Theranos founder Elizabeth Holmes admits to adding Pfizer logo to company reports and hiding the use of third-party devices: Trial week 12 recap
Theranosfounder Elizabeth Holmesreturned to the stand this week in her criminal fraud trial.
- She said she'd used Pfizer's logo without authorization, adding, "I wish I had done it differently."
Her defense has argued she couldn't have knowingly duped people about the company's technology because she believed it worked, thanks to information she received from an array of then-employees and positive research involving pharmaceutical companies, the military, and other parties.
Here are some highlights from her testimony:
Holmes cited research she received from Theranos' then-vice president, Tony Nugent, that she interpreted to mean most errors occurred in the pre-analytical process.
"If we had the ability to automate much of that process, we could reduce the error associated with traditional lab testing," she said, according to Reuters.
A 2008 email from Ian Gibbons, Theranos' former chief scientist, said "performance design goals have been demonstrated," and that Theranos' system was in clinical evaluation at multiple sites. Jurors also saw a 2008 presentation Gibbons sent Holmes about a Stanford study in which Theranos aimed to predict sepsis in cancer patients. The study was two-thirds through, and test results had been precise so far.
"It meant our system was working well," Holmes testified.
A 2012 email from former Theranos vice president Daniel Young said the company could do tests for more than 1,000 billing codes.
'Completed successes' with drugmakers
Jurors saw a 2009 slide of "completed successes" naming studies conducted with pharmaceutical companies like Novartis, AstraZeneca, and Merck, according to The Washington Post.
Gibbons emailed Holmes in 2010 that "essentially all" analyses would be possible with Theranos 4.0, which Holmes took to mean Theranos would be able to run any blood test, according to The New York Times.
"I think we have demonstrated capabilities fully equivalent to lab methods in areas where we have done assay development," Gibbons said in another email that year.
Holmes added Pfizer logo to reports
Theranos wanted partnerships with "every pharmacy company we knew of" and reached out. Walgreens and Safeway bit.
A 2010 presentation Holmes showed to Walgreens' then-Chief Financial Officer Wade Miquelon said: "Theranos systems have been comprehensively validated over the course of the last seven years by ten of the fifteen largest pharmaceutical companies."
Holmes said she put Pfizer and Schering-Plough's logos on validation reports before sharing them with Walgreens because "this work was done in partnership with those companies and I was trying to convey that," according to NPR.
She said she didn't mean for executives to assume those companies produced the reports but added, "I've heard that testimony in this case, and I wish I had done it differently."
Holmes hid commercial device use over trade-secret concerns
Holmes said Theranos' original intention was to have a device at a point of care. Transitioning to have many devices at a central lab raised challenges, such as needing to test multiple samples simultaneously.
Holmes said Theranos modified Siemens devices for this and added that she never told Walgreens or investors because company counsel said to protect it as a trade secret, according to The Wall Street Journal. Theranos disclosed third-party device use to the FDA because it could give trade-secret protection.
Inside the Walgreens and Safeway deals
Holmes discussed delaying the 2013 Walgreens launch because Theranos wasn't ready yet. Jurors saw a 2013 email to the FDA listing tests Theranos ran in Walgreens in which Holmes said some samples were from venous draws. She recalled ending the Walgreens deal in 2016 over regulatory and lab challenges, according to The New York Times.
She also said former Safeway CEO Steven Burd asked Theranos to modify its devices into what would have essentially been "a whole new product." Theranos tried regardless of the difficulty, she says. The challenges that plagued the Walgreens launch also affected the Safeway launch; Burd retired before the launch could happen, and Safeway didn't pursue it after that.
Holmes talks about her ex
Holmes rarely mentions former Theranos president and Chief Operating Officer Ramesh "Sunny" Balwani but said he made Theranos' financial projections, according to ABC News.
Holmes recalled Theranos' unsuccessful attempt to partner with the Army's Telemedicine and Advanced Technology Research Center in 2008 and 2009 to have devices predict post-traumatic stress disorder, according to CNBC.
In a burn study with the Defense Department, Theranos "performed well" but the sample size was small. Holmes discussed a 2012 military study examining device performance in remote areas and high heat in Africa.
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