| | | | |  | | By Erin Schumaker, Daniel Payne, Carmen Paun and Ruth Reader | | | | |  Interest in psychedelics as a treatment for mental health conditions is growing. | AP | The Food and Drug Administration has accepted Lykos Therapeutics’ new drug application for psychedelic-assisted therapy, teeing up 2024 as a potentially transformative year for psychedelic medicine. The FDA granted the application priority review, meaning the agency will review it over six months instead of the standard 10-month timeline. The agency set a target date of Aug. 11 to decide whether to approve the application. Lykos’ application is for talk therapy combined with MDMA, commonly called ecstasy, as a treatment for post-traumatic stress disorder. The company, formerly known as the MAPS Public Benefit Corp., rebranded last month. MAPS’ research arm has studied MDMA as a PTSD treatment for more than 30 years. Its application marks the first time the FDA has considered approving a psychedelic-assisted therapy. Why it matters: PTSD, which often occurs alongside other mental health problems like addiction, depression and anxiety, is difficult to treat. “We’re grateful to those in Washington, D.C., who are working overtime to pave the way” for the treatment’s approval, Juliana Mercer, a Marine Corps veteran and director of veteran advocacy and public policy at the advocacy group Healing Breakthrough, said in a statement. “The federal government is putting skin in the game after decades of philanthropically-funded private research.” About 5 percent of Americans have PTSD in any given year, according to the Department of Veterans Affairs. Veterans, especially those who have deployed, are more likely than civilians to have PTSD. Both male and female veterans with PTSD are at a higher risk for suicide than veterans without the condition. What’s next? The August target date isn’t the end of the line. Should the FDA approve Lykos’ application, the Drug Enforcement Administration must reschedule MDMA before doctors can prescribe it. For now, MDMA remains a Schedule I drug, the highest category under the Controlled Substances Act, classified by the DEA as having no acceptable use as a treatment and posing high risk for abuse.
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Vail, Colo. | Shawn Zeller/POLITICO | This is where we explore the ideas and innovators shaping health care. What do the Quechua people of Peru and Tibetans in the Himalayas have in common? Yes, they live at high altitudes, and mutations in the same gene allow them to do that, Science 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.
| | |  Doctors who treat cancer patients say their burdens are growing. | Getty Images | Oncologists are worried about the future of cancer care. Practices are squeezed by staffing shortages and payment issues, doctors told Daniel at a Community Oncology Alliance roundtable with reporters. Decreasing payments from Medicare are causing some practices to close, they said. Meanwhile, paperwork keeps growing, adding another stressor. The doctors see a future where they can’t keep up with the number of patients who need care because they don’t have the staff to do so. Why it matters: In some cases, that prospect has already become the present. Cancer diagnoses are on the rise and projected to climb further in coming years. What’s next? Congress has shown interest in trying to help, but there’s no consensus on how. In the meantime, doctors are changing care. They've placed new emphasis on team-based care, which empowers nurse practitioners and physician assistants to handle more responsibilities, allowing doctors to focus on tasks only they can perform. The oncologists also lean on technology, deploying apps on patients’ phones to track their symptoms and software to help keep up with the socio-economic burdens patients face. And they said they hoped AI could soon reduce their administrative burdens. Even so: “It’s like putting a little Band-Aid on a mole that’s basically melanoma,” Ted Okon, executive director of the Community Oncology Alliance, said of the mitigations. “We need to do something radical here, and the problem, unfortunately … is Congress is not really good right now at doing radical things.”
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The AI revolution is real, a company fueling it says. | Noreen Nasir/AP Photo | Doctors are increasingly turning to AI for real-world diagnoses. For proof, consider Regard, a company that makes an AI co-pilot for docs. Its software, over a few years, has achieved more than 2 million diagnoses — and is probably just months away from 3 million, according to company co-founder and CEO, Eli Ben-Joseph. Why it matters: There’s growing interest among health providers in AI systems, especially as tools to reduce administrative burdens and improve patient outcomes. “A lot of the health systems really saw the value of what we were bringing last year and are expanding with us,” Ben-Joseph told Daniel. “We’re going to ... triple or quadruple the number of users that we have on the product by June.” AI systems can “learn” without much intervention, but that doesn’t always work in health care, where trust and traceability are important, Ben-Joseph said. Regard manually rolls out system updates — which are based on doctors’ feedback — to ensure humans can review them before they’re implemented. What’s next? Regard is making significant investments in bridging the gap between doctors and AI by bringing physicians into the process of building predictive systems. | | | | Follow us on Twitter | | | | Follow us | | | | |
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