I am a long-time subscriber to Reader’s Digest. I enjoy the jokes and some of the human interest stories, but I have become increasingly disturbed by some of the questionable health information they present. The most recent issue carried a prominent ad for Prevagen on the back cover. In large print, it says “Healthier Brain. Better Life.” It shows pictures of the product’s box and bottle, both of which say “Improves Memory.” And on the box, you can clearly see the claims that it “supports healthy brain function, sharper mind, and clearer thinking.” The ad claims it is “America’s best-selling brain support supplement and has been clinically shown to help with mild memory problems associated with aging.” This statement has an asterisk leading to a small-print boxed FDA disclaimer: “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 editors of Reader’s Digest have obviously not been reading the Science-Based Medicine blog. In a 2015 article, Steven Novella wrote about the entire class of nootropics, or drugs that are designed to enhance cognitive function. He concluded that they are being abused and hyped without adequate evidence, and he deplored the fact that they are being sold as dietary supplements rather than as drugs. He said some manufacturers cheat by including a stimulant, which can benefit patients diagnosed with certain diseases, but “Current non-stimulant nootropics are likely useless in healthy individuals.”
And earlier this year, Jann Bellamy reviewed the evidence for Prevagen and the lawsuit filed against it by the FTC claiming that the company was making false and misleading statements in labeling and advertisements, that:
(1) there is not “competent and reliable scientific evidence” to support Prevagen’s claims, which is required of health care product advertising, and (2) the claim that Prevagen is “clinically proven” is false.
It was not “clinically proven”. The study they’re referring to found that it didn’t work, but the manufacturer relied on post hoc analyses of subgroups and p-hacking that found some apparently positive results. The FTC explained that:
post-hoc data-dredging is unreliable and can’t rule out ‘statistically significant difference’ as mere noise.
What is Prevagen? What does the evidence show?
It is a dietary supplement whose main ingredient, apoaequorin, is a calcium-binding compound first identified in jellyfish. The company website claims that it is safe and effective for improving memory and supporting brain function. It cites three safety studies and one randomized, double-blinded, placebo-controlled clinical trial in community-dwelling older adults who self-reported memory concerns, the Madison Memory Study. That study was negative: “no statistically significant results were observed over the entire study population.” But the company did some data mining and p-hacking and teased out statistically significant p results for two subgroups of individuals with either minimal or no cognitive impairment. Essentially, they tortured the data to make it confess. Then they used the p-hacked data to speculate that Prevagen would benefit their customers: it would “support people with mild memory loss associated with aging.” That conclusion is not supported by the data. Jann’s articledescribes some of the other problems with the study and with the company’s claims. They claim apoaequorin crosses the blood-brain barrier, but the only evidence they have is in dogs. The safety studies they cite were all in rats. They have no evidence that it crosses the human blood-brain barrier or that it is safe in humans. In fact, there are many consumer complaints and reports of side effects. They are not selling it for dogs or rats, but for humans.
In addition, the American Pharmacists Association website raises some other concerns. They say it “is unlikely to be absorbed to a significant degree; instead it degrades into amino acids.” And they say the tests used in the Madison Memory Study were not validated tests.
Conclusion: Prevagen claims not supported by evidence
There is no evidence that Prevagen is effective or safe in humans. We knew that. The FTC knew that. Mainstream scientific organizations knew that. Why didn’t Reader’s Digest know that? Shame on them! The magazine is widely read and respected, and this Prevagen ad, prominently featured in full color on the back cover, will probably persuade many readers to waste their money on this placebo under the mistaken belief that it will help with the memory problems associated with aging.