The trial of Elizabeth Holmes (Theranos)[sentenced to 11+ yrs, 18Nov2022]

An aside: I think she’s a terrible person, but we can criticize her without using a misogynistic term.

Good point. Yes we can. She’s a liar and a manipulator.

Holmes was promising the ability to perform a comprehensive blood panel consisting of “over a thousand” complex serologic tests on site in minutes using their Newton machine. Setting aside all of the contamination issues with microfluidic channels and reliability concerns of performing these tests without laboratory controls, it was never going to be feasible to run complex and very sensitive tests (many of which have to be rerun to eliminate false positives) on a magic black box. What Babson Diagnostics is offering with their BetterWay blood testing is just collecting a prepared fingertip blood sample suitable for running a series of simple serologic tests with a small sample. It is not a comprehensive blood panel and does not include tests that require large volumes or low contamination for reliability.

Stranger

You know, @Bullitt and @Stranger_On_A_Train can both be right here.

Yes, @Bullitt, it’s a step in the right direction, in that there are plenty of people who are hesitant on any, or at least, frequent blood testing due to the draw. So a fingertip prick may lower the barrier to some people getting the testing they need.

@Stranger_On_A_Train is of course MORE correct, in that the comparison between what BetterWay is offering and what Theranos claimed isn’t even apples to oranges. It’s more like comparing a single grape to an entire watermelon. There’s a very basic “fruit” similarity (blood tests) but the scale, requirements, and technology involved aren’t even in the ballpark.

(just in case it isn’t clear, I’m not trying to insult or misgender either of you by the “girls girls” comments, but you both seem to agree and realize that this is very dissimilar to Theranos but are belaboring the point)

Yeah I hear you. Yes Stranger is correct. I was only referring to the finger stick and that could have been made more clear.

Added: for me to refer to her vision for her company was a stretch. But I’m quite familiar with the story and she was lying about sending samples to the lab, inferring they were going into her machines, when she was sending the samples to a full lab with full-sized instruments. Blatant lying.

As i presented my arm for a blood test today, i contemplated whether i would have ordered a couple of finger sticks. I don’t think so? There are a lot of nerves in the finger tip, and when I’ve had finger sticks they have bothered my more than the wound in my arm after a venous blood draw.

What excited me about theranos’ promise was the cheap availability of blood tests. Every drug store could do the tests right away, on-site. And it would be cheaper, too. So maybe i could get blood tests is i were worried about something without gatekeeping of a doctor and an insurance company.

The thing is, if Theranos had actually produced a machine comparable to what Babson Diagnostics is claiming, she wouldn’t be in prison now. It’s one thing to claim you’ll do 1000 tests and you only do 11. But it’s another to claim 1000 tests and actually do zero, and then use fraudulent means pretend that your machine actually is doing something, and then lie constantly about everything else in the process.

A certain amount of embellishment is expected in the startup world. It’s a really high bar to clear before it becomes fraud. Theranos would probably still exist if they had produced a functional product at all, even if it was extremely limited compared to their claims.

Babson Diagnostics isn’t building analyzers; they are just specifying a collection technique and packaging device that doesn’t require a certified phlebotomist to draw large vials of venous blood. The samples are sent to a Babson Diagnostics lab and the test results are being provided within a day, not within minutes as Theranos was claiming.

Again, setting aside all of the contamination and reliability issues that would come with the Newton machine, if all the Newton machine could do is run a few simple tests, it would be a novelty for “health optimizers” or used by people who want a quick check on specific conditions, not a company shaking up the hematological lab industry worth a multibillion dollar valuation. It would not have attracted hundreds of millions of dollars of investment or interest by the Department of Defense for field blood diagnostics.

Stranger

Sure. But again, you don’t go to prison for embellishment. Most startups fall well short of their stated goals–usually failing completely–and the founders don’t go to prison. Because in most cases, they actually have a product of some kind, no matter how limited in functionality. But if they lie from beginning to end, then maybe it’s fraud.

Don’t forget that Theranos’ first “product” also took a day+, not minutes. Because the sample actually was being sent to a lab that processed a dilute version. Which both gave inaccurate results and misrepresented what they were doing. If they had fixed the small sample problem and been transparent about how their first-gen process worked, it wouldn’t have been an issue.

