writing from the FDA supporting her position if she wanted him to
greenlight the use of her machines on army personnel. Her face
conveyed deep displeasure. She resumed her presentation but gave
Shoemaker the cold shoulder for the rest of the day.
—
IN HIS EIGHTEEN-YEAR CAREER in the army, Shoemaker had come
across a lot of people who seemed to think the military was exempt
from civilian regulations and free to conduct medical research as it
pleased. That was simply not the case, though this wasn’t to say it
hadn’t happened in the past. The Pentagon tested mustard gas on
American soldiers during World War II and Agent Orange on
prisoners in the 1960s. But the days of unsupervised, freewheeling
medical experimentation by the military were long gone.
During the Serbian conflict in the 1990s, for instance, the Pentagon
made sure to get the FDA’s assent before offering troops deployed in
the Balkans an experimental vaccine against tick-borne encephalitis.
And only soldiers who wished to receive the vaccine were given it.
Similarly, the army worked closely with the agency to make an
investigational vaccine against botulinum toxin available to soldiers in
Iraq in 2003. At the time, concerns were high that Saddam Hussein
had stockpiled the lethal biological agent, and the promising vaccine,
which had been developed by researchers at Fort Detrick, hadn’t yet
been approved by the FDA.
In both instances, the army consulted an institutional review board,
or IRB—a committee within the military that monitors medical
research to ensure that it is conducted safely and ethically. If the IRB
deems that a proposed study doesn’t pose significant risks, the FDA
will usually allow it to go forward, provided it’s carried out under a
strict protocol the committee has reviewed and approved.
What was valid for vaccines was also valid for medical devices. If
Theranos wanted to try out its blood-testing machines on troops in
Afghanistan, Shoemaker felt certain that it would need to put together
an IRB-approved study protocol. But since Elizabeth had been so