Consumerizing medicine: Are patient-initiated blood tests the future?

 

pink blood

The traditional model of health care has always been pretty linear: 1) observe your symptoms; 2) schedule a visit with your doctor; 3) meet with your doctor, answer questions, possibly have bloodwork or other testing; 4) follow your doctor’s advice.

But what if by the time you see the doctor, it’s too late to head off a serious medical problem? What if your doctor orders a blood test, but the closest lab is a 45-minute bus ride away, will charge a significant co-pay and closes at 5 p.m.?

The biomedical technology company Theranos has set out to upend this traditional model, simplifying the blood-testing process and giving individuals more control. The company’s goal is to establish wellness centers within five miles of every American, where anyone can order from a menu of blood tests with or without a doctor’s order. Walgreens already has 21 operating centers.

Costs are a fraction of what competitors charge: a cholesterol test will run you about $2.99, and a comprehensive reproductive health assessment is an affordable $49.95. A few drops of blood are collected with a finger prick, stored in a “nanocontainer” and shipped to a nearby Theranos lab for analysis. An email summary of the test results is ready within hours. Though Theranos is technically outside of FDA jurisdiction, at least for now, it has voluntarily applied for FDA approval.

In theory, this cheap, accessible model will allow patients to track their own health data at frequent intervals and counteract worrisome trends. “It’s classic disruptive technology,” says Michael Docktor, MD, Boston Children’s Clinical Director of Innovation and Director of Clinical Mobile Solutions. “And I’m a huge believer in patient empowerment.”

Docktor sees patient-initiated testing as a way to educate patients and involve them in their health care. He believes that reliable, important and actionable data spur patients to seek medical help from professionals when necessary. While he does not foresee Theranos becoming mainstream anytime soon, Docktor does predict we will see more and more similar companies in the future.

“There’s a tsunami coming with the commercialization of health care,” he says.

Theranos CEO Elizabeth Holmes believes access to one’s own medical information is a basic human right:

Quality Assurance

By focusing on the consumer experience, Theranos has a lot in common with the likes of Uber, AirBnB and PayPal: all circumvent traditional institutions. Theranos has kept quiet about the details of its technology, and this veil of secrecy has many in the medical field skeptical. A recent New Yorker article points out that “the company has published little data in peer-reviewed journals describing how its devices work or attesting to the quality of the results.”

A similar quality question has troubled the genetic testing company 23andMe, which provides consumers with “ancestry-related genetic reports and un-interpreted raw genetic data” from blood samples. The company originally included a health report with potential implications of the genetic data, but the FDA put a stop to that late last year, concerned that consumers would not know how to handle certain information (for example, learning they have a genetic variant that has been associated with cancer). An article in The New England Journal of Medicine goes further, claiming that even as raw data, “genomic information can be misleading — or just plain wrong — and could cause more harm than good in health care settings.”

Catherine Brownstein, PhD, of the Division of Genetics and Genomics at Boston Children’s Hospital, agrees. “I’m all for patient empowerment,” she says, “but if you call something a ‘breast cancer risk test,’ and it only covers the three most common mutations, not the entire gene, then that can be falsely reassuring and potentially harmful. It’s false advertising, even if the fine print explains it all.”

But let’s assume the Theranos and 23andMe technologies are completely accurate and reliable. Can we handle the truth when there is no clinician involved?

Mark Kellogg, PhD, associate director of chemistry in Boston Children’s Department of Laboratory Medicine, firmly believes that patients should not be presented with raw laboratory data before meeting with a provider. “They need to get the results in context with an explanation, not just a list of numbers,” he says. Often, patients will see a result flagged as “high” or “low,” and become pre-maturely anxious. “In many cases, that flag is for a result that is just outside the limits of normal and unlikely to be of any clinical significance,” says Kellogg. An accurate reading, he says, requires skill and a thorough review of the patient’s history and previous lab results.

Brownstein has other logistical concerns. If a test reveals an abnormality “of unknown significance,” how is this reported? “What is the responsibility to the patients? What are the required next steps?” she asks. “What if something is discovered to be wrong, years later?” All of these questions, says Brownstein, “require protocols and infrastructure.”

The cost for 23andMe genetic testing is not currently covered by health insurance, but Theranos bloodwork is. (Committed to low prices, the company maintains that it will never charge more than half of the Medicaid reimbursement rate for any test.)

Will patient-initiated testing become formally incorporated into the traditional health care model?

Will Theranos’s shockingly low prices encourage too much testing, or exemplify equity in health care? Will people understand how to proceed with their self-testing results and consult a professional when advised, as numerous studies anticipate?

Only time will tell.