Theranos hires compliance execs
PALO ALTO — After getting hit with potentially crippling sanctions earlier this month, blood-testing company Theranos on Thursday tried to clean up its image with the appointment of two new executives focused on quality and compliance.
The beleaguered company announced the addition of Dave Wurtz as regulatory and quality vice president and Daniel Guggenheim as chief compliance officer. Additionally, the firm is creating a new compliance and quality committee to advise executives and board members.
But Theranos declined to offer specifics on how the new hires and the committee will tackle the multitude of problems
the company faces — such as the impending closure of its Newark lab.
“Theranos is committed to meeting the highest standards in its compliance practices,” Guggenheim wrote in a company news release. “I am eager to start to build on the foundation that Theranos is making to be a best-in-class health care company.”
Earlier this month U.S. regulators announced plans to revoke Theranos’ license to operate its Newark lab and ban founder and CEO Elizabeth Holmes from the blood-testing business for at least two years — sanctions that go into effect 60 days from their date of issuance, unless Theranos appeals.
Trouble first started for the company in October when The Wall Street Journal questioned the reliability of Theranos’ signature finger-prick blood tests.
While Theranos has indicated it plans to solve the issues raised by regulators, and do so under Holmes’ continued leadership, the sanctions came as a major blow and have left some experts wondering whether the company’s demise is sealed. Meanwhile, the Department of Justice has launched a criminal investigation into Theranos, and the company faces multiple lawsuits in federal court. Theranos also lost a key partner when Walgreens recently severed ties.
But with Thursday’s announcement, Theranos attempted to project a picture of a company moving forward. Wurtz’s new job duties will include marketing new products and obtaining FDA clearances, according to a news release.
Before joining Theranos, Wurtz was the senior director of regulatory, quality and compliance at global life sciences company ThermoFisher Scientific. Guggenheim was assistant general counsel of regulatory law for San Francisco-based health care company McKesson.
Jeffrey Gibbs, a Washington, D.C., attorney who advises medical device companies and pharmacies, said bringing in new people and changing corporate culture often are positive steps for companies struggling with the types of regulatory issues Theranos faces.
“I wouldn’t necessarily dismiss it as window dressing or PR,” Gibbs said.
Holmes also has a chance to rewrite the public narrative about her company during her scheduled Aug. 1 appearance at the American Association for Clinical Chemistry’s annual meeting in Philadelphia.
Despite the controversy swirling around the company, Theranos still has its supporters, including board member Dr. William Foege. In an op-ed published by The Hill this week, Foege expressed confidence in the company’s ability to grow under Holmes’ leadership.
Foege wrote that he was part of a group of scientists that visited Theranos’ headquarters this year and inspected the company’s data, technology and reports — even experiencing the finger-prick blood tests for themselves.
“Initially skeptical, that group of scientists came to realize the tremendous promise of Theranos’ technologies,” Foege wrote.
He added: “In my opinion, the very foundation of Theranos’ inventions — and its hundreds of patents — is credible. The company’s intellectual property is clearly robust, and many potential partners still request meetings to learn more about the technologies. Under the leadership of Elizabeth Holmes, the company will continue to grow and develop the business. Small-sample testing is as inevitable as the shrinking of computers from room-size machines to the tiny footprint of a smartphone.”