Tag:

The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the latest news that federal regulators may ban founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal investigation into whether it misled investors about its technology and company operations...How has this widely acclaimed biomedical innovator fallen so far, so fast?...Theranos' revolutionary claim...wowed investors, journalists and even groups like the Cleveland Clinic and Walgreens with what you might call an "iMedicine" vision of blood testing...A few drops of blood from a fingertip are collected into a "nanotainer" collection tube and analyzed on the company’s proprietary machine, named after...Thomas Edison. How exactly the Edison devices work is unknown. But the claim was that many – possibly dozens – of tests could be run on those few drops of blood...Millions invested without any proof?...Why didn’t investors and journalists dig more deeply, such as by demanding a head-to-head comparison of Theranos' Edison machine to standard chemistry analyzers?...Part of the problem seems to have been the secrecy surrounding these types of startups...which means that there was...no peer-reviewed information out there about its technology...the leading explanation seems to be that they were enthralled by the company’s charismatic young founder...It still remains possible that Theranos has discovered a breakthrough technology...But even if this increasingly unlikely prospect is a reality, Holmes' erstwhile acolytes need to remember the lessons learned from the pantheon of past pied pipers and summed up by statistician W. Edwards Deming: In God we trust; all others must bring data.