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As an insulin dependent diabetic I am consistently frustrated at how slow the medical device approval market moves. There is a reason that the most advanced ins

As an insulin dependent diabetic I am consistently frustrated at how slow the medical device approval market moves. There is a reason that the most advanced insulin pump that I can buy 2015[0] looks like a pager from 1998, and it is not because the companies are moving too fast. I have been told that the reason all of the supporting software is so outdated is also because they are handcuffed by the FDA approval processes. 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. [0] http://www.medtronicdiabetes.com/treatment-and-products/minimed-530g-diabetes-system-with-enlite http://www.medtronicdiabetes.com/treatment-and-products/mini...

poke111 11y ago
This is also a textbook case of what is seen vs. what is unseen. When someone dies from a treatment that the FDA has approved, that is a visible ("seen") tragedy. When people are suffering from ailments that could be treated more effectively if not for the FDA slowing things down and raising the cost of development, that is unseen. There's no single victim you can point to. But the latter is hard to quantify in the risk vs. reward calculation, and importantly no FDA bureaucrat will ever lose their job or be publicly shamed because of them.
- cmdrfred 11y ago
  How the FDA handled the removal of CFC's from inhalers shows you clearly they are not on the side of the consumer. The slowness likely has something to do with incumbent companies not wanting to spend on R&D. http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much http://www.motherjones.com/kevin-drum/2013/10/heres-why-your...
- WalterBright 11y ago
  This was all clearly laid out (with backing statistics) by Sam Peltzman in his 1974 book "Regulation of Pharmaceutical Innovation". The statistical result of the 1962 Amendments is that the beneficial effects of reducing the amount of bad drugs being released is far more outweighed by losing the beneficial effects of drugs being delayed or not being developed. But people only see the former.
tolmasky 11y ago
> 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.
      - 11y ago
seehafer 11y ago
I worked for MDT Diabetes, and I can tell you the engineers (many of whom are insulin pump users themselves) are just as frustrated as you are.

poke111 11y ago

This is also a textbook case of what is seen vs. what is unseen. When someone dies from a treatment that the FDA has approved, that is a visible ("seen") tragedy. When people are suffering from ailments that could be treated more effectively if not for the FDA slowing things down and raising the cost of development, that is unseen. There's no single victim you can point to. But the latter is hard to quantify in the risk vs. reward calculation, and importantly no FDA bureaucrat will ever lose their job or be publicly shamed because of them.

cmdrfred 11y ago
How the FDA handled the removal of CFC's from inhalers shows you clearly they are not on the side of the consumer. The slowness likely has something to do with incumbent companies not wanting to spend on R&D. http://www.motherjones.com/kevin-drum/2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much http://www.motherjones.com/kevin-drum/2013/10/heres-why-your...
WalterBright 11y ago
This was all clearly laid out (with backing statistics) by Sam Peltzman in his 1974 book "Regulation of Pharmaceutical Innovation". The statistical result of the 1962 Amendments is that the beneficial effects of reducing the amount of bad drugs being released is far more outweighed by losing the beneficial effects of drugs being delayed or not being developed. But people only see the former.

tolmasky 11y ago

> 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.
    - 11y ago

seehafer 11y ago

I worked for MDT Diabetes, and I can tell you the engineers (many of whom are insulin pump users themselves) are just as frustrated as you are.