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A former Theranos lab director testified Friday that Elizabeth Holmes was “trembling” when she was confronted in 2013 about unvalidated blood tests results, as the fraud trial against the former Silicon Valley executive continues.
Dr. Adam Rosendorff told jurors he joined the Holmes' company, which claimed it would revolutionize the health care industry with its proprietary blood-testing technology, in April of 2013 after believing that it could be “the next Apple,” but quickly realized the company was plagued by ineffective technology and inconsistent blood test results despite the company’s bold claims, according to The Daily Beast. He left the company in late 2014.
“I came to believe the company cares more about PR and fundraising than it cares about patient care,” he said. “I wanted to protect myself. I also wanted to get the word out about what was happening to Theranos.”
Rosendorff testified that another factor in his departure was the “unwillingness of management to perform proficiency testing as required by law” and said he “felt pressured to vouch for tests” that he did not have confidence about, The Verge reports.
Shortly after Rosendorff—who had previously served as the medical director for clinical labs for Children’s Hospital of Pittsburgh—signed on as Therano’s lab director, the company was slated to launch its blood-testing machines in Walgreens stores.
However, as the Sept. 9, 2013 launch date approached, Rosendorff said he realized the deadline was “extremely rushed and hurried.”
To illustrate how unprepared the company was, he pointed to an email Holmes sent on Aug. 31, 2013 at 1 a.m. asking an employee how many of the tests had completed validation, with the employee replying that none of the tests met qualifications.
With the scheduled launch over a week away, Rosendorff tried “raising alarm bells” by emailing Holmes and then-Theranos president and chief operating officer Ramesh “Sunny” Balwani about grave concerns he had with the tests, staffing at the lab, and training.
He also brought his concerns directly to Holmes in person.
“She was trembling a little bit, her voice was shaky, it was breaking up,” he testified, according to the The Daily Beast. “She didn’t seem surprised, just nervous and upset. She wasn’t her usual self.”
Rosendorff had asked to delay the launch by a few weeks, but said he was pressured to stick to the original timeline.
Holmes told him that rather than use Theranos technology—which had produced inaccurate and unreliable results—they could rely on conventional lab equipment at Walgreens, CNBC reports.
Holmes had once touted that the company’s Edison machines would be able to conduct various blood tests using just a few drops of blood, but according to Rosendorff—and earlier testimony from Ericka Cheung—the machines often failed quality control.
Rosendorff testified that the devices “failed so frequently it raised doubts in my mind regarding the accuracy of the tests themselves.”
When he brought up the issue of the high failure rates with Balwani, he said he was told it was “not the case.”
Doctors began complaining about patient results, yet rather than having Rosendorff address the complaints himself, he testified that Holmes’ brother Christian was tasked with handling all complaints.
Rosendorff said he was pressured to attribute any bad test results to factors outside of the test itself.
After one test for the pregnancy hormone human chorionic gonadotropin (HCG) erroneously told a patient she was suffering a miscarriage, Rosendorff sent an email to his staff demanding all future tests be run on FDA-approved devices, but the testing continued on Theranos devices.
Holmes herself was included on an email from her brother in June of 2014 about the ongoing problems with the HCG test, with Christian writing that it was “causing serious complaints and patient issues.”
He added in the email, that also copied Balwani, that the lab was “a complete mess.”
Holmes responded by telling Balwani “this is already handled” and said she’d plan to connect with her brother about the issue.
Rosendorff said the problems in the lab didn’t end there. He described them as being widespread and said in some cases the tests had lost their “diagnostic value,” according to The Verge.
As concern among physicians continued to mount, Rosendorff said the anxiety he felt about feeling pressured to push the bad test results eventually caused him to leave the company.
“At one point I started to refuse to talk to physicians. I believe I told one or two the results were wrong and it was causing me emotional discomfort,” he said, according to The Daily Beast.
His testimony is expected to continue this week.
Holmes and Balwani—who will be tried separately—are each facing a dozen charges of wire fraud and conspiracy to commit wire fraud after prosecutors say they duped investors, raising millions of dollars for the company despite the failing technology.
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