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Started By
Message
Feds may ban Theranos CEO Elizabeth Holmes from blood-testing biz
Posted on 4/14/16 at 1:10 am
Posted on 4/14/16 at 1:10 am
quote:
After investigations revealed major problems at its blood-testing lab in California, the high-profile medical startup Theranos is in deep water with the Centers for Medicare and Medicaid Services (CMS). As Ars has reported before, the company faces sanctions, including losing its approval to test human samples.
But, according to a Wednesday report in The Wall Street Journal, the sanctions may also include banning Theranos' CEO and founder, Elizabeth Holmes, and its president, Sunny Balwani, from owning or running any lab for at least two years. The potential ban was mentioned in a letter dated March 18 from the CMS to Theranos. The letter has not been publicly disclosed, but WSJ reporters viewed it.
According to those reporters’ sources, Theranos had 10 days to respond, which it did. The CMS is now looking over its response. If the agency is still displeased with Theranos’ performance, the revocation of its approval to test blood samples and the ban could go into effect within 60 days. Theranos could still appeal the decision, the WSJ noted, but appeals rarely succeed. Between 2001 and the end of 2010, the CMS did not lose a single such case.
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Posted on 4/14/16 at 1:32 am to Street Hawk
quote:Michael Vick had a similar punishment but it was all breeds, as I recall.
the sanctions may also include banning Theranos' CEO and founder, Elizabeth Holmes, and its president, Sunny Balwani, from owning or running any lab for at least two years
Posted on 4/14/16 at 1:32 am to Street Hawk
PS: Money Board, Goddamnit!
Posted on 4/14/16 at 2:29 am to Street Hawk
Pics?
Posted on 4/14/16 at 5:54 am to Street Hawk
Her "labs" were using un-proven technology and really at risk for hurting someone with bad results. I think the punishment is not being able to do any gov work, I think they can still sell to individuals.
Either way, being in the lab business, she and her lab and the medical director who approved it should be out of the business for a long time.
Either way, being in the lab business, she and her lab and the medical director who approved it should be out of the business for a long time.
Posted on 4/14/16 at 6:10 am to Street Hawk
Pics?
Posted on 4/14/16 at 7:13 am to BRgetthenet
Posted on 4/14/16 at 7:37 am to Street Hawk
quote:
Elizabeth Holmes
Saw her in a couple of interviews.... Bitch is seriously mental. She has some sort of Steve Jobs obsession/Messiah complex going on.
Posted on 4/14/16 at 7:41 am to jonboy
I guess when everyone in Silicon Valley is throwing money at you, hailing you as a genius, it goes to your head. But she's probably always been a nut job.
Posted on 4/14/16 at 7:49 am to jeffsdad
quote:
Either way, being in the lab business, she and her lab and the medical director who approved it should be out of the business for a long time.
There are regulations that have to be met for CLIA #s to be used to bill Medicare or federal $
Labs are supposed to be reviewed regularly to keep their CLIA certification which allows the to bill for certain work done.
I need to hear more on this. Someone gave them a CLIA #, you can't give yourself one.
Think of it as an operating permit of some kind for a business from the regulating agency, and then another agency coming in and saying your not permitted for the work.
Now, if they did things differently from the process they certified with CLIA, then I see the problem
Posted on 4/14/16 at 10:45 am to jonboy
quote:
Saw her in a couple of interviews.... Bitch is seriously mental. She has some sort of Steve Jobs obsession/Messiah complex going on.
I saw her on Charlie Rose, and while I wouldn't call her "seriously mental," she did come across kinda weird. It was like she was going overboard to act confident and it actually came off as insecure. Which I guess I could kinda get for a young woman CEO anyway, but apparently she may have been afraid deep down of getting exposed.
And she has the lowest voice alive ever heard from a lady if I recall correctly.
Posted on 4/14/16 at 12:11 pm to jeffsdad
BUT she is HOT!!!
and Fortune mag likes her.
and Fortune mag likes her.
Posted on 4/15/16 at 6:02 am to GeeOH
Up until about a year ago it was relatively easy to get an initial CLIA number. This allowed you to open a lab and do work and a CLIA surveyor would come in within 2 years. They recently began not giving the CLIA numbers out until you were inspected. This has caused some problems in that it takes roughly 2-4 months to get an average size lab started, and you gotta pay your employees etc., while not having any revenue. And CLIA will continue to postpone the initial inspection based on their own personal whims. I have a Florida lab still waiting - been 6 months now. CLIA has a lot of power, comparable to the IRS and in the south is only there to punish, not help.
Posted on 4/15/16 at 6:08 am to jeffsdad
What exactly did they do wrong?
Posted on 4/15/16 at 6:29 am to tigerinthebueche
Well, essentially, they developed a "new" technology that is suppose to allow for all blood testing from a single drop of blood. However, to put it bluntly, it doesnt work. The results are "all over the board". They did not have medical laboratorians in their development stage that would tell them "this is crap" and offer them insight into why you cant just get a number and call that number a valid result. Lab testing is extremely precise and accurate when the specimen is valid. Extremely. The specimen is the ballgame, get a bad one and you won't get the correct results. And fingersticks inherently give dubious results (with a few exceptions).
Posted on 4/15/16 at 6:29 am to Street Hawk
It was yesterday when every magazine and talking head was hailing her as some empowered women's genius 
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