Theranos founder Elizabeth Holmes admits to adding Pfizer logo to company reports and hiding the use of third-party devices: Trial week 12 recap

Theranos founder Elizabeth Holmes leaves after attending her fraud trial at federal court in San Jose, California, U.S. November 22, 2021

Brittany Hosea-Small/Reuters

  • Theranos founder Elizabeth Holmes returned to the stand this week in her criminal fraud trial.
  • She admitted using Pfizer's logo without authorization but said, "I wish I had done it differently."
  • Holmes also said she concealed Theranos' use of third-party devices over trade secret concerns.

Theranos founder Elizabeth Holmes continued testifying in the 12th week of her federal fraud trial this week. 

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:

Reassuring research

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 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-CFO 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, like needing to test multiple samples simultaneously.

Holmes admitted Theranos modified Siemens devices for this and said 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 COO Ramesh "Sunny" Balwani but said he made Theranos' financial projections, according to ABC News.

Military studies

Holmes recalled Theranos' unsuccessful attempt to partner with the army's Telemedicine & Advanced Technology Research Center in 2008 and 2009 to have devices predict PTSD, according to CNBC.

In a burn study with the Department of Defense, 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.

Read the original article on Business Insider

[Author: [email protected] (Sarah Jackson)]

Tags: News, Stanford, Africa, Trends, Merck, Walgreens, New York Times, Fda, Npr, Trial, Pfizer, Siemens, Cnbc, Theranos, Gibbons, Elizabeth Holmes, Reuters, Daniel Young, Holmes, Safeway, Wall Street Journal Theranos, Tech Insider, Sarah Jackson, Burd, New York Times She, Sunny Balwani, Balwani, Schering Plough, Ramesh Balwani, Wade Miquelon, Tony Nugent, Novartis AstraZeneca, Brittany Hosea, Fraud Trial, Elizabeth Holmes trial, Theranos trial, Steven Burd, ABC News Military, Reuters Theranos, Ian Gibbons Theranos, The Washington Post Gibbons, Telemedicine Advanced Technology Research Center, Department of Defense Theranos


November 15, 2021 at 5:30 PM Here's everything that Theranos' four former lab directors have revealed about the company's troubled testing operations in Elizabeth Holmes' fraud trial
November 5, 2021 at 9:03 PM Elizabeth Holmes trial Week 9 recap: The Kissinger connection, and a former lab co-director cites a 'lack of clarity'
September 24, 2021 at 6:47 PM Here's everything you missed in Week 3 of Elizabeth Holmes' Theranos fraud trial
August 30, 2021 at 2:05 PM Embattled Theranos founder Elizabeth Holmes is about to go on trial for fraud. Here's everything you need to know.