It's My Genome and I'll Do What I Wanna

Thursday, July 22, 2010

"Sometime in the next six months I expect to have in my possession a whole genome sequence for myself. Six billion of these ACTGs and order and location which ones have been repeated and deleted all these kinds of things. In the near term I expect that to be useful for answering some health questions now. I also expect those ACTGs all information about them to be useful for me to questions that we don't know the answers to yet but will over the next 20 years. So what I'm seeking this afternoon is...why you might regulate my access to that data, those As, Cs, Ts, and Gs that describe a portion of myself, not knowing what they might be useful for in the future."
Greg Biggers, LDT meeting (based on preliminary transcript) 7/19/10

Fans of DTC genomics seem to be under the impression that the above comments dealt a strong blow against the proposed change in enforcement practices. I'm inclined to think they're reading far too much into too little data. Go figure.

FDA passed on the opportunity to set Mr. Biggers straight a couple times. I assume that's because it's not to their advantage to debate someone standing at an open mic who opens his comments claiming to be their boss.

Be that as it may, I think both Mr. Biggers and his supporters deserve a clear, direct answer, so here goes...

Your genome is your genome. Nobody with any influence is seriously proposing any rule or regulation that prevents any individual from obtaining their personal, uninterpreted genetic sequence. So let's get that clear: it's your genome.

At the risk of pointing out the obvious, we each also own our blood, saliva and various other tissues and fluids. Hopefully, we're on the same page so far.

The fact that we each own our own bodies does not grant service providers carte blanche to sell medical services, interpretations, predictions, diagnoses or other products that make use of these samples. The problem with the "I own my own genome" argument is that there is a very big difference between patients owning information and service providers selling interpretations of that information.

We all own our sequences and I don't see anyone trying to keep any of us from knowing what they are. I doubt FDA will care if we want to spend our time reading SNPedia if that's what makes us happy. After all, it's a free country.

Yes, it's a free country... but it's not a free-for-all. People who make and sell medical interpretations still need to show that their interpretations are based on something other than conjecture, preliminary research papers and the desire to sell stuff. We use fancy terms like "clinical validation" but what we really mean is "prove that you're not full of it."

I share your desire to live in a world where genomic information adds important data to medical decisions. The difference is, I've been in this industry long enough to recognize that half-baked products and empty promises are far more likely to slow the advance of science, not to speed it up. 

We won't all agree on exactly how, when, and where the bar should be set and open debate is a healthy thing. But please understand that the current debate has nothing to do with ownership of personal information. We're talking about the ability of third parties to tell us what our medical information means.

We've regulated that kind of offering in the past and will continue to do so in the future.

 

Tags: CLIA, Enforcement, FDA, IVD, Industry, LDTs

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