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JAMA Questions Stealth Science

The prominent journal has published an article questioning the uptick of stealth research.

Brian Buntz

Theranos (Palo Alto, CA), a secretive blood testing firm, and its 30-year-old CEO, have received a flurry of positive press attention recently, but a prominent medical journal raises questions regarding it approach to science. Although Theranos claims it has reinvented lab testing, making it possible to run hundreds of diagnostic tests using a single drop of blood, the article in the Journal of the American Medical Association (JAMA) points out the lack of peer-reviewed studies related to its technology. It also questions the notion that "all people should be able to order their own diagnostic tests--as many as they wish and whenever and as often as they wish." What about overdiagnosis, false-positives, or the possibility of an uptick in iatrogenic causes? it asks.

Titled "Stealth Research: Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?" the article by John P.A. Ioannidis, MD notes that the technology has certainly won over a slew of well known journals, including Wired TechCrunch, Forbes, Medscape, and Fortune. But the company has little to show when it comes to peer-reviewed studies. Theranos, which is operating in stealth mode, claims it fears it would be a competitive disadvantage to openly share how its technology works. While two studies published related to the company's technology can be accessed via PubMed, the studies were written by the firm's employees and do little to discuss how the technology works.

Ionnidis does praise the company's efforts to lower the cost of blood testing and reduce the pain inherent in venipuncture. He also concedes that the peer-review process can be onerous and points out that evidence suggests that peer reviewers are "hostile to innovation." There has been an uptick in stealth research in recent years, especially for venture-capital-backed firms operating in the biotech field. In the past, many firms kept their technology secret until they could win funding, at which point they would unveil it. But there has recently been an uptick in firms that operate in a quasi-permanent stealth mode. The JAMA article points out that  even if stealth research is justifiable, it makes it difficult to determine whether it is trustworthy.

A recent study published by Research and Markets also questions the company's claims, stating that the verdict is out whether the company has "scaled microfluidic technology across a comprehensive menu of tests?" If the answer to that question is yes, the company could make good on the fawning attention it has received. But that fact is that the question remains unanswered at this point.

Refresh your medical device industry knowledge at BIOMEDevice Boston, May 6-7, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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