Is consumer access to direct testing good or bad?
In April, Mark Cuban, the billionaire entrepreneur, Shark Tank investor, and owner of the Dallas Mavericks, all but broke the Internet when he fired off this trio of tweets to his some 3.5 million Twitter followers:
“If you can afford to have your blood tested for everything available, do it quarterly so you have a baseline of your own personal health”
Mark Cuban @mcuban April 1, 2015
“create your own personal health profile and history. It will help you and create a base of knowledge for your children, their children, etc”
Mark Cuban @mcuban April 1, 2015
‘ a big failing of medicine = we wait till we are sick to have our blood tested and compare the results to “comparable demographics” ‘Mark Cuban @mcuban April 1, 2015
Simply put, Cuban believes that the more data we have about ourselves, the healthier we will be. This view is shared by many, and it has helped spawn an entire industry of direct-to-consumer (DTC) laboratory tests that are marketed to people who aren’t necessarily ill or at risk of disease, but who are curious about their health or concerned about their risk for different disorders.
Self-testing, of course, isn’t anything new. Ever since the first home pregnancy test hit the shelves in the late 1970s, the demand for self-testing services has grown considerably. Today most of us can screen for everything from HIV to high cholesterol and assess our risk for diseases like colon cancer and Alzheimer’s without doctors’ orders — often, from the privacy of our own homes. Some — but not all — of these DTC tests have been cleared by the Food and Drug Administration (FDA), meaning they’re both safe and as accurate as the tests performed in a doctor’s office.
Growing numbers of people are not only ordering these tests but using them to monitor themselves instead of or in addition to an annual physical. Like Cuban, many are doing so far more often than currently recommended. The U.S. Preventive Services Task Force, for example, recommends that healthy people get checked for cholesterol only once every five years — not quarterly — unless a particular health condition suggests otherwise.
Proponents of frequent self-testing believe it gives patients more control over their health and may help in the early diagnosis of diseases. For many, it’s a way to track measures they want to regularly monitor, such as cholesterol or vitamin levels. For others, it’s a way to scan for warning signs of serious conditions like cancer, diabetes, and heart disease and take action as soon as, or even before, they develop.
Terry Finklea, who lives in Upper Arlington, Ohio, first decided to order his blood tests online and get them done at a local LabCorp after feeling “out of whack” even after his primary care physician issued him a clean bill of health.
Most labs provide your results accompanied by a reference range of what is considered “normal.” However, reference ranges are only a guide, and normal ranges can vary from lab to lab and from person to person. That means a lab result that falls outside a reference range may still be normal for you. On the other hand, a lab value that falls within the reference range may not necessarily indicate that everything is okay; there is a small chance that there is an unexpected problem.
By monitoring his blood, Finklea noticed that a particular lab value had steadily dropped over time, though it was still within the normal reference range. This prompted Finklea to see an endocrinologist, who then diagnosed him with and treated him for a hormonal deficiency. He now gets his blood drawn every three months at a local LabCorp. “It’s a way to take more control over my health,” he says.
For Finklea, a major advantage of ordering the blood tests is cost. “It’s significantly less than if my doctor ordered the tests. And that’s not counting the cost of the doctor visit itself,” he says. Costs range from less than $100 to more than $1,000, depending on the type or groups of tests ordered; Finklea says he pays $79 for “a full work-up” that would usually cost him between $300 and $400.
The other advantage is convenience.
“I choose the tests I want online. I print out an order. I get my blood drawn at a lab by my house — the same one I’d go to if the doctor ordered the labs. I get my results online, usually within 24 hours,” he says.
More data is always better, right?
Not everyone agrees that frequent testing is a good thing.
Within hours of Cuban’s tweet, medical experts from around the globe weighed in, an overwhelming number of whom were against his recommendations. And later that month, a poll of more than 1,100 doctors, conducted on SERMO, an anonymous social network for doctors, showed that 87 percent opposed Cuban’s recommendations, while only 13 percent were in favor.
Randy Wexler, an associate professor of family medicine and vice chair of clinical affairs at The Ohio State University in Columbus, says quarterly testing is excessive.
