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Robert Califf: Clinical care should drive AI adoption
It’s day two of the FDA’s advisory committee meeting on regulating generative artificial intelligence tools. Day one, as you might expect, was extremely technical, but it kicked off with provocative remarks from commissioner Robert Califf.
FDA faces a difficult task in ensuring the safety and effectiveness of AI devices under its purview. While it’s a given that any product may perform differently in the real world than in clinical trials, this challenge is magnified in the case of AI, where data models underlying the tools can be continually updated. And where the data inputs flowing into tools can be influenced by the existence of the tools themselves, potentially impacting performance over time.
Califf said that clinical AI tools should be continuously reevaluated while in use to ensure that they are performing as intended. Though some systems for local validation and post-market surveillance exist, Califf suggests a new system for making larger pools of diverse data available for recurrent validation will be necessary.
“I have looked far and wide,” he said. “I do not believe there is a single health system in the United States that’s capable of validating an AI algorithm that’s put into place in a clinical care system.”
Elsewhere, Califf said that he’s heard from clinicians that the incentive to adopt tools is based largely on financial considerations rather than on benefits to patient care.
“Unless you take this issue very seriously and form alliances with those concerned about improving health outcomes, this technology will improve profits at the cost of continued deterioration in our overall health status.”
MedTwitter decamps for bluer skies
Following the election, there’s been a notable migration of prominent voices in medicine and science from Elon Musk’s X to Bluesky, a functionally similar social media platform. People moving to Bluesky say that scientific conversations and expertise once thrived on X but engagement has dropped since Musk bought the company about two years ago. While some have argued for the need to stay on the more prominent platform to spread truth and combat harmful misinformation in front of a larger audience, for many, Bluesky offers a substantive alternative. The company, which was founded by former Twitter CEO Jack Dorsey and launched in February 2023, recently crossed 20 million users.
As STAT’s Katie Palmer reports, X used to be the de facto place to go looking for public announcements from officials, institutions, and experts. What happens now that these voices are increasingly scattered across platforms?
Amazon won’t follow Hims into GLP-1s, yet
Amazon last week announced a micro-update to its pay-per-visit telehealth offering that sent Hims’ stock plummeting in a big way. The tech giant now offers what it calls “upfront” pricing that tells people seeking care for conditions like erectile dysfunction and hair loss how much their treatment will cost, including the cost of the drugs. This sounds a lot like competition for Hims’ core offerings.
But while simpler drugs remain a cash cow, Hims has garnered significant attention for offering compounded versions of GLP-1 drugs like Wegovy. It plans to continue marketing GLP-1s, even as the Food and Drug Administration removes the most popular drugs from its shortage list, making compounding legally dubious. Will Amazon follow?
I caught up with Amazon Health Services chief medical officer Sunita Mishra in New York this week who told me that the company does not dispense compounded GLP-1s through its pharmacy and that Amazon will not launch a standalone weight loss offering until it can do so “responsibly” and in a “thoughtful manner.” She said that compounded medications raise safety concerns and that weight management care should be more than just providing people with a drug.
Amazon’s dealing with a few tensions here. GLP-1s, unlike, say, ED pills, have tricky side effects and require behavioral change to work. In other words, patients seeking GLP-1s really require more elevated, longitudinal care than the transactional encounters offered by many telehealth providers. Mishra pointed out that the company offers weight loss treatment to people enrolled in a primary care subscription with One Medical.
As to the compounding question, Amazon has a pharmacy that fills prescriptions for branded GLP-1s — including fulfillment for Eli Lilly’s direct-to-consumer offering. It doesn’t need to offer compounded drugs to entice investors, so maybe it’s not worth it?
DEA grants telehealth extension — now what?
Last week, the Drug Enforcement Administration issued another extension allowing providers to continue writing prescriptions for opioid addiction and ADHD drugs over telemedicine for one more year, kicking rule-making to the future administration of Donald Trump.
During the pandemic, DEA allowed providers to prescribe controlled drugs like buprenorphine and Adderall without first examining a patient in person. This broke down barriers to access to addiction and other care and proved a boon to telehealth companies. But the DEA’s efforts to replace the exemptions with new rules has met with opposition from telemedicine advocates and other federal agencies who favor more lenient restrictions than the law enforcer.
I spoke to Nate Lacktman, a partner at Foley & Lardner who works with telehealth companies, about the new extension and the prospects for rules going forward. A few notes:
- The DEA only gave itself a year to get new rules in place, citing in part a desire to “avoid incentivizing the investment necessary to develop new telemedicine companies that might encourage or enable problematic prescribing practices.” That’s not a long time, and it would be unprecedented for DEA to propose and finalize a rule before the end of 2025. To get it done in that time frame, Lacktman advocates for a public-private work group that would develop rules. Lacktman said he’s optimistic.
- DEA administrator Anne Milgram is assumed to be stepping down, and it’s unclear how long it could take the incoming administration to replace her or how telehealth rulemaking priorities might change. Lacktman notes that in 2018, Trump signed the SUPPORT Act, directing DEA to hurry up and create a special registration process that allows approved clinicians to write prescriptions for controlled substances over telemedicine. Six years later that rule still isn’t in place. Will a DEA under a new Trump administration get it done?
Schrödinger: AI? Whatever.
Schrödinger is an unusual animal in the AI in drug discovery landscape. In a new interview with CEO Ramy Farid, STAT’s Brittany Trang explains the company’s business model that’s part software suite, part drug pipeline. Farid also offers his frank assessment of the buzzy field AI discovery field.
Specifically: He doesn’t like Schrödinger being called AI at all.
“Right now, in an era where it’s being overhyped and people are being deceitful — I mean, people are saying they’re doing AI and that they somehow solved the problem — it’s dishonest and it’s causing a problem,” he said. “Because when that fails — which it will — are we going to get sucked in with it because we were forced to call what we’re doing ‘AI’? That’s what we’re worried about.”
What we’re reading
- Google reacts angrily to report it will have to sell Chrome, BBC
- New details on a risky medical device show need for more FDA transparency, researchers say, STAT
- Ruth Health CEO announces business closure and offers insights to startups, MobiHealthNews
- AI-guided decisions can devastate lower-income Americans. This group wants to change that, STAT