Wednesday, March 26, 2008

Bringing the genome home ... but why?

This story in the Washington Post gives a decent overview of the growing number of firms out there who promise to improve our lives by giving us insight into our individual genetic profiles. Current players who offer screening include 23andme, Knome (which its founder, Harvard geneticist George Church, wishes we would pronounce "know-me"). Then there are those who claim to provide genetically-based information or advice, ranging from (your DNA is used to find you a suitable date) to Genelex (which offers a mishmash of testing options, ranging from diet advice to predictive testing for periodontal disease) to Navigenics (which claims, "your genes offer a road map to optimal health"). I'm not even going to get into the outfits that offer to trace individuals' ancestry.

Here's a fact about all these businesses: not a one of them is subject to FDA oversight. So all these claims about health benefits, etc., resulting from their services can be completely false (or at least, not based on evidence), and nothing can be done about it. If you read even a *tiny* bit of the scientific literature on genetics and "personalized medicine," you will be struck by how few experts make such claims, at least for the near term. Instead, they talk about the promise of genetics ... while acknowledging that there's an awful lot we don't know. (Along these lines, see this commentary from last week's issue of the Journal of the American Medical Association, featuring none other than the head of the National Human Genome Research Institute.) Bottom line? Given that most health conditions and risks seem to be multifactorial, involving multiple genetic factors as well as environmental influences that we don't yet understand, this stuff is a long way off.

In the meantime, though, consumers should be protected from grossly overstated or unproven claims. Whether that falls to FDA or to someone else (though the Consumer Protection Agency probably has enough work to do at the moment -- lead paint in toys, anyone?), it seems to me the Feds ought to step up on this one.

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