By ART CAPLAN Elizabeth Holmes, the founder and chief executive of the controversial company Theranos, has been charged with an “elaborate, years-long fraud” by the Securities and Exchange Commission. The SEC alleges that Holmes and former company president Ramesh “Sunny” Balwani deceived investors into believing that its key product — a portable blood analyzer —was

By ART CAPLAN
Elizabeth Holmes, the founder and chief executive of the controversial company Theranos, has been charged with an “elaborate, years-long fraud” by the Securities and Exchange Commission. The SEC alleges that Holmes and former company president Ramesh “Sunny” Balwani deceived investors into believing that its key product — a portable blood analyzer —was capable of using drops of blood to do the kinds of workups that now require much more blood—up to ten milliters per test.  Holmes fooled many people including the Theranos board of board of directors, high-powered investors and high ranking members of the military including General James Mattis, a huge fan, who left the Theranos board to become President Trump’s Secretary of Defense.
Things don’t look good for the Theranos leadership in terms of the SEC charges. The company already saw a three-year partnership with Walgreen’s collapse leaving many customers wondering if they had been deceived. The technology, which Holmes and her company touted as disruptive and revolutionary, never worked. So what happened to permit so much enthusiasm and money to be spent on a useless technology?
First, the company never published on its technology. The promise of small volume blood testing sounded great and indeed is great for many reasons not the least of which a lot less misery for patients who need to get a lot of painful blood drawn for tests. But no publication, no data driven presentations at professional society meetings, a lack of transparency turned Theranos into an 8 billion dollar Dutch tulip bubble.

Blathering on about disruption may sell well in Silicon Valley software start-ups and with the titans of change at angel investment firms but it does not fly in health care. Coming up with an app to order food delivery is not the same as proving you have a reliable tool for accurately testing blood or for that matter genes, brains or excretion. Medical devices need to work with amazing reliability and there are government regulatory hurdles appropriately in place to insure they do. A clever PowerPoint and a lot of buzzwords is not what innovation needs to be in health care.
Too much of a good thing is bad. Too much of a good thing that rests on hype, hand-waving and wishful thinking combined with greed is worthless. Let Theranos be a warning—pure disruption is not the best way to go in health care.

http://thehealthcareblog.com/blog/2018/03/14/the-conflicted-disruption-complex/