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

Key to the defense of Quincy Bioscience at a recent trial in a case against the New York attorney general was its reliance on guidance published in 1998 by the Federal Trade Commission: “Dietary Supplements: An Advertising Guide for Industry.”

Prior to the company’s formation, Quincy co-founder and president Mark Underwood had consulted the guidance, according to Geoffrey (“Jeff”) Castello, a partner in New York with the law firm Kelley Drye & Warren LLP.

The FTC document (which an updated guidance supplanted in December 2022) covers how to substantiate or adequately support advertising claims for dietary supplement products like Quincy’s Prevagen, which is marketed to improve memory and whose ingredient apoaequorin was discovered in jellyfish.

According to the 1998 guidance, “The FTC's truth-in-advertising law can be boiled down to two common-sense propositions 1) advertising must be truthful and not misleading; and 2) before disseminating an ad, advertisers must have adequate substantiation for all objective product claims.”

Underwood again reviewed the 1998 advertising guidance upon his decision “to pursue a dietary supplement containing apoaequorin that would be made available without a prescription,” Castello told jurors in his closing arguments on March 7, because the executive “wanted to know exactly what to do so that he [could] ensure that Quincy complied with the law.”

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

Quincy’s science

Founded in 2004, Quincy Bioscience describes itself as focused “on the discovery, development and commercialization of novel technologies to support cognitive function and other normal health challenges associated with aging.”

New York jurors, who were charged this month with deciding whether Quincy had engaged in deceptive business practices and false advertising, learned that 20 years ago the company had negotiated a research agreement still in effect today (through annual renewals) with a laboratory at the University of Wisconsin-Milwaukee. The lab is run by associate dean James R. Moyer Jr., and it studies, in part, how the brain changes due to the aging process.

The jury was presented with evidence highlighting Quincy’s science. That included expert testimony concerning research showing that dogs who took apoaequorin orally showed detectable levels of it in their cerebrospinal fluid and blood plasma. Quincy has argued such findings indicate apoaequorin can cross the blood-brain barrier, while regulators have denied the company has adequate evidence to support such a hypothesis — or that apoaequorin even enters the human brain.

Related:Quincy’s Prevagen trial was a long time coming

Among the science on Prevagen that Castello highlighted in his closing remarks: the dog research, safety studies, the so-called Sunsho Pharmaceutical study and the Madison Memory Study.

“Plaintiff [New York AG’s office] told you at the start of this case that there was no science backing up the marketing claims for Prevagen,” Castello said to the jury in his closing arguments. “Yet, nearly three weeks later, I think you’ve heard more science than you ever thought possible about one dietary supplement.”

At trial, the state’s experts didn’t rely on the FTC guidance in forming their opinions. Quincy, on the other hand, put up on the stand David Schwartz, a neuroscientist and regulatory consultant who works with dietary supplements.

Schwartz noted “that in his line of work, the guidance provides the necessary framework to evaluate scientific substantiation for dietary supplement marketing claims, and that he uses it when he conducts claim substantiation for his dietary supplement clients,” according to Castello’s closing arguments.

The guidance uses a term that should be very familiar to seasoned supplement brands: “competent and reliable scientific evidence.” The document explains “substantiation is flexible” and “need only be adequate, that manufacturers only need to have a reasonable basis for making their claims, and that the government will consider the totality of the evidence when evaluating claims for dietary supplements like Prevagen,” Castillo said. “The guidance makes clear that there is no set protocol as to how the research needs to be conducted and to be acceptable, and no fixed formula for the number or type of studies required. And the guidance further advises that in vitro research, animal research, RCTs [randomized controlled trials], and meta-analyses will all be considered, even if no single type of test is even required.”

Quincy’s experts — specializing in nutrition, neuroscience, epidemiology, claim substantiation for supplements, internal medicine, preventive medicine and public health — all testified they evaluated the guidance and totality of the scientific evidence, as well as considered the marketing claims under review in the trial. And they all reached the same conclusion, according to Castello.

