The Federal Trade Commission (FTC) and the New York State Attorney General have charged Wisconsin-based Quincy Bioscience, manufacturer of the dietary supplement Prevagen (apoaequorin), with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is “clinically shown” to work.

The extensive national advertising campaign for Prevagen, including television spots on national broadcast and cable networks such as CNN, Fox News, and NBC, featured charts depicting rapid and dramatic improvement in memory for users of the product. In fact, the FTC complaint alleges, the marketers based much of their advertising for Prevagen on a single trial, the Madison Memory Study, which gave the drug or placebo to 218 people and had them perform certain tasks on a computer.

“The Madison Memory Study failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks,” the lawsuit claims.

“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” said 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.”

The federal court complaint alleges that the defendants enticed consumers to spend from $24 to $68 for bottles of 30 supplement pills by touting the product’s active ingredient––apoaequorin, a protein derived from jellyfish––to improve memory and reduce memory problems associated with aging. The complaint notes that the supplement is widely available at major retailers, such as Amazon, CVS, the Vitamin Shoppe, and Walgreens, and is also sold directly on the defendants’ websites. The product’s sales have topped $165 million, according to the complaint.

Quincy Bioscience developed and marketed Prevagen on the theory that apoaequorin enters the human brain to supplement proteins that are lost during the natural aging process. The lawsuit says Quincy Bioscience has no data showing that the orally administered protein can cross the blood–brain barrier, and in fact, 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 packaging for Prevagen claims that the once-daily supplement improves memory; supports healthy brain function, a sharper mind, and clearer thinking; and is “clinically tested.” The packaging also includes the familiar disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

The agencies have charged corporate defendants Quincy Bioscience Holding Company, Inc.; Quincy Bioscience, LLC; Prevagen, Inc., doing business as Sugar River Supplements; and Quincy Bioscience Manufacturing, LLC. The agencies also charged the two cofounders of the company, CEO Michael Beaman and President Mark Underwood, who appeared in infomercials for the product.

The agencies allege that the defendants’ marketing claims have violated the FTC Act and New York state laws. The agencies are seeking refunds for consumers who bought the deceptively marketed product.

“The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country,” said New York Attorney General Eric 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 two Democrats on the FTC voted to approve the complaint. The single Republican did not participate, and two of the five commission seats are vacant.

Sources: FTC; January 9, 2017; Reuters; January 9, 2016; and NYup.com; January 9, 2017.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

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Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.