Last week, the FDA sent a letter to Ann Wojcicki — the CEO of direct-to-consumer (DTC) genetic testing company 23andMe — ordering them to stop marketing their Personal Genome Service (PGS), which the FDA defines as a "medical device" subject to specific forms of regulation.
According to Forbes, Wojcicki and her company have flouted regulatory red-tape despite both efforts by the FDA to work with them and 23andMe's own statement that their "relationship with the FDA remains critically important." As a result, the FDA ordered it to stop selling $99 PGS kits.
Historians have noted different aspects of the story, both here at AmericanScience (here and here) and elsewhere (e.g. here and here). I want to take a slightly different tack, one rooted in Sanford Kwinter's response to an address made by Wojcicki at Harvard in 2012. Here is Kwinter:
There's a lot to note about Kwinter's position, which he calls “a position that is perhaps far too rarely put on the record today." It's one of resistance and radical critique, far removed from the usual stance of the historian today. Here, I'd like to explore its implications for our current moment.
"a position that is perhaps far too rarely put on the record today"
Kwinter begins with Spencer Wells' "Genographic Project," a non-medical effort to sequence human populations to learn about their history and diversity. Though Kwinter invites his classes to participate, they never do. Why? "Diffidence," he says (though it sounds more like ambivalence).
It's this diffidence Kwinter wants to introduce into the discussion of the descendants of the Genographic Project, including DTC companies. And this is where his critique takes off. We have become, he insists, "sitting ducks" for "predatory" knowledge aggregators—like 23andMe.
This is close to Charles Seife's comment that the $99 PGS is "a one-way portal into a world where corporations have access to the innermost contents of your cells and where insurers and pharmaceutical firms and marketers might know more about your body than you know yourself."
Seife's is an important critique—though, as Nathaniel Comfort asks: "Is this any more insidious than gmail? If we say yes, we risk running headlong into the genetic determinism this blog rails against. We have to be careful about privileging biological information over social information."
And it's true that some of Kwinter's remarks—about the nature of science, about the power of biological identity—might make science studies scholars cringe. But we shouldn't let our cringes dull Kwinter's critique. Rather, we should take it as a call to bring our tools to bear on the present.
“Who said the consumer is always right? The seller. Never anyone but the seller.”
When we do, we'll see that what Kwinter calls "diffidence" (about the 23andMe project) is similar to the feeling we get when we, as historians, encounter past efforts to "naturalize" scientific progress. In both, we resist claims of inevitability in order to see both power and politics at play.
In both her address and her response, Wojcicki insists repeatedly that personal genetic data is here to stay. If we don't pay 23andMe for it now, we are not only putting our lives at risk (from diseases to which we are predisposed) but also ceding the (data) floor to—yes—China.
That's part of her pitch. The other has to do with red-tape: the medical bureaucracy, she says, is holding back innovation, and patient-consumers deserve to have things sped up. As Kwinter notes, this amounts to saying that "the customer is always right"—which is said, of course, by the sellers.
So who is the consumer, and what are they buying? As individuals, we are pulled in with promises of self-knowledge: find family members, know ancestry, learn about disorders we can help prevent through lifestyle adjustments as long as we make them in time. It's inviting, if not imperative.
But this isn't (just) a self-knowledge service. Rather, as Kwinter puts it, it's "a data-mining—and perhaps, I don't know—a crypto-bio-prospecting" initiative. We are the "consumers" of the direct-to-consumer model, but 23andMe figures us elsewhere as "assets," "resources," and "data."
Which is to say: there are other consumers. Just as the tailored ads on Facebook and Google suggest, your identity—in whatever form—is a valuable commodity. Even if 23andMe (like Google) hangs onto it, there are ways to profit from "streamlining" your digital life for you we can't even imagine.
"the world's trusted source of personal genetic information"
This ambiguity—about what "personal" means, about whether I am "consumer" or "consumed," data-generator or just data—is in 23andMe's mission statement, which is "to be the world's trusted source of personal genetic information." Trusted by whom? Information for whom?
As Evgeny Morozov points out, for some reason we've tended to give "Big Data" a pass: "While 'Big Pharma,' 'Big Food' and 'Big Oil' are derogatory terms used to describe the greediness that reigns supreme in those industries, this is not the case with 'Big Data.'" Why is this?
His point about our collective inability—unwillingness?—to see "data" as just another corruptible commodity applies to DNA as well. Blinded by myths Silicon Valley itself has produced, regulators have failed to see that 2.0 rhetoric often masks 1.0 aims. It's still a market, after all.