Last week’s Congressional hearings on the direct-to-consumer genetics industry (featuring a provocative GAO report based on covertly recorded phone calls made to major DTC companies) have spurred plenty of discussion, including Daniel MacArthur’s post here at Genomes Unzipped and Dan Vorhaus’ post at Genomics Law Report.
But we disagree with some other Genomes Unzipped members about the regulatory future of the industry, and in particular we believe that medical interpretation of genetic data should be regulated.
We are both of the view that in general, it’s preferable to avoid government regulation because it imposes a cost on innovation and reduces market freedom. On the other hand, we accept government regulation over some things in the interest of public safety (e.g. drugs, automobiles), or law and order (e.g. guns, nuclear material). It’s one price we pay for the benefits of living in an orderly society.
In applying these principles to this question Matt Hurles found a good balance: light- or self-regulation on providing people with readouts of their genomes, but heavier regulation on selling a medical interpretation of those data. In other words, if you want your raw genotype data — all those As, Cs, Gs, and Ts, and nothing else — and you’re willing to pay for it, then you should be able to get it. The testing labs already have to pass CLIA certification to ensure they provide high quality data, and we believe all the Unzippers agree that regulation of this aspect of DTC genetics is appropriate.
The trickier question (where disagreement arises) is how to regulate the interpretation of those results, whether by a private company or a medical practitioner. Whereas the technical accuracy side of DTC genetics is carefully monitored, at the moment, the interpretations provided by DTC companies are sold in what is effectively a free market. For other commodities we would generally allow the market to find the right balance between the companies acting in the interest of the customer (provide them with only validated, useful information) and in their own interest (increase profits by providing a sexy story about customers’ genomes). Society doesn’t, however, allow the practice of medicine to operate in an open market because we place a special value on it, and therefore impose regulations to ensure a minimum standard of care.
The key question therefore is whether the medical interpretation of DTC genetic information should be held to that same standard. The GAO report, for all its flaws, has at least shown that DTC genetics companies, by providing inaccurate information about risks, are not currently meeting that interpretive standard. Furthermore, some are following unethical practices (e.g. encouraging people to send in someone else’s DNA without consent), which falls well short of the conduct expected from the medical profession. To us, at least, that’s sufficient grounds for heavier regulation of these aspects of the industry.
Finally, we agree with many comments that we should be careful not to immediately conflate regulation with over-regulation. Nothing we’ve seen so far suggests that some form of sensible regulation can’t be implemented; let’s wait to see the proposed regulations before passing judgement.