(10-07-2016, 02:57 PM)Boston Card link Wrote:Well, if they could do testing with larger containers or needles, then they are basically Quest diagnostics. CMS was the last nail in the coffin, but FDA came first. To give you the order of things:
Oct. 16, 2015: Wall Street Journal comes out with its expose
Oct. 28, 2015: FDA orders Theranos to stop using its technology for all but one test. Given how soon after it came from the WSJ, the FDA had to have been in the process of investigating Theranos long before
Jan. 27, 2016: CMS cited Theranos and said that its testing posed "immediate jeopardy to patients"; the appeal process goes on through April (given CMS' speed, this process likely also predated the WSJ
July 7, 2016: CLIA certificate revoked and Holmes prohibited from running a testing company
The FDA was the first formal regulatory action, and thus had the biggest impact. But it may be fair to say that FDA was shorthand for "federal regulators".
Still disagree with you. Perhaps in retrospect it's more clear, but at the time it absolutely was not. For example, Cleveland Clinic CEO Toby Cosgrove was still more-or-less positive about Theranos even after the FDA action:
http://www.cnbc.com/2015/10/30/well-work...c-ceo.html
Let's think through two different scenarios -- of which it was not, at the time of FDA's action, clear which one was true (from the outside):
1)
Best Case Scenario: FDA found that the nanotainer was a class II device, rather than a class I device as Theranos claimed. That meant Theranos could -- assuming everything was in order -- get 510(k) clearance within three to six months of submission to the agency. Nor was the agency rejecting the premise of Theranos out of hand, as they did with 23andMe. Even if they did, you can still bend the agency your way with concerted effort; the FDA has since come around to 23andMe's way of thinking and regulated the industry (more-or-less) to the company's desires. Not a death knell at all, really.
2)
Worst Case Scenario: which you describe as "basically Quest Diagnostics." That's not that bad a fate! Quest Diagnostics is a $9 billion or so company. Certainly not a world-changer, but it's no shame to have founded that company. No one would've created a thread on Cardboard had Theranos suffered an altogether pretty minor FDA violation,* and wound up a solid lab company.
* (Let's be real -- this was no Vioxx or OxyContin, or metal-on-metal hip, at least from the evidence available at the time of the FDA citation.)
Moreover the tenor of the coverage didn't shift until January, after the CMS action. Until then non-Wall Street Journal media were taking a bit of a he-said,she-said tone to the matter -- certainly respectful of WSJ claims but not dismissing Theranos's out of hand.
It wasn't until January's CMS citation -- which potentially came with a $10,000/day fine, banning from the lab industry, and revocation of lab license -- that the tone changed. I didn't see people predicting the demise of Theranos until January, though it's possible my memory is faulty.
Finally, that CMS's action -- rather than FDA's -- was decisive can be seen in Theranos's acts themselves. The company is laying off 40% of its workforce and shutting off its labs, but still developing devices. (Allegedly.) If they do develop a device, they'd submit to FDA. That means their actions are more consistent with CMS being the decisive blow than FDA.