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U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

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171–180 of 280 posts

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#171

Earlier quoted context omitted.

Innovation requires fraud?

That's not at all what I said. My claim is that innovation often involves ignoring all of the incumbents who say that a new way will never work. Obviously you shouldn't inflate the results of your attempt.

What if incumbents provide valid reasons why something wouldn't work?

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#172
post #108

Earlier quoted context omitted.

There appear to be two different sorts of "disruption": 1) There's disruption that's seen as impractical or insanely difficult (e.g. Tesla, SpaceX). Or technically feasible but with significant social or legal obstables (e.g. AirBnB, Uber). 2) Then there's another category, disruption that defies laws of physics. Kickstarter is replete with examples. This includes things like pocket-size underwater rebreaters, self-f…

What law of physics makes what Theranos attempted to achieve impossible? They were still drawing blood from the patient. Thus, it seems theoretically possible for technology to overcome the challenges the approach presents.

Quoting from a comment on one of Derek Lowe's posts on the subject (http://blogs.sciencemag.org/pipeline/archives/2015/10/15/the...) (note that a large fraction of commenters are active chemistry, medical, or biology researchers):

> The blood you get from a prick will be a mixture of blood from small venules, small arterioles, capillaries and lymph vessels, mixed with whatever loose tissue and cells have been cut by the prick and carried over into the blood. No way you could ever get a reliable CBC from such a sample. Since the kind of general blood tests that this company is targeting are usually CBC + chem panel, even if you could get your chem results from the prick, you still need a normal blood draw for the CBC, so the competitive advantage that they are trying to push (quick sampling by patient at pharmacy, without need for phlebotomist) is lost. On top of that, the variability inherent in chem results from prick blood will be significant for several analytes, like CK and AST (present in muscle so could be raised from prick injury), glucose and lipids (different levels in venous or arterial blood or lymph), etc…

In short, while it might be possible to reliably use only µL of blood for tests, using µL of blood for dozens of tests seems questionable, and the chosen blood source is likely to be mostly worthless.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#173
post #147

Earlier quoted context omitted.

I would say at the very least, the construction of the Model S and the supercharger network are hugely innovative.

But Tesla cars are just that - cars. Nor were they even the first electric cars. Don't get me wrong, they're fantastic and innovative, but the basic technological underpinnings have been long established.

I'd say Tesla's main innovation was on the business end: they realized that batteries are expensive, so EVs must be expensive, and trying to cut corners everywhere else to bring the price down just results in a crappy car people don't want to buy. Instead, make it a great car that's really expensive, but so good that it justifies the high price. Any incumbent could have done this, they just... didn't.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#174

Earlier quoted context omitted.

Elon Musk wasn't playing with people's lives. The FDA exists for a reason.

You sure? The two autopilot deaths say otherwise. There has and will always be risk in starting a company. Your products might have flaws and they might kill. Some companies make it through these events...some don't. Innovation is embracing a crazy idea to move humanity forward. However, it also means embracing all the unknowns.

There have been two highly-publicized Autopilot accidents, recently but only one death. And the second one didn't actually involve Autopilot, that was just the driver either being confused or scammy.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#175
post #119

Earlier quoted context omitted.

Can someone explain me how Theranos' claim is anything else than me claiming that I can do a representative study with 5 participants and have the same statistical significance as others doing a study with 10000 participants? Isn't this just elementary statistics and completely independent from the domain?

If it is known beforehand that all the participants will answer in the same way, testing 5 will produce as much information as testing 10000, so the question is whether any beforehand assertion like that applies. One reason that assertion might not hold is if the 5 being tested come from a special interest group, knowing if that could be the case or not depends on domain knowledge. http://www.bd.com/vacutainer/labnot…

You're confusing random variation (which is helped by sample size) and bias (which isn't)

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#176
post #142

I hope that Holmes' bizarre behavior as the issues went public keep her from ever running anything even remotely close to things that matter for people's lives and well being. Even as the questions were building and the noose was tightening, she would announce a public talk to reveal and openly share information on the company's tech, then mysteriously cancel a short while later -- she did this over and over. I'm sti…

Not sure if scam is the right word. Everyone is capable of deluding themselves into believing their current, morally questionable actions will be seen as justified in the future (when everything works, out of course). I'm sure even Bernie Madoff believed at some point he would win it all back and no one would ever know or be harmed.

I don't agree with your characterization of Bernie Madoff. He knew he was running a scam. He was clearly lying in his marketing materials, saying his fund performed certain trades that they never did. (See Harry Markopolos' book, "No One Would Listen"; that's how Markopolos figured out it was a scam.) I think Madoff is, at the least, a borderline sociopath. (If not an outright one.) A sociopath may think they can get away with it, and no one will know, but they probably don't think no one will be harmed - a sociopath does not care about harming others.

I think it's possible Holmes fits your description - she was in over her head, never set out to scam anyone, and slid down a very bad path without ever intending to. I don't know this is the case, but I believe it's possible. That, however, is not Madoff.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#177

Earlier quoted context omitted.

people swerve all the time because coffee and phones falling out of their hands, because their "cpu" is bug-ridden and decides to show them fiction instead of reality at will. so the connotation that goes with the phrase "playing with people's lives" is completely dishonest when faced with the fact that statistically autopilot is safer than human.

> statistically autopilot is safer than human This is not born out by the currently available facts. Tesla quoted deaths-per-autopilot-mile versus overall deaths-per-mile for all cars on the road. This is very misleading information, for a number of reasons. 1. Teslas are high-end luxury cars and thus have better safety features than the lower end of the market. 2. Teslas are likely to be newer and better maintained…

Autopilot doesn't just give up when it can't handle something. It sounds an urgent alarm telling the driver to take over, and if the driver doesn't, it stops the car and turns on the hazard lights.

Most drivers will take over and disengage Autopilot in doing so, so your point remains, but I wanted to make it clear that the car isn't just doing a "Jesus^H^H^H^H^HDriver take the wheel!" thing.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#178
post #15

If they're going to ban her from operating labs for two years, does that mean they think she'll be, in some way, rehabilitated and capable of soundly running labs after that? Maybe there is little precedent, but that length of time seems a bit arbitrary (and too short?).

That was my first reaction to the headline. Banning her from running a lab for two years feels like banning a murderer from owning a gun for two years, or banning a corrupt politician from holding office for two years. Seems like it ought to be a lot longer!

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#179
post #108

Earlier quoted context omitted.

There appear to be two different sorts of "disruption": 1) There's disruption that's seen as impractical or insanely difficult (e.g. Tesla, SpaceX). Or technically feasible but with significant social or legal obstables (e.g. AirBnB, Uber). 2) Then there's another category, disruption that defies laws of physics. Kickstarter is replete with examples. This includes things like pocket-size underwater rebreaters, self-f…

Solar panel roadways for latter

That falls clearly into the former category.

Extreme to the point of being nonsensical in its impracticality (cost of installation, cost of replacement, current PV efficiencies, etc), but not fundamentally impossible.

Re: U.S. Bans Theranos CEO Elizabeth Holmes from Operating Labs for Two Years

#180
post #36

Earlier quoted context omitted.

Wouldn't Theranos be the owner and operator of the lab?

Can't they work around this by renting the lab?

If they rent the lab, then someone else needs to own it, run it and get it certified. I'm sure the FDA would be OK with that.
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