Here’s everything the four former Theranos lab directors revealed about the company’s troubled testing operations in the Elizabeth Holmes fraud trial

Former Theranos CEO Elizabeth Holmes leaves after a hearing in federal court in San Jose, California, the United States, July 17, 2019.
  • The four former directors of the laboratory of Theranos testify as founder Elizabeth holmes trial for fraud.
  • They detail the cancellation of up to 60,000 tests, being left in the dark and how Holmes responded to the concerns.
  • Here’s everything we’ve learned about Theranos’ lab issues so far, based on their testimony.

Theranos launched despite lack of test validation

Adam Rosendorff, director of the Theranos laboratory from April 2013 to November 2014, said he tried to delay the launch of Theranos devices for patient use due to inaccurate results, according to The Wall Street Journal. He asked founder Elizabeth Holmes for more time and staff to prepare for the launch, noting that: “She was very nervous. She was not his usual calm self. Holmes decided to proceed with the launch despite his concerns and the fact that none of Theranos’ tests had been validated, Rosendorff said.

He also said he was responsible for suggest “reasons other than test performance” for unusual test results to doctors and that Theranos did not have a formal proficiency testing protocol.

In November 2014, Rosendorff emailed Holmes: “I feel really uncomfortable with what’s going on at this company right now. I feel obligated to guarantee results that I cannot trust.

“How sad and disappointing to see this from you,” replied Holmes, according to The New York Times. “Apart from the fact that you’ve never emailed me about the issues you alluded to before, but now email us, you know from every conversation we’ve had together how fundamental it is to all of us that you or any other employee not do anything in which you are not completely confident.

Co-directors stayed in the dark about lab workers, including each other

Lynette Sawyer and Sunil Dhawan were lab co-directors in 2014 and 2015, but never met. Dhawan, who was a dermatologist for Former President and Chief Operating Officer of Theranos, Ramesh “Sunny” Balwani, said he didn’t know while he was sharing the role with Sawyer.

Sawyer said she stayed at Theranos longer than her temporary contract stipulated, noting that Balwani was “insistent” in asking her to stay longer, according to The Wall Street Journal.

“I was very uncomfortable with the lack of clarity around the lab,” she said. testified.

Sawyer added that she had never visited the lab, met Holmes, or looked at data from the Theranos machines. Instead, his job was to sign documents regarding tests performed on third-party devices.

Dhawan said he had never met lab workers, doctors or patients, and between November 2014 and summer 2015, he only visited the lab twice, working no more than 10 hours, according to CNBC. Dhawan says his job was also mainly to sign documents.

More than 50,000 tests were canceled because the devices “did not work”

Kingshuk Das was Theranos’ fourth lab director, from 2016 until he was laid off in 2018, just months before the company collapsed. He says that at the time of joining, he was unaware that Theranos was using his proprietary machines for testing, according to The Wall Street Journal.

Theranos canceled all tests carried out on its Edison machines in 2014 and 2015 because “those instruments didn’t work from the start,” Das said. That came out at 50,000 to 60,000 tests, he estimated. Patients received corrected reports indicating “VOID” and Theranos never used these machines again.

Das was tasked with addressing concerns raised in a January 2016 report from the Centers for Medicare and Medicaid Services, a federal regulator. Following an inspection in November 2015, the agency found that Theranos did not comply with federal rules for facilities that test human specimens, according to CNBC. The report also said, “Poor laboratory practices immediately jeopardize the health and safety of patients. “

Disturbing data led to the shutdown of the lab

Das also discussed his decision to shut down Theranos’ “bug lab”. In April 2016, after reviewing data from an HIV test performed on a third-party device, Das felt there were issues with the test and recommended stopping use of this and all other tests. carried out in the BUGS laboratory, according to The Wall Street Journal. Das said Holmes supported the shutdown.

Source link

Comments are closed.