“Each concluded that the science supported the claims at issue, in Dr. [David] Katz’s words, with room to spare,” Quincy’s lawyer told the jury.

The government’s experts didn’t opine whether Quincy’s claims “are supported with competent and reliable scientific evidence” and admitted “they had never even seen the challenged marketing claims when they issued their opinions in this case,” Castello said.

“Not only were plaintiffs' experts in the dark about the challenged marketing claims, they were completely ignorant of the relevant framework for evaluating the science that they were asked to opine on,” he added in closing remarks. “You heard that none of the plaintiffs' experts knew about the existence of the [FTC] guidance when they formed their opinions, and that is because they have almost no experience in the world of dietary supplements.”

‘Selling fear’

Government lawyer Kathryn Matuschak told the jury a much different story. She is an assistant attorney general with the Bureau of Consumer Fraud and Protection within the New York AG’s office. During closing arguments, she thanked the jurors for their time, then plunged into the reason for their participation.

“We are here because Quincy has made the following deceptive claims on television and on its packaging, throughout this country and throughout the state of New York: Prevagen improves memory. Prevagen improves memory within 90 days. Prevagen reduces memory problems associated with aging. Prevagen supports healthy brain function, sharper mind and clearer thinking. Prevagen is clinically shown to provide all of these benefits,” the assistant attorney general said. “These words were chosen by Quincy Bioscience to sell a protein that makes jellyfish glow.”

Quincy’s advertising was effective, Matuschak said, because the company is “selling fear, perhaps the most powerful tool in the toolbox of the advertising industry.”

She asked the jury to ponder a crucial question: “whether there is competent and reliable scientific evidence to support the advertising and marketing claims that Quincy had made about Prevagen, the advertising claims Quincy chose to make.”

Matuschak said that is the applicable substantiation standard under New York law, which “means the science Quincy has must not be just any science, but science that would be sufficient to support the claims at issue here: Improves memory, clearer thinking, clinically shown.”

Plaintiff’s experts

Mary Sano, Ph.D., is a professor of psychiatry and the director of the Alzheimer’s Disease Research Center at Mount Sinai School of Medicine. She reportedly testified that a randomized, controlled blinded clinical trial is required to support claims to improve memory and thinking.

“Without a randomized double-blind placebo-controlled clinical trial, no amount of animal studies can add up to evidence sufficient to make a claim to improve memory,” Matuschak said. “Even Quincy's own Dr. Schwartz agreed to that.”

Which brings us to Quincy’s Madison Memory Study, highlighted in part two of this series of articles. Matuschak argued Quincy “repeatedly misrepresented what the study actually showed,” and didn’t take time explaining to jurors “what the results might mean outside of the computer tests.”

For example, she noted the company’s experts didn’t discuss whether improving a score on a cognitive task “by one-thousandth of a second translates to any sort of meaningful benefit in real life.”

The government lawyer highlighted what she described as the “primary conclusion of the study and the only reliable one”: The Madison Memory Study did not yield any statistically significant results that were observed over the entire population of human subjects.

(However, post hoc analysis of the results revealed statistically significant results for certain subgroups).

Then she reminded the jury about all the study’s purported flaws, including that the “protocol” failed to mention any plan to evaluate the subgroups.

Janet Wittes is a Harvard University-educated Ph.D. and fellow of the American Statistical Association, American Association for the Advancement of Science, and Society for Clinical Trials. She testified Quincy was far from consistent in presenting results of the Madison Memory Study in a series of write-ups in 2011, 2014 and 2016.

Wittes “explained how each of those write-ups reported different results, different tests, different subgroups and in some cases, different numbers for what are supposed to be the same test results,” Matuschak reminded the jurors. “And she described that the write-ups are an example of selective reporting, where you only show the results that support the conclusions that you want to promote.”

Wittes had other criticisms of the study as well. She reportedly testified that many of the results Quincy characterized as being statistically significant only evaluated the scores of consumers who took Prevagen and ignored the placebo group, failing to demonstrate whether Prevagen improves memory.

