Razib Khan doubts that the FDA going after 23andMe will have long-term consequences:
Genotyping whole genome sequencing services are soon going to be as ubiquitous as white bread. The likelihood that the FDA would ban you from reading your raw results seems low. Rather, their concern is when a firm like 23andMe interprets those results. The glaring weakness in an aggressive strategy against interpretative services is that there will always be firms such as 23andMe, and there’s no reason that they need to be based out of the United States. Not only that, but there are open-source desktop applications, such as Promethease, that provide many of the same results by combining individual raw data with public peer-reviewed literature, if less slickly than 23andMe. To truly eliminate the public health threat that the FDA is concerned about, the U.S. government would have to constrict and regulate the whole information ecology, not just a strategic portion of it, from scientists distributing research about genetic variants, to international genome sequencing firms returning raw results on the cheap.
In hindsight I suspect that the FDA targeting 23andMe is going to seem rather like the RIAA shutting down Napster. The data is coming. The institutions designed to protect the public from fraud need to think more about empowerment rather than engaging in fiat paternalism.
He fleshes out his argument in a more recent post:
Dan MacArthur is probably right that personal genomics enthusiasts overestimated how involved the average person on the street was going to want to get in terms of their own interpretations of returned results. The reality is that even genetic counselors can barely keep up. Someday the field will stabilize, but this is not that day. But overall the information overload is going to get worse and worse, not better, and where the real upside, and game-changer, will be is in the domain of computational tools which helps us make decisions with a minimum of effort. A cartoon model of this might be an artificial intelligence which talks to you through an ear-bud all day, and takes your genomic, epigenomic, and biomarker status into account when advising you on whether you should pass on the dessert. But to get from here to there is going to require innovation. The end point is inevitable, barring a collapse of post-industrial civilization. The question is where it is going to happen. Here in the United States we have the technology, but we also have cultural and institutional road-blocks to this sort of future. If those road-blocks are onerous enough it doesn’t take a genius to predict that high-tech lifestyle advisement firms, whose aims are to replace the whole gamut of self-help sectors with rationally designed applications and appliances, will simply decamp to Singapore or Dubai.
Personal genomics is a small piece of that. And 23andMe is a small piece of personal genomics. But they are not trivial pieces.
The Dish 