You may not have heard of BPC-157 — but maybe you have. The peptide, like many that have gained traction with MAHA, is having a moment. Popular podcasters, wellness clinics, and patients are gravitating to the chemical for relief from health conditions that aren’t always well-managed with traditional treatments. But there’s one problem: “The amount of hype to evidence is just so skewed, it’s crazy,” physician and researcher Flynn McGuire said. He put it even more bluntly in an email: BPC-157 “should not be used by humans.”
Too late. In a thorough write-up, Sara Talpos spoke with people who have taken the peptide. Some described benefits like helping the body heal more quickly and reducing pain. But others report side effects like full-body itchiness, intense anxiety, or anhedonia. Anecdotal evidence like this is some of the only data we have on what these drugs can do in humans.
Read more from Sara about how BPC-157 became a buzzy, mainstream MAHA supplement. As Talpos writes, the story begins in a laboratory in post-communist Croatia. We’re publishing this investigation by Undark, where Sara is a contributing editor.
startupsWhen is an AI doctor a medical device?Call it a sign of things to come. A startup called Doctronic made a splash recently when it announced the use AI to renew prescriptions without clinician input in the state of Utah. Something didn’t sit right with me about the announcement. Sure it got approval from Utah, but why isn’t it a medical device subject to Food and Drug Administration review? The company claimed it was “the practice of medicine” and so exempt from FDA authority. That didn’t seem entirely right either. So I did some asking around and after talking to over a dozen executives, legal scholars, and policy experts, it turns out the question is not nearly as clear-cut as Doctronic would have us believe. Indeed, it appears the company may be planning to market a medical device without authorization. In my story, I explain the law and why it all matters. Read more here regulationFDA wants long-term monitoring of autoimmune patients receiving CAR-TThe FDA is advising drug developers to study the long-term effects of using CAR-T to treat patients with autoimmune conditions, out of concern the therapies could cause cancer or fertility issues. The recommendations, published in an op-ed yesterday in the Annals of Internal Medicine, align with standards for genetic therapies and CAR-T for cancers. Interest among biotechs to study CAR-T as a treatment for lupus, myasthenia gravis, and other autoimmune conditions has exploded in recent years. While the FDA’s new guidance is expected, some experts fear it could be too onerous for some biotechs. Read more from STAT’s Allison DeAngelis. from AXIOS:
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