Feds, New York Accuse Maker Of Prevagen Dietary Supplement Of False Advertising

Prevagen is a dietary supplement that claims to help improve memory in 90 days, but both federal and state regulators are accusing the company behind Prevagen of making false and unsubstantiated claims.

The Federal Trade Commission and New York state Attorney General Eric Schneiderman jointly filed a lawsuit [PDF] in federal court this morning, accusing Quincy Bioscience and its executives of falsely advertising that Prevagen was clinically proven to improve memory in seniors.

According to the complaint, since 2007 Quincy Biosciences relied on a single study to advertise and promote Prevagen as “clinically shown” to support “clearer thinking” and to “improve memory within 90 days.”

Despite these claims, the lawsuit alleges that the study used by Quincy failed to show a statistically significant improvement in the treatment group over the placebo group on any of the cognitive measures used.

The study, called the Madison Memory Study, involved 218 subjects taking either 10 milligrams of Prevagen or a placebo.

The subjects were assessed on nine computerized cognitive tasks, designed to assess a variety of cognitive skills, including memory and learning, at various intervals over a period of 90 days.

The complaint claims that the Madison Memory Study failed to show a statistically significant improvement in the treatment group over the placebo group. In fact, the agencies claim that at day 60, the recall task score for those taking Prevagen declined from what it was on day 30, with the scores also slightly worse than the recall scores of subjects in the placebo group.

To make matters worse, the agencies contend that Quincy’s own research demonstrated the flawed science behind its claims.

The company developed and marketed Prevagen on the theory that its active ingredient, dietary protein apoaequorin, enters the human brain to supplement proteins that are lost during the natural aging process.

Quincy’s own studies show that the protein is rapidly digested in the stomach and broken down into amino acids like any other dietary protein, the suit states.

Still, Quincy continued to widely promote Pervagen, which sold for between $24 to $68 per bottle of 30 pills, in national television and print ad campaigns.

In one informercial, that aired frequently as the “Better Memory Show,” the company used an interview format featuring Quincy president Mark Underwood explaining the problems associated with memory loss, the purported benefits of the Prevagen Products, and research purportedly supporting the company’s memory-improvement claims.

Additionally, the company hawked the products in online through a number of websites, and via a physical presence at retailers, where the “Prevagen Express” bus traveled to health food centers across the country touting the supplement’s supposed effects.

In these marketing efforts, according to the complaint, the company used charts depicting rapid and dramatic improvement in memory for users of the product to entice customers to purchase the pills, which were widely available at major retailers such as Amazon, CVS, the Vitamin Shoppe, and Walgreens.

The agencies allege that the defendants’ marketing claims violated the FTC Act and New York state laws. With the complaint, the agencies are seeking to ban Quincy from used false claims in marketing Prevagen and to obtain refunds for consumers who bought the deceptively marketed product.

In a statement posted on its website, Quincy Bioscience denies any wrongdoing.

“Quincy has amassed a large body of evidence that Prevagen improves memory and supports healthy brain function,” claims the statement. “This evidence includes preclinical rat studies, canine studies, human clinical studies, and, most importantly, randomized, double-blind, placebo-controlled human clinical testing. This type of testing has long been acknowledged by both the FTC and the FDA to be the ‘gold standard’ for scientific evidence.”

Continues Quincy: “The sole dispute rests on the interpretation and analysis of the data, with the regulators attempting to hold the company to a standard that is unreasonable, scientifically debatable, and legally invalid. Their experts simply disagree with ours over how to interpret the study results. The FTC should not be the arbiter in matters of scientific debate. We are proud of the work we have done to support Prevagen’s effects and believe our large body of evidence clearly satisfies the longstanding standard to support such claims.”