{"id":58645,"date":"2015-08-01T16:57:09","date_gmt":"2015-08-01T20:57:09","guid":{"rendered":"http:\/\/1boringoldman.com\/?p=58645"},"modified":"2015-08-01T17:15:51","modified_gmt":"2015-08-01T21:15:51","slug":"backwards-2","status":"publish","type":"post","link":"https:\/\/1boringoldman.com\/index.php\/2015\/08\/01\/backwards-2\/","title":{"rendered":"backwards…"},"content":{"rendered":"\n
Continuing from the why of it…<\/a>, there’s something backwards<\/font><\/em> about Randomized Clinical Trials [probably best called randomized, double blinded, placebo controlled, clinical trials]. If you don’t know the story of how they came to be, these resources on the history of Louis Lasagna ought to help: David Healy’s blog, The Tragedy of Lou Lasagna<\/a><\/font> and Don Klein’s interview with Louis Lasagna<\/a>. Lasagna was quite a figure – originating the study of the placebo effect, rewriting the Hippocratic Oath, and as Senator Kefauver’s science guy in the legislation that brought the efficacy requirement and Clinical Trials into the FDA Mandate in 1962. Prior to 1962, the FDA’s job was to make sure drugs were safe. After 1962, they were required to also certify that they did what the drug maker said they did [efficacy] – at  least sort of. The bar was set low – two positive “adequate and well controlled studies carried out by experts with scientific training<\/font><\/em><\/span>" [out of as many trials as you care to run]. It makes sense. How else can you measure efficacy other than trying the drug out in the target population?<\/div>\n