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| This Dillweed Here |
discover | It’s been a busy few days in the world of personal genomics. By coincidence I have a coauthored comment in Genome Biology out, Rumors of the death of consumer genomics are greatly exaggerated (it was written and submitted a while back). If you haven’t, please read the FDA’s letter, and 23andMe’s response, as much as there is one right now. Since Slate ran my piece on Monday a lot of people have offered smart, and more well informed, takes. On the one hand you have someone like Alex Tabarrok, with “Our DNA, Our Selves”, which is close to a libertarian cri de coeur. Then you have cases like Christine Gorman, “FDA Was Right to Block 23andMe”.
It will be no surprise that I am much closer to Tabarrok than I am to
Gorman (she doesn’t even seem to be aware that 23andMe offers a
genotyping, not sequencing, service, though fuzziness on the details
doesn’t discourage strong opinions from her). An interesting aspect is
that many who are not deeply in the technical weeds of the issue are
exhibiting politicized responses. I’ve noticed this on
Facebook, where some seem to think that 23andMe and the Tea Party have
something to do with each other, and the Obama administration and the
FDA are basically stand-ins. In other words, some liberals are seeing
this dispute as one of those attempts to evade government regulation,
something they support on prior grounds. Though Tabarrok is more well
informed than the average person (his wife is a biologist), there are
others from the right-wing who are taking 23andMe’s side on normative
grounds as well. Ultimately I’m not interested in this this argument, because it’s not going to have any significant lasting power. No one will remember in 20 years. As I implied in my Slate piece
23andMe the company now is less interesting than personal genomics the
industry sector in the future. Over the long term I’m optimistic that it
will evolve into a field which impacts our lives broadly. Nothing the
United States government can do will change that.
Yet tunneling down to the level of 23andMe’s specific issues with the
regulatory process, there is the reality that it has to deal with the
US government and the FDA, no matter what the details of its science
are. It’s a profit-making firm. Matt Herper has a judicious take on
this, 23andStupid: Is 23andMe Self-Destructing? I
don’t have any “inside” information, so I’m not going to offer the
hypothesis that this is part of some grand master plan by Anne Wojcicki.
I hope it is, but that’s because I want 23andMe to continue to
subsidize genotyping services (I’ve heard that though 23andMe owns the
machines, the typing is done by LabCorp. And last I checked the $99
upfront cost is a major loss leader; they’re paying you to get typed).
I’m afraid that they goofed here, and miscalculated. As I said above, it
won’t make a major difference in the long run, but I have many friends who were waiting until this Christmas to purchase kits from 23andMe.
Then there are “the scientists,” or perhaps more precisely the genoscenti. Matt Herper stated to the effect that the genoscenti have libertarian tendencies, and I objected. In part because I am someone who has conservative and/or libertarian tendencies, and I’m pretty well aware that I’m politically out of step with most individuals deeply involved in genetics, who are at most libertarian-leaning moderate liberals, and more often conventional liberal Democrats. Michael Eisen has a well thought out post, FDA vs. 23andMe: How do we want genetic testing to be regulated? Eisen doesn’t have a political ax to grind, and is probably representative of most working geneticists in the academy (he is on 23andMe’s board, but you should probably know that these things don’t mean that much). I may not know much about the FDA regulatory process, but like many immersed in genomics I’m well aware that many people talking about these issues don’t know much about the cutting edge of the modern science. Talk to any geneticist about conversations with medical doctors and genetic counselors, and they will usually express concern that these “professionals” and “gatekeepers” are often wrong, unclear, or confused, on many of the details. A concrete example, when a friend explained to a veteran genetic counselor how my wife used pedigree information combined with genomic data to infer that my daughter did not have an autosomally dominant condition, the counselor asserted that you can’t know if there were two recombination events within the gene, which might invalidate these inferences. Though my friend was suspicious, they did not say anything, because they were not a professional. As a matter of fact there just aren’t enough recombinations across the genome for an intra-genic event to be a likely occurrence (also, recombination likelihood is not uniformly distributed, and not necessarily independent, insofar as there may be suppression of very close events). And this was a very well informed genetic counselor.
