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Kimberly Beauregard was terrified of losing her reminiscence as she entered her 60s. When she saw ads for Prevagen just a few years ago, they impressed her. "Can a protein originally present in a jellyfish enhance your memory? " asks the voice-over in one commercial that used to air on prime-time Tv. "Our scientists say yes." The ad cuts from a swarm of the glowing blue sea creatures to scenes of individuals in white lab coats, smiling senior citizens, and a last assurance that Prevagen has been clinically shown to improve reminiscence. "It was enough to make me say this is nice, there’s going to be some benefit to it," Beauregard mentioned. She wasn’t alone in that religion. Three million persons are estimated to have bought Prevagen since it was first launched by Quincy Bioscience, a Wisconsin-based mostly manufacturer, in 2007. Sales reached $165 million by mid-2015, and the corporate claims Prevagen is now a "best-promoting branded reminiscence complement in chain drug shops throughout the United States." A month’s supply of the "extra strength" selection retails for about $60 at Walgreens, CVS, and Walmart.
Beauregard took Prevagen every single day for nine months, spending around $500 in all, but said she hadn’t seen any reminiscence improvement. Quincy Bioscience has been sued a number of times over allegations of false advertising for Prevagen, together with by the government. After hearing concerning the lawsuits, Beauregard says she felt like her worst nightmare-of dropping her reminiscences-had been exploited by Quincy. "They nearly performed on that worry, really, to become profitable," she mentioned. She’s not alone there, either. Well over half of American adults take supplements, however there are plenty of misconceptions about the trade and how it’s regulated. In a 2019 survey by Pew Charitable Trusts, greater than half the respondents believed that the Food and Drug Administration either checks supplements for security or should approve merchandise earlier than they are sold. Neither is true. Instead, the FDA largely depends on reporting by the companies and customers, in addition to its personal inspections, to identify potential problems once supplements are available on the market.
Commercials for Prevagen have insisted that "it’s safe and effective," an assurance Quincy echoed to regulators. But an investigation by WIRED now shows that for years officials at the FDA questioned the idea for the company’s claims. Multiple FDA inspections, most of which have not been reported before, discovered significant points with Quincy’s manufacturing processes, complaint handling, and the standard control testing that was supposed to ensure its merchandise have been safe. And hundreds of Americans have reported experiencing "adverse events" while taking Prevagen, together with seizures, strokes, heart arrhythmias, chest ache, and dizziness. While the existence of adversarial event reports alone don’t prove a product is the cause, the character and pattern of complaints about Prevagen worried FDA officials, in keeping with company records. Apart from a warning letter sent to Quincy in 2012, the FDA has not publicly indicated it had any concerns about Prevagen. The company determined in 2018 that Quincy addressed the violations cited in the warning letter.