4 ms·

The fact that they're not marketed as a clinical tool for diagnoses? From the 23andme homepage: "A simple DNA test led to an unexpected diagnosis for a mother

by kohanz 13y ago

The fact that they're not marketed as a clinical tool for diagnoses? From the 23andme homepage: "A simple DNA test led to an unexpected diagnosis for a mother and daughter, changing their lives forever.". Obviously the key is the "led to" phrasing, but you can't deny how that wording is trying to position the product. The fact that they are not marketing themselves as a substitute for seeing your doctor and in fact encourage you to seek out your doctor if you have real health concerns? As I mentioned in another 23andme thread, basic take-home pregnancy tests are regulated by the FDA. Certainly, when one of those tells you that you are pregnant, your actions don't stop there and you will eventually follow up with a medical professional. What differentiates 23andme's genetic testing from a pregnancy test? (on a side-note, I would appreciate an explanation for the down-vote on my earlier post in this thread. Are we supposed to down-vote people we disagree with, or was there something wrong with my wording?)

crusso 13y ago
What differentiates 23andme's genetic testing from a pregnancy test? I'd say that it's the specificity of the purpose of the test and the scientific understanding of what is being confirmed. Women go to the drugstore to buy a pregnancy test because they have a REASONABLE EXPECTATION of learning whether or not they're pregnant. Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used instead. 23AM is doing something much different. They're allowing you to have markers identified in your DNA for a very low cost and then they link those markers to labels and information sources as well as tying them in with their own correlations to other 23AM users. It's all very unspecific and bleeding edge. It's not about proving every little correlation and its interpretation - it's about providing that information to users and letting them make their own decisions. What amazes me is that here on HN where we want the source to every driver, the schematic to every chip, and the right to know every secret of the government related to our personal information -- there are those who are arguing that we should not be allowed to have data pulled straight out of our genome and correlated with the data from other users unless fully sanctioned and sanitized by a government agency that is woefully incapable of operating in a fast-moving environment where uncertainty is okay and a REASONABLE EXPECTATION. I would appreciate an explanation for the down-vote on my earlier post in this thread Meh, I got downvoted earlier too... I try not to worry about it since Karma means nothing. I'm more interested in learning new things from others and clarifying my own personal philosophy while practicing expressing myself.
- kohanz 13y ago
  Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used instead. First, you can't substitute UL for the FDA, they have very different mandates. However, with deep enough pockets, UL will hand-hold you through the FDA process. With the kind of funding 23andme has had, following FDA guidelines would not have been prohibitive. Second, pregnancy tests have been around for a relatively long time and are well-understood and established. The point is, if these are still under regulatory control, how can one argue that something much less established, understood, and developed, in terms of a take-home medical test should not be subject to the same rigor. What amazes me is that here on HN where we want the source to every driver, the schematic to every chip, and the right to know every secret of the government related to our personal information -- there are those who are arguing that we should not be allowed to have data pulled straight out of our genome and correlated with the data from other users unless fully sanctioned and sanitized by a government agency that is woefully incapable of operating in a fast-moving environment where uncertainty is okay and a REASONABLE EXPECTATION. The whole point of regulation is that having medical tests, drugs, and devices coming out of a "fast-moving environment" where "uncertainty is okay" is not safe. If you don't like this regulation, either lobby effectively to change it or get your medical services in a non-regulated jurisdiction. To not obey the regulations out of disagreement is like saying "I don't believe that stealing is a crime, so I'm immune to those laws". Take the liberation therapy for multiple sclerosis [1] as an example. Some claim it to be a revolutionary treatment that drastically reduces the symptoms and onset of MS. However, this has yet to be proven in a rigorous clinical trial. You would argue that as a consenting adult, paying for the procedure yourself, you should be allowed to do what you want. And you can, just not in the United States (or Canada, or many other countries). The FDA is not just going to let doctors start implementing this risky and unproven treatment [2]. There are too many people out there who assume that because a food, drug, medical test, device is being sold or used, that it is safe, that we can't just let them find out on their own. Just because you feel fully informed and consenting about these things, doesn't make that the norm. In the end, I'm still not clear on what your stance is. Is it for FDA reform and the reduction of its scope? If so, that needs to be backed up with a rigorous definition of how things stay safe in the new regime. Regulation is all about not letting stuff slip through the cracks. Is it that 23andme is not a medical device and should be exempt from regulation? If so, then when the very first pregnancy test was developed, it should have been regulation-free as well. [1] http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_insufficiency http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_in... [2] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...
jfb 13y ago
META-NOTE: I wouldn't worry overmuch about downvotes. I often fat-finger downvote when using my phone, for instance.

