Does Prevagen Really Work?

Michael Greger M.D. FACLM · November 13, 2023 · Volume 63

4.9/5 - (80 votes)

Why did the makers of Prevagen settle a class action lawsuit in 2020 with the FTC over deceptive business practices and false advertising? Is Prevagen safe?

Discuss

Transcript

Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.

Over the last twenty years or so, Big Pharma has invested more than a half trillion dollars into dementia treatment research, but so far to little avail. In light of this, many have turned to supplements. An AARP commissioned survey found that 36 percent of those 74 years and older take a supplement for brain health, to the tune of billions of dollars a year. The most commonly marketed brain supplement was one I’d frankly never heard of before: Prevagen.

Prevagen contains a protein derived from a luminescent jellyfish the company claims “has been clinically shown to improve memory.” According to the company website, “A landmark double-blind and placebo controlled trial demonstrated Prevagen improved short-term memory, learning, and delayed recall over 90 days.” But when you actually pull up the study, not only did Prevagen fail to improve memory, learning, or recall over placebo, it failed to show a significant improvement in any of the nine measured cognitive tasks tested. As an inquiry into Prevagen published by the Center for Science in the Public Interest was titled, “How Can This Memory Supplement Flunk Its One Trial and Still Be Advertised as Effective?” And not just as effective, but the #1 pharmacist recommended brand. Considering the lack of sound clinical evidence, how is that possible? Presumably, they’re just as blitzed with the same kind of advertising as everyone else.

It’s no surprise the supplement didn’t do anything, since the company’s own studies showed the jellyfish protein was rapidly digested by stomach enzymes. Of course, that didn’t stop them from raking in more than $20 million a year. Claiming the “marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” the Federal Trade Commission and New York State’s Attorney General filed a consumer protection complaint charging the company with making false and unsubstantiated claims. The AARP weighed in, accusing the company of “deceiving millions of aging Americans.”

In a move straight out of the Big Pharma aducanumab playbook, the company went back and conducted more than 30 post hoc analyses of the data, and found a few positive findings on a few tasks for some subgroups. This cherry-picking of subgroups after the fact is a classic example of manipulation, sometimes called “p-hacking” or “data dredging,” that can be described as “placing a bet on a horse after watching the race.”

The makers of Prevagen settled a class action lawsuit in 2020 with the FTC over deceptive business practices and false advertising. Remarkably, though, the settlement allows them to continue to market it, with the court-approved disclaimer that claims are “based on a clinical study of subgroups of individuals …” But with the amount of slicing and dicing of data they did, the chances of finding at least one false positive was estimated at 80 percent.

Prevagen may be more than just a waste of money. The manufacturer was cited for failing to report more than a thousand adverse events related by consumers to the Food and Drug Administration (FDA). Regulators can’t have it both ways, though. If the jellyfish protein is digested away, how can it pose a safety risk? Because dietary supplements are too often adulterated with contaminants. FDA inspectors specifically cited Prevagen’s manufacturing facilities for “objectionable conditions or practices.”

A 2019 survey by Pew found that more than half believed that the Food and Drug Administration requires supplements be tested for safety, but that isn’t true. One study of 24 supplements sold as cognitive performance boosters found that most claimed an ingredient on the label that wasn’t actually in the supplement. And worse, 38 percent contained ingredients not allowed in supplements, like prohibited drugs. Another study of a dozen so-called “brain health supplements” similarly found 8 out of 12 were misbranded (missing an ingredient promised on the label), and 10 out of 12 were deemed adulterated (containing unlisted compounds, for example caffeine in a product that explicitly highlighted all-caps ‘‘DECAFFEINATED’’ on the label). Only 1 of 12 was certiﬁed to contain what it said it did. The bottom line for Prevagen—there is no acceptable evidence that it is effective, and patients should be advised not to take it.

Please consider volunteering to help out on the site.

Sources

Acknowledgements

Motion graphics by Avo Media

Topics

Below is an approximation of this video’s audio content. To see any graphs, charts, graphics, images, and quotes to which Dr. Greger may be referring, watch the above video.

