6 ms·

> I can see the author's point of view, but this is a rare case (for me personally) that I am not in support of more government oversight. This seems to be a t

> I can see the author's point of view, but this is a rare case (for me personally) that I am not in support of more government oversight. This seems to be a trend, when people know about a certain field well, they are against the government oversight of it. The issue of course is that people are usually intimately familiar with maybe ONE field, but get an opinion on everything, and thus are very cautious of all the things they don't know anything about. Software people understand the problems with "making encryption illegal", regular people don't and are more willing to hear the high level "safety issues" of letting hackers hide their information. You are well aware of the issues with these devices, most people aren't and are more willing to hear the high level "safety issues" of letting any ol' device get into the hands of consumers. Scientists know about all the potential benefits of stem cell research, most people without biology degrees are more willing to hear the high level "safety issues" of the frankenstein stories we're sold.

Fomite 11y ago
I'm an epidemiologist, I've with post-licensure trial data, and I'm pretty for government oversight. Because we have the "nutritional supplement" market as a working example of "We give people stuff without bothering to see if any of it actually works".
- dragonwriter 11y ago
  > Because we have the "nutritional supplement" market as a working example of "We give people stuff without bothering to see if any of it actually works". Or, even, if its actually the stuff that it claims to be, much less whether the stuff it claims to be works.
  - WalterBright 11y ago
    I've not seen anyone, not even libertarians, argue in favor of allowing companies to fraudulently misrepresent their products.
    - dragonwriter 11y ago
      I was explicitly referring to the factual status quo of what actually goes on in the supplement industry [0], not what any one has argued people should be allowed to do. [0] see, e.g., http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/ http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-g...
- nostromo 11y ago
  I use a supplement regularly (melatonin) and I'm happy the FDA isn't involved. What pharmaceutical company is going to bother getting FDA approval for an already-patented substance that is dirt cheap and readily available? In the EU, melatonin is regulated and requires a prescription -- which seems to me to be an unnecessary cost and hassle.
  - pdabbadabba 11y ago
    Why not the company that makes the melatonin you are currently taking? Presumably they are making a profit at it. They spent a bunch of money to set up factories to produce, package, and market melatonin, why suppose that FDA approval, but not these hurdles, would stop them? Or what about the patent-holder (if there is one)? One would think they would have ample incentive to seek FDA approval if they have a temporary monopoly on producing the compound.
    - tolmasky 11y ago
      > Presumably they are making a profit at it. They spent a bunch of money to set up factories to produce, package, and market melatonin, why suppose that FDA approval, but not these hurdles, would stop them? Clearly more hurdles are... more hurdles?
      - pdabbadabba 11y ago
        Hard to argue with that logic, of course. But I don't see how this observation is relevant to the question I posed: why we should think that this hurdle, but not the many others that exist today, would stop people from selling melatonin, as nostromo suggested it would. (As opposed to merely making it marginally more difficult which, of course, is undeniable.) Or, perhaps more to the point, why this particular hurdle is not worth the supposed consumer protection benefits of FDA regulation? (Primarily: ensuring that products marketed as having therapeutic value actually do, and that these benefits are not outweighed by dangerous side-effects.)
        11y ago
- jonlucc 11y ago
  I work in pharmaceutical R&D and I am definitely for government oversight. Does the FDA screw up sometimes? Yes. Is it slow? Yes. Should it be scaled back? Not anytime soon.
AnimalMuppet 11y ago
Well, I worked in medical devices for several years, and I think the level of FDA oversight was actually pretty appropriate. There are two dangers: letting a bad device into use, and preventing a good device from entering use. And both "good" and "bad" are relative here, so it's a tricky dance. Personally, I thought the FDA was doing about right. They forced us to really have all our ducks in a row, but that's actually appropriate. But with all that said, I personally found it a horrible environment for an engineer to try to live in, and I got out.
- tolmasky 11y ago
  There's of course a third danger: all the people that won't use their skills to try to develop new technologies due to the costs of FDA approval and the lack of knowledge about those processes. What you end up with is handing the market to huge corporations that can afford the not-product-related huge upfront costs, and who have the institutional knowledge of navigating the approval process. Its interesting that SV is often criticized for not taking on these "big important problems", but at the same time these are markets that can be impenetrable given that the entire fate of the company can be in limbo for years during approval, requiring tremendous up front investment that is harder to predict.
  - AnimalMuppet 11y ago
    > What you end up with is handing the market to huge corporations that can afford the not-product-related huge upfront costs, and who have the institutional knowledge of navigating the approval process. True. Management mentioned it from time to time, as a barrier to entry for competitors.
crisnoble 11y ago
I wonder if part of the problem is that there are not enough industry experts sitting on the government's side of the table. Maybe we the argument shouldn't be over if we need more or less oversight, but more actual experts doing the oversight. However, then we run into the "comcast is installing their shills in the ftc" issue.
x0x0 11y ago
You're talking to the wrong people. I worked for a company that made an FDA approved diagnostic device. And to be clear, for the condition it targeted, an incorrect diagnosis would kill. The approval was slow, expensive, and cumbersome. I absolutely support it. Consider the average code quality you see with every piece of software you touch. Hell, even apple can't update their iphones -- with very few models to test -- without killing wireless on some of them. The FDA required that your code was tested so that given certain inputs, it produced correct outputs every single time, and documentation to that effect. I wish we could speed the process up, but I think it's the best alternative we have going. edit: this was my first serious dev job. They didn't use source control. "source control" was a random computer holding the master copy; after a month or two of development, you'd spend a couple days merging your code into the master copy then copy the merged codebase to your desktop. All 8 devs did this. There were wild merge problems, as you can imagine with that much divergence. "History tracking" was copying the entire directory structure to a series of labeled directories. There were two ways to license the machines: one for human testing (with fda approval), and one for non-human testing. The latter got releases every 3-6 mos. One at least one occasion, code was shipped so broken that it conclusively proved it had never been successfully run, not even once. The "deploy" process was to copy code from the master server, hit build in visual studio, and burn that to cds. Automated tests? What are those? Test suites were run instructions written in a spiral notebook. (To be fair, it's hard to work with bio samples.) I wrote a bunch of code that basically mocked the device by installed a special driver that replayed saved data files. I wrote this on my own time so I could occasionally work from home without lugging a giant contaminated machine back and forth. I shared it with coworkers and it eventually made its way to the testing lab on the other side of the country without my knowledge. When I quit, I deleted all source code. It turns out they hadn't kept a copy of this driver and frantically contacted me several months after I left when an embedded system upgrade broke it. Many of these are symptoms of a company run by bio scientists who viewed engineering as a cost center and barely even a real career. There are lots of companies like this.
- tolmasky 11y ago
  I think its unfair to suggest that the reason iPhones have horrible code quality is because they don't go through some approval process. They don't have good code quality because, sadly, they don't need it. AAPL's market cap will show you that. BECAUSE iPhones aren't mission critical, BECAUSE they won't (directly?) kill anyone, they can get by with poor code quality. That market, for whatever reason, favors shiny over reliability. For an even better example: take iOS game. Those things have a shelf life of a few months, it would make no sense to make sure those things are battle tested.

