war in Afghanistan. After meeting Elizabeth, he’d asked subordinates
at CENTCOM to set up a live field test of the Theranos device.
Under military rules, such requests had to be routed through the
army’s medical department at Fort Detrick in Maryland, where they
usually landed on the desk of Lt. Col. Shoemaker. As deputy director
for the Division of Regulated Activities and Compliance, Shoemaker’s
job was to ensure that the army abided by all laws and regulations
when it experimented with medical devices.
Shoemaker wasn’t your average military bureaucrat. He had a Ph.D.
in microbiology and had spent years doing medical research on
vaccines for meningitis and tularemia, a dangerous bacterium found in
cottontail rabbits that was weaponized by the United States and the
Soviet Union during the Cold War. He’d also been the first army
officer to complete a one-year fellowship at the Food and Drug
Administration, making him the army’s resident expert on FDA
regulations.
With his genial smile and his southern Ohio drawl, Shoemaker had a
calm, self-effacing manner about him, but he could be direct with
people when he needed to be. Theranos’s strategy, which envisioned
bypassing the FDA altogether, was a nonstarter, he warned Elizabeth,
especially if she planned to roll out her devices nationwide by the
following spring, as she had asserted to him. There was no way the
agency would allow her to do that without going through its review
process, he told her.
Elizabeth disagreed forcefully, citing advice Theranos had received
from its lawyers. She was so defensive and obstinate that Shoemaker
quickly realized that prolonging the argument would be a waste of
time. She clearly didn’t want to hear anything that contradicted her
point of view. As he looked around the table, he noted that she had
brought no regulatory affairs expert to the meeting. He suspected the
company didn’t even employ one. If he was right about that, it was an
incredibly naïve way of operating. Health care was the most highly
regulated industry in the country and for good reason: the lives of
patients were at stake.
Shoemaker told Elizabeth she would need to get something in