IS THE “GOLD STANDARD “THE ONLY TEST? It seems bizarre to conduct an experiment with some 19,000 subjects to test something that everybody has known for years. Yet the Chinese eyeglass experiment is representative of an influential line of thinking. There are a large number of scientists who take the position that only “evidence based” knowledge is valid and that the only valid kind of evidence is a randomized controlled experiment. Hence, the eyeglass experiment.

Ed Silverman in yesterday’s Wall Street Journal (May 29) provided an example of the belief that there must be randomized drug tests for the FDA to approve additional uses for drugs. Silverman writes about proposed legislation on the approval process for drugs that would allow the use of “something called ‘clinical experience’ which is defined as a mix of observational studies, patient registries and therapeutic use”. Silverman says that the critics who object to the legislation “point to language that would allow the FDA to approve additional uses for drugs without having to rely on randomized controlled trials.”

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