Theranos Data Tampering Allegations Could Prove Devastating

Kristopher Sturgis

December 29, 2015

2 Min Read
Theranos Data Tampering Allegations Could Prove Devastating

The Wall Street Journal interviewed former employees at blood-testing firm Theranos who maintain the company had deleted unflattering quality control data. If true, the news could be a healthcare counterpart to the Volkswagen emissions scandal.

Kristopher Sturgis

The most-recent exposé published by the Wall Street Journal states that the company deleted inaccurate blood-testing results to make its technology seem more accurate than it was.  

Citing a former Theranos lab worker, the Journal states that the company has consistently had problems living up to the technological promise outlined by company founder and CEO Elizabeth Holmes. It also reports that a former employee had reported the data manipulation to the Centers for Medicare and Medicaid Services (CMS).

Theranos vehemently denies the allegations, stating that the entire incident "simply didn't happen," while confirming that lab worker who spoke to the WSJ about the alleged data-tampering has been fired for misconduct. The company also confirmed that they have not received a copy of the alleged complaint from CMS, and noted that the subject of lab ethics is something the company takes very seriously.

A report from Fast Company states that it is rare for healthcare technology companies to misrepresent quality-control data. While it is unclear whether FDA or CMS would have jurisdiction regarding this matter, lab-testing companies are typically legally required to maintain quality-control records for at least two years after they were created, a standard that is enforced by CMS under Clinical Laboratory Improvements Amendments.

While speaking at a tech conference on Monday, Theranos founder Elizabeth Holmes promised increased transparency as the company attempts to move forward in the coming months. Holmes started the company as an undergrad at Stanford University, and has since raised over $400 million in an effort to develop blood tests that are simpler and cheaper than current methods.

The company has also responded with an open letter to the WSJ, criticizing the Journal for relying upon and citing anonymous sources, as well as reporting on undisclosed and unconfirmed complaints

The potential breach of integrity suggested by the claims of data tampering could do irreparable harm to the company's image, which had already been tainted by multiple damning reports from the Wall Street Journal and other outlets.

The company's founder Elizabeth Holmes continues to be upbeat about the company's prospects, having said recently that its sales volume had never been higher.

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About the Author(s)

Kristopher Sturgis

Kristopher Sturgis is a freelance contributor to MD+DI.

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