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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 but reasonable and a workable compromise had been reached. The limited experiment agreed upon fell short of the more ambitious live field trial Mattis had had in mind. Theranos’s blood tests would not be used to inform the treatment of wounded soldiers. They would only be performed on leftover samples after the fact to see if their results matched the army’s regular testing methods. But it was something. Earlier in his career, Shoemaker had spent five years overseeing the development of diagnostic tests for biological threat agents and he would have given his left arm to get access to anonymized samples from service members in theater. The data generated from such testing could be very useful in supporting applications to the FDA. Yet, over the ensuing months, Theranos inexplicably failed to take advantage of the opportunity it was given. When General Mattis retired from the military in March 2013, the study using leftover de-identified samples hadn’t begun. When Colonel Edgar took on a new assignment as commander of the Army Medical Research Institute of Infectious Diseases a few months later, it still hadn’t started. Theranos just couldn’t seem to get its act together. In July 2013, Lieutenant Colonel Shoemaker retired from the army. At his farewell ceremony, his Fort Detrick colleagues presented him with a “certificate of survival” for having the courage to stand up to Mattis in person and emerging from the encounter alive. They also gave him a T-shirt with the question, “What do you do after surviving a briefing with a 4 star?” written on the front. The answer could be found on the back: “Retire and sail off into the sunset.
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