Madison, WI — Judge Louis Stanton of the U.S. District Court in the Southern District of New York has dismissed the Federal Trade Commission and the New York Attorney General’s complaint against Quincy Bioscience, the makers of Prevagen.
“We are very pleased with the Judge’s decision today,” said John Villafranco, partner at Kelley Drye and counsel representing Quincy Bioscience in a statement released after the Sept. 29 action. “We continue to believe that Quincy Bioscience has presented substantial evidence in support of its claims about Prevagen.”
The 32-page complaint filed in January, claimed that Quincy Bioscience Holdings LLC, along with officers Mark Underwood and Michael Beaman, were guilty of being deceptive in their claims that a study performed by Quincy Bioscience did not actually prove the effectiveness of Prevagen versus the placebo it was tested with.
The dietary supplement Prevagen has been advertised as containing an active ingredient originally obtained from the Aequorea victoria jellyfish known as apoaequorin. It is available in Regular, Extra and Professional Strength in both capsule and chewable versions. Each bottle of Prevagen ranges from approximately $24 to $59 for 30 tablets, with directions to take one tablet daily. Since 2007, Quincy Bioscience has sold a reported $165 million worth of Prevagen to customers who believed in the beneficial claims the drug was supposed to provide based on the study reported by Quincy Bioscience.
Prevagen has been advertised in infomercials, commercials, social media and a “Better Memory Tour” since its release in 2007. The FTC and NY Attorney General maintained there is no “clinical evidence” to support Prevagen’s claim of improving memory and providing cognitive effects.
The scientific clinical study in question was the Madison Memory Study conducted by Quincy Bioscience in which 218 test subjects took either 10 milligrams of Prevagen or a placebo to see if there were benefits to cognition, memory and learning. After an assessment on nine computerized cognitive tasks at varying intervals over 90 days, the Madison Memory Study did not show any significant improvement in the treatment group over the placebo group. When this study was indecisive, over 30 post hoc analyses of the results were performed.
In granting the defendants’ motion to dismiss the federal claims, the judge found the lawsuit neglected “to do more than point to possible sources of error but cannot allege that any actual errors occurred.”
“They [plaintiffs] say that findings based on post hoc exploratory analyses have an increased risk of false positives, and increased probability of results altered by chance alone, but neither explain the nature of such risks nor show that they affected the subgroups’ performance in any way or registered any false positives,” Stanton wrote in his 13-page order dismissing the lawsuit. “Nor do they give any reason to suspect that these risks are so large in the abstract that they prevent any use of the subgroup concept, which is widely used in the interpretation of data in the dietary supplement field.”
An FTC spokesman had no additional comment