line, I need ground truth for the accuracy of the statements below. If I need to see LTC Shoemaker and LTC Mann so they can explain how I am pushing for something unethical or illegal please set up a time for them to meet with me in Tampa when I return to the states [sic] (I am going to be delayed in theater past my original return date). Thanks, M
The CMS inspector’s surprise visit had put Elizabeth on the warpath. In a phone call to Colonel Edgar, she threatened to sue Shoemaker. Edgar relayed her threat to his Fort Detrick colleague, along with news of the inspection. He also forwarded to Shoemaker Elizabeth’s email to Mattis and Mattis’s reaction to it.
When he read the email string, Shoemaker blanched. Mattis was one of the most powerful and fearsome people in the military. The blunt-spoken general had once famously told Marines stationed in Iraq, “Be polite, be professional, but have a plan to kill everybody you meet.” This was not a guy you wanted to get on the wrong side of if you were a lower-ranking army officer.
Shoemaker also felt genuinely bad that his actions had led to an inspection of the company. He was well placed to know how unpleasant such visits could be: his previous assignment had been at the Army Medical Research Institute of Infectious Diseases, where he’d taken over as director of biosurety, the department responsible for securing biothreat agents used in army research, two weeks before Bruce Ivins killed himself in July 2008. The suicide had led to the disclosure that Ivins, an institute researcher, was the likely perpetrator of the 2001 anthrax attacks and to an avalanche of inspections from an alphabet soup of government agencies that had continued unabated for two years. Shoemaker had been the officer on the receiving end of every single one of them.
With Colonel Edgar’s encouragement, he tried to defuse the situation by emailing CMS officials that he had never meant to imply that Theranos had already implemented the regulatory strategy he’d described, merely that it was considering it. He also expressed surprise that the agency had told Theranos he was the one who requested the inspection. The response he got brought another surprise: CMS had told Theranos no such thing; the company already had a copy of his correspondence with the FDA when the inspector arrived.
When he confronted Colonel Edgar with that information, Edgar sheepishly admitted that he had been the one who’d shared his email to Sally Hojvat with Elizabeth in what he described as an oversight. He apologized and invited Shoemaker to come to CENTCOM headquarters in Tampa, Florida, the following week to walk Mattis through the regulatory issues. Shoemaker was nervous about meeting the general face-to-face, but he accepted the invitation. He reached out to Alberto Gutierrez to see if he could join him on the trip, figuring his opinion would carry more weight if it was supported by someone high up at the FDA. Although it was on short notice, Gutierrez agreed to come along.
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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