23andMe: An uninformed viewPosted: November 26, 2013
I am not a bioethicist, and I have never conducted human research or, for that matter, animal research requiring much regulation. So while I have some awareness of the legacies of Tuskegee and the many other evils large and small carried out in the name of research, and think these are incredibly important and not taken seriously enough, I have not grappled first-hand with the concept of Informed Consent or real-life IRBs. So my disclaimer here is that my views come from a place of extreme ignorance, but hey, this is the internet, right?
My first poorly-informed impression: I would guess that the default, baseline level of being “informed” (not in any paperwork sense, but just level of understanding) of a 23andme customer seeking out the company and purchasing their own SNP data from them for $100—without any disclaimers or literature from the company—is much higher than the “informed consent” that is routinely obtained in situations and countries where perceptions of authority and individual choice in medical care are very different from in the US. Yet the US model for informed consent is used globally, both by US researchers abroad and by local researchers around the world. So…if 23andMe is conducting research, is it a problem if they don’t use IRBs? Yes. Given the number of people involved, the kind of research/data, and the relative wealth/security of the participants, is it a big problem relative in the context of medical ethics and how informed consents and IRBs are used, under the FDA’s mandate or not? I don’t think so.
It feels like an important distinction to me that customers seek out 23andMe, not the other way around. They are not recruited to a study. 23andMe is selling information: your own SNP data along with a lot of published associations on a slick web site. That fact that consumers might do something misinformed/stupid/harmful with this information is a given for every service/product for all time. Not trying to sound libertarian—I am somewhere between Canadian and Vulcan on the “collective good” vs. “individual rights” spectrum.
Of course, what services like 23andMe do potentially do is create an industry of snake oil, quack remedies, fear, and self-diagnosis. OK: so right now that’s already about 20% of the internet (“Edit your genome with this one weird trick”). I’d say personal genomics is going to increase the general level of health stupidity and exploitation of fear for profit in this country by ~3-5 farts in the current shitstorm of anti-vax, homeopath, faith healing garbage.
Finally… I don’t know the history of 23andMe’s IRB issues, but here’s what it says in the one paper I’ve read (on cilantro tasting like shit to some poor souls):
Participants were drawn from the customer base of 23andMe, Inc., a consumer genetics company. This cohort has been described in detail previously [14, 28]. Participants provided informed consent and participated in the research online, under a protocol approved by the external AAHRPP-accredited IRB, Ethical and Independent Review Services (E&I Review).
So, I don’t know. I could be easily convinced 23andMe has been sloppy about this stuff, but I can’t get worked up that they are a risk to consumers to any alarming degree, especially compared to the shit FDA is doing on behalf of big pharma, like approving drugs that are purposefully designed and marketed to be abused. 23andMe is not sloppy in their service… I checked a bunch their SNP data for me against my whole genome sequence and the error rate was 0, so that’s cool.