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Vioxx Recall

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Submitted By lmasolak
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Benedictine University

8/4/2014

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 she had doubts about the drug’s safety because of the possibility of cardiovascular issues. After the drug was released to the public, Merck sponsored a study called VIGOR that was completed in 2000. This study compared arthritis patients that used Vioxx and a competing drug called Aleve. After the completion of the study, Merck found out that the group taking Vioxx had five times as many heart attacks as the Aleve group but stated that these findings were due to the heart-protective effects of Aleve and that Vioxx was not responsible (Lawrence & Weber, 2014, p.495). Merck did not do a good enough job testing Vioxx before its release to the public and company executives didn’t take the results of the studies seriously. It seems that Merck took every available option it could to get its product to as many consumers as possible even though there were doubts about its safety. Merck hired hundreds of lobbyists in the nation’s capital and made countless political donations to promote its political agenda on many different issues such as speeding up the approval of new drugs from 27 months in 1993 to just 14 in 2001 (Lawrence & Weber, 2014, p.495). Merck was also able to take advantage of direct-to-consumer advertising. The FDA allowed drug companies to advertise directly to consumers in 1997 and the company spent millions on television and magazine advertising. This allowed consumers to learn about the newly available drugs and put pressure on doctors to offer them to their patients even though their safety has not always been determined. Finally, after multiple safety warnings, Merck recalled Vioxx in 2004 after finding out that Vioxx patients were more than twice as likely to have a heart attack or stroke than those that used a placebo. Merck announced that they are voluntarily withdrawing Vioxx because of new data from a three year clinical study. What should or could Merck have done differently, if anything? First of all, Merck should do a better job testing its products. The company has a huge responsibility because of the amount of people that use its products. Unless Merck’s scientists are 100% satisfied with a particular drug’s safety, it should not be approved for the mass market. It seems that some drug companies do just enough for the drug to get through the FDA inspection because everything is so profit driven. What is the best way for society to protect consumers of prescription medicines? Specifically, what are the appropriate roles for pharmaceutical companies, government regulators and policy makers, patients and their physicians, and the court system in assuring the safety and effectiveness of prescription medicines? I think that the best way for society to protect consumers of prescription medicines is to instill certain laws and guidelines that put more responsibility on all institutions involved the same way that Sarbanes Oxley Act did for the accounting industry. There should be more than one drug safety testing agency and those agencies should not be compensated in any way by the pharmaceutical companies. Government regulators and policy makers shouldn’t be influenced by lobbyists because there is too much at stake when it comes to the drug industry. Patients and their physicians need to be better informed as to the safety and the side effects of the different drugs that are hitting the market. The information that a patient receives about a particular medication, shouldn’t only come from their television in the form of a commercial. The fines and sentences for company executives should be raised and well communicated. How should the present system be changed, if at all, to better protect patients? As mentioned above, the current system needs better oversight when it comes to the testing of new medicines. The rules for lobbyists and how political contributions affect laws that are being passed should be looked at and changed to protect the consumers. There should be a second, separate government testing agency opened besides the FDA. Its fees should not be contingent on how many drugs are approved or how fast they complete their testing.

References Lawrence, A. T., & Weber, J. (2014). Business and society: stakeholders, ethics, public policy (14th ed.). New York: McGraw-Hill Higher.

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