by kohanz 13y ago

crusso 13y ago

What differentiates 23andme's genetic testing from a pregnancy test? I'd say that it's the specificity of the purpose of the test and the scientific understanding of what is being confirmed. Women go to the drugstore to buy a pregnancy test because they have a REASONABLE EXPECTATION of learning whether or not they're pregnant. Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used instead. 23AM is doing something much different. They're allowing you to have markers identified in your DNA for a very low cost and then they link those markers to labels and information sources as well as tying them in with their own correlations to other 23AM users. It's all very unspecific and bleeding edge. It's not about proving every little correlation and its interpretation - it's about providing that information to users and letting them make their own decisions. What amazes me is that here on HN where we want the source to every driver, the schematic to every chip, and the right to know every secret of the government related to our personal information -- there are those who are arguing that we should not be allowed to have data pulled straight out of our genome and correlated with the data from other users unless fully sanctioned and sanitized by a government agency that is woefully incapable of operating in a fast-moving environment where uncertainty is okay and a REASONABLE EXPECTATION. I would appreciate an explanation for the down-vote on my earlier post in this thread Meh, I got downvoted earlier too... I try not to worry about it since Karma means nothing. I'm more interested in learning new things from others and clarifying my own personal philosophy while practicing expressing myself.

kohanz 13y ago
Personally I wish the FDA would get out of the business of validating each pregnancy test product on the market. I'd prefer that something like the UL be used instead. First, you can't substitute UL for the FDA, they have very different mandates. However, with deep enough pockets, UL will hand-hold you through the FDA process. With the kind of funding 23andme has had, following FDA guidelines would not have been prohibitive. Second, pregnancy tests have been around for a relatively long time and are well-understood and established. The point is, if these are still under regulatory control, how can one argue that something much less established, understood, and developed, in terms of a take-home medical test should not be subject to the same rigor. What amazes me is that here on HN where we want the source to every driver, the schematic to every chip, and the right to know every secret of the government related to our personal information -- there are those who are arguing that we should not be allowed to have data pulled straight out of our genome and correlated with the data from other users unless fully sanctioned and sanitized by a government agency that is woefully incapable of operating in a fast-moving environment where uncertainty is okay and a REASONABLE EXPECTATION. The whole point of regulation is that having medical tests, drugs, and devices coming out of a "fast-moving environment" where "uncertainty is okay" is not safe. If you don't like this regulation, either lobby effectively to change it or get your medical services in a non-regulated jurisdiction. To not obey the regulations out of disagreement is like saying "I don't believe that stealing is a crime, so I'm immune to those laws". Take the liberation therapy for multiple sclerosis [1] as an example. Some claim it to be a revolutionary treatment that drastically reduces the symptoms and onset of MS. However, this has yet to be proven in a rigorous clinical trial. You would argue that as a consenting adult, paying for the procedure yourself, you should be allowed to do what you want. And you can, just not in the United States (or Canada, or many other countries). The FDA is not just going to let doctors start implementing this risky and unproven treatment [2]. There are too many people out there who assume that because a food, drug, medical test, device is being sold or used, that it is safe, that we can't just let them find out on their own. Just because you feel fully informed and consenting about these things, doesn't make that the norm. In the end, I'm still not clear on what your stance is. Is it for FDA reform and the reduction of its scope? If so, that needs to be backed up with a rigorous definition of how things stay safe in the new regime. Regulation is all about not letting stuff slip through the cracks. Is it that 23andme is not a medical device and should be exempt from regulation? If so, then when the very first pregnancy test was developed, it should have been regulation-free as well. [1] http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_insufficiency http://en.wikipedia.org/wiki/Chronic_cerebrospinal_venous_in... [2] http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/uc...

jfb 13y ago

META-NOTE: I wouldn't worry overmuch about downvotes. I often fat-finger downvote when using my phone, for instance.