JAMA Questions Theranos's Approach to Science

February 23, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

An opinion piece in the Journal of the American Medical Association has caused a stir by questioning the science of Theranos, Inc., a privately held biotechnology company that has developed novel approaches for laboratory diagnostic testing.

Centered around the idea of "micro testing," John Ioannidis, the author, nestled his criticism within a broader critique of “stealth research” in the biotech industry.

In a TEDMED talk online, the founder and Chief Executive Officer of Theranos, Elizabeth Holmes, claimed that people should be able to order as many blood tests as often as possible and heralded her company as able to facilitate and meet this demand. Theranos’ innovation is to use a tiny amount of blood, a “micro-sample,” as opposed to needle-drawn samples, to do a wide range of diagnostic tests.

Ioannidis pointed out, however, that the drawbacks of the idea of as many blood tests, as often as desired, have not been articulated. He cites as examples, over-diagnosis, false positives, and the potential for the increase in “iatrogenic disease.” Iatrogenic diseases are defined as, “Any adverse condition in a patient occurring as the result of treatment by a physician, surgeon, or other health professional, especially infections acquired by the patient during the course of treatment,” according to Reference.Md.

A number of high-profile publications have written about Theranos, including the Wall Street Journal, Business Insider, the San Francisco Business Times, Fortune, Forbes, Medscape, and the Silicon Valley Business Journal. Missing from this list? Any peer-reviewed scientific journals.

“Theranos is just one example among many for which major efforts and major claims about biomedical progress seem to be happening outside the peer-reviewed scientific literature,” Ioannidis stated. “The main motive appears to be to develop product and services, rather than report new discoveries as research scholarship.”

Peer-reviewed journals have a tendency to be hostile to innovation, however, “stealth research creates total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcements, and massive media hype,” Ioannidis wrote.

The upshot is without peer-reviewed science, the public has only the word of the possible innovators, be they scientists or companies, that the technologies work. Obviously, these people and entities have a vested interest in putting the most positive, optimistic spin on the technologies they are developing.

Analysts are also questioning whether Theranos has actually, “scaled microfluidic technology across a comprehensive menu of tests,” according to an article in Qmed. The study Qmed quoted also concluded that not enough information exists to determine if the technology developed by Theranos will, in fact, disrupt the “the current, centralized, high-throughput laboratory model.”

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