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Regulatory News – Theranos

April 19, 2016

As I often tell my customers, I’m not a regulatory consultant. With that said, I do take some interest in regulatory matters. This particular piece of news caught my eye, yesterday:  Feds May Pull Theranos Lab Licenses, Ban Founder Elizabeth Holmes. This company allegedly recorded that they used different instruments than what were actually used.

I was stunned!

As usual, I’m thinking about this from the LIMS/ELN/LES standpoint because you know that’s always where my mind goes. In any case, in our systems, whether someone is doing research or doing quality control testing, we spend so much time trying to make sure we’re pointing to exactly the right instrument with the right type of information associated with it to verify the way testing is done and etc… that it kind of blows me away that there’s a company that wanted to do exactly the opposite. I mean to say that I “get it” – they did it to make their results come out. However, with all the time the rest of us spend making it all exactly right, it still kind of blows me away.

I guess the rest of us are so busy doing what we think we need to do (making sure all instrument information in the system is exactly correct and up-to-date) that it’s never occurred to us to most of us do anything else. It’s not that I even stop to think to do it so that something “bad” doesn’t happen nor that it’s the “right” thing to do. It’s so programmed into us to do all this that it’s just weird to read about someone who didn’t do this, even if it seems clear what their motive was.

Maybe the bottom line to this is that most people are too busy just getting the work done to think about cheating? With that, I will hit “publish” and return to my project work, for the day.

Gloria Metrick
GeoMetrick Enterprises
http://www.GeoMetrick.com/

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