6 ms·

The entire premise of protecting people from "their own reactions to test results" is so horribly infuriating :(. The context that is missing here, which I am

by saurik 5y ago

The entire premise of protecting people from "their own reactions to test results" is so horribly infuriating :(. The context that is missing here, which I am super curious about: Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? Is there any real organized opposition at all to the FDA doing this that one can attach themselves to?

pimlottc 5y ago
This appears to be a thesis paper for a law degree.
- huitzitziltzin 5y ago
  There is no such thing in the US. Law degrees do not require a thesis. It is an article written for submission to a law review.
  - rhino369 5y ago
    Most schools require a long paper from grads. You typically write one for the journal you work on or maybe for a class you take. Unlike real scholarship, legal "scholarship" is only reviewed by third year law students. It's pretty worthless stuff.
  - DannyBee 5y ago
    This is partially right. JD's generally do not require a thesis. However, LLM's do.
rasengan 5y ago
Agree, it is infuriating. > Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? This looks like a student's thesis. The author, also, appears to be in agreement with you and is hoping to push information to help cause a stand: From the conclusion: > These restrictions illustrate a disturbing trend with major consequences for current and future technologies. Ultimately, the FDA’s decision to act as gatekeeper, limiting consumers’ access to their medical information, is premised on an impermissible value judgment that significantly restricts individual autonomy.
- netizen-936824 5y ago
  >premised on an impermissible value judgment that significantly restricts individual autonomy Similar to the CSA, I'm sensing a theme
brianpan 5y ago
Devil's advocate- Mammograms are a very useful diagnostic tool, but only when applied in the right circumstances because of the rate of false positives. It's recommended for 50+, but when given to a 30-year old, the results are meaningless in most cases (it becomes more likely to get a false positive than a real positive). Knowing when to take tests and interpreting test results are sometimes an important part of the test.
- josephcsible 5y ago
  Sure, a test wouldn't be very useful in that case. But I don't think you should be forbidden from taking a test at your own expense just because it's not useful.
  - scoopertrooper 5y ago
    In the case of a false positive, a test is not merely useless, but actively harmful. Having said that, imposing an age restriction on at-home Mammogram testing kits would mitigate the problem. However, Mammograms are probably not the best choice for at-home testing given that they involve X-rays!
    - saurik 5y ago
      One doesn't need act on a false positive! It is useful to have that data point, and then you can combine it with tons of other data points, and do risk benefit analyses of whether to do anything at all about it even if you are feeling sure. You are assuming people are too stupid to even be allowed to know things, which is an unreasonable starting point.
      - brianpan 5y ago
        The fact that many people here (which I consider smarter and more informed than the average population) misunderstand this, I think proves my point. Mammograms under 50 give MORE false positives that real positives. That means it's not even a useful data point. If you have a positive result, it's you're more likely you do NOT have cancer than you do. You really have to understand your base rate of expected occurrence and the effectiveness of the test. These can wildly affect how to interpret the results and tell you if you should even take the test in the first place. Here's a somewhat related Numberphile about false positives: https://www.youtube.com/watch?v=M8xlOm2wPAA https://www.youtube.com/watch?v=M8xlOm2wPAA
causi 5y ago
The entire medical R&D field seems to have the world's flattest bell curve. Half the people you meet would sell old ladies allergy pills that make you go blind for $500 a pop and the other half would rather have ten thousand pancreatic cancer patients die in screaming agony than risk ten percent of them developing restless leg syndrome.
refurb 5y ago
I would have expected HN to entirely understand the FDA’s approach. How many developers have created what they think is a pretty intuitive UX only to find out users can’t figure out shit? It’s the same with medical device (which tests are). Hell, when I worked with a pharma company their compliance rates with just taking pills as prescribed was 60%. Yeah, 40% of patients failed to take their medicine 2x per day. A simple task like that. So the problem with a covid test is not the test itself, it’s what patients do with that info. If 40% screw up the test, it says negative, so they go to a football game in a stadium, what is the implication. What if they didn’t have the test? Would they just stay home? Is that better.
- saurik 5y ago
  > I would have expected HN to entirely understand the FDA’s approach. Oh, I get it... I just think it is immoral. I also believe that the software developers who go around thinking they are gods that should get to decide whether other people should be allowed to install an app on their phone or an extension in their browser because "people are (apparently) universally too stupid to have such functionality" are also deeply immoral, and have spent over half my life at this point--ever since I started working publicly on network scanners and decompilers through all of my work on jailbreaking the iPhone and now my latest efforts in decentralized systems--fighting against people who think like that (and I am even a politician now!). I strongly believe that people have a right to know things and get access to things that help them know things, and you aren't doing the world any favors by preventing such: you are just going to make people--100% correctly--distrust you and your motives. FWIW, I do see a job for the FDA, and I do appreciate some of the work they do... I would even have sympathy if this were "the tests are inaccurate or unproven, and the FDA doesn't want people to claim a test works that doesn't actually work and has never been tested" (note: I still have issues here, but I would at least have sympathy). But for a test we know works and can legitimately be used correctly in a home (but might theoretically be used incorrectly, sure) but we are just afraid people will do something bad with the information as they don't understand statistics enough to deal with false negatives or whatever? That is just evil, and it mostly stands in the way of actual good work being done. This is the reason why diabetics I know have had to hack into their hardware to cobble themselves full-loop control mechanisms. This attitude would have--in the story presented here--prevented people from having access to pregnancy tests... which should simply feel preposterous at this point in time when clearly at home pregnancy tests are extremely common (seemingly having required a legal challenge to the FDA over it!). And really... if you want to apply population-level analyses, that shouldn't even be the job of the FDA: that's the job of the CDC. And neither the CDC nor the FDA did a good job here of reacting quickly to this pandemic. A covid test even with relatively low accuracy can do wonders for neighborhood-level tracing efforts, but not only did the CDC never mobilize any kind of voluntary test sweeps, the FDA was proactively shutting down efforts by local universities to do it themselves. In the words of a friend of mine who is much more passionate about this than I am: "they have blood on their hands".

