The Theranos Trial: What You Should Know

Oct. 25, 2021 — The promise appeared too good to be true: Walk into your native drugstore, present a number of drops of blood through finger-prick, and get screened for a whole lot of various ailments, rapidly and cheaply. That’s what Silicon Valley startup Theranos, based by Elizabeth Holmes, touted. As it turned out, it wasn’t true. Now Holmes is on trial in federal courtroom in San Jose, CA.

The Theranos Story

Federal prosecutors have charged Holmes and Ramesh “Sunny” Balwani, Theranos’s president and chief working officer, with 9 counts of wire fraud and two counts of conspiracy to commit wire fraud. Both have pleaded not responsible. Their circumstances have been separated, and Balwani will go on trial in 2022.

Prosecutors say the pair knew Theranos couldn’t ship — the gear merely didn’t work — however continued to boost hundreds of thousands of {dollars} from buyers and market the product to docs and shoppers. If convicted, Holmes faces as much as 20 years in jail.

Holmes began Theranos (a mishmash of “therapy” and “diagnosis”) in 2003, when she was 19 years previous. The subsequent yr, she dropped out of Stanford University to run the corporate. The objective: to revolutionize the well being care {industry} by making blood exams broadly, simply, and inexpensively out there. Balwani joined the corporate in 2009. For a while, the pair had been romantically concerned, which can issue into the trial.

Thanks to Holmes’ charismatic presentation (full with TED Talk) and a board of administrators that included former secretaries of state George Shultz and Henry Kissinger, the corporate attracted main buyers. At one level, Theranos was valued at $9 billion.

In 2013, Theranos introduced a partnership with Walgreens drugstores. They deliberate to open Theranos Wellness Centers inside Walgreens areas, the place shoppers might stroll in and have a number of drops of blood taken, 1/1,000 the quantity of a typical draw. Their proprietary, automated laboratory gear would produce ends in just some hours at low price.

But the corporate had one massive drawback: Their expertise didn’t work. The FDA solely accredited it for a single check, for herpes simplex 1 virus.

In October 2015, The Wall Street Journal printed an exposé primarily based on the account of a whistleblower inside Theranos, who mentioned the corporate’s expertise had many flaws. Results had been typically inaccurate. As a outcome, the overwhelming majority of the 200+ exams Theranos carried out had been performed the standard approach, with vials of blood drawn from the arm, on industry-standard gear.

Things spiraled from there, and by June 2016 Walgreens stopped working with Theranos. Lawsuits, layoffs, and failed lab inspections adopted, and a pair of years’ price of exams carried out on Theranos gadgets had been voided. In 2018, the Securities and Exchange Commission charged Holmes and Balwani with “massive fraud.”

Could It Have Worked?

Holmes’ concept was certainly intriguing, but Theranos never managed to pull it off. And even if they’d had limitless amounts of time and money, experts doubt they ever could have. Because most tests are performed only on the liquid part of the blood sample, a single drop from a finger-prick would really provide half as much that’s usable.

“When people heard what appeared to be a revolutionary concept, it sounded like we’d finally reached the days of Star Trek. Do all these tests on a single drop of blood,” says Kimberly Sanford, MD, president of the American Society for Clinical Pathology. “I remember discussing it in a staff meeting, all of us saying this is scientifically impossible, and the entire pathology community said the same.”

Beyond the expertise, the concept of strolling right into a drugstore for blood exams poses different challenges. Interpreting blood check outcomes isn’t as simple because it appears. “Normal” ranges characterize 95% of the wholesome inhabitants, which implies that 5% of wholesome individuals may be anticipated to have outcomes exterior that vary. If you’re one of many 5% and also you’re irregular outcomes and not using a physician’s enter, you might wind up pressured and dealing with a bigger medical workup for nothing, says Amy Karger, MD, PhD, chair of the College of American Pathologists’ Point of Care Testing Committee.

As whistleblower Erika Cheung, a former Theranos lab affiliate, testified at Holmes’ trial, “You’d have about the identical luck flipping a coin as as to if your outcomes had been proper or mistaken.”