Another example of government agencies providing a false sense of Security
What the Theranos Debacle Reveals about Government Regulation
https://fee.org/articles/what-the-t...gulation/?utm_medium=trending_homepage_widget
“Given the pivotal role of labs in medicine, consumers need to trust the quality and accuracy of the tests they get,” Holmes wrote in a
WSJ op-ed. “The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous. I know this firsthand because Theranos, the company I founded, voluntarily committed to submit all of its lab tests for review starting in 2013. On July 2, the FDA cleared the first of those tests, for herpes simplex virus 1, and the associated finger-stick blood-test technology and underlying system on which our tests are run.”
How odd that the “uniquely rigorous” FDA reviewed Theranos’s finger-stick blood-test technology and underlying testing system, yet didn’t catch that they don’t work. The company told federal health regulators in April that all test results from its proprietary Edison devices from 2014 and 2015 were void.
Steve Hammons isn’t the only person Elizabeth Holmes put in harm’s way. And despite the fact that the FDA scrutinized her company’s systems in-depth, from collection devices and software to analytics and methodology, some people are still going to look at this debacle and call for more government oversight.
This is not just the wrong approach, but a dangerous one.