4 ms·

Physician here. (Disclosure: I have no financial interest in this or any related company.) (Edited out some 'heated' remarks) Medicine is NOT, I repeat, NOT 'h

by Shinkei 13y ago

Physician here. (Disclosure: I have no financial interest in this or any related company.) (Edited out some 'heated' remarks) Medicine is NOT, I repeat, NOT 'hard' science. Most of the 'normal' lab values we use when reporting things like elevated white blood cell count, anemia, etc. are based on population studies with the average considered normal and setting extremes as 'abnormal.' You will find that different hospitals even have different values of abnormal. Not to mention, for cutting edge therapies (Oncology, I'm looking at you) there is no 'standard' of care and there is a high variability between physicians. My point is that, I could go on and on about how much the field of Medicine is subject to the vagaries of stuff like regional practice, academic pedigree ("Oh, we at Hopkins always do it this way, but Mass Gen does it that way."), as well as bias like anecdotal evidence (the plural of anecdote is NOT data!) or just plain mis- or dated information. If you are out of med school/training for only a couple years, the amount of new therapies, lab tests, etc. can be staggering and if physicians aren't learning about the new, then they quickly become dated. So, what am I saying? The FDA is holding 23andMe to an unreasonable standard. If your doctor saw the same test results, they might tell you the exact same correlation (oh, you are predisposed to Alzheimer's or Parkinson's). Tests are incredibly complex... I mean we still don't have a perfect pregnancy test! Again, there is sensitivity, specificity, with false positives and false negatives. If you are unfamiliar with how inaccurate medical tests can be, please read up on some of those items. This is the best we've got for now. If people can order pregnancy and HIV tests over the internet, there's no reason they shouldn't be able to find out they 'might' have a predisposition to high blood pressure. I would argue 23andMe is not doing something so radical... as far as I'm concerned, pregnancy and HIV tests should NOT be over the counter if we are going to limit genetic screens because there is a LOT of work to be done in positives of either. Unconvinced? Well consider this. Over the counter Tylenol products are responsible for about 500 deaths per year in the US. Do you believe that Tylenol should be prescription only just because a minority of consumers make mistakes? If not, then you must conclude that over the counter sales of 23andMe should be allowed unless the FDA can show it has ACTUALLY harmed people. http://www.mercurynews.com/business/ci_23974801/tylenol-warn-users-potentially-fatal-overdose-risk http://www.mercurynews.com/business/ci_23974801/tylenol-warn...

FireBeyond 13y ago
You seem to completely miss the point, however - the FDA is asking (telling) 23andMe that they need to provide the documentation of the efficacy of their testing process. Accuracy and margin for errors, and NOT, as you seem to be implying, “forbidding the use of such a service unless accuracy can be guaranteed”. Yes, 23andMe makes claims, and uses phrases like “likely”, “most often”, and so on. The FDA is asking to be provided the evidence that such statements are accurate, or how accurate they are.
- Shinkei 13y ago
  Check their webpage: https://www.23andme.com/health/all/ https://www.23andme.com/health/all/ Under each item, there is an extensive explanation including the technical report regarding the exact details of what is being tested with citations. This is the list of FDA approved 'genetic' tests: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedur... It's a sad mismatch between practice and regulation. Industry is WAY ahead of regulation. Very common tests performed by Clinical Geneticists are not included in this list. Yes, they will give you the disclaimer, but the data is there.

by Shinkei 13y ago

FireBeyond 13y ago

You seem to completely miss the point, however - the FDA is asking (telling) 23andMe that they need to provide the documentation of the efficacy of their testing process. Accuracy and margin for errors, and NOT, as you seem to be implying, “forbidding the use of such a service unless accuracy can be guaranteed”. Yes, 23andMe makes claims, and uses phrases like “likely”, “most often”, and so on. The FDA is asking to be provided the evidence that such statements are accurate, or how accurate they are.

Shinkei 13y ago
Check their webpage: https://www.23andme.com/health/all/ https://www.23andme.com/health/all/ Under each item, there is an extensive explanation including the technical report regarding the exact details of what is being tested with citations. This is the list of FDA approved 'genetic' tests: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/ucm330711.htm http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedur... It's a sad mismatch between practice and regulation. Industry is WAY ahead of regulation. Very common tests performed by Clinical Geneticists are not included in this list. Yes, they will give you the disclaimer, but the data is there.