Theranos Turns to New Medical Advisers to Help Validate Technology

Theranos founder and CEO Elizabeth Holmes at the Fortune Global Forum, November 2015. ( Stuart Isett/Fortune Global Forum)

Saying Theranos needs to do some damage control is like suggesting Donald Trump may want to take a moment to collect his thoughts before opening his mouth to speak.

After damning investigations into the high-flying company's blood-testing technology by both The Wall Street Journal and the federal government, Theranos, once valued at $9 billion, is now struggling to regain legitimacy.

On Thursday, the company announced what appears to be an attempt at rehabilitating its reputation, stating that "nationally respected laboratory and medical experts" have joined its Scientific and Medical Advisory Board.  (You can see who the board members are and the company's description of them below.)

Company spokeswoman Brooke Buchanan says all of the board members have taken part in at least one of three scientific review panels looking at the company's technology.

Buchanan said the board members are being paid "the industry average of an expert in the medical field."

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The board's co-chair, Dr. David Helfet,  director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital, was quoted in Thursday's press release as saying the company "literally took the lid off of the box" when it came to providing board members access to its operations . (He meant "figuratively," we'll have to assume.)

"Experts were shown Theranos’ technology, met with Theranos scientists, and had access to any data," Helfet said.

So what did these panels conclude? I asked Brooke Buchanan. She said the board will meet again in two weeks to "decide and strategize delivery of our data and publication." (See the Friday update below for a Forbes report on what two  board members have to say about Theranos.)

The new board members join an initial group announced by Theranos last October, formed after criticism that its board of directors, which included Henry Kissinger and George P. Schultz, had just one practicing medical professional.

If Theranos does present evidence of its technology's efficacy, it'll be a big deal. To date, the company has published no scientific research to validate its methods, though it said it intended to do so as early as last October. In the absence of publicly available evidence that it can do what it says it can do, the company has left itself wide open to criticism, especially of the kind based on facts.

Those include the deficiencies revealed in a federal inspection of Theranos' Newark laboratory -- the nearly 30 percent failure rate of its proprietary finger-prick blood tests to meet quality control standards among them. Other tests failed as much as 87 percent of the time, the inspection report said.

Despite those eye-popping numbers, Dr. Helfet, the medical board's co-chair, is bullish on the company's prospects, or at least its scientific credibility.

"It is clear that Theranos has done what people thought was impossible,” he said in the press release. "... Theranos’ technology is a groundbreaking feat of science and engineering, making it possible to accurately analyze micro amounts of blood for the same tests routinely done today with traditional venipuncture.”

Dr. Helfet has not returned calls seeking further comment.

Update Friday, April 8: Forbes' Matthew Herper spoke with three members of the advisory board: Helfit, Jack Ladenson, a pathologist at the Washington University School of Medicine in St. Louis, and Steven Spitalnik, vice chairman of laboratory medicine at Columbia University Medical Center. He also talked to Elizabeth Holmes.  From his post:

  • Both Ladenson and Spitalnik describe what they saw as “promising” and “intriguing.” But they declined to answer questions about whether or not these devices are ready to be used clinically, or whether they were ready when they were in use a year ago.“I don’t feel like I have enough information to answer that question,” Spitalnik told me. “Eight hours sitting around a table looking at data and asking questions and having a conversation is enough to whet my appetite, but not to go beyond that.”

Said Ladenson: "“I wouldn’t have joined this thing if I thought this was a loser.”

Theranos medical and advisory board members and their company descriptions:

Susan A. Evans, PhD, FACB
Dr. Evans has over 30 years of experience in diagnostics and health technology companies. She served as President, Secretary, and member of the Board of Directors for the American Association for Clinical Chemistry (AACC), for which she received an award in 2008 for outstanding contributions through service to the profession. Dr. Evans also served as a member of the Board of Directors and President of the National Academy of Clinical Biochemistry (NACB), now the Academy of the AACC.

