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In a new study in JAMA Oncology, researchers found an association between oral bacteria and head and neck squamous cell cancer. The bacteria didn’t cause the cancer, but indicated up to a 50% higher risk.
Totally unrelated: I’m going to put a plea out to my younger brother to please finally schedule his first dentist appointment since graduating college.
And now, the news — including a story about Pfizer’s shocking move to pull its sickle cell pill off the market.
FDA says it will step up on regulating food additives
Food additives rarely face scrutiny once they’re on the market, even those with mounting safety concerns. 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 get into food from packaging. The agency has neither proactively monitored the food additive safety, nor made prompt decisions banning additives once they’re found to be unsafe. (One additive, red dye No. 3, is still allowed in food despite the FDA’s 1990 pledge to halt its use after it was found to cause cancer in rats.)
Safety concerns often need to reach a boiling point for the agency to take action, said former FDA lawyer Stuart Pape, who now represents food companies. Complaints and petitions are like someone turning up the heat on the stove; “Meanwhile, FDA is in another part of the kitchen making a sandwich. They tend to not pay attention to these things until the water is bubbling all over the place,” he said. Read more.
On pandemic preparedness and Medicare reforms
STAT reporters talked to D.C. officials yesterday over 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:
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STAT’s Sarah Owermohle talked to Dawn O’Connell, the assistant secretary at the Administration of Strategic Preparedness and Response, about preparing for the next pandemic and Congress’ complaints that the agency has had a sluggish response to disease outbreaks. “We have to be nimble,” said O’Connell. “We get used to what we’ve just been through, and so we watch the front door while that thing that we’re not expecting slides in the window.” Read more.
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STAT’s Rachel Cohrs-Zhang talked to Sen. Maggie Hassan (D-N.H.) about how she’s pushing for “site neutral” reforms — changing Medicare payments to ensure the program pays the same amount for the same services, no matter where patients get care — and whether she’s willing to cut a deal with Republicans to do it. Read more.
If you feel like you missed out on 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, either virtually or live in Boston. STAT subscribers get 25% off a ticket, and first-time subscribers get a free year of STAT+ with their purchase of a ticket! I’ll be there; it will be so much fun.
Researchers find “pause button” in human development
In over 130 mammal species, including mice and sheep, embryos can pause their development to improve the chances of survival for both the embryo and the mother. This usually happens when the embryo is a blastocyst, right before it implants in the uterus.
Now, scientists have found evidence that humans may also be capable of hitting pause on development. Using blastoids — what 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 Cell were able to find a signaling pathway that induces a dormant embryo phase, much like other species can.
The new discovery has implications for in vitro fertilization. Though embryos implant better when they undergo faster development, being able to slow down growth may allow for a larger time window in which to assess embryo health and sync it with the mother for better implantation in the uterus, said Nicolas Rivron, an author on the paper.
Despite FDA approval, insurance doesn’t always cover gene therapy
Sarah Jenssen, 15, is one of the few girls who have Duchenne muscular dystrophy. Though she can still use the bathroom independently and dress herself, she has lately started relying on a wheelchair. Her family celebrated when the FDA threw open the gates on a gene therapy for the condition earlier this year, widening the approval for Sarepta’s Elevidys to nearly 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 first denied it because Sarah wasn’t able to walk independently anymore, even though that went against the FDA’s label. The issue is complicated: There’s limited data on the treatment’s efficacy for people who are older than 5 years old or use wheelchairs. But such patients also have few options.
“You spend all this time to get the FDA to approve it, and then you have to spend even more time with insurance companies to get them to approve it,” said Jonathan Soslow, one of Sarah’s doctors. Sarah and her family were relieved to hear the insurer 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 continuously choke on stuff (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 hacking and coughing like crazy.
Scientists knew that nerve sensors in the trachea and larynx in our throats helped detect objects that were not supposed to be there. But earlier this year, Laura Seeholzer, a postdoc at UC San Francisco, showed that special kinds of epithelial cells called neuroendocrine cells help those nerves by recognizing water and acid and triggering a coughing or swallowing response.
Seeholzer is this year’s recipient of the Eppendorf & Science Prize for Neurobiology, which recognizes outstanding young neurobiologists for their research and comes with $25,000.
ARPA-H grant goes to lab using 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’ lab 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 15 new, AI-generated preclinical antibiotic candidates by the end of the five-year project.
Phare Bio describes itself as a “social venture” rather than a drug development startup. Its plan to get antibiotics past the “valley of death” in early stage development where most drugs fail is to first use donor and grant funding, then turn to more traditional commercial partnerships and company spinouts to take the drugs through clinical development.
What we’re reading
- Picture imperfect: Scores of papers by prominent neuroscientist Eliezer Masliah fall under suspicion, Science
- 3D mammograms show benefits over 2D imaging, especially for dense breasts, NPR
- Two Nobel Prize winners want to cancel their own CRISPR patents in Europe, MIT Technology Review
- What Pfizer’s decision to pull 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 may be the key to getting a grip on the H5N1 bird flu outbreak, STAT