Emails show Elizabeth Holmes directing response to failed Theranos tests – Ars Technica
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Emails show Elizabeth Holmes directing response to failed Theranos tests
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Tim De Chant
- • 09/27/2021 12:09 pm
- • Categories: Policy
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Theranos’ former lab director, Dr. Adam Rosendorff, told jurors on Friday that he quit the company because he "felt pressured to vouch for tests I did not have confidence in."
The company’s management, he said, was not willing to perform proficiency testing that is required by federal law before clinical laboratories can run tests on patient samples. That, and a series of other issues, caused him to lose confidence in the company. "I came to believe that the company was more about PR and fundraising than patient care," Rosendorff said.
Rosendorff didn’t always have such a dim view of Theranos, though. When he joined the company in April 2013, he was eager to help founder Elizabeth Holmes realize her vision to replace veinous blood draws with finger sticks.
"I thought Theranos had advanced technology that allowed them to do this," he said. "I thought it was going to be the next Apple." Within months, though, he came to doubt that Theranos could deliver what it had been promising, and he began looking for a new job that summer.
Botched rollout
Theranos was scheduled to begin offering diagnostic tests for patients on September 9, 2013, and as that date neared, Rosendorff said he was "raising alarm bells." As of August 31, just weeks before launch, none of the company’s tests had been validated as required by law, and emails show Holmes was aware of the problem. Rosendorff lobbied Holmes and Ramesh "Sunny" Balwani, the company’s president and COO, to delay the public launch so he could sort out issues with testing and staff training. He asked for "a few more weeks to sort through these medical and logistical issues."
Rosendorff said he didn’t feel Balwani, his supervisor, was taking him seriously, so he met with Holmes directly to press for a delay. "She was very nervous," he said of the meeting. "She was not her usual composed self. She was trembling a little bit."
Despite his efforts, Theranos went through with the launch as planned, though third-party devices performed the tests.
"This is already handled"
At some point, Theranos started using its Edison device to test patient samples, and the results were frequently inconsistent or troubling. Earlier last week, the jury heard testimony from a nurse practitioner who had sent one of her patients to Theranos in October 2014 to test for a key pregnancy hormone, hCG.
The first result came back at 12,558, far higher than expected given the stage of the woman’s pregnancy. The second result came back at 125.58, so low that the nurse feared the woman was miscarrying. In the end, Theranos issued a correction for the second test, saying they had misplaced a decimal point. The result should have been 12,558—the exact same number that it had reported for the first test. Ultimately, the woman would go on to give birth.
At the time of the woman’s pregnancy test, Holmes was already aware of problems with the diagnostics. In June 2014, Holmes’ brother, Christian, who served as a liaison between doctors and the lab director, sent her and Balwani an email saying, "Just fyi-hCG right now causing some serious issues and patient complaints."
Holmes replied, saying she’d follow up and telling Balwani, "this is already handled." Rosendorff, who was nominally in charge of the lab, was not copied on any of these emails. In fact, he said in court that this was the first time he was seeing them.
Other questionable tests
Theranos’ devices were also returning questionable results for HDL cholesterol and sodium, potassium, and chloride. They were sometimes so far below the accepted range that Rosendorff suspected problems with the tests themselves. In February 2014, he suggested switching patient tests over to third-party devices. Holmes, Balwani, and another executive didn’t want to make the change, he said. "I got a lot of pushback."
Rather than tell health care providers that they were having problems with the tests, Theranos would void results that were either above or below accepted values. For some patients, that practice was problematic. In one instance, a doctor had ordered a test for a patient with low sodium, and the test results came back low enough that Theranos’ practice was to toss them out. The customer service representative assigned to the case wasn’t sure how to proceed and emailed Rosendorff: "Is it possible that that was the value? If she comes in again, and the value is still critical low, will it be voided again?"
If a doctor suspects a patient has low sodium, they’ll turn to lab tests to confirm it so they can treat accordingly. But Theranos was voiding test results that came in too low—even if those results might have been accurate. The practice of voiding results outside a particular range raises the question of which results, if any, could have been trusted.
"I’m not sure of a clinical value of a sodium assay in which the only time we can report it is when it is not critical and the very situations that require accurate measurement and reporting of abnormal sodium results are voided," Rosendorff wrote to Balwani and Holmes, forwarding the customer service rep’s email.
From Rosendorff’s testimony and from emails introduced by the prosecution, it’s clear that not only was Holmes aware of Theranos’ many testing problems, but she was also directing the response.
As Theranos’ problems persisted and as Rosendorff "felt pressured to defend the company’s results to physicians," he began forwarding emails to his personal Gmail account. "I wanted to protect myself," he told the court.
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