Breaking News

OTC birth control vote, 'pangenome' unveiling, & a pancreatic cancer vaccine

May 11, 2023
Reporter, Morning Rounds Writer
Good morning. Here's your chance: We want to know what you want to know about about ChatGPT and generative AI in science and medicine. Go here to ask STAT.

reproductive Health

FDA panel votes unanimously for over-the-counter birth control pill

Independent experts advising the FDA recommended yesterday that the agency should approve the first over-the-counter birth control pill, a significant step for a contraception method that's been prescribed for decades. Called Opill, it contains only progestin, a safer option than combining progestin and estrogen but one that's most effective when taken at the same time every day. And those with breast cancer or vaginal bleeding shouldn't take it.

Despite yesterday's 17-to-0 vote, FDA approval is not a sure thing. "The FDA has been put in a very difficult position of trying to determine whether it is likely that women will use this product safely and effectively at the nonprescription setting," FDA's Karen Murry said about a decision expected this summer. "FDA does realize how very important women's health is and how important it is to try to increase access to effective contraception." STAT's Ed Silverman has more.


health 

Patch for peanut allergy shows promise in toddlers

For parents of children with peanut allergies, there's little more than vigilance to protect the littlest ones from dangerous reactions. A new NEJM study adds what could be a potential treatment option for toddlers age 1 to 3: a skin patch that gradually exposes the children to escalating amounts of peanut protein to help them increase their tolerance. In the randomized clinical trial, two-thirds of the 307 toddlers with peanut allergies responded to treatment and could tolerate ingesting the equivalent of a few peanuts, compared to one-third of toddlers in the placebo arm.

French pharmaceutical company DBV Technologies, which makes the patch, has not submitted the patch to the FDA for approval. Last month the company said the FDA wanted an additional safety study to get the number of tested participants near 600. Currently an oral therapy for peanut allergy, Palforzia, is approved only for kids age 4 to 17. STAT's Brittany Trang has more.


cancer

Small study of personalized vaccines sparks hope for pancreatic cancer

For 60 years, a diagnosis of pancreatic cancer has meant a survival rate of just 12%. The advent of immunotherapies has meant little for these patients, whose cancers were considered too aggressive for personalized therapeutics. Now a small study shows success waking up immune cells another way: with personalized mRNA vaccines targeting mutations on the surface of the tumors. These vaccines, built in nine weeks after surgery to remove the patients' tumors, boosted T cell immune activity in half of the Phase 1 trial's patients, researchers reported yesterday in Nature.

Eight of 16 patients who received the vaccine and later medicinal therapies showed a strong immune response and no signs of relapse after 18 months. The eight who did not respond to the vaccine had relapsed after a median of 13.4 months. The scientists urge further research among more and more diverse patients than the white participants in their trial. 



Closer Look

Human 'pangenome' published in effort to better reflect global diversity

2653007441_b2cd09dd19_oShaury Nash/Flickr

In a landmark achievement meant to address shortcomings of its historical predecessor, scientists have published the first "pangenome," a reference work that better captures the genetic variability of humans around the world. More than 20 years ago the first human genome sequence was trumpeted as complete, but it really wasn't. Initially based on 11 individuals, it kept a European bias over the intervening years, limiting the value of genetic tests to those with that ancestry. There were also yawning gaps of never-sequenced "finicky, repeat-riddled sections of the human genome," STAT's Megan Molteni writes.

The new version, published yesterday in Nature, adds 119 million bases from the DNA of 47 people mostly from Africa, Asia, and the Americas. It could be many years more before the pangenome's benefits reach patients and families eager to solve their medical mysteries, but a new software tool could help in that translation. Read more.


addiction

There's a racial gap between those who need opioid treatment and those who get it

Buprenorphine is a key medication for treating opioid use disorder. But few of the people with opioid addiction get it, and those who can are disproportionately white, a new NEJM study says. White patients were prescribed buprenorphine at more than twice the rate of Black patients in the six months before an addiction-related health emergency, according to the analysis based. The treatment gap persisted in the six months after an overdose, hospitalization, or admission to a rehab facility.  

The study also found that naloxone, used to reverse opioid overdoses, was also prescribed to white patients at a higher rate than Black patients, as was naltrexone, a third medication used to help prevent opioid cravings while recovering from opioid addiction. Opioid overdose rates among Black people have been soaring. In 2020 they surpassed the death rate among white people for the first time in more than 20 years.  STAT's Lev Facher has more.

health

Ashish Jha on shifting out of the Covid emergency 

AshishJhaSTATUSList
STAT

The pandemic emergency may be over but the pandemic isn't, Ashish Jha (above), the White House Covid-19 response coordinator, said last night at dinner in Boston honoring the 2023 STATUS List. "I see this as a transition out of this emergency phase where we're going to have to deal with this virus. This virus is going to be around forever," he said.

Asked if we'll be better prepared for the next pandemic, he said yes. "We've done a lot of very good things in the last three years that I think are going to be long-lasting benefits."
But, "I've been surprised at how hard it has been to sort of galvanize the forces to do the things we know we can do to get Covid really under control." 

And a warning about unreliable sources of information: "I was caught off guard. ... Any pandemic preparedness plan for the future that does not account for the information ecosystems in which we all live ... if your plan doesn't deal with those things, it's not a serious plan." STAT's Ambar Castillo has more.


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • Insulin makers, PBMs echo old finger-pointing in Senate hearing, STAT
  • Google is training its generative AI to analyze medical images — and talk to doctors about them, STAT
  • The system that failed Jordan Neely, The New Yorker
  • How the FDA's pandemic flexibilities boosted mental health apps — and what happens now, STAT
  • Why aren't we better at predicting when a baby is due? Vox

Thanks for reading! More tomorrow,


Enjoying Morning Rounds? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2023, All Rights Reserved.

No comments