Within the last decade, Wisconsin-based biotechnology company Quincy Bioscience has been promoting its wonder pill, Prevagen, as a supplement for ensuring memory health and cognitive well-being. The company, on its website, claims that users of Prevagen “experience improved memory, a sharper mind, and clearer thinking” (Prevagen, 2018).
Since its development, Prevagen is now available at outlets such as CVS, and has been widely advertised on major TV stations such as CNN, FOX, and ABC. Selling anywhere from $24 to $68 per bottle, Prevagen has sold up to almost a quarter of a billion dollars within the last 10 years.
Prevagen contains the active ingredient, Apoaequorin, a protein isolated from the jellyfish Aequorea victoria. Apoaequorin binds to calcium ions and produces the blue luminescence which this jellyfish exhibits.
So how is this related to memory? Calcium, a major second messenger molecule, when in excess, has been implicated in neuronal cell death and aging, manifesting physiologically as age-related declines in cognitive function and memory. This symptomatology is at the forefront of neurodegenerative disorders such as dementia. The logic is that Apoaequorin, having a strong affinity to calcium, could regulate calcium levels in the brain, and contribute to maintaining cognitive function and memory (Smaili et al., 2009).
Quincy Bioscience used this as the rationale for their Madison Memory Study, a randomized placebo-controlled clinical trial assessing the Apoaequorin-containing Prevagen pill. The company touts this study as the validation of Prevagen’s efficiency as a memory supplement.
However, here is where things start to unravel. First of all, the trial indicated that “no statistically significant results were observed over the entire study population for any of the study’s cognitive tasks.” More importantly, the trial did not directly compare the Apoaequorin and control groups.
The ‘evidence’ that the company continues to tout is the apparent improvement in cognitive performance in retrospective analyses of some specific subgroups of study participants (Lerner & Quincy Bioscience, LLC., 2016). No further research studies and no further evidence have substantiated the company’s claims. All the company did was find the slightest piece of information from one study (that, itself, was inconclusive) to validate their hypothesis. That alone cannot validate the effectiveness of a drug.
Moreover, this pill has ever-present issues of bioavailability. There is research suggesting that the drug is rapidly degraded during digestion alone. Moreover, the Apoaequorin protein, a polar molecule, would likely not be able to penetrate the non-polar blood-brain barrier period, let alone have any significant physiological effect (Moran et al., 2014)
While Prevagen does not have any particularly adverse side effects, no company should market a supplement to the broader public without any substantial scientific evidence of its therapeutic effect.
In fact, in 2017, the Federal Trade Commission (FTC) and New York State Attorney General both charged Quincy Bioscience with making “false and unsubstantiated claims” about Prevagen being “clinically shown” to improve memory and cognition (FTC, 2017). Ultimately, the court case ruled in favor of Quincy Bioscience, citing that, while the complaint indicated the possibility of inconclusive results, “the subgroup concept is widely used in the interpretation of data in the dietary supplement field,” and that the Madison Memory Study utilized “well-accepted procedures” (FTC vs. Quincy Bioscience Holding Company, Inc., 2017).
In other words, finding even the most minute of results from a small group within your study to substantiate your desired hypothesis, flawed as it may be, is a legitimate analysis of the data used by many in the dietary supplement industry. Hence, they got the benefit of the doubt.
In the U.S., dietary supplement companies are not allowed to claim that their products actually prevent or treat diseases. However, once they back their product with any piece of even solitary evidence from clinical research, and then add a disclaimer about the product (no matter how inconspicuous), then they can sell the supplements without an issue.
When advertising, what dietary supplement companies do is list alleged therapeutic effects, each of which is accompanied by an asterisk. These asterisks then lead to a small-font, often inconspicuous footnote saying that the pill has not been evaluated by the U.S. Food and Drug Administration (FDA), and is not intended as a treatment or cure for any disease.
While unethical, the drug companies exonerate themselves by saying that they did technically mention the disclaimer information. In the end, they use this ‘fine print’ tactic to lure people into buying their supplements. In their televised commercial, Quincy Bioscience is employing these very same tactics. However, the disclaimer information flashes up on such a short segment that it can easily go by undetected. The allure of a mysterious wonder drug from an exotic creature like the jellyfish would already divert much of the attention of many viewers from the actual science behind the pill itself.
The FTC said that it would appeal the court decision. However, as it stands, Quincy Bioscience got off scot-free, and are still earning a financial windfall through enticing many consumers into buying a pill of hitherto unproven therapeutic effect. This company’s raison d’être should be to work towards finding the best treatments to save lives and improve societal health, not to maximize profits. Rather than sell an unproven pill, they should be working to expand on what is a valid school of thought regarding calcium and brain health, to develop a therapeutic that has substantial evidence to show that it works.
So, is Prevagen a proven, effective memory supplement? No. Could the compound in jellyfish actually confer some therapeutic benefit? Perhaps, or perhaps not…but more research needs to be done. As an aspiring physician, I am against the notion of marketing a pill that is not proven to be effective. The FDA needs to be more stringent on the sale of such supplements. One piece of data from a single study and adding a disclaimer cannot be the sole requirements for marketing a supplement. More substantiated research evidence is needed. Such measures will be essential both in ensuring justice for consumers, and for setting a precedent in preventing the premature marketing of such supplements in the future.
Federal Trade Commission (FTC). (2017, January 09). FTC, New York State Charge the Marketers of Prevagen With Making Deceptive Memory, Cognitive Improvement Claims. Retrieved from https://www.ftc.gov/news-events/press-releases/2017/01/ftc-new-york-state-charge-marketers-prevagen-making-deceptive
Federal Trade Commission, People of the State of New York, by Eric T. Schneiderman, Attorney General of the State of New York vs. Quincy Bioscience Holding Company, Inc., a corporation, (United States District Court for the Southern District of New York, September 28, 2017).
Lerner, K. C., & Quincy Bioscience, LLC. (2016). Madison Memory Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of Apoaequorin in Community-Dwelling, Older Adults. Adv Mind Body Med, 30(1), 4-11. Retrieved from http://www.prevagen.com/wp-content/uploads/2017/02/ClinicalTrialSynopsis-cmk816.pdf
Moran, D. L., Tetteh, A. O., Goodman, R. E., & Underwood, M. Y. (2014). Safety assessment of the calcium-binding protein, apoaequorin, expressed by Escherichia coli. Regulatory Toxicology and Pharmacology, 69(2), 243-249. doi:10.1016/j.yrtph.2014.04.004
Prevagen. (2018). Who We Are: Quincy Bioscience – The company behind Prevagen®. Retrieved from http://www.prevagen.com/about-the-company/
Smaili, S., Hirata, H., Ureshino, R., Monteforte, P.T., Morales, A.P., Muler, M.L., Terashima, J., Oseki, K., Rosenstock, T.R., Lopes, G.S., & Bincoletto, C. (2009). Calcium and cell death signaling in neurodegeneration and aging. Anais da Academia Brasileira de Ciências, 81(3), 467-475. https://dx.doi.org/10.1590/S0001-37652009000300011