Psychedelics oversight just got stricter

The ideas and innovators shaping health care

Jun 26, 2023 View in browser   By Erin Schumaker, Ben Leonard and Evan Peng THE REGULATORS Psychedelics therapy is the new frontier in treating depression. | AFP via Getty Images Growing interest in psychedelics’ potential as treatments for conditions like depression and post-traumatic stress and substance-use disorders has prompted the Food and Drug Administration to set some guardrails. On Friday, the agency released draft guidance for researchers designing clinical trials for the drugs. The breakdown: The bulk of the new guidance details basic considerations for researchers during the drug development process, including: — Trial conduct — Data collection — Study-participant safety — New drug application requirements “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” Tiffany Farchione, director of the division of psychiatry at the FDA’s Center for Drug Evaluation and Research, said in a statement. Safety warning: The guidance also highlights the potential risks of psychedelic treatments, given that the drugs can produce mood and cognitive changes and hallucinations. Many psychedelics are Schedule I controlled substances that the Drug Enforcement Administration also regulates to prevent misuse. Researchers should collect data about the drugs’ abuse potential during development, according to the guidance. “Should a psychedelic drug that is a Schedule I controlled substance receive FDA approval as a drug product, the abuse potential assessment would assist in determining an appropriate rescheduling action under the Controlled Substances Act,” the guidance says. What’s next: The public has 60 days to submit comments to the FDA.   LISTEN TO POLITICO'S ENERGY PODCAST: Check out our daily five-minute brief on the latest energy and environmental politics and policy news. Don't miss out on the must-know stories, candid insights, and analysis from POLITICO's energy team. Listen today.     WELCOME TO FUTURE PULSE Höfn, Iceland | Evan Peng This is where we explore the ideas and innovators shaping health care. Death is tough to take, and not just for humans. Fruit flies exposed to their dead age faster and ultimately die younger, according to a study by researchers from the University of Michigan, Ann Arbor. Share any thoughts, news, tips and feedback with Ben Leonard at bleonard@politico.com, Ruth Reader at rreader@politico.com, Carmen Paun at cpaun@politico.com or Erin Schumaker at eschumaker@politico.com. Send tips securely through SecureDrop, Signal, Telegram or WhatsApp. Today on our Pulse Check podcast, host Kelly Hooper talks to Daniel Payne about his reporting on House Republicans' desire to reform Medicare’s oft-criticized payment system and why prospects for legislation this year are slim. Listen to today’s Pulse Check podcast TECH MAZE AI is seen by some as a burnout-fighting tool. | AFP via Getty Images Technology firm Leidos, which provides support to every federal agency focused on health, says it’s bullish on artificial intelligence. The Virginia-based firm says it uses generative AI — the kind that can respond to questions and generate content — within its health group to make workflows more efficient. Ron Keesing, senior vice president for technology integration at the firm, said that Leidos deploys the technology to aid its staff in triaging tasks. “We’re able to direct people and connect people to the right clinicians far more effectively by having humans and AI work together,” Keesing told Ben. Why it matters: Leidos sees opportunities to use the technology to serve its clients, like the Veterans Health Administration, the Centers for Disease Control and Prevention and the Food and Drug Administration, Keesing said. Burnout is an issue for health care workers, and a number of tech firms are deploying technology to help doctors manage their inboxes so they can focus more on patients and less on administrative tasks. What’s next? Keesing sees building trust as crucial to expanding AI use. It’s the biggest barrier, he says, because many providers aren’t sure whether AI will help them with their jobs — or take them.   SUBSCRIBE TO POWER SWITCH: The energy landscape is profoundly transforming. Power Switch is a daily newsletter that unlocks the most important stories driving the energy sector and the political forces shaping critical decisions about your energy future, from production to storage, distribution to consumption. Don’t miss out on Power Switch, your guide to the politics of energy transformation in America and around the world. SUBSCRIBE TODAY.     CHECKUP Infertility is a temporary condition for some women who've undergone in vitro fertilization. | Rogelio V. Solis/AP Photo Getting pregnant naturally after in vitro fertilization isn’t all that unusual, new research suggests. In a meta-analysis published Tuesday in the journal Human Reproduction, 1 in 5 women who needed fertility treatment like IVF to conceive their first child became pregnant naturally within three years. Researchers analyzed 11 international studies conducted between 1980 and 2021 that included data on more than 5,000 women. What’s going on? The researchers are aware of a few theories, according to lead study author Annette Thwaites, an academic clinical fellow at the Institute for Women’s Health at the University College London: — Ovarian stimulation from IVF may improve ovarian function — Pregnancy-related hormonal changes — Reduced stress Big picture: Thwaites believes the 1 in 5 statistic may be an undercount. A fast-growing group of people use IVF for reasons other than fertility, she said, such as same-sex couples, surrogates and people screening for genetic conditions. More accurate statistics about the chance of natural pregnancy after fertility treatment could allow women to make informed choices about family planning and future fertility treatment, the study authors note. Even so: The meta-analysis had limitations, including the difficulty of comparing studies from different countries of varying quality. Additionally, studies didn’t consider factors like contraception use, change in partner or natural serial pregnancies in the same woman. Linked national datasets could help improve the estimate’s accuracy and better identify trends over time, according to the study authors. DANGER ZONE Amazon will unveil a new telehealth service next month. | Michael Sohn/AP Photo Amazon is delaying the launch of a major expansion of its Amazon Clinic telemedicine service due to lawmakers’ concerns about its privacy practices that Ben reported first in Future Pulse. According to an email from a person with direct knowledge that Ben subsequently obtained, Amazon will delay its promotional campaign for three weeks, until July 19. Currently, Amazon Clinic is available in 33 states and leans on so-called asynchronous care, meaning patients fill out a form to get care for conditions like urinary tract infections, acid reflux and pink eye, as well as emergency contraception and birth control. Amazon had planned to announce a 50-state launch of synchronous care — via live video — on Tuesday. An Amazon spokesperson denied there was any “delay as a result of an external inquiry.”   Follow us on Twitter Ben Leonard @_BenLeonard_ Ruth Reader @RuthReader Carmen Paun @carmenpaun Erin Schumaker @erinlschumaker   Follow us

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA Please click here and follow the steps to unsubscribe.