How fentanyl is making it harder to start addiction treatment and what's next for OTC naloxone

The country’s drug epidemic killed nearly 108,000 Americans last year, but there’s yet another layer to the crisis. Even as fentanyl sends overdose deaths soaring, it also threatens to make buprenorphine, the world’s most-prescribed addiction drug, inaccessible to the increasing number of patients who need it. Fentanyl appears more likely than other opioids to cause severe withdrawal symptoms for patients put on one of just two medications used to treat opioid use disorder. “It’s the clinical challenge of my career,” Sarah Kawasaki, an addiction doctor and psychiatry professor at Pennsylvania State University, told STAT’s Lev Facher.

Separately, the FDA yesterday issued a "preliminary assessment" that naloxone, the medication used to reverse opioid overdoses, could be safely made available over the counter. Though the announcement doesn't change the status quo, it represents a significant step forward for naloxone access and follows years of calls from overdose-prevention advocates who say naloxone's price and inaccessibility cost thousands of lives each year.

‘I welcome oversight’: Fauci on his pandemic response and political scrutiny

After decades of being viewed as a nonpartisan expert whose counsel was sought by policymakers from both parties, Anthony Fauci conceded yesterday it’s been strange to watch himself become a lightning rod on the political trail, with some Republican candidates arguing he should be imprisoned. But he insisted he had not changed or become political himself.

“Because others choose to drive me into the political arena, does not mean I am in the political arena in what I do, what I think, what I say, what I advise,” Fauci told STAT’s Helen Branswell in a virtual interview at the STAT Summit in Boston. And he’s willing to go to the mat to justify the government’s pandemic response and viral research. “I welcome oversight,” Fauci said. “I have nothing to hide and I can defend everything we’ve done.” Read more from STAT’s Andrew Joseph.

Also at the Summit: Covid and the holidays, gene editing, and the impact of Dobbs

Perfection may be too high a bar in gene editing, science may not be all that polarized, and there may not be a winter Covid surge, speakers at the STAT Summit said yesterday. But the full impact of the Dobbs decision on reproductive health may not yet be known.

Ashish Jha on the holidays and Covid: “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments … there really should be no restrictions on people’s activities. I’m pretty much living life the way I was living life in 2019.”

Chelsea Clinton on the Dobbs decision on abortion: "If I could convey one thing, it’s that until we codify abortion rights at a federal level, abortion is on the ballot in every election."

Biochemist David Liu on the risks of off-target effects in gene editing: “It’s important to realize that there will probably never be a perfectly specific gene-editing agent, just as there has never been a perfectly specific drug that we’ve ever put into a human that only does exactly what we want.”

President Biden’s deputy science adviser Alondra Nelson on science being bipartisan: “Historic legislation like the CHIPS and Science Act, you don’t get without bipartisan buy-in.”

Closer look: Inching closer to the holy grail of male birth control

(MARIA FABRIZIO FOR STAT)

The jokes were almost telling themselves. After a male birth control study ended early, headline writers made hay from men’s troubling side effects after taking experimental contraceptives (“Men Back Out of Male Birth Control Study Because They Couldn’t Handle the ‘Changes in Mood’”). That 2016 study dashed nascent hopes of industry collaboration and the money devoted to research. But now, STAT contributor Eleanor Cummins reports, researchers think they are closer than ever to delivering on the holy grail of hormonal male birth control, with promising — if early — evidence of a contraceptive gel called NES/T and more products in the pipeline.

While female contraceptives also have side effects, “that’s a devil they know,” John Amory, a physician at the University of Washington Medical Center, said of drugmakers. “There’s no precedent for male contraceptives.” A handful of small companies are plowing ahead anyway. Read more.

Amazon leaps into direct-to-consumer telehealth

True to its e-commerce roots, Amazon is jumping into the world of direct-to-consumer telehealth. The tech goliath launched a virtual health storefront yesterday, one you can access through the main Amazon website and its mobile app to message teleproviders and obtain prescriptions for about 20 health conditions. Those conditions include low-hanging fruit like hair loss, acne, and other “lifestyle medications” that require little medical history and no physical examination. The model is comparable to direct-to-consumer telehealth companies like Hims, Ro, and Lemonaid, acquired by 23andMe late last year.

There are limitations to the Amazon Clinic model, initially launching in 32 states. Like some other direct-to-consumer companies, it will not accept insurance for provider visits. And patients may also be hesitant to turn over their sensitive data to a tech giant. STAT’s Katie Palmer explains.

Vaccines aside, mRNA still has a delivery problem

The success of Covid vaccines has been inspiring and indisputable, bringing protection to billions of people who’ve gotten the shots. But delivering mRNA-based medicines to more specific targets in the body — say, tumor cells — has been less straightforward. Many approaches depend on chemical tweaks to lipid nanoparticles, fatty balls that encase and shield fragile mRNA from destructive enzymes that would otherwise chop them up before they could be absorbed by cells. A few companies are taking a different tack.

One is called translation: engineering mRNA to produce protein in certain cells wherever the molecule ends up in the body. Another is also using translation focusing on how messenger RNA attaches to ribosomes, the tiny protein-producing factories inside cells. STAT’s Jonathan Wosen has more, in a story adapted from a new STAT Report on the future of mRNA.

What to read around the web today

Europe faces ‘cancer epidemic’ after estimated 1m cases missed during Covid, The Guardian
Do you really want to read what your doctor writes about you? The Atlantic
Hospital systems Sanford, Fairview plan to create $14 billion Midwest powerhouse, STAT
FDA developing plan to guard against bacteria outbreaks in baby formula, Wall Street Journal
Walmart agrees to pay $3.1 billion in latest settlement stemming from the opioid crisis, STAT