One aspect of the multidimensional mess that is the Theranos story is the company's leveraging of the Do-It-Yourself ethos to promote its product. Theranos provides consumers with a menu of over 200 low-cost diagnostic blood tests for any array of ailments and diseases.
Here's the company's founder, Elizabeth Holmes, at TEDMED in 2014, lacing her stem-winder of a presentation with the ideals of patient self-empowerment.
“My own life’s work in building Theranos is to redefine the paradigm of diagnosis away from one in which people have to present with a symptom in order to get access to information about their bodies," she said, "to one in which every person, no matter how much money they have or where they live, has access to actionable health information at the time it matters.”
She also pitched the crowd an absurdity:
"(T)oday, I can go buy a deadly, exotic animal, a venomous viper, a military truck or armored vehicle. I can buy a tank ... but I can't order a blood-based pregnancy test, or an allergy test. Because that could be dangerous."
Theranos is currently waiting for the Centers for Medicare & Medicaid Services to render a final decision on whether it will lose its license to operate its labs. But for now the company still does tests at its wellness centers in dozens of Walgreens and other locations in Arizona, plus one in California.
Theranos isn't the only company offering blood tests to the worried well. WellnessFX, for instance, has a partnership with Quest Diagnostics, and consumers in all but seven states can use the company's website to order their own tests online.
Like Theranos, WellnessFX has similarly baked in the ideals of patient access and independence.
"A lot of the data that can be used to help understand what is best for the patient, historically that's always been the clipboard that's been turned around facing the physician... and never really been shown to the patient," said WellnessFX cofounder Brent Vaughan in a 2013 promotional video. "Because there's always been this belief that patients can't understand or they don't want to understand this information."
A Growing Trend
Last year, health diagnostics behemoth LabCorp dipped a toe in the DIY waters by allowing Arizona consumers to order their own tests. Labcorp CEO David King said in an email the company's market research shows a "significant percentage" of consumers are interested in initiating tests on their own. The company plans to expand the service into other states later this year.
"As consumers bear more of the cost of health care out of pocket, they should be, and are becoming increasingly engaged in managing their healthcare," King said. "We absolutely support them in doing so."
Last April, Arizona enacted a law -- pushed by Theranos -- that allowed consumers to order their own tests. The bill passed in the House 60 to 0 and the Senate 26 to 2. Democrat Steve Farley was one of the no votes. He isn't surprised at Theranos' unraveling.
"Really what we were being asked to do in that bill was to allow our constituents in Arizona to become beta testers, and use their own bodies as the tool of that beta testing," he said. (Theranos declined to comment.)
The debate over cutting doctors out of the diagnostic loop has been going on a long time. Some academics have been vocal about their reservations. Dr. Norman Paradis, a professor of medicine at Dartmouth who has consulted for diagnostic startups, said the model of offering a wide assortment of tests -- as Theranos does -- is a recipe for disaster.
“If you simply run medical tests in large numbers of people who don’t have the signs and symptoms of a certain disease, then many of the results you get will be false positives,” he said.
And those patients could then wind up going further down the rabbit hole of more invasive, potentially harmful tests and treatment.
Paradis said getting medical students and even residents to appropriately order tests is difficult enough. “So if it’s difficult for them, it’s even harder for the layperson. “
Dr. H. Gilbert Welch, the author of several books on the topic of overdiagnosis, thinks getting your own blood tests is part of the larger negative trend of testing people who aren’t really sick.
"I’m afraid there's a growing sense the path to health is through testing," he said. "But you don’t test yourself to health. Health is much more about how you move, what you eat and finding joy and purpose in life.”
WellnessFX has taken concerns about false positives into account, said Dr. Murdoc Khalegi, its medical director. He said the company works with physicians to make sure the tests it offers are not susceptible to inaccurate results.
"We work very hard to [offer tests] that are something a consumer can understand, like having elevated cholesterol or blood sugar," Khalegi said. "We encourage all of our results to be shared with physicians. But to restrict people from even having that information, which is the way it currently exists in some settings, would be unfortunate. People should be aware if they have certain health risks."
The Center for Democracy & Technology's Michelle De Mooy, who has worked on privacy and transparency issues in health care, dismisses the argument that patients can't make knowledgeable decisions about when to get tested. She said the issue of false positives is "pretty reasonably addressed" with warnings.
Both she and Khalegi point to the high cost of health care as one reason to enable easier access to diagnostic tests. High deductibles and lack of access to transportation or child care are reasons people might choose to get tests in the most efficient, least time-consuming way possible.
"The economic disparity question is one that the health care establishment tends to gloss over," she said.
A Vegan Gets Tested
Despite being asymptomatic, last year, Amy, who lives in Santa Cruz, California, went online to order her own test for anemia. (She didn't want her last name used for reasons of privacy.) The U.S. Preventive Services Task Force has no opinion on testing for iron-deficiency anemia among those who are asymptomatic. But Amy's fellow vegans had convinced her to get tested because cutting out meat and dairy can increase the risk of iron deficiency.
Because of a high deductible and bad experiences with insurance companies, Amy didn't want to go through her insurer.
Her iron level came back low. But rather than take action on her own, she went to a doctor, to whom she mentioned having donated blood a week before the test. Amy hadn't known this would deplete her iron. And because her other numbers were fine, her doctor told her not to worry.
"As a layperson I wouldn’t understand that," Amy said.
The whole experience -- the blood draw notwithstanding -- was painless.
"I liked being able to answer my own questions and to go to the site and pick which things I was curious about. I like being able to do it independently, since I don’t have a regular general practitioner I go to."
In some ways Amy fits the profile that both advocates and opponents of self-testing point to: She had no symptoms of anemia and got a test that wound up being unnecessary. But she also had a psychological need to know and a financial need to pursue that cheaply.
Dr. Murdoc of WellnessFX said that while he defers to official guidelines, as a vegan, Amy probably did the right thing.
"It's a very cheap blood test," he said.
Note: This post was corrected to reflect updated recommendations from the U.S. Preventive Services Task Force on testing for iron-deficiency anemia. Originally, the story said the task force recommended testing in asymptomatic women and small children. But in September 2015 the USPSTF concluded "that the current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency anemia" in both pregnant women and children ages 6 to 24 months.
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