“Within-group results don't take into account other reasons that peoples' performance might change, like the placebo effect,” Matuschak said.

Wittes had a bone to pick with the six results that compared the Prevagen group to the placebo groups and were considered statistically significant. She concluded the results for subgroups AD8 0-1 and 0-2 weren’t reliable and couldn’t be used to support the memory improvement or cognition claims for Prevagen since Quincy failed to prespecify such analyses in its protocol or other documents.

“Dr. Wittes explained this is like betting on a horse race after the race is over and you already know the results, or throwing darts at a blank wall and then drawing the target afterward where the darts happen to land,” Matuschak told the jurors. “While she explained that researchers commonly perform unplanned subgroup analyses on clinical trial data, these analyses are just exploratory and must be interpreted with caution. While the results of such analyses can generate promising ideas for new studies, they are not reliable evidence of effect.”

On the other hand, Castello described the Madison Memory Study as the “gold standard” and said to jurors in closing arguments that Wittes admitted the study was an RCT (double-blind placebo-controlled randomized controlled trial, where human subjects are assigned an intervention) and that she reached the same conclusions as the company after analyzing the raw data.

What’s more, he argued, Wittes failed to consider the totality of the evidence, per FTC guidance: “She reviewed the Madison Memory Study in isolation without considering any of the other evidence supporting the challenged claims.”

Analysis of jury verdict, FTC guidance

If you've been reading this series of articles, you know by now that the jury’s verdict on March 11 was not a complete victory for either Quincy or the state of New York. On the one hand, the jury found all eight challenged statements lacked competent and reliable scientific evidence. On the other hand, the jury determined that six of the eight claims were not materially misleading.

Based on the jury verdict, Quincy may have less confidence in making memory claims related to aging, which the jury found were materially misleading. On a positive note, the company may have increased confidence in such claims as “Prevagen improves memory,” “Prevagen is clinically shown to improve memory,” and “Prevagen provides other cognitive benefits, including but not limited to healthy brain function, a sharper mind and clearer thinking.”

Megan Olsen is SVP and general counsel with the Council for Responsible Nutrition (CRN). She told me in an email that the jury verdict is “extremely pertinent” to her trade group’s conversations with the Federal Trade Commission regarding its “attempts to limit flexibility in the claim substantiation standard.”

Working with FTC attorneys in the case against Quincy, the New York AG defined competent and reliable scientific evidence (CARSE) “as a rigid drug-like standard,” Olsen commented. “The jury subsequently found that the Prevagen claims were not supported by CARSE as defined by the regulators, but the jury still found that the majority of health-related claims — including ‘clinically proven’ claims — about the supplement at issue were not materially misleading.”

As I previously wrote, the jury’s findings are paradoxical in my view. Sure, they found Quincy had no “competent and reliable scientific evidence” for the challenged statements, however they understood that term of art. Yet by finding most of Quincy’s statements were not “materially misleading,” jurors seemed to be concluding that Quincy had a certain amount of convincing evidence to support such claims as “Prevagen improves memory” and “Prevagen is clinically shown to improve memory within 90 days.”

But in the interest of full disclosure, the verdict was full of contradictions, as the jury found that all eight challenged statements “have the capacity or the tendency to deceive.”

Ultimately, one could argue this case demonstrates consumers and regulators have a different understanding of “substantiation” or what precisely is required to support advertising claims for dietary supplement products.

“Viewing that jury as a helpful roadmap for how consumers understand claims and appropriate scientific support, this verdict suggests that consumers understand that the substantiation standard is not one size fits all, and different types of products and claims can be properly supported with different types of scientific evidence,” Olsen concluded. “Suggesting, as the FTC’s substantiation narrative continues to do, that all health-related claims — whether they be for a drug claiming to treat dementia or supplement claiming to improve memory in healthy adults — require the same rigid drug-like CARSE standard for claim support defies the law and reasonable consumer understanding of claims support.”