Does Prevagen Prevent Memory Loss?
Not likely
You may have seen the ad for Prevagen during morning news shows or between innings of a Red Sox game: a video of a pulsating jellyfish, whose nervous system glows green. The substance that provides the green glow is protein called apoaequorin and it is very well studied.
The commercial goes on to say that ‘a double blind placebo controlled study suggests that Prevagen improves recall of older adults who have reported memory problems. If you freeze the screen it reads: These statements have not been evaluated by the FDA. And: Not intended to diagnose, treat, cure or prevent any disease. Then there is a graph that shows memory of impaired patients improving over 90 days. Sometimes the ads include a clip of a woman defeating her granddaughter at chess.
As you might have suspected, there is a back-story. Prevagen is a dietary supplement and thus escapes the scrutiny of the FDA: it needs only to be harmless, not effective. If it were a prescription drug, validated for safety and effectiveness by the FDA, it would contain a package insert, with all manner of chemical information, pharmacodynamics (how long does the drug lasts in the blood), and sites and mechanism of action. There would be data from clinical trials and references to the scientific literature. I read these things the way an investor tackles a financial report, but I have not found one for Prevagen. The only insert is an order form to buy more. And yes, I bought a bottle of it.
The apoaequorin in Prevagen would have to survive the hydrochloric acid and protein destroying enzymes of the stomach; it would have to be absorbed in the small intestine; it would have to get into the blood stream, and it would have to pass the formidable defenses of the blood-brain barrier. It would have to get into affected nerve cells and improve their function. It would have to pick up a second small molecule to become the light emitting aequorin, rather than its precursor apoaequorin. Light emitting proteins like aequorin are well-studied and useful in biology but here is no biological reason to believe that they improve memory or recall in impaired adults.
Quincy Biosciences, the maker of Prevagen, has funded a clinical trial, grandly named the Madison Memory Study. The Madison Memory Study started with 218 adults between the ages of 40 and 91 and lasted for 90 days. The authors conclude that there is little overall difference between treated patients and patients given a sugar pill. However, if they sorted out patients who were minimally impaired, according to a test of recall of words on a list, there seemed to be a slight improvement at the end of 90 days of taking Prevagen. The reported data bear little relationship to the graph shown on TV.. The study was not peer-reviewed, nor was it listed in ClinicalTrials.gov, both serious breaches in the world of clinical trials. E-mail me for a PDF of the paper that reports this trial.
I’m just a country scientist, but I learned during Watergate to follow the money. Advertising on major networks is expensive and Prevagen is advertised a lot. A thirty-pill supply lasts a month and costs $40, unless you buy the extra strength version, which costs $59. What worried family would hesitate, even if there was a small change that Prevagen would help grandma?
How is it possible for a company to sell about $120 million worth of this stuff in a year? Dietary supplements face few constraints, except that they be harmless, which apoaequorin apparently is. (It is made from recombinant DNA expressed in bacteria, not from jellyfish). Serious legal and political battles mounted by the dietary supplements industry have kept d supplements away from the FDA.
Prevagen is not completely safe from regulation. The Federal Trade Commission has accused the makers of fraudulent advertising and has acted against the company, joined by The New York Attorney General’s office. The FTC lost the first round. As I understand it, the judge ruled that Quincy Biosciences described their trial adequately and that was all that was required for a dietary supplement. The decision is mystifying, on a biological and a statistical grounds, but we will see what the appeal brings.
Sadly, the failure of biomedical scientists to create treatments for dementia is partly to blame. This column will try to cover new information from the Alzheimer field and what is being done with the tripled NIH budget ($1.9 billion) for dementia studies of all kinds.
Richard Kessin is Professor Emeritus of Pathology and Cell Biology at Columbia University. He lives in Norfolk and can be reached at Richard.Kessin@gmail.com