10-07-2016, 05:14 PM
To some extent, our disagreement is non-substantive. My original point is that Holmes/Theranos underestimated the role of regulatory agencies in the healthcare setting. Part of their business model was that they thought they could disrupt by ignoring/sidestepping regulation, in much the same way that part of Uber's and AirBnB's business models have been sidestepping regulations aimed at taxis and hotels. But regulation in the healthcare setting is different than regulation of taxis (federal versus local, for one).
But I do think the FDA action was significant. I don't think the analogy to 23andMe is apt. First, 23andMe has only received clearance from the FDA to reinstate its pre-conception screening tests, because those do not "diagnose" a disease; they only tell you the risk of having a child with a disease. 23andMe still cannot return BRCA1 mutation status, or any other health related trait. Secondly, I'm not entirely sure how many of the people who subscribed to 23andMe did so specifically for their genetic risk. Having used their service (pre-FDA), I looked at the health traits and said "meh". And even so, the FDA action has largely shifted 23andme's business model from a DTC genetics company to a drug discovery company (maybe; this is just starting). As for Theranos, the problem with being basically a "Quest diagnostics" is that they are going up against an already successful company named Quest Diagnostics. Without the secret sauce of being able to set up a bunch of small scale portable labs (at Walgreens, etc.) or small kiosks, what distinguished them from Quest?
I'd have to go back, but I'm pretty sure there were a couple articles on top of the WSJ article suspicious of Theranos, especially after the FDA action. I remember another vanity fair (or similar publication) article that was pretty critical. Also, it was around that time that academic researchers started expressing skepticism. I think John Ionnidis (Stanford guy) penned a couple of critical editorials, and the first of a couple of trials comparing the accuracy of results from Theranos to results from other labs showing Theranos was very inaccurate came out, and I think this was before CMS.
BC
But I do think the FDA action was significant. I don't think the analogy to 23andMe is apt. First, 23andMe has only received clearance from the FDA to reinstate its pre-conception screening tests, because those do not "diagnose" a disease; they only tell you the risk of having a child with a disease. 23andMe still cannot return BRCA1 mutation status, or any other health related trait. Secondly, I'm not entirely sure how many of the people who subscribed to 23andMe did so specifically for their genetic risk. Having used their service (pre-FDA), I looked at the health traits and said "meh". And even so, the FDA action has largely shifted 23andme's business model from a DTC genetics company to a drug discovery company (maybe; this is just starting). As for Theranos, the problem with being basically a "Quest diagnostics" is that they are going up against an already successful company named Quest Diagnostics. Without the secret sauce of being able to set up a bunch of small scale portable labs (at Walgreens, etc.) or small kiosks, what distinguished them from Quest?
I'd have to go back, but I'm pretty sure there were a couple articles on top of the WSJ article suspicious of Theranos, especially after the FDA action. I remember another vanity fair (or similar publication) article that was pretty critical. Also, it was around that time that academic researchers started expressing skepticism. I think John Ionnidis (Stanford guy) penned a couple of critical editorials, and the first of a couple of trials comparing the accuracy of results from Theranos to results from other labs showing Theranos was very inaccurate came out, and I think this was before CMS.
BC