and afraid.
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ERIKA CHEUNG AND I had remained in sporadic contact after her parking lot scare in late June, but I didn’t know she’d gathered the courage to reach out to a federal regulator. When I first heard about the CMS inspection, I had no idea it had been triggered by her.
Throughout the fall of 2015 and into the winter of 2016, I tried to find out what the inspection had uncovered. After Yamamoto and Bennett completed their second visit in November, there were rumblings from former Theranos employees in contact with current ones that it hadn’t gone well, but details were hard to come by. In late January, we were finally able to publish a story reporting that the CMS inspectors had found “serious” deficiencies at the Newark lab, citing sources familiar with the matter. How serious became clear a few days later when the agency released a letter it had sent the company saying they posed “immediate jeopardy to patient health and safety.” The letter gave the company ten days to come up with a credible correction plan and warned that failing to come back into compliance quickly could cause the lab to lose its federal certification.
This was major. The overseer of clinical laboratories in the United States had not only confirmed that there were significant problems with Theranos’s blood tests, it had deemed the problems grave enough to put patients in immediate danger. Suddenly, Heather King’s written retraction demands, which had been arriving like clockwork after each story we published, stopped.
However, Theranos continued to minimize the seriousness of the situation. In a statement, it claimed to have already addressed many of the deficiencies and that the inspection findings didn’t reflect the current state of the Newark lab. It also claimed that the problems were 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 dragged on, news surfaced that Holmes would be hosting a fund-raiser for Hillary Clinton’s presidential campaign at Theranos’s headquarters in Palo Alto. She had long cultivated a relationship with the Clintons, appearing at several Clinton Foundation events and forging a friendship with their daughter. The fund-raiser was later relocated to the home of a tech entrepreneur in San Francisco, but a photo from the event showed Holmes holding a microphone and speaking to the assembled guests with Chelsea Clinton at her side. With the election