Why we’re not prepared for the next wave of biotech innovation

(mike reddy for STAT)

It’s easy to lose sight of all that science has achieved in recent years: gene therapies, CRISPR treatments, and Covid vaccines, for starters. It’s why STAT’s Matthew Herper, like some others, says that we’re living in “biology’s century,” having lived through a 20th century dominated by achievements in physics. But what if we’re not ready?

That’s the concern at the heart of Matt’s tour-de-force story this morning, which lays out the ways in which a terrifying dearth of clinical evidence and a logical system to assess discoveries are scuttling our own progress, wasting money, and costing us opportunities to save lives. Matt’s analogy: We’re fine-tuning the Ferrari while the road is turning to mud. The sportscar is medicine — from obesity drugs to CAR-T — and the road is evidence to support them. Clinical trials, real-world evidence, and the U.K. approach to amassing data all come in for critiques. Read more here. Subscribers can join a conversation with Matt at 11 a.m. ET Monday here.

Weight-loss drug had dramatic effect in adolescents with obesity, study finds

In a relatively small, short trial, a weight-loss medicine in high demand for adults led to dramatic effects for adolescents diagnosed with obesity, a result likely to widen its use while reigniting debate over treating body weight as a disease. Semaglutide led to a 17% reduction in BMI compared to placebo in a study of about 200 adolescents aged 12 to 18. On average, those on semaglutide lost 34 pounds, or 15% of their body weight, over the 68-week study, out in NEJM yesterday. Those on placebo gained an average of 5 pounds, or 3% of their baseline weight.

The drug stimulates the hormone GLP-1, which helps produce insulin and reduce blood sugar. Its side effects, including nausea and rarely gallstones, need further scrutiny, but these early results suggest semaglutide could be a powerful tool for adolescents unable to lose weight through diet and exercise. STAT’s Damian Garde has more.

Monkeypox might spread before symptoms show

People infected with monkeypox may be able to transmit the virus to others before they notice symptoms, a new British study says, which could explain many infections in the current international outbreak. The analysis, published yesterday in BMJ, relied on data from 2,746 people infected in the U.K. from May 6 to Aug. 1. As many as 53% of transmission events could have occurred before the person transmitting the virus developed symptoms, the researchers conclude.

While some experts have pushed back on that figure, Esther Freeman of Harvard Medical School said pre-symptomatic transmission at that level or less points to a need for vaccination policies. “We know that there could be some pre-symptomatic or pre-people-noticing-their-symptoms transmission,” she told STAT’s Helen Branswell. “The way to handle this is to not wait till people know they've been exposed to be vaccinated but to have pre-exposure vaccination.” Read more.

Closer look: When telehealth startups offer ketamine to eager patients, experts worry

(COLE BURSTON/AFP via Getty Images)

With rules loosened by the realities of pandemic precautions, telehealth has bloomed. So, too, have at least a dozen companies that recently started prescribing ketamine online. Typically, federal law requires an in-person exam before a patient can get a controlled substance like ketamine online for treatment-resistant major depression. But now startups like Peak, Mindbloom, Nue Life, and Wondermed are offering to prescribe and deliver generic ketamine lozenges, eliminating trips to clinics for infusions of the drug.

As STAT’s Katie Palmer reports, ketamine is being pitched to treat not just depression or anxiety, but lesser issues like “stress,” “feeling lost,” and “bad habits.” That worries experts. “They're doing something that's dangerous and unproven,” Michael Banov, a psychiatrist who provides IV ketamine in his Georgia clinic, told Katie. “And it's really trivializing the use of ketamine.” Read more.

There's an opioid overdose crisis, but not everyone agrees on expanding methadone access

Methadone is one of just three medications approved in the U.S. to treat opioid use disorder. And it works: One 2018 study showed patients receiving it were 59% less likely to die of an overdose than those not getting the medication. So amid an overdose crisis, it seems like expanding access to the addiction treatment would be wise. Currently, methadone can be prescribed only within an opioid treatment program requiring patients to have frequent drug tests, attend counseling, show they’ve experienced opioid addiction for a year, and show up to a clinic each day for one dose.

But providers have a warning, STAT’s Lev Facher tells us: Be careful what you wish for. Allowing doctors to prescribe it directly to patients could backfire, they argue, by leading to an increase in low-quality care or even overdoses on methadone itself. Read why.

Psilocybin’s effect on depression not as long-lasting in larger trial

There’s been plenty of hype around psychedelic therapy, but research is catching up. Yesterday's results from the largest study of psilocybin were published in NEJM, and they’re mixed. While the Phase 2 clinical trial concluded the drug reduced or eliminated symptoms of treatment-resistant depression in more than one-third of patients on the highest dose, the effects didn’t last as long as in earlier, smaller studies. Any response is promising, but the durability was disappointing, Jimmy Potash of Johns Hopkins, who was not involved in the study, told STAT’s Olivia Goldhill.

Psilocybin is given alongside intensive therapy, making it difficult to disentangle the impact of therapists versus the drug. It’s also hard to standardize the treatment outside of a carefully supervised trial. “When you scale up and create sites all over the world, it’s hard to have the same quality of therapeutic experience,” said Potash. Read more.

What to read around the web today

Why daylight saving time is worse for your body than standard time, Washington Post
When it comes to caring for underserved patients, health tech is still figuring out what success looks like, STAT
CVS, Walgreens announce opioid settlements totaling $10B, Associated Press
Physicians rally to avert Medicare payment cuts, STAT
I froze my eggs. Now I’m in the middle of the abortion fight, Boston Globe
Medicare punts on quality rules for new type of rural hospital, STAT