Does Prevagen really improve memory?
According to the company’s website, people who use people Prevagen (Quincy Bioscience) can “experience improved memory, a sharper mind, and clearer thinking. Unfortunately, no peer-reviewed studies have been published to back up these claims. In addition, the FDA has warned Quincy Bioscience in the past against claiming Prevagen could treat conditions such as head injuries and Alzheimer's disease and for failing to report adverse reactions, and the FTC has charged Prevagen's markets with making false and unsubstantiated claims. The FDA has also claimed that the key ingredient, apoaequorin, a synthetic protein, is not an acceptable ingredient in a dietary supplement.
Prevagen touts that it’s the only supplement containing apoaequorin, a protein that it says was originally plucked from a jellyfish in the Puget Sound and which aging brains “need for healthy function.” But the lawsuit filed in January against Quincy Bioscience asserts that this protein does just about as much for the brain as a royale with cheese (and other assorted run-of-the-mill proteins):
Prevagen cannot work as represented because apoaequorin, the only purported active ingredient in Prevagen, is completely destroyed by the digestive system and transformed into common amino acids no different than those derived from other common food products such as chicken, cold cuts, hamburgers, etc.
The brain supplement’s website shares three studies under its research tab. One of studies lists Mark Y. Underwood, the president of Quincy Bioscience, who said in an interview with TINA.org that all clinical trials were done in-house.
When the FDA came knocking
The FDA sent Underwood a warning letter in 2012 over the alleged illegal marketing of Prevagen as a drug without the agency’s approval. The letter also noted that the product did not satisfy the definition of a dietary supplement because the only dietary ingredient on the label — “synthetically produced apoaequorin” — did not qualify as such.
Perhaps most importantly, the FDA said an inspection found that the company had received more than 1,000 adverse health events associated with the product, but failed to report serious cases, including seizures and strokes, to the agency as required. The unreported events and complaints were submitted to Quincy Bioscience between May 2008 and December 2011. Underwood said “less than two dozen” of the more than 1,000 adverse health events were “serious.”
Underwood said the company has made “adjustments” to its reporting procedure regarding adverse health events. Since August 2010, the FDA has received more than 50 adverse event reports related to Prevagen products, documents obtained by TINA.org through a Freedom of Information Act (FOIA) request show. But he refuted much of what the FDA alleged in its 2012 letter and said that the company stands by its advertising and clinical trials. He declined to comment on the class-action lawsuit.