Over the last twenty years or so, Big Pharma has invested more than a half trillion dollars into dementia treatment research, but so far to little avail. In light of this, many have turned to supplements. An AARP commissioned survey found that 36 percent of those 74 years and older take a supplement for brain health, to the tune of billions of dollars a year. The most commonly marketed brain supplement was one I’d frankly never heard of before: Prevagen.

Prevagen contains a protein derived from a luminescent jellyfish the company claims “has been clinically shown to improve memory.” According to the company website, “A landmark double-blind and placebo controlled trial demonstrated Prevagen improved short-term memory, learning, and delayed recall over 90 days.” But when you actually pull up the study, not only did Prevagen fail to improve memory, learning, or recall over placebo, it failed to show a significant improvement in any of the nine measured cognitive tasks tested. As an inquiry into Prevagen published by the Center for Science in the Public Interest was titled, “How Can This Memory Supplement Flunk Its One Trial and Still Be Advertised as Effective?” And not just as effective, but the #1 pharmacist recommended brand. Considering the lack of sound clinical evidence, how is that possible? Presumably, they’re just as blitzed with the same kind of advertising as everyone else.

It’s no surprise the supplement didn’t do anything, since the company’s own studies showed the jellyfish protein was rapidly digested by stomach enzymes. Of course, that didn’t stop them from raking in more than $20 million a year. Claiming the “marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” the Federal Trade Commission and New York State’s Attorney General filed a consumer protection complaint charging the company with making false and unsubstantiated claims. The AARP weighed in, accusing the company of “deceiving millions of aging Americans.”

In a move straight out of the Big Pharma aducanumab playbook, the company went back and conducted more than 30 post hoc analyses of the data, and found a few positive findings on a few tasks for some subgroups. This cherry-picking of subgroups after the fact is a classic example of manipulation, sometimes called “p-hacking” or “data dredging,” that can be described as “placing a bet on a horse after watching the race.”

The makers of Prevagen settled a class action lawsuit in 2020 with the FTC over deceptive business practices and false advertising. Remarkably, though, the settlement allows them to continue to market it, with the court-approved disclaimer that claims are “based on a clinical study of subgroups of individuals …” But with the amount of slicing and dicing of data they did, the chances of finding at least one false positive was estimated at 80 percent.

Prevagen may be more than just a waste of money. The manufacturer was cited for failing to report more than a thousand adverse events related by consumers to the Food and Drug Administration (FDA). Regulators can’t have it both ways, though. If the jellyfish protein is digested away, how can it pose a safety risk? Because dietary supplements are too often adulterated with contaminants. FDA inspectors specifically cited Prevagen’s manufacturing facilities for “objectionable conditions or practices.”

A 2019 survey by Pew found that more than half believed that the Food and Drug Administration requires supplements be tested for safety, but that isn’t true. One study of 24 supplements sold as cognitive performance boosters found that most claimed an ingredient on the label that wasn’t actually in the supplement. And worse, 38 percent contained ingredients not allowed in supplements, like prohibited drugs. Another study of a dozen so-called “brain health supplements” similarly found 8 out of 12 were misbranded (missing an ingredient promised on the label), and 10 out of 12 were deemed adulterated (containing unlisted compounds, for example caffeine in a product that explicitly highlighted all-caps ‘‘DECAFFEINATED’’ on the label). Only 1 of 12 was certiﬁed to contain what it said it did. The bottom line for Prevagen—there is no acceptable evidence that it is effective, and patients should be advised not to take it.

Please consider volunteering to help out on the site.

Motion graphics by Avo Media

Doctor's Note

A couple of weeks ago, I released a video on a controversial Alzheimer’s drug that used the same scam: Controversy Around FDA’s Approval of Biogen Alzheimer’s Drug, Aducanumab.

With supplements these days, it’s the Wild West. See, for example, Supplement Regulation and Side Effects: Efforts to Suppress the Truth.

For more on how to live your longest, healthiest life, preorder my new book How Not to Age. (As always, all proceeds I receive from all of my books are donated to charity.)

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