Elizabeth Holmes throws scientists under the bus

Elizabeth Holmes, founder of Theranos Inc., arrives in federal court in San Jose, California, Monday, November 22, 2021. Holmes targeted ultra-wealthy families as early backers of Theranos to avoid the potential pressure from major investment firms to go publicly, according to an investor at DeVo's family office who kicked in $ 100 million for the start-up of blood tests.
Enlarge / Elizabeth Holmes, founder of Theranos Inc., arrives in federal court in San Jose, California, Monday, November 22, 2021. Holmes targeted ultra-wealthy families as early backers of Theranos to avoid the potential pressure from major investment firms to go publicly, according to an investor at DeVo’s family office who kicked in $ 100 million for the start-up of blood tests.

David Paul Morris / Bloomberg

Elizabeth Holmes would like the jury to know that researchers, at Theranos and at other companies, led her astray.

One of these scientists was Ian Gibbons, who led Theranos’ scientific research efforts. In 2008, he sent her a presentation on the company’s latest technology, saying that “performance design goals have been demonstrated”, that “the results have been excellent” and that the company’s technology was in “clinical evaluation in several places.”

Holmes told the court she felt it meant the company met its “design goals” even though she did not define what those goals were.

Then there were studies conducted by researchers from other pharmaceutical companies. A presentation sent to Holmes via e-mail in February 2009 contained a slide entitled “Completed Successes” and listed a number of major name companies, including Pfizer, GlaxoSmithKline, Novartis, Mayo Clinic, AstraZeneca and Merck.

What did that slide mean, Downey Holmes asked. “We had successfully achieved the goals of the program,” she said, a response that nicely refuses to specify those goals. Should they validate the technology? To receive the final payment on a contract? It was not clear.

Scientists of other companies

Weeks ago, the jury heard testimony from researchers at Pfizer and Schering-Plow, which were acquired by Merck, and said none of the companies had validated Theranos’ technology. The jury also learned that the lack of validation did not stop Holmes from to send investors a Theranos-written report with the logos of these companies placed prominently at the top.

In her testimony yesterday, Holmes maintained that she believed Schering-Plow and later Merck had positive attitudes toward Theranos’ technology based on a call with one of the company’s scientists.

To support this view, defense attorneys viewed an email from Holmes’ assistant summarizing a 2010 call with Constance Cullen, the Schering-Plow scientist who had been to the task of reviewing Theranos’ technology. The assistant said that Cullen told Holmes to “be free” to use her name when contacting other Merck scientists. “All in all, it was fantastic, I think,” wrote Holmes’ assistant. “Calling her every morning for the last 3 weeks finally paid off …”

In previous testimony, Cullen said she was not impressed with Theranos’ technology and that she was inundated with work following Merck’s acquisition of Schering-Plow. One interpretation of the 2010 call could be that an overworked Cullen was just trying to get a persistent Holmes off his back.

Rose-colored glasses

In a moment of clarity, however, Holmes acknowledged that even though she had wanted to work with the Department of Defense, Theranos never had an agreement. Investors have testified that the company told them that its devices were used in the field by the military.

But other parts of Holmes’ testimony suggest she saw almost every development with pink glasses. Although Pfizer had not validated Theranos’ technology, Holmes kept hoping that a Pfizer director’s call for “further interactions” would lead to a concrete agreement, not just more meetings.

Holmes too said that she thought “our system worked well” after Gibbons sent her a 2008 report saying “analysis results have been accurate.”

What neither Holmes nor her lawyer discussed was that accurate results do not always mean a system works well. An accurate analysis gives results that are close to each other. An accurate analysis reports the true value, or at least close to it. A good test is both accurate and precise. Theranos’ “accurate” analysis results may have been technically impressive – the machines returned the same value over and over again – but that does not necessarily mean they were accurate. (Gibbons died of suicide in 2013, shortly before he was due to testify in a patent lawsuit involving Theranos.)

In another email exchange, Gibbons Holmes said that an upcoming revision of the company’s device, version 4.0, “will be able to perform any measurement required in a distributed test setting. It is anticipated that several different measurement technologies will be incorporated. ”

Holmes apparently felt that this product roadmap was solid evidence of the technical capacity of her companyrather than a possible path to achieve them. “I understood that the four series could take any blood sample,” she told the court.

Holmes’ testimony continues today.

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