Opinion

The FDA’s crazy crackdown on genetic testing

Here’s an interesting fight. On one side we have a group whose motto is “Don’t be evil.” The other side is very different: It’s the federal government.

In keeping with the times, in which presidents enforce whatever rules they feel like enforcing on any particular day, the Food and Drug Administration has added a new dimension to its mission. Now it’s the Food, Drug and Information Administration, because this week it ordered an info source to shut down.

Its opponent is a company called 23andMe, which for six years has been providing consumers with 98% reliable data about what’s in their genes. All of the sudden that must stop, said the FDA in a letter dated Nov. 22 that effectively ordered the company, which has one product, to shut down.

23andMe, backed in part by Google capital, is run by CEO Anne Wojcicki, who is currently separated from her husband, Google co-founder Sergey Brin. For the last several years, for 99 bucks, its customers have found that they swab some saliva, put it in a tube, send it to 23andMe’s labs and get back information on genetic traits. You may learn that you are predisposed to diabetes or cancer or merely that you lack the gene that causes “asparagus pee.” 23andMe isn’t, it seems obvious, a provider of drugs or medicines. It is simply an information service.

But the FDA has the power to regulate medical devices, which is the pretext it is using to stop 23andMe. Ordering it to stop selling its personal genome service, the FDA declared that the tube “is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.’

It would seem that 23andMe could simply put the words, “not intended for us in the diagnosis, cure, mitigation, treatment or prevention of disease” on its website and satisfy the FDA, but we all know that the motto of today’s federales is “We make it up as we go along.” The FDA seems determined to conduct a lengthy war with 23andMe.

Stretching for examples of how 23andMe represents a public-health menace, the FDA came up with an absurdity. In its letter to Wojcicki, it cited the possibility that a gene linked to breast cancer, BRCA, could be revealed by 23andMe testing: “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.”

That’s nuts. What woman would schedule a life-changing procedure such as chemotherapy or mastectomy based on a $99 mail-order test? What doctor would perform such a procedure without followup? 23andMe never claimed its results are 100% conclusive, nor does it advise clients to go get a scalpel and a mirror and start cutting. From the 23andMe.com site: “Learning your genetic risk for various diseases and conditions will allow you and your doctor to focus on the lifestyle changes and preventative steps that matter most for you . . . you will learn about variations in your DNA that can help your doctor determine if you need more or less of a medication compared to most people.” (Emphasis added).

Using the same reasoning, the FDA might as well shut down WebMd.com because people might type their symptoms into the site, and the response might affect whether or not they choose to go to a doctor. Any computer or iPhone thereby becomes a “medical device” that people can use for the “diagnosis, cure, mitigation, treatment or prevention of disease.”

Come to think of it, that thermometer you use to check your temperature is pretty dangerous too — it might give you either a false positive or a false negative — but why stop there? You exercise to mitigate or prevent disease, don’t you? Maybe the FDA should take your running shoes and your yoga pants away.

What’s different about 23andMe is that its saliva-testing tube is new, hence scary to the FDA, which is like a prim Victorian lady in a neck-high flannel dress holding one hand to her throat in generalized fear and shock while the other holds one of those ear trumpets she holds up while yelling, “Eh?” If FDA Lady doesn’t understand what you’re up to when you leave the house, you’re grounded indefinitely, made to sit in the corner on a stiff wing chair wishing the cat smell would go away. “What for? I’ll tell you what for, Missy! Because I said so!”

If only the reality were that congenial, though. In fact, little old FDA Lady has lots of huge friends, like NSA Creep upstairs reading your e-mail and IRS Thug getting out the brass knuckles because of your political affiliations.

What do all three of them have in common? They’ve had just about enough of your smart-mouth questions, sonny boy.