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

Brittany Gould was wearing a black mask that had a clear window so you could see her mouth. She got choked up telling the court her story with Theranos 2014. The company's tests were inexpensive and her language was cheap. She was told she was miscarrying by the results. This would have been her fourth miscarriage.
US v. Elizabeth Holmes prevented Gould from giving testimony about the emotional effects of the poor test. Jurors were not able to hear her describe how the experience affected her. In an interview with The Wall Street Journal, Gould said that the loss of all these pregnancies and babies, as well as the feeling of losing another one, was a great deal.

It was a dull experience until the incorrect result was returned

Gould's poor results are the first example of how Theranos testing affected patients. We have not yet seen any patients whose lives were affected by Theranos tests. However, we have heard about employees complaining about inaccurate lab results and bad lab practices.

Gould will be one of the witnesses that Holmes faces on 10 counts of wire fraud as well as two of conspiracy. It is difficult to determine how many patients were given bad results. Although there was a database that contained millions of results from companies, it was encrypted so the government couldn't access it. The original database was destroyed.

She testified that Gould went to Walgreens which had Theranos wellness centres, and got her finger poked. The experience, aside from the finger stick test was not remarkable until the incorrect result returned. Gould was called by her nurse practitioner, who informed her that she had miscarried.

Although Goulds brief moment was brief, Audra Zachman, her nurse practitioner, gave a more detailed testimony. Zachman had received Theranos promotional material at Southwest Contemporary Womens Care. Theranos was a very exciting company to her when she heard about it. The company even offered to put a lab in one of her offices.

This is a red flag.

Gould's history of miscarriages made her high-risk pregnancy. Zachman ordered tests to check for hCG. Zachman stated that in a normal pregnancy, it doubles every 48-72 hours. Gould took her first Quest test on September 30, 2014 with a value 1.005. On October 2, 2014, Gould took a Quest test with a value of 1,005. A Theranos test revealed that her levels had increased to 12,558. On October 4, a second Theranos testing showed that these values had dropped to 125.58.

Zachman informed Gould that the test results suggested a miscarriage. However, she advised Gould to continue taking her prenatal vitamins as well as to take another test. Quest's October 6th test showed results that were consistent with a normal pregnancy. The next Quest value was also consistent.

Zachman stated that these results were a red flag for Theranos. She had never seen anything similar to the results Gould received.

Zachman complained about Theranos and apparently corresponded to Holmes brother Christian. He blamed the data entry, not the test. The corrected values were still alarming, as they were identical to the October 2nd results. Usually, if hGC does not rise, it is a sign of an ectopic pregnancy. This means that the fetus may have implanted outside the womb.

Zachman was not satisfied with her explanation from Theranos so she stopped referring patients to them. She kept receiving results from Theranos, however, because her patients brought them in. They didn't need to be referred by a doctor to draw blood.

With inaccurate results, you can't give accurate patient care.

Zachman, who was cross-examined, testified that Theranos had offered a variety of corrective actions. This made Theranos sound like an Amazon seller who begs for negative reviews to be removed. Zachman was a member of the Southwest Contemporary Womens Care Board that evaluated new products. Theranos agreed to conduct a study with 30 participants comparing the results to Quest and third-party labs. Christian Holmes provided his email address and telephone number. Elizabeth Holmes offered her a meeting.

Zachman, who was a co-author of the Theranos study with her employer, still did not refer patients to Theranos. She also said that her colleagues didn't. She was both a healthcare provider as well as a woman and found the experience with Gould so shocking that she decided to not use Theranos.

Gould also stopped using Theranos. She stated that inaccurate results can make it impossible to provide accurate patient care.

According to the defense, Theranos performed 300 additional hCG tests on patients at Southwest Contemporary Womens Care between October 2015-October 2016.

Evidently, the defense didn't question Gould. The defense wanted jurors to consider the following question: If it was a fraud, would Theranos do more with the study or so on?

These documents were also used as a way to point fingers at lab directors

The morning's testimony was similar: Surekha Gangakhedkar was cross-examined. She had previously developed tests at Theranos but quit because she was concerned about patients receiving those tests. The defense first tried to prove that shed had done good work with Celgene and Centocor drug companies.

The defense also displayed emails that Holmes sent to Gangakhedkar congratulating her for her work. One of these was at 12:20 AM on Wednesday.

Gangakhedkar signed several documents to prove that Theranos took its tests seriously. These documents were detailed about how the tests were developed and were very long. However, these documents are not the same as what is required to obtain approval for testing patients.

These documents were also used as a way to blame the lab directors for failing to perform the tests.

Holmes was named the "good boss".

Holmes, like Zachman, was seen as the boss who wanted things to go right with Gangakhedkar and Zachman. This was not just about the emails and kudos. Holmes granted Gangakhedkar a month-long vacation to allow her to visit extended family members in India. Holmes tried to convince Gangakhedkar not to leave, but she was unsuccessful. Holmes suggested a leave of absence and asked if she could do anything to help Gangakhedkar remain.

Balwani was, however, portrayed as the bad boss who repeatedly downplayed Gangakhedkars team work.

The testimony of Zachman and Gangakhedkar was similar in that when something goes wrong, Theranos and Holmes try to fix it. One thing was clear: Gould did not have a similar story. Zachman was not the most affected by the poor test results. Theranos was aware that she was the one who suffered from the poor results.

Zachman was offered Christian Holmes' phone number and an Elizabeth Holmes meeting, but Gould did not testify to any similar. Perhaps she wasn't important enough to Theranos to be interested in her. She was a patient.