Prevagen

Prevagen the poster child for Quackery

I have become increasingly frustrated during my period of home confinement, with the numerous ads for OTC “memory aid” Prevagen. If you have not seen these ads, I’m surprised.

Summary of the issues:

1)      Apoaequorin is a protein. Which would be predicted to have no bioavailability by oral absorption? Think of insulin (also a protein), you cannot take this medicine orally and instead requires injection. All proteins are digested into their component building blocks (amino acids) before being absorbed in the gut. Do claims that orally taken protein will give your body any health benefit other than the amino acid building blocks? No.

2)      Studies have proven the health benefit? The company sponsored study in fact did not show any health benefit. The Madison Memory Study involved 218 participants and failed to show statistical benefit. The full study has never been published because it does not support the companies claim. Instead the company “massaged” the data, looking at smaller subgroups, a process called “p-hacking”.
To illustrate this point, I would like to share my experiences during cardiology training at the University of Washington in Seattle. I helped many ongoing research trials, including on involving thrombolytics given to heart attack patients (TIMI). Well done trial that did show overall benefit. It is quite normal for medical trials to include subsets which are predefined (male vs, female, old vs. young, diabetes etc.). What is not considered acceptable is to analyze the data afterwards with random subgroups (horoscope sign, patients with the first name “Alice”). Because the U of W is fully of great teachers, I can remember the teaching example. Eleven out of twelve horoscope sign category patients had benefit, but one did not. There were only two patients with the first name Alice, and both had bleeding side effects (not considered benefit in study). Does it make any sense to treat patients named Alice born under the sign Virgo differently than other patients based upon this analysis?
Back to Prevegen, they did 30 such subset analysis’s, and found two which met statistical criteria. Only in certain age group, with certain pretreatment test score, did results show benefit, likely by random chance alone.
Also in the below graph involving 8, 30 and 90 days, all showing upward trend, my understanding is that the 60 day data, did not follow this trend (placebo better the treatment), so they just omitted the data.

3)      Can the product be described as health supplement? The Food and Drug Administration in the U.S. has charged that Quincy Bioscience is marketing Prevagen as a dietary supplement, a category for which it does not qualify since apoaequorin is synthetically produced. Based on the claims made for the product, is should be classified as a drug, but it has never been approved as such. That would require a degree of evidence that the company cannot provide. FDA also claims that the company has not disclosed over a thousand reported adverse reactions to Prevagen including seizures, strokes, and worsening symptoms of multiple sclerosis as well as chest pains, tremors, fainting and curiously, memory impairment and confusion.

Summary. I associate Madison and the University of Wisconsin with many important health advances. The use of UV radiation to “sterilize” milk was also found to increase Vitamin D in milk, a process which I think is universally applied to milk products in US. I also tell the story of Wisconsin dairy farmers asking the university to help with a mysterious bleeding condition. They identified the active drug leading to clotting disorder, (I think it was in red clover), and named it after the Wisconsin-Research-Foundation (Warfarin, also known by trade name Coumadin). I realize that Quincy Bioscience is not affiliated with the university. I must admit that the most famous person I ever met from Madison was Chris Farley. He made me laugh but tragically died young. If the residents of Madison don’t express their disgust with quackery, I am worried that the shadow of shame will extend to all their graduates and residents. Did you go to the U of W associated with science (Washington) or the once associated with cheese (Wisconsin)?