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What’s roiling a would-be ‘Moderna 2.0,’ another lawsuit challenging Medicare’s drug-price powers, & a view from makers of a chatbot for eating disorders

June 12, 2023
Reporter, Morning Rounds Writer
Good morning. Today we have a STAT and Boston Globe investigation into a biotech once seen as another Moderna, legal actions from the U.S. Chamber of Commerce (on Medicare drug-price negotiation) and from employers and workers (on exorbitant health insurance prices), and a perspective from developers of a chatbot for people with eating disorders.

a stat and boston globe investigation

The inside story of how data integrity issues roiled a biotech seen as 'Moderna 2.0'

LARONDE_HQAlex Hogan/STAT

Over the last 18 months, a Boston-area biotech started by the same VC firm that bankrolled Moderna has been quietly dealing with a data integrity issue that resulted in it shelving its two most advanced drug programs, a STAT and Boston Globe investigation has found. Staff began questioning the data as the biotech, Laronde, was raising its $440 million Series B round.

The case has highlighted how easy it can be to get carried away with the promise of new therapies, despite signs of trouble: Laronde had been developing a GLP-1 anti-obesity therapy and a handful of other drug candidates that used a new form of RNA that is believed to be longer-lasting. Questions about the GLP-1 data simmered for months before coming to a head in early 2022, former employees said. Laronde has now shelved the GLP-1 candidate. "As a clearer picture of our historic GLP-1 efforts emerged in 2022, we engaged our board and investors and took appropriate action," Laronde said in a statement. "Those experiments do not bear on the prospects of our other platform applications." Meanwhile, dozens of staff have left the biotech, including three members of the C-suite. Read more.


drug pricing

U.S. Chamber of Commerce joins the fray on Medicare drug-price negotiation

Last week Merck took aim at the law that allows Medicare to negotiate drug prices in a lawsuit arguing the Inflation Reduction Act provision violates the First and Fourth Amendments. Now the U.S. Chamber of Commerce has taken a different tack. Its lawsuit, filed Friday, contends Congress is taking too much power away from the courts. The reasoning: Congress violated the constitutional separation of powers by insulating Medicare's decisions about which drugs are selected and a "maximum fair price" from review by courts.

The Chamber, whose board includes executives from Genentech, Bristol Myers Squibb, and Pfizer, also contends that because Medicare doesn't have to seek comment from drugmakers on the program — though the agency has done so — drugmakers are deprived of due process rights. And it calls what drugmakers have to pay if they refuse to comply an "excessive fine" under the Eighth Amendment. Read more from STAT's Rachel Cohrs.


addiction

Health leaders call for more research on fentanyl test strips

As fentanyl has come to contaminate much of the illicit drug supply in the U.S., drug-checking — testing a supply of illicit drugs to determine its contents — has taken on more importance in overdose prevention. Once classified as illegal paraphernalia, fentanyl test strips to do so are now legal in most states. Top addiction scientists and key public health officials are calling for more research into the test strips for fentanyl and other substances, including Nora Volkow, director of the National Institute on Drug Abuse, FDA Commissioner Robert Califf, and NIH Acting Director Lawrence Tabak.

"With new reports about additional harmful contaminants, such as xylazine, in illicit drugs, it has become clear that drug-checking practices require careful consideration," they wrote in a NEJM perspective published Saturday. "It is critical to encourage implementation of such promising practices while supporting research on implementation and expansion of additional drug-checking approaches." Read more from STAT's Lev Facher.



Closer Look

Fed up with flagrantly high prices, employers and workers take health insurers to court

Push has come to shove for companies, unions, and workers frustrated by exorbitant prices for health coverage. They're suing health insurers based on the belief that hospitals, doctors, and other providers are charging flagrantly high prices without fear of pushback because they ultimately get paid. And employers allege that insurers use contracts to block claims data so effectively that it's impossible to know what they're being charged. Three examples:

  • A woman alleged her employer's insurer, CVS Health's Aetna, conspired with a subcontractor, UnitedHealth's Optum, to create "dummy codes" for certain services.
  • Ford sued Blue Cross Blue Shield of Michigan, and the broader network of Blues plans, alleging the Blues "divided territory and fixed prices" like a cartel.
  • Unions representing laborers in Connecticut sued Elevance Health and alleged it blocked the unions from obtaining their own claims data and overcharged them by willingly overpaying providers.

STAT's Bob Herman has more, including insurers' responses.


biotech

FDA advisers endorse new Alzheimer's drug. Next up: payment questions and competition

A unanimous vote by an FDA panel of experts clears the way for expanded approval of Leqembi, an Alzheimer's treatment from Eisai and Biogen that won provisional FDA approval in January. The agency isn't required to abide by the expert's 6-0 vote in its final decision, expected by July 6, but FDA staff repeatedly endorsed Leqembi's supporting data Friday. What's less clear is what might happen with payment for the drug, given by infusion every two weeks and estimated to cost $26,500 a year.

Medicare currently all but forbids reimbursing for new Alzheimer's drugs, but has promised to loosen those restrictions if Leqembi wins full FDA approval — although details of future coverage remain unclear. More certain is the competition Leqembi will likely face in 2024, when Eli Lilly seeks FDA approval for donanemab, its amyloid-targeting therapy that slowed patients' rate of decline. STAT's Adam Feuerstein and Damian Garde have more.


health tech

Opinion: Why they created a chatbot to address eating disorders

AdobeStock_308561928Adobe

Once people develop eating disorders, fewer than 20% ever receive any care. Because Ellen Fitzsimmons-Craft of Washington University and C. Barr Taylor of Stanford have committed their careers to increasing detection of and care for eating disorders, they agreed to develop a chatbot called Tessa to help. Neither has a commercial interest in Tessa, they note in a STAT First Opinion.

After an NPR story on the chatbot aired in May, the backlash began. Bringing in health tech rather than human touch for eating disorders is wrong, critics said. More blowback came after, unbeknownst to the authors, the company that hosts Tessa rolled out an AI component, one that encouraged dieting, the Wall Street Journal reported. "We could not have been more disappointed and upset to hear this," Fitzsimmons-Craft and Taylor write. Read more on how they still believe a chatbot — not ChatGPT — might help meet the need for trained therapists.


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Thanks for reading! More tomorrow,


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