Chapter 14, Problem 44E

Exercises 41 through 44 refer to a clinical trial named APPROVe designed to determine whether Vioxx, a medication used for arthritis and acute pain, was effective in preventing the recurrence of colorectal polyps in patients with a history of colorectal adenomas. APPROVe was conducted between $2002$ and $2003$ and involved $2586$ participants, all of whom had a history of colorectal adenomas. The participants were randomly divided into two groups: $1287$ were given $25$ milligrams of Vioxx daily for the duration of the clinical trial (originally intended to last three years), and $1299$ patients were given a placebo. Neither the participants nor the doctors involved in the clinical trial knew who was in which group. During the trial, $72$ of the participants had cardiovascular events (mostly heart attacks or strokes). Later it was found that $46$ of these people were from the group taking the Vioxx and only $26$ were from the group taking the placebo. Based on these results, the clinical trial was stopped in 2003 and Vioxx was taken off the market in $2004$.

What conclusions would you draw from APPROVe?