Thread by @ChiaraEisner, THREAD: Interested in the story behind @Prevagen but the @WIRED investigation we [...]

THREAD: Interested in the story behind @Prevagen but the @WIRED investigation we pub this week was just too long? I got you.

Read this for some of the most interesting bits from the article ( https://www.wired.com/story/prevagen-made-millions-fda-questioned-safety/),">https://www.wired.com/story/pre... and NEW info and docs published HERE for the 1st time:

Americans Took Prevagen for Years—as the FDA Questioned Its Safety

From the memory supplement’s launch in 2007 through 2016, agency officials repeatedly raised concerns as the number of consumer complaints grew.

https://www.wired.com/story/prevagen-made-millions-fda-questioned-safety/

The main ingredient in Prevagen, a synthetic (jellyfish) protein, is made from E-coli via fermentation.

The process requires stringent quality control. But from ‘11-‘16 the FDA found manufacturing and quality issues at Prevagen sites.

Prev. UNPUBLISHED FDA docs from ‘11 & ‘16:

From 2011 through 2018, the FDA found that Quincy was not reporting adverse events according to FDA law.

*Serious* adverse events are reports that describe someone who experienced something fatal, life threatening, requiring of hospitalization, or resulting in serious damage...

Quincy failed to report dozens of adverse events they heard about from ppl who took Prevagen that inspectors later flagged as serious. Many that Quincy failed to report showed ppl had exp seizures, strokes, heart arrhythmias, and vertigo.

See prev. UNPUBLISHED FDA doc from 2015:

In 2018, the FDA finally issued a “close out” letter to Quincy, which stated that it appeared the company had addressed the violations in the warning letter that was issued to the company 6 yrs b4, in 2012: the only enforcement action the FDA seems to have taken against Quincy.

But the FTC lawsuit continues, because Quincy is still relying on research to sell Prevagen as “effective” that has serious issues.

FTC says the post-hoc analysis QB did on results “greatly increases the probability that some stat. sig. differences would occur by chance alone”

But also, NEW from me:

1. Tho research was paid for by Quincy, makers of Prevagen & the 2nd author is Mark Underwood, co-founder, no conflict of interest is stated in the paper in “Advances in mind-body medicine” (see photos)

2. EIC of Advances had his medical license suspended

3. There’s an advertisement for Prevagen on the back cover of the SAME edition of Advances that the Quincy research was published in.

Unbelievable?

See my photos.

There’s more!

But for now, share this thread with anyone who may have taken Prevagen because they still have 3 days left to file a claim in the settlement and get $ back from the company: https://kccsecure.com/quincybiosciencesettlement/Claimant

And">https://kccsecure.com/quincybio... read the full investigation @WIRED: https://www.wired.com/story/prevagen-made-millions-fda-questioned-safety/">https://www.wired.com/story/pre...

Americans Took Prevagen for Years—as the FDA Questioned Its Safety

From the memory supplement’s launch in 2007 through 2016, agency officials repeatedly raised concerns as the number of consumer complaints grew.

https://kccsecure.com/quincybiosciencesettlement/Claimant

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