No DNA Testing For You, Thanks to the FDA
Personal genetic tests are safe, innovative, and the future of medicine. So why is the most transparent administration ever shutting down an inexpensive and popular service? Because it can.
In its infinite wisdom, the Food and Drug Administration (FDA) has forbidden the personal genetic testing service 23andMe from soliciting new customers, claiming the company hasn’t proven the validity of its product.
The real reason? Because when it comes to learning about your own goddamn genes, the FDA doesn’t think you can handle the truth. That means the FDA is now officially worse than Oedipus’s parents, Dr. Zaius, and the god of Genesis combined, telling us that there are things that us mere mortals just shouldn’t be allowed to know.
23andMe allows you to get rudimentary information about your genetic makeup, including where your ancestors came from and DNA markers for over 240 different hereditary diseases and conditions (not all of them bad, by the way). Think of it as the H&M version of the haute couture genetic mark-up that Angelina Jolie had done prior to having the proactive mastectomy that she revealed this year.
23andMe is fun and it’s cool and, as my Reason colleague Ronald Bailey has shown, it is a small but meaningful step toward a glorious future of radically individualized medical interventions and a deeper understanding of the human condition on a fundamental level. Marlo Thomas had no idea just how right she was when she released her Free to Be...You and Me records.
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.
Given what we already know about small but hugely important variations in individual body chemistry, the FDA’s whole mental map needs to be redrawn. "The search for one-dimensional, very simple correlations - one drug, one clinical effect in all patients - is horrendously obsolete," Huber told me in a recent interview. And the FDA's latest action needs to be understood in that context - it's just one more way in which a government which now not only says we must buy insurance but plans whose contours are dictated by bureaucrats who arbitrarily decide what is best for all of us.
There’s no doubt that over time outfits such as 23andMe will flourish. Individualization and personalization have already arrived everywhere in our lives, from the infinite numbers of coffee drinks we can get in the morning to online experiences we tailor without a sense of wonder that ability once inspired to so many other aspects of our lives. Good technology tends to win out over time, despite all the attempts by the old guard to stifle it.
But there’s no question that as part of what Wired co-founder Louis Rossetto, who knows a bit or two about innovation and prognostication himself, has recently called “the death throes of the mega-state,” the FDA and the federal government more generally will do everything it can to hold back the future like Canute with the waves.
My advice for those of you who want to sign up with 23andMe but can’t spit in their test tubes for at least a while? Hock your lougies in the FDA’s general direction instead.