FDA, Allied Monopolists, and Allied Media Continue War on Medical Testing Innovation

These three want lab-testing pioneer Theranos to be history. The future of medicine is at stake. Action Alert!
In 2013, we reported on Theranos, a new and exciting venture that had the potential to revolutionize medicine by making medical testing cheaper, faster, and more convenient. The basic idea was simple—to create testing technology that would allow individuals to keep tabs on their own health at a fraction of the cost and inconvenience of traditional blood testing. This idea was powerful enough to attract a flood of investments and a star-studded board of directors.
Recently, however, Theranos has been repeatedly attacked both by federal regulators and the mainstream media, both of whom seem particularly eager to deflate the enthusiasm over this innovative company. Worse, it seems to be working— Walgreen’s recently announced that it is suspending many aspects of its relationship with Theranos, including closing the Theranos Wellness Center in Palo Alto, California.
Walgreen’s announcement comes in the wake of a Center for Medicare and Medicaid Services (CMS) letter detailing an inspection of a Theranos laboratory in which a number of deficiencies were found—including one that the agency said “posed immediate jeopardy to patient health and safety.”
This CMS letter must be put into perspective. Experts say that federal regulators issue many of these kinds of letters to labs as well as providers—suggesting this is less of a “five-alarm fire” than routine government business. Further, the CMS citation that posed “immediate jeopardy” to patients applied to one specific area of their Newark, California, operation—not the entire lab, and certainly not Theranos’ Arizona lab where 90% of the company’s tests are processed!
It hardly needs to be said that media coverage does not emphasize these nuances. The Wall Street Journal in particular seems to have an axe to grind. Recall that last November the newspaper published back-to-back front-page stories attacking Theranos. Their more recent story is titled “Deficiencies Found at Theranos Lab.” Other stories echo this sentiment with titles like, “Is Theranos Finished?” and “Theranos Sounded Too Good to Be True—and It Is.”
As has been the case with many innovators before Theranos, the sharks are circling—including the FDA. We’ve noted before how the FDA is seeking to regulate laboratory tests as medical devices, a clear overstep of its authority noted even by members of Congress.
The road to innovation is often a bumpy one, but if we allow federal regulators, entrenched medical testing companies, and the media to bury Theranos, it is consumers who lose. Let’s remember what’s at stake: the refinement of this technology could alter the medical landscape for millions of consumers who will no longer be at the mercy of a medical monopoly. Right now, two companies (LabCorp and Quest Diagnostics) control most of the market for medical testing. Enticed by all the money to be made in this field, hospitals are also increasingly getting in on the action.
Consider the world that a company like Theranos could make possible. Chronic diseases could be caught early and monitored like they never could before. With the speed and convenience of this testing, more individuals would be empowered to take control of their health. For instance, a person might read an article about the importance of vitamin D in the morning and, on the spur of the moment, pop in to a nearby drug store that afternoon to get an inexpensive vitamin D 25-OH test, thus providing a near-immediate answer to the question of their own vitamin D level. Or, rather than a hypothyroid patient going to an endocrinologist every few months to measure hormone levels, a patient can simply stop into a Walgreen’s and get the routine blood work they need to manage their condition. Anyone who has ever had to try to convince their doctor of why a certain test is needed will appreciate the approach being pioneered by Theranos. We must defend it and other innovators from those who want to use government regulation as a weapon to kill competitors, especially competitors offering a cheaper product.
Action Alert! Write to the FDA and urge them to not kill this important potential innovation. Please send your message immediately.

 
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