I read recently about the cease and desist letters sent to 23andme and other personal genomics companies selling tests directly to consumers. 23andme has responded, saying that they agree with the ultimate need for regulation, but that harnessing the consumer internet for personal genomics is a really valuable scientific tool.
I have to say I find myself doubtful about the urgency of this regulatory move. It smacks more of the hand of the AMA, an entrenched industry trying to make sure that the new tools of genetic testing remain under the thumb of doctors, than of true consumer protection. You have only to walk into Whole Foods to encounter a multi-billion dollar industry of supplements making all kinds of dubious health claims, which is completely unregulated. Why pick on personalized medicine, which has way more substance, and at least so far, way more care in the types of claims it makes?
I’m a happy 23andme customer, and it’s hard for me to see how the information they provide consists in any way of medical advice that should be subject to regulation. They are very clear to mark the scientific status of any genetic studies they report on, and never begin to presume to diagnostics. In many ways, the service is a kind of “RSS for the genome,” feeding you the results of the latest scientific studies that might be relevant to you. You can find these same studies simply by googling for them. 23andme simply says “this might be relevant” using data that you’ve provided about yourself via your genetic sample.
The benefits of what companies like 23andme are doing is enormous. Once you understand even a tiny bit about how genes affect our response to drugs, you realize just how flawed many clinical studies are. If people have different genetically programmed response to drugs, what is the right dosage? Is the drug effective? (What if it’s 100% effective for 3% of the population, due to their genetics, while it’s completely ineffective for the rest. Would we ever know?)
Ideally, every clinical study going forward would have a genetic screening component. And new studies should be done on old treatments to correlate their effectiveness with genetic data. But that’s hugely expensive.
23andme (and presumably other similar services) have come up with a very clever hack that will vastly increase the available store of genetic information that can be used to cross check various medical studies. They recruit a large population of those who are merely curious. But once that genotype data is available, they can begin to do surveys of their user population to gather corresponding phenotype data. (That is, matching genetic data with observable characteristics.)
This will be a boon to science. As Linda Avey, one of the founders, wrote on the 23andme blog:
Our first mission is to enable personal access to genetic information and provide a look, through the prism of an individual’s genome, at the flood of research discoveries being published. Our longer-term goal is to utilize a web-based platform that gives individuals the ability to share details related to their personal traits-including diseases they have and how they respond to therapies-uniformly layered on their genetic profiles to start building the evidence needed to drive targeted diagnoses and treatments.
I hope that regulators will seize the opportunity provided by the consumer internet to open up the frontier of personalized medicine. This is our data, the most personal data we have. I don’t see why it should be forced into the straight-jacket of the 20th century medical industry. We tried that with music, and what did that get us?
I’d say to let this area run for a while, and start thinking about regulation if and when it starts to go awry. Right now, the companies I’m aware of are being very careful not to promise anything that needs to be regulated.