5 ms·

This is more complex than the simplistic picture you paint. I'm moderately on the side of government not interfering where possible. But medicine and medical d

This is more complex than the simplistic picture you paint. I'm moderately on the side of government not interfering where possible. But medicine and medical devices is one area in which such interference is quite likely a positive influence, on the whole. Fact is, we don't want a return to the era of patent medicines. For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. And these people will base life- and health-affecting decisions on the results provided by unregulated products. Then maybe they'll get sick or die. That's why there are regulatory standards for medical devices and services. These standards don't prevent the sale of 23andme's services, but require that they are either a) regulated and proven to work, or b) explicitly and clearly described as not being so. Yes, there are rampant inefficiencies within this system. But I'd wager that it's probably better than the alternative.

dnautics 13y ago
For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Now it is debatable as to whether the individual's interpretation is (for example in the Alcohol Dehydrogenase gene, many, many, many caucasian users don't bother to read that the test is only informative for asians, but it's definitely there, in bold letters, etc.) Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? Maybe it's "because I'm sophisticated", but this biochemist can't really see that happening.
- dragonwriter 13y ago
  > The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Certainly, there is science to support certain claims of the class made in the reports 23andMe provides being made with some degree of reliability based on the kind of inputs 23andMe takes in. Whether what 23andMe actually does from end-to-end makes the actual reports they provide reliable in real world condition is...well, exactly the question they have seem to have decided not to expend the effort to answer even after initiating the process of getting clearance from the FDA to market their diagnostic product.
- matthewmacleod 13y ago
  The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable That's the point of certification - is the process reliable? Are the warnings clear? I won't cast any aspersions on the product (because it's pretty awesome), but I do see these as risks and requirements. Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? "I've got all these symptoms of diabetes. But 23andme said I had a low risk! It's probably nothing. Guess I'll eat another pie." If 23andme has shoddy lab practices, or unclear explanation of the limitation of their testing, then that's a risk. The process of certification involves managing that risk.
  - deleted 13y ago
    [deleted]
- aestra 13y ago
  >Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001877.. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001877.... (this study is about mammograms of healthy women, another example of a health screening tool) We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. The trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, after 10 years (RR 1.02, 95% CI 0.95 to 1.10) or on all-cause mortality after 13 years (RR 0.99, 95% CI 0.95 to 1.03). Numbers of lumpectomies and mastectomies were significantly larger in the screened groups (RR 1.31, 95% CI 1.22 to 1.42) for the two adequately randomised trials that measured this outcome; the use of radiotherapy was similarly increased. So women who get more screening get more treatment but didn't live longer (unnecessary treatment) Study continues: This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress for many months because of false positive findings. It is thus not clear whether screening does more good than harm. To help ensure that the women are fully informed of both benefits and harms before they decide whether or not to attend screening, we have written an evidence-based leaflet for lay people that is available in several languages on www.cochrane.dk.
  - dnautics 13y ago
    yes, but getting a mammogram has an additional layer of regulation in between the end-user of 23andMe. A licensed radiologist should look the person askew when they insist on getting extra mammograms because of 23andMe, and order a follow-up BRCA test before proceeding.
    - aestra 13y ago
      Wow, no. You aren't seeing it. A mammogram is a screening test. 23andMe is another type of screening test. You aren't getting extra mammograms because of 23andMe, they are the same thing. Mammogram can screen you for early detection of a serious disease. 23andMe can do the same (they advertise - this is what the FDA has a problem with). More screening for all diseases doesn't mean better outcome, and can be harmful, depending on the test, the people screened, the disease, etc., etc. and can lead to more disease (needless treatment). Throwing more screening at the wall for every disease doesn't do more good all the time. Especially when we learn that some diseases (prostate cancer) cause no symptoms most of the time. Treating these asymptomatic prostate cancers is very harmful, because they are harmless unless they progress. The treatment is risky and has serious side effects (impotence!) Every time we have a screening test, we have to look at the science. What are we screening for? What is the good? What is the bad? Who is helped? Who is harmed? Do the positives outweigh the negatives? Another outdated screening tool is the breast self exam - it was found (in scientific studies) it didn't do any good and caused harm (http://en.wikipedia.org/wiki/Breast_self-examination http://en.wikipedia.org/wiki/Breast_self-examination) Lots of over treatment without a reduce in cancer rates. Also, just learning about it increases women's worry and anxiety about breast cancer. This is a harmful screening tool. This was studied and abandoned. ---- BRCA test has nothing to do with this example. Mammograms are currently very common in women a certain age >40 or >50. Most women get them every few years as part of their health maintenance to check for the presence of cancer, tumors or lumps. Right now there is research coming out that is questioning that practice, but the practice hasn't caught up to the research and most doctors say "get your mammogram" without informing patients of the risks, they treat it like it is "all good." That was the point of this research to ask "are we doing the right thing here by screening all these healthy women with mammograms? Let's study that." I will personally opt out of the mammogram hype when I reach the mammogram age. I'm also going to inform my mother of the current research on the matter, I know she's already had a few mammograms herself.

