General James Mattis joined the Theranos board of directors in July 2013, a few months after retiring as head of US Central Command, and the first thing he had been trying to do for more than a year by that point was put Elizabeth Holmes’s fingerprick blood analyser into the hands of soldiers in Afghanistan. The device was called the Edison. It was meant to run hundreds of tests on a single drop of blood drawn from a finger. The reason it never reached a forward operating base was not a failed proficiency test, not a board revolt, and not a regulator at the FDA acting on its own. It was a lieutenant colonel at the US Army Medical Research and Materiel Command named David Shoemaker, who kept writing emails saying the device was not FDA compliant and would not be cleared for use on service members.
Shoemaker is the load-bearing figure in this story. Nothing else stopped the Edison. Not the board, which included two former secretaries of state, a former secretary of defense, and a former chairman of the Joint Chiefs of Naval Operations. Not Walgreens, which had agreed to deploy the device in retail pharmacies. Not the venture investors who had pushed the company to a valuation of around $9 billion. A regulatory officer in Maryland, three pay grades below Mattis, kept the device off the battlefield by refusing to let it pass without an FDA review that Theranos was never going to survive.
Mattis pushed for deployment from inside CENTCOM
Mattis met Holmes after a speech in San Francisco in 2011, and as he later testified at her criminal trial, she pricked his finger that night to show him what the machine claimed to do. He was, in his own words from the stand, instantly impressed. By 2012, while still in uniform as the four-star general commanding CENTCOM, Mattis was pressing the Army to procure and test the Edison in Afghanistan. Emails obtained by the Washington Post in 2015 showed him telling Holmes he was “kicking this plan into overdrive.”
The Army was less convinced. When Shoemaker, the Army’s regulatory expert on combat medicine, looked at what Theranos was proposing, he saw a device that had not been cleared by the FDA being prepared to run blood tests that would inform decisions about wounded soldiers. He raised the issue with the FDA in 2012. The FDA official who responded, whose name was later redacted from the released emails, wrote back that, in plain terms, Theranos was not FDA compliant.
Holmes wrote to Mattis. Mattis got angry at Shoemaker.
When Shoemaker’s pushback reached Holmes, she wrote to Mattis directly. The email is quoted in John Carreyrou’s Bad Blood. Shoemaker, she wrote, had communicated “blatantly false information” to regulators about Theranos and she would very much appreciate Mattis’s help in getting it corrected. Mattis forwarded the email to a colonel on his staff with a note demanding to know who Shoemaker was and what was going on.
Shoemaker held his line. He did agree to meet with Sunny Balwani, the Theranos chief operating officer, and lectured him on lab regulations, but he made clear that the scenario Theranos was proposing was out of the question without either CLIA certification at each deployment site or full FDA approval of the Edison as a medical device. A narrower compromise was eventually struck. Theranos was allowed to run anonymised leftover samples after the fact, comparing its results against the Army’s regular blood testing methods, but no service member would ever bleed into a Theranos cartridge in a way that affected their care.
That narrow comparison study is what kept the device off the battlefield. Mattis kept pushing. In one email later surfaced by reporters, he wrote that he had been trying to get this device tested in theatre legally and ethically, that the path looked relatively straightforward, and that they were a year into the effort and still not deployed. The field test he wanted never happened.
The Walgreens rollout went forward anyway
While the Army was quietly refusing to certify the Edison, Theranos was publicly succeeding everywhere else. In September 2013, the company opened its first retail testing location inside a Walgreens at 300 University Avenue in Palo Alto. By November, the partnership had expanded to Walgreens stores in the Phoenix metropolitan area. Customers walked in, gave a fingerprick, and walked out believing the future of medicine had arrived.
Almost none of those tests were actually run on an Edison. Internal records and trial testimony later showed that the vast majority of patient samples were diluted and run on commercial blood analysers made by Siemens, the same machines used by ordinary hospital labs. The fingerprick volumes were too small for those machines, so Theranos diluted the samples, which degraded the accuracy further.
The Edison itself, when used for VIP demonstrations at Theranos headquarters in Palo Alto, was running a hidden routine. Daniel Edlin, a former Theranos project manager, testified at the Holmes trial that the device had a demo app that suppressed failure messages and a “null protocol” that allowed it to be activated without actually analysing a sample. As John Carreyrou described to Marketplace, visitors had their finger pricked, the cartridge was loaded into the black box, and the moment they left the room a technician removed the sample and walked it to the lab, where it was run by hand or on a modified Siemens machine in a different building.
Why nobody on the board caught it
The Theranos board read like a State Department reunion. Henry Kissinger. George Shultz. William Perry. Sam Nunn. Gary Roughead. James Mattis. None of them had a background in medical diagnostics. Holmes had built a room of people who knew how power worked but did not know how a blood analyser worked. Mattis testified at trial that Holmes was his sole source of information about the company and that he never saw the underlying technical data on the Edison.
