closer look
Momentum is building to hold medical devices to the gold standard of clinical trials
Adobe
It's common sense: Testing a medical device against a placebo is nothing like comparing a sugar pill to an active drug in the gold standard of double-blinded, randomized clinical trials. Device makers have long argued it would be unethical to subject patients to an invasive treatment that by definition wouldn't work but could harm them. To gain FDA approval now, makers of devices with low to medium risk need only prove they're substantially equivalent to a device already on the market.
Now there's a growing movement to make testing more rigorous, a debate stirred by a new study from device giant Abbott that tested its TriClip, designed for patients with a heart condition that causes blood to leak backward through their tricuspid heart valves. "If you're going to unleash something into the public space, I think it's morally and ethically crucial to know it works," cardiac electrophysiologist John Mandrola told STAT's Lizzy Lawrence. Read more.
politics
Hospitals are not on board for this money-saving plan
There's a unicorn prancing about Capitol Hill. It's that rare policy that could save Medicare a boatload of money, cut patient costs, and enjoys longtime bipartisan support. Hospitals are not in the cheering section, though. Known as the "site-neutral payment policy," it means Medicare would pay the same amount for services whether they are administered in a hospital or at a doctor's office. One recent estimate says it could save the federal government $100 billion, and also chill health care consolidation and its higher prices.
If Medicare were to pay less for a service, some patients would, too, if they don't have extra insurance coverage, as they now pay around 20% of the bill for outpatient services. Hospitals argue their higher costs for round-the-clock care to all comers merit higher payments. STAT's Rachel Cohrs rounds up the players involved, including lobbyists and health policy analysts, and their arguments. Read more.
Infectious disease
How hybrid immunity offers better protection against Covid-19
While we await word from FDA on spring Covid boosters (see above), some related news: Throughout the pandemic there have been hints that people who've recovered from Covid-19 infections and received Covid vaccination are better protected against the virus than people who've had just one or the other. A new paper in Science Translational Medicine exploring why this protection is superior connects hybrid immunity to distinct signatures in T cells and B memory cells.
Based on their longitudinal study involving 613 people, they say the combination of infection and vaccination increased spike-protein antibody responses and changed the spike-protein memory B cell pool in such a way that protection was better at mucosal sites — the nose, the lungs — where the virus is most likely to enter the body. The scientists say more work, including larger studies, will be needed to definitively prove that hybrid immunity boosts immune protection, but until then they recommend that unvaccinated people get their Covid shots after infection.
health
Opioids prescribed after childbirth do not harm breastfeeding infants, study finds
It's [can cut if too flippant: not exactly man bites dog, but it's] pretty rare that we can share reassuring news about opioids. In this case, it's a BMJ study looking at whether opioids after childbirth — most often following C-sections — harm infants by way of breast milk. Codeine, morphine, and other opioids are often given to control pain after surgery. They do pass into breast milk, but in amounts thought to be too low to cause problems in infants. The researchers set out to be sure, comparing more than 85,000 mothers who filled an opioid prescription in the week after delivery to similar mothers matched from more than 538,000 mothers who didn't.
In the infants' first 30 days of life, after accounting for the mother's age and underlying health, there was no difference between the groups in how many infants were admitted to a hospital for any reason, with an identical rate of 3.5%. "Opioids do not present a unique hazard for infants of breastfeeding mothers," a companion editorial asserts.
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