For years, the drug Vioxx, developed and marketed by Merck, wasone of the blockbuster drugs on the market. One of a number ofso-called Cox-2 anti-inflammatory drugs, Vioxx was considered bymany people a miracle drug for alleviating the pain from arthritisand other painful afflictions. Vioxx was marketed heavily ontelevision, prescribed by most physicians, and used by an estimatedtwo million Americans. All of that changed in October 2004, whenthe results of a large study were released. The study, whichfollowed approximately 2600 subjects over a period of about 18months, concluded that Vioxx use over a long period of time causeda significant increase in the risk of developing serious heartproblems. Merck almost immediately pulled Vioxx from the Americanmarket and doctors stopped prescribing it. On the basis of thestudy, Merck faced not only public embarrassment but the prospectof huge financial losses.
More specifically, the study had 1287 patients use Vioxx for an18 period, and it had another 1299 patients use a placebo over thesame period. After 18 months, 45 of the Vioxx patients haddeveloped serious heart problems, whereas only 25 patients on theplacebo developed such problems.
*Given these results, would you agree with the conclusion thatViozz caused a significant increase in the risk of developingserious heart problems? First, answer this from a purelystatistical point of significant means statistically significant.*What hypothesis should you test, and how should you run thetest?
*When you run the test, what is the corresponding p-value? Next,look at it from the point of view of patients. *If you were a Vioxxuser, would these results cause you significant worry? After all,some of the subjects who took placebos also developed heartproblems, and 45 might not be considered that much larger than 25 .Finally, look at it from Merck’s point of view. *Are the resultspractically significant to the company?* What does it stand tolose? *Develop an estimate, no matter how wild it might be, of thefinancial losses Merck might incur. Just think of all of thoseAmerican Vioxx users and what they might do.
