Health Letter, March 2017
By Michael Carome, M.D.
If you regularly watch nightly national news on TV, you have probably seen ads for the dietary supplement apoaequorin (Prevagen). One ad opens with video of beautiful blue jellyfish and asks, “Can a protein originally found in jellyfish improve your memory?” The ad announcer continues:
“Our scientists say yes! Researchers have discovered a protein that actually supports healthier brain function. It’s the breakthrough in a supplement called Prevagen. As we age, we lose proteins that support our brain. Prevagen supplements these proteins, and has been clinically shown to improve memory. It’s safe and effective. For support of healthier brain function, a sharper mind and clearer thinking, try Prevagen for yourself today.”
If these ads sound suspect, it’s because they are: The claims in the ads are too good to be true.
Fortunately, the ads caught the attention of federal regulators and state authorities, and in January, the Federal Trade Commission (FTC) and the New York state attorney general together filed a lawsuit against Wisconsin-based Quincy Bioscience, the maker of Prevagen, and it co-founders, Mark Underwood and Michael Beaman.
The FTC and New York Attorney General Eric Schneiderman charged the company with false advertising promoting the memory and cognitive benefits of Prevagen. The FTC alleged that the following claims, among others, made by the makers of Prevagen are false:
- Prevagen is clinically shown to improve memory in 90 days.
- Prevagen is clinically shown to reduce memory problems associated with aging.
- Prevagen is clinically shown to provide other cognitive benefits, including but not limited to, healthy brain function, a sharper mind, and clearer thinking.
Invalid scientific evidence
Quincy Bioscience primarily relied on a single randomized study to support the claims that Prevagen is clinically proven to improve memory. The study, known as the Madison Memory Study, involved 218 subjects, ages 40 to 91, taking either Prevagen or placebo capsules and undergoing nine computerized tests designed to assess memory, learning and other cognitive skills over a 90-day period.
According to the complaint lodged by the FTC and the New York attorney general, an analysis using data from all study subjects failed to show a statistically significant improvement in the subjects taking Prevagen compared with placebo-group subjects on any of the nine computerized cognitive tasks. But after failing to find a treatment benefit, the researchers allegedly conducted more than 30 analyses of various subgroups of subjects for each of the nine tasks, making it likely that they would find some statistically significant differences by chance alone. Indeed, they found differences on a few of the subgroup analyses, but the vast majority showed no significant differences. Such subgroup data mining is bad science.
Moreover, the company’s claims about Prevagen improving memory and cognition rely on the theory that the protein apoaequorin moves into the brain from the blood. But the FTC and New York attorney general allege that the company has no evidence of this protein entering the human brain after oral consumption. To the contrary, the company’s own research shows that the protein in Prevagen, like other proteins in the diet, is rapidly broken down in the stomach. Thus, it is likely that little, if any, intact apoaequorin ends up in the bloodstream after ingestion. (For similar reasons, drugs that contain proteins as active ingredients, such as insulin and growth hormone, need to be administered by injection to have pharmacologic effects.)
“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” says Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.”
Harm to consumers
The FTC and New York attorney general alleged that consumers have suffered and will continue to suffer substantial financial injury as a result of Quincy Bioscience’s illegal advertising of Prevagen.
Prevagen is sold in bottles containing 30 tablets, which represents a 30-day supply if taken once daily as suggested on the product’s label. The price per bottle has ranged from $24 to $70 depending on the seller, strength and form. People who were duped into taking this supplement daily for one year could have spent as much as $850.
Quincy Bioscience and its co-defendants have advertised, distributed and sold Prevagen to the public and health care professionals since at least 2007 through their own websites and numerous health stores, pharmacies, and retail stores and websites. Sales of the product in the U.S. from 2007 through mid-2015 totaled $165 million.
The company’s aggressive marketing campaign has included advertisements on the company’s websites; infomercials; TV ads aired nationally on broadcast and cable networks, including CNN, Fox News, and NBC; radio ads; and a social media presence, including Facebook, Instagram, Twitter and YouTube.
“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country,” says Schneiderman. “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.”
The FTC and New York attorney general hopefully will put an end to this apparent hoax and force the company to provide refunds to deceived consumers and give up its ill-gotten profits. And consumers should be skeptical about most health claims made by dietary supplement makers.