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Case Study #1 – Science & Big Pharma

As you view the lecture video for this case study, use this worksheet to record your answers. You will submit these answers by completing the “Case Study #1 – Science & Big Pharma Assignment” in Canvas.

1. a. What major side effect do you predict with non-specific NSAIDs? (1 pt)

1. b. What is the basis for this side effect? (why does it occur?) (1 pt)

1. c. How could you design a pain-relieving drug to reduce this side effect? (1 pt)

2. In the graph showing GI side effects in the VIGOR study

a. what is the independent variable? (0.5 pts)

b. what is the dependent variable? (0.5 pts)

c. what can you conclude about Vioxx and Naproxyn in terms of GI side-effects? (1 pt)

3. a. (1.5 pts) # of myocardial infarctions (MIs) in naproxyn group:

# of MIs in Vioxx group:

# of MIs in 20,000,000 Americans taking Vioxx:

3. b. (1 pt) New % MIs in Vioxx group (n= 4047):

New # of MIs in 20,000,000 Americans taking Vioxx:

4. a. How many more or fewer complicated GI events happened on Vioxx, relative to Naproxyn? (1 pt)

(fill in #) MORE or FEWER (circle which one) on Vioxx

b. How many more or fewer serious cardiovascular events happened on Vioxx, relative to Naproxyn? (1 pt)

(fill in #) MORE or FEWER (circle which one) on Vioxx

c. In one or two sentences, summarize the impact of Vioxx relative to Naproxyn on GI side effects and on cardiovascular adverse outcomes (2 pts)

5. a. What do the APPROVe study data suggest about Vioxx and cardiovascular events? (1 pt)

5. b. Are the APPROVe study data consistent with the VIGOR study data? (explain your answer) (1 pt)

5. c. Based on the APPROVe study, do you think Vioxx is safe? Why or why not? (1.5 pts)b

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