[washingtonismoney]

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.

1) I can't speak to whatever Holmes's attitude was. But she certainly wasn't trying to flout regulations; in fact, her original strategy (it appears) was to use regulations to evade other forms of scrutiny. And Holmes went through legislative channels in Arizona to establish the direct-to-consumer lab marketing; they didn't establish wildcat labs on the streets of Tempe.

You cite Ioannidis later in your post, but the source of his annoyance was that Theranos was planning on using FDA clearance/approval to evade peer reviewed journals. Which is an informal form of regulation but not quite the same as the Uber/Airbnb approach to the law.

2) re: 23andMe -- they may or may not return BRCA1 status, I'm not familiar with their exact service at the moment. But they do return data diagnosing disease -- for example for Bloom Syndrome. So they certainly could, should they choose to go through the proper clearance.

And I'm not sure that their strategy has shifted. They sell Health + Ancestry kits at $199 -- surely, with every kit at a loss. I don't believe their prices have shifted dramatically; they were always trying to amass lots of data on consumers' genomes and pair that with the many quizzes, etc. they offer to consumers to learn phenotypic information.

3) There were some articles expressing scrutiny. Before WSJ, Business Insider ran an article quoting scientists expressing skepticism -- but this was a "show us what you've got" article, not an "utter fraud" article. Some industry publications (e.g. Dark Daily) had also written skeptical articles. Besides Ioannidis, among the scientific community, I recall one Canadian physician wrote a similarly skeptical article. But certainly the tone was mostly adulatory.

After the WSJ article the tone shifted. But while some articles shifted -- a Fortune writer wrote a mea culpa that his overly credulous article was, well, overly credulous -- overall the tone was, "Wow, Elizabeth Holmes has a lot to prove," but certainly not in the tone of "This business is an outright fraud/doomed to fail," as the consensus currently is.

[washingtonismoney]

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.

1) I can't speak to whatever Holmes's attitude was. But she certainly wasn't trying to flout regulations; in fact, her original strategy (it appears) was to use regulations to evade other forms of scrutiny. And Holmes went through legislative channels in Arizona to establish the direct-to-consumer lab marketing; they didn't establish wildcat labs on the streets of Tempe.

You cite Ioannidis later in your post, but the source of his annoyance was that Theranos was planning on using FDA clearance/approval to evade peer reviewed journals. Which is an informal form of regulation but not quite the same as the Uber/Airbnb approach to the law.

2) re: 23andMe -- they may or may not return BRCA1 status, I'm not familiar with their exact service at the moment. But they do return data diagnosing disease -- for example for Bloom Syndrome. So they certainly could, should they choose to go through the proper clearance.

And I'm not sure that their strategy has shifted. They sell Health + Ancestry kits at $199 -- surely, with every kit at a loss. I don't believe their prices have shifted dramatically; they were always trying to amass lots of data on consumers' genomes and pair that with the many quizzes, etc. they offer to consumers to learn phenotypic information.

3) There were some articles expressing scrutiny. Before WSJ, Business Insider ran an article quoting scientists expressing skepticism -- but this was a "show us what you've got" article, not an "utter fraud" article. Some industry publications (e.g. Dark Daily) had also written skeptical articles. Besides Ioannidis, among the scientific community, I recall one Canadian physician wrote a similarly skeptical article. But certainly the tone was mostly adulatory.

After the WSJ article the tone shifted. But while some articles shifted -- a Fortune writer wrote a mea culpa that his overly credulous article was, well, overly credulous -- overall the tone was, "Wow, Elizabeth Holmes has a lot to prove," but certainly not in the tone of "This business is an outright fraud/doomed to fail," as the consensus currently is.