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If it was the FDA's fault, you'd see scientists regrowing limbs and testing nano-bots in rats. The FDA actually has a great system of emergency and compassionat
by elil17 7y ago
If it was the FDA's fault, you'd see scientists regrowing limbs and testing nano-bots in rats. The FDA actually has a great system of emergency and compassionate use authorizations that allow early testing of experimental drugs and devices. These systems came into place because of a long history of medical disasters: see thalidomide, Elixir sulfanilamide, and so many more.
- WalterBright 7y agoI'm not arguing the reason for the regulations. I'm pointing out that the regulations greatly slow down and increase the cost of medical innovations.
- thombat 7y agoTrue, but it isn't the case that we know how to repair blood vessels or regrow limbs in other vertebrates. Medical regulations haven't retarded basic research, it's just that biology is fundamentally very complex and most medical progress amounts to diligent iteration of inspired guesswork and observation.
- WalterBright 7y agoPeople are not likely to invest in research and development without a corresponding probability of making money off of it. The regulations make that very difficult.
- elil17 7y agoThat’s why the government provides drug research grants and 20-year drug monopolies (aka patents)
- WalterBright 7y agoNowhere near enough to compensate for the costs and delays of the regulations, unless it is a blockbuster drug. Government research grants are doled out by a bureaucratic committee unwilling to take risks - so the grants are for safe, incremental, conservative, political gains. (After all, the committee has to answer to whoever their oversight bureaucrats are.) This is not where game-changing innovation comes from.
- smabie 7y agoIt's pretty hard to know the path not taken. I used to work at the FDA, and let me tell you, they're basic reason for existence is to slow down innovation. Many think it's worth it, but I personally believe that their risk aversion has hurt much more people than it has helped. But from a political perspective, it's the right move because no one is going to blame you for hypothetically preventing some life-saving wonder drug from existing; they're going to blame you for approving some drug that kills a bunch of people. In the first case, the harm is almost impossible to quantify or even reason about, in the second case the harm is direct and known.
- WalterBright 7y agoThat's exactly what's researched in the book: "Regulation of Pharmaceutical Innovation" by Sam Peltzman
- zozbot234 7y ago> If it was the FDA's fault, you'd see scientists regrowing limbs and testing nano-bots in rats. Can't do that either, the IRB says it's not allowed under research ethics unless the rats have given informed consent.
- elil17 7y agoUnfortunately, now that we have a “smart” printer, we need the printers consent before we can print the informed consent papers