Fomite 11y ago

I'm an epidemiologist, I've with post-licensure trial data, and I'm pretty for government oversight. Because we have the "nutritional supplement" market as a working example of "We give people stuff without bothering to see if any of it actually works".

dragonwriter 11y ago
> Because we have the "nutritional supplement" market as a working example of "We give people stuff without bothering to see if any of it actually works". Or, even, if its actually the stuff that it claims to be, much less whether the stuff it claims to be works.
- WalterBright 11y ago
  I've not seen anyone, not even libertarians, argue in favor of allowing companies to fraudulently misrepresent their products.
  - dragonwriter 11y ago
    I was explicitly referring to the factual status quo of what actually goes on in the supplement industry [0], not what any one has argued people should be allowed to do. [0] see, e.g., http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-general-targets-supplements-at-major-retailers/ http://well.blogs.nytimes.com/2015/02/03/new-york-attorney-g...
nostromo 11y ago
I use a supplement regularly (melatonin) and I'm happy the FDA isn't involved. What pharmaceutical company is going to bother getting FDA approval for an already-patented substance that is dirt cheap and readily available? In the EU, melatonin is regulated and requires a prescription -- which seems to me to be an unnecessary cost and hassle.
- pdabbadabba 11y ago
  Why not the company that makes the melatonin you are currently taking? Presumably they are making a profit at it. They spent a bunch of money to set up factories to produce, package, and market melatonin, why suppose that FDA approval, but not these hurdles, would stop them? Or what about the patent-holder (if there is one)? One would think they would have ample incentive to seek FDA approval if they have a temporary monopoly on producing the compound.
  - tolmasky 11y ago
    > Presumably they are making a profit at it. They spent a bunch of money to set up factories to produce, package, and market melatonin, why suppose that FDA approval, but not these hurdles, would stop them? Clearly more hurdles are... more hurdles?
    - pdabbadabba 11y ago
      Hard to argue with that logic, of course. But I don't see how this observation is relevant to the question I posed: why we should think that this hurdle, but not the many others that exist today, would stop people from selling melatonin, as nostromo suggested it would. (As opposed to merely making it marginally more difficult which, of course, is undeniable.) Or, perhaps more to the point, why this particular hurdle is not worth the supposed consumer protection benefits of FDA regulation? (Primarily: ensuring that products marketed as having therapeutic value actually do, and that these benefits are not outweighed by dangerous side-effects.)
      - 11y ago
jonlucc 11y ago
I work in pharmaceutical R&D and I am definitely for government oversight. Does the FDA screw up sometimes? Yes. Is it slow? Yes. Should it be scaled back? Not anytime soon.

