Makers of a product called Prevagen are falsely advertising it as a memory booster, and falsely claiming the product can get into the human brain, the charges claim.
But the company pushed back hard, insisting its product is safe and calling the FTC is a “lame-duck” federal agency with heads who are about to be replaced by the incoming administration of president-elect Trump.
It’s the latest battle in an ongoing war between the federal government and the Wisconsin-based Quincy Bioscience. In 2012, the Food and Drug Administration filed a warning letter to Quincy, saying it was making medical claims for a product that had not gone through the formal drug approval process.
“The Federal Trade Commission and New York State Attorney General have charged the marketers of the dietary supplement Prevagen with making false and unsubstantiated claims that the product improves memory, provides cognitive benefits, and is clinically shown to work,” the FTC said in a statement.
“The extensive national advertising campaign for Prevagen, including TV spots on national broadcast and cable networks such as CNN, Fox News, and NBC, featured charts depicting rapid and dramatic improvement in memory for users of the product.”
The capsules, which sell for anywhere between $40 and $90 for a bottle, supposedly contain a protein called apoaequorin, which is made by some jellyfish that luminesce.
The company tried, but failed, to show it can help people, the FTC says.
“The Madison Memory Study failed to show a statistically significant improvement in the treatment group."
“Defendants primarily rely on one double-blind, placebo-controlled human clinical study using objective outcome measures of cognitive function. This study, called the Madison Memory Study, involved 218 subjects taking either 10 milligrams of Prevagen or a placebo,” the charge alleges.
“The Madison Memory Study failed to show a statistically significant improvement in the treatment group over the placebo group on any of the nine computerized cognitive tasks.”
The Alzheimer’s Association didn't want to weigh in on Prevagen in particular but the organization's science officer Maria Carrillo noted that there's no product out there that's been proven to help memory.
"The Alzheimer’s Association has serious concerns about people using dietary supplements as an alternative or in addition to physician-prescribed, FDA-approved therapies in an attempt to treat or prevent Alzheimer’s disease or other dementias," she said.
"First and foremost, the effectiveness and safety are unknown. In addition, the purity of the product is unknown. Finally, dietary supplements can have serious interactions with prescribed medications."
Nonetheless, the company said the study did show the product works.
“Defendants, however, do not have studies showing that orally-administered apoaequorin can cross the human blood brain barrier and therefore do not have evidence that apoaequorin enters the human brain,” according to the charge.
“There is no reason for a short-staffed and lame-duck FTC to rush this complaint through.”
It doesn’t actually matter, because Prevagen is marketed as a supplement.
The Dietary Supplement Health and Education Act (DSHEA), passed in 1994, specifically exempts vitamins and supplements from FDA's pre-marketing scrutiny, although the agency can warn against products found to be dangerous.
Related: Vaccine Advocate Takes on Alternative Medicine Industry
And the FTC, as well as the Justice Department and state officials, can act against misleading marketing practices.
“The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence.”
The suit seeks to fine Quincy and force it to pay back consumers who bought the pills.
"First and foremost, the effectiveness and safety are unknown. In addition, the purity of the product is unknown."
However, the company said it will fight the charges.
“We vehemently disagree with these allegations made by only two FTC commissioners. This case is another example of government overreach and regulators extinguishing innovation by imposing arbitrary new rules on small businesses like ours,” it said in a statement.
“There is no reason for a short-staffed and lame-duck FTC to rush this complaint through.”
Members of Congress often defend companies. The FDA has frequently complained that DSHEA allows supplement makers to sell useless and often harmful products to trusting consumers, but Congress has failed to revise the legislation.
The maker of Prevagen, Quincy Bioscience, LLC (“Quincy”), settled a class action lawsuit in 2020 with the Federal Trade Commission (FTC) charging it with deceptive business practices and false advertising related to Prevagen. The settlement allows Quincy Bioscience to continue marketing Prevagen provided it qualifies its advertising claims with a court-approved disclaimer. The disclaimer Quincy now uses for Prevagen, “based on a clinical study of subgroups of individuals who were cognitively normal or mildly impaired,” has a technical meaning not likely understood by the typical dietary supplement consumer.
Quincy identified these clinical subgroups in an unplanned post hoc analysis performed after it failed to find a statistically significant treatment effect for Prevagen versus placebo in a study population as a whole. Most critically, Quincy’s claim of Prevagen’s statistically significant efficacy in certain patient subgroups is unreliable given that the analysis was not adjusted for multiple testing in accordance with good statistical practice. Congress can protect the public’s health from future legal settlements like Quincy v. FTC by revising U.S. dietary supplement regulations to require manufacturers provide strong, preapproved scientific evidence to substantiate the marketing claims for their products.
A JAMA viewpoint article entitled "The Rise of Pseudomedicine for Dementia and Brain Healthopens in a new tab or window" caught my eye recently, and I immediately thought of the widely-advertised, jellyfish-derived and totally useless supplement Prevagen.
