Kevin Lomangino is the managing editor of HealthNewsReview.org. He tweets as @KLomangino.
Major League Baseball players are sharpening their skills this month in Florida’s pre-season Grapefruit League.
Meanwhile, Quincy Bioscience, a supplement company, is sharpening its pitch for a chewable supplement that supposedly “improves memory” and “supports clearer thinking.”
A free sample of the product, called Prevagen, was handed out to our Publisher, Gary Schwitzer, who was taking in some pre-season action while traveling in Florida. Schwitzer told me he “apparently must have looked like a prime candidate for memory-loss therapy while searching for the men’s room.”
He emailed me a photo of the product package along with a link to a critical evaluation of the supplement by Gayle Nicholas Scott, PharmD, an assistant professor at Eastern Virginia Medical School in Norfolk.
Writing at Medscape in 2016, Scott said that clinical research on the active ingredient in Prevagen — a protein called apoaequorin that’s derived from a glowing jellyfish– is “nonexistent.”
An abstract of a manufacturer-sponsored study was published in 2011; however, a full report of the study has not been published in the peer-reviewed literature.
Details of the methodology of this manufacturer-sponsored study (or any study using apoaequorin) have not been posted on ClinicalTrials.gov.
My visit to the Prevagen website today confirmed that there were still no links to peer-reviewed, published research documenting clinical benefits from the supplement. The only effectiveness study under the site’s “research” tab was self-published by the company and reported that “no statistically significant results were observed over the entire study population.” Improvement in cognitive function was reported only in specific subgroups of study participants, but it’s important to keep in mind that subgroup analyses do not offer strong evidence of a benefit, experts say.
Why is the product allowed to be sold if there’s no good evidence that it works? Remember that supplements are regulated much less stringently than drugs in the United States. “The U.S. Food and Drug Administration (FDA) does not determine whether dietary supplements are effective before they are marketed,” notes the NIH office of Dietary Supplements.
What’s more, the company website claims apoaequorin has undergone “extensive safety testing” and that the company is “not aware of any common side effects associated with taking Prevagen.”
FDA documents reveal otherwise. The company has not been forthcoming about sharing that information, according to Scott:
In a warning letter to the manufacturer, the US Food and Drug Administration cited failure to report more than 1000 adverse events, such as seizures, strokes, and worsening symptoms of multiple sclerosis, some of which resulted in hospitalization.
The manufacturer’s website does not mention these adverse effects but cites the product’s safety in two animal studies,[9,10] which the manufacturer used to obtain “generally regarded as safe” (GRAS) status for the use of apoaequorin as a food additive.
According to the GRAS documentation, as of January 2014, the manufacturer had received 2281 reports of adverse events. The top 10 adverse effects were:
Headache: 428 events (18.76%);
Dizziness: 172 events (7.54%);
Nausea: 155 events (6.80%);
Hypertension: 84 events (3.68%);
Diarrhea: 74 events (3.24%);
Memory impairment: 74 events (3.24%);
Insomnia: 63 events (2.76%);
Anxiety: 54 events (2.37%);
Stomach pain: 51 events (2.24%); and
Confusion: 46 events (2.02%).
This is not the first time we’ve written about spring training health and medical marketing – also with a men’s room angle.
Nor is it an isolated example of a useless product touted as “clinically tested” or even “clinically proven.”
Such claims and their sports tie-ins are ubiquitous in the media and follow an increasingly predictable schedule. With the NCAA basketball tournament around the corner, can promotions for “Vasectomy Madness” be far behind?