Read “Merck, the FDA, and the Vioxx Recall” Case on pages 480-489 of the text. Answer the following...

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Read “Merck, the FDA, and the Vioxx Recall” Case on pages 480-489 of the text. Answer the following questions by critically analyzing the situation, weaving course content into your answers, and developing convincing recommendations. Case write-up maximum 2000 words. As stated previously, assume you are a management consultant who Merck has hired to review their situation and make recommendations.
Part 1 (900-1100 words) As a consultant, convince Merck upper management to consider what you believe are the important issues that Merck should address concerning the “Merck, the FDA and the Vioxx Recall” case. Divide Part 1 into four sections as described below. The sections need not be equal in word length.

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4/1/13 https://elearning.uhv.edu/bbcswebdav/pid-343350-dt-content-rid-1514227_1/courses/V_20131_BUSI_6351_36550/6351caseAssign.u12.htm BUS6351 CASE ASSIGNMENT GENERAL COMMENTS ON WRITTEN ASSIGNMENT The case write-up is due on or before April 29, 2013, 11pm. The due date is the latest date and time the assignment will be accepted before points will be deducted for lateness. The written assignment is to use a minimum of 12 point (mm) type. The assignment will have a word limit of 2000 words, 900-1100 words for Part 1 and 900-1100 words for Part 2. Please adhere to this limit. Going over the word limit is a student fairness issue (as is being late with assignments as discussed above). Points will be deducted if assignments go over the maximum words allowed. Since the assignment has a word limit, make each word count. Avoid empty sentences that add little to your analysis and recommendations. You may discuss this assignment with your classmates. BUT, YOUR SUBMITTED PAPER MUST BE YOURS AND YOURS ALONE and in your own words. Assignments will be graded based on the following criteria: 1) Scope and completeness – all questions assigned are answered and all parts and sections are completed. 2) Weaving course concepts into case analysis – cases are applications of the course concepts and material. Frequent and proper use of course terms and concepts in the write-up are absolutely necessary. 3) Critical analysis (with specificity) – student thoroughly analyzes situation, recognizes relevant issues and supports arguments and conclusions with sound and appropriate depth of evidence. 4) Recommendations and conclusions – logic and judgment are sound and conclusions flow plausibly from strong arguments with justification. 5) Consistency, clarity, grammar, spelling, on-time, adheres to word limit, no typos, sentences and paragraphs, etc. – Much of business is communication and clarity and consistency of ideas and expressions along with proper...

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David · Accepted Answer

P a g e  | 1
C A S E  A N A L Y S I S :  M E R C K ,  T H E  F D A  
A N D  T H E  V I O X X  R E C A L L
P a g e  | 2
INTRODUCTION
This is a case analysis report, prepared on Merck; a leading pharmaceutical company in terms 
of profit. It is among the top five pharmaceutical companies in US, with strong research and 
development framework that helps the company in launching innovative medicines that assist 
in development of the society. Organization had a huge market reputation, as it was 
continuously awarded by Fortune magazine for seven consecutive years as the most admired 
organization. Merck was known in the market for its innovative product offerings and ethical 
service delivery approach of doing business. However, from 2004, company saw a negative 
turnaround phase that took a stable organization to a negative performance level with fall in 
stock prices and profits of the company.  
Vioxx a pain killer, regarded as a miracle drug invented by the company had negative impact 
on the patient’s heart; for this reason, it has been recall in the year 2004, after 84 million 
people have consumed it worldwide, out of which 55,000 died. After the recall of the drug 
almost 6000 lawsuits have been charged on the company. This case analysis has been written 
with objectives of analyzing the ethical position of the company, its strategies and 
recommended strategies for the same (Lawrence & Weber, 2010).  
QUESTION 1  
Do you believe Merck acted in a socially responsible and ethical manner in regard to 
Vioxx? Why or why not? In your answer, please address the company’s drug 
development and testing, marketing and advertising, relationship with government 
regulators and policy market and handling of recall.
P a g e  | 3
ANSWER  
Before commenting on the ethical position of Merck, it is important to analyze its position, 
strategies and actions.  Therefore, here is a critical evaluation of different organizational 
actions taken by the company, which are as follow;  
DRUG DEVELOPMENT AND TESTING  
Various surveys and analysis were taken during the drug development and testing phase, 
which states that different analysis at the development phase shows that Vioxx will help in 
blocking the COX-2 enzyme that helps in controlling the pain in the stomach and also it 
keeps the COX-1 beneficial enzyme at its place. However, according to the market research 
report in 1997, a Merck Scientist has written an email mentioning the ill impact that medicine 
will have on the cardiovascular of the patient who intake it, but this email has been taken out 
of context. 
Similarly, according to the results of VIGOR study also the drug users had five times high 
chances of heart attack then the consumer that uses other medicines which are available over 
the counters.  
MARKETING AND ADVERTISING 
Another important aspect is the advertisement of medicines in the market, though the 
company used many of the marketing tricks used by other pharmaceuticals companies; this 
includes gifts to doctors, free meals, tickets etc. According to the given data in the year 2003, 
the company spent around $422 million just to market Vioxx to doctors and different 
hospitals. According to the information given in the Wall street Journal, on Merck name 
Dodge Ball Vioxx, shows that how the company trained its employees and sales 
representatives to avoid the questions regarding the concerns about the medicine.  
P a g e  | 4
Another important aspect occurred when FDA allowed direct to consumer marketing of 
medicines, the company took advantage of this freedom and done huge expenditure of around 
$ 500 million to advertise Vioxx in the market; it also launched TV commercials taking 
Olympic figure skater, Dorothy Hamill and influence customer choice of medicine, which is 
not ethical.  
GOVERNMENT REGULATORS AND POLICY MARKET 
Increasing involvement of political parties in influencing the decision of FDA has both 
positive and negative impact on the decision taken by the management. The formation of 
PAC, the non-profit organization that has the power to take unlimited donation without 
disclosing the name of the contributor, was also used by Merck to provide soft money 
contribution, as the company spent around $40.

Read “Merck, the FDA, and the Vioxx Recall” Case on pages XXXXXXXXXXof the text. Answer the following questions by critically analyzing the situation, weaving course content into your answers, and...

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