by saurik 5y ago

pimlottc 5y ago

This appears to be a thesis paper for a law degree.

huitzitziltzin 5y ago
There is no such thing in the US. Law degrees do not require a thesis. It is an article written for submission to a law review.
- rhino369 5y ago
  Most schools require a long paper from grads. You typically write one for the journal you work on or maybe for a class you take. Unlike real scholarship, legal "scholarship" is only reviewed by third year law students. It's pretty worthless stuff.
- DannyBee 5y ago
  This is partially right. JD's generally do not require a thesis. However, LLM's do.

rasengan 5y ago

Agree, it is infuriating. > Is this article written to send to a court or some legislative body? Is it maybe the moral equivalent of an amicus brief? Is this "merely" detailed research that might be cited by someone else in such an argument? This looks like a student's thesis. The author, also, appears to be in agreement with you and is hoping to push information to help cause a stand: From the conclusion: > These restrictions illustrate a disturbing trend with major consequences for current and future technologies. Ultimately, the FDA’s decision to act as gatekeeper, limiting consumers’ access to their medical information, is premised on an impermissible value judgment that significantly restricts individual autonomy.

netizen-936824 5y ago
>premised on an impermissible value judgment that significantly restricts individual autonomy Similar to the CSA, I'm sensing a theme

brianpan 5y ago

Devil's advocate- Mammograms are a very useful diagnostic tool, but only when applied in the right circumstances because of the rate of false positives. It's recommended for 50+, but when given to a 30-year old, the results are meaningless in most cases (it becomes more likely to get a false positive than a real positive). Knowing when to take tests and interpreting test results are sometimes an important part of the test.

