Friday Factoids

David Ermer–CDC, CMS, COVID-19, FDA, Generative AI, Medical / Rx research, NIH, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Beware the Ides of March. Wm. Shakespeare

From Washington, DC,

  • STAT News reports
    • “A panel of expert advisers to the Food and Drug Administration on Friday voted in favor of expanding the use of CAR-T therapy in blood cancer, despite concerns about the powerful treatment’s side effects.
    • “The group voted 11-0 that the benefits of Carvykti, a CAR-T medicine from Johnson & Johnson and Legend Biotech, outweighed its risk for patients with multiple myeloma whose disease has persisted despite initial treatment. The same panel voted 8-3 in favor of Abecma, from Bristol Myers Squibb and 2seventy Bio, for multiple myeloma patients who’ve received at least two lines of therapy. Currently both medicines are approved only for patients who have been treated for myeloma with four or more medications.”
    • “In clinical trials, each drug proved to significantly delay disease progression compared to standard therapy. But zooming in on the data, the FDA observed an alarming imbalance of deaths in the early months of both studies, finding that more patients in the CAR-T group died of myeloma or side effects than those receiving the standard of care.
    • “That’s a legitimate concern, panelists said, but one that is outweighed by the potential for a single dose of CAR-T to help patients live without the need for regular, taxing cancer treatment.”
  • MedTech Dive notes,
    • “Intuitive Surgical said Thursday it received 510(k) clearance from the Food and Drug Administration for a fifth-generation robotic surgery system intended to help the company keep its dominant market share in the face of looming competition.
    • “The da Vinci 5 system incorporates features that surgeons have long sought, such as feedback that simulates the feel of the patient’s body tissue, a smaller physical footprint in the operating room, and better console ergonomics.
    • “The improvements “can help drive incremental demand for the system and raise the bar for competition in the future,” William Blair analyst Brandon Vazquez said Friday in a note to clients.”
  • One Digital offers its thoughts about “How will the Inflation Reduction Act of 2022 Impact Employer-Sponsored Group Health Plans in 2025?”
    • It’s not good news, and the FEHBlog doesn’t understand why CMS is making life so difficult for plan sponsors, e.g.,
      • “[T]he Centers for Medicare and Medicaid Services (CMS) released Draft CY 2025 Part D Redesign Program Instructions on January 31, 2024. These instructions, which are still in draft form, noted that one of the methods previously used by a majority of plan sponsors to determine the creditable nature of their plans, the creditable coverage simplified determination methodology, would no longer be a “valid method to determine whether an entity’s prescription drug coverage is creditable or not.”

From the public health and medical research front,

  • The Centers for Disease Control informs us,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 16 jurisdictions experienced high or very high activity compared to 22 jurisdictions previous week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity increased slightly nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to low.
    • “Reported on Friday, March 15th, 2024.“
  • STAT News gives us good news,
    • “A series of new studies are raising hopes that CAR-T, a process in which treatments are made by genetically editing a patient’s own white blood cells, can eventually be used to treat an incurable and deadly type of brain cancer, called glioblastoma multiforme, or GBM.
    • “In the most dramatic result, from a three-person study conducted by researchers at Massachusetts General Hospital, a 72-year-old man saw his tumor shrink 18.5% in just two days and then decrease further over the next two months until it was 60% smaller than when treatment began. That’s notable because glioblastoma is a cancer where drugs can normally only prevent a tumor from growing. Researchers say the results, published in the New England Journal of Medicine on Wednesday, do not mean the treatment is ready to be used widely but give reason to think they are on the right track.”
  • Healio calls our attention to a study on the benefits of bariatric surgery.
    • Bariatric surgery was associated with reductions in body weight, blood pressure, total cholesterol, triglycerides, glucose and HbA1c.
    • Adults who underwent surgery reduced their 10-year Atherosclerotic cardiovascular disease ASCVD risk by 34.4%.
  • The National Institutes of Health’s Director, in her blog, discusses a study suggesting that during sleep, a neural process helps clear the brain of damaging waste.
    • “We’ve long known that sleep is a restorative process necessary for good health. Research has also shown that the accumulation of waste products in the brain is a leading cause of numerous neurological disorders, including Alzheimer’s and Parkinson’s diseases. What hasn’t been clear is how the healthy brain “self-cleans,” or flushes out that detrimental waste.
    • “But a new study by a research team supported in part by NIH suggests that a neural process that happens while we sleep helps cleanse the brain, leading us to wake up feeling rested and restored. Better understanding this process could one day lead to methods that help people function well on less sleep. It could also help researchers find potential ways to delay or prevent neurological diseases related to accumulated waste products in the brain.
    • “The findings, reported in Nature, show that, during sleep, neural networks in the brain act like an array of miniature pumps, producing large and rhythmic waves through synchronous bursts of activity that propel fluids through brain tissue. Much like the process of washing dishes, where you use a rhythmic motion of varying speeds and intensity to clear off debris, this process that takes place during sleep clears accumulated metabolic waste products out.”

From the U.S. healthcare business front,

  • MedTech Dive lets us know,
    • “Most U.S. hospital executives expect low- to mid-single-digit increases in procedure volumes this year, according to a survey conducted by BTIG analysts.
    • “The forecast, which reflects the resolution of staff shortages at most surveyed sites and a small overall rise in capital equipment budgets, could benefit Boston Scientific, Medtronic and Stryker, the analysts wrote Wednesday in a note to investors.
    • “Robotic surgery jumped up the list of spending priorities, climbing from sixth to third place year over year. The change is a “good sign” for Intuitive Surgical, the analysts said, although the forecast of a continued slump in bariatric procedures has negative implications for the company.”
  • Per Fierce Healthcare,
    • “Medicare households are spending far more on healthcare than other households, according to a new KFF analysis.
    • “Researchers analyzed data from the 2022 Consumer Expenditure Survey, tracking spending trends between 2013 and 2022. At the end of that window, health-related expenses in Medicare households averaged $7,000, or 13.6% of total household spending.
    • “By comparison, non-Medicare households spent on average 6.5% of their total on health-related expenditures, or $4,900.
    • “Healthcare expenses included insurance premiums, medical services, prescription drugs and medical supplies like crutches, hearing aids and eyeglasses.”
  • From Healthcare IT News, a Gartner expert points to AI and hospital-at-home as the biggest emerging technologies at HIMSS24. Veronica Walk, senior director analyst, healthcare and life sciences, at the consulting giant offers an end-of-the-week look at the emerging technologies at the conference that provider organization C-suite executives must grasp. Check it out.
  • Fierce Healthcare discusses why payers and providers continue to tussle over Change Healthcare cyberattack response. Hint: The reason is money.