dnautics 13y ago

For every user of 23andme who is well-informed enough to know that the information is not reliable, experience shows that there will be another who is not. The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Now it is debatable as to whether the individual's interpretation is (for example in the Alcohol Dehydrogenase gene, many, many, many caucasian users don't bother to read that the test is only informative for asians, but it's definitely there, in bold letters, etc.) Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? Maybe it's "because I'm sophisticated", but this biochemist can't really see that happening.

dragonwriter 13y ago
> The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable. Certainly, there is science to support certain claims of the class made in the reports 23andMe provides being made with some degree of reliability based on the kind of inputs 23andMe takes in. Whether what 23andMe actually does from end-to-end makes the actual reports they provide reliable in real world condition is...well, exactly the question they have seem to have decided not to expend the effort to answer even after initiating the process of getting clearance from the FDA to market their diagnostic product.
matthewmacleod 13y ago
The funny thing here, is that barring lab errors, which I think are highly unlikely unless they are being incredibly shoddy, which would take effort, the information that 23andMe provides is very reliable That's the point of certification - is the process reliable? Are the warnings clear? I won't cast any aspersions on the product (because it's pretty awesome), but I do see these as risks and requirements. Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? "I've got all these symptoms of diabetes. But 23andme said I had a low risk! It's probably nothing. Guess I'll eat another pie." If 23andme has shoddy lab practices, or unclear explanation of the limitation of their testing, then that's a risk. The process of certification involves managing that risk.
- deleted 13y ago
  [deleted]
aestra 13y ago
>Could you explain a scenario where basing life and health decisions on 23andMe's product could lead to sickness and death? http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001877.. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001877.... (this study is about mammograms of healthy women, another example of a health screening tool) We found that breast cancer mortality was an unreliable outcome that was biased in favour of screening, mainly because of differential misclassification of cause of death. The trials with adequate randomisation did not find an effect of screening on cancer mortality, including breast cancer, after 10 years (RR 1.02, 95% CI 0.95 to 1.10) or on all-cause mortality after 13 years (RR 0.99, 95% CI 0.95 to 1.03). Numbers of lumpectomies and mastectomies were significantly larger in the screened groups (RR 1.31, 95% CI 1.22 to 1.42) for the two adequately randomised trials that measured this outcome; the use of radiotherapy was similarly increased. So women who get more screening get more treatment but didn't live longer (unnecessary treatment) Study continues: This means that for every 2000 women invited for screening throughout 10 years, one will have her life prolonged and 10 healthy women, who would not have been diagnosed if there had not been screening, will be treated unnecessarily. Furthermore, more than 200 women will experience important psychological distress for many months because of false positive findings. It is thus not clear whether screening does more good than harm. To help ensure that the women are fully informed of both benefits and harms before they decide whether or not to attend screening, we have written an evidence-based leaflet for lay people that is available in several languages on www.cochrane.dk.
- dnautics 13y ago
  yes, but getting a mammogram has an additional layer of regulation in between the end-user of 23andMe. A licensed radiologist should look the person askew when they insist on getting extra mammograms because of 23andMe, and order a follow-up BRCA test before proceeding.
  - aestra 13y ago
    Wow, no. You aren't seeing it. A mammogram is a screening test. 23andMe is another type of screening test. You aren't getting extra mammograms because of 23andMe, they are the same thing. Mammogram can screen you for early detection of a serious disease. 23andMe can do the same (they advertise - this is what the FDA has a problem with). More screening for all diseases doesn't mean better outcome, and can be harmful, depending on the test, the people screened, the disease, etc., etc. and can lead to more disease (needless treatment). Throwing more screening at the wall for every disease doesn't do more good all the time. Especially when we learn that some diseases (prostate cancer) cause no symptoms most of the time. Treating these asymptomatic prostate cancers is very harmful, because they are harmless unless they progress. The treatment is risky and has serious side effects (impotence!) Every time we have a screening test, we have to look at the science. What are we screening for? What is the good? What is the bad? Who is helped? Who is harmed? Do the positives outweigh the negatives? Another outdated screening tool is the breast self exam - it was found (in scientific studies) it didn't do any good and caused harm (http://en.wikipedia.org/wiki/Breast_self-examination http://en.wikipedia.org/wiki/Breast_self-examination) Lots of over treatment without a reduce in cancer rates. Also, just learning about it increases women's worry and anxiety about breast cancer. This is a harmful screening tool. This was studied and abandoned. ---- BRCA test has nothing to do with this example. Mammograms are currently very common in women a certain age >40 or >50. Most women get them every few years as part of their health maintenance to check for the presence of cancer, tumors or lumps. Right now there is research coming out that is questioning that practice, but the practice hasn't caught up to the research and most doctors say "get your mammogram" without informing patients of the risks, they treat it like it is "all good." That was the point of this research to ask "are we doing the right thing here by screening all these healthy women with mammograms? Let's study that." I will personally opt out of the mammogram hype when I reach the mammogram age. I'm also going to inform my mother of the current research on the matter, I know she's already had a few mammograms herself.