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?
Does Prevagen Really Work?
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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.
- Ito K, Romero K. Placebo effect in subjects with cognitive impairment. Int Rev Neurobiol. 2020;153:213-230.
- Block BR, Albanese SG, Hume AL. Online promotion of “brain health” supplements. Sr Care Pharm. 2021;36(10):489-492.
- Quincy Bioscience Holding Co.: Opinion and Order. US FTC. Jul 2019.
- Moran DL, Underwood MY, Gabourie TA, Lerner KC. Effects of a supplement containing apoaequorin on verbal learning in older adults in the community. Adv Mind Body Med. 2016;30(1):4-11.
- Fair L. Prevagen complaint suggests mindfulness about memory claims. US FTC. Jan 2017.
- Prevagen: how can this memory supplement flunk its one trial and still be advertised as effective?. CSPI. Nov 2017.
- Grossman S, Nathan JP, Siuzdak A, Liang J, Sprycha C. Prevagen®: analysis of clinical evidence and its designation as a “#1 pharmacist recommended brand.” Sr Care Pharm. 2022;37(8):335-338.
- Moran DL, Tetteh AO, Goodman RE, Underwood MY. Safety assessment of the calcium-binding protein, apoaequorin, expressed by Escherichia coli. Regul Toxicol Pharmacol. 2014;69(2):243-249.
- FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims. US FTC. Jan 2017.
- Gabriel BA. AARP Asks Court to Declare Prevagen Ads Misleading. AARP. Mar 2018.
- Quincy Bioscience Holding Company: FTC Amended Reply. US FTC. Jul 2018.
- Federal Trade Commission & People of the State Of New York V. Quincy Bioscience Holding Co. (2d Cir.), Brief of the Federal Trade Commission, 17-3745 & 17-3791. US FTC. Mar 2018.
- Walker K. Strengthening the regulation of dietary supplements—lessons from prevagen®. Food and Drug Law Institute (FDLI). Nov 2021.
- Warning Letter. US FDA. Oct 2012.
- Eisner C. Americans took prevagen for years—as the FDA questioned its safety. Wired. Oct 2020.
- Rapoport R, Czyzewicz E. Methodology Report: FDA Supplement Survey. SSRS. Jul 2019.
- Q1141 Perceptions of Dietary Supplements and the FDA. SSRS. Oct 2019.
- Crawford C, Deuster PA. Be in the know: dietary supplements for cognitive performance. J Spec Oper Med. 2020;20(2):132-135.
- Crawford C, Boyd C, Avula B, Wang YH, Khan IA, Deuster PA. A public health issue: dietary supplements promoted for brain health and cognitive performance. J Altern Complement Med. 2020;26(4):265-272.
- Apoaequorin (Prevagen) to improve memory. Med Lett Drugs Ther. 2021;63(1636):175-176.
Motion graphics by Avo Media
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.
- Ito K, Romero K. Placebo effect in subjects with cognitive impairment. Int Rev Neurobiol. 2020;153:213-230.
- Block BR, Albanese SG, Hume AL. Online promotion of “brain health” supplements. Sr Care Pharm. 2021;36(10):489-492.
- Quincy Bioscience Holding Co.: Opinion and Order. US FTC. Jul 2019.
- Moran DL, Underwood MY, Gabourie TA, Lerner KC. Effects of a supplement containing apoaequorin on verbal learning in older adults in the community. Adv Mind Body Med. 2016;30(1):4-11.
- Fair L. Prevagen complaint suggests mindfulness about memory claims. US FTC. Jan 2017.
- Prevagen: how can this memory supplement flunk its one trial and still be advertised as effective?. CSPI. Nov 2017.
- Grossman S, Nathan JP, Siuzdak A, Liang J, Sprycha C. Prevagen®: analysis of clinical evidence and its designation as a “#1 pharmacist recommended brand.” Sr Care Pharm. 2022;37(8):335-338.
- Moran DL, Tetteh AO, Goodman RE, Underwood MY. Safety assessment of the calcium-binding protein, apoaequorin, expressed by Escherichia coli. Regul Toxicol Pharmacol. 2014;69(2):243-249.
- FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims. US FTC. Jan 2017.
- Gabriel BA. AARP Asks Court to Declare Prevagen Ads Misleading. AARP. Mar 2018.
- Quincy Bioscience Holding Company: FTC Amended Reply. US FTC. Jul 2018.
- Federal Trade Commission & People of the State Of New York V. Quincy Bioscience Holding Co. (2d Cir.), Brief of the Federal Trade Commission, 17-3745 & 17-3791. US FTC. Mar 2018.
- Walker K. Strengthening the regulation of dietary supplements—lessons from prevagen®. Food and Drug Law Institute (FDLI). Nov 2021.
- Warning Letter. US FDA. Oct 2012.
- Eisner C. Americans took prevagen for years—as the FDA questioned its safety. Wired. Oct 2020.
- Rapoport R, Czyzewicz E. Methodology Report: FDA Supplement Survey. SSRS. Jul 2019.
- Q1141 Perceptions of Dietary Supplements and the FDA. SSRS. Oct 2019.
- Crawford C, Deuster PA. Be in the know: dietary supplements for cognitive performance. J Spec Oper Med. 2020;20(2):132-135.
- Crawford C, Boyd C, Avula B, Wang YH, Khan IA, Deuster PA. A public health issue: dietary supplements promoted for brain health and cognitive performance. J Altern Complement Med. 2020;26(4):265-272.
- Apoaequorin (Prevagen) to improve memory. Med Lett Drugs Ther. 2021;63(1636):175-176.
Motion graphics by Avo Media
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Does Prevagen Really Work?
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Content URLDoctor'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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