Holmes and Balwani make my blood boil. I was a manufacturing engineer for nearly 30 years who specialized in bringing cutting edge, never before done, electronic components and products from a CAD drawing to prototyping to many millions of things in the field. I have been exactly where they were in terms of things not working out and we were always honest about it. Sometimes the whole thing was dropped and others had a reduction in scope in terms of features or performance or they worked out fine but took longer than expected to be ready. (Most worked out just fine).
What they did was outrageous and massively out of the norm. The fact that it involved a healthcare diagnostic product makes it orders of magnitude worse. Those two people were straight up sociopaths.
Yes. I think there are lots of tests that can be alarming if you do them once a year and get a weird result, that are NOT alarming if you look at them regularly and see ordinary variation. And you are more likely to see real trends with regular tests, too.
I had a really high triglycerides number about 7 years ago. I happened to realize that it was right after Halloween, and perhaps 50% of my calories over the two days prior to that blood draw had been from Milky Way bars. So i asked my doctor if we could wait until the next annual appointment before acting on the results. We did, and it was totally normal the next year. (And has been since.)
Fwiw, when i had covid, i also had a lot of soon-to-expire covid tests lying around, so I tested myself daily. It was interesting to watch the rise and fall of antigen levels. (They peaked the day the new CDC rules said i could go out in public. ) Was that strictly necessary? Of course not. And if tests are rare and expensive things that you need to get from a doctor, of course you wouldn’t do that. But it did give me a lot of confidence when it was safe to hang out with friends without infecting them.
Anyway, lots of startups never produce any product at all and aren’t charged with fraud. Theranos wasn’t charged with fraud for failing to produce what they had planned to make. They were charged with fraud for fraudulently claiming they had a product when they didn’t. They were charged with fraud, not with failure, because they lied to investors. I think they should also have been charged with assault or malpractice or something for actually jabbing patients with their useless fake product and giving people fake results. People made important medical decisions based on those fake results. They probably killed someone.
Actually, no, Holmes and Balwani were much more than just garden variety crooks. They managed to convince many people who should have known better that they had something when they did not.
They were. It was still a form of fraud, but against the patients rather than investors. The fact that patients received inaccurate test results and acted on those false results was an important part of the trial.
However, only Balwani was found guilty of those charges. Holmes was not (she was only found guilty of defrauding investors).
But I’m also on team “there are a lot of nerves in my fingers”.
The main advantage of a finger stick is that you don’t need a trained phlebotomist to do it, most anyone can stick a finger. So that makes the test potentially cheaper.
For a few weeks after I had a borderline glucose reading I was checking my glucose daily with a finger stick. Holy mother of God those things hurt. I’ve also had a lot of blood draws and not a single one of them hurt the way a finger stick does. Anyone who chooses a finger stick over a blood draw because of pain either is unfamiliar with one of those procedures or has their nerves arranged very differently from mine.
Whole blood donations are as frequently as 56 days. For PLTs you can donate weekly, but over the course of a year you’ll bump up against limits on RBC loss, so most of us donate every other week and can maintain that rhythm, so to speak.
I’m at just under 200 donations. For the finger sticks, the fingertips have many nerve endings and you don’t want to stick there. It’ll hurt. You stick at the side of the fingertip. Minimal pain.
Whoa, back off, Jack. I retired after decades in Silicon Valley tech, specifically with biomed startups. Don’t lump us all in with the assholes, liars, and cheats at Theranos.
The FDA, and the regulatory agencies at each country, mandate specifics about your quality systems’ requirements. We do not and can not “move fast and break things”, while non-regulated Silicon Valley industries certainly can. Developing game software? Sure go ahead, move fast and break things. Developing medical devices? You cannot.
We did great things to help people. I’m proud that I did my little bit to help develop medical robotics that did brain surgery non-invasively, where the patient can have their brain tumor surgically operated on, and they can drive themselves home shortly after, that same day. There, I worked for a bonafide genius of a neurosurgeon. The guy was brilliant (and still is).
I also helped develop robotics for pulmonary surgery that employed endoluminal surgical techniques — again, minimally invasive, for the lungs. A startup, their device has not yet been cleared for sale for the US market.
Certified companies are audited regularly by the FDA and the NBs, notified bodies, to achieve and maintain their CE Markings.
Don’t lump us together with those Theranos assholes.
) Was that strictly necessary? Of course not. And if tests are rare and expensive things that you need to get from a doctor, of course you wouldn’t do that. But it did give me a lot of confidence when it was safe to hang out with friends without infecting them.