The Theranos Trial: What You Should Know

Oct. 25, 2021 -- The committedness seemed excessively bully to beryllium true: Walk into your section drugstore, supply a fewer drops of humor via finger-prick, and get screened for hundreds of antithetic diseases, rapidly and cheaply. That’s what Silicon Valley startup Theranos, founded by Elizabeth Holmes, touted. As it turned out, it wasn’t true. Now Holmes is connected proceedings successful national tribunal successful San Jose, CA.

The Theranos Story

Federal prosecutors person charged Holmes and Ramesh “Sunny” Balwani, Theranos’s president and main operating officer, with 9 counts of ligament fraud and 2 counts of conspiracy to perpetrate ligament fraud. Both person pleaded not guilty. Their cases person been separated, and Balwani volition spell connected proceedings successful 2022.

Prosecutors accidental the brace knew Theranos couldn’t present -- the instrumentality simply didn’t enactment -- but continued to rise millions of dollars from investors and marketplace the merchandise to doctors and consumers. If convicted, Holmes faces up to 20 years successful prison.

Holmes started Theranos (a mishmash of “therapy” and “diagnosis”) successful 2003, erstwhile she was 19 years old. The adjacent year, she dropped retired of Stanford University to tally the company. The goal: to revolutionize the wellness attraction manufacture by making blood tests widely, easily, and inexpensively available. Balwani joined the institution successful 2009. For immoderate time, the brace were romantically involved, which whitethorn origin into the trial.

Thanks to Holmes’ charismatic presumption (complete with TED Talk) and a committee of directors that included erstwhile secretaries of authorities George Shultz and Henry Kissinger, the institution attracted large investors. At 1 point, Theranos was valued astatine $9 billion.

In 2013, Theranos announced a concern with Walgreens drugstores. They planned to unfastened Theranos Wellness Centers wrong Walgreens locations, wherever consumers could locomotion successful and person a fewer drops of humor taken, 1/1,000 the magnitude of a emblematic draw. Their proprietary, automated laboratory instrumentality would nutrient results successful conscionable a fewer hours astatine debased cost.

But the institution had 1 large problem: Their exertion didn’t work. The FDA lone approved it for a azygous test, for herpes simplex 1 virus.

In October 2015, The Wall Street Journal published an exposé based connected the relationship of a whistleblower wrong Theranos, who said the company’s exertion had galore flaws. Results were often inaccurate. As a result, the immense bulk of the 200+ tests Theranos performed were done the accepted way, with vials of humor drawn from the arm, connected industry-standard equipment.

Things spiraled from there, and by June 2016 Walgreens stopped moving with Theranos. Lawsuits, layoffs, and failed laboratory inspections followed, and 2 years’ worthy of tests performed connected Theranos devices were voided. In 2018, the Securities and Exchange Commission charged Holmes and Balwani with “massive fraud."

Could It Have Worked?

Holmes’ conception was surely intriguing, but Theranos ne'er managed to propulsion it off. And adjacent if they’d had limitless amounts of clip and money, experts uncertainty they ever could have. Because astir tests are performed lone connected the liquid portion of the humor sample, a azygous driblet from a finger-prick would truly supply fractional arsenic overmuch that’s usable.

“When radical heard what appeared to beryllium a revolutionary concept, it sounded similar we’d yet reached the days of Star Trek. Do each these tests connected a azygous driblet of blood,” says Kimberly Sanford, MD, president of the American Society for Clinical Pathology. “I retrieve discussing it successful a unit meeting, each of america saying this is scientifically impossible, and the full pathology assemblage said the same.”

Beyond the technology, the thought of walking into a drugstore for humor tests poses different challenges. Interpreting humor trial results isn’t arsenic straightforward arsenic it seems. “Normal” ranges correspond 95% of the steadfast population, which means that 5% of steadfast radical tin beryllium expected to person results extracurricular that range. If you’re 1 of the 5% and you’re looking astatine abnormal results without a doctor’s input, you whitethorn upwind up stressed and facing a larger aesculapian workup for nothing, says Amy Karger, MD, PhD, seat of the College of American Pathologists’ Point of Care Testing Committee.

As whistleblower Erika Cheung, a erstwhile Theranos laboratory associate, testified astatine Holmes’ trial, “You’d person astir the aforesaid luck flipping a coin arsenic to whether your results were close oregon wrong."