Califf cautions against adopting AI for financial reasons

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Robert Califf: Medical care ought to drive AI adoption

It’s day two of the FDA’s advisory committee assembly on regulating generative synthetic intelligence instruments. Day one, as you may anticipate, was extraordinarily technical, but it surely kicked off with provocative remarks from commissioner Robert Califf.

FDA faces a tough activity in making certain the security and effectiveness of AI gadgets underneath its purview. Whereas it’s a on condition that any product could carry out otherwise in the actual world than in scientific trials, this problem is magnified within the case of AI, the place knowledge fashions underlying the instruments will be regularly up to date. And the place the info inputs flowing into instruments will be influenced by the existence of the instruments themselves, doubtlessly impacting efficiency over time.

Califf mentioned that scientific AI instruments needs to be constantly reevaluated whereas in use to make sure that they’re performing as meant. Although some programs for native validation and post-market surveillance exist, Califf suggests a brand new system for making bigger swimming pools of numerous knowledge obtainable for recurrent validation will probably be obligatory.

“I’ve regarded far and large,” he mentioned. “I don’t consider there’s a single well being system in the US that’s able to validating an AI algorithm that’s put into place in a scientific care system.”

Elsewhere, Califf mentioned that he’s heard from clinicians that the motivation to undertake instruments is predicated largely on monetary concerns slightly than on advantages to affected person care.

“Until you are taking this situation very significantly and type alliances with these involved about bettering well being outcomes, this expertise will enhance earnings at the price of continued deterioration in our general well being standing.”

MedTwitter decamps for bluer skies

Following the election, there’s been a notable migration of outstanding voices in drugs and science from Elon Musk’s X to Bluesky, a functionally comparable social media platform. Folks transferring to Bluesky say that scientific conversations and experience as soon as thrived on X however engagement has dropped since Musk purchased the corporate about two years in the past. Whereas some have argued for the necessity to keep on the extra outstanding platform to unfold reality and fight dangerous misinformation in entrance of a bigger viewers, for a lot of, Bluesky gives a substantive different. The corporate, which was based by former Twitter CEO Jack Dorsey and launched in February 2023, not too long ago crossed 20 million customers.

As STAT’s Katie Palmer reviews, X was once the de facto place to go on the lookout for public bulletins from officers, establishments, and consultants. What occurs now that these voices are more and more scattered throughout platforms?

Learn extra right here

Amazon received’t comply with Hims into GLP-1s, but

Amazon final week introduced a micro-update to its pay-per-visit telehealth providing that despatched Hims’ inventory plummeting in a giant manner. The tech big now gives what it calls “upfront” pricing that tells folks searching for look after situations like erectile dysfunction and hair loss how a lot their therapy will price, together with the price of the medication. This sounds quite a bit like competitors for Hims’ core choices.

However whereas easier medication stay a money cow, Hims has garnered important consideration for providing compounded variations of GLP-1 medication like Wegovy. It plans to proceed advertising and marketing GLP-1s, even because the Meals and Drug Administration removes the most well-liked medication from its scarcity record, making compounding legally doubtful. Will Amazon comply with?

I caught up with Amazon Well being Companies chief medical officer Sunita Mishra in New York this week who instructed me that the corporate doesn’t dispense compounded GLP-1s by way of its pharmacy and that Amazon won’t launch a standalone weight reduction providing till it may possibly achieve this “responsibly” and in a “considerate method.” She mentioned that compounded drugs increase security considerations and that weight administration care needs to be extra than simply offering folks with a drug.

Amazon’s coping with a number of tensions right here. GLP-1s, in contrast to, say, ED tablets,  have tough unintended effects and require behavioral change to work. In different phrases, sufferers searching for GLP-1s actually require extra elevated, longitudinal care than the transactional encounters supplied by many telehealth suppliers. Mishra identified that the corporate gives weight reduction therapy to folks enrolled in a main care subscription with One Medical.

As to the compounding query, Amazon has a pharmacy that fills prescriptions for branded GLP-1s — together with success for Eli Lilly’s direct-to-consumer providing. It doesn’t want to supply compounded medication to entice buyers, so perhaps it’s not value it?

DEA grants telehealth extension — now what?

Final week, the Drug Enforcement Administration issued one other extension permitting suppliers to proceed writing prescriptions for opioid habit and ADHD medication over telemedicine for yet another 12 months, kicking rule-making to the long run administration of Donald Trump.

Through the pandemic, DEA allowed suppliers to prescribe managed medication like buprenorphine and Adderall with out first analyzing a affected person in particular person. This broke down limitations to entry to habit and different care and proved a boon to telehealth corporations. However the DEA’s efforts to interchange the exemptions with new guidelines has met with opposition from telemedicine advocates and different federal companies who favor extra lenient restrictions than the legislation enforcer.

I spoke to Nate Lacktman, a companion at Foley & Lardner who works with telehealth corporations, concerning the new extension and the prospects for guidelines going ahead. A number of notes:

The DEA solely gave itself a 12 months to get new guidelines in place, citing partly a want to “keep away from incentivizing the funding essential to develop new telemedicine corporations which may encourage or allow problematic prescribing practices.” That’s not a very long time, and it might be unprecedented for DEA to suggest and finalize a rule earlier than the tip of 2025. To get it achieved in that timeframe, Lacktman advocates for a public-private work group that may develop guidelines. Lacktman mentioned he’s optimistic.
DEA administrator Anne Milgram is assumed to be stepping down, and it’s unclear how lengthy it may take the incoming administration to interchange her or how telehealth rulemaking priorities may change. Lacktman notes that in 2018, Trump signed the SUPPORT Act, directing DEA to rush up and create a particular registration course of that permits accredited clinicians to write down prescriptions for managed substances over telemedicine. Six years later that rule nonetheless isn’t in place. Will a DEA underneath a brand new Trump administration get it achieved?

Schrödinger: AI? No matter.

Schrödinger is an uncommon animal within the AI in drug discovery panorama. In a brand new interview with CEO Ramy Farid, STAT’s Brittany Trang explains the corporate’s enterprise mannequin that’s half software program suite, half drug pipeline. Farid additionally gives his frank evaluation of the buzzy discipline AI discovery discipline.

Particularly: He doesn’t like Schrödinger being referred to as AI in any respect.

“Proper now, in an period the place it’s being overhyped and individuals are being deceitful — I imply, individuals are saying they’re doing AI and that they someway solved the issue — it’s dishonest and it’s inflicting an issue,” he mentioned. “As a result of when that fails — which it’s going to — are we going to get sucked in with it as a result of we had been compelled to name what we’re doing ‘AI’? That’s what we’re apprehensive about.”

Learn extra of Farid’s takes, plus a dive on how Schrödinger makes use of computational physics and machine studying, right here

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