Lab 1 - Vioxx lab (MOL S11)

Lab 1 - Vioxx lab (MOL S11) - Laboratory 1 What Happened...

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Laboratory 1: What Happened with Vioxx? 11 LABORATORY 1: WHAT HAPPENED WITH VIOXX? Overview and Objectives On September 30, 2004, Merck pharmaceutical company announced the immediate recall of Vioxx , one of its best-selling drugs. This was the largest and most expensive pharmaceutical recall in history and the first wave of lawsuits are now being settled in the U.S. courts. What happened with Vioxx ? Why was this drug developed and why was it recalled? We will use this event as a case study to examine various questions about the design, testing, advertising, and prescription of pharmaceuticals. Before becoming available to patients, all pharmaceuticals are carefully tested for safety and efficacy (i.e., effectiveness). This is accomplished using clinical trials and the process is carefully monitored by the Food and Drug Administration (FDA). But sometimes the results from these trials are open to several different possible interpretations. The central controversy surrounding the Vioxx recall is whether earlier clinical trials did or did not show that the drug produced an increase risk of heart problems in people who took it. During this laboratory exercise, you will examine how the recall was reported in the media and also analyze the data that was generated from an important clinical trial. Preparation You preparation for the laboratory project will consist of two parts: Read the section on “Making Decisions Using Statistical Data.” This section provides an introduction to statistical concepts and how they apply to making decisions about pharmaceuticals. You will use this background during the laboratory session when you analyze statistical data from a clinical trial. Read the reprint of the front-page story in The New York Times that described the Vioxx recall. Answer the questions on pages 11 - 12 and bring the completed assignment to the laboratory session. The pre-lab assignment replaces the quiz for this lab.
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Laboratory 1: What Happened with Vioxx? 12 MAKING DECISIONS USING STATISTICAL DATA The two major criteria for a successful drug are that it is “safe” and “effective.” These criteria are evaluated using clinical trials, where the candidate drug is tested on patients in comparison to a placebo or another (usually older) type of drug. But how do we know whether any observed difference between the two treatments is meaningful as opposed to random variation? Is the difference due to the new drug or does it arise from some other factor that is unrelated to the treatment? How can we address the well-known fact that different patients respond to a drug in different ways? To answer these questions it is necessary to use the methods of statistics . Statistical methods allow us to describe our data in concise mathematical terms and use well-established norms for determining the significance of a finding; these methods are referred to as descriptive statistics . This section provides an introduction to some central concepts in statistical reasoning 1. Data Sets and Distributions
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Lab 1 - Vioxx lab (MOL S11) - Laboratory 1 What Happened...

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