You have got to feel sorry for 23andMe.
Ha! What a funny thing for me to say. Genetic counselors don’t feel sorry for 23andMe. After all, they offer a service of which many of us are deeply distrustful, suspecting that for all the data they provide, all the fact-filled blurbs and fancy graphics, their outpouring of information often serves to obscure rather than to illuminate the more significant truth: that most of the time, these reports are not a valid or reliable source on which to base decisions about your health and well-being. That their message promotes a kind of mantra of genetic determinism that complicates our job, since it creates expectations that cannot be fulfilled. That their credibility and media presence have less to do with scientific bona fides than an intimate relationship between their founder Anne Wojcicki and Google’s Sergei Brin, which gives 23andMe access to both some very deep pockets and the reflected glory of an association with the epitome of technological wizardry.
And now they are doing research, and they don’t even have to bother with an IRB. It’s so unfair.
But really, you should feel sorry for 23andMe. I’m serious.
It’s not easy being them. Think about it this way: the entire premise of the 23andMe sales pitch is that they can offer you valuable information. Valuable how? Well, presumably because it will SAVE YOUR LIFE, or something to that effect. “Personalize your healthcare,” they say on the website. “Prepare for serious diseases.” However, at the same time, 23andMe can not say that any of this valuable information is diagnostic. They have to be careful not even to imply that it is diagnostic, because offering diagnostic information constitutes a medical test, and medical tests are subject to a much more rigorous degree of government regulation. If you were a company, would you care to invite a greater degree of scrutiny from the FDA? No, you would not.
It’s a fine line they walk. You’d have to be clear-headed and on your game to walk a line like that. I bet those guys in corporate communications at 23andMe have to stay stone cold sober all the time. You know that show Mad Men? The opposite of that.
Now, a tough job gets even tougher. Last month, 23andMe announced their first-ever patent, awarded for a method of determining an individual’s risk for Parkinson’s disease, a finding drawn from a study of 5,000+ PD patients who were offered the 23andMe genome screen virtually for free – what the company refers to as “the largest Parkinson’s community for genetic research in the world.” This was a big day for the company, since the patent represents not only a new potential line of revenue but proof in principle for their strategy of crowd-sourced genetic research. Given their outsider status, 23andMe was probably prepared for a certain level of pushback from the standard-bearers of academic research. What they may not have expected was that their big day would be marred by an insurrection in the ranks – but to their apparent surprise, the announcement drew outraged responses from many 23andMe research participants.
It turns out that many in the “Parkinson’s community” felt betrayed by the patent application, perceiving it as an unexpected move to monetize on the part of the company they believed was only interested in a cure – after all, Sergei Brin himself has revealed that he has a genetic risk for PD. While the press releases from 23andMe emphasize the importance of the patent as not a money-maker but an inducement for other companies to use this information to develop treatments – “the patent will be important for a biotech or pharmaceutical company to pursue drug development” – the majority of the voices making themselves heard seem to find this a dubious distinction. Admittedly, it defies logic to assume that a commercial entity would file for a patent merely so someone else could (eventually) make a profit, and in fact if we are looking for evidence of capitalistic intent, we can find it conveniently staring out at us from the informed consent that all 23andMe customers are required to sign: “If 23andMe develops intellectual property and/or commercializes products or services, directly or indirectly, based on the results of this study, you will not receive any compensation.”
So why did so many research participants feel deceived by a naked expression of commercial intent? Well, it turns out that, once again, hard cold facts spelled out in black and white, however clearly stated, were less convincing than a fundamentally different message that was never articulated but merely implied, insinuated, forcefully and emotionally conveyed by the fundamental nature of the language used. “Join us” they said. “Everyone can help.” 23andMe research is billed as a community effort, “powering research breakthroughs.” It’s like a research Wiki. “I had assumed that 23andMe was against patenting genes and felt in total cahoots all along with you guys,” said one research participant. “If I’d known you might go that route with my data, I’m not sure I would have answered any surveys.”
Okay, so as insurrections go, this one is a bit of a tempest in a test tube. Should we care? Is it a problem if a small number of people who didn’t read the fine print feel misused? C’MON PEOPLE. You haven’t been abused. You haven’t been robbed. You did not sacrifice flesh or blood — just a little spit. But the objections of the 23andMe crowd should be noted by all companies (or researchers) who want to make use of the DNA and altruism of willing donors. It’s a very fine line you draw for yourself when you unpack those chromosomes: hard to walk, easy to trip over. If you tell people that the genomic revolution is all about their health, and it turns out to be more about your profits, once-willing participants may be more inclined to spit at you than spit for you. If 23andMe plans to make data mining an integral part of their revenue stream – and this patent is one pretty clear indication of their intent – then they will have to find a way to convince their target audience that this is a chimera of a company, a capitalist beast with the loving heart of a non-profit enterprise.