I came across your inflamed post from March 9th and the more I read the more disappointed I became, especially when I read your comment “following twitter, it seems there may be a distinction between raw sequence and interpretation. it may be the latter where there are “gatekeepers.” probably for reasons of liability, public safety, etc. (ergo, FDA). i see the logic, but from a perspective of utility i don’t think that the regs will improve human well being. though that’s probably not the implicit rationale behind “interested parties.”” The distinction there is ABSOLUTELY CRUCIAL. There is a huge difference between providing your raw genomic information, and providing diagnostic interpretation. The AMA letter http://www.ama-assn.org/resources/doc/washington/consumer-genetic-testing-letter.pdf clearly stated that it was directed to ” direct to consumer (DTC) genetic tests that make medical claims” and it is “the making of medical claims” that puts certain offerings of DTC genetic testing squarely in the FDA’s domain; uninterpreted DTC genetic test results – the raw sequence – are NOT in the FDA’s domain under current regulations. Medical claims are. And I have not heard the FDA claim that they would even try to regulate uninterpreted DTC genetic test results. Have you? (not a rhetorical question) I found your sloppy, over-emotional post — and the unthinking overreactions by commentors, to be deeply disheartening. How can people claim to be super-smart and bellow about their right to their own information and to be better informed than 99% of MDs (sheesh there is some unsubstantiated overstatement) — how can these people lack the basic common sense, much less decency, to read carefully and think through the actual regulatory issues, before starting to self-righteously holler about being stepped on? Shame on all of you who did that. Razib – please post an “oops I over-reacted” with respect to this entire over-heated mess that you have poured oil onto. That would show some integrity and thoughtfulness, which we need more of. We do not need more emotional over-reactions to regulatory issues. The dietary supplement people are doing just fine with that.
Before entering into a presumptuous and patronizing lecture, it would have been nice to explicitly admit some conflict of interest here (some MDs arguing for control over this industry did in earlier comments). The IP originates from Joan and Sanford I. Weill Medical College and Graduate School of Medical Sciences of Cornell University. This is the internet. If you're going to get stuffy and professorial you might want to use your real name.