4 ms·

I think you make a good point, and broadly agree with you. I think the problem with Elizabeth Holmes (vs. the traditional tech founder) is that she's in biotech

I think you make a good point, and broadly agree with you. I think the problem with Elizabeth Holmes (vs. the traditional tech founder) is that she's in biotech, where the stakes are much higher and the industry is much more controlled. It'd be the same if she was in the aviation space. If she ran a SaaS platform, this wouldn't really be a story - it'd just be a crappy place to work, and a service that's not ever properly implemented, and there might be some level of fraud at a financial level, but nothing as bad as what she did. A business CRM breaking is bad, but not as bad as giving inaccurate medical results to someone leading to a misdiagnosis or worse.

randycupertino 8y ago
That is the part that is craziest to me. They took a software developer (Sunny Balwani) who had an information systems degree and plopped him down to run a life sciences company like it was nbd. I think a lot of technology people don't understand the scope of regulatory and medical implications of working in life sciences. It's not just simple as "code it up and flip the switch!" Theranos isn't the only firm I've seen crash and bail due to that cavalier attitude.
- jhbadger 8y ago
  Yeah, although they didn't crash and bail but just get penalized a bit, 23 & Me didn't really get that they actually had to obey FDA rules for genetic testing. They literally ignored the FDA's complaints and were eventually stopped from making diagnostic (rather than ancestry) analyses for a while.
  - denzil_holles 8y ago
    There's a big difference between the tests from 23andMe and Theranos. 23andMe produces data that's risk-based (i.e. your risk of developing coronary heart disease) but isn't immediately actionable. Most of what you could do to address the risks reported by 23andMe is stuff you should already be doing -- eating healthy, sleeping more, exercising, quitting smoking/alcohol. Theranos was doing standard lab tests, like blood electrolytes. Blood electrolytes are highly regulated by the body and are only abnormal in serious medical illness. If your blood sodium level is too low (hyponatremia) that's a medical emergency and you need to be in the ER (hyponatremia can indicate end-organ failure like renal failure, heart failure; it can also indicate serious endocrine abnormalities like SIADH or too much water intake 'frat-boy' syndrome). Uncorrected hyponatremia can lead to permanent neurological disease (classically brainstem herniation).

randycupertino 8y ago

That is the part that is craziest to me. They took a software developer (Sunny Balwani) who had an information systems degree and plopped him down to run a life sciences company like it was nbd. I think a lot of technology people don't understand the scope of regulatory and medical implications of working in life sciences. It's not just simple as "code it up and flip the switch!" Theranos isn't the only firm I've seen crash and bail due to that cavalier attitude.

jhbadger 8y ago
Yeah, although they didn't crash and bail but just get penalized a bit, 23 & Me didn't really get that they actually had to obey FDA rules for genetic testing. They literally ignored the FDA's complaints and were eventually stopped from making diagnostic (rather than ancestry) analyses for a while.
- denzil_holles 8y ago
  There's a big difference between the tests from 23andMe and Theranos. 23andMe produces data that's risk-based (i.e. your risk of developing coronary heart disease) but isn't immediately actionable. Most of what you could do to address the risks reported by 23andMe is stuff you should already be doing -- eating healthy, sleeping more, exercising, quitting smoking/alcohol. Theranos was doing standard lab tests, like blood electrolytes. Blood electrolytes are highly regulated by the body and are only abnormal in serious medical illness. If your blood sodium level is too low (hyponatremia) that's a medical emergency and you need to be in the ER (hyponatremia can indicate end-organ failure like renal failure, heart failure; it can also indicate serious endocrine abnormalities like SIADH or too much water intake 'frat-boy' syndrome). Uncorrected hyponatremia can lead to permanent neurological disease (classically brainstem herniation).