February 20, 2017
By Alex Keown, BioSpace.com Breaking News Staff
STANFORD, Calif. – Investigative reports by the Wall Street Journal are largely credited with the downfall of would-be-biotech-disruptor Theranos, but there were members of the scientific community who were also raising concerns about the ultra-secretive company.
In early 2015, before the Journal’s initial expose, John P. A. Ioannidis, a professor of medicine, health research and policy and statistics at Stanford University, the alma mater of Theranos founder Elizabeth Holmes, penned a column in the Journal of American Medicine Association questioning the company’s lack of peer-reviewed material. Theranos and Holmes were darlings of Silicon Valley investors. Holmes and her associates were able to raise funds and push the company to a value once estimated at $9 billion all without ever publishing information on the company’s blood-testing technology in any scientific publication. In his 2015 column, Ioannidis questioned the value of research continuously conducted in “stealth mode.” In his column, Ioannidis points out that although the company was getting glowing reviews in the media for its goals of disrupting the diagnostics industry, cutting costs and putting more power into the hands of patients, there was never any mention of “… how exactly the technology behind its blood test works.” While Holmes often talked about how the company’s technology could provide early diagnosis of a disease, Ioannidis said there was never any discussion of false positives, over diagnosis nor the potential for escalation of “latrogenic disease secondary to … overly zealous diagnostic and screening efforts.” That was a problem for the Stanford professor.
“Products, services and profit appear to be more important than scientific publications,” Ioannidis said.
He said at a time of increasing recognition of the importance of transparency of in laboratory and clinical research, relying on stealth as opposed to peer-review, even for profit-driven companies, seems “paradoxical.” He said stealth research creates “total ambiguity about what evidence can be trusted in a mix of possibly brilliant ideas, aggressive corporate announcement and mass media hype.”
Following the publishing of that column in the journal, Theranos’ counsel reached out to Ioannidis to seek a retraction. Theranos has been known for using the weight of its legal team to quell any negative publicity. The Wall Street Journal said it had been targeted by Theranos following its initial reports about the lack of efficacy of the company’s technology.
Ioannidis told Forbes that Theranos suggested he co-author a paper with Holmes for publication “supporting the company view that FDA clearance offered the highest possible level of evidence for any diagnostics blood test technology.” Additionally, the legal team suggested he “recant” his misgivings about the company, Forbes said. Ioannidis declined.
Ioannidis has not been the only scientist outside the company to question Theranos and its technology. Several months after Ioannidis published his column in JAMA, Eleftherios P. Diamandis, the head of clinical biochemistry at Mount Sinai Hospital in Toronto, raised concerns in an issue of the journal Clinical Chemistry and Laboratory Medicine. In a report by Business Insider, Diamandis questioned the company’s claims of innovation in four areas – speed, cost, pain associated with blood tests and delivery of results to patients. Diamandis said in his 2015 article that the company was not breaking any new ground. Much like Stanford’s Ioannidis, Diamandis also questioned the lack of any peer-reviewed research. He said it was hard to judge a technology when the details are kept secret.
