Laboratory director sounded the alarm on flawed tests

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Adam Rosendorff, who served as laboratory director for the now defunct blood testing company from 2013 to 2014, said he alerted founder and CEO Elizabeth Holmes to the problems with the tests, but his warnings were ignored.

“I came to believe that the company cared more about public relations and fundraising than patient care,” said Dr. Rosendorff.

Her comments capped week three of testimony in Ms Holmes’ criminal fraud trial. He is the fourth former employee to testify as federal prosecutors build their case against Ms Holmes, who allegedly defrauded patients and investors by claiming her blood test machine could diagnose more than 200 health problems using just a few drops. blood from a finger prick.

Dr Rosendorff said Ms Holmes knew the company’s devices were producing inaccurate results, but pushed Theranos to start testing real patients. He said he left about a year and a half after joining the company after determining that patient care was not the company’s priority.

Ms Holmes has pleaded not guilty to a dozen counts of wire fraud and conspiracy to commit wire fraud.

When he accepted the post, Dr Rosendorff was inspired by what he called Ms Holmes’ sincere dedication to improving patient care. He said that while he didn’t know much about the technology Theranos was building, he believed it would be innovative.

“I thought it would be the next Apple,” he said.

Dr Rosendorff said his impressions changed soon after joining the startup. On August 29, 2013, just over a week before Theranos was set to launch its devices to test patients’ blood, Dr Rosendorff sent Ms Holmes an email explaining how even simple tests returned very distant results, according to a copy of an email that was posted in court. He said he asked for more time to sort out issues, hire more staff and improve training. He also went to Ms Holmes’ office, where she had posted a piece of paper in the window showing the number of days until the commercial launch.

“She was very nervous,” said Dr Rosendorff. “She wasn’t his usual calm.” He described Ms Holmes as shaking and her voice cracked.

In an email presented to the court and dated August 31, 2013, Ms Holmes asked her staff how many tests had been validated, a process required by federal regulatory guidelines before a test could be used for care. to patients. A staff scientist replied that none of the tests had been validated. It took about nine days before Theranos was supposed to launch its devices for use on real patients, Dr Rosendorff said.

Dr Rosendorff reported to Ramesh “Sunny” Balwani, Ms Holmes’ second in command and ex-boyfriend. Dr Rosendorff said Mr Balwani often dismissed his concerns or responded with hostility, so the lab director sometimes raised his concerns. directly to Ms Holmes because, as CEO, he believed she would be empowered to resolve issues.

Theranos’ tests continued to provide inaccurate and at times highly implausible results. Dr Rosendorff gave examples of tests for sodium and HDL, a measure of cholesterol, that were so much below the normal range for healthy individuals that he thought they were wrong.

In some tests, patients whose actual results were better than those considered normal or healthy might appear normal on Theranos tests, Dr Rosendorff said. These patients would not get the treatment they needed, he said.

Theranos’ hCG test, which measured a key hormone to indicate pregnancy and normal pregnancy progression, also gave erratic results, Dr Rosendorff said.

Earlier this week, patient Brittany Gould and her nurse practitioner, Audra Zachman, testified in court that they had received two test results from Theranos which indicated Ms Gould was having a miscarriage when she actually had one. healthy pregnancy.

After having the same pregnancy marker tested two more times, by another blood test provider, Ms Zachman confirmed that Ms Gould still had a healthy pregnancy. Mrs. Gould said she later had a baby girl.

In May 2014, Dr Rosendorff said he was concerned that the hCG test might not be suitable for patient care. He sent an email in all caps to staff instructing them not to post test results of pending patients and to run the hormonal test only on third-party commercial analyzers that Theranos had in its lab.

Despite his directive, hCG testing continued to be performed on Theranos proprietary devices, according to court testimony.

As complaints from doctors and patients mounted, Dr Rosendorff was tasked with responding to doctors’ inquiries and providing alternative explanations for questionable results, such as a patient’s medication affecting the result, he said.

“I have often been asked to find reasons other than test performance,” said Dr Rosendorff.

Christian Holmes, Mrs Holmes’ brother who also worked in the company, was the liaison between Dr Rosendorff and the doctors. The former lab chief said Mr Holmes discussed the company’s “messages” with him.

“At Theranos, I felt compelled to defend the company’s results with the doctors,” said Dr Rosendorff, adding that his superiors “were pushing me to rationalize, to justify the erroneous results.”

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