(It looks like this has become Regulation Week here on Genomes Unzipped; Daniel’s initial post sparked a ferocious comments thread, and follow-up posts from Caroline, Dan V and Jeff and Kate continue to add fuel to the discussion. We have one more post on regulation to come to round off the week, before next week returning to our regular, more balanced schedule of posts.)
It’s becoming clear that the arguments with regards to direct-to-consumer (DTC) genetics here aren’t really about regulation per se; I doubt anyone wants to see companies be allowed to make any claims they wish without requiring accuracy or consumer protection. So what exactly are we arguing about?
There are a set of arguments that essentially come down to how one trusts the FDA to act rationally and in everyone’s best interests: some people point to recent statements from FDA officials as evidence that they will apply overly strict regulation, or regulation that requires implausible amounts of money and effort to comply with; others point to the American government’s strong tradition of supporting business, and assume that cooler heads will prevail when it actually comes to making policy. These are arguments about the FDA specifically, and the American legal and legislative system in general, that only one of the Genomes Unzipped contributors has a strong background in.
Beyond specific questions about the actions of the FDA, discussions in the comments here and elsewhere appear have brough up two differing viewpoints about what DTC regulation should look like. One viewpoint (e.g. Daniel MacArthur’s) proposes a Trade Standards/consumer protection type regulatory mechanism; ensuring technical accuracy, associations and health claims based on well-supported scientific evidence, and a lack of misleading or confusing claims or presentation. The other suggests that we need to go further, and proposes something more akin to the regulation of medical practice; some combination of proven clinical utility, proven lack of significant clinical harm, direct supervision by a trained medical professional and high standards of informed consent.
To put it another way, the first viewpoint suggests that industry best practice, embodied by 23andMe’s white papers, deCODEme’s Code of Conduct, and the transparency afforded by the Genetic Testing Registry grants sufficient protection for the public. The role of regulation should be to distill these best practices into legal guidelines, which companies that stray from can be prosecuted for. Any more regulation, and we intefere with the right of individuals to access and engage with their own genetic information, any less and we allow them to be taken advantage of.
The second viewpoint implies fatal flaws in existing best practice, and that by making medical claims the DTC genetic testing industry have attempted to take on the mantle of medical professionals. Carrier testing, BRCA screening and breakdowns of actionable health risks are the purview of clinical geneticists, with the extensive training, vetting and oversight doctors are subject to; if DTC genetics companies want to share this turf, they should be subject at least some of the same requirements.
My aim in this post isn’t to come to a conclusion on which approach is correct; I seem to have convinced myself of both views sequentially while writing it. From my point of view, the series of posts and the diverse comments they have inspired have helped me clarify in my mind, if not what I think is the right approach, at least what questions need to be asked to lead us to the right approach.
Tomorrow we will have our last regulation post (for the moment) by Dan Vorhaus, summarising the various issues that have been raised, and the key questions we need to think about as we move forward.