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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.
... 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.
soylentnews.org
The accusation isn't that patients' privacy was violated. The issue is that there should have been an Institutional Review Board that reviewed the researchers' protocols and plans for interacting with subjects and handling samples to ensure that subjects were treated ethically and safely (among other things). And there was, at least for some parts of the research, but not for all of it. According to them, the part that didn't go through review was lab work that didn't involve any interaction with the subjects. So while these safety and ethics issues are very important with medical research, at the moment there's no indication of a major problem with Theranos' approach. They'll likely need to perform another IRB review, making sure to include every part of the research, and making sure it's super thorough. As long as their method works, I would hope that a new IRB review would satisfy regulators.
Easily, I'd imagine. If the tests are inaccurate or are improperly performed, people might unknowingly spread a disease, or undergo potentially dangerous treatment that they don't require. That's a serious enough consequence to require regulation.