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What is the FDA's problem with it? I feel like with this sort of thing and the 23andme.com issue that the FDA is being too restrictive about things that really

What is the FDA's problem with it? I feel like with this sort of thing and the 23andme.com issue that the FDA is being too restrictive about things that really shouldn't even be under their jurisdiction in the first place. For drugs, stringent testing and regulations is great, but how is someone going to harm themselves by knowing things about their own genome or recording things like their own body temperature and heart rate?

camus2 10y ago
The FDA thing is an excuse. The FDA didn't shut down their product, they are lying.
- JohnJamesRambo 10y ago
  Oh yep you are right. That article seems to be completely misleading or lying about that. https://twitter.com/walterdebrouwer/status/809107133635514369?ref_src=twsrc%5Etfw https://twitter.com/walterdebrouwer/status/80910713363551436...
- deleted 10y ago
  [deleted]
- wyager 10y ago
  The GP's question is valid, though. Why does the FDA insist on shutting down or restricting services like 23AndMe when the worst case scenario for a service failure is that you get a false positive on a disease risk indicator (for which you're going to have to go to a real doctor to confirm anyway) or you think you're 1/8th Irish when you're actually 1/8th Welsh?
  - jmcdiesel 10y ago
    The FDA's claim to jurisdiction (which I feel is BS) ... is that 23&me were providing "medical advice" or "diagnoses" by saying that you share genomes linked to x percent chance of Y ...
    - deeth_starr_v 10y ago
      Am I missing something? 23&me were forced to validate their service with the FDA. They did and got passed. So they proved that their medical diagnosis are accurate. I don't understand the hating on the FDA. It's better than having full-time quackery going on. Edit: Here's an example. 23&Me tells you you're going to develop Alzheimer's. There's no test for that (before it develops), so you can't go to a doctor to validate it. Beyond the mental pain of living with this for years it's reasonable to assume some people would end their lives rather than be a burden to loved ones. But if they fucked up with their analysis and no one forced them to prove it? Edit2: Also, exempt 23&me from FDA regulation? Why should your lab be regulated either? This isn't just a slippery-slope argument. I don't understand the argument to exempt 23&me.
      - jmcdiesel 10y ago
        Because 23&me are not providing a medical diagnoses. They never were. They are giving you what they calculate as your chances to to carry or possibly have or develop health issues based on their database of other people's dna ... they are showing statistical similarities and never claim to make diagnosis.. What does the FDA have to do with statistical analysis?
        drewgross 10y ago
        To most people, there is no difference between "your chances to to carry or possibly have or develop health issues" and a diagnosis. Sure, I suppose I can see some small technicality that makes them different, but really, the way you react to either is about the same, which makes them about the same.
      - JohnJamesRambo 10y ago
        But on the other side of the coin what if the person made life changes that reduced their chance for Alzheimer's and never succumbed to it? Shouldn't a person have access to that information if they want it? Why should the FDA not allow the gathering of information about your own genome?
  - nimish 10y ago
    A false disease positive or negative can easily fuck up your life. Lots of follow-up tests are invasive or expensive and take time. The FDA is totally right to require high standards and premarket approval.
    - wyager 10y ago
      No one would give you invasive follow-up tests without getting a second genetic test. Doctors aren't stupid; they know that most positives are false positives.
- CamperBob2 10y ago
  This appears to be the case. From one of the comments: Chuck Juhl Contract Consultant/Analyst at C.W. Juhl Consulting I warned folks two years ago that Scanadu was a scamadu. It's unlikely that the reason for the FDA action is because Scanadu could not devise a secure method to transmit data to a cell phone. Other consumer medical devices with similar features have FDA approva already, including the CheckMe device. It's more likely that Scamadu was scamming the FDA as well with its faux "usability" study. According to an FOIA request, the FDA has no record of Scanadu submitting a 510k application for the Scout or any other device. And as an aside, Scanadu did not make the final cut for the X-Prize either.
  - transfire 10y ago
    Isn't the CheckMe just a vital signs monitor like you would find in any hospital? Ok, maybe it's a bit smaller and does a touch more (ECG). But I don't think it does as much the X-Prize "tricorders" are supposed to.
    - CamperBob2 10y ago
      Point being, there's apparently no indication that the company even asked for FDA approval.
transfire 10y ago
The sheep implicitly trust their government. They do not understand that they are in bed with Big Industry -- in fact they ARE Big Industry b/c of the "revolving door". So here's the real deal. The FDA has basically made up a rule that a medical device can only do one test (its a little more complicated than that but that's the gist of it). That's why if you look at the X-Prize finalists they aren't really "tricorders" at all. Each test has a separate component. Of course, even that probably won't be good enough and neither of these will see the light of day. The same thing goes for what happened to 23&Me. The official statement from the FDA was "they were concerned that people would self-diagnose". Heaven forbid people should do such a thing in a free country! But what it really boils down to is the huge $$$ made on tests for individual genes -- each of which, I've read, can cost $1,000+ w/o insurance. If we could just do our whole genome in one fell swoop, think of all the money the industry would loose.

camus2 10y ago

The FDA thing is an excuse. The FDA didn't shut down their product, they are lying.

