By now, Theranos is well known and the company’s name provokes a strong reaction from anyone who knows its troubled and highly publicized story. The company has been scrambling to answer for its practices since the publication of an investigative story last fall in The Wall Street Journal, which acted as the impetus for a web of questions that have since been raised. At the center of these are issues ranging from the questionable capacity of its technology to the death of its former chief scientist.
That said, my interest lies in another important topic that’s largely been overlooked. As a scientist, I have been increasingly interested in the role and responsibility of its Scientific and Medical Advisory Board (SMAB) that was put into place in April. Specifically, a few things intrigue me: its role in the company, the SMAB’s thoughts on the science and how its members were brought on board. I'm also curious about the decision made by each of the eight members to join a ship that while not yet sinking, was one in which a count of life jackets on board would have been understandable.
As a scientist, I thought that my fellow scientists and physicians — my peers — who joined Theranos in order to increase its transparency and communication would be willing to talk about their role on the advisory board and the developing technology.
But boy, was I wrong.
I emailed the SMAB members asking for an interview, but received just one response. It read, “Thank you for your note. I will not discuss any aspects of my advisory role with Theranos.”
My emails were instead forwarded from the SMAB board to the media relations company, Hill + Knowlton Strategies, charged with managing Theranos’ image. This resulted in several email exchanges (and phone calls) between myself and a member of the PR team. Throughout this time, two months, I was informed that an effort was being made to schedule an interview with a board member. I submitted my interview questions upon his request… and heard crickets. After all of this back and forth, which started on July 21st, I was informed that an interview could not be granted. Then it could. Always 'next week.'
Now, I know that I am not from The New York Times (although they are not getting interviews either) but I am a scientist and a peer of the members of the SMAB. Being told that I cannot ask a question to another scientist goes against what science is and who scientists are. We are trained to ask questions of one another and, by doing so, move science and medicine forward. The fact that I was told that those lines of communication were closed off was not only an affront but also, a huge red flag.
As far as I can tell, there have recently been two notable SMAB communications. One, in August, was the presence of SMAB member Dr. Susan Evans at the American Association for Clinical Chemistry (AACC) meeting where the founder and C.E.O., Elizabeth Holmes, presented Theranos’ newest technology. The other was a piece on the blog site called The Hill entitled “Theranos: looking ahead”, written by Dr. William Foege (also on our Board of Scientific Advisors), who presented his view — full of sentiment and lacking in evidence — that “there is another side to the story.” (1) In the blog post he stated that, “The SMAB was formed to help Theranos communicate to the world the science and technologies it has developed to realize this vision.” But his 546-word essay is about the only communication that the SMAB has done in its five months of existence.
The reality is that Dr. Foege’s piece was nothing but more of the same from Theranos – empty words with no content. He wrote that he and other SMAB members “met with Theranos scientists who demonstrated the company’s ability to accurately process small samples on a range of tests.” And that they “experienced the finger-stick collection process ourselves, receiving reliable results.”
Doesn’t Theranos realize that if it presented those “reliable results” through the peer-review process — as scientists and physicians are expected to do — and prove its accuracy to process small samples on a range of tests (something that has been widely disputed) that it would solve many of the company’s problems? Instead of using these eight physicians and scientists to speak to their colleagues and address concerns, Theranos has cordoned them off. So much so, it’s to the point where they don’t respond to an email from a fellow scientist, hence perpetuating the idea that there is little more at Theranos than smoke and mirrors.
Smoke and mirrors may be fine in other fields – but not ours. Science is not about that. It’s about data, shared curiosity, collaboration and being held accountable. We in the scientific community pride ourselves on the open exchange of ideas and reagents, the peer review process and being a community of scholars. So Ms. Holmes may be a businessperson, but she is not a scientist. And if Theranos’ lack of transparency continues under her leadership, the same troubling obfuscation will befall the members of her SMAB.
The Theranos medical advisory board now includes the following members: (2)
David Helfet, MD, Director of the Orthopedic Trauma Service, Hospital for Special Surgery, and Professor of Orthopedic Surgery, Weill Cornell Medicine
Susan A. Evans, PhD, FACB, former president of the American Association For Clinical Chemistry (AACC)
William Foege, MD, former Director of the U.S. Center for Disease Control and Prevention (CDC)
Ann M. Gronowski, PhD, DABCC, Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis
Larry J. Kricka, D. Phil, FRCPath, professor of Pathology and Laboratory Medicine at the University of Pennsylvania
Jack Ladenson, PhD, DABCC, Professor of Clinical Chemistry at Washington University School of Medicine
Andy O. Miller, MD, Assistant Attending Physician in Infectious Diseases at the Hospital for Special Surgery and New York-Presbyterian Hospital, and an Assistant Professor of Clinical Medicine at Weill Cornell Medicine
Steven Spitalnik, MD, Professor of Pathology and Cell Biology and the Vice-Chairman of Laboratory Medicine at Columbia University Medical Center (CUMC)
*Alan H.B. Wu, Ph.D. was added to the Theranos SMAB in mid-September.