> After reading Bad Blood as well ... No patients were harmed.
You apparently didn't read it very well. Patients went to ERs, had drug dosages changed, invasive tests and procedures performed as a result of these results.
> It's Theranos's investors and Theranos's business partners that are mostly at fault. They didn't do their due diligence
And it's probably the FDA's fault, too, right? You know, since they should have known that a locked and partly covered side door to a lab is where the Theranos equipment really was, and that the lab they were inspecting had been carefully prepared and "sanitized" for their benefit, and Theranos hoped that if this wasn't uncovered they'd be certified based on the "prepared" lab. Balwani and Holmes forbidding anyone from using the real lab, or going through that door when inspectors were on-site was... "just hoping that it would work", not actively deceptive and fraudulent, right? What due diligence might have helped discover that?
FDA is not omniscient. No regulator is. It’s hard to catch someone intelligent and cunning in a lie every time. The industry relies on a combination of individual integrity (i.e. not wanting to hurt people, which works fine in 80% of cases) and regulation being a deterrent against fraud (for the minority that would release snake oil to make a quick buck).
I am glad Holmes and Balwani are facing the music. I would have preferred to see more than just Holmes and Balwani face charges though. There’s no way you pass an inspection from CMS and FDA when you have a “pay no attention to the man behind the curtain” part of the building without others being in on it.
In the wake of Theranos I have heard serious criticism of CMS & FDA to this effect (we need more regulations because clearly they're not getting the job done.)
You apparently didn't read it very well. Patients went to ERs, had drug dosages changed, invasive tests and procedures performed as a result of these results.
> It's Theranos's investors and Theranos's business partners that are mostly at fault. They didn't do their due diligence
And it's probably the FDA's fault, too, right? You know, since they should have known that a locked and partly covered side door to a lab is where the Theranos equipment really was, and that the lab they were inspecting had been carefully prepared and "sanitized" for their benefit, and Theranos hoped that if this wasn't uncovered they'd be certified based on the "prepared" lab. Balwani and Holmes forbidding anyone from using the real lab, or going through that door when inspectors were on-site was... "just hoping that it would work", not actively deceptive and fraudulent, right? What due diligence might have helped discover that?