FDA on the safety of food additives

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In a new study in JAMA Oncologyresearchers found a link between oral bacteria and squamous cell cancer in the head and neck region. The bacteria did not cause the cancer, but indicated an up to 50% higher risk.

Completely unrelated: I’m going to make a plea to my younger brother to finally schedule his first dental appointment since graduating college.

And now the news – including a story about Pfizer’s shocking move to withdraw its sickle cell pill from the market.

The FDA says it will intensify regulation of food additives

Food additives are rarely scrutinized once they hit the market, even as safety concerns mount. At a Food and Drug Administration meeting on Wednesday, regulators said they plan to change that, STAT’s Lizzy Lawrence tells us.

Food additives include dyes, preservatives and chemicals that enter food through packaging. The agency has not proactively monitored the safety of food additives or made quick decisions to ban additives once they are found to be unsafe. (One additive, Red Dye No. 3, is still allowed in food, despite the FDA’s 1990 promise to discontinue its use after it was found to cause cancer in rats.)

Safety concerns often have to reach a boiling point before the agency can take action, said former FDA attorney Stuart Pape, who now represents food companies. Complaints and petitions are like someone turning up the heat; “Meanwhile, the FDA is in another part of the kitchen making a sandwich. They tend not to pay attention to these things until the water is bubbling in all directions,” he said. Read more.

On pandemic preparedness and Medicare reform

STAT reporters spoke with DC officials yesterday about bagels and “breakfast salad” in front of a live audience. (What is breakfast salad? “Honestly, breakfast salad is no different than salad salad. There were some thinly sliced ​​radishes and quartered hard-boiled eggs,” STAT’s John Wilkerson told me.)

Some highlights:

• STAT’s Sarah Owermohle spoke with Dawn O’Connell, the deputy secretary of the Administration of Strategic Preparedness and Response, about preparing for the next pandemic and Congress’ complaints that the agency has been slow to respond to disease outbreaks. “We have to be agile,” O’Connell said. “We get used to what we just experienced and so we look at the front door as that thing we don’t expect slides through the window.” Read more.

• STAT’s Rachel Cohrs-Zhang spoke with Sen. Maggie Hassan (D-N.H.) about how she’s pushing for “site-neutral” reforms — changing Medicare payments to ensure that the program pays the same amount for the same services regardless where patients receive care – and whether she is willing to make a deal with Republicans for that. Read more.

If you feel like you’ve been missing cool live convos between STAT reporters and movers and shakers in the health world, don’t forget to sign up for next month’s flagship STAT Summit, virtually or live in Boston. STAT subscribers get a 25% discount on a ticket, and new subscribers get a year of free STAT+ when purchasing a ticket! I’ll be there; it will be so much fun.

Researchers find ‘pause button’ in human development

In more than 130 mammal species, including mice and sheep, embryos can pause their development to increase the chances of survival of both the embryo and the mother. This usually happens when the embryo is a blastocyst, just before it implants in the uterus.

Now scientists have found evidence that humans may also be able to interrupt development. Using blastoids – which STAT’s Megan Molteni explained to us last year is a ball of 100 to 200 stem cells that mimic an embryo – researchers in a new study published in Cel were able to find a signaling pathway that induces a dormant embryo stage, just as other species can.

The new discovery has implications for in vitro fertilization. Although embryos implant better when they undergo faster development, the fact that they can slow growth allows for a greater window in which the health of the embryo can be assessed and synchronized with the mother for better implantation in the uterus, says Nicolas Rivron, an author of the study. paper.

Despite FDA approval, insurance does not always cover gene therapy

Sarah Jenssen, 15, is one of the few girls with Duchenne muscular dystrophy. Although she can still go to the toilet and dress herself independently, she has recently become dependent on a wheelchair. Her family celebrated when the FDA opened the gates to a gene therapy for the condition earlier this year, expanding approval for Sarepta’s Elevidys to almost everyone, regardless of age or disease progression.

But getting insurance to pay for Sarah’s $3.2 million gene therapy hasn’t been easy. The family’s insurer initially denied this because Sarah could no longer walk independently, even though that was against the FDA label. The issue is complicated: there is limited data on the effectiveness of the treatment in people who are older than 5 years or use wheelchairs. But such patients also have few options.

“You spend all this time getting the FDA to approve it, and then you have to spend even more time with insurance companies to get them to approve it,” says Jonathan Soslow, one of Sarah’s doctors. Sarah and her family were relieved to hear that the insurer had recently agreed to cover the therapy. Read more from STAT’s Andrew Joseph.

Have you ever almost choked on food? You have these cells to thank for your survival

You never really think about how miraculous it is that we don’t choke on things all the time (why do our air tube and our food tube share an entrance?) until you get some water down the wrong pipe or inhale a clump of rice and start choking like crazy coughing and coughing.

Scientists knew that nerve sensors in the trachea and larynx in our throat helped detect objects that weren’t supposed to be there. But earlier this year, Laura Seeholzer, a postdoc at UC San Francisco, showed that special types of epithelial cells called neuroendocrine cells help those nerves by recognizing water and acid and inducing a cough or swallowing response.

Seeholzer is this year’s recipient of the Eppendorf & Science Prize for Neurobiologywhich recognizes outstanding young neurobiologists for their research and awards $25,000.

ARPA-H grant goes to lab that uses AI to discover new antibiotics

The latest grant from the Advanced Research Projects Agency for Health, also known as ARPA-H, is for AI-powered antibiotics.

The agency announced yesterday that it is awarding a $27 million grant to Phare Bio and Jim Collins’ laboratory at MIT/Harvard’s Wyss Institute. (The lab was recently profiled in a New Yorker article). Using AI, the team plans to develop new classes of antibiotics and also create an open-source database for AI-based antibiotic discovery so that other scientists can use the information the team generates along the way. The goal is to have fifteen new AI-generated preclinical antibiotic candidates by the end of the five-year project.

Phare Bio describes itself as a ‘social enterprise’ and not as a drug development startup. The plan to get antibiotics past the “valley of death” at early stages of development, where most drugs fail, is to first use donor and grant funding and then turn to more traditional commercial partnerships and corporate spinouts to push the drugs through the guide clinical development.

What we read

• Image imperfect: dozens of articles by prominent neuroscientist Eliezer Masliah are suspected Science
• 3D mammograms show advantages over 2D imaging, especially in dense breasts. NPR
• Two Nobel Prize winners want to revoke their own CRISPR patents in Europe MIT Technology Review
• What Pfizer’s decision to discontinue its sickle cell drug means for patients, the company and the FDA, STAT
• Paralyzed jockey loses ability to walk after manufacturer refuses to fix battery for his $100,000 exoskeleton 404 Media
• Sequencing wastewater material could be key to getting to grips with H5N1 bird flu outbreak, STAT