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Former Theranos lab director Dr Adam Rosendorff told jurors on Friday he left the company because he “felt compelled to vouch for tests I didn’t trust.” .
Company management, he said, was unwilling to perform proficiency testing required by federal law before clinical laboratories could perform tests on patient samples. This, and a series of other issues, caused him to lose confidence in the company. “I came to believe that the company was more about public relations and fundraising than patient care,” said Rosendorff.
However, Rosendorff didn’t always have such a grim view of Theranos. When he joined the company in April 2013, he was eager to help founder Elizabeth Holmes achieve her vision of replacing venous blood sampling with finger pricks.
“I thought Theranos had cutting edge technology that allowed them to do this,” he said. “I thought it would be the next Apple.” Within months, however, he came to doubt that Theranos could keep his promises, and he started looking for a new job that summer.
Sloppy deployment
Theranos was due to start offering diagnostic tests to patients on September 9, 2013, and as that date approaches, Rosendorff has said he is “sounding the 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 issue. Rosendorff lobbied Holmes and Ramesh “Sunny” Balwani, the company’s president and chief operating officer, to delay the public launch so that it could sort out issues with testing and staff training. He asked for “a few more weeks to sort out these medical and logistical problems.”
Rosendorff said he didn’t think Balwani, his supervisor, took him seriously, so he met directly with Holmes to request a postponement. “She was very nervous,” he said of the meeting. “She wasn’t his usual quiet self. She was shaking a little.
Despite its best efforts, Theranos carried out the launch as planned, although third-party devices performed the testing.
“It’s already settled”
At one point, Theranos began using his Edison device to test patient samples, and the results were often inconsistent or disturbing. Earlier last week, the jury heard testimony from a nurse practitioner who sent one of her patients to Theranos in October 2014 to test for a key pregnancy hormone, hCG.
The first result came back to 12,558, much higher than expected given the stage of the woman’s pregnancy. The second result came down to 125.58, so low the nurse was concerned the woman would miscarry. Ultimately, Theranos released a correction for the second test, claiming they misplaced a decimal point. The result should have been 12,558, exactly the same number he reported for the first test. In the end, the woman was going to give birth.
By the time of the woman’s pregnancy test, Holmes was already aware of the diagnostic issues. In June 2014, Holmes’ brother Christian, who served as the liaison between the doctors and the lab director, sent him and Balwani an email saying, “Just fyi-hCG at the moment chatting about serious problems and complaints from patients. “
Holmes responded, saying she would follow up and telling Balwani, “It’s already handled.” Rosendorff, who was nominally in charge of the lab, was not copied to any of those emails. In fact, he said in court that it was the first time he had seen them.
Other questionable tests
Theranos’ devices also returned questionable results for HDL cholesterol and sodium, potassium, and chloride. They were sometimes so far from the accepted range that Rosendorff suspected problems with the tests themselves. In February 2014, he suggested taking patient tests to third-party devices. Holmes, Balwani and another executive did not want to make the change, he said. “I had a lot of hindsight.”
Rather than telling healthcare providers they were having issues with the tests, Theranos would override results above or below accepted values. For some patients, this practice was problematic. In one case, a doctor ordered a test for a low sodium patient, and the test results were low enough that Theranos’ practice was to throw them out. The customer service representative assigned to the case was unsure of how to proceed and emailed Rosendorff: “Is it possible that this is the value?” If it comes back and the value is still critical, will it be canceled again? “
If a doctor suspects that a patient has low sodium, they will look to lab tests to confirm it so they can treat accordingly. But Theranos was overruling the test results which were too low, even though those results could have been accurate. The practice of overriding results outside of a particular range raises the question of what results, if any, could have been reliable.
“I am not sure of the 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 results. sodium abnormalities are canceled, ”Rosendorff wrote to Balwani and Holmes, forwarding the customer service representative’s email.
From Rosendorff’s testimony and the emails presented by the prosecution, it is clear that not only was Holmes aware of Theranos’ many testing issues, but she was also leading the response.
As Theranos’ problems persisted and Rosendorff “felt compelled to defend the company’s results with the doctors,” he began forwarding emails to his personal Gmail account. “I wanted to protect myself,” he told the court.
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