As blood testing startup Theranos works to remedy severe deficiencies in its lab practices, new details have emerged about the extent to which the company has put people’s lives in danger. According to an unreleased report obtained by The Wall Street Journal, the company performed an important blood test on 81 individuals despite erratic results.
The federal report hasn’t been made available to the public, but WSJ reporters have spoken to people who are familiar with it. They claim that Theranos ran an important hematology blood test on over 80 people during a six-month span from April to September 2015 despite getting erratic results from quality-control checks that were meant to ensure the test’s accuracy.
The new report is supposedly more detailed than the January 2016 summary letter that followed a federal inspection of Theranos’s lab in Newark, California, led by the by the federal Centers for Medicare and Medicaid Services (CMS). The feds cited deficient practices in five categories, saying the company was putting patient health and safety and jeopardy. The new report expands on these accusations.
The lab test in question is a hematology test called “prothrombin time” that measures the length of time it takes blood to clot. It’s an important step in the treatment of patients who are at risk of strokes or who have blood disorders. Failure to properly perform hematology tests can be hazardous for patients who are taking blood thinners, such as wafarin (which goes under the tradename Coumadin). Too much of these blood thinners can cause fatal bleeding, and too little can leave patients vulnerable to clots and strokes.
Theranos “ignored quality-control results for the blood-clotting test that fell short of its own criteria,” reported the WSJ. Lab technicians at Theranos apparently deviated from the typical result by more than two standard deviations. (Most labs use the two-standard deviation criteria but no more.) A person familiar with the report told the WSJ that there were typically up to seven quality-control failures in a single day.
An expert cited by the WSJ said that doctors should disregard results from patients who received the blood-clotting tests from Theranos, saying “Those results are not worth anything.”
Theranos has already contacted potentially affected patients. CMS is currently reviewing a formal plan of correction submitted by Theranos last month. In the meantime, the beleaguered company is asking CMS not to publicly release inspection report on grounds that it would “compromise Theranos trade secrets.” Regardless, details reported by WSJ make it sound like the company was even more cavalier than we previously thought.
Update: In an emailed statement to Gizmodo, Theranos representatives said that, “We have conducted assessments to identify any patients affected or having the potential to be affected by the issues identified by CMS, and we have no reason to believe that these issues have affected patients’ health,” adding that, “At its heart, the CMS report is about people and processes in one Theranos lab in the past, and does not reflect the current state of that lab.”