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Elizabeth Holmes testifies that Theranos had ‘successes’ with pharmaceutical com...

 3 years ago
source link: https://www.washingtonpost.com/technology/2021/11/22/elizabeth-holmes-testimony-live-updates/
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Elizabeth Holmes testifies that Theranos had ‘successes’ with pharmaceutical companies
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Theranos founder Elizabeth Holmes testifies during her fraud trial at federal court in San Jose on Nov. 22. (Vicki Behringer/Reuters)
Yesterday at 11:00 a.m. EST|Updated yesterday at 6:18 p.m. EST

SAN JOSE — Elizabeth Holmes took the stand for the second time Monday to defend herself against charges she defrauded investors regarding the capabilities of her blood-testing start-up Theranos.

The entrepreneur rose to international fame roughly a decade ago as her start-up promised to run dozens of blood tests from just a few drops of blood. But prosecutors have alleged for the first two months of the federal trial that she knew the limits of the company’s technology, and specifically that Theranos overplayed what it said were approvals with two large pharmaceutical companies.

Her defense team on Monday sought to dispute that. Her lead lawyer, Kevin Downey, asked about the results of studies in which tests run on Theranos devices were compared with the results of tests conducted on traditional equipment in partnership with pharmaceutical companies.

“It performed well,” Holmes responded in response to one such question.

The founder of Theranos began testifying Friday afternoon in a late-day surprise, and she is now expected to testify for several days. The entrepreneur, who started Theranos when she was a student at Stanford, is charged with 11 counts of wire fraud and conspiracy to commit wire fraud.

She has pleaded not guilty, and her defense lawyers have argued that she acted in good faith while running the company.

Theranos was a highflying and closely watched Silicon Valley start-up with hundreds of employees and hundreds of millions in funding when an explosive Wall Street Journal investigation cast doubts on the company‘s abilities in 2015. Concerned former employees spoke out about Theranos’s blood-testing device, which was designed to run multiple tests in a portable machine from a few drops of blood, to say it was not functioning properly and often returned erratic results.

Theranos crumbled in 2018 amid media and regulatory investigations. The case is closely watched in Silicon Valley, where start-ups have long relied on a “fake it till you make it” credo. The verdict could shape how start-ups evaluate risk and present promises to investors and partners.

On Monday, the defense team showed jurors a slide from a presentation at Theranos that showed “Completed Successes” — a list of studies the company completed with various pharma companies. Many of the studies were designed for the larger companies to evaluate how well Theranos’s technology performed compared with traditional testing methods.

During the prosecution’s case, representatives from Pfizer and Schering-Plough testified that they were unimpressed with Theranos’s technology and did not pursue further partnerships with the start-up, according to the Wall Street Journal.

“I was dissatisfied, quite honestly,” Connie Cullen, a scientist who worked at Schering-Plough, said on the stand, according to the Journal. “There was insufficient technical detail for us to be able to evaluate the technology.”

Cullen and a representative from Pfizer said they did not approve the final reports that Theranos allegedly showed to investors, which included logos from the pharmaceutical companies — suggesting they were endorsing Theranos’s technology.

On the stand Monday, Holmes said that she had not spoken directly to Cullen about the results of the Theranos test with Schering-Plough, but that she heard from an employee that Cullen was pleased. Holmes also said that she did not hear directly from Pfizer about the study it conducted with Theranos, but that the two companies continued talking as recently as 2015.

Though Holmes testified that many of the studies with pharmaceutical companies were successful, Theranos did not make significant deals with the companies after the validation studies.

The prosecution rested its case Friday after calling 29 witnesses over two months. Former employees testified that the Theranos device could run only about a dozen blood tests and that the company was largely relying on outside machines to complete tests.

Business partners and investors outlined their disappointment in working with Theranos, which many witnesses said failed to live up to its promises.

