The Price of Predatory Marketing on Older Adults: A Perspective on Prevagen Potency

ABSTRACT

The calcium-binding protein apoaequorin has been studied for its possible indication to improve human cognition and memory. Faculty at Quincy Bioscience developed Prevagen with this in mind, claiming its apoaequorin-formulated supplement may decrease age-related memory loss. A summary of the pathway orally administrated apoaequorin would take in order to penetrate the central nervous system (CNS), with particular focus on digestive elements and blood-brain barrier (BBB) permeability is presented. A discussion of the ethicality of the research and marketing practices of Quincy Bioscience in the commercial sale of Prevagen is given as well.

Introduction

Apoaequorin's Use for Memory Loss Mitigation

Researchers Osamu Shimomura, Martin Chalfie, and Roger Tsien won Nobel prizes for the discovery of glowing proteins in fish, including aequorin's role in jellyfish Aequorea Victoria's bioluminescence. Aequorin is a photoprotein with three calcium-binding sites that partake in aequorin's catalytic ability to produce bioluminescence. While our knowledge of marine biochemical processes has expanded because of their research, less consideration was given to a pharmacological application of aequorin's calcium-binding capabilities. Recent studies have been conducted to test apoaequorin, a subunit of aequorin, and its calcium-binding abilities for potential uses in medically regulating pathological calcium toxicity and calcium-mediated signaling pathways.

Prevagen and its Bioavailability

Prevagen is a $60 dietary supplement directed to be taken once daily in oral capsule form. Prevagen, though not deemed a drug by the FDA by definition, and not found on clinicaltrials.gov as part of any past or present clinical trial, is strongly suggested it can improve memory and prevent memory loss associated with aging.For Prevagen to be effective as an oral supplement, it must first survive digestion and be absorbed into the bloodstream.[10] After this, it would have to cross the blood-brain barrier (BBB).[11] Finally, to efficiently decrease ischemic cell death or affect positive change in memory formation, Prevagen would have to bind a sufficient amount of calcium within the hippocampus neuron region, the region of the brain associated with learning and memory.[12]

Discussion

According to the FDA, a drug is defined as a product designed for diagnosis, recovery, rehabilitation, cure, or disease prevention. Prevagen is intentionally categorized as a supplement that does not need approval from the FDA to be marketed to the public. Nevertheless, Quincy Biosciences commercializes Prevagen to the public as appropriate for those with mild memory loss due to the effects of aging. They advertise on their website: "Prevagen has been clinically shown to help with mild memory loss associated with aging."[RG1] However, there is limited clinical or basic science evidence to substantiate that statement.[21] The company would appear to be targeting the fears of the vulnerable minds in the older community.

Research Practices

Prevagen is advertised as a supplement that is capable of improving memory and helping with memory loss associated with aging, with the company going as far as to claim that these findings are clinically proven. However, when investigating these claims, there are concerns regarding these reports.First is that the basis of their clinically proven claims is a single study, the Madison Memory Study.[22] This study was conducted by researchers at Quincy Bioscience, the same biotechnology company responsible for developing Prevagen. This would be an apparent conflict of interest. Because of commercial interests and confirmation bias, it is unclear whether this research is to be trusted, especially when it is the only research provided as evidence to support their claims. Further, this study reports no statistical significance in the difference between the control groups and the experimental groups.[22] Therefore, the only study provided as evidence for apoaequorin activity when orally consumed does not fully support their claims.

Second, Prevagen makes apparent contradictory claims when providing their safety assessment studies. It was shown that apoaequorin is broken down by digestion,[14] making it unlikely to cause an immune response. This means that when taken as recommended, apoaequorin would not make it to the blood-brain barrier and cross into the extracellular space of the brain as an intact, calcium-binding compound.

Conclusion

Their misleading claims in marketing appear to take advantage of and capitalize on the susceptible target audience of older consumers. Advertising, in general, should be truthful and accurate, but especially so when it comes to protected classes based on age, race, gender, certain health conditions, among others. There is at least one court case by the state of New York filed in 2017[23] against the makers of Prevagen, arguing that the company is making deceptive claims that have violated the Federal Trade Commission Act and the laws of the state.

The individuals targeted for this marketing are those who are older and may have issues with memory loss or cognitive ability. Research has shown that adults 65 years of age or older consistently had lower levels of literacy in comparison to younger age groups.[24] Because of this, members of this community could be more prone to misinterpreting information. Thus, when presented with false claims of possible remediation, they are more susceptible to accept them as authentic. In an article by Drolet and colleagues [25], the authors describe how older adults can more easily fall victim to this kind of marketing. Some of the reasons explaining this provided by the article include changes in sensory functioning and awareness, as well as the "older consumers experienc[ing] significant declines in cognitive ability that can negatively affect their comprehension of persuasive communications."[25]

Although the FTC legally allows it, a higher standard should be expected and enforced when marketing to these older individuals. This includes being extremely clear about what the supplement has been scientifically proven to do and supporting their claims with substantial evidence. A more considerable amount of pharmacological testing would be required to establish that apoaequorin functions as claimed. This would include studies establishing survival of the supplement through digestion, penetrating the blood-brain barrier, or conducting a clinical trial for Prevagen to substantiate their claims. As it stands now, due to calcium playing a role in a plethora of cell functions, it is implausible that apoaequorin would be able to target neuronal brain cells specifically. More experimental testing should be performed before releasing Prevagen to the public as a dietary supplement to ensure its proper function in assuredly aiding memory loss associated with aging. From the current research, it can be concluded that the oral consumption of apoaequorin likely exerts its effect as a placebo as no clear mechanism exists to alter brain function. Can a protein found in jellyfish really improve your memory? These scientists say "No."

Credit: Inquiries Journal