Who was that masked bureaucrat? I didn’t even have a chance to thank him.
Dr. Alberto Gutierrez—the FDA’s director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health—talks to NEWSWEEK about the personal genomics crackdown:
So the problem is that the companies are testing for genetic variants that might affect the way consumers make medical decisions?
That’s correct … If you’re making a claim about [a genetic variant that affects the metabolism of the anticoagulant drug] warfarin, and somebody decides based on the result they get that they want to change their dosing, that is a fairly risky decision. That could affect their health. If they’re not feeling well on their current dose and the drug is expensive, we don’t know what they would do.
Last time I checked, one could not buy warfarin over-the-counter. Oh well, I guess there’s still no way we could ever know what they would do. Fortunately the NIH would never support a website where anyone could input her own genotype data to evaluate her own warfarin dosing.
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What Knome sells is more of a service than a device. It’s basically a software program that explains genetic data that consumers can have generated elsewhere. Can you explain to me why it requires pre-market clearance?
Software is a medical device, and they’re making medical claims. They’re taking results and making medical claims that come out of those results.
Gosh, I sure hope WebMD, mayoclinic.com, yourdiagnosis.com, medhelp.org, medicinenet.com, healthcaremagic.com, emedicine, MedicineNet, and healthline.com have pre-market clearance. And fortunately the NIH would never support software blah blah blah…
UPDATE: In contrast to my screed, the Genomics Law Report offers a more balanced, detailed and sober analysis.
I work as an Assistant Professor in the Duke University Institute for Genome Sciences & Policy (although this site and its content are my own).
In 2007 I became the fourth subject in Harvard geneticist George Church's Personal Genome Project. As the PGP moves forward, I am chronicling the dawn of personal genomics, that is, people obtaining their genomic information for whatever reason(s) and figuring out what to do with it. I am interested in the relevant technologies and especially the attendant privacy and other ethical/legal/social issues.
This blog may also discuss some of my non-genome interests or, to paraphrase Dwight Yoakam, "Guitars, Cadillacs, hillbilly music, etc etc."
The header image comes from the Liz Lerman Dance Exchange's multimedia performance piece, "Ferocious Beauty: Genome."