You're missing the big trend. In addition to the availability of DIY hardware and more ways for patients to find each other and communicate, other developed or developing countries are approving treatments before the FDA. The size of the US market still holds back medical research, but at some point in this century, the size of the "early adopter" markets with sufficient buying power will be big enough that it won't matter.
Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands.
P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.
That's a good solution. I'm getting a Dexcom pretty soon (relatively recently diagnosed.) It's a bit depressing to compare the speed of the Dexcom hacker community to the speed of Dexcom's FDA-approved software releases, but at least we aren't still stuck with Medtronic.
> P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days.
I don't think you understand that if 20,000 diabetics die because they are banned from effective treatment, DIY treatments save 5,000 of them, and 500 of those 5,000 have a negative effect, then it is a big improvement in overall national health, even though a 10% failure rate is horrifying.
The article you linked about one drug in West Germany does not take into account the overall benefit to health of learning that information and allowing more beneficial drugs to also enter the market quickly.
You could quibble about the numbers but it's important to understand the principle before doing so.
Signed, one American Type 1 diabetic who is tired of the FDA letting us die by keeping the best tools out of our hands.
P.S. If an analogy helps you, think about how music piracy ended up giving us Spotify, and how it had to come from Europe to break into the US market, and how it blocked Americans to avoid getting shut down in its early days. Or, think about how Jobs essentially tricked the labels into allowing iTunes. The traditional record label publishing model is analogous to the FDA's drug trial model. The FDA can make any number of arguments about how their method is more rigorous and beneficial, but at some point, newer methods of getting similar results are coming along, and at some point after that, those methods will be backed by a power with the resources and inclination to bring the benefits of rigor to the new methods without resorting to the old methods.