confined to the way the lab was run and had no bearing on the
soundness of its proprietary technology. It was impossible to disprove
these claims without access to the inspection report. CMS usually
made such documents public a few weeks after sending them to the
offending laboratory, but Theranos was invoking trade secrets to
demand that it be kept confidential. Getting my hands on that report
became essential.
I called a longtime source of mine in the federal government who
had access to it. The most he was willing to do was read some passages
over the phone. That was enough for us to report one of the
inspection’s most serious findings: the lab had continued to run a
blood-clotting test for months despite repeated quality-control failures
indicating that it was faulty. “Prothrombin time,” as the test was
known, was a dangerous test to get wrong because doctors relied on it
to determine the dosage of blood-thinning medication they prescribed
to patients at risk of strokes. Prescribing too much blood thinner could
cause patients to bleed out, while prescribing too little could expose
them to fatal clots. Theranos couldn’t refute our story, but it argued
once more that its proprietary technology was not at issue. The
prothrombin time test had been performed on regular venous samples
using commercial equipment, it said. When its back was against the
wall, the company was willing to admit to using conventional
analyzers if doing so could help maintain the illusion that its own
devices worked.
To try to force CMS to release the inspection report, I filed a
Freedom of Information Act request for any and all documents
connected to the Newark lab inspection and requested that it be
expedited. But Heather King continued to urge the agency not to make
the report public without extensive redactions, claiming that doing so
would expose valuable trade secrets. It was the first time the owner of
a laboratory under the threat of sanctions had demanded redactions to
an inspection report, and CMS seemed unsure how to proceed. With
each passing day, I became concerned that the full inspection findings
would never be released.
As the tug-of-war with Heather King over the inspection report