Theranos Would Be Thriving in the Covid-19 Pandemic
Relaxed regulations, misinformation, and a big potential payout are reminiscent of the conditions that cultivated Theranos
In November 2015, the U.S. House of Representatives held a hearing about draft guidance from the U.S. Food and Drug Administration (FDA) about closing a regulatory loophole exploited by Theranos. However, the draft guidance was never put into law, with one congressman objecting, “Why in the world would a lab develop a test that wasn’t safe and accurate?” The short answer: because its founder wanted to become the world’s youngest self-made female billionaire.
We’ve seen the U.S. Centers for Disease Control and Prevention (CDC) flounder as it scrambled to develop a test for SARS-CoV-2, heard President Trump blame Obama-era regulations for the lack of tests, and are now hearing about serology tests that can determine if we can go back to work. Because of my role in exposing the Theranos scandal and starting a diagnostic company of my own, I have been asked countless times: “What is going on with coronavirus testing?” While there is certainly value in moving as fast as possible during this crisis, I am worried that we are creating an environment that facilitates many of the same mistakes Theranos made.