It’s been over a week since I’ve addressed the “F.D.A. D.T.C.” controversy. I plan on getting back to the issue in more detail later, but right now I thought I’d point you to Robert Verbruggen’s article in National Review. It’s titled ‘The FDA’s Genetic Paternalism’. Robert contacted me for my take on the issue, and you get a few choice quotes from yours truly. It being National Review you can guess the general tenor of the objections from that quarter. Over the past few weeks tracking inbound links and Twitter mentions it does look as if the coming possible restrictions on direct-to-consumer personal genomics have triggered more suspicion and opposition from the political Right. Even with that said, my friends Michelle and Zack, who I think are accurately characterized as on the political Left, also both expressed great reservations about the thrust of Jeffrey Shuren’s comments. Nor do I think that the Genomes Unzipped crowd are all Right-libertarians. Even those who assert the need for regulation and some intermediation between genomic results and the patient/consumer are unhappy with the way the government and some pro-regulation activists have been approaching the matter.
Overall I’d say there are two broad political-philosophical tracks by which you can approach the issue of regulation of genomic results. The first is one of rights. That is, you have a right to your genomic information. This is a clean and simple intuition, though the reality is that “fundamental rights” are often contested and constrained. So let us contest for our right! The second avenue is one of consequentialism. What are the consequences of D.T.C. personal genomics? I think in my writing on this topic you can infer that I believe a relatively loose regulatory regime for D.T.C. personal genomics at this stage of the industry is justified. This may make some readers nervous, as they believe that loose regulation in other domains has wrought havoc on our society. But to my mind most of the negative consequences of D.T.C. personal genomics being unfettered from specialist interpretation seem rather overwrought in the broader context other public health issues. There is far more low hanging fruit in terms of efficacy upon which the fiat power of government could be brought to bear, but many of those actions are blocked by the nature of interest group politics. D.T.C. personal genomics as an actionable complement to personal health is not “prime time” yet in any case, and the instinct to restrict & regulate at this stage seems like the precautionary principle gone wild. Yes, 23andMe is not too big to fail, like Goldman Sachs or AIG, but it is small enough that the government can make it fail. In which case the American consumer has been protected from the malevolent intentions of Sergey Brin’s wife, and can look forward to the blossoming of Asian genomics firms which step in to fill the breach.
I can accept that the public in some cases needs to be “protected from itself.” But let us set the bar high.