Elizabeth had successfully pitched to James Mattis, 4-star General, about deploying Theranos in Afghanistan. General Mattis was known to look out for his troops.
Elizabeth’s plan around regulation - the real blood analysis would be beamed to California to be done by professionals; only the CLIA compliance for the Palo Alto lab was needed - no FDA.
Lt. Col. Shoemaker, responsible for the army’s compliance with medical regulations, was openly critical of the Theranos' workaround. He asked a colleague about it.
Turns out, the FDA had power to regulate LDTs (Laboratory Developed Tests). However, when FDA was empowered to do so in 1976, LDTs weren’t common. But in the 1990s, LDTs had become more complex and for mass use - e.g. genetic tests. Still, Theranos' model didn’t comply with federal regulations. Either all locations get CLIA, or all devices get FDA-approved. Unfortunately, this email blew up.
Yamamoto was sent to inspect the Palo Alto lab. Surprisingly, Theranos knew of the inspection. Sunny defended the CLIA certificate as a way of learning how labs work. As for the lack of novel devices, Theranos had no plans to deploy them without FDA clearance.
Elizabeth emailed General Mattis about Shoemaker. Mattis, feared and powerful, demanded to see Shoemaker.
The meeting concluded with Theranos performing tests on de-identified leftover samples, which the army could cross-check with its regular testing methods. Yet, Theranos failed to take advantage of this opportunity.
I fail to see how this is de-identified enough to alleviate need to obtain informed consent. Still, I like General Mattis - he gracefully listens to opposing view, unlike Elizabeth.