JUN 02, 2016 3:26 PM PDT

Not Sharing Data May Have Cost Theranos Billions

WRITTEN BY: Xuan Pham
Why Forbes downgrades Elizabeth Holmes' worth from $9 billion to nothing
Elizabeth Holmes, founder of Theranos, recently dropped off the Forbes’ list as a self-made billionaire darling when they recently revised their estimate of her worth from $9 billion to a shocking $0.
 
Theranos, not surprisingly, disputed Forbes’ analysis. “As a privately held company, we declined to share confidential information with Forbes,” Brooke Buchanan, Theranos spokeswoman, said in an emailed statement to the New York Times “As a result, the article was based exclusively on speculation and press reports.”
 
But it’s not all speculation, as the science – or lack of science, rather – hasn’t seem to support Theranos’ claims to fame from the beginning.
 
The company was founded on the revolutionary idea of blood testing using just a few droplets via a finger prick. They claimed that over 100 blood tests could be done on just a few blood droplets. Their “less is more” approach extended to costs per test, advertising over 150 tests offered at less than $10. And investors couldn’t get enough. Walgreens, the U.S. drugstore supergiant also wanted in on the potential rise to glory and partnered with Theranos to set up Wellness Clinics that offered the droplet testing.

On the outside, the technology’s potential was enormous. But one major criticism that has always been present is the lack of scientific evidence to support Theranos’ claims. Since its founding days, the company has yet to release any details of their testing equipment or methodology. And they’ve not published any data in peer-reviewed scientific literature. In short, their claims, cannot be verified by the scientific community, which raise significant concerns over whether the technology is really capable of delivering on its diagnostic promises.

Doubts over Theranos’ “one drop” method was further heightened when a recent study, by an unrelated group, found that one drop of blood is insufficient and inaccurate even for common measurements like total white blood count (WBC), platelet count and three-part WBC differential. The research found that droplet samples gave huge variations in the results as compared to samples collected by the traditional venipuncture method that draws tubes of blood from an arm vein. This begs the question of how much trust can doctors put into data collected from a single drop of blood, on which they use for diagnostic purposes.

It would have been a perfect opportunity for Theranos to share its data and possibly rebut allegations. However, Holmes and her company kept quiet. So instead of scientific data, what Theranos has on record is a laundry list of allegations against the accuracy of their tests. They have also faced serious non-compliance issues with two federal agencies: the Federal Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA). Most recently, because of its deficiencies and unresolved compliance issues, the US Centers for Medicare and Medicaid Services even proposed to ban Holmes from owning or running any laboratories for a minimum of two years. This is the most severe sanction that can be levied by the US government. In response to this threat, Theranos corrected tens of thousands of blood tests performed and voided two years worth of results from its proprietary blood-testing machine, the Edison.
 

In defending its practices, the company cited proprietary concerns and the desire to protect their technology from competitors. But the disregard for scientific transparency may have cost Theranos. Forbes’ revision of Holmes’ estimated worth took into account the laundry list of allegations against Theranos, which seriously undermines how much money investors are willing to sink into the company.

If there were ever a more pertinent time for Holmes to reveal her cards, it would be now. 
 
About the Author
I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
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