If Theranos had “been transparent about how their first-gen process worked”, it would have been readily apparent that they didn’t actually have a product. As for “fix[ing] the small sample problem”, it is clear that a lot of people believe that complex serologic test should be capable of being run on an arbitrarily small sample but there are numerous tests that need a minimum volume. What Holmes was promising was so obviously bunk (as many subject matter experts told her even in the concept phase) and the problems that were encountered throughout the ‘development’ process that the really shocking thing is that Theranos was able to persist in this sham and attract uncritical investment for as long as it did.

In general, the SiVal tech industry really needs to stay the fuck out of the biomed startup space because “move fast and break things” is an ethically deficient philosophy when it comes to the health and well-being of the general public and especially people seeking medical care.

Stranger

Presuming that BetterWay isn’t fraudulent, they appear to have developed a process that achieves accurate results with a “pea-sized” volume of blood for the 11 tests that they handle. That’s a notable improvement over a typical blood draw. Theranos didn’t even achieve that. They took a pinprick sample, diluted it, and ran it through conventional equipment. And the results were as bad as you might expect.

Is it the"fears of the needle" that makes it so terrible for some people? Because personally I find a finger stick a lot more painful than the needle in the vein. I just had blood drawn two days ago, and it was almost laughable painless.

Next time you get a finger stick test, ask them to squeeze your finger hard while they prick it (and don’t get it on your index finger). I used to hate those when they just held my finger. Now I barely feel them.

Interesting! If I ever need a fingerstick again, I’ll do that!

Diabetic here. Lots of finger sticks over the decade-plus I’ve been in the Club.

There are sticks and there are sticks. Some lancets are much fatter than others. Some drive a lot deeper. Some people who operate those things don’t adjust the force up or down versus aiming at the soft side skin of your pinkie versus aiming at the thick hard “thumbprint” skin of your thumb. etc.

Doing this frequently you also learn that your fingers are actually a patchwork of very teeny nerve endings. Once in awhile you jab a nerve square on and it hurts a LOT. For a couple minutes. Other times, just a millimeter away, you feel nothing as you happened to strike a spot between nerve endings.

Someone who gets sticks only a few times per lifetime wouldn’t have the repetitions to notice all that nuance.

I was forgetting diabetics would rarely need as much blood as you’d get from a vein.

I will defer to your experience. I do get them monthly during blood donation, which is enough to start to see some patterns, but not to the extent you do. Squeezing is the one thing I’ve noticed consistent results around.

When people get their blood or other body parts tested for anything they want, without adequate education about what the results could mean in the context of their own medical histories, without information about the risk of false positive and false negative results, this tends to lead to:

  • a whole lot of people panicking about ‘abnormal’ results which are completely trivial and meaningless 99.9+% of the time
  • a whole lot of tests performed which were never medically necessary or indicated in the first place
  • a whole lot of additional, and in many cases more invasive tests to ensure further that nothing’s really wrong.
  • occasional bad outcomes from those more invasive tests, like infections, bleeding, organ failures, etc.

Back before retirement, I spent countless hours with patients explaining why their lab tests didn’t necessarily mean what they thought or feared or celebrated.

Laboratory Medicine is a physician specialty in itself, with rigorous training and board certification exams aimed at ensuring expertise in the science behind testing technology, indications and contra-indications for different tests and result interpretation.

I hope we continue to create more and more specific and selective tests with fewer ambiguities which require less risk and invasive procedures. Those are the types of tests that educated patients should be able to check on their own.

But for the vast majority of tests, we still need someone in the process who knows which tests are truly indicated, and understands what the results will mean in the context of that patient’s medical history and present conditions.

I’ll quit now before I go deeper into the weeds with the whole ‘number needed to treat’ and ‘number needed to harm’ diagrams and formulas.
/rant

FYI, LabCorp now has their “OnDemand” program where you can get bloodwork done without a doctor involved. It’s a normal test of course where they take multiple vials (and/or urine), but it’s a fairly complete collection for a couple hundred bucks. I had one done recently and plan on doing it again every 6-12 months.

Qadgop’s concerns are well-noted of course, but I’m not the panicky type (almost to the point of my detriment), and see the tests as being more useful to track changes over time rather than being indicative on their own (and in any case, most of my results were totally within the normal range, and the exceptions were just barely so). If something changes dramatically, I’d like to know.

So you’re saying that super easy (and presumably reasonably cheap) access to quick diagnostic data would turn up the anxiety of “I’m not a Doctor, but I read on WebMD…” types to 11. Hmmm. I can see that happening.