The blood testing start-up Theranos came under intense media scrutiny back in October. Now, the Wall Street Journal reports that U.S. health regulators are investigating complaints about the company’s lab and research practices.
The newspaper has discovered that complaints made by two former employees are being investigated. The first was filed in September to the Centers for Medicare and Medicaid Services, and explains that the company’s management continued testing its technology despite concerns over “major stability, precision and accuracy” issues with its devices. The second was filed to the Food and Drug Administration just this month, explaining that an application for FDA approval submitted last year contained breaches of research protocol.
In the complaint to CMS, the former lab employee alleged that Theranos managers were made aware of accuracy problems with its Edison devices in 2013 and 2014 but pressured lab employees to keep processing patient samples without taking corrective actions...
The complaint to the FDA alleged that Theranos hadn’t fully assembled the proprietary machines used for [its] herpes study when the experiments began. The former employee also alleged that the company underreported the rate at which the machines broke down during the study.
The newspaper claims to have seen copies of both complaints. It also claims that FDA investigators have interviewed the ex-employee who submitted the complaint, while the Centers for Medicare and Medicaid Services has inspected the Theranos labs as part of a scheduled audit. However, both regualtors haven’t issued any statements about the investigations.
For its part, Theranos— which is valued at $9 billion—claims not to have seen the complaints. Speaking to the Journal, Theranos spokesperson Brooke Buchanan explained:
“[W]e have no basis to evaluate what is in it or even if a complaint has been filed... Agencies have a process for evaluating complaints, and many complaints are not substantiated. We trust our regulators to properly investigate any complaints, and we look forward to continuing our strong and productive relationships with them.”
The complaints and investigation follow claims made by WSJ reporter John Carreyrou about the legitimacy of the Theranos technology. As Gizmodo’s George Dvorsky explained in October:
Theranos is having to rely on diagnostic machines manufactured by other companies, such as Siemens, and that its own custom-built Edison machines are churning out dramatically different results than those produced by traditional equipment. What’s more, and as the company has previously conceded, some of its tests still require full blood draws.
Carreyrou also claims that Theranos may have conducted its own proficiency testing, which is an industry no-no. In defense, Theranos says it performed the tests properly—a claim that has been contradicted by former employees.
Theranos CEO Elizabeth Holmes, pictured above, has called the WSJ article “false” and “misleading.” Her company has since agreed to publish data about its experiments. But with fresh complaints about the start-up surfacing, it seems it may have more to do to convince authorities and the public alike of the quality of its work.
Image by AP