The endorsement chain went vertically. Mattis trusted Shultz. Shultz trusted Holmes. Investors trusted the board. Walgreens, as later reporting by the Wall Street Journal showed, had paid Johns Hopkins researchers to test the Edison in 2011 but Theranos never delivered a working device to them. Walgreens proceeded with the deal anyway.
The Tyler Shultz problem
George Shultz’s grandson Tyler joined Theranos as an intern in 2013 and stayed on as a research engineer. He spent eight months inside the lab. He watched Edison machines fail quality control checks. He watched data points get deleted from proficiency runs in a way Erika Cheung, his colleague, later called cherry-picking. In April 2014, he sent Holmes a long email outlining what he had seen. She forwarded it to Balwani, who replied to Tyler with a message that ridiculed his grasp of mathematics and lab science. Tyler quit the next day.
He tried to tell his grandfather. George Shultz, then ninety-three, sided with Holmes. He told Tyler that Holmes had explained the issues and that they were not real. The family fractured over it. Lawyers retained by Theranos followed Tyler. He was warned he would be financially destroyed if he spoke to a reporter, which he eventually did anyway.
How the deception lasted as long as it did
The Walgreens rollout began in September 2013. John Carreyrou’s first Wall Street Journal investigation appeared in October 2015. That is more than two years of public deployment, during which real patients received real test results that were sometimes wildly wrong. Some were told they had elevated prostate-specific antigen levels. Some were told they had abnormal calcium, potassium, or glucose readings that sent them to emergency rooms. After CMS inspectors arrived at the Newark laboratory in late 2015, Theranos was eventually forced to void or correct tens of thousands of test results from 2014 and 2015.
The deception survived because every layer of oversight assumed another layer was doing the work. Walgreens assumed the venture investors had done diagnostic due diligence. The investors assumed the board had. The board assumed the science was sound because Holmes said it was and because she had a Stanford pedigree, a Steve Jobs wardrobe, and the same baritone voice in every meeting.
Regulators were similarly outflanked. Theranos operated its lab under a CLIA certification, which covers clinical laboratory operations, rather than seeking full FDA approval for the Edison as a medical device. The company argued that its tests were laboratory-developed tests and therefore exempt from device review. That regulatory gap was the legal space the entire company lived inside. The only person in the federal apparatus who consistently refused to accept the framing was Shoemaker.
What Shoemaker did differently
Shoemaker is worth dwelling on, because he is the one official in this story who behaved the way the entire system was supposed to behave. He did not care that Holmes had been on the cover of Fortune. He did not care that Mattis was advocating internally for deployment. He looked at the regulatory file, saw that the Edison was a medical device that had not been cleared by the FDA, and refused to certify a path for it onto soldiers.
Holmes tried to go around him. She emailed Mattis and asked him to intervene with regulators. Mattis tried. The line held. Shoemaker eventually agreed to a narrower test of leftover anonymised samples, but he never agreed to put the Edison into the workflow of actual battlefield medicine. According to Spencer Ackerman’s reconstruction in Rolling Stone, when Shoemaker went to the FDA himself, the FDA showed up at Theranos’s office in 2012 for an inspection that Holmes treated as a personal attack.
Shoemaker, an Army lieutenant colonel with no political power, took on a four-star CENTCOM commander, the secretary of state’s social circle, and a billion-dollar company. He did it by writing emails that said the device was not FDA compliant and that the law was the law. The device never deployed. No service member ever bled into a Theranos cartridge in the field.
The fallout, and what was inside the box at the end
Theranos voided or corrected tens of thousands of test results in 2016. The Centers for Medicare and Medicaid Services revoked the Newark lab’s certification. Walgreens terminated the partnership and sued. The valuation collapsed to zero. The SEC charged Holmes and Balwani in 2018 with raising more than $700 million from investors through what it called an elaborate, years-long fraud.
Holmes was convicted in January 2022 on four counts of investor fraud and sentenced to 135 months at Federal Prison Camp Bryan in Texas, where she reported in May 2023. Balwani was convicted at a separate trial later in 2022 and sentenced to nearly thirteen years. Mattis testified at Holmes’s trial as a government witness. He told the court that, looking back, he was disappointed at the level of transparency from Holmes and that they had been deprived of fundamental issues.
The remaining Edison machines were boxed up and sent into evidence storage. Some sit in federal warehouses. Some were sold at liquidation auctions to laboratory scrap buyers who cracked them open out of curiosity. Inside, behind the sleek black casing and the proprietary cartridge slot, the engineering was modest. Off-the-shelf pumps. Repurposed pipettes. A robotic arm of the kind used in undergraduate chemistry labs. Nothing inside the box was ever going to run two hundred tests on a single drop of blood, and an Army lieutenant colonel in Maryland was the only person in the country who had bothered to say so before someone got hurt.
