| By Elizabeth Cooney | Happy New Year! The holiday break certainly was eventful. Looking ahead, we bring you 3 to watch in multiple sectors of health, medicine, and policy. | | After the House investigation, questions remain for FDA and Biogen on Alzheimer's drugs (HYACINTH EMPINADO/STAT) It makes for chilling reading to see how a company's single-minded ambition to build a blockbuster drug — with an “unjustifiably high price” — played out. A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Biogen’s Aduhelm, the first new drug for Alzheimer’s disease in two decades. Aduhelm’s downfall is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, the investigation says, based on internal Biogen documents. The investigators cited STAT’s reporting that first uncovered the FDA’s unusual coordination with Biogen ahead of the drug’s approval. The story isn’t over yet. The FDA hasn’t made clear what has changed since the debacle was detailed, days before the agency is expected to approve lecanemab, another Alzheimer’s drug, one developed by Biogen’s partner Eisai. STAT’s Damian Garde and Rachel Cohrs have more questions. | Priorities pile up for health agencies Where to begin? The nation’s federal health agencies have a 2023 to-do list that reaches back to what was left undone by last year’s last-minute mammoth spending package and forward to a future with Covid but without more pandemic funding. STAT’s Sarah Owermohle is tracking these issues for 2023: - The search continues for two top scientists: Francis Collins’s successor at NIH has yet to be named and NIAID needs a new leader after Anthony Fauci’s retirement.
- FDA faces a reckoning: It’s not just drug approvals under fire (see above), but also tobacco, the baby formula shortage, and food (all of it).
- CMS is bracing: It's looking at a Medicaid cliff, when millions will lose coverage, and a watershed moment, when the agency can negotiate drug prices for the first time.
Read more, including what might be in store for a climate office. | Covid hospitalizations are ticking up Covid case numbers come with asterisks about likely being undercounts, and while hospitalization data may seem more solid, they are also hard to interpret. Still, it’s worth noting the number of people in the U.S. hospitalized with Covid-19 is about to surpass this summer’s spike, federal data show. And it seems clear Covid is rising again, STAT’s Andrew Joseph reports. That may not be shocking, but the pandemic has taken many surprising turns, 23 experts told STAT’s Helen Branswell. The stunners include scientific ones, from the metronomic march of variants (as opposed to milder “drift” in the virus) to the astonishing development and manufacture of highly effective vaccines. Then there’s the world’s response to the pandemic, featuring deepening political divides, disparagement of scientists and health care providers, and stumbles in the public health response. Now we're living through a phenomenon we’ve seen before: the panic/neglect cycle. Read more. | In-depth analysis of biopharma and the life sciences Sign up for STAT+ to access in-depth analysis of biopharma, inside intelligence from Capitol Hill, the latest on medicine tech, and more. Subscribe today to start your free 30-day trial. | Closer look: The fourth wave of the overdose crisis (alex hogan/stat) It’s no longer just the opioid crisis. For more than 20 years, opioid overdoses have been urgent health care emergencies in the U.S., driven by the over-prescribing of opioids such as OxyContin. A second wave of addiction deaths began when people moved from prescription opioids to much riskier heroin. The third wave saw the proliferation of potent synthetic opioids such as fentanyl. Now we’re at the fourth wave: polysubstance use created by an increasingly more toxic drug supply. That more lethal drug market is found on the street. STAT’s Alex Hogan rode with physician Coley King (above, right) as he delivered “street medicine” from a van in Santa Monica, Calif., checking in with Francesca Coleman (above, left) in Tongva Park. Most of King’s patients are unhoused, and most, like Coleman, are feeling this fourth wave. Watch Alex’s two documentaries, on the fourth wave and overdoses among the vulnerable, along with Hyacinth Empinado’s explainer on how fentanyl test strips work. | Buy now, pay later comes to health care bills In what sounds like a throwback to layaway plans, buy now, pay later is a growing trend in health care. Platforms like Afterpay and Affirm — financing options designed to ease online shopping — are creeping into health care as options for inflation-hammered people struggling to pay out-of-pocket medical costs or bills not covered by insurance at all. “Buy now, pay later is a small fraction of the health space, but it is exploding,” Jay Zagorksy, an economist at Boston University, told STAT’s Katie Palmer. Some health services have started offering payment plans through leading e-commerce lenders, and a new crop of companies has emerged to offer these plans explicitly for medical bills. But consumer advocates worry the approach could put people at risk of overextending themselves, without the same consumer protections they’d get with existing highly regulated financial products. Read more. | After workplace scandal, Lander pivots to new gig In January 2021, President Biden elevated science adviser to a Cabinet-level position when he named Eric Lander to the role, challenging him to reinvigorate American science. The celebrated genomics researcher, famous for racing with Craig Venter to sequence the human genome as well as co-founding the Broad Institute of MIT and Harvard, is now notorious for his resignation in February 2022 from science adviser and head of the White House Office of Science and Technology Policy over accusations of workplace bullying. Now he’s back. Lander’s latest project is leading a new nonprofit called Science for America, STAT’s Megan Molteni reports. Its mission is to serve as a “solutions incubator” for some of the world’s most pressing problems, including the climate and energy crisis, cancer and pandemic preparedness, and equity in STEM education. Lander did not respond to requests for interviews, but Megan has more on who’s involved in this new venture. | | | What we're reading - Chinese health official raises Covid alarm ahead of Lunar New Year holiday, Wall Street Journal
- When does life begin? New York Times
- Diabetes in youth is set to skyrocket in coming decades, STAT
- A doctor saved a Marine’s life in Vietnam. A photo just reunited them, Washington Post
- Wegovy may help obese teens lose weight but isn't a magic bullet, STAT
| Thanks for reading! More tomorrow, | | Have a news tip or comment? Email Me | | | |
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