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FDA on food additive safety

September 28, 2024
in Health
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Get your day by day dose of well being and drugs each weekday with STAT’s free publication Morning Rounds. Join right here.

In a brand new examine in JAMA Oncology, researchers discovered an affiliation between oral micro organism and head and neck squamous cell most cancers. The micro organism didn’t trigger the most cancers, however indicated as much as a 50% increased threat.

Completely unrelated: I’m going to place a plea out to my youthful brother to please lastly schedule his first dentist appointment since graduating school.

And now, the information — together with a narrative about Pfizer’s stunning transfer to drag its sickle cell capsule off the market.

FDA says it would step up on regulating meals components

Meals components not often face scrutiny as soon as they’re in the marketplace, even these with mounting security issues. At a Meals and Drug Administration assembly on Wednesday, regulators mentioned they plan to vary that, STAT’s Lizzy Lawrence tells us.

Meals components embrace dyes, preservatives, and chemical substances that get into meals from packaging. The company has neither proactively monitored the meals additive security, nor made immediate choices banning components as soon as they’re discovered to be unsafe. (One additive, crimson dye No. 3, remains to be allowed in meals regardless of the FDA’s 1990 pledge to halt its use after it was discovered to trigger most cancers in rats.)

Security issues usually want to succeed in a boiling level for the company to take motion, mentioned former FDA lawyer Stuart Pape, who now represents meals firms. Complaints and petitions are like somebody turning up the warmth on the range; “In the meantime, FDA is in one other a part of the kitchen making a sandwich. They have a tendency to not take note of these items till the water is effervescent in all places,” he mentioned. Learn extra.

On pandemic preparedness and Medicare reforms

STAT reporters talked to D.C. officers yesterday over bagels and “breakfast salad” in entrance of a reside viewers. (What’s breakfast salad? “Actually, breakfast salad is not any completely different than salad salad. There have been some thinly sliced radishes and quartered hard-boiled eggs,” STAT’s John Wilkerson instructed me.)

Some highlights:

STAT’s Sarah Owermohle talked to Daybreak O’Connell, the assistant secretary on the Administration of Strategic Preparedness and Response, about getting ready for the following pandemic and Congress’ complaints that the company has had a sluggish response to illness outbreaks. “We’ve got to be nimble,” mentioned O’Connell. “We get used to what we’ve simply been by, and so we watch the entrance door whereas that factor that we’re not anticipating slides within the window.” Learn extra.

STAT’s Rachel Cohrs-Zhang talked to Sen. Maggie Hassan (D-N.H.) about how she’s pushing for “web site impartial” reforms — altering Medicare funds to make sure this system pays the identical quantity for a similar providers, irrespective of the place sufferers get care — and whether or not she’s prepared to chop a cope with Republicans to do it. Learn extra.

In case you really feel such as you missed out on cool reside convos between STAT reporters and movers and shakers within the well being world, don’t neglect to join subsequent month’s flagship STAT Summit, both just about or reside in Boston. STAT subscribers get 25% off a ticket, and first-time subscribers get a free 12 months of STAT+ with their buy of a ticket! I’ll be there; it is going to be a lot enjoyable.

Researchers discover “pause button” in human improvement

In over 130 mammal species, together with mice and sheep, embryos can pause their improvement to enhance the possibilities of survival for each the embryo and the mom. This normally occurs when the embryo is a blastocyst, proper earlier than it implants within the uterus.

Now, scientists have discovered proof that people may be able to hitting pause on improvement. Utilizing blastoids — what STAT’s Megan Molteni defined to us final 12 months is a ball of 100 to 200 stem cells that mimic an embryo — researchers in a brand new examine revealed in Cell had been capable of finding a signaling pathway that induces a dormant embryo part, very like different species can.

The brand new discovery has implications for in vitro fertilization. Although embryos implant higher once they bear sooner improvement, with the ability to decelerate progress might enable for a bigger time window wherein to evaluate embryo well being and sync it with the mom for higher implantation within the uterus, mentioned Nicolas Rivron, an creator on the paper.

Regardless of FDA approval, insurance coverage doesn’t all the time cowl gene remedy

Sarah Jenssen, 15, is among the few ladies who’ve Duchenne muscular dystrophy. Although she will be able to nonetheless use the lavatory independently and costume herself, she has currently began counting on a wheelchair. Her household celebrated when the FDA threw open the gates on a gene remedy for the situation earlier this 12 months, widening the approval for Sarepta’s Elevidys to just about everybody no matter age or illness development.

However getting insurance coverage to pay for Sarah’s $3.2 million gene remedy hasn’t been simple. The household’s insurer first denied it as a result of Sarah wasn’t in a position to stroll independently anymore, despite the fact that that went towards the FDA’s label. The difficulty is difficult: There’s restricted information on the remedy’s efficacy for people who find themselves older than 5 years previous or use wheelchairs. However such sufferers even have few choices.

“You spend all this time to get the FDA to approve it, after which it’s a must to spend much more time with insurance coverage firms to get them to approve it,” mentioned Jonathan Soslow, one in all Sarah’s docs. Sarah and her household had been relieved to listen to the insurer just lately agreed to cowl the remedy. Learn extra from STAT’s Andrew Joseph.

Have you ever ever virtually choked on meals? You’ve these cells to thank to your survival

You by no means actually take into consideration how miraculous it’s that we don’t repeatedly choke on stuff (why do our air tube and our meals tube share an entrance??) till you get some water down the fallacious pipe or inhale a clump of rice and begin hacking and coughing like loopy.

Scientists knew that nerve sensors within the trachea and larynx in our throats helped detect objects that weren’t presupposed to be there. However earlier this 12 months, Laura Seeholzer, a postdoc at UC San Francisco, confirmed that particular sorts of epithelial cells referred to as neuroendocrine cells assist these nerves by recognizing water and acid and triggering a coughing or swallowing response.

Seeholzer is that this 12 months’s recipient of the Eppendorf & Science Prize for Neurobiology, which acknowledges excellent younger neurobiologists for his or her analysis and comes with $25,000.

ARPA-H grant goes to lab utilizing AI to find new antibiotics

The newest grant from the Superior Analysis Initiatives Company for Well being, also called ARPA-H, is for AI-powered antibiotics.

The company introduced yesterday that it’s awarding a $27 million grant to Phare Bio and Jim Collins’ lab at MIT/Harvard’s Wyss Institute. (The lab was just lately profiled in a New Yorker article). Utilizing AI, the group plans to develop new courses of antibiotics and in addition create an open-source database for AI-based antibiotic discovery in order that different scientists can use the data the group generates alongside the best way. The purpose is to have 15 new, AI-generated preclinical antibiotic candidates by the top of the five-year mission.

Phare Bio describes itself as a “social enterprise” fairly than a drug improvement startup. Its plan to get antibiotics previous the “valley of demise” in early stage improvement the place most medication fail is to first use donor and grant funding, then flip to extra conventional business partnerships and firm spinouts to take the medication by medical improvement.

What we’re studying

Image imperfect: Scores of papers by distinguished neuroscientist Eliezer Masliah fall underneath suspicion, Science
3D mammograms present advantages over 2D imaging, particularly for dense breasts, NPR
Two Nobel Prize winners wish to cancel their very own CRISPR patents in Europe, MIT Expertise Assessment
What Pfizer’s resolution to drag its sickle cell drug means for sufferers, the corporate, and the FDA, STAT
Paralyzed jockey loses capability to stroll after producer refuses to repair battery for his $100,000 exoskeleton, 404 Media
Sequencing wastewater materials will be the key to getting a grip on the H5N1 chicken flu outbreak, STAT



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