NEW YORK - Once called the world’s youngest female self-made billionaire, Elizabeth Holmes propagated a medical myth about the powers of testing and prevention. She was taken down by a newspaper reporter who revealed that her blood testing company, Theranos, was delivering inaccurate results, but the larger point of the saga is this: Even if her much-hyped testing device had worked, it probably wouldn’t have made the world appreciably healthier.
It was hard to know if the proprietary technology worked, but not so hard to ask whether there’s any evidence that more blood testing was what the world really needed.
In the new HBO documentary “The Inventor,” the notion of blood testing as panacea is presented as a given. This assumption underlies the filmmaker’s attempt to convince us that Holmes is not really such a bad person. (For a more serious but also dramatic treatment, read the writings of Wall Street Journal reporter John Carreyrou.)
The film focuses on the question of what’s wrong with Holmes, but the more interesting question is what was wrong with all those people who bought into her story — parts of which were downright preposterous.
It sounded reasonable enough at first when she proposed doing blood tests using a sample collected from a finger stick rather than puncturing a vein. She was vague about whether she’d come across a new idea for how to do this, or all she had was an idea of an idea. Given enough money, she might have come up with something.
But soon that idea morphed into the promise that her company’s technology could instantaneously perform hundreds of lab tests from a tiny droplet of blood using a machine so compact it could be deployed in the battlefield, or in every home. By the time Holmes delivered a TED talk in 2014, the promise had morphed into saving the world with a complete overhaul of global health care.
There, she told a story of how much she “loved” an uncle who died from skin cancer. “We see a world in which every person has access to actionable health information at the time it matters. A world in which no one has to say ‘if only I’d known sooner,’ a world in which no one has to say goodbye too soon,” she said, more or less suggesting that her device would end skin cancer deaths, and premature death more generally. (The talk has been removed from the TED site.)
She employed a conspiratorial tone, painting herself as a preventive medicine crusader going up against the medical establishment. While Holmes was crusading for the miracle of prevention, the medical establishment was facing sobering scientific data showing the harm of some campaigns for mass cancer screening. The imperfections of mammograms for breast cancer and PSA tests for prostate cancer had led some patients to get unnecessary treatments, sometimes losing their breasts or prostate glands.
Cancer blood tests are still in the testing stage. Johns Hopkins University cancer researcher Bert Vogelstein has published results of tests on a couple of so-called liquid biopsies — including one blood test that can pick up very early stage pancreatic cancer. But, as he explained to me some time ago, such tests shouldn’t be widely used unless they are extremely accurate. And even then, doctors have to be careful of over-treatment. Not all early cancers will ever spread; not all patients will be better off treated than untreated.
It wasn’t clear whether Holmes was implying such tests were ready for prime time and she would make them accessible, or that she’d secretly invented them. Either way it was grossly misleading.
In early 2015, Stanford medical professor John Ioannidis wrote about what he saw as “stealth science” at Theranos. When I called him recently he said that while there are a few good screening tests, such as pap smears for cervical cancer, the premise that more screenings will make us healthier is unfounded and could lead to more over-diagnosis.
Holmes’s promises had political appeal, with a vision of making health care a personal responsibility. “We can’t engage the individual in changing outcomes unless individuals have access to the information they need to do so,” she said in one talk. “The right to protect the health and well-being of every person … of those we love … is a basic human right.”
There’s a strong argument that health care is a human right, but what she suggested instead is the right to choose our own blood tests and interpret the results ourselves, and then if something comes up positive, well, it’s not so clear. She made all this sound very altruistic.
Of course, she didn’t clearly promote shoving the responsibility for health care back on patients, and that was part of her genius. As I pointed out in a column about attending her 2016 talk at a meeting of the American Association of Clinical Chemistry, she leaves out key information and encourages listeners to fill in the gaps with what they want to hear. (It’s a skill Donald Trump also employs.)
At the meeting, an audience member asked whether there was any evidence that giving healthy people more blood tests would result in better health. Holmes answered: “There are 9 million cases of undiagnosed diabetes.” There’s an innuendo here that her technology could do something for at least some of these people. Otherwise why would she say this?
And yet she had not improved tests for diabetes. As experts told me at the meeting, lack of cheaper tests is not the problem for diabetics. It’s lack of health care.
Ioannidis and his colleagues recently published a paper about other so-called unicorns in the medical field — startups valued at more than a billion dollars. “Many have similar problems with lack of evidence,” he said.
While early detection in medicine is hard, in business it’s much easier to catch pathology early.
Faye Flam is a Bloomberg columnist.