Does the supplement Prevagen improve memory? A court case is asking that question.
The front of the box of the dietary supplement Prevagen says it improves memory and supports healthy brain function, sharper mind and clearer thinking.
The side of the box says: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
The disclaimer, required by FDA rules, offers a reminder of how the federal government does - and doesn't - regulate dietary supplements. And Prevagen provides an interesting test of the relationship between manufacturers and government.
Supplements are regarded by the FDA as a food, not a drug. That means they are not tested by the agency before they are put on the market, although the FDA is responsible for removing any that are found to be unsafe once they are for sale.
Many medical experts say research has not found solid evidence that any supplements are effective at preventing neurological diseases that cause dementia. And they say that better treatments for the normal memory gaps often experienced with aging include exercise and a healthy diet.
Scott Gottlieb, FDA commissioner from 2017 to 2019, conceded that the growth of the supplements industry, which includes vitamins, minerals, herbs and other ingredients marketed for a wide range of uses, had outpaced the agency's ability to monitor it.
"What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 - and possibly as many as 80,000 or even more - different products available to consumers," he said in 2019.
That growth has been propelled by heavy advertising in print, radio and television and on the Internet. Prevagen's commercials, for example, feature relatable older adults full of robust enthusiasm for its benefits - who are labeled as "paid testimonialists" or "Prevagen content contributors."
"In the kind of work that I do, you are surrounded by people who are all younger than you," one says, looking over the shoulder of a younger person at a computer screen. "I had to get help to stay competitive."
A 68-year-old describes himself as a motivational speaker and substitute teacher. "I honestly feel that's my calling - to give back to younger people."
And they're active. Walking, fly-fishing, shooting hoops and singing the supplement's praises.
"After about 30 days of taking it, we noticed a clarity that we didn't notice before."
"After a period of time, my memory improved. It was a game changer."
"People say to me, 'Man, you've got a memory like an elephant!' "
Four years ago, the Federal Trade Commission and the New York attorney general sued the makers of Prevagen over what they asserted were false claims that it improves memory and brain functioning. After a long delay, the suit, which includes a request for consumer refunds, is moving forward again.
Neurologists and other medical experts say some supplements stray into what they call pseudomedicine. "Pseudomedicine refers to supplements and medical interventions that exist within the law and are often promoted as scientifically supported treatments, but lack credible efficacy data," three University of California neurologists wrote in a 2019 article in JAMA. "With neurodegenerative disease, the most common example of pseudomedicine is the promotion of dietary supplements to improve cognition and brain health."
Joanna Hellmuth, the lead author, said the article was prompted by a discussion among the faculty at the Memory and Aging Center in the Department of Neurology at the University of California at San Francisco. They talked about how heartbreaking it was seeing vulnerable dementia patients and their families being swept up in the marketing of brain health supplements, considering the likely false promise of hope and the financial drain.
Discussing supplements also takes away time from discussing healthy steps patients can take that are supported by the data, including exercise and social engagement, she said.
The initial Prevagen case was dismissed by a lower court judge, but a federal appeals court in New York reversed that ruling and sent the case back to the lower court. The parties have been engaged in discovery and are expected to complete the last phase on Oct. 22. A mid-November status conference could determine the next steps in this long-running litigation against Quincy Bioscience Holding Co., Quincy Bioscience, Quincy Bioscience Manufacturing and Prevagen Inc., a complex of companies owned principally by co-founders, Mark Underwood and Michael Beaman.
At the time the lawsuit was filed, the company "vehemently" denied the allegations and called the lawsuit "another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours."
"Prevagen is safe," the news release went on to say. "Neither the FTC nor the New York Attorney General has alleged that Prevagen can cause or has caused harm to anyone. And hundreds of thousands people tell us it works and improves their lives."
It added that "Quincy has amassed a large body of evidence that Prevagen improves memory and supports healthy brain function. This evidence includes preclinical rat studies, canine studies, human clinical studies, and, most importantly, randomized, double-blind, placebo-controlled human clinical testing. This type of testing has long been acknowledged by both the FTC and the FDA to be the 'gold standard' for scientific evidence.
"The sole dispute rests on the interpretation and analysis of the data, with the regulators attempting to hold the company to a standard that is unreasonable, scientifically debatable, and legally invalid," according to the news release. "Their experts simply disagree with ours over how to interpret the study results."
Prevagen representatives did not respond to emails or phone calls requesting an interview.
Class-action suits also have been filed against the makers of Prevagen, claiming that its advertising was deceptive. In one, settled in 2020, Quincy Bioscience denied wrongdoing but agreed to provide refunds to eligible class members for 30 percent of their purchases with payments capped at $70 with proof of purchase or $12 without proof of purchase. Another case ended in a mistrial after jurors deadlocked.
The producers of Neuriva, another supplement marketed as a brain booster, recently settled a class action and agreed to change all references from "clinically proven" and "science proved" on labeling and marketing to "clinically tested" and "science tested" or other similar language.
The problem, Hellmuth said, is that most consumers won't see a distinction between "clinically tested" and "clinically proven" and that "the companies are casting this aura of science" when it isn't backed up.
The Alzheimer's Association warns in its discussion of alternative medicine that a "growing number of herbal remedies, dietary supplements and 'medical foods' are promoted as memory enhancers or treatments to delay or prevent Alzheimer's disease and other dementias. Claims about the safety and effectiveness of these products, however, are based largely on testimonials, tradition and a rather small body of scientific research."
Privately-held Prevagen's sales were said to have totaled $165 million between 2007 and 2015, according to the FTC's and the New York attorney general's 2017 lawsuit, but are likely much larger now because of rapid growth in the market.
The dispute over Prevagen's effectiveness centers on two things. One is a synthetic ingredient called apoaequorin designed to replicate a protein found in jellyfish. Critics, including the two entities suing it and the Alzheimer's Drug Discovery Foundation, point to evidence that it probably is digested in the stomach, leaving nothing to get past the blood-brain barrier that acts as the brain's concierge.
While the FTC case rests on marketing, the FDA raised questions in a 2012 "warning letter" about whether Prevagen should be classified as a drug rather than a supplement. It also stated that Prevagen's marketing cited studies and included statements by Prevagen users suggesting it was a treatment for Alzheimer's and other diseases and alleged that it had failed to report adverse events, including strokes and seizures that had been reported to the company, to the FDA.
An FDA spokesperson said the action "was closed out in 2018. Quincy Bioscience has satisfactorily addressed FDA concerns."
The other criticism raised by the FTC and New York attorney general lawsuit is that the company-funded test of the supplement doesn't pass muster. Quincy Bioscience describes the study as a randomized, double-blinded, placebo-controlled trial.
But, according to the FTC and the New York attorney general, the trial involved 218 subjects taking either 10 milligrams of Prevagen or a placebo and "failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks."
The complaint alleges that after the Madison Memory Study failed to "find a treatment effect for the sample as a whole," Quincy's researchers broke down the data in more than 30 different ways.
"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," the lawsuit said. Post hoc studies are not uncommon but are generally not regarded as proof until confirmed, scientific experts say.
According to the Center for Science in the Public Interest, which filed an amicus brief in support of the agencies' charges, the subsequent analyses produced "three results that were statistically significant (and more than 27 results that weren't)."
Hellmuth hopes Congress will pass legislation beefing up FDA oversight of supplements, but says she doubts it is a fight "anyone wants to take on."
Claims for these products, she says, should be verified so that patients and consumers can believe in them.
Related Content
California's disappearing salmon
Saving the biggest name for last, Biden joins Newsom to campaign on eve of recall
