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FDA Finds Flaws In Theranos' Zika Tests (techcrunch.com)
An anonymous reader quotes a report from TechCrunch: This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn't welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports (Warning: may be paywalled). Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board. Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety. Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.
How much of the hype behind this company centered on the fact that its leader was a young, attractive, blonde woman from Stanford?
How much actually focused on the product and the likelihood of it succeeding?
Our news today is more entertainment than fact.
Alternative Right.
She's like an 8 year old playing doctor at the playground. She has unbridled enthusiasm, uses lots of big words that she overheard adults using, and pushes all the other kids who make fun of her for pretending to be something she's not.
... but the FDA is still finding something to complain about.
This is after preeminent scientists argue that bioethics needs to get out of the way of modern research.
An interesting parallel, by the way, was John Nestor. Here was a guy that intentionally (and even with good intention) drove 55MPH in the fast lane of DC traffic. He was, at best, misguided, since speed differential is more dangeous than speed and his actions were likely safety-reducing. He was also an FDA bureaucrat that never approved a drug and was ultimately fired for his "caution" that probably cost more lives and more lifesaving drugs than it ever saved.
If the company had adhered to the FDA's rules from the beginning instead of doing everything they could to cut corners, deceive investors, and generally act like the law doesn't apply to them the FDA might have cut them some slack this time. But they poisoned that relationship. Now the FDA is going to make them follow the letter of the law, every time, no exceptions.
... but the FDA is still finding something to complain about.
I can't see it say anywhere that the diagnostic test from Theranos works. It just says that there are problems with associated protocols. Seems like yet another example of their corner cutting behavior. Theranos doesn't exactly have a good history of producing reliable diagnostic tests.
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