The article, written by three prominent neurologists and dementia researchers at the University of California San Francisco, discusses the lack of science behind the $3.2 billion industry promoting unproven supplements for improved cognition and brain health.
Unproven supplements like Prevagen (Made from jellyfish! With a hard to pronounce crucial ingredient!) utilize a facade of "proven benefits" and succeed by promoting themselves as science-backed on radio, television, and the internet.
The JAMA article notes that this industry thrives due to the increasing prevalence of Alzheimer's disease, and its lack of effective treatments.
Consumers, it goes on to say, who are intent on finding methods to prevent dementia need to know three things:
There is no known dietary supplement that prevents cognitive decline for dementia.
Supplements do not undergo FDA testing for safety or review for efficacy.
Some supplements may cause harm. For example, vitamin E increases risk of hemorrhagic stroke and, in high doses, increases risk of death.
The Facade of Science-Backed Research
Companies like Quincy Bioscience, the maker of Prevagen, utilize sophisticated techniques that supply false scientific backing for brain health interventions.
The website for Prevagenopens in a new tab or window states "Prevagen improves memory" and "has been clinically shown to help with mild memory loss associated with aging."
As the JAMA articled pointed out, these bogus brain supplement companies quote scientific articles that appear valid but lack essential features such as "sufficient participant characterization, treatment randomization and fail to include limitations." These bad papers are often published in predatory open-access journals.
In the case of Prevagen, despite marketing that includes "The Science Behind Prevagen," there isn't even a single study published in the peer-reviewed scientific literature -- predatory or otherwise.
If you click on the "View the Study" link you will be taken to a PDF of the "Madison Memory Studyopens in a new tab or window," which is a study sponsored by Quincy Bioscience, performed by an employee of Quincy Bioscience and published in-house by Quincy Bioscience.
In the world of real science, this type of study is ignored and considered extremely preliminary until it is reproduced by a reputable unbiased scientific lab and published in a peer-reviewed journal. The chances for biased results are way too high to trust.
FTC Files Suit Against Quincy Bioscience
According to the Federal Trade Commission (FTC), which charged Quincy Bioscience with false and deceptive advertising in 2017opens in a new tab or window, the initial version of this company study found that Prevagen was no more effective than a placebo at improving any of the nine cognitive skills, including memory, that the company measured.
"The marketing for Prevagen is a clear-cut fraud, from the label on the bottle to the ads airing across the country," said New York Attorney General Eric Schneiderman. "It's particularly unacceptable that this company has targeted vulnerable citizens like seniors in its advertising for a product that costs more than a week's groceries, but provides none of the health benefits that it claims."
"The marketers of Prevagen preyed on the fears of older consumers experiencing age-related memory loss," said Jessica Rich, director of the FTC's Bureau of Consumer Protection. "But one critical thing these marketers forgot is that their claims need to be backed up by real scientific evidence."
The suitopens in a new tab or window seeks to fine Quincy and force it to pay back consumers who bought the pills.
Since then, Quincy went back and "re-analyzed" their in-house data, coming up with three parameters that improved and challenged the FTC in court. This process is called p-hacking and any significant findings gathered through this process are highly suspect.
A great article on the Prevagen caseopens in a new tab or window from the McGill University Office of Science and Society summarizes the problems with this re-analysis:
"This is an after-the-fact, unplanned exploration of the data to see if anything else of interest happened in the trial. Some might call it a fishing expedition. Scientists do this all the time, but with a big caveat: post hoc results are considered tentative, not conclusive. Before they're accepted as valid outcomes, they need to be confirmed by additional studies."
"That's because random events happen all the time in scientific studies. Some of them may seem statistically significant, but they're flukes and not the result of cause-and-effect. And the more post hoc analyses you do (like the more than 30 Quincy Bioscience did), the more likely you'll encounter these chance results."
"Scientists guard against accepting them as real by setting a high bar for statistical significance and by not accepting post hoc findings until they've been tested again."
Despite the total lack of proven efficacy and the lawsuit by the FTC, the company continues to heavily market Prevagen and reap millions of dollars in profits from the gullible. Prevagen is sold at the pharmacies of the companies shown here opens in a new tab or window, which should immediately remove this snake oil if their aim is to help consumers.
For a more in-depth analysis, see the deep dive by Jann Bellamy at Science-Based Medicine in "Prevagen goes P-hacking."opens in a new tab or window
Anthony Pearson, MDopens in a new tab or window, is a private practice noninvasive cardiologist and medical director of echocardiography at St. Luke's Hospital in St. Louis. He blogs on nutrition, cardiac testing, quackery, and other things worthy of skepticism at The Skeptical Cardiologistopens in a new tab or window, where a version of this post first appeared.
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