Tessier-Lavigne, the university's president and an elite neuroscientist, is under investigation for alleged research misconduct brought to light by scientific-image experts and a student newspaper. As the list of flagged studies he co-authored has grown, so has unease over a scientific process built on trust but short on safeguards.

None of the dozens of data-integrity experts, Stanford faculty, students, other scientists, or former lab members at Stanford and elsewhere interviewed by STAT's Jonathan Wosen believed Tessier-Lavigne manipulated data or knowingly published questionable results from his lab. Tessier-Lavigne has repeatedly said he never submitted a paper without believing the data were correct and accurately presented. Still, some called the altered images a smoking gun. Others warn against a rush to judgment. And a few call the allegations a distraction from important science. Read more about what's at stake.

health
Telehealth ads promoting weight-loss and other drugs occupy a gray area for regulation

Karen Pennar/STAT

If you've ridden the subway in New York City lately, you know it's hard to miss all the ads splashed on station walls and turnstiles promoting the weight-loss drugs Wegovy and Ozempic. Telehealth companies like Ro and Calibrate are behind these direct-to-consumer campaigns, operating in a gray regulatory zone unlike the strict boundaries the FDA erected for drugmakers long ago, such as requiring warnings about a medicine's possible risks and side effects.

"There's a real need for better regulation, and a real need for consumers to be smarter, more skeptical, because these messages are sales messages. They're not trying to inform you, they're trying to get you to use something," said Steven Woloshin, who co-leads the Center for Medicine and Media at The Dartmouth Institute and founded the Lisa Schwartz Foundation for Truth in Medicine. A Ro spokesperson told STAT's Mohana Ravindranath, "Ro is not a health care provider." Read more.

insurance

Medicare Advantage plans will have to stop denying required care

Last month, we told you about a STAT investigation that found Medicare Advantage companies have increasingly used unregulated algorithms to determine when they can cut off patients' care, even when they are at odds with medical notes on a patient's health status. Yesterday, the Biden administration issued final regulations that, starting next year, would crack down on Medicare Advantage insurers for denying care inappropriately — including if they rely on algorithms to do so.

That means Medicare Advantage plans can't reject coverage of procedures, prescription drugs, tests, or supplies that would otherwise be covered in the traditional Medicare program. Medicare Advantage, the privatized version of the original Medicare program, covers more than 31 million older adults and people with disabilities in insurance plans. Many of those people are in nursing homes or rehab facilities, and judges often rule that the algorithms run afoul of Medicare law. STAT's Bob Herman has more.

Closer Look

Opinion: Synthetic biology accelerated life-saving Covid vaccines. It could also prove deadly

To understand the power of synthetic biology, just look at mRNA vaccines for Covid-19. But that technological feat comes with a price, Michael Specter, a staff writer at The New Yorker and a visiting scholar at the MIT Media Lab, writes in a STAT First Opinion. While quickly sharing the SARS-CoV-2 sequence sped up vaccine development and saved lives, he says open scientific exchange could also seed a deadly biological weapon.

"Making the sequence of just one dangerous virus public would create an information hazard," he says. "And the possibility of that happening is growing faster than any virus that only infects the body." Now that biology has become digital information, he argues, it's time to rein it in: "It is hard to imagine that a species that could figure out how to write, print, and alter DNA cannot figure out a reasonable approach to regulating it." Read more.

pHARma
Supply chain troubles hit cancer drugs, too
Nationwide shortages of critical drugs are nothing new, but the dearth of medications, from anesthetics to saline for IVs, has hit a nearly five-year peak. That includes oncology drugs, many of which are low-cost, sterile, injectable generic medications that routinely save or extend the lives of children and adults. When these medicines are in short supply, that means agonizing decisions — and what physician Andrew Schuman recently called "a tragedy happening in slow motion."

How did we get here? STAT contributor Jill Neimark describes an opaque pharmaceutical supply chain whose base ingredients are mostly made in China and India, subject to pandemic disruptions. Then there's the just-in-time approach to inventory in the U.S. But there are also heroes: hospital pharmacists working behind the scenes. "You shake every tree to go find the stuff a patient needs to stay alive," South Dakota pharmacist Ashley Hansen said. Read more.

Pharma

Air pollution fuels tumor growth in lung cancer for non-smokers

We breathe in more than 20 carcinogens every day, depending on where we live and work. A new study in Nature concludes that one kind of air pollution, fine particulate matter (PM2.5), promotes the growth of tumors in lung cancer. They focused on a type of lung cancer driven by EGFR mutations, which are more common in never-smokers or light smokers. In the four countries they studied — England, Taiwan, South Korea, and Canada — greater exposure to PM2.5 after three years was linked to more cases of lung cancer with EGFR mutations.

Using mouse models and human tissues to understand the mechanism at work, they found that PM2.5 pollution, which can travel deep into the lung, triggered an influx of immune cells and the release of inflammatory signaling molecules. Together, they aggravated existing cancer mutations, possibly awakening dormant mutated cells. The finding suggests inflammation could be a target for preventive therapies.

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What we're reading

Where is the White House's new pandemic response office? STAT
This questionable study caught fire in anti-vaccine circles. How did it get through peer review? The Chronicle of Higher Education
Two Alabama districts show stark divide in pandemic's toll on schools, Washington Post
With Apollo Endosurgical acquisition, Boston Scientific dives into the obesity treatment market, STAT
These drugs are so futuristic that doctors need new training, Wall Street Journal
Former Magellan Diagnostics execs charged with selling defective lead testing machines used for kids, Boston Globe