Monthly Archives: November 2013

Omar Little on the FDA and 23andMe

23andme are either there today or they aren’t. They dealt the play last summer when they started this process, and advertised it. They’ve upped it by framing themselves as a daring company. But they’re going after the FDA with this strategy. And if you come at the king, you best not miss.

That is from a blog post by John Wilbanks (HT: chemjobber on twitter). Defending the FDA by analogy to Omar Litte, a rip-and-runner (he robs drug dealers) from the old HBO show The Wire, is pretty interesting. (See Youtube here for an example.) It got me thinking…What else does our old friend Omar have to say about our present situation?

Well, most critics of 23andMe say that the company’s problem is its own making. True, its boneheaded regulatory affairs strategy of late consists of simply ignoring communications from the FDA. Of course, the FDA understandably became irritated, and it has responded. But is its response good policy? We all will be unable to use an affordable, at-home testing service to easily learn about the most important parts of our own genomes. That seems bad. But maybe it’s good: 23andMe’s quality control might be inadequate, and the FDA’s policy may offer us a strong protection against inaccurate information. Who knows? 23andMe’s critics may not be keen to address that particular issue, but most of them can agree with Omar on the simple fact that the game is out there, and it’s either play or get played.

roundup of reactions to FDA’s move against 23andMe

On Friday, the FDA sent genetic testing company 23andMe a warning letter, saying that 23andMe “must immediately discontinue” marketing their service, a personal analysis of customers’ genomes, to the American public.  The FDA’s move has attracted heavy criticism. Here are some highlights:

Economist Alex Tabarrok blogging at marginalrevolution:

Moreover, the FDA wants to judge not the analytic validity of the tests, whether the tests accurately read the genetic code as the firms promise (already regulated under the CLIA) but the clinical validity, whether particular identified alleles are causal for conditions or disease. The latter requirement is the death-knell for the products because of the expense and time it takes to prove specific genes are causal for diseases. Moreover, it means that firms like 23andMe will not be able to tell consumers about their own DNA but instead will only be allowed to offer a peek at the sections of code that the FDA has deemed it ok for consumers to see.”

Berin Szoska, president of a technology freedom advocacy group:

“Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.”

Genetics professor Michael Eisen via Twitter:

“billions of dollars worth of supplements and homeopathic treatments sold with bogus health claims, and FDA goes after @23andme???”

Law, Philosophy, and Genomic Sciences Professor Nita Farahany blogging at the Volokh Conspiracy:

“But just because information can help in the diagnosis of a medical condition does not mean it should be considered a “medical device” subject to FDA jurisdiction.”

Slate’s Gary Merchant:

But the FDA was not required to take this heavy-handed and drastic action. We know this because many of the exact same genetic tests are already being provided to consumers through their physicians, without any FDA approval. There are approximately 3,000 genetic tests now commercially available through your doctor, of which only a handful have received FDA approval. So it is apparently now unlawful for 23andMe to sell you a genetic test but OK for your physician to order the exact same test, at a much higher cost to the consumer. This is an unjustified and unwarranted double standard.

Journalist Timothy Lee writing at the Washington Post:

More to the point, patients have a right to make dumb decisions if they want to. We don’t ban patients from reading medical textbooks or WebMD, even though doing so undoubtedly leads to some harmful self-diagnoses. In a free society, patients have a right to accurate information about their health, even if medical professionals and regulators fear patients will misuse it. That includes information about our genetic code.”

Long-time genetics blogger Rhazib Khan:

The institutions designed to protect the public from fraud need to think more about empowerment rather than engaging in fiat paternalism.

Not everyone is so critical of the FDA. Christine Gorman at Scientific American supported them, and so did Hank Greely at Stanford’s Center for Law and the Biosciences. Hank Greely’s take is the best defense of the FDA’s actions I have seen; be sure to take a look.

So far, 23andMe’s public response to the letter seems to consist of little more than a single, less-than-substantive blog post. Something tells me we’ll be hearing a lot more from them in the near future.