Rosemary for Remembrance

Theranos purported to be a company that could do bloodwork from a pinprick rather than from IV blood draws. This claim earned them billions of dollars in VC and got its founder, Elizabeth Holmes, who dropped out of Harvard to pursue her idea, on the cover of multiple magazines. As of last fall, she was (on paper) worth $4.5 billion.

The only problem is, Theranos’ technology didn’t work. At all. Last fall Medicaid reviewed the lab results for warfarin testing . This test determines whether the blood thinner you’re taking will make you bleed to death. It’s kind of a crucial test that way. All 81 results Medicare reviewed were wrong. Every single one.

The FDA formal letter revoking Theranos’ certification is available at the New York Times. It is a thing of beauty.

http://www.nytimes.com/interactive/2016/07/08/business/document-Theranos-Sanctions-Letter.html
Just a sample for your delight:

D2094
... The April 1, 2016 letter accompanying the second submission states that "documentation explains how the laboratory came to its conclusions regarding patient outcomes (Ex JJ, Tab 3A)".  However, Ex JJ, Tab 3A simply states: "Patient Impact: Based on PT investigation, no patient impact," and does not say how the laboratory came to its conclusions that no patients were affected.