Slashdot Mirror
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.
...before you get the idea that you need to start doing things properly?
Theranos really don't seem to be getting the hint that if they want to be taken seriously now they need to be utterly scrupulous about everything they do.
Paul Leader
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.
Nope. The FDA didn't find a thing wrong with the actual test.
The FDA found flaws in the process used to validate the test, and more specifically around the patient data privacy.
That has nothing to do with a judgement that the underlying test isn't effective.
... 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.
She started off iam sure with good intentions until she discovered it (their magic machine "Edison") doesnt actually work, by then she had enough funding to make her rich for life, she couldn't just stop and say sorry it doesn't work and hand the money back to investors she would be ruined, now she is in too deep to stop and so the charade continues until she is forced to stop.
shame peoples lives are at risk while it continues, much like Teslas "autopilot", how many innocent people have to die until you call a project a failure ?
I thought Theranos had been banned form blood work. Why are they still in operation?
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.
There's nothing about the test being wrong. It' just that they ignored patient safety while conducting trials.
If you don't read the article, please don't write the headline.
A thousand pounds of wood moving at 300 feet per minute. Don't get in the way.
... 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
These people are trying to run big pharm like it's a startup selling kitten mittens. Do it fast, get it to the market without proper testing and let our users beta test. It's all an internet scam, the only difference between Theranos and some other dot com blowout, is the government has more control over approval for medical treatments and devices.
I wonder how much longer it will take before people finally realize Theranos and Holmes are a scam.
http://arstechnica.com/science...
Fail blood tests, or rather, no verified blood tests using the new, totally fantastic, awesomely amazing process, labs which don't meet standards, labs which don't even use the new, totally fantastic, awesomely amazing process, and now, in a blatant attempt to shift attention from all their other failures, Theranos and their fraud owner fail the Zika test.
I'd say put a fork in it because it's done, but I'm sure this train wreck of a company and financial disaster will valiantly cling to every scrap of life it can before the prosecutions begin.
We will bankrupt ourselves in the vain search for absolute security. -- Dwight D. Eisenhower
Ah, scam. Thought it said man for a moment.
Science today is more entertainment than fact.
... but the FDA is still finding something to complain about.
Specificaly, the complaint is that proper protocols (proceedures) were not followed. This is the United States Government, Food and Drug Administration... the protocols are in writing and detailed. They say what you will and will not do at each stage of testing, and how you will do it. If your company cannot follow directions, you do not get to sell your product.
There is plenty of room for the FDA to ease up on experimental medicine, but I've got to assume you're either a very competent troll or a marketing shill. Theranos doesn't do anything new, they in fact pretend to do the same thing as everyone else cheaper, while not doing it at all. They are marketing people who decided their next scam should be in healthcare, aka: the ultimate scum of Humanity.
Move fast and kill people.
There is no such thing as a "fast" lane in the United States. Calling it such is part of the problem. There are "travel" lanes and "passing" lanes (and in some cases slow-vehicle lanes for steep grades). It's not a "left" lane. It's not a "fast" lane. They are "passing" lanes.
Also, I think it was Abraham Lincoln who said(?) "The best way to get rid of an unjust law is to enforce it strictly."
Forcing others to abide by an unjust law as a form of civil disobedience in an attempt to get the law repealed is something I will applaud every time.
Theranos is trying to behave like a tech startup: take huge investment, run on nothing but chutzpah and marketing for years, and produce nothing of value.
Now their "disruptive, out of the box thinking" has led them to skip required procedures that are in place to protect research of all kinds in the US.
Sorry, but you need to play by the rules when it comes to the FDA, or you don't get to play the game.
Just dead wrong. Here in California it is most certainly the fast lane
http://www.leginfo.ca.gov/cgi-bin/displaycode?section=veh&group=21001-22000&file=21650-21664
21654. (a) Notwithstanding the prima facie speed limits, any
vehicle proceeding upon a highway at a speed less than the normal
speed of traffic moving in the same direction at such time shall be
driven in the right-hand lane for traffic or as close as practicable
to the right-hand edge or curb, except when overtaking and passing
another vehicle proceeding in the same direction or when preparing
for a left turn at an intersection or into a private road or
driveway.
(b) If a vehicle is being driven at a speed less than the normal
speed of traffic moving in the same direction at such time, and is
not being driven in the right-hand lane for traffic or as close as
practicable to the right-hand edge or curb, it shall constitute prima
facie evidence that the driver is operating the vehicle in violation
of subdivision (a) of this section.
(c) The Department of Transportation, with respect to state
highways, and local authorities, with respect to highways under their
jurisdiction, may place and maintain upon highways official signs
directing slow-moving traffic to use the right-hand traffic lane
except when overtaking and passing another vehicle or preparing for a
left turn.
What the FDA really needs to do is ease up on "me-too" products. The latest drug price scandals were not a result of drug patents, but because getting permission to sell something like an Epi-Pen takes a long time and is expensive. So, drug company A produces something, realizes it's got a monopoly, and raises the price a lot. Drug company B can take a year or three and spend lots of money and get permission to produce the same thing, and drug company A then drops the price to previous levels to hurt drug company B. Most countries do their own negotiation of drug prices, and have a lot of leverage, but the free market would do almost as well for out-of-patent drugs if it weren't for the friction in entering the market.
"When you have eliminated the unacceptable, whatever is left, however improbable, must be the truthiness" - Holmes
... it is that the company didn't jump through the right hoops.
Makes you wonder who in government Theranos pissed off. It is starting to look like someone is waging a state-sponsored vendetta against them.
That's not the case here. Plenty of people (pretty much everyone) got approved for Zika blood testing. Theranos didn't get approved because they are scammers.
They may not have working tests but this complaint is weird as it doesn't have anything to do with that. I suspect most labs do a lot of tests poorly, like urincultures or Lyme testing. It all depends on what the corporate interests want to detect, what they can get away with, and what is profitable. The lack of specifics here about the actual efficacy of the test makes it sound like a smear campaign, as if someone was a bigger lobbyist. Or is the FDA trying to give them another chance to get the test working?
Insightful. I see this division all the time: some fields succumb to theory; others require a consequentialist outlook.
Alternative Right.
This was accepted because the attractive girl fits into one of our media tropes, the Girl Power! trope. It also fits into our Silicon Valley trope.
These tropes encourage us to believe that the unlikely is possible because that's the way it happens in movies. If Theranos had been helmed by an old white guy, there would have been media pushback, critical questions, etc.
Instead the consumer audience accepted it with glowing excitement.
Alternative Right.
At that point, we should just call them what they are: celebrities. Sort of like how people expect spiritual and political advice from rock stars and movie actors.
Alternative Right.
There's a lot of "smart" (or perhaps clever) around today. Michael Crichton called it "thin intelligence."
Alternative Right.
At least it's an organic offering from Fleshlight Inc.
Alternative Right.
http://www.vanityfair.com/news...
Alternative Right.
Great contribution. An alt right blogger expanded on this:
http://www.amerika.org/science...
Which is the more realistic image? ...beats me, but the one on the left, I'd like to get her phone number.
Alternative Right.