“Unless you’re screening for something specific, there is no evidence to recommend bloodwork at such frequency, and, on the contrary, it can be harmful,” he explains.
He’s concerned about the idea of self-testing in general and believes that laboratory tests should be interpreted by a doctor and as part of a broader health profile. A lab value alone, without taking into consideration family history and other risk factors, “means nothing,” Wexler says.
Wexler says he has several patients who order their own labs for cost reasons, but the tests are ordered in consultation with a doctor and are interpreted by a doctor. Failing to work with a doctor, he says, puts patients at risk for false positives — when test results incorrectly indicate you have a particular medical condition when you do not — or false negatives — test results that incorrectly indicate you don’t have a certain medical condition when, in fact, you do.
Take, for instance, the prostate-specific antigen (PSA) test. Until recently, most doctors encouraged annual PSA screening for all men starting at age 50, or between ages 40 and 45 for men at high risk of developing the disease. PSA is a protein made by the prostate gland that may signal prostate cancer. However, the usefulness of PSA-testing as a prostate cancer screening tool remains under debate. This is because most men who have an increased PSA level do not actually have prostate cancer; their PSA is elevated for other reasons.
“False-positive results can not only cause emotional distress but can lead to further and more invasive testing and treatments — both of which can cause serious harm,” says Jim Williams, a primary care physician in Washington, D.C. He’s just as worried about false negatives, which he says can lead to “false reassurance that everything is okay.”
But while concerns about testing continue to emerge, so do companies interested in competing in the market. 23andMe recently relaunched its DTC genetic test that provides information on carrier status, telling parents if they carry genetic mutations that may develop into disease in their children. The spit-kit test has information on 36 diseases, such as cystic fibrosis and sickle cell anemia, and sells for $199. The company’s previous test, which was shut down by the FDA in November 2013, tested for 240 health conditions. Company officials say they are continuing to work with the FDA and hope to get approval to provide information on health risks in the future.
Taking a hybrid approach, Seattle-based Arivale is offering DTC testing combined with health coaching. For $2,000 a year, people who sign on for Arivale services receive a one-time full genomic sequence; blood, saliva, and stool-sample tests; and a Fitbit to record daily data. The tests are ordered by physicians affiliated with Arivale.
Each client is also connected with an Arivale coach, a registered dietitian nutritionist who works with the client on a regular basis to translate the data generated by the tests and offers personalized recommendations, such as which exercise is best to engage in, based on your genetics, or which kind of food to eat, based on your gut health. All data is reviewed by physicians as well, and if abnormalities are detected, clients are notified that they should share the findings with their primary care doctor.
Arivale, which is currently available only in Seattle but has plans to expand to San Francisco and additional cities in 2016, offers “more than just a series of tests,” says co-founder Lee Hood, because it’s pairing guidance on which tests are appropriate to order with coaches who can help clients make sense of the results and their meaning for current or future health conditions. The idea, notes Hood, is to offer insight, “which, if acted on, will lead to improved wellness or avoidance of disease.”
Do you monitor your weight, track your calories, or count your steps? If you do, you’re in good company: According to one study, 7 out of 10 adults in the U.S. track a health indicator for themselves or for a loved one. Health trackers, such as Fitbit, Jawbone Up, and Basis, make it easy to follow your activity, calories burned, and quality of sleep. Other trackers, such as the Oura ring, monitor how fast your heart is beating and how much oxygen is in your blood.
People who ascribe to the Quantified Self movement take that monitoring a bit further. Some track the quality of air or wear EEGs.
Larry Smarr, an astrophysicist turned computer programmer, is a professor at the University of California, San Diego. He is also one of the first people to quantify the daily rhythms of his body to such an extent that The Atlantic dubbed him “The Measured Man.” Eager to lose a few pounds, Smarr began to self-quantify by tracking his food intake and exercise. He soon moved beyond activity tracking and now regularly tracks his sleep patterns, has his blood drawn for laboratory tests as often as eight times a year, and regularly sends in stool samples for analysis. By merging other data sets, increasing numbers of people like Smarr are creating a comprehensive view of their quantified selves.