My son’s birth is among my most treasured memories. I knew immediately his arrival had transformed my life. But, the joy of that memory comes with a reminder of how government intrudes into our most magical moments. While I had to wait weeks for my son’s birth certificate, the hospital wasted no time providing his Social Security number. He had a government number before he was even declared legally alive!
It doesn’t end there, of course. What, for example, could be more personal than information about our own DNA? Yet the U.S. Food and Drug Administration (FDA) recently cracked down on 23andMe, a company providing genetic testing services through a $99 home-use kit.
The FDA banned 23andMe from providing health-related information to consumers until the test is government approved, since the agency considers it a medical device subject to regulatory review. While the review proceeds, 23andMe can provide customers with ancestry information and raw genetic data—only part of the information consumers seem to want.
In short, 23andMe examines a customer’s DNA to identify genetic variations linked to the traits that make each one of use different. This tells us what parts of the world our ancestors came from or offers insights about physical characteristics like height and hair color. But it can also indicate whether we’ll have a higher or lower susceptibility to various diseases or whether we’re likely to respond well to certain medicines.
What this analysis does not do is tell customers they have or will get cancer, heart disease, diabetes, or other health conditions. It can only assess a customer’s level of risk for contracting one of these diseases at some point in the future. Some genetic associations are well established, while others appear to be more tenuous—so the results are often suggestive, rather than definite.
The FDA fears that consumers, not understanding the implications of many genetic linkages, will overreact to our 23andMe results. Thinking a heightened risk is a diagnosis, they may seek an unnecessary medical procedure. Or, when told they’re at a lower risk of obesity or alcoholism, they may treat their genetic profiles as a license to engage in risky behavior.
In effect, the FDA is trying to protect us from ourselves. To do so, the agency stretched the definition of diagnostic tests, which Congress has given it the authority to regulate, to capture 23andMe non-diagnostic analysis.
Conservatives and libertarians have been joined by many liberals in crying foul about this perceived government overreach, with good reason. It’s frightening to think regulators are thwarting this nascent attempt to demystify the relationship between genes and health.
Misinformation can in fact be dangerous. We see this in the scandalous “vaccination wars,” in which celebrities have used their star power—and a discredited scientific study on autism—to scare people away from vaccination, putting children and adults at needless risk. Likewise, people could get mistaken notions about health information provided by 23andMe if they’re not careful.
But the fact remains that health information is not the same as a diagnosis. So, while 23andMe may suggest a possible level of risk for certain ailments, it’s not a directive or recommendation for a course of action.
In fact, people have been doing health risk analysis and genetic “testing” for decades. The family medical history surveys we fill out when visiting a new doctor or buying life insurance are simply a cruder way to take a snapshot of our genetic profiles. In all probability, I may have inherited some genetic risk factors from my grandparents. Until now, to confirm that supposition, I had to see a doctor and pay for the office visit and a test. But now, technology is changing the rules of the game, giving us more and more precise information.
Unfortunately for 23andMe and its would-be customers, FDA regulators need only declare that the company is providing a diagnostic test to capture it in its regulatory net. And they may get away with it, given how permissive courts tend to view regulators’ interpretations of their own legal power.
Does that mean the FDA can regulate all medically-related information? That’s a very wide net indeed, and scary in its implications. I would prefer that market mechanisms and their feedback loops provide guidance as to the efficacy and usefulness of 23andMe.
And though these home use kits may leave us asking how significant the results may be, we should welcome the opportunity to have more information to better inform our health decisions. Just how much we should know—and not know—about ourselves is a question best answered not by government, but by you and me.