The debate continues about the Edison analyzer technology used at Theranos, at least on a restricted basis currently. Huge media attention was invoked by a recent investigative piece in the Wall Street Journal that was also the centerpiece in my recent blog note (see: Theranos Business Model Begins to Unravel; Much Negative Press Follows). The New York Times subsequently published an interesting follow-up piece (see: Theranos, a Blood Testing Start-Up, Defends Its Accuracy); Below is an excerpt from it:
Ms. Holmes now says she is planning to release a 16-page point-by-point rebuttal of the articles, a document that concludes by accusing the articles’ author of having an agenda that considered Theranos “a target to be taken down.” The rebuttal even dissects the motivations of various people quoted in the articles.“We’ll put this out there and let people judge for themselves what the facts are,” Ms. Holmes said on Tuesday in an interview with The New York Times.....But the company, which is highly secretive about its technology, has not announced any new policies in response to the criticism. Theranos, Ms. Holmes said, had no immediate plans to do what skeptics say would most persuade them: publish data in peer-reviewed medical journals showing that its test results were as accurate as those of more established laboratories. She said that other institutions testing Theranos’s products might eventually publish papers, but that the company, for now, was concentrating on getting its tests approved by the Food and Drug Administration. That, she said, would provide even better external validation....
Ms. Holmes, who started the company at age 19 and has said that she devotes nearly every waking hour to it, has graced the covers of magazines including Fortune, Inc. and The New York Times’s T magazine, and she is a frequent presence on the conference circuit. She recently appeared at Vanity Fair’s New Establishment Summit alongside Facebook’s chief executive, Mark Zuckerberg, and Walt Disney’s chief, Robert A. Iger.....A spokesman for The Wall Street Journal thanked Ms. Holmes for attending the conference but added, “Nothing said at the conference by Ms. Holmes refutes the accuracy” of the articles. The Wall Street Journal is not the only one raising questions. Jean-Louis Gassée, a former senior executive at Apple, wrote in a [recent] blog post ...that the results of two tests from Theranos raised alarms about his health when results for the same tests on the same day from Stanford Hospital did not (see: Theranos Trouble: A First Person Account). Moreover, the Theranos results varied more widely from one day to the next than those from Stanford, he said.
I have the following brief comments:
- Never before has the founder/CEO of a clinical reference lab achieved the status of a media rock star. This attention should (hopefully) die down soon but I it seems possible that a number of VC's in Silicon Valley may be heatedly discussing the relative merits of lab proficiency testing over their morning latte's.
- Ms. Holmes continues to avoid publication of comparison validation data in peer-reviewed medical journals, the gold standard in the field of clinical pathology. I have blogged previously about the announced relationship between Cleveland Clinic and Theranos, which could potentially provide such scientific validation (see: Cleveland Clinic Develops Business Partnership with Theranos; Further Discussion about the Cleveland Clinic Relationship with Theranos). However, I doubt whether the Clinic would risk wading into this media frenzy in any way with a publication about Edison, either pro or con. The latter type of report, of course, would never be permitted by Theranos.
- I am encouraged by the fact that a single customer complaint about the accuracy of the Theranos lab results could seem to shake the foundations of what is reportedly a company with a market value of $9B. Perhaps we need to take into account that the specific customer was, in fact, Jean-Louis Gassée, a former senior executive at Apple.
- As to whether Theranos is a considered “a target to be taken down,” I think that a lot of lab professionals are highly concerned that her current modus operandi ignores institutions and processes that have delivered many decades of high quality lab testing in the U.S.
Update on 10/23/2015 @ 1:48 PM EDST: Ok, Theranos: Here's the Data the World Need to See