This is not right and needs to be stopped right now, period (yes, I am subscriber of 23 and me since 2009). Ronald Bailey (of Liberation Biology fame) is outraged like most of us:
The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.
It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test. Nevertheless the agency orders that...
...23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.
The folks at TechFreedom have just launched a petition at Change.org to FDA Adminstrator Margaret Hamburg urging her to reverse this ridiculous ban. From the petition:
The FDA also cites the genotype results that indicate the sensitivity of patients to the blood-thinning medication warfarin. Again, such results would be used by patients to talk with their doctors about their treatment regimens should the time come that they need to take the drug. In fact, in 2010 the FDA actually updated its rules to recommend genetic testing to set the proper warfarin dosages for patients.
It is notable that the FDA cites not one example of a patient being harmed through the use of 23andMe's genotype screening test. Nevertheless the agency orders that...
...23andMe must immediately discontinue marketing the PGS (Personal Genome Service) until such time as it receives FDA marketing authorization for the device.
The folks at TechFreedom have just launched a petition at Change.org to FDA Adminstrator Margaret Hamburg urging her to reverse this ridiculous ban. From the petition:
The FDA seems to think that Americans can’t be trusted with more information about their potential health risks because some people might make rash decisions with it. But banning personal genomics isn’t the answer.
We haven’t all used 23andMe yet, but those of us who have know the real problem is that doctors themselves are behind the curve. When 23andMe sent us our results, we followed their advice: we asked our doctor to talk about them. Most doctors didn’t know where to begin. But the more of us ask, the more the medical profession is catching up: brushing up on genomics, taking the time to understand the site, and talking to us about our results and what, if anything, to do about them. By prompting such dialogue, 23andMe has sparked a revolution in how the medical profession uses genetic information.
We urge you not to short-circuit this revolution. Please trust us — and our doctors — to make responsible use of our own genetic information. Instead of banning new technologies, the FDA should focus on educating doctors and patients about the benefits, and limitations, of genetic testing.
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