Quincy’s Prevagen trial was a long time coming

On March 11, Quincy Bioscience Holding Co. racked up both wins and losses in a civil jury verdict in New York.

The office of the New York attorney general was tasked with proving that Quincy — the marketer of the memory supplement Prevagen — had engaged in fraud or illegality, deceptive business practices and false advertising in violation of state law.

The trial featured a battle of the experts who presented the jurors with competing narratives: That Quincy had sufficient evidence, or lacked it, to make such claims as “Prevagen improves memory,” “Prevagen is clinically shown to improve memory” and “Prevagen reduces memory problems associated with aging.”

In a 7-year-old case that focused on the science behind Prevagen, whose ingredient apoaequorin was discovered in jellyfish, jurors were introduced to the concept of “competent and reliable scientific evidence.” But before we explore how the CARSE standard played out in court (in part three of this series), let’s revisit how Quincy got to trial in the first place.

Madison Memory Study

In researching and ultimately “substantiating” the advertised health benefits of their products, few supplement brands invest in the so-called gold standard of an RCT, or double-blind placebo-controlled randomized controlled trial, where human subjects are assigned an intervention.

Related:Quincy Bioscience wins and loses in jury trial over memory supplement Prevagen

Quincy is the rare exception. That didn’t stop the Federal Trade Commission and office of the New York attorney general from suing the company and its co-founders in January 2017.

The lawsuit filed in U.S. District Court alleged violations of New York state law and the FTC Act. To quote a core allegation in the suit, “The 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.”

That’s not the whole story. Researchers conducted over 30 post hoc analyses of the results, evaluating data segmented by variations of subgroups for each of the nine tasks. This work revealed statistically significant results for certain subgroups.

In the “AD8 0-1 subgroup,” for example, participants who took Prevagen “showed statistically significant improvements over those who received the placebo in three of the nine tasks (measuring memory, psychomotor function and visual learning),” according to a 2017 order from Judge Louis L. Stanton. These trial participants also “showed a trend toward significance in two more tasks (measuring verbal learning and executive function),” the judge observed.

Related:Quincy Bioscience tells jurors it relied on FTC guidance in supporting claims for Prevagen

Another subgroup (AD8 0-2) who took the supplement demonstrated “statistically significant improvements” over trial participants who took the placebo in measuring executive function, attention and visual learning, noted Stanton, who added the same subgroup “showed a trend toward significance in one more task (measuring memory).”

“Based on those findings, the study concluded that ‘Prevagen demonstrated the ability to improve aspects of cognitive function in older participants with either normal cognitive aging or very mild impairment, as determined by ADS screening,’” the judge wrote.

The government wasn’t impressed. Quincy’s post hoc analysis, an expert for the New York AG recently testified, is the equivalent of betting on a horse after the race is over.

“[T]he vast majority of these post hoc comparisons failed to show statistical significance between the treatment and placebo groups,” state and federal regulators proclaimed in their 2017 lawsuit, filed in the U.S. District Court for the Southern District of New York. “Given the sheer number of comparisons run and the fact that they were post hoc, the few positive findings on isolated tasks for small subgroups of the study population do not provide reliable evidence of a treatment effect.”

Stanton sided with Quincy, dismissing the lawsuit in 2017.

“All that is shown by the complaint is that there are possibilities that the study's results do not support its conclusion,” he wrote in his order. “It does not explain how the number of post hoc comparisons run in this case makes the results as to the AD8 0-1 and AD8 0-2 subgroups unreliable, or that the statements touting the study's results are false or unsubstantiated.”

The government got pummeled before the case against Quincy had a chance to enter the deep rounds: mountains of discovery or an eventual trial.

Appeal revives lawsuit

Regulators filed an appeal, and in 2019, a three-judge panel with the U.S. Court of Appeals for the Second Circuit vacated Stanton’s judgment. The panel found that “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.”

The appellate court juxtaposed Quincy’s sweeping claim — “Prevagen improved memory for most subjects within 90 days” — with the lawsuit’s key gripe: 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.”

“Taking these allegations as true, not only has the FTC adequately alleged that Quincy’s study undermines its representations that ‘the majority of people’ experience cognitive improvement from taking Prevagen, but the FTC has also stated a claim that Quincy’s representations that this cognitive improvement is clinically supported are deceptive,” the Second Circuit wrote.

The fight was on again, and ultimately led to a jury trial in New York featuring a battle of the experts earlier this month. In part three of this series, we’ll dive into what the experts had to say…