I’m interrupting my blog hiatus to discuss direct-to-consumer (or DTC) genetic testing, an issue that has recently become a cause célèbre (at least among the relatively small group of people concerned about it) and that I think deserves wider attention, as it’s an early indicator of some of the disruption that will occur around health care in the 21st century.
In recent years the cost of sequencing human genomes (i.e., the DNA information that makes you you) has been dropping like a rock. While getting your complete personal genomic data is still relatively expensive (thousands of dollars), the cost of getting less complete data is now at the point where it’s almost an impulse purchase; for example, the startup company 23andme offers a service for $199 plus $5 per month that provides information on various places where your genome might differ from other peoples (“single nucleotide polymorphisms” or “SNPs,” pronounced “snips”) and some interpretation on what such differences might mean.
I have some interest in where the genetics revolution is taking us, and am a regular reader of Daniel MacArthur’s “Genetic Future” blog and a couple of others on related topics. A few months ago I read about 23andMe having an end of year sale, and thought it might be fun to spring for my own 23andMe data. Unfortunately when I went to order my own test kit and entered in my home address I got the following notice:
Notice to Maryland Customers
We are currently unable to offer our services in the state of Maryland. We apologize for the inconvenience. Contact us at help@23andme.com for more information.
I was then advised to “select another state.”
Based on a post by genealogy blogger Tim Agazio and an informative report from the Genetics and Public Policy Center at Johns Hopkins, it appears that 23andMe has run afoul of Maryland laws and regulations that prohibit offering medical test services directly to individuals, with DTC genetic test services like 23andMe’s being considered to fall under this prohibition.
There are fierce disputes over to what extent government (both at the Federal and state level) should regulate services that provide personal genetic data directly to consumers, including interpretation of that data. Each side has its arguments. To simplify and somewhat caricature them, one side seeks to protect uninformed consumers from fly-by-night companies that scam patients by offering inaccurate tests and misleading and even dangerous medical interpretations of genetic data. The other side sees an overly paternalistic government trying to shut down innovative new startups at the behest of physicians trying to hold on to their traditional role as the gatekeepers of medical information of interest to patients.
My sympathies are with the latter view. As we saw in the “direct shipping” controversy, paternalism can definitely be taken too far, with extreme hypothetical scenarios being used to squelch innovative new services in a manner that (not so coincidentally) happens to favor incumbent providers with political clout. I believe that individuals have a right to order tests that provide information about their own genome, and that a lighter and more nuanced regulatory regime is ultimately in the best interests of the general public.
So, back to Maryland: For a state that’s looking to promote biotechnology as an engine of its future economy, it seems misguided to choke off business innovation in the area of personal genomics, especially in an era when people are living longer and are urged to take more personal responsibility for their health. I find it ironic that NEA, one of 23andMe’s investors, has two of its three US offices in Maryland, but Maryland is a “no-go area” for 23andMe’s service. It’s not so much ironic but depressing that 23andMe and similar companies can’t solicit as customers geneticists and others in Maryland who are potential future entrepreneurs in this space.
Unless, of course, they move to Virginia. I think the whole “Virginia is better for businesses than Maryland” theme is a bit overblown in general, but in this case I think it’s on the mark. The relevant Virginia law seems much more commonsensical, allowing individuals to order their own medical tests and absolving physicians of any responsibility if people don’t consult a medical professional concerning the tests’ results.
So here’s my challenge to Allan Kittleman (my representative in the Maryland Senate) and Gail Bates and Warren Miller (my representatives in the Maryland House of Delegates): Next legislative session, why not focus less on legislation that’s primarily relevant to yesterday’s industries and instead turn your attention to more sensible regulation of one of the emerging industries of tomorrow?
UPDATE 2015/07/29: Fixed various broken links.
Andre Gous - 2011-03-18 07:32
I enjoyed your article, thank you. My company, Precision Quality DNA, opposes government regulation on principle – but in the DTC market, it is an exceptionally bad idea. As if that’s not bad enough, the approach the FDA has been taking is especially inappropriate. As far as I can tell, my company is “the lone ranger” when it comes to making a principled stand in favor of the free market. More details can be read at: http://pqdna.com/hjsasp/gn02.cfm?ID=087913282360 Thank you for speaking out. Regards, Andre Gous CEO, Precision Quality DNA
Rob W (warthenr@yahoo.com) - 2011-04-12 14:21
I completely agree that this is strange for a bio friendly state to be so backwards. I would understand if they required some sort of disclaimer that the information provided is still in it’s infancy and may be improved upon as we learn more information, but getting more and more DNA out there and can only help us better understand some our history.
hecker - 2011-04-12 16:04
Rob W: Thanks for stopping by. It would be interesting to explore the history of the relevant Maryland laws and regulations around lab testing. I’m pretty sure this all predates the genetic testing controversy, and it may even predate Maryland involvement in biotech. I’m not sure if the motivation for the law was primarily government paternalism (i.e., we need to protect people from themselves) or if there was a major push by doctors or other special interest groups to block direct-to-consumer lab testing.