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The Theranos Trial: What You Need to Know

25 Oct. 2021 – The promise seemed too good to be true: Walk into your local drugstore, give a few drops of blood through a finger prick, and be screened quickly and cheaply for hundreds of different diseases. This is what Silicon Valley startup Theranos, founded by Elizabeth Holmes, put forward. As it turned out, this was not true. Holmes is now on trial in federal court in San Jose, California.

The Theranos story

Federal prosecutors have charged Holmes and Ramesh “Sunny” Balwani, Theranos’ president and chief operating officer, with nine counts of wire fraud and two counts of conspiracy to commit wire fraud. Both pleaded not guilty. Their cases are separate, and Balwani will be tried. 2022

Prosecutors say the two knew Theranos could not deliver – the equipment simply did not work – but went on to raise millions of dollars from investors and market the product to doctors and consumers. If convicted, he faces up to 20 years in prison prison.

Holmes started Theranos (a mixture of “therapy” and “diagnosis”) in 2003, when she was 19 years old. The following year she left Stanford University to study the company. The goal: to revolutionize the healthcare industry blood tests widely, easily and cheaply available. Balwani joined the business in 2009. For some time, the couple was romantically involved, which may play a role in the trial.

Thanks to Holmes’ charismatic presentation (complete with TED Talk) and a board of directors that included former Secretary of State George Shultz and Henry Kissinger, the company attracted large investors. At one point, Theranos’ value was worth $ 9. billion.

In 2013, Theranos announces a partnership with Walgreens pharmacy. They planned to open Theranos wellness centers in Walgreens locations, where consumers could walk in and have a few drops of blood taken, 1/1 000 the amount of a typical draw. Their own automated laboratory equipment would deliver low cost results in a matter of hours.

But the company has one big problem: their technology is not working. The FDA only approved it for a single test herpes simplex 1 virus.

In October 2015, The Wall Street Journal a statement published based on the report of a whistleblower in Theranos, who said that the technology of the enterprise has many flaws. Results were often inaccurate. Consequently, the vast majority of the 200+ tests that Theranos performed were done in the traditional way, with bottles of blood drawn from the arm, at industry standard. equipment.

Things started to turn from there, and by June 2016, Walgreens had stopped working with Theranos. Lawsuits, retrenchments and failed laboratory inspections followed, and 2 years of tests performed on Theranos devices were declared void. In 2018, the Securities and Exchange Commission approved Holmes and Balwani of “massive fraud. “

Could it have worked?

Holmes’ concept was certainly interesting, but Theranos never got it right. And even if they had unlimited time and money, experts doubt they ever could. Because most tests are performed only on the liquid part of the blood sample, a single drop of a finger prick will actually provide half as much as is useful.

“When people heard what looked like a revolutionary concept, it sounded like we had finally reached the days of Star Trek. Do all these tests on a single drop of blood, “said Kimberly Sanford, MD, president of the American Association of Clinical Pathology.” I remember discussing it in a staff meeting, all of us said it was scientifically impossible. , and the whole pathology community said the same thing. “

Beyond technology, the idea of ​​going to a pharmacy for blood tests presents other challenges. The interpretation of the blood test results is not as simple as it seems. ‘Normal’ series represent 95% of the healthy population, which means that 5% of healthy people can be expected to achieve results outside the range. If you are one of the 5% and you are looking at abnormal results without a doctor’s input, you may be stressed and face a bigger medical job for free, says Amy Karger, MD, PhD, chair of the College or American The Test Committee for Pathologists’ Point of Care.

As whistleblower Erika Cheung, a former Theranos lab assistant, testified during Holmes’ trial: “You’ll have about the same luck if you toss a coin or your results were correct or wrong. “

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