...Merck, the FDA, and the Vioxx Recall 1. Do you believe that Merck acted in a socially responsible and ethical manner with regard to Vioxx? Why or Why not? In your answer, please address the company’s drug development and testing, marketing and advertising, relationships with government regulators and policymakers, and handling of the recall. I do not believe that Merck made a socially responsible decision when Vioxx was introduced into the pharmaceutical market. Scientists that were involved in product development and testing knew that there were serious health risks that could be side effects of the medication- such as cardiovascular complications. If they considered the lives that could have potentially been and as we know now were affected, the medication could have been revamped with changes that would minimize these harmful side effects. During the development and testing phase for Vioxx – issues regarding the safety of the drug were questioned due to the many cases of heart attacks resulting from the medication (more so than Aleve and Celebrex). The advertising technique that was used was thru direct-to-consumer. This was new in the pharmaceutical industry as it was the first time they were allowed to advertise to consumers. They used an Olympic figure skater as the primary character within their commercials. Consumers then would request this medication, making doctors feel obliged to prescribe. The government and policymakers received large sums of money from the...
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...Case Study: Merck and the Vioxx Recall Kelvin Gabel Benedictine University Case Study: Merck and the Vioxx Recall According to Lawrence and Weber (2014), former Merck CEO George W. Merck implied a corporate vision of social responsibility for Merck & Co., Inc. (Merck) when he stated in 1950 that medicine was for the people and that loyalty to that concept would lead to greater profits. On the surface, it appears Merck has historically lived its declared mission of putting people first. This is demonstrated by the company forfeiting patent and profits from the antibiotic streptomycin and the drug Mectizan (Lawrence, 2014). Merck was well rewarded for its people first philosophy. Though it was ranked fifth in asset and market value, it ranked first in profits. Additionally the company had a stellar reputation of being perceived as the most ethical and socially responsible of the major drug companies (Lawrence, 2014). Today Merck Pharmaceutical’s mission statement is “to discover, develop and provide innovative products and services that save and improve lives around the world (Merck, 2015).” Reading Merck’s current mission statement lacks both the compassion of placing people first and the implied social responsibility of Mr. Merck’s statement in 1950. To be contextually correct historically in forming a view of Merck and the Vioxx recall issue, I sought to find a corporate mission statement from the period of the recall which was in 2006. According to Culp...
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...Analysis #1 Tuesday, January 22, 2013 Matt Janes Merck & Company, Inc: The Recall of Vioxx Introduction Geroge W. Merck stated once stated, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow. Initially, Vioxx was the blockbuster drug that Merck needed due to the upcoming Zocor patent cliff in 2006. With an estimated 27,785 heart attacks and sudden cardiac deaths that could have been avoided if Celebrex had been used instead of Vioxx, Merck faces the possibility of not only having to pay enormous civil and criminal penalties, but also losing the trust of patients. Many parties are partially culpable, but Merck faces the severe uphill battle of regaining a reputation that once served as a market differentiator; in the 1980’s, Merck was voted the “Most Admired Company in American Business” for seven consecutive years. A critical issue in this case is to analyze the events listed in the case and propose an alternate course of action that may help prevent future deaths from other pharmaceutical drugs while not prohibitively restricting innovative research that could potentially save lives if tested properly. Critical Points and Issues Merck was relying on the success of Vioxx due to Zocor’s expiring patent and the direct competition Vioxx was engaged in with Celebrex, which had a first mover advantage. While Celebrex was also a Cox-2 inhibitor, Vioxx was the only Cox-2 inhibitor proven to be beneficial for ulcers...
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...Abstract The following text examines the recall of the drug Vioxx and the pharmaceutical industry’s responsibilities when it comes to ethical testing and distribution of consumer medicines. The role of the Federal Drug Administration is examined. The text also contemplates the actions that Merck, the maker of Vioxx, took during the product’s recall and how we can improve the current drug testing system to protect consumers. INTRODUCTION Merck, one of the biggest pharmaceutical companies in the world, created Vioxx, a once best-selling painkiller. In 2004, the company learned that its drug increased the risk of stroke and heart attack. After a few different studies, Merck finally gave in and recalled the product. The company had to face troubling questions and allegations that Vioxx had caused many deaths even though it wasn’t proven to be completely safe. Do you believe that Merck acted in a socially responsible and ethical manner with regard to Vioxx? Why or why not? In your answer, please address the company’s drug development and testing, marketing and advertising, relationships with government regulators and policy makers, and handling of the recall. I don’t think that Vioxx acted in a socially responsible and ethical manner with regard to Vioxx. Even before the drug was approved and released into the market, there was evidence that Vioxx wasn’t 100% safe. Dr. Alise Reicin, one of the scientists that worked for Merck at the time in 1997, stated in an e-mail that...
