Congress demands Theranos CEO Elizabeth Holmes explain what went wrong

Citing clinical laboratory failures, U.S. Representatives request information on how Theranos is attempting to correct those flawed test results. 
By Jeff Lagasse
08:49 AM

The United States House of Representatives' Committee on Energy and Commerce penned a letter to Theranos founder and CEO Elizabeth Holmes insisting that she explain what the embattled blood-testing startup is doing to address inaccuracies and questionable adherence to federal guidelines.

Congressional officials cited clinical laboratory failures that led Theranos to void two years of test results from its proprietary Edison blood-testing device, affecting patients who may have received inaccurate or unwarranted medical care on the basis of those results.

"Given Theranos' disregard for patient safety and its failure to immediately address concerns by federal regulators, we write to request more information about how company policies permitted systematic violations of federal law and how Theranos is working with regulators to address these failures," the letter read.

The committee also requested information on how the company is attempting to correct the flawed test results that were sent to patients and medical professionals.

It's the latest in a series of hardships for the Palo Alto outfit. On May 19, Theranos conceded that it had informed regulators it had voided the blood testing results from its Edison machines, as well as tests run on traditional machines, from 2014 and 2015.

In April, The Centers for Medicare and Medicaid Services released a "lightly redacted" copy of a letter it sent to Theranos claiming that its proprietary testing devices often failed to meet the company's own accuracy requirements for certain tests -- in one instance, failing to accurately detect prostate cancer.

Earlier that month, CMS had proposed a number of different sanctions, including banning Theranos founder Elizabeth Holmes from the blood-testing business for at least two years. Other recommendations included the revocation of the company's Clinical Laboratory Improvement Amendments of 1988 certificate, or alternatively, a civil monetary penalty of $10,000 per day for each day of non-compliance. For now, those sanctions are on hold while Theranos is given the chance to take corrective measures.

The committee's letter, drawing on 2015 inspection reports from the Food and Drug Administration, accused Theranos of a number of additional deficiencies, including recordkeeping failures, failure to conduct quality audits, and failures in validation processes to ensure that an unnamed device "conforms to defined user needs and intended uses."

On top of that, the committee claims inspectors found that 81 of 81 results reported to patients on the blood thinner Warfarin were inaccurate. "Too much Warfarin can lead to internal bleeding and too little can leave a patient with an increased risk of stroke," the committee wrote.

In addition to requesting what Theranos is doing to address its deficient test results, the committee is asking the company to detail changes it's making in its internal policies to prevent future compliance issues, and to determine the root cause of the compliance failures via an internal investigation. The committee is also asking what steps Theranos is taking to assist medical professionals and patients who have have been adversely affected by the test results.

Theranos has until July 14 to respond to the committee's requests. A Theranos spokesperson said Friday that the company will soon send a response detailing the steps it has taken.

"Patient safety and clinical quality are our top priorities," the spokesperson said via email. "We look forward to answering the members' questions and explaining the enhancements we have put in place. That includes new operational leadership, best practices in our laboratories, continuing and constructive engagement with our regulators and ongoing communications with physicians and our patients."

Theranos became the focus of a class action lawsuit in May accusing the company of consumer fraud.

Twitter: @JELagasse

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