The New York Attorney General and the Federal Trade Commission (FTC) have filed a lawsuit against the makers of Prevagen, alleging that there is no evidence the pill enhances memory or prevents memory loss.
The complaint (PDF) was filed by the FTC and New York AG Eric T. Schneiderman in the U.S. District Court for the Southern District of New York on January 9, naming Quincy Bioscience, Prevagen Inc., as well as certain executives within the companies as defendants.
The Prevagen lawsuit claims that the dietary supplement, which can cost up to $69 per bottle, is being marketed through false and misleading advertising. Schneiderman and the FTC say that the manufacturers claim it is “clinically shown” to improve memory, yet say there is no such scientific evidence.
Claims that Prevagen and its active ingredient, the protein apoaequorin, can “improve memory within 90 days” and supports “clearer thinking” are based off of one lone study that failed to show a statistically significant difference over a placebo, according to the lawsuit.
“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country,” Schneiderman said in a press release. “It’s particularly unacceptable that this company has targeted vulnerable citizens like seniors in its advertising for a product that costs more than a week’s groceries, but provides none of the health benefits that it claims.”
Prevagen went on sale in 2007 and is sold at pharmacies nationwide, including CVS, Walgreens, Rite-Aid and through Amazon. The lawsuit estimates that Prevagen sales totaled $165 million from 2007 through mid-2015.
The lawsuit details print ads, television commercials and other marketing techniques used by the makers of the dietary supplement, which New York and the FTC say were intentionally misleading.
“Defendants’ claims that their product improves memory and cognition rely on the theory that the product’s dietary protein, apoaequorin, enters the human brain to supplement endogenous proteins that are lost during the natural process of aging. Defendants developed their product and created their marketing campaign based on this theory,” the lawsuit states. “Defendants, however, do not have studies showing that orally-administered apoaequorin can cross the human blood brain barrier and therefore do not have evidence that apoaequorin enters the human brain. To the contrary, Defendants’ safety studies show that apoaequorin is rapidly digested in the stomach and broken down into amino acids and small peptides like any other dietary protein.”
At issue is the Madison Memory Study, which involved 218 subjects who took either 10 milligrams of Prevagen or a placebo, and were assessed on nine computerized cognitive tasks. According to the lawsuit, the results failed to show a statistically significant improvement over the use of a placebo on any of those tasks.
The lawsuit indicates that upon failing to get results, the researchers “conducted more than 30 post hoc analyses” trying to find subgroups in each of the nine tasks that could be used to show some improvement. Even then, they failed to find statistically significant memory improvements without taking very isolated subgroups’ results, the lawsuit states.
The complaint seeks to ban future false claims involving Prevagen and calls for disgorgement of ill-gotten gains and civil penalties for violating New York consumer protection laws.