Infromation about DNA testing

Up until a few days ago, for $99, you could spit in a test tube and send it to 23andMe’s Los Angeles-based labs and get a picture of who you were on a genetic level. The company keeps a constantly growing online database of new studies and information about genetics and illnesses; it also hosts a thriving (and totally voluntary) community of people who can talk among themselves. Unlike your doctor, who is likely to bitch and moan and drag his heels when you ask for a copy of your latest blood test, 23andMe lets you easily access and even download your personal genetic service (PGS) readout. (Some folks have even used the info to make the ultimate statement in personal music.)

Not no more. While the company can keep serving its current clients (full disclosure: I’m one of them, though with an asterisk I’ll explain in a second), it can’t grow its customer base until it jumps through more hoops as laid out by the FDA.. Although the company says it will do what it takes, the smart money is always on government bureaucrats shutting down whatever they want. The ultimate beef, says the government, is that 23andMe is giving away too much information to the unwashed masses without scratching the right bureaucratic backs first:

Your company’s website at www.23andme.com/health (most recently viewed on November 6, 2013) markets the PGS for providing “health reports on 254 diseases and conditions,” including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

The FDA is especially worried that folks like you and me will get some news that will literally cause us to hack off our own breasts, remove our own testicles, or become so genetically arrogant that we’ll stop seeing the doctor altogether:

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, while a false negative could result in a failure to recognize an actual risk that may exist.

You got that? The FDA is seriously claiming that you might learn you have a possibility of developing breast cancer and then insist on having the potentially cancerous body part lopped off. And that you'll be able to find a doctor or hospital or taxidermist who will do any or all of that without doing further tests and followups. They don’t provide a single instance of this happening nor do they specify any possible medical world in which this might happen, but that’s enough to shut down 23andMe for the foreseeable future. (The company has issued a short statement about how they will work to meet the FDA’s demands.)

The FDA is now apparently taking policy cues from The End, a 1978 comedy starring Burt Reynolds and Dom DeLuise. In that groaner, Burt is convinced he is going to die soon and sets about offing himself. Spoiler alert: Hilarity doesn’t ensue. It’s a Burt Reynolds-Dom DeLuise showcase after all.

I’m still waiting on the results of my second spit test from 23andMe, which I sent in a couple of weeks ago. I was informed that the saliva I provided in my first sample was so lame that it couldn’t provide a legitimate reading of my DNA—a curious and dispiriting result that made me angry without triggering any action in me other than wanting to drink some water. If and when I learn something potentially dangerous—or potentially uplifting (like most kids, I went through a phase in which I hoped against hope that I would turn out to be adopted rather than the obvious and incontrovertible product of my dear, departed parents)—it will be the start of a new conversation with my doctors and friends.

And regardless of the limits of a $99 DNA test, it will be a more informed, not a more-hysterical conversation revolving around what body parts I need to lose immediately.

But don’t expect the FDA to understand any of that. Peter Huber of the Manhattan Institute, a conservative think tank, has an important new book out called The Cure in the Code: How 20th Century Law is Undermining 21st Century Medicine.. Huber writes that whatever sense current drug-approval procedures once might have had, their day is done. Not only does the incredible amount of time and money – 12 years and $350 million at a minimum – slow down innovation, it’s based on the clearly wrong idea that all humans are the same and will respond the same way to the same drugs.