Confirming what we detailed earlier this week, queen of the unicorns Elizabath Holmes is in big trouble...
- *THERANOS 'NOT IN COMPLIANCE' WITH GOVERNMENT RULES, AGENCY SAYS
- *CENTERS FOR MEDICARE AND MEDICAID SERVICES COMMENTS IN LETTER
- *THERANOS HAD 'DEFICIENT PRACTICES' AT LABORATORY, CMS SAYS
- *PRACTICES POSED 'JEOPARDY TO PATIENT HEALTH AND SAFETY'
As Bloomberg reports,
Deficiencies at a laboratory run by medical testing startup Theranos Inc. “pose immediate jeopardy to patient health and safety,” U.S. government regulators said in a letter to the company released Wednesday.
Theranos violated at least five regulations governing clinical laboratories that operate medical diagnostics used to do things like test blood levels or assess disease, the U.S. said in the letter, which is dated Jan. 25.
Theranos has 10 days to show the Centers for Medicare and Medicaid Services it is taking action to immediately fix the issues.
Full CMS statement below:
http://www.scribd.com/embeds/296875201/content
* * *
This deficiency report is critical to Theranos future relationship with its main retail partner Walgreens Boots Alliance,
The drugstore operator has 41 blood-drawing “wellness centers” in stores in Arizona and California, which are Theranos’s primary access to consumers. Walgreens had aimed to expand the sites nationwide but has suspended those plans until Theranos answers questions about its technology, said the people familiar with the matter.
In recent weeks, Walgreens has debated whether to close the wellness centers, and the results of the latest inspection by CMS could lead the retailer to take an even harder look at what remains of its partnership with Theranos, these people said.
Since October, Walgreens representatives have met a number of times with Theranos Chief Executive Elizabeth Holmes and her executive team but were dissatisfied with their responses, the people added.
An earlier review of the contract led Walgreens officials to conclude that it would be difficult to exit the agreement, but the inspection findings could alter that conclusion, according to people familiar with the matter.
Just what does this say about the following 12 members of the Theranos board?
Or perhaps that was the idea...
This is a board that may have made sense (twenty years ago) for a defense contractor, but not for a company whose primary task is working through the FDA approval process and getting customers in the health care business. (Theranos does some work for the US Military, though like almost everything else about the company, the work is so secret that no one seems to know what it involves.)
The only two outside members that may have had the remotest link to the health care business were Bill Frist, a doctor and lead stockholder in Hospital Corporation of America, and William Foege, worthy for honor because of his role in eradicating small pox. My cynical reaction is that if you were Ms. Holmes and wanted to create a board of directors that had little idea what you were doing as a business and had no interest in asking, you could not have done much better than this group of septuagenarians.