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...Merck, the FDA, and the Vioxx Recall In 1999 the Food and Drug Administration (FDA) had approved Vioxx, what would become Merck’s “blockbuster” drug. Although the FDA had approved the drug there was uncertainty of the safety of drug. Vioxx was approved to treat a variety of conditions, such as osteoarthritis and acute pain, but there was also a chance that it would increase cardiovascular problems. What I found most interesting about this case was the changes in how drugs are brought to consumers, from how they are approved to how they are informed of the drug. Strengths Merck was heading in the right direction with its drug Vioxx. They wanted the drug to be a “blockbuster”, used for multiple symptoms and everyday use. Merck used direct-to-consumer advertising to fuel sales of Vioxx. Vioxx seemed to benefit stakeholders on both ends of the spectrum, until it was found to cause cardiovascular problems. Merck did continue to research the effects of its drug and eventually voluntarily withdrew Vioxx. This is a strength in that they made the right ethical decision to withdraw the drug, even though it did take almost 5 years. Weaknesses Merck’s weakness would be that it did not research its drug thoroughly enough for possible problems before seeking approval from the FDA. The FDA etimates that 139,000 people in the United States had had a heart attack or stroke as a result of taking VIoxx. This could have been prevented if Merck had properly researched the drug or recalled...
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...I believe neither Merck nor Pfizer acted ethically or socially responsible during the Vioxx disaster. Evidence suggests that Merck might have knows about the harmful side effects of Vioxx and yet they hesitated for over 3 years to recall the drug. There was also an allegation that the company had manipulated and covered-up the results of the medical trials in their favor. An ethical thing to do would be to simultaneously recall the drug as well as inform the public about the dangers of using Vioxx. Instead Merck not only continued to produce and sell the drug, they had also spent hundreds of millions of dollars a year in marketing, partly to counteract any questions raised. According to The Wall Street Journal Merck’s “training document listed potential tough questions about Vioxx and said in capital letters, "DODGE!" , meaning that the company advised marketers to avoid direct answers on the health consequences of the drug. The article even mentions that many doctors and medical professors who raised questions about the safety of Vioxx were being pressured and intimidated by Merck. There is no doubt that all this behavior was deliberate and illegal. A company doing this kind of practices cannot call itself ethical. After the Vioxx scandal, Pfizer - the producer of Celebrex and Bextra (drugs with a very similar chemical composition to Vioxx and its biggest competitors) was in a perfect spot to immediately recall it’s medicine from the market and therefore prove to the public...
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...Overview : 1. Merck was founded in 1668 2. Globl drug manufacture in the world 3. Merck’s significant investment in internal research and development (R&D) was a strategic advantage with which few companies could compete 4. Merck’s recent $41 billion “reverse-merger” with Schering-Plough represented a significant step away from a closed R&D model toward a more open innovation strategy. Merck is a global research-driven company that discovers, develops, manufactures, and markets a broad range of innovative products to improve human and animal health. 5. They call The Harvard Pharma, because By 1950, five Merck researchers had won Nobel prizes for their contributions to medicine. Head scientists were successful in the recruitment and retention of superior research personnel because Merck maintained an academic, university-like atmosphere in which scientists were given freedom to explore their personal research interests. 6. Fosamax drugs revention of osteoporosis 7. Recall drugs vioxx 8. The joining of these two former rivals in March 2009 was seen as a necessary step toward diversification and increased economies of scale, propelled by imminent patent expirations and increasing pressure from shareholders, government, and customers to control costs. 9. The deal was structured as a “reverse-merger” to permit SP to bypass a change-of-control clause in a drug partnership it had with Johnson & Johnson (J&J). SP and J&J shared the rights to the blockbuster drugs Remicade and...
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...Business Listen to the Chapter Audio on mythinkinglab.com CASE 1.1 Explore the Concept on mythinkinglab.com Merck and the Marketing of Vioxx On September 30, 2004, Merck & Co. announced the withdrawal of Vioxx, its highly profitable pain reliever for arthritis sufferers, from the market.1 This announcement came only seven days after company researchers found in a clinical trial that subjects who used Vioxx more than 18 months had a substantially higher incidence of heart attacks. Merck chairman and CEO Raymond V. Gilmartin described the action as “the responsible thing to do.” He explained, “It’s built into the principles of the company to think in this fashion. That’s why the management team came to such an easy conclusion.”2 In the lawsuits that followed, however, damaging documents emerged casting doubt on Merck’s claim that it had acted responsibly by taking appropriate precautions in the development and marketing of the drug. For decades, Merck’s stellar reputation rested on the company’s emphasis on science-driven research and development. Merck employed some of the world’s most talented and best-paid researchers and led other pharmaceutical firms in the publication of scientific articles and the discovery of new medicines for the treatment of serious conditions that lacked a satisfactory treatment. For seven consecutive years in the 1980s, Merck was ranked by Fortune magazine...
