Today was the first direct connection between Theranos Labs problems and Elizabeth Holmes. Surekha Gangakhedkar was the former manager of assay systems. Her job was to prepare blood tests for patients. Gangakhedkar quit because the system was not reliable. She described herself as unhappy, stressed and worried about the launch.
Gangakhedkar met Holmes to discuss her reasons for resigning. She didn't believe the Edisons were suitable enough for patient use. Gangakhedkar testified that Holmes said to Holmes that Theranos had promised to deliver the products to customers.
The launch was a concern of mine.
Holmes is being tried for wire fraud and conspiracy. He wasn't directly connected to the lab inadequacies mentioned by the other witnesses. Holmes, however, was involved in the R&D lab. He even emailed Gangakhedkar at 2AM to inquire about the progress of validation testing.
Gangakhedkar said that she saved and printed email correspondence when Gangakhedkar resigned. She was concerned about the launch. I was afraid that things wouldn't go according to plan and was worried about being blamed.
Gangakhedkars account confirmed Erika Cheung's whistleblower testimony. Cheung, who testified earlier this week that Theranos was a place where secrecy was the norm, said that she was discouraged from listing Theranos on her LinkedIn page. Gangakhedkar stated that there was general guidance to not share information outside of one's immediate group.
That was frustrating for her. She was unable to communicate with the hardware team directly about the issues she was having with the machines because of the secrecy. Holmes, Sunny Balwani (her co-defendant), were given instructions to keep the secret. Sunny Balwani is currently being tried separately.
The software team was present up to 3:07 AM and is now here at 10 AM.
We received a lot of emails from Holmes, or from her during Gangakhedkars' direct testimony. Holmes provided specific instructions to Gangakhedkars staff about work priorities and checked in to verify that the tests she wanted to validate were being done. One of those emails arrived at 1:44 AM on Saturday.
Balwani sent another email to Holmes ccd indicating that Gangakhedkars wasn't working hard enough. He wrote that the software team was present until 3:07AM, and is now here at 10 AM. Gangakhedkars was then verbally abused for leaving the machines idle during the evenings.
Gangakhedkar was uncomfortable because of the secrecy and pressure. She said that the Edison 3.0 and 3.5 devices were not reliable. She was on vacation in August 2013 and returned to find that the machines were being used to test samples for patients.
Theranos also revealed that they were going to modify other machines in order to use the smaller samples collected by them. Holmes pressured Gangakhedkar for approval of tests in order to move to the clinical laboratory.
She resigned in September. She was joined by another member of her team who resigned that day. Gangakhedkar accepted the resignations and told Gangakhedkar she was also quitting.
No matter what, we launch.
Gangakhedkar and Cheung both concluded their testimony today. They said that there were serious quality control issues with Edison devices. If a device failed QC, it was recalibrated. This process could take over 12 hours if all went well. Cheung stated that people were forced to sleep in their cars because the process was too slow. These samples were being run over and over for several days.
Gangakhedkar stated later that the Edison machines that were not readily available was one of the stumbling blocks in validating blood test results. She said that there was a shortage because the machines had to be calibrated so frequently.
Gangakhedkar also printed a letter from Daniel Young, Theranos Vice President. Gangakhedkar wrote Holmes to inform him that data was missing from the server regarding tests on an Edison device version. Young replied that the wrong cartridges were used in those runs and that he recommends repeating them.
Gangakhedkar denied that. She resigned five days later after Holmes sent her an email at 1AM. Gangakhedkar stated that she felt she was making a difference. She said it was a big disappointment that all her hard work would be wasted.
She testified that she received the message that we will launch no matter what. Gangakhedkar will be back on the witness stand next week, despite her immunity from prosecution.
