Elizabeth Holmes: still absolutely, resolutely in denial…
...What system of education or business culture encourages and tolerates such a delusional, wingnut, swinging-from-the-rafters claim such as that Theranos, the would-be bloody unicorn, is not already a dead horse?...MOREHere's why he was so right, from Forbes:
Is there any precedent to the 2 year ban that Elizabeth Holmes received from the FDA? originally appeared on Quora: the knowledge sharing network where compelling questions are answered by people with unique insights.
Answer by Jane Chin, Ph.D, President of the Medical Science Liaison Institute, Founder of LinkedIn’s Alternative PHD Careers group, on Quora:
The FDA did not ban Elizabeth Holmes from operating labs for two years and impose an undisclosed monetary fine; CMS (Centers for Medicare & Medicaid Services) did. This is an important distinction, because FDA regulates food and drug/device safety, while CMS goes after people and companies that steal from (defraud) the government via its Medicare/Medicaid reimbursement system, as well as regulate clinical laboratories under CLIA.
With this CMS-not-FDA distinction in mind, here’s some perspective: getting on the wrong side of CMS is asking for a death wish in the healthcare business. Pharma companies will sooner pay hundreds of millions and even billions of penalty dollars (and many do: see Big Pharma’s Big Fines) than be banned from doing business that involves Medicare and Medicaid Services. The loss of business from CMS is catastrophic to a life science company and is equivalent to a death sentence for the entire product franchise*.
Banning an individual, on the other hand, requires CMS to decide there is enough evidence of willful wrongdoing and fraud to warrant a ban. Most of the bans that are covered by business news involve physicians defrauding Medicare and Medicaid, and CMS does not appear to be doing a very good job figuring out which sleazy doctors are simply going on to defraud another branch of its reimbursement system (see Banned from Medicare, still billing Medicaid).
However, in the case of Elizabeth Holmes, here is a very high profile (TED talks, magazine covers) business individual who has profited from government reimbursement of a device that has been in the spotlight for scrutiny but few in the scientific community actually know “how it does what it does.”Thus, there hasn’t been a precedent of a very famous company founder getting the CMS “stamp of death” ban in a very public and dramatic way....MORE
One Saturday in June 2015 I was in the office reading Medical Xpress and saw a sharp guy commenting on Theranos.
Getting to the end of the story I had one of those "Holy crap!" epiphanies and linked to it in Theranos: She's Young, She's Rich, Is She A Marketing Huckster?.
A few months later (Oct. 2015) the Wall Street Journal's John Carreyrou started the series of exposés that I figured would be a lock for a 2016 Pulitzer. That didn't happen so he'll have to be content with the two prizes he's already won.
Here's our intro to that first WSJ piece:
The story we linked to in June's "Theranos: She's Young, She's Rich, Is She A Marketing Huckster?" was based on the thinking of one of the heavyweights of laboratory diagnostics, Dr. Dr. Eleftherios P. Diamandis*, who was dubious.That post was one of our least read.Funny how stuff works out....
...*He gets the double Doc for his M.D. PhD.And here's Carreyrou's latest, Wall Street Journal, July 10, 2016:
Under Fire, Theranos CEO Stifled Bad News
...Ms. Holmes maintains a heavy security detail. Men with earpieces escort her wherever she goes outside the Palo Alto headquarters. Their code name for her is “Eagle 1,” current and former employees say. Mr. Balwani, until he retired, was “Eagle 2,” they say...I'd say Mr. Murphy nailed it.
