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Second, I think we need regulation here You have no business telling other people what information they can or cannot acquire, and by what means they do so. Ev
by maratd 16y ago
Second, I think we need regulation here
You have no business telling other people what information they can or cannot acquire, and by what means they do so. Even if you're right, you still have no business dictating to others what they can and cannot do, simply because you consider yourself to be more learned and qualified to make a diagnosis.
I went to the doctor. I needed to have specific tests done, because my ethnicity is prone to very specific genetic defects in children. My wife and I needed to know if we had the appropriate markers and if precautions should be taken. I was quoted $3000 per person. That would be $6000 for myself and my wife.
23andme does those same tests and more, for $100 each. On top of that, our doctor is willing to use their results and add it to our medical records.
Again, who declared you or anyone, fit to determine which information I'm privy to and how I go about retrieving it?
- prat 16y agoSo I assume you are also against FDA regulation to force pharma companies to list adverse reactions alongside there drug commercials? If you are, then the discussion is mute, if you aren't then your point is.
- Symmetry 16y agoI think there's a large difference between prohibiting the disclosure of information, and requiring it.
- sixcorners 16y ago> you still have no business dictating to others what they can and cannot do, simply because you consider yourself to be more learned and qualified to make a diagnosis. You cannot lie to the consumer about your product.
- maratd 16y agoWho lied? 23andme is a social network with a twist. They are not pretending to be your doctor. In fact, they make you read various disclosures that reinforce that self-obvious fact.
- sixcorners 16y agoI was responding specifically to the claim that "you still have no business dictating to others what they can and cannot do." As far as 23andme is concerned, if they are not making any medical claims then they should have nothing to worry about. The linked to article linked to another article that said as much.
- deleted 16y ago[deleted]
- maratd 16y agoThis is EXACTLY my point. Your arrogance in assuming that I don't know that and then as a consequence, crowning yourself qualified to make that decision for me. That is unbelievably fucked up. Neither you nor the FDA have the MORAL right to make that decision for me. Maybe my wife and I can't afford 6K? Maybe our insurance doesn't cover it? You have no idea how informed I am. You have no idea what my financial situation is. You have no right to make those sorts of decisions for me. The FDA should stick to its mandate. It's the Food and Drug Administration, not the Anything-Remotely-Medical Administration. My genome is MY genome. Nobody has a right to it but me. NOBODY can tell me when or how I can access it.
- mbreese 16y agoI don't know your circumstances, and you don't know mine either. I am sorry that you have to deal with this though... I'm not saying that you don't have the right to know what your genome is. I'm saying that you have the right to get accurate information about what it means...
- temphn 16y agoAffymetrix is not their vendor, Illumina is. With all due respect you don't seem to know much about this space. The vast majority of laboratory developed tests (including millions upon millions of blood and urine tests done every year by LabCorp and Quest) are not cleared by the FDA. They are regulated by CLIA, like 23andMe is. So we are not debating "zero" vs "some" regulation. This is a turf war between two agencies in HHS: FDA vs. CMS. It has nothing to do with safety and everything to do with jurisdiction and funding dollars. FDA is also going after other "sister" agencies within HHS, like Blumenthal's ONC, to take over regulation of EMR and get the bling. If Shuren can get both LDTs and EMRs classified as "medical devices", he will at a stroke have increased CDRH's ambit from just "medical devices" to all laboratory tests and all medical records in the US. It will no longer be a distant third in funding to CDER and CBER, the drugs and biologics/vaccines groups in the FDA. And budgets will be increased to match. What we are debating is whether 23andMe should face $50 million of regulatory costs (to get a 510k through the FDA) vs. $5 million of regulatory costs (the ballpark amount to get a CLIA lab running). http://www.bloomberg.com/news/2010-08-04/medical-device-makers-face-revamped-u-s-rules-for-approvals.html http://www.bloomberg.com/news/2010-08-04/medical-device-make... "The cost of clearing a device through the existing 510(k) program may range from less than $1 million to as much as $50 million, compared with $50 million to $150 million under a more- stringent FDA program for higher-risk devices such as heart pacemakers"