Yamamoto arrived unannounced at Theranos’s offices in Palo Alto. By then, the company had completed its move to the old Facebook building located at 1601 South California Avenue, less than a mile from its former home on Hillview Avenue.
Sunny and Elizabeth ushered Yamamoto into a conference room. When he explained that his agency had received a complaint about Theranos and that he was there to look into it, he was surprised to learn that they knew where and who it came from. Someone had apparently tipped them off about Shoemaker’s email to the FDA. Elizabeth was not pleased, a sentiment made clear by the scowl on her face. She and Sunny professed not to know what Shoemaker had been talking about in his email. Yes, Elizabeth had met with the army officer, but she had never told him Theranos intended to deploy its blood-testing machines far and wide under the cover of a single CLIA certificate.
Why then had Theranos applied for a CLIA certificate? Yamamoto asked. Sunny responded that the company wanted to learn about how labs worked and what better way to do that than to operate one itself? Yamamoto found that answer fishy and borderline nonsensical. He asked to see their lab.
They couldn’t deny him access the way they had to Kevin Hunter. This was the representative of a federal regulatory agency, not some private lab consultant they could thumb their noses at. So Sunny reluctantly took the inspector to a room on the second floor of the new building. After Dupuy’s firing, Theranos had moved the lab there from its temporary East Meadow Circle location.
What Yamamoto found in the room didn’t impress him but didn’t raise any big concerns either: it was a small space with a couple of people in white lab coats and a smattering of commercial diagnostic instruments that were sitting idle. It looked like any other lab. No sign of any special or novel blood-testing technology. When he pointed this out, Sunny said the Theranos devices were still under development and the company had no plans to deploy them without FDA clearance—flatly contradicting what Elizabeth had told Shoemaker on not one but two occasions. Yamamoto wasn’t sure what to believe. Why would the army officer have made all that stuff up?
There were no clear violations he could point to about the way Theranos was currently operating, however, so he let Sunny off with a long lecture about lab regulations. He made sure to emphasize that the scenario Shoemaker had described in his email to Sally Hojvat—experimental blood analyzers operated remotely from one CLIA-certified mother base—was out of the question. If Theranos intended to eventually roll its devices out to other locations, those places would need CLIA certificates too. Either that or, better yet, the devices themselves would need to be approved by the FDA.
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ELIZABETH WASN’T ONE to sit still and quietly take it when she felt her company was under attack. In a blistering email to General Mattis, she hit back against the person who had dared to put hurdles in her way. Shoemaker, she wrote, had communicated “blatantly false information” to the FDA and CMS about Theranos. She went on to heap several paragraphs of scorn on the lieutenant colonel and listed seven inaccurate statements he had allegedly made to the agencies “compiled with assistance from our counsel.” Her email closed with a request:
We are taking swift action to correct these misleading statements. I would very much appreciate your help in getting this information corrected with the regulatory agencies—LTC Shoemaker communicated to the FDA that he was giving them “a heads-up” about “what Theranos was up to” and provided the agency with incorrect information that makes us appear to be in violation of the law. Since this misinformation came from within DoD, it will be invaluable if this information is formally corrected by the right people in DoD. Thank you for your thoughts and as always for your time.
With my best regards,
Elizabeth.
When he read Elizabeth’s email a few hours later, Mattis was furious. He forwarded it to Colonel Erin Edgar, CENTCOM’s command surgeon and the aide-de-camp he’d put in charge of making the Theranos field test happen, with a note that conveyed his anger:
Erin: Who is LTC Shoemaker and what is going on here?…I have tried to get this device tested in theater asap, legally and ethically, and I need to know did this visit happen as related below and how do we overcome this new obstacle…Bottom