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  1. Regulatory News, Stories, and Features

Patient Advocacy Lies at Heart of FDA Agent’s Theranos Case


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By: Pat El-Hinnawy and Erin Peabody 

As patients seek legal recourse for harms they suffered at the hands of fraudulent start-up Theranos, there’s one FDA criminal investigator who understands their pain—perhaps better than anyone. 

You might say George Scavdis put his personal life on hold for six years. From mid-2016 until the spring of 2022, the FDA special agent was consumed with one task: learning as much as he could about the patients behind the Theranos scandal.  

While the world was becoming intimately familiar with the leading figures of the case—Theranos founder Elizabeth Holmes and her business partner Ramesh Balwani—Special Agent Scavdis was laser-focused on the lesser-known actors in the story: the patients and doctors who’d put their trust in the company’s much-celebrated blood test. According to Theranos representatives, its breakthrough medical device could conduct over a thousand tests for a broad range of diseases and conditions—including cancer, diabetes, and HIV—while requiring only a few drops of a patient’s blood.   

For some, that blood test eventually delivered difficult, if not, devastating health news. For other patients, its results translated into agonizing medical decisions. But perhaps most disturbing of all for those impacted was finding out, weeks, months, and even years later, that the test they had relied on was not only inaccurate—its founders knew it was bogus and had promoted it anyway. 

Scavdis, who works for the FDA’s Office of Criminal Investigations, also known as OCI, now serves as Special Agent-in-Charge of OCI’s Metro Washington Field Office.  He spent six years of his career seeking out patients and healthcare providers and listening to their stories. The powerful testimonies he documented, along with other doggedly tracked-down details, helped paint a crystal-clear picture of how Theranos misled, and in some cases, physically or emotionally harmed, an untold number of U.S. patients. His persistence to connect with these individuals, even when reluctant to get involved in such a high-profile case, helped build the government’s argument against Holmes and Balwani to eventually put them behind bars. 

The FDA’s Office of Criminal Investigations, or OCI 

Scavdis played an integral role in the Theranos case because it is the FDA’s mission, as well as its regulatory authority and mandate, to ensure the safety and efficacy of all medical device products sold and used in this country. The criminal investigations office, staffed with 215 special agents strategically positioned in offices across the United States and Europe, has primary responsibility for all criminal investigations conducted by the FDA. This includes any threats to Americans that involve foods, drugs, vaccines, medical devices, and other medical products. 

A Mountain of Data 

Over the years, Scavdis would come to spend a great deal of time on the Theranos case scrutinizing records—especially those belonging to a government database containing more than six million documents. There, he tediously located and gathered Theranos test results and patient records, cross-referenced them with Theranos customer complaint logs, internal Theranos emails, and emails from prescribing physicians—all so he could build a list of potential witnesses. Ultimately, Scavdis identified more than 70 doctors and patients to interview, many of whom would contribute to the deeply troubling narrative regarding Theranos’ devices and patient harm.   

“Calling the patients out of the blue and asking them to relive perhaps the most painful or scariest times of their lives was hard,” Scavdis recalls, “it felt cruel. But hearing their stories is what drove us to get those patients some measure of justice.”   

Some doctors and patients who spoke to the special agent expressed hope that the fraudulent motives eventually attributed to Theranos were wrong or misplaced. They liked that Theranos products were cheap and available, compared to similar products, and that there was competition in the marketplace. To those skeptics, Scavdis would often gently counter: “Can I ask you to concede that I may have facts that you don’t?”   

Patient Harm   

One of the most troubling patient stories that Scavdis would learn about was the case of a pregnant woman whose Theranos test indicated that she was miscarrying. Gratefully, she later learned, she was not. Another woman revealed to Scavdis the pain and fear she experienced when her Theranos blood test indicated that her life-threatening ectopic pregnancy had been dissolved when, in fact, it had not.    

Scavdis also spoke with a doctor so alarmed by a Theranos test’s highly abnormal results that he urged his patient to go directly to a nearby emergency room because he feared the individual was at serious risk for a heart attack. The hospital rushed tests of its own, using a different diagnostic method, and discovered, with much good news for the patient, that the individual’s results were well within the normal range.  

Scavdis delivered these and many other findings to the Department of Justice (DOJ) attorneys prosecuting the case. The FDA special agent, working closely with those who had suffered or were impacted negatively by the inept and error-prone medical device, was piling up proof of Theranos’ victims, as well as its schemes to defraud.       

The Holmes Trial and Verdict  

In September of 2021, Scavdis eventually relocated to San Jose to focus even more intently on his witnesses and be available for the Holmes trial. For four months, he interviewed new witnesses, reinterviewed old ones, and conferred with his partnering DOJ attorneys—up until the moment the Holmes’ defense team rested its case on December 8, 2021.  

Given the scope and poignancy of all his collected testimony, Scavdis would be the primary architect of a 300-slide PowerPoint presentation the government used during its closing argument against Holmes—a powerful and visual reminder to the jury of the patients, and their families and doctors, whose lives are at the heart of the case. 

For its part, the jury returned a verdict of guilty to Holmes on one count of conspiracy and three counts of wire fraud in connection to her scheme to defraud investors. Later, Balwani was also found guilty not only of defrauding investors, but also of defrauding Theranos patients, something Holmes had not been convicted of.  

“It was difficult after the Holmes verdict to look our patient witnesses in the eyes as we asked them to relive their experience, yet again, in the Balwani trial,” said Scavdis, “and not feel like we let them down when Holmes was acquitted on the patient counts.   

“But after the Balwani verdict, we felt like we were able to get justice for them and for all the patient victims. It was a big sense of relief.” 

Holmes and Balwani are currently serving sentences in federal prison thanks, in no small part, to FDA Special Agent-in-Charge George Scavdis. 

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