Conflicting claims in scientific studies not enough to dismiss Prevagen case
Remember This One?
The Second Circuit Court of Appeals breathed new life into a joint complaint by the Federal Trade Commission (FTC or Commission) and the state of New York against Quincy Bioscience, a “biotechnology company focused on the discovery, development and commercialization of novel technologies to support cognitive function and other normal health challenges associated with aging.”
The original complaint dealt with Quincy’s flagship product, Prevagen, which the company had been marketing as a memory-improvement supplement. Quincy bolstered these claims with what it called the Madison Memory Study, which it claimed was “a landmark double-blind and placebo controlled” study.
Post Hoc or Ad Hoc?
The heart of the complaint was an analysis of the aforementioned study, which hinged on Quincy’s sampling of the data. The original study conducted by Quincy, the FTC argued, failed to establish that Prevagen provided any statistically significant memory benefit. Regardless of this finding, the Commission asserted, Quincy went ahead and made claims based on the results of “more than 30 post hoc analyses” of the main study data. The Commission alleged that by dividing the original study data into smaller chunks, the analyses allowed Quincy to dodge the rigor of the larger data sets in the main study – even though the sample size of the post hoc analyses flooded the claims with statistical noise and rendered them unreliable.
In September 2017, the Southern District of New York dismissed the case, arguing that although the FTC had raised the possibility that the post hoc analyses were flawed, it hadn’t presented evidence that they were actually compromised.
The circuit court vacated the case and remanded it to the Southern District. “The FTC has stated a plausible claim that Quincy’s representations about Prevagen are contradicted by the results of Quincy’s clinical trial and are thus materially deceptive in violation of the FTC Act and New York General Business Law,” it wrote. Specifically, the court considered the contradiction between Quincy’s claim that Prevagen improved memory function within 90 days and the FTC’s finding that the Madison Memory Study “failed to show a statistically significant improvement … .”
The court also found plausible the FTC’s allegations regarding the ineffectuality of Prevagen’s main ingredient, apoaequorin, which the Commission claimed “is rapidly digested in the stomach and broken down into amino acids and small peptides like any other dietary protein.”
The court left a door open for Quincy, however, noting “that Defendants-Appellees have raised several grounds for affirmance that the district court did not consider. We express no opinion on these arguments, and the district court may consider them in the first instance on remand.”