We have been informed (and warned) that the world of laboratory medicine is about to be revolutionized. Recently for example a company in Silicon Valley called Theranos has been touted as the next new thing which will disrupt everything we know about lab tests: making them patient driven (i.e. patients can order their own tests and are given any results directly), highly accurate, done on only a tiny drop of blood, and affordable, with transparent pricing. I was so excited when I first read about this several years ago that I repeatedly went to their web site and requested contact and more information (there was a spot for providers to do this), and I heard…crickets.
But the hopeful hype was not rescinded, making me believe that it was still possible. In the meantime rumors of conflicts between the FDA and Theranos have appeared in a series of articles in Wall Street Journal. Certainly the FDA shut down the medical information arm of genetics testing company 23andme (also in Silicon Valley), from which they are just beginning to recover. Suggestions have been made that the reality of new lab testing does not live up to the hype. Who to believe? Perhaps meaningful reform and reinvention is only a matter of time. Let’s hope so.
Some of these “new” lab tests are looking at genes associated with cancers, and hold out the promise of individualized, highly effective treatments. Yet another recent Wall Street Journal article asks “Is Lab Testing the Wild West of Medicine?” Arguments between innovators (and their investors) and the FDA are made public: the innovators arguing that last century’s lab tests are outdated, painful and cut the patient out of their own information, and the FDA afraid that “unproven” tests will lead to “unproven therapies” and “heartbreak”. The heartbreak example they cite in the article refers to women who get mastectomies (based on BRCA gene results) that may not have been “necessary”. OK. But how about the heartbreak of losing a mother, sister or wife to an inherited form of breast cancer that might have been detected?
Is the FDA the villain or the hero? Historically it's been a little of both. The oft cited example of Thalidomide, from which the FDA protected American women while European women, not so protected, gave birth to terribly deformed infants, was one of their heroic moments (although, folks, it was a loooong time ago). On the other hand, however, FDA opposition to people receiving their own genetic information, has not been their finest hour, in my opinion.
The vitamin and supplement world, for example, has managed to convince consumers that FDA regulation of their products would simply mean they would lose access to them. Possibly true, but not the whole story. Were FDA oversight applied to these products, adulteration—intentional or accidental—would be less common. When I buy an over-the-counter herbal medication, I can't be sure what’s on the label accurately reflects the entirety of what’s in the bottle. Apparently, that was the trade-off people were willing to accept to keep the FDA out of the equation.
Back to your genetic information: who owns genetic and laboratory information anyway? Is there any reason in the world you can’t know your own answers? I personally don’t think so. Should doctors be mandatory gate-keepers to such information? Is this wisdom or guild (job) protectionism? Should my daughter, herself not a doctor, be able to order a blood count to see if she is anemic? I personally think so. But wait! How will she be able to interpret the results? Use the web? Maybe. Do her own research? Maybe. But it will require her—and all of us—to accept a degree of uncertainty in interpretation that the current, paternalistic medical system claims to protects us from, especially if the labs so ordered are more complex than a blood count.
And another thing: is ordering our own lab tests the “gateway behavior” that will lead to all medication being over-the-counter and available without a doctor’s prescription? Maybe.
I personally feel all of this is moving in the right (albeit somewhat uncomfortable) direction. The road will be rough and hotly contended, because there is a lot of money at stake—billions—in all the relevant sectors of the medical economy, and not just doctors’ salaries.
This is like the stomach churning feeling of a ship in the high seas going to the New World. In a perfect world the FDA—or someone like them—would have oversight over new lab tests. But the FDA moves at the speed of glaciers while our expectations move at the speed of light (or of hope?); the latter entirely understandable if, for example, you are sick or have a sick child.
Unless regulators pick up the pace and collaborate with people like Eric Topol, and other “creative disruptors”, they will, in my opinion, be sidelined and made increasingly irrelevant. Just when we need them most.
