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23andMe Under Fire: What's Next for Personalized Medicine?

Zvi Mowshowitz

The FDA has sent a warning letter to 23andMe, Inc. telling them to stop marketing their genetic testing service.

This action illustrates many of the things deeply wrong with our medical system.

23andMe democratized personal genetic testing. For $99, they test for a wide and growing variety of genetic variants, some associated with increased disease risk. All their competitors charge several times that amount; one genetic test for parents checking to see if they carry dangerous genes bills insurance for $1,800. By shutting down 23andMe, the FDA is effectively denying many Americans access to the information hidden in their genomes.

Why is the FDA doing this?

Fundamentally, their argument is about proof. 23andMe is selling people tools to learn about themselves, but hasn't proven that the information will lead to better health outcomes. The FDA states, “we still do not have any assurance that the firm has analytically or clinically validated the P.G.S. for its intended uses, which have expanded from the uses that the firm identified in its submissions. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the P.G.S.'s uses and consumer base without obtaining marketing authorization from F.D.A.”

Imagine if this principle were used in other areas of life. What if a travel service wasn't allowed to find you the best deals, or an investigative journalist wasn't allowed to cover City Hall, unless it could be proved that the information was good for you? Would you be able to trust the authorities of such a country? How would you make informed decisions?

The 23andMe case is a reminder that we live in a world where medical information is tightly regulated. The FDA does not allow people to make their own judgments about diagnostic testing services. In such a world, personalized medicine companies need to figure out how to legally provide information to the people who need it.

23andMe fell afoul of the law because they are offering and promising more than just genetic data. It is currently illegal for organizations not licensed by the FDA to sell devices that diagnose disease. 23andMe markets itself as providing recommendations -- on its website, it says "Based on your DNA, we’ll provide specific health recommendations for you. Get personalized recommendations.”

At MetaMed, we've long been aware of the legal issues surrounding the practice of medicine. We do not practice medicine. And, for us, this is a guiding principle, not just a legal technicality.

It's a doctor's job to make judgment calls: to offer recommendations or make a diagnosis. Our role is to inform, not to decide. Personalized medical research can tell you what your medical history and individual biology, including your genetic results, mean for your risk of disease. We can tell you what the scientific research says: which treatments have been shown to work for patients like you, and which have been shown ineffective. We can tell you about possible options, whether they're standard treatments, lifestyle changes, experimental therapies, or treatments available in other countries -- and we can give you hard numbers about how well they work. What we can't do is substitute our judgment for yours or your doctor's. Once you have all the information you need, the decision is yours.

23andMe offers a valuable, cost-effective service. We often inform our patients about the option to get genetic testing, and they overwhelmingly choose 23andMe. But their recent legal troubles illustrate the risks of disrupting the healthcare industry without understanding the law. There's emerged something of a personalized health movement -- an explosion of diagnostic tests and self-tracking tools that help people understand their own biological data. It has the potential to do tremendous good, as we learn more about the individual factors that affect the risk of disease and empower people with the information they need to live longer and healthier lives. But execution matters, and if personalized medicine is to get off the ground, companies will have to take care to remain neutral, objective providers of information and data.