| Would you eat 800 pounds of jellyfish every day to try to improve your memory? That's the idea behind Prevagen. The dietary supplement's main ingredient is a synthetic copy of a jellyfish protein, grown entirely in a lab. As its manufacturer informed the Food and Drug Administration in 2007, one capsule "would be the equivalent of 400–800 lbs of raw jellyfish consumed." This week on Backchannel, investigative reporter Chiara Eisner dove into the history of Prevagen and its manufacturer, Quincy Bioscience, a Wisconsin-based startup that turned an idea about jellyfish into a multimillion-dollar business whose products appear on retail shelves and in prime-time ads nationwide. For most of that time, largely unbeknownst to consumers, the company was under investigation. Based on interviews and hundreds of pages of FDA documents, many never reported before, Eisner reconstructs a years-long dance between Quincy and US regulators over what exactly Prevagen was, what the supplement claimed to do, and whether it was safe for people to take. As thousands of Americans reported experiencing health issues while taking Prevagen—including seizures, strokes, heart arrhythmias, chest pain, and dizziness—FDA officials grew alarmed. "These are not typical complaints associated with supplements," one investigator told Quincy after an inspection in 2015. "The serious nature and quantity of complaints raises questions about the safety of the product." The FDA also repeatedly faulted the company's procedures for investigating and reporting complaints, as required by law, in addition to its manufacturing and quality control practices. Quincy insists that Prevagen "has been thoroughly tested" and "is generally recognized as safe." In 2018, the FDA issued the company a close-out letter, its way of saying a firm has corrected violations. But lawmakers, consumer safety advocates, and even agency officials say broader issues remain with how the supplement industry is regulated, leaving millions of Americans at risk. Caitlin Kelly | Senior Editor, WIRED |
WordPress.com
