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Trump’s pick for defense secretary went to the mat for the troubled blood-testing company Theranos

General James Mattis has been confirmed as secretary of defense (Video: Jenny Starrs/The Washington Post, Photo: Evan Vucci/The Washington Post)

Retired Marine Gen. James N. Mattis, reportedly President-elect Donald Trump's pick for secretary of defense, had a long military career, leading the U.S. Central Command before he retired in 2013. But a series of emails obtained by The Post last year revealed that, in a lesser-known incident late in his military tenure, Mattis took the unusual step of personally pushing for a start-up company — the controversial blood-testing Theranos — to land a deal for a military field test.

In 2012, Theranos — which has since had a long and tortuous fall from Silicon Valley darling to cautionary tale — was a secretive blood-testing company with politically connected board members.  Mattis first met Theranos chief executive Elizabeth Holmes in 2011 at a Marine Memorial event, a Theranos spokeswoman told The Post.

The emails revealed Mattis's interest in the start-up's blood-testing technology and the personal actions he took to try and push its technology into a field test in Afghanistan. Theranos promised to revolutionize blood testing by performing rapid tests on small volumes of blood, using a closely held technology.

E-mails reveal concerns about Theranos’s FDA compliance date back years

In June 2012, Holmes emailed Gen. Mattis, attaching a memo about Theranos's regulatory certifications. The four-star Marine general was busy overseeing the war in Afghanistan, but he responded promptly.

“I’ve met with my various folks and we’re kicking this into overdrive to try to field your lab in the near term,” Mattis wrote to Holmes in June 2012. "Please don't hesitate to call me or to send an email if you sense that we need to talk."

“Again, my thanks for what you're doing and for your willingness to work with us on this," he wrote. "I’m convinced that your invention will be a game-changer for us and I want it to be given the opportunity for a demonstration in-theater soonest.”

Internal military emails reveal that to follow up, Mattis personally called a major general at Fort Detrick — the home of the U.S. Army Medical Research and Materiel Command, which oversees and executes medical research.

During that month, Lt. Col. David Shoemaker, a military regulatory expert, wrote to an official at the Food and Drug Administration with questions about the company's regulatory strategy. The FDA official, whose identity was redacted from the emails, wrote that "bottom line, Theranos is not FDA compliant. ... We will be following up with them and recommending a path forward so that they come into compliance."

Recently, Theranos has run into a slew of regulatory issues. Last fall, Food and Drug Administration inspectors issued a report citing the company for using an unapproved medical device — its nanotainers — for small volume blood collection. Earlier this year, federal regulators from the Centers for Medicare and Medicaid Services flagged numerous “deficient practices” at the company’s Newark, Calif., laboratory, including some that were deemed potentially harmful to patients. Those problems led to sanctions, including a two-year ban on Holmes owning or operating a clinical laboratory, which the company is now appealing. But in October, Theranos announced it has decided to shutter its clinical laboratories and wellness centers and lay off 340 employees.

Troubled Theranos hits another wall as Zika test withdrawn

Mattis's eagerness to deploy the technology was known and noticed at lower ranks. Near the end of the month, Shoemaker wrote another email to an undisclosed recipient: "The Theranos issue has taken on quite the life of its own within the Army. General Mattis who is the 4-star general in charge of Central Command ... wants to see the Theranos device put into Afghanistan."

In early August, Holmes wrote directly to Mattis, complaining about the military regulatory review of her technology and accusing Shoemaker of misrepresenting her technology.

“I know how incredibly busy you are but thought it was the right thing to let you know the following,” Holmes wrote.

She complained that the military had "communicated blatantly false information about our company, indicating that we were acting in violation of FDA and CMS law, which we have never done and of course would never do."

She requested that he intervene.

"Since this misinformation came from within DoD, it will be invaluable if this information is formally corrected by the right people in DoD," Holmes wrote.

Mattis was quick to forward that email internally, with frustration.

“I have tried to get this device tested in theater asap, legally and ethically,” Mattis wrote. “This appears to be relatively straight-forward yet we’re a year into this and not yet deployed.”

Shortly after, Shoemaker and others traveled to meet with Mattis, according to the emails.

"The meeting with GEN Mattis lasted about 15 minutes and went okay," Shoemaker wrote. "He wants to see the side-by-side comparison study (theranos vs. current lab testing) done in theater asap."

Under siege, Theranos introduces a new technology

Shoemaker added that an unnamed person who was sent to the meeting on behalf of FDA "lent additional credibility" to the military's view that Theranos "was not compliant."

The issue doesn't appear to have ended there. In November, Col. Kent Kester wrote in an email that Mattis was pushing the technology, but it didn't have proper regulatory clearances.

He went on to say that it appeared "there is an intentional effort to short-cut a variety of processes necessary prior to fielding" and added that the medical staff at the U.S. Central Command "feel caught in the middle of something that feels quite political."

Then, in April of 2013, Shoemaker received an email from an unnamed person in the military, noting that the company had caught the attention of the Navy surgeon general.

"It seems Theranos has very good lobbyists," the person wrote to Shoemaker. The person wrote that Rear Adm. Bruce Doll "wants the company to understand that there is a process, and that we must do things by the book. It's not exactly clear what Theranos wants, but it is most likely to get their mystery device into the acquisition/Decision Gate process."

After retiring from the military, Mattis joined the board of the beleaguered blood testing company, which has been found to have severe regulatory compliance problems. Theranos has also announced it is laying off 340 employees, shutting down its clinical laboratory and wellness centers, and now faces a slew of lawsuits from patients, investors and a former business partner.

Shortly after he retired in 2013, Mattis asked a Defense Department ethics official about future employment with Theranos.

“Absent additional information regarding your personal or substantial participation in potential procurement of the Afghanistan pilot test of the Theranos device ... I further advise you not to represent Theranos before the DoD [Department of Defense] and DON [Department of the Navy] on that particular matter for the lifetime of the matter,” Robert D. Hogue, counsel for the Marine Corps commandant, wrote to Mattis.

Mattis serves on the company's board — a role that may be reevaluated if he becomes secretary of defense.