The Food and Drug Administration takes a very careful approach to its approval of new drugs before they are approved for use: http://www.fda.gov/drugs/developmentapprovalprocess/default.htm. However sometimes the FDA gives the go-ahead to a drug which is later found to be unsafe and is withdrawn from the market. A well known case involves the Cox-2 inhibitor VIOXX - see for example http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166532.htm and http://en.wikipedia.org/wiki/Rofecoxib which was approved by the FDA in 1999 and withdrawn in 2004.

Given that the FDA is so careful, why do such mistakes happen? Is it bad science, bad statistics orsimple bad luck? Maybe some of each? Or something else? Discuss in the context of Units One andTwo.

As an aside there is now (since 2013) some concern at the use of ibuprofen Advil,Motrin, Excedrin etc. See for example http://www.forbes.com/sites/johnlamattina/2013/06/01/the-fdas-dilemma-aboutibuprofen-and-cardiovascular-risk/andhttp://www.nlm.nih.gov/medlineplus/druginfo/meds/a682159.html . The first articlestates that ibuprofen may be equally hazardous as VIOXX. You are welcome to mention this in your discussion posting