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Merck The Fda And The Vioxx Recall Case Study Analysis

Merck, the Fda, and the Vioxx Recall Essay

1113 WordsDec 15th, 20125 Pages

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.
No, Merck didn’t act in a corporate social responsibility in regards to Vioxx. Corporate social responsibility means that a corporation should act in a way that enhances society and its inhabitants and be held accountable for any of its actions that affect people, their communities, and their environment.
Over a five year period from 1999 to 2004 over 139,000 people in the United States has had a heart attack or stroke as a result of…show more content…

For example, the state of Texas has sued Merck for violating its Medicaid fraud law and demands $168 million from the company.
What should or could Merck have done differently, if anything?
It appears that Merck's executives either forgot to follow or chose to ignore George W. Merck's advice when they made decisions regarding Vioxx.
In our free-enterprise system, the basic purpose of a company should be to satisfy its target customers' needs and wants effectively, competitively, ethically, socially responsibly, and profitably. Companies express this idea through different words in order to fit their particular business situations.
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 policymakers, patients and their physicians, and the court system in assuring the safety and effectiveness of prescription medicines?
Although a successful business must be a profitable one, the corporate behavior of maximizing profit at the expense of ethics and social responsibility is highly objectionable and should be discouraged. The Vioxx recall case is a perfect example.
A business must carefully balance profit and social responsibility. When business executives fail to maintain this balance and seek undeserved or excessive profit, problems will occur. Such problems frequently cause severe damage to both

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1. United States Securities and Exchange Commission. Form 10-Q: quarterly report pursuant to section 13 or 15(d) of the Securities Exchange Act of 1934 Note 7 to consolidated financial statements (http://phx.corporate-ir.net/phoenix.zhtml?c=73184&p=irol-SECText&TEXT=aHR0cDovL2NjYm4uMTBrd2l6YXJkLmNvbS94bWwvZmlsaW5nLnhtbD9yZXBvPXRlbmsmaXBhZ2U9NDMxNDgxMiZkb2M9MSZudW09MTI=

2. Merck. Vioxx (rofecoxib): frequently asked questions. www.vioxx.com/rofecoxib/vioxx/consumer/faq.jsp

3. Morrison BW. Memo to Alan Nies, Barry Gertz, Beth Seidenberg. Letter to Ken Lasseter; manuscript draft for protocol 023. 18 Feb, 1998. Merck. Bates Nos MRK-NJ0017794 to MRK-NJ0017822. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Morrison1998.pdf

4. Food and Drug Administration, Division of Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products. HFD-550, medical officer review. Vioxx (rofecoxib), NDA 21-042/052. Washington, DC: FDA, 1999.

5. Food and Drug Administration. FDA advisory committee briefing document NDA 21-042, s007: VIOXX gastrointestinal safety. Washington, DC: 2001.

6. Merck. Vioxx. In response to your questions: cardiovascular system, clinical profile in osteoarthritis studies. Whitehouse Station NJ: Merck, 2000. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Merck2000CVcard.pdf

7. Waxman HA. Merck documents show aggressive marketing of Vioxx after studies indicated riskwww.democrats.reform.house.gov/story.asp?ID=848&Issue=Prescription+Drugs

8. Waxman HA. Memo re: the marketing of Vioxx to physicians. Washington, DC: US House of Representatives, 2005.

9. Weinblatt M. Memo to Drs. Bjorkman, Neaton, Shapiro, Silman, and Sturrock re: Interim non-endpoint safety analysis of VIGOR—unblinded minutes. November 18, 1999. Found in sNDA S-007: P088C: Appendix 3.9.2 at p.2939-2946 (Bates No. MRK-00420015464-MRK-00420015471. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/VigorDSMB.pdf

10. Merck. Medical affairs procedures and policies. Procedure 23: collaborative research efforts and megatrials. Appendix 2: Merck guidelines for data and safety monitoring boards. 29 Feb, 1999. Bates Nos MRK-AFK0047772 to AFK0047791. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Merck1999guidelines.pdf

11. Reicin AS. Letter re: financial disclosure for Merck and Co, Inc sponsored protocol entitled: “A double-blind, randomized, stratified, parallel-group study to assess the incidence of PUBs during chronic treatment with MK-0966 or naproxen in patients with rheumatoid arthritis (VIGOR).” 4 Feb, 2000. Merck. Bates Nos MRK-MEW00012 to MRK-MEW00014. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/ReicinWeinblatt2000.pdf

12. Merck and Co. Multidisciplinary strategic advisory board for cox-2 inhibitors, consulting agreement. February 29, 2000. Bates Nos MRK-STI0037747 to STI0037751. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/WeinblattContract.pdf

13. Scolnick EM. Email communication to Deborah Shapiro, Alise Reicin, and Alan Nies re: Vigor. 9 Mar, 2000. Bates No MRK-ABH0016219. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Scolnick2000.pdf

14. Drazen JM. Hidden data counfounds medical journal editors. Wall Street Journal 2006. May 19:A11.

15. Cannon CP, Curtis SP, FitzGerald GA, Krum H, Kaur A, Bolognese JA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the multinational etoricoxib and diclofenac arthritis long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771-81. [PubMed]

16. Fries JF. Letter to Raymond Gilmartin re: physician intimidation. 9 Jan, 2001. Merck. Bates No MRK-ABH0002204 to MRK-ABH0002207. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Fries2001.pdf

17. Morrison BW. Email communication to Rhonda Sperling, Alise Reicin, Deborah Shapiro, et al. re: fw: for review [peer]: 2001-ms-2470 (full paper) - due date Monday, 27 August 2001. 17 Aug, 2001. Bates Nos MRK-ACF0005697 to MRK-ACF0005699. www.vioxxdocuments.com/Documents/Krumholz_Vioxx/Morrison2001.pdf

18. Meier B, Kolata G, Pollack A. Medicine fueled by marketing intensified trouble for pain pills. New York Times 2004. Dec 19:A1.

19. Meier B, Saul S. Marketing of Vioxx: how Merck played game of catch-up. New York Times 2005. Feb 11:A1.

20. Berenson A, Harris G, Meier B, Pollack A. Dangerous data—retracing a medical trail. New York Times 2004. Nov 14:A1.

21. IMS Health. National prescription audit plus time period 1999 to September 2004, extracted 2004. Plymouth Meeting, PA: IMS Health, 2004.

22. Targum SL. Review of cardiovascular safety database, rofecoxib. NDA 21-042, S-007. Washington, DC: FDA, 2001. www.fda.gov/ohrms/dockets/ac/01/briefing/3677b2_06_cardio.pdf

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