February 5, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PALO ALTO, Calif. – What does a company under scrutiny for the state of a laboratory and the capabilities of its blood testing technology do to address its problems? Hire a writer. That’s what embattled Theranos sees as one of the tools in changing the course of the conversation about the company.
Theranos is seeking a candidate who can “conceptually solve problems through the power of excellent storytelling,” according to a posting on its website. The position demands the storyteller be able to integrate narratives using multiple mediums, including the written word in the form of books, television, film, as well as retail and emerging Web entertainment. In addition, the candidate must be able to “handle stressful situations.”
The question is, of course, how will a writer be able to aid the company that has come under fire multiple times over the past six months? Most recently federal regulators warned the blood-testing company that its Newark, Calif. Laboratory has “deficient practices” that “pose immediate jeopardy to patient health and safety.” Following a Nov. 20 inspection, the letter told Theranos that its laboratory practices at the Newark site were not in compliance with conditions set forth by the federal Clinical Laboratory Improvement Amendment (CLIA). The letter said the company’s hematology practices at that site “posed immediate jeopardy to the health and safety” of patients.
That report jeopardized a relationship between Theranos and Walgreens, which offers the company’s blood-testing kits in some of its stores. Walgreens said it did not want any of the tests to be sent to that California site for testing, demanding its kits be sent to testing facilities in Arizona, where Theranos conducts the majority of its lab work.
Brooke Buchanan, vice president of communications at Theranos, told BioSpace in an email that deficiencies found in Newark do not reflect the whole of that site. Nor, she said, does it include the company’s Arizona facility, where more than 90 percent of its testing is done.
That was not the first time the company came under scrutiny for practices in its facilities. Following an inspection of its labs earlier this summer by the U.S. Food and Drug Administration, federal regulators called the company’s proprietary Nanotainer tubes an uncleared medical device. Regulators were critical of some of the practices its inspectors observed, including improper classification for its proprietary Nanotainer tubes used for blood specimens. The FDA said Theranos’ Nanotainer blood specimen tubes are not properly filed as a Class II medical device, but are instead being identified as a Class I medical exempt device. As a result, the FDA said Theranos is “currently shipping this uncleared medical device in interstate commerce between California, Arizona and Pennsylvania.” Other observations made by FDA inspectors include a criticism that a method for addressing complaints regarding a possible failure of the device to meet its specifications were not “reviewed, evaluated and investigated where necessary.”
To make matters worse, there were reports Theranos attempted to skirt federal law by asking a Department of Defense (DOD) official to intervene in an inquiry by the U.S. Food and Drug Administration. In 2012, the Department of Defense raised concerns about Theranos’ blood testing technology and notified the FDA. The Washington Post reported Theranos Chief Executive Officer Elizabeth Holmes sought aid from Marine Gen. James Mattis to “squelch those ‘inaccurate’ concerns” raised by the DOD official. Theranos told the Post the Department of Defense was interested in adapting the company’s blood tests for battlefield use in a pilot program that would not have required FDA approval.
In the fall of 2015, Theranos was also the subject of multiple articles by the Wall Street Journal. Citing former Theranos employees the Journal alleged that the company only performs 10 percent of its blood tests on its proprietary technology and opts to perform the majority of its blood tests using technology acquired from other companies.
