the practice. I told her about her colleagues’ signed statements and warned her that the company would probably try the same heavy-handed tactics with her when she returned.
Dr. Stewart emailed a few days later to let me know that Balwani and two other men had indeed come by to speak to her as soon as she’d gotten back to Arizona. The receptionist had told them she was busy with patients, but they had refused to leave and had stayed in the waiting room for hours until she finally came out to shake their hands. They had made her agree to meet with them the following Friday morning, which was in two days. I had a bad feeling about that meeting, but there was nothing I could do about it. Dr. Stewart promised she wouldn’t bow to any pressure. She felt it was important to take a stand for her patients and the integrity of lab testing.
When Friday arrived, I tried to check in with Dr. Stewart several times in the morning but couldn’t reach her. She called back in the early evening, as I was driving out to eastern Long Island for the weekend with my wife and three kids. She sounded rattled. She told me Balwani had tried to make her sign a statement similar to the one her colleagues had signed, but she had politely refused. Furious, he had threatened to drag her reputation through the mud if she appeared in any Journal article about Theranos. Her voice trembling, she pleaded with me to no longer use her name. As I tried to reassure her that it was an empty threat, it dawned on me that there was nothing these people would stop at to make my story go away.
| TWENTY-TWO |
La Mattanza
The early days of July 2015 brought two pieces of good news for Theranos. The first was that the FDA had approved the company’s proprietary finger-stick test for HSV-1, one of two strains of herpes virus. The second was that a new law Arizona had passed allowing its citizens to get their blood tested without a doctor’s order—a bill Theranos had practically written itself and heavily lobbied for—was about to go into effect.
The company celebrated these milestones by throwing a Fourth of July party at the new headquarters on Page Mill Road. The festivities started in the cafeteria with rousing speeches from Holmes and Balwani and then moved outside to the building’s courtyard, where an open bar, catered food, and techno music awaited employees.
Theranos touted the herpes test approval as proof that its technology worked, but I remained deeply skeptical. In laboratory parlance, the herpes test was a qualitative test. Such tests provided simple yes-or-no answers to the question of whether a person had a certain disease. They were technically much easier to get right than quantitative tests designed to measure the precise amount of an analyte in the blood. Most routine blood tests were quantitative ones.
I called a source of mine who was high up in the FDA’s medical-device division. He confirmed my thinking. The herpes test approval was a one-off clearance that was in no way a blanket endorsement of Theranos’s technology, he said. In fact, the clinical data the company had submitted to the agency for a number of its other finger-stick tests were poor and wouldn’t pass muster, he added. When in turn I told him about the things I had learned in the course of my reporting, ranging from Theranos’s practice of running diluted finger-stick samples on commercial analyzers to its gaming of proficiency testing and the questionable test results some doctors and patients had received, he sounded disturbed.
Part of the problem was that, three years after Holmes’s clash with the now-retired Lieutenant Colonel David Shoemaker, Theranos continued to operate in a regulatory no-man’s-land. By using its proprietary devices only within the walls of its own laboratory and not seeking to commercialize them, it was able to continue to avoid close FDA scrutiny. At the same time, it gave the appearance of cooperating with the agency by publicly supporting its drive to regulate laboratory-developed tests and voluntarily submitting some of its own LDTs, like the herpes test, to it for approval.
My source said it was hard for the agency to take any adverse action against a company that portrayed itself as the lab world’s biggest advocate of FDA regulation, especially one as politically connected as Theranos. At first, I thought he was referring to its board of directors, but that