Last July, before I moved to the spacious new digs here at PLoS, I wrote a rather lengthy and mournful post about the ugliness that was the Congressional hearings on direct-to-consumer genomics:
We saw a very similar hearing — with the same undercover M.O. and public perp walk — in 2006. Were/are some companies behaving badly? Absolutely. And they should be called on the carpet. But let’s not kid ourselves: this dog and pony show was as much an opportunity for chest beating and righteous indignation as it was for “protecting the public health.” It was an opportunity for politicians to scream “snake oil” and fret about the possibility of their constituents “jumping off a building” as much as it was an attempt to bring about constructive change to a nascent industry’s practices. Why is that? Why is the demand for data never made of the alarmists? Why do the companies not get to see the GAO’s report ahead of time? Why did the FDA exhibit a genuine spirit of open inquiry and invite a broad range of stakeholders to its meeting while Congress could not be bothered to do the same? Why does the outcome of such hearings always seem to be a foregone conclusion?
As far as I can tell, we still don’t have satisfactory answers to these questions (I’m not holding my breath). And now Michael Lee over at the FDA Blog raises at least one more: did the FDA behave disingenuously during its public humiliation of 23andMe?
A smoking gun? I don’t know. Videos can be misleading sometimes, right? Would potential misrepresentation of 23andMe’s activities be a huge deal, even under oath? By itself, probably not. So why flog this horse eight months later? Because right now the FDA is revisiting the issue of how and whether to regulate consumer genomics companies. If last year’s monkey trial hearings were predicated on testimony that turns out to have been anything less than cricket, then–in my mind, at least–it calls into question whether the self-righteousness of those who were doing the finger-pointing ought to be taken at face value.
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