—
AT 3:00 P.M. SHARP on August 23, 2012, Colonel Edgar escorted the two
men into Mattis’s office on MacDill Air Force Base in Tampa. The
sixty-one-year-old general was an intimidating figure in person:
muscular and broad shouldered, with dark circles under his eyes that
suggested a man who didn’t bother much with sleep. His office was
decorated with the mementos of a long military career. Amid the flags,
plaques, and coins, Shoemaker’s eyes rested briefly on a set of
magnificent swords displayed in a glass cabinet. As they sat down in a
wood-paneled conference room off to one side of the office, Mattis cut
to the chase: “Guys, I’ve been trying to get this thing deployed for a
year now. What’s going on?”
Shoemaker had gone over everything again with Gutierrez and felt
confident he was on solid ground. He spoke first, giving a brief
overview of the issues raised by an in-theater test of the Theranos
technology. Gutierrez took over from there and told the general his
army colleague was correct in his interpretation of the law: the
Theranos device was very much subject to regulation by the FDA. And
since the agency hadn’t yet reviewed and approved it for commercial
use, it could only be tested on human subjects under strict conditions
set by an institutional review board. One of those conditions was that
the test subjects give their informed consent—something that was
notoriously hard to obtain in a war zone.
Mattis was reluctant to give up. He wanted to know if they could
suggest a way forward. As he’d put it to Elizabeth in an email a few
months earlier, he was convinced her invention would be “a game-
changer” for his men. Gutierrez and Shoemaker proposed a solution: a
“limited objective experiment” using leftover de-identified blood
samples from soldiers. It would obviate the need to obtain informed
consent and it was the only type of study that could be put together as
quickly as Mattis seemed to want to proceed. They agreed to pursue
that course of action. Fifteen minutes after they’d walked in,
Shoemaker and Gutierrez shook Mattis’s hand and walked out.
Shoemaker was immensely relieved. All in all, Mattis had been gruff