June 07, 2018

The Sting of the Jellyfish

Several years ago, the public health community launched an initiative to persuade pharmacies to stop selling cigarettes. Responding to steady pressure, CVS announced in 2014 that it was pulling all tobacco products from the shelves of its approximately 7700 stores. The result? Overall sales of cigarettes dropped, with fewer teens starting to smoke and more people quitting. The other chains, such as Walgreen’s and Rite Aid, have not yet followed suit, but the precedent has been set: retailers dedicated to the promotion of health should not be in the business of peddling death—and cigarettes are the leading cause of preventable death in the U.S., accounting for over half a million deaths per year.

In the same vein, we might ask why news organizations that are dedicated to ferreting out the truth continue to allow ads that peddle falsehoods. And that’s exactly what CNN, Fox News and MSNBC are doing when they advertise Prevagen, a protein that its manufacturer, Quincy Bioscience (a company that seems to be devoted almost exclusively to making and selling Prevagen) touts as “clinically shown to improve memory,” exhorting aging individuals to “try Prevagen for yourself today” in order to “support healthier brain function, a sharper mind and clearer thinking.”

These claims are untrue. The FDA issued a warning letter to the company in 2012, arguing that the company’s unverified health claims indicate that it is selling a drug and not a “supplement” (as the company calls Prevagen) and thus must go through the rigorous approval process for new drugs. Today, the manufacturer continues to call Prevagen a “supplement” because it is a synthetic version of a protein found in jellyfish and continues to make the same claims about its effectiveness, though with the disclaimer in small print that “these statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat cure or prevent any disease.” 

In 2016, the Federal Trade Commission’s Bureau of Consumer Protection and the NY State Attorney General filed a lawsuit arguing that, contrary to its manufacturer's claims, Prevagen has not been shown to improve memory in 90 days; it has not been shown to reduce memory problems associated with aging; and it has not been shown to produce other cognitive benefits.That lawsuit, incidentally, was dismissed because the judge failed to understand that the methodology used in the clinical trial on which the company’s assertions are based is irredeemably flawed. With the added support of AARP, the case has been appealed to the Second Circuit Court of Appeals. 

Why anyone should be motivated to take Prevagen based on its activity in jellyfish, which are not known for their cognitive abilities, is a mystery to me. 

Why anyone should think that the active ingredient, Apoaequorin, could possibly do anything when it is destroyed in the stomach by the enzyme pepsin and therefore doesn’t even make it into the circulation is another puzzle. And why anyone should believe that Apoaequorin could affect brain function (if it somehow managed to elude stomach enzymes and find its way into the blood stream) when it is 40 times too large to cross the blood-brain barrier is also unknown. But what is clear is that Quincy Bioscience has been successful in earning $165 million between 2007 and 2015. It is willing to spend big bucks on advertising on national television to promote its product because it knows the strategy works.

Followers of CNN, MSNBC, or Fox trust the news they hear from commentators on those stations. Because they trust the station, they tend to trust its advertisers. News programs have an ethical responsibility to vet the ads they run; they don’t have to like the products, they don’t have to want the products themselves, but they should be committed to fact-checking their veracity.

A separate question is why FDA regulation of “supplements” is confined to assuring that they are accurately labeled—that is, that the ingredients are correctly listed on the bottle. Manufacturers of dietary supplements do not have to prove them safe nor do they have to make claims about efficacy that are accurate or truthful. A related question is why products such as Prevagen can bypass the FDA's regulatory process for new drugs by calling themselves “supplements,” a term primarily applied to vitamins and minerals but increasingly used for all sorts of “herbs and botanicals” as well as other substances found in nature, or their synthetic analogs. 

In today’s anti-regulatory climate, we cannot realistically expect increased government protection for vulnerable consumers. We can expect—and demand—ethical behavior from any organization dedicated to promulgating the truth.

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