A recent Huffington Post article explains how a 31-year old college dropout wants to alter your relationship with your doctor — but in a good way. Elizabeth Holmes, a self-made billionaire, is in the process of shaking up the stodgy laboratory testing industry. The first of her tests have received clearance from the U.S. Food and Drug Administration, with others to follow.
Holmes is the founder of Theranos, a Silicon Valley biotechnology company using nanotechnology and microfluidics to revolutionize laboratory testing. According to Holmes, laboratory medicine is the basis for 80 percent of clinical decision making. But it’s relatively expensive, inconvenient and not used to its full potential. Currently, insurers refuse to pay for “unnecessary” medical testing, which includes most testing before symptoms appear. While doctors want to perform testing because it makes them money, patients are unlikely to have anything tested before they experience symptoms. By contrast, Holmes wants to encourage laboratory tests before you get sick as a means of detecting the onset of disease before it becomes serious. And she wants to make it both convenient and affordable enough that people will be willing to pay out of pocket.
Think about the last time you had a lab test. You probably visited your doctor after already showing symptoms and he (or she) ordered a series of tests that were never explained to you. You had to hunt down a place to draw a blood sample, without knowing what anything would cost. You found a blood or lab collection point (usually an office front located near a hospital) and made an appointment during business hours. After waiting, they called you in and took two or three vials of blood. A week or so later you played phone tag all day with your doctor’s office staff trying to find out your test results (you probably annoyed the office staff since they don’t believe you need to know your lab results; your doctor would supposedly have told you if there was a problem). A month later you discovered the blood tests cost $500, but your insurer’s negotiated discount was $175, which you owed because you had a high deductible health plan. If you had unknowingly visited a hospital outpatient lab, your bill would have been much higher.
Theranos tests are faster (results arrive in less than four hours), less painful and cheaper than traditional blood tests. Quietly working on the project since 2003, her firm has been able to shrink the blood testing equipment down to a kiosk that will fit in a drugstore. Her team also reduced the multi-vial blood draw down to a single finger prick. Theranos can perform hundreds of tests on a single drop of blood. Pricing is transparent and cheap — costing about half of what Medicare pays for lab tests (prices here). Patients then have electronic access to the test results. The firm has more than 40 wellness centers (mostly in Arizona) with plans to open more than 8,000 more in Walgreens pharmacies nationwide. Soon, consumers will be able to literally swing by their local Walgreens a few times a year and track their health metrics and blood chemistry in a way unimaginable before Theranos. Theranos will send results to your doctor or connect you with a doctor nearby if a result is out of the normal range.
You would think the medical community would be abuzz about Theranos; and the new era in personal medicine and prevention that it is trying to bring about. But if you though that, you would be wrong! In his report, Fortress and Frontier in American Health Care, Mercatus Center scholar Robert Graboyes describes our health care system as a fortress “…protecting patients from risks and providers from competitors. The Fortress discourages creative destruction and disruptive innovation…”
By contrast, he uses the example of Information technology (IT) as the Frontier, where creative destruction and disruptive innovation are the norm. “IT innovators have not needed permission to create and have thus been able to tap into serendipitous genius; the result has been plummeting costs,” Graboyes explains.
There is no better example of the Fortress versus Frontier in medicine than Theranos. For example, a University of Chicago professor who’s the director of Clinical Chemistry Laboratories, recently complained in an interview, “They completely bypassed the traditional process of peer review or publishing in peer-reviewed journals or having peer labs evaluate their product.”
The firm was also singled out in a JAMA viewpoint article by John Ioannidis, a professor at the Stanford School of Medicine. Ioannidis accused the firm of engaging in what he called “stealth research.” Theranos’ crime? Professor Ionnidis doesn’t like the fact that Theranos has been very secretive about how its innovative technology works (sometimes described as a lab on a microchip) because it doesn’t want its competitors to copy its research.
According to Ioannidis:
“Theranos is just one example among many for which major efforts and major claims about biomedical progress seem to be happening outside the peer-reviewed scientific literature. Many of these efforts and claims have a biotechnology flavor, and the people involved often include a blend of engineers, physical scientists, and venture capitalists. The main motive appears to be to develop products and services, rather than report new discoveries as research scholarship. Products, services, and profit appear to be more important than scientific publications.”
Well duh! Put another way, this silly Silicon Valley interloper had the gall to bring together people outside academic medicine — “…a blend of engineers, physical scientists, and venture capitalists” — to improve laboratory medicine (and make money) without asking the academic medical establishments’ collective permission!
So why all the animosity? Rather than seek peer review (that is: approval) from professors of academic medicine who also consult with competing laboratory technologies, Theranos has chosen to work directly with the U.S. Food and Drug Administration to validate the accuracy of its testing. The firm is also working to help consumers bypass the traditional physician gatekeeper arrangement and allow patients direct access to laboratory services before their symptoms appear. Indeed, the firm championed a new law in Arizona that lets patients order their own lab tests and access the results without a physician.
Several years ago the scientific newsletter, Access to Energy, discussed how in the coming years mass spectrometry held the potential of rendering your doctor obsolete. Chemical analysis of blood chemistry, fecal material, saliva, breath, and sweat could someday be used to identify and catalog the relationship of bodily fluids to disease. The article argued that using mass spectrometry in volume would lower the cost. Moreover, over time it could generate a database of metrics to identify disease and conditions, such that a trip to the doctor could become obsolete. Of course, physicians will always play a role in our health care system. But anything that boosts information about health status could make use of doctors’ time more efficient.
