PhotoSpitting into a tube might be construed by some as bad manners but as the Food and Drug Administration sees it, it amounts to using an unlicensed medical device if the tube came from 23andMe, which for $99 and a tubeful of spit will provide you with your personal genome.

Millions of people -- including me -- have signed up for the service and, a few weeks after submitting our samples, received an amazingly complete batch of information "on 240+ health conditions and traits" in our genetic code.

I also ordered the kits for my family, thinking we could spend some cozy evenings around the fire comparing our risks of atrial fibrillation, Alzheimer's disease, breast cancer and other cheerful topics. So far, it hasn't been much of a conversation starter but, on the positive side, none of us found much of anything to worry about in the reports we received.

Perhaps the most interesting finding so far was the one that said that 3% of my DNA is Neanderthal in origin, putting me in ther 94th percentile of non-homo sapien ancestery among those of European lineage. This despite my relatively slight frame and lack of noticeable eyebrow ridge.

Oh, my genome also shows a lower than average risk of Alzheimer's, which is good, although my wife has a higher than average risk, so if you balance those out, we're roughly back at average, couplewise. 

Nanny state

The author's ancestors

The FDA's stated concern with all of this is not that we'll all waste $99 and a lot of time poring over results that may or may not mean anything but rather that we will be driven to drastic measures because of the findings.

As an example, the agency said, "if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions."

Well, maybe, although when I told my internist that the 23andMe test showed I had a higher risk of atrial fibrillation, he scoffed and said the sample size was too small.

"Besides," he said, "A genetic predisposition is just that -- a predisposition. It doesn't mean you'll ever get it or that it will be severe. Just forget it." (The geneticist's answer to this, we're told, is that most doctors don't know much about genetics). 

The FDA's fear that a woman might be driven to having a prophylactic mastectomy because of her DNA results may be overstated, given the average physician's seeming aversion to genetic fortune-telling.

It's hard to imagine an oncologist agreeing to such a procedure without undertaking much more extensive testing and putting the patient through extensive counseling.

Nevertheless, for now, if you haven't already ordered your 23andMe kit, you'll have to get in line and wait for a possible change of heart by the FDA.

Share your Comments