A big problem for psychedelic medicine

The ideas and innovators shaping health care

Jun 05, 2024 View in browser   By Erin Schumaker, Ruth Reader, Carmen Paun and Daniel Payne THE LAB Most people who take a psychedelic drug know that they did. | AP An FDA advisory committee on Tuesday dealt a severe blow to drugmaker Lykos Therapeutics, finding that its proposed treatment for post-traumatic stress disorder, the psychedelic drug MDMA combined with therapy, is not effective. The decision also underscored a big problem for psychedelic medicine going forward: It’s basically impossible to conduct a double-blind trial involving the drugs. That’s the gold standard clinical trial in which half of patients receive the drug and the other half get a placebo and neither the participants nor the trial researchers are supposed to know who gets what. Why’s that? The mind-altering effects of psychedelic drugs are so pronounced that participants can usually figure out whether they received one. And, as the FDA advisers noted, people who know they received the drug may have an expectation bias toward its effectiveness. It's an issue that came up repeatedly during the advisers' meeting. Even so: Critics of MDMA therapy and of Lykos, including psychedelic researchers, expressed concern about alleged misconduct in Lykos' clinical trials, including that researchers may have pressured study subjects not to report negative effects. Lykos responds: In a statement after the advisory committee votes, CEO Amy Emerson said the firm was disappointed but “committed to continuing to collaborate with the FDA with their ongoing review.” She added that Lykos would work with the FDA to answer questions raised at the committee meeting. She said Lykos was in ongoing discussions with the FDA about a risk evaluation and mitigation strategy program that would seek to reduce the chance of adverse events stemming from its treatment.   THE GOLD STANDARD OF HEALTHCARE POLICY REPORTING & INTELLIGENCE: POLITICO has more than 500 journalists delivering unrivaled reporting and illuminating the policy and regulatory landscape for those who need to know what’s next. Throughout the election and the legislative and regulatory pushes that will follow, POLITICO Pro is indispensable to those who need to make informed decisions fast. The Pro platform dives deeper into critical and quickly evolving sectors and industries, like healthcare, equipping policymakers and those who shape legislation and regulation with essential news and intelligence from the world’s best politics and policy journalists. Our newsroom is deeper, more experienced and better sourced than any other. Our healthcare reporting team—including Alice Miranda Ollstein, Megan Messerly and Robert King—is embedded with the market-moving legislative committees and agencies in Washington and across states, delivering unparalleled coverage of health policy and the healthcare industry. We bring subscribers inside the conversations that determine policy outcomes and the future of industries, providing insight that cannot be found anywhere else. Get the premier news and policy intelligence service, SUBSCRIBE TO POLITICO PRO TODAY.     WELCOME TO FUTURE PULSE Moran, Wyo. | Shawn Zeller/POLITICO This is where we explore the ideas and innovators shaping health care. If you like to drink while flying, German researchers have bad news for you. Lab experiments showed that blood oxygen drops to worrisome levels and heart rates increase when people fall asleep after drinking alcohol in flight, due to the low air pressure typical of airplane cabins, NBC News reports. 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 or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. AROUND THE AGENCIES Schweikert wants to use the VA as an AI testing ground. | AP Photo The Department of Veterans Affairs, which provides health care to more than 9 million ex-servicemembers, is not typically on the cutting edge of technology. But that could be changing, our Ben Leonard reports. Rep. David Schweikert (R-Ariz.) got overwhelming bipartisan support for a pair of amendments he added to a spending bill for the agency on Wednesday to bolster its use of artificial intelligence. Schweikert said on the House floor that he hopes it could be a test of sorts before introducing the technology to other parts of the government. “Anything we can do to expedite VA claims efficiently and effectively is worthwhile," Rep. Debbie Wasserman Schultz (D-Fla.), ranking member of the Appropriations Military Construction-VA Subcommittee, said in response to Schweikert’s amendments. “We are likely at the nascent stage.” The details: The amendments would provide $1 million to help the agency use the technology to process claims and $10 million to study the benefits of using AI to tackle fraud and to improve oversight, data accuracy and financial management. The forecast: The spending bill passed along party lines, but the overwhelming bipartisan support for the amendments indicates they could make the cut when the House and Senate ultimately reconcile their respective versions. The agency’s current efforts: The VA earlier this year launched an AI strategy, and in line with President Joe Biden’s sweeping executive order on the technology from October, the agency launched a “comprehensive review” of its current work with AI and future opportunities. It hopes to develop public datasets for AI testing and to make "long-term investments" in AI research, as well as get involved in public-private partnerships. The agency has also launched an “AI Tech Sprint.”   JOIN US ON 6/13 FOR A TALK ON THE FUTURE OF HEALTH CARE: As Congress and the White House work to strengthen health care affordability and access, innovative technologies and treatments are increasingly important for patient health and lower costs. What barriers are appearing as new tech emerges? Is the Medicare payment process keeping up with new technologies and procedures? Join us on June 13 as POLITICO convenes a panel of lawmakers, officials and experts to discuss what policy solutions could expand access to innovative therapies and tech. REGISTER HERE.     TECH MAZE Klobuchar wants AI guardrails. | Francis Chung/POLITICO Experts from academia, think tanks and a national laboratory rhapsodized to Congress’ Joint Economic Committee on Tuesday about the ways AI could revolutionize the health care industry. “A lot of care could occur not just outside of the walls of a clinic, but even outside of seeing a clinician,” Brian Miller, a fellow at the right-leaning think tank American Enterprise Institute, said of AI’s power to transform the way care is delivered. The representatives and senators on the panel were most intrigued with the idea that AI could help cut health care costs — particularly for Medicare recipients. Why it matters: Both Democrats and Republicans are eager to pass legislation that will pave the way for AI advancement. Rep. David Schweikert (R-Ariz.) used the hearing to tout his bill, the Health Technology Act, which would allow AI to prescribe drugs. Even so: Lawmakers are also concerned about mitigating potential harms AI could cause and creating safeguards. “We’ve got to make sure we’ve got it right,” said Sen. Amy Klobuchar (D-Minn.).   Follow us on Twitter Carmen Paun @carmenpaun Daniel Payne @_daniel_payne Ruth Reader @RuthReader Erin Schumaker @erinlschumaker   Follow us

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