Holmes’ entire day of testimony was his longest day ever
first time for him criminal—fraud lawsuit, Elizabeth Holmes targeted Tuesday by prosecutors on the most serious charges leveled against her, offering a narrative of herself as a well-intentioned if inexperienced entrepreneur in her attempt to transform healthcare Had some success.
Ms. Holmes’ full day of testimony was the longest ever in her defense against 11 charges of fraud and conspiracy related to the then-defunct startup Theranos Inc., which collapsed in 2018. After that 11 weeks of testimony Supporting the prosecution’s case that Ms. Holmes intentionally got into trouble while trying to set up her own blood-testing company misled investors and patients About the capabilities of his technology.
Her testimony on Tuesday, her third day at the witness stand, comes after the trial lawyers sought to set aside the prosecution’s strongest evidence.
Elizabeth Holmes denies deception in her criminal trial
Ms. Holmes told the jury that she added the logos of major drug companies to Theranos documents with honest intentions; that it did not try to circumvent regulatory oversight, but was transparent with the Food and Drug Administration; And that Theranos turned to using a commercial blood analyzer to deal with high blood-sample volumes because of the retail partner’s decision, not because it was trying to mislead anyone into what its own devices were doing. can.
While on the stand, Ms. Holmes looked intently at her lawyer and flashed an occasional smile. During the break, he hugged tightly to his partner, mother and friends who had come to support him.
Ms. Holmes faces a maximum prison term of 20 years for each fraud. matter seems to be headed for a conclusion, as the defendant is traditionally the last witness to be called in criminal trials. The prosecution will have an opportunity to cross-examine him and offer a rebuttal after the defense concludes its case.
Ms. Holmes said that in 2012 Walgreens Boots Alliance Inc. Theranos began using the commercial blood analyzer after changing its business model to accommodate a request from Theranos, which had a partnership with Theranos.
But Theranos continues to claim that it can run more than 200 tests on a small amount of blood with the prick of a finger using its proprietary device. Prosecutors’ evidence showed that it could run only a dozen tests on its machines—even those tests were unreliable—and that for the majority it relied on commercially available machines, allowing them to run on a small scale. Changed to be able to run tests on samples. Revealed from blood, court records and testimony.
In 2015, at a conference days after it was first reported by The Wall Street Journal Theranos’ problems with its technology, Ms Holmes stressed: “We have never used commercially available laboratory equipment for finger-stick based tests.”
In her court testimony, Ms. Holmes said that when Theranos and Walgreens made an agreement to keep Theranos devices in their drugstores in order to offer on-site blood tests to customers, Walgreens changed its mind and Theranos Instead, he was asked to run the test in his own laboratory. Eventually, Theranos was flooded with blood samples, and the company was sick.
It became impractical to test hundreds of samples on its proprietary equipment, Ms. Holmes said, since each machine could only run one sample at a time, so Theranos purchased commercial analyzers and designed them to work with the small samples of blood collected. modified for.
“It made a lot more sense,” she testified, because “you can process all those samples at the same time.”
A Walgreens spokesperson declined to comment. A former Walgreens executive involved in the partnership disputed Ms. Holmes’ account in an interview on Tuesday, saying the companies agreed to the new arrangement after Walgreens attorneys dismissed the startup’s theory that its equipment could be used. Can be done in drugstores without regulatory oversight.
Ms Holmes said Theranos told the FDA about the change to the lab-based test, but did not tell anyone else, including Walgreens, because it was a trade secret.
Ms. Holmes tried to show that Theranos was transparent with the FDA about all relevant aspects of its business, including beginning the process of obtaining regulatory approval for its blood-testing machine in 2013. It said that Theranos shared with the FDA video that recorded the inner workings of Theranos’ devices and the tests taking place in real time.
“I was confident it was ready to get FDA approval,” Ms. Holmes said of Theranos’ technology in 2013.
When the FDA inspected Theranos’ laboratories in 2015, the agency declared its proprietary device for collecting small blood samples “fuzzy.” effectively banning their use and forcing Theranos to give up his signature blood-collecting method. In 2016 Theranos withdrew FDA request for emergency approval of blood test after regulator found Theranos had failed to implement patient protectionWhile studying the new test.
Ms. Holmes confirms she has added the logo pfizer Inc. PFE -0.23% And Schering Plough Corporation MRK 1.42% to Theranos documents, which were shared with investors. He testified that he thought at the time that it was appropriate to use the logo because the work discussed in the documents was done with those pharmaceutical companies.
Walgreens executives and several investors obtained documents emblazoned with the Pfizer and Schering-Plow logos and testified that they understood the drug companies validated Theranos’ technology.
Asked by her lawyer, Kevin Downey, whether she was trying to mislead anyone about the nature of Theranos’ relationship with drug companies, Ms. Holmes said that was not the case.
“But I have heard that testimony in this case and I wish I had done it differently,” Ms. Holmes testified.
Theranos conducted studies with Schering-Plough and Pfizer to demonstrate the performance of their devices. Scientists from both companies testified to the government that They were not influenced by Theranos and determined that their employers should not work with startups. They disagreed with claims about Theranos’ technology and The logo was added without his permission, They said.
Ms. Holmes offered a different look. “This work was done in partnership with those companies and that’s what I was trying to convey,” she said. That said, the results of the study with Pfizer were particularly exciting, and she wanted Walgreens and other investors to know about them.
“‘The devices worked and I thought the data was really cool and I wanted to share it with them,'” she testified.