| | | | |  | | By Erin Schumaker, Toni Odejimi, Daniel Payne and Ruth Reader | | | | | 
Next up in the psychedelic revolution: magic mushrooms | John Moore/Getty Images | | | “The FDA’s decision on Lykos Therapeutics’ MDMA-assisted therapy does not change the reality for patients who urgently need and deserve better treatment options for serious mental illnesses.” Chris Williams, chief communications officer at Compass Pathways | | Don’t count out magic mushrooms. That’s the message from British biotech company Compass Pathways, which is evaluating ‘shrooms, or psilocybin, alongside psychological support, for treatment-resistant depression. Approval of the regimen by the FDA could render the agency’s decision last week to reject a different treatment protocol for post-traumatic stress disorder involving the drug MDMA a mere setback in the psychedelic revolution. The FDA’s decision on MDMA isn’t affecting Compass' Phase 3 trials, according to Chris Williams, Compass' chief communications officer. "Robust monitoring and rigorous standards are at the core of our programs at Compass and we believe that generating clear and compelling clinical evidence is the best way to bring new medicines to patients as quickly as possible," Williams said in a statement. Even so: The FDA’s rejection of Lykos Therapeutics’ MDMA application has cast a pall on the burgeoning psychedelic medicine movement. While Lykos can reapply after conducting another late-stage study, doing so would be expensive and could take years. The journal Psychopharmacology’s decision this weekend to retract three MDMA-assisted therapy papers by Lykos' nonprofit arm, citing unethical conduct, has created further doubt. (Lykos told Erin it disagrees with the retraction, believes corrections to the papers should have sufficed, and that the retracted data was not what the company submitted to the FDA.) Compass, which developed and patented its own synthetic psilocybin, is taking a more business-first approach than Lykos, which drew skepticism from FDA advisers and outside analysts for its researchers’ missionary zeal.
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Dragsviki, Norway | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. Hitting the bong daily, for years — in contrast to the occasional toke — could lead to an increased risk of head and throat cancers, according to a new study. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Ruth Reader at rreader@politico.com, Erin Schumaker at eschumaker@politico.com, or Toni Odejimi at aodejimi@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. | | |  An encouraging text can help vapers quit, a study found. | AP | Quitting vaping is easier for teens if they receive encouraging text messages, according to a study in JAMA Network Open by the Truth Initiative, an anti-tobacco nonprofit. How’s that? The study examined over 1,600 teens, ages 13-17, who wanted to quit vaping from October 2021 to October 2023, with some receiving messages touting the health benefits of quitting, warning of tobacco’s health risks, and offering advice on mindfulness and coping skills. Those who received the messages were 35 percent more likely to quit vaping compared with teens who did not receive them. The text messages were part of the Truth Initiative’s “This is Quitting” program. The study ran for seven months, with all the groups getting monthly check-ins about their quitting progress. What’s next? Amanda Graham, chief health officer at the Truth Initiative and a study co-author, told Toni the group plans to continue promoting the text messages and has rolled it into a broader initiative with the Mayo Clinic.
| | | | DON’T MISS OUR AI & TECH SUMMIT: Join POLITICO’s AI & Tech Summit for exclusive interviews and conversations with senior tech leaders, lawmakers, officials and stakeholders about where the rising energy around global competition — and the sense of potential around AI and restoring American tech knowhow — is driving tech policy and investment. REGISTER HERE. | | | | | | | | |  That AI may work on this head, but not another. | AFP via Getty Images | Advanced artificial intelligence that works well in one part of the health system may not work in another, researchers have found. Rama Chellappa, interim co-director of the Data Science and AI Institute at Johns Hopkins University, says that “domain shift” could prove a significant issue for AI in health care, especially as companies look to scale their systems. Health systems taking on new systems will need to calibrate the AI tools for their particular circumstances — and keep a record of the changes that were made, Suchi Saria, a Johns Hopkins professor of computer science, said. That principle remains true for different populations: an AI system that works well for one group of patients may fail another. Some researchers say the technology’s abilities have advanced faster than their abilities to audit it, though quality assurance measures are improving. “We are getting better at detecting it,” Chellappa said of bias in AI. Why it matters: Systems that perform differently in different environments complicate efforts to regulate the tech as it’s being deployed. Some experts say any effort to vet AI tools will need to account for that. A hospital, for example, will need to preview how a system would work on its patients. | | | | Follow us on Twitter | | | | Follow us | | | | |
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