AnimalMuppet 11y ago

Well, I worked in medical devices for several years, and I think the level of FDA oversight was actually pretty appropriate. There are two dangers: letting a bad device into use, and preventing a good device from entering use. And both "good" and "bad" are relative here, so it's a tricky dance. Personally, I thought the FDA was doing about right. They forced us to really have all our ducks in a row, but that's actually appropriate. But with all that said, I personally found it a horrible environment for an engineer to try to live in, and I got out.

tolmasky 11y ago
There's of course a third danger: all the people that won't use their skills to try to develop new technologies due to the costs of FDA approval and the lack of knowledge about those processes. What you end up with is handing the market to huge corporations that can afford the not-product-related huge upfront costs, and who have the institutional knowledge of navigating the approval process. Its interesting that SV is often criticized for not taking on these "big important problems", but at the same time these are markets that can be impenetrable given that the entire fate of the company can be in limbo for years during approval, requiring tremendous up front investment that is harder to predict.
- AnimalMuppet 11y ago
  > What you end up with is handing the market to huge corporations that can afford the not-product-related huge upfront costs, and who have the institutional knowledge of navigating the approval process. True. Management mentioned it from time to time, as a barrier to entry for competitors.

crisnoble 11y ago

I wonder if part of the problem is that there are not enough industry experts sitting on the government's side of the table. Maybe we the argument shouldn't be over if we need more or less oversight, but more actual experts doing the oversight. However, then we run into the "comcast is installing their shills in the ftc" issue.

x0x0 11y ago

You're talking to the wrong people. I worked for a company that made an FDA approved diagnostic device. And to be clear, for the condition it targeted, an incorrect diagnosis would kill. The approval was slow, expensive, and cumbersome. I absolutely support it. Consider the average code quality you see with every piece of software you touch. Hell, even apple can't update their iphones -- with very few models to test -- without killing wireless on some of them. The FDA required that your code was tested so that given certain inputs, it produced correct outputs every single time, and documentation to that effect. I wish we could speed the process up, but I think it's the best alternative we have going. edit: this was my first serious dev job. They didn't use source control. "source control" was a random computer holding the master copy; after a month or two of development, you'd spend a couple days merging your code into the master copy then copy the merged codebase to your desktop. All 8 devs did this. There were wild merge problems, as you can imagine with that much divergence. "History tracking" was copying the entire directory structure to a series of labeled directories. There were two ways to license the machines: one for human testing (with fda approval), and one for non-human testing. The latter got releases every 3-6 mos. One at least one occasion, code was shipped so broken that it conclusively proved it had never been successfully run, not even once. The "deploy" process was to copy code from the master server, hit build in visual studio, and burn that to cds. Automated tests? What are those? Test suites were run instructions written in a spiral notebook. (To be fair, it's hard to work with bio samples.) I wrote a bunch of code that basically mocked the device by installed a special driver that replayed saved data files. I wrote this on my own time so I could occasionally work from home without lugging a giant contaminated machine back and forth. I shared it with coworkers and it eventually made its way to the testing lab on the other side of the country without my knowledge. When I quit, I deleted all source code. It turns out they hadn't kept a copy of this driver and frantically contacted me several months after I left when an embedded system upgrade broke it. Many of these are symptoms of a company run by bio scientists who viewed engineering as a cost center and barely even a real career. There are lots of companies like this.

tolmasky 11y ago
I think its unfair to suggest that the reason iPhones have horrible code quality is because they don't go through some approval process. They don't have good code quality because, sadly, they don't need it. AAPL's market cap will show you that. BECAUSE iPhones aren't mission critical, BECAUSE they won't (directly?) kill anyone, they can get by with poor code quality. That market, for whatever reason, favors shiny over reliability. For an even better example: take iOS game. Those things have a shelf life of a few months, it would make no sense to make sure those things are battle tested.