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Genetic tests are classified as medical devices, a category requiring a strict approval process with the FDA [1]. The other "bullshit" products [2] you mentione
by mcphilip 13y ago
Genetic tests are classified as medical devices, a category requiring a strict approval process with the FDA [1]. The other "bullshit" products [2] you mentioned do not fall in this category. The debate should start at whether 23andme tests should be classified as medical devices instead of claiming malicious targeting by lawsuits and the FDA.
[1]http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy http://www.nbcnews.com/id/37638671/#.UpWQiNIwrIy
[2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works.
- cromwellian 13y agoI personally don't think the government has a right to tell me I can't read my DNA. A medical device that tells me the chemical content of my spit can't physically harm me.
- krapp 13y agoThe government isn't saying you don't have a right to read your DNA, it's claiming this particular device is fraudulent and its ads are deceptive.
- jonallanharper 13y agoThe FDA’s letter to 23andMe calls “particularly concerning” the information the tests would provide about the gene linked to breast cancer (BRCA) “because of the potential health consequences that could result from false positive or false negative assessments.” According to 23andMe's site: "You should not change your health behaviors solely on the basis of information from 23andMe. Make sure to discuss your Genetic Information with a physician or other health care provider before you act upon the Genetic Information resulting from 23andMe Services. For most common diseases, the genes we know about are only responsible for a small fraction of the risk. There may be unknown genes, environmental factors, or lifestyle choices that are far more important predictors. If your data indicate that you are not at elevated genetic risk for a particular disease or condition, you should not feel that you are protected. The opposite is also true; if your data indicate you are at an elevated genetic risk for a particular disease or condition, it does not mean you will definitively develop the disease or condition. In either case, if you have concerns or questions about what you learn through 23andMe, you should contact your physician or other health care provider." (Paraphrased from Harry Binswanger's article: http://onforb.es/1iQEN4U http://onforb.es/1iQEN4U)
- SilasX 13y agoThat's messed up, that there are stricter standards for a) (correctly) reporting the current state of research regarding a patient's genetic markers, than for b) someone to sell an unproven, expensive technique as a remedy as long as they include some disclaimers.
- MartinCron 13y ago[2]Acupuncture seems to help my migraines. I'm comfortable with not having a rational explanation for why it works. The placebo effect is a perfectly rational explanation for why acupuncture seems to help with your migraines.
- jmagoon 13y agoIt's always impossible to tell on the internet, but I would suggest that you would be unlikely to make this statement if you've actually had migraines.
- projct 13y agoOne would be more likely to make the statement the GP made (placebo effect helping with migraines) if one trusts data over anecdotes: http://www.ncbi.nlm.nih.gov/pubmed/20187863 http://www.ncbi.nlm.nih.gov/pubmed/20187863 pdf of above review: http://www.researchgate.net/publication/41620466_Migraine_treatment_and_placebo_effect/file/9c96051745dcd672fe.pdf http://www.researchgate.net/publication/41620466_Migraine_tr...)
- MartinCron 13y agoFair enough. My wife suffers from migraines, so I don't mean to trivialize. Nor do I mean to demean by suggesting that it is the placebo effect. If it brings you relief, I am in no position to judge.