JohnJamesRambo 10y ago
Oh yep you are right. That article seems to be completely misleading or lying about that. https://twitter.com/walterdebrouwer/status/809107133635514369?ref_src=twsrc%5Etfw https://twitter.com/walterdebrouwer/status/80910713363551436...
deleted 10y ago
[deleted]
wyager 10y ago
The GP's question is valid, though. Why does the FDA insist on shutting down or restricting services like 23AndMe when the worst case scenario for a service failure is that you get a false positive on a disease risk indicator (for which you're going to have to go to a real doctor to confirm anyway) or you think you're 1/8th Irish when you're actually 1/8th Welsh?
- jmcdiesel 10y ago
  The FDA's claim to jurisdiction (which I feel is BS) ... is that 23&me were providing "medical advice" or "diagnoses" by saying that you share genomes linked to x percent chance of Y ...
  - deeth_starr_v 10y ago
    Am I missing something? 23&me were forced to validate their service with the FDA. They did and got passed. So they proved that their medical diagnosis are accurate. I don't understand the hating on the FDA. It's better than having full-time quackery going on. Edit: Here's an example. 23&Me tells you you're going to develop Alzheimer's. There's no test for that (before it develops), so you can't go to a doctor to validate it. Beyond the mental pain of living with this for years it's reasonable to assume some people would end their lives rather than be a burden to loved ones. But if they fucked up with their analysis and no one forced them to prove it? Edit2: Also, exempt 23&me from FDA regulation? Why should your lab be regulated either? This isn't just a slippery-slope argument. I don't understand the argument to exempt 23&me.
    - jmcdiesel 10y ago
      Because 23&me are not providing a medical diagnoses. They never were. They are giving you what they calculate as your chances to to carry or possibly have or develop health issues based on their database of other people's dna ... they are showing statistical similarities and never claim to make diagnosis.. What does the FDA have to do with statistical analysis?
      - drewgross 10y ago
        To most people, there is no difference between "your chances to to carry or possibly have or develop health issues" and a diagnosis. Sure, I suppose I can see some small technicality that makes them different, but really, the way you react to either is about the same, which makes them about the same.
    - JohnJamesRambo 10y ago
      But on the other side of the coin what if the person made life changes that reduced their chance for Alzheimer's and never succumbed to it? Shouldn't a person have access to that information if they want it? Why should the FDA not allow the gathering of information about your own genome?
- nimish 10y ago
  A false disease positive or negative can easily fuck up your life. Lots of follow-up tests are invasive or expensive and take time. The FDA is totally right to require high standards and premarket approval.
  - wyager 10y ago
    No one would give you invasive follow-up tests without getting a second genetic test. Doctors aren't stupid; they know that most positives are false positives.
CamperBob2 10y ago
This appears to be the case. From one of the comments: Chuck Juhl Contract Consultant/Analyst at C.W. Juhl Consulting I warned folks two years ago that Scanadu was a scamadu. It's unlikely that the reason for the FDA action is because Scanadu could not devise a secure method to transmit data to a cell phone. Other consumer medical devices with similar features have FDA approva already, including the CheckMe device. It's more likely that Scamadu was scamming the FDA as well with its faux "usability" study. According to an FOIA request, the FDA has no record of Scanadu submitting a 510k application for the Scout or any other device. And as an aside, Scanadu did not make the final cut for the X-Prize either.
- transfire 10y ago
  Isn't the CheckMe just a vital signs monitor like you would find in any hospital? Ok, maybe it's a bit smaller and does a touch more (ECG). But I don't think it does as much the X-Prize "tricorders" are supposed to.
  - CamperBob2 10y ago
    Point being, there's apparently no indication that the company even asked for FDA approval.

transfire 10y ago

The sheep implicitly trust their government. They do not understand that they are in bed with Big Industry -- in fact they ARE Big Industry b/c of the "revolving door". So here's the real deal. The FDA has basically made up a rule that a medical device can only do one test (its a little more complicated than that but that's the gist of it). That's why if you look at the X-Prize finalists they aren't really "tricorders" at all. Each test has a separate component. Of course, even that probably won't be good enough and neither of these will see the light of day. The same thing goes for what happened to 23&Me. The official statement from the FDA was "they were concerned that people would self-diagnose". Heaven forbid people should do such a thing in a free country! But what it really boils down to is the huge $$$ made on tests for individual genes -- each of which, I've read, can cost $1,000+ w/o insurance. If we could just do our whole genome in one fell swoop, think of all the money the industry would loose.