He Regulated Medical Devices. His Wife Represented Their Makers.; The New York Times, August 20, 2024

 Christina Jewett, The New York Times; He Regulated Medical Devices. His Wife Represented Their Makers.

"For 15 years, Dr. Jeffrey E. Shuren was the federal official charged with ensuring the safety of a vast array of medical devices including artificial knees, breast implants and Covid tests.

When he announced in July that he would be retiring from the Food and Drug Administration later this year, Dr. Robert Califf, the agency’s commissioner, praised him for overseeing the approval of more novel devices last year than ever before in the nearly half-century history of the device division.

But the admiration for Dr. Shuren is far from universal. Consumer advocates see his tenure as marred by the approval of too many devices that harmed patients and by his own close ties to the $500 billion global device industry.

One connection stood out: While Dr. Shuren regulated the booming medical device industry, his wife, Allison W. Shuren, represented the interests of device makers as the co-leader of a team of lawyers at Arnold & Porter, one of Washington’s most powerful law firms."

The Epic Rise and Fall of Elizabeth Holmes; The New York Times, January 3, 2022

David Streitfeld. The New York Times; The Epic Rise and Fall of Elizabeth Holmes

In Silicon Valley’s world of make-believe, the philosophy of “fake it until you make it” finally gets its comeuppance

"Whenever anyone — a regulator, an investor, a reporter — wanted to know a little more about exactly how the Theranos machines functioned, the company cried “trade secrets.” The real secret, of course, was that Theranos didn’t have any trade secrets because its machines didn’t work. But her answer worked for a long time."

Review: 'The Inventor' is a coolly appalling portrait of Elizabeth Holmes and the Theranos scandal; The Los Angeles Times, March 14, 2019

Justin Chang, The Los Angeles Times;

Review: 'The Inventor' is a coolly appalling portrait of Elizabeth Holmes and the Theranos scandal

"As a quick glance at this week’s headlines will remind you — a staggering college admissions scandal, a wave of indictments in the cases of Paul Manafort and Jussie Smollett — we are living in deeply fraudulent times. But if there are few people or institutions worthy of our trust anymore, perhaps we can still trust that, eventually, Alex Gibney will get around to making sense of it all. Over the course of his unflagging, indispensable career he has churned out documentaries on Scientology and Enron, Lance Armstrong and Casino Jack — individual case studies in a rich and fascinating investigation of the American hustler at work.

 

Gibney approaches his subjects with the air of an appalled moralist and, increasingly, a grudging connoisseur. His clean, straightforward style, which usually combines smart talking heads, slick graphics and reams of meticulous data, is clearly galvanized by these charismatic individuals, who are pathological in their dishonesty and riveting in their chutzpah. And he is equally fascinated by the reactions, ranging from unquestioning belief to conflicted loyalty, that they foster among their followers and associates, who in many cases shielded them, at least for a while, from public discovery and censure.

 

“The Inventor: Out for Blood in Silicon Valley,” Gibney’s latest exercise in coolly measured outrage, is an engrossing companion piece to his other works in this vein. The subject of this HBO documentary is Elizabeth Holmes, the self-styled biotech visionary who dropped out of Stanford at age 19 and founded a company called Theranos, which promised to bring about a revolution in preventive medicine and personal healthcare. Its top-secret weapon was a compact machine called the Edison, which could purportedly run more than 200 individual tests from just a few drops of blood, obtained with just a prick of the finger.

 

Holmes’ vision of a brave new world — one in which anyone could stop by Walgreens and obtain a comprehensive, potentially life-saving snapshot of their health — proved tantalizing enough to raise more than $400 million and earned her a reputation as possibly the greatest inventor since, well, Thomas Edison. Her investors included Betsy DeVos, Rupert Murdoch and the Waltons; Henry Kissinger, George Shultz and James Mattis sat on her board of directors. But that was all before the Wall Street Journal’s John Carreyrou and other investigative journalists exposed glaring faults in the Edison’s design and sent the company’s $10-billion valuation spiraling down to nothing. Theranos dissolved in 2018, and Holmes and former company president Sunny Balwani were charged with conspiracy and fraud.

 

Full disclosure: As the son of a retired medical technologist who spent more than 30 years testing blood the traditional way, I approached “The Inventor” with great fascination and more than a little schadenfreude. The movie, for its part, seems both magnetized and repelled by its subject, a reaction that it will likely share with its audience. Gibney is perhaps overly fond of deploying intense, lingering close-ups of Holmes’ face and peering deep into her unnerving blue eyes (“She didn’t blink,” a former employee recalls). If the eyes are the windows to the soul, “The Inventor” just keeps looking and looking, as though uncertain whether or not its subject has one."