The letter the Feds sent to Theranos [pdf]
To start with, I am a clinical lab medical director and clinical pathologist. I&#x27;ve commented on Theranos a few times before on HN. That said, I think three things have been missed in all of this<p>1) There are a lot of bad labs out there like Theranos, and Theranos&#x27; story is thus only unique because of how pumped up it got. Clinical labs are &quot;old economy&quot; businesses, and the idea that someone could sprinkle &quot;new economy&quot; fairy dust and turn it into an Uber or Netflix success story is more about the echo chamber that is Silicon Valley, the general lack of scientific interest or rigor in clinical diagnostics in the tech industry, a somewhat Aspergey yet charismatic CEO, black turtlenecks, and friendship with important ex-government officials and VC folks than anything special about what was going on in their laboratory. Plenty of labs have been caught and shut down for what Theranos has done, and while I didn&#x27;t think that it was actually occurring there, I am not terribly surprised.<p>2) The magic of their Edison box, even if it had turned out to work, was not nearly as impressive if you know anything about how clinical labs operate today. The claims that they have made (can do tests on MICROLITERS and have imprecision LESS THAN 5-10%!) are actually standard these days for many assays. As a lab director, I was always disturbed by the lay press puff pieces that said things about Theranos that were totally uninteresting and unimpressive to anyone knowledgeable...what clearly happened was that no one at Forbes, etc.. actually asked anyone who works in a clinical lab to comment. The commentary always focused more on the phenomenon of Theranos, rather than the substance...probably because the substance was super boring.<p>3) What has consistently been missed, and is still missed today, is that even if Theranos&#x27; technology worked and their labs weren&#x27;t being run with a criminal disregard for standard laboratory practice, is that Theranos&#x27; business objectives would STILL be a horrible idea. Their push to democratize health information, to do more testing early to prevent disease rather than detect late, to test for lots of things in healthy people to increase &quot;wellness&quot;, etc... is all total bullshit. With few exceptions, lab tests are for sick people, and testing healthy people with lots of tests simply consumes money and generates false positive results that are expensive to work up. Also, there are NO TESTS for all of the conditions (cancers, etc...) that they claim to be helping you detect early. Getting your sodium and potassium levels weekly won&#x27;t help you avoid kidney disease, cancer, or diabetes, but it will make your pocketbook shrink and it will give you some falsely abnormal values 1 in 20 times you do it. This has been the true play of Theranos, which is to do a massive amount of testing on well people, marketed directly to healthly people without the advice of doctors, with the intent of arming a bunch of worried well people with an avalanche of insignificant noisy information to present to their physicians. This helps no one other than Theranos.<p>I have often seen a lot of objections to (3) from people on HN, especially tech-sorts who think that they are better able to handle data than the average person. However, this is fundamentally flawed. For those who are interested in Bayesian analyses, consider the utility of any test when the pre-test probability is low - the answer is that positive results are almost always false positives, or at least difficult to interpret.  The answer is not getting more tests, even if it&#x27;s cheap. Lab tests these days ARE cheap...it&#x27;s the clinical followup that is expensive.<p>I will be very interested to see how this all plays out now. The big players, Labcorp and Quest, have both tried the direct-to-consumer&#x2F;in-drugstore model for testing, and amusingly actually shut their offerings down years ago because of lack of interest. The truth of the matter is that making health information more available to people sounds great, but really, the only people who end up collecting that information are affluent, worried-well people who should be discouraged from testing in the first place. The people who need more routine testing are poor, socially-underserved and neglected people with chronic illnesses, but I do not think that Theranos is planning on opening test facilities in Flint, Michigan to give Hemoglobin A1c monitoring tests for free to the elderly impoverished people there. To the contrary, they&#x27;ve tried to open in areas where they can get customers who they can trap into believing that they need lab tests like they need step counts from a fitbit. Hopefully, this bump in the road will caution others trying to do the same thing, but I really doubt it.