July 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
WASHINGTON – Palo Alto, California-based Theranos is now facing a new challenge from a United States Congressional Committee as federal lawmakers are demanding answers from the company on its lab practices and decision to void blood-testing data impacting tens of thousands of patients.
On June 30, the U.S. House of Representatives Committee on Energy and Commerce sent a letter to Elizabeth Holmes, Theranos’ chief executive officer, seeking information on the company’s failure to comply with federal clinical laboratory testing standards as well as the company’s decision to void two years’ worth of data sent to customers.
Although Theranos said that data only amounted to about 1 percent of blood tests, there were reportedly tens of thousands of corrected results sent to patients and doctors. So far there have been a few lawsuits filed against the company from customers who relied on the tests for health treatments. Theranos spokesperson Brooke Buchanan told BioSpace at the time that the lawsuits were without merit and the company “will vigorously defend itself against these claims.”
In its five-page letter to Theranos, federal lawmakers laid out all of the criticism Theranos has faced over the past year. The committee members, led by U.S. Rep. Frank Pallone Jr., a Democrat from New Jersey, gave Holmes and Theranos until July 14 to respond.
“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 lawmakers said in the letter.
The lawmakers are seeking information on how patients were notified about the voiding of the testing results, how the company determined no patients were adversely impacted by the decision to void, and how the company determined that the tens of thousands of tests it voided amounted to only 1 percent.
BioSpace reached out to Theranos this morning, but has not yet heard back. However, the company did provide an earlier response to Bloomberg, saying it plans to explain the improvements the company has made to its laboratory, which includes “new operational leadership, best practices in our laboratories, continuing and constructive engagement with our regulators and ongoing communications with physicians and our patients.”
Since late summer of 2015, Theranos has been under siege as more and more questions arose about the efficacy of its blood-testing technology. Those questions ultimately led the U.S. Center for Medicare and Medicaid to investigate the company’s Newark, Calif. blood testing laboratory where investigators found egregious practices. In a lightly redacted 45-page letter dated March 18 over those concerns, the CMMS repeatedly used the bold-texted phrase “the laboratory’s allegation of compliance is not credible and the evidence of correction is not acceptable.” The phrase is used to indicate how Theranos failed to meet federal Clinical Laboratory Improvement Amendments (CLIA) guidelines.
Theranos is also the subject of a criminal investigation by the U.S. Department of Justice with investigations centering on whether or not Theranos and its executives misled investors as to the efficacy of its blood-testing products.
Theranos’ troubles caused Walgreens to break ties with the company. In June, Walgreens announced it planned to close all 40 Theranos Wellness Centers at its stores in Arizona—a critical blow to Theranos as Walgreens was its biggest source of revenue.
“In light of the voiding of a number of test results, and as the Centers for Medicare and Medicaid Services (CMS) has rejected Theranos’ plan of correction and considers sanctions, we have carefully considered our relationship with Theranos and believe it is in our customers’ best interests to terminate our partnership,” Brad Fluegel, Walgreens’ chief health care commercial market development officer, said in a statement.
