Theranos was meant to revolutionize the blood testing industry with groundbreaking technology. However, its’ failure to deliver and consequent collapse showed that “Theranos was like anything in life, what glitters may not be gold; it might not even be silver or copper!” – Dr. Eleftherios P. Diamandis, Clinical Biochemist at the University of Toronto, Canada
Dr. Eleftherios P. Diamandis
In 2003, Theranos was founded by then 19-year-old Elizabeth Holmes. She had a radical, new vision for blood testing that she claimed would empower patients. Instead of the traditional blood draw from the arm, Theranos would offer dozens of tests for cholesterol to cancer using a tiny amount of blood from a finger prick.
Needle-less bloodtests made Holmes youngest self-made billionaire
Theranos rolled out “Theranos Wellness Centers” in Walgreens (a major pharmacy chain) in several American states where individuals could order and analyze their own tests without any physician involvement. Ms. Holmes was widely praised as the next Steve Jobs, and promised to save Medicaid and insurance companies hundreds of millions of dollars while relieving people who were afraid of needles. In 2014, Theranos was valued at $10 billion and Ms. Holmes became the youngest self-made female billionaire.
Technology shrouded in extreme secrecy
Despite this success, concerns began to emerge about Theranos’ extreme secrecy and its’ technology. Dr. Eleftherios Diamandis, a Clinical Biochemist at the University of Toronto, Canada was one of the first scientists to write about flaws in the Theranos model. In an extensive opinion paper in the De Gruyter journal Clinical Chemistry and Laboratory Medicine, entitled Theranos phenomenon: promises and fallacies, Dr. Diamandis pointed out potential issues with the sensitivity, specificity and robustness of Theranos’ tests.
Dr. Diamandis’s subsequent pieces on Theranos (Theranos phenomenon – part 2, Theranos phenomenon- part 3, Theranos phenomenon-part 4: Theranos at an international conference and Theranos phenomenon– part 5: Theranos’ presentation at the American Association for Clinical Chemistry Annual Conferences 2016) provided scientific background as the company faced more and more problems.
Theranos’ false claims divulged
In 2014, damaging whistleblower testimony revealed that Theranos technology was failing quality checks and was unreliable. Many other tests were performed on commercial machines using normal volumes of blood. Theranos voided two years of test results and the Centers for Medicare and Medicaid Services closed two labs.
Lawsuits from Walgreens, investors and patients who took the tests piled up and Forbes magazine revised Ms. Holmes’s wealth to zero. In March 2018, the United States Securities and Exchange Commission (a major American financial regulator) ordered Ms. Holmes to pay $500 000 to settle charges of gross fraud. Consequently, it is likely the Theranos saga is at its conclusion.
In a final piece “The meteoric rise and dramatic fall of Theranos: lessons learned for the diagnostic industry” published in the journal Clinical Chemistry and Laboratory Medicine, Dr. Diamandis and student Clare Fiala compile lessons learned from the Theranos saga which are reproduced below.
- Be transparent and release peer reviewed data to the scientific community, general public and regulators
- Do not make false claims about products and be clear about what your product can and cannot do
- No amount of marketing can make up for technologies that do not work
- Misleading investors, consumers and regulators will come back to bite you
- Be proactive: hire knowledgeable advisors right at the beginning, not when problems arise
- Be clear what your technology can do today – not what you hope it can do someday
This work demonstrates the dangers and consequences of scientific fraud using the example of infamous blood testing company Theranos, through an expert biochemistry perspective.
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