Great quote in the WSJ comment section: http://blogs.wsj.com/numbersguy/a-statistical-test-gets-its-closeup-1050/tab/comments/ http://blogs.wsj.com/numbersguy/

Great quote in the WSJ comment section: http://blogs.wsj.com/numbersguy/a-statistical-test-gets-its-closeup-1050/tab/comments/ http://blogs.wsj.com/numbersguy/a-statistical-test-gets-its-... The agency will bend their statistical significance requirements when hypothesizing that a treatment has risks, but almost never does when considering the efficacy of a treatment. That is the long and short of it. The FDA makes up the rules as they go along. As for the particular issue at stake, the Supreme Court's ruling in the Zicam case is horrifying: http://online.wsj.com/article/SB10001424052748703712504576235683249040812.html?mod=googlenews_wsj http://online.wsj.com/article/SB1000142405274870371250457623... It is indeed true that statistical significance is not the be-all and end-all. It is also true that you need some method of determining whether a result could be due to chance or not. This is particularly true when you have trial lawyers and regulators who smell blood. Dow Corning was sued and had its reputation dragged through the mud because people thought breast implants were causing some kind of disease. Turns out that wasn't true at all: http://query.nytimes.com/gst/fullpage.html?sec=health&res=9B03E6D9103BF932A15755C0A96F958260&n=Top%2fReference%2fTimes%20Topics%2fOrganizations%2fI%2fInstitute%20of%20Medicine http://query.nytimes.com/gst/fullpage.html?sec=health&re... Now that statistical significance has been jettisoned as a defense, any group of anecdotal injuries of dubious provenance is in theory grounds for a class action lawsuit. And trial lawyers specialize in turning that particular kind of theory into practice. There's a reason that "mesothelioma" was the #1 Adword for a while -- ambulance chasers bid on it like crazy. The Supreme Court has just made it a whole lot easier for them.