You do not watch television if you have not seen the remarkable ad campaign for Prevagen, an over-the-counter supplement for “brain health.” The advertising industry has outdone itself with slick, convincing anecdotes that report the amazing benefits of this drug that hit the market in 2007. These efforts appear to be highly effective in tantalying people to buy the product. In 2019, Quincy Bioscience, makers of Prevagen, spent $67 million on ads for the product, and realized $165 million in revenue for this product in 2015 (attempts to verify and update these numbers from the company have met with no response)
One little problem: the advertising campaign bears all the marks of fraud.
First, what is the basis of the supplement? There is a protein in jellyfish, apoaequorin, that is also in the human brain. The idea is for people to ingest the supplement that has the protein and have it travel to the brain to improve “healthy brain function, sharper mind, and clearer thinking.” The protein, however, is broken down in the digestive tract and has no chance to take up residence in the brain.
Undaunted, Quincy conducted one trial (serious science would require many studies in multiple settings with diverse populations) of the drug that found a slight advantage for memory in a small number of subjects. The quality of the research has met with virtually universal derision.
Nevertheless, the FDA (the federal Food and Drug Administration) approved Prevagen as a supplement for over-the-counter sales. The decision to market Prevagen as a supplement was critical to the approval process. “Pharmaceuticals” are subject to far more rigorous testing, and, in the words of an executive at Quincy, they did not want to wait for the extended time that would be necessary to approve a drug, rather than a supplement. In addition, the company was careful to refrain from asserting benefit for a described disease entity, like Alzheimer”s Disease, limiting itself to claims for improvement in symptoms. This avoided elevated levels of regulatory scrutiny.
A Fusillade of Criticism and Lawsuits
In recent years, Prevagen has gained notoriety for reasons Quincy had not planned on. In 2017 the Federal Trade Commission (FTC) and the New York Attorney General sued Quincy Biosciences for making false claims,citing the senselessness of the “science” that underlies the supplement’s supposed benefits, On the bandwagon of criticism of the inadequacy of the clinical studies that claimed benefit for taking Prevagen, the FTC noted that the company’s own clinical study in actuality showed no statistically significant improvement in memory and cognitive function between those given Prevagen and those given a placebo. The FDA has opened a case stating that Prevagen did not warn its users that seizures and strokes were some of the many adverse side effects reported by people taking Prevagen. Curiously, memory impairment and confusion are also possible side effects that the company has chosen to ignore. Finally, by 2020, seven class action lawsuits have been filed against Quincy regarding allegations of false advertising.
Failure on Multiple Fronts
Clearly there has been regulatory failure, maybe even mischief, in the approval of Prevagen. But the libertarian streak in me thinks that people who allow themselves to be entranced by transparently exploitative advertising get what they deserve. On the other hand, I am very angry at the naked cynicism of a company that pushes a useless, maybe even dangerous, product in the pursuit of profit.