‘I wish I had done it differently’

  • Theranos founder Elizabeth Holmes returned to the stand this week in her criminal fraud trial.
  • She said she had used the Pfizer logo without permission, adding: “I wish I had done it differently.”
  • Holmes also said she hid Theranos’ use of third-party devices because of trade secret concerns.

Theranos founder Elizabeth Holmes went on to testify in the 12th week of her federal fraud case this week.

Her defense has argued that she could not have deliberately fooled people about the company’s technology because she believed it worked, thanks to information she received from a number of employees at the time 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, which she interpreted to mean that 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 laboratory testing,” she told Reuters.

An 2008 email from Ian Gibbons, Theranos ‘former chief researcher, said “performance design goals have been demonstrated” and that Theranos’ system was in clinical evaluation at several locations. Jurors also saw a 2008 presentation that Gibbons sent to Holmes about a Stanford study in which Theranos aimed to predict sepsis in cancer patients. The survey was two-thirds through, and the test results so far had been accurate.

“It meant our system worked well,” Holmes testified.

A 2012 email from former Theranos vice president Daniel Young said the company could perform tests on more than 1,000 billing codes.

‘Completed successes’ with drug manufacturers

Jury members saw a 2009 slide of “completed successes” naming studies conducted with pharmaceutical companies such as Novartis, AstraZeneca and Merck, according to The Washington Post.

Gibbons emailed Holmes in 2010 that “essentially all” analyzes would be possible with Theranos 4.0, which Holmes assumed to mean Theranos would be able to run any blood test, according to The New York Times .

“I think we have demonstrated abilities that are fully equivalent to laboratory methods in areas where we have performed assay development,” Gibbons said in another email the same year.

Holmes added the Pfizer logo to reports

Theranos wanted partnerships with “all the pharmacy companies we knew of” and reached out. Walgreens and Safeway bites.

A 2010 presentation Holmes told Walgreens’ then CFO Wade Miquelon said: “Theranos systems have been extensively validated over the last seven years by ten of the fifteen largest pharmaceutical companies.”

Holmes said she put Pfizer and Schering-Plow logos on validation reports before sharing them with Walgreens because “this work was done in partnership with these companies and I was trying to convey that,” according to NPR.

She said she did not believe executives should assume these companies produced the reports, but added: “I have heard that testimony in this case and I wish I had done it differently.”

Holmes’ covert use of commercial entity over trade secret concerns

Holmes said Theranos’ original intention was to have a unit at a nursing home. The transition to having many units in a central laboratory raised challenges, such as the need to test multiple samples simultaneously.

Holmes said Theranos modified Siemens devices for this, adding that she never told Walgreens or investors because the firm’s attorney said they should protect it as a trade secret, according to The Wall Street Journal. Theranos revealed third-party use of devices to the FDA because it could provide trade secret protection.

Inside the Walgreens and Safeway deals

Holmes discussed postponing the Walgreens launch in 2013 because Theranos was not ready yet. Jurors saw an email from 2013 to the FDA noting tests Theranos was driving in Walgreens, where Holmes said some samples were from venous traits. She recalled terminating the Walgreens deal in 2016 due to regulatory and laboratory challenges, according to The New York Times.

She also said former Safeway boss Steven Burd asked Theranos to change his devices to what would have been essentially “a brand new product.” Theranos tried regardless of the degree of difficulty, she says. The challenges that plagued the Walgreens launch also affected the Safeway launch; Burd withdrew before the launch could take place, and Safeway did not pursue it after that.

Holmes talks about his 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.

Military studies

Holmes recalled Theranos’ failed attempt to partner with the Army Research Center for Telemedicine and Advanced Technology in 2008 and 2009 to get units to predict post-traumatic stress disorder, according to CNBC.

In a combustion study with the Department of Defense, Theranos “performed well,” but the sample size was small. Holmes discussed a 2012 military study examining the unit’s performance in remote areas and high temperatures in Africa.

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