William H. Foege, MD
Dr. Foege is an epidemiologist and former Director of the U.S. Center for Disease Control and Prevention (CDC). He is recognized as the health innovator behind the successful campaign to eradicate smallpox in the 1970s, Dr. Foege received the Presidential Medal of Freedom in 2012, the nation’s highest civilian honor. He was a senior medical advisor for the Bill and Melinda Gates Foundation from 1999 until his retirement in 2011. Dr. Foege is a member of the Theranos Board of Counselors and has served on Theranos’ Medical Board.

Ann M. Gronowski, PhD, DABCC
Dr. Gronowski is a professor in the Department of Pathology and Immunology and the Department of Obstetrics and Gynecology at the Washington University School of Medicine in St. Louis. She is board certified in Clinical Chemistry and is Co-Medical Director of the clinical chemistry, serology, and immunology laboratories at Barnes-Jewish Hospital. She is a past President of the American Association of Clinical Chemistry (AACC) and a past President of the American Board of Clinical Chemistry (ABCC). Dr. Gronowski is author of over seventy peer-reviewed articles and a number of textbooks including Tietz’s Applied Laboratory Medicine and Handbook of Clinical Laboratory Testing During Pregnancy.

David Helfet, MD, Co-Chairman
Dr. Helfet is the Director of the Orthopedic Trauma Service, Hospital for Special Surgery and New York-Presbyterian Hospital, and Professor of Orthopedic Surgery, Weill Cornell Medicine. Dr. Helfet is the Past President of the Orthopaedic Trauma Association and has been extensively involved nationally and internationally on boards and courses dealing with trauma. Dr. Helfet is annually ranked as one of New York Magazine’s “Best Doctors in New York” and Castle-Connolly’s “America’s Top Doctors.” Dr. Helfet has published extensively on orthopedic trauma topics including numerous articles and book chapters.

Larry J. Kricka, D. Phil, FRCPath
Dr. Kricka is a professor of Pathology and Laboratory Medicine at the University of Pennsylvania and was director of the General Chemistry Laboratory and the Endocrinology Laboratory at the Hospital of the University of Pennsylvania. He is a Fellow of the Royal College of Pathologists, and a member of the Editorial Board of Clinical Chemistry, and Analytical Biochemistry, and past editor-in-chief of Luminescence. He was President of the American Association for Clinical Chemistry (AACC) in 2001 and was a member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Executive Board. Dr. Kricka holds over 30 U.S. patents; and is the author/co-author of over 500 articles, abstracts, book chapters, and papers; and 22 books.

Jack Ladenson, PhD, DABCC
Dr. Ladenson is the Oree M. Carroll and Lillian B. Ladenson Professor of Clinical Chemistry at Washington University School of Medicine. He has been active in a number of professional organizations and has served as President of the American Association for Clinical Chemistry (AACC) and the Academy of Clinical Laboratory Physicians and Scientists (ACLPS). He is also a past chair of the Editorial Board of the journal Clinical Chemistry. He has received numerous awards from professional organizations, Washington University, and its Medical Alumni Association. He also directs clinical pathology programs for Pathologists Overseas Inc.

Andy O. Miller, MD
Dr. Miller is an 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. His areas of clinical expertise and research activity are orthopedic and rheumatologic infectious disease. He has been selected for inclusion on the Super Doctors® 2015 list. He is board certified in Infectious Diseases and Internal Medicine by the American Board of Internal Medicine.

Steven Spitalnik, MD
Dr. Spitalnik is a Professor of Pathology and Cell Biology and the Vice-Chairman of Laboratory Medicine at Columbia University Medical Center (CUMC). As the Medical Director of the Clinical laboratories on the CUMC campus of the New York-Presbyterian Hospital, he coordinates the clinical service, educational, and scholarly activities of the Division. In addition, he is the Co-Director of the Laboratory of Transfusion Biology, which pursues NIH-funded research aimed at improving transfusion practice. He is a long-standing member of the Academy of Clinical Laboratory Physicians & Scientists, serving as its President in 2002-03 and, in 2005, receiving its Gerald T. Evans Award for outstanding leadership and service to the Academy. In addition to being board certified in both Anatomic and Clinical Pathology, Dr. Spitalnik is a member of the Editorial Boards of Transfusion, Transfusion Medicine Reviews, and Current Opinion in Hematology, and is the lead author of Clinical Pathology Board Review.

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