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.
—
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