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Presented by Arnold Ventures: The ideas and innovators shaping health care | | | | |  | | By Carmen Paun, Erin Schumaker and Daniel Payne | Presented by Arnold Ventures | | | | | |  Semaglutide, the active ingredient in new weight-loss drugs, is going for big bucks in Europe. | AFP via Getty Images | Tightly controlled access to weight-loss drugs Ozempic and Wegovy in Europe allows a black market to flourish, and drug regulators across the pond aren’t coordinating to squelch it. That’s what POLITICO’s Ashleigh Furlong and Helen Collis found in examining the continent’s response. Why it matters: POLITICO found numerous online sites in Europe purporting to offer the weight-loss drugs’ active ingredient, semaglutide, at prices of as much as several hundred dollars for a week’s supply. One site, based in the U.K., even shows users how to combine two ingredients to make it. State of play: Europe’s drugs regulator, which ensures medicines in the bloc are safe and effective, said it has no responsibility for fake injections mailed to European citizens from fraudulent online pharmacies and labs. The European Medicines Agency told POLITICO that “dealing with falsified or counterfeit medicines is a matter for law enforcement.” Drugs regulators in Germany, Italy and France passed the buck, too: — German officials said their regulatory agency doesn’t have a role in stopping illegal online sales because that’s a job for the police and customs authorities. — Italian officials directed POLITICO to the World Health Organization’s falsified medical products officer. — French officials shared an update on the misuse of Ozempic by patients who do not meet the criteria to use the drug. Law enforcement: A spokesperson at Europol told POLITICO the EU’s cops are aware of the black market and “targeting the trafficking of such illegal substances,” but the agency couldn’t say more.
| | | | A message from Arnold Ventures: Same service, same price. You should be charged the same price when you receive the same medical service, no matter where you get it. But today, patients, employers, and taxpayers are charged billions because big hospital systems are buying up small physician practices. And when the logo on the door changes, you pay over 14% more for the same routine services. It's time to make site-neutral health care a reality. Learn more. | | | | | | | 
Shepherdstown, W.Va. | Shawn Zeller | | This is where we explore the ideas and innovators shaping health care. The tongue is a "check-engine light for the body," the Harvard Health Letter asserts in a new primer on tongue health. The report has advice for how to identify ailments that affect the tongue, such as thrush, canker sores, scarlet fever and black hairy tongue. Share any thoughts, news, tips and feedback with Carmen Paun at cpaun@politico.com, Daniel Payne at dpayne@politico.com, Evan Peng at epeng@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 Alice Miranda Ollstein talks with Carmen about how former President George W. Bush and other Republicans are working to convince anti-abortion groups and conservatives to support reauthorizing the global HIV/AIDS program PEPFAR.
| | | | | | | A message from Arnold Ventures:   | | | | | | | JOIN 9/19 FOR A TALK ON BUILDING THE NEW AMERICAN ECONOMY: The United States is undergoing a generational economic transformation, with a renewed bipartisan emphasis on manufacturing. Join POLITICO on Sept. 19th for high-level conversations that examine the progress and chart the next steps in preserving America’s economic preeminence, driving innovation and protecting jobs. REGISTER HERE. | | | | | | | | | 
Pig kidneys could help alleviate a shortage in the organ bank. | Charlie Neibergall/AP Photo | The longest documented case of a pig kidney functioning in a human ended Wednesday, when a team at the NYU Langone Transplant Institute removed the organ from the body of a man who’d been kept alive on a ventilator to study the transplantation. The brain-dead patient was removed from ventilation after two months of study. “We have learned a great deal throughout these past two months of close observation and analysis, and there is great reason to be hopeful for the future,” Dr. Robert Montgomery, the transplant surgeon who led the study, said in a statement. Why it matters: If researchers can make pig kidneys work in humans, that could help ease an organ shortage that’s left nearly 90,000 people waiting for a kidney transplant as of January. Montgomery’s team first reported a month ago that it had modified the pig kidney so the man’s body wouldn’t reject it and the organ would manage the important tasks of a human kidney. What’s next? The research team will pore over the data and conduct additional tests to determine cellular and molecular changes that might help doctors manage transplants in future studies and perhaps one day in living humans.
| | | | A message from Arnold Ventures: When hospitals consolidate, prices go up, and everyone loses. As big hospitals are gaming the system, patients and taxpayers are paying the price. Site-neutral payment policies would put an end to hospital consolidation, and protect Americans from more than $140 billion in overpayments every year. It’s no wonder that 85% of voters from both sides support site-neutral policy solutions. Now, Congress has the opportunity to protect patients and save taxpayer dollars. It’s time to put patients before profits and enact site-neutral health care. Learn more. | | | | | | | JOIN US ON 9/20 FOR A TALK ON TRANSFORMING HEALTHCARE BILLING: Bipartisan legislation in the House and Senate would align costs for services across hospitals and doctors’ offices and reduce out-of-pocket spending that could potentially save the federal government billions of dollars. Can this legislation survive a polarized Congress? Join POLITICO on Sept. 20 to explore this and whether site-neutral payments and billing transparency policies could help ease health care costs. REGISTER HERE. | | | | | | | | |  A new drug may offer hope to those suffering from post-traumatic stress disorder. | Getty Images | MDMA, the psychedelic drug more commonly known as ecstasy, is one step closer to becoming an approved treatment for post-traumatic stress disorder. The California-based Multidisciplinary Association for Psychedelic Studies has completed the final clinical trial it needs to apply for approval from the Food and Drug Administration. Patients who had moderate to severe PTSD were divided into two groups. Over the course of three treatment sessions, one group received MDMA-assisted psychotherapy, or MDMA-AT. The second group received a combination of talk therapy and a placebo for three sessions. MAPS published its results Thursday in the journal Nature Medicine. What do they say? Eighty-seven percent of patients who received MDMA-AT saw their symptoms meaningfully improve. And 71 percent of that group improved so much that they no longer met the criteria for a PTSD diagnosis. By comparison, 48 percent of the group that received talk therapy and a placebo improved to the point of no longer meeting the criteria for PTSD. Participants were more racially diverse than those who took part in an earlier study in 2021, with 34 percent of those in the latest group identifying as nonwhite. The backstory: The FDA and Congress are pushing for more study of psychedelics’ potential to treat mental illnesses that now afflict more than a quarter of Americans, as Erin and Katherine Ellen Foley reported last month. What’s next? MAPS has said it plans to file for regulatory approval of MDMA by the end of the year, which could put it on track to get the FDA’s endorsement as a treatment for PTSD in 2024. | | | | Follow us on Twitter | | | | Follow us | | | | |  |
