Certainly, not trying to defend Theranos, just trying to understand how bad this really is. Because it sounds pretty horrible...
“There have been massive recalls of single tests in the past, but I’m not aware of one where a company recalled the entirety of the results from its testing platform,” said Geoffrey Baird, associate professor in the department of laboratory medicine at the University of Washington in Seattle. “I believe that’s unprecedented.”
Based on my ~10 years experience in device/diagnostic industry, I concur with this assessment. I don't think anything at this scale has ever happened. There are only two reasons a diagnostic company would issue such a sweeping retraction of test results:
- The product just plain doesn't work
- The administration of the product (lab procedures, etc) was so shoddy that accuracy can't be guaranteed.
Either of those conclusions is damning. Generally a company tries to limit the scope of the damage, either by scoping for type of test, i.e. "Oh well Edison is fine, but this this particular test (say cholesterol) is failing. The other tests are fine though" or scoping for time "We had some poor lab procedures from September thru December but we cleaned house and we're all better now". The WSJ report implies they did neither.
What I keep asking though, is where were the employees in all this? I also spent over a decade in the device industry, and everyone I worked with, from biochemists to engineers to Regulatory Affairs people would have been screaming loudly. We took patient safety very seriously. Any suggestion that our instrumentation was defective was immediately investigated. This is typical in the medical device industry. I can't believe that the rank and file people working at Theranos were really any different.
So where are their voices?
2. How do you think the original WSJ article came about? http://www.wsj.com/articles/theranos-has-struggled-with-bloo...
Which you and I know are especially illegal in the life science industries at the federal and state (in most states) levels. But given how secretive Holmes was toward potential investors and customers this would not surprise me.