The first patient testimony about a Theranos test result: a miscarriage that wasn’t

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    Brittany Gould, who wore a black mask with a see-through window through which her mouth could be seen, choked when she told the court about her experience with Theranos in 2014. She had used the company’s tests because they were cheap – their language was “inexpensive” – ​​and the results falsely told her she had a miscarriage. It would have been her fourth miscarriage in a row.

    The U.S. defense against Elizabeth Holmes blocked Gould’s testimony of the poor test’s emotional impact so the jury didn’t hear how it affected them. But “the loss of all these babies and pregnancies and the experience of losing another is a lot,” Gould told the Wall Street Journal in a pre-trial interview.

    The experience was unremarkable – until the wrong result came back

    Gould’s poor results are the first real-life example of how Theranos’ tests affected patients. So far we’ve heard from staff about bad labs and inaccurate results – but we’ve never seen ordinary people whose lives have been affected by it.

    Gould is among the patients the government will call to testify against Holmes, who has faced ten wire fraud charges and two wire fraud conspiracies. But it’s hard to know exactly how many patients have had poor results. Although there was a company database with millions of results, it was encrypted and the government was not given a password for it; the original version of the database was destroyed.

    Gould went to Walgreens, the Theranos spa, and “stabbed my finger,” she testified. Apart from the fingerstick test, the experience was unremarkable – until the wrong result came back. Her nurse called Gould and had to bring her the bad news that it looked like she had a miscarriage.

    Although Gould’s moment on the stand was brief, her nurse Audra Zachman testified in greater detail. Zachman had received Theranos’ promotional materials at her Southwest Contemporary Women’s Care practice. Theranos was “very exciting” when she first heard about it, especially since the company offered to set up a laboratory under one of the practice’s offices.

    Gould’s previous miscarriages meant her pregnancy was classified as high risk, so Zachman ordered tests for hCG, an important hormone in pregnancy. In a normal pregnancy, its value doubles every 48 to 72 hours, Zachman said. Gould first tested Quest on September 30, 2014 with a value of 1,005. Then on October 2nd, a Theranos test showed that her values ​​had risen to 12,558; On October 4th, another Theranos test showed that these values ​​had dropped to 125.58.

    While Zachman shared with Gould that the test values ​​indicated a miscarriage, she also told Gould to keep taking her prenatal vitamins and take another test. This October 6 test by Quest showed results consistent with a normal pregnancy. Likewise the next value of Quest.

    These results “stood out as such a red flag” over Theranos, “said Zachman. She had never seen anything like the results Gould had received.

    Zachman complained to Theranos and apparently corresponded with Holmes’ brother Christian. He blamed the data entry process, not the test. But the revised readings were still worrying as they were the same as the October 2nd results. If the hGC does not rise, it usually indicates an ectopic pregnancy in which the fetus implanted outside the uterus.

    Since Zachman received no explanation from Theranos that satisfied her, she no longer referred patients there. Even so, she kept getting results from Theranos because her patients brought them with them; they didn’t need a doctor’s order to get a blood draw.

    “You cannot provide accurate patient care with inaccurate results.”

    In cross-examination, Zachman said about a number of corrective actions Theranos offered – which made the company sound like one of those Amazon sellers asking you to remove your bad review. You see, Zachman was on the Southwest Contemporary Women’s Care Board evaluating new products. So Theranos offered to conduct a study with 30 people and compare their results with those from Quest and a third-party laboratory. Christian Holmes offered her his home email address and phone number. She was also offered a meeting with Elizabeth Holmes.

    When the results of Theranos’ study, which was conducted with her employer, came back, Zachman still did not refer patients to Theranos, saying that her colleagues largely did not either. The experience with Gould was so staggering to her – both as a health care provider and as a woman, she said – that the study failed to convince her to use the tests.

    Gould no longer used Theranos either. “You cannot provide accurate patient care with inaccurate results,” she said at the booth.

    But between October 2015 and October 2016, Theranos conducted an additional 300 hCG tests for patients at Southwest Contemporary Women’s Care, according to the defense.

    Obviously the aim was to weaken the impact of Zachman’s testimony; the defense did not question Gould. The question the defense wanted to ask the jury apparently was, “Would Theranos go above and beyond – with the trial and so on – if it were really a fraud?”

    These documents were also used to point fingers at the laboratory ladder

    The morning’s testimony was similar: Surekha Gangakhedkar, who had previously developed tests in Theranos and given up because of concerns about bringing those tests to patients, was cross-examined. First, the defense tried to prove that they had done a really good job with pharmaceuticals companies Centocor and Celgene.

    The defense also showed emails from Holmes congratulating Gangakhedkar on their work, one of which came at 12:20 a.m. on a Wednesday.

    Then, to show that Theranos had taken his tests seriously, a number of documents were presented that Gangakhedkar had signed. These reports detailed how the tests were developed and were extensive. But these documents are not the same as those required to get approval to test on patients.

    These documents were also used to point the finger at the laboratory managers who were ultimately responsible for the tests.

    Holmes was presented as a “good boss”

    With Gangakhedkar, as with Zachman, Holmes was presented as the “good boss” who just wanted to do everything right. It wasn’t just the kudos emails. Holmes approved a month’s leave so Gangakhedkar could take her family to meet an extended family in India. And when Gangakhedkar stopped, Holmes tried to talk her out of it. Holmes offered a leave of absence and asked if there was anything else she could do to get Gangakhedkar to stay.

    Balwani, on the other hand, was portrayed as the “bad boss” who had repeatedly downplayed Gangakhedkar’s work.

    Zachman and Gangakhedkar’s testimony felt similar – if something went wrong, Theranos or Holmes would try to fix it. But one thing stood out: Gould had no similar story. She was most affected by the bad test results, not Zachman. And Theranos knew the bad results were hers.

    While Zachman was offered Christian Holmes’ phone number and a meeting with Elizabeth Holmes, Gould said nothing similar. Maybe she just wasn’t important enough to make Theranos want to win. After all, she was just a patient.

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