Holmes’s defense called two witnesses before Holmes on Friday, including a former Theranos board member who joined after the Journal investigation. The board member, Fabrizio Bonanni, a former executive vice president at biotech company Amgen, said he was impressed with Theranos’s technology when he met with company leaders in 2016.

Jury excused for the day; Holmes to testify again tomorrow

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By Rachel Lerman4:08 p.m.
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Holmes’s testimony ended for the day Monday after the former Theranos CEO answered questions for about two hours.

Holmes’s defense attorney asked her about studies Theranos conducted with pharmaceutical companies, including many designed to evaluate how well Theranos’s technology worked — pointing out the start-up’s positive relationships with the companies.

Theranos performed well in the studies and continued talking with many of the pharma companies after they ended, Holmes testified.

Theranos’s relationship with pharmaceutical companies is a key aspect of the prosecution’s case against Holmes. Prosecutors have alleged that Theranos misrepresented its relationship with pharma companies to investors and business partners.

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Holmes testifies she didn’t speak directly to prior witness about results of pharmaceutical study

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By Rachel Lerman3:44 p.m.
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Holmes testified that she didn’t speak directly with a Schering-Plough scientist about the results of a validation report that was designed for the pharmaceutical company to see how well Theranos’s technology worked.

The scientist, Constance Cullen, testified earlier in the trial that she found Holmes’s behavior during the report to be “cagey,” according to the Wall Street Journal. Prosecutors have alleged that Theranos improperly put Schering-Plough’s logo on a document that it showed to an investor to make it seem like the pharma company had validated Theranos’s technology.

Holmes said Monday that she received an email from one of her employees who had talked to Cullen, suggesting that Cullen was pleased with Theranos.

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Some investors previously testified about the technology’s issues

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By Rachel Lerman3:19 p.m.
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Prosecutors also previously called the former CEO of Safeway, Steven Burd, who testified about the grocery chain’s ultimately failed partnership with Theranos to put the blood-testing devices in stores.

“I was bothered by it. I was disappointed,” he said of repeated delays. Eventually, the partnership crumbled.

Investors testified about what they didn’t know when they gave the company money — especially that Theranos was relying on third-party lab machines to run most of its tests. Former defense secretary Jim Mattis, who served on the company’s board, testified that Theranos’s technology was never used by the military, a key point of the prosecutor’s case.

On Friday, the defense called a witness to briefly summarize Theranos’s patents and other records, as well as a former board member, before calling Holmes to the stand.

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Holmes testifies of Theranos’s early work with pharma companies

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By Rachel Lerman2:46 p.m.
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Holmes’s lawyer talked the defendant through several projects Theranos worked on with pharmaceutical companies, including Novartis, Merck and AstraZeneca.

Some of the projects included validation studies for the large pharma companies to assess how well Theranos’s technology performed against traditional methods. Many of the studies took place in 2008 and 2009.

Holmes testified several times that Theranos’s technology performed well when evaluated next to traditional methods.

“I remember it being really good,” she said of the results of one study that compared Theranos’s technology to standard practices.

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Theranos trial is closely watched in Silicon Valley

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By Rachel Lerman2:18 p.m.
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The closely-watched Theranos trial was delayed more than an hour Monday as the judge met with lawyers in chambers.

Holmes is expected to resume testifying Monday in a case that has captivated Silicon Valley.

The spectacular collapse of Theranos in 2018 following media and regulatory investigations triggered some limited soul searching in Silicon Valley, according to interviews with more than a dozen investors, founders and lawyers.

But little cultural change has occurred in the start-up industry in the years since, they say. One former Theranos employee told the Washington Post he hopes that the case is a wake-up call for the industry.

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Holmes testifies about Theranos’s dealings with Defense Department

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By Rachel Lerman2:16 p.m.
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Holmes confirmed in testimony Monday that Theranos never formalized a deal to work on any programs with the Defense Department.

The company attempted to partner with the department in 2008 and 2009 on several programs, including one that would have studied infection in trauma patients, she said.

