eight months away and Clinton considered the front-runner, it was a reminder of how politically connected Holmes was. Enough to make her regulatory problems go away? Anything seemed possible.
I went back to my source and, this time, cajoled him into leaking the whole inspection report to me. Running 121 pages long, the document was as damning as one could expect. For one thing, it proved that Holmes had lied at the Journal’s tech conference the previous fall: the proprietary devices Theranos had used in the lab were indeed called “Edison,” and the report showed it had used them for only twelve of the 250 tests on its menu. Every other test had been run on commercial analyzers.
More important, the inspection report showed, citing the lab’s own data, that the Edisons produced wildly erratic results. During one month, they had failed quality-control checks nearly a third of the time. One of the blood tests run on the Edisons, a test to measure a hormone that affects testosterone levels, had failed quality control an astounding 87 percent of the time. Another test, to help detect prostate cancer, had failed 22 percent of its quality-control checks. In comparison runs using the same blood samples, the Edisons had produced results that differed from those of conventional machines by as much as 146 percent. And just as Tyler Shultz had contended, the devices couldn’t reproduce their own results. An Edison test to measure vitamin B12 had a coefficient of variation that ranged from 34 to 48 percent, far exceeding the 2 or 3 percent common for the test at most labs.
As for the lab itself, it was a mess: the company had allowed unqualified personnel to handle patient samples, it had stored blood at the wrong temperatures, it had let reagents expire, and it had failed to inform patients of flawed test results, among many other lapses.
Heather King tried to prevent us from publishing the report, but it was too late. We posted it on the Journal’s website and the accompanying story quoted a laboratory expert who said its findings suggested the Edisons’ results were no better than guesswork.
The coup de grâce came a few days later when we obtained a new letter CMS had sent to Theranos. It said the company had failed to correct forty-three of the forty-five deficiencies the inspectors had cited it for and threatened to ban Holmes from the blood-testing business for two years. As with the inspection report, Theranos was desperately trying to keep the letter from becoming public, but a new source had contacted me out of the blue and leaked it to me.
When we reported news of the threatened ban, it was no longer possible for Holmes to downplay the gravity of the situation. She had to come out and say something, so she gave an interview to Maria Shriver on NBC’s Today show in which she professed to be “devastated.” But not enough, it seemed, to apologize to the patients she had put in harm’s way. Watching her, I got the distinct impression that her display of contrition was an act. I still didn’t sense any real remorse or empathy.
After all, Theranos’s employees, its investors, and its retail partner, Walgreens, had all learned of the inspection’s findings and the threatened ban by reading the Wall Street Journal. If Holmes was sincere about making things right, why had she tried so hard to suppress their disclosure?
* * *
—
IN MAY 2016, I returned to the San Francisco Bay Area to try to find out what had happened to Tyler Shultz. It was almost exactly a year to the day since we’d met at the beer garden in Mountain View. Erika had told me Tyler was working on a research project with a nanotechnology professor at Stanford, so I drove my rental car to Palo Alto and searched for him in Stanford’s School of Engineering. After asking around, I finally located him in a room in the materials science building.
Tyler wasn’t surprised to see me. Erika had given me his real email address and I’d written to him to let him know I was coming back through town. He’d been noncommittal about meeting with me. Now that I was there, though, he relented. We walked over to a nearby cafeteria to grab some lunch and slipped into easy banter.
Tyler seemed in good spirits. He told me he was part of a small group of researchers at Stanford that had teamed up with a Canadian company to compete