> Regulations are to prevent cynical, or stupid, people from offering dangerous untested unproven "treatments" at great cost to desperate and ill people. That'

> Regulations are to prevent cynical, or stupid, people from offering dangerous untested unproven "treatments" at great cost to desperate and ill people. That's the rationale for the regulations, but it's not why we have them. The laws we have didn't get passed because the public demanded protection. They got passed because industry groups pushed hard for them, as a way to lock out potential competitors. A system actually designed to prevent harm would look quite different. Preventing the use of a good treatment (type I statistical error) is just as bad as allowing a bad treatment (type II statistical error). A balanced regulatory regime would make both kinds of errors with about equal probability. Our current system is so heavily biased toward preventing type II errors that we accept a vast number of type I errors.