The Theranos trial: what you need to know

October 25, 2021 – The promise seemed too good to be true: Walk into your local pharmacy, provide a few drops of blood per finger prick, and get tested for hundreds of different diseases, quickly and inexpensively. This is what the Silicon Valley startup Theranos, founded by Elizabeth Holmes, has been touting. It turned out that was not true. Holmes is now on trial in federal court in San Jose, California.

The story of Theranos

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

Prosecutors said the couple knew Theranos couldn’t deliver – the equipment just wasn’t working – but continued to raise millions of dollars from investors and market the product to doctors and consumers. If convicted, Holmes faces up to 20 years in prison jail.

Holmes started Theranos (a mishmash of “therapy” and “diagnosis”) in 2003, when she was 19. The following year, she dropped out of Stanford University to lead the business. The goal: to revolutionize the healthcare industry by making some blood testing widely, easily and inexpensively. Balwani joined the company in 2009. For a while, the couple had a romantic relationship, which could be factored into the lawsuit.

Thanks to Holmes’ charismatic presentation (with TED Talk) and a board of directors that included former Secretaries of State George Shultz and Henry Kissinger, the company has attracted significant investors. At one point, Theranos was valued at $ 9 billion.

In 2013, Theranos announced a partnership with Walgreens pharmacies. They were planning to open Theranos wellness centers in Walgreens stores, where consumers could walk in and have a few drops of blood drawn, 1 / 1,000 of the amount of a typical draw. Their proprietary automated lab equipment would produce results in hours at low cost.

But the company had a big problem: its technology was not working. The FDA only approved it for one test, for herpes simplex 1 virus.

In October 2015, The the Wall Street newspaper released a briefing based on the account of a whistleblower within Theranos, who said the company’s technology had many flaws. The results were often inaccurate. As a result, the vast majority of the more than 200 tests performed by Theranos have been performed in the traditional manner, with vials of blood drawn from the arm, to industry standards. equipment.

Things got out of hand from there and in June 2016, Walgreens stopped working with Theranos. Lawsuits, layoffs and failed lab inspections followed, and 2 years of testing on Theranos devices was canceled. In 2018, the Securities and Exchange Commission accused Holmes and Balwani of “massive fraud.”

Could it have worked?

Holmes’ concept was certainly intriguing, but Theranos never managed to make it come true. And even if they had had unlimited amounts of time and money, experts doubt they ever had. Since most tests are done only on the liquid portion of the blood sample, a single drop from a finger prick would actually provide half of what is usable.

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

Beyond technology, the idea of ​​walking into a pharmacy for blood tests poses other challenges. Interpreting blood test results is not as straightforward as it seems. The “normal” ranges represent 95% of the healthy population, which means that 5% of healthy people should have results outside of this range. If you’re in the 5% and look for abnormal results without a doctor’s advice, you may find yourself stressed out and facing a bigger medical check-up for nothing, says Amy Karger, MD, PhD, president of the College of American Pathologists Point of Service Examination Committee.

As whistleblower Erika Cheung, former laboratory associate of Theranos, testified during Holmes’ trial: “You would have about the same chance of knowing if your results were good or not. wrong. “

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