23andMe and Regulators: Genetics, Information, Paternalism
June 19, 2008
CA regulators (through the Department of Public Health) have sent cease and desist letters to 13 direct to consumer genetic testing companies, demanding that they stop sales until they prove that
1) their labs are certified by both the state and federal government
2) the tests they’re selling to CA residents have been prescribed by a doctor (which state law requires)
Here’s one such article on the matter
These letters (it seems to me) signal to some much wider and far reaching implications for direct-to-consumer genetic testing….
23andMe originally said they weren’t going to fall under HIPAA [HIPAA = Health Insurance Portability and Accountability Act – the relevant Title II portion regulates the security and privacy of health-related data] regulations because they weren’t a healthcare/medical provider. (side note: I’ve always found that argument a bit puzzling given both the way people view genetic information and the actual information 23andMe was claiming they could provide about people’s dispositions to certain illnesses and conditions) but now that regulators are saying Californians need a prescription to get these tests done, it seems the Department of Health is inclined to start looking at these companies as part of the health care system.
So why does that matter? What will HIPAA mean for companies like 23andMe?
Well it’s hard to say (for me… since I’m by no means a subject matter expert) but for one – right now users can (I believe) trace back both their genetic heritage and see where their friends are “really from”, too. I’m guessing there’s an opt-in (or at least opt-out) option for this but HIPAA might interpret this sharing of genetic information as too loose. Further, HIPAA is going to (again, I think) have a problem if I can tack specific medical information back to specific individuals.
Further, because they (and other direct-to-consumer genetic testing companies) said they were unregulated, that meant medical researchers wouldn’t need approval to send out casual surveys to, say, all the clients who have a disposition to Type II diabetes (because, again, IRB standards won’t apply either). They can then ask them whatever questions they want and *importantly* use the information for whatever they’d like. Informed consent wouldn’t be required and they’d have no obligation (nor be under any requirement) to treat and protect the data in any way. So if 23andMe is now seen as under HIPAA regulation, none of that is going to be possible. Say goodbye to the vision of all 23andMe’ers working together to benchmark on a genetic level. Never going to happen. (Well, I shouldn’t say “never”… but they’re going to have to jump through a lot more hoops before anything like that is going to be allowed)
So what do I think about all this? Well, I’m generally opposed to government regulation of business and I’m even more vehemently opposed to any sort of regulation that looks like the government is trying to tell me what information I can and can’t have about myself, and further, what I should be able to do with that information. Why should I need a prescription to find out information about my own genetic code? If I want to spit in a cup or have a swab swished around in my mouth, pay $999, and get my DNA coded, so frakin be it. It’s my DNA, it’s my money, and it’s information that I should have access to (if companies like 23andMe want to help give it to me)… whether or not a doctor agrees.
However, there are other issues I do have with 23andMe and other companies that are suggesting that your DNA will show you who you really are.
For one, while there’s no question that our genetic make up plays a large part in our identity and "who we are", it seems that there’s a way for this sort of thing to fuel a *very dangerous* genetic-determinism myth.
- For one, what’s literally coded in our genes is only one part of what’s expressed anyway. Epigenetics at least seems to be overlooked by these companies. [if you’re curious, NOVA made an interesting film about epigenetics].
- Further, I want to say that we should really spend time thinking about the intimate and inextricable relationship between genes and environment. We can see just by looking at cases of childhood trauma that the environment/the way we’re treated/etc. literally shapes brain development. For instance, I read in Bruce Perry’s "The Boy Who Was Raised a Dog" - if you leave a baby alone all day without human connection, certain parts of the brain just never develop - they’ll lack the ability to have normal social relations, to empathize, to love, to derive pleasure for human interactions, etc. - and they’ll have these problems because their brain itself will develop in a certain way (not because their genes were coded a certain way). So genes determine some stuff, but how we’re treated determines a lot, too (and not only of our social existence, but our very physical makeup and gene expression, too). So I guess what I’m saying is that there is a potential worry that this sort of "Oh let’s send out these surveys and figure out what gene is responsible" is failing to appreciate how complicated and interconnected all aspects of our existence are with each other. Further, it seems to (conceivably) perpetuate a myth that there’s this hard and fast line between what’s genetically determined about me and what’s pliable in the social realm. They transform each other.
- Further, there’s a lot of statistics/probabilities etc. associated with this stuff. To say Diabetes Type II is 26% genetically determined or that we are "sort of" sure that there’s a genetic marker for avoidance of errors or bipolar etc. etc. - does the average person really understand statistics enough to make sense of this independent of some sort of guidance? Are those who help provide the information under any obligation to make sure it’s interpreted ‘correctly’? There’s no genetic counseling attached to this service … and I wonder if without it, people are going to make poor conclusions about the genetic fate.
So I’m not a fan of what the Department of Public Health is trying to do but I’m also weary of the direction these companies might be going. But (unlike some confused souls) my concerns with the direction certain companies and industries are going doesn’t induce me to run towards the government and cry “regulate!!!!” We just need to, as consumers (and, really, as concerned and intelligent citizens generally), demand an ethically sound approach to genetics from these businesses.