Most days as I’m getting dressed for work (and the long commute downstairs) CNN is on the bedroom TV. Thankfully Wolf and Jake can’t see back!
Because of its older audience CNN has catheter, knee brace and stair chair ads. And then there’s Prevagen.
As the ad describes it, Prevagen is pretty much Viagra for brain functions. Getting forgetful? Take some of this.
The ad is quite well done. This is no cheapie infomercial quality production.
As we get older EVERYONE questions their own ability to remember. It’s one of the scariest parts of aging.
So here we have the most trusted name in news bringing Prevagen into my world. And, of course, I’m curious. I too have forgotten the subject in the middle of a sentence.
From US FDA Warning Letter to Quincy Bioscience, makers of Prevagen:
As noted on the list of inspectional observations issued to your headquarters and warehouse facility in Madison, Wisconsin, on December 22, 2011, our inspection of that facility revealed that you failed to report serious adverse events associated with your Prevagen products to FDA, as required by section 761(b)(1) of the Act. Specifically, you failed to report to FDA adverse events like seizures, strokes, and worsening symptoms of multiple sclerosis that had been reported to your firm as being associated with use of Prevagen products. Some of these adverse events resulted in hospitalization. In total, our inspection found records of more than 1000 adverse events and product complaints that had been reported to your firm between May 2008 and December 1, 2011. Some of these involved heart arrhythmias, chest pain, vertigo, tremors, and syncope (fainting), in addition to the seizures, strokes, and worsening of multiple sclerosis already mentioned. As of the beginning of the inspection, only two of these adverse events had been reported to FDA or investigated by your firm.
Why is this stuff still being sold today? There’s more. Nerdy, but interesting reading.
There’s one bit of good news. Prevagen can be assured this is one subject I won’t forget.