miscarriage that was not – .


Brittany Gould, wearing a black mask with a transparent window through which her mouth could be seen, choked as she told the court about her experience with Theranos in 2014. She had used the company’s tests because they were cheap – her tongue was “profitable” – and the results told her, mistakenly, that she was having a miscarriage. It would have been her fourth consecutive miscarriage.

Defense in US v. Elizabeth Holmes blocked Gould’s testimony about the emotional impact of the bad test, so jurors didn’t hear how it affected her. But “losing all these babies and pregnancies, and thinking I’m losing another one, is a lot,” Gould said. The Wall Street Journal during a pre-trial interview.

Gould’s poor results are the first real-life example of how Theranos’ tests affected patients. So far employees have told us about bad labs and inaccurate results, but we haven’t seen ordinary people whose lives have been affected.

Gould is among the patients the government will call to testify against Holmes, who faces 10 counts of wire fraud and two of conspiracy to commit wire fraud. But it is difficult to know exactly how many patients received poor results. Although there is a corporate database with millions of results, it was encrypted and the government did not get the password; the original version of the database has been destroyed.

Gould went to Walgreens, which was home to Theranos Wellness Centers, and “pricked my finger,” she said. Besides the finger test, the experience was mundane – until the bad result came back. Her nurse practitioner called Gould and had to give him the bad news that she appeared to be having a miscarriage.

While Gould’s time at the stand was brief, his nurse practitioner, Audra Zachman, testified at greater length. Zachman had received promotional material from Theranos in his practice, Southwest Contemporary Women’s Care. Theranos was “very exciting” when she first heard about it, especially since the company offered to set up a lab under one of the firm’s desks.

Gould’s previous miscarriages meant her pregnancy was considered high risk, so Zachman ordered tests for hCG, an important hormone during pregnancy. In a normal pregnancy, its value doubles every 48 to 72 hours, Zachman said. Gould first took a Quest test on September 30, 2014, with a score of 1005. Then, on October 2, a Theranos test showed his levels had jumped to 12,558; on October 4, another Theranos test showed those values ​​had dropped to 125.58.

While Zachman told Gould that the test values ​​suggested miscarriage, she also told Gould to keep taking her prenatal vitamins and have another test. This test, from Quest on October 6, showed results consistent with a normal pregnancy. The next value of Quest too.

These results “stood out as a red flag” about Theranos, Zachman said. She had never seen anything like Gould’s results.

Zachman complained to Theranos and apparently corresponded with Holmes’ brother Christian. He blamed the data entry process, not the test. But the corrected values ​​remained of concern, as they were the same as the October 2 results. Usually, when hGC does not increase, it indicates an ectopic pregnancy, where the fetus has implanted outside the uterus.

Because Zachman did not receive an explanation that satisfies her from Theranos, she stopped referring patients there. Yet she continued to get results from Theranos because her patients brought them to her; they did not need a doctor’s prescription to take a blood test.

In cross-examination, Zachman testified to a number of corrective actions Theranos offered, which made the company feel like one of those Amazon sellers begging you to remove your bad review. You see, Zachman was on the board of directors of Southwest Contemporary Women’s Care that evaluated new products. Theranos therefore offered to conduct, and did, a 30-person study comparing its results to those of Quest and a third-party lab. Christian Holmes offered her his private email address and phone number. He was also offered a meeting with Elizabeth Holmes.

When the results came back from Theranos’ study, conducted with his employer, Zachman still hasn’t referred patients to Theranos and says his colleagues haven’t either. The experience with Gould upset her so much – both as a healthcare provider and as a woman, she said – that the study couldn’t convince her to use the tests.

Gould no longer used Theranos either. “You can’t provide accurate patient care with inaccurate results,” she said at the stand.

But between October 2015 and October 2016, Theranos performed 300 more hCG tests for patients at Southwest Contemporary Women’s Care, according to defense evidence.

Obviously, the goal was to lessen the impact of Zachman’s testimony; the defense did not question Gould. The question the defense wanted jurors to ask themselves, it seemed, was, “Would Theranos go beyond – with the study and so on – if this was really a fraud?” “

The morning’s testimony was in a similar vein: Surekha Gangakhedkar, who had previously developed tests at Theranos and resigned due to concerns about the possibility of bringing these tests to patients, was cross-examined. First, the defense tried to establish that it had done a good job with the pharmaceutical companies Centocor and Celgene.

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

Then, to show that Theranos took his tests seriously, a number of documents were presented that Gangakhedkar had signed. These reports detailed how the tests had been developed and were voluminous. But these documents are not the same as what is required to obtain approval for patient testing.

These documents were also used to point the finger at laboratory directors as being ultimately responsible for testing.

With Gangakhedkar, as with Zachman, Holmes was presented as the “good boss” who just wanted to do things right. It wasn’t just the congratulatory emails. Holmes approved a month-long vacation for Gangakhedkar to take his family to meet extended family in India. And when Gangakhedkar resigned, Holmes tried to talk him out of it. Holmes offered time off and asked if there was anything else she could do to make Gangakhedkar stay.

Balwani, on the other hand, was portrayed as the “bad boss”, who repeatedly downplayed the work of the Gangakhedkar team.

Zachman and Gangakhedkar’s testimonies were similar – when something was wrong, Theranos or Holmes would try to fix it. But one thing did stand out: Gould didn’t have a similar story. She was most affected by the poor 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 did not testify to anything similar. Maybe she just wasn’t important enough for Theranos to want to win. After all, she was just a patient.


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