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...IMPACT OF TOTAL QUALITY MANAGEMENT IN INDIAN PHARMACEUTICAL COMPANIES’ PERFORMANCE Name: Singh Sudhanshu Bala, Roll no.- ITM/BIT/MUMBAI/09/1- 17 2. INDEX Serial No. Title Page No. 1. Title Page 1 2. Index 2 3. Title of the Thesis 3 4. Background of Research 4 5. Objectives 10 6. Scope 11 7. Methodology 11 8. Review of Literature 12 9. Gaps in Literature 14 10. Summary of the Proposal 14 11. Work Plan 16 12. References 17 3. TITLE OF THE THESIS: IMPACT OF TOTAL QUALITY MANAGEMENT IN INDIAN PHARMACEUTICAL COMPANIES’ PERFORMANCE 4. BACKGROUND OF RESEARCH: Total quality management (TQM) - TQM has been defined as an integrated organizational effort designed to improve quality at every level. TQM is also defined as quest of excellence, fitness for use, value for money, customer satisfaction etc. The International Organisation for Standards (ISO) defines TQM as, "TQM is a management approach for an organisation, centered on quality, based on the participation of all its members and aiming at long-term success through customer satisfaction and benefits to all members of the organisation and to society." ISO 8402:1994 TQM acts as an umbrella under which everyone in the organisation...
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...ROBERT F. HARTLEY • Cindy Claycomb 12th Edition T W E L F T H E D I T I O N MARKETING MISTAKES AND SUCCESSES Robert F. Hartley Late of Cleveland State University Cindy Claycomb Wichita State University VICE PRESIDENT & EXECUTIVE PUBLISHER SENIOR EDITOR PROJECT EDITOR EDITORIAL ASSISTANT ASSOCIATE DIRECTOR OF MARKETING MARKETING MANAGER MARKETING ASSISTANT DESIGN DIRECTOR PRODUCT DESIGNER SENIOR PRODUCTION MANAGER ASSOCIATE PRODUCTION MANAGER PRODUCTION EDITOR COVER DESIGNER George Hoffman Franny Kelly Brian Baker Jacqueline Hughes Amy Scholz Kelly Simmons Marissa Carroll Harry Nolan Allison Morris Janis Soo Joel Balbin Eugenia Lee Kenji Ngieng This book was set in 10/12 New Caledonia by Aptara®, Inc. and printed and bound by Courier/Westford. The cover was printed by Courier/Westford. This book is printed on acid-free paper. Founded in 1807, John Wiley & Sons, Inc. has been a valued source of knowledge and understanding for more than 200 years, helping people around the world meet their needs and fulfill their aspirations. Our company is built on a foundation of principles that include responsibility to the communities we serve and where we live and work. In 2008, we launched a Corporate Citizenship Initiative, a global effort to address the environmental, social, economic, and ethical challenges we face in our business. Among the issues we are addressing are carbon impact, paper specifications and procurement, ethical...
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...213-255_Trevino_08p4.qxd 6/21/06 5:18 PM Page 213 PA R T IV ETHICS AND THE ORGANIZATION 213 213-255_Trevino_08p4.qxd 6/21/06 5:18 PM Page 214 CHAPTER 8 ETHICAL PROBLEMS OF ORGANIZATIONS INTRODUCTION In the third quarter of 2002, the Brookings Institution, a Washington, D.C., think tank, estimated that the corporate scandals that began with the Enron debacle in late 2000 would cost the U.S. economy $35 billion. That is the equivalent of a $10 increase per barrel of oil.1 It is, in a word, staggering. And we may not have seen the end of it. Long before Enron’s collapse, a number of business ethicists and business professionals watched with concern as Wall Street analysts demanded increasingly strong corporate financial performance to support rising corporate stock prices. At the same time, the gargantuan compensation packages (including stock options) of the top executives running these companies became inextricably linked to their companies’ stock prices. In 1990, average CEO pay at major corporations was 107 times the pay of the average worker. By 2004, CEO pay had risen to 431 times the pay of the average employee. (If the pay of average workers in the United States had risen as fast as CEO pay, the lowest paid workers would be earning $23.03 an hour, not $5.15 an hour.)2 It was an “accident” waiting to happen, although everyone was making so much money in the market that no one wanted to admit that something could be fundamentally...
