Califf warns against adopting AI for financial reasons

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Robert Califf: Clinical care must drive AI adoption

FDA’s second day advisory board meeting On organizing productive AI tools. Day one was extremely technical, as you might expect, but it started with provocative statements from commissioner Robert Califf.

The FDA faces a difficult task in ensuring the safety and effectiveness of AI devices under its jurisdiction. While it is certain that any product may perform differently in the real world from clinical trials, this challenge is even greater when it comes to artificial intelligence, where the data models underlying the tools can be constantly updated. Situations where data inputs flowing into vehicles may be affected by the presence of the vehicles, potentially affecting performance over time.

Clinical AI tools need to be continually re-evaluated during use to ensure they are performing as intended, Califf said. Although some systems exist for local verification and post-market surveillance, Califf suggests that a new system will be required to make larger pools of diverse data available for repeated verification.

“I looked too far,” he said. “I do not believe there is a single healthcare system in the United States that can validate an AI algorithm implemented in a clinical care system.”

Elsewhere, Califf said he has heard from clinicians that the incentive to adopt the tools is largely based on financial considerations rather than benefits to patient care.

“Unless you take this issue very seriously and build alliances with those concerned about improving health outcomes, this technology will increase profits at the expense of the continued deterioration of our overall health.”

MedTwitter is leaving for bluer skies

Following the election, there was a notable shift in prominent voices in the medical and scientific world from Elon Musk’s X to Bluesky, a functionally similar social media platform. People who moved to Bluesky say scientific talks and expertise once thrived at X, but attendance has fallen since Musk bought the company nearly two years ago. While some argue for the need to remain on a more prominent platform to spread the truth and combat harmful misinformation before a wider audience, for many, Bluesky offers an important alternative. Founded by former Twitter CEO Jack Dorsey and launched in February 2023, the company recently reached 20 million users.

Like STAT’s Katie Palmer reportsX was the de facto place to go to get public announcements from authorities, institutions and experts. What happens now that these voices are increasingly dispersed across platforms?

Amazon won’t follow Hims on GLP-1s yet

Amazon last week announced a micro update to its pay-per-visit telehealth offering, sending shares of Hims falling at great speed. The tech giant now offers “prepaid” pricing that tells people seeking care for conditions like erectile dysfunction and hair loss how much their treatment will cost, including the cost of medications. This sounds a lot like the competition for Hims’ core offerings.

But Hims’ earnings soared as simpler drugs continued to be a source of cash important attention Because it offers compounded versions of GLP-1 drugs like Wegovy. It plans to continue marketing GLP-1s even if the Food and Drug Administration removes the most popular drugs from its deficiency list, making compounding legally questionable. Will Amazon follow?

I met with Sunita Mishra, Amazon’s chief medical officer, in New York this week, and she told me that the company does not distribute compounded GLP-1s through its pharmacy and that Amazon won’t launch a standalone weight-loss offering until it does so “responsibly.” and “in a thoughtful way.” He said compounded drugs raise safety concerns and that weight management care needs to be more than just providing people with medications.

Amazon is dealing with a few tensions here. GLP-1s, unlike ED pills, for example, have misleading side effects and require behavior modification to work. In other words, patients seeking GLP-1s truly require a higher level of long-term care than the transactional encounters offered by many telehealth providers. The company offers weight loss treatment to people enrolled in a primary care subscription with One Medical, Mishra said.

As for the compounding question, Amazon has a pharmacy that fills branded GLP-1 prescriptions — including fulfilling prescriptions from Eli Lilly direct-to-consumer offer. It doesn’t need to offer compounding drugs to attract investors, so it might not be worth it?

DEA expands telehealth coverage – now what?

Last week, the Drug Enforcement Administration announced another extension handed rule-making authority to Donald Trump’s future administration by allowing providers to continue writing prescriptions for opioid addiction and ADHD medications instead of telemedicine for another year.

During the pandemic, the DEA allowed providers to prescribe controlled drugs like buprenorphine and Adderall without first examining a patient in person. This has eliminated barriers to accessing addiction and other care services and has been a boon for telehealth companies. But DEA efforts to replace exemptions with new rules faced opposition from telemedicine advocates and other federal agencies that favor softer restrictions than law enforcement.

I spoke with Nate Lacktman, a partner at Foley & Lardner who works with telehealth companies, about the new expansion and the rules’ prospects moving forward. A few notes:

The DEA gave itself just one year to enact the new rules, citing in part a desire to “avoid encouraging investments necessary to develop new telemedicine companies that could encourage or enable problematic prescribing practices.” That’s not a very long time, and it would be unprecedented for the DEA to propose and finalize a rule before the end of 2025. Lacktman is advocating for a public-private working group that would develop rules so that this could be done within that time frame. Lacktman said he is optimistic.
RIA manager Anne Milgram It is assumed he will leave office, and it is unclear how long it will take for the incoming administration to replace him or how telehealth rulemaking priorities might change. Lacktman notes that Trump signed the SUPPORT Act in 2018, which directed the DEA to rush and create a special registration process that would allow approved clinicians to write prescriptions for controlled substances via telemedicine. Six years later, this rule is still not in effect. Will the DEA under the new Trump administration be able to achieve this?

Schrödinger: Artificial intelligence? Anyway.

Schrödinger is an unusual animal in artificial intelligence in the field of drug discovery. One New interview with CEO Ramy FaridSTAT’s Brittany Trang explains the company’s business model, which is part software suite, part drug pipeline. Farid also offers his candid assessment of the popular AI discovery space.

Specifically: Schrödinger doesn’t like being called artificial intelligence at all.

“Right now, in an age where this is overhyped and people are deceitful — meaning people are saying they’re building AI and they’re somehow solving the problem — it’s dishonesty and it’s causing the problem,” he said. “Because when that fails—and it will—are we going to get carried away because we have to call what we’re doing ‘AI’? That’s what we’re worried about.”

You can find more from Farid here, as well as more information about how Schrödinger uses computational physics and machine learning.

What are we reading

Reacted angrily when Google announced it would have to sell Chrome, BBC
New details about a risky medical device show the FDA needs more transparency, researchers say: STATISTICS
Ruth Health CEO announces business closure and offers insights into startups, MobiSağlıkNews
AI-driven decisions could devastate low-income Americans. This group wants to change that, STATISTICS