Theranos’s military involvement is a key piece of the prosecutor’s case against Holmes, whom they allege misled investors into thinking the company was working with the military.

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Holmes resumes testimony for second day

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By Rachel Lerman1:45 p.m.
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After a delay of more than 90 minutes, Holmes took the stand for the second day of her testimony Monday in federal court here, where she faces 11 charges of wire fraud and conspiracy to commit wire fraud.

A mix of journalists, spectators and Holmes’s supporters began lining up before 3 a.m. here to get one of the limited seats inside the courtroom and an overflow room broadcasting audio and video of the trial.

She has pleaded not guilty to all charges.

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Former lab worker Erika Cheung previously testified

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By Rachel Lerman1:11 p.m.
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Previously on the stand in September, former lab worker Erika Cheung told the court that she grew worried about results from blood tests run on Theranos’s own devices, saying the machines were often not passing quality control checks.

“It was very concerning in a research context because once that translates to a patient setting, it’s giving you a good indication that the system isn’t working reliably enough to feel confident and comfortable in running patient samples,” she said.

She quit the job when she felt her concerns weren’t being listened to, and later reported an official complaint to the Centers for Medicare and Medicaid Services, which oversees clinical labs.

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Trial start delayed

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By Rachel Lerman12:34 p.m.
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The trial, which was scheduled to begin at 9 a.m. Pacific on Monday, was delayed as the lead prosecutor and defense lawyer appeared to meet with the judge in chambers.

Holmes is expected to take the stand shortly for the second day in her trial where she is facing federal wire fraud charges.

Jurors had not yet been brought into the courtroom, and the two lead lawyers left the room through a door that leads to the judge’s chambers.

Holmes testified Friday she believed Theranos device highly capable

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By Rachel Lerman12:10 p.m.
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During her first hour of testimony on Friday, Theranos founder Holmes said she believed the company’s device could be used broadly in blood testing.

“While you were there, did you believe that Theranos developed technology that was capable of running any blood test?” her attorney Kevin Downey asked her on the stand Friday.

“I did,” Holmes replied.

Investors and business partners have testified that Theranos presented its portable blood-testing device as capable of running a wide variety of tests.

But in reality, prosecutors have alleged, the device could only be used on a limited number of tests, and results were inconsistent. Theranos was relying on outside machines to complete most blood tests, witnesses have testified.

Holmes confirmed Friday that in Theranos’s clinical lab, only 12 blood tests were analyzed on one of the company’s small devices. The clinical lab offered more than 70 small sample tests overall, she confirmed.

Other blood-technology companies are growing in the wake of Theranos

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By Rachel Lerman11:34 a.m.
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Theranos’s embattled final years cast a shadow over other blood-diagnostic technology companies, entrepreneurs told The Washington Post.

But it hasn’t stopped many companies from raising hundreds of million of dollars from investors as they work to develop technology that enables less-invasive blood-testing procedures.

Still, for years, other companies had to work against the assumption that the entire category of technology demanded wariness.

“There came to be this absurd connection between blood testing and fraud,” said Tim Blauwkamp, co-founder and chief scientific officer at blood-diagnostic company Karius.

Karius, founded in 2014, develops a technology that can identify pathogens in a blood draw by detecting the DNA the small organisms have left behind in the bloodstream. The company has now raised about $250 million from investors.

The trial so far: Two months and more than 30 witnesses

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By Rachel Lerman11:04 a.m.
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Holmes was the third witness called to the stand for the defense, only hours after the prosecutors rested their case Friday morning.

During more than two months of trial, the government called 29 witnesses including several former Theranos employees, business partners and investors.

The prosecutor’s case hinges on showing that Holmes misled investors and patients about how well the company’s blood-testing technology worked — and did it with the intent to defraud them.

“Out of time and out of money, Elizabeth Holmes decided to lie,” prosecutor Robert Leach said during opening statements in September. And she did so repeatedly, he alleged.


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