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...www.it-ebooks.info www.it-ebooks.info E L E V E N T H E D I T I O N MARKETING MISTAKES AND SUCCESSES 3 0 T H A N N I V E R S A RY Robert F. Hartley Cleveland State University JOHN WILEY & SONS, INC. www.it-ebooks.info VICE PRESIDENT & PUBLISHER EXECUTIVE EDITOR ASSISTANT EDITOR PRODUCTION MANAGER PRODUCTION ASSISTANT EXECUTIVE MARKETING MANAGER ASSISTANT MARKETING MANAGER MARKETING ASSISTANT DESIGN DIRECTOR SENIOR DESIGNER SENIOR MEDIA EDITOR George Hoffman Lise Johnson Carissa Doshi Dorothy Sinclair Matt Winslow Amy Scholz Carly DeCandia Alana Filipovich Jeof Vita Arthur Medina Allison Morris This book was set in 10/12 New Caledonia by Aptara®, Inc. and printed and bound by Courier/Westford. The cover was printed by Courier/Westford. This book is printed on acid-free paper. Copyright © 2009, 2006, 2004, 2001, 1998, 1995, 1992, 1989, 1986, 1981, 1976 John Wiley & Sons, Inc. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning or otherwise, except as permitted under Sections 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc. 222 Rosewood Drive, Danvers, MA 01923, website www.copyright.com. Requests to the Publisher for permission should...
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...Executive Summary: Pfizer-Wyeth Merger Deal Overview: On January 25, 2009, Pfizer and Wyeth entered into the merger agreement, pursuant to which, subject to the terms and conditions set forth in the merger agreement, Wyeth will become a wholly-owned subsidiary of Pfizer. Upon completion of the merger, each share of Wyeth common stock issued and outstanding will be converted into the right to receive, subject to adjustment under limited circumstances, a combination of $33.00 in cash, without interest, and 0.985 of a share of Pfizer common stock in a taxable transaction. Pfizer will not issue more than 19.9% of its outstanding common stock at the acquisition date in connection with the merger. The exchange ratio of 0.985 of a share of Pfizer common stock will be adjusted if the exchange ratio would result in Pfizer issuing in excess of 19.9% of its outstanding common stock as a result of the merger Deal Terms Breakdown: Transaction Value Transaction Consideration Purchase price per WYE share $50.19 Existing Cash Used $22,213 32.7% Cash per WYE share $33.00 New Debt $22,500 33.1% PFE stock value per WYE share $17.19 Total Cash $44,713 65.8% PFE shares per WYE share 0.985 Stock Consideration $23,289 34.2% Premium to 1/23/09 WYE price 29.3% Total Consideration $67,303 100.0% Total WYE shares (MM,diluted) 1,341 Total Equity...
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...Q3 2010 www.businessmonitor.com siNGapore pharmaceuticals & healthcare report INCLUDES 10-YEAR FORECASTS TO 2019 issN 1748-216X published by Business monitor international ltd. SINGAPORE PHARMACEUTICALS & HEALTHCARE REPORT Q3 2010 INCLUDING 5-YEAR AND 10-YEAR INDUSTRY FORECASTS BY BMI Part of BMI’s Industry Report & Forecasts Series Published by: Business Monitor International Copy deadline: June 2010 Business Monitor International Mermaid House, 2 Puddle Dock, London, EC4V 3DS, UK Tel: +44 (0) 20 7248 0468 Fax: +44 (0) 20 7248 0467 Email: subs@businessmonitor.com Web: http://www.businessmonitor.com © 2010 Business Monitor International. All rights reserved. All information contained in this publication is copyrighted in the name of Business Monitor International, and as such no part of this publication may be reproduced, repackaged, redistributed, resold in whole or in any part, or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping, or by information storage or retrieval, or by any other means, without the express written consent of the publisher. DISCLAIMER All information contained in this publication has been researched and compiled from sources believed to be accurate and reliable at the time of publishing. However, in view of the natural scope for human and/or mechanical error, either at source or during production, Business Monitor International accepts no...
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...Week 1 |[pi|Week 1: Business Ethics and International Responsibility (May 1 - May 8) | | |[pic]|Help |[p| |c][| | | | | |ic| |pic| | | | | |] | |] | | | | | | | | | | Week 1 Introduction Hi! It's Week 1, and we're set to go. This course is perhaps a little different from the typical MBA course. Rather than studying the internal workings of a business, we shall instead delve into the legal, political, and social cultures of our city, nation, and world and see how these affect everything we do in business. We shall study the gamut of legal concepts, from product liability, to civil rights, to intellectual property rights, to antitrust and consumer protection. Underpinning all of these legal concepts, however, will be two foundational aspects: (a) the ethical issues within, and (b) the "world view" without. Milton Friedman, Immanual Kant, Blanchard and Peale, Laura Nash . . . these are just a few of the names of ethicists and...
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