josephcsible 5y ago
Sure, a test wouldn't be very useful in that case. But I don't think you should be forbidden from taking a test at your own expense just because it's not useful.
- scoopertrooper 5y ago
  In the case of a false positive, a test is not merely useless, but actively harmful. Having said that, imposing an age restriction on at-home Mammogram testing kits would mitigate the problem. However, Mammograms are probably not the best choice for at-home testing given that they involve X-rays!
  - saurik 5y ago
    One doesn't need act on a false positive! It is useful to have that data point, and then you can combine it with tons of other data points, and do risk benefit analyses of whether to do anything at all about it even if you are feeling sure. You are assuming people are too stupid to even be allowed to know things, which is an unreasonable starting point.
    - brianpan 5y ago
      The fact that many people here (which I consider smarter and more informed than the average population) misunderstand this, I think proves my point. Mammograms under 50 give MORE false positives that real positives. That means it's not even a useful data point. If you have a positive result, it's you're more likely you do NOT have cancer than you do. You really have to understand your base rate of expected occurrence and the effectiveness of the test. These can wildly affect how to interpret the results and tell you if you should even take the test in the first place. Here's a somewhat related Numberphile about false positives: https://www.youtube.com/watch?v=M8xlOm2wPAA https://www.youtube.com/watch?v=M8xlOm2wPAA

causi 5y ago

The entire medical R&D field seems to have the world's flattest bell curve. Half the people you meet would sell old ladies allergy pills that make you go blind for $500 a pop and the other half would rather have ten thousand pancreatic cancer patients die in screaming agony than risk ten percent of them developing restless leg syndrome.

refurb 5y ago

I would have expected HN to entirely understand the FDA’s approach. How many developers have created what they think is a pretty intuitive UX only to find out users can’t figure out shit? It’s the same with medical device (which tests are). Hell, when I worked with a pharma company their compliance rates with just taking pills as prescribed was 60%. Yeah, 40% of patients failed to take their medicine 2x per day. A simple task like that. So the problem with a covid test is not the test itself, it’s what patients do with that info. If 40% screw up the test, it says negative, so they go to a football game in a stadium, what is the implication. What if they didn’t have the test? Would they just stay home? Is that better.

saurik 5y ago
> I would have expected HN to entirely understand the FDA’s approach. Oh, I get it... I just think it is immoral. I also believe that the software developers who go around thinking they are gods that should get to decide whether other people should be allowed to install an app on their phone or an extension in their browser because "people are (apparently) universally too stupid to have such functionality" are also deeply immoral, and have spent over half my life at this point--ever since I started working publicly on network scanners and decompilers through all of my work on jailbreaking the iPhone and now my latest efforts in decentralized systems--fighting against people who think like that (and I am even a politician now!). I strongly believe that people have a right to know things and get access to things that help them know things, and you aren't doing the world any favors by preventing such: you are just going to make people--100% correctly--distrust you and your motives. FWIW, I do see a job for the FDA, and I do appreciate some of the work they do... I would even have sympathy if this were "the tests are inaccurate or unproven, and the FDA doesn't want people to claim a test works that doesn't actually work and has never been tested" (note: I still have issues here, but I would at least have sympathy). But for a test we know works and can legitimately be used correctly in a home (but might theoretically be used incorrectly, sure) but we are just afraid people will do something bad with the information as they don't understand statistics enough to deal with false negatives or whatever? That is just evil, and it mostly stands in the way of actual good work being done. This is the reason why diabetics I know have had to hack into their hardware to cobble themselves full-loop control mechanisms. This attitude would have--in the story presented here--prevented people from having access to pregnancy tests... which should simply feel preposterous at this point in time when clearly at home pregnancy tests are extremely common (seemingly having required a legal challenge to the FDA over it!). And really... if you want to apply population-level analyses, that shouldn't even be the job of the FDA: that's the job of the CDC. And neither the CDC nor the FDA did a good job here of reacting quickly to this pandemic. A covid test even with relatively low accuracy can do wonders for neighborhood-level tracing efforts, but not only did the CDC never mobilize any kind of voluntary test sweeps, the FDA was proactively shutting down efforts by local universities to do it themselves. In the words of a friend of mine who is much more passionate about this than I am: "they have blood on their hands".