Does Prevagen help in reducing memory loss?

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 blue. The substance that provides the blue 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 validated 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 drug the FDA would have tested Prevagen for safety and effectiveness. Had it passed scrutiny (which I believe it would not), Prevagen would be sold with a package insert, with all manner of chemical information, pharmacodynamics (measurement of how long 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. I bought a bottle of it to learn that there is no useful insert. 

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. There is no biological reason I can see to believe that it could improve memory or recall in impaired adults.

Quincy Biosciences, the maker of Prevagen, has funded a clinical trial, named the Madison Memory Study, which enrolled 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 placebo pill. However, if they sorted out patients who were minimally impaired to begin with 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. This sort of post-hoc searching is not statistically valid. The reported data bear little relationship to the graph shown on TV, which is strange. 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.

Advertising on major networks is expensive and Prevagen is advertised a lot.  A 30-pill supply lasts a month and costs $40, unless you buy the extra strength version, which costs $59. What worried family would hesitate, if there were even a small chance 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 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 and New York state lost the first round in court.  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 to me on biological and statistical grounds, but we will see what the appeal brings. For a more sophisticated analysis of statistics in the law and as it pertains to this case, see the October 2017 blog by Rebecca Tushnet, Professor of Law at Harvard Law School. The blog is easily found at tushnet.blogspot.com.

Sadly, the failure of biomedical scientists to create treatments for dementia is partly to blame for the success of dietary supplements. 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.